equipoise for sale

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Antiviral agent. Specifically inhibits influenza viruses A and B, coronavirus associated with severe acute respiratory syndrome (SARS).According to the mechanism of the antiviral action relates to fusion inhibitors (fusion), interacts with hemagglutinin of the virus and prevent fusion of the lipid envelope of the virus and cell membranes. It provides moderate immunomodulatory effects. Interferon has activity stimulates humoral and cellular immune responses, phagocytic function of macrophages, increases resistance to viral infections. It reduces the incidence of complications associated with viral infection and exacerbations of chronic bacterial diseases.
The therapeutic efficacy in viral infections manifested in reducing the severity of intoxication and clinical effects, reducing the duration of the disease, reducing the risk of complications.
It belongs to low-toxic drugs (LD50> 4 g / kg). It does not appear to have any adverse effects on the human body when administered orally in the recommended dosages.

Pharmacokinetics . Rapidly absorbed and distributed to organs and tissues. The maximum plasma concentration at admission in a dose of 50 mg is achieved in 1.2 hours, in a dose of 100 mg – 1.5 hours is metabolized in the liver.. The half-life is 17 – 21 hours, about 40% is excreted in unchanged form, mostly in the bile (38.9%) and traces of the kidneys (0.12%).. During the first day shows 90% of the administered dose.

Indications

Prevention and treatment in adults and children:
– influenza A and B, SARS, severe acute respiratory syndrome (SARS) (including complicated by bronchitis, pneumonia);
– secondary immunodeficiency states;
– complex therapy of chronic bronchitis, pneumonia, and recurrent herpetic infection.
Prevention of postoperative infectious complications and the normalization of immune status.
Combined therapy of acute intestinal infection rotavirus etiology in children older than 3 years.

Contraindications

Hypersensitivity to the drug, children under 3 years.

Dosing and Administration

Inside, before meals. Single dose: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg (2 tablets of 100 mg or 4 tablets of 50 mg).

For nonspecific prevention: – by direct contact with patients with influenza and other acute respiratory viral infection: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 1 time a day for 10 – 14 days – during epidemics of influenza and other acute respiratory viral infections, for the prevention of exacerbations of chronic bronchitis, recurrent herpetic infection: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 2 once a week for 3 weeks. – for the prevention of SARS (in contact with the patient): adults and children over 12 years prescribed 200 mg once a day for 12-14 days. – prevention of postoperative complications: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg for 2 days prior to surgery, and then for 2-5 days after surgery.

For the treatment of: – the flu and other acute respiratory viral infections without complications: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5 days – influenza and other acute respiratory viral infections with the development of complications (bronchitis, pneumonia, and OE): children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5 days, followed by a single dose of 1 times a week for 4 weeks. Severe acute respiratory syndrome (SARS): adults and children over 12 years – 200 mg 2 times a day for 8-10 days. in the complex treatment of chronic bronchitis, herpetic infection: children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5-7 . days, then a single dose of 2 times a week for 4 weeks Combined therapy of acute intestinal infection rotavirus etiology in children older than 3 years: from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years – 200 mg four times a day (every 6 hours) for 5 days.

Side effect

Rarely – allergic reactions.

Overdose

Not marked.

Interaction with other drugs

In the appointment of other drugs adverse effects were noted.

special instructions

It does not show the central neurotropic activity and can be used in medical practice as a preventive measure in healthy persons of various professions, including requiring attention and coordination of movements (transport drivers, operators, etc.).

release Form

Tablets, film-coated 50mg, 100mg.
10 tablets in blisters.
At 10, 20, 30 or 40 tablets bank polymer.
1, 2, 3 or 4 blisters or bank polymer 10, 20, 30 or 40 tablets, together with instructions for use in a stack of cardboard. how much to inject for weight loss

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equipoise for horses

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Pharmacological properties equipoise for horses ® – antimicrobial topical application helps to heal wounds (burns, trophic, purulent, etc.), provides effective protection from infection of wounds, reduce the time of treatment and the preparation of a wound to skin grafts, in many cases, leads to improvement state, eliminates the need for transplantation.
part of the cream sulfanilamide – sulfathiazole silver is bacteriostatic antimicrobial agent with broad antibacterial bacteriostatic action against Gram-positive and Gram-negative bacteria. The mechanism of antimicrobial action sulfathiazole -ugnetenie growth and reproduction of bacteria associated with a competitive antagonism with para-aminobenzoic acid and digidropteroatsintetazy suppression that leads to disruption of the synthesis of dihydrofolic acid and eventually its active metabolite – tetrahydrofolic acid required for the synthesis of purines and pyrimidines microbial cells. Present in the preparation of silver ions enhance antibacterial sulfanilamide – they inhibit the growth and division of bacteria by binding of deoxyribonucleic acid with microbial cells. In addition, the silver ions weaken the sensitizing properties of sulfanilamide.
Due to the minimal resorption of the drug it has no toxic effect.
Contained in the preparation of silver sulfathiazole, has little solubility, whereby after topical application concentration of the active substance in wound continuously maintained at the same level. Only a small amount of silver sulfathiazole appears in the bloodstream, and then subjected to acetylation in the liver.
The urine is in the form of active metabolites and partly in an unmodified form. Absorption of silver sulfathiazole increases after application to extensive wound surfaces.

Indications

  • Burns of varying degree, of any nature (thermal, solar, chemical, electric current, radiation, etc.); frostbite.
  • bedsores; leg sores of different genesis (including at chronic venous insufficiency, occlusive disease, blood circulation disorders in diabetes, erysipelas, etc.);
  • Festering wounds; small household injuries (cuts, abrasions);
  • Infected dermatitis, impetigo, a simple contact dermatitis, microbial eczema; streptostafilodermii.

Contraindications

  • Hypersensitivity to sulfathiazole and other sulfonamides.
  • Congenital deficiency of glucose-6-phosphate dehydrogenase.
  • Prematurity, infants under 2 months (the risk of “nuclear” jaundice).

Pregnancy and lactation
Application equipoise for horses ® during pregnancy and breast-feeding is permitted in cases where the surface of the burn does not exceed 20% of the body surface and the potential benefit to the mother to assess physician prevails over potential risk to the fetus and child.

Dosing and Administration
External -. Both open pit and under occlusive dressings
after cleansing and debridement of the wound is applied to the drug under sterile conditions and the thickness of 2-3 mm 2-3 times a day. The wound during treatment should be completely covered with cream. If part of the wound open, you must also put the cream. Imposition of occlusive dressings – is possible, but is not mandatory.
The cream is applied to the complete healing of wounds or until skin grafting. In the case of the drug exudate may appear on infected wounds. Before applying the cream should be washed wound 0.1% aqueous solution of chlorhexidine or other antiseptic.
The maximum daily dose – ’25
The maximum duration of treatment – 60 days.

Side effects
Allericheskie reactions, local reactions (burning, itching, redness of the skin). Prolonged use may leukopenia, deskvamatozny dermatitis.

Overdose
Cases of overdose are not logged in.

Interaction with other medicinal products
is not recommended to be used in conjunction with other topical medications. Folic acid and its structural analogs are able to weaken the antimicrobial action sulfathiazole.

Special instructions:
In hepatic and / or renal failure is necessary to control the concentration of serum sulfathiazole.
Caution should be exercised when used in patients in shock condition with extensive burns, due to the inability to collect full allergic history.

The effect on vehicles and machinery handling ability
drug does not limit the ability of the mind-body, the ability of road management and maintenance machinery in motion.

Product form
Cream for external use 2%.
In 15 g and 40 g in aluminum, inside lacquered lithographed tubes.
In 400 g in boxes made of polypropylene (for hospitals).
1 tube with instruction on use is placed in a cardboard box.
In 10 boxes polypropylene together with instructions for use on the number of boxes placed in a shipping carton (for hospitals). anabolic steroids online shop

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definition of equipoise

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Definition of equipoise is a highly non-steroidal aromatase inhibitor – an enzyme, whereby in postmenopausal women androstenedione in peripheral tissues is converted into estrone and then to estradiol. Reduced levels of circulating estradiol in breast cancer patients has a therapeutic effect. In postmenopausal women,  in a daily dose 1 mg of estradiol levels causes a decrease of 80%.  Does not have progestogenic, androgenic and estrogenic activity. At daily doses up to 10 mg had no effect on the secretion of aldosterone and cortisol, therefore when using the drug definition of equipoise not required substitution corticosteroids.

Effect on bone mineral density has been shown that in patients with gormonopozitivnym early breast cancer in postmenopausal women who are taking definition of equipoise , changes in bone can be prevented in accordance with the standards established for the treatment of patients with a certain risk of fractures. Thus, the advantage definition of equipoise in combination with bisphosphonates (compared to treatment only drug Arimidex ® ) in patients with moderate and high risk of fractures has been demonstrated after 12 months in terms of bone mineral density, structural changes in the bone tissue and markers of bone resorption. Moreover, in the low risk changes were noted index of bone mineral density with treatment with one drug definition of equipoise and supportive treatment with vitamin D and calcium.

Lipids
When therapy with definition of equipoise , including, when taken in combination with bisphosphonates, revealed no changes in plasma lipid levels.

Pharmacokinetics
Absorption definition of equipoise prompt, the maximum plasma concentration is reached within 2 hours after ingestion (fasting). Food slightly decreases the rate of absorption, but not its extent and does not result in a clinically significant effect on the equilibrium concentration of drug in plasma after a single reception of the daily dose of the drug Arimidex ® . After 7-day dosing is achieved approximately 90-95% of the equilibrium concentration in plasma definition of equipoise. Recorded definition of equipoise pharmacokinetic parameters depending on the time or dose not. The pharmacokinetics of definition of equipoise is independent of age in postmenopausal women.
The connection to plasma proteins -. 40%
of definition of equipoise is displayed slowly from the plasma elimination half-life is 40-50 hours. Extensively metabolized in postmenopausal women. Less than 10% of the dose is excreted in the urine unchanged within 72 hours after dosing.
The metabolism of definition of equipoise is carried out N-dealkylation, hydroxylation and glucuronidation. Metabolites are excreted primarily in the urine. Triazole, the major metabolite, determined in plasma, does not inhibit aromatase.
The clearance of definition of equipoise after oral intake in liver cirrhosis or renal dysfunction does not change.

testimony

 

  • Adjuvant treatment of postmenopausal breast cancer early gormonopolozhitelnogo.
  • Treatment of advanced breast cancer in postmenopausal women.
  • Adjuvant therapy gormonopolozhitelnogo early breast cancer in postmenopausal women after tamoxifen therapy for 2-3 years.Contraindications
  • Hypersensitivity to definition of equipoise or other components of the formulation
  • Pregnancy and lactation
  • In premenopausal women
  • Severe renal impairment (creatinine clearance less than 20 mL / min)
  • Moderate or severe hepatic impairment (safety and efficacy not established)
  • Concomitant therapy with tamoxifen or medicines that contain estrogen
  • Children’s age (safety and efficacy in children has not been established)Precautions: osteoporosis, hypercholesterolemia, coronary heart disease, liver dysfunction, lactase deficiency, glucose-galactose malabsorption,Dosing and Administration
    Inside. Swallow the tablet whole with water. It is recommended to take the drug at the same time. Adults, including the elderly: 1 mg orally 1 time a day for a long time. If signs of progression of the drug disease should be discontinued. In the adjuvant treatment of the recommended duration of treatment – 5 years. Impaired renal function: No dosage adjustment in patients with mild to moderate renal impairment is not required Violations of liver function: No dosage adjustment in patients with mild disorders liver function is not required.Side effects:
    The incidence was calculated from the number of adverse events observed in the phase III study in 9366 postmenopausal women with operable breast cancer treated for 5 years, with the incidence of adverse events in the control groups and the opinion of the investigator regarding the relationship of undesirable effects on study medication is not taken into account.
    Determination of the frequency of adverse reactions: very often (greater than or equal to 10%); often (from 1 to less than 10%); infrequently (less than 0.1 to 1%); rare (0.01 to less than 0.1%), very rarely (less than 0.01%)From the circulatory system:
    very often – tides. On the part of the musculoskeletal system: very often – arthralgia / joint stiffness, arthritis often – bone pain infrequently – trigger finger. Reproductive system: often – dry vaginal mucosa;vaginal bleeding (mainly in the first weeks after the cancellation or change of previous hormonal therapy Arimidex ® ). Skin and skin appendages: very often – skin rash, often – thinning hair (alopecia), allergic reactions, rarely – urticaria, rarely – erythema multiforme, anaphylactoid reactions, cutaneous vasculitis (including isolated cases of purpura (Henoch-Henoch syndrome)), very rarely – Stevens-Johnson syndrome, angioedema. On the part of the digestive system: very often – nausea, often – diarrhea, vomiting. On the part of the hepatobiliary system: often – increasing the activity of alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, rarely – increased activity of gamma glutamyltransferase and concentrations of bilirubin, hepatitis. From the nervous system: very often – headache; often – drowsiness, carpal tunnel syndrome ( mainly observed in patients with risk factors for this disease). On the part of metabolism: often – anorexia, hypercholesterolemia. The drug can cause a reduction in bone mineral density due to snizheniemkontsentratsii circulating estradiol, thereby increasing the risk of osteoporosis and bone fractures. Other: very often.

    Overdose
    describe individual clinical cases of accidental overdose. A single dose of the drug Arimidex ® , which could lead to the symptoms, life-threatening, has not been established.
    The specific antidote does not exist in the case of overdose, treatment should be symptomatic. It is possible to induce vomiting if the patient is conscious. Dialysis can be performed. Recommended general supportive therapy, monitoring patients and control the function of vital organs and systems.

    Interaction with other medicinal products and other forms of drug interaction
    studies for drug interactions with phenazone (antipyrine) and cimetidine indicate that the combined use of the drug Arimidex ® with other drugs are unlikely to bring a clinically significant drug interactions mediated by cytochrome P450.
    Clinically significant drug interaction while taking the drug Arimidex ® in conjunction with other commonly prescribed drugs available.
    at the moment, there are no data on the use of Arimidex drug ® in combination with other anticancer drugs.
    the drugs containing estrogen, reduces the pharmacological effect of Arimidex drug ® , and therefore, they are not shall be appointed at the same time with the drug Arimidex ® .
    it should appoint a drug tamoxifen concurrently with Arimidex ® , as it may weaken the pharmacological action of the latter.

    Special instructions:
    The safety and efficacy in children has not been established.
    Women with retseptorootritsatelnoy tumor estrogen efficacy of Arimidex drug ® has not been demonstrated, except in cases where there was a previous positive clinical response to tamoxifen.
    In case of doubt in the hormonal status of the patient menopause must be confirmed by the definition of sex hormones in the blood serum.
    There are no data on the use of Arimidex drug ® in patients with moderate or severe hepatic impairment and in patients with severe renal insufficiency (creatinine clearance less than 20 ml / min).
    in the case of persistent uterine bleeding in patients receiving Arimidex drug ® needed consultation and supervision of the gynecologist.
    preparations containing estrogens should not be administered concurrently with the drug Arimidex ® , since these drugs will neutralize its pharmacological effect.
    By reducing the level of circulating estradiol, Arimidex ® can cause a reduction in bone mineral density with a consequent increase in fracture risk.
    Patients with such a high risk should be treated according to the Instructions on the treatment of data of complications.
    In patients with osteoporosis or with risk of osteoporosis, bone mineral density should be assessed by densitometry eg, DEXA scan (Dual-Energy X-ray absorptiometry – dual-energy X-ray absorptiometry) at the beginning of the treatment and in dynamics. If necessary, must be initiated to treat or prevent osteoporosis, under the close supervision of a physician.
    No data on the concomitant use of definition of equipoise and drug-analogues LHRH.
    Unknown improves whether definition of equipoise treatment results when used in conjunction with chemotherapy.
    The data on the safety of long-term treatment with definition of equipoise are not yet available.
    in applying the drug Arimidex ® more than tamoxifen observed ischemic disease, but the statistical significance is not observed.
    The efficacy and safety Arimidex drug ® and tamoxifen for their simultaneous use, regardless of hormone receptor status are comparable to those using a single tamoxifen. The exact mechanism for this phenomenon is not yet known.

    Effects on ability to drive and other machines
    Some side effects of the drug Arimidex ® , such as fatigue and drowsiness, may adversely affect the ability to perform potentially hazardous activities that require high concentration and speed of psychomotor reactions. In this connection, it is recommended with the appearance of these symptoms to be careful in the management of vehicles and mechanisms.

    Product form

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equipoise only cycle

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The mechanism equipoise only cycle of action of equipoise only cycle Fondaparinux is a synthetic and selective inhibitor of activated factor . The antithrombotic activity of fondaparinux equipoise only cycle is the result of selective inhibition of Factor Xa, mediated by antithrombin . By selectively binding to AT III, fondaparinux equipoise only cycle potentiates cypionate for sale equipoise only cyclethe ability of the original AT III neutralize factor Xa. The neutralization of factor Xa interrupts the coagulation cascade and inhibits both thrombin formation and thrombus formation. Fondaparinux equipoise only cycle does not inactivate thrombin (activated factor Pa) and has no effect on platelets. Pharmacodynamics / pharmacokinetics of fondaparinux equipoise only cycle is determined by its concentration in the plasma, expressed in terms of anti-Xa-factor activity. To assess the calibration anti-Xa activity can be used only fondaparinux equipoise only cycle, it is not suitable for an international standard of heparin or low molecular weight heparins. This calibration is an expression of fondaparinux equipoise only cycle concentration in mg of fondaparinux calibration / liter.

Absorption
After subcutaneous administration of equipoise only cycle fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%). Following single subcutaneous administration of 2.5 mg fondaparinux equipoise only cycle young healthy volunteers maximum 4-chlorodehydromethyltestosterone plasma concentration (mean C max = 0.34 mg / L) was reached after 2 hours after dosing. Concentration in blood plasma constituting the above half the maximum concentration achieved within 25 minutes after administration.
In healthy elderly pharmacokinetics of fondaparinux equipoise only cycle is linear over a dose range 2.8 mg subcutaneously. With a single administration per day equilibrium concentration in plasma is reached after 3-4 days at a magnification of 1.3 times the values of C max and area under the curve “concentration-time» (AUC).
The mean pharmacokinetic parameters of fondaparinux equipoise only cycle in balance in patients undergoing substitutional hip surgery and drug treated “Arikstra” subcutaneously at a dose of 2.5 mg per day were C max– 0.39 mg / l (31%), t max – 2.8 hour (18%) and C min – 0.14 mg / l (56%). In elderly patients undergoing surgery for hip fracture, the equilibrium concentration of fondaparinux equipoise only cycle were: C max – 0.50 mg / l (32%), C min – 0.19 mg / l (58%).
In patients with symptoms of deep vein thrombosis and pulmonary embolism, treated with fondaparinux equipoise only cycle 5 mg (with a body weight less than 50 kg), 7.5 mg (with a body weight of 50 to 100 kg) and 10 mg (at a body weight of 100 kg) subcutaneously 1 once a day; Similar values were recorded the maximum and minimum equilibrium concentrations in plasma when selecting doses according to body weight in all categories. Maximum equilibrium concentration of the drug in plasma ranged from 1.20 mg / l to 1.26 mg / l. Average minimum equilibrium concentrations in the plasma of these patients ranged from 0.46 mg / l to 0.62 mg / l. Distribution In healthy volunteers fondaparinux equipoise only cycle by intravenous or subcutaneous administration, mainly distributed in the blood, and only to a small extent in the intercellular liquid, since the apparent volume of distribution at equilibrium and unstable state is 7-11 l. In vitro fondaparinux equipoise only cycle in high (not less than 94%) and specifically binds to antithrombin III (AT III). Binding of equipoise only cycle fondaparinux with other plasma proteins, including platelet factor IV of, or red blood cells is negligible. Metabolism In vivo metabolism of fondaparinux equipoise only cycle has not been studied, since most of the administered dose of the drug is excreted unchanged in the urine in patients with normal renal function. Elimination fondaparinux equipoise only cycle excreted by the kidneys unchanged. In healthy individuals 64 – 77% of a single dose of the drug administered subcutaneously or intravenously is excreted in urine within 72 hours. The half-life (T1 / 2) is about 17 hours in healthy young people, and about 21 hours – in elderly healthy subjects. In patients with normal renal function, the mean value of the clearance of fondaparinux equipoise only cycle was 7.82 ml / min.

Special groups of patients Patients with impaired kidney excretion of equipoise only cycle fondaparinux is slower in patients with renal insufficiency, since it is mainly excreted by the kidneys unchanged. In patients receiving prophylactic treatment after surgery for hip fracture or hip replacement, total clearance of fondaparinux equipoise only cycle 25% lower than with mild renal impairment (creatinine clearance of 50-80 ml / min), 40% below in patients with moderate renal impairment (creatinine clearance of 30-50 ml / min) and 55% lower in patients with severe renal impairment (creatinine clearance less than 30 mL / min) compared to patients with normal renal function. Appropriate final half-life of 29 hours in moderate and 72 h in severe forms of kidney failure. A similar relationship between the clearance of fondaparinux equipoise only cycle and the degree of severity of renal failure was observed in patients with deep vein thrombosis. Prevention of venous thromboembolic complications in the pharmacokinetic model used data on patients with a creatinine clearance of less than 23.5 ml / min, underwent surgery on the lower limbs and treated with fondaparinux equipoise only cycle. As a result of pharmacokinetic modeling, it was shown that the use of fondaparinux equipoise only cycle in patients with a creatinine clearance of 20 to 30 ml / min at a dose of 1.5 mg per day or 2.5 mg every other day corresponds to that in patients with mild to moderate severity of dysfunction renal (creatinine clearance 30-80 ml / min) receiving 2.5 mg per day. Due to the limitations of the currently available data, the drug “ARIXTRA” should not be used in patients with severe renal impairment. patients with hepatic impairment is believed that the concentration of free fondaparinux equipoise only cycle in plasma does not change with mild to moderate liver dysfunction, so on the basis of pharmacokinetics in the dose adjustment is not necessary. After a single subcutaneous injection of fondaparinux equipoise only cycle in patients with impaired liver function moderate (functional class in the classification of Child-Pugh), C max and AUC were down 22-39% compared with patients with normal liver function. Reduction of fondaparinux equipoise only cycle concentration in the plasma is attributable to reduced binding to antithrombin III due to reduced levels of this enzyme in the plasma of patients with impaired liver function, thereby increasing the excretion of equipoise only cycle by the kidneys fondaparinux. The pharmacokinetics of fondaparinux equipoise only cycle with severe hepatic impairment has not been studied. Children: Pharmacokinetic parameters of fondaparinux were described in the pharmacokinetic analysis based on blood sampling data from 24 children. Appointment once daily 0.1 mg / kg subcutaneously in children is based on a similar exposure of fondaparinux observed in adults when administered the recommended doses for the treatment of deep vein thrombosis and pulmonary embolism. Patients older Elimination of fondaparinux equipoise only cycle in patients over the age of 75 years slows. In a study of fondaparinux equipoise only cycle when administered at a dose of 2.5 mg as a prophylactic measure after surgery for hip fracture or hip replacement, total clearance of fondaparinux equipoise only cycle was about 25% less in patients over the age of 75 years compared to patients under the age of 65 years. A similar relationship between the clearance of fondaparinux equipoise only cycle and age was observed in patients with deep vein thrombosis. Sex When dose adjustment for body weight there was no difference between the sexes. Race Scheduled research pharmacokinetic differences have been conducted. However, tests carried out with the participation of healthy individuals of Asian origin (Japan) found no difference in the pharmacokinetic profile as compared with that in healthy individuals Caucasians. Similarly, no differences were observed in the clearance of fondaparinux equipoise only cycle patients between Caucasoid and Negroid races, which have borne orthopedic surgery. Body weight Patients with body weight below 50 kg total clearance of fondaparinux equipoise only cycle was reduced by approximately 30%.

testimony

 

  • Prevention of venous thromboembolic events in patients undergoing a “great” orthopedic surgery of the lower limbs, such as when:
    • hip fracture, including extended prophylaxis in the postoperative period;
    • replacement surgery of the knee joint;
    • of a hip replacement.
  • Prevention of venous thromboembolic events in patients undergoing abdominal surgery, the presence of risk factors for thromboembolic complications.
  • Prevention of venous thromboembolic events in patients with non-surgical profile of risk factors for these complications due to restricted mobility during the acute phase of the disease.
  • Treatment of deep vein thrombosis.
  • Treatment of pulmonary thromboembolism except hemodynamically unstable patients or patients who are in need of thrombolytic therapy or embolectomy.
  • Treatment of acute coronary syndrome, expressed as:
    • unstable angina or myocardial infarction without ST-segment elevation in patients who are not candidates emergency (within <120 mins) invasive treatment (percutaneous coronary revascularization), for the prevention of cardiovascular death, myocardial infarction, or refractory ischemia;
    • myocardial infarction with ST segment elevation in order to prevent death, reinfarction in patients receiving thrombolytic therapy or patients who initially received reperfusion therapy.
  • Treatment of acute symptomatic thrombosis of superficial veins of the lower limbs without concomitant deep-vein thrombosis.

Contraindications:

Hypersensitivity to fondaparinux equipoise only cycle or any other component of the drug.
The active clinically significant bleeding.
Acute bacterial endocarditis.
Severe renal impairment (creatinine clearance <20ml / min).

Carefully

We do not recommend the use of fondaparinux equipoise only cycle immediately prior to and during primary percutaneous coronary intervention (CHKB) in patients with myocardial infarction with ST-segment elevation.
Monotherapy fondaparinux equipoise only cycle is not recommended in patients with myocardial infarction without ST-segment elevation and ST-segment elevation at not primary CHKB; should evaluate the possibility of the combined purpose of unfractionated heparin. The available clinical data on the combined use of equipoise only cycle fondaparinux and unfractionated heparin during primary CHKB not limited. The product “Arixtra”, like other anticoagulants, should be used with caution in patients with increased risk of bleeding, ie, in such pathologies as congenital or acquired disorders of blood coagulation system in the form of bleeding, peptic ulcer and 12 duodenal ulcer in the acute stage and recently transferred intracranial hemorrhage, severe liver function, as well as soon after surgery on the brain or spine, or . ophthalmologic operations
For groups at high risk of bleeding against the use of anticoagulants include patients older than 75 years, patients weighing less than 50 kg, patients with moderate renal impairment (creatinine clearance less than 50 mL / min). In the appointment of “Arixtra” drug to patients referred to the risk, it is recommended to be careful.
In the treatment of unstable angina or myocardial infarction without ST segment elevation and myocardial infarction with ST-segment elevation Caution should be exercised with concomitant use of fondaparinux equipoise only cycle with other drugs that increase the risk bleeding (for example, inhibitors of GPIIb / IIIa or thrombolytics).

Pregnancy and lactation

Cumulative to date data on the use “Arixtra” of the drug in pregnant women are insufficient, and the drug “ARIXTRA” should not be given to pregnant women except in cases where the expected benefit outweighs the potential risk to the fetus. During the period of preparation “ARIXTRA” breastfeeding is not recommended.

Dosing and Administration

Mostly subcutaneous administration should be alternately left and right anterolateral surface of the anterior abdominal wall. To avoid the loss of the drug should not be prior to injection remove any air bubbles from the syringe. The needle should be introduced to the entire length perpendicular to the fold of skin, which is gripped between the thumb and forefinger; fold of skin is not is expanded throughout the administration.
The drug Arixtra is intended for use only under medical supervision. The patient is allowed to independently carry out subcutaneous injection only if the doctor considers it necessary, with a mandatory follow-up at the doctor and only after proper training techniques of subcutaneous injection. Intravenous administration (first dose only in patients with myocardial infarction with ST-segment elevation) drug Arixtra is found or directly into the catheter using the mini-containers with 0.9% equipoise only cycle chloride solution (25 ml or 50), wherein the pre-formulation is diluted. When using the drug Arixtra syringes in order to avoid the loss of the drug should not be prior to injection remove any air bubbles from the syringe. After injection of a sufficient amount catheter rinse solution of 0.9% to ensure delivery of the full dose of the drug.When administered using infusion mini-containers must be carried out within 1-2 minutes.

Adults

 

Prevention of venous thromboembolic complications Orthopedic and abdominal surgery The recommended dose of Arixtra is 2.5 mg of drug subcutaneously with 1 time a day after the operation. The initial dose is administered no earlier than six hours after the operation, provided a wealthy hemostasis. The course of treatment should last for a period of increased risk for venous thromboembolic complications, usually to transfer the patient to outpatient treatment, at least 5-9 days. Experience shows that in patients undergoing surgery for hip fracture, the duration of the period of increased risk for venous thromboembolic complications than 9 days after surgery. For such patients should be decided to extend the use of prophylactic drug Arixtra to 24 days. Patients with non-surgical profile presence of thromboembolic complications risk factors The recommended dose of the drug Arixtra is 2.5 mg subcutaneously once daily 1. The duration of treatment in this case ranges from 6 to 14 days. Thrombosis Treatment of deep vein thrombosis and pulmonary embolism recommended dose Arikstra preparation by subcutaneous injection one time per day is as follows: 5 mg for patients weighing less than 50 kg; 7.5 mg for patients with a body weight of 50-100 kg . 10 mg for patients weighing more than 100 kg Treatment should continue for at least 5 days and discontinued no earlier than would be possible on a full translation of adequate therapy with oral anticoagulants, ie when the values of international normalized ratio (MHO) from 2 to Z. Add to therapy with vitamin K antagonists are needed as soon as possible, usually within 72 hours. Usually duration of drug Arixtra is 5 to 9 days. Treatment of unstable angina or myocardial infarction without ST-segment elevation The recommended dose of the drug Arixtra is 2.5 mg subcutaneously once daily 1. Treatment should begin as soon as possible after diagnosis and continued for 8 days or until the patient’s discharge from the hospital, if it occurred earlier than 8 days. If the patient is supposed to conduct CHKB on the background of treatment with Arixtra, during CHKB be administered unfractionated heparin (UFH), according to standard practice in this hospital; thus it is necessary to consider the risk of bleeding, which is present in the patient, and that this risk level affects, including, and the time elapsed since the last dose Arikstra drug. Time resuming administration Arikstra after removal of the catheter should be determined on based on the clinical condition of the patient. In clinical studies, treatment with ARIXTRA resumed no earlier than 2 hours after catheter removal.In patients undergoing coronary artery bypass grafting (CABG), if possible, Arixtra drug is not administered within 24 hours before surgery. Introduction ARIXTRA drug may be resumed 48 hours after CABG.Treatment of myocardial infarction with ST-segment elevation recommended dose of the drug Arixtra is 2.5 mg 1 time per day. The first dose is injected, subsequent doses are administered subcutaneously. Treatment should begin as soon as possible after diagnosis and continued for 8 days or until the patient’s discharge from the hospital, if it occurred earlier than 8 days. If the patient is not supposed to conduct primary CHKB on the background of treatment with Arixtra, during CHKB UFH should be administered according to standard practice in this hospital; thus it is necessary to consider the risk of bleeding, which is available in a patient, and that this risk level affects, including, and the time elapsed since the last dose of drug. resuming administration Arikstra after catheter removal time should be determined on the basis of the clinical condition of the patient. In clinical studies, treatment with ARIXTRA resumed no earlier than 3 hours after catheter removal. In patients undergoing bypass surgery when possible Arikstra drug is not administered within 24 hours before surgery. The introduction of the drug may be restarted 48 hours after CABG. The treatment of thrombosis of superficial veinsrecommended dose of Arixtra is 2.5 mg of drug subcutaneously 1 time per day. Indications for use of the drug Arixtra 2.5 mg is an acute, symptomatic, isolated, spontaneous superficial vein thrombosis of the lower limbs, in which the extent of the affected area is not less than 5 cm, and the corresponding loss was documented on the basis of the results of ultrasound or other objective methods . Treatment should begin as soon as possible after diagnosis and after exclusion of concomitant DVT or superficial veins thrombosis length of not more than 3 cm from the anastomosis saphenofemoral. Patients with high risk for thromboembolic complications duration of treatment should be at least 30 and not more than 45 days. The patient is allowed to independently carry out subcutaneous injection only if the doctor considers it necessary, with a mandatory follow-up at the doctor and only after proper training techniques of subcutaneous injection.

atients requiring surgery or other invasive procedures.

  • Patients with thrombosis of the superficial veins requiring surgery or other invasive procedures, if possible, should not receive fondaparinux for at least 24 hours prior to surgery.
    Use of fondaparinux can at least resume after 6 hours after reconstitution hemostasis.

Special patient groups

Children
Use of the drug Arixtra is not recommended in children under the age of 17 years due to lack of efficacy and safety data. Elderly patients (over 75 years) drug Arixtra should be used with cautious in elderly patients, ie. In. With age is reduced renal function. In elderly patients undergoing surgery, you must strictly comply with the time the first dose of ARIXTRA drug. Patients with low body weight Prevention of venous thromboembolism and treatment of unstable angina or myocardial infarction with or without ST-segment elevation in patients weighing less than 50 kg have an increased risk bleeding. Speed excretion fondaparinux decreases with decreasing body weight. The drug Arixtra should be used with cautious in this group of patients. Thrombosis Treatment of superficial veins efficacy and safety of ARIXTRA drug in patients weighing less than 50 kg have not been studied, therefore its use in these patients is not recommended. Patients with impaired renal function Prophylaxis of venous thromboembolism Not ARIXTRA should be prescribed to patients with creatinine clearance less than 20 ml / min. If creatinine clearance is from 20 to 50 ml / min, the dose should be reduced to 1.5 mg once a day. In mild renal impairment (creatinine clearance greater than 50 mL / min) a dose reduction is needed. Treatment of unstable angina or myocardial infarction with or without ST segment elevation Use of the drug Arixtra is not recommended for use in patients with creatinine clearance less than 20 ml / min. No dose adjustment is required in patients with creatinine clearance 20 mL / min. The treatment of thrombosis of superficial veins should not be prescribed the drug Arixtra in patients with creatinine clearance less than 20 ml / min. If creatinine clearance is from 20 to 50 ml / min, the dose should be reduced to 1.5 mg once a day. In mild renal impairment (creatinine clearance greater than 50 mL / min) a dose reduction is required. The safety and efficacy of this drug in a dose of 1.5 mg have not been studied. Patients with hepatic impairment Prevention of venous thromboembolism and treatment of unstable angina or myocardial infarction with or without ST-segment elevation for patients with impaired mild to moderate liver function severity of the correction dose ARIXTRA is not required. Patients with severe hepatic insufficiency drug Arixtra should be used with caution, since the use of this drug in this patient group has not been studied. The treatment of thrombosis of superficial veins efficacy and safety of the drug Arixtra in patients with severe hepatic impairment have not been studied, so the use of the drug in this group of patients is not recommended.

Side effect

Adverse reactions shown below are listed in accordance with a lesion of organs and organ systems, and frequency of occurrence. The frequency is defined as follows: very common (≥1 / 10), commonly (≥1 / 100 and <1/10), uncommon (≥1 / 1000 and <1/100), rare (≥1 / 10,000 and . <1/1 000), very rare (<1/10 000)
These adverse events should be considered in surgical and therapeutic context, depending on the evidence. Infectious and parasitic diseases rare: infection of surgical wounds. Violations of the blood and lymphatic system often anemia, bleeding (various sites, including rare cases of intracranial and / or intracerebral and retroperitoneal hemorrhage and / or bleedings), purpura. Uncommon: thrombocytopenia, thrombocythemia, platelet abnormality, coagulation disorders. violations by the immune system rare: allergic reactions (including . very rare reports of angioedema, anaphylactoid and / or anaphylactic reactions) Violations of the metabolism and nutrition rare: hypokalaemia. Disorders of the nervous system Uncommon: headache. rare: anxiety, confusion, dizziness, spatial disorientation, drowsiness.Violations by vessels rare:. hypotension Disorders of the respiratory system, thorax and mediastinum rare: shortness of breath, cough. Violations of the gastrointestinal tract Uncommon: nausea, vomiting.rare: abdominal pain, dyspepsia, gastritis, constipation , diarrhea. Violations of the liver and biliary tract Uncommon: abnormal results of liver function tests, increased concentration of liver enzymes in the blood. rare: increased bilirubin concentration in the blood. Violations of the skin and subcutaneous tissue disorders Uncommon: rash, itching, discharge from the wound. General disorders and at the injection site Common: edema. Uncommon: fever, peripheral edema. rare: reaction at injection site, chest pain, pain in the lower extremities, fatigue, flushing of the face (flushing), syncope, genital edema.

Interaction with other drugs

Fondaparinux equipoise only cycle does not inhibit cytochrome P450 isozymes group (CYP1A2, CYP2A6, CYP2C9, CYP2C19 , CYP2D6, CYP2E1 , or CYP3A4) in vitro. Consequently, one should not expect drug interactions “Arikstra» in vivo with other drugs to suppress the level of metabolism mediated CYP system. Since fondaparinux equipoise only cycle binding to plasma proteins, except ATSH slightly, should not be expected interactions with other drugs at the level of competitive binding to plasma proteins. In clinical studies, fondaparinux equipoise only cycle has been shown that its co-administration with oral anticoagulants (warfarin), antiplatelet agents (acetylsalicylic acid), NSAIDs (piroxicam) and cardiac glycosides (digoxin), does not affect the pharmacokinetics or pharmacodynamics of fondaparinux equipoise only cycle. Fondaparinux equipoise only cycle does not affect the activity of warfarin, nor the bleeding time during treatment with acetylsalicylic acid or piroxicam, or on the pharmacokinetics and pharmacodynamics of digoxin at steady state.
In the absence of compatibility “ARIXTRA” solution of the drug data should not be mixed with other drugs .

Overdose

Symptoms
Doses “ARIXTRA is” in excess of the recommended can lead to increased risk of bleeding. Treatment of overdose complicated by bleeding, should lead to “ARIXTRA” elimination of the drug and to seek a primary cause. It is necessary to decide on the choice of method to start appropriate treatment, which may include surgical hemostasis, supplementation of blood loss, transfusion of fresh frozen plasma, plasmapheresis.

special instructions

 

The drug Arixtra is intended for subcutaneous and intravenous use. Do not administer intramuscularly! Bleeding Fondaparinux should be used with caution in patients at increased risk of bleeding due to inherited or acquired bleeding disorders (eg platelet count less than 50,000 / mm³), diseases of the gastrointestinal tract ulcerations in the active phase, recent myocardial intracranial hemorrhage or surgery on the brain, spinal cord or of the organs, as well as in specific groups of patients, as described below. It should not be used concurrently with fondaparinux for the prevention of venous thromboembolic events drugs, under the influence of which increases the risk of bleeding. Such drugs include dezirudin, fibrinolytic agents, receptor antagonists of glycoprotein IIb / IIIa of platelets, heparin, low molecular weight heparin or heparinoids. Can be carried out concomitant therapy with vitamin K antagonist, if necessary Other antiplatelet drugs (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. In case of emergency in the concomitant use of these drugs require careful monitoring of the patient. CHKB and the risk of blood clots in the guiding catheter is not recommended the use of fondaparinux immediately prior to and during the primary CHKB in patients with myocardial infarction with ST-segment elevation. Similarly, in patients with unstable angina or myocardial infarction without ST-segment elevation in life threatening situations, causing the need for urgent revascularization is not recommended fondaparinux CHKB before and during it. These are patients with refractory or recurrent angina associated with dynamic deviation of segment ST, heart failure, life threatening arrhythmias or haemodynamic instability. Monotherapy fondaparinux is not recommended in patients with unstable angina or myocardial infarction without ST-segment elevation and myocardial infarction with ST-segment elevation during the primary CHKB not due to an increased risk of blood clots in the guiding catheter. Therefore, in accordance with standard practice, the treatment should assess the possibility of combined purpose UFH. Thrombosis of the superficial veins should exclude concomitant deep vein thrombosis or thrombosis of superficial veins, where the lesion is localized for no more than 3 cm from the saphenofemoral anastomosis, as the use of Arixtra drug at a dose of 2 5 mg has not been studied in the presence of the above diagnoses. Efficacy and safety of fondaparinux 2.5 mg been studied in the following groups of patients: patients with thrombosis of the superficial veins after sclerotherapy or intravenous vein complications in patients with thrombosis of the superficial veins in a history of the previous 3 months, patients with a history of thromboembolic complications in previous 6 months, or patients with active malignant tumor. spinal / epidural anesthesia when using Arixtra drug concurrently with the spinal / epidural anesthesia or lumbar puncture, during the “big” orthopedic surgery can not exclude the possibility of epidural or spinal hematoma, which can result in long-term or permanent paralysis. The risk of these rare events may be increased with the use of permanent postoperative epidural catheters or simultaneous administration of other drugs that affect hemostasis. Elderly patients Elderly patients are more at risk of bleeding than the rest of the population.As kidney function generally decreases with age, in elderly patients fondaparinux excretion can be reduced, and thus, the exposure is increased. The drug Arixtra in elderly patients should be used with caution. Low body weight

Prevention of venous thromboembolic complications and treatment of unstable angina or myocardial infarction with or without ST-segment elevation

  • in patients weighing less than 50 kg are at increased risk of bleeding. The elimination rate of fondaparinux decreases with decreasing body weight. The drug Arixtra should be used with cautious in this group of patients.
  • Treatment of venous thrombosis surface
    no sufficient clinical data for use fondaparinux patients weighing less than 50 kg, so its use in such patients is not recommended.

Renal impairment
Fondaparinux is mainly excreted by the kidneys.

  • Prevention of venous thromboembolic events
    in patients with creatinine clearance less than 50 mL / min, increases the risk of bleeding and venous thromboembolic complications, therefore fondaparinux should be used with caution. There is insufficient clinical data on the use of fondaparinux in patients with creatinine clearance less than 30 ml / min.
  • Treatment of unstable angina or myocardial infarction with or without ST segment elevation
    There is limited clinical data on the use of fondaparinux in patients with unstable angina or myocardial infarction without ST segment elevation and myocardial infarction with ST segment elevation, and creatinine clearance in the range of 20-30 ml / min, therefore, the possibility of such patients is estimated in terms of the ratio of expected benefits to the possible risk.
  • Superficial vein thrombosis Treatment
    Fondaparinux is not recommended in patients with creatinine clearance less than 20 ml / min. In patients with a creatinine clearance in the range of 20-50 ml / min the dose should be reduced to 1.5 mg once a day. Efficacy and safety of a dose of 1.5 mg have not been studied.

Severe hepatic dysfunction

  • Prevention of venous thromboembolic complications and treatment of unstable angina or myocardial infarction with or without ST-segment elevation
    dose adjustment when used in this group of patients is not required. However, due to shortage of coagulation factors in patients with severe liver disease increases the risk of bleeding, so use the drug Arixtra in these patients with caution.

Treatment of thrombosis of superficial veins
do not have sufficient data on the use of fondaparinux in this group of patients. Therefore its use in this patient group is not recommended. Geparinindutsirovannaya thrombocytopenia drug Arixtra should be used with caution in patients with a history of thrombocytopenia geparinindutsirovannoy. So far not conducted special clinical studies on the efficacy and safety of the drug Arixtra in patients with geparinindutsirovannoy thrombocytopenia type II. Rare reports have been received of thrombocytopenia geparinindutsirovannoy development in patients treated with fondaparinux. Fondaparinux does not bind to the 4th platelet factor and has perekresnyh serum reactions in patients with geparinindutsirovannoy thrombocytopenia type II was no significant relationship between the use of the drug and the development geparinindutsirovannoy thrombocytopenia has been established. Latex allergy Base finished graduated syringe needle may contain dry natural latex, which potentially can cause allergic reactions in individuals with hypersensitivity to latex.

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equipoise vs deca

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The mechanism of action equipoise vs deca is a human monoclonal antibody (isotype IgGl), specifically binds to an epitope that includes both small and large molecules extracellular loop.  Molecule is a transmembrane phosphoprotein that is expressed on B lymphocytes, starting from pre-B cells to mature B cells, as well as on the cells of B-cell tumors. B-cell tumors include chronic lymphocytic leukemia  and non-Hodgkin’s lymphoma. Upon binding to the antibody molecule CD20 remains on the cell membrane is equipoise vs deca not removed from the surface (shedding) and enters into the cell (internalization). Binding equipoise vs decaa with located near membrane specific epitope  is binding and complement activation on the cell surface, leading to developing complement-dependent cytotoxic reactions and lysis of the tumor cells. It has been shown that the expressed equipoise vs deca causes cell lysis, accompanied by high levels of expression of protective proteins of the complement. Furthermore, the binding equipoise vs decaa cause cell death by a mechanism and antibody-dependent cellular cytotoxicity. It was also shown that equipoise vs deca causes cell lysis with both high and low expression equipoise vs deca, as well as cells resistant to rituximab. Pharmacodynamic properties of patients with hematological neoplastic diseases content of B cells in the blood decreased after the first injection equipoise vs decaa. In patients with refractory CLL equipoise vs deca average reduction of B cells in the blood after the first injection was 23%, and after the introduction of the eighth – 92%. In most patients, blood B cells remained low throughout the course of treatment and then gradually increased (however, 3 months after the end of treatment equipoise vs decaom average grade of B cells was 68% lower than their concentration before treatment). ImmunogennostProtein drugs such equipoise vs decau may elicit an immune response, but the formation of antibodies against equipoise vs decaa may be less intense than usual as equipoise vs deca is, firstly, a human antibody, and secondly, it causes the death of B cells. The main clinical study of antibodies to equipoise vs decau been identified; moreover, equipoise vs decaa  concentration in blood were very low, making the detection of such antibodies is unlikely.

Pharmacokinetics Absorption The maximum concentration in serum equipoise vs decaa usually observed at the end of the introduction or immediately after it. Data on the pharmacokinetics were obtained from 146 patients with CLL resistant to prior therapy. The geometric mean for C max (maximum plasma concentration) after the first injection (300 mg) was 63 pg / ml after eight weekly administration (the 7th administration of 2000 mg) geometric mean for C max is equal to 1482 g / ml, and geometric mean for AUQ Reputation (0-∞) (area under the curve “concentration-time”) amounted to 674.463 micrograms-hour / mL; after the introduction of the twelfth (fourth monthly administration at a dose of 2,000 mg), the geometric mean for the C max is equal to 881 mg / ml, and the geometric mean of the AUC (0-∞) was 265.707 g-h / ml. Distribution The volume of distribution is small equipoise vs decaa. The mean value of the volume of distribution at steady state (OASIS), depending on the dose and numbers of administration in different studies ranged from 1.7 to 5.1 liters. Metabolism equipoise vs deca – a protein for which the normal metabolic pathway consists in breaking down into peptides by proteolytic enzymes and individual amino acids.Therefore it is not generally accepted research conducted drug biotransformation. Excretion equipoise vs deca removed from the body in two ways: non-target, and all the other IgG molecules, and due to the interaction with the target, namely, binding to B cells. Already after the first injection equipoise vs decaa a rapid and sustained reduction in the number of the CD20 + B cells, so the further administration of the drug, he will have to communicate with a much smaller number of the CD20 + cells. As a result, the subsequent introductions equipoise vs decaa its clearance value (CL) will be lower and the value of half-life (t1 / 2) – much higher than in the first administered; after repeated weekly injections of the AUC and C max increased in a greater extent than expected for the estimated accumulation equipoise vs decaa calculated on the basis of data obtained from its first introduction. In studies conducted in patients with CLL, the mean values of TC and t1 / 2 were 64 ml / h (range: 4,3-1122 ml / h) and 1.3 days (range 0.2-6.0 days) after the first injection, 8.5 ml / h (range 1,3-41,5 ml / h) and 11.5 days (range: 30.6 2.3 days) after the fourth administration of 9.5 ml / hr (range 2,2-23,7 ml / h) and 15.8 days (range 8,8-61,5 days) after administration of the eighth and 10.1 ml / h (range: 3,3-23, 6 ml / h) and 13.9 days (range:. 9,0-29,2 days) after the introduction of the twelfth individual patient groups Elderly (65 years and older): as shown in cross-population pharmacokinetic analysis of patients aged 21 to 86 years across studies, age had no significant effect on the pharmacokinetics of equipoise vs decaa. Children and adolescents (under 18 years):data on the pharmacokinetics of equipoise vs decaa in this age group are not available. Gender: under cross-analysis showed that the floor has a moderate impact (14-25%) on the pharmacokinetics of equipoise vs decaa – women with max and AUC were slightly higher (in the test group, 41% of patients were male and 59% – women). These differences were considered to be non-clinical significance, so adjust the dose depending on the sex of the patient is not recommended. Renal function: in cross population analysis in patients with creatinine clearance, varying in the range from 33 to 287 ml / min, it was shown that clinically significant relationship between the value of the creatinine clearance, before the introduction of certain equipoise vs decaa, and pharmacokinetics of the last missing. As a correct dose for patients with mild or moderate renal severity of failure (creatinine clearance of> 30 ml / min) is not recommended. For patients with severe renal impairment (creatinine clearance <30 mL / min), the pharmacokinetics data for equipoise vs decaa absent. Abnormal liver function: data on the pharmacokinetics of the drug in patients with impaired liver function no. However, as equipoise vs deca, and all the other molecules of IgGl, catabolized by the most conventional proteolytic enzymes, the prevalence of which is by no means limited to the tissues of the liver, liver function abnormalities are unlikely to have any impact on the rate of removal from the body equipoise vs decaa.

Indications for use

Treatment of patients with chronic lymphocytic leukemia (CLL) after failure of prior therapy with the inclusion of fludarabine and / or alemtuzumab.

Contraindications for use

 

  • Hypersensitivity to equipoise vs decau or other ingredients;
  • children and adolescents up to 18 years;
  • severe renal dysfunction (creatinine clearance less than 30 mL / min);
  • Pregnancy and lactation.Precautions
    Hepatitis B is a history of loss of lung function and heart disease in history.Dosage and administration:
    equipoise vs deca should be entered under the supervision of a physician who is experienced in the use of anticancer drugs. In connection with the potential development of anaphylactoid reactions, infusion equipoise vs decaa is carried out under immediate availability of equipment and medicines needed to provide emergency assistance in such situations.
    The drug is administered as an intravenous infusion, and before use should be diluted. The concentrated solution should be mixed only with 0.9% sodium chloride intravenous solution (see. Use Method ). Do not mix in the container equipoise vs deca for administration with other drugs. Premedication 30 minutes – 2 hours prior to administration to patients need to hold equipoise vs decaa premedicated according to the following dosing scheme.

    Number injection (dose) The dose intravenous corticosteroids The dose of analgesic The dose of antihistamine
    1 (300 mg) The equivalent of 100 mg of prednisolone An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine
    2 (2000 mg) The equivalent of 100 mg of prednisolone An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine
    3-8 (2000 mg) Equivalent 0-100 mg prednisolone a) An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine
    9 (2000 mg) The equivalent of 100 mg of prednisolone An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine
    10-12 (2000 mg) The equivalent of 50-100 mg prednisolone b) An equivalent of 1000 mg of paracetamol (acetaminophen) Equivalent to 10 mg cetirizine

     

    a) If the second injection is completed without the development of serious adverse reactions, dose, at the physician’s discretion, can be reduced.
    b) If the ninth completed without the introduction of serious adverse events, dose, at the physician’s discretion, can be reduced to the equivalent of 50 mg of prednisolone.

    Dosages
    The recommended dose is 300 mg equipoise vs decaa for the first injection and 2,000 mg equipoise vs decaa- for all subsequent injections. Administration scheme provides 8 consecutive weekly injections, and after 4-5 weeks -. 4 consecutive monthly (i.e. every 4 weeks) administration of the first and second introduction initial speed injection at the first and second introduction should be 12 ml / h ( cm. use method ).During the introduction of the speed should be gradually increased so that every 30 minutes, it was doubled and increased to a maximum of 200 ml / hour (see. The method use). Subsequent introduction If a second administration is terminated without developing serious adverse reactions associated with the introduction of all other administration can be carried out at an initial rate of 25 ml / h, which should gradually increase, doubling every 30 minutes to a maximum of 400 ml / h (cm. The method of use). Changes in dose and resumption of treatment of adverse reactions associated with the introduction equipoise vs decaa, It may cause the need to reduce the rate of administration.

    In the case of mild or moderate adverse reactions administration should be discontinued and, if the patient’s condition is stable, again to resume at a rate equal to half of that at which the introduction was interrupted. If at the time of cessation of equipoise vs decaa because of adverse reactions did not manage to increase the speed of the original, equal to 12 ml / hour, then the resumption of its introduction should be done with a standard initial velocity of 12 ml / h. In the future, the rate of introduction, taking into account the tolerance of the drug to patients and the physician’s discretion, can be increased in the normal way (so that the speed was doubled no faster than once every 30 minutes).

    In case of serious adverse reactions administration should be discontinued and, if the patient’s condition It remains stable, to resume again at a rate of 12 ml / h.Subsequently, rate of administration, based on patient tolerability and the physician’s discretion, can be increased by the standard procedure (so that the doubled speed no faster than once every 30 minutes).

    Method of Use
    1) Before dilution equipoise vs decaa
    Before breeding check equipoise vs decaa concentrate for the presence therein of the particles and discoloration. Do not use equipoise vs deca if its color changed. The concentrate may contain a small amount of visible (clear or whitish) amorphous particles equipoise vs decaa. These particles are removed by the filters included in kit for administration. Do not shake the vial before performing equipoise vs decaom described test. 2) How to make a solution for intravenous administration Prior to administration equipoise vs decaa concentrate should be diluted in 0.9% sodium chloride solution for intravenous administrationunder aseptic conditions . The dose of 300 mg – 3 use vial (total of 15 ml, 5 ml vial):



  • with capacity of 0.9% sodium chloride solution for intravenous administration to a volume of 1000 ml and remove Collect 15 ml;
  • from each of the 3 vials equipoise vs decaom Collect 5 ml of concentrate (15 ml total) and enter them into a container volume of 1000 ml;
  • not shake the container – mix the contents by gentle inversion.
    A dose of 2000 mg

    The dose of 2000 mg of 5 ml vials The dose of 2000 mg of 50 ml vials
    For a dose of 2000 mg vials using 20 (total – 100 ml, 5 ml vial): For a dose of 2000 mg using 2 vials (total – 100 ml, 50 ml vial):
    • with capacity of 0.9% sodium chloride solution for intravenous administration to a volume of 1000 ml Select and delete 100 ml;
    • with capacity of 0.9% sodium chloride solution for intravenous administration to a volume of 1000 ml Select and delete 100 ml;
    • from each of the 20 vials equipoise vs decaom Collect 5 ml concentrate (vsego 100 mL) and enter them into a container volume of 1000 ml;
    • From each of two vials equipoise vs decaom Collect 50 ml of concentrate (total – 100 ml) and enter them into a container volume of 1000 ml;
    • not shake the container – mix the contents by gentle inversion.
    • not shake the container – mix the contents by gentle inversion.

    3) Introduction of
    equipoise vs deca should not be administered intravenously or fast bolus.     For intravenous use attached to the drug infusion system with built-in filters.
    Concentrate equipoise vs decaa for solution for infusion does not contain preservatives, so its cultivation should be under aseptic conditions. The prepared solution for infusion should be stored at a temperature no higher than 25 ° C and use within 24 Chov after cooking. After this period, the remains of the solution should be destroyed. equipoise vs deca should not be mixed or administered simultaneously with other drugs or solutions for intravenous administration. To avoid this, before and after the introduction of equipoise vs decaa necessary to flush the system for the administration of 0.9% sodium chloride solution.The first and the second administration of the drug should be administered within 6.5 hours after an infusion or through an indwelling catheter in accordance with the following scheme. The scheme for the introduction of 1 and 2 administrations equipoise vs decaa

     

    Time, min infusion rate in ml / h
    0-30 12
    31-60 25
    61-90 50
    91-120 100
    More than 121 200

    If the second introduction passed without the development of serious adverse reactions , other administration (12.3) should be done within 4 hours via an infusion system or through an indwelling catheter in accordance with the following scheme.

    The scheme for the introduction of administrations equipoise vs decaa from 3 to 12 , min infusion rate in ml / h 0-30 25 31-60 50 61-90 91-120 100 200 More than 121 400 Special patient groups ChildrenSafety and efficacy in children younger than equipoise vs decaa 18 not been studied. elderly patients any significant effect of age on the efficacy and safety of the drug has been noted. Taking into account the available data on the efficacy and safety of the drug in the elderly, no dose adjustment in this group is not required. Patients with renal impairment No specific pharmacokinetic studies equipoise vs decaa in patients with impaired renal function have not been conducted. However, it is unlikely that patients with impaired renal function need to adjust the dose of the drug. Patients with impaired hepatic functionThere are no specific studies equipoise vs decaa pharmacokinetics in patients with hepatic impairment have been conducted. However, it is unlikely that patients with impaired liver function will need to adjust the dose of the drug.

    Side effects

    Adverse events reported below are listed according to the anatomical and physiological classification and frequency of occurrence. The frequency is defined as follows: very common (≥1 / 10), commonly (≥1 / 100 and <1/10), uncommon (≥1 / 1000 and <1/100), rare (≥1 / 10,000 and <1/1 000), very rare (<1/10 000, including isolated cases), not known (frequency can not be determined on the basis of available data). Frequency categories were formed on the basis of clinical trials of the drug. On the part of hematopoiesis Very common: neutropenia, anemia. Common: febrile neutropenia, thrombocytopenia, leukopenia. Uncommon: Agranulocytosis, coagulopathy, lymphopenia, erythrocyte germ cell aplasia. On the part of the immune reactions, including anaphylactic shock. On the part of metabolism and nutrition Infrequent: . tumor lysis syndrome, Cardio-vascular system Common: tachycardia, hypertension, hypotension. Respiratory system, organs of the chest and mediastinum Common: pain gortanno- pharyngeal region, shortness of breath, cough, bronchospasm, discomfort in the chest, nasal congestion, hypoxia. On the part of the gastrointestinal tract Common: nausea, obstruction of the small intestine, diarrhea. skin and subcutaneous tissue Very common: rash. Common: pruritus, urticaria, “hot flashes.” The general reaction is often: fatigue, chills, rash, release syndrome cytokines, pyrexia, back pain.Secondary infections Very common: bronchitis, pneumonia. Common: sepsis, septic shock, infection by Herpes zoster , infektsiimochevyvodyaschih ways. It is not known: progressive multifocal leukoencephalopathy, hepatitis B.

    Overdosing

    results of clinical tests did not contain any data about equipoise vs decaa overdose cases.

    Interaction with other medicinal products
    There were no drug-drug interaction studies between equipoise vs decaom and other drugs have not been conducted.
    In a joint application with drugs equipoise vs decaa having immunosuppressive activity, may increase the risk of infectious diseases.

    Special instructions and precautions for the use of
    infusion reactions
    when using equipoise vs decaa may experience infusion reactions, requiring the temporary discontinuation of treatment or it is canceled. Reactions to weaken premedication may, however, even in this case, the reaction may develop, mainly during the first injection. Reactions to the introduction may include: anaphylactic reactions, adverse events with the cardiovascular system, chills, cough, cytokine release syndrome, diarrhea, dyspnoea, fatigue, “tides”, increased or decreased blood pressure, nausea, pain, fever, rash and hives. Cases of serious reactions to the introduction of equipoise vs decaa, including cytokine release syndrome, have been described even with the use of sedation. In case of serious reactions to the administration should immediately suspend the administration of the preparation and conduct symptomatic treatment (recommendation to change the speed of drug administration after the development of responses to the introduction given in section “Dosage and administration”).
    The most common reactions to develop in the day of the first administration, and their severity decreases with subsequent administrations. In patients with impaired lung function in history may be at increased risk of complications from the respiratory system caused by the development of serious reactions to the introduction, so during the introduction equipoise vs decaa for respiratory function should be carefully monitored. Tumor lysis syndrome In patients with CLL when administered equipoise vs decaa can develop tumor lysis syndrome (SLO). Therapeutic measures at the Arctic include the correction of electrolyte balance, monitoring of renal function, maintenance of water balance and symptomatic treatment. Progressive multifocal leukoencephalopathy in patients with CLL treated with cytotoxic drugs, may develop progressive multifocal leukoencephalopathy (PMOLEP), including those leading to death. Diagnosis PMOLEP be excluded in all patients who report on the development of their neurological symptoms or change in the nature of neurological symptoms that existed previously. If you suspect a PMOLEP equipoise vs decaom treatment should be discontinued and consult a neurologist. VaccinationSafety vaccination with live attenuated or inactivated vaccines, and the ability to develop primary or secondary immune response to them equipoise vs decaom were not investigated at the time of treatment. Since the quantitative content of B cells is reduced, the response to vaccination can be attenuated. Before vaccination of patients undergoing treatment equipoise vs decaom, you must weigh the risks and benefits of vaccination in these patients. Due to the risk of infection to avoid the introduction of live attenuated vaccines during or after therapy equipoise vs decaom to normalize the number of B-lymphocytes. Hepatitis BPatients receiving equipoise vs deca, there is an increased risk of infection with hepatitis B virus due to immunosuppressive therapy effect (HBV) infection and its reactivation, which may, inter alia, lead to death.Before treatment equipoise vs decaom should identify patients at high risk of disease caused by HBV. Carriers of HBV during treatment ofatutumabom and within 6-12 months after it is necessary to carefully monitor the laboratory and clinical signs of active HBV infection. Treatment equipoise vs decaom those patients who develop viral hepatitis, should be discontinued and appropriate to conduct their anti-viral therapy. Data regarding safety equipoise vs decaa use in patients with active hepatitis are insufficient to make a definitive conclusion. Cardiovascular disease The state of patients with heart disease history should be carefully monitored. If patients develop severe or life-threatening cardiac arrhythmias, treatment should be discontinued equipoise vs decaom. Intestinal obstruction in patients treated with anti-CD20 monoclonal antibodies, in particular equipoise vs decaom sometimes noted the development of bowel obstruction. Patients with complaints of abdominal pain, especially developing at the beginning of the course equipoise vs decaom treatment should be evaluated and assign them the appropriate therapy. Laboratory tests Since equipoise vs deca binds to all CD20-positive lymphocytes (both tumor and normal), during treatment equipoise vs decaom necessary at regular intervals carry out the control hemogram; if patients develop cytopenia, a study should be done more often. With the development of cytopenia is necessary to carry out the appropriate therapy.

     

    Effects on ability to drive vehicles, machinery
    Research equipoise vs decaa influence on the ability to drive a car or work not performed on automatic equipment. Based on the pharmacology equipoise vs decaa, reasons to suspect that the adverse effect of the drug on these kinds of no activity. When considering the possibility of the patient to perform activities that require high concentration and psychomotor speed reactions must be taken into account his clinical condition and the profile of adverse reactions equipoise vs decaa.

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