Fraxiparine 9500ME ml sphre3800ME 0.4 ml N10
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Calcium Nadroparin
Composition
1 syringe nadroparin calcium 3800 IU anti-Ha.
Pharmacological effect
Calcium nadroparin is a low molecular weight heparin (LMWH), obtained by depolymerization from standard heparin, is a glycosaminoglycan with an average molecular weight of 4300 daltons. Shows a high ability to bind to plasma protein antithrombin III (AT III). This binding leads to accelerated inhibition of factor Xa, which is the reason for the high antithrombotic potential of nadroparin. Other mechanisms that provide the antithrombotic effect of nadroparin include activation of a tissue factor conversion inhibitor (TFPI), activation of fibrinolysis by direct release of a tissue plasminogen activator from endothelial cells, and modification of blood rheological properties (decrease in blood viscosity and increase in platelet and granulocyte membrane permeability). Calcium nadroparin is characterized by higher anti-Xa factor activity compared to anti-IIa factor or antithrombotic activity and has both immediate and prolonged antithrombotic activity. Compared with unfractionated heparin, nadroparin has less effect on platelet function and aggregation and less pronounced effect on primary hemostasis. In prophylactic doses, nadroparin does not cause a pronounced decrease in APTT. In the course of treatment during the period of maximum activity, it is possible to increase the APTT to a value 1.4 times higher than the standard. Such prolongation reflects the residual antithrombotic effect of nadroparin calcium.
Indications
- prevention of thromboembolic complications (in surgical and orthopedic interventions. In patients with a high risk of thrombus formation in acute respiratory and / or heart failure under conditions of ICU). - treatment of thromboembolism. - prevention of blood coagulation during hemodialysis. - treatment of unstable stenocardia and myocardial infarction without Q wave.
Contraindications
- thrombocytopenia with a history of nadroparin - signs of bleeding or increased risk of bleeding associated with impaired hemostasis (except for DIC, not caused by heparin) - organic organ damage with a tendency to bleeding (for example,acute gastric or duodenal ulcer) - trauma or surgery on the brain and spinal cord or on the eyes - intracranial hemorrhage - acute septic endocarditis - severe renal failure (CC less than 30 ml / min) in patients receiving Fraxiparine for treatment of thromboembolism, angina and myocardial infarction without Q wave - childhood and adolescence (up to 18 years) - hypersensitivity to nadroparin or any other components of the drug. With caution, Fraxiparine should be prescribed in situations involving an increased risk of bleeding: - in liver failure - in renal failure - in severe hypertension - in case of peptic ulcers in anamnesis or other diseases with an increased risk of bleeding - in circulatory disorders in the choroid and retina - in the postoperative period after operations on the brain and spinal cord or on the eyes - in patients with a body weight less than 40 kg - in the case of the duration of treatment, it is longer than recommended (10 days) - in case of non-compliance with the recommended treatment conditions (especially duration and dose setting based on body weight for course use) - when combined with drugs that increase the risk of bleeding.
Use during pregnancy and lactation
Experiments on animals did not show the teratogenic or fetotoxic effects of nadroparin calcium, however, at present there are only limited data concerning the penetration of nadroparin calcium through the placenta in humans. Therefore, the appointment of the drug Fraxiparine during pregnancy is not recommended, except when the potential benefit to the mother exceeds the risk to the fetus. Currently, there are only limited data regarding the release of nadroparin calcium in breast milk. In this regard, the use of nadroparin calcium during breastfeeding is not recommended.
Dosage and administration
When s / c administration, it is preferable to administer the drug in the patient's position, in the s / c tissue of the anterolateral or posterolateral surface of the abdomen, alternately on the right and left side. Introduction to the thigh is allowed. To avoid loss of the drug when using syringes, you should not remove air bubbles before injection.The needle should be inserted perpendicular, rather than at an angle, into a pinched skin fold formed between the thumb and forefinger. The fold should be maintained throughout the entire period of drug administration. Do not rub the injection site after the injection. For the prevention of thromboembolism in general surgical practice, the recommended dose of Fraxiparine is 0.3 ml (2850 anti-Xa ME) s / c. The drug is administered for 2-4 hours before surgery, then - 1 time / day. Treatment is continued for at least 7 days or during the entire period of increased risk of thrombosis, until the patient is transferred to the outpatient mode. For the prevention of thromboembolism during orthopedic operations, Fraxiparine is injected s / c in a dose that is set depending on the patient’s body weight at the rate of 38 anti-Ha IU / kg, which can be increased to 50% on the 4th postoperative day. The initial dose is prescribed 12 hours before the operation, the 2nd dose - 12 hours after the end of the operation. Further, Fraxiparine is continued to be applied once a day during the entire period of increased risk of thrombus formation until the patient is transferred to the outpatient mode. The minimum duration of treatment is 10 days. Body weight (kg) Dose of Fraxiparine, administered 12 hours before and 12 hours after the operation, then 1 time / day until the 3rd day after surgery. Dose of Fraxiparine, administered 1 time / day, starting from the 4th day after surgery. Volume (ml) Anti-Xa (ME) Volume (ml) Anti-Xa (ME) is less than 50 0.2 1900 0.3 2850 50-69 0.3 2850 0.4 3800 & # 8805 .70 0.4 3800 0.6 5700 Patients with a high risk of thrombus formation (usually located in the intensive care unit and intensive care unit / respiratory failure and / or respiratory tract infection and / or heart failure /) Fraxiparine is prescribed n / a 1 time / day in a dose, setting ivaemoy depending on the patient's body weight. Fraxiparine is used during the entire period of the risk of thrombosis. Body weight (kg) Dose of Fraxiparine with the introduction of 1 time / day Volume of Fraxiparine (ml) Anti-Xa (ME) & # 8804. 70 0.4 3800> 70 0.6 5700 In the treatment of unstable stenocardia and myocardial infarction without Q wave, Fraxiparine is prescribed s / c 2 times / day (every 12 hours). The duration of treatment is usually 6 days. In clinical studies in patients with unstable angina / myocardial infarction without Q wave, Fraxiparine was prescribed in combination with acetylsalicylic acid at a dose of 325 mg / day. The initial dose is administered as a single IV bolus injection, the subsequent doses are given sc.Dose set depending on body weight at the rate of 86 anti-Ha IU / kg. Body weight (kg) Initial dose for IV injection (bolus) Doses for subsequent sc injection (every 12 h) Anti-Xa (ME) less than 50 0.4 ml 0.4 ml 3800 50-59 0.5 ml 0.5 ml 4750 60- 69 0.6 ml 0.6 ml 5700 70-79 0.7 ml 0.7 ml 6650 80-89 0.8 ml 0.8 ml 7600 90-99 0.9 ml 0.9 ml 8550 & # 8805. 100 1.0 ml 1.0 ml 9500 In the treatment of thromboembolism, oral anticoagulants (in the absence of contraindications) should be prescribed as soon as possible. Therapy with Fraxiparine is not stopped until the target values of the prothrombin time are reached. The drug is prescribed s / c 2 times / day (every 12 hours), the usual duration of the course is 10 days. The dose depends on the patient's body mass at the rate of 86 anti-Xa IU / kg body weight. Body weight (kg) Dose with the introduction of 2 times / day, duration 10 days Volume (ml) Anti-Xa (ME) less than 50 0.4 3800 50-59 0.5 4750 60-69 0.6 5700 70-79 0.7 6650 80-89 0.8 7600 & # 8805. 90 0.9 8550 Prevention of blood coagulation in the extracorporeal circulation during hemodialysis The dose of Fraxiparine should be set for each patient individually, taking into account the technical conditions of dialysis. Fraxiparine is injected once into the arterial line of the dialysis loop at the beginning of each session. For patients without an increased risk of bleeding, the recommended initial doses are set, depending on body weight, but sufficient for a 4-hour dialysis session. Body weight (kg) Injection into the arterial line of the dialysis loop at the beginning of the dialysis session Volume (ml) Anti-Xa (ME) is less than 50 0.3 2850 50-69 0.4 3800 & # 8805. 70 0.6 5700 In patients with an increased risk of bleeding, you can use half the recommended dose of the drug. If the dialysis session lasts longer than 4 hours, additional small doses of Fraxiparine may be administered. For subsequent dialysis sessions, the dose should be adjusted depending on the effects observed. The patient should be observed during the dialysis procedure in connection with the possible occurrence of bleeding or signs of thrombus formation in the dialysis system. Elderly patients do not require dose adjustment (except for patients with impaired renal function). Before treatment with Fraxiparine, it is recommended to monitor indicators of renal function. In patients with mild to moderate renal insufficiency (CK & # 8805. 30 ml / min and less than 60 ml / min), no dose reduction is required to prevent thrombosis, patients with severe renal failure (CK less than 30 ml / min) dose should be reduced by 25%.In patients with mild and moderate renal insufficiency for the treatment of thromboembolism or for the prevention of thromboembolism in patients with a high risk of thrombosis (with unstable angina and myocardial infarction without a Q wave), the dose should be reduced by 25%, the drug is contraindicated in patients with severe renal failure. In patients with impaired liver function, special studies on the use of the drug have not been conducted.
Side effects
Adverse reactions are presented depending on the frequency of occurrence: very often (> 1/10), often (> 1/100, less than 1/10), sometimes (> 1/1000, less than 1/100), rarely (> 1/10 000, less than 1/1000), very rarely (less than 1/10 000). On the part of the blood coagulation system: very often - bleeding of various sites, often in patients with other risk factors. From the hematopoietic system: rarely - thrombocytopenia. very rarely - eosinophilia, reversible after discontinuation of the drug. On the part of the hepatobiliary system: often - increased activity of hepatic transaminases (usually transient). On the part of the immune system: very rarely - hypersensitivity reactions (angioedema, skin reactions). Local reactions: very often - the formation of a small subcutaneous hematoma at the injection site. in some cases, there is the appearance of dense nodules (not meaning encapsulation of heparin), which disappear after a few days. very rarely, skin necrosis, usually at the injection site. Necrosis is usually preceded by purpura or an infiltrated or painful erythematous spot, which may or may not be accompanied by general symptoms (in such cases, treatment with Fraxiparine should be stopped immediately). Other: very rarely, priapism, reversible hyperkalemia (associated with the ability of heparins to suppress the secretion of aldosterone, especially in patients at risk).
special instructions
Adverse reactions are presented depending on the frequency of occurrence: very often (> 1/10), often (> 1/100, less than 1/10), sometimes (> 1/1000, less than 1/100), rarely (> 1/10 000, less than 1/1000), very rarely (less than 1/10 000). On the part of the blood coagulation system: very often - bleeding from various sites, more often in patients with other risk factors. From the hematopoietic system: rarely - thrombocytopenia. very rarely - eosinophilia, reversible after discontinuation of the drug.On the part of the hepatobiliary system: often - increased activity of hepatic transaminases (usually transient). On the part of the immune system: very rarely - hypersensitivity reactions (angioedema, skin reactions). Local reactions: very often - the formation of a small subcutaneous hematoma at the injection site. in some cases, there is the appearance of dense nodules (not meaning encapsulation of heparin), which disappear after a few days. very rarely, skin necrosis, usually at the injection site. Necrosis is usually preceded by purpura or an infiltrated or painful erythematous spot, which may or may not be accompanied by general symptoms (in such cases, treatment with Fraxiparine should be stopped immediately). Other: very rarely, priapism, reversible hyperkalemia (associated with the ability of heparins to suppress the secretion of aldosterone, especially in patients at risk).