Fraksiparin solution for infection. syringe of 0.6 ml No. 10

Pharmacological properties

Pharmacodynamics. nadroparin — the low-molecular heparin received from standard heparin by a depolymerization method is glikozaminoglikany with an average molecular weight of 4300 yes. nadroparin shows the high level of protein-binding of blood plasma iii antithrombin. such affinity causes the accelerated factor ingibition ha and is the main reason of high antitrombotichesky activity of a nadroparin. other mechanism of antitrombotichesky activity of a nadroparin — stimulation of inhibitor of a factor of fabric conductivity, activation of a fibrinolysis by direct release of the activator of fabric plasminogen from epithelium cells, modification of haemo rheological parameters (decrease in viscosity of blood and fluidity of thrombocytes and membrane granulocytes). nadroparin has the high level of a ratio between anti-ha and anti-iia - activity. has the immediate and prolonged antitrombotichesky effect. in comparison with not fractional heparin nadroparin influences function and aggregation of thrombocytes less effectively and it is very insignificant — on primary hemostasis.

Pharmacokinetics is defined by measurement anti-Ha - factorial activity of blood plasma.

Bioavailability. After p / to introduction With _max in blood plasma it is reached in 3–5 h. Bioavailability almost full (about 88%).

in 10 min. with T _½ 2 h

Removal. After p / to introduction of T _½ about 3.5 h make. However anti-Ha - the activity remains for at least 18 h after an injection of a nadroparin in a dose 1900 Anti-ha of ME.

Special groups of patients

Patients of advanced age. As physiological function of kidneys decreases with age, process of removal slows down. It is necessary to consider a possibility of development of a renal failure in this group of patients and to respectively adjust a medicament dose.

Renal failure. Data of clinical trials on studying pharmacokinetic parameters of a nadroparin at it in in introduction by the patient with various degree of a renal failure confirm correlation between clearance of a nadroparin and clearance of creatinine. Average AUC and T _½ in a moderate renal failure (clearance of creatinine of 36-43 ml/min.) increased by 52 and 39% respectively, the average plasma clearance decreased to 63% of norm. Noted broad individual variability. At patients with a heavy renal failure (clearance of creatinine of 10-20 ml/min.) of AUC and T _½ increased to 95 and 112% respectively in comparison with those at healthy volunteers. The plasma clearance in a heavy renal failure decreased to 50% in comparison with patients with normal function of kidneys. At patients with a heavy renal failure (clearance of creatinine of 3-6 ml/min.) which are on a hemodialysis, AUC and T _½ increased by 62 and 65% respectively in comparison with healthy volunteers. The plasma clearance at the patients with a heavy renal failure who are on a hemodialysis decreased to 67% of that at patients with normal function of kidneys.

Indication

Prevention of tromboembolic episodes as a result of the general or orthopedic surgical interventions at patients with high risk of tromboembolic episodes. treatment of a deep vein thrombosis. prevention of fibrillation at a hemodialysis. treatment of unstable stenocardia and myocardial infarction without pathological tooth of q on the ECG in combination with acetylsalicylic acid.

Use

Should pay special attention to specific recommendations about dosing of each separate medicament of group of low-molecular heparins as different units of measure (me or mg) are applied to definition of doses of these drugs. therefore nadroparin it is impossible to apply as replacement of other low-molecular heparin during a course of treatment. the extra care and observance of specific instructions for use are necessary for each form of release of a nadroparin.

for introduction in oil. Control of quantity of thrombocytes at treatment nadropariny is necessary.

Should adhere to special recommendations concerning time of dosing of a nadroparin during spinal/epidural anesthesia or a lumbar puncture (see. Special INSTRUCTIONS).

Technician p / to introduction. It is recommended to enter p / to Fraksiparin's injection in position of the patient lying to the anterolateral area of an abdominal wall, alternately on the right and at the left. In order to avoid loss of medicament it is not necessary to delete vials of air from previously filled syringe before an injection. The needle is entered perpendicular to a body surface (and not at an angle) pleated by skins, taken big and index by fingers (to hold during administration of solution).

Prevention of tromboembolic episodes

General surgery. The recommended Fraksiparin's dose — 0.3 ml (2850 ME anti-Ha - factorial activity), is entered p / to for 2 h before surgical intervention. Further doses are entered 1 time a day in the next days.

Orthopedic surgical interventions. The medicament is administered p / to in the doses depending on the body weight of the patient (table). Doses select at the rate of 38 ME anti-Ha - factorial activity on 1 kg of body weight and at the rate of 57 ME anti-Ha - factorial activity on 1 kg of body weight of the patient from the 4th postoperative day. The initial dose is entered for 12 h before operation, the second — in 12 h after operation. The subsequent doses enter 1 time a day during the entire period of risk and before transfer of the patient to out-patient treatment.

Maximum duration of treatment at the general surgical interventions is 10 days, except cases of the increased risk of emergence of tromboembolic episodes.

after the end of treatment of the recommended duration, it is necessary to continue preventive treatment, in particular by means of oral anticoagulants. However it is necessary to take into account that the clinical advantage of long-term treatment is not studied by low-molecular heparin or the antagonist of vitamin K yet.

Treatment of a deep vein thrombosis. Any suspicion of a deep vein thrombosis has to be confirmed with results of the corresponding analyses.

Fraksiparin p / to 2 times a day (each 12 h). The dose is calculated according to the body weight of the patient, as shown in the table, at the rate of 0.01 ml (85 anti-Ha - factorial activity) on 1 kg of body weight of the patient.

Dosing for patients whose body weight of 100 kg or 40 kg, did not investigate. At patients with the body weight of 100 kg the efficiency of treatment by low-molecular heparin can be reduced, at patients with the body weight of 40 kg the risk of bleeding increases. Special clinical observation is necessary.

as soon as possible with intake of oral anticoagulants if there are no contraindications. Duration of treatment by Fraksiparin should not exceed 10 days, including the stabilization period upon transition on antagonists of vitamin K, except for cases when there are difficulties of stabilization. Treatment by oral anticoagulants needs to be begun as soon as possible.

Prevention of fibrillation at a hemodialysis. The dose of a nadroparin is selected individually, considering also specifications of carrying out a hemodialysis.

As a rule, nadroparin is applied in the form of one-time bolyusny intravaskulyarny introduction to the arterial shunt of an extracorporal contour at the beginning of each session of a hemodialysis. The initial dose makes 65 ME anti-Ha - factorial activity on 1 kg of body weight of the patient. At patients without the increased risk of developing of bleedings the initial dose is calculated according to body weight and is sufficient for a session of a hemodialysis lasting up to 4 h (the table is lower).

At the increased risk of developing of bleedings a dose it is necessary to lower half.

Treatment of unstable stenocardia and myocardial infarction without pathological tooth of Q on the ECG. Use of a nadroparin p / to 2 times a day (each 12 h) in a combination with acetylsalicylic acid is recommended (the recommended dose: 75–325 mg inside after the minimum initial load dose of 160 mg). The usual duration of treatment — 6 days before clinical stabilization.

in a look in in a bolyusny injection, the subsequent doses are entered p / to. The dose is expected proceeding from the body weight of the patient at the rate of 86 ME anti-Ha - factorial activity 1 kg of body weight of the patient (the table is lower).