NOVOSEVEN (NovoSeven)

     Synonym : Eptakog alfa (activated), Eptacog alfa (activated).

     The composition and the form of : 1 bottle of powder for injection preparation solution contains eptakoga alfa (activated recombinant coagulation factor VII a) 1.2; 2.4 or 4.8 mg (60, 120 or 240 units of coagulation of international standard FVIIa 89 KED - 688; 1 KE D with 1000 IU); complete with a solvent (water injection) in vials of 2.2; 4.3 and 8.5 ml, respectively, sterile needles for mixing, sterile disposable syringe for mixing and introduction , sterile system for transfusion and 2 alcohol swabs, in one box set.

     The drugs act : Gemostaticheskoe.

Activates blood svertyvayuschuyu system.

     Indication : Bleeding (including prevention in surgical operations) in patients with hereditary or acquired hemophilia with inhibitors of coagulation factors (FVIII or FIX).

     Contraindications : Giperchuvstvitelnost proteins to mice, homyachkov or cows.

     Application of pregnancy and breast-feeding : In pregnancy only if clearly needed. At the time of treatment should stop breastfeeding.

     Side Effects : In rare cases, fever, headache, vomiting, changes in AD, itching of the skin, reddish skin, in some cases, reducing the number of platelets and fibrinogena level, the emergence of PDF and D dimer, tromboticheskie complications (including myocardial infarction ).

     Dosing and Administration : W / in a bolyusnoy Injection (2-5 min). Dose choose individually depending on the testimony 3-6 KED (60-120 µ g) / kg; The recommended initial dose of 4.5 KE-D (90 µ g) / kg. The interval between the introduction and the length of treatment depends on the severity of bleeding, and inhibitors of the required level of factor VII. With strong krovotecheniyah or after major surgery treatment can last up to 2-3 weeks.

The solution for injection preparation in giving conditions. Before breeding powder and solvent heated to room temperature (but not more than 37 ° C), following the dissolution produce attached to the preparation instructions. Introduction should immediately following the development, if the solution is not used immediately, for the length and conditions of storage rests with the user. After cultivating drugs can be used in a 24-hour storage in the refrigerator at a temperature of 2-8 ° C. Any solution if it undiluted particles.

     Precautions : Special caution should be exercised when the patient underwent surgery, he has razmozzhennaya wounds, severe atherosclerosis or tromboticheskie complications septicaemia.

Avoid simultaneous application concentrates protrombinovogo complex (activated or not activated).

We should not impose a syringe with any other drugs.

     Special instructions : The strengths krovotecheniyah product should be introduced in the hospital. Bleeding light or medium gravity can be treated at home, in close cooperation with Hib center or a clinical haematologist, but not longer than 24 hours If we can not stop the bleeding, hospitalization is required.

     Shelf life : 3 years. After cooking is not stored

     Storage conditions : In the dark place at a temperature of 2-8 ° C (not freezing). Do not store in plastic dissolved drug injection devices, not to the direct sunlight.

Materials allowed to copy only with the active hyperlink to the handbook of medicines