Novoseven

Roman name

NovoSeven #

The composition and the form of

1 orange powder for the preparation of injection solution contains eptakoga alpha (rekombinantny activated coagulation factor VIIa) 1.2; 2.4 or 4.8 mg (60, 120 or 240 units dependent on international standard 89/688 FVIIa-owned; 1 KED with 1,000 IU); together with the solvent (water for injection), in bottles of 2.2; 4.3 and 8.5 ml, respectively, sterile needles for mixing, sterile needles time for mixing, and the introduction of sterile transfusion and 2 alcohol swabs, in a Box 21.90.

Of drugs

Gemostaticescoe. Activates svertawatuyu the blood.

Indications

Bleeding (including in the prevention of surgery) in patients with hereditary or acquired hemophilia with inhibitors to coagulation factors (FVIII or FIX).

Pregnancy and lactation

When pregnancy only if clearly needed. At the time of treatment should stop breastfeeding.

Contraindications

Гиперчувствительност ь protein to mice, homachkov or cows.

Side-Effects

In rare cases, a high fever, headache, vomiting, changes in AD itching, red skin, in some cases, decrease in the number of platelets and fibrinoguena level, the emergence of brochures and D-dimer, tromboticeskie complications (including myocardial infarction).

Specific guidance

With strong artistic methods product should be in hospital. Bleeding mild or moderate severity can be treated at home, in close collaboration with the Centre gemofilnym or vrachom-gematologom, but not more than 24 hours If the bleeding stopped fails, the hospitals obligatory.

Precautions

Special caution should be exercised when the patient underwent surgery, he has razmozjennaya wound, severe arteriosclerosis or tromboticeskie complications Septizemia.sleduet avoid simultaneous application concentrates protrombinovogo complex (activated or not activated). There should be one sprite with any other drugs.

Dosing and Administration

In / in in the form of injections bolusna (2-5 minutes). Dose picked individually depending on the testimony in the 3-6 Corporation (60-120 µ g) / kg; Recommended starting dose of 4.5 KED (90 µ g) / kg. The interval between wvedeniami and duration of treatment depended on the severity of bleeding, the inhibitors, and the required level of factor VII. With strong artistic methods or after major surgery treatment can take as long as 2-3 Ned.rastvor for injection are in aseptic conditions. Before raising powder and solvent heated to room temperature (but not more than 37 ° C), dissolved following are attached to the drug instructions. Introduction should implement immediately after breeding if solution is not used immediately, for the length and conditions of storage rests with the user. After breeding drug can be used up to 24 hours in storage in the refrigerator at a temperature of 2-8 ° C. Any solution with the undiluted particles.

Storage conditions

por.d / in. : In the refrigerator at a temperature of 2-8 ° C (not freezing). Do not store product dissolved in plastic injection, do not expose sunlight.

Shelf life

por.d / in. : 2 g.por.d / in. : 3 and

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