Novoseven 200IU

• Bleeding in patients with haemophilia: Bleeding episodes and control of bleeding during surgery in haemophilia A or B patients.
• Bleeding due to factor VII deficiency: Bleeding control during surgery or invasive procedures in patients with factor VII deficiency.
• Glanzmann's thrombasthenia: Bleeding control during surgery or invasive procedures in patients with Glanzmann's thrombasthenia.

Recombinant factor VIIa is a biosynthetic preparation of activated factor VII produced by recombinant DNA technology. It is a vitamin K-dependent glycoprotein. It promotes haemostasis by activating the extrinsic pathway of the coagulation cascade. It replaces deficient activated coagulation factor VII, which complexes with tissue factor and may activate coagulation factor X and factor IX.

Adult Dose:

• Bleeding in haemophilia patients: 90 mcg/kg IV bolus (2-5 min); additional doses may be given 2-3 hrly as needed.
• Bleeding due to factor VII deficiency: 15-30 mcg/kg IV bolus (2-5 min) 4-6 hrly until haemostasis achieved.
• Glanzmann's thrombasthenia: 90 mcg/kg IV bolus (2-5 min) 2 hrly; give at least 3 doses.

Common Side Effects:

• Blood clot in the blood vessels (thromboembolic events)
• Nausea
• Vomiting
• Skin reactions
• Fever
• Headache
• Changes in blood pressure
• Anaphylaxis (rare)

Use in Pregnancy: It is preferable to avoid use during pregnancy. Animal studies have shown adverse effects on the fetus. Should be given only if potential benefit justifies potential risk.

Precautions:

• It is not known whether Eptacog Alfa alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
• Caution in advanced atherosclerotic disease, crush injury, septicemia or disseminated intravascular coagulation (DIC).
• Caution in patients with history of CHD, liver disease, undergoing major surgery, at risk of thromboembolic phenomena.
• Remote possibility of hypersensitivity to mouse IgG, bovine IgG & other residual culture proteins.
• Monitor prothrombin time & factor VII coagulant activity in factor VII deficient patients.

Overdose: Overdose may cause thrombosis or thromboembolic events. In case of overdose, seek immediate medical attention.

Storage: Store between 2-25°C prior to reconstitution. Do not freeze. Protect from light. For reconstitution, add the recommended diluent (histidine) and swirl gently until dissolved.