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| Drug class description : | Factor VIII. |
| Generic Name : | Recombinant factor VIII (rDNA) (cho) [moroctocog alfa] |
| Drug description : | Lyophilised powder in vials plus solvent for solution for injection and administration set. |
| Presentation : | Powder for injection, moroctocog alfa (recombinant coagulation factor VIII) with nominal antihaemophilic factor activities of 250i.u. , 500i.u. , 1,000i.u. |
| Indications : | Control and prevention of haemorrhagic episodes and for routine and surgical prophylaxis in patients with haemophilia A (congenital factor VIII deficiency or classic haemophilia). |
| Adult Dosage : | Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia A. Administered by slow intravenous injection according to body weight, severity of haemorrhage and presence of inhibitors. Refer to Summary of Product Characteristics. Characteristics. |
| Child Dosage : | Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia A. Administered by slow intravenous injection according to body weight, severity of haemorrhage and presence of inhibitors. Refer to Summary of Product Characteristics. |
| Contra Indications : | Known severe hypersensitivity to the active substance or to mouse, hamster or bovine proteins or any of the excipients. As ReFacto does not contain von Willebrand factor, do not use for von Willebrand's disease. |
| Special Precautions : | Advise patients of early signs of hypersensitivity reactions. Pregnancy and lactation. Monitor for Factor VIII inhibitors and activity regularly. |
| Interactions : | No formal drug interaction studies have been conducted with ReFacto. |
| Adverse Reactions : | Hypersensitivity reactions - discontinue. Headache, fever, chills, flushing, nausea, vomiting, lethargy. Development of inhibitors. In trials the following adverse affects were reported: nausea, dyspnoea, venous access catheter complications, headache, paraesthesia, transaminase elevation, altered taste, fever, dizziness, chills, injection site reaction, somnolence, fatigue, perspiration, pain, anaphylaxis, acne, pruritus, rash, blurred vision, anorexia, gastritis, gastroenteritis, tachycardia, coughing, trauma, moniliasis, increased bilirubin, slight creatinine phosphokinase muscle brain isotype (CK MB) elevation and muscle weakness. |
| Manufacturer : | Wyeth |
| Drug Availability : | (POM) |
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