NovoSeven eptacog alfa (activated) Name of the medicinal product NovoSeven Recombinant coagulation factor Vlla, eptacog alfa (activated) 60 KlU/vial (1.2 mg/vial)Composition Active ingredient: Recombinant coagulation factor Vlla.Excipients: Sodium Chloride, Calcium Chloride Dihydrate Glycylglycine, Polysorbate 80, Mannitol, Water for Injections PhEur. Pharmaceutical form Powder for injection. Strength of active ingredient The powder for injection contains: 60 KlU/vial corresponding to 1.2 mg/vial. The reconstituted product contains: 30 KlU/ml corresponding to 0.6 mg/ml. 1 KIU equals 1000 IU (International Units). Description - Package The NovoSeven package contains:
Pharmacotherapeutic group Coagulation factors, ATC code B02B D05. Marketing authorisation holder: Novo Nordist A/S Novo Allé, DK-2880 Bagsvaerd, Denmark.Manufacturer: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark.What you must know about the product which the doctor has prescribed for you General information NovoSeven is a medicine that works by activating the clotting system in the blood at the site of bleeding in patients with bleeding complications due to the development of inhibitors against coagulation factor VlIl or IX Therapeutic indications Contra-indications Inform your doctor before taking this product if you: - have just undergone surgery
Special warnings and special precautions during use Medication with NovoSeven should be guided by a specialised centre.See your doctor if your bleeding does not stop. Inform your doctor of known hypersensitivity to foreign protein. Keep all medicines safely away from children. Pregnancy and breastfeeding NovoSeven should only be given to a pregnant woman if clearly needed. If you are breast-feeding, your doctor may advise you to stop the treatment with NovoSeven or stop breast-feeding. Interactions with other medicines Before you take this medicine, you should consult your doctor concerning any other medicine you use. |
Dosage After reconstitution the medicine should be injected intravenously over 2-5 minutes (bolus injection). Dosage range 3-6 KIU (60-120 >9) per kg body weight per single dose. The initial dose is usually 4.5 KIU (90 µg) per kg body weight. Your doctor might change the dosage. Dosage intervals Consult your doctor regarding the dosage schedule and duration of treatment. The treatment may be continued for 2-3 weeks. Omission of dosage and sudden discontinuation of treatment should be advised by your doctor. Reconstitution Always use aseptic technique (eg wash your hands prior to use etc).
Administration
Remember to discard the used needles in a safe way (e.g. use the needle disposal can).
Overdose If too much NovoSeven is injected, seek medical advice at once.
Undesirable side effects Serious side effects are rarely seen with NovoSeven but in case anything unusual does happen, consult your doctor. On rare occasions reactions such as rash, itching fever, nausea, headache, general discomfort, perspiration or changes in blood pressure may occur. Major adverse events possibly related to treatment with NovoSeven have been reported in seven cases (renal failure, ataxia, cerebrovascular disorder, angina pectoris, atrial arrythmia and circulatory shock). continued |
Expiry date The expiry date is stated on the outer carton and labels. Do not use the product after this date. Special precautions for storage Keep NovoSeven refrigerated (2°C-8°C) Do not freeze, to prevent damage to the diluent bottle. |
Use preferably immediately or at least within 3 hours after reconstitution. Do not store reconstituted NovoSeven in plastic syringes. Do not expose to direct sunlight. Last revision: October 1995. |