Aafact is a monoclonal purified factor VIII concentrate.
Made from FFP
It consists of a protein fraction prepared from fresh-frozen human plasma.
It is used in cases of acute haemorrhage, pre-operative and post-operative treatment and prophylaxis in haemophilia A patients (congenital factor VIII deficiency) and in patients with an acquired reduction in factor VIII activity.
Not indicated in
AAfact is not effective in Aafact in patients with other coagulation disorders, such as a congenital factor IX shortage (haemophilia B), acquired factor IX shortage, and an inherited coagulation illness called Von Willebrand’s disease.
It is available as a powder for infusion for intravenous administration. A vial of 5 or 10 ml of water for injections is supplied with the package.
- The active substance in Aafact is human coagulation factor VIII. After reconstitution in water for
- injection Aafact contains 100 IU factor VIII per ml.
- Aafact also contains the following excipients: polyethylene glycol, sodium chloride, albumin, Lhistidine and calcium chloride.
Contents of the pack
The commercial package comprises a vial of Aafact meant for 5 ml (500 IU) or 10 ml (1000 IU) of solution.
- The vial with powder should be stored in the box at 2°C - 8°C.
- The refrigerator is an appropriate place for this. Before its shelf life has expired, Aafact can be stored for 2 months at room temperature (15°C - 25°C).
The dosage varies and is determined by the treating physician. The exact dose will depend on the amount of factor VIII in your blood (your blood level), on the location and extent of the bleeding, on the severity of your clinical situation and on your body weight. Your physician will check your blood level regularly. After the administration of 1 IU (International Unit) of factor VIII per kilogram of body weight, your factor VIII blood level will increase by 2 IU/dl.
The usual dosage amount is:
- To prevent haemorrhages: 20 – 40 IU Aafact per kilogram of body weight, 2 – 3 times per week.
- More frequent administration or higher doses may be necessary in some cases.
- With haemorrhages and during operations: as much as is needed in order to achieve the desired blood level
Risk of diseases
In the early 1990s, pharmaceutical companies began to produce recombinant synthesized factor products, which now prevent nearly all forms of disease transmission during replacement therapy.
- Patients with haemophilia A may develop so-called antibodies (inhibitors) against factor VIII.
- In rare cases (1 to 10 in 10,000 users) sensitivity or allergic reactions may occur.
- In some cases the hypersensitivity reaction can proceed in a serious, life-threatening allergic reaction (anaphylaxis) whereby shock can occur
Do not use Aafact If you are hypersensitive (allergic) for the active substance or for any of the other excipients of Aafact
Cautions and warnings
- Immediately consult with your physician if, during treatment with Aafact, bleeding does not stop as expected.
- The product must be clear and may not contain any particles or lumps after reconstitution in the provided water for injections.
- The product must not be administered if any turbidity, particles or lumps are visible.
It is Manufactured in Europe by Sanquin Plasma Products B.V. Plesmanlaan 125 1066 CX Amsterdam The Netherlands.
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