Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Human coagulation factor VIII
DKSH MALAYSIA SDN. BHD.
Human coagulation factor VIII
10 ml
CSL Behring GmbH
BERIATE ® Human Coagulation Factor VIII (250IU, 500IU, 1000IU) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ WHAT IS IN THIS LEAFLET 1. What Beriate is used for 2. How Beriate works 3. Before you use Beriate 4. How to use Beriate 5. While you are using it 6. Side effects 7. Storage and Disposal of Beriate 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT BERIATE IS USED FOR Beriate 250/500/1000 is made from human plasma (this is the liquid part of the blood) and it contains human coagulation Factor VIII. It is used to prevent or to stop bleedings caused by the lack of Factor VIII (haemophilia A) in the blood. It may also be used in the management of acquired Factor VIII deficiency. HOW BERIATE WORKS Factor VIII is involved in blood clotting (coagulation). Lack of Factor VIII means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. The replacement of Factor VIII with Beriate 250/500/1000 will temporarily repair the coagulation mechanisms . BEFORE YOU USE BERIATE It is strongly recommended that every time that Beriate 250/500/1000 is given, you should record the date of administration, the batch number and the injected volume in your treatment diary. - _When you must not use it _ If you are allergic (hypersensitive) to the human coagulation factor VIII or to any of the ingredients of this medicine (listed in section Product Description). _ _ _Pregnancy and lactation _ If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. During pregnancy and breast-feeding, Beriate 250/500/1000 should be given only if it is clearly indicated. No fertility data are available. - _Before you start use it _ Talk to your doctor or pharmacist before using Beriate 250/500/1000. Allergic type hypersensitivity reactions are possible. Your doctor should inform you of the EARLY SIGNS OF HYPERSENSITIVITY REACTIONS. These include hives, generalised skin rash, tightness o সম্পূর্ণ নথি পড়ুন
Attachment-MY Beriate Proposed PI based on CCDS revision 23-AUG-2019 1. NAME OF THE MEDICINAL PRODUCT Beriate 250 IU Powder and solvent for solution for injection or infusion Beriate 500 IU Powder and solvent for solution for injection or infusion Beriate 1000 IU Powder and solvent for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains nominally: 250/500/1000 IU human coagulation factor VIII (FVIII). After reconstitution with 2.5/5/10 ml Beriate 250/500/1000 contains 100 IU/ml factor VIII. The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The mean specific activity of Beriate is approximately 400 IU/mg protein. Produced from the plasma of human donors. Excipient with known effect: Sodium approximately 100 mmol/l (2.3 mg/ml). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection or infusion. White powder and clear, colourless solvent for solution for injection/infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). This product may be used in the management of acquired factor VIII deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. Treatment monitoring During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in underweight or overweight patients. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. Patients should be monitored for the development of সম্পূর্ণ নথি পড়ুন