Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FACTOR VIII/ANTIHAEMOPHILIC FACTOR/AHF
GRIFOLS MALAYSIA SDN. BHD.
FACTOR VIII/ANTIHAEMOPHILIC FACTOR/AHF
5ml mL
Grifols Therapeutics, Inc.
KOĀTE-DVI _Consumer Medication Information Leaflet (RiMUP) _ Active Ingredient: antihemophilic factor VIII (human) 250 IU / 5 mL Page 1 WHAT IS IN THIS LEAFLET 1. What KOĀTE-DVI is used for 2. How it works 3. Before you use KOĀTE-DVI 4. How to use KOĀTE-DVI 5. While you are using it 6. Side effects 7. Storage and Disposal of KOĀTE-DVI 8. Further Information WHAT KOĀTE-DVI IS USED FOR KOĀTE-DVI is used for the treatment and prevention of bleeding, or in order to perform emergency and elective surgery, for patients with haemophilia A (congenital factor VIII deficiency). Limitation of use KOĀTE-DVI is not indicated for the treatment of von Willebrand disease. HOW KOĀTE-DVI WORKS KOĀTE-DVI is one of the group of medicines called clotting factors. KOĀTE-DVI contains human coagulation factor VIII obtained from human plasma. KOATE-DVI temporarily replaces the missing clotting factor in order to control or prevent bleeding episodes. BEFORE YOU USE KOĀTE-DVI -When you must not use it Do not use KOĀTE-DVI if you are allergic to human coagulation factor VIII or to any of the other ingredients of this medicine (see FURTHER INFORMATION ). If you want more detailed information then ask your doctor. - Before you start to use it Talk to your doctor, pharmacist or nurse before using KOĀTE-DVI. • Rarely you may have an anaphylactic reaction (a sudden severe allergic reaction) such as rash, tightness of the chest, dizziness, nausea, vomiting, or difficulty breathing. If these symptoms occur, you must stop using the product immediately and contact your doctor. • Your doctor should perform some tests to make sure that the dosage of KOĀTE-DVI you are receiving is enough to achieve and maintain appropriate coagulation factor VIII levels and thus stop any bleeding. • If your bleeding is not controlled with KOĀTE-DVI, consult your doctor immediately. You may have developed factor VIII inhibitors. These are antibodies which block the clotting effect of factor VIII. Your doctor will perform some tests to confirm wheth Прочитать полный документ
colors: BLACK K/P Corporation Job No. 41292 / 45648 / 47272 Client: Grifols Therapeutics LLC Cat. No. 3054840 Fonts: Nimbus Sans Condensed Edits: reb Date: 11/18/2016, 10/21, 10/22, 1/20/2020 1/21, 1/22, 2/6 ID: 1,4,14 Size: 5-1/8" x 15" (Spec 9024812) Proof 7 Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (% normal or IU/dL) x 0.5 • Estimate the expected _in vivo_ peak increase in Factor VIII level, expressed as IU/dL (or % normal), using the following formula: Estimated Increment of Factor VIII (% normal or IU/dL) = [Total Dose (IU)/Body Weight (kg)] x 2 • Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Base the dose and frequency on the individual clinical response. Control and Prevention of Bleeding Episodes A guide for dosing KOĀTE-DVI for the control and prevention of bleeding episodes (1,2) is provided in Table 1. Consideration should be given to maintaining a Factor VIII activity at or above the target range. Table 1: Dosage Guidelines for Patients with Hemophilia A Type of Bleeding Factor VIII:C Level Required (% of normal) Doses (IU/kg) Frequency of Doses (hours) Duration of Therapy (days) Minor Large bruises Significant cuts or scrapes Uncomplicated joint hemorrhage 30 15 12 (twice daily) Until hemorrhage stops and healing has been achieved (1–2 days). Moderate Nose, mouth and gum bleeds Dental extractions Hematuria 50 25 12 (twice daily) Until healing has been achieved (2–7 days, on average). Major Joint hemorrhage Muscle hemorrhage Major trauma Hematuria Intracranial and intraperitoneal bleeding 80-100 Initial: 40-50 Maintenance: 25 12 (twice daily) For at least 3–5 days Until healing has been achieved for up to 10 days. Intracranial hemorrhage may require prophylaxis therapy for up to 6 months. Surgery Prior to surgery: 80-100 After surgery: 60-100 40-50 30-50 Once 12 (twice daily) Prior to surgery For the next 7–10 days, or until healing has been achieved. It should be emphasized that the dosage of KOĀTE-DVI required for Прочитать полный документ