Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MOROCTOCOG ALFA
PFIZER (MALAYSIA) SDN. BHD.
MOROCTOCOG ALFA
4ml 1 Units; 4ml 1 Units
WYETH FARMA, S.A
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ XYNTHA ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Moroctocog alfa (250 IU, 500 IU, 1000 IU or 2000 IU)Xyntha 1 WHAT IS IN THIS LEAFLET 1. What XYNTHA is used for 2. How XYNTHA works 3. Before you use XYNTHA 4. How to use XYNTHA 5. While you are using it 6. Side Effects 7. Storage and Disposal of XYNTHA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT XYNTHA IS USED FOR XYNTHA is an injectable medicine that is used to help control and reduce bleeding in people with hemophilia A (a bleeding disorder in which the blood does not clot properly). XYNTHA is also used after surgery. XYNTHA is not used to treat von Willebrand’s disease (A bleeding disorder caused by low levels of clotting protein in the blood). XYNTHA is appropriate for use in children of all ages, including newborns. HOW XYNTHA WORKS XYNTHA temporarily replaces the missing clotting factor VIII that is needed for effective bleeding stoppage and repairing the damage of injury. BEFORE YOU USE XYNTHA - _When you must not use it_ Do not take XYNTHA - if you are hypersensitive (allergic) to XYNTHA or to any of the other ingredients of the medicine. _Pregnancy and lactation_ Consult your doctor if you are pregnant, trying to get pregnant or think you may be pregnant. It is not known if XYNTHA may harm your unborn baby or passes into your milk and if it can harm your baby. Do not take XYNTHA if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Talk to your doctor, pharmacist or nurse before taking XYNTHA: - if you have a symptoms of allergic reaction like rash with itching, chest tightness, wheezing, low blood pressure. Discontinue XYNTHA if allergic symptoms occur and administer appropriate emergency treatment. - _Taking other medicines_ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, superma Lestu allt skjalið
Pfizer Confidential CLD T itle : Moroctocog alfa (Xyntha) CLD Date : 21 27 August March 20210 Country : Malaysia Reference Document : USPI Dated 14 August 2020 Reason for change : PfLEET 2021-0068668 (D): Addition of Routine Prophylaxis indication2016-0022456 (D): PLLR Conversion per FDA PLLR : PfLEET 2018-0043970 (D): T he moroctocog alfa (AF-CC) CDS is being revised to provide additional information based on the completion of study B1831001 (#313) (an open label clinical study evaluating efficacy, safety and PK of 2 prophylaxis treatment regimens in children). Pfizer Confidential 1 XYNTHA ® MOROCTOCOG ALFA 1. NAME O F THE MEDIC INAL PRO DUC T XYNT HA 250 IU powder and solvent for solution for injection XYNT HA 500 IU powder and solvent for solution for injection XYNT HA 1000 IU powder and solvent for solution for injection XYNT HA 2000 IU powder and solvent for solution for injection 2. Q UALITATIVE AND Q UANTITATIVE C O MPO SITIO N T he active ingredient in XYNT HA, Antihemophilic Factor (Recombinant), is a recombinant antihemophilic factor (rAHF), also called coagulation factor VIII, which is produced by recombinant DNA technology. It is secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. T he cell line is grown in a chemically defined cell culture medium that contains recombinant insulin , but does not contain any materials derived from human or animal sources. T he rAHF in XYNTHA is a purified glycoprotein, with an approximate molecular mass of 170 kDa consisting of 1,438 amino acids, which does not contain the B-domain. The amino acid sequence of the rAHF is comparable to the 90 + 80 kDa form of human coagulation factor VIII. T he purification process uses a series of chromatography steps, one of which is based on affinity chromatography using a patented synthetic peptide affinity ligand. T he process also includes a solvent-detergent viral inactivation step and a virus-retaining nanofiltration step. T he potency expressed in International Units (IU) is determined using the chromog Lestu allt skjalið