Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
Moroctocog alfa (AF-CC)
PFIZER PRIVATE LIMITED
B02BD02
2000IU/vial
INJECTION, POWDER, FOR SOLUTION
Moroctocog alfa (AF-CC) 2000IU/vial
INTRAVENOUS
Prescription Only
Vetter Pharma-Fertigung GmbH & Co. KG (Pre-filled Syringe Diluent)
ACTIVE
2010-04-28
MRP COMPONENT DESCRIPTION: COMPONENT PACKAGING PLANT ITEM CODE PHARMA CODE BARCODE NO. JOB NO. PASS NO. DATE LAST MODIFIED LITERATURA XYNTHA MY/SG PATIENT LEAFLET (Front) ALGETE PAA009563 87 N/A 262012A04 4 06 Apr 10 Profile Black TINT VALUES BLACK - 50% BLACK - 48% BLACK - 40% BLACK - 36% BLACK - 30% BLACK - 29% BLACK - 24% BLACK - 20% BLACK - 16% BLACK - 10% TEXT SIZE THE BODY TEXT ON THIS A/W IS AT: 8.0 PT THE SMALLEST TEXT ON THIS A/W IS AT: 4.7 PT FRONT Non printable area Bar code (Laetus) - High 5 mm Bar code (Laetus) DIMENSION: 575 X 350 MM (FOLDED: 115 X 58,3 MM) Code material - ALGETE (Font: Helvetica, Size: 7) PAA000000 Read Directio n PATIENT INFORMATION LEAFLET XYNTHA ™ ( ZIN-tha) [ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN-FREE] Please read this Patient Information carefully before using XYNTHA and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical problems or your treatment. WHAT IS XYNTHA? XYNTHA is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia A. Hemophilia A is also called classic hemophilia. XYNTHA is not used to treat von Willebrand’s disease. DOSAGE STRENGTHS: XYNTHA is supplied as white to off-white powder in the following dosages: • 250 IU (International Units) • 500 IU (International Units) • 1000 IU (International Units) • 2000 IU (International Units) WHAT SHOULD I TELL MY DOCTOR BEFORE USING XYNTHA AND WHEN SHOULD XYNTHA NOT BE USED? Tell your doctor about all of your medical conditions, including if you: • are pregnant or planning to become pregnant. It is not known if XYNTHA may harm your unborn baby. • are breastfeeding. It is not known if XYNTHA passes into your milk and if it can harm your baby. Tell your doctor and pharmacist about all Baca dokumen lengkap
1 NAME OF THE MEDICINAL PRODUCT XYNTHA 2 QUALITATIVE AND QUANTITATIVE COMPOSITION XYNTHA is supplied as a white to off-white powder in the following dosages: • 250 IU • 500 IU • 1000 IU • 2000 IU 3 PHARMACEUTICAL FORM Powder and solvent for solution for intravenous (IV) injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 4.1.1 CONTROL OF BLEEDING EPISODES IN HEMOPHILIA A XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). 4.1.2 ROUTINE AND SURGICAL PROPHYLAXIS IN PATIENTS WITH HEMOPHILIA A XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for routine and surgical prophylaxis in patients with hemophilia A. XYNTHA is appropriate for use in children of all ages, including newborns. XYNTHA does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION FOR INTRAVENOUS USE AFTER RECONSTITUTION • Treatment with XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free should be initiated under the supervision of a physician experienced in the treatment of hemophilia A. • Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Doses administered should be titrated to the patient's clinical response. In the presence of an inhibitor, higher doses may be required. • One International Unit (IU) of factor VIII activity corresponds approximately to the quantity of factor VIII in one milliliter (mL) of normal human plasma. The calculation of the required dosage of factor VIII is based upon the empirical finding that, on average, 1 IU of factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2 IU/dL. The required dosage is determined using the following formula: The expected _in vivo Baca dokumen lengkap