Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
MOROCTOCOG ALFA
PFIZER PHARMACEUTICALS ISRAEL LTD
B02BD02
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
MOROCTOCOG ALFA 1000 IU/VIAL
I.V
Required
PFIZER INC, USA
COAGULATION FACTOR VIII
COAGULATION FACTOR VIII
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)
2022-12-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only XYNTHA ® 250 IU XYNTHA ® 500 IU XYNTHA ® 1000 IU XYNTHA ® 2000 IU LYOPHILIZED POWDER AND DILUENT FOR SOLUTION FOR INTRAVENOUS (IV) INJECTION EACH VIAL CONTAINS: MOROCTOCOG ALFA 250IU, 500IU, 1000IU, 2000IU For a list of inactive ingredients and allergens, see section 6, ‘Further information.’ READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Treatment and prophylaxis of bleeding in patients with hemophilia A )congenital factor VIII deficiency(. THERAPEUTIC GROUP: coagulation factor. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE if you have had immediate, life-threatening sensitivity reaction, including anaphylaxis, to the active ingredient or to any of the other ingredients in this medicine, which are listed in section 6, including sensitivity to protein derived from hamster. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE CONTACT YOUR DOCTOR IMMEDIATELY IF BLEEDING IS NOT CONTROLLED AFTER INJECTING THE MEDICINAL PRODUCT. BEFORE TREATMENT WITH XYNTHA ® , TELL YOUR DOCTOR IF: you have any allergies, including an allergy to hamsters. you are pregnant or are planning to become pregnant. you are breastfeeding or are planning to breastfeed. CHILDREN AND ADOLESCENTS XYNTHA ® may be used in children and adolescents of all ages. TESTS AND FOLLOW-UP Your body may produce antibodies to the medicinal product, that may reduce the efficacy of the medicinal product. The attending doctor may ask you to take periodic blood tests to monitor these antibodies in your blood. DRUG INTERACTIONS IF YOU ARE TAKING OR Prečítajte si celý dokument
Xyntha LPD WC 09 Aug 2022 1 2021-0072524 FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT XYNTHA ® 250 IU XYNTHA ® 500 IU XYNTHA ® 1000 IU XYNTHA ® 2000 IU QUALITATIVE AND QUANTITATIVE COMPOSITION For the full list of excipients ROUTE OF ADMINISTRATION DOSAGE FORM / STRENGTH CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS Intravenous Infusion Available as 250, 500, 1000, or 2000 IU in single-use vials. Polysorbate 80 (0.4 mg/vial or prefilled dual-chamber syringe ), Sucrose (12 mg/vial or prefilled dual- chamber syringe ), L-Histidine (6 mg/vial or prefilled dual-chamber syringe ), Calcium Chloride Dihydrate (1 mg/vial or prefilled dual-chamber syringe ), Sodium Chloride (72 mg/vial or prefilled dual-chamber syringe ) [after reconstitution with diluent]. Xyntha is prepared by a modified process that eliminates any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation. The purification process uses a series of chromatography steps, one of which is based on affinity chromatography using a synthetic peptide affinity ligand. The process also includes a solvent-detergent viral inactivation step and a virus-retaining nanofiltration step. The labelled potency of Xyntha is based on the European Pharmacopoeial chromogenic substrate assay, in which the Pfizer In-House Recombinant Factor VIII Potency Reference Standard has been calibrated to the WHO 7 th International Standard using the one-stage clotting assay. This method of potency assignment is intended to harmonize Xyntha with clinical monitoring using a one-stage clotting assay. 2. INDICATIONS AND CLINICAL USE Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) GERIATRICS (≥ 65 YEARS OF AGE): Clinical studies of Xyntha did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical Xyntha LPD WC 09 Aug 2022 2 2021-0072524 experience has not identified diffe Prečítajte si celý dokument