Pays: Israël
Langue: anglais
Source: Ministry of Health
AGALSIDASE BETA
SANOFI ISRAEL LTD
A16AB04
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
AGALSIDASE BETA 35 MG/VIAL
I.V
Required
GENZYME EUROPE B.V., THE NETHERLANDS
AGALSIDASE BETA
AGALSIDASE BETA
Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. (alfa - galactosidase A deficiency).
2017-05-31
876954 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only FABRAZYME 35 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ACTIVE INGREDIENT: Each vial contains agalsidase beta 35 mg After reconstitution each vial contains 5 mg of agalsidase beta per ml. Inactive ingredients and allergens: see section 2 ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START 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 to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Fabrazyme is indicated for use as long‑term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. THERAPEUTIC GROUP: other alimentary tract and metabolism products – enzymes. Fabrazyme contains the active substance agalsidase beta and is used as enzyme replacement therapy in Fabry disease, where the level of α‑galactosidase enzyme activity is absent or lower than normal. If you suffer from Fabry disease, a fat substance, called globotriaosylceramide )GL‑3(, is not removed from the cells of your body and starts to accumulate in the walls of the blood vessels in your organs. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive )allergic( to agalsidase beta or to any of the other ingredients in this medicine )see section 6(. SPECIAL WARNINGS ABOUT USING THIS MEDICINE TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING FABRAZYME. If you are treated with Fabrazyme, you may develop infusion related reactions. An infusion related reaction is any side effect occurring during the infusion or until the end of the infusion day )see section 4(. If you e Lire le document complet
1 1. NAME OF THE MEDICINAL PRODUCT Fabrazyme 35 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains a nominal value of 35 mg of agalsidase beta. After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta. The reconstituted solution must be diluted further (see section 6.6). Agalsidase beta is a recombinant form of human α-galactosidase A and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture. The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of α-galactosidase. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white lyophilisate or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fabrazyme treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases. Posology The recommended dose of Fabrazyme is 1 mg/kg body weight administered once every 2 weeks as an intravenous infusion. Infusion of Fabrazyme at home may be considered for patients who are tolerating their infusions well. The decision to have a patient move to home infusion should be made after evaluation and recommendation by the treating physician. Patients experiencing adverse events during the home infusion need to immediately STOP THE INFUSION PROCESS and seek the attention of a healthcare professional. Subsequent infusions may need to occur in a clinical setting. Dose and infusion rate should remain constant while at home, and not be changed without supervision of a healthcare professional. _ _ Special populations _ _ _Renal impairment _ No dose adjustment is necessary fo Lire le document complet