البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
TALIGLUCERASE ALFA
PFIZER PHARMACEUTICALS ISRAEL LTD
A16AB11
POWDER FOR SOLUTION FOR INFUSION
TALIGLUCERASE ALFA 200 U/VIAL
I.V
Required
PFIZER GLOBAL MANUFACTURIN, PHARMACIA AND UPJOHN COMPANY LLC, USA
TALIGLUCERASE ALFA
TALIGLUCERASE ALFA
ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease
2017-08-31
Elelyso PIL CC 190522 ENG 2022-0075212 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only ELELYSO ® POWDER FOR SOLUTION FOR INFUSION Each vial with powder contains: taliglucerase alfa 200 Units Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’ and 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 to treat your illness. 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? ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme given by injection that is indicated for long-term enzyme replacement therapy for adults and pediatric patients above 2 years with a confirmed diagnosis of Type 1 Gaucher disease. THERAPEUTIC GROUP: Recombinant active hydrolytic lysosomal enzyme, β-glucocerebrosidase 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (see section 6). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH ELELYSO, TELL YOUR DOCTOR IF: • You previously had a severe hypersensitivity reaction following intravenous infusion with ELELYSO. • You are pregnant or breastfeeding. TESTS AND FOLLOW-UP In patients who developed anti-drug antibodies or who had hypersensitivity reactions after treatment with ELELYSO or after treatment with other enzyme replacement therapy, it may be necessary to monitor the antibody levels. DRUG INTERACTIONS IF YOU ARE TAKING OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING NONPRESCRIPTION MEDICINES AND DIETARY SUPPLEMENTS, TELL YOUR DOCTOR OR PHARMACIST. اقرأ الوثيقة كاملة
Elelyso LPD CC 141223 1 2022-0083203 NAME OF THE MEDICINAL PRODUCT Elelyso ® QUALITATIVE AND QUANTITATIVE COMPOSITION Taliglucerase alfa 200 U/vial For the full list of excipients, see section "DESCRIPTION" below. PHARMACEUTICAL FORM Powder for solution for infusion 1 INDICATIONS AND USAGE ELELYSO (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults and pediatric patients above 2 years with a confirmed diagnosis of Type 1 Gaucher disease. 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSAGE Treatment-naïve patients: The recommended dosage for treatment-naïve adult and pediatric patients above 2 years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120 minute intravenous infusion. Patients switching from imiglucerase: If it is acceptable to switch from a stable imiglucerase dosage to ELELYSO, initiate ELELYSO intravenous treatment (60- to 120-minute infusion) with the same units/kg imiglucerase dosage and subsequently administer ELELYSO every other week. Dosage adjustments can be made based on achievement and maintenance of each patient’s therapeutic goals 2.2 PREPARATION INSTRUCTIONS ELELYSO should be reconstituted, diluted, and administered under the supervision of a healthcare professional. Prepare ELELYSO according to the following steps using aseptic technique: a. Determine the number of vials to be reconstituted based on the patient’s weight in kg and the recommended dose _[see Dosage and Administration_ _(2.1)]_. Round the number of vials up to the next whole number. b. Remove the required number of vials from the refrigerator. Do not leave these vials at room temperature longer than 24 hours prior to reconstitution. Do not heat or microwave these vials. Elelyso LPD CC 141223 2 2022-0083203 c. Reconstitute each vial of ELELYSO with 5.1 mL of Sterile Water for Injection to yield a reconstituted product with a concentration of 40 units/mL and an extracta اقرأ الوثيقة كاملة