البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
TEDUGLUTIDE
NEOPHARM LTD, ISRAEL
A16AX08
POWDER FOR SOLUTION FOR INJECTION
TEDUGLUTIDE 5 MG/VIAL
S.C
Required
SHIRE NPS PHARMACEUTICALS INC., USA
TEDUGLUTIDE
Gattex is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.
2023-02-08
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (MEDICINAL PRODUCTS) 1986 This medicine can be sold with a physician's prescription only GATTEX 5MG POWDER FOR SOLUTION FOR SUBCUTANEOUS INJECTION ACTIVE INGREDIENT: Each vial contains 5 mg Teduglutide. For the list of excipients in the medicinal product, please see section 6: “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, contact the physician or the pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. In addition to the leaflet, a Patient Safety Information Card is available for Gattex. This card contains important safety information which you must know prior to starting treatment and during the treatment with Gattex and follow it. Read the Patient Safety Information Card and the Patient Leaflet prior to starting treatment with the medicinal product. Keep the card for further reading if required. 1. WHAT IS THE MEDICINE INTENDED FOR ? Gattex contains the active substance teduglutide. It improves the absorption of nutrients and fluid from your remaining gastrointestinal tract (gut). Gattex is used to treat adults, children and adolescents (aged 1 year and above) with Short Bowel Syndrome. Short Bowel Syndrome is a disorder arising from an inability to absorb food nutrients and fluid across the gut. It is often caused by surgical removal of all or part of the small intestine. No safety and efficacy data is available for children below the age of 1 year. THERAPEUTIC GROUP: alimentary tract and metabolism products. 2. BEFORE USING THIS MEDICINE DO NOT USE THE MEDICINE IF: • You are hypersensitive (allergic) to the active ingredient or any of the other ingredients that this medicine contains or to tetracyclines. • If you have or are suspected to have cancer . • If you have had can اقرأ الوثيقة كاملة
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT GATTEX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 5 mg of teduglutide*. *A glucagon-like peptide-2 (GLP-2) analogue produced in _Escherichia coli_ cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. The powder is white. PATIENT SAFETY INFORMATION CARD The marketing of Gattex is subject to a risk management plan (RMP) including a ‘Patient safety information card’. The ‘Patient safety information card’, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gattex is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a medical professional with experience in the treatment of Short Bowel Syndrome (SBS). Treatment should not be initiated until it is reasonable to assume that a patient is stable following a period of intestinal adaptation. Optimisation and stabilisation of intravenous fluid and nutrition support should be performed before initiation of treatment. Clinical assessment by the physician should consider individual treatment objectives and patient preferences. Treatment should be stopped if no overall improvement of the patient condition is achieved. Efficacy and safety in all patients should be closely monitored on an ongoing basis according to clinical treatment guidelines. Posology _Adults_ The recommended dose of Gattex is 0.05 mg/kg body weight once daily. The injection volume per body weight is provided below in Table 1. Due to the heterogeneity of the SBS population, a carefully monitored down-titr اقرأ الوثيقة كاملة