Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Teduglutide 5mg; Water for injection 0.5 mL
Takeda New Zealand Limited
5 mg
Powder for injection with diluent
Active: Teduglutide 5mg Excipient: Dibasic sodium phosphate heptahydrate Histidine Hydrochloric acid Mannitol Monobasic sodium phosphate monohydrate Sodium hydroxide Water for injection Active: Water for injection 0.5 mL
Prescription
Revestive is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Patients should be stable at least to 4 weeks on their parenteral support regimen before initiating teduglutide therapy
Package - Contents - Shelf Life: Combination pack, Drug product powder in Type I glass vial closed with rubber stopper, diluent in PFS - 28 dose units - 48 months from date of manufacture stored at or below 25°C. Do not freeze. - Syringe, glass, Diluent in PFS closed with rubber stopper - 1 dose units - 48 months from date of manufacture stored at or below 30°C. Do not freeze. - Vial, glass, Drug product powder in Type I glass vial closed with rubber stopper - 1 dose units - 48 months from date of manufacture stored at or below 25°C. Do not freeze.
2017-08-10
REVESTIVE ® NZ CMI V2.0 1 REVESTIVE ® _teduglutide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET BEFORE YOU START USING REVESTIVE. This leaflet answers some common questions about REVESTIVE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using REVESTIVE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. The information in this leaflet was last updated on the date listed in 'Product description' section'. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. WHAT REVESTIVE IS USED FOR REVESTIVE is used to treat adults with Short Bowel Syndrome who need additional nutrition or fluids from intravenous feeding (parenteral support). Short Bowel Syndrome is a disorder arising from an inability to absorb food nutrients and fluid across the gastrointestinal tract (gut). It is often caused by surgical removal of all or part of the small intestine. REVESTIVE contains the active substance teduglutide. It improves the absorption of nutrients and fluid from your remaining gut. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU USE REVESTIVE _WHEN YOU MUST NOT USE IT _ DO NOT USE REVESTIVE IF YOU HAVE AN ALLERGY TO: • any medicine containing teduglutide • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, t Đọc toàn bộ tài liệu
NEW ZEALAND DATA SHEET REVESTIVE DS V2.0 (CCDS V8) 1 1 REVESTIVE 5 mg powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 5 mg of teduglutide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. REVESTIVE contains teduglutide powder and solvent for solution for injection. Each single-use vial contains 5 mg of teduglutide as a white lyophilised powder. The solvent is water for injections. After reconstitution, each vial contains 5 mg teduglutide in 0.5 mL of solution, corresponding to a concentration of 10 mg/mL with pH 6.9-7.9. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications REVESTIVE is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Patients should be stable at least to 4 weeks on their parenteral support regimen before initiating teduglutide therapy. 4.2 Dose and method of administration Treatment should be initiated under the supervision of a medical professional with experience in the treatment of SBS. Dose The recommended daily dose of REVESTIVE is 0.05 mg/kg body weight administered by subcutaneous injection once daily. After reconstitution with the solvent (0.5 mL water for injections), the prepared solution from each vial contains 10 mg/mL of teduglutide. Treatment effect should be evaluated on an ongoing basis. Clinical assessment by the physician should consider individual treatment objectives and patient preferences. If no overall improvement is achieved after 12 months, the need for continued treatment should be assessed. Continued treatment is recommended for patients who have weaned off parenteral nutrition. _Special populations _ _Elderly: _No dose adjustment is necessary in patients above the age of 65 years. _Hepatic impairment: _No dose adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects. Teduglutide has not Đọc toàn bộ tài liệu