Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
teduglutide
Takeda Pharmaceuticals International AG Ireland Branch
A16AX08
teduglutide
Other alimentary tract and metabolism products,
Malabsorption Syndromes
Revestive 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.Revestive 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.
Revision: 22
Authorised
2012-08-30
47 B. PACKAGE LEAFLET 48 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT REVESTIVE 1.25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION teduglutide For children and adolescents This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your child’s doctor, pharmacist or nurse. - This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same. - If the child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Revestive is and what it is used for 2. What you need to know before you use Revestive 3. How to use Revestive 4. Possible side effects 5 How to store Revestive 6. Contents of the pack and other information 1. WHAT REVESTIVE IS AND WHAT IT IS USED FOR Revestive contains the active substance teduglutide. It improves the absorption of nutrients and fluid from your child’s remaining gastrointestinal tract (gut). Revestive is used to treat children and adolescents (aged 4 months 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE REVESTIVE DO NOT USE REVESTIVE - if your child is allergic to teduglutide or any of the other ingredients of this medicine (listed in section 6) or trace residues of tetracycline. - if your child has or is suspected to have cancer. - if your child has had cancer in the gastrointes Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Revestive 1.25 mg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder contains 1.25 mg of teduglutide*. After reconstitution, each vial contains 1.25 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 2.5 mg/ml. *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 and solvent for solution for injection. The powder is white and the solvent is clear and colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Revestive is indicated for the treatment of patients 4 months corrected gestational age 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 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 _Paediatric population (≥4 months) _ Treatment should be initiated under the supervision of a m Прочетете целия документ