Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Lanreotide
Originalis B.V.
H01CB; H01CB03
Lanreotide
Solution for injection in pre-filled syringe
Somatostatin and analogues; lanreotide
2023-02-10
PACKAGE LEAFLET: INFORMATION FOR THE USER SOMATULINE® AUTOGEL® 120 MG, SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE Lanreotide 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 doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Somatuline Autogel is and what it is used for 2. What you need to know before you use Somatuline Autogel 3. How to use Somatuline Autogel 4. Possible side effects 5. How to store Somatuline Autogel 6. Contents of the pack and other information 1. WHAT SOMATULINE AUTOGEL IS AND WHAT IT IS USED FOR WHAT SOMATULINE AUTOGEL IS AND HOW IT WORKS The name of your medicine is Somatuline Autogel. It is a long acting formulation of Somatuline. Lanreotide, the active substance, belongs to a group of medicines called ‘antigrowth hormones’. It is similar to another substance (a hormone) called ‘somatostatin’. Lanreotide lowers the levels of hormones in the body such as growth hormone (GH), and insulin-like growth factor 1 (IGF-1) and inhibits the release of some hormones in the gastrointestinal tract and intestinal secretions. Additionally, it has an effect on some advanced type of tumours (called neuroendocrine tumours) of the intestine and pancreas by stopping or delaying their growth. WHAT SOMATULINE AUTOGEL IS USED FOR: • The long term treatment of acromegaly (a condition where your body produces too much growth hormone) • The relief of symptoms associated with acromegaly such as feeling tired, headaches, sweating, joint pain and numb hands and feet • The relief of symptoms such as flushing and diarrhoea that Belgenin tamamını okuyun
Health Products Regulatory Authority 10 February 2023 CRN00D4QP Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Somatuline Autogel 120mg, solution for injection in a pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains a supersaturated solution of lanreotide acetate corresponding to 0.246 mg of lanreotide base/mg of solution, which ensures an actual injection dose of 120 mg of lanreotide. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in a pre-filled syringe. _ _ _Product imported from Belgium._ White to pale yellow semi solid formulation. 4 CLINICAL PARTICULARS As per PA0869/004/004 5 PHARMACOLOGICAL PROPERTIES As per PA0869/004/004 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Water for injections Glacial acetic acid (for pH adjustment) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the pouch, syringe and outer package of the product on the market in the country of origin. After opening the protective laminated pouch, the product should be administered immediately. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in refrigerator between (2°C to 8°C) in the original package. Once removed from the refrigerator, product left in its sealed pouch may be returned to the refrigerator for continued storage and later use, provided it has been stored for no longer than 24 hours at below 40°C and the number of temperature excursions does not exceed three. 6.5 NATURE AND CONTENTS OF CONTAINER Somatuline Autogel is supplied in a pre-filled syringe (clear polypropylene) fitted with an automatic safety system, a needle (stainless steel), a plastic needle sheath (LDPE) and a plunger stopper (bromobutyl rubber). Health Products Regulatory Authority 10 February 2023 CRN00D4QP Page 2 of 2 Each pre-filled syringe is packed in a laminated pouch (polyethylene teraphtalate/aluminium /polyethylene laminate) and a cardboard box. Box of one 0 Belgenin tamamını okuyun