Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lanreotide acetate
Ipsen Ltd
H01CB03
Lanreotide acetate
240mg/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030403; GTIN: 5036611000240
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER SOMATULINE ® AUTOGEL ® 60 MG, SOLUTION FOR INJECTION IN A PREFILLED SYRINGE. SOMATULINE ® AUTOGEL ® 90 MG, SOLUTION FOR INJECTION IN A PREFILLED SYRINGE. SOMATULINE ® AUTOGEL ® 120 MG, SOLUTION FOR INJECTION IN A PREFILLED 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 symptoms and 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. 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 treatment of acromegaly (a condition where your body produces too much growth hormone) The relief of symptom Leggi il documento completo
OBJECT 1 SOMATULINE AUTOGEL 60 MG, SOLUTION FOR INJECTION IN A PREFILLED SYRINGE Summary of Product Characteristics Updated 04-Jan-2018 | Ipsen Ltd 1. Name of the medicinal product Somatuline ® Autogel ® 60 mg, solution for injection in a prefilled syringe Somatuline ® Autogel ® 90 mg, solution for injection in a prefilled syringe Somatuline ® Autogel ® 120 mg, solution for injection in a prefilled syringe 2. Qualitative and quantitative composition Lanreotide (I.N.N.), 60 mg, 90 mg or 120 mg (as acetate) Each prefilled syringe contains a supersaturated solution of lanreotide acetate corresponding to 0.246 mg lanreotide base/mg of solution, which ensures an actual injection dose of 60 mg, 90 mg or 120 mg of lanreotide, respectively. For excipients, see 6.1. 3. Pharmaceutical form Solution for injection in a prefilled syringe. White to pale yellow semi-solid formulation. 4. Clinical particulars 4.1 Therapeutic indications Somatuline Autogel is indicated for: • The treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatment. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels and where possible to normalise these values. • The treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours (GEP-NETs) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease (see section 5.1). • The treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumours. 4.2 Posology and method of administration POSOLOGY ACROMEGALY The recommended starting dose is 60 mg to 120 mg administered every 28 days. The dose should be individualised according to the response of the patient (as judged by a reduction in symptoms and/or a reduction in GH and/or IGF-1 le Leggi il documento completo