Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
LANREOTIDE AS ACETATE
MEDISON PHARMA LTD
H01CB03
SOLUTION FOR INJECTION
LANREOTIDE AS ACETATE 90 MG/DOSE
DEEP S.C.
Required
IPSEN PHARMA, FRANCE
LANREOTIDE
LANREOTIDE
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 treatmfent .The goal of treatment in acromegaly is to reduce GH and IGF-1 levels and where possible to normalize these values. Somatuline autogel is also indicated for the treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.Somatuline autogel is also indicated for the treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (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.
2017-12-31
SOMA-PIL-1021-V1 Page 1 of 12 Somatuline-Autogel-60-90-120-mg-ENG-D30-F Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Somatuline Autogel 60 mg Somatuline Autogel 90 mg Somatuline Autogel 120 mg Solution for injection in a pre-filled syringe Each pre-filled syringe contains lanreotide acetate at a ratio of 0.246 mg lanreotide base in 1 mg of solution. Name and quantity of active ingredient: Somatuline Autogel 60 mg: Each pre-filled syringe contains 60 mg lanreotide (as acetate) Somatuline Autogel 90 mg: Each pre-filled syringe contains 90 mg lanreotide (as acetate) Somatuline Autogel 120 mg: Each pre-filled syringe contains 120 mg lanreotide (as acetate) For a list of inactive ingredients: see section 6 'Additional information'. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. What is this medicine intended for? This medicine is intended for: The treatment of acromegaly (a condition where your body produces too much growth hormone) when growth hormone and/or IGF-1 levels remain abnormal after surgery and/or radiotherapy. The treatment of symptoms associated with neuroendocrine tumors. The treatment and control of some advanced tumors of the intestine and pancreas (called gastroenteropancreatic neuroendocrine tumors or GEP- NETs) when these tumors cannot be removed by surgery. Therapeutic group: somatostatin analogs. 2. Before using this medicine Do not use this medicine if: You are sensitive (allergic) to the active ingredient lanreotide, somatostatin or medicines from the same family (analogs of somatostatin) or any of the other ingredients that this medicine contains (listed Διαβάστε το πλήρες έγγραφο
SOMA-SPC- 1223 -V1 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Somatuline ® Autogel ® 60 mg Somatuline ® Autogel ® 90 mg Somatuline ® Autogel ® 120 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Somatuline ® Autogel ® 60 mg: Each pre-filled syringe contains 60 mg of lanreotide (as acetate) Somatuline ® Autogel ® 90 mg: Each pre-filled syringe contains 90 mg of lanreotide (as acetate) Somatuline ® Autogel ® 120 mg: Each pre-filled syringe contains 120 mg of lanreotide (as acetate) Each pre-filled 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 section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled 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. SOMA-SPC- 1223 -V1 Page 2 of 12 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 red Διαβάστε το πλήρες έγγραφο