Land: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LANREOTIDE ACETATE; LANREOTIDE ACETATE
ZUELLIG PHARMA SDN BHD
LANREOTIDE ACETATE; LANREOTIDE ACETATE
1 Units
IPSEN PHARMA BIOTECH
SOMATULINE® AUTOGEL® 60 MG, 90 MG, 120 MG Lanreotide Prolonged-release solution for injection in a pre-filled syringe Somatuline® Autogel® 60 mg, 90 mg and 120 mg is a prolonged-release solution for injection in a pre- filled syringe containing 60 mg, 90 mg and 120 mg of lanreotide acetate respectively. SOMATULINE® AUTOGEL® 60 MG 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 60 mg. For full list of excipients, see List of excipients. SOMATULINE® AUTOGEL® 90 MG 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 90 mg. For full list of excipients, see List of excipients. SOMATULINE® AUTOGEL® 120 MG 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. For full list of excipients, see List of excipients. PHARMACEUTICAL FORM Prolonged-release solution for injection in a pre-filled syringe. White to pale yellow semi-solid formulation. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS SOMATULINE® AUTOGEL® 60 MG & 90 MG • Treatment of acromegaly when secretion of Growth Hormone (GH) and Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy • Treatment of the clinical syndrome associated with acromegaly • Treatment of the clinical symptoms of neuroendocrine (particularly carcinoid) tumours SOMATULINE® AUTOGEL® 120 MG • Treatment of acromegaly when secretion of Growth Hormone (GH) and Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy • Treatment of the clinical syndrome associated with acromegaly • Treatment of the clinical symptoms of neuroendocrine (particularly carcinoid) tumours • Treatment of grade 1 and a subset of grade 2 Lestu allt skjalið