Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
OCTREOTIDE
NOVARTIS ISRAEL LTD
H01CB02
SOLUTION FOR INJECTION / INFUSION
OCTREOTIDE 0.05 MG/ML
S.C, I.V
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
OCTREOTIDE
OCTREOTIDE
Prevention of complications following pancreatic surgery. Symptomatic control and reduction of GH and IGF-1plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. Sandostatin treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery or in the interim period until radiotherapy becomes fully effective. Relief of symptoms associated with functional gastroenteropancreatic endocrine tumours: - Carcinoid tumours with features of the carcinoid syndrome - VIPomas - Glucagonomas - Gastrinomas / zollinger-Ellison syndrome usually in conjunction with proton pump inhibitors or H2- antagonist therapy - Insulinomas for pre-operative control of hypoglycaemia and for maintenance therapy - GRFomas. Sandostatin is not an antitumour therapy and is not curative in these patients.Emergency management of bleeding gastro-oesophageal varices secondary to cirrhosis in combination with specific therapy such as endoscopic sclerotherapy.
2020-03-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 This medicine is dispensed with a doctor’s prescription only SANDOSTATIN ® 0.05 MG/ML, SOLUTION FOR INJECTION/INFUSION Name and quantity of active ingredient: EACH 1 ML AMPOULE CONTAINS 0.05 MG OCTREOTIDE SANDOSTATIN ® 0.1 MG/ML, SOLUTION FOR INJECTION/INFUSION Name and quantity of active ingredient: EACH 1 ML AMPOULE CONTAINS 0.1 MG OCTREOTIDE SANDOSTATIN ® 0.5 MG/ML, SOLUTION FOR INJECTION/INFUSION Name and quantity of active ingredient: EACH 1 ML AMPOULE CONTAINS 0.5 MG OCTREOTIDE Inactive ingredients and allergens: see section 6 ‘Additional information’. See also ‘Important information about some of this medicine’s ingredients’. 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 for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is intended for: Preventing complications following pancreatic surgery. Controlling symptoms and reducing plasma levels of growth hormone (GH) and insulin like growth factor 1 (IGF 1) in patients with acromegaly whose illness is inadequately controlled by surgery or radiotherapy. Treatment with SANDOSTATIN is also intended for patients with acromegaly who are unfit or unwilling to undergo surgery or are in the interim period until radiotherapy becomes fully effective. Relief of symptoms associated with functional endocrine gastro entero pancreatic (GEP) tumors: • Carcinoid tumors with features of the carcinoid syndrome • VIPomas • Glucagonomas • Zollinger-Ellison syndrome, usually in combination with proton pump inhibitors or H 2 antagonists therapy • Insulinomas, for pre-operative control of hypoglycemia and maintenance treatment • GRFomas SANDOSTATIN is no Baca dokumen lengkap
SAS API DEC21 V4 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sandostatin 0.05mg/ml Sandostatin 0.1 mg/ ml Sandostatin 0.5 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule of 1 ml contains 0.05, 0.1 or 0.5 mg octreotide (as octreotide acetate) For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection /infusion. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1. Therapeutic Indications Prevention of complications following pancreatic surgery. Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. Sandostatin treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumors: • Carcinoid tumors with features of the carcinoid syndrome. • VIPomas. • Glucagonomas. • Gastrinomas/Zollinger-Ellison syndrome, usually in conjunction with proton pump inhibitors, or H2-antagonist therapy. • Insulinomas, for pre-operative control of hypoglycemia and for maintenance therapy. • GRFomas. Sandostatin is not an anti-tumors therapy and is not curative in these patients. Emergency management of bleeding gastro-esophageal varices secondary to cirrhosis in combination with specific therapy such as endoscopic sclerotherapy. 4.2. Posology and method of administration SAS API DEC21 V4 2 _ _ Posology General target population _Acromegaly _ Initially 0.05 to 0.1 mg by subcutaneous (s.c.) injection every 8 or 12 hours. Dosage adjustment should be based on monthly assessment of GH and IGF-1 levels (target: GH <2.5 ng/mL; IGF-1 within normal range) and clinical symptoms, and on tolerability. In most patients, the optimal daily dose will be 0.3 mg. A maximum dose of 1.5 mg per day should not be exceeded. For patients on a stable dose of Sandost Baca dokumen lengkap