국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Octreotide acetate 0.56 mg/mL equivalent to octreotide 500 mcg/mL
Max Health Limited
Octreotide acetate 0.56 mg/mL (equivalent to octreotide 500 mcg/mL)
500 mcg/mL
Solution for injection
Active: Octreotide acetate 0.56 mg/mL equivalent to octreotide 500 mcg/mL Excipient: Glycine Hydrochloric acid Mannitol Water for injection
Ampoule, glass, Type I, box of five 1 mL ampoules, 5 mL
Prescription
Prescription
BCN Peptides SA
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. Octreotide treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.
Package - Contents - Shelf Life: Ampoule, glass, Type I, box of five 1 mL ampoules - 5 mL - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 2 weeks not refrigerated stored at or below 25°C protect from light
2011-07-11
Page 1 of 15 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Octreotide 0.05 mg/mL, 0.1 mg/mL and 0.5 mg/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL ampoule of Octreotide solution for injection contains 0.05 mg, 0.1 mg or 0.5 mg of octreotide as octreotide acetate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Octreotide is a clear colourless solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For 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. Octreotide treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. For the relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumours: • Carcinoid tumours with features of the carcinoid syndrome • Vasoactive intestinal peptide secreting tumours (VIPomas) • Glucagonomas • Gastrinomas/Zollinger-Ellis syndrome, usually in conjunction with proton pump inhibitors, or H2-antagonist therapy • Insulinomas, for pre-operative control of hypoglycaemia and for maintenance therapy • GRFomas. Octreotide is not an antitumour therapy and is not curative in these patients. For prevention of complications following pancreatic surgery. Emergency management to stop bleeding and to protect from re-bleeding owing to gastro- oesophageal varices in patients with cirrhosis. Octreotide is to be used in association with specific treatment such as endoscopic sclerotherapy. Page 2 of 15 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Acromegaly Initially 0.05 to 0.1 mg by subcutaneous 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. 전체 문서 읽기