Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
OCTREOTIDE ACETATE
Fresenius Kabi Limited
H01CB02
OCTREOTIDE ACETATE
50 Microgram/ML
Solution for Injection
Product subject to prescription which may not be renewed (A)
Somatostatin and analogues
Authorised
2013-03-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Octreotide 50 micrograms/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of 1 ml solution for injection contains octreotide acetate equivalent to 50 micrograms octreotide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless to slightly brownish solution. pH of the solution: 3.9 – 4.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 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 tumours, e.g.carcinoid tumours with features of carcinoid syndrome (see section 5.1). Octreotide is not an anti-tumour therapy and is not curative in these patients. 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. Treatment of TSH-secreting pituitary adenomas: when secretion has not normalised after surgery and/or radiotherapy; in patients in whom surgery is inappropriate; in irradiated patients, until radiotherapy is effective. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Acromegaly_ Initially 0.05to 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 Läs hela dokumentet