Indications : התוויות

Therapeutic indications                                        Concomitant administration of Octreotide and bromocriptine increases the bioavailability of bromocriptine.
Symptomatic treatment and reduction of growth hormone
(GH) and IGF-1 plasma levels in patients with acromegaly           Limited published data indicate that somatostatin analogues inadequately controlled by surgery or radiotherapy.                may decrease the metabolic clearance of compounds meta- Octreotide Bendalis is also indicated for acromegalic patients     bolised by cytochrome P450 enzymes, possibly due to the unable or unwilling to undergo surgery, or in the initial stage    suppression of growth hormone. As Octreotide cannot be until radiotherapy becomes fully effective.                        excluded as a cause of this effect, other medicinal products which are primarily metabolised by CYP3A4 and have a low
Treatment of symptoms associated with functional gastro- therapeutic index (e.g. quinidine, terfenadine) should be enteropancreatic (GEP) endocrine tumours, e.g. carcinoid administered with caution.
tumours with features of a carcinoid syndrome (see section 5.1).
Octreotide Bendalis is not an anti-tumour therapy and is           4.6 Fertility, pregnancy and lactation not curative in such patients.                                     Pregnancy Prevention of complications following pancreatic surgery.          There is only very limited experience (fewer than 300 preg- nancy outcomes) from the use of Octreotide in pregnant
Emergency management to stop bleeding and to prevent women, and in approximately one third of the cases the re-bleeding from gastro-oesophageal varices in patients pregnancy outcomes are unknown. The majority of reports with cirrhosis. In such cases, Octreotide Bendalis is to be were spontaneous, and more than 50 % of the pregnancies used in conjunction with specific treatment such as endo- involved patients with acromegaly. Most women were scopic sclerotherapy.
exposed to Octreotide during the first trimester of pregnancy
Treatment of TSH-secreting pituitary adenomas:                     at doses of 100-1200 micrograms/day of Octreotide Bendalis - when secretion has not returned to normal after surgery          s.c. or 10-40 mg/month of Octreotide Bendalis. Congenital and/or radiotherapy.                                             anomalies were reported in about 4 % of pregnancies for - in patients in whom surgery is inappropriate.                    which the outcome is known. No causal relationship with - in irradiated patients, until radiotherapy is effective.         Octreotide is suspected in these cases.