OCTREOTIDE 100 Microgram/ML Solution for Injection

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

OCTREOTIDE ACETATE

Fáanlegur frá:

Fresenius Kabi Limited

ATC númer:

H01CB02

INN (Alþjóðlegt nafn):

OCTREOTIDE ACETATE

Skammtar:

100 Microgram/ML

Lyfjaform:

Solution for Injection

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Somatostatin and analogues

Leyfisstaða:

Authorised

Leyfisdagur:

2013-03-01

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Octreotide 100 micrograms/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 1 ml solution for injection contains octreotide acetate equivalent to 100 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: G