| 1. NAME OF THE MEDICINAL PRODUCT
Octreotide 50 micrograms/1 ml Solution for Injection
4. Clinical particulars
4.1 Therapeutic indications
Para 2 - Octreotide is not an antitumour therapy and is therefore not curative in these patients.
4.2 Posology and method of administration
Para 1 - Administration by the subcutaneous route:
Octreotide should be administered by the subcutaneous route without reconstitution or dilution.
Para 2 - Administration by the intravenous route:
GEP tumours where a rapid response is needed (i.v. administration as a bolus): Octreotide should be diluted with 0.9% (w/v) Sodium Chloride solution for injection at a ratio not exceeding 1:100. Dilution with Glucose solution is not recommended.
Para 3 - To reduce discomfort, let Octreotide injection reach room temperature before administration. Avoid multiple injections at short intervals at the same administration site.
Para 4 - Octreotide injection should be inspected prior to administration and only clear solutions without particles should be used.
4.3 Contraindications
Hypersensitivity to Octreotide or to any of the excipients of Octreotide (see section 6.1 Full list of excipients).
4.4 Special warnings and precautions for use
Para 4 - Octreotide may reduce insulin requirements in patients receiving treatment for type I diabetes mellitus. In non-diabetics and type II diabetics with partially intact insulin reserves, Octreotide administration can result in prandial increases in glycaemia.
Para 5 - Blood glucose levels should therefore be carefully monitored particularly at the initiation of treatment with Octreotide or when the dose is changed. Unstable blood sugar concentrations may be avoided by dividing the daily dose into several injections
Para 8 - Liver function should be monitored during treatment with Octreotide.
6.3 Shelf life
Para 2 - Storage conditions after dilution:
The chemical and physical stability of Octreotide solution diluted in 0.9% sodium chloride solution for injection and stored in PVC bags or in polypropylene syringes has been demonstrated for seven days when stored at below 25ºC. From a microbiological point of view, the product should be used immediately. If not used immediately, storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2ºC to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.
6.5 Nature and contents of container
Para 1 - 2 ml Type I amber glass vials for injection, with a teflon-faced rubber stopper, aluminium seal and flip-off plastic cap, containing 1 ml of Octreotide solution for injection.
Packs of 5 and 30 vials containing 1 ml of solution for injection.
10. DATE OF REVISION OF THE TEXT
DATE CHANGE
June 2009
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