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1. NAME OF THE MEDICINAL PRODUCT
Name change from Mayne to Hospira
Octreotide Hospira 100 micrograms/1 ml Solution for Injection
4. Clinical particulars
Name change from Mayne to Hospira
4.1 Therapeutic indications
For the relief of symptoms associated with gastroenteropancreatic tumours (GEP tumours) including:
• Carcinoid tumours with features of carcinoid syndrome
• VIPomas
• Glucagonomas
Octreotide Hospira is not an antitumour therapy and is therefore not curative in these patients.
4.2 Posology and method of administration
Name change from Mayne to Hospira throughout section 4.2
Administration by the subcutaneous route:
Octreotide Hospira should be administered by the subcutaneous route without reconstitution or dilution.
Administration by the intravenous route:
GEP tumours where a rapid response is needed (i.v. administration as a bolus): Octreotide Hospira 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.
To reduce discomfort, let Octreotide Hospira injection reach room temperature before administration. Avoid multiple injections at short intervals at the same administration site.
Octreotide Hospira injection should be inspected prior to administration and only clear solutions without particles should be used.
4.3 Contraindications
Name change from Mayne to Hospira
Hypersensitivity to Octreotide or to any of the excipients of Octreotide Hospira (see section 6.1 Full list of excipients).
4.4 Special warnings and precautions for use
Name change from Mayne to Hospira throughout section 4.4
Octreotide should only be used under specialist hospital supervision with appropriate facilities available for diagnosis and evaluation of response.
As growth hormone secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defect), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures should be considered.
Sudden escape of gastroenteropancreatic endocrine tumours from symptomatic control by Octreotide may occur rarely, with rapid recurrence of severe symptoms.
Octreotide Hospira 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.
Blood glucose levels should therefore be carefully monitored particularly at the initiation of treatment with Octreotide Hospira or when the dose is changed. Unstable blood sugar concentrations may be avoided by dividing the daily dose into several injections
Thyroid function should be monitored in patients receiving long-term Octreotide therapy.
In patients with cirrhosis, dosage adjustment may be necessary (see section 4.2. Posology and Method of Administration).
The development of gallstones has been reported (estimated at between 15% and 30%) in association with Octreotide treatment. Ultrasonic examination for gallstones before, and at 6 to 12 month intervals during prolonged Octreotide treatment is recommended. The presence of gallstones in patients treated with Octreotide is usually asymptomatic; symptomatic stones should be treated in normal manner.
Liver function should be monitored during treatment with Octreotide Hospira.
6.3 Shelf life
Name change from Mayne to Hospira
Medicinal product as packaged for sale: 2 years
Shelf-life after first opening: The product must be used immediately and any unused drug-product must be discarded.
Storage conditions after dilution:
The chemical and physical stability of Octreotide Hospira 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
Name change from Mayne to Hospira
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 Hospira solution for injection.
Packs of 5 and 30 vials containing 1 ml of solution for injection.
Not all pack sizes may be marketed.
7. MARKETING AUTHORISATION HOLDER
Address change
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW
United Kingdom
10. DATE OF REVISION OF THE TEXT
Date change
January 2008
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