Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Sandostatin 50 microgram/1 ml, solution for injection/infusion.
Sandostatin 100 microgram/1 ml, solution for injection/infusion.
Sandostatin 500 microgram/1 ml, solution for injection/infusion.
Octreotide 50 microgram /1 ml, solution for injection/infusion.
Octreotide 100 microgram/1 ml, solution for injection/infusion.
Octreotide 500 microgram/1 ml, solution for injection/ infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear, colourless solution. |
S*andostatin 50 microgram/1 ml, solution for injection/infusion:* One ampoule of 1 ml contains 50 microgram octreotide (as octreotide acetate)
Sandostatin 100 microgram/1 ml, solution for injection/infusion: One ampoule of 1 ml contains100 microgram octreotide (as octreotide acetate)
Sandostatin 500 microgram/1 ml, solution for injection/infusion: One ampoule of 1 ml contains 500 microgram octreotide (as octreotide acetate)
Excipient(s) with known effect: Contains less than 1 mmol (23 mg) sodium per dose, i.e. is essentially “sodium-free”.
For the full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Octreotide |
Octreotide is a synthetic octapeptide derivative of naturally occurring somatostatin with similar pharmacological effects, but with a considerably prolonged duration of action. It inhibits pathologically increased secretion of growth hormone (GH) and of peptides and serotonin produced within the GEP endocrine system. |
| List of Excipients |
|---|
|
Lactic acid |
One-point-cut colourless, type I glass ampoule with two colour code rings containing clear colourless solution.
Sandostatin 50 microgram/1 ml: one blue and one yellow.
Sandostatin 100 microgram/1 ml: one blue and one green.
Sandostatin 500 microgram/1 ml: one blue and one pink.
Packs of three, five, six, ten, twenty and fifty ampoules packed in a cardboard tray which is placed in an outer box.
Multipacks of ten packs, each containing three ampoules.
Not all strengths or pack sizes may be marketed.
NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Sandostatin 50 microgram/1 ml – PL 00101/0212
Sandostatin 100 microgram/1 ml – PL 00101/0213
Sandostatin 500 microgram/1 ml – PL 00101/0214
03 April 1989 / 07 June 2007
| Drug | Countries | |
|---|---|---|
| SANDOSTATIN | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Japan, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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