SANDOSTATIN Solution for injection Ref.[7977] Active ingredients: Octreotide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR

Product name and form

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.

Qualitative and quantitative composition

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
Mannitol (E421)
Sodium hydrogen carbonate
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR

Marketing authorization dates and numbers

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

Drugs

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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