Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Sandostatin LAR 10 mg, 20mg or 30mg powder and solvent for suspension for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for suspension for injection. Powder: White to white with yellowish tint. Solvent: Clear, colourless to slightly yellow or brown solution. |
One vial contains 10 mg, 20mg or 30mg octreotide (as octreotide acetate).
Excipients 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 |
|---|
|
Powder (Vial): Poly (DL-lactide-co-glycolide) Solvent (Prefilled syringe): Carmellose sodium |
Unit packs containing one 6 mL glass vial with rubber stopper (bromobutyl rubber), sealed with an aluminium flip-off seal, containing powder for suspension for injection and one 3 mL colourless pre-filled glass syringe with front and plunger stopper (chlorobutyl rubber) with 2 mL solvent, co-packaged in a sealed blister tray with one vial adapter and one safety injection needle.
Multipacks of three unit packs, each unit pack containing: one 6 mL glass vial with rubber stopper (bromobutyl rubber), sealed with an aluminium flip-off seal, containing powder for suspension for injection and one 3 mL colourless pre-filled glass syringe with front and plunger stopper (chlorobutyl rubber) with 2 mL solvent, co-packaged in a sealed blister tray with one vial adapter and one safety injection needle.
Not all pack sizes may be marketed.
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Sandostatin LAR 10mg: PL 00101/0511
Sandostatin LAR 20mg: PL 00101/0512
Sandostatin LAR 30mg: PL 00101/0513
29 April 1998
| Drug | Countries | |
|---|---|---|
| SANDOSTATIN LAR | Australia, Cyprus, Estonia, Croatia, Ireland, Japan, Lithuania, Malta, Romania, Singapore, Turkey, United Kingdom, South Africa |
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