OLATUTON Powder and solvent for suspension for injection Ref.[49976] Active ingredients: Octreotide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG, United Kingdom

Product name and form

Olatuton 10 mg Powder and Solvent for Prolonged-release Suspension for Injection.

Pharmaceutical Form

Powder and solvent for prolonged-release suspension for injection.

Powder: White to off-white powder, free of foreign particles.

Solvent: Clear, colourless solution, practically free from particles.

Qualitative and quantitative composition

Each vial contains octreotide acetate equivalent to 10 mg octreotide.

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)
Mannitol (E421)

Solvent (Prefilled syringe):

Carmellose sodium
Mannitol (E421)
Poloxamer
Water for injections

Pack sizes and marketing

Each unit contains one glass vial with rubber stopper (chlorobutyl rubber), sealed with an aluminium cap with a dark blue flip-off seal, containing powder for suspension for injection and one colourless pre-filled glass syringe with tip cap and plunger stopper (bromobutyl rubber) with 2 ml of solvent, co-packaged in a plastic tray with one vial adapter and one safety injection needle.

Packs of one and three units are available.

Not all pack sizes may be marketed.

Marketing authorization holder

TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG, United Kingdom

Marketing authorization dates and numbers

PL 00289/2219

29/05/2019

Drugs

Drug Countries
OLATUTON Ireland, Malta, United Kingdom

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