GLYTRIN Sublingual spray, solution Ref.[27718] Active ingredients: Glycerol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU, United Kingdom

Product name and form

Glyceryl Trinitrate Spray 400 micrograms/metered dose, sublingual spray.

Pharmaceutical Form

Sublingual spray, solution.

(Sublingual spray)

Qualitative and quantitative composition

Glyceryl Trinitrate: 400 micrograms per metered dose.

Excipient(s) with known effect:

Ethanol (alcohol) – 7.5mg per spray.

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Glycerol

Glycerol has uses as a hyperosmotic, osmotic diuretic, and ophthalmic agent. It may be used as an eye drop in the treatment of glaucoma to reduce intraocular pressure, as a solution or suppository for short-term treatment of constipation, to evacuate the bowel prior to a colonoscopy, and in some ocular surgeries. It may be given intravenously to reduce pressure inside the brain and used externally on the skin as a moisturizer.

List of Excipients

Peppermint oil
Propellant HFC 134A (1,1,1.2 Tetrafluoroethane)
Ethanol

Pack sizes and marketing

Internally lacquered monobloc aluminium pressurised container (canister) sealed with a metered spray valve. The product is presented in packs with one container.

Each container contains either 1760.0 mg of solution (according to 11400.0 mg of solution and propellant) providing 200 single metered doses, or 1584.0 mg of solution (according to 10260.0 mg of solution and propellant) providing 180 metered doses.

Marketing authorization holder

Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU, United Kingdom

Marketing authorization dates and numbers

PL 16431/0018

15/09/2005

Drugs

Drug Countries
GLYTRIN Austria, Ireland, New Zealand, Singapore, United Kingdom

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