ISOKET Solution for infusion or injection Ref.[28020] Active ingredients: Isosorbide dinitrate

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Merus Labs Luxco II S.à r.l., 26-28, rue Edward Steichen, L-2540 Luxembourg

Product name and form

Isoket 0.5 mg/ml Solution for Infusion or Injection.

Pharmaceutical Form
Solution for infusion or injection. Clear, colourless solution.

Qualitative and quantitative composition

Each ml contains 0.5 mg of isosorbide dinitrate.

Each 10 ml pre-filled syringe contains 5 mg of isosorbide dinitrate.

Each 50 ml bottle contains 25 mg of isosorbide dinitrate.

Excipients:

Each ml contains 3.54 mg (0.154 mmol) sodium (as sodium chloride).

Each 10 ml pre-filled syringe also contains 35.4 mg (1.54 mmol) sodium (as sodium chloride).

Each 50 ml bottle also contains 177 mg (7.7 mmol) sodium (as sodium chloride).

For a full list of excipients, see section 6.1.

Active Ingredient	Description
Isosorbide dinitrate	Isosorbide dinitrate is an organic nitrate, which in common with other cardioactive nitrates, is a vasodilator.

List of Excipients
Sodium chloride Water for injection Hydrochloric acid for pH adjustment Sodium hydroxide for pH adjustment

Pack sizes and marketing

50 ml glass bottles (glass type 1 or 2) with a laminated rubber stopper. The stopper consists of butyl rubber. The inner side of the stopper, coming into contact with the product is laminated with a film, consisting of a copolymer of tetrafluorethylene, ethylene and a fluorine containing vinyl monomer.

10 ml prefilled glass syringes with rubber plunger, stopper and cap and polystyrene plunger rod.

Not all pack sizes may be marketed.

Marketing authorization holder

Merus Labs Luxco II S.à r.l., 26-28, rue Edward Steichen, L-2540 Luxembourg

Marketing authorization dates and numbers

PL 44374/0020

October 2003

Drugs

Drug	Countries
ISOKET	Germany, Estonia, Ireland, Lithuania, Malta, Mexico, United Kingdom

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