ISOKET 1 mg/ml Concentrate for solution for injection / infusion Ref.[7875] Active ingredients: Isosorbide dinitrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Norgine Pharmaceuticals Limited, Norgine House, Widewater place, Moorhall Road, Harefield, Middlesex, UB9 6NS, UK

Product name and form

Isoket 1 mg/ml concentrate for solution for injection or infusion.

Pharmaceutical Form

Concentrate for solution for injection or infusion (sterile concentrate).

Clear, colourless solution.

Qualitative and quantitative composition

Each ml contains 1 mg of isosorbide dinitrate.

Each 10 ml ampoule contains 10 mg of isosorbide dinitrate.

Each 50 ml bottle contains 50 mg of isosorbide dinitrate.

Each 100 ml contains 100 mg of isosorbide dinitrate.

Excipients with known effect:

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

Each 10 ml ampoule contains 35.4 mg (1.54 mmol) sodium (as sodium chloride).

Each 50 ml bottle contains 177 mg (7.70 mmol) sodium (as sodium chloride).

Each 100 ml bottle contains 354 mg (15.4 mmol) sodium (as sodium chloride).

For the 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 injections
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid solution (for pH-adjustment)

Pack sizes and marketing

Ten 10 ml clear glass ampoules.

Clear, Type I glass vials sealed with a grey stopper and a red flip-off aluminium cap, containing 50ml or 100ml of concentrate and packed in a cardboard carton.

Clear, Type I glass vials sealed with a grey stopper and a red flip-off aluminium cap, containing 50ml or 100ml of concentrate and packed in a cardboard carton containing a Sterifix Minispike to aid withdrawal of the product from the bottle.

Not all pack sizes may be marketed.

Marketing authorization holder

Norgine Pharmaceuticals Limited, Norgine House, Widewater place, Moorhall Road, Harefield, Middlesex, UB9 6NS, UK

Marketing authorization dates and numbers

PL 20011/0051

Date of latest renewal: 10 February 2002

Drugs

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

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