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
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. |
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 |
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.
Norgine Pharmaceuticals Limited, Norgine House, Widewater place, Moorhall Road, Harefield, Middlesex, UB9 6NS, UK
PL 20011/0051
Date of latest renewal: 10 February 2002
| Drug | Countries | |
|---|---|---|
| ISOKET | Germany, Estonia, Ireland, Lithuania, Malta, Mexico, United Kingdom |
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