Isoket 1mg/ml Concentrate for solution for injection or infusion, 10 ml Ampoule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

isosorbide dinitrate

Available from:

UCB Pharma Limited

ATC code:

C01DA08

INN (International Name):

isosorbide dinitrate

Dosage:

1mg/ml

Pharmaceutical form:

Concentrate for solution for injection or infusion

Units in package:

10 x 10 ml ampoules

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic group:

Vasodilators used in cardiac diseases

Therapeutic indications:

It is indicated in the treatment of unresponsive left ventricular failure secondary to acute myocardial infarction, unresponsive left ventricular failure of various aetiology and severe or unstable angina pectoris. and during percutaneous transluminal coronary angioplasty to facilitate prolongation of balloon inflation and to prevent or relieve coronary spasm.

Authorization status:

Authorised

Authorization date:

2015-08-07

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoket 1mg/ml Concentrate for solution for injection or infusion, 10 ml Ampoule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1mg isosorbide dinitrate.
Each 10 ml ampoule contains 10mg isosorbide dinitrate.
Each ml of concentrated solution contains 3.54mg sodium (as sodium chloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for injection or infusion (sterile concentrate).
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intravenous
Isoket is indicated in the treatment of unresponsive left ventricular failure secondary to acute myocardial infarction,
unresponsive left ventricular failure of various aetiology and severe or unstable angina pectoris.
Intra-coronary
Isoket is indicated during percutaneous transluminal coronary angioplasty to facilitate prolongation of balloon inflation
and to prevent or relieve coronary spasm.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
Adults, including the elderly.
Intravenous route
A dose of between 2 mg and 12 mg per hour is usually satisfactory. However, dosages up to 20 mg per hour
administered should be adjusted to the patient response.
Intra-coronary Route
The usual dose is 1 mg given as a bolus injection prior to balloon inflation. Further doses may be given not exceeding
5 mg within a 30 minute period.
Children
The safety and efficacy of Isoket has not yet been established in children.
Elderly
There’s no evidence that dose adjustment in elderly patients is needed.
Administration
Isoket is a concentrated solution and must be diluted prior to use. The diluted solution should never be injected directly
in the form of a bolus except via the intra- coronary route prior to balloon�