Isoket 1mg/ml Concentrate for solution for Injection or Infusion, 50ml bottle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Isosorbide dinitrate

Available from:

Merus Labs Luxco II S.à.R.L.

ATC code:

C01DA; C01DA08

INN (International Name):

Isosorbide dinitrate

Dosage:

0.1 percent weight/volume

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Organic nitrates; isosorbide dinitrate

Authorization status:

Not marketed

Authorization date:

1984-11-13

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoket 1mg/ml Concentrate for solution for Injection or Infusion, 50ml
bottle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre contains 1mg isosorbide dinitrate.
Each 50ml bottle contains 50mg isosorbide dinitrate.
Each millilitre also contains 3.54mg sodium (as sodium chloride)
Each 50ml bottle contains 177mg 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.
Paediatric population
The safety and efficacy of Isoket has not yet been established in
children.
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