Isoket 0.5 mg/ml Solution for Infusion or Injection

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:

0.05 percent weight/volume

Pharmaceutical form:

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:

1989-01-09

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoket 0.5 mg/ml Solution for Infusion or Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Isosorbide dinitrate 0.05% w/v, equivalent to 25 mg/50 ml (500
micrograms/ml).
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
Solution for infusion or injection
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 aetiologies 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
Adults, including the elderly
_INTRAVENOUS ROUTE:_
Isoket 0.5 mg/ml (undiluted) is intended for intravenous
administration by slow infusion via a syringe pump.
Alternatively it can be administered as an admixture with a suitable
vehicle such as Sodium Chloride Injection B.P. or
Dextrose Injection B.P.
A dose of between 2 mg and 12 mg per hour is usually satisfactory.
However, dosages up to 20 mg per hour may be
required. In all cases the dose administered should be adjusted to the
patient response.
_INTRA-CORONARY ROUTE:_
Isoket 0.5 mg/ml can be injected directly by this route according to
the proposed dosage schedule.
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.
OLDER PEOPLE
There’s no evidence that dose adjustment in elderly patients is
needed.
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