ISOKET Solution for Infusion 0.05 %w/v
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
10-05-2024
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Virkt innihaldsefni:
ISOSORBIDE DINITRATE
Fáanlegur frá:
UCB Pharma Limited
Skammtar:
0.05 %w/v
Lyfjaform:
Solution for Infusion
Leyfisdagur:
2010-08-06
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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.
IRISH MEDICINES BOARD
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