Isoket 0.5 mg/ml Solution for Infusion or Injection

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Isosorbide dinitrate

可用日期:

Merus Labs Luxco II S.à.R.L.

ATC代码:

C01DA; C01DA08

INN（国际名称）:

Isosorbide dinitrate

剂量:

0.05 percent weight/volume

药物剂型:

Solution for infusion

处方类型:

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

治疗领域:

Organic nitrates; isosorbide dinitrate

授权状态:

Not marketed

授权日期:

1989-01-09

产品特点

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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