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

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Isosorbide dinitrate

Sẵn có từ:

Merus Labs Luxco II S.à.R.L.

Mã ATC:

C01DA; C01DA08

INN (Tên quốc tế):

Isosorbide dinitrate

Liều dùng:

0.1 percent weight/volume

Dạng dược phẩm:

Concentrate for solution for infusion

Loại thuốc theo toa:

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

Khu trị liệu:

Organic nitrates; isosorbide dinitrate

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

1984-11-13

Đặc tính sản phẩm

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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