Isoket 1mg/ml Concentrate for solution for injection or infusion, 10 ml Ampoule

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Isosorbide dinitrate

Предлага се от:

Merus Labs Luxco II S.à.R.L.

АТС код:

C01DA; C01DA08

INN (Международно Name):

Isosorbide dinitrate

дозиране:

1 milligram(s)/millilitre

Лекарствена форма:

Concentrate for solution for injection/infusion

Вид предписание :

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

Терапевтична област:

Organic nitrates; isosorbide dinitrate

Статус Оторизация:

Marketed

Дата Оторизация:

1982-12-01

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Isoket 1 mg/ml Concentrate for solution for injection or infusion
Isosorbide dinitrate
10 ml ampoule
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
•
In this leaflet, Isoket 1 mg/ml concentrate for solution for injection
or infusion will be called
Isoket.
WHAT IS IN THIS LEAFLET:
1. What Isoket is and what it is used for
2. What you need to know before you use Isoket
3. How to use Isoket
4. Possible side effects
5. How to store Isoket
6. Contents of the pack and other information
1. WHAT ISOKET IS AND WHAT IT IS USED FOR
Isoket belongs to a group of medicines called organic nitrates.
Organic nitrates work by widening the
blood vessels in your heart to allow an increased amount of blood to
flow to areas which need it.
Isoket is used to treat heart failure (heart problems that can cause
shortness of breath or ankle
swelling) and angina pectoris.
Angina usually feels like a tight pain in the chest, neck or arm area.
It is also used sometimes during surgical procedures on the heart.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ISOKET
DO NOT USE ISOKET IF:
•
You are allergic to isosorbide dinitrate, other nitrates or any of the
other ingredients of this
medicine (listed in section 6)
•
You suffer from anaemia (reduction in red blood cells which can make
the skin pale and
cause weakness or breathlessness)
•
You have had a brain haemorrhage (bleeding)
•
You have had a head injury (head trauma) or raised intracranial
pressure (high pressure
within your skull)
•
You have a low blood volume (hypovolaemia)
•
You have very low blood pressure
•
Your blood has stopped circulating around your body properly
(circulatory failure)
•
You ha

Данни за продукта

Health Products Regulatory Authority
27 March 2023
CRN00DG89
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoket 1mg/ml Concentrate for solution for injection or infusion, 10
ml Ampoule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1mg isosorbide dinitrate.
Each 10 ml ampoule contains 10mg isosorbide dinitrate.
Each ml of concentrated solution contains 3.54mg sodium (as sodium
chloride).
For the 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
Posology
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.
Older People
There's no evidence that dose adjustment in elderly patients in
needed.
Paediatric Population
The safety and efficacy of Isoket has not yet been established in
children.
Method of administration
Isoket is a concentrated solution and must be diluted prior to use.
The diluted solution should never be injected directly in the
form of a bolus except via the intra- coronary route prior to balloon
inflation. A dilution of 50% is advocated for intracoronary
administration.
Isoket can be administered as an intravenous admixture w