Isoprenaline hydrochloride Macure 0.2 mg/ml concentrate for solution for infusion

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

ISOPRENALINE HYDROCHLORIDE

Disponible desde:

Macure Pharma ApS

Código ATC:

C01CA02

Designación común internacional (DCI):

ISOPRENALINE HYDROCHLORIDE

Dosis:

0.2 milligram(s)/millilitre

formulario farmacéutico:

Concentrate for solution for infusion

Área terapéutica:

isoprenaline

Estado de Autorización:

Marketed

Fecha de autorización:

2021-07-23

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOPRENALINE HYDROCHLORIDE MACURE 0.2
MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
isoprenaline hydrochloride
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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
1.
What Isoprenaline hydrochloride Macure is and what it is used for
2.
What you need to know before you use Isoprenaline hydrochloride Macure
3.
How to use Isoprenaline hydrochloride Macure
4.
Possible side effects
5.
How to store Isoprenaline hydrochloride Macure
6.
Contents of the pack and other information
1.
WHAT ISOPRENALINE HYDROCHLORIDE MACURE IS AND WHAT IT IS USED FOR
Isoprenaline hydrochloride Macure contains the active substance
isoprenaline, which has a stimulating
effect on a certain part of the nervous system (sympathomimetic).
Isoprenaline leads to, among other
things, increased heart rate, increased heart contractility and
dilatation of blood vessels, which decreases
blood pressure.
Isoprenaline hydrochloride Macure is used for the short-term treatment
of:
-
slow heart rate in patients awaiting the insertion of a pacemaker or
when this is
contraindicated.
-
sudden fainting with loss of consciousness caused by a slowing of
heart rate (called Adams-
Stokes syndrome).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ISOPRENALINE HYDROCHLORIDE MACURE
DO NOT USE ISOPRENALINE HYDROCHLORIDE MACURE
-
if you are allergic to isoprenaline hydrochloride or any of the other
ingredients of this
medicine (listed in section 6).
-
if you are also taking adrenaline, a medicine used in intensive care
to treat cardiac arrest
-
if

Ficha técnica

Health Products Regulatory Authority
28 June 2022
CRN00CNRG
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoprenaline hydrochloride Macure 0.2 mg/ml concentrate for solution
for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.2 mg isoprenaline hydrochloride equivalent to 0.17 mg
isoprenaline.
Each ampoule of 5 ml contains 1.0 mg isoprenaline hydrochloride.
Excipients(s) with known effect:
Each ampoule contains 16 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate for solution for infusion is clear and colourless or
pale yellow.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of permanent bradycardia due to atrio-ventricular
block while pending a pacemaker or when a
pacemaker is contraindicated.
Short-term treatment of Adams-Stokes syndrome.
National and international recommendations and guidelines on the
appropriate use of isoprenaline should be followed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Isoprenaline hydrochloride Macure must only be administered by
physicians trained in anaesthesia, cardiology or intensive
care, in an appropriately monitored or critical care setting.
Circulatory and respiratory functions should be closely monitored.
Isoprenaline should not be used routinely.
Posology
Isoprenaline hydrochloride Macure should be carefully titrated under
close monitoring to the lowest possible dose that obtains
a heart rate of 50-60 beats per minute.
The recommended start dose is 0.01 microgram/kg/minute.
The dose can be increased in increments of 0.01 microgram/kg/minute
until a maximal dose of 0.15 microgram/kg/minute.
The rate of infusion should be adjusted based on the heart rate of the
patient.
_CONCOMITANT USE WITH ADRENALINE:_
Do not inject Isoprenaline hydrochloride Macure at the same time as
adrenaline in any circumstances. However, if the
administration of the two medicinal products is necessary, they can be
give