Isoprenaline Macure 0.2 mg/ml concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ISOPRENALINE HYDROCHLORIDE

Available from:

Macure Pharma ApS Hejrevej 39, DK-2400 Copenhagen NV , Denmark

ATC code:

C01CA02

INN (International Name):

ISOPRENALINE HYDROCHLORIDE 0.2 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

ISOPRENALINE HYDROCHLORIDE 0.2 mg/ml

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-12-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOPRENALINE 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 Macure is and what it is used for
2.
What you need to know before you use Isoprenaline Macure
3.
How to use Isoprenaline Macure
4.
Possible side effects
5.
How to store Isoprenaline Macure
6.
Contents of the pack and other information
1.
WHAT ISOPRENALINE MACURE IS AND WHAT IT IS USED FOR
Isoprenaline 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 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 MACURE
DO NOT USE ISOPRENALINE 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 you suffer from a faster-than-usual heart rhythm
-
if your heart is stressed (atrial or ventricular hyperexcitability)
-
if you have taken t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Isoprenaline 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 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 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 Macure at the same time as adrenaline in
any circumstances. However, if
the administration of the two medicinal products is necessary, they
can be given alternately every 4
hours (see sections 4.3 and 4.5).
Method of administration
Intravenous use.
Dilute 10 ml (2 ampoules �