ISOPRENALINE MACURE isoprenaline hydrochloride 1 mg/5 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isoprenaline hydrochloride, Quantity: 1 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium citrate dihydrate; water for injections; sodium hydroxide; hydrochloric acid; sodium chloride; citric acid monohydrate; disodium edetate

Administration route:

Intracardial, Intramuscular, Intravenous, Subcutaneous

Units in package:

5 x 5 mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy. For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation). (See Section 4.3 Contraindications.) For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available. (See Section 4.3 Contraindications.) For bronchospasm occurring during anaesthesia. As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolaemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure and cardiogenic shock. (See Section 4.4 Special warnings and precautions for use)

Product summary:

Visual Identification: Clear, colourless or pale yellow solution for injection.; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-04-26

Patient Information leaflet

ISOPRENALINE MACURE isoprenaline hydrochloride 1 mg/5 mL solution for
injection
1
ISOPRENALINE MACURE 1 MG/5 ML
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ISOPRENALINE MACURE?
ISOPRENALINE MACURE contains the active ingredient isoprenaline
hydrochloride. ISOPRENALINE MACURE is primarily used to
treat heart block and cardiac arrest. It may also be used to help you
breathe when your airways spasm and contract; or in
combination with other medicines when your body is not getting enough
blood flow (shock). For more information, see
Section 1. Why am I using Isoprenaline Macure? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ISOPRENALINE MACURE?
Do not use if you have ever had an allergic reaction to isoprenaline
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Isoprenaline Macure? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Isoprenaline Macure and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ISOPRENALINE MACURE?
•
Your doctor will decide what dose you will receive. The dosage will
depend on your condition.
•
A doctor or nurse will usually prepare and administer the injection.
•
Follow all instructions given to you by your doctor or pharmacist.
More instructions can be found in Section 4. How is Isoprenaline
Macure given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ISOPRENALINE MACURE?
THINGS YOU
SHOULD DO
•
Call your doctor straight away if you are pregnant while being given
this medicine
•
Remind any doctor, nurse or pharmacist you visit that you have been
given Isoprenaline Macure
•
Gett

Summary of Product characteristics

Product Information - Australia
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION –
ISOPRENALINE MACURE (ISOPRENALINE HYDROCHLORIDE)
INJECTION
1. NAME OF THE MEDICINE
Isoprenaline hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ISOPRENALINE MACURE injection solution contains 1 mg of isoprenaline
hydrochloride in 5 mL (1:5000).
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Clear, colourless or pale yellow solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For mild or transient episodes of heart block that do not require
electric shock or pacemaker therapy.
For serious episodes of heart block and Adams-Stokes attacks (except
when caused by ventricular tachycardia or
fibrillation). (See Section 4.3 Contraindications.)
For use in cardiac arrest until electric shock or pacemaker therapy,
the treatments of choice, are available. (See
Section 4.3 Contraindications.)
For bronchospasm occurring during anaesthesia.
As an adjunct to fluid and electrolyte replacement therapy and the use
of other drugs and procedures in the
treatment of hypovolaemic and septic shock, low cardiac output
(hypoperfusion) states, congestive heart failure
and cardiogenic shock. (See Section 4.4 Special warnings and
precautions for use)
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
ISOPRENALINE MACURE should generally be started at the lowest
recommended dose and the rate of
administration gradually increased if necessary while carefully
monitoring the patient.
National and international recommendations and guidelines on the
appropriate use of isoprenaline should be
followed.
The usual route of administration is by intravenous infusion or bolus
intravenous injection. In dire emergencies, the
drug may be administered by intracardiac injection. If time is not of
the utmost importance, initial therapy by
intramuscular or subcutaneous injection is preferred.
_ADULTS _
Recommended dosage for adults with shock and hypoperfusion states
ROUTE OF ADMINISTRATION
PREPARATION OF DILUTIO