ISOPRENALINE HYDROCHLORIDE MEDSURGE isoprenaline hydrochloride 0.2 mg/1 mL injection solution ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isoprenaline hydrochloride, Quantity: 200 microgram

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intracardial, Intramuscular, Intravenous Bolus, Intravenous Infusion, Subcutaneous

Units in package:

5 x1 mL ampoules, 25 x 1mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Isoprenaline Hydrochloride is indicated: 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, colorless to slightly yellow colour solution. Practically free from any visible particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-02-10

Patient Information leaflet

ISOPRENALINE HYDROCHLORIDE MEDSURGE
1
ISOPRENALINE HYDROCHLORIDE MEDSURGE
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 HYDROCHLORIDE MEDSURGE?
Isoprenaline Hydrochloride Medsurge contains the active ingredient
Isoprenaline hydrochloride. Isoprenaline hydrochloride
is used to treat heart block and cardiac arrest. For more information,
see Section 1. Why am I using Isoprenaline
Hydrochloride Medsurge? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ISOPRENALINE HYDROCHLORIDE MEDSURGE?
Do not use if you have ever had an allergic reaction to Isoprenaline
Hydrochloride Medsurge 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 Hydrochloride Medsurge? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Isoprenaline Hydrochloride Medsurge
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 HYDROCHLORIDE MEDSURGE?

Your doctor will decide what dose of Isoprenaline Hydrochloride
Medsurge you will receive. The dosage will depend on
your condition.
More instructions can be found in Section 4. How do I use Isoprenaline
Hydrochloride Medsurge? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ISOPRENALINE HYDROCHLORIDE MEDSURGE?
THINGS YOU SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are using
Isoprenaline Hydrochloride Medsurge.
THINGS YOU SHOULD NOT DO

Do not stop using this medicine suddenly

You must not be given Isoprenaline Hydrochloride Medsurge if you have
an allergy to Isoprenaline or any of the ingredients listed at the end
of
this leaflet.
DRI

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
ISOPRENALINE HYDROCHLORIDE MEDSURGE (ISOPRENALINE HYDROCHLORIDE)
SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Isoprenaline hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ISOPRENALINE HYDROCHLORIDE MEDSURGE injection solution contains 0.2 mg
(200 microgram) of isoprenaline hydrochloride in 1 mL (1:5000) and 1.0
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
Solution for Injection
Clear, colorless to slightly yellow colour solution. Practically free
from any visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Isoprenaline hydrochloride is indicated:
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 hydrochloride should generally be started at the lowest
recommended dose and the rate of
administration gradually increased if necessary while carefully
monitoring the patient.
2
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. Elderly patients may
be more sensitive to the