CIPLA ISOPRENALINE isoprenaline hydrochloride 1.0 mg/5 mL injection solution ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isoprenaline hydrochloride, Quantity: 1 mg

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular, Intravenous Bolus, Subcutaneous, Intracardial, Intravenous Infusion

Units in package:

10 x 5 mL Ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CIPLA ISOPRENALINE 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 brochospasm 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 cariodgenic shock (see section 4.4 Special warnings and precautions for use).

Product summary:

Visual Identification: Clear colourless to practically colourless solution and no visible particulates; Container Type: Ampoule; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-03-24

Patient Information leaflet

CIPLA ISOPRENALINE
1
Cipla Isoprenaline
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 CIPLA ISOPRENALINE?
Cipla Isoprenaline contains the active ingredient isoprenaline. Cipla
Isoprenaline is used to treat heart block and cardiac arrest.
Cipla Isoprenaline is intended to be used in hospitals only.
For more information, see Section 1. Why am I using Cipla
Isoprenaline? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA ISOPRENALINE?
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
Cipla Isoprenaline? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Isoprenaline 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 CIPLA ISOPRENALINE?
•
Your doctor will decide what dose you will receive. The dosage will
depend on your condition.
•
Cipla Isoprenaline will normally be given to you as an injection under
the skin, or into the vein, muscle or heart.
•
Follow all directions given to you by your doctor or pharmacist
carefully.
More instructions can be found in Section 4. How do I use
Cipla Isoprenaline? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA ISOPRENALINE?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cipla Isoprenaline
•
Tell your doctor if you are pregnant or plan to become pregnant or are
breast-feeding.
•
Tell your doctor or pharmacist if you are taking any other medicines,
including any that you
get without a prescription from your pharmacy, supermarket or health
food sh

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - CIPLA ISOPRENALINE
(ISOPRENALINE HYDROCHLORIDE) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Isoprenaline hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipla Isoprenaline solution for injection 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
Cipla Isoprenaline is clear colourless to practically colourless
solution and with no visible particles.
Cipla
Isoprenaline
should
be
inspected
visually
(in
diffused
light)
for
particulate
matter
and
discolouration prior to administration. Such solutions should not be
used.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cipla Isoprenaline 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
Cipla Isoprenaline should generally be started at the lowest
recommended dose and the rate of
administration gradually increased if necessary while carefully
monitoring the patient.
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
importan