AMIODARONE GH INJECTION amiodarone hydrochloride 150mg/3mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amiodarone hydrochloride, Quantity: 150 mg

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Amiodarone hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: polysorbate 80; benzyl alcohol; water for injections; hydrochloric acid; sodium hydroxide

Administration route:

Intravenous

Units in package:

10 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Severe cases of tachyarrhythmias (eg. Wolff-Parkinson-White Syndrome, supraventricular, nodal and ventricular tachyardias, atrial flutter and fibrillation, ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended that the patient should be regularly monitored for possible toxicity (eg. thyroid function, chest X-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation.,Amiodarone GH injection may be used for treatment initiated in a hospital for severe cases of tachyarrhythmias (atrial, junctional and ventricular) not responding to other therapy and when a rapid response is required. Amiodarone GH injection should only be used where facilities exist for cardiac monitoring and defibrillation should the need arise.

Product summary:

Visual Identification: A clear, slightly yellow solution contained in a glass Type 1 ampoule .; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2016-02-04

Patient Information leaflet

Amiodarone GH Injection CMI v2 May 2018
Page 1 of 4
CONSUMER MEDICINE INFORMATION
AMIODARONE GH INJECTION
_AMIODARONE HYDROCHLORIDE SOLUTION FOR INJECTION _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Amiodarone GH Injection.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT AMIODARONE GH INJECTION
IS USED FOR
This medicine is used to control a
fast or irregular heart beat.
It works by lengthening the gap
between the one heart beat and
the next, helping to bring the
heart rate to a slower and more
regular pace.
Amiodarone GH Injection is not
recommended for use in
children.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU TAKE AMIODARONE GH
INJECTION
_ _
_WHEN YOU MUST NOT USE _
_AMIODARONE GH INJECTION _
1.
DO NOT USE AMIODARONE GH
INJECTION IF YOU ARE ALLERGIC
TO AMIODARONE OR IODINE OR
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
The symptoms of an allergic
reaction may include a rash,
itching, swelling, coughing,
an asthma attack or
hayfever.
2.
DO NOT USE THIS MEDICINE IF
YOU ARE PREGNANT OR
INTENDING TO GET PREGNANT.
This medicine is best avoided
in the 3 months before
getting pregnant and during
pregnancy.
This is because it can stay in
the body for several months
even after you stop taking it.
3.
DO NOT BREASTFEED IF YOU ARE
USING THIS MEDICINE AS IT CAN
BE FOUND IN BREAST MILK.
If you are breastfeeding,
alternative feeding
arrangements such as bottle
feeding should be made for
your baby.
TALK TO YOUR DOCTOR ABOUT
THE RISKS AND BENEFITS OF
TAKING THIS MEDICINE DURING
P

Summary of Product characteristics

Amiodarone GH Injection PI v03 May 2018
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION – AMIODARONE GH INJECTION
(AMIODARONE HYDROCHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Amiodarone hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amiodarone GH Injection contains 150 mg amiodarone hydrochloride in
each 3 mL ampoule.
Amiodarone hydrochloride is a Class III antiarrhythmic agent.
Amiodarone hydrochloride is a fine white crystalline powder. It is
slightly soluble in water and
is soluble in alcohol and chloroform. It is an amphiphilic compound
and contains iodine in its
formulation.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Amiodarone GH is a solution for injection.
Amiodarone GH Injection is a clear, slightly yellow solution for
intravenous administration
contained in colourless glass ampoules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe cases of tachyarrhythmias (eg. Wolff-Parkinson-White Syndrome,
supraventricular,
nodal and ventricular tachyardias, atrial flutter and fibrillation,
ventricular fibrillation) not
responding to other therapy. Treatment should be initiated in
hospital. It is recommended
that the patient should be regularly monitored for possible toxicity
(eg. thyroid function, chest
X-ray, ophthalmological examination, liver function etc.) during the
entire course of therapy
and for several months after discontinuation.
Amiodarone GH Injection may be used for treatment initiated in a
hospital for severe cases of
tachyarrhythmias (atrial, junctional and ventricular) not responding
to other therapy and
when a rapid response is required. Amiodarone GH Injection should only
be used where
facilities exist for cardiac monitoring and defibrillation should the
need arise.
Amiodarone GH Injection PI v03 May 2018
Page 2 of 25
4.2
DOSE AND METHOD OF ADMINISTRATION
AMIODARONE GH INJECTION DOES NOT CONTAIN AN ANTIMICROBIAL
PRESERVATIVE. IT IS FOR SINGLE USE
IN ONE PATIENT ONLY. DISCARD ANY REMAINING RESIDUE.
Due to poor absorption