AMIODARONE JUNO 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; water for injections; benzyl alcohol; 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 HHH 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 HHH 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:

Licence status A

Authorization date:

2016-02-04

Patient Information leaflet

Amiodarone
Juno
CMI
Page 1 of 4
CONSUMER MEDICINE INFORMATION
AMIODARONE JUNO
_AMIODARONE HYDROCHLORIDE SOLUTION FOR INJECTION _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Amiodarone Juno 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
JUNO 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 Juno 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 USE
AMIODARONE JUNO
INJECTION
_ _
_WHEN YOU MUST NOT USE _
_AMIODARONE JUNO INJECTION_
_ _
1.
DO NOT USE AMIODARONE
JUNO 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
PREGNANCY AND
B

Summary of Product characteristics

Amiodarone Juno PI v3.0
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION – AMIODARONE JUNO
(AMIODARONE HYDROCHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Amiodarone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amiodarone Juno 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 Juno is a solution for injection.
Amiodarone Juno 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 tachycardias, 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 Juno 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 Juno should only be used where
facilities exist for
cardiac monitoring and defibrillation should the need arise.
4.2
DOSE AND METHOD OF ADMINISTRATION
AMIODARONE JUNO DOES NOT CONTAIN AN ANTIMICROBIAL PRESERVATIVE. IT IS
FOR SINGLE USE IN ONE
PATIENT ONLY. DISCARD ANY REMAINING RESIDUE.
Amiodarone Juno PI v3.0
Page 2 of 22
Due to poor absorption and wide inter-patient variability of
absorption the initial loading and
subs