Cordarone X Intravenous

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Amiodarone hydrochloride 50 mg/mL;  

متاح من:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (الاسم الدولي):

Amiodarone hydrochloride 50 mg/mL

جرعة:

150mg/3mL

الشكل الصيدلاني:

Solution for injection

تركيب:

Active: Amiodarone hydrochloride 50 mg/mL   Excipient: Benzyl alcohol Polysorbate 80 Water for injection

الوحدات في الحزمة:

Ampoule, 6 x 3ml, 6 dose units

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Sanofi Chimie

الخصائص العلاجية:

Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome. All types of tachyarrhythmias including; supraventricular, nodal and ventricular tachycardias, atrial flutter and fibrillation; ventricular fibrillation; when other agents cannot be used. The injection is to be used when a rapid response is required.

ملخص المنتج:

Package - Contents - Shelf Life: Ampoule, 6 x 3ml - 6 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, 10 x 3ml - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

تاريخ الترخيص:

1984-08-06

نشرة المعلومات

CORDARONE X
®
1
CORDARONE X
®
_Amiodarone hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cordarone X tablets
and 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. In deciding to give you
Cordarone X, your doctor has
weighed the risks of you taking
Cordarone X against the benefits it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT CORDARONE X IS
USED FOR
Cordarone X is used to control a fast
or irregular heart beat.
It works by lengthening the gap
between one heart beat and the next,
helping to bring the heart rate to a
slower and more regular pace.
Cordarone X is not recommended for
use in children.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT USE _
_CORDARONE X _
1.
DO NOT USE CORDARONE X 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 CORDARONE X IF YOU
ARE PREGNANT OR INTENDING TO GET
PREGNANT.
Cordarone X 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 CORDARONE X 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
CORDARONE X DURING PREGNANCY
AND BREASTFEEDING.
4.
DO NOT USE CORDARONE X IF YOU
HAVE OR HAVE HAD ANY THYROID
PROBLEMS.
5.
DO

خصائص المنتج

New Zealand Data Sheet
Cordarone X - amiodarone hydrochloride
cordarone-x-ccdsv21-dsv17-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
CORDARONE X
Cordarone X 100 mg and 200 mg tablets
Cordarone X Intravenous Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cordarone X 100 mg tablets: Each tablet contains 100 mg of amiodarone
hydrochloride. They also
contain 48.0 mg lactose monohydrate and approximately 37.5 mg iodine.
Excipient with known effect: Tablets contain Lactose monohydrate
Cordarone X 200 mg tablets: Each tablet contains 200 mg of amiodarone
hydrochloride. They also
contain 96.0 mg lactose monohydrate and approximately 75 mg iodine.
Cordarone X Intravenous Solution*: Each 3 mL ampoule of Cordarone X
Intravenous solution
contains 150 mg amiodarone hydrochloride. Each Cordarone X Intravenous
ampoule contains
approximately 56 mg iodine and benzyl alcohol.
* Not Marketed.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cordarone X 100 Tablets: white to off-white circular tablets, scored
on one side with logo on
reverse side. Approximately 8.7 mm in diameter.
Cordarone X 200 Tablets: white to off-white circular tablets, scored
on one side with logo on
reverse side. Approximately 10.5 mm in diameter.
Cordarone X Intravenous is a clear, pale yellow solution for
intravenous administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment should be initiated only under hospital or specialist
supervision.
New Zealand Data Sheet
Cordarone X - amiodarone hydrochloride
cordarone-x-ccdsv21-dsv17-20jun22
Page 2
TABLETS:
Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome.
Atrial flutter and fibrillation
when other agents cannot be used.
All types of tachyarrhythmias of paroxysmal nature including:
supraventricular, nodal and
ventricular tachycardias, ventricular fibrillation; when other agents
cannot be used. Tablets are
used for stabilisation and long term treatment.
SOLUTION FOR INJECTION:
Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome. All
t