CORDARONE INJ 150MG (3ML AMP)

দেশ: মাল্যাশিয়া

ভাষা: ইংরেজি

সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

সক্রিয় উপাদান:

AMIODARONE HYDROCHLORIDE

থেকে পাওয়া:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (আন্তর্জাতিক নাম):

AMIODARONE HYDROCHLORIDE

প্যাকেজ ইউনিট:

6Units Units

Manufactured by:

SANOFI WINTHROP INDUSTRIE

পণ্য বৈশিষ্ট্য

QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ampoule
Amiodarone (INN) hydrochloride
............................................................ 150mg
Excipients: polysorbate 80, benzyl alcohol, water for injection
.............. q.s. 3ml
PHARMACEUTICAL FORM
Solution for IV injection in ampoules
Clear pale yellow liquid, practically free from particles.
CLINICAL PARTICULARS
Therapeutic indications
Serious arrhythmias when treatment via the oral route is not
appropriate, namely:
- atrial arrhythmia, with rapid ventricular rhythm;
- Wolf-Parkinson-White syndrome tachycardia;
- documented symptomatic and incapacitating ventricular arrhythmia.
Cardiopulmonary resuscitation in the event of cardiac arrest related
to ventricular fibrillation
resistant to external electric shock.
Posology and method of administration
Due to the formulation of the product, do not use concentrations of
less than 2 ampoules in
500 ml. Use only isotonic glucose solution.
Do not add any other products to the infusion vehicle.
Amiodarone must be administered via the central venous route except
for cardiopulmonary
resuscitation in the event of cardiac arrest related to ventricular
fibrillation resistant to external
electric shock in which case, in the absence of a central venous
route, the peripheral venous
route may be used (see Special warnings and special precautions for
use).
Serious arrhythmias when oral use is not suitable, except for
cardiopulmonary resuscitation in
the event of cardiac arrest related to ventricular fibrillation
resistant to external electric shock:
Infusion via the central venous route.
- Initial treatment: on average 5 mg/kg in glucose solution,
preferably using an electric syringe,
administered over 20 minutes to 2 hours, possibly repeated 2 or 3
times per 24-hour period.
The short action of the medicinal product requires continuation of the
infusion.
- Maintenance treatment: 10 to 20 mg/kg/day (on average 600 to 800
mg/24 h, up to 1.2 g/24
h) in 250 ml glucose solution, over a few days.
Initiate replacement treatment