Amiodarone Hydrochloride 150 mg/3mL

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Amiodarone hydrochloride 50 mg/mL

Boleh didapati daripada:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (Nama Antarabangsa):

Amiodarone hydrochloride 50 mg/mL

Dos:

50 mg/mL

Borang farmaseutikal:

Concentrate for injection

Komposisi:

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

Unit dalam pakej:

Ampoule, glass, Type I, colourless, 3 mL, 10 dose units

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Cambrex Profarmaco Milano Srl

Tanda-tanda terapeutik:

Treatment should be initiated only under hospital or specialist supervision. Indicated for treatment of · 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.

Ringkasan produk:

Package - Contents - Shelf Life: Ampoule, glass, Type I, colourless, 3 mL - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Tarikh kebenaran:

2010-07-16

Ciri produk

1
AMIODARONE HYDROCHLORIDE 150 MG/3 ML
01102015
NEW ZEALAND DATA SHEET
AMIODARONE HYDROCHLORIDE 150 MG/3 ML
_Amiodarone hydrochloride _
Concentrated Injection
150 mg/3 mL
NAME OF THE MEDICINE
NON-PROPRIETARY NAME
Amiodarone hydrochloride
CHEMICAL STRUCTURE
CAS NUMBER
1951-25-3
DESCRIPTION
The
active
ingredient
of
Amiodarone
Hydrochloride
150
mg/3
mL
is
amiodarone
hydrochloride
(2-n-butyl-3(4-(2-diethylaminoethoxy)-3,5-diiodobenzoyl)
benzofuran
hydrochloride). 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.
The excipients of Amiodarone Hydrochloride 150 mg/3 mL are polysorbate
80, benzyl
alcohol and water for injections, as well as hydrochloric acid and
sodium hydroxide for pH
adjustment.
Each 3mL ampoule contains 60.6mg of benzyl alcohol and approximately
56mg iodine.
2
AMIODARONE HYDROCHLORIDE 150 MG/3 ML
01102015
PHARMACOLOGY
_ACTIONS _
Amiodarone is a Class III antiarrhythmic agent prolonging the action
potential duration and
hence refractory period of atrial, nodal and ventricular tissues,
thereby giving a very broad
spectrum of activity. An increase in the refractory period of the
atrial cells is a major
contributing action to the control of atrial tachyarrhythmias.
A reduction in the permeability of the A-V node, both anterograde and
retrograde, explains
the efficacy of the medicine in nodal tachycardias caused by re-entry
through the A-V node.
Its action on ventricular arrhythmias is explained by a number of
mechanisms. The effect on
the atrium and A-V node results in a reduction in the frequency of
stimuli reaching the
ventricle thus giving the ventricular cell mass time to repolarise in
cases where there has
been
desynchronisation
of
the
refractory
periods.
Furthermore,
a
lengthening
of
the
refractory period of the His-Purkinje system and ventricular
contractile fibres reduces or
prevents