AMIODARONE HCL 150mg3mL INJECTION Bioindustria L.I.M.

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

AMIODARONE HYDROCHLORIDE

Prieinama:

MMS PHARMA (MALAYSIA) SDN. BHD.

INN (Tarptautinis Pavadinimas):

AMIODARONE HYDROCHLORIDE

Vienetai pakuotėje:

3ml mL

Pagaminta:

Bioindustria Laboratorio Italiano Medicinali (L.I.M.) S.p.A.

Prekės savybės

Specifiche cliente: BIOINDUSTRIA L.I.M.
Oggetto: foglio illustrativo - MODIFICA
NOME: AMIODARONE CLORIDRATO BIOINDUSTRIA LIM
(malese)
Codice:M2K187/2
Dimensioni: 15 X 39,2 CM.
Stampa: F/R PIEGATO
CARATTERE USATO:
NOME PRODOTTO: Helv. neue
bold corpo 12 Ridim. 95%
TESTO: Helv neue 7,4 rid. 85%
interlinea 7
NERO
TIPO
CARTA
GR/MG
Visto si stampi
DATA:
4A
40
PRESENTATION:
AMIODARONE HCL 150MG/3 ML INJECTION BIOINDUSTRIA LABORATORIO ITALIANO
MEDICINALI (L.I.M.):
Each amber neutral glass ampoule contains sterile, clear, colourless
or slightly yellowish solution visually free from particulates
solution
for infusion/injection use. Each carton box contains five 3mL ampoules
and one leaflet.
When the product is mixed with diluent solution (1 ampoule in 250ml of
5% dextrose), the mixture is clear and free of particles.
COMPOSITION:
Each ampoule contains active ingredient of Amiodarone Hydrochloride
150mg/3mL. Excipients include Benzyl Alcohol 2.02% w/v as
preservative, Polysorbate 80, and Water for Injection.
PHARMACODYNAMIC:
Anti-Arrhythmic Properties:
- Prolongation of phase 3 of the cardiac fibre action potential
resulting mainly in a decrease in potassium current (class III from
Vaughan
Williams’ classification). This prolongation is not related to heart
rate;
- Reduced sinus automaticity leading to bradycardia unresponsive to
atropine administration;
- Noncompetitive alpha- and beta-adrenergic inhibition;
- Slowing in sinoatrial, atrial and nodal conduction, which is more
marked when the heart rate is high;
- No change in intraventricular conduction;
- Increase in refractory period and decrease of myocardial
excitability at the atrial, nodal and ventricular levels;
- Slowing of conduction and prolongation of refractory periods in
accessory atrioventricular pathways;
- Reduced cardiac contractility mainly after IV injection.
PHARMACOKINETICS:
Following IV injection, blood concentration of amiodarone rapidly
decreases as impregnation of tissues occurs. The maximum effect is
obtained 15 minutes following injection then