INOTROP (Dobutamine HCl 25mgml Concentrate for Solution for Infusion)

Land: Maleisië

Taal: Engels

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

Werkstoffen:

DOBUTAMINE HYDROCHLORIDE

Beschikbaar vanaf:

MEDISPEC (M) SDN.BHD

INN (Algemene Internationale Benaming):

DOBUTAMINE HYDROCHLORIDE

Eenheden in pakket:

2 x 10ml Vials

Geproduceerd door:

PT. PRATAPA NIRMALA

Productkenmerken

INOTROP
DOBUTAMINE HCL 25 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
NAME OF THE MEDICINAL PRODUCT
Inotrop (Dobutamine HCL 25 mg/ml Concentrate for Solution for
Infusion)
COMPOSITION
Each mL contains :
Dobutamine hydrochloride equivalent to Dobutamine 25 mg
Each vial of 10 mL contains a total of Dobutamine Hydrochloride
equivalent to
Dobutamine 250 mg
PRODUCT DESCRIPTION
Clear, colorless to slightly yellowish, odorless solution, free from
visible dirt, packaged in
10R clear DIN vial, 20-mm red ready to sterilized rubber stopper,
20-mm green flip off
Description after dilution (with NaCl 0.9% solution for infusion,
Dextrose 5% for infusion
and Ringer lactate solution for infusion) : Clear, colorless to
slightly yellowish, odorless
solution, free from visible dirt.
The product is not supplied with the diluents
PHARMACOLOGY
_PHARMACODYNAMICS _
Inotrop (Dobutamine hydrochloride Injection) is a direct-acting
inotropic agent whose
primary activity results from stimulation of the β-receptors of the
heart while producing
comparatively mild chronotropic, hypertensive, arrhythmogenic, and
vasodilative effects.
It does not cause the release of endogenous norepinephrine, as does
dopamine.
In animal studies, dobutamine hydrochloride produces less increase in
heart rate and less
decrease
in
peripheral
vascular
resistance
for
a
given
inotropic
effect
than
does
isoproterenol.
_PHARMACOKINETICS _
In patients with depressed cardiac function, both dobutamine and
isoproterenol increase
the cardiac output to a similar degree.
In the case of dobutamine, this increase usually not accompanied by
marked increases in
heart rate and cardiac stroke volume is usually increased.
Facilitation of atrioventricular conduction has been observed in human
electrophysiologic
studies and in patients with atrial fibrillation.
Systemic vascular resistance is usually decreased with administration
of dobutamine.
Occasionally, minimum vasoconstriction has been observed.
The onset of action of Inotrop is within 1 to 2 minutes; however, as
much as 10 minut