DOBUTAMINE INJECTION SDZ SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE)

থেকে পাওয়া:

SANDOZ CANADA INCORPORATED

এটিসি কোড:

C01CA07

INN (আন্তর্জাতিক নাম):

DOBUTAMINE

ডোজ:

12.5MG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE) 12.5MG

প্রশাসন রুট:

INTRAVENOUS

প্যাকেজ ইউনিট:

20ML

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

SELECTIVE BETA 1-ADRENERGIC AGONISTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0112000001; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2012-04-30

পণ্য বৈশিষ্ট্য

_Dobutamine Injection SDZ _
_Page 1 of 12_
PRODUCT MONOGRAPH
PR
DOBUTAMINE INJECTION SDZ
12.5 mg/mL dobutamine (as dobutamine hydrochloride)
Manufacturer’s Standard
Sympathomimetic
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Date of Preparation: April 24, 2012
Submission Control No.: 154066
_ _
_Dobutamine Injection SDZ _
_Page 2 of 12_
PR
DOBUTAMINE INJECTION SDZ
12.5 mg/mL dobutamine (as dobutamine hydrochloride)
Manufacturer’s Standard
THERAPEUTIC CLASSIFICATION
Sympathomimetic
ACTION AND CLINICAL PHARMACOLOGY
Dobutamine is a direct-acting inotropic agent whose primary activity
results from stimulation of
the

-receptors of the heart while producing less marked chronotropic,
hypertensive,
arrhythmogenic or vasodilatory effects. Dobutamine, unlike dopamine,
does not cause the
release of endogenous norepinephrine. No specific effect on the renal
vasculature has been
observed. Dobutamine produces less increase in heart rate and less
decrease in peripheral
vascular resistance for a given inotropic effect than does
isoproterenol as demonstrated in both
animal and human studies.
The onset of action is within 1 to 2 minutes, although the peak effect
of a particular infusion may
not be reached for 10 minutes. The plasma half-life in humans is 2
minutes.
INDICATIONS AND CLINICAL USE
Dobutamine Injection SDZ is indicated in the treatment of adults with
cardiac decompensation
due to depressed contractility resulting from organic heart disease or
following cardiac surgical
procedures in which parenteral therapy is necessary for inotropic
support.
Most clinical experience with dobutamine is short-term - up to several
hours in duration. In the
limited number of patients who were studied for 24, 48 and 72 hours, a
persistent increase in
cardiac output occurred in some, whereas the output of others returned
toward baseline values.
CONTRAINDICATIONS
Dobutamine Injection SDZ is contraindicated in patients with
pheochromocytoma, idiopathic
hypertrophic subaortic stenosis, and in those patients wit