DBL DOBUTAMINE 250mg/20mL (as hydrochloride) injection

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

dobutamine hydrochloride, Quantity: 14.01 mg/mL (Equivalent: dobutamine, Qty 12.5 mg/mL)

থেকে পাওয়া:

Pfizer Australia Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Injection, solution

রচনা:

Excipient Ingredients: sodium metabisulfite; water for injections

প্রশাসন রুট:

Intravenous

প্যাকেজ ইউনিট:

1 x 250mg/20mL

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Dobutamine Hydrochloride Injection is indicated in adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery.

পণ্য সারাংশ:

Visual Identification: A clear, colourless or slightly tinged yellow solution, free from visible particulates.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

1993-11-30

তথ্য লিফলেট

DBL™ DOBUTAMINE
HYDROCHLORIDE INJECTION
_Dobutamine Hydrochloride (do-BEWT-a-meen)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Dobutamine
Hydrochloride Injection.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given DBL
Dobutamine Hydrochloride Injection
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT DBL
DOBUTAMINE
HYDROCHLORIDE
INJECTION IS USED FOR
DBL Dobutamine Hydrochloride
Injection is used in patients who
require short-term treatment of heart
failure following a heart attack or
heart surgery.
DBL Dobutamine Hydrochloride
Injection acts directly on the heart
muscle to increase the force of each
contraction.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DBL
DOBUTAMINE HYDROCHLORIDE
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
There is no evidence that DBL
Dobutamine Hydrochloride Injection
is addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL DOBUTAMINE
HYDROCHLORIDE
INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DBL
DOBUTAMINE HYDROCHLORIDE
INJECTION IF YOU HAVE AN ALLERGY TO
DOBUTAMINE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Symptoms of an allergic reaction to
DBL Dobutamine Hydrochloride
Injection may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
YOU SHOULD NOT BE GIVEN DBL
DOBUTAMINE HYDROCHLORIDE
INJECTION IF YOU HAVE ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
a heart condition called idiopathic
hypertrophic sub aortic stenosis
(a narrowing

পণ্য বৈশিষ্ট্য

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AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™
DOBUTAMINE
HYDROCHLORIDE
INJECTION
(DOBUTAMINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Dobutamine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
20
mL
vial
of
DBL
Dobutamine
Hydrochloride
Injection
contains
dobutamine
hydrochloride 280.2 mg (250 mg dobutamine equivalent) and sodium
metabisulfite 4.4 mg.
Dobutamine hydrochloride is a white to practically white, crystalline
powder. It is sparingly
soluble in water and methyl alcohol; soluble in alcohol.
EXCIPIENT WITH KNOWN EFFECT:
•
Sodium Metabisulfite
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL Dobutamine Hydrochloride Injection is a sterile solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Dobutamine Hydrochloride Injection is indicated in adults who
require short-term
treatment of cardiac failure secondary to acute myocardial infarction,
or cardiac surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The rate of infusion needed to increase cardiac output usually ranges
from 2.5 to 10
micrograms/kg/min (see table). On rare occasions, infusion rates up to
40 micrograms/kg/min
have been required to obtain the desired effect. However, the
possibility of intensifying
myocardial ischaemia should be borne in mind and the lowest effective
dose infused.
RATES OF INFUSION FOR CONCENTRATIONS OF 250, 500 AND 1,000
MICROGRAMS/ML
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Supercedes: pfpdobui11020
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Drug
Delivery
Rate
(microgram/kg/min)
Infusion Delivery Rate
250 microgram/mL
1
(mL/kg/min)
500 microgram/m
L
2
(mL/kg/min)
1000 microgram/m
L
3
(mL/kg/min)
2.5
0.01
0.005
0.0025
5
0.02
0.01
0.005
7.5
0.03
0.015
0.0075
10
0.04
0.02
0.01
12.5
0.05
0.025
0.0125
15
0.06
0.03
0.015
1.
250 mg per litre of diluent
2.
500 mg per litre or 250 mg per 500 mL of diluent
3.
1000 mg per litre or 250 mg per 250 mL of diluent.
The rate of administration and the duration of therapy should be
ad