DBL STERILE DOPAMINE CONCENTRATE 200mg/5mL injection ampoule

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

dopamine hydrochloride, Quantity: 40 mg/mL

Saatavilla:

Pfizer Australia Pty Ltd

Lääkemuoto:

Injection, concentrated

Koostumus:

Excipient Ingredients: sodium metabisulfite; water for injections

Antoreitti:

Intravenous

Kpl paketissa:

5 x 5 mL

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

INDICATIONS AS AT 31 October 2003: For the correction of haemodynamic imbalance present in: Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure. As an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia. In chronic cardiac decompensation as in congestive failure.

Tuoteyhteenveto:

Visual Identification: Clear colourless or pale yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-10-08

Pakkausseloste

DBL™
STERILE
DOPAMINE CONCENTRATE
_Dopamine (DO-pa-meen)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Sterile
Dopamine Concentrate.
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
Sterile Dopamine Concentrate
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 STERILE
DOPAMINE
CONCENTRATE IS USED
FOR
Dopamine acts in different ways,
depending on the dose given. At low
doses, dopamine increases blood
flow to the kidneys. At higher doses,
it increases the blood flow to the
muscles and can increase the heart’s
pumping efficiency.
Dopamine may be used to increase
low blood pressure in people who
have:
•
experienced a heart attack
•
a severe infection
•
lost blood during an accident
•
kidney failure
•
problems after surgery.
Dopamine may be used to help the
heart pump better in some people
with congestive heart failure.
Your doctor may have prescribed
DBL Sterile Dopamine Concentrate
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DBL STERILE
DOPAMINE CONCENTRATE HAS BEEN
PRESCRIBED FOR YOU.
There is no evidence that dopamine
is addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL STERILE DOPAMINE
CONCENTRATE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DBL STERILE
DOPAMINE CONCENTRATE IF YOU HAVE
AN ALLERGY TO DOPAMINE OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
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 DOPAMINE
IF YOU HAVE ANY

Valmisteyhteenveto

Version: pfpdopai10821
Supersedes: pfpdopai10619
Page 1 of 14
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
STERILE
DOPAMINE
CONCENTRATE
(DOPAMINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Dopamine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dopamine hydrochloride is a naturally occurring biochemical
catecholamine precursor of
noradrenaline
and
adrenaline.
The
chemical
name
of
dopamine
hydrochloride
is
4-(2-
aminoethyl) benzene-1,2-diol hydrochloride and has the chemical
formula C
8
H
11
NO
2
.HCl.
DBL Sterile Dopamine Concentrate is a sterile solution of Dopamine
Hydrochloride BP in
water for injection, containing 1% sodium metabisulfite. The strength
supplied is 200
milligrams/5 mL in a clear glass ampoule.
EXCIPIENT WITH KNOWN EFFECT
Sodium metabisulfite
For the full list of excipients, see
SECTION 6.1
LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Dopamine hydrochloride is a white, odourless powder, freely soluble in
water and soluble in
alcohol. It is sensitive to light, alkalis, iron salts and oxidising
agents. The pH of the solution
is approximately 4.
IT MUST BE DILUTED BEFORE USE.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the correction of haemodynamic imbalance present in:
Acute hypotension or shock associated with myocardial infarction,
endotoxic septicaemia,
trauma and renal failure.
As an adjunct after open heart surgery, where there is persistent
hypotension after correction
of hypovolaemia.
In chronic cardiac decompensation as in congestive failure.
4.2
DOSE AND METHOD OF ADMINISTRATION
WARNING: DOPAMINE IS A POTENT DRUG. IT MUST BE DILUTED BEFORE
ADMINISTRATION.
DO NOT ADD TO ALKALINE SOLUTIONS SUCH AS SODIUM BICARBONATE, AS THESE
INACTIVATE
DOPAMINE
.
Version: pfpdopai10821
Supersedes: pfpdopai10619
Page 2 of 14
In appropriate cases, restoration of blood volume with plasma, whole
blood, or a suitable
plasma expander, should be instituted prior to administration: central
venous pressure should
be 10 to 15cm H
2
O, or pulmonary wedge pressure 14 to 18mm Hg.
DOSAGE
_ADULT _
When ap