DBL™ Sterile Dopamine Concentrate

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Dopamine hydrochloride 40 mg/mL;  

Tilgængelig fra:

Pfizer New Zealand Limited

INN (International Name):

Dopamine hydrochloride 40 mg/mL

Dosering:

200 mg/5mL

Lægemiddelform:

Solution for injection

Sammensætning:

Active: Dopamine hydrochloride 40 mg/mL   Excipient: Sodium metabisulfite Water for injection

Enheder i pakken:

Ampoule, glass, Type I, clear, one point cut, 5 x 5mL, 25 mL

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

BASF PharmaChemikalien GmbH & Co KG

Terapeutiske indikationer:

Latest Regulatory Activity

Produkt oversigt:

Package - Contents - Shelf Life: Ampoule, glass, Type I, clear, one point cut, 5 x 5mL - 25 mL - 36 months from date of manufacture stored at or below 30°C

Autorisation dato:

1985-05-23

Produktets egenskaber

Version 5.0
Page 1 of 13
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME_ _
DBL
™
Sterile Dopamine Concentrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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(S) WITH KNOWN EFFECT
Sodium Metabisulfite
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL
™
Sterile Dopamine Concentrate is a sterile solution for injection
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 5.0
Page 2 of 13
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.
MODE OF ADMINISTRATION
The
rate
of
administration
should
be
controlled
in
order
to
prevent
inadvertent
bolus
administration: constant evaluation of therapy should be undertaken
(ie. blood volume, ECG,
arterial
blood
pressure,
urine
output,
augmentation
of
myocardial
contractility
and
distribution of peripheral perfusion. Measurement of central venous
pressure an