Sterile Dopamine Concentrate BP 160mg/ml, 5ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOPAMINE HYDROCHLORIDE

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

C01CA04

INN (International Name):

DOPAMINE HYDROCHLORIDE

Dosage:

160 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

dopamine

Authorization status:

Not marketed

Authorization date:

1989-08-17

Patient Information leaflet

PATIENT LEAFLET: INFORMATION FOR THE PATIENT
STERILE DOPAMINE CONCENTRATE BP 160MG/1ML, 5ML
dopamine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START BEING GIVEN THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Sterile Dopamine Concentrate BP 160mg/ml,
5ml. It will be referred to as
“Dopamine Concentrate” for ease of use hereafter.
WHAT IS IN THIS LEAFLET
1.
What Dopamine Concentrate is and what it is used for
2.
What you need to know before you are given Dopamine Concentrate
3.
How Dopamine Concentrate is given to you
4.
Possible side effects
5.
How to store Dopamine Concentrate
6.
Contents of the pack and other information
1.
WHAT DOPAMINE CONCENTRATE IS AND WHAT IT IS USED FOR
Sterile Dopamine Concentrate BP contains 800mg of dopamine
hydrochloride per 5ml (160 mg in
1ml) which helps to improve the blood circulation following a heart
attack, injury, blood poisoning,
kidney failure, heart failure and open heart surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOPAMINE CONCENTRATE
You should not be given Dopamine Concentrate
-
if you are allergic to dopamine hydrochloride or any of the other
ingredients of this medicine (listed
in section 6).
-
if you have high blood pressure due to a tumour near the kidney
(phaeochromocytoma)
-
if you have a rapid, irregular heart beat
-
if you have an overactive thyroid gland
-
if you are being given certain anaesthetics, such as halothane and
cyclopropane
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given Dopamine Concentrate
•
if you have an obstruction of the blood vessels (e.g. hardening of the
arteries)
•
if you have a disease of the liver or kidneys
•
if you are pregnant
•
if you use or have

Summary of Product characteristics

Health Products Regulatory Authority
25 August 2021
CRN00CF1T
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sterile Dopamine Concentrate BP 160mg/ml, 5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml sterile concentrate contains 160mg dopamine hydrochloride.
Each 5ml ampoule contains 800mg of dopamine hydrochloride.
Excipients with known effect
Each ml of sterile concentrate contains 2.42mg of sodium and 10.0mg
sodium metabisulphite (E 223)
Each 5ml ampoule contains 12.1mg sodium and 50mg sodium metabisulphite
(E 223)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless or pale yellow sterile concentrate for solution for
infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the correction of haemodynamic imbalance such as is seen in
circulatory decompensation accompanying myocardial
infarction, trauma, endotoxic septicaemia, renal failure, congestive
cardiac failure and open heart surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults including the elderly:
The initial rate of infusion is 2 to 5 micrograms per kilogram body
weight per minute and this may be increased gradually by
increments of 5 to 10 micrograms/kg/minute until the optimum dose for
the individual is achieved.
Up to 50 micrograms/kg/minute may be required and even higher doses
have been used.
The usual dilution is 1,600 micrograms per ml and this may be achieved
by transfer, aseptically, of 800mg of dopamine
hydrochloride to 500ml of one of the following sterile intravenous
solutions :-
Sodium Chloride Injection
5% Dextrose Injection
5% Dextrose and 0.9% Sodium Chloride Injection
5% Dextrose and 0.45% Sodium Chloride Solution
5% Dextrose in Ringer Lactate Solution
Sodium Lactate 1/6 Molar Injection
Lactated Ringer's Injection
Alkaline solutions such as 5% sodium bicarbonate should NOT be added
to dopamine hydrochloride because the drug will be
inactivated.
_Paediatric population_
Safety and effectiveness in child