Dopamine 200mg/5ml solution for infusion ampoules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Dopamine hydrochloride

Dostupné z:

Pfizer Ltd

ATC kód:

C01CA04

INN (Medzinárodný Name):

Dopamine hydrochloride

Dávkovanie:

40mg/1ml

Forma lieku:

Solution for infusion

Spôsob podávania:

Intravenous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 02070100; GTIN: 5015997829157

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOPAMINE 40 MG/ML STERILE CONCENTRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What Dopamine Sterile Concentrate is and what it is used for
2.
Before Dopamine Sterile Concentrate is used
3.
How Dopamine Sterile Concentrate is used
4.
Possible side effects
5.
How Dopamine Sterile Concentrate is stored
6.
Further information
1.
WHAT DOPAMINE STERILE CONCENTRATE IS AND WHAT IT IS
USED FOR
Dopamine is a medicine that stimulates the heart and has effects on
the blood vessels.
Dopamine Sterile Concentrate can be used:
•
to treat low blood pressure or shock (reduction of blood flow through
the body
tissues) after a heart attack, blood poisoning, trauma (injury) or
kidney failure
•
in combination with other treatments where low blood pressure occurs
after
open heart surgery
•
in congestive heart failure (heart failure due to a build up of
fluid/blood)
2.
BEFORE DOPAMINE STERILE CONCENTRATE IS USED
DOPAMINE STERILE CONCENTRATE SHOULD NOT BE USED
•
if you have a tumour that causes an increase in blood pressure
•
if you have an overactive thyroid gland
•
if you have irregular or rapid heartbeats
•
if you have shown signs of hypersensitivity (severe allergy) to
dopamine or
sodium metabisulphite in the past
If possible, tell your doctor if any of the above applies to you
before this medicine is
used.
SPECIAL CARE NEEDS TO BE TAKEN WITH DOPAMINE STERILE CONCENTRATE
•
if you have diabetes
•
if you have kidney or liver problems
•
if you have a history of blood circulation problems (you will be
monitored for
any changes in colour or temperature of your fingers or toes)
If possible, tell your doctor if any of the above applies to you
before this medicine is
used.
TAKING/USING OTHER

Súhrn charakteristických

OBJECT 1
DOPAMINE 40 MG/ML STERILE CONCENTRATE
Summary of Product Characteristics Updated 24-Feb-2016 | Hospira UK
Ltd
1. Name of the medicinal product
Dopamine 40 mg/ml Sterile Concentrate
2. Qualitative and quantitative composition
Each ml of concentrate contains 40 mg dopamine hydrochloride
Each 5 ml ampoule of concentrate contains 200 mg dopamine
hydrochloride
For excipients, see 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion
Ampoules containing a clear colourless or pale yellow solution
4. Clinical particulars
4.1 Therapeutic indications
Dopamine is indicated for the correction of haemodynamic imbalance
present in:
1) Acute hypotension or shock associated with myocardial infarction,
endotoxic septicaemia, trauma and
renal failure.
2) As an adjunct after open heart surgery where there is persistent
hypotension after correction of
hypovolaemia.
3) In chronic cardiac decompensation as in congestive failure.
4.2 Posology and method of administration
To be administered by intravenous infusion only after dilution with
the appropriate diluents.
A suitable metering device is required in the infusion system to
control the rate of flow, and this should
be adjusted to the optimum patient response and monitored constantly
in the light of the individual
patient's response.
ADULTS
Where appropriate, the circulating blood volume must be restored with
a suitable plasma expander or
whole blood, prior to administration of dopamine hydrochloride.
Begin infusion of dopamine hydrochloride solution at doses of 2.5
microgram/kg/min in patients who are
likely to respond to modest increments of heart force and renal
perfusion.
In more severe cases, administration may be initiated at a rate of 5
microgram/kg/min and increased
gradually in 5- to 10 microgram/kg/min increments up to 20 to 50
microgram/kg/min as needed. If doses
in excess of 50 microgram/kg/min are required, it is advisable to
check urine output frequently.
Should urinary flow begin to decrease in the absence of hypotension,
reduction of dopamine dosa