HOSPIRA NORADRENALINE 1:1000 noradrenaline (norepinephrine) 4mg / 4mL concentrate for IV injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

noradrenaline (norepinephrine) acid tartrate monohydrate

Tilgjengelig fra:

Pfizer Australia Pty Ltd

INN (International Name):

noradrenaline (norepinephrine) acid tartrate monohydrate

Autorisasjon status:

Registered

Informasjon til brukeren

Hospira
™
Noradrenaline
CMI
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HOSPIRA™ NORADRENALINE 1:1000
CONCENTRATE FOR INTRAVENOUS INJECTION
_Noradrenaline (Norepinephrine) Acid Tartrate Monohydrate_
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name _
_ _
_Pharmacist Name _
_Consumer Address _
_ _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about Hospira
Noradrenaline 1:1000.
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 Hospira
Noradrenaline 1:1000 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 HOSPIRA
NORADRENALINE 1:1000
IS USED FOR
Hospira Noradrenaline 1:1000 is
only given by a doctor or nurse in
an emergency situation, usually in
hospital as a result of serious
conditions which cause a
dramatic drop in blood pressure.
Such conditions could be:
•
a heart attack
•
infection in the blood
•
severe reaction to a drug
•
severe reaction to a blood
transfusion
•
allergic reactions
Hospira Noradrenaline 1:1000 is
used to restore blood pressure
back to normal.
This medicine belongs to a group
of medicines called
sympathomimetic amines.
It works by making the heart beat
more forcefully and constricting
blood vessels.
This results in a higher blood
pressure and greater blood flow
to the heart and other organs of
the body.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
There is no evidence that Hospira
Noradrenaline 1:1000 is
addictive_. _
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
HOSPIRA NORADRENALINE
1:1000
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN
HOSPIRA NORADRENALINE 1:1000 IF
YOU HAVE AN AL

Preparatomtale

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Supersedes: 2.0
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AUSTRALIAN
PRODUCT
INFORMATION
HOSPIRA
™ NORADRENALINE 1:1000 CONCENTRATE FOR IV
INJECTION
(NORADRENALINE
(NOREPINEPHRINE)
AS
ACID
TARTRATE MONOHYDRATE)
1.
NAME OF THE MEDICINE
Noradrenaline (norepinephrine) (as acid tartrate monohydrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains noradrenaline (norepinephrine) 4 mg in 4 mL
(1:1000), present as 8 mg of
noradrenaline (norepinephrine) acid tartrate monohydrate in 4 mL.
EXCIPIENT(S) WITH KNOWN EFFECT:
Sulfites
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Hospira
Noradrenaline
(norepinephrine)
1:1000
is
a
sterile,
colourless
(or
practically
colourless), concentrated solution for injection available in single
use vials.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For
the
restoration
of
blood
pressure
in
certain
acute
hypotensive
states
(e.g.
phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal
anaesthesia, myocardial
infarction, septicaemia, blood transfusion and drug reactions).
As an adjunct in the treatment of cardiac arrest. To restore and
maintain an adequate blood
pressure after an effective heartbeat and ventilation have been
established by other means.
4.2 DOSE AND METHOD OF ADMINISTRATION
Hospira Noradrenaline 1:1000 is a concentrated solution for injection
which must be diluted in
glucose containing solutions prior to infusion. An infusion of Hospira
Noradrenaline 1:1000
should be given into a large vein (see Section 4.4 Special warnings
and precautions for use)
Hospira
Noradrenaline 1:1000 must be administered in 5% glucose solution in
distilled water
or 5% glucose in saline solution, and must not be administered in
saline solution alone. Whole
blood or plasma, if indicated to increase blood volume, should be
administered separately.
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Supersedes: 2.0
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This product contains no antimicrobial preservative, to reduce
microbiological hazard, use as
soon as practicable after preparation. If storage is neces