NORADRENALINE BNM noradrenaline (as acid tartrate monohydrate) 1mg/1mL injection concentrated ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

noradrenaline (norepinephrine) acid tartrate monohydrate, Quantity: 2 mg/mL (Equivalent: noradrenaline (norepinephrine), Qty 1 mg/mL)

Available from:

Boucher & Muir Pty Ltd

INN (International Name):

noradrenaline (norepinephrine) acid tartrate monohydrate

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intravenous

Units in package:

10 ampoules/pack

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: A clear and colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-07-20

Patient Information leaflet

NORADRENALINE BNM
_CONCENTRATE FOR IV INJECTION 1 MG/1 ML & 4 MG/4 ML_
_Noradrenaline (norepinephrine) (as acid tartrate monohydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given Noradrenaline
BNM.
This leaflet answers some common
questions about Noradrenaline BNM.
It does not contain all the available
information. The most up-to-date
Consumer Medicine Information can
be downloaded from
www.ebs.tga.gov.au.
Reading this leaflet 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 giving you Noradrenaline
BNM against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT NORADRENALINE
BNM IS USED FOR
Noradrenaline BNM contains
noradrenaline (norepinephrine) acid
tartrate monohydrate. It belongs to a
group of medicines called
sympathomimetic amines. It works
by making the heartbeat 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.
Noradrenaline BNM is given in
emergency situations as a result of
medical conditions which cause a
dramatic drop in blood pressure.
Such situations/conditions could be:
•
associated with surgical
procedures
•
infections caused by poliovirus
•
a heart attack
•
infection in the blood
•
severe reaction to a medicine
•
severe reaction to a blood
transfusion
•
allergic reactions.
Noradrenaline BNM is used to
restore blood pressure back to
normal. It is given only by a doctor
or nurse, usually in hospital.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Noradrenaline BNM is only available
with a doctor's prescription.
There is no evidence that
Noradrenaline BNM is addi

Summary of Product characteristics

NORADRENALINE BNM
1
PRODUCT INFORMATION
NORADRENALINE BNM 1:1000
NORADRENALINE (NOREPINEPHRINE) (AS ACID TARTRATE MONOHYDRATE)
CONCENTRATE FOR IV INJECTION
1
NAME OF THE MEDICINE
Noradrenaline (norepinephrine) (as acid tartrate monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL ampoule contains noradrenaline (norepinephrine) 1 mg in 1 mL
(1:1000), present
as 2 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in
1 mL.
Each 4 mL ampoule contains noradrenaline (norepinephrine) 4 mg in 4 mL
(1:1000), present
as 8 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in
4 mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Noradrenaline BNM is a sterile, clear colourless concentrated solution
for injection available
in ampoules.
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
Noradrenaline BNM is a concentrated solution for injection which must
be diluted in glucose
containing solutions prior to infusion. An infusion of Noradrenaline
BNM should be given
into a large vein (see Section 4.4 Special warnings for precautions
for use).
NORADRENALINE BNM
2
Noradrenaline BNM 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.
This product contains no antimicrobial preservative; to reduce
microbiological hazard use
as soon as practicable after preparation. If storage is necessary,
hold at 2 to 8°C for not mo