Noradrenaline BNM

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Noradrenaline acid tartrate 2 mg/mL Equivalent to 1 mg/mL noradrenaline base;  

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (International Name):

Noradrenaline acid tartrate 2 mg/mL (Equivalent to 1 mg/mL noradrenaline base)

Dosage:

1 mg/mL

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Noradrenaline acid tartrate 2 mg/mL Equivalent to 1 mg/mL noradrenaline base   Excipient: Nitrogen Sodium chloride Water for injection

Prescription type:

Prescription

Manufactured by:

Cambrex Profarmaco Milano Srl

Therapeutic indications:

For the restoration of blood pressure in certain acute hypotensive states (e.g. phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusions 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:

Package - Contents - Shelf Life: Ampoule, glass, Type 1, 4 mL - 10 dose units - 18 months from date of manufacture stored at or below 25°C protect from light. Do not refrigerate, do not freeze. - Ampoule, glass, Type 1, 1 mL - 10 dose units - 18 months from date of manufacture stored at or below 25°C protect from light. Do not refrigerate, do not freeze.

Authorization date:

2015-07-13

Patient Information leaflet

1
NORADRENALINE BNM
Consumer Medicine Information
NORADRENALINE BNM
_NORADRENALINE (NOREPINEPHRINE) (AS ACID TARTRATE MONOHYDRATE) _
Concentrate for IV injection 1 mg/1 mL & 4 mg/4 mL
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.
2
NORADRENALINE BNM
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

Summary of Product characteristics

1
NORADRENALINE BNM
NORADRENALINE (NOREPINEPHRINE) CONCENTRATED SOLUTION FOR INTRAVENOUS
INJECTION 1MG/ML
NEW ZEALAND DATA SHEET
1
NORADRENALINE BNM (1 MG/1 ML AND 4 MG/4 ML
CONCENTRATED INJECTION) NORADRENALINE BNM
1 mg/1 mL and 4 mg/4 mL concentrated injection.
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.
EXCIPIENT(S) WITH KNOWN EFFECT:
Each ampoule also contains the excipients sodium chloride 8.4 mg/mL
for tonicity.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Noradrenaline BNM is a sterile noradrenaline (norepinephrine)
concentrated solution for
injection available in ampoules.
The solution has a pH of 3.0 to 4.5.
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.
2
NORADRENALINE BNM
NORADRENALINE (NOREPINEPHRINE) CONCENTRATED SOLUTION FOR INTRAVENOUS
INJECTION 1MG/ML
4.2
DOSE AND METHOD OF ADMINISTRATION
_ Restoration of blood pressure in acute hypotensive states _
Blood
volume
depletion
should
always
be
corrected
as
fully
as
possible
before
any
vasopressor is administered. When, as an emergency measure,
intra-aortic pressures must be
maintained to prevent cerebral or coronary artery ischaemia,
noradrenaline (norepinephrine)
can be administered before and concurrently with blood volume
replacement.
_Average dosage _
Add
four
1
mL
ampoules
(4
mL)
of
Nora