NORALIN Noradrenaline (norepinephrine) (as acid tartrate monohydrate) 10 mg/50 mL solution for intravenous infusion, vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

noradrenaline (norepinephrine) acid tartrate monohydrate, Quantity: 20 mg (Equivalent: noradrenaline (norepinephrine), Qty 10 mg)

Available from:

Boucher & Muir Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid

Administration route:

Intravenous Infusion

Units in package:

Pack of 1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the restoration of blood pressure in certain acute hypotensive states (e.g. phaeochromocytomectomy, sumpathectomy, 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: Clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 17 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-04-17

Patient Information leaflet

1
NORALIN
Consumer Medicine Information
NORALIN
_NORADRENALINE (NOREPINEPHRINE) (AS ACID TARTRATE MONOHYDRATE) _
Solution for intravenous infusion 3 mg/50 mL, 5 mg/50 mL, 6 mg/50 mL &
10 mg/50 mL
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you are given Noralin.
This leaflet answers some common questions about Noralin. 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
Noralin 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 NORALIN IS USED FOR
Noralin 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.
Noralin 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.
2
NORALIN
Noralin 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.
Noralin is only available with a doctor's prescription.
There is no evidence that Noralin is addictive.
BEFORE YOU ARE GIVEN NORALIN
_ _
Noralin

Summary of Product characteristics

NORALIN
1
PRODUCT INFORMATION
NORALIN
NORADRENALINE (NOREPINEPHRINE) (AS ACID TARTRATE MONOHYDRATE)
SOLUTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Noradrenaline (norepinephrine) (as acid tartrate monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Noralin is available in the following strengths:
•
Noradrenaline (norepinephrine) (as acid tartrate monohydrate) 3 mg/50
mL
•
Noradrenaline (norepinephrine) (as acid tartrate monohydrate) 5 mg/50
mL
•
Noradrenaline (norepinephrine) (as acid tartrate monohydrate) 6 mg/50
mL
•
Noradrenaline (norepinephrine) (as acid tartrate monohydrate) 10 mg/50
mL
Each 3 mg/50 mL vial contains noradrenaline (norepinephrine) 0.06 mg
in 1 mL, present as
0.12 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in
1 mL.
Each 5 mg/50 mL vial contains noradrenaline (norepinephrine) 0.1 mg in
1 mL, present as
0.2 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in
1 mL.
Each 6 mg/50 mL vial contains noradrenaline (norepinephrine) 0.12 mg
in 1 mL, present as
0.24 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in
1 mL.
Each 10 mg/50 mL vial contains noradrenaline (norepinephrine) 0.2 mg
in 1 mL, present as
0.4 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in
1 mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Noralin is a sterile, clear colourless solution for intravenous
infusion available in 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).
NORALIN
2
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
Noralin should only be administered by healthcare professionals
familia