NORADRENALINE JUNO noradrenaline (norepinephrine) (as acid tartrate) 2 mg/2 mL concentrated solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

noradrenaline (norepinephrine) acid tartrate monohydrate, Quantity: 4 mg (Equivalent: noradrenaline (norepinephrine), Qty 2 mg)

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

noradrenaline (norepinephrine) acid tartrate monohydrate

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections; sodium chloride

Administration route:

Intravenous

Units in package:

10

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: Clear solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2015-11-09

Patient Information leaflet

Noradrenaline Juno
1
NORADRENALINE JUNO
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NORADRENALINE JUNO?
Noradrenaline Juno contains the active ingredient noradrenaline.
Noradrenaline Juno is used by a doctor in an emergency to
r
estore blood pressure back to normal.
For more information, see Section 1. Why am I using Noradrenaline
Juno? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NORADRENALINE JUNO?
Do not use if you have ever had an allergic reaction to noradrenaline
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Noradrenaline Juno?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with noradrenaline and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE NORADRENALINE JUNO?
Your doctor will decide what dose you will receive. This depends on
your condition and how you respond to noradrenaline.
Often the dose is adjusted according to how the medicine is affecting
your blood pressure.
More instructions can be found in Section 4. How do I use
Noradrenaline Juno?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NORADRENALINE JUNO?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are being
treated with noradrenaline.
DRIVING OR USING
MACHINES
Do not drive or use any machines or tools until you know how
noradrenaline affects you.
For more information, see Section 5. What should I know while using
Noradrenaline Juno? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Side effects include: skin and tissue damage close to the site of
injection, anxiety, headache, dizziness, low or irregular hear

Summary of Product characteristics

Australian Product Information
Product Information v6.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_NORADRENALINE JUNO _
_NORADRENALINE (NOREPINEPHRINE) AS ACID TARTRATE MONOHYDRATE _
_ _
1 NAME OF THE MEDICINE
Noradrenaline (norepinephrine) as acid tartrate monohydrate.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The 2 mL ampoule contains noradrenaline (norepinephrine) 2 mg
(1:1000), present as 4 mg
of noradrenaline (norepinephrine) acid tartrate monohydrate.
The 4 mL ampoule contains noradrenaline (norepinephrine) 4 mg (
1:1000)
, present as 8 mg
of noradrenaline (norepinephrine) acid tartrate monohydrate.
Both ampoules have a pH of 3.0 to 4.5.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Noradrenaline JUNO 1:1000 is a sterile noradrenaline concentrated
solution for injection
available in 2 mL and 4 mL 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 JUNO 1:1000 is a concentrated solution for injection
which must be diluted in
glucose containing solutions prior to infusion. An infusion of
Noradrenaline JUNO 1:1000
should be given into a large vein (see SECTION 4.4 SPECIAL WARNINGS
AND
PRECAUTIONS FOR USE).
Noradrenaline JUNO 1:1000 must be administered in 5% glucose solution
in distilled water.
Noradrenaline JUNO 1:1000 must not be administered in saline solution
alone. Whole blood
or plasma, if indicated to increase blood volume, should be
administered separately.
Australian Product Information
Product Information v6.0
Page | 2
This product contains no antimicrobial preservative, to reduce
microbiolog