NORADRENALINE MEDSURGE noradrenaline (norepinephrine) (as acid tartrate monohydrate) 4 mg/4 mL concentrated injection ampoule

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

noradrenaline (norepinephrine) acid tartrate monohydrate, Quantity: 8 mg/mL (Equivalent: noradrenaline (norepinephrine), Qty 4 mg/mL)

זמין מ:

Medsurge Pharma Pty Ltd

טופס פרצבטיות:

Injection, concentrated

הרכב:

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

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

10 x 4 mL

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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.

leaflet_short:

Visual Identification: Clear colourless or yellowish 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

מצב אישור:

Registered

תאריך אישור:

2022-03-01

עלון מידע

NORADRENALINE MEDSURGE
NORADRENALINE (NOREPINEPHRINE) ACID TARTRATE MONOHYDRATE
Noradrenaline Medsurge CMI Edition 0.4 Aug 2022
1
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 MEDSURGE?
Noradrenaline Medsurge contains the active ingredient noradrenaline
(norepinephrine) acid tartrate monohydrate.
Noradrenaline concentrated injection 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.
Noradrenaline concentrated injection 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, however, may have prescribed Noradrenaline concentrated
injection for another purpose.
There is no evidence that Noradrenaline concentrated injection is
addictive.
This medicine is only available with a doctor's prescription.
For more information, see Section 1. Why am I using Noradrenaline
Medsurge?
i
n the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NORADRENALINE MEDSURGE?
Do not use if you have ever had an allergic reaction to Noradrenaline
acid tartrate monohydrate 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 Medsurge?

מאפייני מוצר

NORADRENALINE
(NOREPINEPRINE)
_ _
PRODUCT INFORMATION
Edition 0.4 March 2022
Page
1
of
10
AUSTRALIAN PRODUCT INFORMATION
NORADRENALINE MEDSURGE
[NORADRENALINE (NOREPINEPHRINE) (AS ACID TARTRATE
MONOHYDRATE)]
CONCENTRATED 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 2 mL ampoule contains noradrenaline (norepinephrine) 2 mg in 2 mL
(1:1000), present as 4 mg of
noradrenaline (norepinephrine) acid tartrate monohydrate in 2 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.
Each 5 mL ampoule contains noradrenaline (norepinephrine) 5 mg in 5 mL
(1:1000), present as
10 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 5
mL.
Each 8 mL ampoule contains noradrenaline (norepinephrine) 8 mg in 8 mL
(1:1000), present as
16 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 8
mL.
Each 10 mL ampoule contains noradrenaline (norepinephrine) 10 mg in 10
mL (1:1000), present
as 20 mg of noradrenaline (norepinephrine) acid tartrate monohydrate
in 10 mL.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Concentrated injection.
Noradrenaline (norepinephrine) is a sterile, clear colourless or
yellowish solution, concentrated solution
for injection available in ampoules.
~GE
NORADRENALINE
(NOREPINEPRINE)
_ _
PRODUCT INFORMATION
Edition 0.4 March 2022
Page
2
of
10
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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