Levophed 1:1000 noradrenaline (norepinephrine) 4mg / 4mL Concentrate for IV Injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

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

Prieinama:

Pfizer Australia Pty Ltd

INN (Tarptautinis Pavadinimas):

noradrenaline (norepinephrine) acid tartrate monohydrate

Vaisto forma:

Injection, concentrated

Sudėtis:

Excipient Ingredients: sodium metabisulfite; sodium chloride; water for injections

Vartojimo būdas:

Intravenous

Vienetai pakuotėje:

10 vials per pack

Klasė:

Medicine Registered

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

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.

Produkto santrauka:

Visual Identification: Colourless or practically colourless liquid; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizacija statusas:

Licence status A

Leidimo data:

2012-11-29

Pakuotės lapelis

LEVOPHED™ 1:1000
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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 BEING TREATED WITH LEVOPHED?
LEVOPHED contains the active ingredient noradrenaline
(norepinephrine). LEVOPHED is used by a doctor in an emergency to
restore blood pressure back to normal.
For more information, see Section 1. Why am I being treated with
LEVOPHED? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH LEVOPHED?
Do not start treatment if you have ever had an allergic reaction to
LEVOPHED 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
treatment with LEVOPHED? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LEVOPHED 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 IS LEVOPHED GIVEN?
Your doctor will decide what dose you will receive. This depends on
your condition and how you respond to LEVOPHED. Often, the
dose is adjusted according to how the medicine is affecting your blood
pressure.
More instructions can be found in Section 4. How is LEVOPHED given? in
the full CMI.
5.
WHAT SHOULD I KNOW DURING AND AFTER TREATMENT WITH LEVOPHED?
THINGS YOU
SHOULD DO
•
Remind any doctor, nurse, dentist or pharmacist who is treating you
that you have been given or are
being given LEVOPHED.
DRIVING
OR USING
MACHINES
•
Do not drive or use any machines or tools until you know how LEVOPHED
affects you.
For more information, see Section 5. What should I know during and
after treatment with LEVOPHED? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Side effects include: skin and tissue damage close to the site of
injection, anxiety, headac

Prekės savybės

Version: pfplevoi10822
Supersedes Version: pfplevoi10920
AUSTRALIAN PRODUCT INFORMATION
LEVOPHED™ 1:1000 (NORADRENALINE (NOREPINEPHRINE)
AS ACID TARTRATE MONOHYDRATE)
1.
NAME OF THE MEDICINE
Noradrenaline (norepinephrine) acid tartrate monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial 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:
Sodium metabisulfite
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
LEVOPHED
™
1:1000 is a sterile, clear colourless solution, concentrated solution
for injection
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).
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
LEVOPHED
™
1:1000 is a concentrated solution for injection which must be diluted
in glucose
containing solutions prior to infusion. An infusion of LEVOPHED
™
1:1000 should be given into a
large vein (see Section 4.4 Special warnings and precautions for use)
LEVOPHED
™
1:1000 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 more than 24 hours.
Version: pfplevoi10822
Supersedes Version: pfplevoi10920
LEVOPHED
™
1:1000 is for single use