METARAMINOL WKT metaraminol (as tartrate) 5mg in 10mL solution for injection ampoule

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

metaraminol tartrate, Quantity: 9.5 mg

Tilgjengelig fra:

Wockhardt Bio Pty Ltd

Legemiddelform:

Injection, solution

Sammensetning:

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

Administreringsrute:

Intravenous

Enheter i pakken:

10 ampoules

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma. It may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia.

Produkt oppsummering:

Visual Identification: Clear glass ampoule filled with a clear colourless solution practically free from particles.; 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

Autorisasjon status:

Registered

Autorisasjon dato:

2023-05-12

Informasjon til brukeren

METARAMINOL WKT SOLUTION FOR INJECTION CMI V1.2 MAY 2022
1
METARAMINOL WKT *
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 METARAMINOL WKT ?
METARAMINOL WKT contains the active ingredient metaraminol tartrate is
used to increase your blood pressure which
can drop during spinal anaesthesia or can drop as a reaction to
medications or surgical complications.
For more information, see Section 1. Why am I using METARAMINOL WKT?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METARAMINOL WKT ?
Do not use if you have ever had an allergic reaction to metaraminol
tartrate 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
METARAMINOL WKT in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Metaraminol tartrate 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 METARAMINOL WKT ?
The dose of METARAMINOL WKT Injection you will receive depends on your
medical condition and other factors such as
your weight. METARAMINOL WKT Injection is administered in a hospital
as an injection into a vein or is diluted before use
and given with fluids into a vein. This medicine must only be given by
a doctor or nurse.
More instructions can be found in Section 4. How do I use METARAMINOL
WKT? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METARAMINOL WKT ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Metaraminol
Tell your doctor if you have or have had any medical conditions,
especially the following:
•
Liver disease
•
Heart or thyroid disease
•
High blood pressure
•
Diabetes
•
Malaria.

Preparatomtale

METARAMINOL WKT V1.5 May 2023
1
AUSTRALIAN PRODUCT INFORMATION
METARAMINOL WKT (Metaraminol tartrate) INJECTION
1
NAME OF THE MEDICINE
Metaraminol tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
METARMINOL WKT is available in clear glass ampoules as a solution for
injection or infusion
in two strengths:
Metaraminol (as tartrate) 10 mg/1 mL
Metarminol (as tartrate) 5 mg/10 mL
EXCIPIENTS WITH KNOWN EFFECT
Each ampoule contains sodium metabisulfite 2.5 mg/mL as an antioxidant
For full list of excipients see
SECTION 6.1
LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
METARAMINOL WKT solution for Injection is a clear colourless sterile
solution.
4
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Prevention and treatment of the acute hypotensive state occurring with
spinal anaesthesia;
adjunctive treatment of hypotension due to haemorrhage, reactions to
medications, surgical
complications, and shock associated with brain damage due to tumour or
trauma.
It may also be useful as an adjunct in the treatment of hypotension
due to cardiogenic shock or
septicaemia.
DOSE AND METHOD OF ADMINISTRATION
Metaraminol WKT Injection is administered intravenously only
(injection or infusion). The
injection solution contains no antimicrobial preservative and is for
single use in one patient only.
Discard any residue.
Because the maximum effect is not immediately apparent, at least ten
minutes should elapse
before increasing the dosage. As the effect tapers off when the
vasopressor is discontinued, the
patient should be carefully observed so that therapy can be
reinitiated promptly if the blood
pressure falls too rapidly. Patients with coexistent shock and
acidosis may show a poor response
to vasopressors. Established methods of shock management, such as
blood or fluid replacement
when indicated, and other measures directed to the specific cause of
the shock also should be
used.
METARAMINOL WKT V1.5 May 2023
2 INTRAVENOUS INFUSION (FOR ADJUNCTIVE TREATMENT OF HYPOTENSION)
METARAMINOL WKT 10 mg/1 mL Solution for Injection should be used to
prep