METARAMINOL WOCKHARDT 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: water for injections; sodium hydroxide; sodium chloride; sodium metabisulfite; hydrochloric acid

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 WOCKHARDT SOLUTION FOR INJECTION CMI V1.3 MAY 2023
1
METARAMINOL WOCKHARDT*
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 WOCKHARDT?
METARAMINOL WOCKHARDT 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
WOCKHARDT? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METARAMINOL WOCKHARDT?
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 WOCKHARDT? 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 WOCKHARDT?
The dose of METARAMINOL WOCKHARDT Injection you will receive depends
on your medical condition and other factors
such as your weight. METARAMINOL WOCKHARDT 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
WOCKHARDT ? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METARAMINOL WOCKHARDT?
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

Preparatomtale

METARAMINOL WOCKHARDT V1.5 MAY 2023
1
AUSTRALIAN PRODUCT INFORMATION - METARAMINOL
WOCKHARDT (Metaraminol tartrate) INJECTION
1
NAME OF THE MEDICINE
Metaraminol tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
METARMINOL WOCKHARDT is available in clear glass ampoules as a
solution for injection or
infusion in two strengths:
Metaraminol (as tartrate) 10 mg/1 mL
Metaraminol (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 WOCKHARDT 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 WOCKHARDT 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 WOCKHARDT V1.5 MAY 2023
2
INTRAVENOUS INFUSION. (FOR ADJUNCTIVE TREATMENT OF HYPOTENSION.)
METARAMINOL WOCKHARDT 10 mg/1 m