METARAMINOL TORBAY metaraminol (as tartrate) 2.5 mg/5 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metaraminol tartrate, Quantity: 4.75 mg (Equivalent: metaraminol, Qty 2.5 mg)

Available from:

Clinect Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

10

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: A clear colourless sterile solution, visibly free from particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-11-15

Patient Information leaflet

METARAMINOL TORBAY™
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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 USING METARAMINOL TORBAY?
Metaraminol Torbay contains the active ingredient metaraminol
tartrate. Metaraminol Torbay 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
Torbay? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METARAMINOL TORBAY?
Do not use if you have ever had an allergic reaction to Metaraminol
Torbay 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 Torbay? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Metaraminol Torbay 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 TORBAY?
•
Metaraminol Torbay must only be given by a doctor or nurse.
•
Metaraminol Torbay is administered in a hospital as an injection into
a vein or diluted before use and given with fluids into a
vein.
•
Your doctor will decide what dose of Metaraminol Torbay you will
receive and how long you will receive it for. This depends on
your medical condition and other factors, such as your weight.
More instructions can be found in Section 4. How do I use Metaraminol
Torbay? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METARAMINOL TORBAY?
THINGS YOU
SHOULD DO
•
Always follow your doctor's instructions carefully.
•
Your doctor or nurse will monitor your blood pressure.
•
Remind any doctor, dentist or pharmacist you visit that you are us

Summary of Product characteristics

Metaraminol Torbay PI
1
AUSTRALIAN PRODUCT INFORMATION
METARAMINOL TORBAY (METARAMINOL) SOLUTION FOR
INJECTION OR INFUSION
1
NAME OF THE MEDICINE
Metaraminol tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metaraminol Torbay solution for injection or infusion 10 mg/1 mL
contains metaraminol (as
tartrate) 10 mg in 1 mL solution (equivalent to 10 mg/mL).
Metaraminol Torbay solution for injection 5 mg/10 mL contains
metaraminol (as tartrate)
5 mg in 10 mL solution (equivalent to 0.5 mg/mL).
Metaraminol Torbay solution for injection 2.5 mg/5 mL contains
metaraminol (as tartrate)
2.5 mg in 5 mL solution (equivalent to 0.5 mg/mL)
Excipients with known effect: sodium metabisulfite.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Metaraminol Torbay is a clear colourless sterile solution for
intravenous administration,
visibly free from particles.
4
CLINICAL PARTICULARS
4.1
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Metaraminol Torbay is for intravenous administration only (injection
or infusion) and should
be used in one patient on one occasion only. It contains no
antimicrobial preservative.
Unused solution should be discarded.
Metaraminol Torbay PI
2
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 bloo