METARAMINOL PHEBRA metaraminol (as tartrate) 5mg/10mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metaraminol tartrate, Quantity: 9.5 mg

Available from:

Phebra Pty Ltd

INN (International Name):

Metaraminol tartrate

Pharmaceutical form:

Injection

Composition:

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

Administration route:

Intravenous

Units in package:

5

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 solution. Practically free from any visible particles.; Container Type: Vial; 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

Authorization status:

Licence status A

Authorization date:

2016-11-30

Patient Information leaflet

Metaraminol Phebra
1 of 3
_Version 03_
_ _
METARAMINOL PHEBRA
CONTAINS METARAMINOL (AS TARTRATE) 0.5 MG/ML
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Metaraminol Phebra. It
does not contain all the available
information. It does not take the place
of talking to your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Metaraminol Phebra
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT METARAMINOL
PHEBRA IS USED FOR
The name of your medicine is
Metaraminol Phebra. It contains the
active ingredient metaraminol tartrate.
Metaraminol Phebra is used to increase
your blood pressure which can drop
during spinal anaesthesia or can drop
as a reaction to medications or surgical
complications.
_HOW METARAMINOL PHEBRA _
_WORKS _
Metaraminol Phebra belongs to a group
of medicines known as
sympathomimetic amines.
It strengthens the contraction of the
heart muscle and constricts blood
vessels to help increase the blood
pressure.
There is no evidence that Metaraminol
Phebra is addictive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
This medicine is available only with a
doctor’s prescription.
Metaraminol Phebra is not
recommended for use in children.
BEFORE YOU ARE GIVEN
METARAMINOL PHEBRA
_WHEN YOU MUST NOT BE GIVEN _
_IT_
_ _
YOU SHOULD NOT BE GIVEN
METARAMINOL PHEBRA IF:
•
you are allergic to metaraminol or
any of the ingredients listed at the
end of this leaflet. Metaraminol
Phebra contains sodium
metabisulfite. A sulfite may cause
an allergic-type reaction or an
asthmatic episode in certain
susceptible people.
•
you are being given cyclopropane
or halothane anaesthesia (unless
clinical circumstances demand
their use).
Metaraminol Phebra is not
recommended

Summary of Product characteristics

PRODUCT INFORMATION
Product Information – Metaraminol Phebra
Page 1 of 7
Version 03
METARAMINOL PHEBRA
®
(METARAMINOL TARTRATE)
1
NAME OF THE MEDICINE
Metaraminol tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metaraminol tartrate is a white, crystalline powder, which is freely
soluble in water, slightly soluble in alcohol, and
practically insoluble in chloroform and in ether.
Each mL of Metaraminol Phebra solution for injection contains
metaraminol (as tartrate) 0.5 mg, sodium chloride
9 mg, sodium metabisulfite 1.2 mg as antioxidant in water for
injections to 1 mL. Tartaric acid and/or sodium
hydroxide are added for pH adjustment.
List of excipients with known effect: sodium chloride and sodium
metabisulfite.
This medicine contains sodium as sodium chloride and sodium
metabisulfite.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Metaraminol 0.5 mg/mL solution for injection.
A clear colourless sterile solution of metaraminol tartrate equivalent
to 0.5 mg/mL metaraminol
.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
Metaraminol Phebra 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.
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 coexis