METARAMINOL PHEBRA metaraminol (as tartrate) 10 mg/1 mL injection vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

metaraminol tartrate, Quantity: 18.96 mg (Equivalent: metaraminol, Qty 10 mg)

Disponible des:

Phebra Pty Ltd

formulario farmacéutico:

Injection

Composición:

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

Vía de administración:

Intravenous

Unidades en paquete:

5

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: sterile, clear, colourless to slightly yellow/pink solution, practically free from visible particles; Container Type: Vial; 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

Estat d'Autorització:

Registered

Data d'autorització:

2018-01-16

Informació per a l'usuari

Metaraminol Phebra
1 of 3
_Version 02_
_ _
METARAMINOL PHEBRA
CONTAINS METARAMINOL (AS TARTRATE) 10 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
recommende

Fitxa tècnica

PRODUCT INFORMATION
Australian Product Information – Metaraminol Phebra 10 mg/mL
Injection
Page 1 of 7
Version 03
METARAMINOL PHEBRA 10 MG/ML INJECTION
(METARAMINOL (AS TARTRATE))
1
NAME OF THE MEDICINE
Metaraminol tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Metaraminol Phebra injection contains metaraminol (as
tartrate) 10 mg and sodium metabisulfite 2.0
mg as antioxidant.
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.
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 Phebra is a clear colourless to slightly yellow/pink
sterile solution of metaraminol tartrate equivalent
to 10 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 coexistent shock
and acidosis may show a poor response to vasopressors. Established
metho