METARAMINOL GH PHARMA metaraminol (as tartrate) 5 mg/10 mL solution for injection, vial

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

metaraminol tartrate, Quantity: 9.5 mg (Equivalent: metaraminol, Qty 5 mg)

متاح من:

Global Harvest Pharmaceuticals Pty Ltd

الشكل الصيدلاني:

Injection, solution

تركيب:

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

طريقة التعاطي:

Intravenous

الوحدات في الحزمة:

5

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

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.

ملخص المنتج:

Visual Identification: Clear colourless sterile solution; 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

الوضع إذن:

Registered

تاريخ الترخيص:

2019-06-07

نشرة المعلومات

CMI- METARAMINOL GH Pharma INJECTION
Page 1 of 4
CONSUMER MEDICINE INFORMATION
METARAMINOL GH PHARMA INJECTION
METARAMINOL TARTRATE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Metaraminol GH Pharma
Injection. It
does not contain all the available information. It does not take the
place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risk of you being given
Metaraminol GH Pharma Injection against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again.
WHAT METARAMINOL GH PHARMA INJECTION IS USED FOR
The name of your medicine is Metaraminol GH Pharma Injection. It
contains the active
ingredient Metaraminol tartrate.
Metaraminol GH Pharma Injection is used to increase your blood
pressure which can drop
during spinal anaesthesia or can drop as a reaction to medications or
surgical
complications.
Your doctor may have prescribed Metaraminol GH Pharma Injection for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY METARAMINOL GH
PHARMA INJECTION
WAS PRESCRIBED FOR YOU. Your doctor may have prescribed it for another
reason.
_ _
HOW METARAMINOL GH PHARMA INJECTION WORKS
Metaraminol GH Pharma Injection 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 GH Pharma Injection is
addictive.
BEFORE YOU TAKE METARAMINOL GH PHARMA INJECTION
WHEN YOU MUST NOT TAKE IT
You should not be given Metaraminol GH Pharma Injection if:
•
You are allergic to the active ingredient or any of the inactive
ingredients
mentioned at the end of this leaflet under Product Description.
Metaraminol GH
CMI- METARAMINOL GH Pharma INJECTION
Page 2 of 4
Pharma Injection contains sodium metabisulfite. A sulfite may cause an
allergic-
type re

خصائص المنتج

Metaraminol GH Pharma
V06-0519
Page 1 of 7
AUST R 99402
AUST R 300197, AUST R 304084
AUSTRALIAN PRODUCT INFORMATION
METARAMINOL GH PHARMA INJECTION (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.
ACTIVE INGREDIENT
Metaraminol tartrate
EXCIPIENTS
For full list of excipients see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
METARAMINOL GH PHARMA Injection is a clear colourless sterile
solution.
METARAMINOL GH PHARMA Injection is available as solution for injection
containing
metaraminol tartrate 10 mg/mL in clear glass ampoules and 3 mg/6 mL
and 5 mg/10 mL in
clear glass vials.
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 GH Pharma 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 shoc