EPHEDRINE HYDROCHLORIDE MYX ephedrine hydrochloride 25mg/1mL injection ampoule

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

ephedrine hydrochloride

Tilgjengelig fra:

Mayne Pharma International Pty Ltd

INN (International Name):

Ephedrine hydrochloride

Autorisasjon status:

Registered

Informasjon til brukeren

v 1.0
1
EPHEDRINE HYDROCHLORIDE MYX™
INJECTION
_Ephedrine Hydrochloride MYX, solution for injection, 25 mg/1 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ephedrine
Hydrochloride MYX. 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 taking Ephedrine
Hydrochloride MYX against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT EPHEDRINE
HYDROCHLORIDE MYX
INJECTION IS USED FOR
Ephedrine Hydrochloride MYX is
used to treat the low blood pressure
which may occur during spinal
anaesthesia.
It works by contracting the blood
vessels in your limbs, so that more
blood is available for your heart.
Your doctor may have prescribed
this medicine for another reason.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
Ephedrine Hydrochloride MYX is
available only with a doctor’s
prescription.
Ephedrine Hydrochloride MYX is
not approved for use in children.
BEFORE YOU ARE GIVEN
EPHEDRINE
HYDROCHLORIDE MYX
INJECTION
_WHEN YOU MUST NOT GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN
EPHEDRINE HYDROCHLORIDE MYX
IF:
•
YOU HAVE AN ALLERGY TO
EPHEDRINE OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET
Symptoms of an allergic
reaction to ephedrine may
include:
-
shortness of breath,
wheezing or difficulty in
breathing
-
swelling of the face, lips,
tongue or other parts of the
body
-
rash, itching or hives on
the skin.
•
YOU HAVE, OR HAVE HAD ANY OF
THE FOLLOWING MEDICAL
CONDITIONS:
-
heart problems
-
pheochromocytoma (a rare
tumour of the adrenal
gland near the kidney)
-
closed angle glaucoma (a
condition in which there is
a build up of pressure in
the eye)
-
mood/thought disorders
and were given
monoamine oxidase
(MAO) inhibitors in last
two weeks or about to
commenc

Preparatomtale

v 2.0
1
AUSTRALIAN PRODUCT INFORMATION
EPHEDRINE HYDROCHLORIDE MYX
® (EPHEDRINE HYDROCHLORIDE)
INJECTION
1.
NAME OF THE MEDICINE
Ephedrine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ephedrine Hydrochloride MYX Injection is a sterile solution of
ephedrine hydrochloride
in water for injections. Each mL contains 25 mg of ephedrine
hydrochloride (equivalent
to 20.5 mg ephedrine) in water for injections.
For the full list of excipients, see
_section 6.1 List of Excipients_
.
3.
PHARMACEUTICAL FORM
Ephedrine Hydrochloride MYX is a clear and colourless solution for
injection.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Ephedrine Hydrochloride MYX Injection is indicated in the treatment of
hypotension
secondary to spinal anaesthesia.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Ephedrine Hydrochloride MYX Injection is not approved for use in
children (see
_section_
_4.4 Special Warnings and Precautions for Use – Paediatric Use_
).
Ephedrine Hydrochloride MYX Injection must be diluted prior to
administration.
Ephedrine Hydrochloride MYX Injection contains no preservative and is
for single use in
one patient on one occasion only. Discard any remaining residue.
The injection should be given slowly. Care should be taken to
avoid extravasation, since
this may result in tissue necrosis and sloughing. Ephedrine
hydrochloride should
be
administered in the lowest effective dose.
Dilute 1 mL of Ephedrine Hydrochloride MYX Injection to 10 mL with
saline 0.9% to
produce a 2.5 mg/mL solution. This solution should be given as a slow
intravenous
v 2.0
2
injection of 2.5 to 5 mg (maximum 10 mg), repeated as needed every 3-4
minutes to a
maximum of 30 mg.
A lack of efficacy after 30 mg should lead to reconsideration of the
choice of the
therapeutic agent.
During therapy with a pressor agent, blood pressure should be elevated
to slightly less
than the
patient’s normal blood pressure. In previously normotensive
patients, systolic
blood pressure should
be maintained at 80 to 100 mmHg. In previously hypertensive
patien