EPHEDRINE HYDROCHLORIDE SXP ephedrine hydrochloride 30mg / mL solution for injection ampoule

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

ephedrine hydrochloride, Quantity: 30 mg

Tilgjengelig fra:

Southern Cross Pharma Pty Ltd

INN (International Name):

Ephedrine hydrochloride

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

5 ampoules

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Ephedrine Hydrochloride Injection is indicated in the treatment of hypotension secondary to spinal anaesthesia.

Produkt oppsummering:

Visual Identification: EPHEDRINE 30 mg/ml solution for injection in ampoules of 1 ml is a sterile solution containing 30 mg of Ephedrine hydrochloride.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2017-03-03

Informasjon til brukeren

Ephedrine Hydrochloride Injection CMI
Page 1
EPHEDRINE HYDROCHLORIDE SXP
INJECTION
Ephedrine Hydrochloride _(e-FED-rin HYE-droe-KLOR-ide)_
_ _
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ephedrine Hydrochloride SXP
Injection. It does not contain all
the available information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given Ephedrine Hydrochloride
SXP Injection against the
benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET IN A SAFE
PLACE. You may need to read it
again.
WHAT EPHEDRINE
HYDROCHLORIDE SXP
INJECTION IS USED FOR
Ephedrine Hydrochloride SXP
Injection 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 SXP
Injection is available only with a
doctor’s prescription.
Ephedrine Hydrochloride SXP
Injection is not approved for use
in children.
BEFORE YOU ARE
GIVEN EPHEDRINE
HYDROCHLORIDE SXP
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT_
_ _
YOU SHOULD NOT BE GIVEN
EPHEDRINE
HYDROCHLORIDE SXP
INJECTION 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:
-
some heart problem such
as ventricular fibrillation,
tachyarrhythmias,
coronary thrombosis and
idiopathic hypertrophic
subaortic stenosis)
-
p

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
EPHEDRINE HYDROCHLORIDE SXP (EPHEDRINE HYDROCHLORIDE) INJECTION
_ _
1. NAME OF THE MEDICINE
Ephedrine hydrochloride.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ephedrine hydrochloride injection contains the active ingredient
ephedrine hydrochloride.
Ephedrine hydrochloride injection comes in one strength containing 30
mg/ mL.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Ephedrine hydrochloride is a white to almost white crystalline powder
or colourless crystals.
Ephedrine hydrochloride solution for injection is a sterile solution.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Ephedrine Hydrochloride Injection is indicated in the treatment of
hypotension secondary to spinal
anaesthesia.
4.2. DOSE AND METHOD OF ADMINISTRATION
Ephedrine Hydrochloride SXP Injection is not approved for use in
children (see Section 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
Ephedrine Hydrochloride SXP Injection must be diluted prior to
administration.
Ephedrine Hydrochloride Injection is administered by the intravenous
route. 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. The parenteral adult dose
should not exceed 150 mg in 24 hours.
A lack of efficacy after 30 mg should lead to reconsideration of the
choice of the therapeutic agent.
Product is for single use in one patient only. Discard any residue.
AS A PRESSOR:
Adult dose:
Dilute 1 mL of Ephedrine Hydrochloride SXP to 10 mL with 0.9% Sodium
chloride to produce a 3 mg/mL
solution. This medicine should be administered immediately after
dilution. Up to 30 mg in increments of 3 to
7.5 mg (maximum of 10mg). After the development of hypotension, by
slow intravenous administration.
PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT
There are no specific dosage recommendations for patients with renal
or hepatic impairment.
COMPATIBILITIES
Ephed