EES erythromycin 200mg/5mL (as ethyl succinate) granules for oral liquid bottle

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

erythromycin ethyl succinate

Beschikbaar vanaf:

Amdipharm Mercury Australia Pty Ltd

INN (Algemene Internationale Benaming):

Erythromycin ethyl succinate

Autorisatie-status:

Registered

Bijsluiter

EES
™
_200 MG/5 ML GRANULES; 400 MG/5 ML GRANULES_
_erythromycin as ethyl succinate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EES.
It does not contain all of 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 risks of you taking EES against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT EES IS USED FOR
EES is used to:
•
treat certain bacterial infections;
these infections may occur in
different parts of the body
•
control acne
•
prevent infections in patients with
a history of rheumatic disease,
congenital heart disease or other
acquired valvular heart disease
and who may be allergic to
penicillin antibiotics.
Your doctor, however, may have
prescribed EES for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY EES HAS BEEN
PRESCRIBED FOR YOU.
EES is an antibiotic that belongs to
the group of medicines called
macrolides. These medicines work
by killing or stopping the growth of
bacteria, which cause infections or
make acne worse.
EES will not work against infections
caused by viruses, such as colds or
flu.
EES is available only with a doctor's
prescription.
BEFORE YOU TAKE EES
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE EES IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
erythromycin
•
any of the ingredients listed at the
end of this leaflet
•
other antibiotics from the
macrolide family, including:
-
clarithromycin
-
roxithromycin.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
YOU MUST NOT TAKE EES IF:
•
you are taking
-
terfenadine or astemizole
-
cisapride, pimozide or
dompe

Productkenmerken

EES
®
1
AUSTRALIAN PRODUCT INFORMATION
EES
®
ERYTHROMYCIN AS ETHYL SUCCINATE
GRANULES FOR ORAL LIQUID
1
NAME OF THE MEDICINE
Erythromycin ethyl succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EES granules
are available for oral administration in a strength of 200
mg erythromycin (as
ethyl succinate) per 5
mL and 400
mg erythromycin (as ethyl succinate) per 5
mL once
reconstituted.
Erythromycin is produced by a strain of
_Streptomyces erythraeus_
and belongs to the
macrolide group of antibiotics. It is basic and readily forms salts
with acids. The base, the
stearate salt, and the esters are poorly soluble in water. EES
products contain the ethyl
succinate ester of erythromycin.
Excipients with known effect: sucrose and saccharin sodium
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
EES 200 MG/5 ML GRANULES
Pink free flowing granules. When reconstituted with water to make 100
mL of 200 mg
(erythromycin) per 5 mL, pink opaque cherry flavoured suspension.
EES 400 MG/5 ML GRANULES
Pink free flowing granules. When reconstituted with water to make 100
mL of 400 mg
(erythromycin) per 5 mL, pink opaque cherry flavoured suspension.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_STREPTOCOCCUS PYOGENES _(GROUP A BETA-HAEMOLYTIC STREPTOCOCCUS):_ _
Upper and lower respiratory tract, skin and soft tissue infections of
mild to moderate
severity.
When
oral
medication
is
preferred
for
treatment
of
the
above
conditions,
penicillin G, V, or erythromycin are alternate drugs of choice.
EES
®
2
When oral medication is given, the importance of strict adherence by
the patient to the
prescribed dosage regimen must be stressed. A therapeutic dose should
be administered for
at least 10 days.
ALPHA-HAEMOLYTIC STREPTOCOCCI (VIRIDANS GROUP):
Although no controlled clinical efficacy trials have been conducted,
oral erythromycin has
been suggested by the American Heart Association and the American
Dental Association for
use in a regimen for prophylaxis against bacterial endocarditis in
pat