ERYTHROMYCIN PANPHARMA erythromycin (as lactobionate) 1 g powder for Injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

erythromycin lactobionate, Quantity: 1.49 g (Equivalent: erythromycin, Qty 1 g)

Available from:

Panpharma Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1, 10, 25

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oral erythromycin is not considered to be the antibiotic of choice in severely ill patients.,Erythromycin Panpharma (sterile erythromycin lactobionate) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Intravenous therapy should be replaced by oral administration at the appropriate time.,? Upper respiratory tract infections caused by Streptococcus pyogenes (Group A beta-haemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae); Haemophilus influenzae (many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved).,? Lower respiratory tract infections caused by Streptococcus pyogenes (Group A beta-haemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae).,? Respiratory tract infections due to Mycoplasma pneumoniae.,? Skin and skin structure infections caused by Streptococcus pyogenes and Staphylococcus aureus (resistant staphylococci may emerge during treatment).,? Diphtheria - As an adjunct to diphtheria antitoxin in infections due to Corynebacterium diphtheriae to prevent establishment of carriers and to eradicate the organism in carriers.,? Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin Panpharma (sterile erythromycin lactobionate) followed by erythromycin stearate, base or ethyl succinate orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin.,? Before treatment of gonorrhoea, patients who are suspected of also having syphilis should have microscopic examination for T. pallidum (by immuno-fluorescence or dark field) before receiving erythromycin and monthly serologic tests for a minimum of 4 months thereafter.,? Legionnaires' disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' disease.

Product summary:

Visual Identification: A white or slightly yellow powder.; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-10-18

Patient Information leaflet

[MEDICINE NAME]
®
™
1
ERYTHROMYCIN
PANPHARMA
_erythromycin 1 g (as lactobionate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ERYTHROMYCIN
PANPHARMA. It does not contain
all the available information. It does
not take the place of talking to your
doctor or nurse.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
ERYTHROMYCIN PANPHARMA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT
ERYTHROMYCIN
PANPHARMA IS USED
FOR
ERYTHROMYCIN PANPHARMA
contains erythromycin, an antibiotic
that belongs to the group of
medicines called macrolides. These
medicines work by killing or
stopping the growth of bacteria that
cause infections.
ERYTHROMYCIN PANPHARMA
is used to treat certain bacterial
infections. These infections may
occur in different parts of the body.
ERYTHROMYCIN PANPHARMA
will not work against infections
caused by viruses, such as colds or
flu.
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.
BEFORE YOU ARE GIVEN
ERYTHROMYCIN
PANPHARMA
TELL YOUR DOCTOR IF YOU HAVE ANY OF
THE FOLLOWING CONDITIONS OR IF YOU
HAVE EVER EXPERIENCED ANY OF THESE
CONDITIONS.
It is very important that your doctor
is aware of these matters when
determining whether or not to
prescribe ERYTHROMYCIN
PANPHARMA.
_WHEN YOU MUST NOT BE GIVEN _
_ERYTHROMYCIN _
_PANPHARMA _
YOU MUST NOT BE GIVEN
ERYTHROMYCIN
PANPHARMA IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
erythromycin
•
any of the ingredients listed at the
end of this leaflet.
•
other from the macrolide family,
including:
−
clarithromycin
−
roxithromycin
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swel

Summary of Product characteristics

ERYTHROMYCIN PANPHARMA (erythromycin lactobionate)
Version 1.3
1 of 20
AUSTRALIAN PRODUT INFORMATION – ERYTHROMYCIN
PANPHARMA (ERYTHROMYCIN LACTOBIONATE)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Erythromycin lactobionate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin Panpharma is available as a sterile, lyophilized cake for
reconstitution
containing the equivalent of 1 g erythromycin activity.
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.
Erythromycin Panpharma (sterile erythromycin lactobionate) is a
soluble salt of
erythromycin
suitable
for
intravenous
administration.
The
main
component
is
erythromycin A lactobionate.
3
PHARMACEUTICAL FORM
Powder for injection. For intravenous infusion following
reconstitution and dilution.
4
CLINICAL PARTICULARS
444
4444444444444444444444444
Oral erythromycin is not considered to be the antibiotic of choice in
severely ill patients.
Erythromycin
Panpharma
(sterile
erythromycin
lactobionate)
is
indicated
in
the
treatment of infections caused by susceptible strains of the
designated organisms in
the diseases listed below when oral administration is not possible or
when the severity
of the infection requires immediate high serum levels of erythromycin.
Intravenous
therapy should be replaced by oral administration at the appropriate
time.
•
Upper respiratory tract infections caused by _Streptococcus pyogenes_
(Group
A beta-haemolytic streptococci); _ Streptococcus pneumoniae_
(_Diplococcus _
_pneumoniae_); _Haemophilus influenzae_ (many strains of _H.
influenzae_ are not
susceptible to the erythromycin concentrations ordinarily achieved).
•
Lower respiratory tract infections caused by _Streptococcus pyogenes_
(Group
A beta-haemolytic streptococci); _ Streptococcus pneumoniae_
(_Diplococcus _
_pneumoniae_).
•
Respiratory tract infections due to _Mycoplasma pneumoniae_.
•
Skin and skin structure infections caused by _Streptococcus pyogenes_
an