ERYTHROMYCIN-LINK erythromycin 1g (as lactobionate) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

erythromycin lactobionate, Quantity: 1.4882 g/g (Equivalent: erythromycin, Qty 1 g)

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oral erythromycin is not considered to be the antibiotic of choice in severely ill patients.,ERYTHROMYCIN-LINK (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 s

Product summary:

Visual Identification: Lyophilized cake, white to slightly yellow; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-10-26

Patient Information leaflet

ERYTHROMYCIN-LINK
_erythromycin 1 g (as lactobionate)_
CONSUMER MEDICINE INFORMATION
ERYTHROMYCIN-LINK
1
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
ERYTHROMYCIN-LINK. 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 being given
ERYTHROMYCIN-LINK against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT
ERYTHROMYCIN-
LINK IS USED FOR
ERYTHROMYCIN-LINK 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-LINK is used
to treat certain bacterial infections.
These infections may occur in
different parts of the body.
ERYTHROMYCIN-LINK 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-
LINK
_ _
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-
LINK.
_WHEN YOU MUST NOT BE _
_GIVEN ERYTHROMYCIN-_
_LINK _
YOU MUST NOT BE GIVEN
ERYTHROMYCIN-LINK 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

Summary of Product characteristics

ERYTHROMYCIN-LINK PI V1
1
AUSTRALIAN PRODUCT INFORMATION
ERYTHROMYCIN-LINK
®
ERYTHROMYCIN (AS LACTOBIONATE) POWDER FOR INJECTION
1 NAME OF THE MEDICINE
Erythromycin lactobionate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ERYTHROMYCIN-LINK (sterile erythromycin lactobionate) is a soluble
salt of erythromycin suitable
for intravenous administration containing the equivalent of 1g
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.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
ERYTHROMYCIN-LINK (sterile erythromycin lactobionate) is available as
a sterile, lyophilized cake
for reconstitution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral erythromycin is not considered to be the antibiotic of choice in
severely ill patients.
ERYTHROMYCIN-LINK (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).
•
Diph