FISAMOX amoxicillin (as sodium) 500 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin sodium

Available from:

Viatris Pty Ltd

Authorization status:

Registered

Patient Information leaflet

R:\CMI\Aspen Pharmacare Australia Pty Ltd\Current\eBS\Fisamox_CMI_Feb
16.doc
FISAMOX
®
_Amoxycillin (as amoxycillin sodium) Powder for Injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about FISAMOX
®
.
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 receiving FISAMOX
®
against the benefits this medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT FISAMOX
® IS USED FOR
FISAMOX
®
is an antibiotic used to treat some infections in different parts of
the body caused by bacteria.
FISAMOX
®
will not work against infections caused by viruses, such as colds or
the flu.
FISAMOX
®
is an antibiotic that belongs to a group of medicines called
penicillins. These antibiotics work
by killing the bacteria that are causing your infection.
Your doctor may have prescribed FISAMOX
®
for another reason. Ask your doctor why FISAMOX
®
has
been prescribed for you.
This medicine is available only with a doctor’s prescription.
There is no evidence that FISAMOX
®
is addictive.
BEFORE YOU ARE GIVEN FISAMOX
®
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT USE FISAMOX
® IF:
•
YOU HAVE AN ALLERGY TO FISAMOX
® OR OTHER PENICILLINS.
Some of the symptoms of an allergic reaction may include skin rash,
itching and difficult breathing.
•
YOU HAVE HAD AN ALLERGIC REACTION TO CEPHALOSPORINS.
You may have an increased chance of being allergic to FISAMOX
®
if you are allergic to
cephalosporins.
If you are not sure whether you should start taking FISAMOX
®
, talk to your doctor.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF:
1. YOU HAVE AN ALLERGY TO FISAMOX
® OR OTHER PENICILLINS.
2. YOU HAVE HAD ANY TYPE OF ALLERGIC REACTION TO CEPHALOSPORIN
MEDICINES.
You may have an increased chance of being allergic to FISA

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – FISAMOX AMOXICILLIN (AS AMOXICILLIN
SODIUM) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Amoxicillin (as amoxicillin sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FISAMOX
®
Powder for Injection is available in vials containing 500mg or 1 g of
amoxicillin (as
amoxicillin sodium) in boxes of 5 or 10 vials.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FISAMOX
®
is indicated in the treatment of infections due to susceptible strains
of the
organisms listed below. FISAMOX
®
Powder for Injection is intended for use where the
patient’s condition precludes the administration of the oral form.
Therapy should be guided by bacteriological studies, including
sensitivity tests, and by
clinical response. However in emergency cases where the causative
organism has not yet
been identified, therapy with amoxicillin may be useful. Clinical
judgement will decide
whether combination with another antibiotic would provide a
sufficiently broad spectrum of
activity pending sensitivity test results.
SEPTICAEMIA (BACTERIAL)
_H. influenzae, E. coli_ (
see Section 5.1 Microbiology
), _P. Mirabilis,_ Streptococci, _S. pneumoniae, _
_S. faecalis and Salmonella typhi._
SKIN AND SKIN STRUCTURE
Streptococci, non-β-lactamase-producing Staphylococci, _E. coli_ (
see Section 5.1 Microbiology
).
RESPIRATORY, ACUTE AND CHRONIC
_H. influenzae,_ Streptococci, _S. pneumoniae,_
non-β-lactamase-producing Staphylococci, _E. coli_
(
see Section 5.1 Microbiology
).
GENITO-URINARY TRACT (COMPLICATED AND UNCOMPLICATED), ACUTE AND
CHRONIC
_E. coli_ (
see Section 5.1 Microbiology
), _P. mirabilis and S. faecalis._
GONORRHOEA
_N. gonorrhoeae_ (non-β-lactamase-producing)
2
PROPHYLAXIS OF ENDOCARDITIS
FISAMOX
®
may
be
used
for
the
prophylaxis
of
bacterial
endocarditis
in
individuals
at
particular risk, such as those with prosthetic heart valves or those
who have previously had
endocarditis.
4.2
D
OSE AND METHOD OF ADMINI