IBIAMOX amoxicillin 1g (as sodium) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin, Quantity: 1 g

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous, Intramuscular

Units in package:

10, 1 x 5 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

IBIAMOX is intended for use where the patient?s condition precludes the administration of the oral form of amoxicillin. It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms.,Note: Therapy should be guided by bacteriological studies, including sensitivity tests, and clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxicillin sodium 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 Pharmacodynamic properties - Microbiology); P. mirabilis; Streptococcus; Strep. pneumoniae; Strep. faecalis and Salmonella typhi.,Skin and Skin Structure: Staphylococcus (non-penicillinase-producing), Streptococcus; E. coli (see section 5.1 Pharmacodynamic properties - Microbiology).,Respiratory, Acute and Chronic: H. influenzae; Streptococcus; Strep. pneumoniae; Staphylococcus (non-penicillinase producing); E. coli (see section 5.1 Pharmacodynamic properties - Microbiology).,Genitourinary Tract (complicated and uncomplicated), Acute and Chronic: E. coli (see section 5.1 Pharmacodynamic properties - Microbiology); P. mirabilis and Strep. faecalis.,Gonorrhoea: N. gonorrhoeae (nonpenicillinase producing),Prophylaxis of endocarditis: Amoxicillin sodium 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.

Product summary:

Visual Identification: CLEAR GLASS VIALS CONTAINING A WHITE OR ALMOST WHITE POWDER; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2003-02-21

Patient Information leaflet

1
IBIAMOX
TM
_Amoxycillin_
_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ibiamox. It does not contain all
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 being
administered Ibiamox against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING ADMINISTERED THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read
it again.
WHAT IBIAMOX IS U SED FOR
Ibiamox contains amoxycillin, an
antibiotic that belongs to a group
of medicines called penicillins.
These antibiotics work by killing
the bacteria that are causing your
infection. Ibiamox, like other
antibiotics, will not work against
infections caused by viruses such
as colds or the flu. This medicine
is available only with a doctor's
prescription.
BEFORE YOU ARE GIVEN
IBIAMOX
_WHEN YOU MUST NOT BE_
_ _
_GIVEN IT_
_ _
DO NOT USE IBIAMOX IF
:
1.
You have an allergy to
Ibiamox (amoxycillin) or other
penicillins. Symptoms of an
allergic reaction may include
skin rash, itching, difficulty
breathing or swelling.
2.
You have had an allergic
reaction to cephalosporin
antibiotics. You may have an
increased chance of being
allergic to Ibiamox if you are
allergic to cephalosporins.
3.
The packaging is torn or
shows signs of tampering.
4.
The expiry date (EXP) printed
on the pack has passed. If you
use this medicine after the expiry
date has passed, it may not work
as well.
IF YOU ARE NOT SURE WHETHER
YOU SHOULD BE GIVEN IBIAMOX,
TALK TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IT_
_ _
YOU MUST TELL YOUR DOCTOR IF:
1.
You have any type of allergic
reaction to penicillin,
amoxycillin or cephalosporin
antibiotics. You may have an
increased chance of being
allergic to Ibiamox if you are
allergic to cephalosporins.
2.
You have any allergies to any
other medicines or any other
substances, such as foods,
preservatives or dyes.
3.
You

Summary of Product characteristics

Australian Product Information
PI v 1.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
IBIAMOX 1 G (_AMOXICILLIN (AS SODIUM)_)
_ _
1 NAME OF THE MEDICINE
Ibiamox contains amoxicillin (as sodium).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin is a semisynthetic antibiotic and is a member of the
penicillinase- stable group of
penicillins
derived
from
the
penicillin
nucleus,
6-aminopenicillanic
acid.
It
is
identified
chemically as sodium (2S,5R,6R)-6[[(2R)-2-amino-2-(4-
hydroxyphenyl)acetyl]amino]-3,3-
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylate.
Amoxicillin sodium is a white or almost white powder, very
hygroscopic, very soluble in water,
sparingly soluble in ethanol, very slightly soluble in acetone.
Ibiamox is a white to off-white powder in a clear glass vial. Each 1 g
vial of amoxicillin contains
sodium 3.3mmol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
amoxicillin (as sodium), 1 g powder for injection vial
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IBIAMOX is intended for use where the patient’s condition precludes
the administration of the
oral form of amoxicillin. It is indicated for the treatment of the
following infections due to
susceptible strains of sensitive organisms.
NOTE: Therapy should be guided by bacteriological studies, including
sensitivity tests, and
clinical response. However, in emergency cases where the causative
organism has not been
identified, therapy with amoxicillin sodium 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
PHARMACODYNAMIC
PROPERTIES - MICROBIOLOGY); _P. mirabilis_; Streptococcus; _Strep_.
_pneumoniae_; _Strep. faecalis _
and _Salmonella typhi_.
SKIN AND SKIN STRUCTURE: Staphylococcus (non-penicillinase-producing),
Streptococcus; _E. _
_coli _(see SECTION 5.1 PHARMACODYNAMIC PROPERTIES - M