IBIMICYN ampicillin 1g (as sodium) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ampicillin, Quantity: 1 g

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous, Intramuscular, Intraperitoneal, Intrapleural, Intraarticular, Intrathecal

Units in package:

1 x 5 vials, 10 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of infections due to susceptible strains of Gram-positive and Gram-negative organisms (See Microbiology). Bacteriological studies to determine the causative organisms and their sensitivity to Ampicillin sodium should be preformed.

Product summary:

Visual Identification: CLEAR GLASS VIALS CONTAINING A WHITE OR ALMOST WHITE POWDER; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-02-20

Patient Information leaflet

1
IBIMICYN
_._
_Ampicillin_
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about IBIMICYN.
It does not contain all the available
information. It does not take the
place of talking to your pharmacist
or doctor.
All medicines have risks and
benefits. Your pharmacist or doctor
has weighed the risks of you taking
IBIMICYN against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
_WHEN YOU MUST NOT TAKE IT_
Do not use IBIMICYN if:
1.
You have an allergy to:
-
IBIMICYN (ampicillin)
-
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
IBIMICYN if you are allergic to
cephalosporins.
3.
If the packaging is torn or shows
signs of tampering.
3.
You have any other medical
conditions, including:
-
asthma, hayfever or hives
-
kidney problems
-
glandular fever (infectious
mononucleosis)
4.
You are pregnant or intend to
become pregnant.
Your doctor will discuss the
possible risks and benefits of using
IBIMICYN during pregnancy.
5.
You are breast-feeding or plan to
breast-feed.
Your doctor will discuss the
possible risks and benefits of taking
/ using IBIMICYN while breast-
feeding.
IF YOU HAVE NOT TOLD YOUR
4. If the expiry date (EXP) printed
PHARMACIST OR DOCTOR ABOUT ANY
OF THE ABOVE, TELL HIM/HER BEFORE
WHAT IBIMICYN IS USED
FOR
IBIMICYN is an antibiotic that
belongs to a group of medicines
called penicillins. These antibiotics
work by killing the bacteria that are
causing your infection.
IBIMICYN, 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.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT
THIS MEDICINE.
Your pharmacist or doctor may
h

Summary of Product characteristics

Juno Pharmaceuticals Pty Ltd
Australian Product Information
PI v 1.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
IBIMICYN 500 MG (_AMPICILLIN (AS SODIUM)_)
IBIMICYN 1 G (_AMPICILLIN (AS SODIUM)_)
_ _
1
NAME OF THE MEDICINE
Ampicillin (as sodium).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibimicyn is a white to off-white powder contained in a clear glass
vial. This product contains
no excipients.
It occurs as a white, crystalline powder, odourless; taste bitter,
hygroscopic.
It is freely soluble in water, sparingly soluble in acetone and
practically insoluble in ether, fatty
oils and in liquid paraffin.
Each gram of ampicillin sodium contains approximately 2.7 mmol of
sodium.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
ampicillin (as sodium), 500 mg powder for injection vial
ampicillin (as sodium), 1 g powder for injection vial
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IBIMICYN is indicated for:
Treatment of infections due to susceptible strains of Gram-positive
and Gram-negative
organisms (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES-MICROBIOLOGY).
Bacteriological
studies to determine the causative organisms and their sensitivity to
Ampicillin sodium should
be performed.
4.2 DOSE AND METHOD OF ADMINISTRATION
_RESPIRATORY TRACT INFECTIONS: _
Adults: 250-500 mg six hourly.
Children: 25-50 mg/kg/day in equally divided doses six hourly.
_CHRONIC BRONCHITIS: _
Adults: 500 mg six hourly, (high dosage therapy - 1 g six hourly).
_URINARY TRACT INFECTIONS: _
Adults: 500 mg six hourly.
Juno Pharmaceuticals Pty Ltd
Australian Product Information
PI v 1.0
Page | 2
Children: 50 mg/kg/day in equally divided doses, six hourly.
_GASTROINTESTINAL TRACT INFECTIONS: _
Adults: 500-750 mg six hourly.
Children: 50-70 mg/kg day in equally divided doses, six hourly.
It should be recognised that in the treatment of chronic urinary tract
and intestinal infections,
frequent bacteriological and clinical appraisals are necessary.
Smaller doses than those recommended above should not be used