ERTAPENEM KABI ertapenem (as sodium) 1g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ertapenem sodium, Quantity: 1.046 g

Available from:

Fresenius Kabi Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium bicarbonate; sodium hydroxide

Administration route:

Intravenous Infusion

Units in package:

1, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ertapenem is indicated for the treatment of patients, aged 3 months or more, with moderate to severe infections (except meningitis, see PRECAUTIONS) caused by susceptible strains of microorganisms which are suspected or proven to be resistant to all other antibiotics, or for patients unable to tolerate other antibiotics.,Ertapenem is also indicated for initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including post-partum endomyometritis, septic abortion and post-surgical gynaecological infections.,Ertapenem is also indicated for the treatment of diabetic foot infections, which require parenteral antibiotic therapy and are caused by susceptible bacterial pathogens which are suspected or proven to be resistant to all other registered antibiotics, or for patients unable to tolerate other antibiotics.,Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Therapy with ertapenem may be initiated empirically before the results of these tests are known; once these results become available, antimicrobial therapy should be adjusted accordingly.

Product summary:

Visual Identification: White to yellowish powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-11-23

Patient Information leaflet

CMI for Ertapenem Kabi
October 2018
1.3.2 - CMI clean
Page 1 of 4
ERTAPENEM KABI
Ertapenem sodium
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ertapenem Kabi. 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 or your child taking
Ertapenem Kabi against the
benefits they expect it will 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 ERTAPENEM KABI
IS USED FOR
Ertapenem Kabi contains the active
ingredient, ertapenem sodium.
Ertapenem is an antibiotic used to
treat infections caused by bacteria
(germs).
These infections include:
•
infections within the abdomen
(stomach)
•
pelvic infections
•
diabetic foot infections in
patients without osteomyelitis.
Ertapenem may also be used in
patients not responding to, or
unable to tolerate, other antibiotics.
Ertapenem belongs to a class of
antibiotics called carbapenems. It
works by killing the bacteria
causing your infection.
Your doctor, however, may
prescribe Ertapenem Kabi for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ERTAPENEM
KABI HAS BEEN PRESCRIBED FOR
YOU OR YOUR CHILD.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
ERTAPENEM KABI
When you or your child must
not be given it
DO NOT USE ERTAPENEM KABI IF:
•
YOU HAVE AN ALLERGY TO
ERTAPENEM OR ANY OF THE OTHER
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
YOU HAVE AN ALLERGY TO OTHER
ANTIBIOTICS IN THE SAME CLASS
AS ERTAPENEM
•
YOU HAVE HAD A SERIOUS
ALLERGIC REACTION (ANAPHYLAXIS)
TO BETA-LACTAM ANTIBIOTICS,
INCLUDING PENICILLINS OR
CEPHALOSPORINS
•
THE VIAL CAP SHOWS SIGNS OF
TAMPERING
•
THE EXPIRY DATE PRINTED ON THE
PACK HAS PASSED.
If this medicine is used after the
expiry date has passed, it may
not work.
DO NOT USE ERTAPENEM KABI IN
CHILDREN UNDER 3 MONTHS OF

Summary of Product characteristics

Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION – ERTAPENEM KABI (ERTAPENEM) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Ertapenem sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1.046 grams ertapenem sodium, equivalent to 1 gram
ertapenem, as the
active ingredient; the inactive ingredients are sodium bicarbonate and
sodium hydroxide. The
sodium content is approximately 137 mg (approximately 6.0 mEq).
3
PHARMACEUTICAL FORM
Ertapenem Kabi is supplied as a white to yellowish sterile lyophilized
powder for intravenous
(IV) infusion after reconstitution with appropriate diluent (SEE
SECTION 4.2 DOSE AND METHOD
OF ADMINISTRATION).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ertapenem is indicated for the treatment of patients, aged 3 months or
more, with moderate
to severe infections (except meningitis, SEE SECTION 4.4 SPECIAL
WARNINGS AND PRECAUTIONS
FOR USE) caused by susceptible strains of microorganisms which are
suspected or proven to
be resistant to all other antibiotics, or for patients unable to
tolerate other antibiotics.
Ertapenem is also indicated for initial empiric therapy for the
treatment of complicated intra-
abdominal infections and acute pelvic infections including post-partum
endomyometritis,
septic abortion and post-surgical gynaecological infections.
Ertapenem is also indicated for the treatment of diabetic foot
infections, which require
parenteral antibiotic therapy and are caused by susceptible bacterial
pathogens which are
suspected or proven to be resistant to all other registered
antibiotics, or for patients unable to
tolerate other antibiotics.
Appropriate specimens for bacteriological examination should be
obtained in order to isolate
and identify the causative organisms and to determine their
susceptibility to ertapenem.
Therapy with ertapenem may be initiated empirically before the results
of these tests are
known; once these results become available, antimicrobial therapy
should be adjusted
accordingly
.
Page 2 of 24
4.2
DOSE AND METHOD OF ADMINISTRATION
The usu