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

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

ertapenem sodium, Quantity: 1.046 g (Equivalent: ertapenem, Qty 1 g)

Предлага се от:

Juno Pharmaceuticals Pty Ltd

Лекарствена форма:

Injection, powder for

Композиция:

Excipient Ingredients: sodium bicarbonate; sodium hydroxide; nitrogen

Начин на приложение:

Intramuscular, Intravenous Infusion

Броя в опаковка:

1, 10

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Treatment,ERTAPENEM JUNO 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 JUNO 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 JUNO 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 JUNO may be initiated empirically before the results of these tests are known; once these results become available, antimicrobial therapy,should be adjusted accordingly.

Каталог на резюме:

Visual Identification: A sterile, pyrogen-free with to yellowish powder in 20 mL colorless clear sterile, pyrogen-free vials.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

2019-07-17

Листовка

Ertapenem Juno Consumer Medicines Information Juno Pharmaceuticals Pty
Ltd
1
ERTAPENEM JUNO
_FOR INJECTION _
_Ertapenem _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ERTAPENEM JUNO. 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 using
ERTAPENEM JUNO against
the benefits they expect it will
have for you or your child.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it
again.
WHAT ERTAPENEM
JUNO IS USED FOR
ERTAPENEM JUNO 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 JUNO may also
be used in patients not
responding to, or unable to
tolerate, other antibiotics.
ERTAPENEM JUNO belongs to
a class of antibiotics called
carbapenems. It works by killing
the bacteria causing your
infection.
Your doctor may have
prescribed ERTAPENEM
JUNO for another reason.
Ask your doctor if you have any
questions about why
ERTAPENEM JUNO has been
prescribed for you.
BEFORE YOU ARE GIVEN
ERTAPENEM JUNO
WHEN YOU OR YOUR CHILD MUST
NOT BE GIVEN IT
DO NOT USE ERTAPENEM
JUNO IF:
•
YOU HAVE AN ALLERGY TO
ERTAPENEM JUNO OR
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET
•
YOU HAVE AN ALLERGY TO
OTHER ANTIBIOTICS IN THE
SAME CLASS AS
ERTAPENEM JUNO
•
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 you use this medicine after the
expiry date has passed, it may
not work.
DO NOT USE ERTAPENEM
JUNO BY INJECTION INTO A
MUSCLE IF:
•
you have an allergy to
amide-type local
anaesthetics, particul

Данни за продукта

Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_ERTAPENEM JUNO (ERTAPENEM (AS SODIUM)) _
_ _
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, and the
inactive ingredients sodium bicarbonate and sodium hydroxide. The
sodium content is
approximately 137 mg (approximately 6.0 mEq).
For the full list of excipients, see Section 6.1 List of Excipients.
3 PHARMACEUTICAL FORM
ERTAPENEM JUNO is supplied as a sterile lyophilised powder for
intravenous infusion or
intramuscular injection containing 1 gram ertapenem as free acid.
ERTAPENEM JUNO is supplied as sterile lyophilized powder for
intravenous infusion after
reconstitution with appropriate diluent (see SECTION 4.2 DOSE AND
METHOD OF ADMINISTRATION:
INSTRUCTIONS
FOR
USE)
for
transfer
to
50
mL
0.9%
Sodium
Chloride
Injection
or
for
intramuscular injection following reconstitution with 1% lidocaine
(lignocaine) hydrochloride.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ERTAPENEM JUNO 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
JUNO
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 JUNO 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 examin