MEROPENEM JUNO meropenem (as trihydrate) 1 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

meropenem trihydrate, Quantity: 1140 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium carbonate

Administration route:

Intravenous, Intravenous Bolus, Intravenous Infusion

Units in package:

10 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Meropenem Juno is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:,,? Community acquired lower respiratory tract infection ,,? Hospital acquired lower respiratory tract infection,,? Complicated urinary tract infection,,? Febrile neutropaenia,,? Intra-abdominal and gynaecological (poly microbial) infections,,? Complicated skin and skin structure infections,,? Meningitis,,? Septicaemia

Product summary:

Visual Identification: White to light yellow coloured powder.; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-07-15

Patient Information leaflet

1
MEROPENEM JUNO POWDER FOR INJECTION
_Meropenem trihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Meropenem 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 risk of you taking Meropenem
Juno 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 IS MEROPENEM
JUNO USED FOR
Meropenem is an antibiotic used in
adults and children to treat certain
serious infections caused by bacteria,
such as:
•
Infections of the lungs
•
Infections
of
the
kidney
or
bladder (urinary tract infection)
•
Febrile neutropaenia
•
Infections around the stomach or
bowel
•
Infections
of
the
vagina
and
womb
•
Serious skin infections
•
Infections
in the
lining
of the
brain (meningitis)
•
Infections
in the
blood
stream
(septicaemia)
Meropenem belongs to a group of
medicines
called
carbapenem
antibiotics. These medicines work by
killing the bacteria that are causing
your infection.
Meropenem
will
not
work
against
fungal
or
viral
infections
(such
as
colds or flu).
Meropenem
is
an
injection
and
is
usually only used in hospitals. It is
available
only
with
a
doctor's
prescription.
ASK
YOUR
DOCTOR
IF
YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Meropenem is not addictive.
MEROPENEM
JUNO
IS
NOT
RECOMMENDED
FOR
USE
IN
CHILDREN
UNDER THE AGE OF 3 MONTHS.
Safety
and
effectiveness
in
children
younger than 3 months have not been
established.
BEFORE YOU ARE GIVEN
MEROPENEM JUNO
WHEN
YOU
MUST
NOT
BE
GIVEN
MEROPENEM JUNO
DO NOT USE MEROPENEM JUNO IF YOU
HAVE AN ALLERGY TO:
•
any
medicine
containing
meropenem
•
any
other
carbopenems,
penicillins
or
other
beta
lactam
antibiotics
•
any of the ingredients listed at th

Summary of Product characteristics

Juno Pharmaceuticals Pty Ltd
Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
MEROPENEM JUNO _(MEROPENEM (AS TRIHYDRATE)) _
_ _
1 NAME OF THE MEDICINE
Meropenem, as meropenem trihydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Meropenem Juno powder for intravenous injection or infusion
500 mg
1 g
Active ingredient
Meropenem trihydrate
570 mg
1.14 g
Equivalent to anhydrous meropenem
500 mg
1 g
Excipient
Sodium carbonate
104 mg
208 mg
3 PHARMACEUTICAL FORM
Meropenem Juno powder for intravenous injection is presented as a
sterile white or light
yellow powder containing meropenem trihydrate equivalent to meropenem,
500 mg or 1 g,
blended with sodium carbonate. Meropenem Juno powder for intravenous
injection contains
208 mg sodium carbonate for each gram of meropenem (anhydrous
potency). It contains no
preservative.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meropenem Juno is indicated for treatment of the following infections,
in adults and children
(aged 3 months and over), when the causative organisms are known or
suspected to be
resistant to commonly used antibiotics:
•
Community acquired lower respiratory tract infection
•
Hospital acquired lower respiratory tract infection
•
Complicated urinary tract infection
•
Febrile neutropaenia
•
Intra-abdominal and gynaecological (poly microbial) infections
•
Complicated skin and skin structure infections
•
Meningitis
•
Septicaemia
Juno Pharmaceuticals Pty Ltd
Australian Product Information
Page | 2
4.2 DOSE AND METHOD OF ADMINISTRATION
TREATMENT
ADULTS
Usual dose
500 mg to 1 g by intravenous administration every 8 hours depending on
type and severity
of infection, the known or suspected susceptibility of the pathogen(s)
and the condition of the
patient.
Exceptions
1.
Febrile episodes in neutropaenic patients - the dose should be 1 g
every 8 hours.
2.
Meningitis - the dose should be 2 g every 8 hours.
As with other antibiotics, caution may be required in using meropenem
as monotherapy in
critically ill patients with known or