MEROPENEM RANBAXY meropenem (as trihydrate) 500mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

meropenem trihydrate, Quantity: 570 mg (Equivalent: meropenem, Qty 500 mg)

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Meropenem trihydrate

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium carbonate

Administration route:

Intravenous Bolus, Intravenous Infusion

Units in package:

5 vials, 10 vials, 1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MEROPENEM RANBAXY is indicated for the 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 neutropenia, - intra-abdominal and gynaecological (polymicrobial) infections, - complicated skin and skin structure infections, - meningitis, - septicaemia.

Product summary:

Visual Identification: White to pale yellow crystalline powder in clear glass vial sealed with grey rubber stopper and flip-off seal.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-07-07

Patient Information leaflet

MEROPENEM RANBAXY
1
MEROPENEM RANBAXY
_Meropenem Injection _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
MEROPENEM
RANBAXY.
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
taking
MEROPENEM RANBAXY against
the benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT MEROPENEM
RANBAXY IS USED FOR
MEROPENEM RANBAXY contains
the active ingredient meropenem.
Meropenem belongs to a group of
medicines
called
carbapenem
antibiotics. These medicines fight
bacteria that cause infections in the
body.
Meropenem
will
not
work
against viral (such as colds and flu)
or fungal diseases.
Your doctor may have prescribed
MEROPENEM RANBAXY to you
or your child (aged 3 months or
above) for the treatment of the
following bacterial infections:
•
Infections
of
the
lungs
(pneumonia or bronchitis)
•
Infections
of
the
bladder
or
kidney (urinary tract infection)
•
Infection of tissues around the
stomach or gut
•
Infections of the ovaries, vagina
or womb
•
Skin infections
•
Infections
of
the
membranes
surrounding the brain and spinal
cord (meningitis)
•
Infections of the blood
(septicaemia)
•
High
fever
and
significant
reduction in white blood cells
resulting decreased resistance to
infection (febrile neutropenia)
MEROPENEM RANBAXY is given
by injection, usually in hospitals, and
is
available
only
with
a
doctor's
prescription.
MEROPENEM RANBAXY is not
addictive.
SAFETY
AND
EFFECTIVENESS
OF
MEROPENEM RANBAXY IN
CHILDREN YOUNGER THAN 3 MONTHS OF
AGE HAVE NOT BEEN ESTABLISHED. IT IS
NOT RECOMMENDED FOR USE IN THESE
CHILDREN.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS
BEEN
PRESCRIBED
FOR
YOU
OR
YOUR CHILD.
Your doctor may have prescribed it
for another rea

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
MEROPENEM RANBAXY (MEROPENEM TRIHYDRATE)
1.
NAME OF THE MEDICINE
Meropenem trihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Meropenem powder for injection or infusion is a white to pale yellow
crystalline sterile
powder for reconstitution. One vial contains meropenem trihydrate
equivalent to
meropenem 500 mg or 1000 mg and mannitol. The inactive ingredient
sodium carbonate
104 mg or 208 mg respectively.
3.
PHARMACEUTICAL FORM
MEROPENEM RANBAXY
is supplied as a sterile lyophilised powder for intravenous
infusion available in single dose clear glass vials. The product is a
white to pale yellow
crystalline powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
MEROPENEM RANBAXY
is indicated for the 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 neutropenia
•
intra-abdominal and gynaecological (polymicrobial) infections
•
complicated skin and skin structure infections
•
meningitis
•
septicaemia
4.2.
DOSE AND METHOD OF ADMINISTRATION
_ADULTS _
_Usual dose _
of
MEROPENEM RANBAXY
is 500 mg to 1 g by intravenous administration
every eight hours depending on type and severity of infection, the
known or suspected
susceptibility of the pathogen(s) and the condition of the patient.
_EXCEPTIONS: _
Febrile episodes in neutropenic patients: The dose should be 1 g every
eight hours.
Meningitis: The dose should be 2 g every eight hours.
As with other antibiotics, caution may be required in using meropenem
as monotherapy in
2
critically ill patients with known or suspected
_Pseudomonas aeruginosa _
lower respiratory
tract infection.
Regular
sensitivity
testing
is
recommended
when
treating
_Pseudomonas _
_aeruginosa _
infection.
MEROPENEM RANBAXY
should be given as an intravenous b