ROPENN meropenem (as trihydrate) 1 g powder for injection vial

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

meropenem trihydrate

Dostupné s:

Medis Pharma Pty Ltd

INN (Mezinárodní Name):

Meropenem trihydrate

Stav Autorizace:

Registered

Informace pro uživatele

ROPENN POWDER FOR INJECTION
_Meropenem (as trihydrate)_
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ropenn. 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 Ropenn 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 ROPENN IS USED FOR
Ropenn 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 neutropenia

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)
Ropenn belongs to a group
of medicines called
carbapenem antibiotics.
These medicines work by
killing the bacteria that are
causing your infection.
Ropenn will not work
against fungal or viral
infections (such as colds or
flu).
Ropenn is given by 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.
Ropenn is not addictive.
Ropenn 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
ROPENN
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT TAKE ROPENN IF YOU
HAVE AN ALLERGY TO:

any medicine
containing meropenem

any of the ingredients
listed at the end of this
leaflet.
Some of the symptoms of an
allergic reaction may
include shortness of breath,
wheezing or difficulty
breathing; swel

Charakteristika produktu

ROPENN Product Information
PI 280115 V.2
Page 1 of 11
NAME OF THE MEDICINE
Meropenem (as meropenem trihydrate), powder for injection
Meropenem trihydrate
Formula: C
17
H
25
N
3
O
5
S.3H
2
O
Mw: 437.52
CAS: 119478-56-7 (meropenem trihydrate).
DESCRIPTION
Meropenem trihydrate occurs as a white to light yellow crystalline
powder.
It is sparingly
soluble in water, practically insoluble in ethanol (96 per cent) and
in methylene chloride.
ACTIVE:
Meropenem (as meropenem trihydrate).
INACTIVE:
Sodium carbonate.
Meropenem powder for intravenous injection or infusion
_ _
_ _
_ _
_ _
_ _
500 MG
1 G
_Active ingredient_
MEROPENEM (as the trihydrate)
570 mg
1.14 g
Equivalent to anhydrous meropenem
500 mg
1 g
_ _
_Excipient_
Sodium carbonate
104 mg
208 mg
PHARMACOLOGY
Carbapenem antibiotic (for parenteral use) that is stable to human
dehydropeptidase-1
(DHP-1).
_MICROBIOLOGY _
Meropenem exerts its bactericidal action by interfering with vital
bacterial cell wall
synthesis. The ease with which it penetrates bacterial cell walls, its
high level of stability
to all serine beta-lactamases and its marked affinity for the
Penicillin Binding Proteins
(PBPs) explain the potent bactericidal action of meropenem against a
broad spectrum of
aerobic and anaerobic bacteria. Bactericidal concentrations are
commonly the same as the
minimum inhibitory concentrations (MICs).
Meropenem is stable in susceptibility tests and these tests can be
performed using normal
routine methods. _In vitro_ tests show that meropenem acts
synergistically with various
antibiotics. It has been demonstrated both _in vitro_ and _in vivo_
that meropenem has a post-
antibiotic effect.
ROPENN Product Information
PI 280115 V.2
Page 2 of 11
Meropenem is usually active, _in vitro_ and in clinical infections,
against the following strains
of bacteria.
_ _
COMMONLY SUSCEPTIBLE SPECIES

GRAM-POSITIVE AEROBES
_Enterococcus faecalis (note that E.faecalis can naturally display
intermediate _
_susceptibility), Staphylococcus aureus _(methicillin-susceptible
stains only: methi