Meropenem Kabi meropenem (as trihydrate) 500 mg Powder for Injection Vials

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

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

Pieejams no:

Fresenius Kabi Australia Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Meropenem trihydrate

Zāļu forma:

Injection, powder for

Kompozīcija:

Excipient Ingredients: sodium carbonate

Ievadīšanas:

Intravenous

Vienības iepakojumā:

20 mL x 1, 20 mL x 10

Klase:

Medicine Registered

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

INDICATIONS,Meropenem Kabi 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

Produktu pārskats:

Visual Identification: white or light yellow powder in a glass vial with rubber stopper, sealed with an aluminium cap and violet polypropylene disc; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizācija statuss:

Registered

Autorizācija datums:

2013-03-25

Lietošanas instrukcija

CMI for Meropenem Kabi
Jul, 2018
Page 1 of 3
MEROPENEM KABI
Meropenem trihydrate
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Meropenem 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 risk of you taking Meropenem
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
IS
MEROPENEM
KABI 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
KABI
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 KABI
_ _
_WHEN YOU MUST NOT BE GIVEN _
_MEROPENEM KABI _
DO NOT USE MEROPENEM KABI IF
YOU HAVE AN ALLERGY TO:

any
medicine
containing
meropenem

any
other
carbopenems,
penicillins
or
other
beta
lactam antibiotics

any o

Produkta apraksts

Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION- MEROPENEM
(MEROPENEM (AS TRIHYDRATE))
1 NAME OF THE MEDICINE
Meropenem, as meropenem trihydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Meropenem Kabi 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 Kabi 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 Kabi 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 Kabi 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
Page 2 of 13
4.2
DOSE AND METHOD OF ADMINISTRATION
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 suspected _Pseudomonas
aeruginosa_ lower respiratory
tract infection.
Regular sensitivity testing is recommended when t