DBL MEROPENEM FOR INJECTION meropenem (as trihydrate) 500mg powder for injection vial

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

meropenem trihydrate

Mevcut itibaren:

Pfizer Australia Pty Ltd

INN (International Adı):

Meropenem trihydrate

Yetkilendirme durumu:

Registered

Bilgilendirme broşürü

DBL
TM MEROPENEM FOR INJECTION
_Meropenem (MARE-oh-PEN-um)_
CONSUMER MEDICINE INFORMATION
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL
TM
Meropenem for Injection.
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 DBL
TM
Meropenem for Injection
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 DBL
TM
MEROPENEM FOR
INJECTION IS USED FOR
DBL
TM
Meropenem for Injection 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).
DBL
TM
Meropenem for Injection
belongs to a group of
medicines called carbapenem
antibiotics. These medicines work
by killing the bacteria that are
causing your infection.
DBL
TM
Meropenem for Injection
will not work against fungal
or viral infections (such as colds or
flu).
DBL
TM
Meropenem for Injection 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.
DBL
TM
Meropenem for Injection is
not addictive.
DBL
TM
MEROPENEM FOR INJECTION
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.
BEFOR

Ürün özellikleri

Product Information - Australia
DBL™
MEROPENEM FOR INJECTION
NAME OF MEDICINE
Meropenem Trihydrate
The chemical name of meropenem trihydrate is
-Azabicyclo[3.2.0]hept-2-ene-2-
carboxylic acid,
3-[[5-[(dimethylamino)carbonyl]-3-pyrrolidinyl]thio]-6-(1-
hydroxyethyl)-4-methyl-7-oxo, trihydrate,
[4_R_-[3(3_S_*,5_S_*),4α,5β,6β (_R_*)]]-
.(4_R,_5_S_,6_S_)-3-[[(3_S_,5_S_)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]
-6-[(1_R_)-1-
hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-carboxylic
acid,
trihydrate. The molecular formula of meropenem trihydrate is C
17
H
25
N
3
O
5
S·3H
2
O and
its CAS number is 119478-56-7.
The structural formula of meropenem trihydrate is shown below:-
DESCRIPTION
DBL™ Meropenem for Injection is presented as a sterile white powder
containing
meropenem trihydrate equivalent to meropenem, 500 mg or 1 g, blended
with sodium
carbonate anhydrous. DBL™ Meropenem for Injection contains 208 mg
sodium
carbonate anhydrous for each gram of meropenem (anhydrous potency). It
contains
no antimicrobial preservative and is for use in one patient on one
occasion only.
20mL
30mL
DBL™ Meropenem for Injection 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 anhydrous
104 mg
208 mg
Meropenem for Injection PI 4.0
- 1 -
Product Information - Australia
PHARMACOLOGY
Meropenem is a 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
β
-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).
Mer