DBL™ Meropenem for Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Meropenem trihydrate 570.475mg equivalent to meropenem 500 mg

Available from:

Pfizer New Zealand Limited

INN (International Name):

Meropenem trihydrate 570.475 mg (equivalent to meropenem 500 mg)

Dosage:

500 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Meropenem trihydrate 570.475mg equivalent to meropenem 500 mg Excipient: Nitrogen Sodium carbonate

Units in package:

Vial, type I clear glass, grey bromobutyl closure, aluminium flip off seal, 20 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Hospira Healthcare India Pvt. Ltd

Therapeutic indications:

DBL Meropenem for Injection 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 neutropenia · Intra-abdominal and gynaecological (polymicrobial) infections · Complicated skin and skin structure infections · Meningitis · Septicaemia

Product summary:

Package - Contents - Shelf Life: Vial, type I clear glass, grey bromobutyl closure, aluminium flip off seal, 20 mL vials - 10 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2011-06-28

Patient Information leaflet

DBL
TM
 Meropenem for Injection CMI 

Page 1 

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

Summary of Product characteristics

New Zealand Data Sheet
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
PHARMACOLOGY
Meropenem is a carbapenem antibiotic for parenteral use, that is
stable to human
dehydropeptidase-1 (DHP-1).
Hosp 3
-1-
New Zealand Data Sheet
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).
Meropenem is stable in susceptibility tests and