Meropenem Ranbaxy

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Meropenem trihydrate 570mg equivalent to meropenem 500 mg

Fáanlegur frá:

Douglas Pharmaceuticals Limited

INN (Alþjóðlegt nafn):

Meropenem trihydrate 570 mg (equivalent to meropenem 500 mg)

Skammtar:

500 mg

Lyfjaform:

Powder for injection

Samsetning:

Active: Meropenem trihydrate 570mg equivalent to meropenem 500 mg Excipient: Sodium carbonate

Einingar í pakka:

Vial, glass, single dose, clear Type 1, bromo butyl closure, al seal, PP button, 1 dose unit

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Sun Pharmaceutical Industries Ltd

Ábendingar:

For treatment, in adults and children, of the following infections caused by single or multiple susceptible bacteria and as empiric therapy prior to the identification of the causative organisms: - Lower respiratory tract infections - Urinary tract infections, including complicated infections - Intra-abdominal infections - Gynaecological infections, including postpartum infections - Skin and skin structure infections - Meningitis - Empiric treatment, including initial monotherapy, for presumed bacterial infections in host-compromised, neutropenic patients -Septicaemia

Vörulýsing:

Package - Contents - Shelf Life: Vial, glass, single dose, clear Type 1, bromo butyl closure, al seal, PP button - 1 dose units - 24 months from date of manufacture stored at or below 25°C 2 hours reconstituted (not refrigerated) stored at or below 25°C. Minimum, using glucose / sodium bicarbonate reconstitution fluid 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). Maximum, using 0.9% w/w sodium chloride as reconstitution fluid - Vial, glass, single dose, clear Type 1, bromo butyl closure, al seal, PP button - 5 dose units - 24 months from date of manufacture stored at or below 25°C 2 hours reconstituted (not refrigerated) stored at or below 25°C. Minimum, using glucose / sodium bicarbonate reconstitution fluid 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). Maximum, using 0.9% w/w sodium chloride as reconstitution fluid - Vial, glass, single dose, clear Type 1, bromo butyl closure, al seal, PP button - 10 dose units - 24 months from date of manufacture stored at or below 25°C 2 hours reconstituted (not refrigerated) stored at or below 25°C. Minimum,using glucose / sodium bicarbonate reconstitution fluid 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). Maximum,using 0.9% w/w sodium chloride as reconstitution fluid

Leyfisdagur:

2011-10-18

Upplýsingar fylgiseðill

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

Vara einkenni

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
MEROPENEM RANBAXY 500 mg powder for injection
MEROPENEM RANBAXY 1 g powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each MEROPENEM RANBAXY 500 mg vial contains meropenem trihydrate
equivalent to 500 mg
anhydrous meropenem.
Each MEROPENEM RANBAXY 1 g vial contains meropenem trihydrate
equivalent to 1 g
anhydrous meropenem.
EXCIPIENT(S) WITH KNOWN EFFECT
Each MEROPENEM RANBAXY 500 mg vial contains 104 mg sodium carbonate.
Each MEROPENEM RANBAXY 1 g vial contains 208 mg sodium carbonate.
For the full list of excipients, _see Section 6.1._
3.
PHARMACEUTICAL FORM
White to pale yellow crystalline sterile powder packed in clear Type 1
glass vials for
reconstitution for injection or infusion.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
MEROPENEM RANBAXY is indicated for treatment, in adults and children
aged 3 months and
older, of the following infections caused by single or multiple
susceptible bacteria (see _Section _
_5.1_) and as empiric therapy prior to the identification of the
causative organisms:
•
Lower Respiratory Tract Infections
•
Urinary Tract Infections, including complicated infections
•
Intra-abdominal Infections
•
Gynaecological Infections, including postpartum infections
•
Skin and Skin Structure Infections
•
Meningitis
•
Septicaemia
•
Empiric treatment, including initial monotherapy, for presumed
bacterial infections in host-
compromised, neutropenic patients.
2 | P a g e
Because of its broad spectrum of bactericidal activity against
Gram-positive and Gram-negative
aerobic and anaerobic bacteria, meropenem is effective for the
treatment of polymicrobial
infections.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS _
500 mg to 1 g by intravenous administration every 8 hours depending on
type and severity of
infection, the known or expected susceptibility of the pathogen(s) and
the condition of the
patient.
_Exceptions _
1.
Febrile episodes in neutropenic patients - the dose should be 1 g
every 8 hours.
2.
Meni