Meropenem Zentiva 1000mg Powder for solution for injection or infusion

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

MEROPENEM

MAH:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC_code:

J01DH02

INN:

MEROPENEM 1000 mg

pharmaceutical_form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

composition:

MEROPENEM 1000 mg

prescription_type:

POM

therapeutic_area:

ANTIBACTERIALS FOR SYSTEMIC USE

authorization_status:

Withdrawn

authorization_date:

2013-01-07

PIL

 
PACKAGE LEAFLET: INFORMATION FOR THE USER  

Meropenem Zentiva
 500 mg powder for solution for injection or infusion 
Meropenem Zentiva
 1000 mg powder for solution for injection or infusion 

Meropenem 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.  
Keep this leaflet. You may need to read it again.  
If you have any further questions, ask your doctor or nurse.  
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, 
even if their symptoms are the same as yours.  
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, 
please tell your doctor or nurse.  

IN THIS LEAFLET:  
1. What Meropenem Zentiva is and what it is used for  
2. Before you use Meropenem Zentiva 
3. How to use Meropenem Zentiva  
4. Possible side effects  
5. How to store Meropenem Zentiva 
6. Further information  

1. WHAT MEROPENEM ZENTIVA IS AND WHAT IT IS USED FOR  

Meropenem Zentiva belongs to a group of medicines called
carbapenem antibiotics. It works 
by killing bacteria, which can cause serious infections.  

Infection affecting the lungs (pneumonia)  
Lung and bronchial infections in patients suffering from
cystic fibrosis  
Complicated urinary tract infections  
Complicated infections in the abdomen  
Infections that you can catch during or after the delivery  
Complicated skin and soft tissues infections  
Acute bacterial infection of the brain (meningitis)  

Meropenem Zentiva 
may be used in the management of neutropenic patients with fever that is 
suspected to be due to a bacterial infection. 

2. BEFORE YOU USE MEROPENEM ZENTIVA 

DO NOT USE MEROPENEM ZENTIVA 
-if you are allergic (hypersensitive) to meropenem or any of
the other ingredients of 
Meropenem Zentiva (listed in Section 6 Futher information).

SPC

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT  

Meropenem Zentiva
 500 mg Powder for solution for injection or infusion 
Meropenem Zentiva
 1000 mg Powder for solution for injection or infusion 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  

Meropenem Zentiva
 500 mg 
Each vial contains meropenem trihydrate equivalent to 500
mg anhydrous meropenem. 

Meropenem Zentiva
 1000 mg 
Each vial contains meropenem trihydrate equivalent to 1000
mg anhydrous meropenem. 

Excipients:  
Each 500 mg vial contains 104 mg sodium carbonate which equates to
approximately 2.0 mEq of 
sodium (approximately 45 mg). To be taken into consideration
by patients on a controlled sodium 
diet. 
Each 1000 mg vial contains 208 mg sodium carbonate which equates to approximately 4.0 mEq of 
sodium (approximately 90 mg). To be taken into consideration by patients on a controlled sodium 
diet. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM  

Powder for solution for injection or infusion.  
A white to light yellow powder. 

4. CLINICAL PARTICULARS  

4.1 THERAPEUTIC INDICATIONS  

Meropenem Zentiva is indicated for the treatment of the
following infections in adults and children 
over 3 months of age (see sections 4.4 and 5.1):  

Pneumonia, including community acquired pneumonia and nosocomial
pneumonia.  
Broncho-pulmonary infections in cystic fibrosis  
Complicated urinary tract infections  
Complicated intra-abdominal infections  
Intra- and post-partum infections  
Complicated skin and soft tissue infections  
Acute bacterial meningitis  

Meropenem may be used in the management of neutropenic patients
with fever that is suspected to 
be due to a bacterial infection.  
Consideration should be given to official guidance on the
appropriate use of antibacterial agents.