MEROPENEM 1 Grams Pdr for Soln Inj/Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MEROPENEM TRIHYDRATE (STERILE)

Available from:

Ranbaxy Ireland Limited

ATC code:

J01DH02

INN (International Name):

MEROPENEM TRIHYDRATE (STERILE)

Dosage:

1 Grams

Pharmaceutical form:

Pdr for Soln Inj/Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Carbapenems

Authorization status:

Authorised

Authorization date:

2011-07-15

Patient Information leaflet

 
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PACKAGE LEAFLET 

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PACKAGE LEAFLET: INFORMATION FOR THE USER 
MEROPENEM 500 MG
POWDER FOR SOLUTION FOR INJECTION OR INFUSION 
MEROPENEM 1G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

(Meropenem)  

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions,
ask your doctor or pharmacist. 
- 
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, 
even if their signs of illness are the same as yours. 
- 
If  you get any side effects, talk to your doctor or nurse.

This includes any possible side effects 
not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET: 
1. 
What Meropenem is and what it is used for 
2. 
What you need to know before you use Meropenem 
3. 
How to use Meropenem 
4. 
Possible side effects 
5. 
How to store Meropenem 
6. 
Contents of the pack and further information. 

1. 
WHAT MEROPENEM IS AND WHAT IT IS USED FOR 

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

Meropenem may be used to treat bacterial inf

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem 1 g powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 1g anhydrous meropenem.
Excipients(s) with known effect :
Each 1 g vial contains 208 mg sodium carbonate which equates to approximately 4.0 mEq of sodium (approximately 90
mg).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White to pale yellow crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meropenem Powder for Solution for injection or Infusion 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):
• Severe pneumonia, including hospital and ventilator-associated 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
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the
infections listed above.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The tables below provide general recommendations for dosing.
The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated,
including its severity, and the clinical response.
A dose of up to 2 g three