Meropenem 500mg Powder for Solution for Injection or Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Meropenem

Available from:

Noridem Enterprises Limited

ATC code:

J01DH; J01DH02

INN (International Name):

Meropenem

Dosage:

500 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Prescription type:

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

Therapeutic area:

Carbapenems; meropenem

Authorization status:

Marketed

Authorization date:

2012-09-07

Patient Information leaflet

Page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM 500 MG & 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
meropenem
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
THE NAME OF YOUR MEDICINE IS ONE OF THE FOLLOWING:
-
_Meropenem 500 mg Powder for solution for injection or infusion _
-
_Meropenem 1 g Powder for solution for injection or infusion _
_In the rest of this leaflet your medicine is called Meropenem. _
_________________________________________________________________
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 other 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 infection of the blood which
might be associated with a type
of infection menti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem 500mg Powder for Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous
meropenem.
Excipients with known effect
Each 500 mg vial
contains
104 mg sodium carbonate
which equates
to approximately 2.0 mEq of
sodium
(approximately 45 mg).
For the 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 is indicated in adults and children aged over 3 months for
the treatment of the following infections (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
Posology
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.
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