Meropenem 0.5 g Powder for solution for injection or infusion

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Meropenem

Disponible depuis:

Accord Healthcare Ireland Ltd.

Code ATC:

J01DH; J01DH02

DCI (Dénomination commune internationale):

Meropenem

Dosage:

0.5 gram(s)

forme pharmaceutique:

Powder for solution for injection/infusion

Domaine thérapeutique:

Carbapenems; meropenem

Statut de autorisation:

Not marketed

Date de l'autorisation:

2018-02-16

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE USER MEROPENEM 0.5 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION MEROPENEM 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.
WHAT IS IN THIS LEAFLET:
1.
What Meropenem infusion is and what it is used for
2.
What you need to know before you use Meropenem infusion
3.
How to use Meropenem infusion
4.
Possible side effects
5.
How to store Meropenem infusion
6.
Contents of the pack and other information.
1.
WHAT MEROPENEM INFUSION IS AND WHAT IT IS USED FOR
Meropenem infusion contains the active substance meropenem and belongs
to a group of
medicines called carbapenem antibiotics. It works by killing bacteria,
which can cause serious
infections.
Meronem is used to treat the following in adults and children aged 3
months and older:

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 infusion may be used in the management of neutropenic
patients with fever that
is suspected to be due to a bacterial infection.
Meropenem infusion may be used to treat bacterial infection of the
blood which might be
associated with a type of infection mentioned above.
2.
WHAT YOU NEED TO KNOW BEFORE Y

Résumé des caractéristiques du produit

Health Products Regulatory Authority
07 September 2021
CRN00CG8C
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem 0.5 g Powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg anhydrous meropenem (as meropenem
trihydrate).
Excipient(s) with known effect:
Each vial contains approximately 45.1 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to light yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meropenem is indicated for the treatment of the following infections
in adults and children aged 3 months and older (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
Meropenem may be used in the management of neutropenic patients with
fever that is suspected to be due to a bacterial
infection.
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of the
infections listed above.
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.
A dose of up to 2 g three times daily in adults and adolescents and a
dose of up to 40 mg/kg three times daily in children may
be particularly appropriate when treating some types of infections,
such as infections due to less susceptible bacterial species
(e.g. _Enterobacteriaceae,Pseudomonas aeruginosa,Acinetobacter _s