Meropenem 500 mg powder for solution for injection/infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Meropenem Trihydrate

Dostupné z:

Steriscience B.V.

ATC kód:

J01DH02

INN (Medzinárodný Name):

Meropenem Trihydrate

Forma lieku:

Powder for solution for injection/infusion

Terapeutické oblasti:

meropenem

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2023-01-13

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
MEROPENEM 1
G POWDER FOR SOLUTION FOR INJECTION/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
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
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.
Meropenem
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
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 mentioned above.
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2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
MEROPENEM
DO NOT USE MEROPENEM:

if you are allergic to
Merop

Súhrn charakteristických

Health Products Regulatory Authority
24 January 2023
CRN009X9Y
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem 500 mg powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 500 mg
meropenem.
Excipient with known effect
Each vial contains 45 mg sodium (as sodium carbonate).
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
A white to pale yellow powder and free from visual agglomerates.
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
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.
A dose of up to 2000 mg 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_ or
_Acinetobact