Meropenem 1 g powder for solution for injection/infusion

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Meropenem Trihydrate

Saatavilla:

AS Kalceks

ATC-koodi:

J01DH02

INN (Kansainvälinen yleisnimi):

Meropenem Trihydrate

Lääkemuoto:

Powder for solution for injection/infusion

Terapeuttinen alue:

meropenem

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2023-01-20

Pakkausseloste

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 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 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. It belongs to a
group of medicines called
carbapenem antibiotics. It works by killing bacteria, which can cause
serious infections.
This medicine 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).
This medicine may be used in the management of patients with low
levels of white blood cells called
neutrophils with fever that is suspected to be due to a bacterial
infection.
This medicine 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 YOU USE MEROPENEM
DO NOT USE MEROPENEM

if you are a

Valmisteyhteenveto

Health Products Regulatory Authority
20 January 2023
CRN00CFV9
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem 1 g powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 1 g meropenem.
Excipient with known effect
Each vial contains approximately 90 mg sodium (as sodium carbonate).
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 over 3 months of age (see sections
4.4 and 5.1):

Severe pneumonia, including hospital and ventilator‑associated
pneumonia

Bronchopulmonary infections in cystic fibrosis

Complicated urinary tract infections

Complicated intra‑abdominal infections

Intra- and postpartum 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 causes by less susceptible bacterial
species (such as _Enterobacterales_, _Pseudomonas aer