Meropenem Infomed 1 g powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Meropenem

Available from:

Infomed Fluids Srl

ATC code:

J01DH02

INN (International Name):

Meropenem

Dosage:

1 gram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

meropenem

Authorization status:

Marketed

Authorization date:

2021-05-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM INFOMED 500 MG
POWDER FOR SOLUTION FOR INJECTION/INFUSION
MEROPENEM INFOMED 1 G
POWDER FOR SOLUTION FOR INJECTION/INFUSION
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 Infomed is and what it is used for
2.
What you need to know before you use Meropenem Infomed
3.
How to use Meropenem Infomed
4.
Possible side effects
5.
How to store Meropenem Infomed
6.
Contents of the pack and other information
1. WHAT MEROPENEM INFOMED IS AND WHAT IT IS USED FOR
Meropenem Infomed 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 infections 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 (stomach)
•
Infections that you can catch during or after giving birth
•
Complicated skin and soft tissue infections
•
Acute bacterial infection of the brain (meningitis)
Meropenem Infomed may be used in the management of neutropenic
patients
(
patients with
low levels of
white blood cells)
with fever that is suspected to be
due to a bacterial infection.
Meropenem Infomed may be used to treat bacterial infection of the
blood which
might be associated with one of the infections mentioned above.
2. WHAT YOU NEED TO KNOW

Summary of Product characteristics

Health Products Regulatory Authority
10 May 2021
CRN00940L
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem Infomed 1 g powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous
meropenem.
Excipients 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/infusion.
A white to light yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meropenem Infomed 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 Infomed may be used in the management of neutropenic
patients with fever that is suspected to be due to a
bacterial infection
Meropenem Infomed may be used in the 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