Meropenem 2 g powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Meropenem Trihydrate

Available from:

Hikma Farmacêutica (Portugal) S.A.

ATC code:

J01DH02

INN (International Name):

Meropenem Trihydrate

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

meropenem

Authorization status:

Not marketed

Authorization date:

2022-11-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM 2 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 and belongs to the 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
(patients with low levels of
white blood cells called neutrophils) 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MEROPENEM
DO NOT USE MEROPENEM
-
if you are allergic to meropenem or any of the other ingredients of
th

Summary of Product characteristics

Health Products Regulatory Authority
18 November 2022
CRN009Z8G
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem 2 g powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Meropenem 2 g
Each vial contains meropenem trihydrate equivalent to 2 g anhydrous
meropenem
Excipient(s) with known effect:
Each 2 g vial contains 416 mg sodium carbonate which equates to
approximately 8.0 mEq of sodium (approximately 180 mg).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion
White to light yellow crystal 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.
· 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.
For the administration of doses less than 2 g it is recommended the
use of the 500 mg and 1000 mg formulation.
Health Products Regulatory Authority
18 November 2022
CRN009Z8G
Page 2 of 13
A dose of up to 2 g three times daily in