Meropenem 1 g powder for solution for injection or infusion

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Meropenem Trihydrate

Boleh didapati daripada:

Fresenius Kabi Deutschland GmbH

Kod ATC:

J01DH; J01DH02

INN (Nama Antarabangsa):

Meropenem Trihydrate

Dos:

1 gram(s)

Borang farmaseutikal:

Powder for solution for injection/infusion

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

Carbapenems; meropenem

Status kebenaran:

Marketed

Tarikh kebenaran:

2010-10-01

Risalah maklumat

ACSI079F01
FRONT
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM 500 MG 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 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 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEROPENEM
DO NOT USE MEROPENEM
-
if you are allergic (hypersensitive) to Meropenem or any of
the other ingredients of this medicine (l

Ciri produk

Health Products Regulatory Authority
18 August 2022
CRN00CTJN
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem 1 g powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial/bottle contains meropenem trihydrate equivalent to 1 g
anhydrous meropenem.
Excipients with known effect:
Each 1 g vial/bottle contains 3.92 mmol (or 90.25 mg) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A white or 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
- 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 1 and 2 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_, _Pseud