Meropenem 1g powder for soluton for injection or infusion

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

MEROPENEM

Disponible desde:

Venus Pharma GmbH Am Bahnhof 1-3, Werne, D 59368, Germany

Código ATC:

J01DH02

Designación común internacional (DCI):

MEROPENEM 1 g

formulario farmacéutico:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Composición:

MEROPENEM 1 g

tipo de receta:

POM

Área terapéutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estado de Autorización:

Authorised

Fecha de autorización:

2020-01-25

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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, 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 belongs to a group of medicines called carbapenem
antibiotics. It works by killing
bacteria, which can cause serious infections.
•
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 Meropenem
(listed in Section 6 Further information).
•
you are allergic (hypersensitive) to other antibiotics such as
penicillins, c

Ficha técnica

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1. NAME OF THE MEDICINAL PRODUCT
Meropenem 1 g powder for solution for injection or infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous
meropenem.
Excipients:
Each 1 g vial contains 208 mg sodium carbonate which equates to
approximately 4.0 mEq of
sodium (approximately 90 mg)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for Solution for injection or infusion.
A white to yellowish 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
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
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as infections due to less susceptible bacterial species (e.g.
_Enterobacteriaceae_
,
_Pseudomonas _
_aeruginosa, Acinetobacter _
spp.), or very sever