MEROPENEM

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

MEROPENEM TRIHYDRATE (STERILE)

Dostupné s:

Accord Healthcare Limited

ATC kód:

J01DH02

INN (Mezinárodní Name):

MEROPENEM TRIHYDRATE (STERILE)

Dávkování:

0.5 Grams

Léková forma:

Pdr for Soln Inj/Inf

Druh předpisu:

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

Terapeutické oblasti:

meropenem

Stav Autorizace:

Authorised

Datum autorizace:

2018-02-16

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem 0.5 g Powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg anhydrous meropenem (as meropenem
trihydrate).
Excipient(s) with known effect:
Each vial contains approximately 45.1 mg sodium.
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 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 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 due to less
susceptible bacterial species (e.g._ Enterobacteriaceae, Pseudomonas
aeruginosa, Acinetobacter_ spp.) or very severe
infections.
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