Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
MEROPENEM TRIHYDRATE (STERILE)
Accord Healthcare Limited
J01DH02
MEROPENEM TRIHYDRATE (STERILE)
1 Grams
Pdr for Soln Inj/Inf
Product subject to prescription which may not be renewed (A)
meropenem
Authorised
2018-02-16
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 contains 1 g anhydrous meropenem (as meropenem trihydrate). Excipient(s) with known effect: Each vial contains approximately 90.2mg 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. H E A L T H P R O D U C T S R E G U Přečtěte si celý dokument