País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Meropenem Trihydrate
Fresenius Kabi Deutschland GmbH
J01DH; J01DH02
Meropenem Trihydrate
1 gram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Carbapenems; meropenem
Marketed
2010-10-01
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 Llegiu el document complet
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 Llegiu el document complet