País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Meropenem
Infomed Fluids Srl
J01DH02
Meropenem
500 milligram(s)
Powder for solution for injection/infusion
meropenem
Marketed
2021-05-07
PACKAGE LEAFLET: INFORMATION FOR THE USER MEROPENEM INFOMED 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION MEROPENEM INFOMED 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION 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 Infomed is and what it is used for 2. What you need to know before you use Meropenem Infomed 3. How to use Meropenem Infomed 4. Possible side effects 5. How to store Meropenem Infomed 6. Contents of the pack and other information 1. WHAT MEROPENEM INFOMED IS AND WHAT IT IS USED FOR Meropenem Infomed 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 infections 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 (stomach) • Infections that you can catch during or after giving birth • Complicated skin and soft tissue infections • Acute bacterial infection of the brain (meningitis) Meropenem Infomed may be used in the management of neutropenic patients ( patients with low levels of white blood cells) with fever that is suspected to be due to a bacterial infection. Meropenem Infomed may be used to treat bacterial infection of the blood which might be associated with one of the infections mentioned above. 2. WHAT YOU NEED TO KNOW Leia o documento completo
Health Products Regulatory Authority 10 May 2021 CRN00940L Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Meropenem Infomed 500 mg powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Excipients with known effect: Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2.0 mEq of sodium (approximately 45 mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion. A white to light yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Meropenem Infomed 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 Infomed may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection Meropenem Infomed may be used in the 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. Health Products Regulatory Authority 10 May 2021 CRN00940L Page 2 of 11 A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three ti Leia o documento completo