País: Malta
Idioma: inglés
Fuente: Medicines Authority
MEROPENEM
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
J01DH02
MEROPENEM 50 mg/ml
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
MEROPENEM 50 mg/ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2011-01-31
_ _ Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER Meropenem 500 mg and 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 delivery Complicated skin and soft tissue 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 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 to meropenem or any of the other ingredients of Meropenem (listed in Section 6) you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Meropenem Hospira 500 mg Powder for Solution for Injection or Infusion Meropenem Hospira 1 g Powder for Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. When reconstituted with 10 ml sterile Water for Injections, each ml contains 50 mg meropenem. Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem. When reconstituted with 20 ml sterile Water for Injections, each ml contains 50 mg meropenem. Excipients(s) with known effect: Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2.0 mEq of sodium (approximately 45 mg). Each 1 g vial contains 208 mg sodium carbonate which equates to approximately 4.0 mEq of sodium (approximately 90 mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. A white to pale 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 The tables below provide general recommendations for dosing. The dose of Meropenem adm Leer el documento completo