Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
MEROPENEM
Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta
J01DH02
MEROPENEM 1000 mg
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
MEROPENEM 1000 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2013-01-07
PACKAGE LEAFLET: INFORMATION FOR THE USER Meropenem Zentiva 500 mg powder for solution for injection or infusion Meropenem Zentiva 1000 mg powder for solution for injection or infusion Meropenem READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. IN THIS LEAFLET: 1. What Meropenem Zentiva is and what it is used for 2. Before you use Meropenem Zentiva 3. How to use Meropenem Zentiva 4. Possible side effects 5. How to store Meropenem Zentiva 6. Further information 1. WHAT MEROPENEM ZENTIVA IS AND WHAT IT IS USED FOR Meropenem Zentiva 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 the delivery Complicated skin and soft tissues infections Acute bacterial infection of the brain (meningitis) Meropenem Zentiva may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. 2. BEFORE YOU USE MEROPENEM ZENTIVA DO NOT USE MEROPENEM ZENTIVA -if you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meropenem Zentiva (listed in Section 6 Futher information). Přečtěte si celý dokument
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Meropenem Zentiva 500 mg Powder for solution for injection or infusion Meropenem Zentiva 1000 mg Powder for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Meropenem Zentiva 500 mg Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Meropenem Zentiva 1000 mg Each vial contains meropenem trihydrate equivalent to 1000 mg anhydrous meropenem. Excipients: Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2.0 mEq of sodium (approximately 45 mg). To be taken into consideration by patients on a controlled sodium diet. Each 1000 mg vial contains 208 mg sodium carbonate which equates to approximately 4.0 mEq of sodium (approximately 90 mg). To be taken into consideration by patients on a controlled sodium diet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion. A white to light yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Meropenem Zentiva 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): Pneumonia, including community acquired pneumonia and nosocomial 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. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Přečtěte si celý dokument