Страна: Вірменія
мова: англійська
Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cefepime (cefepime dihydrochloride monohydrate)
AbiPharm LLC
J01DE01 վերարտադրված դեղ
cefepime (cefepime dihydrochloride monohydrate)
1000mg
powder for solution for injection/infusion
(1) glass vial
Prescription
Registered
2019-08-08
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RIIDOR ® (CEFEPIME HYDROCHLORIDE POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G) READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START TAKING 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 pharmacist. 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 pharmacist. WHAT IS IN THIS LEAFLET? 1. WHAT RIIDOR ® IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RIIDOR ® 3. HOW RIIDOR ® IS GIVEN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE RIIDOR ® 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT RIIDOR ® IS AND WHAT IT IS USED FOR A fourth generation cephalosporin that binds to bacterial cell membranes and inhibits cell wall synthesis; Therapeutic Effect: Bactericidal. Riidor ® is indicated in the treatment of the following infections Cefepime susceptible organisms: SEVERE AND COMPLICATED URINARY TRACT INFECTIONS (including those associated with pyelonephritis). SEVERE PNEUMONIA including cases associated with concurrent bacteremia due to susceptible strains. SEVERE SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes. COMPLICATED INTRA-ABDOMINAL INFECTIONS (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RIIDOR ® _ _ _YOU MUST NOT BE GIVEN RIIDOR_ ® _ IF: _ You are allergic to any ingredient in Cefepime or to another cephalosporin antibiotic (eg, Cephalexin) You have had a severe allergic reaction to a penicillin antibi Прочитайте повний документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT RIIDOR ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cefepime Hydrochloride (equivalent to Cefepime 1.0 g) 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Riidor ® is indicated in the treatment of the following infections cefepime susceptible organisms: Severe and Complicated Urinary Tract Infections (including those associated with pyelonephritis). Severe pneumonia including cases associated with concurrent bacteremia due to susceptible strains. Severe Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes. Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended adult and pediatric dosages and routes of administration are outlined in the following table Riidor ® should be administered intravenously over approximately 30 minutes. Before administration ensure that the powder has been fully dissolved in the solution. Administration duration should be within 10 days. ADULTS INDICATION DOSE FREQUENCY Pneumonia (moderate to severe) 1-2 g, IV Every 12h Uncomplicated and complicated Urinary Tract Infection Mild to moderate Every 12h Uncomplicated and complicated skin and skin structure Tract infection 2 g, IV Every 12h Complicated Intra-abdominal Infections 2 g, IV Every 12h - including cases associated with concurrent bacteremia or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need 2 for continued antimicrobial therapy should be re-evaluated frequently. - IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli when the IM rou Прочитайте повний документ