Ország: Örményország
Nyelv: angol
Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cefuroxime (cefuroxime sodium)
Reyoung Pharmaceutical Co. Ltd.
J01DC02
cefuroxime (cefuroxime sodium)
750mg
powder for solution for injection/infusion
(1) glass vial 10ml, (50) glass vials 10ml
Prescription
Registered
2020-03-17
CTD – MODULE 1 - ADMINISTRATIVE INFORMATION 1.3 PRODUCT INFORMATION TRO-XIME 750 mg powder for solution for injection/infusion (Cefuroxime) Troge Medical GmbH · Milchstrasse 19 · 20148 Hamburg · Germany _PACKAGE LEAFLET _ PROPOSED TEXT MATTER for the Patient Information Leaflet (PIL), _In English_ PACKAGE LEAFLET: INFORMATION FOR THE USER TRO-XIME 750 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION_ _ (CEFUROXIME) 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 nurse. - 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 TRO-XIME is and what it is used for 2. What you need to know before you are given TRO-XIME 3. How TRO-XIME is given 4. Possible side effects 5. How to store TRO-XIME 6. Contents of the pack and other information 1. WHAT TRO-XIME IS AND WHAT IT IS USED FOR The name of this medicine is TRO-XIME 750 mg powder for solution for injection/infusion referred to as TRO-XIME throughout the package leaflet. TRO-XIME contains the active substance Cefuroxime sodium. It is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins_. _ TRO-XIME is indicated for the treatment of the following infections in adults and children, including neonates (from birth): The lungs or chest (Chronic bronchitis & community acquired pneumonia), urinary tract, skin and soft tissue, intra abdominal infections. It is also used to prevent infections during surgery. Your doctor may test type of bacteria causing your infection and monitor whether bacteria are sensitive to TRO-XIME during your treatment. CTD – MODULE 1 - ADMINISTRATIVE INFORMATION 1.3 PRODUCT INFORMATION TRO-XIME 750 mg powder for solution for injection/infusion (Cefurox Olvassa el a teljes dokumentumot
CTD – MODULE 1 – ADMINISTRATIVE INFORMATION AND PRESCRIBING INFORMATION 1.3 PRESCRIBING INFORMATION TRO-XIME 750 MG powder for solution for injection/infusion Troge Medical GmbH · Milchstrasse 19 · 20148 Hamburg · Germany Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE MEDICINAL PRODUCT TRO-XIME 750 MG powder for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 750 mg of cefuroxime (in form of sodium salt). The total quantity of sodium per vial is 42 mg. _No other excipients (see section 6.1). _ 3. PHARMACEUTICAL FORM _Powder for solution for injection/infusion. _ Description: A white to faintly yellow, crystalline powder. Color of reconstituted solution: Off-white to yellow suspension for intramuscular use or a clear and yellowish solution for intravenous administration. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS TRO-XIME is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1). • Community acquired pneumonia. • Acute exacerbations of chronic bronchitis. • Complicated urinary tract infections, including pyelonephritis. • Soft-tissue infections: cellulitis, erysipelas and wound infections. • Intra-abdominal infections (see section 4.4). • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section). CTD – MODULE 1 – ADMINISTRATIVE INFORMATION AND PRESCRIBING INFORMATION 1.3 PRESCRIBING INFORMATION TRO-XIME 750 MG powder for solution for injection/infusion Troge Medical GmbH · Milchstrasse 19 · 20148 Hamburg · Germany Page 2 of 17 In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4 Olvassa el a teljes dokumentumot