Ország: Örményország
Nyelv: angol
Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
metronidazole (metronidazole benzoate)
Medical Horizon Ltd
P01AB01
metronidazole (metronidazole benzoate)
25mg/ml
suspension oral
glass bottle 100ml and measuring cup
Prescription
Registered
2019-09-19
PATIENT INFORMATION LEAFLET FLAZON Dosage strength of metronidazole is 125mg/5ml. Oral Suspension 100 ml 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. This medicine has been prescribed only 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 these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1.What Flazon oral suspension is and what it is used for 2.Before you take Flazon 3.How to take Flazon 4.Possible side effects 5.How to store Flazon 6.Further information WHAT FLAZON IS AND WHAT IT IS USED FOR Your medicine is oral suspension. It contains metronidazole benzoate. This belongs to a group of medicines called antibacterials. Each 1ml of Flazon contains 0.04 g of metronidazole benzoate, which is equivalent to 0.025g metronidazole. METRONIDAZOLE CAN BE USED FOR: ADULTS AND CHILDREN OVER 1 YEAR • preventing infections after you have an operation • treating infections including infections of your blood, brain, lungs, bones, lining of your abdomen, pelvis and infections following childbirth or around the area where you had an operation • treating trichomoniasis. This is a sexually transmitted infection, in both males and females • treating amoebiasis - an infection of your intestine or liver caused by a parasite • treating giardiasis - an infection that causes swelling of your intestines ADULTS AND CHILDREN OVER 10 YEARS ONLY • treating vaginosis - an infection and swelling of your vagina • treating swollen gums and ulcers in your mouth (gingivitis) and other dental infections • treating ulcers and pressure sores on your leg CHILDREN (1-12 YEAR) It can also be used in children to treat a bacterial infection in the stomach (Helicobacter pylori) NEWBORNS (FULL TERM) It can be used in full term newborns for treating bacte Olvassa el a teljes dokumentumot
PRODUCT – FLAZON ORAL SUSPENSION Page 1 of 8 SUMMARY PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Flazon Dosage strength for metronidazole is 125mg/5ml. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Metronidazole Benzoate Ph Eur 200mg/5ml. For excipients, see 6.1 3. PHARMACEUTICAL FORM Oral Suspension 100ml Each 1ml of Flazon contains 0.04 g of metronidazole benzoate, which is equivalent to 0.025g metronidazole. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications The medicine is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected as the pathogen, is active against a wide range of pathogenic micro- organisms, notably Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia, Balantidium coli and other species of bacteroides, fusobacteria, eubacteria, clostridia and anaerobic cocci. It is indicated in Adults, Children and Newborns with a gestation age of over 40 weeks for: • The treatment of septicaemia, bacteraemia, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis, peritonitis and postoperative wound infections from which one or more pathogenic anaerobes have been isolated. • The prevention of post-operative infections caused by anaerobic bacteria particularly species of bacteroides and anaerobic streptococci. Adults and Children over 10 years only for: • Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginitis or Gardnerella vaginitis). • Acute dental infections (e.g. acute pericoronitis and acute apical infections). • Anaerobically infected leg ulcers and pressure sores. Adults and Children for: • The treatment of urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male. PRODUCT – FLAZON ORAL SUSPENSION Page 2 of 8 • All forms of amoebiasis (intestinal and extra-intestinal disease and that of symptomless cyst passers) • Giardiasis • Acute ulcerative gingivitis. Children for • Eradication of Helicobacter py Olvassa el a teljes dokumentumot