Quốc gia: Nam Phi
Ngôn ngữ: Tiếng Anh
Nguồn: South African Health Products Regulatory Authority (SAHPRA)
Sanofi-Aventis South Africa (Pty) Ltd
See ingredients
SUSPENSION
EACH 5 ml SUSPENSION CONTAINS BENZOYL METRONIDAZOLE 320 mg EQUIVALENT TO 200 mg METRONIDAZOLE
Registered
1976-02-02
Flagyl suspension: Implementable summary received 24.10.2021 FINAL PIL (CLEAN COPY) DATED 24.10.2021 PAGE 1 OF 12 PATIENT INFORMATION LEAFLET: SCHEDULING STATUS: S4 FLAGYL SUSPENSION : each 5 mL of suspension contains benzoyl metronidazole equivalent to metronidazole 200 mg Contains sugar: sucrose 3 g/5 mL Preservatives: methyl hydroxybenzoate 0,08 % _m/v _and propyl hydroxybenzoate 0,02 % _m/v _ For excipients, see section 6.1._ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START TAKING FLAGYL: • Keep this leaflet. You may need to read it again • If you have any further questions, please ask your doctor or [your] pharmacist, nurse or other health care provider • FLAGYL has been prescribed for you or your child personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET: 1 What FLAGYL is and what it is used for 2 What you need to know before you take or give FLAGYL to your child 3 How to receive FLAGYL 4 Possible side effects 5 How to store FLAGYL 6 Contents of the pack and other information. Flagyl suspension: Implementable summary received 24.10.2021 FINAL PIL (CLEAN COPY) DATED 24.10.2021 PAGE 2 OF 12 1. WHAT FLAGYL IS AND WHAT IT USED FOR: FLAGYL contains metronidazole, and it works by killing bacteria and parasites that cause infections in your body. IT CAN BE USED TO: • Treat infections caused by certain bacteria • Prevent infections after surgery. If you or your child need any further information on your illness, speak to your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OR GIVE FLAGYL TO YOUR CHILD: DO NOT TAKE FLAGYL OR GIVE FLAGYL TO YOUR CHILD IF: • You or your child are allergic (hypersensitive) to metronidazole or any of the other ingredients in FLAGYL. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • You or your child are taking the medicine, busulfan (treatment for cancer of blood cells). ( Đọc toàn bộ tài liệu
Flagyl suspension: Amended in line e-mail request received with implementable summary dated 24.10.2021 Date submitted: 04.11.2021 FINAL APPROVED PI (CLEAN COPY) DATED 24.10.2021 PAGE 1 OF 16 SCHEDULING STATUS: S4 1. NAME OF THE MEDICINE: FLAGYL SUSPENSION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each 5 ml of suspensions contains: benzoyl metronidazole equivalent to metronidazole 200 mg Contains sugar: sucrose 3 g/5 mL Preservatives: methyl hydroxybenzoate 0,08 % _m/v _and propyl hydroxybenzoate 0,02 % _m/v _ For excipients, see section 6.1. 3. PHARMACEUTICAL FORM: Off-white, coarse, oral suspension with an orange and lemon odour. 4. CLINICAL PARTICULARS: 4.1 THERAPEUTIC INDICATIONS: a) In the oral treatment of: urogenital trichomoniasis non-specific vaginitis all forms of amoebiasis giardiasis acute ulcerative gingivitis (Vincent's) acute pericoronitis. Flagyl suspension: Amended in line e-mail request received with implementable summary dated 24.10.2021 Date submitted: 04.11.2021 FINAL APPROVED PI (CLEAN COPY) DATED 24.10.2021 PAGE 2 OF 16 b) Treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly _Bacteroides fragilis_ and other species of Bacteroides and including other species for which metronidazole is bactericidal, such as fusobacteria, clostridia, eubacteria and anaerobic streptococci. FLAGYL has been used successfully for anaerobic infections in the following conditions: pelvic inflammatory disease and postoperative wound infections. Combined therapy is often indicated as there are usually mixed infections. c) Prevention of postoperative infections due to anaerobic bacteria: i) Given before and after gynaecological surgery ii) Given before and after appendectomy iii) Given before and after colonic surgery d) Treatment of _Helicobacter pylori_-associated gastritis and duodenal ulcer. FLAGYL is used in combination with bismuth subsalicylate or colloidal bismuth subcitrate and appropriate antibiotic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTR Đọc toàn bộ tài liệu