Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Amoxicillin , Clavulanic acid
Dafra Pharma GmbH, SWITZERLAND
Amoxicillin and Clavulanic acid
875 mg
Tablet, Film-coated
Bilim Pharmaceuticals A.S, TURKEY
Physical description: White to off-white coloured, one surface scored, other surface engraved with ‘KF’ oblong film coated tablets; Local technical representative: Harleys (T) Limited (4194)
Registered/Compliant
2021-12-13
PATIENT INFORMATION LEAFLET DAFRACLAV® 1000 AMOXICILLIN 875 MG + CLAVULANIC ACID 125 MG FILM COATED TABLETS 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 1. WHAT IS DAFRACLAV® 1000 AND WHAT IT IS USED FOR Dafraclav® 1000 contains amoxicillin and clavulanic acid (ATC code: J01CR02). These are antibiotics, working by killing bacteria that cause infections. Amoxicillin belongs to the group of “penicillins”. Clavulanic acid prevents amoxicillin from being inactivated by enzymes produced by the bacteria. Dafraclav® 1000 is used in the treatment of the following infections: respiratory tract infections (including middle ear and sinus infections), skin and skin structure infections (including dental infections), urinary tract infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAFRACLAV® 1000 _DO NOT TAKE DAFRACLAV® 1000 IF YOU _ are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Dafraclav® 1000 (listed in section 6), have ever had a severe allergic (hypersensitive) reaction to any other antibiotic; this can include a skin rash or swelling of the face or neck, have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. _TAKE SPECIAL CARE WITH DAFRACLAV® 1000 IF YOU _ have glandular fever (infectious mononucleosis), have liver or kidney problems, are not passing water regularly. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dafraclav® 1000. _SPECIAL WARNINGS AND PRECAUTIONS FOR USE _ inflammation of the large intestine has been reported in association with all antibiotics including amoxic Read the complete document
DAFRACLAV® 1 G FILMCOATED TABLETS 1. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each white FILMCOATED TABLET contains Amoxicillin trihydrate equivalent to 875 mg amoxicillin, potassium clavulanate equivalent to 125 mg clavulanic acid as active ingredients. 2. PHARMACEUTICAL FORM: Cardboard containing 2 blisters with 10 film coated tablets. OTHER PHARMACEUTICAL DOSAGE FORMS: Dafraclav® 625 mg Film coated tablet (15 tablets); Dry powder Dafraclav® BD 400/57 mg Forte Oral Suspension, 70 ml; Dry powder Dafraclav® BD 200/28 mg Pediatric Oral Suspension, 70 ml. 3. CLINICAL PROPERTIES 3.1 THERAPEUTIC INDICATIONS: Dafraclav® is indicated in the treatment of the following infections caused by the microorganisms indicated below. UPPER RESPIRATORY TRACT INFECTIONS (including otitis media and sinusitis) due to beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. LOWER RESPIRATORY TRACT INFECTIONS due to beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. SKIN AND SKIN STRUCTURE INFECTIONS due to beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp. URINARY TRACT INFECTIONS. Since Dafraclav® contains amoxicillin, it can be used in the treatment of infections caused by bacteria susceptible to ampicillin. Additionally, if in a mixed infection a microorganisms is susceptible to ampicillin and the other which is a beta-lactamase producer is susceptible to Dafraclav®, such an infection can be treated by the administration of Dafraclav® alone, addition of another antibiotic is not required. Since in vitro Streptococcus pneumoniae is more susceptible to amoxicillin compared to ampicillin and penicillin, Streptococcus pneumoniae strains that are moderately susceptible to penicillin and ampicillin in microbiological tests are fully susceptible to Dafraclav®. 3.2 POSOLOGY AND METHOD OF ADMINISTRATION: Dafraclav® must be taken before or during meals. The absorption of Clavulanic acid is better when Dafraclav® is taken b Read the complete document