DAFRACLAV® BD 200/28 mg POWDER FOR ORAL SUSPENSION contains 200 mg amoxicillin equivalent of amoxicillin trihydrate and potassium clavulanate equivalent to 28 mg clavulanic acid activity per 5 ml of suspension as active ingredients. Each cardboard box contains 1 bottle of 70 ml. Bottle containing enough powder mixture to give 70 ml suspension after reconstitution with water. Supplied with a measure spoon. Other pharmaceutical forms available: Dry powder DAFRACLAV® BD 400/57 mg Forte Oral Suspension, 70 ml DAFRACLAV® 625 mg Filmcoated tablet (15 tablets) DAFRACLAV® 1 g Filmcoated tablet (10 tablets). 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®. Directions for Mixing Oral suspension: Add water until the half of the bottle and shake well. Wait for 5 minutes for homogeneous disper­sion. Add water until marked level on the bottle and shake well again. The reconstituted suspension is active for 7 days when stored in refrigerator. Shake the bottle well before each use. Do not put in the freezer. Posology: Pediatric patients older than 12 weeks (3 months) of age: based on its amoxicillin content DAFRACLAV® BD 200/28 mg PEDIATRIC ORAL SUS­PENSION is used according to the following dosing schedule: Dosing schedule for 200 mg/5 ml Suspension, based on the infection: Otitis media, sinusitis, lower respiratory tract infections and more severe infections: 45 mg / kg day (divided into two equal portions and administered every 12 hours) Less severe infections: 25 mg / kg day (divided into two equal portions and administered every 12 hours) In children weighing more than 40 kg, adult dosing schedule is applied. DAFRACLAV® may be taken before or after meals. However, if taken before meals, absorption of the potassium clavulanate is increased. For this reason it is recommended that DAFRACLAV® is taken before meals. Culture and susceptibility testing should be carried out prior to initiation of DAFRACLAV® therapy. However, treatment may be started without waiting test results. Therapy may then be adjusted according to test results when they are available. Shake well before use.

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