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Download Sef film tablet 500 mg, 16 tablets, Sef film tablet 1 g, 16
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Sef Sef film tablet 500 mg, 16 tablets, Sef film tablet 1 g, 16-20 tablets, Sef suspension 250 mg/ 5 mL, 80-100 mL COMPOSITION: Each tablet contains cephalexin monohydrate equivalent to 500 mg - 1 g cephalexin. Each 5 mL suspension contains cephalexin monohydrate equivalent to 250 mg cephalexin. PHARMACOLOGICAL PROPERTIES: A wide-spectrum, bactericidal, first-generation cephalosporin for oral use. Spectrum of Activity: ß-hemolytic streptococci Staphylococci (penicillinase-producing and non-producing) Streptococcus pneumoniae Escherichia coli Proteus mirabilis Klebsiella sp. Haemophilus influenzae Moraxella catarrhalis INDICATIONS: The following infections due to cephalexin-susceptible organisms Upper respiratory tract infections Otitis media Skin and soft-tissue infections Genitourinary tract infections CONTRAINDICATIONS: Is contraindicated in patients known to be hypersensitive to cephalosporins. WARNINGS AND PRECAUTIONS: Should be used with caution in patients hypersensitive to penicillins because of partial cross-allergy. SIDE EFFECTS / ADVERSE EFFECTS: SEF is generally well tolerated. The adverse reactions which were observedduringSEFtherapyandresolvedfollowingdiscontinuationoftreatmentareasfollows:Gastrointestinal: Diarrhea (rarely severe enough to necessitate withdrawal of therapy), nausea, vomiting, abdominal pain and dyspepsia. Hypersensitivity reactions: Urticaria, angioedema and rarely erythema multiforme. Other: Eosinophilia, neutropenia, thrombocytopenia and transient elevations in SGOT and SGPT. DRUG INTERACTIONS: An increase in nephrotoxicity can occur when used concurrently with aminoglycosides. Absorption can be decreased when given concomitantly with cholestyramine. DOSAGE AND ADMINISTRATION: Adults: Daily 1-4 g doses should be administered in 6-12 hours intervals. In the treatment of streptococcal pharyngitis, skin and soft-tissue infections and uncomplicated cystitis 500 mg doses administered every 12 hours are often adequate. Children: The commonly used dosage schedule is 25-50 mg/kg administered every 6-12 hours intervals. In the treatment of streptococcal pharyngitis and skin and soft-tissue infections in children over 1 year of age, the total daily dosage can be given in equally divided doses with 12 hour intervals. In the treatment of very severe infections, this dose can be increased 2 fold. In the treatment of otitis media, the daily dosage of 75-100 mg/kg should be administered with 6 - 8 hour intervals. In streptococcal infections treatment with SEF should be continued for at least 10 days. STORAGE CONDITIONS: Should be kept out of reach of children, at room temperature (< 25ºC) and in its package. AVAILABLE FORMS: “SEF tablet 500 mg, 16-tablets blister packs, SEF tablet 1 g, 16-20 tablets blister packs, SEF suspension 250 mg/5 mL, 80-100 mL bottles” NAME AND ADDRESS OF THE AUTHORISATION HOLDER: Mustafa Nevzat Ilac Sanayii A.Ş. Prof. Dr. Bülent Tarcan Sok., Pak Iş Merkezi No: 5/1 34349 Gayrettepe/Istanbul. NAME AND ADDRESS OF THE MANUFACTURING COMPANY: Mustafa Nevzat Ilac Sanayii A.Ş. Çobançeşme Mah. Sanayi Cad. No.13 Yenibosna-Istanbul.
