Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ceftibuten
Merck Sharp & Dohme Corp.13900 North West 57th Court
ceftibuten
36mg/ml
powder for oral suspension
Prescription
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CEDAX 400 mg hard capsules CEDAX 36 mg/ml powder for oral suspension - bottle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CEDAX 400 MG HARD CAPSULES Each capsule contains: _Active ingredient_ : Ceftibuten 400 mg CEDAX 36 MG/ML GRANULES FOR ORAL SUSPENSION 5 ml of suspension contain: _Active ingredient_ : Ceftibuten 180 mg For the excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules. Powder for oral suspension. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS CEDAX is indicated for the treatment of infections caused by susceptible pathogens, and espe- cially: • UPPER RESPIRATORY TRACT INFECTIONS : pharyngitis, tonsillitis, sinusitis, otitis media. • LOWER RESPIRATORY TRACT INFECTIONS : bronchitis, primary community-acquired pneumonia, broncho-pneumonia. • URINARY TRACT INFECTIONS : acute and chronic pyelitis, cystopyelitis, cystitis, urethritis. As a drug of second choice in uncomplicated acute gonococcal urethritis. • ENTERITIS AND GASTROENTERITIS in children, both complicated and uncomplicated infections caused by _Salmonella, Shigella_ or _E. coli_ . Cedax has not demonstrated activity against spe- cies of _Campylobacter_ or _Yersinia_ . 4.2. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: _Lower respiratory tract infections_ : Pneumonia: 200 mg twice a day; acute bacterial sinusitis and acute exacerbations of chronic bronchitis: 400 mg once a day. _Upper respiratory tract infections_ : 400 mg once a day. _Urinary tract infections_ : 400 mg once a day. CHILDREN AGED 6 MONTHS AND OVER: _Uncomplicated lower respiratory tract infections_ : 9.0 mg/kg once a day. _Upper respiratory tract infections_ (e.g. otitis media): 9.0 mg/kg once a day. _Urinary tract infections_ : 9.0 mg/kg once a day. The maximum daily dose in children should not exceed 400 mg/day. CEDAX oral suspension can be taken one to two hours before or after meals. CEDAX capsules may be taken without regard to food. 4.3. CONTRAINDICATIONS Hypersensitivi Pročitajte cijeli dokument