Valsts: Tanzānija
Valoda: angļu
Klimata pārmaiņas: Tanzania Medicinces & Medical Devices Authority
Cefuroxime Axetil
ZIM LAboratories Limited, INDIA
Cefuroxime Axetil
500 mg
Film Coated Tablet
ZIM LABORATORIES LIMITED, INDIA
Physical description: Light red colored, caplet shaped film coated having break line on one side and plain on other side; Local technical representative: Salama Pharmaceuticals Limited (9410)
Registered/Compliant
2019-08-02
Summary of Product Characteristics 1. Name of the medicinal product CEFRIM 500 (Cefuroxime 500 mg Film Coated Tablet) 2. Qualitative and quantitative composition Each 500 mg film coated tablet contains NNN mg cefuroxime (as axetil). For the full list of excipients: see section 6.1. 3. Pharmaceutical form Film Coated tablets Light red colored, caplet shaped film coated having break line on one side and plain on other side 4. Clinical particulars 4.1 Therapeutic indications Cefuroxime axetil is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1). - Acute streptococcal tonsillitis and pharyngitis. - Acute bacterial sinusitis. - Acute otitis media. - Acute exacerbations of chronic bronchitis. - Cystitis - Pyelonephritis. - Uncomplicated skin and soft tissue infections. - Treatment of early Lyme disease. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology The usual course of therapy is seven days (may range from five to ten days). Table 1. Adults and children (≥40 kg) Indication Dosage Acute tonsillitis and pharyngitis, acute bacterial sinusitis 250 mg twice daily Acute otitis media 500 mg twice daily Acute exacerbations of chronic bronchitis 500 mg twice daily Cystitis 250 mg twice daily Pyelonephritis 250 mg twice daily Uncomplicated skin and soft tissue infections 250 mg twice daily Izlasiet visu dokumentu