Pays: Tanzanie
Langue: anglais
Source: Tanzania Medicinces & Medical Devices Authority
Ciprofloxacin Hydrochloride
Cadila Healthcare Limited, INDIA
Antibacterials for systemic use, quinolone antibac
Ciprofloxacin Hydrochloride
500
Tablets
Pinnacle Life Science Limited, INDIA
Physical description: White coloured, caplet shaped, biconvex, film coated tablets, plain on both side; Local technical representative: Abacus Pharma Africa Limited (8473)
Registered/Compliant
2021-10-09
PRESCRIBING INFORMATION (SUMMARY OF PRODUCT CHARACTERISTICS) 1. NAME OF THE MEDICINAL PRODUCT Strength: 500 mg Brand Name: CIPROBID 500 INN Name: Ciprofloxacin Tablet USP 500 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH FILM COATED TABLET CONTAINS Ciprofloxacin Hydrochloride USP Equivalent to Ciprofloxacin 500 mg Excipients q.s. Colour- Titanium Dioxide For full list of excipients see section 6.1 3. PHARMACEUTICAL FORM: Form: Tablet u DESCRIPTION : CIPROBID 500 Tablet is white colored, caplet shaped, biconvex film coated tablets, plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Ciprofloxacin tablets are indicated for the treatment of the following infections. ADULTS - Lower respiratory tract infections due to Gram-negative bacteria - exacerbations of chronic obstructive pulmonary disease - broncho-pulmonary infections in cystic fibrosis or in bronchiectasis - pneumonia - Chronic suppurative otitis media - Acute exacerbation of chronic sinusitis especially if these are caused by Gram- negative bacteria - Urinary tract infections & Genital tract infections - Infections of the gastro-intestinal tract (e.g. travellers' diarrhoea) - Intra-abdominal infections - Infections of the skin and soft tissue caused by Gram-negative bacteria - Infections of the bones and joints - Inhalation anthrax (post-exposure prophylaxis and curative treatment) CHILDREN AND ADOLESCENTS - Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa - Complicated urinary tract infections and pyelonephritis - Inhalation anthrax (post-exposure and curative treatment) Ciprofloxacin may also be used to treat severe infections in children and adolescents when it is considered to be necessary. Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: Posology The dosage is determined by the indication, the severity and the site of the infection, the suscepti Lire le document complet