Land: Armenien
Språk: engelska
Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ciprofloxacin (ciprofloxacin hydrochloride monohydrate)
KRKA d.d.
J01MA02
ciprofloxacin (ciprofloxacin hydrochloride monohydrate)
250mg
tablets film-coated
(10/1x10/) in blister
Prescription
Registered
2022-03-09
1. NAME OF THE MEDICINAL PRODUCT Ciprinol ® 250 mg film-coated tablets Ciprinol ® 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg or 500 mg ciprofloxacin as ciprofloxacin hydrochloride, respectively. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 250 mg: round, white, biconvex, bevel edged, scored on one side. The tablet can be divided into equal doses. 500 mg: oval, white, biconvex, scored on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprinol ® film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy. Consideration should be given to official guidance on the appropriate use of antibacterial agents. _Adults_ - Lower respiratory tract infections due to Gram-negative bacteria - Acute exacerbations of chronic obstructive pulmonary disease In acute exacerbations of chronic obstructive pulmonary disease Ciprinol ® should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. - 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 - uncomplicated acute cystitis In uncomplicated acute cystitis ciprofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. - acute pyelonephritis - complicated urinary tract infections - bacterial prostatitis - Genital tract infections - Gonococcal uretritis and cervicitis due to susceptible _Neisseria gonorrhoeae_ - Epididymo-orchitis including cases due to suscepti Läs hela dokumentet