Država: Singapur
Jezik: engleski
Izvor: HSA (Health Sciences Authority)
CIPROFLOXACIN HCl 3.5 MG/ML EQV CIPROFLOXACIN
NOVARTIS (SINGAPORE) PTE LTD
S01AX13
3.5 mg/mL
SOLUTION
CIPROFLOXACIN HCl 3.5 MG/ML EQV CIPROFLOXACIN 0.3 % w/v
OPHTHALMIC, AURICULAR (OTIC)
Prescription Only
S.A. ALCON-COUVREUR NV
ACTIVE
2002-05-14
Ciloxan Mar 2022.SIN Page 1 of 9 CILOXAN® STERILE OPHTHALMIC AND OTIC SOLUTION (CIPROFLOXACIN 0.3 % ) 1 TRADENAME(S) CILOXAN® Sterile Ophthalmic and Otic Solution 0.3%. CILOXAN (ciprofloxacin hydrochloride solution), 0.3% as base 2 DESCRIPTION AND COMPOSITION Eye/Ear drops, solution. ACTIVE SUBSTANCE(S) 1 ml of solution contains 3.5 mg ciprofloxacin hydrochloride monohydrate equivalent to 3 mg ciprofloxacin base. EXCIPIENTS Excipient with known effect: 1 mL of solution contains 0.06 mg of benzalkonium chloride. Other excipients: disodium edetate, mannitol, acetic acid, sodium acetate trihydrate, hydrochloric acid and / or sodium hydroxide for pH adjustment, and purified water. 3 INDICATIONS OCULAR USE: • Ciloxan Eye drops is indicated for the treatment of corneal ulcers and superficial infections of the eye and its adnexa, caused by strains presumed or reported susceptible to Ciprofloxacin, in particular _ Pseudomonas _ _aeruginosa _ and other Gram-negative bacteria resistant to usual tr eatments. OTIC USE: • Ciloxan Ear drops is indicated for localized or diffuse otitis externa accompanied by a strong inflammatory reaction and of which the strains are susceptible to Cipr o floxacin. 4 DOSAGE REGIMEN AND ADMINISTRATION EYE DROPS DOSAGE REGIMEN _ _ CORNEAL ULCERS Ciloxan Eye drops must be administered at the following intervals, even during night- time: • On the first day, instill 2 drops into the affected eye(s) every 15 minutes for the first 6 hours and then 2 drops into the affected eye(s) every 30 minutes for the remainder of the day. • On the second day, instill 2 drops into the affected eye(s) hourly. Ciloxan Mar 2022.SIN Page 2 of 9 • On the third through the fourteenth day, place two drops into the affected eye(s) every 4 hours. If the patient needs to be treated longer than 14 days, the dosing regimen is at the discretion of the attending physician. SUPERFICIAL BACTERIAL INFECTIONS OF THE EYE AND ADNEXA • For the first two days instill one or two drops into the conjunctival sac of the infect Pročitajte cijeli dokument