Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
OLOPATADINE AS HYDROCHLORIDE
K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL
S01GX09
EYE DROPS, SOLUTION
OLOPATADINE AS HYDROCHLORIDE 1 MG / 1 ML
OCULAR
Required
COOPER S.A., GREECE
OLOPATADINE
For the temporary prevention of itching of the eye due to allergic conjunctivitis.
2020-07-20
1/5 OLOPATADINE S.K 1MG/ML EYE DROPS SOLUTION 1. Summary of Product Characteristics Name of the medicinal product OLOPATADINE S.K. 1 mg/mL eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of solution contains 1 mg olopatadine (as hydrochloride). Excipient(s) with known effect: Benzalkonium chloride 0.1 mg/ml. Disodium hydrogen phosphate dodecahydrate (E339) 12.61 mg/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution (eye drops). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary prevention of itching of the eye due to allergic conjunctivitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose is one drop of OLOPATADINE S.K in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Treatment may be maintained for up to four months, if considered necessary. _Use in elderly _ No dosage adjustment in elderly patients is necessary. _Paediatric patients _ OLOPATADINE S.K may be used in paediatric patients three years of age and older at the same dose as in adults. The safety and efficacy of OLOPATADINE S.K in children aged under 3 years has not been established. No data are available. _Use in hepatic and renal impairment _ Olopatadine in the form of eye drops (OLOPATADINE S.K ) has not been studied in patients with renal or hepatic disease. However, no dosage adjustment is expected to be necessary in hepatic or renal impairment (see section 5.2). Method of administration For ocular use only. After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the product. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. In case of concomitant therapy with other topical ocular medicines, an interval of five minutes should be allowed between successive applications. Eye ointments should b Կարդացեք ամբողջական փաստաթուղթը