OLOPATADINE S.K.

Pajjiż: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

OLOPATADINE AS HYDROCHLORIDE

Disponibbli minn:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

Kodiċi ATC:

S01GX09

Għamla farmaċewtika:

EYE DROPS, SOLUTION

Kompożizzjoni:

OLOPATADINE AS HYDROCHLORIDE 1 MG / 1 ML

Rotta amministrattiva:

OCULAR

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

COOPER S.A., GREECE

Żona terapewtika:

OLOPATADINE

Indikazzjonijiet terapewtiċi:

For the temporary prevention of itching of the eye due to allergic conjunctivitis.

Data ta 'l-awtorizzazzjoni:

2020-07-20

Karatteristiċi tal-prodott

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