Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
NEDOCROMIL SODIUM
Fisons Limited
NEDOCROMIL SODIUM
2 %w/v
Eye Drops Solution
Withdrawn
2007-04-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tilavist Eyedrops Solution 2.0% w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nedocromil sodium: 2.0% w/v. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tilavist is indicated for the prevention and treatment of allergic conjunctivitis, including seasonal allergic conjunctivitis, perennial allergic conjunctivitis and vernal kerato-conjunctivitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For ocular use. Adults (including the elderly) and children aged 6 years and over: In seasonal allergic conjunctivitis: one drop into each eye twice daily increasing when necessary to four times daily. In perennial allergic conjunctivitis and vernal kerato-conjunctivitis: one drop into each eye four times daily. Tilavist should be used regularly to ensure optimum control of symptoms. There is only limited clinical trial experience with Tilavist in children aged 3 to 6 years. Therefore use in this age range cannot be recommended. 4.3 CONTRAINDICATIONS Tilavist is contraindicated in patients with known hypersensitivity to nedocromil sodium, benzalkonium chloride or other constituents of the formulation. Tilavist should not be used in patients while wearing soft contact lenses. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In patients who continue to wear hard or gas permeable contact lenses during Tilavist treatment, the lenses should be taken out of the eye prior to instillation of the drops and not inserted again for at least 15 minutes. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/09/2006_ _CRN 2027581_ _page number: 1_ 4.5 INTERACTION WITH OTHE Lue koko asiakirja