Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
P-AMINOBENZOIC ACID PADIMATE O
Stiefel Laboratories (U.K.) Ltd.
P-AMINOBENZOIC ACID PADIMATE O
%v/v
Cutaneous Suspension
Withdrawn
2008-07-10
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SpectraBan 15 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Solution A pink transparent liquid having a faint odour of alcohol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SpectraBAN 15 is a protective sunscreen lotion indicated in patients at risk from exposure to UV light in the UVB wavelength range (290 - 320nm). Use of the product should allow fifteen times normal exposure to sunlight before burning. SpectraBAN 15 is indicated in sensitive conditions such as polymorphic light eruptions and solar urticaria, and any condition made worse by UVB light such as lupus erythematosus. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Apply carefully and evenly to areas to be exposed or protected only by light clothing. Allow to dry before dressing. Allow 45 minutes before swimming or sweat producing exercise. A single application may give day long protection, but the product should be reapplied during prolonged sunning or after swimming or excessive sweating. 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not apply to broken skin. Avoid contact with the eyes, mouth and other mucous membranes. SpectraBAN 15 can stain clothing and other items permanently. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. Padimate O 3.2 % w/w Para-Aminobenzoic Acid 5.0 % w/w IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/07/2006_ _CRN 2025126_ _page number: 1_ 4.6 PREGNANCY AND LACTATION There are no restrictions on the use of SpectraBAN 15 in pregnancy and lactation. 4.7 EFFEC Lugege kogu dokumenti