Land: Canada
Taal: Engels
Bron: Health Canada
METHOXSALEN
VALEANT CANADA LP / VALEANT CANADA S.E.C.
D05AD02
METHOXALEN, TOPICAL
10MG
LOTION
METHOXSALEN 10MG
TOPICAL
30ML
Prescription
PIGMENTING AGENTS
Active ingredient group (AIG) number: 0107802001; AHFS:
CANCELLED POST MARKET
2015-08-05
1 PRESCRIBING INFORMATION OXSORALEN Lotion 1% (Methoxsalen, USP) Melanin Repigmentation Photochemotherapy of Psoriasis and Atopic Dermatitis Valeant Canada LP 2150 St-Elzear Blvd., West Laval, Quebec H7L 4A8 Canada Date of Preparation: September 27, 2004 Address Updated: September 04, 2014 Control#: 094181 2 PRESCRIBING INFORMATION OXSORALEN Lotion 1% (methoxsalen, USP) Melanin repigmentation Photochemotherapy of Psoriasis and Atopic Dermatitis INDICATIONS Repigmentation of vitiliginous lesions and treatment of psoriasis and atopic dermatitis in combination with high intensity UVA light. Oral route is preferred if extensive repigmentation is desired since topical application can only be applied to a small area at a time. CONTRAINDICATIONS Oxsoralen Lotion 1% is contraindicated in patients exhibiting idiosyncratic reactions to psoralens or with a history of a sensitivity reaction to the drug; in patients with diseases associated with photosensitivity (e.g., lupus erythematosus, porphyria cutanea tarda, erythropoietic protoprophyria, varietate porphyria, xeroderma pigmentosum, albinism, hydroa vacciniforme, leukoderma of infectious origin, polymorphous light eruptions), except under special circumstances; in patients with melanoma or history of melanoma; and in patients with invasive squamous cell carcinoma. Safety in patients 12 years and under, in aphasic people, in pregnant women or in women of childbearing age has not been established. No preparation with any photosensitizing capacity, internal or external, should be used concomitantly with methoxsalen therapy. 3 WARNINGS Methoxsalen is a potent drug capable of producing severe burns if improperly used. Oxsoralen Lotion should be applied ONLY by a physician under controlled conditions as to light exposure and subsequent light shielding. OXSORALEN LOTION 1% SHOULD NEVER BE DISPENSED TO A PATIENT FOR HOME APPLICATION. Oxsoralen Lotion 1% should be applied only to small, well-defined vitiliginous lesions, preferably those lesions that can be protected by clothing Lees het volledige document