1. NAME OF THE MEDICINAL PRODUCT ULTRA-MEDANINE 0.2 % 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 15 ml contains: Active ingredient: Methoxsalen (ammoidin) 0.03 gm, i.e. (0.01gm/5mL) For list full of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Local paint. Clear colorless to pale yellow solution free from foreign bodies 4. CLINICAL DATA 4.1. Therapeutic indications As a part of photochemotherapy for: Psoriasis, vitiligo, mycosis fungoides, cutaneous T- cell lymphomas, lichen planus, alopecia areata decalvant, photodermatoses, mastocytosis skin, dermatitis atopic . 4.2. Dosage and method of administration Treatment by topical applications of METHOXSALEN in solution must be reserved for topicalized and limited lesions, and easy to protect from any overexposure to the sun. Always start with the weak solution at 0.10 % (which we can if necessary further dilute with alcohol at 60° to reduce the concentration to half or a quarter). It must be carried out with the greatest caution to avoid any risk of burns. Apply the solution with a fitted cotton pad and taking care to stay away from the edges of the plaques, to avoid causing unsightly peripheral hyperpigmentation. Irradiation by exposure to sunlight It should be carried out at the end of the afternoon. Given the fact that erythema only occurs 48 hours after exposure, the sessions will instead be done every 48 hours at the beginning. The exposure times must be strictly respected and very gradually increased: 1st _ week : 1/4 minute 2 nd week : 1/2 minute 3rd _ week : 1 minute 4th _ week : 1.5 to 2 minutes. The exposure time should only be increased if the erythema has not become too severe 48 hours after the last session. In case of excellent tolerance (highly pigmented skin) the strong solution can be used after 3 to 4 weeks, returning to exposure times of 1/4 minute. The exposure time will be gradually increased again. UVA irradiation (PUVA) Exposure to UVA lamps, one hour after application of the solution, must be progressive from a dose of 0.25 to 0.50 j/cm2 at the first session. The progression from one session to another is 0.25 j/ cm 2.In case of excessive erythema or pruritus, the treatment must be interrupted temporarily; it will be resumed with a dose not exceeding half of the previous dose. Balneopuvatherapy It combines a bath containing methoxsalen and UVA irradiation. The bath is prepared by diluting a bottle of METHOXSALEN strong solution which being at 0.75% in 80 to 100 liters of water, to obtain a concentration of 1.8 mg to 2.2 mg of methoxsalen per liter (i.e. 2 bottles of 0.75% conc for an adult bathtub of 150 to 160 liters). The bath, lasting for 15 minutes, is followed by irradiation carried out immediately after drying (without rubbing but by dabbing). Doses of recommended U.V.A. are lower. For the first session, the dose is 0.20 j/cm2; it is gradually increased from 0.02 to 0.05 j/cm2 at each session to reach a maximum of approximately 1 j/cm2. At the end of each irradiation session: (sun or U.V.A.) the treated areas must be rigorously rinsed, and protected against any overexposure to the sun's rays by wearing clothes, gloves, scarf, etc... and for the uncovered parts which cannot be protected, apply a total sunscreen cream for at least 24 hours following each session. 4.3. Contraindications Contraindications due to Methoxsalen: • Use for cosmetic purposes, for tanning. • Skin conditions aggravated by the sun (lupus erythematosus, porphyria). Contraindications due to PUVA therapy: • Cataract, • History of skin cancer, • Previous treatment with arsenical agents, ionizing radiation, • Children.
