Land: Israël
Taal: Engels
Bron: Ministry of Health
METHOXSALEN
A.L. MEDI-MARKET LTD.
D05AD02
SOLUTION FOR BLOOD FRACTION MODIFICATION
METHOXSALEN 20 MCG / 1 ML
EXTRACORPOREAL
Required
G.L. PHARMA GMBH, AUSTRIA
METHOXSALEN
Oxsoralen is indicated in adults for extracorporeal use in the palliative treatment of advanced stage cutaneous T-cell lymphoma in patients who have not been responsive to other forms of treatment
2021-11-15
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Oxsoralen 20 mcg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 20 micrograms methoxsalen. One 5 ml ampoule contains 100 micrograms methoxsalen. Excipients with known effect: 10.4 mg ethanol 96%, 17.7 mg sodium per ampoule For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for blood fraction modification Clear, colourless solution pH 5.0 to 7.0 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxsoralen 20 mcg/ml solution is indicated in adults for extracorporeal use in the palliative treatment of advanced stage cutaneous T-cell lymphoma in patients who have not been responsive to other forms of treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ During each photopheresis treatment with methoxsalen, the dosage is calculated according to the treatment volume, using the formula below: Treatment volume x 0.017 ml of Oxsoralen 20 mcg/ml for each treatment For example: Treatment volume = 240 ml x 0.017 = 4.1 ml of Oxsoralen 20 mcg/ml _Paediatric population (under 18 years of age) _ The safety and efficacy of Oxsoralen 20 mcg/ml in children and adolescents under the age of 18 years have not been established for this indication. _Hepatic or renal impairment _ Oxsoralen 20 mcg/ml solution has not been clinically tested in patients with renal or hepatic impairment. Liver enzymes should be monitored regularly before and during therapy (see section 4.4). Method of administration Extracorporeal use. _Note: _ Extracorporeal photochemotherapy is to be carried out only by persons with special training and in institutions disposing of the suitable equipment for this treatment. Psoralen and UV irradiation therapy should take place under constant supervision by a physician with the appropriate training. The working instructions for the procedure (according to the company manufacturing the equipment in use and/or to recent guidelines) must be followed strictly. The content of the ampoule Lees het volledige document