OXSORALEN 20 MCGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

METHOXSALEN

Available from:

A.L. MEDI-MARKET LTD.

ATC code:

D05AD02

Pharmaceutical form:

SOLUTION FOR BLOOD FRACTION MODIFICATION

Composition:

METHOXSALEN 20 MCG / 1 ML

Administration route:

EXTRACORPOREAL

Prescription type:

Required

Manufactured by:

G.L. PHARMA GMBH, AUSTRIA

Therapeutic area:

METHOXSALEN

Therapeutic indications:

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

Authorization date:

2021-11-15

Summary of Product characteristics

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