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Indications for Use
Optune Treatment Kit is intended for the treatment of patients with newly diagnosed
GBM and for the treatment of patients with recurrent GBM.
Newly diagnosed GBM
NovoTTF-200A (Optune
TM
) Treatment Kit is intended for the treatment of patients with
newly diagnosed GBM, after surgery and radiotherapy with adjuvant Temozolomide,
concomitant to maintenance Temozolomide. The treatment is intended for adult
patients, 18 years of age or older, and should be started more than 4 weeks after
surgery and radiation therapy with adjuvant Temozolomide. Treatment may be given
together with maintenance Temozolomide (according to the prescribing information in
the Temozolomide package insert) and after maintenance Temozolomide is stopped.
Recurrent GBM
NovoTTF-200A (Optune
TM
) Treatment Kit is intended for the treatment of patients with
recurrent GBM who have progressed after surgery, radiotherapy and Temozolomide
treatment for their primary disease. The treatment is intended for adult patients, 18
years of age or older, and should be started more than 4 weeks after the latest
surgery, radiation therapy or chemotherapy.
Содержание Optune NovoTTF 200A
Страница 1: ...USER MANUAL...
Страница 2: ...Document number QSD EUUM 002 EN Version 02...
Страница 19: ...19...
Страница 25: ......
Страница 29: ...21 Full Charge Empty 25 Charge 50 Charge 75 Charge...
Страница 41: ...33 Serial Number Class II equipment per IEC 60601 1 Medical device...
Страница 53: ...45 BS EN 62368 1 Audio video information and communication technology equipment Safety requirements...