Posology : מינונים

3     DOSAGE AND ADMINISTRATION
General Information
Treatment with RADICAVA should be initiated and monitored in specialized centers, by physicians experienced in the management of patients with ALS.
Treatment with RADICAVA may only be initiated if the patient has clinically definite, clinically probable or ͆probable laboratory/EMG-supported ALS͇.

The efficacy of RADICAVA has so far only been shown when therapy is initiated in early stage disease (patients are either capable of working or at least can independently perform activities of daily living). Whilst there is evidence in support of the efficacy of RADICAVA when initiated in patients with a more advanced stage of the disease, this data is very limited overall.
There is no adequate data supporting continuation of RADICAVA therapy in patients with pronounced impairment of respiratory function (rule of thumb: %FVC ≤ 50%) or in patients with pronounced functional worsening. In patients with significant worsening of overall and/or pulmonary symptoms/function, consideration should therefore be given to discontinuing RADICAVA.

3.1      Dosage Information
The recommended dosage of RADICAVA is an intravenous infusion of 60 mg administered over a 60-minute period, according to the following schedule:
• An initial treatment cycle with daily dosing for 14 days, followed by a 14-days drug-free period
• Subsequent treatment cycles with daily dosing for 10 days out of 14-days periods, followed by 14-days drug-free periods

3.2      Preparation and Administration Information for RADICAVA
RADICAVA is for intravenous infusion only.
Preparation
Dilute two ampoules (60mg in total) with an appropriate volume of physiological saline for intravenously administration over 60 minutes period, once a day.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Administration
Administer the diluted 60 mg dose of RADICAVA over a total of 60 minutes IV infusion.
Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction [see Warnings and Precautions (6.1, 6.2)].
Other medications should not be injected into the infusion bag or mixed with RADICAVA.


4 DOSAGE FORM AND STRENGTH
RADICAVA is supplied for intravenous infusion in a single-dose ampoule containing 30 mg of edaravone in 20 mL clear and colorless aqueous solution.