RADICAVA™ IV Concentrate Solution for Infusion 30mg/20mL

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Edaravone

Available from:

Mitsubishi Tanabe Pharma Malaysia Sdn. Bhd.

INN (International Name):

Edaravone

Units in package:

10 x 20 mL Ampoules

Manufactured by:

Nipro Pharma Corporation Ise Plant

Summary of Product characteristics

1
RADICAVA
®
edaravone
1.
NAME OF THE MEDICINE PRODUCT
RADICAVA
®
IV concentrate solution for infusion 30mg/20ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
(INN: Edaravone)
Each ampoule contains 30mg of edaravone in 20mL. After dilution, 1mL
of solution contains
approximately 0.43mg of edaravone.
RADICAVA contains sodium bisulfite, a sulfite that may cause allergic
type reactions. For the full list
of excipients, see
_List of excipients (section 6.1). _
_ _
3.
PHARMACEUTICAL FORM
Injection
A clear and colourless aqueous solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
RADICAVA (edaravone) is indicated to slow the loss of function in
patients with amyotrophic lateral
sclerosis (ALS).
4.2
POSOLOGY AND MODE OF ADMINISTRATION
Posology
The usual adult dosage is two ampoules (60 mg of edaravone) diluted
with 100mL of physiological
saline, etc., which is administered intravenously over 60 minutes once
a day.
_Special population _
_Paediatric Use _
Safety and effectiveness of RADICAVA in paediatric patients have not
been established.
_Geriatric Use _
Of the 184 patients with ALS who received RADICAVA in 3
placebo-controlled clinical trials, a total
of 53 patients were 65 years of age and older, including 2 patients 75
years of age and older. No
overall differences in safety or effectiveness were observed between
these patients and younger
patients, but greater sensitivity of some older individuals cannot be
ruled out.
_Renal Impairment _
Mild and moderate renal impairment have no clinically significant
effects on the pharmacokinetics of
edaravone. No dose adjustment is needed in these patients. No studies
have been performed to
characterize the pharmacokinetics of edaravone or establish its safety
in patients with severe renal
impairment.
_Hepatic Impairment _
Mild,
moderate
and
severe
hepatic
impairment
have
no
clinically
significant
effects
on
the
pharmacokinetics of edaravone. No dose adjustment is needed in these
patients.
2
Mode of Administration
Administer two ampoules (60mg of edaravon