GENERIC NAME OF MEDICINAL PRODUCT:

A. Edaravone Injection JP 1.5mg/1ml (EDARVOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Edaravone Injection JP 1.5mg/1ml
Each ml contains:
Edaravone JP………………….1.5mg
Water for Injections IP..….q. s

THERAPEUTIC INDICATION:

Edaravone injection is used to treat amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; a condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken). Edaravone injection is in a class of medications called antioxidants. It may work to slow the nerve damage associated with the worsening of ALS symptoms.

DIRECTION OF USE:

To be diluted prior to Intravenous infusion.
See enclosed leaflet for further information.

CAUTION AND WARNING:

CAUTION: Do not use if solution is not clear or has suspended matter.
Not for bolus Injection.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Neurologists.

STORAGE AND DOSAGE:

Storage: Store below 25°C.
excursion not permitted to 30℃ (86°F).
Store in a cool, dry and dark place.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Neurologists.

Edaravone Injection JP 1.5mg/ml Technical Specification:

Product Name:Edaravone Injection JP
Brand Name:EDARVOTAJ
Strength:1.5mg/1ml
Dosage Form:Liquid Injection
Packing:20ml Single Dose Ampoule
Route of Administration:For I.V. Infusion use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Amyotrophic lateral sclerosis, Antioxidant
Indication: Edaravone injection is used to treat amyotrophic lateral sclerosis, which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken.
Storage:Store at temperature not exceeding 30°C.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Edaravone Injection JP 1.5mg/1ml (EDARVOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Edaravone Injection JP 1.5mg/1ml
    Each ml contains:
    Edaravone JP………………….1.5mg
    Water for Injections IP..…………q. s

THERAPEUTIC INDICATION:

Edaravone injection is used to treat amyotrophic lateral sclerosis (ALS, Lou Gehrig’s disease; a condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken). Edaravone injection is in a class of medications called antioxidants. It may work to slow the nerve damage associated with the worsening of ALS symptoms.

DIRECTION OF USE:

To be diluted prior to Intravenous infusion.
See enclosed leaflet for further information.

CAUTION & WARNING:

CAUTION: Do not use if solution is not clear or has suspended matter.
Not for bolus Injection.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Neurologists.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Excursion not permitted to 30℃ (86°F).
Store in a cool, dry and dark place.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

Dosage: As directed by the Neurologists.