Edaravone infusion solution 30 mg/100 mL bag (NP) 10 bags

Edaravone infusion solution 30 mg/100 mL bag (NP), 10 bags — Nipro, Japan

Edaravone is a prescription (Rx) neuroprotective agent — a free radical scavenger (brain protectant, 脳保護剤) used in hospital and specialist practice in Japan. This presentation is the ready-to-use bag: 10 sealed infusion bags (kits) of 100 mL, each containing 30 mg of edaravone in an isotonic solution, manufactured by Nipro Corporation under the Japanese Pharmacopoeia. The pack itself is marked 点滴専用 (for drip infusion only) and 30分かけて点滴 (infuse over 30 minutes): the bag is used as supplied, no dilution or mixing is required. Edaravone is given only under medical supervision and by prescription.

Product overview

• Trade name: Edaravone Intravenous Infusion Solution 30 mg Bag (NP) — エダラボン点滴静注液30mgバッグ「NP」
• Active ingredient: edaravone 30 mg per 100 mL bag (Japanese Pharmacopoeia)
• Dosage form: ready-to-use intravenous infusion solution in a closed bag (kit), administered by drip infusion
• Pack size: 10 bags × 100 mL per carton
• Manufacturer: Nipro Corporation (Osaka, Japan)
• Country of origin: Japan
• Product category: neuroprotective agent — free radical scavenger (brain protectant)
• Legal status in Japan: prescription-only medicine (Rx)

What edaravone is used for

Approved indications in Japan:

• Acute ischaemic stroke — improvement of neurological deficits and of the impairment of activities of daily living, with treatment started within 24 hours of onset
• Amyotrophic lateral sclerosis (ALS) — slowing of the progression of functional decline (edaravone was approved for ALS in Japan before anywhere else)

Both uses are supervised, hospital-based treatments: they require a confirmed diagnosis, an infusion protocol and monitoring, and are not suitable for self-treatment.

How it is used

The bag is a finished infusion kit — the solution is administered as supplied, over 30 minutes, as printed on the pack (30分かけて点滴).

• Intravenous drip infusion only (点滴専用); no dilution, no admixture.
• Usual regimen in acute ischaemic stroke in Japan: 30 mg (one bag) twice a day, morning and evening, for 14 days.
• In ALS, Japanese protocols use 60 mg per infusion over 60 minutes (two 30 mg bags) on scheduled treatment days, in repeated cycles.
• The dose, the number of days and any combination with other infusions are decided only by the treating physician.

Possible side effects

• Raised liver enzymes (ALT, AST), rash, nausea, headache, fever, discomfort at the infusion site
• Less commonly: fall in blood pressure, anaemia, leucopenia, thrombocytopenia
• Rare but serious reactions have been reported: acute kidney injury, liver dysfunction, disseminated intravascular coagulation, acute lung injury, hypersensitivity and anaphylaxis

Blood tests are performed during treatment; any unusual symptom should be reported to the medical team immediately.

Important precautions

• Prescription medicine — it must be prescribed and administered by a qualified physician; it is not intended for self-administration.
• Use with caution in patients with impaired kidney or liver function, in the elderly, and in patients receiving other infusions or medicines.
• Inform the doctor about pregnancy, planned pregnancy or breastfeeding.
• Do not use a bag that is damaged, leaking, discoloured, or contains particles.
• Keep out of the reach of children.

Storage and packaging

• Store at room temperature, protected from light; do not freeze.
• Do not use after the expiry date printed on the pack.
• Supplied as 10 sealed 100 mL bags in the original carton.

Important notice

The product photograph is published for identification only. The description reproduces the manufacturer's labelling and general prescribing information and cannot replace the advice of a doctor or pharmacist: edaravone is a prescription medicine and any use must be agreed with a healthcare professional.

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