Edaravone Injection 20ml: 30mg

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Guangzhou Sinolead Biotech Co., Ltd.

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Edaravone Injection 20ml: 30mg
Sinolead
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20ml: 30mg
China
Product Description

Edaravone Injection is an antioxidant drug often used for managing conditions associated with oxidative stress, such as amyotrophic lateral sclerosis (ALS) and acute ischemic stroke. Below is a specification for the Edaravone Injection 20 mL: 30 mg.

1. Composition:

  • Active Ingredient: Edaravone, a free radical scavenger.
  • Concentration: 30 mg per 20 mL solution (1.5 mg/mL).
  • Formulation: Aqueous solution intended for intravenous (IV) administration.

2. Pharmacological Action:

  • Antioxidant Properties: Edaravone acts as a free radical scavenger, reducing oxidative damage in cells.
  • Reduction of Neuronal Damage: Helps prevent brain cell injury due to ischemia (lack of blood flow), often seen in stroke.
  • Cytoprotective Effect: Reduces the severity of symptoms in neurodegenerative diseases by protecting nerve cells.

3. Indications:

  • Acute Ischemic Stroke: Reduces damage during ischemic stroke to improve recovery and outcomes.
  • Amyotrophic Lateral Sclerosis (ALS): Used to slow disease progression in ALS patients, reducing the decline in physical function.

4. Dosage and Administration:

  • Route: Administered by intravenous infusion, generally under medical supervision.
  • Typical Dosage:
    • For Stroke: Often administered as 30 mg (1 vial) twice daily, typically for 14 days, with variations based on patient response.
    • For ALS: A cycle regimen is usually followed, involving daily administration for 14 days followed by a 14-day drug-free period, with subsequent cycles adjusted per treatment guidelines.
  • Infusion Duration: Typically infused over 30-60 minutes.

5. Storage Conditions:

  • Temperature: Store at a controlled room temperature, generally between 15°C and 30°C.
  • Protect from Light: Keep in a protective container to avoid degradation from light.
  • Shelf Life: Commonly 2-3 years from the date of manufacture if stored properly.

6. Contraindications:

  • Allergy: Contraindicated in patients with known hypersensitivity to edaravone or its excipients.
  • Renal Impairment: Should be used cautiously in patients with severe renal dysfunction.

7. Precautions and Warnings:

  • Allergic Reactions: Watch for signs of hypersensitivity reactions, which may be serious and include anaphylaxis.
  • Liver Function: Monitor liver function as edaravone may elevate liver enzymes.
  • Pregnancy and Lactation: Use only if the benefit outweighs the potential risk to the fetus or infant, as safety in pregnancy and lactation has not been established.

8. Side Effects:

  • Common: Headache, dizziness, fatigue, nausea, and rash.
  • Severe: Allergic reactions, including anaphylaxis, and potential liver function abnormalities.

9. Packaging:

  • Typically packaged in 20 mL glass vials, each containing 30 mg of edaravone, ready for dilution and infusion.

Edaravone Injection should be administered under the guidance of a healthcare professional who can monitor for efficacy and potential side effects.

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