L-Asparaginase (Lyophilized) 500 IU, 10,000 IU Pre-Filled Syringe
L-Asparaginase (Lyophilized) 500 IU, 10,000 IU Pre-Filled Syringe - Image 2
Categories:, SKU: 00001-85
L-Asparaginase (Lyophilized) 500 IU, 10,000 IU Pre-Filled Syringe

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Description

PRODUCT DESCRIPTION:

 

L-Asparaginase is a critical antineoplastic enzyme used as part of combination chemotherapy regimens in the treatment of acute lymphoblastic leukemia (ALL).

It works by depleting circulating asparagine, an amino acid essential for the survival of leukemia cells.

This lyophilized formulation, presented in a ready-to-reconstitute pre-filled syringe, ensures dose accuracy, extended shelf life, and ease of administration, particularly in controlled hospital environments.

Formulation & Presentation:

  • Dosage Form: Sterile Injectable
  • Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
  • Available Strengths:
    • 500 IU
    • 10,000 IU
  • Route of Administration: Intravenous (IV) or Intramuscular (IM) after appropriate reconstitution or as per clinical indication and severity. Reconstituted as per protocol Intravenous infusion. To be administered under supervision of a qualified oncologist or day-care oncology units. (As per physician’s discretion or decision) Administered as continuous infusion, typically as part of combination chemotherapy regimens

Therapeutic Indications:

  • First-line and relapsed treatment of Acute Lymphoblastic Leukemia (ALL)
  • Part of pediatric and adult ALL regimens (e.g., as per BFM or CALGB protocols)
  • Investigational/Off-label in certain lymphomas

Side Effects:

  • COMMON:
    • Hypersensitivity reactions
    • Pancreatitis
    • Hyperglycemia
    • Coagulation abnormalities
    • Nausea and vomiting
  • SERIOUS (RARE):
    • Anaphylaxis
    • Thrombosis or hemorrhage
    • Hepatotoxicity
    • Severe pancreatitis
    • Central nervous system effects (e.g., confusion, seizures)
  • PRECAUTIONS:
    • Perform allergy testing or desensitization if prior hypersensitivity suspected
    • Monitor pancreatic enzymes, liver function tests, and coagulation profile regularly
    • Use with caution in patients with pre-existing liver disease or diabetes
    • Ensure appropriate reconstitution technique and use within recommended time post-dilution

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TECHNICAL INFORMATION

Product Specifications

  • HSN Code: To be assigned per international classification standards & import jurisdiction
  • Weight: Approx. 40g per Carton (With Packaging)
  • Dimensions: 15 x 1 x 8 CMS
  • Shelf Life: 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications
  • Storage:
    • Pre-Filled Syringes: Store below 2°C–8°C
    • Lyophilized Injection: Store below 25°C
    • Do not freeze. Requires cold-chain logistics. Protect from moisture and direct sunlight. Use strictly as per label guidelines.

Regulatory Status & Supply Information

  • Regulatory Status: WHO-GMP Compliant Manufacturing. COA, MSDS, Stability Data, Batch Record & Dossier Support available on request
  • Export Dossiers: Available in CTD/eCTD formats
  • Stability: Compliant
  • MOQ: Negotiable based on market & registration status
  • Export Options: Available for private label, institutional supply, or branded export

Who Should Source This Product?

  • Government oncology programs in LATAM, Africa & South Asia
  • Pediatric oncology units in tertiary care hospitals
  • NGOs and humanitarian organizations supporting childhood cancer treatment
  • Distributors and importers catering to leukemic care protocols
  • Institutions participating in global leukemia awareness and treatment programs

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation support for effective registration in global markets
  • Trusted consortium network simplifying India’s pharma supply chain
  • Multiple approved manufacturers for optimal fit in import destinations
  • Audited and compliant manufacturing network across India
  • Customizable branding, packaging & formulation options
  • Full logistics and cold-chain export support
  • Proven expertise in specialty injectables and regulatory-sensitive products

Contact Details

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