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PEG L Asparaginase Injection Supplier


PEG L Asparaginase Injection
Business Type Manufacturer, Exporter, Supplier
Brand Name GJ
Best Before 6 months from Manufacture date
Form Of Medicine Injection
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Preferred Buyer From

Location All Countries Except India

Product Details

Grade Medicine Grade
Storage Store in cool and dry place
Packaging Size 5 ml

Warnings:

  • Contraindications
  • Hypersensitivity
  • History of (with prior L-asparaginase treatment): pancreatitis; hemorrhagic events; serious thrombosis


Cautions:

  • No more than 2 mL should be administered at any one injection site
  • Anaphylaxis or serious allergic reactions may occur, monitor patient for 1 hr after administration; discontinue with serious allergic reactions
  • Glucose intolerance reported (irreversible in some cases); monitor serum glucose
  • Hepatotoxicity and abnormal liver function, including elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin (direct and indirect), and depression of serum albumin, and plasma fibrinogen may occur; monitor
  • Discontinue if pancreatitis occurs; evaluate patients with abdominal pain for pancreatitis
  • Serious thrombotic events, including sagittal sinus thrombosis reported; discontinue if this occurs
  • Increased prothrombin time, increased PTT and hypofibrinogenemia may occur; monitor for coagulopathy


Pregnancy & Lactation

  • Pregnancy Category: C
  • Lactation: not known if excreted in breast milk


Pregnancy Categories

  • A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
  • B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
  • C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
  • D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
  • X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.


Pharmacology

  • Mechanism of Action
  • Modified version of L-asparaginase depletes asparagine, the aminoacid required for protein synthesis, and in turn kills leukemic cells


Pharmacokinetics

  • Half-Life: 5-5.6 days
  • Onset: Asparagine depleted within 4 days (IM)
  • Duration: 21 days (IM); 2-4 weeks (IV in asparaginase naive adults)
  • Vd: 1.5 L/m² (IM in children); 2.4 L/m² (IV in adults)
  • Metabolism: Systemically
  • Peak plasma time: 3-4 days (IM)
  • Excretion: Urine (trace amounts)


Storage

  • Refrigerate
  • Do not use if cloudy or if precipitate is present
  • Do not freeze
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