Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**\[DOSAGE AND ADMINISTRATION\]** The usual dose is 50 to 200 KU/kg to be administered by intravenous drip infusion every day or every other day. The dosage may be adjusted depending on the age and condition of the patient. **(Preparation)** See 7. Precautions Concerning Use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
INTRAVENOUS
Medical Information
**\[INDICATIONS\]** Acute leukemia (including blastic crisis in chronic leukemia), malignant lymphoma.
**CONTRAINDICATIONS** **(LEUNASE Inj. is contraindicated in the following patients.)** Patients with a history of serious hypersensitivity to any of the components of the product.
L01XX02
asparaginase
Manufacturer Information
KYOWA KIRIN ASIA PACIFIC PTE. LTD.
NIPRO PHARMA CORPORATION (ODATE PLANT)
Active Ingredients
Documents
Package Inserts
202006_1.4.3c.LUNS-PI.IG(V4)(Submission20200429).pdf
Approved: July 14, 2020