Cladribine
CLADRIBINE INJECTION
5736aecc-cc1d-47dd-86c0-5fb2e9d70f61
HUMAN PRESCRIPTION DRUG LABEL
Apr 19, 2023
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cladribine
PRODUCT DETAILS
INGREDIENTS (4)
Drug Labeling Information
REFERENCES SECTION
REFERENCES
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Santana VM, Mirro J, Harwood FC, et al: A phase I clinical trial of 2-Chloro-deoxyadenosine in pediatric patients with acute leukemia. J. Clin. Onc., 9: 416 (1991).
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Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U. S. Government Printing Office, Washington, D. C. 20402.
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AMA Council Report. Guidelines for Handling Parenteral Antineoplastics, JAMA, March 15 (1985).
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National Study Commission on Cytotoxic Exposure--Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
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Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents, Med. J. Australia 1:425 (1983).
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Jones RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. Ca--A Cancer Journal for Clinicians, Sept/Oct. 258-263 (1983).
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American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic Drugs in Hospitals. Am. J. Hosp. Pharm., 42:131 (1985).
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OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (antineoplastic) Drugs. Am. J. Hosp. Pharm., 43:1193 (1986).
†Viaflex® containers, manufactured by Baxter Healthcare Corporation - Code No. 2B8013 (tested in 1991)
‡MEDICATION CASSETTE™ Reservoir, manufactured by SIMS Deltec, Inc. - Reorder No. 602100A (tested in 1991)
Manufactured by
THYMOORGAN PHARMAZIE GmbH,
Schiffgraben 23, 38690 Goslar, Germany
Distributed by
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922
Revised March 2020
127.207.019/02