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INFUSION & MEDICAL CENTER_________1. Patient NameDOBPatient Phone/Cell #Patient demographic and insurance information to be faxed with Infusion Order Form2. Medical Information (Please select primary
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The exulizumab label on accessdatafda.gov provides detailed information about the drug, including its indications, dosage, administration, and safety information as approved by the FDA.
Manufacturers and sponsors of exulizumab are required to file the label with the FDA, ensuring that the drug complies with regulatory standards.
To fill out the exulizumab label, the applicant must follow FDA guidelines, ensuring all required sections such as product information, usage instructions, and safety warnings are accurately completed.
The purpose of the exulizumab label is to inform healthcare providers and patients about the drug's approved uses, dosing information, and potential side effects, ensuring safe and effective use.
The information that must be reported includes the active ingredients, indications, dosage forms, routes of administration, contraindications, warnings, and adverse reactions.
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