Rx Item-Kedrab 150U/Ml Singledose Presrv Free Vial 1X10Ml by Kedrion Bio

For: Rabies Prophylaxis KedRAB [rabies immunoglobulin (human)] is a human plasma derived anti-rabies immunoglobulin indicated for post-exposure prophylaxis (PEP) of rabies infection. These highlights do not include all the information needed to use KEDRAB safely and effectively. See full prescribing information for KEDRAB. KEDRAB Rabies Immune Globulin (Human) Solution for intramuscular injection Initial U.S. Approval: 2017 INDICATIONS AND USAGE KEDRAB is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine (1). Do not administer additional (repeat) doses of KEDRAB once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine (1). Do not administer KEDRAB to persons with a history of a complete pre-exposure or post-exposure rabies vaccination and confirmed adequate rabies antibody titer (1). DOSAGE AND ADMINISTRATION For wound infiltration and intramuscular use (2). Post-exposure prophylaxis consists of a single dose of KEDRAB and a full course of rabies vaccine. Administer KEDRAB and the rabies vaccine as soon as possible after exposure (2.1). Dosage: 20 IU/kg body weight (2.1). Infiltrate as much of the dose as possible into and around the exposure site (if visible); administer the remainder intramuscularly at sites distant from the site of vaccination (2.2). DOSAGE FORMS AND STRENGTHS Single-use vials containing 2 mL or 10 mL ready-to-use ; CONTRAINDICATIONS None (4). WARNINGS AND PRECAUTIONS KEDRAB should not be administered to individuals who have documented previous vaccination against rabies (5.1). Shock or anaphylactic reaction may occur following administration of KEDRAB (5.2). Individuals with IgA-deficiency and antibodies against IgA may develop hypersensitivity reactions to KEDRAB (5.3). Individuals with increased risk of thrombosis and thrombotic complications should be monitored following KEDRAB administration (5.4). Individuals receiving KEDRAB, particularly those at increased risk for hemolysis, should be monitored following KEDRAB administration (5.5). KEDRAB administration may interfere with development of an immune response to live attenuated viral vaccines (5.6). KEDRAB may interfere with serologic tests (5.7). KEDRAB may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to minimize the risk of viral transmission (5.8, 11). ADVERSE REACTIONS The most frequent adverse events in subjects treated with KEDRAB in clinical trials were injection site pain, headache, muscle pain, and upper respiratory tract infection (6). To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. Customer Service (1-855-353-7466) in the United States. Outside of the United States, the company distributing these products should be contacted. Voluntary reporting of adverse reactions may also be made to the FDA through MedWatch at 1-800-FDA-1088 or on the Internet at www.fda.gov/medwatch. or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Do not administer KEDRAB in the same syringe, or into the same anatomical site, as the rabies vaccine (2, 7). Immunization with live vaccines: KEDRAB may interfere with the response to live vaccines, such as measles, mumps, polio or rubella; avoid immunization with live virus vaccines within 3 months after KEDRAB administration, or in the case of measles vaccine, within 4 months after KEDRAB administration (7). See 17 for PATIENT COUNSELING INFORMATION. Revised: 8/2017

RX ITEM-Kedrab 150U/Ml Singledose Presrv
Item No.:RX76125-0150-10 NDC No.76125-0150-10 76125-150-10 7612515010 76125015010 UPC No.:376125150105 376125-150105 3-76125-15010-5 Item No.:015010

Kedrab 150U/Ml Singledose Presrv Free Vi
BRAND: KEDRAB NDC: RX76125-0150-10 ,RX76125015010 UPC: 376125-150105,376125150105 Generic Name: RABIES IMMUNE GLOBULIN Description: KEDRAB, 150U/ML, (1500 UNITS), SINGLEDOSE PRESRV FREE VIAL,

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