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Microsoft Word - A-NBRL-USPI-v53-Hep B-Lactation-Transplacental-C[removed]doc
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Document Date: 2014-09-05 16:59:49


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Company

Amgen Inc. / /

Country

United States / Canada / /

Event

Product Issues / Product Recall / /

Facility

American College of Rheumatology / DO NOT store / /

IndustryTerm

dry natural rubber / proteinaceous solutions / treatment of heart failure / organ systems / drug products / mg/mL solution / /

MedicalCondition

anaphylactic reaction / transverse myelitis / Patients With Heart Failure / Demyelinating disease / TB / severe fungal infection / lymphoma / HBV / active infection / Ankylosing Spondylitis / serious allergic reactions / sterility / serious systemic illness / endemic / invasive fungal infection / Rheumatoid Arthritis / skin cancer / pneumocystosis / Plaque Psoriasis / Anaphylaxis / serious infections / Non-melanoma skin cancer / hepatitis B / tuberculosis infection / central nervous system demyelinating disorders / Melanoma / severe plaque psoriasis / severely active rheumatoid arthritis / multiple sclerosis / mycoses / extrapulmonary disease / aspergillosis / adult psoriasis / endemic tuberculosis / histoplasmosis infections / aplastic anemia / blastomycosis / bacterial sepsis / severe disease / endemic mycoses / Allergic Reactions Allergic reactions / persistent fever / infections / seizure disorders / Psoriatic Arthritis / lupus-like syndrome / sepsis / severe systemic illness / serious allergic reaction / Polyarticular Juvenile Idiopathic Arthritis / lymphoma and non-melanoma skin cancer / Adult Rheumatoid Arthritis / leukemia / Congestive heart failure / latent tuberculosis infection / HBV infection / Opportunistic infections / recurrent infection / disease / active ankylosing spondylitis / active HBV infection / MALIGNANCIES Lymphoma / peripheral nervous system demyelinating disorders / sometimes fatal fungal infections / Severe Alcoholic Hepatitis / Carcinogenesis / optic neuritis / tuberculosis infections / acute and chronic leukemia / neutropenia / candidiasis / Active tuberculosis / active arthritis / histoplasmosis / active TB / legionellosis / localized disease / cardiovascular disease / clinically important localized infections / lymphomas / delayed-type hypersensitivity / latent tuberculosis / opportunistic infection / tumor necrosis factor / latent infection / heart failure / chronic moderate / Reported infections / Allergic Reactions / coccidioidomycosis / lymphoma and other malignancies / patient developed cellulitis / infection / invasive fungal infections / autoimmune hepatitis / inflammation / depression / severely active polyarticular juvenile idiopathic arthritis / serious infection / pancytopenia / tuberculosis / poorly controlled diabetes / Merkel cell carcinoma / /

MedicalTreatment

immunization / anti-fungal therapy / Immunizations / phototherapy / anti-viral therapy / Immunosuppression / antibiotic therapy / /

Organization

Administration of Enbrel / Administration for Juvenile Idiopathic Arthritis Pediatric Patients Weight Recommended Dose / Administration for Adult Patients Patient Population Adult RA / DOSAGE AND ADMINISTRATION / FDA / American College of Rheumatology / /

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Position

general U.S. population / physician / /

Product

Cyclophosphamide / Sulfasalazine / Subcutaneous Injection / Enbrel / PATIENT COUNSELING INFORMATION See Medication / Bacteriostatic Water for Injection / FDAapproved Medication / /

Technology

antibodies / Pharmacokinetics / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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