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Biology / Erythropoietin / Darbepoetin alfa / Epoetin alfa / Anemia / Methoxy polyethylene glycol-epoetin beta / Chronic kidney disease / DAHANCA / Continuous erythropoietin receptor activator / Erythropoiesis-stimulating agents / Medicine / Growth factors


HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Mircera safely and effectively. See full prescribing information for Mircera. Mircera (methoxy polyethylene glyco
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Document Date: 2014-10-08 13:53:43


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Company

HR 3 / /

Event

FDA Phase / /

Facility

Always store Mircera / Laboratory Monitoring ADVERSE REACTIONS / /

IndustryTerm

injection site / parenteral solution / treatment of anemia associated with chronic kidney disease / epoetin alfa / treatment of anemia due to cancer / breast cancer treatment / healthcare practitioner / mL solution / placebo / drug products / hepatitis C treatment / /

MedicalCondition

anaphylactic reaction / cervical cancers / Appropriately control hypertension / neo-adjuvant breast cancer / Seizures / Uncontrolled hypertension / chronic inflammatory conditions / serious allergic reactions / Early breast cancer / prior stroke / ischemic heart disease / complete boxed warning Chronic Kidney Disease / skin rash / anaphylaxis / hepatitis C / Hypertensive encephalopathy / severe anemia / locoregional disease / available Locoregional disease control / fatigue / metastatic breast cancer / nonfatal myocardial infarction / chronic kidney disease / non-small cell lung cancer / renal disease / tachycardia / diarrhea / active malignant disease / anaphylactic reactions / head and neck cancer / INDICATIONS AND USAGE Anemia Due to Chronic Kidney Disease / advanced non-small cell lung cancer receiving / vitamin deficiency / dL (M) cancer / pruritus / All-cause mortality All-cause mortality Stroke / breast cancer / II diabetes / coexistent cardiovascular disease / severe allergic reactions / tumor / premonitory neurologic symptoms / iron deficiency / congestive heart failure / e.g. anaphylactic reactions / Hypertension / bronchospasm / Cancer / Seizures Seizures / Control hypertension / g/dL cancer / disease / nasopharyngitis / Carcinogenesis / Cervical cancer / deep venous thrombosis / vascular access thrombosis / STROKE / Thromboembolism / primary squamous cell carcinoma / seizure / Renal Insufficiency / MYOCARDIAL INFARCTION / nonsmall cell lung cancer / diabetes mellitus / deep vein thrombosis / heart failure / urticaria / angioedema / allergic reactions / VENOUS THROMBOEMBOLISM / Study/Tumor / infection / AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease / inflammation / thrombosis / anemia / myocardial ischemia / Pure red cell aplasia / /

MedicalTreatment

radiation therapy / orthopedic procedures / chemotherapy / radiotherapy / surgery / coronary artery bypass surgery / bypass / hemodialysis / dialysis / spinal surgery / /

Organization

For administration / Mircera administration / DOSAGE AND ADMINISTRATION / FDA / NHS / Administration of Mircera Mircera / /

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Position

Investigator / needle guard / advanced head / /

Product

Mircera / Aranesp / polyethylene glycol / SC injection / DOSAGE FORMS AND STRENGTHS Injection / /

ProvinceOrState

South Carolina / /

Technology

radiation / antibodies / ESA / Pharmacokinetics / chemotherapy / Pharmacodynamics / CAD / dialysis / /

URL

www.fda.gov/medwatch / /

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