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Phenols / Diols / Gonadotropin-releasing hormone agonist / Testosterone / Estradiol / Gonadotropin-releasing hormone / Leuprorelin / Gonadotropin-releasing hormone antagonist / Endocrine system / GnRH agonists / Triptorelin


HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRELSTAR safely and effectively. See full prescribing information for TRELSTAR. These highlights do not include all
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Document Date: 2013-03-15 15:20:35


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City

Reference / /

Company

Watson Pharma Inc. / Watson Laboratories Inc. / /

Event

Product Recall / FDA Phase / Product Issues / /

Facility

Laboratory Tests Response / Laboratory Test Interactions / Laboratory Test Interactions Chronic / Laboratory Values During Treatment The / /

IndustryTerm

injection site / rubber stopper / treatment of advanced prostate cancer / Monitor for cardiovascular disease / chemical name / treatment for patients with prostate cancer / drug products / /

MedicalCondition

metastatic prostate cancer / Anaphylactic shock / Chest pain / headache / Urinary retention / cerebrovascular accident / leg pain / Known hypersensitivity / Laboratory Test Interactions Chronic / transient ischemic attack / Conjunctivitis / ophthalmoplegia / peripheral Infections / Peripheral Nervous System Disorders Headache Dizziness / Hypersensitivity Reactions Anaphylactic shock / Gastrointestinal Disorders Diarrhea Vomiting / chronic and continuous administration / skin and appendages disorders pruritus urinary system disorders urinary tract infection / Hypersensitivity / prostate cancer / liver disease / Cardiovascular Diseases / Back pain / moderate renal insufficiency / Diabetes Hyperglycemia / hepatic insufficiency / hyperprolactinemia / paralysis / General Disorders / thrombophlebitis / advanced prostate cancer / Hypertension / pituitary apoplexy / disease / sudden cardiac death / Geriatric Use Prostate cancer / pituitary adenoma / hematuria / Carcinogenesis / Hyperglycemia / erectile dysfunction / deep venous thrombosis / bladder outlet obstruction / sudden headache / Diabetes / cardiovascular disease / Endocrine Breast pain Gynecomastia / pain / vomiting / renal insufficiency / myocardial infarction / Cardiovascular Disorders Hypertension / diabetes mellitus / Urinary Disorders Urinary tract infection Urinary retention / angioedema / allergic reactions / pulmonary emboli / Eye pain / Whole Hot flush Pain Leg pain Fatigue / spinal cord compression / Breast Disorders Erectile dysfunction / impotence / /

Organization

World Health Organization / TRELSTAR / DOSAGE AND ADMINISTRATION / FDA / /

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Position

physician / General / treating physician / /

Product

Application Site Disorders Injection / reconstituted suspension / Adverse Reactions Application Site Injection / DOSAGE FORMS AND STRENGTHS Injectable suspension / mannitol / sterile water for injection / sterile water / The suspension / estradiol / testosterone / TRELSTAR / patients / /

Technology

Diagnostic tests / Pharmacokinetics / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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