| Document Date: 2014-06-02 14:56:30
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Company IgG / Ames / Sandoz Inc. / / Country United States / / Event Product Issues / / IndustryTerm glatiramer acetate injection / treatment / in vitro systems / injection site / glatiramer acetate solution / placebo / nonpyrogenic solution / / MedicalCondition photophobia / corneal ulcer / neoplasms / Vaginitis / systemic neoplasms / hydrocephalus / Aphasia / myopathy / herpes zoster / duodenal ulcer / Arthritis / ulcerative stomatitis / esophagitis / rheumatoid arthritis / coma / hallucinations / convulsion / cellulitis / facial paralysis / osteomyelitis / bursitis / cirrhosis / xanthoma / stomatitis / anaphylaxis / gout / serum sickness / multiple sclerosis / stomach ulcer / bradycardia / psoriasis / hematemesis / angina / hepatitis / Injection Site Erythema / nephrosis / Asthma / Tremor Migraine Syncope Speech Disorder / pneumonia / specific syndrome / pulmonary embolus / hypoventilation / paraplegia / cardiomyopathy / Nutritional Disorders / fibrosarcomas / injection site abscess / arthralgia / hypothyroidism / chronic treatment / Carcinogenesis / Eczema / transient chest pain / body’s tumor / pustular rash / neuralgia / melena / Palpitations Tachycardia Eye Disorder Diplopia Nausea Vomiting Dysphagia / stupor / kidney failure / urogenital neoplasm / CNS neoplasm / concentration disorder / pancreatitis / SLE syndrome / pyelonephritis / atrial fibrillation / infection / contact dermatitis / rash / eosinophilia / pancytopenia / injection site melanosis / coronary occlusion / glaucoma / circumoral paresthesia / oral moniliasis / allergic reaction / cholecystitis / myoclonus / gastrointestinal carcinoma / Chest Pain / warts / Vascular Disorders / benign skin neoplasm / Leukopenia / erythema nodosum / tenosynovitis / experimental autoimmune encephalomyelitis / dermatitis / lymphoma tk / cerebrovascular accident / pericardial effusion / thrombocytopenia / herpes / carcinoma / urethritis / cardiomegaly / hyperthyroidism / Known hypersensitivity / colitis / objective neurologic signs / myocardial infarct / hay fever / muscle disorder / hypersensitivity / myelitis / injection site skin necrosis / bladder carcinoma / fungal dermatitis / deep thrombophlebitis / hypokinesia / pancreas disorder / MS / nocturia / ovarian cyst / sepsis / breast carcinoma / ovarian carcinoma / muscle atrophy / menorrhagia / suspicious papanicolaou smear / Hypotension / ataxia / arrhythmia / lipoma / epistaxis / priapism / peripheral vascular disease / congestive heart failure / Necrosis / psychotic depression / Hypertension / lymphedema / flushing / kidney calculus / dyspnea / furunculosis / hematuria / brain edema / optic neuritis / otitis externa / Benign Neoplasm / transient stupor / skin necrosis / hernia / mydriasis / pain / maculopapular rash / pleural effusion / urticaria / angioedema / postural hypotension / sarcomas / Goiter / skin carcinoma / Hyperventilation / vesiculobullous rash / varicose veins / thrombosis / impotence / meningitis / anemia / syndrome / cataract / / MedicalTreatment immunization / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position blinded neurologist / / / Product Controlled Clinical Trials Glatiramer Acetate Injection / Skin Necrosis At injection / Injection Site Inflammation Edema Injection Site Reaction Pyrexia Injection / Nervous System Disorders Glatiramer Acetate Injection / Injection Site Pain Injection Site Pruritus Injection / DSS Glatiramer Acetate Injection / mannitol / Glatiramer Acetate Injection / Anxiety Nervousness Micturition Urgency Injection / Renal Function / / ProvinceOrState Alabama / / PublishedMedium the Immediate Post / / Technology antibodies / Pharmacokinetics / / URL www.fda.gov/medwatch / /
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Glatiramer Acetate (Glatiramer Acetate) INJECTION, SOLUTION [Sandoz Inc] -