| Document Date: 2014-08-12 12:33:32
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City Reference / / Company UCB Inc. / / Currency pence / / Event Product Recall / Product Issues / FDA Phase / Company Expansion / / Facility Laboratory Findings / / IndustryTerm machinery / Epilepsy Treatment / healthcare / administration site / drug products / / MedicalCondition dyskinesia / erythema multiforme / partial seizures / Partial Onset Seizures KEPPRA / infestations Pharyngitis / PGTC seizures / increased seizure / seizures / leukopenia / panic attack / Primary Generalized Tonic-Clonic Seizures KEPPRA / Primary Generalized Tonic-Clonic Seizures / myoclonic and primary generalized tonic-clonic seizure / thrombocytopenia / infestations Nasopharyngitis / muscle weakness / Alopecia / toxic epidermal necrolysis / Stevens-Johnson syndrome / balance disorder / adult epilepsy / partial seizure / hyponatremia / Fatigue / Juvenile Myoclonic Epilepsy KEPPRA / Diarrhea / either ataxia / hepatitis / Myoclonic Seizures / neck pain / Infections / Influenza / idiopathic generalized epilepsy / Partial Onset Seizures / ataxia / incoordination / General disorders / epilepsy experiencing partial onset seizures / adult partial onset seizure / nasopharyngitis / Withdrawal Seizures / Carcinogenesis / neutropenia / eczema / Vertigo / seizure / pre-existing ataxia / controlled adult partial onset seizure / hepatic failure / pancreatitis / epilepsy / infection / dizziness / Juvenile Myoclonic Epilepsy / depression / rash / pharyngitis / Anxiety Hostility Paresthesia Emotional Lability Respiratory System Pharyngitis Rhinitis Cough Increased Sinusitis Special Senses Diplopia KEPPRA / pancytopenia / hours ESRD / / MedicalTreatment alternative therapy / intravenous infusion / adjunctive therapy / Hemodialysis / dialysis / / Organization Oral administration / Preparation And Administration of KEPPRA Injection Dose Withdraw Volume / DOSAGE AND ADMINISTRATION / FDA / / / Position General Information 2.2 Initial Exposure / General / General Information KEPPRA injection / / Product Sodium chloride / Dextrose / Valproate sodium / Withdrawal Seizures Antiepileptic / Serious Dermatological Reactions 5.4 Coordination Difficulties / Diazepam / Keppra / Lorazepam / KEPPRA injection / Seizures / Dosing / INDICATIONS AND USAGE KEPPRA injection / S-017 / Renal Function OVERDOSAGE / KEPPRA tablets / Renal Function / Seizures Antiepileptic drugs / / RadioStation 2014 When / / Technology UDP / Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / http /
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NDA[removed]S-017 Keppra Injection FDA Approved Labeling text dated Aug 2014 Replacement Therapy (2.3): When switching from oral KEPPRA, the initial total daily intravenous dosage of KEPPRA should be equivalent to the tota