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Company Ames / / Event Product Issues / / Facility Laboratory The / / IndustryTerm Prevention of Malaria / treatment of malaria / treatment of acute malaria infections / the symptoms / machinery / food / substituted chemical structural analog / assay systems / chemical name / malaria treatment / / MedicalCondition P. vivax malaria infections / chest pain / bradycardia / irregular pulse / headache / Skin Disorders / Seizures / leukopenia / hallucinations / early vomiting / nausea / skin rash / anaphylaxis / thrombocytopenia / muscle weakness / sinus arrhythmia / tremor / syncope / leukocytosis / fatigue / febrile illness / encephalopathy / erythema multiforme / bradycardia / PRECAUTIONS General Hypersensitivity / tachycardia / hypersensitivity / diarrhea / restlessness / malaria infections / muscle cramps / oral live typhoid vaccines / sinus bradycardia / pruritus / paranoia / severe neuropsychiatric disorders / hearing impairment / alternative malaria / hypotension / ataxia / extrasystoles / abdominal pain / insomnia / panic attacks / Cardiovascular Disorders / P. vivax malaria / hypertension / cardiopulmonary arrest / schizophrenia / tumors / disease / flushing / malaria / dyspnea / chills / Carcinogenesis / vestibular disorders / vertigo / erythema / fever / retinal degeneration / seizure / anxiety disorder / vomiting / renal insufficiency / psychiatric disorders / urticaria / severe malaria / dehydrogenase deficiency / exanthema / cardiac disease / epilepsy / Stevens-Johnson syndrome Musculoskeletal Disorders / infection / retinal edema / acute malaria infections / dizziness / sleep disorders / depression / rash / active depression / acute infection / paresthesia / acute / uncomplicated P. falciparum malaria / tinnitus / serious infection / disorders / acute malaria / / MedicalTreatment immunization / retreatment / alternative therapy / contraception / hemodialysis / Vaccinations / chemoprophylaxis / dialysis / / Organization Concomitant administration / Lariam administration / DOSAGE AND ADMINISTRATION / / Position physician / General / PRECAUTIONS General / / Product mefloquine / carbamazepine / primaquine / mefloquine hydrochloride / Patients Medication / P. falciparum Five tablets / phenytoin / talc / valproic acid / Rx / LARIAM / liver / / Region South East Asia / / Technology Pharmacokinetics / dialysis / / SocialTag 
Microsoft Word - August03PIapprovalletter.doc