| Document Date: 2013-09-17 09:06:14
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City Reference / / Company Draw / ITT / SUSPECTED ADVERSE REACTIONS / Ther-Rx Corporation / / Currency pence / / Event Product Issues / / IndustryTerm castor oil / non-pyrogenic solution / injection site / yellow solution / healthcare / control / sterile solution / active pharmaceutical ingredient / chemical name / products containing castor oil / Depression Monitor / drug products / / MedicalCondition hormone-sensitive cancer / preterm labor1 Preeclampsia / injection site cellulitis / spontaneous preterm labor / active preterm labor / Headache / Uncontrolled hypertension / Urinary tract infection / nausea / gestational diabetes / thromboembolic disorders / Respiratory disorders / Liver tumors / fatigue / preterm labor / gestational hypertension Gestational diabetes Oligohydramnios / singleton spontaneous preterm birth / miscarriage / prior spontaneous singleton preterm birth / hypersensitivity / diarrhea / thromboembolic disease / pruritus / renal dysfunction / Allergic Reactions Allergic reactions / Infections / spontaneous preterm birth / asthma / gestational hypertension / Pulmonary embolus / Hypertension / suspected breast cancer / Nervous system disorders / Dyspnea / Carcinogenesis / preterm birth / active liver disease / migraine / seizure disorder / thromboembolism / erythema / fever / clinical depression / Vomiting / pain / preterm births / urticaria / angioedema / recurrent preterm birth / Allergic reactions / Digestive disorders / epilepsy / irritation / oligohydramnios / dizziness / preeclampsia / thrombosis / Depression / rash / breast disorders / / Organization Makena administration / FDA / / / Product benzyl benzoate / hydroxyprogesterone caproate / fertility / / Technology ultrasound / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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Makena (hydroxyprogesterone caproate) injection label