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Heparins / Coagulation system / Low molecular weight heparin / Thrombocytopenia / Anticoagulant / Deep vein thrombosis / Protamine sulfate / Platelet / Factor X / Blood / Hematology / Medicine


NDA[removed]S-158 Page 3 Heparin Sodium Injection, USP Rx only DESCRIPTION
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Document Date: 2009-03-31 14:52:43


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City

Deerfield / /

Company

USP / Baxter International Inc. / DESCRIPTION Heparin / Stephens / Alteon Inc. / Baxter Healthcare Corporation / /

Event

FDA Phase / /

Facility

Storage Store / Laboratory Samples Addition / /

IndustryTerm

injection site / intravenous solutions / sterile solution / heterogeneous / heparin product / infusion solution / drug products / /

MedicalCondition

Heparin Induced Thrombocytopenia / peripheral arterial embolism / disseminated intravascular coagulation / headache / vascular purpuras / PRECAUTIONS General Thrombocytopenia / HITT Heparin-induced thrombocytopenia / cerebral vein thrombosis / Kelton J. Delayed-Onset Heparin-Induced Thrombocytopenia / nausea / thrombocytopenia / resultant acute adrenal insufficiency / rhinitis / Heparininduced Thrombocytopenia / often resembling anaphylaxis / bradycardia / pulmonary embolism / Hypersensitivity / hyperlipemia / thromboembolic disease / liver disease / infections / Generalized hypersensitivity / Miscellaneous Osteoporosis / hemophilia / hypotension / asthma / Thrombocytopenia Thrombocytopenia / Local Irritation Local irritation / cutaneous necrosis / renal arterial thrombosis / priapism / thrombophlebitis / Postoperative Thromboembolism A / cancer / Nosebleeds / disease / mesenteric thrombosis / chills / shock / Carcinogenesis / venous thrombosis / stroke / postoperative deep vein thrombosis / thromboembolism / transient alopecia / skin necrosis / Itching / fever / severe hypertension / venous and arterial thromboses / vomiting / myocardial infarction / Severe thrombocytopenia / postoperative deep venous thrombosis / deep vein thrombosis / urticaria / pulmonary emboli / anaphylactoid shock / acute and chronic consumptive coagulopathies / Atrial fibrillation / clinical pulmonary embolism / thrombosis / documented hypersensitivity / erythema / mild pain / bacterial endocarditis / recurrent thrombosis / such thrombocytopenia / syndrome / disorders / Once active thrombosis / /

MedicalTreatment

cardiac surgery / open-heart surgery / Blood Transfusion / neurosurgery / intravenous infusion / surgery / blood transfusions / embolization / hip surgery / major surgery / resuscitation / eye surgery / amputation / Extracorporeal Dialysis / dialysis / /

Organization

DOSAGE AND ADMINISTRATION / /

Person

Deep Subcutaneous (Intrafat) / Francis J. Delayed-Onset Heparin / /

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Position

General / PRECAUTIONS General / representative / /

Product

dicumarol / protamine sulfate / phenylbutazone / Sodium Chloride / nitroglycerin / indomethacin / Oral Anticoagulant When / Heparin Lock Flush / Dosette / ibuprofen / warfarin sodium / HEP-LOCK U/P / dipyridamole / Intermittent Intravenous Injection / HEP-LOCK / Heparin Sodium / nicotine / S-158 / /

ProvinceOrState

Illinois / /

PublishedMedium

Annals of Emergency Medicine / Annals of Internal Medicine / /

Technology

alpha / / the heparin product / neurosurgery / dialysis / /

SocialTag