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NDA[removed]S-017 Page 3 Extraneal (icodextrin) Peritoneal Dialysis Solution Dangerous Drug-Device Interaction
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Document Date: 2009-05-18 14:53:12


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Company

Ames / /

Currency

pence / /

Event

FDA Phase / /

Facility

Laboratory Test Interactions / Laboratory Tests Serum Electrolytes Decreases / Laboratory Test Interactions Blood Glucose Blood / /

IndustryTerm

container systems / clear solution / peritoneal dialysis solutions / food / Blood glucose monitoring devices / chemical components / peritoneal solution / peritoneal dialysis solution / isosmotic peritoneal dialysis solution / treatment of hypoglycemia / /

MedicalCondition

loss of consciousness / hypocalcemia / coma / unrecognized hypoglycemia / polycystic kidneys / peritonitis / glycogen storage disease / diarrhea / end-stage renal disease / hypoglycemia / infections / back pain / hypotension / potassium deficiency / hyperkalemia / congestive heart failure / hypertension / tumors / shortness of breath / shock / Carcinogenesis / ESRD / exit site infection / diabetes / exfoliative dermatitis / allergy / vomiting / pain / lactic acidosis / pancreatitis / hypercalcemia / infection / inborn errors of metabolism / renal failure / hypokalemia / Rash / acute renal failure / /

MedicalTreatment

Peritoneal Dialysis / continuous ambulatory peritoneal dialysis / antibiotics / surgery / CAPD / dialysis / /

/

Position

transporter patients / physician / General / representative / /

Product

potassium chloride / cefazolin / Sodium Chloride / Extraneal / Sigma DP2 Digital Camera / dextrose / gentamicin / ampicillin / Sodium Lactate / ceftazidime / digoxin / Calcium Chloride / S-017 / /

Technology

alpha / polymerization / microwave / Geriatrics / Pharmacokinetics / Dialysis / /

URL

www.glucosesafety.com / /

SocialTag