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warnings
WARNINGS There have been reports of overdosage of R-Gene ® 10 in pediatric patients leading to death. EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING R-GENE ® 10 INTO PEDIATRIC PATIENTS. OVERDOSAGE OF R-GENE ® 10 IN PEDIATRIC PATIENTS CAN RESULT IN HYPERCHLOREMIC METABOLIC ACIDOSIS, CEREBRAL EDEMA, OR POSSIBLY DEATH. Hypersensitivity reactions, including anaphylaxis have been reported. Appropriate medical support should be available during R-Gene ® 10 administration. If anaphylaxis or other serious hypersensitivity reaction occurs, R-Gene ® 10 should be discontinued and appropriate medical treatment initiated. R-Gene ® 10 should always be administered by intravenous infusion because of its hypertonicity. R-Gene ® 10 is a diagnostic aid and is not intended for therapeutic use.
ADVERSE REACTIONS Adverse reactions associated with 1670 infusions in premarketing studies were as follows: Non-specific side effects consisting of nausea, vomiting, headache, flushing, numbness and local venous irritation were reported in approximately 3% of the patients. One patient had an allergic reaction which was manifested as a confluent macular rash with reddening and swelling of the hands and face. The rash subsided rapidly after the infusion was terminated and 50 mg of diphenhydramine were administered. One patient had an apparent decrease in platelet count from 150,000 to 60,000. One patient with a history of acrocyanosis had an exacerbation of this condition following infusion of R-Gene ® 10. Post Marketing Experience: The following adverse events have been reported during post-marketing use: extravasation leading to burn-like reaction and/or skin necrosis requiring surgical intervention, hypersensitivity reactions including anaphylaxis, and hematuria that in some cases occurred 1–2 days after an R-Gene ® 10 administration. Because these adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.