(arginine HCl)
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.
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