Dextrose 25% Ansyr™ Syringe Warnings and Precautions

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WARNINGS

25% Dextrose Injection, USP is hypertonic and may cause phlebitis and thrombosis at the site of injection.

Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as loss of consciousness.

PRECAUTIONS

Frequent monitoring of serum glucose concentrations is required when intravenous dextrose is given to pediatric patients, particularly neonates and low birth weight infants. Do not administer unless the solution is clear and seal is intact. Discard unused portion.

Solutions containing dextrose should be used with caution in infants of diabetic mothers except as may be indicated in neonates who are hypoglycemic.

Care should be exercised to insure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted.

Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with 25% dextrose solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.

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Warnings and Precautions

WARNINGS

25% Dextrose Injection, USP is hypertonic and may cause phlebitis and thrombosis at the site of injection.

Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as loss of consciousness.

PRECAUTIONS

Frequent monitoring of serum glucose concentrations is required when intravenous dextrose is given to pediatric patients, particularly neonates and low birth weight infants. Do not administer unless the solution is clear and seal is intact. Discard unused portion.

Solutions containing dextrose should be used with caution in infants of diabetic mothers except as may be indicated in neonates who are hypoglycemic.

Care should be exercised to insure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted.

Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with 25% dextrose solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.

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