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Normocarb HF

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Normocarb HF

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Serious Electrolyte, Acid-base, Glucose and Fluid Imbalances

Fluid imbalance and electrolyte, acid-base, and glucose disturbances can occur during therapy. The patient's hemodynamic status, and fluid, electrolyte, glucose and acid-base balance should be monitored throughout the procedure.

Use In Specific Populations

Preganancy

Pregnancy Category C

NORMOCARB HF™ is a replacement solution of electrolytes and bicarbonate and is pharmacologically inactive. Animal reproduction studies have not been conducted with NORMOCARB HF™. While there are no adequate and well-controlled studies in pregnant women, appropriate administration of NORMOCARB HF™ with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm, or affect reproductive capacity. Maintenance of normal acid-base balance is important for fetal well being.

Nursing Mothers

NORMOCARB HF™ is a replacement solution of electrolytes and bicarbonate and is pharmacologically inactive. The components of NORMOCARB HF™ are excreted in human milk. Appropriate administration of NORMOCARB HF™ with monitoring of fluid, electrolyte, acid-base and glucose balance is not expected to harm a nursing infant.

Pediatric Use

No adequate and well-controlled studies have been conducted with NORMOCARB HF™ in adult or pediatric patients. Safety and effectiveness in pediatric patients newborn to 17 years of age were based on eight non-controlled published pediatric studies and one published pediatric scientific literature review. The exact composition of the buffer and electrolytes in the solution during CRRT were not described in adult or pediatric studies; however, plasma electrolyte levels were similar between adults and children.

Geriatric Use

No adequate and well-controlled studies have been conducted with NORMOCARB HF™ in elderly patients.

Last reviewed on RxList: 7/6/2012
This monograph has been modified to include the generic and brand name in many instances.

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