HETASTARCH Use in Specific Populations

(6% hetastarch in 0.9% sodium chloride injection)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident.

There are no adequate and well-controlled studies in pregnant women. 6% Hetastarch in 0.9% Sodium Chloride Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

It is not known whether hetastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 6% Hetastarch in 0.9% Sodium Chloride Injection is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of hetastarch in pediatric patients have not been established. Adequate, well-controlled clinical trials to establish the safety and effectiveness of 6% Hetastarch in 0.9% Sodium Chloride Injection in pediatric patients have not been conducted.

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Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident.

There are no adequate and well-controlled studies in pregnant women. 6% Hetastarch in 0.9% Sodium Chloride Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

It is not known whether hetastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 6% Hetastarch in 0.9% Sodium Chloride Injection is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of hetastarch in pediatric patients have not been established. Adequate, well-controlled clinical trials to establish the safety and effectiveness of 6% Hetastarch in 0.9% Sodium Chloride Injection in pediatric patients have not been conducted.

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