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M.V.I. ADULT Use in Specific Populations (multi-vitamin infusion - ADULT)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Administration of the approved recommended dose of M.V.I. Adult in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant women should follow the U.S. Recommended Daily Allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant women. Deficiency of essential vitamins may result in adverse pregnancy outcomes (see Clinical Considerations). Animal reproduction studies have not been conducted with M.V.I. Adult administered by intravenous infusion.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Deficiency of essential vitamins has been associated with adverse pregnancy and fetal outcomes, such as maternal folic acid deficiency and an increased risk of neural tube defects. Therefore, parental nutrition with multiple vitamins injection should be considered if a pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake.

8.2 Lactation

Risk Summary

Multiple vitamins present in M.V.I. Adult are also present in human milk. Administration of the approved recommended dose of M.V.I. Adult in parenteral nutrition is not expected to cause harm to a breastfed infant. There is no information on the effects of M.V.I. Adult on milk production. Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonlactating women. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for M.V.I. Adult and any potential adverse effects on the breastfed child from M.V.I. Adult or from the underlying maternal condition.

8.4 Pediatric Use

M.V.I. Adult is indicated for the prevention of vitamin deficiency in pediatric patients aged 11 years and older receiving parenteral nutrition. M.V.I. Adult is not indicated for use in pediatric patients below the age of 11 years.

8.5 Geriatric Use

Reported clinical experience has not identified differences in responses between the elderly and younger patients.

8.6 Renal Impairment

M.V.I. Adult has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin A levels in patients with renal impairment [see Warnings and Precautions (5.25.5)].

8.7 Hepatic Impairment

M.V.I. Adult has not been studied in patients with hepatic impairment. Monitor vitamin A level in patients with liver disease or high alcohol consumption [see Warnings and Precautions (5.5)].

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