to Better Support Patients with Cystic Fibrosis, Families and Healthcare Providers
Patient Proven and Clinically Tested Technologies to facilitate the absorption of the fat-soluble vitamins – A, D, E, K Dual technologies, two absorption enhancers, to support target multivitamin levels in individuals who have difficulty absorbing fats and fat-soluble vitamins, as seen in Cystic Fibrosis. Solubilizing or emulsifying agents support the bioavailability of “oil in water” systems, as seen with fat-soluble vitamins in the GI tract.
Engineered to address breaches into the Softgel seal that can result in leaking Bottles from GenADEK Lot #1732915 (Pilot) and Lot #2047690 (Production) were randomly tested for seal integrity, and intrusion of the moisture seeking hydrophilic structure into the seam of the Softgel seal Latent Leakers on production run 0.1%.
Latent leakers appear post manufacturing due to penetration of the seam in the Softgel seal.
Latent leakers may result from physical agitation, heat, cold or moisture.
USAGE AND DIRECTIONS
GenADEK Multivitamin Softgels are specifically formulated to meet the dietary needs of individuals who have difficulty absorbing fat and fat-soluble vitamins, as seen in cystic fibrosis; and contain the fat-soluble vitamins A, D, E and K, plus B vitamins, vitamin C, folic acid, zinc, Co-Q10 and selenium. GenADEK also contains the antioxidants beta-carotene, ascorbic acid, alpha-tocopherol, Co-Q10 and zinc.
GenADEK Multivitamin Softgels are formulated to contain the amount of vitamin D recommended by the CF Foundation’s September 2010 multi-specialty ad hoc committee recommendations for age-specific, step increases, in vitamin D3 intake (1) and were designed to meet or exceed, the daily supplemental vitamin recommendations outlined in the Cystic Fibrosis Foundation Nutrition Consensus Statement published in 2002, vitamin K as recommended by the 2002 European CF Society Nutrition Consensus Report, and recent studies.
GenADEK Multivitamin Softgels includes patient proven and clinically tested technologies to enhance absorption of fat-soluble vitamins, and were engineered to minimize breaches in the softgel seal that can cause softgels to leak.(2)
Age 4 to 10 years: One (1) softgel daily. Age 10 years and older: One (1) softgel twice daily, or as directed by physician. Best taken with meals and supplemental pancreatic enzymes.
GenADEK Multivitamin Softgels may be used for nutritional supplementation in individuals whose diets are deficient in the fat-soluble vitamins A, D, E, and K or who have difficulty absorbing fat-soluble vitamins as seen in cystic fibrosis.† For use solely under medical supervision.
GenADEK Multivitamin Softgels are safety sealed for your protection. If the safety seal is broken or missing, do not use and contact MVW Nutritionals immediately at 1-855-236-8584.
Keep out of reach of children. Use caution when administering to children or individuals who have difficulty swallowing softgels.
To report a serious adverse event, please contact MVW Nutritionals immediately at 1-855-236-8584.
Do not use this product if you have a known sensitivity or allergy to any of the ingredients.
Excessive amounts of vitamin A during pregnancy may be harmful to the fetus. Women of childbearing age should consult their physician regarding total vitamin A intake during pregnancy.
Vitamin K interferes with anticoagulant medications, so persons taking anticoagulant drugs should consult with their physician before beginning use of GenADEK Softgels.
Bottles of 60 medium brown softgel capsules
Store at room temperature (59°F – 86°F), in a dry place away from direct sunlight.
(1). J Clin Endocrinol Metab, April 2012, 97(4): 1082-1093: An Update on the Screening, Diagnosis, Management and Treatment of Vitamin D Deficiency in Individuals with Cystic Fibrosis: Evidence-Based Recommendations from the Cystic Fibrosis Foundation.
(2). Data on file.
†This statement has not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
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