Description
MVW Modulator Formulation Softgel Minis are specifically formulated to supplement the dietary needs of individuals with A, D, E and K who are prescribed modulator therapy and are receiving a CF-specific multivitamin, and have elevated serum vitamin levels of A, E or D.
MVW Modulator Formulation Softgel Minis: This “New CF Multivitamin”TM includes lower levels of preformed vitamin A (retinyl palmitate), while offering higher levels of pro-vitamin A (beta carotene). This provides a more individualized and regulated approach to achieving target serum retinol levels, while addressing the reduced conversion efficiency of beta carotene that is seen due to genetic variation in the BCMO1 gene.
MVW Modulator Formulation Softgel Minis contain the fat-soluble vitamins
A, D, E and K, plus a higher amount of vitamin C, and zinc to support this “New CF”TM. The product is rich in antioxidants due to the beta carotene, ascorbic acid,
alpha-tocopherol, and zinc content; and are gluten and soy free.
MVW Modulator Formulation Softgel Minis were developed to meet or exceed the daily fat-soluble supplemental recommendations as outlined in the 2002 Cystic Fibrosis Foundation Consensus Statement, the recommendations by the 2010 CF Foundation’s September multi-specialty ad hoc committee recommendations for age-specific step increases in vitamins D3, and vitamin K as described in the 2011 Endocrine Society Clinical Practice Guidelines, and recent studies. This “New CF Multivitamin”TM offers both clinically studied and patient proven absorption technologies; combined with new and novel approaches to better support absorption through the addition of a solubilizer, supporting the needs of “New CF”TM.
USAGE AND DIRECTIONS
Dosage Administration
Age 4 to 10 years: 2 softgels daily
Age 10 years and older: 2 softgels twice daily, or as directed by physician.
Best taken with meals containing fat and supplemental pancreatic enzymes.
Usage Information
MVW Modulator Formulation Softgel Minis may be used in individuals who are prescribed a modulator therapy and elevated serum vitamin levels of A, D or E are seen when a modulator and traditional CF-specific multivitamin is taken concomitantly. For use solely under the direction, control, and supervision of a medical professional. For use solely under medical supervision.
Safety
MVW Modulator Formulation Multivitamin Supplements are safety sealed and provide both outer (surrounding the bottle cap) and inner safety (affixed to the top of the rim of the bottle) seals. If either safety seal is not intact, do not use the product and call MVW Nutritionals immediately at (855) 236-8584 / (855) CF MULTI.
Use caution in any individual who has difficulty swallowing a softgel, or other solid dosage form, as this product may pose a choking hazard.
Keep out of reach of children.
To report a serious adverse event, please contact MVW Nutritionals immediately at 1-855-236-8584/(855) CF MULTI.
Contraindications
Do not take this product if you have known or suspected allergies or sensitivities to any of the ingredients. Please review the Supplement Facts and Other Ingredients prior to taking the first dose.
High 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 and consider both dietary and supplemental vitamin A intake during this discussion.
Pregnant or breast feeding women should avoid oral dosing of peppermint, and avoid this product as not enough is known about its potential effects on fetuses or nursing infants.
Vitamin K is known to interfere with anticoagulant medications. Persons taking anticoagulants should consult with their physician prior to taking the first dose of MVW Modulator Formulation Multivitamin Supplements.
How Supplied
Bottles of 120 softgel capsules
Storage
Store at room temperature in a dry place away from direct sunlight.
† This statement has not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Supplement Facts
Are the MVW vitamins available through any special programs?
Yes, they are available through the AbbVie CF Care Forward program
(https://www.creon.com/CFPatients/CFCareForward)
and the Live2Thrive program
(https://www.live2thrive.org).
Ask about other program availability.
Are they available through my CF Specialty Pharmacy?
Our complete line of products are stocked by most of the CF Specialty Pharmacies across the country.
How are local pharmacists getting MVW Complete Formulation products through their wholesalers?
The Order Entry Numbers for MVW Nutritional Multivitamins – chewables, standard softgels, chewables and softgels with higher D, and drops are reflected in the chart below:
- Advise the pharmacist that the three major wholesalers – McKesson, ABC and Cardinal – have assigned order entry numbers for products that may be ordered through their respective wholesale distribution centers.
- The pharmacist should enter the number in their order entry system. If their local distribution center has already stocked the desired product, the order will process and product will arrive at to the pharmacist with the next shipment from the wholesaler – normally one to two days.
- If the local distribution center has never stocked the product, the order entry system will display one of two error messages: product discontinued, manufacturer backorder. Should the pharmacist get either of these two messages, they must CALL their local distribution center, provide the item number, and request that they stock the product. Distributors call this “activating an item” or “bringing the item in”. NOTE: Only an item with an assigned order entry can be activated at the local distribution center level in this manner.
- For products without an item number, the local distribution center must call their corporate office, and request that corporate assign an item number.
- If the pharmacist is (i) less than co-operative, or (ii) has questions, please call our toll-free number – (855) CF-MULTI – and we be happy to assist in this process.
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