ZYVIT- ascorbic acid, cholecalciferol, thiamin hcl, pyridoxal 5 phosphate, folic acid, methylcobalamin, adenine dinucleotide, ub

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
24-10-2017

Aktivni sastojci:

ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J), PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W), NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916), COENZ

Dostupno od:

TMIG Inc.

INN (International ime):

ASCORBIC ACID

Sastav:

ASCORBIC ACID 125 mg

Administracija rute:

ORAL

Terapijske indikacije:

Zyvit Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

Proizvod sažetak:

Zyvit tablets are supplied as tan, oblong shaped tablets with no imprintin a child-resistant bottle of 30ct. (69176-600-30*) Dispensed by Prescription† *TMIG Inc. does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies. † This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx).  This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable.  The ingredients, indication or claims of this product are not to be construed to be drug claims.

Status autorizacije:

Dietary Supplement

Svojstava lijeka

                                ZYVIT- ASCORBIC ACID, CHOLECALCIFEROL, THIAMIN HCL, PYRIDOXAL 5
PHOSPHATE, FOLIC ACID,
METHYLCOBALAMIN, ADENINE DINUCLEOTIDE, UBIQUINONE TABLET
TMIG INC.
----------
HEALTH CLAIM:
Zyvit Tablets Dietary Supplement
Dispensed by Prescription
SUPPLEMENT FACTS
SERVING SIZE: 1 TABLET
Servings per Bottle: 30
AMOUNT PER SERVING:
% DAILY VALUE
Vitamin C (as ascorbic acid)
125 mg
208%
Vitamin D3 (as cholecalciferol)
500 IU
125%
Thiamin (Vitamin B1 as thiamin HCl)
25 mg
1,667%
Vitamin B6 (as pyridoxal 5’ phosphate)
12.5 mg
625%
Folic Acid
1 mg
250%
Vitamin B12 (as methylcobalamin)
1 mg
16,667%
NADH (reduced nicotinamide-adenine dinucleotide)
5 mg
*
CoEnzyme Q-10 (ubiquinone)
50 mg
*
_*Daily Values (DV) not established._
OTHER INGREDIENTS: cellulose, magnesium stearate, and silicon dioxide.
DESCRIPTION:
Zyvit Tablets is an orally administered prescription vitamin
formulation for the clinical dietary
management of suboptimal nutritional status in patients where advanced
folate supplementation is
required and nutritional supplementation in physiologically stressful
conditions for maintenance of good
health is needed.
WARNING AND PRECAUTIONS
This product is contraindicated in patients with a known
hypersensitivity to any of the ingredients.
Zyvit tablets should only be used under the direction and supervision
of a licensed medical practitioner.
Use with caution in patients that may have a medical condition, are
pregnant, lactating, trying to
conceive, under the age of 18, or taking medications.
PREGNANCY AND LACTATION
Zyvit is not intended for use in pregnant or lactating patients.
DOSAGE & ADMINISTRATION
Usual adult dose is 1 tablet once or twice daily or as prescribed by a
licensed medical practitioner.
†
HOW SUPPLIED HEALTH CLAIM:
Zyvit tablets are supplied as tan, oblong shaped tablets with no
imprintin a child-resistant bottle of 30ct.
(69176-600-30*)
Dispensed by Prescription
*TMIG Inc. does not represent these product codes to be National Drug
Codes (NDC). Product codes
are formatted according to standard industry pra
                                
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