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Vitrum® Plus (Tablets) Instructions for Use

Marketing Authorization Holder

Takeda Pharmaceuticals, LLC (Russia)

Manufactured By

Eagle Nutritionals Inc. (USA)

For

TAKEDA PHARMACEUTICALS INTERNATIONAL, AG (Switzerland)

Labeled By

UNIPHARM, Inc. (USA)

Dosage Form

Bottle OTC Icon Vitrum® Plus Film-coated tablets: 30, 60, 100, 120, or 130 pcs.

Dosage Form, Packaging, and Product Composition

Film-coated tablets, with a mass of 1455 mg.

1 tab. % of RSPL1 or AIL2
Retinyl acetate 1.72 (1.55-2.58) mg 215 (194-323)%1*
Colecalciferol 0.01 (0.009-0.015) mg 200 (180-300)%1*
D-alpha-tocopheryl acetate 13.5 (12.2-20.3) mg TE 135 (122-203)%1*
Ascorbic acid 60 (54-90) mg 100 (90-150)%1*
Thiamine mononitrate 1.5 (1.35-2.25) mg 107 (96-161)%1*
Riboflavin 1.7 (1.53-2.55) mg 106 (96-159)%1*
Pyridoxine hydrochloride 2 (1.8-3) mg 100 (90-150)%1*
Cyanocobalamin 6 (5.4-9) mcg 600 (540-900)%1*
Niacinamide 20 (18-30) mg 111 (100-167)%1*
Phytomenadione 25 (23-40) mcg 21 (19-33)%2
Pantothenic acid (as calcium D-pantothenate) 10 (9-15) mg 167 (150-250)%1*
Folic acid 0.4 (0.36-0.6) mg 200 (180-300)%1*
D-biotin 30 (27-45) mcg 60 (54-90)%1
Calcium 162 (145.8-202.5) mg 16 (15-20)%1
Magnesium 100 (90-125) mg 25 (23-31)%1
Zinc 15 (13.5-18.7) mg 100 (90-125)%1*
Iodine 150 (135-240) mcg 100 (90-160)%1*
Phosphorus 125 (112.5-156.2) mg 16 (14-20)%1
Iron 16 (14.4-20) mg 114 (103-143)%1*
Copper 2 (1.8-2.5) mg 200 (180-250)%2*
Manganese 2.5 (2.25-3.12) mg 125 (113-156)%2*
Selenium 25 (23-40) mcg 36 (33-57)%1
Chromium 25 (23-40) mcg 50 (46-80)%2
Molybdenum 25 (23-40) mcg 36 (33-57)%2
Vanadium 10 (9-16) mcg 67 (60-107)%2*

1 % of the Recommended Daily Intake Level (RSPL) according to TR TS 022/2011, Appendix 2;
2 % of the Adequate Intake Level (AIL) according to the “Unified Sanitary-Epidemiological and Hygienic Requirements for Goods Subject to Sanitary-Epidemiological Surveillance (Control)” (Chapter II, Section 1, Appendix 5);
* does not exceed the upper permissible intake level.

Composition dibasic calcium phosphate anhydrous, magnesium oxide, carrier microcrystalline cellulose, stabilizer stearic acid, potassium chloride, vitamin C (Ascorbic acid), iron fumarate, vitamin E (D-alpha-tocopheryl acetate), carrier magnesium stearate, tablet coating Opadry II white (stabilizer hypromellose, colorant titanium dioxide, carrier polydextrose, anti-caking agent talc, maltodextrin, medium-chain triglycerides), stabilizer croscarmellose sodium, stabilizer silicon dioxide, vitamin PP (Niacinamide), zinc oxide, vitamin B5 (calcium D-pantothenate), vitamin A (Retinyl acetate), manganese sulfate, Folic acid, vitamin D3 (Colecalciferol), D-biotin, vitamin B6 (Pyridoxine hydrochloride), vitamin K1 (Phytomenadione), copper oxide, chromium chloride, vitamin B1 (Thiamine mononitrate), vitamin B2 (Riboflavin), potassium iodide, sodium selenate, sodium molybdate, sodium metavanadate, vitamin B12 (Cyanocobalamin).

30 pcs. – polyethylene bottles (1) – cardboard boxes.
60 pcs. – polyethylene bottles (1) – cardboard boxes.
100 pcs. – polyethylene bottles (1) – cardboard boxes.
120 pcs. – polyethylene bottles (1) – cardboard boxes.
130 pcs. – polyethylene bottles (1) – cardboard boxes.

Therapeutic Category

Dietary supplement – an additional source of vitamins and trace elements

Properties

This dietary supplement contains a complex of vitamins and minerals. It helps reduce the risk of developing hypovitaminosis and mineral deficiencies, including during the recovery period after various illnesses, injuries, surgeries, during seasonal disease outbreaks (cold, flu), and during periods of forced dietary restrictions (diet).

It also helps maintain the functional state of the nervous system during periods of high psychoemotional stress.

Scope of Application

Of the Vitrum® Plus product

As a dietary supplement

  • To reduce the risk of developing hypovitaminosis and mineral deficiencies;
  • During the recovery period after various illnesses, injuries, surgeries and during seasonal disease outbreaks (flu, colds);
  • During periods of forced dietary restrictions (diet);
  • To maintain the functional state of the nervous system during periods of high psychoemotional stress.

ICD codes

ICD-10 code Indication
E56.9 Vitamin deficiency, unspecified
E61.9 Nutritional deficiency, unspecified
E63.1 Disparate intake of food elements
Z54 Convalescence
Z73.0 Burn-out
Z73.3 Stress, not elsewhere classified (physical and mental strain)
ICD-11 code Indication
5B5K.Z Mineral deficiency, unspecified
5B7Z Malnutrition, unspecified
QB7Z Convalescence, unspecified
QD85 Burn-out
QE01 Stress, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Adults: 1 tablet/day, with meals.

The duration of use is 2-3 weeks. If necessary, the course can be repeated after one month.

Contraindications

  • Individual intolerance to the product components;
  • Pregnancy;
  • Breastfeeding.

Use during pregnancy and lactation

Contraindicated for use during pregnancy and breastfeeding.

Special instructions

This is a dietary supplement and is not a medicinal product.

It is recommended to consult a doctor before use.

Persons with thyroid diseases are advised to consult an endocrinologist.

Storage Conditions

The product should be stored out of the reach of children at a temperature between 15°C (59°F) and 25°C (77°F) and relative air humidity not exceeding 60%.

Shelf Life

Shelf life – 2 years.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

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