Dikirogen^® (Powder) Instructions for Use

Marketing Authorization Holder

Invar, LLC (Russia)

Manufactured By

Biofarma, S.r.l. (Italy)

Or

Nutrilinea S.r.l. (Italy)

Contact Information

Invar LLC (Russia)

Dosage Form

Dikirogen®

Powder: 4 g sachet 30 pcs.

Dosage Form, Packaging, and Product Composition

Powder for the preparation of an oral drink with orange flavor, weighing 4 g.

Composition: fructose, Myo-inositol, silicon dioxide (anti-caking agent), D-chiro-inositol, orange flavor, citric acid (acidity regulator), manganese pidolate (amino acid complex), Folic acid.

% of the recommended daily intake level according to TR TS 022/2011, Appendix 2: Folic acid – 100%.
% of the adequate intake level according to the “Unified Sanitary-Epidemiological and Hygienic Requirements for Products Subject to Sanitary-Epidemiological Surveillance (Control)”, Chapter II, Section 1, Appendix 5: Inositol (total) – 240%, Manganese – 250%, do not exceed the upper permissible intake level.

Nutritional and energy value (1 sachet): carbohydrates – 4 g; 15 kcal/65 kJ.

4 g – sachet (30) – cardboard packs.

Therapeutic Category

Dietary supplement for supporting the function of the reproductive system

Properties

Dietary supplement for improving the functional state of the female reproductive system, incl.

• For menstrual cycle disorders;
• For premenstrual syndrome;
• For hyperandrogenism, including polycystic ovary syndrome (PCOS);
• During pregravid preparation, incl. when preparing for in vitro fertilization (IVF), using assisted reproductive technologies (ART).

For improving the functional state of the male reproductive system, incl.

• For reduced fertility;
• For deterioration of sperm quality (pathozoospermia).

For improving metabolic parameters of carbohydrate and lipid metabolism

• For increased body weight;
• For insulin resistance;
• For preventing the development of gestational diabetes mellitus (GDM).

Dikirogen^® contributes to

• Restoration of the menstrual cycle, especially in case of irregular, infrequent and/or scanty menstruation;
• Reduction of painful sensations and mood changes associated with premenstrual syndrome;
• Improvement of skin and hair condition in case of sex hormone imbalance.

Used as pregravid preparation, contributing to the qualitative maturation of the egg and proper development of the embryo.

Dikirogen^® contributes to

• Normalization of sex hormone levels in men;
• Improvement of sperm quality.

Dikirogen^® contributes to the reduction of insulin resistance severity, waist circumference and body weight, incl. in PCOS.

The combination of two active forms of inositol – myo-inositol and D-chiro-inositol – is the most physiological and preferable, since both of these isomers are normally present in the body, exerting a regulatory effect on different biological processes.

Main properties of the components

Myo-inositol

• Participates in maintaining the physiological balance of sex hormones;
• Contributes to the normalization of androgen and prolactin levels in blood serum and elimination of hyperandrogenism manifestations in women (increased hair growth, acne, excess body weight), incl. in PCOS;
• Participates in the regulation of the menstrual cycle, contributing to its normalization;
• Plays a role in egg maturation as part of preparation for successful fertilization;
• Contributes to reducing the risk of developing ovarian hyperstimulation syndrome (OHSS) during ART;
• Contributes to the normalization of sex hormone levels in men;
• Contributes to an increase in the total number and number of progressively motile spermatozoa;
• Participates in the transmission of intracellular signal from insulin receptors, contributing to the elimination of insulin resistance and associated metabolic disorders, increased waist circumference and body weight;
• Contributes to improved glycemic control in patients with GDM.

D-chiro-inositol

• Contributes to the reduction of testosterone levels in hyperandrogenism in women and normalization of ovulation;
• Contributes to an increase in testosterone levels in men when it is initially reduced;
• Enhances the action of myo-inositol;
• Contributes to the improvement of metabolic parameters of carbohydrate and lipid metabolism in case of increased body weight.

Folic acid participates in the process of cell division, its role is especially important during periods of rapid cell division and growth, for example during intrauterine development.

Folic acid intake is recommended when planning pregnancy and throughout the first trimester of pregnancy for the harmonious development of the fetus.

Manganese is a trace element involved in various metabolic reactions and hormonal regulation of the menstrual cycle.

The ability of manganese to eliminate manifestations of premenstrual syndrome has been demonstrated.

A favorable effect of manganese on male fertility has been demonstrated.

Scope of Application

Of the product Dikirogen^®

• As a dietary supplement – a source of inositol, folic acid and manganese

ICD codes

Dosage Regimen

Adults: 1 sachet per day with meals, after preliminary dissolution in 1/2 glass of water. Duration of intake is 30 days. If necessary, the intake can be repeated.

Intake of Dikirogen^® can be started on any day of the menstrual cycle.

Consultation with a doctor is recommended before use. Upon doctor’s recommendation, the frequency and duration of intake may be changed.

There is limited clinical experience with the use of Dikirogen^® in adolescents over 14 years of age.

Contraindications

• Individual intolerance to the product components.

Use during pregnancy and breastfeeding

Pregnant and breastfeeding women should take after consultation and under medical supervision.

Special instructions

Dietary supplement. Not a medicinal product.

Consultation with a doctor is recommended before use.

Drug Interactions

Simultaneous intake of manganese with other divalent metals, such as iron, copper, zinc, is not recommended. If simultaneous intake of Dikirogen^® and products containing iron, copper, zinc is necessary, it is recommended to take them during different meals.

Dispensing Status

Places of sale are determined by the national legislation of the member states of the Eurasian Economic Union.

Storage Conditions

The product should be stored in the original packaging in a place inaccessible to children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

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.