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Instruction for use: Divigel

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Active substance: Estradiol

Code: G03CA03 Estradiol

Pharmacological groups

Estrogens, gestagens; their homologues and antagonists

Nosological classification (ICD-10)

M81.0 Postmenopausal osteoporosis

Menopause osteoporosis, Osteoporosis in menopause, Osteoporosis in menopause, Osteoporosis in postmenopausal women, Osteoporosis in the postmenopausal period, Postmenopausal osteoporosis, Osteoporosis in postmenopausal women, Perimenopausal osteoporosis, Postmenopausal osteoporosis, Post-menopausal osteoporosis, Postmenopausal osteoporosis, Postmenopausal demineralization of bones, Osteoporosis with estrogen deficiency, Osteoporosis in postmenopausal women, Osteoporosis in postmenopausal women and after hysterectomy

N95.1 menopausal and menopausal status of women

Atrophy of the mucosa of the lower genital tract, caused by estrogen deficiency; Vaginal dryness; Autonomic dysfunction in women; gipoestrogeniya state; Deficiency of estrogen in menopausal women; Degenerative changes of the mucous membrane in the menopause; Natural menopause; an intact uterus; climacteric; Menopause women; Menopause in women; menopausal depression; Climacteric ovarian dysfunction; Menopause; Climacteric neurosis; Menopause; Menopausal symptoms complicated psychovegetative; Climacteric syndrome; Climacteric vegetative disorders; Climacteric psychosomatic disorder; menopausal disorders; Menopausal disorders in women; menopausal condition; Climacteric vascular disorders; Menopause; Menopausal vasomotor symptoms; menopausal period; Lack of estrogen; Feeling the heat; Pathological menopause; perimenopause; menopause; postmenopausal; Premature menopause; premenopauznom period; tides; hot flashes; flushing in the Meno and postmenopausal; Hot flashes / hot flashes in menopause; Heart attack during menopause; Early menopause in women; Disorders of menopause; climacteric syndrome; Vascular complications of menopause; Physiological menopause; Estrogendefitsitnye state; premature Menopause

Composition and form of release

Gel transdermal 1 g

active ingredient

Estradiol 1 mg

(in the form of estradiol hemihydrate)

auxiliary substances: carbomers (carbopol 974 P); trolamine; propylene glycol; ethyl alcohol (96%); purified water - up to 1.0 g

in multilayer packets of 0.5 or 1 g; in a 28 or 91 package.

pharmachologic effect

Pharmacological action - replenishing the deficiency of estrogens.

Dosing and Administration

Transdermally. The divigel can be used for long-term and cyclical therapy. The usual starting dose is 1.0 mg of estradiol (1.0 g of gel, respectively) per day, but the choice of the initial dose may be based on the severity of the symptoms. Depending on the clinical picture, the dose can be changed after 2-3 cycles individually from 0.5 to 1.5 g per day, which corresponds to 0.5 to 1.5 mg of estradiol per day.

Patients with an intact (unoperated) uterus during treatment with Divigel are recommended to prescribe a progestogen (eg medroxyprogesterone acetate, norethisterone, norethisterone acetate or dihydrogesterone) for 10-12 days per cycle. After the course of gestagen use, menstrual bleeding should occur. With extraordinary or prolonged uterine bleeding it is necessary to establish the cause of their occurrence.

In patients in the postmenopausal period, the duration of the cycle can be increased to 3 months.

The gel is usually applied once a day to the clean skin of the lower part of the anterior wall of the abdomen, lumbar region, shoulders, forearms, or alternately on the right or left buttocks, alternating between application sites. The area of application should be equal to 1-2 palms. After applying the drug, you should wait a few minutes until the gel dries (2-3 min). Place the application of the gel can not be rinsed for 1 hour. Avoid accidental contact with the eye. Wash hands immediately after applying the gel.

If the patient has forgotten to apply the gel, you should do this as soon as possible, however no later than within 12 hours from the time of application of the drug on a schedule. If more than 12 hours have passed, then the application of the Divigel should be postponed until the next time. With irregular use of the drug (missed doses), menstrual-like uterine breakthrough bleeding may occur.

Conditions of leave from pharmacies

On prescription.

storage Conditions

At a temperature of no higher than 25 C.

Keep out of the reach of children.

Shelf life of Divigel

3 years.

Do not use after the expiry date printed on the package.

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