Instruction for use: Omnadren 250

Active substance:

Testosterone [mixture of esters]

ATX code

G03BA03 Testosterone

Pharmacological group

Androgens, antiandrogens

Antineoplastic hormonal agents and hormone antagonists

Nosological classification (ICD-10)

C50 Malignant neoplasm of breast

Cancer of the nipple and areola of the breast, Breast carcinoma, The hormone-dependent form of recurrent breast cancer in women in menopause, Hormone-dependent breast cancer, Disseminated breast carcinoma, Disseminated Breast Cancer, Malignant breast cancer, Malignant neoplasm of breast, Contralateral breast cancer, Locally advanced or metastatic breast cancer,Locally-distributed breast cancer, Locally-recurring breast cancer, Metastatic breast carcinoma, Metastasis of breast tumors, Metastatic breast carcinoma, Inoperable breast carcinoma, Incompatible breast cancer, Breast cancer in women with metastases, Breast cancer in men with metastases, Breast Cancer, Breast cancer in men, Mammary cancer, Breast cancer with distant metastases, Breast cancer in postmenopausal women, Breast cancer hormone-dependent, Breast cancer with local metastases, Breast cancer with metastases, Breast cancer with regional metastases,Breast cancer with metastases, Common hormone-dependent forms of breast cancer, Common Breast Cancer, Recurrent Breast Cancer, Recurrence of breast tumors, Breast cancer, Estrogen-dependent breast cancer, Estrogen-Dependent Breast Cancer, Disseminated breast cancer with overexpression of HER2, Tumors of the mammary glands

D26 Other benign neoplasms of the uterus

Fibromyoma of the uterus, Myoma, Uterine fibroids, Fibromyoma, Myoma of the uterus, Fibrrios, Meigs syndrome, Tumors of the uterus

E25 Adrenogenital disorders

Macroghenytozomy in boys, Adrenogenital syndrome, Decreased function of the sex glands, Congenital dysfunction of the adrenal cortex, Apera-Halle Syndrome, Crook-Apera-Halle Syndrome

E29 Testicular dysfunction

Hypofunction of gonads in men, Androgenic dysfunction, Dysfunction of the sex glands, Dysfunction of gonads in men, Underdevelopment of the genitals in men, Primary hypogonadism in men

F52.2 Lack of genital response

Secondary impotence, Hypoxeality, Impotence, Impotence on the basis of neurasthenia, Impotence on the background of functional nervous disorders, Impotence of different origin, Violation of potency, Erection disorder, Potency disorders, Erectile Dysfunction, Disturbances of an erection of a various genesis, Inadequate erection, Weakening the potency, The weakening of sexual activity, Erection loss, Decrease in sexual potency in men, Sexual disorders in men, Sexual disorders, Weak potency, Decreased potency, Reduced potency, erectile disfunction, Erectile dysfunction, neurogenic

N46 Male infertility

Azoospermia, Asthenospermia, Infertility, Infertility male, Marriage is infertile, Dispersion, Violations of spermatogenesis, Oligoastenozoospermia III-IV stage, Oligoastenospermia, Oligozoospermia, Oligospermia, Disorders of testicular functions, Spermatogenesis disorders, Inhibition of spermatogenesis, Yang syndrome

N50 Other diseases of male genital organs

N80 Endometriosis

Endometrioid endometriosis

Composition

Solution for injection oil 1 ml

Testosterone propionate 30 mg

Testosterone phenylpropionate 60 mg

Testosterone isocaproton 60 mg

Testosterone capronate 100 mg

Auxiliary substances: benzyl alcohol; Peanut butter for injections

In ampoules of 1 ml; In a cardboard pack of 5 ampoules.

pharmachologic effect

Pharmacological action - androgenic, anabolic.

It binds and stimulates the corresponding (testosterone) receptors of the cells.

Pharmacodynamics

Stimulates protein synthesis by retaining the necessary ions of potassium, sulfur, phosphorus, enhances the fixation of calcium in the bones, increases muscle mass of the body. Affects the development and function of the external genitalia, prostate gland, seminal vesicles, secondary sexual characteristics (voice, hair). Defines the constitution of the body and sexual behavior, activates libido and potency, stimulates spermatogenesis. It is an antagonist of female sex hormones - estrogens. Weaken the negative manifestations of menopause.

Clinical Pharmacology

The testosterone esters have different rates of absorption and elimination, which provides a quick and long-lasting (up to 4 weeks) effect after a single injection: testosterone propionate is active during the first day, the action of testosterone phenylpropionate and isocapro- nate begins 24 hours after injection and continues up to 2 weeks

Indications In men - post-stroke syndrome, oligospermia, eunuchoidism, impotence, male menopause, etc .; In women - breast cancer, endometriosis, myoma.

Contraindications

Neoplasms of the prostate, impaired liver and kidney function, hypercalcemia, hypercalciuria, heart failure, asthenia, the period before puberty in boys, elderly men, pregnancy.

pregnancy and lactation

Contraindicated in pregnancy.

Side effects

On the part of the digestive tract: cholestatic jaundice, increased activity of aminotransferases.

From the genitourinary system: peripheral edema, fluid retention in the body, bleeding from the genital tract, oligospermia, increased libido in men, impaired spermatogenesis.

Allergic reactions: pain, itching, redness at the injection site.

Other: acne, phlebothrombosis, hypercalcemia, bone pain; Extremely rare - increased sensitivity to insulin in patients with hypoglycemia. In women after prolonged use, symptoms of masculinization may appear.

Interaction

The effect is weakened by inducers of microsomal liver enzymes (rifampicin, barbiturates, carbamazepine, salicylates, phenylbutazone, phenytoin).

Dosing and Administration

In / m, deep in the gluteus muscle. The dose is set individually depending on the indications and reaction of the patient.

In primary male hypogonadism: depending on the degree of insufficiency of the gonads (according to the clinical evaluation and the results of laboratory studies), first one time is administered every 1-2 weeks, after reaching the therapeutic effect - once every 3 weeks.

With menopause in men: 1 time in 2 weeks, after reaching the therapeutic effect - 1 time in 3 weeks.

Infertility in men (azospermia, oligospermia): 2 ml 1 time every 2 weeks (with the appearance of a painful erection of the penis, the treatment is stopped).

With menopausal syndrome in women: 1 ml 1 time every 2-3 weeks.

With breast and ovarian cancer: 1-2 ml every 1-2 weeks, long-term treatment.

Storage conditions

In the dark place at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

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