Index of drugs

Hormone replacement therapy in peri- and postmenopausal women with symptoms of estrogen deficiency.

1 ml contains 200 mg of prasterone enanthate and 4 mg of estradiol valerate in an oil solution.

A combined preparation containing a natural female sex hormone - estradiol, and a natural weak androgen - prasterone. Removes symptoms of a deficiency of women's hormones during the menopause, such as a rapid feeling of heat, increased sweating, depressive moods; delays the occurrence of atrophic changes in the skin and mucous membranes, especially within the genital area. The effect of the drug starts a few days after administration and lasts for 4-6 weeks. The drug does not work contraceptively.

Hypersensitivity to the components of the preparation. Pregnancy and breastfeeding. Breast cancer - diagnosed or suspected. Bleeding from the genital tract, the causes of which have not been explained. Established or suspected precancerous or estrogen-dependent cancers. Current or past history of benign or malignant liver tumors. Untreated hyperplasia of the endometrium. acute liver disease or a history of liver disease if the liver function parameters have not returned to normal. Active or previous arterial thromboembolic events (eg myocardial infarction, angina pectoris, stroke). Active venous thromboembolism (deep venous thrombosis, pulmonary embolism) or its occurrence in the past. Significant hypertriglyceridaemia. Porphyria. Otosclerosis that has been exacerbated during pregnancy.

Particularly cautiously use in patients with: uterine fibroids or endometriosis, history of thromboembolic disorders or risk factors (eg positive personal or family history, significant obesity - BMI> 30 kg / m², systemic lupus erythematosus, longer immobilization, extensive trauma or surgical procedures, recurrent spontaneous abortions) - a predisposition to thrombophilia should be excluded; risk factors for the development of estrogen-dependent tumors (eg breast cancer in first-degree relatives), hypertension, liver diseases (eg liver adenoma), diabetes with or without vascular complications, cholelithiasis, migraine or severe headache, systemic lupus erythematosus, endometrial hyperplasias in history of history, epilepsy, bronchial asthma, otosclerosis, multiple sclerosis, porphyria, tetany, minor chorea, cardiac or renal dysfunction due to fluid retention (in patients with terminal renal failure, the active substance concentration of the preparation may be increased), hypertriglyceridemia, hereditary angioedema. Treatment should be discontinued immediately if: jaundice or hepatic dysfunction, significant increase in blood pressure, migraine headache, venous thromboembolism, if the patient becomes pregnant or there is a change in tone. The preparation should be discontinued 4-6 weeks before planned long-term immobilisation after surgery, especially operations in the abdominal cavity or orthopedic surgery on the lower limbs. Do not resume treatment before the patient is completely started. In patients who use HRT, there is an increased risk of breast cancer after several years of use, which increases with the prolongation of treatment, but after a few (at the latest five) years after discontinuation of therapy is again reduced to the appropriate baseline risk. Long-term estrogen intake only increases the risk of endometrial hyperplasia and thus increases the risk of endometrial cancer - this requires supplementary progestogen administration (reduces the risk of disease, though it does not eliminate it). In patients with uterine removed, the use of estrogen only in HRT is associated with an increased risk of ovarian cancer. Due to the increased risk of liver cancer, it should be taken into consideration if there is increased epigastric pain, enlargement of the liver or bleeding in the abdominal cavity.

The drug is contraindicated during pregnancy and breastfeeding. You should not get pregnant during treatment. Menstruating patients are advised to use non-hormonal methods of contraception. If you become pregnant while using HRT, treatment should be stopped immediately.

Rarely may occur: rash, hypersensitivity, various skin changes (pruritus, eczema, urticaria, skin reactions at the injection site, hair loss, erythema nodosum, acne), increased libido, a feeling of tension in the breast, breast pain or enlargement, increase or decrease body weight, swelling, bleeding or spotting from the uterus and virilization symptoms. In addition, there may be: estrogen-dependent benign and malignant tumor (endometrial cancer, breast cancer); venous thromboembolism (deep vein or pelvic deep vein thrombosis, pulmonary embolism); myocardial infarction and stroke, gallbladder disease, skin and subcutaneous tissue diseases (chloasma, erythema multiforme, vascular purpura), dementia.

1 ampule deeply intramuscularly every 4 weeks. If the symptoms disappear for longer than 4 weeks, the drug may be administered at appropriately longer intervals. The product should be administered very slowly to prevent short-term adverse reactions (coughing, coughing, breathing disorders) that may occur over time or immediately after administration. For treatment of postmenopausal symptoms, the lowest effective dose should be used. HRT should continue as long as the benefits outweigh the risks of using the medicine.