Testosteronum prolongatum Jelfa, PharmaSwiss Česká republika
indications:
Testosterone replacement therapy in hypogonadism, when testosterone deficiency is confirmed by clinical features and biochemical tests.
Composition:
1 ml of solution contains 100 mg testosterone enanthate. The product contains peanut oil from peanuts and benzyl alcohol.
Action:
Ester derivative of a natural male sex hormone - testosterone, for parenteral use. It has a strong androgenic effect, stimulates the growth of the testicles, prostate gland, seminal vesicles, and affects spermatogenesis. Initiates the creation of second and third order sexual characteristics. It shapes the mental characteristics of men, weakens the symptoms of the menopausal period. It shows an anabolic effect, causing skeletal muscle hyperplasia, increases bone mineral density, stimulates erythropoietin production in the kidneys, increases hemoglobin. In men with hypopituitarism, testosterone removes the symptoms of hypogonadism. The preparation is absorbed slowly, its prolonged action allows for a significant extension of the intervals between individual injections. It takes full effect after a few - up to 14 days after the injection. The healing effect expires 7-10 days after the end of administration. It binds about 98% with a specific globulin-binding fraction of testosterone and estradiol. Metabolized in the liver and excreted mainly in the urine. T0,5 is 2-3 days.
Contraindications:
Hypersensitivity to testosterone enanthate, benzyl alcohol or peanut oil. Nephrotic syndrome. Suspected and orrogen-dependent prostate cancer. Cancer of the mammary gland. Liver cancer, now or in the past.
Precautions:
Do not use the product in children and adolescents under 18 years of age. Androgens may accelerate the progression of asymptomatic prostate cancer and benign prostatic hyperplasia. Caution should be exercised in patients with cancer who are at risk of hypercalcaemia (and subsequent hypercalcemia) due to bone metastases, and it is recommended to monitor plasma Calcium levels. Hypercalcemia may require discontinuation of the preparation. In patients with severe heart, hepatic or renal failure, serious complications of edema with congestive heart failure or without congestive heart failure should be discontinued immediately. Use with caution in patients with renal or hepatic impairment since no efficacy and safety studies have been performed in these groups of patients, liver function should be monitored. Occurring hepatitis is the reason for discontinuation of treatment. It should be remembered to limit the use of intramuscular injections in patients with acquired or congenital blood coagulation disorders. Exercise caution in patients with epilepsy and migraine (risk of exacerbation of disease states). In patients treated with androgens, in which plasma testosterone levels normalize after replacement therapy, insulin sensitivity may improve. Some clinical symptoms such as irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive exposure to androgens, requiring a change in dosage. Androgens are not an appropriate means to accelerate muscle development. If the symptoms of excess androgen persist or recurrence of these symptoms during treatment with the recommended doses, the preparation should be discontinued permanently.
Pregnancy and lactation:
The preparation is contraindicated in women and can not be used in pregnant or breast-feeding women.
Side effects:
The following may occur: gynecomastia, priapism, oligospermia when using high doses; male pattern baldness, acne; retention of sodium, chlorine, water, potassium, calcium and inorganic phosphates; nausea; congestive jaundice, hepatic dysfunction, hepatic purpura or hepatic neoplastic lesions; inhibition of coagulation factors II, V, VI and X, bleeding in patients treated with oral anticoagulants, polycythemia; libido changes, headache, anxiety, paresthesia; intensification of pre-existing sleep apnea; inflammation and pain at the injection site.
Dosage:
Intramuscularly, deep into the gluteal muscle, inject very slowly. The dose is selected individually, depending on the patient's indications and reactions. It should be given 100-200 mg, and if necessary up to 300 mg every 1 week. After an improvement of 100 mg every 2-4 weeks.