Injectable solution. Description of the drug product clean, oily, balkan medical remedies (balkan-pharmaceuticals.org) yellow solution. Pharmacotherapeutic group and tin atc androgen, derivatives of 3-oxandrosten (4), g03ba03.
Pharmacological properties pharmacodynamic properties. Testosterone undekanoat is recognized as the energy -intensive ether of natural androgeen, testosterone. Active form, testosterone, grows as a result of splitting the side chain. Testosterone is the primary androgenic hormone, synthesized and ovice distinguishing. It guarantees the growth and formation of the male reproductive system and secondary sexual characteristics (prostate ripening, seminal bubbles, penis and scrotum), distribution of the hair of men (face, forehead, chest), the development of the larynx, the muscles of the figure and the distribution of fats. Saves nitrogen, sodium, potassium and phosphorus in the liver, increases anabolism and reduces protein catabolism. The premature increase in the concentration of the male sex hormone - in plasma in the prepuberty period can lead to the closure of the epiphysis and the cessation of growth. It stimulates the production of erythropoetin and red blood cells. The reverse newsletter mechanism inhibits the secretion of luteinizing hormones and a pituitary gland similar to the pituitary gland, and gives rise to suppression of spermatogenesis. In the fair sex, it inhibits the function of the gonadrophic pituitary gland, ovaries, mammary glands, causes endometrial atrophy. Due to the action of the estrogen antagonist, it is used during the treatment of uterine myosa, endometriosis, and breast cancer. This shows a useful effect on the menopause. After intramuscular injection, testosterone undkanoat in the form of an oily solution by internet resources is cleaned in testosterone and non-canine acid. The seventh holiday and 24 nmol/l, respectively, on the 14th day after the completion of the unified intramuscular administration of 1000 mg of non -kanoat testosterone. The post-bee levels of testosterone decreased with the estimated half-life of 53 days. Metabolism testosterone obtained by splitting the ether of testosterone undecanoate is metabolized and cured similarly endogenous testosterone. It is widely metabolized by the liver and extrahepatic. Urine metabolites include androsterone and etiocolanone.
Therapeutic readings testosterone replacement therapy for your hypogonadism, when testosterone deficiency was confirmed by a clinical assessment and biochemical tests. > doses and method of introduction introduction method: intramuscularly. This frequency of administration is effective to support the calculated concentration of a male hormone and does not yet accumulate the drug. Injections are required to be carried out quite slowly. Testosterone u is introduced strictly intramuscularly. Some attention should be paid to avoiding intravascular injection. Initiation of treatment concentration of male sex hormone - in plasma should be measured before and during the initiation of therapy. The first distance between the administrations is reduced to a minimum to six weeks. With this dose of load, you can achieve sufficient concentrations of the male sex hormone - in a stable state. Plasma concentrations below normal values indicate the need to reduce the interval between administrations. But high plasma concentrations can be considered an increase in the distance between the administrations. The injection interval must be at the recommended value of 10 to fourteen percent of weeks. Additional data on special groups of patients guys, and adolescents testosterone u is not indicated for the user for the younger generation and offspring also did not go clinically evaluated by the stronger sex with mature up to more than 15. Patients and old data did not indicate the need to adjust the dose in elderly patients. Liver disorders. The use of testosterone u is contraindicated to people with previous or real liver tumors.
Complications the complications indicated in the list are distributed by frequency, devices, protocol and organ. Frequency groups, 1/1000), very rarely ( vascular disorders general: hot flashes. Unusual: hypertensive arterial, dizziness. Respiratory, breast and mediastinal disorders unusual: bronchitis, sinusitis, cough, shortness of breath, snoring, dysphony. Gastrointestinal disorders unusual: diarrhea, nausea. A rash, a papular papular rash, itching, xeroderma. Violations of muscle-muscular and connective tissue arthralgia, pain in the limbs, muscle cramps, muscle tension, myalgia, muscular and skeletal block, blood creative. > disorders of the kidneys and urine unusual: a decrease in urine stream, deduction of urine, nokturia, dysuria. Reproductive system and breast disorders general: an increase in prostatic antigen, benign prostate hyperplasia. , Prostate indusion, prostatitis, increased libido, decrease in libido, pain in the eggs, breast augmentation, mastodynamics, gynecomastia. Hematoma, irritation. Unusual: fatigue, asthenia, hyperhidrosis, night sweat. Diagnostic research unusual: an increase in estradiol, an increase in free male sex hormone - blood.
Contraindications - hypersensitivity to the usual substance or to each expression patients. Tumors in the life of human society or presence. - Women. Reduction of testosterone or dose.
Warning and special security measures for the use of elderly patients who received androgens can be at risk of developing prostate hyperplasia. Despite the fact that there are no clear signs of an androgenic challenge of the prostate tumors, they will multiply the probability of developing an existing prostate tumors. So, prostate cancer needs to be removed before starting treatment with testosterone. In the role of security measures, a regular examination of the prostate in womanizers is recommended. The levels of hemoglobin and hematocrit need to be checked in a timely manner in long -term androgenic patients to establish polycysticemia. Cases of malignant and benign liver tumors with visitors to hormones were reported, including androgenic compounds. If the abdominal pain, the liver or signs of intra -abdominal hemorrhage appear in people using testosterone u, for differential diagnosis, the belly tumor should also be remembered. Caution in patients with edema, since androgenic therapy is able to raise sodium retention. No clinical trials with testosterone undekanoat existed in children or older adolescents up to eighteen years old. In small children, testosterone, with a male bonus, is able to cause accelerated growth and ripening of cubes and premature closing of the epiphyse, this reducing the final height. If necessary, it is possible to develop general acne. The previously existing state of apnea during sleep is possible. And also in absolutely all oil solutions, the non -canoat testosterone should introduce strictly intramuscularly and very slowly. In some cases, pulmonary microembolism of fatty solutions has the opportunity to entail symptoms such as cough, shortness of breath, malaise, hyperhidrosis, chest pain, dizziness, paresthesia or syncope. These reactions can occur in the process either instantly after injection and reversible. Most of treatment supports, for example, additional oxygen. Or use machines.
Work with other medicines, other types of interaction - medicines that affect testosterone barbiturates and other enzyme inducers cooperation with medications that inducing microsomal enzymes that induce drugs that induce microsomal ones are able to raise testosterone clearance. - The influence of androgens on other drugs oxifenbutazone increased levels of oxyphenbutazone in serum. The activity of oral anticoagulants, with possible dose adjustment. Outside of these results, the restriction of the use of balkan pharmaceuticals intramuscular injections for patients with hereditary or acquired blood coagulation problems should be studied as a general rule. With this, it may be necessary to reduce the dose of hypoglycemic agents.
Presentation, packaging 250 mg/ml for injection. 4 ml in ampoules. Five (5) or ten (10) bottles together with instructions in a cardboard card. .
The conditions for reliability three years old. Do not abuse after the date of expiration of the implementation specified in the list.