Nebido

Nebido – the drug with androgenic action used for carrying out testosterone of replacement therapy.

Form of release and structure

Nebido is issued in the form of solution for intramuscular introduction: oil, transparent, with a yellowish shade (on 4 ml in ampoules from amber glass or bottles of dark glass like I, on 1 ampoule or a bottle in a cardboard pack with the pasted holder).

Enter into structure of 4 ml (1 ampoule or 1 bottle) of solution:

• Active ingredient: ундеканоат testosterone – 1 g;
• Auxiliary components: benzyl benzoate – 2 g, the castor purified oil – 1,18 g.

Indications to use

Nebido is appointed to men at insufficiency of testosterone at primary and secondary hypogonadism (replacement therapy by testosterone).

Contraindications

• Liver tumors (in the presence of instructions in the anamnesis or now);
• Androgenzavisimy carcinoma of milk or prostatic glands;
• The hypercalcemia accompanying malignant tumors;
• Age up to 18 years (due to the lack of the necessary data allowing to estimate efficiency and safety of use of drug);
• Hypersensitivity to drug components.

Care is demanded by Nebido's appointment at an apnoea syndrome.

Women cannot use drug.

Route of administration and dosage

Nebido is entered intramusculary, (not to allow hit of substance in a blood vessel), right after packaging opening.

For maintenance of sufficient level of testosterone (without substance cumulation) the drug is administered 1 time in 10-14 weeks in a dose of 1 g (contents of 1 ampoule or 1 bottle).

Before therapy it is necessary to determine the size of content in testosterone serum. The first break between injections can be reduced, but it should not be less than 6 weeks. At a dose of 1 g _{of Css} (stationary concentration of substance in blood) it is reached quickly.

At the end of an interval between administrations of drug it is recommended to measure concentration in testosterone serum. Further therapy is adjusted depending on this indicator – at level below normal indicators reduction of a break between injections and vice versa can be required. At the same time the interval has to remain within the recommended range (10-14 weeks).

Dose adjustment for elderly patients is not required.

Side effects

Most often in time Nebido's use was noted development of such disturbances as pain in an injection site and an acne.

The side effects arising during therapy (from ≥1/100 to <1/10 – it is frequent, from ≥1/1000 to <1/100 – infrequently):

• Cardiovascular system: often – inflows; infrequently – increase in arterial pressure, dysfunction of cardiovascular system, hypertensia, dizziness;
• Nervous system: infrequently – a headache, a tremor, migraine;
• System of digestion: infrequently – nausea, diarrhea;
• Lymphatic system and blood: often – a polycythemia; infrequently – increase in quantity of erythrocytes and level of hemoglobin, increase in a hematocrit;
• Immune system: infrequently – hypersensitivity;
• Biliary tract and liver: infrequently – increase in activity of aspartate aminotransferase, a deviation in "hepatic" tests;
• Urinary tract and kidneys: infrequently – dysfunction of urinary tract, reduction of volume of the emitted urine, a dysuria, an ischuria, a nocturia;
• Connecting and skeletal muscular tissue: infrequently – extremity pains, an arthralgia, skeletal and muscular rigidity, muscular spasms, a mialgiya, muscular tension, increase in activity of a kreatinfosfokinaza in blood;
• Mammary glands and generative organs: often – a benign hyperplasia of a prostate, pathological results of inspection of a prostate, increase in level of prostatspetsifichesky antigen; infrequently – prostatitis, an intraepithelial neoplasia of a prostate, pain in testicles, consolidation of a prostate, dysfunction of a prostate, increase or decrease a libido, a gynecomastia, pain and consolidation in a mammary gland, increase in level of oestradiol, testosterone and free testosterone in blood;
• Hypodermic fabrics and skin: often – an acne; infrequently – an itch, a xeroderma, rash, an alopecia, papular rash, an erythema;
• Food and metabolism: often – increase in weight; infrequently – a hypercholesterolemia, increase in appetite, increase in level of triglycerides and cholesterol in blood, and also glikozilirovanny hemoglobin;
• Bodies of a mediastinum and thorax, respiratory system: infrequently – sinusitis, bronchitis, a dysphonia, cough, snore, short wind;
• Mentality: infrequently – aggression, a depression, sleeplessness, disturbances in the emotional sphere, concern, irritability;
• Disturbances in an injection site and the general frustration: often – various reactions in an injection site (in the form of pains, discomfort, an itch, hypostasis, a hematoma, irritation in an injection site); infrequently – an adynamy, increased fatigue, night perspiration, a hyperhidrosis.

In rare instances at a microembolism of a pulmonary artery by Solutio oleosa emergence of cough, asthma, indisposition, hyperhidrosis, stethalgias, dizzinesses, paresthesias or a faint can be observed. As a rule, these disturbances developing in time of an injection or right after it have reversible character. When carrying out clinical and post-market researches exceptional cases of developing of a fatty microembolism of a pulmonary artery were registered.

There are data on development after Nebido's injections of anaphylactic reactions.

Besides, there are data on development of nervousness, aggression, increase of erections, an apnoea in a dream, various skin reactions (including seborrhea), and also about isolated cases of developing of jaundice.

Therapy by drugs with the maintenance of high doses of testosterone, as a rule, leads to the reversible termination or decrease in a spermatogenesis and, respectively, reduction of the size of testicles. In rare instances replacement therapy of a hypogonadism can lead testosterone to persistent painful erections (priapism).

During performing high-dosage or long therapy by testosterone development of hypostases and increase of cases of a delay of liquid in an organism can sometimes be observed.

Special instructions

The patients undergoing long therapy by androgens for identification of cases of a polycythemia need to check a hematocrit and hemoglobin periodically.

At elderly patients Nebido's use can increase risk of developing of a hyperplasia of a prostate. Also drug can promote growth of already available carcinoma in this connection its exception before purpose of treatment by drug is recommended.

In rare instances in usage time of sexual steroids, including testosterone, development of benign tumors of a liver was noted, is even more rare – malignant that can lead to development of intra belly bleedings. At emergence of severe pains in an upper part of a stomach, increase in a liver or existence of symptoms of intra belly bleeding it is not necessary to exclude probability of existence of a tumor of a liver when carrying out differential diagnosis.

The patient at use Nebido, inclined to hypostases, it is necessary to be careful as treatment by androgens can lead to a delay of removal of ions of sodium.

Use of testosterone at treatment of patients is younger than 18 years along with a masculinization can lead to acceleration of growth and maturing of a bone tissue, and also premature short circuit of region of growth of an epiphysis and, respectively, decrease in final growth.

During Nebido's use it is necessary to consider probability of development of the following states:

• Appearance of ordinary eels;
• Strengthening of the existing apnoea syndrome in a dream;
• Decrease in a spermatogenesis (has reversible character).

Androgens should not be used for increase in physical data and strengthening of development of muscles in healthy men.

To avoid a microembolism of a pulmonary artery (the main symptoms: a hyperhidrosis, cough, a faint, short wind, paresthesias, an indisposition, dizziness, pain behind a breast), Nebido's introduction has to be carried out slowly. At its development performing the supporting treatment is shown, for example, appoint additional oxygen.

Nebido's reception can lead to virilescence of a female fruit at some stages of development, however there are no data on risk of additional deterioration in development of bodies.

Medicinal interaction

At the combined Nebido's use with some drugs / substances the following effects can be observed:

• Barbiturates and other inductors of enzymes: increase of clearance of testosterone;
• Oksifenbutazon: increase in its concentration in blood serum;
• Peroral anticoagulants: increase in their activity (dose adjustment can be required; it is always necessary to observe restrictions of rather intramuscular injections by the patient with the hereditary or acquired disturbances of coagulability of blood);
• Medicines with hypoglycemic action: strengthening of hypoglycemic effect of insulin (the dose decline of hypoglycemic means can be required).

Due to the lack of data on compatibility Nebido should not mix with other medicines.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C.

Period of validity – 5 years.