Nebido roztwór do wstrzykiwań działanie, dawkowanie, cena, refundacja Medycyna Praktyczna
Nebido 1000mg/4 ml (Nebido 1000mg/4 ml (transdermal)) and Nebido 1000mg/4 ml (Nebido 1000mg/4 ml (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. One Nebido 1000mg/4 ml (Nebido 1000mg/4 ml (transdermal)) or Nebido 1000mg/4 ml (Nebido 1000mg/4 ml (transdermal)) WITH ADHESIVE system should be placed on clean, dry, scrotal skin. Nebido 1000mg/4 ml (Nebido 1000mg/4 ml (transdermal)) or Nebido 1000mg/4 ml (Nebido 1000mg/4 ml (transdermal)) WITH ADHESIVE should be worn hours.
2 Posology and method of administration Posology
Experimental data in rats have shown increased incidences of prostate cancer after treatment with testosterone. Nebido should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other aetiology, responsible for the symptoms, has been excluded before treatment is started. Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see section 4.4). Fatty fluid NEBIDO® can reach the lungs (pulmonary microembolics of oily solutions) and in rare cases may cause symptoms such as coughing, difficulty in breathing, general unwellness, excessive sweating, chest pain, dizziness, tingling or fainting. These symptoms can occur during or immediately after injection and are reversible. Following the use of hormonal agents such as testosterone compounds, it has rarely been observed that good and malignant liver tumors occur.
It also performs functions, e.g. in the skin, muscles, skeleton, kidney, liver, bone marrow, and CNS. The active form, testosterone, is formed by cleavage of the side chain. The most frequently reported undesirable effects during treatment with Nebido are acne and injection site pain. Nebido should be permanently withdrawn if symptoms of excessive androgen exposure persist or reappear during treatment with the recommended dosage regimen. Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.
Prior to testosterone initiation, all patients must undergo a detailed examination in order to exclude a risk of pre-existing prostatic cancer. Local guidelines for safety monitoring under testosterone replacement therapy should be taken into consideration. The injection interval should be within the recommended range of 10 to 14 weeks. Careful monitoring of serum testosterone levels is required during maintenance of treatment. Measurements should be performed at the end of an injection interval and clinical symptoms considered. These serum levels should be within the lower third of the normal range.
4 Special precautions for storage
Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine contains 2000 mg benzyl benzoate in each 4 ml ampoule/vial which is equivalent to 500 mg/ml. Nebido is not for use in women and must not be used in pregnant or breast-feeding women.
In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimise the individual VTE risk. There is limited experience on the safety and efficacy of the use of Nebido in patients over 65 years of age.
- Following the use of hormonal substances such as androgen compounds, cases of benign (non-cancerous) and malignant (cancerous) liver tumours have been observed to occur.
- Before your doctor injects Nebido, he/she will examine you to check that you do not have prostate cancer.
- The most appropriate MedDRA term to describe a certain adverse reaction is listed.
- If you miss a scheduled NEBIDO injection, contact your doctor for guidance.
Testosterone undergoes extensive hepatic and extrahepatic metabolism. After the administration of radio-labelled testosterone, about 90% of the radioactivity appears in the urine as glucuronic and sulphuric acid conjugates and 6% appears in the faeces after undergoing enterohepatic circulation. Following intramuscular administration of this depot formulation the release rate is characterised by a half life of 90±40 days.
An increase in serum levels of testosterone above basal values may be seen one day after administration. Mark, a 52-year-old construction worker, had been experiencing fatigue, low libido, and difficulty sleeping for several months. He also noticed a decrease in muscle mass and an increase in belly fat. Feeling sluggish and unmotivated, Mark’s work performance began to suffer. After consulting his doctor, he underwent blood tests that confirmed low testosterone levels. After discussing treatment options, Mark opted for TRT with NEBIDO injections every 12 weeks.
The use of Nebido is contraindicated in men with past or present liver tumours (see section 4.3). Each ampoule / vial with 4 ml solution for injection contains 1000 mg testosterone undecanoate. In clinical studies of 104 patients treated with Nebido 1000mg/4 ml (Nebido 1000mg/4 ml (transdermal)), the most common adverse effects reported were local effects. In US clinical trials, most of the 72 patients filling out a daily questionnaire reported scrotal itching, discomfort, or irritation at some time during therapy. Of Trenbolone enanthate buy online all the daily questionnaire responses, 7% reported itching, 4% discomfort, and 2% irritation.