Nebido 1000 mg 4ml solution for injection SPC
Like all medicines, this medicine can cause side effects, although not everybody getsthem. 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.
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.
Patient leaflet – NEBIDO 1000 MG / 4ML SOLUTION FOR INJECTION
- Regular exercise, particularly strength training, can also help stimulate testosterone production and improve overall health.
- Nebido may also affect the results of some laboratory tests (e.g. thyroid gland).
- High-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema.
- Therefore, testosterone replacement therapy should be used with caution in these patients.
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.
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.
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.
Nebido 1000 mg/4 ml sol inj (liek.skl.hnedá.) 1×4 ml
His relationship with his partner improved considerably, highlighting the positive impact TRT can have on a man’s sexual health and overall well-being. Testosterone has been found to be non-mutagenic in vitro using the reverse mutation model (Ames test) or hamster ovary steroids buy online cells. A relationship between androgen treatment and certain cancers has been found in studies on laboratory animals.
It also performs functions, e.g. inthe skin, muscles, skeleton, kidney, liver, bone marrow and CNS. Testosterone undecanoate is an ester of the naturally occurring androgen, testosterone. The active form, testosterone, is formed by cleavage of the side chain. NEBIDO®-related clinical trials were not performed in men under 18 years of age.
how to use nebido
If your testosterone levels are high, your doctor may decide to give you injections less often. Otherwise, your optimum level of testosterone will not be maintained. If your testosterone levels are high, your doctor may decide to give you injections less often.
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 all the daily questionnaire responses, 7% reported itching, 4% discomfort, and 2% irritation.
Ingestion of Nebido 1000mg/4 ml, or the contents of any of the Nebido 1000mg/4 ml (Nebido 1000mg/4 ml (transdermal)) products will not result in clinically significant serum Nebido 1000mg/4 ml concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of Nebido 1000mg/4 ml from any of the Nebido 1000mg/4 ml (Nebido 1000mg/4 ml (transdermal)) products will not produce adequate serum Nebido 1000mg/4 ml levels due to its short half-life (about 10 minutes). Each ampoule/vial with 4 ml solution for injection contains 1000 mg testosterone undecanoate corresponding to 631.5 mg testosterone. Maintaining your Testosterone Undecanoate levels during treatment The injection interval should always be within the recommended range of 10 to 14 weeks. In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.