Nebido 1000 mg 4ml Ampoule 1pc Im

This is enough to maintain sufficient testosterone levels without leading to a build-up of testosterone in theblood. Your doctor will measure your blood testosterone levels before starting treatment and during the early stages of treatment. Your doctor may give you the second injection after only six weeks in order to quickly reach the necessary testosterone level. Care should be taken to inject Nebido deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be taken to avoid intravasal injection (see section 4.4 under “ Application” ). The contents of an ampoule / vial are to be injected intramuscularly immediately after opening.

Start of treatment

• If your medicine shows signs of deterioration or discolouration seek the advice of your pharmacist who will tell you what to do.
• Your doctor will measure your testosterone levels regularly at the end of an injection interval to make sure it is at the right level.
• The injection interval should always be within the recommended range of 10 to 14 weeks.
• Suspected anaphylactic reactions after Testosterone Undecanoate injection have been reported.
• In patients suffering from severe cardiac, hepatic or renal insufficiency or ischemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.

Athletes treated for testosterone replacement in primary and secondary male hypogonadism should be advised that the medicinal product contains an active substance which may produce a positive reaction in anti-doping tests. As a general rule, the limitations of using intramuscular injections in patients with acquired or inherited blood clotting irregularities always have to be observed. 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.

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Your doctor will inject Nebido (1 ampoule / vial) very slowly into a muscle. This is enough to maintain sufficient testosterone levels without leading to a build-up of testosterone in the blood. There are no studies undertaken to demonstrate the efficacy and safety of this medicinal product in patients with renal or hepatic impairment.

If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur in men using Nebido, a liver tumour should be included in the differential-diagnostic considerations. The use of Nebido is contraindicated in men with past or present liver tumours (see section 4.3). Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see section 4.4). If you are suffering from severe heart, liver or kidney disease,treatment with Nebido may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure. Please be sure to inform your doctor if you suffer from a disturbance of blood clotting, because this is important for your doctor to know before deciding to inject Nebido. Nebido may also affect the results of some laboratory tests (e.g. thyroid gland).

SUMMARY OF PRODUCT CHARACTERISTICS

The patient should therefore be observed during and immediately after each injection in order to allow for early recognition of possible signs and symptoms of pulmonary oily microembolism. As with all oily solutions, Nebido must be injected strictly intramuscularly and very slowly. Suspected anaphylactic reactions after Nebido injection have been reported.

Treatment with high doses of testosterone preparations commonly may reversibly stop or reduce sperm production (see also under “Possible side effects” ). Abuse of testosterone, especially if you take too much of this medicine alone or with other anabolic androgenic steroids, can cause serious health problems to your heart and blood vessels (that can lead to death), mental health and/or the liver. Treatment with high doses of testosterone preparations commonly may reversibly stop or reduce sperm production (see also under “Possible side effects”). Abuse of testosterone, especially if you take too much of this medicine alone or with other anabolic androgenic steroids, can cause serious health problems to your heart and blood vessels (that can lead to death), mental health and/or the liver. As a general rule, the limitations of using intramuscular injections in patients with acquired or inherited bleeding disorders always have to be observed. There is limited experience on the safety and efficacy of the use of Nebido in patients over 65 years of age.

In case of severe complications characterized by oedema with or without congestive heart failure treatment must be stopped immediately (see section 4.8). Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation. 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. Athletes treated for testosterone replacement in primary and secondary male hypogonadism should be advised that the medicinal product contains an active substance which may produce a positive reaction in anti-doping tests. 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.

Special care will be taken to avoid injection into a blood vessel (see “Administration”). Before your doctor injects Nebido, he/she will examine you to check that you do not have prostate cancer. If you are suffering from severe heart, liver or kidney disease, treatment with Nebido may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure. The solution for intramuscular injection is to be visually inspected prior to use and only clear solutions free from particles should be used. Dependent on the target organ, the spectrum of activities of testosterone is mainly androgenic (e.g. prostate, seminal vesicles, epididymis) or protein-anabolic (muscle, bone, haematopoiesis, kidney, liver). No special therapeutic measure apart from termination of therapy with the medicinal product or dose reduction is necessary after overdose.

Following intramuscular administration of this depot formulation the release rate is characterised by a half life of 90±40 days. Each ampoule / vial with 4 ml solution for injection contains 1000 mg testosterone undecanoate. Maintaining your Testosterone Undecanoate levels during treatment The injection interval should always be within the recommended range of 10 to 14 weeks. Testosterone has been found to be non-mutagenic in vitro using the reverse mutation model (Ames test) or hamster ovary cells. A relationship between androgen treatment and certain cancers has been found in studies on laboratory animals.

Fertility studies in rodents and primates have shown that treatment with anavar testosterone can impair fertility by suppressing spermatogenesis in a dose dependent manner. In serum of men, about 98% of the circulating testosterone is bound to sex hormone binding globulin (SHBG) and albumin. Only the free fraction of testosterone is considered as biologically active. Following intravenous infusion of testosterone to elderly men, the elimination half-life of testosterone was approximately one hour and an apparent volume of distribution of about 1.0 l/kg was determined.