Nebido 1000 mg 4 ml solution for injection Summary of Product Characteristics SmPC emc

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).

How to store Nebido

With this loading dose, sufficient steady state testosterone levelsmay be achieved more rapidly. Treatment with high doses of testosterone preparations commonly stops or reduces sperm production, although this returns to normal after treatment ceases. Testosterone replacement therapy of poorly functioning testicles (hypogonadism) can in rare cases cause persistent, painful erections (priapism). High-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema (swelling due to fluid retention). Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady state testosterone levels may be achieved more rapidly.

what nebido is and what it is used for

• Currently, there is no consensus about age specific testosterone reference values.
• Prior to opening, ensure that any solution in the upper part of the ampoule flows down to the lower part.
• 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.

Nebido is an intramuscularly administered depot preparation of testosterone undecanoate and thus circumvents the first-pass effect. Following intramuscular injection of testosterone undecanoate as an oily solution, the compound is gradually released from the depot and is almost completely cleaved by serum esterases into testosterone and undecanoic acid. An increase in serum levels of testosterone above basal values may be seen one day after administration. The treatment did not exhibit any adverse side effects on the prostate gland, including prostate-specific antigen. Following intramuscular injection of testosterone undecanoate as an oily solution, the compound is gradually released from the depot and is almost completely cleaved by serum esterases into testosterone and undecanoic acid. An increase in serum levels of testosterone above basal values may be seen one day after administration.

NEBIDO 1000 MG / 4ML SOLUTION FOR INJECTION – patient leaflet, side effects, dosage

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.

These reactions may occur during or immediately after the injection and are reversible. 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. Treatment is usually supportive, e.g. by administration of supplemental oxygen. Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible.

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.

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.

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. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered. As with all oily solutions, Nebido must be injected strictly intramuscularly and very slowly (over two minutes). Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope.

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 https://www.ljastore.com/winstrol-50-mg-biotech-beijing-effects/ 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.

Fertility studies in rodents and primates have shown that treatment with 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.