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

Testosterone is the most important androgen of the male, mainly synthesised in the testicles, and to a small extent in the adrenal cortex. The most appropriate MedDRA term to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.

• Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.
• By maintaining stable testosterone levels, it helps restore energy, vitality, and overall well-being.
• It is crucial to confirm these symptoms through thorough medical evaluations before starting therapy.
• Special care must be taken to avoid intravasal injection (see section 4.4 under “Application”).
• Treatment with high doses of testosterone preparations commonly may reversibly stop or reduce sperm production (see also under “Possible side effects”).

Before you start Nebido injections, there are some steps to take https://www.thaidiagnostics.com/a-review-of-steroids-that-help-maintain-muscle-2/ with your medical team. First, your doctor will have to take a testosterone blood sample to measure the amount of testosterone and other contents in the blood. These measures will be important so that your medical team can determine whether the treatment is having the desired effect. In the beginning, your doctor may choose to give you the second injection after only 6 weeks of treatment to frontload the effects and get you started with your Nebido injections and the benefits that come with it. This is done to quickly reach the desired testosterone level so that you can enter the maintenance portion of the treatment.

Conditions to Avoid

By reporting side effects, you can help provide more information on the safety of this medicine. Treatment with high doses of testosterone preparations commonly may reversibly stop or reduce sperm production (see also under “Possible side effects”). 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.

Nebido Testosterone Undecanoate 1000mg/4ml Ampoule POM x1

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. Your doctor will regularly examine your prostate and breast, especially if you are elderly. Your injections may likely decrease in cost, while giving you a more optimized dose. You may also avoid the “crashes” caused by the dips in between injections, which is more commonly experienced on Nebido/Aveed.

There it can be stored and gradually released over a period of time. Also, Nebido is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). 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. Urinary medicinal products include androsterone and etiocholanolone. Following intramuscular administration of this depot formulation the release rate is characterised by a half life of 90±40 days.

After removal of the plastic cap (A) do not remove the metal ring (B) or the crimp cap (C). 6ml brown glass (type I) vial with grey bromobutyl (foil-clad ETFE) injection stopper and bordered cap, containing a fill volume of 4 ml. Toxicological studies have not revealed other effects than those which can be explained based on the hormone profile of Nebido. This medicine contains 2000 mg Benzyl benzoate in each 4 ml ampoule/vial which is equivalent to 500 mg/ml. Suspected anaphylactic reactions after Nebido injection have been reported.

This therapy is intended for men with clinically and biochemically confirmed testosterone deficiency. With a single injection, it provides a steady release of testosterone for up to weeks, minimizing the need for frequent administration. It is an injectable solution containing testosterone undecanoate at a concentration of 250 mg/ml.

Aveed is pretty much the same as Nebido, being a long lasting form of testosterone called testosterone undecanoate. The solution for intramuscular injection is to be visually inspected prior to use and only clear solutions free from particles should be used. This medicinal product does not require any special storage conditions. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Fertility studies in rodents and primates have shown that treatment with testosterone can impair fertility by suppressing spermatogenesis in a dose dependent manner.

Once injected, typically into a muscle, Nebido is stored in the body and gradually released over time. This steady release ensures consistent testosterone levels, making the treatment highly effective for men experiencing testosterone deficiency. Nebido is widely recognized in the UK as a trusted option for testosterone replacement therapy, particularly through the NHS.

Like all medicines, NEBIDO® may have side effects in people who are sensitive to the ingredients in its contents. Your doctor will determine the dosage of your medicine and apply it to you, depending on your disease. Your doctor, especially if you are older, will perform regular prostate examinations, and will regularly take a blood sample from you.