1000 mg / 4 ml solution for injection
testosterone undecanoate
What Nebido is and what it is used for
The active ingredient in Nebido is testosterone, a male hormone.
Nebido is injected into a muscle where it can be stored and gradually released. Nebido is given to adult men as a testosterone replacement to treat various ailments caused by testosterone deficiency (male hypogonadism ). These symptoms should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as:
- impotence
- infertility
- low sexual drive
- fatigue
- Depression
- osteoporosis due to low hormone levels
What you need to know before you use Nebido
Do not use Nebido
- if you are allergic to testosterone undecanoate or any of the other ingredients of this medicine (listed in section 6)
- if you have androgen-dependent cancer or suspected prostate or breast cancer
- if you have or have had a liver tumor.
Nebido is not for use by women.
Warnings and cautions
Talk to your doctor before using Nebido if you have or have ever had:
- epilepsy
- heart, kidney or liver problems
- migraine
- temporary pauses in breathing during sleep ( apnea ), as it may worsen during treatment
- cancer, as it may be necessary to regularly measure calcium levels in the blood
- high blood pressure or if you are being treated for high blood pressure because testosterone can cause an increase in blood pressure et
- problems with blood coagulation
- bleeding disorders (ie haemophilia )
- thrombophilia (a disorder of the blood coagulation that increases the risk of thrombosis – blood clots in blood vessels).
- Factors that increase your risk of blood clots in veins: previous blood clots in a vein, smoking, obesity, cancer, immobility (immobility), if someone in your close family has had blood clots in the legs, lungs or other organs at a young age (eg an age below about 50 years) or with increasing age.
How to recognize a blood clot: painful swelling in a leg or sudden discoloration of the skin e.g. pale, red or blue, sudden shortness of breath, sudden unexplained cough that may cause you to cough up blood, sudden chest pain, severe instability or dizziness, severe abdominal pain, sudden loss of vision. Seek medical attention immediately if you notice any of these symptoms.
If you suffer from severe heart, liver, or kidney failure, treatment with Nebido can lead to severe complications in the form of fluid accumulation in the body that is sometimes accompanied by heart failure.
Your doctor should perform the following blood tests before and during treatment: testosterone levels in the blood, complete blood cell count.
If your liver does not work
No formal studies have been performed in patients with hepatic impairment. You will not be prescribed Nebido if you have ever had a liver tumor (see ” Do NOT use Nebido “).
Children and young people
Nebido should not be used by children and adolescents. There are no data on the use in male patients under 18 years of age.
Elderly patients (65 years or older)
Your doctor will not need to adjust your dose if you are over 65 years of age (see ” Medical examination/follow-up” ).
Build muscle and drug tests
Nebido should not be used to build muscle or improve the physical performance of individuals who do not need treatment with Nebido for medical reasons.
Nebido can give a positive result in doping tests.
Addiction and addiction
Always take this medicine exactly as your doctor or pharmacist has told you.
Testosterone abuse, especially if you use too much medicine alone or in combination with other anabolic androgenic steroids, can cause serious health problems for your heart and blood vessels (which can lead to death), mental health, and/or liver.
Individuals who abuse testosterone may become addicted and may experience withdrawal symptoms when dose one changes markedly or if treatment is stopped abruptly. You should not abuse this drug separately or with other anabolic androgenic steroids as it may pose serious health risks (see “Possible side effects” )
Medical examination / follow-up
Male hormones can accelerate the development of prostate cancer and enlarged prostate gland (benign prostatic hyperplasia ). Before starting treatment with Nebido, your doctor should examine to check that you do not have prostate cancer.
Your doctor will regularly examine your prostate gland and breast tissue, especially if you are older. He/she will also take regular blood tests.
Following the use of hormonal substances such as androgenic compounds, cases of benign (non-carcinogenic) and malignant (carcinogenic) liver tumors have been observed.
Other medicines and Nebido
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Your doctor may need to adjust your dose if you are taking any of the following medicines:
- adrenocorticotropic hormone (ACTH) or corticosteroids (used to treat various diseases such as rheumatism, arthritis , allergies and asthma ). Nebido can increase the risk of water accumulation in the body, especially if your heart or liver is not functioning properly.
- blood-thinning tablets (coumarin-based, oral anticoagulants ) as this may increase the risk of bleeding. The doctor will check the dose one.
- drugs used to treat diabetes . It could benecessary to adjust the dose of one of your blood sugar lowering medicines. Like other androgens , testosterone can increase the effect of insulin .
Be sure to tell your doctor if you have problems with blood clotting as it is important for your doctor to know before deciding to inject Nebido.
Nebido may also affect some laboratory tests (eg thyroid ). Tell your doctor or laboratory staff that you are using Nebido.
Pregnancy and breastfeeding
Nebido should not be used by women and should not be used by pregnant or breastfeeding women.
Fertility
Treatment with high-dose testosterone preparations may temporarily stop or reduce sperm production (see also “Possible side effects”).
Driving and using machines
Nebido has no observed effect on the ability to drive or use machines.
Nebido contains benzyl benzoate
This medicine contains 2000 mg benzyl benzoate per 4 ml ampoule/vial equivalent to 500 mg/ml.
How to use Nebido
Your doctor will inject Nebido (1 ampoule/vial) very slowly into a muscle. He/she will give you the injections every 10 to 14 weeks.
Injections given at these time intervals can maintain adequate testosterone levels without giving too high levels of testosterone in the blood.
Nebido is for intramuscular injection only. Particular care will be taken not to inject one into a blood vessel (see ” Administration “).
Beginning of treatment
Your doctor will measure your testosterone levels before and at the beginning of treatment. Your doctor may give you the second injection after 6 weeks to quickly reach the required testosterone level, depending on your symptoms and testosterone levels.
Maintenance treatment
The injection intervals should always be within the recommended time range of 10-14 weeks. Your doctor will make regular measurements of your testosterone levels at the end of an injection interval to make sure they are at the right level. If the level is too low, the doctor may decide to give the injections more often. If testosterone levels are too high, your doctor may decide to give you injections less often. For you to maintain your optimal testosterone level, you mustn’t forget about your scheduled injection visits.
If you have the impression that the effect of Nebido is too strong or too weak, talk to your doctor.
If you use more Nebido than you should
Symptoms of an overdose of Nebido include
- irritation
- nervousness
- weight gain
- persistent or frequent erections
If you experience any of these, consult your doctor. Your doctor will give you your injections less often or end the treatment.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are acne and injection site pain.
Common side effects ( may affect up to 1 in 10 people):
- abnormally high number of red blood cells
- weight gain
- hot flashes
- acne
- enlarged prostate and associated problems
- various reactions where an injection was given (eg pain, bruising or irritation)
Uncommon side effects ( may affect up to 1 in 100 people):
- allergic reaction
- increased appetite, altered blood test results (eg increased blood sugar or blood fats)
- depression, emotional disturbance, insomnia, restlessness, aggression or irritability
- headaches, migraines or tremors
- heart disease, high blood pressure or dizziness
- bronchitis , sinusitis, cough, shortness of breath, snoring or voice problems
- diarrhea or nausea
- altered liver test results
- hair loss or various skin reactions (eg itching , redness or dry skin)
- joint pain, pain in arms and legs, muscle problems (eg spasms , pain or stiffness) or increased creatine phosphokinase in the blood
- urinary tract disorders (eg decreased urine flow, retention of urine in the bladder, nocturnal urination)
- prostate disorders (eg intraepithelial neoplasia of the prostate , or increasing hardness or inflammation of the prostate ), altered sexual desire, sore testicles, tender, hard or enlarged breasts, or elevated levels of the male and female hormones
- fatigue, general feeling of weakness, heavy sweating or night sweats
Rare side effects ( may affect up to 1 in 1,000 people):
- Nebido is an oil solution, which can end up in the lungs (microembolism in the lungs from oil solutions), which in rare cases can lead to symptoms such as cough, shortness of breath, general malaise, severe sweating, chest pain, dizziness, numbness / tingling or fainting. These reactions can occur during or immediately after injection one and go back ( reversible ).
Suspected anaphylactic reactions have been reported following injection of Nebido.
In addition to the side effects listed above, the following have been reported during treatment with preparations containing testosterone: nervousness, hostility, temporary pauses in breathing during sleep, various skin reactions such as dandruff and oily skin, increased hair growth, more frequent erections, and in very rare cases yellowish eyes and skin (jaundice).
Treatment with high-dose testosterone preparations often interrupts or reduces sperm production. However, the condition passes when the treatment is stopped.
Testosterone replacement therapy for weakly functioning testicles ( hypogonadism ) can in rare cases give a persistent, painful erection (priapism). Treatment with testosterone in high doses or for a long time can lead to water retention and edema (swelling due to fluid retention).
A common risk of increased red blood cell count, hematocrit (the percentage of red blood cells in the blood), and hemoglobin (the component of red blood cells that carry oxygen) have been observed in regular blood tests for testosterone products in general.
How to store Nebido
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the label after “EXP”. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance in Nebido is testosterone undecanoate 250 mg / ml (equivalent to 157.9 mg testosterone ).
One vial / vial contains 1000 mg testosterone undecanoate (equivalent to 631.5 mg testosterone ). - The other ingredients are benzyl benzoate and castor oil.
What the medicine looks like and contents of the pack
Nebido is a clear, yellowish oil solution. The package contains:
1 brown glass ampoule/glass vial with 4 ml solution for injection
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Bayer AB
Box 606
SE-169 26 Solna
Manufacturer
Bayer AG
D-13342 Berlin
Germany
This medicinal product is authorized under the European Economic Area under the names:
- Cyprus, Czech Republic, Greece, Denmark, Estonia, Latvia, Luxembourg, Malta, Poland and Portugal: Nebido
- Austria: Nebido 1000 mg / 4 ml solution for injection
- Belgium: Nebido 1000 mg / 4 ml, solution for injection
- Croatia: Nebido 1000 mg / 4 ml otopina for injection
- Finland: Nebido 1000 mg / 4 ml injection tea, liuos
- France: Nebido 1000 mg / 4 ml, injectable solution
- Germany: Nebido 1000 mg Solution for injection
- Hungary: Nebido 250 mg / ml oldatos injection
- Iceland: Nebido 1000 mg / 4 ml solution for injection
- Italy: NEBID 1000 mg / 4 ml inoperable solution
- Lithuania: Nebido 1000 mg / 4 ml injekcinis tirpalas
- Netherlands: Nebido 1000 mg / 4 ml
- Norway: Nebido 1000 mg / 4 ml solution for injection
- Slovakia: Nebido 1000 mg / 4 ml injectable drug
- Slovenia: Nebido 1000 mg / 4 ml injection for injection
- Spain: REANDRON 1000 MG / 4 ML INYECTABLE SOLUTION
- Sweden: Nebido 1000 mg / 4 ml solution for injection
- United Kingdom and Ireland: Nebido 1000 mg / 4 ml, solution for injection