Nebido 1000 MG/4 ML ingredient testosterone

INSTRUCTIONS FOR USE

NEBIDO® (250 mg / ml) vial4 ml

is administered intramuscularly in.

• Excipients: Benzyl benzoate, castor oil suitable for injection.

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When you go to the doctor or hospital during the use of this medicine, tell your doctor that you are taking this medicine.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is NEBIDO® and what is it used for?

2. Cautions before using NEBIDO®

3. How to use NEBIDO®?

4. What are the possible side effects?

5. NEBIDO® storage

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1. What is NEBIDO® and what is it used for?

• NEBIDO® contains 1000 mg of testosterone undecanoate in 4 ml of solution.

• Testosterone undecanoate, an active ingredient in NEBIDO®, is an ester of testosterone, the most important sex hormone found in men. It provides male type characteristics in males.

• NEBIDO® is available as 1 vial containing 4 ml of solution.

• NEBIDO® is used to supplement testosterone insufficiency in men.

2. Cautions before using

NEBIDO® DO NOT use NEBIDO®

if:

- Masculinity forming properties, or if the features of the development of the stimulus depends on androgen, a hormone that prostate or male mammary gland cancer you have or suspect or have had

-if there is an increase of cancer-related blood calcium in your amount or if it has happened in the past

- if you have liver tumors or if it was in the past,

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- If you are allergic to any of the substances in the drug,If you are a woman.

CAREFULLY USE NEBIDO®

if:

- If you are elderly,

- If you have a prostate problem,

- If you have an increase in your red blood cells,If you have a

-liver tumor,,

- If you have a tendency to pay- If you are

under 18 years old

- If you have problems with breathing during sleep.

Male hormones may increase the development of prostate cancer and the growth of benign prostate gland (benign prostatic hypertrophy). Before injecting NEBIDO®, your doctor will examine you to check for prostate cancer. If your age is advanced, the risk of developing prostate enlargement during the use of androgens such as NEBIDO® may be higher. Although there is no clear evidence that androgens constitute prostate cancer, they may increase the growth of existing prostate cancer.

Your doctor, especially if you are older, will perform regular prostate examinations, and will regularly take a blood sample from you.

Following the use of hormonal agents such as testosterone compounds, it has rarely been observed that good and malignant liver tumors occur. These liver tumors were very rare and malignant (cancerous). Although it is unlikely that a tumor will emerge, this will be a health concern. In rare cases, there may be internal bleeding from these tumors that may endanger life. Therefore, if you suffer from severe abdominal pain, you should consult a doctor immediately. All unusual sensations that you may feel in your upper abdomen cannot be considered as a possible sign of the tumor or bleeding. However, it will be correct to inform your doctor of the situation that does not occur within a short time.

NEBIDO® and similar androgen-containing drugs are not suitable for increasing muscle development and physical ability in healthy individuals.

Reactive anaphylactic (a systemic and dangerous disease that is sudden due to allergy and is fatal if not urgently treated) is reported after Nebido injection.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Use ofuse of

NEBIDO® with food and drink There is no information available on theNEBIDO® with food and drink.

Vehicle and machine useuse of

No effect on thevehicles and machines has been observed.

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Important information about some of the excipients

contained in NEBIDO® NEBIDO® may cause serious allergic reactions due to the castor oil contained in it.

Use with other drugsuse

• If youNEBIDO® with the following drugs, tell your doctor. Performing some blood tests may be appropriate:

- tranquilizers or sleeping problems of drugs used to correct (for example barbiturates, or other enzyme inducers)

- with a pain reliever oxyphenbutazone,

- blood clotting (anticoagulant) drugs

- for treating diabetes medications

If prescription or Please inform your doctor or pharmacist if you are currently using any prescription medication or have recently used it.

3. How to use NEBIDO®?

Instructions for appropriate use and dose / frequency of administration:

Your doctor will determine the dosage of your medicine and apply it to you, depending on your disease.

NEBIDO® is administered at intervals of 10-14 weeks.

Your doctor will regularly test your testosterone values ​​at the start and early stages of treatment to ensure that your testosterone levels are at the right level. If the level in question is too low, you may decide to apply more frequent injections. If your testosterone levels are high, you can reduce the frequency of injections. Do not skip your injection appointments. Otherwise, the appropriate testosterone level will not be maintained.

Please contact your doctor if you believe that NEBIDO® is too low or too high.

Method and method of:

administrationNEBIDO® should be administered intramuscularly. The application should be extremely slow.

Different age groups::

Use in children It should not be used in children and adolescents. NEBIDO®-related clinical trials were not performed in men under 18 years of age.

Use in the elderly: Dose adjustment is not required in elderly patients.

Specific Use Cases:

Renal / hepatic impairment: NEBIDO® should be used with caution in patients with renal or hepatic impairment, since there is no study with NEBIDO® in these patients. NEBIDO® should not be used in patients with past or already liver tumors.

If you have an impression that the effect of NEBIDO® is too strong or too weak, talk to your doctor or pharmacist.

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If you have used more NEBIDO® than you should use: If you have used more than NEBIDO®

, talk to a doctor or pharmacist.

If you forget to use NEBIDO®:

Do not take double doses to compensate for forgotten doses.

Effects when

NEBIDO® is discontinued When treatment with NEBIDO® is terminated, symptoms of testosterone deficiency may reappear.

If you have any further questions regarding the use of this medicine, ask your doctor.

4. What are the possible side effects?

Like all medicines, NEBIDO® may have side effects in people who are sensitive to the ingredients in its contents.

If this occurs, stop using NEBIDO® and tell your doctor immediately or contact your nearest hospital emergency department:

• Hypersensitivity

This is a very serious side effect.

If you have this, you have serious allergy to NEBIDO®. You may need urgent medical attention or hospitalization.

If you notice any of the following, report to your doctor immediately or contact the emergency department of the hospital nearest you:

• Cardiovascular disease

• High blood pressure

• Shortness of breath

• Increase in prostate enzymes

• Prostate growth

• Prostate cancer

• Prostate infection

• Prostatic stiffness

• Prostate disease

• Anaphylactic reaction (a systemic and dangerous disease that occurs suddenly due to allergy and is fatal if not urgently treated)

These are all serious side effects. Emergency medical intervention may be required.

If you notice any of the following, tell your doctor:

• Increase in red blood cells

• Weight gainIncrease in

•appetite • Increase in the

amount of sugar-bound hemoglobinIncrease in

•blood fats

• Depression

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• Emotional disorder

• Insomnia

• Fatigue

• Irritability

• Tension

• Headache

• Migraine

• Chills

• Hot flashes

• Stuns

• Blood pressure elevation

• Bronchitis

• Sinusitis

• Cough

• Snoring

• Sound Disorder

• Diarrhea

• Nausea

• Disorder in liver tests

• Acne

• Hair loss

• Redness

• Rash

• Itching

• Dry skin

• Joint pain

• Arm-leg pain

• Muscle spasm

• Muscle tension

• Muscle pain

• Muscle stiffness

• Increase in muscle enzymes

• Decrease in urine flow

• Urinary incontinence

• Id r tract diseases

•Night  Inability

urination• Painful urination

• Sexual desire increase or decrease

• Testicular pain in

• hardness in the breast

• Breast pain

• Breast enlargement

• an increase in female hormones

• blood free testosterone increase

• Injection site reactions

• Excessive sweating

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• Night sweats

• Speech difficulty

• Frequent urination at night

These are mild side effects of NEBIDO®.

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.

In addition to the aforementioned side effects, testosterone-containing compounds have reported irritability, aggression, short cuts in breath during sleep, a number of skin reactions such as dandruff and oily skin, more frequent erections, and extremely rare eye and skin yellowing (jaundice).

Suspected anaphylactic reactions after nebido injection (a systemic and dangerous disease that occurs suddenly due to allergy and which are fatal if not urgently treated) have been reported.

Treatment with high-dose testosterone-containing compounds usually reduces or stops the production of sperm, even after the treatment is discontinued. In rare cases, the treatment of testosterone-supplementing testes (hypogonadi