Drop Card 1 Symptoms & Dosage

Differential Strata of Androgen Levels Associated With VariousSymptoms.3

Nebido® A Simple Dosing Regimen.1,2 Dosing frequency should be adjusted according to a patient’s testosterone level and clinical symptoms.1 It is recommended that the first injection interval is reduced to 6 weeks to rapidly achieve steady-state testosterone levels.1Nebido® Maintains Serum Testosterone Levels WithinThe Normal Physiological Range.2 Serum testosterone [nmol/L]Pharmacokinetics of Testosterone Enanthate (TE) and Testosterone Undecanoate (TU) i.m. in Hypogonadal Men* 4 60 250 mg TE 50 1000 mg TU 40 30 Normal range 10-35 nmol/L 20 10 0 0 2 4 6 8 10 12 Weeks after single administration* Basal testosterone levels < 6 nmol/LReference:1- Nebido Summary of product Characteristics. NOV 2012.2- Traish AM Haider A, Doros G, Saad F. Long-term testosterone therapy in hypogonadal men ameliorates elements of the metabolicnsyndrome: an observational, long-term registry study. Int J Clin Pract,2014;68(3):314-329.3- Zitzmann M, Faber S, Nieschlag E. Association of specific symptoms and metabolic risks with serum testosterone in older men. J Clin Endocrinal Metab. 2006;91(11):4335-43.4- Nieschlag & Behre 1996Abbreviated Package Insert Leaflet: Product Name: Nebido 1000 mg solution for injection Composition: The active substance is: testosterone undecanoate. 1 mL solution for injection contains 250 mg testosterone undecanoate, equivalent to 157.9 mg testosterone. 1 vial with 4 mL solution for injection contains 1000 mg testosterone undecanoate. The other ingredients are: benzyl benzoate and refined castor oil.Indications: Nebido contains the male sex hormone testosterone as its active substance. Nebido is injected via the intramuscular route. It is stored in the muscle and gradually released over a prolonged period of time. Nebido is used in adult men for testosterone replacement therapy to treat various complaints caused by a lack of testosterone (male hypogonadism). These clinical signs must be confirmed by two mutuallyindependent measurements of testosterone concentrations in the blood. Such clinical signs may include the following: sexual dysfunction (impotence), sterility (infertility), reduced sex drive, tiredness, depressed mood, loss of bone substance due to low hormone concentrations. Contraindications: if allergic (hypersensitive) to testosterone undecanoate or any of the other ingredients of Nebido have, or have ever had, prostateor male breast cancer, either suspected or confirmed, the growth of which is stimulated by male sex hormones (androgens). have, or have ever had, a liver tumour. Nebido is not intended for use in women. Nebido must not be used in children and adolescents. No data are available for the use of Nebido in male adolescents below 18 years of age. Warning and precautions: The patient should inform the doctor if he have,or have ever had, any of the following illnesses: epilepsy, heart, kidney or liver disease, migraine, temporary gaps in the breathing while asleep (sleep apnoea), as these may get worse. cancer, as the calcium concentrations in blood may have to be regularly monitored. blood-clotting disorders. suffer from a severe heart, liver or kidney disorder, treatment with Nebido may cause serious complications due to the onset of fluidaccumulation within the body, which may sometimes be accompanied by a build-up of blood (congestive heart failure). Elderly patients (65 years or older). over 65, doctor will generally not perform any dose adjustment (dose increase). liver no longer works properly: No formal studies have been performed in patients with impaired liver function. have ever had a liver tumour, the doctor will not prescribed Nebido. Medicalexaminations/check-ups: Male sex hormones can speed up the growth of pre-existing prostate cancer or benign prostate enlargement (benign prostate hypertrophy). Before injecting Nebido, the doctor will examine the patient to check whether he have prostate cancer. The doctor will regularly examine the prostate and breast, especially if elderly. He will also take regular blood samples. When using hormonal substances, e.g.androgen preparations, cases of benign (non-cancerous) and malignant (cancerous) liver tumours have been observed. Effects if misused for doping purposes: The use of Nebido can lead to positive results in doping tests. Androgens, such as those contained in Nebido, are not suitable for stimulating muscle development in healthy persons or for enhancing physical performance. The health consequences of using Nebidoas a doping agent cannot be predicted; serious health hazards cannot be excluded. Interactions: The patient should inform the doctor or pharmacist if he is taking or have recently taken any other medicines, including medicines obtained without a prescription. The doctor may have to adjust the dose if the patient is taking or using one or several of the following medicines: the ACTH hormone (adrenocorticotropic hormone– a certain pituitary hormone) or corticosteroids (used to treat various disorders, e.g. rheumatism, arthritis, allergies and asthma): Nebido can increase the risk of fluid accumulation in tissue, especially if you suffer from heart or liver disease. tablets that prevent the blood from clotting (anticoagulants). If the patient is diabetic, it may be necessary to adjust the insulin dose. Nebido can also affect the results of some laboratorytests (e.g. thyroid). The patient should tell the doctor that he is using Nebido. Pregnancy and breast-feeding: Nebido is not intended for use in women. Nebido must not be used in pregnant or breast-feeding women. Testosterone replacement therapy can temporarily suppress sperm production. Driving and using machines: Nebido has no influence on the ability to drive and use machines. Administration: The doctor willinject Nebido (1 vial) very slowly into a muscle. The injections will be given every 10 to 14 weeks. This will be enough to maintain sufficient testosterone levels, without causing any accumulation of testosterone in the blood. Special care must be taken to avoid injecting into a blood vessel. Nebido is intended for intramuscular injection only, whereby special care must be taken to avoid injecting into a blood vessel. Start oftreatment: Before the start of treatment and during the early treatment phase, the doctor will measure testosterone concentrations in the blood. To achieve sufficient testosterone levels rapidly, the doctor may give a second injection as early as after 6 weeks. This procedure will depend on the signs of illness (symptoms) and how high the testosterone levels are. Maintaining testosterone levels during treatment: The injectioninterval should remain within the recommended range of 10 to 14 weeks. The doctor will measure the testosterone concentrations at the end of each injection interval to ensure that the patient is receiving the right amount. If the concentration is too low, the doctor may give the injections more frequently. If the testosterone levels are too high, the doctor may give the injections less frequently. The patient should not miss hisinjection appointments. Otherwise, his optimal testosterone levels will not be maintained. The patient should talk to his doctor if he have the impression that the effect of Nebido is too strong or too weak. If the patient is administered too much Nebido: The following symptoms, among others, may indicate that the have been administered too much Nebido: irritability, nervousness, weight gain, persistent and frequent erections,The patient should talk to his doctor if he have any of these symptoms. The doctor will give him Nebido injections less frequently or will discontinue treatment. Side effects: Like all medicines, Nebido can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if the patient notice any side effects not listed in this leaflet, the patient should tell his doctor or pharmacist. The most commonside effects are acne and pain at the injection site. increase in blood cells, weight gain, hot flushes, acne, benign prostate enlargement and associated symptoms, rise in a PSA level (prostate-specific blood test), various reactions at the injection site (e.g. pain, bruising and irritation), allergic reaction, increase in red blood cells and rise in haemoglobin levels (Hb) in the blood, increased appetite, changes in blood test results (e.g.increase in blood sugar and fats), depression, emotional disorder, insomnia, restlessness, aggression and irritability, headache, migraine and trembling, impairment of cardiovascular system, high blood pressure and dizziness, bronchitis, sinusitis, cough, shortness of breath, snoring and hoarseness, diarrhoea and nausea, changes in blood test results to measure liver function, hair loss and various skin reactions (e.g. itching,redness and dry skin), joint pain, pain in the extremities, muscle disorders (e.g. muscle cramps, muscle pain and muscle stiffness) and a rise in creatine phosphokinase in the blood, urinary tract disorders (e.g. decreased urine flow, inability to pass water, night-time urination), prostate disorders (e.g. prostatic intraepithelial neoplasia (tumour formation), hardening and inflammation of the prostate), altered sex drive, painful testicles,painful, hardened or enlarged breast, rise in male or female sex hormones in the blood, tiredness, weakness, excessive sweating and night sweats, Nebido, as an oily liquid, can get into the lungs (pulmonary microembolism of oily solutions) which, in rare cases, may lead to signs and symptoms such as cough, shortness of breath, generally feeling unwell, excessive sweating, chest pain, dizziness, “stinging and pins-and-needles”and fainting. These reactions can occur during or immediately after the injection and are reversible. Suspected cases of hypersensitivity reactions (anaphylactic reactions) have been reported following a Nebido injection.In addition to the side effects listed above, the following side effects have been reported during treatment with preparations containing testosterone: nervousness, hostility, short gaps in breathing while asleep,various skin reactions including flaking and greasy skin, frequent erections and, very rarely, yellowing of the skin and eyes (jaundice). Treatment with high doses of testosterone preparations will generally halt or reduce sperm production. These changes regress upon discontinuation of treatment. Testosterone replacement therapy to treat decreased testicular function (hypogonadism) can, in rare cases, cause painful persistenterections (priapism). High-dose treatment or long-term treatment with testosterone occasionally leads to increased incidence of fluid accumulation and oedema (swelling caused by fluid accumulation). Notes: The solution for intramuscular injection must be visually inspected prior to use. Only clear, particle-free solutions may be used. The contents of an vial must be injected via the intramuscular route immediately after openingthe vial. This medicinal product is intended for single use only. Any unused solution must be discarded. Administration: Special care must be taken to ensure that intravascular injections are avoided. In common with all oily solutions, Nebido must be injected precisely and very slowly via the intramuscular route. In rare cases, pulmonary microembolism of oily solutions can lead to signs and symptoms such as cough, dyspnoea,malaise, hyperhidrosis, thoracic pain, dizziness, paraesthesia or syncope. These reactions can occur during or immediately after the injection and are reversible. Treatment is usually with supportive measures, e.g. by additional administration of oxygen. Suspected cases of anaphylactic reactions following Nebido injections have been reported. Warnings: During testosterone treatment, careful and regular examinations of theprostate and breast must be performed using currently established testing methods (rectal digital examination and monitoring of the PSA serum level) at least once yearly and twice yearly in elderly patients and in patients at risk (with certain clinical or family-related risk factors). In addition to laboratory tests to determine testosterone concentrations, the following laboratory parameters should also be regularly checked in patientson long-term androgen therapy: haemoglobin, haematocrit and liver function tests. Date of the information: November, 2012. For further information please contact: Bayer Middle East FZE, Dubai Internet City, Office Park Building, Block A, 5th Floor - P.O.Box 500829 Phone: +971 4 4452700 - Fax: +971 4 4413247 - Web: www.Bayer.com - Email : [email protected]