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Trade Name |
Testosterone Enanthate/Norma |
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ÁTC_Code |
G03BA03 | |
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Active Substance |
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Phamaceutical Form |
OILY.INJ.SOL | |
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Composition |
250mg/ml | |
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Product Id |
10219 | |
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Specification |
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| TESTOSTERONE ENANTHATE/NORMA® Specific Product Characteristics (S. P. C.) - Trade name of the Medicinal Product TESTOSTERONE ENANTHATE/NORMA ® -Qualitative and Quantitative Composition: Each ml of Testosterone Enanthate/Norma® (one ampoule) contains 250 mg Testosterone Enanthate (corresponding approximately to 180 mg Testosterone). -Pharmaceutical Form Oily Inj. Solution -Clinical Particulars/Therapeutic Indications: In men As a replacement therapy in male hypogonadal disorders caused by either primary testicular disorders or epiphyses insufficiency. In women As a supplementary therapy in disseminated breast carcinoma in postmenopausal period. -Posology and Administration: Posology-Administration for males: Testosterone Enanthate/Norma® should be intramuscularly injected just like all oily solutions. Reactions of short duration that may develop in patients during or immediately after the injection (cough, dyspnea) are avoided, based on the exprerience gained, following a very low rate of the intramuscular administration. Hypogonadism In order to maintain the sufficient androgenic result, 250 mg should be intramuscularly injected every 3-4 weeks. Depend to each individualized hormonal insufficiency it may be imperative to curtail the time intervals between the injections. Often time periods up to 6 weeks between the injections may be sufficient. Posology-Administration for females: Testosterone Enanthate/Norma® should be intramuscularly injected just like all oily solutions. Reactions of short duration that may develop in patients during or immediately after the injection (cough, dyspnea) are avoided, based on the exprerience gained, following a very low rate of the intramuscular administration. During cancer therapy, androgenic treatment does not replace either operation or radiation. Testosterone Enanthate/Norma® is administered as a supplementary therapy in disseminated breast carcinoma in postmenopausal period. Intramuscularly injected every 2 weeks may induce, at a certain percentage of the patients, objective remissions. Most often pain remisses and the general condition of the patient is improved while the stimulating action of Testosterone on the mental state is proved to be extremely advantageous. Osteal metastasis is positively affected. Sometimes in order to maintain the positive results it is imperative to decrease the intermediate periods of time. -Contraindications: Prostatic cancer, breast cancer in males, prior or existing liver tumors (it is administered in women as a supplementary therapy in disseminated breast carcinoma not caused by metastasis). -Special Warnings and Precautions for Use: The prolonged action of testosterone enanthate allows longer periods of time between the injections. Testosterone ester has not only prolonged activity but also very intense androgenic action. The duration of action of a 250mg ampoule of Testosteron Enanthate/Norma® increases in relation to the hormonal initial value, within 2-4 weeks approximately. It is recommended that the prostate be examined regularly during treatment. Androgens are not indicated to induce muscular development or increase the energy level. If, in women with breast carcinoma during hormonal treatment, hypercalcemia develops, then the treatment should be discontinued. In rare reports, following administration of hormonal active substances, such as those contained in Testosterone Enanthate/Norma®, benign and malignant hepatic transformations may develop, which have caused individually life-threatening abdominal hemorrhages. For this reason when unusual abdominal pain develops and does not recede immediately, the doctor should be informed, as the treatment may be imperative to be discontinued. -Interactions with Other Drugs and Other Form of Interactions: Interactions with other drugs have not been reported till now. -Effects on Ability to Drive and Use Machines: None. -Adverse Events: High doses or prolonged treatment with testosterone increases occasionally water retention and oedema development. In patients with the tendency to develop oedema caution is required. In women with individualized sensitivity to androgenic stimule may experience symptoms of virilisation such as acne, hypertrichosis, voice changes, (caution is required especially in women that work as singers or speakers). Prolonged treatment and large doses suppress spermatogenesis. If, in isolated cases, more often or prolonged penile erection occurs then the dose should be reduced or the treatment should be discontinued so as to avoid possible damage. -Overdosage: Poisoning phenomena: Poisoning phenomena in acute overdosage (intentional or by mistake oral administration of higher doses) should not be expected based on the experimental pharmacotoxicological action of the pharmaceutical product Data on poisoning phenomena in humans have not been reported. For this reason, advise on special therapeutic measures cannot be given. -Ecxipients: Benzyl Benzoate, Oleum Ricine. -Special storage instructions: Do not store above 25 degrees C protected from light. Keep out of the reach and sight of children. -Contents and type of the container: Glass hydrolysis class I ampoule of 1 ml Ohis leaflet was last approved on 20-08-2003. Marketing Authorization Holder: NORMA HELLAS S.A. 54, Menandrou St, 10431 Athens Greece Tel: 210 52 22 282 Fax: 210 52 21 468 E mail: norma@comtech.gr http://www.normahellas.gr |
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