Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Testosterone enantate
Alliance Pharmaceuticals Ltd
G03BA03
Testosterone enantate
250mg/1ml
Solution for injection
Intramuscular
Schedule 4 (CD Anab)
Valid as a prescribable product
BNF: 06040200; GTIN: 5024403000233
Testosterone PIL UK 007 PATIENT INFORMATION LEAFLET TESTOSTERONE ENANTATE 250MG/ ML SOLUTION FOR INJECTION Testosterone Enantate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Testosterone Enantate is and what it is used for 2. What you need to know before you use Testosterone Enantate 3. How to use Testosterone Enantate 4. Possible side effects 5. How to store Testosterone Enantate 6. Contents of the pack and other information 1. WHAT TESTOSTERONE ENANTATE IS AND WHAT IT IS USED FOR Testosterone Enantate is a manufactured version of the naturally occurring male sex hormone, testosterone. It is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as: • Impotence • Infertility • Low sex drive • Tiredness • Depressive moods • Bone loss caused by low hormone levels. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TESTOSTERONE ENANTATE Testosterone PIL UK 007 DO NOT USE TESTOSTERONE ENANTATE: • if you are allergic to Testosterone Enantate or any of the other ingredients of this medicine (listed in section 6) • if you suffer from androgen (steroid hormone) dependent prostate cancer or breast cancer • if you have high calcium levels in your blood • if you have or have had tumours of the liver • if you have kidney disease (nephrosis) WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE USING Lesen Sie das vollständige Dokument
OBJECT 1 TESTOSTERONE ENANTATE AMPOULES Summary of Product Characteristics Updated 02-Dec-2016 | Alliance Pharmaceuticals 1. Name of the medicinal product Testosterone Enantate 250 mg/ ml Solution for Injection. 2. Qualitative and quantitative composition Each 1ml ampoule contains 250mg Testosterone Enantate (the equivalent of about 180 mg testosterone) in oily solution. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection. Clear, yellowish oily solution. 4. Clinical particulars 4.1 Therapeutic indications Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. 4.2 Posology and method of administration METHOD OF ADMINISTRATION Solution for intramuscular injection. The injection must be administered extremely slowly (see 4.4 Special warnings and precautions for use and 4.8 Undesirable effects). The oily solution is injected immediately after its drawing up into the syringe. POSOLOGY To stimulate development of underdeveloped androgen-dependent organs and for initial treatment of deficiency symptoms, 250mg Testosterone Enantate intramuscularly every two to three weeks. For maintenance treatment: 250mg Testosterone Enantate intramuscularly every three to six weeks, according to individual requirement. Serum testosterone levels should be measured before start of treatment and occasionally during the treatment at the end of an injection interval. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered. SPECIAL POPULATIONS PAEDIATRIC POPULATION Testosterone Enantate is not indicated for use in children and adolescents (see 4.4 Special warnings and precautions for use). Safety and efficacy have not been adequately determined in children and adolescents. ELDERLY PATIENTS Limited data do not suggest the need for a dosage adjustment in elderly patients (see 4.4 Special war Lesen Sie das vollständige Dokument