Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Testosterone propionate; Testosterone phenylpropionate; Testosterone decanoate; Testosterone isocaproate
Aspen Pharma Trading Ltd
G03BA03
Testosterone propionate; Testosterone phenylpropionate; Testosterone decanoate; Testosterone isocaproate
30mg/1ml ; 60mg/1ml ; 100mg/1ml ; 60mg/1ml
Solution for injection
Intramuscular
Schedule 4 (CD Anab)
Never Valid To Prescribe As A VMP
BNF: 06040200; GTIN: 5013257001671 5013945300536
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SUSTANON 250, 250 MG/ML, SOLUTION FOR INJECTION (testosterone esters) 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 further questions, please ask your doctor or your 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. WHAT IS IN THIS LEAFLET: 1. WHAT SUSTANON 250 IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE SUSTANON 250 IS ADMINISTERED 3. HOW SUSTANON 250 IS ADMINISTERED 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SUSTANON 250 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SUSTANON 250 IS AND WHAT IT IS USED FOR Sustanon 250 is a clear pale yellow solution for injection containing the active ingredient testosterone in 4 (250 mg/ml) separate forms. The active substances of Sustanon 250 (see section 6 “What Sustanon 250 contains” are turned into testosterone by your body. Testosterone is a natural male hormone known as an androgen. In men, testosterone is produced by the testicles. It is necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. It is necessary for the growth of body hair, the development of bones and muscles, and it stimulates the production of red blood cells. It also makes men’s voices deepen. Sustanon 250 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 and bone loss caused by low hormone levels. Sustanon 250 may Baca dokumen lengkap
OBJECT 1 SUSTANON 250, 250MG/ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 03-Jan-2017 | Aspen 1. Name of the medicinal product Sustanon 250, 250mg/ml solution for injection 2. Qualitative and quantitative composition Sustanon 250 is a solution in oil. Each ampoule contains 1 ml arachis oil containing the following active substances: - 30 mg Testosterone propionate - 60 mg Testosterone phenylpropionate - 60 mg Testosterone isocaproate - 100 mg Testosterone decanoate All four components are esters of the natural hormone testosterone. The total amount of testosterone per ml is 176 mg. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection A clear, pale yellow 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. Testosterone administration may also be used as supportive therapy for female-to-male transsexuals. 4.2 Posology and method of administration POSOLOGY In general, the dose should be adjusted to the response of the individual patient. _Adults (incl. elderly):_ Usually, one injection of 1ml per 3 weeks is adequate. _Paediatric population:_ Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Sustanon 250 should be treated with caution (see section 4.4). _Female-to-male transsexuals:_ Different specialist centres have used doses varying from one injection of 1ml every two weeks to one injection of 1ml every four weeks. Method of administration Sustanon 250 should be administered by deep intramuscular injection. 4.3 Contraindications • Pregnancy (see section 4.6). • Known or suspected carcinoma of the prostate or breast (see section 4.4.). • Breast-feeding. • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including arachis oil. Sustanon 250 is therefore contraindicated in patien Baca dokumen lengkap