Section 1 Addition of 'solution for injection' after product name
Section 2 Actives have been re-formatted as lower case
Section 3 Pharmaceutical form has been re-described as 'solution for injection'
Section 4.1 Addition of the following sentence: Testosterone administration may also be used as supportive therapy for female-to-male transsexuals.
Section 4.2 Addition of the following text:
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.
Section 4.3 The following text has been amended from: Hypersensitivity to one of the excipients to Hypersensitivity to the active substance or to any of the excipients.
Section 4.4 Addition of the following text:
Long term monitoring should include measurement of haemoglobin.
Female-to-male transsexual supportive therapy
Before initiating Sustanon for female-to-male transsexuals, specialist assessment should be undertaken, including psychiatric assessment. A complete personal and medical history should be taken. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual. The following should be monitored:
▪ signs of osteoporosis,
▪ changes in lipid profile.
In patients with a personal or family history of breast cancer and with a personal history of endometrial cancer, careful monitoring should be undertaken.
Subject to specialist advice, hysterectomy and bilateral oophorectomy should be considered after 18-24 months of testosterone treatment, to reduce the possible increased risk of endometrial and ovarian cancer.
Continued surveillance is required to detect osteoporosis in patients who have undergone oophorectomy, as testosterone may not fully reverse the decline in bone density in these patients.
Continued surveillance is required to detect endometrial and ovarian cancer in patients on long term treatment who have not proceeded to hysterectomy and bilateral oophorectomy.
Section 4.8 The word 'develop' has been re-arranged in the following sentence:
Hoarseness of the voice may be the first symptom of vocal change which may lead to irreversible lowering of the voice. If signs of virilisation develop, particularly lowering of the voice, treatment should be discontinued unless the effects are desired treatment outcomes.
The following text has been added:
The following undesirable effects have also been observed:
§ acne
§ disturbance of liver function
§ polycythaemia
§ hypertension
§ weight gain (in female-to-male transsexuals)
Section 5.1 Addition of ATCCode:
ATC code: GO3B A urogenital system (including sex hormones)
Section 5.2 Addition of 'in males' (underlined and in bold).
A single dose of Sustanon 250 in males leads to an increase of total plasma testosterone, with peak level reached approximately 24-48hrs (tmax) after administration. Plasma testosterone levels return to the lower limit of the normal range in males after approximately 21 days.
Additional sentence added:
In female-to-male transsexuals, a single dose of Sustanon 250 repeated every two weeks resulted in mean trough testosterone levels towards the upper end of the normal male range at 2, 4 and 12 months.
Section 6.1 strength removed from excipients:
Benzyl Alcohol Ph. Eur.
Arachis Oil Ph. Eur.
Section 6.2 The following text has been removed: No relevant incompatibilities are known and has been replaced by 'not applicable'
Section 6.6 ‘Not applicable’ has been deleted and replaced by ‘No Special requirements’
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