Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**4.2 Posology and method of administration** Posology: In general, the dose should be adjusted according to the response of the individual patient. _Adults (incl. elderly):_ Usually, one injection of 1 ml per three weeks is adequate. _Paediatric population:_ Safety and efficacy have not been adequately determined in children and adolescents. Method of administration: Sustanon should be administered by deep intramuscular injection.
INTRAMUSCULAR
Medical Information
**4.1 Therapeutic indications** Testosterone replacement therapy in male with primary and secondary hypogonadal disorders, (either congenital or acquired) when testosterone deficiency has been confirmed by clinical features and biochemical tests, for example: - After castration, - Eunuchoidism, - Hypopituitarsim, - Endocrine impotence, - Male climacteric symptoms such as decreased libido and decreased mental and physical activity, - Certain types of infertility due to disorders of spermatogenesis In female to male transsexuals: - masculinization.
**4.3 Contraindications** - Known or suspected carcinoma of the prostate or breast (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Hypersensitivity to the active substance or to any of the excipients, including arachis oil. Sustanon is therefore contraindicated in patients allergic to peanuts or soya (see section 4.4. – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)
G03BA03
testosterone
Manufacturer Information
DCH AURIGA SINGAPORE
EVER Pharma Jena GmbH (bulk and primary packager)
Active Ingredients
Documents
Package Inserts
Sustanon Injection PI.pdf
Approved: June 9, 2020