Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Nebido 1000 mg/4 ml, solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, yellowish oily solution. |
Each ml solution for injection contains 250 mg testosterone undecanoate corresponding to 157.9 mg testosterone.
Each ampoule/vial with 4 ml solution for injection contains 1000 mg testosterone undecanoate corresponding to 631.5 mg testosterone.
Excipient with known effect: 2000 mg benzyl benzoate per ampoule/vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Testosterone |
Testosterone, secreted by the testes and its major metabolite dihydrotestosterone (DHT), is responsible for the development of the external and internal genital organs and for maintaining the secondary sexual characteristics (stimulating hair growth, deepening of the voice, development of the libido); for a general effect on protein anabolism; for development of skeletal muscle and body fat distribution; for a reduction in urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion. |
| List of Excipients |
|---|
|
Benzyl benzoate |
Ampoule: 5-ml brown glass (type I) ampoules, containing a fill volume of 4 ml.
Pack size: 1 × 4 ml.
Vial: 6ml brown glass (type I) vial with grey bromobutyl (foil-clad ETFE) injection stopper and bordered cap, containing a fill volume of 4 ml.
Pack size: 1 × 4 ml.
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
PL 00010/0549
Date of first authorisation: 20th October 2004
Date of lastest renewal: 25th November 2008
| Drug | Countries | |
|---|---|---|
| NEBIDO | Austria, Brazil, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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