Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology park, Dublin 17, D17 E400, Ireland
Belkyra 10mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). A clear, colourless solution, free from visible particles. The formulation is adjusted to pH 8.3 with hydrochloric acid or sodium hydroxide and has a tonicity compatible with that of biological tissues and fluids at an osmolality of 300 mOsm/kg. |
1 ml solution for injection contains 10 mg deoxycholic acid.
Each vial contains 20 mg of deoxycholic acid in 2 ml solution.
Excipient(s) with known effect: Each mL contains 184 µmol (or 4.23 mg) of sodium from sodium chloride, sodium hydroxide and disodium phosphate anhydrous.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Deoxycholic acid |
Deoxycholic acid is a cytolytic drug, which when injected into localized subcutaneous fat, physically disrupts the cell membrane of adipocytes. The destruction of adipocytes elicits a tissue response in which macrophages are attracted to the area to eliminate cellular debris and lipids, which are then cleared through natural processes. |
| List of Excipients |
|---|
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Water for injection |
Solution for injection in a vial (Type I glass), fitted with a stopper (chlorobutyl rubber) and a seal (aluminium) with flip-top lid (polypropylene).
One carton contains 4 vials. Each vial contains 2 ml solution for injection.
Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology park, Dublin 17, D17 E400, Ireland
PA2103/003/001
Date of first authorisation: 2nd June 2017
| Drug | Countries | |
|---|---|---|
| BELKYRA | Austria, Brazil, Canada, Estonia, Spain, Finland, Hong Kong, Ireland, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, United Kingdom |
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