Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands
PHEBURANE 483 mg/g granules.
| Pharmaceutical Form |
|---|
|
Granules. White to off-white granules. |
Each gram of granules contains 483 mg of sodium phenylbutyrate.
Excipient(s) with known effect: Each gram of sodium phenylbutyrate contains 124 mg (5.4 mmol) of sodium and 768 mg of sucrose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sodium phenylbutyrate |
Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate. Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys. On a molar basis, phenylacetylglutamine is comparable to urea (each containing 2 moles of nitrogen) and therefore provides an alternate vehicle for waste nitrogen excretion. |
| List of Excipients |
|---|
|
Sugar spheres (sucrose and maize starch) |
HDPE bottle, child-resistant closure with desiccant, containing 174 g of granules. Each carton contains one bottle.
A calibrated measuring spoon is provided.
Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands
EU/1/13/822/001
Date of first authorisation: 31 July 2013
Date of latest renewal: 23 March 2018
| Drug | Countries | |
|---|---|---|
| PHEBURANE | Austria, Australia, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, United Kingdom |
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