PHEBURANE Granules Ref.[7695] Active ingredients: Sodium phenylbutyrate

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands

Product name and form

PHEBURANE 483 mg/g granules.

Pharmaceutical Form

Granules.

White to off-white granules.

Qualitative and quantitative composition

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)
Hypromellose
Ethylcellulose N7
Macrogol 1500
Povidone K25

Pack sizes and marketing

HDPE bottle, child-resistant closure with desiccant, containing 174 g of granules. Each carton contains one bottle.

A calibrated measuring spoon is provided.

Marketing authorization holder

Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands

Marketing authorization dates and numbers

EU/1/13/822/001

Date of first authorisation: 31 July 2013
Date of latest renewal: 23 March 2018

Drugs

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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