Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Immedica Pharma AB, SE-113 29 Stockholm, Sweden
AMMONAPS 500 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. The tablets are off-white, oval and embossed with “UCY 500”. |
Each tablet contains 500 mg sodium phenylbutyrate.
Excipient(s) with known effect:
Each tablet contains 2.7 mmol (62 mg) of sodium.
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 |
|---|
|
Microcrystalline cellulose |
HDPE bottles, with child resistant caps, containing 250 or 500 tablets.
Not all pack sizes may be marketed.
Immedica Pharma AB, SE-113 29 Stockholm, Sweden
EU/1/99/120/001 (250 tablets)
EU/1/99/120/002 (500 tablets)
Date of first authorisation: 08/12/1999
Date of latest renewal: 08/12/2009
| Drug | Countries | |
|---|---|---|
| AMMONAPS | Austria, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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