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Swedish Orphan Biovitrum Ltd
1 Fordham House Court, Fordham House Estate, Newmarket Road, Cambridgeshire, CB7 5LL
Telephone: +44 (0)1638 722 380
Fax: +44 (0) 1638 723 167
WWW: http://www.sobi.com
Medical Information Direct Line: + 44 (0) 1638 722 380
Medical Information e-mail: sobi@professionalinformation.co.uk
Customer Care direct line: +44 (0) 1638 722 380
Medical Information Fax: + 44 (0) 1638 723 167

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Summary of Product Characteristics last updated on the eMC: 31/08/2011
SPC AMMONAPS 940 mg/g granules

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 31/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
From 10 2009 to 10 2010
Updated on 18/08/2010 and displayed until 31/08/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following sections have been updated;
2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of granules contains 940 mg of sodium phenylbutyrate.

One small spoon of AMMONAPS granules contains 149 mg of sodium.

One medium sized spoon of AMMONAPS granules contains 384 mg of sodium.

One large spoon of AMMONAPS granules contains 1116 mg of sodium.

4.2       Posology and method of administration; Note not changes to the text, only the order that the paragraphs appear.

4.8       Undesirable effects: Note the order in which the paragraphs appear has been changed along with the following paragraph that has been updated;

Adverse reactions mainly involved the reproductive and gastrointestinal system.

The adverse reactions are listed below, by system organ class and by frequency. Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

6.3       Shelf life: the following sentence has been added to this section.

During the shelf life the patient may store the finished product for a single period of 3 months at a temperature not above 25°C, after which the product must be discarded.

6.4       Special precautions for storage: A sentence has been removed from this section

6.5       Nature and contents of container: the following sentence has been updated/added to this section

HDPE bottles, with child resistant caps, containing 266 g or 532 g of granules.

6.6       Special precautions for disposal and other handling:the following paragraph has been updated.

It is recommended that a heaped measuring spoon is removed from the container and a flat surface, e.g. the blade of a knife, is drawn across the top of the measure. This will give the following doses: small measure 1.2 g, medium measure 3.1 g and large measure 9.0 g of sodium phenylbutyrate.

9.         DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION: the date of latest renewal has been updated to 08/12/2009
10.         DATE OF REVISION OF THE TEXT: the date has been updated to 10/2009
Updated on 20/01/2009 and displayed until 18/08/2010
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  sodium phenylbutyrate