The following sections have been updated/modified:
3. PHARMACEUTICAL form
The capsules contain a white to off white powder.
4.2 Posology and method of administration
Special populations
There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment.
Paediatric population
The safety and effect of nitisinone have been studied in the paediatric population. The dose recommendation in mg/kg body weight is the same in children and adults.
Method of administration
The capsule may be opened and the content suspended in a small amount of water or formula diet immediately before intake.
4.4 Special warnings and precautions for use: The following has been removed:
Dietary restriction in relation to visual disorders
The following sub title has been added:
Monitoring of plasma tyrosine levels
4.7 Effects on ability to drive and use machines
The following sentence has been added:
If the patient experiences adverse reactions affecting the vision, the ability to drive and use machines should be considered.
4.8 Undesirable effects: the following paragraph has been modified;
The adverse reactions considered at least possibly related to treatment are listed below, by body system organ class, and absolute 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, adverse reactions are presented in order of decreasing seriousness.
5.1 Pharmacodynamic properties: the following sentence has been modified.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16A X04.
The following paragraphs have been removed:
This medicinal product has been authorised under “Exceptional Circumstances”.
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of latest renewal: 21/02/2010
10. DATE OF REVISION OF THE TEXT
01/2010
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