Exakte Wirkstoffkennungen und zitierbare Passagen zu Wechselwirkungen, Gegenanzeigen und Nebenwirkungen.
Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
Description of selected adverse reactions
Nitisinone treatment leads to elevated tyrosine levels. Elevated levels of tyrosine have been associated
with eye-related adverse reactions, such as e.g. corneal opacities and hyperkeratotic lesions in HT-1
and AKU patients. Restriction of tyrosine and phenylalanine in the diet should limit the toxicity
associated with this type of tyrosinemia by lowering tyrosine levels (see section 4.4).
In clinical studies of HT-1, granulocytopenia was only uncommonly severe (<0.5x109/L) and not
associated with infections. Adverse reactions affecting the MedDRA system organ class ‘Blood and
lymphatic system disorders’ subsided during continued nitisinone treatment.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Paediatric population
The safety profile in HT-1 is mainly based on the paediatric population since nitisinone treatment
should be started as soon as the diagnosis of hereditary tyrosinemia type 1 (HT-1) has been
established. From clinical study and post-marketing data there are no indications that the safety profile
is different in different subsets of the paediatric population or different from the safety profile in adult
patients.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Version 2025-07-04T13:48:00Z · SHA-256 d2301bd3b7146d81a83f0b30dfedb2d14565c57b83f31faec0b24a019fab3b2e · Passage 42f7144177697b690f59b1bda795c3fd216297691cf296a2e1269a137feab3cd · Zeichen 3901–4256 im Abschnitt
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