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Ravicti
Eintrag öffnenRavicti · 4.1 Therapeutic indications · 1
Eintrag öffnenRavicti · 4.3 Contraindications · 1
Eintrag öffnenRavicti · 4.3 · • Hypersensitivity to the active substance. • Treatment of acute hyperammonaemia.
Eintrag öffnenRavicti · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenRavicti · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenRavicti · 4.5 · A potential effect on CYP2D6 isoenzyme cannot be excluded and caution is advised for patients who receive medi
Eintrag öffnenRavicti · 4.5 · Compatibility studies have demonstrated glycerol phenylbutyrate chemical and physical in-use stability with th
Eintrag öffnenRavicti · 4.5 · Concomitant use of medicinal products known to inhibit lipase should be given with caution as glycerol phenylb
Eintrag öffnenRavicti · 4.5 · Effects of glycerol phenylbutyrate on other CYP isoenzymes have not been studied in humans and cannot be exclu
Eintrag öffnenRavicti · 4.5 · Glycerol phenylbutyrate and/or its metabolites, PAA and PBA, have been shown to be weak inducers of CYP3A4 enz
Eintrag öffnenRavicti · 4.5 · Other medicinal products such as corticosteroids, valproic acid, haloperidol and probenecid may have the poten
Eintrag öffnenRavicti · 4.5 · The effects of glycerol phenylbutyrate on cytochrome P450 (CYP) 2C9 isoenzyme and potential for interaction wi
Eintrag öffnenRavicti · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenRavicti · 4.8 Undesirable effects · 1
Eintrag öffnenRavicti · 4.8 · 8 Uncommon Hypoalbuminaemia, hypokalaemia Psychiatric disorders Common Food aversion Nervous system disorders
Eintrag öffnenRavicti · 4.8 · 9 median exposure in the 2 months to less than 2 years of age was 9 months (range 0.2 to 20.3 months). Adverse
Eintrag öffnenRavicti · 4.8 · Additional adverse reactions have been evaluated in a clinical study including 16 UCD patients less than 2 mon
Eintrag öffnenRavicti · 4.8 · Adverse reactions reported in more paediatric than adult patients during long-term treatment with glycerol phe
Eintrag öffnenRavicti · 4.8 · Any adverse reaction reported in one patient met the uncommon criteria. Due to the rarity of the UCD populatio
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