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Brineura
Eintrag öffnenBrineura · 4.1 Therapeutic indications · 1
Eintrag öffnenBrineura · 4.3 Contraindications · 1
Eintrag öffnenBrineura · 4.3 · Brineura must not be administered as long as there are signs of acute intracerebroventricular access device le
Eintrag öffnenBrineura · 4.3 · CLN2 patients with ventriculo-peritoneal shunts.
Eintrag öffnenBrineura · 4.3 · Life-threatening anaphylactic reaction to the active substance or to any of the excipients listed in section 6
Eintrag öffnenBrineura · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenBrineura · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenBrineura · 4.5 · No interaction studies have been performed. Cerliponase alfa is a recombinant human protein and systemic expos
Eintrag öffnenBrineura · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenBrineura · 4.8 Undesirable effects · 1
Eintrag öffnenBrineura · 4.8 · 7 Table 2: Frequency of adverse reactions with Brineura
Eintrag öffnenBrineura · 4.8 · 8 Hypersensitivity Hypersensitivity reactions were reported in 19 of 38 patients (50%) treated with Brineura.
Eintrag öffnenBrineura · 4.8 · Adverse reactions observed are listed below, by system organ class and frequency, following the MedDRA frequen
Eintrag öffnenBrineura · 4.8 · Convulsions Convulsions are a common manifestation of CLN2 disease and are expected to occur in this populatio
Eintrag öffnenBrineura · 4.8 · Description of selected adverse reactions
Eintrag öffnenBrineura · 4.8 · MedDRA MedDRA Frequency System organ class Preferred term Infections and infestations Device-related infection
Eintrag öffnenBrineura · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenBrineura · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenBrineura · 4.8 · Summary of the safety profile
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