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Strimvelis
Eintrag öffnenStrimvelis · 4.1 Therapeutic indications · 1
Eintrag öffnenStrimvelis · 4.3 Contraindications · 1
Eintrag öffnenStrimvelis · 4.3 · Current or previous history of leukaemia or myelodysplasia.
Eintrag öffnenStrimvelis · 4.3 · History of previous gene therapy.
Eintrag öffnenStrimvelis · 4.3 · Hypersensitivity to the product or to any of the excipients listed in section 6.1.
Eintrag öffnenStrimvelis · 4.3 · Positive test for human immunodeficiency virus (HIV) or presence of any other transmissible infectious agent l
Eintrag öffnenStrimvelis · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenStrimvelis · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenStrimvelis · 4.5 · Live vaccines
Eintrag öffnenStrimvelis · 4.5 · No interaction studies have been performed. Strimvelis is not expected to interact with the hepatic cytochrome
Eintrag öffnenStrimvelis · 4.5 · The safety of immunisation with live viral vaccines following Strimvelis treatment has not been studied. Vacci
Eintrag öffnenStrimvelis · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenStrimvelis · 4.8 Undesirable effects · 1
Eintrag öffnenStrimvelis · 4.8 · Adverse reactions are listed below by MedDRA body system organ class and by frequency. The frequency categorie
Eintrag öffnenStrimvelis · 4.8 · Description of selected adverse reactions 7 Lymphoid T cells leukaemia due to insertional oncogenesis Out of 3
Eintrag öffnenStrimvelis · 4.8 · General disorders and Pyrexia administration site conditions
Eintrag öffnenStrimvelis · 4.8 · Hepatobiliary disorders Autoimmune hepatitis
Eintrag öffnenStrimvelis · 4.8 · Immune reconstitution All the identified adverse reactions in the table (apart from those potentially related
Eintrag öffnenStrimvelis · 4.8 · Investigations Hepatic enzyme Antineutrophil increaseda, cytoplasmic antibody Antinuclear antibody positive (A
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