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Aldurazyme
Eintrag öffnenAldurazyme · 4.1 Therapeutic indications · 1
Eintrag öffnenAldurazyme · 4.3 Contraindications · 1
Eintrag öffnenAldurazyme · 4.3 · Severe hypersensitivity (e.g. anaphylactic reaction) to the active substance or to any of the excipients liste
Eintrag öffnenAldurazyme · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenAldurazyme · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenAldurazyme · 4.5 · Aldurazyme should not be administered simultaneously with chloroquine or procaine due to a potential risk of i
Eintrag öffnenAldurazyme · 4.5 · No interaction studies have been performed. Based on its metabolism, laronidase is an unlikely candidate for C
Eintrag öffnenAldurazyme · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenAldurazyme · 4.8 Undesirable effects · 1
Eintrag öffnenAldurazyme · 4.8 · 6 MedDRA Very common Common Not known System Organ Class Immune system Anaphylactic reaction Hypersensitivity
Eintrag öffnenAldurazyme · 4.8 · 7 MedDRA MedDRA Frequency System Organ Class Preferred term Cardiac disorders tachycardia Very common General
Eintrag öffnenAldurazyme · 4.8 · A single patient with pre-existing airway compromise developed a severe reaction three hours from the start of
Eintrag öffnenAldurazyme · 4.8 · Additionally, a few patients who had a prior history of severe MPS I- related upper airway and pulmonary invol
Eintrag öffnenAldurazyme · 4.8 · Description of selected adverse reactions Immunogenicity Almost all patients developed IgG antibodies to laron
Eintrag öffnenAldurazyme · 4.8 · In a phase 4 study 33 MPS I patients received 1 of 4 dose regimens: 100 U/kg IV every week (recommended dose),
Eintrag öffnenAldurazyme · 4.8 · In patients with clinical decline, assessing urinary GAGs, ADA and neutralising antibodies should be considere
Eintrag öffnenAldurazyme · 4.8 · In the Phase 2 and 3 studies, 60 patients were tested for in-vitro neutralising effects. Four patients (three
Eintrag öffnenAldurazyme · 4.8 · Paediatric population ADRs to Aldurazyme reported during a Phase 2 study in a total of 20 patients, under 5 ye
Eintrag öffnenAldurazyme · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
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