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20 angezeigte Treffer · Seite 2, keine Gesamtzahl für „HyQvia“
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Begriffe & Kennungen
HyQvia · 4.8 · A prospective, Phase 4, multicentre study in Europe evaluated 42 paediatric subjects (age 2 to < 18 years) who
Eintrag öffnenHyQvia · 4.8 · A total of 13 out of 83 subjects who participated in pivotal PID study developed an antibody capable of bindin
Eintrag öffnenHyQvia · 4.8 · A total of 16 out of 132 patients who received rHuPH20 developed anti-rHuPH20 binding antibodies at least once
Eintrag öffnenHyQvia · 4.8 · Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia
Eintrag öffnenHyQvia · 4.8 · Antibodies against rHuPH20
Eintrag öffnenHyQvia · 4.8 · Cases of transient aseptic meningitis, transient haemolytic reactions, increase in serum creatinine level and/
Eintrag öffnenHyQvia · 4.8 · Description of selected adverse reactions
Eintrag öffnenHyQvia · 4.8 · Feeling hot and Pyrexia Very Common Common
Eintrag öffnenHyQvia · 4.8 · For safety with respect to transmissible agents, see section 4.4.
Eintrag öffnenHyQvia · 4.8 · Frequencies have been evaluated using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/1
Eintrag öffnenHyQvia · 4.8 · HyQvia has not been evaluated in clinical studies in children or adolescent patients (0 to 18 years) with CIDP
Eintrag öffnenHyQvia · 4.8 · In the pivotal study 160603 there were 2 of the 24 paediatric patients with total anti-rHuPH20 antibody levels
Eintrag öffnenHyQvia · 4.8 · Influenza like illness* Not Known Not Known
Eintrag öffnenHyQvia · 4.8 · Local reactions at infusion sites: swelling, soreness, redness, induration, local heat, itching, bruising and
Eintrag öffnenHyQvia · 4.8 · MedDRA Frequency Frequency System Organ Adverse drug reactions per patient per infusion Class (SOC) N=228 N=7,
Eintrag öffnenHyQvia · 4.8 · Paediatric population
Eintrag öffnenHyQvia · 4.8 · Post-authorisation safety studies (EU 161302, US 161406) included 15 and 77 elderly subjects, respectively. Ov
Eintrag öffnenHyQvia · 4.8 · Primary Immunodeficiency
Eintrag öffnenHyQvia · 4.8 · Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphyla
Eintrag öffnenHyQvia · 4.8 · Reporting of suspected adverse reactions
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