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Kovaltry
Eintrag öffnenKovaltry · 4.1 Therapeutic indications · 1
Eintrag öffnenKovaltry · 4.3 Contraindications · 1
Eintrag öffnenKovaltry · 4.3 · • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Known allergic
Eintrag öffnenKovaltry · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenKovaltry · 4.5 Interactions with other medicinal products and other forms of interaction · 1
Eintrag öffnenKovaltry · 4.5 · No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been repor
Eintrag öffnenKovaltry · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenKovaltry · 4.8 Undesirable effects · 1
Eintrag öffnenKovaltry · 4.8 · 6 Table 2: Frequency of adverse drug reactions in clinical trials
Eintrag öffnenKovaltry · 4.8 · 7 During clinical trials with Kovaltry in approximately 200 pediatric and adult patients diagnosed with severe
Eintrag öffnenKovaltry · 4.8 · A total of 236 (193 PTPs, 43 PUPs/MTPs) patients constituted the pooled safety population in the three phase I
Eintrag öffnenKovaltry · 4.8 · Description of selected adverse reactions
Eintrag öffnenKovaltry · 4.8 · Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with fact
Eintrag öffnenKovaltry · 4.8 · Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion sit
Eintrag öffnenKovaltry · 4.8 · Immunogenicity The immunogenicity of Kovaltry was evaluated in PTPs and PUPs/MTPs.
Eintrag öffnenKovaltry · 4.8 · MedDRA Adverse reactions Frequency System Organ Class Blood and lymphatic system Lymphadenopathy uncommon diso
Eintrag öffnenKovaltry · 4.8 · Paediatric population In the clinical studies no age-specific differences in ADR were observed except for FVII
Eintrag öffnenKovaltry · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenKovaltry · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
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