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Esperoct
Eintrag öffnenEsperoct · 4.1 Therapeutic indications · 1
Eintrag öffnenEsperoct · 4.3 Contraindications · 1
Eintrag öffnenEsperoct · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenEsperoct · 4.3 · Known allergic reaction to hamster protein.
Eintrag öffnenEsperoct · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenEsperoct · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenEsperoct · 4.5 · No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.
Eintrag öffnenEsperoct · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenEsperoct · 4.8 Undesirable effects · 1
Eintrag öffnenEsperoct · 4.8 · 7 an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre is
Eintrag öffnenEsperoct · 4.8 · 8 Paediatric population
Eintrag öffnenEsperoct · 4.8 · Anti-PEG antibodies During the clinical study programme, thirty-seven patients had pre-existing anti-PEG antib
Eintrag öffnenEsperoct · 4.8 · Anti-drug antibodies There was one case of persistent anti-drug antibodies concomitant with the confirmed case
Eintrag öffnenEsperoct · 4.8 · Description of selected adverse reactions
Eintrag öffnenEsperoct · 4.8 · Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with fact
Eintrag öffnenEsperoct · 4.8 · Factor VIII inhibitors One confirmed case of factor VIII inhibitor occurred in an 18 year-old previously treat
Eintrag öffnenEsperoct · 4.8 · Frequencies have been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 t
Eintrag öffnenEsperoct · 4.8 · Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion sit
Eintrag öffnenEsperoct · 4.8 · In some PUPs, temporary decreased factor VIII IR has been observed in the absence of detectable factor VIII in
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