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Jivi
Eintrag öffnenJivi · 4.1 Therapeutic indications · 1
Eintrag öffnenJivi · 4.3 Contraindications · 1
Eintrag öffnenJivi · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenJivi · 4.3 · Known allergic reactions to mouse or hamster proteins.
Eintrag öffnenJivi · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenJivi · 4.5 Interactions with other medicinal products and other forms of interaction · 1
Eintrag öffnenJivi · 4.5 · Interactions of human coagulation factor VIII (rDNA) products with other medicinal products have not been repo
Eintrag öffnenJivi · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenJivi · 4.8 Undesirable effects · 1
Eintrag öffnenJivi · 4.8 · 8 Tabulated list of adverse reactions
Eintrag öffnenJivi · 4.8 · 9 severe haemophilia A (FVIII:C < 1%), and ≥ 150 previous exposure days and 108 paediatric PTPs < 12 years of
Eintrag öffnenJivi · 4.8 · A total of 256 patients constituted the safety population from 4 pivotal Phase I and III studies (one phase I
Eintrag öffnenJivi · 4.8 · Anti-PEG antibodies Immunogenicity against PEG with development of specific IgM anti-PEG antibodies was observ
Eintrag öffnenJivi · 4.8 · Description of selected adverse reactions
Eintrag öffnenJivi · 4.8 · Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with fact
Eintrag öffnenJivi · 4.8 · FVIII inhibitors No de novo or confirmed cases of inhibitor against factor VIII occurred. A single unconfirmed
Eintrag öffnenJivi · 4.8 · Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection si
Eintrag öffnenJivi · 4.8 · Immunogenicity Immunogenicity was evaluated during clinical studies with Jivi in 159 (including surgery patien
Eintrag öffnenJivi · 4.8 · MedDRA Standard Adverse reactions Frequency System Organ Class Blood and lymphatic system disorders FVIII inhi
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