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Alhemo
Eintrag öffnenAlhemo · 4.1 Therapeutic indications · 1
Eintrag öffnenAlhemo · 4.3 Contraindications · 1
Eintrag öffnenAlhemo · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenAlhemo · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenAlhemo · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenAlhemo · 4.5 · Adding concizumab to plasma containing a sequence-identical analogue (SIA) of emicizumab resulted in an 33% sy
Eintrag öffnenAlhemo · 4.5 · Additive and sometimes synergistic increase in thrombin peak as quantified in the thrombin generation assay ha
Eintrag öffnenAlhemo · 4.5 · In vitro and ex vivo drug-drug interaction studies were performed with rFVIIa, aPCC, rFVIII or rFIX in blood f
Eintrag öffnenAlhemo · 4.5 · No drug-drug interaction clinical trials have been conducted. A drug-drug interaction toxicity study with rFVI
Eintrag öffnenAlhemo · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenAlhemo · 4.8 Undesirable effects · 1
Eintrag öffnenAlhemo · 4.8 · 78 of the clinical trial participants were adolescents (≥ 12 to < 18 years). The safety profile was similar be
Eintrag öffnenAlhemo · 4.8 · Description of selected adverse reactions
Eintrag öffnenAlhemo · 4.8 · General disorders and Injection site reactions Very common administration site disorders
Eintrag öffnenAlhemo · 4.8 · Injection site reactions Injection site reactions were reported across the multiple dose clinical trials. The
Eintrag öffnenAlhemo · 4.8 · Paediatric population
Eintrag öffnenAlhemo · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenAlhemo · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenAlhemo · 4.8 · Summary of the safety profile
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