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Pepaxti
Eintrag öffnenPepaxti · 4.1 Therapeutic indications · 1
Eintrag öffnenPepaxti · 4.3 Contraindications · 1
Eintrag öffnenPepaxti · 4.3 · • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Breast-feeding
Eintrag öffnenPepaxti · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenPepaxti · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenPepaxti · 4.5 · No interaction studies have been performed with melphalan flufenamide. Based on available in vitro and clinica
Eintrag öffnenPepaxti · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenPepaxti · 4.8 Undesirable effects · 1
Eintrag öffnenPepaxti · 4.8 · 7 System OrganClass Adverse reactions Frequency overall Frequency Grade 3/4
Eintrag öffnenPepaxti · 4.8 · 8 Infections All patients in the target population are at risk of infections due to their immunodeficient stat
Eintrag öffnenPepaxti · 4.8 · Anaemia Anaemia was reported in 66% of patients, and Grade 3 anaemia was reported in 41% of patients and Grade
Eintrag öffnenPepaxti · 4.8 · Bleeding Any Grade bleeding was reported in 21% of patients. Grade 3 bleeding was reported in 2% and Grade 4 b
Eintrag öffnenPepaxti · 4.8 · Description of selected adverse reactions
Eintrag öffnenPepaxti · 4.8 · Grade 3/4 neutropenia resulted in dose delay, dose reduction and dose discontinuation of Pepaxti in 26%, 9% an
Eintrag öffnenPepaxti · 4.8 · Infections and Septic shock Uncommon Uncommon infestations Sepsis1 Common Common 2 Pneumonia Very common Commo
Eintrag öffnenPepaxti · 4.8 · Infections occurred in cycle concomitant with Grade 3/4 neutropenia in 21% of patients. Clinically significant
Eintrag öffnenPepaxti · 4.8 · Neutropenia Neutropenia was reported in 72% of patients, Grade 3/4 neutropenia was reported in 66% of patients
Eintrag öffnenPepaxti · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenPepaxti · 4.8 · Respiratory, thoracic Pulmonary Uncommon Uncommon and mediastinal embolism disorders Dyspnoea Very common Unco
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