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Zaltrap
Eintrag öffnenZaltrap · 4.1 Therapeutic indications · 1
Eintrag öffnenZaltrap · 4.3 Contraindications · 1
Eintrag öffnenZaltrap · 4.3 · For contraindications related to FOLFIRI components (irinotecan, 5-FU, and folinic acid), refer to the current
Eintrag öffnenZaltrap · 4.3 · Hypersensitivity to aflibercept or to any of the excipients listed in section 6.1.
Eintrag öffnenZaltrap · 4.3 · Ophthalmic / intravitreal use due to hyperosmotic properties of ZALTRAP (see section 4.4).
Eintrag öffnenZaltrap · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenZaltrap · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenZaltrap · 4.5 · Population pharmacokinetics analysis and inter study comparisons did not reveal any pharmacokinetic drug-drug
Eintrag öffnenZaltrap · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenZaltrap · 4.8 Undesirable effects · 1
Eintrag öffnenZaltrap · 4.8 · 10 System Organ Class Adverse Reaction Frequency Category All grades Grades ≥3 Common Arterial thromboembolism
Eintrag öffnenZaltrap · 4.8 · 11 System Organ Class Adverse Reaction Frequency Category All grades Grades ≥3 Musculoskeletal and connective
Eintrag öffnenZaltrap · 4.8 · 12 Fistula formation Fistula formation involving GI and non-GI sites has occurred in patients treated with ZAL
Eintrag öffnenZaltrap · 4.8 · 14 Additional adverse reactions and laboratory abnormalities reported with a ≥5 % difference (all grades) in p
Eintrag öffnenZaltrap · 4.8 · 15 Immunogenicity data are highly dependent on the sensitivity and specificity of the assay. Additionally, the
Eintrag öffnenZaltrap · 4.8 · 9 having ≥ 2 % greater incidence (all grades) in the aflibercept treatment group in comparison to the placebo
Eintrag öffnenZaltrap · 4.8 · Compromised wound healing Treatment with ZALTRAP is associated with potential for compromised wound healing (w
Eintrag öffnenZaltrap · 4.8 · Description of selected adverse reactions
Eintrag öffnenZaltrap · 4.8 · Diarrhoea and dehydration In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 6
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