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Eintrag öffnenImcivree · 4.1 Therapeutic indications · 1
Eintrag öffnenImcivree · 4.3 Contraindications · 1
Eintrag öffnenImcivree · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenImcivree · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenImcivree · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenImcivree · 4.5 · In vitro studies showed that setmelanotide has low potential for pharmacokinetic interactions related to cytoc
Eintrag öffnenImcivree · 4.5 · No interaction studies have been performed.
Eintrag öffnenImcivree · 4.6 Fertility, pregnancy, and lactation · 1
Eintrag öffnenImcivree · 4.8 Undesirable effects · 1
Eintrag öffnenImcivree · 4.8 · 11 System organ class Frequency Very common Common Uncommon Neoplasms benign, Melanocytic naevus - Dysplastic
Eintrag öffnenImcivree · 4.8 · 12 System organ class Frequency Very common Common Uncommon Musculoskeletal and - Arthralgia, Musculoskeletal
Eintrag öffnenImcivree · 4.8 · 13 A total of 291 paediatric patients (n=15 aged 2 to less than 6 years; n=98 aged 6 to less than 12 years, n=
Eintrag öffnenImcivree · 4.8 · Adverse reactions obtained from clinical studies and post-marketing surveillance are listed below by MedDRA sy
Eintrag öffnenImcivree · 4.8 · Description of selected adverse reactions
Eintrag öffnenImcivree · 4.8 · Gastrointestinal disturbance Nausea and vomiting were reported in 36% and 17% of patients, respectively, treat
Eintrag öffnenImcivree · 4.8 · Hyperpigmentation disorders Skin darkening was observed in 66% of patients treated with setmelanotide. This ge
Eintrag öffnenImcivree · 4.8 · Injection site reactions Injection site reactions occurred in 45% of patients treated with setmelanotide. The
Eintrag öffnenImcivree · 4.8 · Paediatric population
Eintrag öffnenImcivree · 4.8 · Penile erections Spontaneous penile erection and erection increased were reported in 14% and 13% of male patie
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