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Myalepta
Eintrag öffnenMyalepta · 4.1 Therapeutic indications · 1
Eintrag öffnenMyalepta · 4.3 Contraindications · 1
Eintrag öffnenMyalepta · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenMyalepta · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenMyalepta · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenMyalepta · 4.5 · Leptin is a cytokine and has the potential to alter the formation of cytochrome P450 (CYP450) enzymes. Since i
Eintrag öffnenMyalepta · 4.5 · No interaction studies have been performed in humans.
Eintrag öffnenMyalepta · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenMyalepta · 4.8 Undesirable effects · 1
Eintrag öffnenMyalepta · 4.8 · 10 System Organ Class Very common Common Frequency not known* General disorders and Fatigue, Injection Fat tis
Eintrag öffnenMyalepta · 4.8 · 11 metreleptin treatment based on the currently available body of evidence. LD patients with a blocking activi
Eintrag öffnenMyalepta · 4.8 · A total of 148 patients with generalised and partial LD received metreleptin during clinical studies.
Eintrag öffnenMyalepta · 4.8 · Across two completed clinical studies (NIH 991265/20010769 and FHA101), there were 52 paediatric patients (4 i
Eintrag öffnenMyalepta · 4.8 · Acute pancreatitis associated with discontinuation of metreleptin In clinical studies, 6 patients (4 with gene
Eintrag öffnenMyalepta · 4.8 · Adverse reactions are classified by MedDRA System Organ Class and absolute frequency in Table 7. Frequencies a
Eintrag öffnenMyalepta · 4.8 · Description of selected adverse reactions
Eintrag öffnenMyalepta · 4.8 · Hypoglycaemia Metreleptin may decrease insulin resistance in diabetic patients, resulting in hypoglycaemia in
Eintrag öffnenMyalepta · 4.8 · Immunogenicity In clinical trials (Studies NIH 991265/20010769 and FHA101), the rate of ADAs for generalised L
Eintrag öffnenMyalepta · 4.8 · In generalised LD patients, the overall incidence of adverse reactions was similar regardless of age. Serious
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