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Increlex
Eintrag öffnenIncrelex · 4.1 Therapeutic indications · 1
Eintrag öffnenIncrelex · 4.3 Contraindications · 1
Eintrag öffnenIncrelex · 4.3 · 3 INCRELEX is contraindicated in children and adolescents with active or suspected neoplasia, or any condition
Eintrag öffnenIncrelex · 4.3 · As INCRELEX contains benzyl alcohol, it must not be given to premature babies or neonates.
Eintrag öffnenIncrelex · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenIncrelex · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenIncrelex · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenIncrelex · 4.5 · No interaction studies have been performed. Doses of insulin and/or other hypoglycaemic medicinal products may
Eintrag öffnenIncrelex · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenIncrelex · 4.8 Undesirable effects · 1
Eintrag öffnenIncrelex · 4.8 · 6 Immune system disorders Not known: Systemic hypersensitivity (anaphylaxis, generalized urticaria, angioedema
Eintrag öffnenIncrelex · 4.8 · 7 Uncommon: Injection site rash, injection site swelling, lipohypertrophy Investigations Uncommon: Increased w
Eintrag öffnenIncrelex · 4.8 · Description of selected adverse reactions
Eintrag öffnenIncrelex · 4.8 · During clinical trials in other indications totaling approximately 300 patients, reports of local and/or syste
Eintrag öffnenIncrelex · 4.8 · Hypoglycaemia Of the 115 (28%) subjects who experienced one or more episode of hypoglycaemia, 6 subjects exper
Eintrag öffnenIncrelex · 4.8 · Injection site hypertrophy This reaction occurred in 71 (17%) subjects from the clinical trials and was genera
Eintrag öffnenIncrelex · 4.8 · Intracranial hypertension/increased intracranial pressure This occurred in 4 subjects (0.96%); in two subjects
Eintrag öffnenIncrelex · 4.8 · Intracranial hypertension/increased intracranial pressure occurred in 4 (0.96%) of patients from the clinical
Eintrag öffnenIncrelex · 4.8 · Neoplasms There have been post-marketing reports of benign and malignant neoplasms in children and adolescents
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