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Bronchitol
Eintrag öffnenBronchitol · 4.1 Therapeutic indications · 1
Eintrag öffnenBronchitol · 4.3 Contraindications · 1
Eintrag öffnenBronchitol · 4.3 · Bronchial hyperresponsiveness to inhaled mannitol (see section 4.4).
Eintrag öffnenBronchitol · 4.3 · Hypersensitivity to the active substance.
Eintrag öffnenBronchitol · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenBronchitol · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenBronchitol · 4.5 · No formal interaction studies have been conducted. However, Bronchitol has been used in clinical studies in co
Eintrag öffnenBronchitol · 4.5 · There are no data on concomitant use of hypertonic saline with Bronchitol as it was excluded from the Phase 3
Eintrag öffnenBronchitol · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenBronchitol · 4.8 Undesirable effects · 1
Eintrag öffnenBronchitol · 4.8 · 5 Initiation dose assessment The most commonly observed adverse reaction associated with the use of Bronchitol
Eintrag öffnenBronchitol · 4.8 · 6 Skin and subcutaneous tissue Uncommon Acne, Cold sweat, Pruritus, Rash, Rash pruritic disorders Musculoskele
Eintrag öffnenBronchitol · 4.8 · 7 Musculoskeletal and Uncommon Musculoskeletal chest pain connective tissue disorders Renal and urinary disord
Eintrag öffnenBronchitol · 4.8 · Description of selected adverse reactions Twenty seven (7.1%) out of 378 patients who undertook the mannitol t
Eintrag öffnenBronchitol · 4.8 · Frequencies are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare
Eintrag öffnenBronchitol · 4.8 · Initiation dose (6 to 17 years of age) The most commonly observed adverse reaction associated with the use of
Eintrag öffnenBronchitol · 4.8 · Paediatric population (6 to 17 years of age) Frequency, type and severity of adverse reactions in children are
Eintrag öffnenBronchitol · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenBronchitol · 4.8 · Summary of the safety profile The safety profile of Bronchitol has been evaluated in clinical studies involvin
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