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SPC: BRONCHITOL Inhalation powder, hard capsule (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Bronchitol 40 mg inhalation powder, hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 40 mg mannitol. Mean delivered dose per capsule is 32.2 mg. For the full list of excipients, see section 6.1.

Pharmaceutical form

Inhalation powder, hard capsule. Clear colourless hard capsules marked with PXS 40 mg and containing white or almost white powder.

Therapeutic indications

Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.

Posology and method of administration

Posology Initiation dose assessment Before commencing treatment with Bronchitol all patients should be assessed for bronchial hyperresponsiveness to inhaled mannitol during administration of their initiation ...

Contraindications

Hypersensitivity to the active substance. Bronchial hyperresponsiveness to inhaled mannitol (see section 4.4).

Special warnings and precautions for use

Hyperresponsiveness to mannitol Patients must be monitored for bronchial hyperresponsiveness to inhaled mannitol during their initiation dose assessment before commencing the therapeutic dose regimen of ...

Interaction with other medicinal products and other forms of interaction

No formal interaction studies have been conducted. However, Bronchitol has been used in clinical studies in conjunction with standard cystic fibrosis therapies such as mucolytics, antibiotics (including ...

Fertility, pregnancy and lactation

Pregnancy There are limited data from the use of mannitol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As ...

Effects on ability to drive and use machines

Bronchitol has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The safety profile of Bronchitol has been evaluated in clinical studies involving more than 1200 patients (See Table 1). Initiation dose assessment The most commonly observed ...

Overdose

Susceptible persons may suffer bronchoconstriction in the event of an inhaled overdose. If excessive coughing and bronchoconstriction occurs, a beta<sub>2</sub> agonist should be given, and oxygen if necessary. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Cough and cold preparations, Mucolytic ATC code: R05CB16 Mechanism of action Bronchitol is an inhaled hyperosmotic medicinal product. While the exact mechanism of action is unknown, ...

Pharmacokinetic properties

Absorption In a study of 18 healthy male adult volunteers, the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously was 0.59% ± 0.15. The rate ...

Preclinical safety data

In male rats after 13 weeks of inhaled mannitol dosing, elevated circulating lymphocyte numbers and mandibular lymph node plasmacytosis was observed at doses greater than 9.3 fold the maximal dose. The ...

List of excipients

None.

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years. Discard the inhaler and its cap 1 week after first use.

Special precautions for storage

Store below 30°C. Store in the original blister in order to protect from moisture. The capsules must only be removed immediately before use.

Nature and contents of container

Aluminium/polyamide/PVC/aluminium blisters. Cartons containing 10 or 280 capsules for initial dose and treatment use respectively. The initiation dose carton contains 1 blister (of 10 capsules) and one ...

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland

Marketing authorization number(s)

EU/1/12/760/001-002

Date of first authorization / renewal of the authorization

Date of first authorisation: 13 April 2012 Date of latest renewal: 11 January 2017

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