BRETARIS GENUAIR Inhalation powder (2023)
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Περιεχόμενα
Name of the medicinal product
Bretaris Genuair 322 micrograms inhalation powder.
Qualitative and quantitative composition
Each delivered dose (the dose leaving the mouthpiece) contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium. This corresponds to a metered dose of 400 µg aclidinium bromide equivalent to ...
Pharmaceutical form
Inhalation powder. White or almost white powder in a white inhaler with an integral dose indicator and a green dosage button.
Therapeutic indications
Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Posology and method of administration
Posology The recommended dose is one inhalation of 322 micrograms aclidinium twice daily. If a dose is missed the next dose should be taken as soon as possible. However, if it is nearly time for the next ...
Contraindications
Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.
Special warnings and precautions for use
Paradoxical bronchospasm Administration of Bretaris Genuair may cause paradoxical bronchospasm. If this occurs, treatment with Bretaris Genuair should be stopped and other treatments considered. Deterioration ...
Interaction with other medicinal products and other forms of interaction
Co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has not been studied and is not recommended. Although no formal <em>in vivo</em> drug interaction studies ...
Fertility, pregnancy and lactation
Pregnancy There are no data available on the use of aclidinium bromide in pregnant women. Studies in animals have shown fetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium ...
Effects on ability to drive and use machines
Aclidinium bromide may have minor influence on the ability to drive and use machines. The occurrence of headache, dizziness or blurred vision following administration of aclidinium bromide (see section ...
Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions with Bretaris Genuair were headache (6.6%) and nasopharyngitis (5.5%). Tabulated summary of adverse reactions The frequencies ...
Overdose
High doses of aclidinium bromide may lead to anticholinergic signs and symptoms. However, single inhaled doses up to 6,000 µg aclidinium bromide have been administered to healthy subjects without systemic ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airway diseases, anticholinergics <b>ATC Code:</b> R03BB05 Mechanism of action Aclidinium bromide is a competitive, selective muscarinic receptor ...
Pharmacokinetic properties
Absorption Aclidinium bromide is rapidly absorbed from the lung, achieving maximum plasma concentrations within 5 minutes of inhalation in healthy subjects, and normally within the first 15 minutes in ...
Preclinical safety data
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential, toxicity to reproduction and ...
List of excipients
Lactose monohydrate
Incompatibilities
Not applicable.
Shelf life
3 years. To be used within 90 days of opening the pouch.
Special precautions for storage
Keep the inhaler inside the pouch until the administration period starts.
Nature and contents of container
The inhaler device is a multicomponent device made of polycarbonate, acrylonitrile-butadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene and stainless steel. ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Instructions for Use Getting Started Read these Instructions for Use before you start using the ...
Marketing authorization holder
Covis Pharma Europe B.V., Gustav Mahlerplein 2, 1082MA Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/12/781/001 EU/1/12/781/002 EU/1/12/781/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 July 2012 Date of last renewal: 20 April 2017
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