ONBREZ BREEZHALER Inhalation powder, hard capsule (2021)
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Περιεχόμενα
Name of the medicinal product
Onbrez Breezhaler 150 microgram inhalation powder, hard capsules.
Qualitative and quantitative composition
Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol. The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 120 microgram indacaterol. ...
Pharmaceutical form
Inhalation powder, hard capsule. Transparent (uncoloured) capsules containing a white powder, with IDL 150 printed in black above a black bar and company logo printed in black below the black bar.
Therapeutic indications
Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Posology and method of administration
Posology The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler. The dose should only be increased on medical advice. The inhalation ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Asthma Onbrez Breezhaler is a long-acting beta<sub>2</sub>-adrenergic agonist, which is only indicated for COPD and should not be used in asthma due to the absence of long-term outcome data in asthma. ...
Interaction with other medicinal products and other forms of interaction
Sympathomimetic medicinal products Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Onbrez Breezhaler. ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of indacaterol in pregnant women available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically ...
Effects on ability to drive and use machines
Onbrez Breezhaler has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common adverse reactions at the recommended doses were nasopharyngitis (14.3%), upper respiratory tract infection (14.2%), cough (8.2%), headache (3.7%) and muscle ...
Overdose
In COPD patients, single doses of 10 times the maximum recommended therapeutic dose were associated with a moderate increase in pulse rate, systolic blood pressure and QTc interval. An overdose of indacaterol ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for obstructive airways diseases, selective beta-2-adrenoreceptor agonists ATC code: R03AC18 Mechanism of action The pharmacological effects of beta<sub>2</sub>-adrenoceptor ...
Pharmacokinetic properties
Indacaterol is a chiral molecule with R-configuration. Pharmacokinetic data were obtained from a number of clinical studies, from healthy volunteers and COPD patients. Absorption The median time to reach ...
Preclinical safety data
Effects on the cardiovascular system attributable to the beta<sub>2</sub>-agonistic properties of indacaterol included tachycardia, arrhythmias and myocardial lesions in dogs. Mild irritancy of the nasal ...
List of excipients
<u>Capsule content:</u> Lactose monohydrate <u>Capsule shell:</u> Gelatin
Incompatibilities
Not applicable.
Shelf life
30 months.
Special precautions for storage
Do not store above 30°C. Store in the blister in order to protect from moisture and only remove immediately before use.
Nature and contents of container
Onbrez Breezhaler is a single-dose inhalation device. Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl methacrylate acrylonitrile butadiene styrene. ...
Special precautions for disposal and other handling
Each inhaler should be disposed of after all capsules have been used. Instructions for handling and use Please read the full Instructions for Use before using the Onbrez Breezhaler. Pull off the cap. ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/09/593/001-005
Date of first authorization / renewal of the authorization
Date of first authorisation: 30 November 2009 Date of latest renewal: 18 September 2014
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