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Onbrez Breezhaler is a brand name for Indacaterol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). 3
Verbatim from this product's EMA label. Tap a section to expand.
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 of the content of one 300 microgram capsule once a day, using the Onbrez Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD.
The maximum dose is 300 microgram once daily. Onbrez Breezhaler should be administered at the same time of the day each day. If a dose is missed the next dose should be taken at the usual time the next day. Special populations Elderly Maximum plasma concentration and overall systemic exposure increase with age but no dose adjustment is required in elderly patients (65 years and over).
Hepatic impairment No dose adjustment is required for patients with mild and moderate hepatic impairment. There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment. Renal impairment No dose adjustment is required for patients with renal impairment.
Paediatric population There is no relevant use of Onbrez Breezhaler in the paediatric population (under 18 years). Method of administration For inhalation use only. Onbrez Breezhaler capsules must not be swallowed. The capsules must only be removed from the blister immediately before use.
6). The Onbrez Breezhaler inhaler provided with each new prescription should be used. Patients should be instructed on how to administer the product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.
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5%). These were in the vast majority mild or moderate and became less frequent if treatment was continued. At the recommended doses, the adverse reaction profile of Onbrez Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation.
Mean heart rate changes were less than one beat per minute, and tachycardia was infrequent and reported at a similar rate as under placebo treatment. Relevant prolongations of QTcF were not detectable in comparison to placebo. e. >450 ms (males) and >470 ms (females)] and reports of hypokalaemia were similar to placebo.
The mean of the maximum changes in blood glucose were similar between Onbrez Breezhaler and placebo. Tabulated summary of adverse reactions The Onbrez Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
4 764 patients were exposed to indacaterol up to one year at doses up to twice the maximum recommended dose. Of these patients, 2 611 were on treatment with 150 microgram once daily and 1 157 on treatment with 300 microgram once daily.
Approximately 41% of patients had severe COPD. The mean age of patients was 64 years, with 48% of patients aged 65 years or older, and the majority (80%) was Caucasian. Adverse reactions in Table 1 are listed according to MedDRA system organ class in the COPD safety database.
Within each system organ class, adverse reactions are ranked by frequency in descending order according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000), not known (cannot be estimated from the available data).
7 Table 1 Adverse reactions Adverse reactions Frequency category Infections and infestations Nasopharyngitis Very common Upper respiratory tract infection Very common Sinusitis Common Immune system disorders Hypersensitivity1 Uncommon Metabolism and nutrition disorders Diabetes mellitus and hyperglycaemia Common Nervous system disorders Headache Common Dizziness Common Paraesthesia Uncommon Cardiac disorders Ischaemic heart disease Common Palpitations Common Atrial fibrillation Uncommon Tachycardia Uncommon Respiratory, thoracic and mediastinal disorders Cough Common Oropharyngeal pain including throat irritation Common Rhinorrhoea Common Paradoxical bronchospasm Uncommon Skin and subcutaneous tissue disorders Pruritus/rash Common Musculoskeletal and connective tissue disorders Muscle spasm Common Musculoskeletal pain Common Myalgia Uncommon General disorders and administration site conditions Chest pain Common Peripheral oedema Common 1 Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Onbrez Breezhaler.
Asthma Onbrez Breezhaler is a long-acting beta2-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. 4 Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Hypersensitivity Immediate hypersensitivity reactions have been reported after administration of Onbrez Breezhaler. If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Onbrez Breezhaler should be discontinued immediately and alternative therapy instituted.
Paradoxical bronchospasm As with other inhalation therapy, administration of Onbrez Breezhaler may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs Onbrez Breezhaler should be discontinued immediately and alternative therapy substituted.
e. as rescue therapy. In the event of deterioration of COPD during treatment with Onbrez Breezhaler, a re- evaluation of the patient and of the COPD treatment regimen should be undertaken. An increase in the daily dose of Onbrez Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Systemic effects Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Onbrez Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2- adrenergic agonists.
Cardiovascular effects Like other beta2-adrenergic agonists, indacaterol may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In case such effects occur, treatment may need to be discontinued.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These were reported voluntarily from a population of uncertain size, and it is therefore not always possible to reliably estimate the frequency or establish a causal relationship to exposure to the medicinal product. Therefore the frequency was calculated from clinical trial experience.
At 600 microgram once daily, the safety profile of Onbrez Breezhaler was overall similar to that of recommended doses. An additional adverse reaction was tremor (common). Description of selected adverse reactions In Phase III clinical studies, healthcare professionals observed during clinic visits that on average 17 to 20% of patients experienced a sporadic cough that occurred usually within 15 seconds following inhalation and typically lasted for 5 seconds (about 10 seconds in current smokers).
It was observed with a higher frequency in female than in male patients and in current smokers than in ex-smokers. 2% of patients reported cough as an adverse event). There is no evidence that cough experienced post inhalation is associated with bronchospasm, exacerbations, deteriorations of disease or loss of efficacy.
8 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Therefore, long-acting beta2-adrenergic agonists (LABA) or LABA containing products such as Onbrez Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
Hypokalaemia Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.
5), which may increase the susceptibility to cardiac arrhythmias. Hyperglycaemia Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose. Upon initiation of treatment with Onbrez Breezhaler plasma glucose should be monitored more closely in diabetic patients.
5 During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1 to 2% on Onbrez Breezhaler at the recommended doses than on placebo. Onbrez Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.
Excipients The capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.