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Indacaterol Maleate and Glycopyrronium Bromide Powder For Inhalation, Hard Capsules/Ultibro

Function and indication: This product is suitable for maintenance bronchodilator treatment of adult patients with chronic obstructive pulmonary disease (COPD) (including chronic bronchitis and emphysema) to relieve symptoms.
Dosage and administration: The recommended dosage is once a day, inhaling one capsule of the drug each time, using the attached powder inhaler. It is recommended to inhale this product at the same time every day. If a dose of the drug is missed, please make up as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day. Usage This product is only for oral inhalation administration, and this capsule cannot be taken orally. The capsule can only be administered using the attached powder inhaler. Patients should be instructed to use this product correctly. Patients who have not seen improvement in respiratory symptoms should be asked whether they have swallowed the drug instead of inhaling it. Please refer to the installation and use instructions of the powder inhaler in this manual. Special populations Renal impairment Patients with mild to moderate renal impairment can use this product at the recommended dose. Patients with severe renal impairment or end-stage renal disease requiring dialysis should only use this product when the expected benefits outweigh the potential risks (see [Precautions] and [Pharmacokinetics]). Hepatic impairment Patients with mild to moderate hepatic impairment can use this product at the recommended dose. There are no data for patients with severe hepatic impairment, so this product should be used with caution in these patients (see [Pharmacokinetics]). For pediatric population, see the [Pediatric Population] section. For elderly population, see the [Elderly Population] section.
Adverse Reactions:
The safety profile is based on experience with the combination of this product and the individual components. Safety Summary The safety of this product is based on data from up to 15 months of use at the recommended therapeutic dose. This product shows adverse reactions similar to those of the individual components. Because this product contains indacaterol and glycopyrronium, the type and severity of adverse reactions of the combination product are expected to be related to the individual components. The safety profile of this product is typical of anticholinergic and beta-adrenergic symptoms associated with its individual components. Other most common adverse reactions associated with this product (incidence of at least 3% of patients using this product and higher than placebo) are cough, nasopharyngitis and headache. Adverse reactions detected during clinical studies and from post-marketing sources are summarized and listed according to MedDRA system organ class (Table 1). Adverse reactions are listed by frequency within each system organ class, with the most common reaction listed first. Within each frequency group, adverse reactions are listed in decreasing order of severity. In addition, the corresponding frequency category for each adverse reaction is as follows: 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); unknown (cannot be estimated based on available data). See the package insert for details of adverse reactions of concern. The most common adverse event with anticholinergics is dry mouth (0.64% vs. 0.45% with placebo); however, the incidence of this adverse event with glycopyrronium was lower than with glycopyrronium alone. Most dry mouth events were suspected to be drug-related and were mild (none were severe). Cough was common but usually mild. Certain serious adverse events, including hypersensitivity reactions and ischemic heart disease, have been reported as adverse drug reactions for indacaterol alone. The incidence of hypersensitivity reactions and ischemic heart disease reported for this product was 2.06% vs. 1.9% for placebo, and 0.67% vs. 0.78% for placebo, respectively.
This product is contraindicated in patients with allergic reactions to the active ingredients or any of the excipients.