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  • Eklira Genuair
    / Astra Zeneca


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Inhalation Powder

    60 X 0.4 mg

    partial basket chart 53969 5578

    Related information


    Dosage

    The recommended dose is one inhalation of 322 µg Aclidinium twice daily.
    No dose adjustments required in the elderly or in the presence of hepatic or renal impairment. Patients should be instructed on how to administer the product correctly.  There is no relevant use of this drug in children and adolescents (under 18 years of age) in the indication of COPD. The inhaler can be used up to 90 days after opening the pouch.
    See prescribing information for full details.


    Indications

    Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).


    Contra-Indications

    Hypersensitivity to Aclidinium bromide, atropine or its derivatives, including ipratropium, oxitropium or tiotropium, or to the excipients.


    Special Precautions

    Asthma: This drug should not be used in asthma; clinical trials of Aclidinium bromide in asthma have not been conducted.
    Paradoxical bronchospasm: As with other inhalation therapies, administration of this drug  may cause paradoxical bronchospasm. If this occurs, should be stopped and other treatments considered.
    Deterioration of disease: Aclidinium bromide is a maintenance bronchodilator and should not be used for the relief of acute episodes of bronchospasm, i.e. as a rescue therapy. In the event of a change in COPD intensity while the patient is being treated with Aclidinium bromide so that the patient considers additional rescue medication is required, a re-evaluation of the patient and the patients’ treatment regimen should be conducted.
    Cardiovascular effects: Cardiovascular safety profile is characterized by the anticholinergic effects. Aclidinium bromide should be used with caution in patients with a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV.
    Anticholinergic Activity: Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.
    Consistent with its anticholinergic activity, Aclidinium bromide should be used with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).
    Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
    See prescribing information for full details.


    Side Effects

    Headache, nasopharyngitis , sinusitis, cough and diarrhea, tachycartia, blurred vision, dysphonia, dry mouth and urinary retention.
    See prescribing information for full details.


    Drug interactions

    Co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has not been studied and is not recommended.
    Although no formal in vivo drug interaction studies have been performed, inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
    In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide at the therapeutic dose are not expected to cause interactions with P-glycoprotein (P-gp) substrate drugs or drugs metabolised by cytochrome P450 (CYP450) enzymes and esterases.


    Pregnancy and Lactation

    Pregnancy: There are no data available on the use of aclidinium bromide in pregnant women. Studies in animals haveshown fetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide. Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks.
    Breast-Feeding: It is unknown whether aclidinium bromide and/or its metabolites are excreted in human milk. As animal studies have shown excretion of small amounts of aclidinium bromide and/or metabolites into milk, a decision must be made whether to discontinue breast-feeding or to discontinue therapy with aclidinium bromide taking into account the benefit of breast-feeding for the child and the benefit of long-term aclidinium bromide therapy to the woman.
    Fertility: Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide. It is considered unlikely that aclidinium bromide administered at the recommended dose will affect fertility in humans.


    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 anticholinergic adverse effects. Additionally, no clinically relevant adverse effects were observed following 7-day twice daily dosing of up to 800 µg aclidinium bromide in healthy subjects.
    Acute intoxication by inadvertent medicinal product ingestion of aclidinium bromide is unlikely due to its low oral bioavailability and the breath-actuated dosing mechanism of the Genuair inhaler.


    Important notes

    Shelf life: 3 years. To be used within 90 days of opening the pouch.


    Manufacturer
    Industrias Farmaceuticas Almirall, S.L. SPAIN
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