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  • Trelegy Ellipta 92/55/22 mcg
    / GSK


    Active Ingredient *
    Vilanterol (as trifenatate) 22 mcg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Inhalation Powder

    1 X 14 doses

    partial basket chart 20049

    Inhalation Powder

    1 X 30 doses

    partial basket chart

    Related information


    Dosage

    Adults: The recommended and maximum dose is one inhalation of once daily, at the same time each day. If a dose is missed the next dose should be taken at the usual time the next day.
    Renal impairment: No dosage adjustment is required in patients with renal impairment.
    Hepatic impairment: No dosage adjustment is required in patients with mild, moderate or severe hepatic impairment. This drug should be used with caution in patients with moderate to severe hepatic impairment.


    Indications

    Long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
    Indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
    Important Limitations of Use: NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.


    Contra-Indications

    Hypersensitivity to the active substances or to any of the excipients.


    Special Precautions

    After inhalation, patients should rinse their mouth with water without swallowing.
    The Ellipta inhaler contains pre-dispensed doses and is ready to use.
    The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture. The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled. The patient should be advised to not open the tray until they are ready to inhale a dose.
    The inhaler will be in the ‘closed’ position when it is first taken out of its sealed tray. The “Discard by” date should be written on the inhaler label and carton in the space provided. The date should be added as soon as the inhaler has been removed from the tray. The “Discard by” date is 6 weeks from the date of opening the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening.
    If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost. The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
    It is not possible to accidentally take extra medicine or a double dose in one inhalation.
    See prescribing information for full details.


    Side Effects

    Common: Pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain.
    See prescribing information for full details.


    Drug interactions

    Clinically significant drug interactions mediated by fluticasone furoate/umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
    Interaction with beta-blockers: Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol. If beta-blockers are required, cardioselective beta-blockers should be considered, however, caution should be exercised during concurrent use of both non-selective and selective beta-blockers.
    Interaction with CYP3A4 inhibitor: Fluticasone furoate and vilanterol are rapidly cleared by extensive first pass metabolism mediated by enzyme CYP3A4.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women. Administration of Trelegy Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
    LactationIt is unknown whether fluticasone furoate, umeclidinium, vilanterol or their metabolites are excreted in human milk.
    See prescribing information for full details.


    Overdose

    An overdose will likely produce signs, symptoms or adverse effects associated with the individual components’ pharmacological actions (e.g. Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, dry mouth, visual accommodation disturbances, tachycardia, arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
    There is no specific treatment for an overdose with this drug If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
    Cardioselective beta-blockade should only be considered for profound vilanterol overdose effects that are clinically concerning and unresponsive to supportive measures. Cardioselective beta-blocking medicinal products should be used with caution in patients with a history of bronchospasm.
    Further management should be clinically indicated or as recommended by the national poisons centre, where available.


    Important notes

    Storage: Do not store above 30°C. If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use.
    Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use.
    See prescribing information for full details.


    Manufacturer
    Glaxo Operations UK Ltd
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