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  • Ultibro Breezhaler
    / Novartis


    Active Ingredient *

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Inhalation Powder

    6 X 110/50 mcg

    partial basket chart 52780 21119

    Inhalation Powder

    12 X 110/50 mcg

    partial basket chart 21119

    Inhalation Powder

    30 X 110/50 mcg

    partial basket chart 21119

    Related information


    Dosage

    The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler. It is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day.
    Elderly population: It can be used at the recommended dose in elderly patients (75 years of age and older).
    Renal impairment: It can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk.
    Hepatic impairment: It can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use in patients with severe hepatic impairment, therefore caution should be observed in these patients.
    Paediatric population: There is no relevant use in the paediatric population (under 18 years) in the indication COPD. The safety and efficacy in children have not been established. No data are available.
    Method of administration: For inhalation use only. The capsules must not be swallowed.
    See prescribing information for full details.


    Indications

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


    Contra-Indications

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


    Special Precautions

    This product should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of this product belong.
    Asthma:
    It should not be used for the treatment of asthma due to the absence of data in this indication.
    Not for acute use: It is not indicated for the treatment of acute episodes of bronchospasm.
    Hypersensitivity related to indacaterol: Immediate hypersensitivity reactions have been reported after administration of indacaterol, one of the components. If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, treatment should be discontinued immediately and alternative therapy instituted.
    Paradoxical bronchospasm: In clinical studies, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with other inhalation therapy and can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted.
    Anticholinergic effects related to glycopyrronium: Narrow-angle glaucoma Urinary retention.
    Patients with severe renal impairment: In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Ultibro Breezhaler should be used only if the expected benefit outweighs the potential risk. These patients should be monitored closely for potential adverse reactions.
    Cardiovascular effects: It should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
    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. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment, 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 plasma glucose should be monitored more closely in diabetic patients.
    Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled, therefore caution and appropriate monitoring are advised in such patients.
    General Disorders: It should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
    See prescribing information for full details.


    Side Effects

    This drug showed similar adverse reactions to the individual components. As it contains indacaterol and glycopyrronium, the type and severity of adverse reactions associated with each of these components may be expected in the combination. Summary of most common adverse reactions: Upper respiratory tract infection, Nasopharyngitis, Urinary tract infection, Sinusitis, Rhinitis, Hypersensitivity, Hyperglycaemia and diabetes mellitus, Dizziness, Headache, Cough, Oropharyngeal pain including throat irritation, Dyspepsia, Dental caries, Bladder obstruction and urinary retention, Pyrexia, Chest pain.
    See prescribing information for full details.


    Drug interactions

    Concomitant administration of orally inhaled indacaterol and glycopyrronium, under steady-state conditions of both components, did not affect the pharmacokinetics of either component.
    Concomitant use not recommended: Beta-adrenergic blockersBeta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists. Therefore it should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use. Where required, cardioselective beta-adrenergic blockers should be preferred, although they should be administered with caution.
    Drugs known to prolong QTc interval: As with other beta2-agonists, it should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval may have an increased risk of ventricular arrhythmias.
    Anticholinergics: The co-administration with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.
    Sympathomimetic agents: Concomitant administration of other sympathomimetic agents (alone or as part of combination therapy) may potentiate the adverse events of indacaterol.
    Caution required with concomitant use: Hypokalaemic treatment: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassiumsparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution.
    To be taken into account with concomitant use: Metabolic and transporter based interactions Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-glycoprotein (P-gp), raises the systemic exposure of indacaterol up to two-fold. The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with indacaterol in clinical studies of up to one year at doses up to twice the maximum recommended indacaterol dose.
    Cimetidine or other inhibitors of organic cation transport: In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%. Based on the magnitude of these changes, no clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of the organic cation transport.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no data from the use in pregnant women available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures.
    Breast-feeding: It is not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk.
    See prescribing information for full details. 


    Overdose

    There is no information on clinically relevant overdosing. An overdose could lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding. Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalised. Use of cardioselective beta blockers may be considered for treating beta2-adrenergic effects, but only under the supervision of a physician and with extreme caution since the use of beta-adrenergic blockers may provoke bronchospasm.
    See prescribing information for full details.


    Important notes

    Lactose: contains lactose monohydrate/lactose hydrate.
    Storage: Do not store above 25°C. Store in the original packaging in order to protect from moisture. Do not remove the capsules from the blister until immediately before use. Dispose each inhaler after 30 days of use.
    See prescribing information for full details.


    Manufacturer
    Novartis Pharma Stein AG Switzerland
    Licence holder
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