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Prescribing Information


Trimbow 87/5/9 Pressurised Metered Dose Inhaler (pMDI) Prescribing Information Please refer to the full Summary of Product Characteristics (SPC) before prescribing. Presentation: Each Trimbow 87/5/9 pMDI delivered dose contains 87micrograms (mcg) of beclometasone dipropionate (BDP), 5mcg of formoterol fumarate dihydrate (formoterol) and 9mcg of glycopyrronium. This is equivalent to a metered dose of 100mcg BDP, 6mcg formoterol and 10mcg glycopyrronium. Indications: Maintenance treatment in adult patients with moderate to severe chronic


obstructive pulmonary disease (COPD) not


adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2


‑agonist (for effects on symptoms control and prevention of exacerbations see section 5.1 of SPC). Dosage and administration: For inhalation in adult patients (≥18 years). 2 inhalations twice daily (bd). Can be used with the AeroChamber Plus®


spacer device. BDP


in Trimbow is characterised by an extrafine particle size distribution which results in a more potent effect than formulations of BDP with a non‑extrafine particle size distribution (100mcg of BDP extrafine in Trimbow are equivalent to 250mcg of BDP in a non‑extrafine formulation). Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and precautions: Not for acute use in treatment of acute episodes of bronchospasm or to treat COPD exacerbation. Discontinue immediately if hypersensitivity or paradoxical bronchospasm. Deterioration of disease: Trimbow should not be stopped abruptly. Cardiovascular effects: Use with caution in patients with cardiac arrhythmias, aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, occlusive vascular diseases, arterial hypertension and aneurysm. Caution should also be used when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females) either congenital or induced by medicinal products. Trimbow should not be administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias. Caution in patients with thyrotoxicosis, diabetes mellitus, phaeochromocytoma and untreated hypokalaemia. Increase in pneumonia and pneumonia hospitalisation in COPD patients receiving ICS observed. Clinical features of pneumonia may overlap with symptoms of COPD exacerbations. Systemic effects of ICS may occur, particularly at high doses for long periods, but are less likely than with oral steroids. These include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation, decrease in bone mineral density, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression and aggression. Use with caution in patients with pulmonary tuberculosis or fungal/viral airway infections. Potentially serious hypokalaemia may result from beta2


-agonist therapy. Formoterol may cause a


rise in blood glucose levels. Glycopyrronium should be used with caution in patients with narrow- angle glaucoma, prostatic hyperplasia or urinary retention. Use in patients with severe hepatic or renal impairment should only be considered if benefit outweighs the risk. Interactions: Since glycopyrronium is eliminated via renal route, potential drug interactions could occur with medicinal products affecting renal excretion mechanisms e.g. with cimetidine (an inhibitor of OCT2 and MATE1 transporters in the kidney) co‑administration, glycopyrronium showed a slight decrease in renal excretion (20%) and a limited increase in total systemic exposure (16%). Possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded and therefore caution and appropriate monitoring is advised. Related to formoterol: Non-cardioselective beta-blockers (including eye drops) should be avoided. Concomitant administration of other beta-adrenergic drugs may have potentially additive effects. Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants and phenothiazines can prolong the QTc interval and increase the risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2


-sympathomimetics. Hypertensive reactions


may increase the likelihood of arrhythmias in patients receiving digitalis glycosides. Related to glycopyrronium: Co-administration with other anticholinergic-containing medicinal products is not recommended. Excipients: Presence of ethanol may cause potential interaction in sensitive patients taking metronidazole or disulfram. Fertility, pregnancy and lactation: Should only be used during pregnancy if the expected benefits outweigh the potential risks. Children born to mothers receiving substantial doses should be observed for adrenal suppression. Glucocorticoids and metabolites are excreted in human milk. It is unknown whether formoterol or glycopyrronium (including their metabolites) pass into human breast-milk but they have been detected in the milk of lactating animals. Anticholinergic agents like glycopyrronium could suppress lactation. A risk/benefit decision should be taken to discontinue therapy in the mother or discontinue breastfeeding. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy. Effects on driving and operating machinery: None or negligible. Side effects: Common: pneumonia (in COPD patients), pharyngitis, oral candidiasis, urinary tract infection, nasopharyngitis, headache, dysphonia. Uncommon: influenza, oral fungal infection, oropharyngeal candidiasis, oesophageal candidiasis, sinusitis, rhinitis, gastroenteritis, vulvovaginal candidiasis, granulocytopenia, dermatitis allergic, hypokalaemia, hyperglycaemia, restlessness, tremor, dizziness, dysgeusia, hypoaesthesia, otosalpingitis, atrial fibrillation, electrocardiogram QT prolonged, tachycardia, tachyarrhythmia, palpitations, hyperaemia, flushing, cough, productive cough, throat irritation, epistaxis, diarrhoea, dry mouth, dysphagia, nausea, dyspepsia, burning sensation of the lips, dental caries, rash, urticaria, pruritus, hyperhidrosis, muscle spasms, myalgia, pain in extremity, musculoskeletal chest pain, dysuria, urinary retention, fatigue, asthenia, C-reactive protein increased, platelet count increased, free fatty acids increased, blood insulin increased, blood ketone body increased, blood cortisol decreased. Rare: Lower respiratory tract infection (fungal), hypersensitivity reactions, including erythema, lips, face, eyes and pharyngeal oedema, decreased appetite, insomnia, hypersomnia, angina pectoris (stable and unstable), ventricular extrasystoles, nodal rhythm, sinus bradycardia, blood extravasation, hypertension, paradoxical bronchospasm, oropharyngeal pain, angioedema, nephritis, blood pressure increased, blood pressure decreased. Very rare: thrombocytopenia, adrenal suppression, glaucoma, cataract, dyspnoea, growth retardation, peripheral oedema, bone density decreased. Unknown frequency: psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (Refer to SPC for full list of side effects). Legal category: POM Packs and price: £44.50 1x120 actuations. Marketing authorisation No: EU/1/17/1208/002 UK Distributor: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG. Date of preparation: Jun 2017. AeroChamber Plus® Medical International.


may occur following co‑administration with MAOIs including drugs with similar properties (e.g. furazolidone, procarbazine). Risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons. Concomitant treatment with xanthine derivatives, steroids or diuretics may potentiate a possible hypokalaemic effect of beta2


-agonists. Hypokalaemia is a registered trademark of Trudell


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.


Adverse events should also be reported to Chiesi Limited on 0800 0092329 (GB), 1800 817459 (IE).


WITH VULNERABLE PATIENT POPULATIONS AT HEIGHTENED RISK OF COMPLICATIONS OF THE FLU AND THE COMMON COLD, RESEARCHERS ARE LOOKING TOWARDS REVOLUTIONARY DELIVERY CONCEPTS TO CIRCUMVENT ISSUES WITH CONVENTIONAL METHODS OF VACCINATION.


MICRONEEDLES FOR A


virus, in rare cases including death, the Health Protection Scotland (HPS) reports an uptake of the fl u vaccine during the 2016/2017 fl u season was only 44.9 per cent in those aged six months to under 65 years, in one or more clinical high risk groups, which was a decrease of 9.1 per cent on the previous two years. Other alarming fi gures reported showed the rate of individuals over 65 years old receiving the jab was the lowest in a decade at 73 per cent, and less than half of pregnant women were


MAJOR ISSUE D


By Kurtis Moffatt


espite the potential severe complications that may arise as a result of the infl uenza


vaccinated in 2016/2017 compared to 64.9 per cent in 2010/2011. While inoculations showed a slight increased among healthcare workers and primary school children, more must be done to increase immunisation rates, ultimately reducing the risk of severe health consequences.


Researchers have questioned such reasons for falling vaccination rates, and have suggested numerous explanations for the low statistics. Scientists explain that while traditional intramuscular (IM) hypodermic needles provide a low cost and rapid method of delivery, they cannot be easily used by patients


beclometasone/formoterol/ glycopyrronium (87/5/9 mcg)


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