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Measure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.
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A European review has considered MHRA evidence together with additional information from spontaneous reporting and published literature.
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We have received reports of Colobreathe (colistimethate sodium) capsules shattering when pierced by their inhaler device.
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From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
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We remind you to provide clear information to patients and caregivers regarding risk of accidental patch transfer and ingestion of patches, and need for appropriate disposal of patches.
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After every use, an ambulance should be called even if symptoms are improving, the individual should lie down with legs raised and, if at all possible, should not be left alone.
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Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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Restricted dose and duration of use.
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All products to be named and prescribed as caffeine citrate.
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Codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone.
Furthermore, a significant risk of se…
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Avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur.
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Safety review initiated following post-surgical fatalities in ultra-rapid metabolisers
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The Commission on Human Medicines recommend that existing levels of monitoring, education, and awareness measures by pharmacists should be maintained.
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Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.
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Healthcare professionals should advise patients and/or carers of the changes in the dose, packaging, dose dispenser and leaflet.
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Levofloxacin (a fluoroquinolone antibiotic) is unfavourable as first-line treatment for several indications.
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Care must be taken with dosing as the 2 products are not equivalent.
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Reminder that paediatric paracetamol liquids had been developed to ensure children receive optimum dosing for their age.
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Care needed when transferring from unlicensed formulations.
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Updated dosing for paediatric paracetamol liquids has been developed to ensure children receive the optimum dose for their age.
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Prescribers should be vigilant for possible thrombotic adverse reactions.
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Sitaxentan (Thelin▼) withdrawn due to hepatotoxicity.
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Safety studies of Spiriva Respimat▼
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Should not be used for cough under 18 years
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Benefits of these medicines used in conjunction with inhaled corticosteroids (ICS) in the control of asthma symptoms in children outweigh any apparent risks.
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Risk of psychological and behavioural side effects.
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Aluminium can be leached from glass after contact with calcium gluconate solution, leading to a risk of exposure to aluminium. Accumulation of aluminium might have adverse effects on bone mineralisation and neurological deve…
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European Medicines Agency has recommends the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy - should no longer be used for obstructive sleep apnoea or chronic shift work sleep disor…
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Patients should be transferred to alternative bronchodilator therapy.
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Risk of accidental overdose, particularly in infants and neonates.
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Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in the later stages, may increase the risk of persistent pulmonary hypertension in the newborn. Healthcare professionals are encouraged to enquire…
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Recent epidemiological evidence suggests a possible small increased risk of congenital cardiac defects in association with fluoxetine in early pregnancy, similar to that seen with paroxetine. There are insufficient data to d…
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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The design and content of the Patient Information Leaflets for methylphenidate products are being updated with the latest guidance on safe and effective use for patients and carers
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Patients who require a liquid oral formulation of a β-agonist should be switched to a more-selective short-acting β2-agonist such as salbutamol or terbutaline.
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If new movement disorders occur during treatment consider dose reduction or a gradual discontinuation of treatment in consultation with specialist advice.
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Updated advice for healthcare professionals not to mix or infuse ceftriaxone with solutions containing calcium.
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How to reduce risk of illicit use.
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Use of has led to serious paracetamol overdose in a 6-month-old infant.
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Overall benefits of long-acting β-agonists (LABAs) in the treatment of chronic obstructive pulmonary disease (COPD) continue to outweigh any risks.
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Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers.
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Continued monitoring of medicines with a black triangle status.
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These medicines are not first-line options for insomnia.
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Advice on how to use cough and cold medicines safely for children under 12 years.
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Updated guidance to use methylphenidateto safely and effectively for attention deficit hyperactivity disorder (ADHD) in children of 6 years or older and adolescents.
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Atomoxetine is associated with treatment-emergent psychotic or manic symptoms in children and adolescents - consider stopping this if symptoms occur.
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Licensed doses and differences in potency between different inhaled corticosteroids; advice for use with spacer device.
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Long-acting β2 agonists (LABA) should only be prescribed in conjunction with inhaled corticosteroids for the treatment of moderate to severe asthma.