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SALBULIN MDPI NOVOLIZER is a brand name for Albuterol (also known as Salbutamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Salbulin MDPI Novolizer 100 micrograms is indicated in adults, adolescents and children aged 6 to 12 years. Salbulin MDPI Novolizer 100 micrograms is recommended for use in patients with reversible airways obstruction such as asthma for relief and prevention of bronchospasm. It should be used to relieve asthma…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose depends on the type, severity, and course of the disorder. Adults (including older people and adolescents) For the relief of acute asthma symptoms including bronchospasm a starting dose of one inhalation (100 micrograms) is recommended for adults; this dose may be increased to two inhalations if necessary.
For prevention of exercise-induced or allergen induced symptoms two inhalations (200 micrograms) should be taken 10-15 minutes prior to challenge. The maximum on-demand use in any 24 hours should not exceed 8 inhalations (equivalent to 800 micrograms).
For chronic therapy, two inhalations up to four times a day. Children (aged 6 to 12 years) For the relief of acute asthma symptoms including bronchospasm a starting dose of one inhalation (100 micrograms) is recommended for children aged 6 years and above; this dose may be increased to two inhalations if necessary.
For prevention of exercise-induced or allergen induced symptoms one inhalation (100 micrograms) should be taken 10-15 minutes prior to challenge and a further inhalation (to a total of 200 micrograms), if necessary. The maximum on-demand use in any 24 hours should not exceed 4 inhalations (equivalent to 400 micrograms).
Chronic therapy:
The usual dosage for children under the age of 6-12 years: up to two inhalations 4 times daily. Children below 6 years of age Salbulin MDPI Novolizer is not recommended for use in children below age 6 due to insufficient data on safety and efficacy.
For all patients:
When other salbutamol inhalers are replaced by Salbulin MDPI Novolizer 100 micrograms, it may be necessary to adjust the dosage regimen as the amount of salbutamol delivered to the lung may vary between different inhalers. 4). Method of administration Salbulin MDPI Novolizer 100 micrograms is for oral inhalation use only.
There should be an interval of at least 1 minute between 2 inhalations. Instructions for using the Novolizer device (Powder inhaler device) Figure Refilling 1. Lightly press together the ribbed surface of both sides of the lid, move the lid forwards, and lift off.
2. Remove the protective aluminium foil from the cartridge container and take out the new cartridge. 3. Insert the cartridge into the Novolizer device with the dosage counter facing the mouthpiece. 4. Replace the lid into the side guides from above and push down flat towards the button until it snaps into place.
). This effect may be potentiated by the concomitant administration of other drugs, in particular xanthine derivatives, glucocorticoids, diuretics and cardiac glycosides (digoxin). Serum potassium levels should be monitored in these situations.
Monoamine oxidase inhibitors and tricyclic antidepressants may increase the risk of cardiovascular side effects. 3). Safety in pregnant women has not been established. No controlled clinical trials with salbutamol have been conducted in pregnant women.
Rare reports of various congenital anomalies following intrauterine exposure to salbutamol (including cleft palate, limb defects and cardiac disorders) have been received. Some of the mothers were taking multiple medications during their pregnancies.
Salbutamol MDPI Novolizer should not be used during pregnancy unless clearly necessary. Breast-feeding As salbutamol is probably secreted in breast milk, its use in nursing mothers required careful consideration. It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.
Fertility There is no information on the effects of salbutamol on human fertility. 3). 7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed. 8 Undesirable effects Up to 10% of patients may experience adverse reactions.
These reactions are dose-dependent. The most commonly reported adverse reactions are: taste alteration (bad, unpleasant and unusual taste), mouth and throat irritation, fine tremor (usually of the hands), nausea, sweating, restlessness, headache and dizziness.
These undesirable effects may subside on continuation of treatment within 1-2 weeks. As with other inhalation therapies, in rare cases paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing. Paradoxical bronchospasm should be treated immediately with an alternative fast-acting inhaled bronchodilator and Salbulin MDPI Novolizer 100 micrograms discontinued immediately.
Patients should be warned that they may experience a different taste upon inhalation compared to their previous inhaler. Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lung function testing, as patients are at risk of severe attacks and even death.
The use of brochodilators such as Salbulin MDPI Novolizer 100 micrograms should not delay the introduction and regular use of inhaled corticosteroid therapy. Daily patient self-assessment of asthma control following instructions on the use of Salbulin MDPI Novolizer 100 micrograms and any other drugs required for the management of asthma is important in order that the course of the disease can be followed and the success of both bronchodilator and anti- inflammatory therapy monitored.
The patient should be instructed in the regular measurement of peak expiratory flow rate (PEFR) using a portable peak flow meter. If asthma control does not improve satisfactorily or deteriorates, or if the short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required, medical advice must be sought in order that the clinical condition can be re-assessed and therapeutic management revised appropriately.
In this situation anti-inflammatory therapy may be required, the dose of anti-inflammatory therapy may need to be increased, or a short course of oral glucocorticoids may be needed. Failing to respond to treatment with salbutamol may signal a need for urgent medical advice or treatment.
, inhaled corticosteroids) should be advised to continue taking their anti- inflammatory medication even when symptoms decrease, and they do not require Salbutamol MDPI Novolizer. Increasing use of bronchodilators and in particular short-acting inhaled beta2 adrenergic agonists to relieve symptoms indicates deterioration of asthma control, and patients should be warned to seek medical advice as soon as possible.
Hypersensitivity to the active substance salbutamol or to the excipient lactose monohydrate (which contains small amounts of milk proteins).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The cartridge can be left in the Novolizer device until it is empty, but it must be replaced with a new cartridge within 6 months of removal from its sealed container.
Note:
Salutamol MDPI Novolizer 100 micrograms cartridges may only be used in the Novolizer Powder inhaler. Usage 1. The Novolizer device must be kept horizontal when it is being used. 2. Remove the protective cap. 3. Prime the Novolizer device by completely depressing the large coloured button.
A loud double click will be heard and the colour of the control window will change from red to green. The coloured button should then be released. The colour green in the window indicates that the Novolizer device is primed and ready for use.
Cartridge container 4. The patient should exhale (not into the powder inhaler). 5. The lips should be placed around the mouthpiece and the powder inhaled steadily, deeply and as rapidly as possible (to the maximum inhalation). During this breath a loud click should be heard, indicating that the inhalation was sufficiently strong.
The patient should hold their breath for a few seconds and then continue breathing normally. If the patient needs to take more than 1 inhalation, steps 2 - 5 should be repeated. 6. The protective cap should be replaced. 7. The number of inhalations left is indicated by the dosage counter.
Note:
The large coloured button should only be pressed immediately before inhalation. It is not possible for the patient to administer a double inhalation in error using the Novolizer device. The clicking sound and the change of colour in the control window indicate that inhalation has been performed correctly.
If the colour of the control window does not change then inhalation should be repeated. The Novolizer device cannot be primed a second time unless the inhalation has been performed correctly. If inhalation is not completed correctly after several attempts, then the patient should consult their doctor/physician.
Cleaning The Novolizer device should be cleaned at regular intervals; at a minimum at least every time the cartridge is changed. Instructions for the patient on how to clean the Novolizer device can be found in the Patient Information Leaflet.
Note:
In order to ensure correct use of the Novolizer device, patients should receive thorough instructions on how to use the Novolizer device and their inhaler technique checked to ensure that they are able to use it correctly. Children should only use this product under the supervision of an adult.
The patient should be assessed and, if necessary, alternative therapy instituted. Hypersensitivity reactions such as rash, urticaria, dermatitis, pruritus and erythema have been observed. There have been very rare reports of angioedema (oedema of the face, lips, eyes and throat), bronchospasm, hypotension, collapse, thrombopenia and nephritis.
Tachycardia, with or without peripheral vasodilatation, may occur. In common with other β2 agonists, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles), palpitations, angina pectoris, and blood pressure effects have been reported in association with the use of salbutamol, usually in susceptible patients.
There are also reports of the stimulating effects on the central nervous system after inhalation of salbutamol which manifest themselves in hyperactive behaviour, sleeping disturbances and hallucinations. These observations were predominantly made in children up to 12 years of age.
Adverse events are listed below by system organ class and frequency.
Frequencies are defined as:
Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100); Rare (≥ 1/10,000, < 1/1,000); Very rare (< 1/10,000) ), Not known (cannot be estimated from the available data) Organ System Frequency Adverse drug reaction Blood and lymphatic system disorders Very rare Thrombopenia Immune system disorders Very rare Hypersensitivity reaction Metabolism and nutrition disorders Rare Hypokalaemia, hyperglycaemia, increase of insulin, free fatty acids, glycerol and ketone bodies Psychiatric disorders Common Restlessness Common Fine tremor, dizziness Rare Hyperactive behaviour Nervous system disorders Very rare Hyperexcitability, sleeping disturbances, hallucinations Rare Tachycardia, cardiac arrhythmia (atrial fibrillation, supraventricular tachycardia, extrasystoles), palpitations, angina pectoris, blood pressure effects (lowering or increase) Cardiac disorders Very rare Myocardial ischaemia Rare Peripheral vasodilatation Vascular disorders Very rare Collapse Rare CoughRespiratory, thoracic and mediastinal disorders Rare Paradoxical bronchospasm Gastrointestinal disorders Common Nausea, taste alteration Common Sweating Skin and subcutaneous tissue disorders Very rare Pruritus, rash, erythema, urticaria, angioedema Musculoskeletal disorders Rare Muscle cramps Renal and urinary disorders Very rare Nephritis General disorders and administration site condition Common Headache, application site reaction (mouth and throat irritation, burning sensation of the tongue) Lactose-monohydrate contains small amounts of milk proteins and can therefore cause allergic reactions.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
Under these conditions, the patient’s therapy plan should be reassessed. Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality.
, daytime symptoms, night-time awakening, and activity limitation due to asthma) for proper treatment adjustment as these patients are at risk for overuse of salbutamol. Patients should be advised that a sudden and increasing deterioration of asthma symptoms can be life-threatening.
Therefore, medical assistance must be sought immediately. The dose and frequency of inhalation of short-acting beta 2 agonists should only be increased following medical advice and if a previously effective dose of inhaled salbutamol no longer provides relief for a duration of three hours following administration, the patient should be advised to promptly seek medical advice.
9). If acute asthma symptoms are not relieved or gets even worse following a second inhalation, or if patients are unable to trigger the Novolizer device during an acute asthma attack, medical assistance should be sought immediately.
Potentially serious hypokalaemia may result from beta 2-agonist therapy, mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivates, steroids, and diuretics.
Serum potassium levels should be monitored in such situations. Inhalation of high doses of salbutamol can increase the blood glucose level. Therefore, blood glucose levels in diabetic patients should be monitored closely. In the following cases, salbutamol should only be used with caution and if strictly indicated: - serious cardiac disorders, in particular recent myocardial infarction - coronary heart disease, hypertrophic obstructive cardiomyopathy and tachyarrhythmia - severe and untreated hypertension - aneurysm - hyperthyroidism - diabetes which is difficult to control - pheochromocytoma There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol.
g. ischaemic heart disease, tachyarrhythmia or severe heart failure) who are receiving salbutamol for respiratory disease, should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease.
Care should be taken when treating acute asthma attacks or exacerbation of severe asthma as increased serum lactate levels, and rarely, lactic acidosis have been reported after the use of high doses of salbutamol. This is reversible on reducing the dose of salbutamol.
This medicinal product contains lactose. The amount of lactose contained in Salbulin MDPI Novolizer does not normally cause problems in lactose intolerant people. However, in patients with profound enzyme deficiency, lactose intolerance has been reported very rarely following inhalation of powder containing lactose.
Inhaled salbutamol preparations are not indicated for threatened abortion.