SALBUTAMOL NEUTEC

5 mg. This may be increased to 5 mg. Treatment may be repeated up to four times daily. In adult dosing, up to 40 mg per day, can be given under strict medical supervision in hospital for the treatment of severe airways obstruction. 5 mg.

This may be increased to 5 mg. Treatment may be repeated up to four times daily. Other pharmaceutical forms may be more appropriate for administration in children under 4 years old. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.

Method of administration Salbutamol inhaled formulations are administered by the inhaled route only, to be breathed in through the mouth with a nebuliser. The solution must not be injected or swallowed. Salbutamol has a duration of action of 4 to 6 hours in most patients.

Salbutamol Neutec is intended to be used undiluted. g. jet nebuliser or mesh nebuliser, after the single dose ampoule has been opened and its contents transferred to the nebuliser chamber. The use of the solution for nebulization is not only limited to the given examples but can also be based on the experience of the clinical professional.

For full instructions on the use of the nebuliser the patient should be instructed to read the leaflet of the respective device carefully before starting the inhalation. 82 * PARI LC Plus Nebuliser and PARI BOY® SX Compressor was used in in vitro studies ** Deepro HCM-86C Nebuliser was used in in vitro studies No information is available in respect of pulmonary inhalation and deposition patterns across nebuliser systems that have not been studied.

The use of an alternative untested nebuliser system may alter the pulmonary deposition of the active substance, this in turn may alter the efficacy and safety of the product and dose adjustment may then become necessary. As many nebulisers operate on a continuous flow basis, it is likely that nebulised medicinal product will be released in the local environment.

Salbutamol Neutec should therefore be administered in a well-ventilated room, particularly in hospitals when several patients may be using nebulisers in the same space at the same time.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) including isolated reports.

Very common and common reactions were generally determined from clinical trial data. Rare and very rare reactions were generally determined from spontaneous data. System organ class Adverse reaction Frequency Angioedema Very Rare Urticaria Very Rare Bronchospasm Very Rare Hypotension Very Rare Immune system disorders Collapse Very Rare Hypokalaemia RareMetabolism and nutrition disorders Lactic acidosis Very Rare Tremor Common Headache Common Nervous system disorders Psychomotor hyperactivity Very Rare Tachycardia Common Palpitations Uncommon Arrhythmia Very Rare Atrial fibrillation Very Rare Supraventricular tachycardia Very Rare Extrasystoles Very Rare Cardiac disorders Myocardial ischaemia Not known Vascular disorders Vasodilatation Rare Respiratory, thoracic and mediastinal disorders Bronchospasm paradoxical Very Rare Stomatitis UncommonGastrointestinal disorders Throat irritation Uncommon Musculoskeletal and connective tissue disorders Muscle cramps Uncommon Regarding undesirable effects linked to metabolism and nutrition disorders, potentially serious hypokalaemia may result from beta-2 agonist therapy.

Furthermore, Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute asthma exacerbation. Regarding undesirable effects linked to respiratory and thoracic disorders, as with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing.

This has to be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. Inhaled salbutamol should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.

General considerations Increasing use of short-acting inhaled beta-2 agonists to control symptoms indicates deterioration of asthma control. If either the usual relief is diminished or the usual duration of action reduced, the patient’s therapy plan should be reassessed.

Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma, maintenance treatment such as inhaled glucocorticoids is warranted to achieve and maintain control. Failing to respond to treatment with salbutamol may signal a need for urgent medical advice or treatment.

Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy. A responsible adult must supervise the treatment with salbutamol in children.

Salbutamol should be administered cautiously to patients with thyrotoxicosis. Salbutamol inhalation formulations must not be used to prevent or inhibit premature labour or threatened abortion. Acute angle closure glaucoma A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide.

A combination of nebulised salbutamol with nebulised anticholinergics should therefore be used cautiously. Patients must receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.

Serious hypokalaemia 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 concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia.

It is recommended that serum potassium levels are monitored in such situations. Metabolic changes In common with other beta-adrenoceptor agonists, Salbutamol can induce reversible metabolic changes, for example increased blood sugar levels.

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