AIRSALB CFC-FREE 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: Symptomatic treatment of reversible bronchoconstriction due to bronchial asthma and chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. Prophylaxis of exercise and allergen induced asthma. AirSalb is particularly useful for the relief of symptoms of asthma, providing it does not…
Verbatim from this product's MHRA label. Tap a section to expand.
AirSalb is intended for inhalation only. Posology The aim should be individual dose. Adults and adolescents aged 12 years and older Relief of attacks: 1-2 inhalations as required. Maximum dose: 8 inhalations per day. To prevent allergen- or exercise-induced symptoms, two inhalations should be taken 10-15 minutes before challenge.
Paediatric population The effect of salbutamol for children < 4 years has not yet been determined. 1. Dose recommendations cannot be made. Children below 12 years of age Relief of attacks: 1 inhalation as required. The dose may be increased to two inhalations if required.
Maximum dose:
On-demand use of salbutamol should not exceed 2 inhalations four times daily. 4). To prevent allergen- or exercise-induced symptoms, one inhalation, or two if necessary, should be taken 10-15 minutes before challenge. The maximum dose is up to two inhalations 4 times daily.
Method of administration Handling A faulty inhalation technique with pressurised inhalers is very common. It is therefore important that the patient be instructed in the correct inhalation technique. The patient’s inhalation technique should be checked at visits.
AirSalb may be used with a Vortex® or AeroChamber® Plus spacer device by children and patients who find it difficult to synchronise aerosol actuation with inspiration. For instructions on the use of the Vortex® or AeroChamber® Plus spacer device please refer to the information leaflets of the spacer devices.
Priming/Re-priming the device Before AirSalb is used for the first time, or if it has not been used for 7 days or more, it is important to check that the spray is functioning. The protective cap should be removed, the inhaler be shaken and sprayed twice into the air.
Instructions for use The inhalation should be performed sitting or standing, wherever possible. 1. The protective cap should be removed. The inside and outside should be checked to make sure that the mouthpiece is clean. 2. The inhaler should be shaken thoroughly for a couple of seconds before use.
3. The inhaler should be held upright with the bottom of the container upwards. The thumb should be put on the base, below the mouthpiece. The patient should breathe out as far as is comfortable, but he should not breathe into the mouthpiece.
Undesirable effects are classified according to organ system and frequency. The frequency range is defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Very common, common and uncommon undesirable effects have been obtained from clinical trials. Rare, very rare and unknown undesirable effects were generally determined from spontaneous post-marketing reports. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Organ system Adverse reactions Frequency Immune system disorders Hypersensitivity reactions incl. g. 4) Not known Vascular disorders Peripheral vasodilatation Rare Respiratory, thoracic and mediastinal disorders Paradoxical bronchospasm** Very rare Gastrointestinal disorders Irritation in mouth and throat Uncommon Musculoskeletal and connective tissue disorders Muscle cramps Common *Reported spontaneously in post-marketing data therefore frequency regarded as unknown.
** As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator.
Salbutamol should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted. Undesirable effects typical of beta2-agonists, such as skeletal muscle tremor and palpitations, can occur especially at the beginning of treatment, and are often dose-dependent.
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) or search for MHRA Yellow Card in Google play or Apple App store.
Treatment of asthma normally follows a gradually adjusted programme, and the patient’s response to therapy must be monitored clinically and with lung function tests. g. inhaled corticosteroids) should be advised to continue taking their anti-inflammatory medication even when symptoms decrease, and they do not require AirSalb.
An increased use of short-acting bronchodilators, in particular beta-2 agonists to relieve symptoms indicates deterioration of asthma control, and patients should be warned to seek medical advice as soon as possible. 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.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In the following cases AirSalb 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 - diabetes which is difficult to control - pheochromocytoma - uncontrolled hyperthyroidism - untreated hypokalaemia.
Cardiovascular effects may be seen with sympathomimetic medicinal products, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists.
g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4. The mouthpiece should be placed in the mouth between the teeth and the lips should be closed around it without biting it. 5. Just after starting to breathe in through the mouth, the patient should press down the canister to release a puff while still breathing in steadily and deeply.
6. The breath should be held, the inhaler taken from the mouth and the finger from the top of the inhaler. The breath should be held for a few seconds, or as long as is comfortable. 7. If another puff is required, the inhaler should be kept upright and the patient should wait about half a minute before repeating steps 2 to 6.
8. After use, the mouthpiece should always be covered to keep out dust and fluff. The mouthpiece cover should be replaced firmly and snapped into position. 6.
Inhaler content:
The inhaler should be shaken to check the remaining amount of medicine in it. AirSalb should not be used if no liquid can be detected in the inhaler while shaking.
Cold temperature use:
If the inhaler has been stored beneath 0 °C, it has to be warmed in the hands of the patient for 2 minutes, be shaken and sprayed twice into the air before use.
Hypokalaemia can be potentiated in cases of concomitant treatment with xanthine derivatives, steroids or diuretics, and in hypoxia. The serum potassium level should therefore be monitored in risk patients, especially in the treatment of acute severe asthma with high doses of AirSalb.
When initiating treatment with AirSalb in diabetics, extra checks of blood glucose levels are recommended, as beta2-agonists increase the risk of hyperglycaemia. Sudden and progressive deterioration of asthma control is potentially life- threatening.
If the effect of AirSalb becomes less effective, the patient should be warned to seek medical advice, as repeated inhalations must not delay the initiation of other important therapy. Treatment with increased doses of corticosteroids should be considered.
As with other inhalation therapy, paradoxical bronchospasm may occur, with increased wheezing immediately after administration. Should this occur, the preparation should be immediately discontinued and replaced by alternative treatment.
1% w/w. The amount in metered dose of this medicinal product is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicinal product will not have any noticeable effects.