BUDESONIDE

5 mg nebuliser suspension should be adjusted to the need of the individual.

Dosage schedules:

The dose delivered to the patient varies depending on the nebulising equipment used. The nebulisation time and the dose delivered is dependent on flow rate, volume of nebuliser chamber and fill volume. 5 mg nebuliser suspension should be adjusted to the need of the individual.

The dose should be reduced to the minimum needed to maintain good asthma control. The highest dose (2 mg per day) for children under 12 years should only be considered in children with severe asthma and during limited periods. 5 mg nebuliser suspension is: Adults (including the elderly): Usually 1 – 2 mg twice daily.

In very severe cases the dosage may be further increased.

Paediatric population Children 12 years and older:

Dosage as for adults. 5 – 1 mg twice daily. Maintenance The maintenance dose should be individualised and be the lowest dose which keeps the patient symptom-free. 5 - 1 mg twice daily. 5 mg twice daily. 5 mg nebuliser suspension may permit replacement or significant reduction in dosage of oral glucocorticosteroids while maintaining asthma control.

5 mg nebuliser suspension is started, the patient should be in a relatively stable phase. 5 mg nebuliser suspension is then given in combination with the previously used oral steroid dose for about 10 days. 5 milligrams prednisolone or the equivalent each month) to the lowest possible level.

5 mg nebuliser suspension . For further information on the withdrawal of oral corticosteroids, see section

Tabulated list of adverse reactions The following definitions apply to the incidence of undesirable effects: 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).

4). Description of selected adverse reactions The candida infection in the oropharynx is due to drug deposition. Advising the patient to rinse the mouth out with water after each dosing will minimise the risk. 4). Facial skin irritation, as an example of a hypersensitivity reaction, has occurred in some cases when a nebuliser with a face mask has been used.

To prevent irritation, the facial skin should be washed with water after use of the face mask. In placebo-controlled studies, cataract was also uncommonly reported in the placebo group. Clinical trials with 13119 patients on inhaled budesonide and 7278 patients on placebo have been pooled.

15% on placebo. 4. 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.

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4. 9% saline and with solutions for nebulisation of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium bromide. The admixture should be used within 30 minutes. 5 mg nebuliser suspension is recommended, rather than combined treatment with oral corticosteroids, because of the lower risk of systemic effects.

Croup In infants and children with croup, the usual dose is 2 mg of nebulised budesonide. This dose is given as a single administration, or as two 1 mg doses separated by 30 minutes. Dosing can be repeated every 12 hour for a maximum of 36 hours or until clinical improvement.

5 mg nebuliser suspension . , PARI Baby mask with PARI Baby bend). The nebulizer should be connected to an air compressor with an air flow of 5-8 l/min, and the fill volume should be 2-4 ml. The nebulisation time and the dose delivered are dependent on breathing pattern and fill volume.

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