Abbreviated Prescribing Information
Vannair

Presentation: Budesonide/Formoterol fumarate dihydrate pressurised inhalation suspension for oral inhalation (pMDI). Indication: Asthma – treatment of asthma to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations in adults and adolescents (≥ 12 yr). Chronic obstructive pulmonary disease (COPD) – symptomatic treatment of moderate to severe COPD in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. Vannair is not indicated for the initiation of bronchodilator therapy in COPD. Dosage: Asthma –1) Vannair pMDI anti-inflammatory reliever therapy (patients with mild disease) 80/2.25 μg Adult & Adolescent ≥ 12yr: 2 inhalations as needed in response to symptoms. If symptoms persist after a few minutes, 2 additional inhalations should be taken. No more than 12 inhalations should be taken on any single occasion. A total daily dose of more than 16 inhalations is normally not needed, however a total daily dose of up to 24 inhalations can be used temporarily. 2) Vannair pMDI anti-inflammatory reliever plus maintenance therapy 80/2.25 μg Adult & Adolescent ≥ 12yr: Patients should take 2 inhalations of Vannair pMDI 80/2.25 μg as needed in response to symptoms to control asthma. If symptoms persist after a few minutes, 2 additional inhalations should be taken. No more than 12 inhalations should be taken on any single occasion. Recommended maintenance dose is 4 inhalations per day, given as either 2 inhalations in the morning and evening or as 4 inhalations in either the morning or evening. A total daily dose of more than 16 inhalations is normally not needed, however a total daily dose of up to 24 inhalations can be used temporarily. 3) Vannair pMDI maintenance therapy (fixed dose) 80/2.25 μg Adult & Adolescent ≥ 12yr: 2 or 4 inhalations b.d. Max daily dose is 8 inhalations. 80/4.5 μg Adult & Adolescent ≥ 12yr: 2 inhalations b.d. Max daily dose is 4 inhalations. 160/4.5 μg Adult & Adolescent ≥ 12yr: 2 inhalations b.d. Max daily dose is 4 inhalations. COPD - Vannair pMDI 160/4.5 μg Adults: 2 inhalations twice daily. Max daily dose is 4 inhalations. Contraindications: Hypersensitivity to budesonide, formoterol or any other ingredients present in this formulation. Precautions: This medicine should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinue, if possible, once asthma control is achieved. Vannair pMDI (for asthma patients on Vannair AIR and MART) or a separate short-acting bronchodilator (for patients using Vannair pMDI as fixed dose maintenance therapy only and for COPD patients) must be available for rescue at all times; Oral corticosteroid usage: not to be used to initiate treatment with inhaled steroids in patients being transferred from oral steroids. Care when commencing Vannair; Potential systemic effects of inhaled corticosteroids: HPA axis suppression and adrenal insufficiency, bone density, growth, visual disturbance, infections / tuberculosis; Patients with increased susceptibility to sympathomimetic amines; Patients with pre-existing cardiovascular conditions; Hypokalaemia (particularly in acute exacerbation and patients receiving digoxin); Diabetes; Pneumonia; Not for children <12 yr; Pregnancy & lactation. Interactions: CYP3A4 inhibitors (eg, ketoconazole); β-receptor blocking agents (non-selective); other sympathomimetic agents; xanthine derivatives, mineralocorticosteroids and diuretics; monoamine oxidase inhibitors, tricyclic antidepressants, quinidine, disopyramide, procainamide, phenothiazines, and antihistamines. Undesirable effects: palpitations; Candida infections in the oropharynx, pneumonia; headache; tremor; mild irritation in the throat; coughing, hoarseness. Full local prescribing information is available upon request. API.HK.VAN.0423.

HK-10000 19/02/2024