Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: AstraZeneca UK Ltd., 600 Capability Green, Luton, Bedfordshire, LU1 3LU, UK
Oxis Turbohaler is indicated in adults, adolescents and children aged 6 years and older, as add on therapy to maintenance treatment with inhaled corticosteroids, for the relief of broncho-obstructive symptoms and prevention of exercise-induced symptoms, in patients with asthma when adequate treatment with corticosteroids is not sufficient.
Oxis Turbohaler is also indicated in adults for the relief of broncho-obstructive symptoms in patients with chronic obstructive pulmonary disease (COPD).
Use of doses above those normally required by the individual patient on more than 2 days per week, is a sign of suboptimal disease control and maintenance treatment should be reassessed.
In asthma, Oxis Turbohaler can be used once or twice daily (‘regular dosage’) and as ‘relief medication’ to relieve acute broncho-obstructive symptoms.
Relief medication: 1 inhalation for the relief of acute broncho-obstructive symptoms.
Regular dosage: 1 inhalation once or twice daily. Some patients may need 2 inhalations once or twice daily.
Prevention of exercise-induced bronchoconstriction: 1 inhalation before exercise.
The daily dose for regular use should not exceed 4 inhalations, however occasionally up to a maximum of 6 inhalations may be allowed within a 24-hour period. No more than 3 inhalations should be taken on any single occasion.
Relief medication: 1 inhalation for the relief of acute broncho-obstructive symptoms.
Regular dosage: 1 inhalation once or twice daily.
Prevention of exercise-induced bronchoconstriction: 1 inhalation before exercise.
The regular daily dose should not exceed 2 inhalations, however, occasionally up to a maximum of 4 inhalations may be allowed within a 24-hour period. No more than 1 inhalation should be taken on any single occasion.
Regular dosage: 1 inhalation once or twice daily.
The daily dose for regular use should not exceed 2 inhalations.
If required, additional inhalations above those prescribed for regular therapy may be used for relief of symptoms, up to a maximum total daily dose of 4 inhalations (regular plus as required). More than 2 inhalations should not be taken on any single occasion.
There are no special dosing requirements for elderly patients.
There are no data available for use of Oxis Turbohaler in patients with hepatic or renal impairment (see also section 5.2).
Oxis Turbohaler is not recommended for use in children below 6 years due to insufficient data on safety and efficacy.
NB! A lower strength (6 micrograms/dose) is also available.
Oxis Turbohaler is inspiratory flow driven which means that, when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note! It is important to instruct the patient to breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is obtained.
It is important to instruct the patient never to chew or bite on the mouthpiece and never to use the inhaler if it has been damaged or if the mouthpiece has become detached.
The patient may not taste or feel any medication when using Oxis Turbohaler due to the small amount of drug dispensed.
Detailed instructions for use are packed together with each inhaler.
There is limited clinical experience on the management of overdose.
An overdose would likely lead to effects that are typical of β2-agonists: tremor, headache, palpitations. Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting. Supportive and symptomatic treatment is indicated.
Use of cardioselective beta-blockers may be considered, but only subject to extreme caution since the use of β-adrenergic blocker medication may provoke bronchospasm. Serum potassium should be monitored.
2 years.
This medicinal product does not require any special storage conditions. Keep the container/cap tightly closed.
Oxis Turbohaler is a multidose, inspiratory flow driven, dry powder inhaler. The inhaler is made of plastic parts (PP, PC, HDPE, LDPE, LLDPE, PBT).
Each inhaler contains 60 doses.
Each pack contains either 60 doses (1 inhaler), 3x60 doses (3 inhalers), 10x60 doses (10 inhalers), 18x60 doses (18 inhalers) or 20x60 doses (20 inhalers).
Not all pack-sizes may be marketed.
No special requirements.
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