Posology : מינונים

4.2       Posology and method of administration
The dosage of OXIS TURBUHALER should be individualised.

Oxis Turbuhaler is not recommended for use in children below 6 years due to insufficient data on safety and efficacy.


OXIS TURBUHALER             31 5. 2012, RH


Relief of broncho-obstructive symptoms
Adults
Normal dosage: 4.5 - 9 micrograms once or twice daily. The dose can be administered in the morning and/or at night.      Some patients may need 18 micrograms once or twice daily. A daily dose above 36 micrograms is not recommended.

If required, additional actuations above those prescribed for the regular maintenance therapy may be used for relief of symptoms up to a maximum total daily dose of 54 micrograms (maintenance plus as required). More than 27 micrograms should not be taken at any single occasion. However, frequent use, which is more than twice daily and/or more than 2 days per week, of doses above normal maintenance treatment is a sign of suboptimal asthma control and treatment should be reassessed.

Children 6 Years of Age and Older
Normal dosage: 4.5 - 9 micrograms once or twice daily. The dose can be administered in the morning and/or at night. A daily dose above 18 micrograms is not recommended.

Special patient groups:
No adjustment of dose should be required in the elderly, or in patients with renal or hepatic impairment at the recommended normal doses (See also Special warnings and special precautions for use).

Chronic Obstructive Pulmonary Disease (COPD).
Adults
Normal dosage: 9 micrograms once or twice daily. The maximum daily dose for regular use is 18 micrograms.
If required, additional actuations above those prescribed for the regular maintenance therapy may be used for relief of symptoms up to a maximum total daily dose of 36 micrograms (maintenance plus as required). More than 18 micrograms should not be taken on any single occasion. However, frequent use, which is more than twice daily and/or more than 2 days per week, of doses above normal maintenance treatment is a sign of suboptimal control and treatment should be reassessed.

Prevention of exercise-induced bronchoconstriction (EIB)
Adults and children 6 years and older:
4.5 - 9 micrograms before exercise (see below: “Warnings”).

The maximum daily dose given for normal dosage should not be exceeded.


OXIS TURBUHALER           31 5. 2012, RH
         Instruction for correct use of Turbuhaler
Turbuhaler 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 carefully read the instructions for use in the patient information leaflet which are packed together with each inhaler
• to breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs
• never to breathe out through the mouthpiece

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 Turbuhaler due to the small amount of drug dispensed.