Posology : מינונים

4.2   Posology and method of administration

Posology
For inhalation use.
Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of Flutiform inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Once control of asthma is achieved with the lowest strength of Flutiform inhaler administered twice daily treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. As a general principle the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Regular review of patients as treatment is stepped down is extremely important.

There are no data available for use of Flutiform inhaler in patients with COPD. Flutiform inhaler should not be used in patients with COPD.

Patients should be given the strength of Flutiform inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease. Note: Flutiform 50 microgram/5 microgram per actuation, strength is not appropriate in adults and adolescents with severe asthma. Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily dose (in micrograms). If an individual patient should require doses outside the recommended dose regimens, appropriate doses of the β2 agonist and the inhaled corticosteroid in separate inhalers, or appropriate doses of the inhaled corticosteroid alone, should be prescribed.

Flutiform inhaler is delivered by a press-and-breathe pressurised metered dose inhaler (pMDI) which also contains an integrated dose indicator. Each inhaler will provide at least 120 actuations (60 doses).

Flutiform 50 /5 inhaler – only

Recommended dose for adults and adolescents and children aged 5 years and above: Flutiform 50 /5 inhaler - two inhalations (puffs) twice daily normally taken in the morning and in the evening.

For adults and adolescents
If the patient’s asthma remains poorly controlled the total daily dose of the inhaled corticosteroid can be increased by administering a higher strength of this combination product – i.e.
Flutiform 125 /5 inhaler - two inhalations (puffs) twice daily. This strength should not be used in children under the age of 12 years.

For adults only:
The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product – i.e. Flutiform 250 /10 inhaler - two inhalations (puffs) twice daily. This highest strength is for use in adults only, it should not be used in adolescents and children.

Children under 5 years:
Experience in children under the age of 5 years is limited (see sections 4.4, 4.8, 5.1 & 5.3).
Flutiform inhaler in any strength is not recommended for use in children less than 5 years of age; Flutiform inhaler should not be used in this young age group.

Flutiform 125 /5 inhaler – only

Recommended dose for adults and adolescents aged 12 years and above:
Flutiform 125 /5 inhaler - two inhalations (puffs) twice daily normally taken in the morning and in the evening.

Patients may be transferred to the lowest strength of this combination product i.e. Flutiform 50 /5 inhaler if their asthma is adequately controlled. A patient’s dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

For adults only:
The total daily dose can be further increased if asthma remains poorly controlled by administering the highest strength of this combination product – i.e. Flutiform 250 /10 inhaler - two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents aged 12 years and above.

Children under 12 years:
No data are available for this strength of Flutiform inhaler in children. Experience in children under the age of 12 years is limited (see sections 4.4, 4.8, 5.1 & 5.3). Flutiform 125 /5 inhaler is not recommended for use in children less than 12 years of age; Flutiform 125 /5 inhaler should not be used in this young age group.


Flutiform 250 /10 inhaler – only
Recommended dose for adults:
Flutiform 250 /10 inhaler - two inhalations (puffs) twice daily normally taken in the morning and in the evening.

Patients may be transferred to a lower strength of this combination product i.e. Flutiform 125 /5 inhaler or ultimately Flutiform 50 /5 inhaler if their asthma is adequately controlled. A patient’s dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Adolescents under 18 years and children:
No data are available for this strength of Flutiform inhaler in children or adolescents. Experience in children is limited to the lowest strength (50 microgram/5 microgram) (see sections 4.4, 4.8, 5.1 & 5.3). Flutiform inhaler in this strength (250 microgram/10 microgram per actuation) is not recommended for use in adolescents or children; Flutiform 250 /10 inhaler should not be used in this young age group.

Flutiform 250 /10 inhaler should not be used in adolescents or children.
However there are lower strengths available i.e. 50 microgram/5 microgram per actuation which may be used in children above 5 years old or adolescents or 125 microgram/5 microgram per actuation which may be used in adolescents.


Flutiform inhaler - all strengths
Special patient groups:
There is no need to adjust the dose in elderly patients.
There are no data available for use of Flutiform inhaler in patients with hepatic or renal impairment (see section 5.2). These patients should be regularly monitored by a physician to ensure titration to the lowest dose at which effective control of symptoms is maintained. As the fractions of fluticasone and formoterol which reach systemic circulation are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe hepatic impairment.

General information:
Inhaled corticosteroids alone are the first line of treatment for most patients. Flutiform inhaler is not intended for the initial treatment of mild asthma. For patients with severe asthma the inhaled corticosteroid therapy should be established before prescribing a fixed-dose combination product.

Patients should be made aware that Flutiform inhaler must be used daily for optimum benefit, even when asymptomatic.

Patients using Flutiform inhaler should not use additional long-acting β2 agonists for any reason. If asthma symptoms arise in the period between doses, an inhaled, short-acting β2 agonist should be taken for immediate relief.

For patients who are currently receiving medium to high doses of inhaled corticosteroid therapy, and whose disease severity clearly warrants treatment with two maintenance therapies, the recommended starting dose is two inhalations twice daily of Flutiform 125 /5 inhaler.

Use of a spacer device with Flutiform inhaler is recommended in patients who find it difficult to synchronise aerosol actuation with inspiration of breath. The AeroChamber Plus® is the recommended spacer device.

Patients should be instructed in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs.

Re-titration to the lowest effective dose should always follow the introduction of a spacer device.

Method of administration
For inhalation use.

To ensure proper administration of the drug, the patient should be shown how to use the inhaler correctly by a physician or other health professionals. The correct use of the pressurised metered dose inhaler (pMDI) is essential for successful treatment. The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use and pictograms in the leaflet.

The actuator has an integrated counter which counts down the number of actuations (puffs) remaining. This counter is also colour coded. It starts off green then, when there are less than 50 puffs (actuations) left it changes to yellow and when there are less than 30 puffs (actuations) left it changes to red. The counter counts down from 120 to 60 in intervals of 10, and from 60 to 0 in intervals of 5. When this is getting near to zero the patient should be advised to contact their prescriber for a replacement inhaler. The inhaler must not be used after the dose indicator reads “0”.

Priming the inhaler
Before using the inhaler for the first time, or if the inhaler has not been used for 3 days or more, or after exposure to freezing or refrigerated conditions (see section 6.4) the inhaler must be primed before use:
•      Remove the mouthpiece cover and shake the inhaler well.
•      Actuate (puff) the inhaler whilst pointing it away from the face. This step must be performed 4 times.
•      The inhaler should always be shaken immediately before use.
Whenever possible patients should stand or sit in an upright position when inhaling from the inhaler.

Steps to follow when using the inhaler:
1.     Remove the mouthpiece cover and check that the mouthpiece is clean, and free from dust and dirt.
2.     The inhaler should be shaken immediately before releasing each actuation (puff) to ensure that the contents of the inhaler are evenly mixed.
3.    Breathe out as far as is comfortable and as slowly and deeply as possible.
4.    Hold the canister vertically with its body upwards and put the lips around the mouthpiece.
Hold the inhaler upright with a thumb(s) on the base of the mouthpiece and a forefinger /index finger(s) on the top of the inhaler. Do not bite the mouthpiece.
5.    Breathe in slowly and deeply through the mouth. After starting to breathe in press down on the top of the inhaler to release one actuation (puff) and continue to breathe in steadily and deeply (optimally for about 2-3 seconds for children and 4-5 seconds in adults).
6.    While holding breath, remove the inhaler from mouth. Patients should continue to hold their breath for as long as is comfortable (optimally about 10 seconds), then breathe out slowly.
Do not breathe out into the inhaler.
7.    For the second actuation (puff), keep the inhaler in a vertical position for about half a minute, and then repeat steps 2 to 6.
8.    After use, replace the mouthpiece cover.

IMPORTANT: Do not perform steps 2 to 6 too quickly.

Patients may be advised to practise their technique in front of a mirror. If a mist appears following inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2.

For patients with weak hands, it may be easier to hold the inhaler with both hands. Therefore the index fingers should be placed on the top of the inhaler canister and both thumbs on the base of the inhaler.

Patients should rinse their mouth, gargle with water or brush the teeth after inhaling and spit out the residue to minimise the risk of oral candidiasis or dysphonia.

Cleaning:
Patients should be advised to read the Patient Information Leaflet carefully for cleaning instructions:
The inhaler should be cleaned once a week.
•      Remove the mouthpiece cover.
•      Do not remove the canister from the plastic casing.
•      Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
•      Replace the mouthpiece cover in the correct orientation.
•      Do not put the metal canister into water.

If a patient requires an AeroChamber Plus® spacer device then they must be advised to read the instructions provided by the manufacturer to ensure they use it and clean and maintain it properly.