OSMOHALE INHALATION POWDER HARD CAPSULES - patient leaflet, side effects, dosage

2. Open: Hold the base of the inhaler firmly with one hand and open the device by rotating the mouthpiece in the direction of the arrow as shown.

5. Pierce Capsule: Hold the inhaler upright and fully depress both piercing buttons on the sides of the device at the same time.

Do this once only, since piercing the capsule more than once may cause it to split/fragment.

The piercing action makes holes in the capsule and allows the powder in the capsule to be released during inhalation.

Note: During a successful inhalation you should hear a ‘rattling’ sound as the capsule spins in the inhaler.

8. Exhale: Remove the inhaler from the patient’s mouth, allow them to exhale and resume normal breathing.

Package Leaflet:

Information for the user

What is in this leaflet:

Important Points to Note

• a. The inhaler device is for SINGLE USE ONLY (one device per challenge) and should not be cleaned during the challenge. Discard the inhaler following each Osmohale® challenge. The inhaler must not be sterilised or re-used as this may compromise the integrity of subsequent test results.

• b. When the patients are exhaling during the Osmohale® challenge, ensure they do so AWAY from the inhaler to minimise humidity within the device.

• c. When piercing the capsule, do so once only (by depressing both buttons simultaneously and fully) as re-piercing may cause the capsule to split/fragment.

• d. Using rubber gloves when administering the test and handling Osmohale® capsules may increase static and inhibit capsule movement within the inhalation device.

• e. If you suspect that static is an issue or notice that the sound of the capsule ‘rattling’ cannot be heard during inhalation of Osmohale®, firmly tap the base of the inhaler with one hand whilst holding the inhaler with the other (mouthpiece facing downwards at a 45° angle). This should ensure that the capsule has been ‘dislodged’ from the piercing chamber into the spinning chamber.

3. Load: Make sure your hands are dry, remove a capsule from the Osmohale® pack and place into the inhaler as illustrated.

It does not matter which way the capsule is placed in the chamber.

6. Prepare for Inhalation: Tilt the inhaler so that the mouthpiece faces slightly downward at a 45 degree angle as shown on the picture below, until the capsule drops forward into the spinning chamber. Keep the device tilted in this way and instruct the patient to breathe out completely (away from the inhaler).

9. Check: The Osmohale® capsule must spin in the inhaler in order to empty. A second inhalation (using the same capsule) may be required immediately if the capsule is not empty following inhalation. Check the capsule following each inhalation.

osmohole®

MANNITOL

• f. Inhalation of Osmohale® may cause cough and/or a dry throat. This is a routine adverse effect of bronchial challenge testing. You can offer the patient a glass of water at challenge completion.

• g. This challenge test is time critical and requires an osmotic gradient to be established and maintained. Prolonged time intervals between doses may affect the validity of results and should be avoided.

Osmohale® Challenge Instructions

PLEASE REFER TO THE FULL SUMMARY OF PRODUCT CHARACTERISTICS BEFORE PERFORMING THIS CHALLENGE TEST.

Further information can be obtained by contacting: The Marketing Authorisation Holder: Pharmaxis Europe Limited 108 Q House, Furze Road, Sandyford, Dubin 18, D18AY29, Ireland.

4. Close: Keeping the device in an upright position, twist the mouthpiece into the closed position until you hear it ‘click’.

7. Inhale: The patient should tilt their head back slightly, and keeping the inhaler at a 45 degree angle, raise the device to their mouth and ensure they close their lips tightly around the mouthpiece. Encourage the patient to take a controlled rapid and deep inspiration to fill the lungs. The patient should then hold their breath for five seconds.

Please Note: The inhaler device is designed for SINGLE USE ONLY (one device per challenge) and should not be cleaned during the challenge. Discard the inhaler following each Osmohale® challenge. The inhaler must not be sterilised or re-used as this may compromise the integrity of subsequent test results.

Osmohale inhalation powder, hard capsule

Mannitol

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

medicine to keep your air passages open and the test will be stopped.

Do not take vigorous exercise on the day of the test, especially before the test is done as this may affect the test results.

Do not smoke for at least 6 hours before the test as this may affect the test results.

Do not take Osmohale on your own. Osmohale is only to be given in a suitable laboratory or clinic by trained professionals familiar with the use of similar tests and their possible effects, under the supervision of an experienced doctor.

Children and adolescents

Children under the age of 6 should not be given Osmohale or perform the test.

Osmohale is not recommended in patients 6–18 years of age, due to limited information on the use of Osmohale in this population.

Other medicines and Osmohale

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking medicines to treat asthma or allergies, you may need to stop taking these before the test. These medicines may affect your body’s response to Osmohale. Your doctor will tell you which medicine(s) to stop and for how long (usually between 6 hours and 4 days before the test).

Osmohale with food and drink

Do not drink coffee, tea or cola, eat chocolate or any other foods containing caffeine on the day of the test.

Fertility, pregnancy and breast-feeding

Do not take the Osmohale test if you are pregnant.

You can take Osmohale while breast-feeding,

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No effects have been observed. CSP278/04

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SCALE : 100%

BPN 43416 PL 13962

History of Changes:

08/12/15 7.30am Add “United Kingdom” to Mawdsleys address page 2. re Aaron

08/12/15 11.10am Move post code after “Doncaster”. re Aaron

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much medicine, tell the doctor or healthcare professional performing the test straight away. You may feel that you cannot breathe, become wheezy or cough if you have taken too much Osmohale. The doctor may give you oxygen and medicines to help you breathe.

Procedure Guidelines

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STEP 1: Make sure the patient has withheld the following medications (See table below).

Recommended Medication Withholding Times

Failure to withhold medications may affect the results of the Osmohale® challenge.

Recommended periods for withholding medications are generally based on their duration of action.

Food: Ingestion of significant quantities of coffee, tea, cola drinks, chocolate or other foods containing caffeine may decrease bronchial responsiveness and should be totally avoided on the day of the test.

Other factors that may affect results: Smoking and vigorous exercise should not be undertaken on the day of the test as this may affect test results.

STEP 2: The patient should be seated for the test. Explain the procedure; include what is required for an FVC manoeuvre and FEV1 measurement and the type of inspiratory flow required for the inhaler. Demonstrate as required.

STEP 3: Enter the patient’s details in the spirometer (age, height, race, date of birth, gender etc).

STEP 4: Determine the pre-challenge FEV1.

Ask the patient to perform an FVC manoeuvre according to the ATS/ERS guidelines, perform three acceptable manoeuvres of which two are reproduced. Use the highest value as prechallenge FEV1. The patient’s FEV1 should be > 70% of the predicted value. Caution should be used in patients with an FEV1 of less than 70% of the predicted value.

STEP 5: Calculate the baseline FEV1 (0 mg)

• a. Remove the 0 mg Osmohale® capsule from the blister, twist open the inhaler (as per the arrow on the device), place the capsule inside and close the device.

• b. Pierce the capsule once only by depressing the coloured buttons on either side of the inhaler.

• c. Ask the patient to put on the nose clip, and breathe through their mouth.

• d. Tilt the inhaler at a 45° angle (mouthpiece down). Check the capsule has moved from the piercing chamber into the spinning chamber closest to the mouthpiece. You can often hear the capsule fall forward or see the capsule through the vents on each side of the device. Give the inhaler to the patient ensuring that they keep the inhaler at the same angle.

• e. Ensure the patient is sitting up straight. Ask the patient to exhale (away from the inhaler), seal their lips around the inhaler mouthpiece and take a controlled rapid and deep inspiration until their lungs are full. During successful inhalation you should hear a ‘rattling’ sound as the capsule spins within the device.

• f. At the end of the patient’s inha­lation, start a 60 second timer, and ask the patient to hold their breath for 5 seconds. When 5 seconds has passed, instruct the patient to exhale through their mouth (away from the inhaler), remove the nose clip and breathe normally.

• g. When the timer beeps after 60 seconds, immediately instruct the patient to perform two acceptable FEV1 measurements. These measurements must be within 0.15 l (150 ml) variability. If there is greater than 0.15 l variability between readings instruct the patient to perform another FEV1. Record the highest FEV 1 reading as the baseline FEV 1 . If the highest FEV 1 is > 10% lower than the pre-challenge FEV 1 do not continue with the test.

• h. Calculate the target FEV 1. A positive Osmohale® challenge result is achieved when the patient’s FEV1 falls > 15% from their baseline FEV1. To calculate the target FEV1, multiply the baseline FEV1 (the highest reading obtained at 0 mg) obtained above by 0.85. Record this value.

STEP 6: 5 mg capsule

a. Insert 5 mg capsule into the inhaler and pierce as in Step 5.

• b. Repeat as in steps 5c – f above.

• c. Following inhalation remove the capsule from the inhaler and check to ensure it has been emptied completely, if not, a 2nd inhalation will be required immediately.

• d. Load the 10 mg capsule in readiness for the next dose.

• e. At 60 seconds following inhalation, immediately measure the patient’s FEV1 twice (acceptability criteria must be met). Use the highest of these two values to calculate the change in FEV1.

• f. Compare the FEV1 value at this dose to the target FEV1. If the FEV1 value is equal to or below the target value, or there has been an incremental fall of > 10% from the previous dose, the challenge is positive and complete. If not, immediately proceed to next dose step.

STEP 7: 10 mg, 20 mg, 40 mg capsules

Administer the 10 mg, 20 mg and 40 mg doses following the directions given above (in step 6) for the 5 mg dose.

STEP 8: 80 mg dose (2 × 40 mg capsules)

• a. Insert and pierce the first of the 40 mg capsules that comprise the 80 mg dose.

• b. The patient should inhale the dose in the same manner as previous doses, hold their breath for 5 seconds and exhale.

• c. Remove the first 40 mg capsule from device and check to ensure it has been emptied completely, if not, a 2nd inhalation will be required immediately. Do this following the administration of every capsule.

• d. Following inhalation, load the second 40 mg capsule and offer to the patient immediately following exhalation.

• e. Instruct the patient to inhale the 2nd capsule immediately to ensure that the osmotic effect of Osmohale® is cumulative.

• f. Activate timer at the end of the 2nd capsule inhalation.

• g. Instruct the patient to hold their breath for 5 seconds before exhaling.

• h. At 60 seconds following inhalation of the 2nd capsule, immediately measure the patient’s FEV1 twice (acceptability criteria must be met). Use the higher of these two values to calculate the change in FEV1.

• i. Compare the FEV1 value at this dose to the target FEV1. If the FEV1 value is equal to or below the target value, or there has been an incremental fall of > 10%, the challenge is positive and complete. If not, immediately proceed to next dose step.

STEP 9: 1st of 160 mg dose (4 × 40 mg capsules)

• a. Insert and pierce the 1st of the 40 mg capsules that comprise the 160 mg dose.

• b. The patient should inhale the dose in same manner as previous doses, hold their breath for 5 seconds and exhale.

• c. Remove capsule from device and check to ensure it has been emptied completely, if not, a 2nd inhalation will be required immediately. Do this following the administration of every capsule.

• d. Following inhalation, load the 2nd 40 mg capsule and offer to the patient immediately following exhalation.

• e. The patient should inhale contents of the 2nd capsule, hold their breath for 5 seconds and exhale.

• f. Following inhalation, load the 3rd 40 mg capsule and offer to the patient immediately following exhalation.

• g. The patient should inhale the contents of the 3rd capsule, hold their breath for 5 seconds and exhale.

• h. Immediately following inhalation, load the 4th 40 mg capsule and offer to the patient immediately following exhalation.

• i. Instruct the patient to inhale the 4th capsule immediately to ensure that the osmotic effect of Osmohale® is cumulative.

• j. Activate timer at the end of the 4th capsule inhalation.

• k. Instruct the patient to hold their breath for 5 seconds, before exhaling.

• l. At 60 seconds following inhalation of the 4th capsule, immediately measure the patient’s FEV1 twice (acceptability criteria must be met). Use the higher of these two values to calculate the change in FEV1.

• m. Compare the FEV1 value at this dose to the target FEV1. If the FEV1 value is equal to or below the target value, or there has been an incremental fall of > 10% from the previous dose the challenge is positive and complete. If not, immediately proceed to next dose step.

STEP 10: 2nd x 160 mg dose (4 × 40 mg capsules)

Administer the 2nd 160 mg dose following the directions given above in step 9.

STEP 11: 3rd x 160 mg dose (4 × 40 mg capsules)

Administer the 3rd 160 mg dose following the directions given above in step 9.

At the completion of this dose, 635 mg has been administered. Providing a positive response has not been met, the challenge should be considered negative and complete.

STEP 12: Following completion of the challenge with a positive result you should administer a bronchodilator and monitor the patient for 15 minutes to ensure their FEV1 has returned to within 5% of pre-challenge level. (In the case of a negative result you may or may not wish to give a bronchodilator).

Osmohale® Challenge

Inhaler device

Challenge Outcomes

Positive Osmohale® Challenge Result

A positive Osmohale® response may be achieved in 2 ways:

• > 15% fall in FEV1 from baseline (using the post 0 mg FEV1 as comparator)

• > 10% incremental fall in FEV1 (between consecutive Osmohale® doses)

CSP278/04

BPN 43416 PL 13962

History of Changes:

08/12/15 7.30am Add “United Kingdom” to Mawdsleys address page 2. re Aaron

08/12/15 11.10am Move post code after “Doncaster”. re Aaron