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OSMOHALE INHALATION POWDER HARD CAPSULES

Active substance(s): MANNITOL

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Transcript
The following information is intended for
medical or healthcare professionals only:
Contraindications
Known hypersensitivity to mannitol or to any
of the capsule ingredients.
Osmohale should not be given to patients
with severe airflow limitation (FEV1 <50%
predicted or <1.0 l) or conditions that may
be compromised by induced bronchospasm
or repeated blowing manoeuvres. These
include: aortic or cerebral aneurysm,
uncontrolled hypertension, myocardial
infarction or a cerebral vascular accident in
the previous six months.
Special warnings and precautions for use
Osmohale is to be administered by inhalation
only. Inhaled mannitol causes
bronchoconstriction. The Osmohale
inhalation test should only be conducted in
suitable laboratories/clinics under the
supervision of an experienced physician and
by a physician or another health professional
appropriately trained to perform bronchial
provocation tests and to manage acute
bronchospasm. The responsible physician,
appropriately trained to treat acute
bronchospasm, including appropriate use of

resuscitation equipment, must be close
enough to respond quickly to an emergency.
A stethoscope, sphygmomanometer, and
pulse oximeter should be available. Patients
should not be left unattended during the
procedure once the administration of
Osmohale has begun.
Medications to treat severe bronchospasm
must be present in the testing area. They
include adrenaline for subcutaneous
injection, and salbutamol or other beta
agonists in metered-dose inhalers. Oxygen
must be available. A small-volume nebuliser
should be readily available for the
administration of bronchodilators.
General precautions when conducting
spirometry and bronchial provocation testing
should be observed, and caution should be
exercised in patients with the following:
ventilatory impairment (baseline FEV1 of less
than 70% of predicted normal values or an
absolute value of 1.5 l or less in adults),
spirometry induced bronchoconstriction,
haemoptysis of unknown origin,
pneumothorax, recent abdominal or thoracic
surgery, recent intraocular surgery, unstable
angina, inability to perform spirometry of
acceptable quality or upper or lower
respiratory tract infection in the previous 2
weeks.

If a patient has spirometry induced asthma or
the FEV1 fall following the 0 mg capsule is
greater than 10%, a standard dose of
bronchodilator should be given and the
Osmohale challenge discontinued.
Exercise: Vigorous exercise should be fully
avoided on the day of the test, as this may
affect test results.
Smoking: Since smoking may affect test
results it is recommended that patients
refrain from smoking for at least 6 hours
prior to testing.
The Osmohale test should not be used in
patients below 6 years of age due to their
inability to provide reproducible spirometric
measurements.
There is limited information on the use of
Osmohale in patients 6-18 years of age
therefore Osmohale is not recommended in
this population.
The effects of repeat Osmohale testing within
a short period of time have not been
investigated therefore careful consideration
should be given to repeat use of Osmohale.

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

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.

1. Remove Cap: Using both hands,
hold the inhaler upright and
remove the cap.

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.

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

Further information can be
obtained by contacting:

2. What you need to know
before you take Osmohale

What is in this leaflet:

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

®

1. What Osmohale is and what it is
used for
2. What you need to know before you
take Osmohale
3. How to take Osmohale
4. Possible side effects
5. How to store Osmohale

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.

Osmohale® Challenge Instructions
PLEASE REFER TO
THE FULL SUMMARY
OF PRODUCT
CHARACTERISTICS
BEFORE PERFORMING THIS
CHALLENGE TEST.

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

Information for the user

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).

®

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.

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.

These instructions show you
how to use the inhaler device.

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.

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.

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

Inhaler instructions



INFORMATION FOR MEDICAL OR
HEALTHCARE PROFESSIONALS

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.

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.

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.

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.

• If you have any further questions,
ask your doctor or pharmacist.

6. Contents of the pack and other
information

1. What Osmohale is and
what it is used for
Osmohale is a test to see if you have
airways sensitivity or not.
Osmohale contains the active substance
mannitol.
Airways sensitivity may be caused by
inflammation of the airways, making it
difficult to breathe sometimes. People with
airways sensitivity are often very susceptible
to factors in the environment such as
exercise, dust, smoke and other irritants.
Your doctor or another specifically trained
healthcare professional will ask you to
breathe in Osmohale, using a small inhaler.

• 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 • For people who do have airways
sensitivity, their airways will become
yours.
• If you get any side effects talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.

The Marketing Authorisation Holder:
Pharmaxis Pharmaceuticals Limited
The Priory
Stomp Road, Burnham
Bucks SL1 7LW
United Kingdom
Tel: +44(0)1628 902 121
Fax: +44(0)1628 669 355

narrower and so they may find it harder to
breathe.

• People who do not have airways
sensitivity will not experience their
airways becoming narrower when
breathing in Osmohale. They will still be
able to breathe normally.
As part of the test, you will be asked to
blow into a tube that will measure the
effect of Osmohale on your lungs.
This medicine is only used to see whether
you have airways sensitivity.

PL 13962

SCALE : 100%
Pharmaxis Ltd.
OSMOHALE LEAFLET UNITED KINGDOM AND IRELAND
CSP278/02
200x558mm
24/02/12

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24/02/12 8.30am Changes to existing art as per Word doc & pdf. re Clare
01/05/12 7.00am On P2 delete “Children & adolescents” paragraph, “Belgium”, change “19 February” to “April”. re Clare

Do not take Osmohale:
• if you are allergic (hypersensitive) to
mannitol or any of the other ingredients;
• if your lung capacity is severely
reduced (this will be measured prior to
the test);
• if you now have or used to have a
swollen or weakened blood vessel
around the heart or brain (aneurysm);
• if you have high blood pressure which
is not controlled by medicine;
• if you have had a heart attack in the
last 6 months;
• if you have had a stroke in the last 6
months.

Warnings and precautions
Talk to your doctor or pharmacist
before taking Osmohale:
• if your lung capacity is reduced (this
will be measured prior to the test);
• if you have previously experienced
difficulty in breathing, or have
wheezed or coughed during a
spirometry test (blowing into a
measuring instrument);
• if you are coughing up blood;
• if you have air in the pleural space
between the chest wall and the lungs,
causing chest pain and shortness of
breath (pneumothorax);

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.

• if you have recently had stomach,
chest or eye surgery;

Fertility, pregnancy and
breast-feeding

• if you experience chest pain (angina
pectoris);

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.

• if you have problems performing the
spirometry test (the person doing the
test will tell you);
• if you have had an infection of the
airways in the last 2 weeks.
If you experience breathlessness,
wheezing and/or cough during the
spirometry test, you may be given a

Driving and using machines
No effects have been observed.

CSP278/02

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Adults
You will be given Osmohale via an inhaler
by a doctor or another specially trained
healthcare professional who will be with
you throughout the test. You will not be
left on your own.
You must not put Osmohale capsules in
your mouth or swallow them.

Performing the test
1. You will be asked to sit comfortably on
a chair.
2. Initially you will be asked to blow
forcefully into a tube (spirometry test).
3. A nose clip will then be put on your
nose so you will only be able to breathe
in and out of your mouth.
4. After breathing out fully, you will be
asked to deeply breathe in the
Osmohale medicine using a special
inhaler.
5. You will then hold your breath for five
seconds before breathing out.
6. The nose clip will be removed and you
will be asked to breathe normally.
7. Next you will be asked to blow
forcefully into the tube again. This test
measures the effect of Osmohale on
your lungs.
8. Steps 3-7 may be repeated up to 9
times with more and more Osmohale
depending on the effect on your lungs
(as measured in step 7), until the test is
finished.
9. Once the test has finished you may be
given a medicine to help you breathe.
If you are unsure about any part of the
test, or have questions about the
medicine, please talk to the doctor or
another specially trained healthcare
professional performing the test.

If you have been given more
Osmohale than you should
If you think you may have been given too

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.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

List of side effects
Common (may affect up to 1 in 10 people):
• Asthma
• Breathlessness
• Chest tightness
• Cough
• Feeling sick
• Headache
• Sore nose and throat and discomfort
when swallowing
• Runny nose
• Vomiting
Uncommon (may affect up to 1 in 100
people):
• Cold hands and feet
• Diarrhoea
• Feeling dizzy
• Feeling jittery
• Feeling thirsty
• Feeling tired
• Flushing and sweating
• Hoarseness
• Itching and rash
• Itchy eyes
• Less oxygen in the blood
• Mouth ulcers
• Nosebleeds
• Stomach pain
• Sore muscles and joints

If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.

5. How to store Osmohale
• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry
date which is stated on the carton after
EXP. The expiry date refers to the last day
of that month.
• Do not store above 25°C.

6. Contents of the pack and
other information
What Osmohale contains
The active substance is mannitol.
The mannitol powder is contained within
capsules which are utilised for inhalation. A
capsule contains 0 mg, 5 mg, 10 mg, 20 mg
or 40 mg mannitol.

What Osmohale looks like and
contents of the pack
The powder is white to off-white.
The empty capsule is clear.

• 15 x 40 mg capsules
• 1 inhaler



3. How to take Osmohale

BLACK

Marketing Authorisation Holder
Pharmaxis Pharmaceuticals Limited
The Priory
Stomp Road
Burnham
Bucks SL1 7LW
United Kingdom

Manufacturer responsible for batch
release
Mawdsleys Clinical Services
Quest 22, Silk Road,
Off Wheatley Hall Road
Doncaster
DN2 4LT

Procedure Guidelines
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.
Time to
Withhold
6 – 8 hours

8 hours

For any information about this medicine,
please contact the local representative of
the Marketing Authorisation Holder:
Tel: +44(0) 1628 902 121
Fax: +44(0) 1928 669 355
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Aridol: France, Finland, Germany, Greece,
Norway, Portugal, Sweden
Osmohale: Denmark, Ireland, Italy,
Netherlands, Spain, UK
This leaflet was last revised in April 2012

12 hours

Medication
INHALED NON-STEROIDAL
ANTI-INFLAMMATORY
AGENTS
e.g. sodium
cromoglycate,
nedocromil sodium
SHORT-ACTING BETA2
AGONISTS
e.g. salbutamol, terbutaline
INHALED
CORTICOSTEROIDS
e.g. beclomethasone;
budesonide; fluticasone

12 hours

IPRATROPIUM BROMIDE

24 hours

INHALED
CORTICOSTEROIDS PLUS
LONG-ACTING BETA2
AGONISTS
e.g. fluticasone and
salmeterol; budesonide
and formoterol

24 hours

LONG-ACTING BETA2
AGONISTS
e.g. salmeterol;
formoterol

24 hours

THEOPHYLLINE

72 hours

TIOTROPIUM BROMIDE

The 10 mg capsule is half yellow, half clear,
marked 10 mg.

72 hours

ANTIHISTAMINES
e.g. cetirizine,
fexofenadine, loratadine

The 20 mg capsule is half pink, half clear,
marked 20 mg.

4 days

The 5 mg capsule is half white, half clear,
marked 5 mg.

The 40 mg capsules are half red, half clear,
marked 40 mg.

LEUKOTRIENE-RECEPTOR
ANTAGONISTS
e.g. montelukast

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.

The capsules are supplied in blister packs.
One diagnostic kit, packed in a box, consists
of:
• 1 empty capsule
• 1 x 5 mg capsule
• 1 x 10 mg capsule
• 1 x 20 mg capsule

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 45º 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 noseclip 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 FEV1 reading as the baseline
FEV1. If the highest FEV1 is ≥ 10% lower than
the pre-challenge FEV1 do not continue with
the test.
h. Calculate the target FEV1. 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.

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 x 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 x 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
STEP 6: 5 mg capsule
manner as previous doses, hold their breath
a. Insert 5 mg capsule into the inhaler and pierce
as in Step 5.
for 5 seconds and exhale.

PL 13962

SCALE : 100%
Pharmaxis Ltd.
OSMOHALE LEAFLET UNITED KINGDOM AND IRELAND
CSP278/02
200x558mm
24/02/12

BLACK

24/02/12 8.30am Changes to existing art as per Word doc & pdf. re Clare
01/05/12 7.00am On P2 delete “Children & adolescents” paragraph, “Belgium”, change “19 February” to “April”. re Clare

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.

Osmohale® Challenge
Inhaler device

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.

Mouthpiece

‘Spinning’
Chamber
‘Piercing’
Buttons

Filter

‘Piercing’
Chamber

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.

Challenge Outcomes

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.

Positive Osmohale® Challenge Result

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

An Osmohale® challenge is considered to be negative when a cumulative
dose of 635 mg of Osmohale® has been administered and the patient’s FEV 1
has not fallen by ≥ 15% from baseline.

Administer the 2nd 160 mg dose following the
directions given above in step 9.
STEP 11: 3rd x 160 mg dose (4 x 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).

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)

Negative Osmohale® Challenge Result

Equipment
Osmohale® Kit (containing Osmohale® capsules, inhaler device and
instruction leaflet)
Spirometer & mouthpiece
Nose clip
Timer (which can be set to 60 seconds)
Calculator
Bronchodilator (e.g. salbutamol)
Oxygen and other relevant emergency equipment should be readily available
as per standard Bronchial Provocation Testing protocols.

CSP278/02

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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