GLAXOSMITHKLINE BabyHALER Owner's manual

IMPORTANT: PLEASE READ
Page 1 of 4
Device Identifier 94010
License 9310
CONSUMER INFORMATION
BabyHALER®
SPACER DEVICE
Read this carefully before you start using this device. Keep
this leaflet. You may need to read it again. If you have
further questions, please ask your doctor or your pharmacist.
The medicine for use with this device has been prescribed
for your baby, and you should not pass it on to others. It
may harm them, even if their symptoms are the same as your
baby’s.
For hygiene reasons, the BabyHALER®must be used by a
single patient.
Do not allow your child to play with the BabyHALER®.
For use only with GlaxoSmithKline FLOVENT®HFA
inhaler, as prescribed by your doctor.
The BabyHALER®is not a toy. Do not allow the baby/child
to play with the BabyHALER®unsupervised. Small parts
may cause harm.
Your BabyHALER®
A BabyHALER®is a device to help babies and small infants
take inhaled medicines. It has a soft facemask which you
can place gently over your baby’s nose and mouth. The
BabyHALER®will help you make sure your baby gets the
correct dose of medicine each time.
PLEASE REFER TO THIS DIAGRAM FOR IDENTIFICATION OF
BabyHALER®PARTS
How to use your BabyHALER®
Before using the BabyHALER®for the first time, read the
following instructions. If you are not sure how to use the
BabyHALER®, ask your doctor, nurse or pharmacist. Clean
the BabyHALER®before first use (see the section “How to
Clean Your BabyHALER®”).
Checking the valves
Before you use your BabyHALER®, you need to check that
the two blue valves are working properly. Hold the
BabyHALER®with the facemask towards you. Press the
facemask to your mouth. You should be able to see a part of
each of the two blue valves. Very gently breathe in and out
through the facemask. When you breathe out, the outside
valve at the top of the BabyHALER®should move up
slightly. When you breathe in, the inside valve should move
towards you slightly. (If this is not happening, see the
section “Looking after the valves”).
Preparing the inhaler
PLEASE TAKE NOTE OF THE PRESCRIBING
INFORMATION INDICATED BY YOUR
HEALTHCARE PROVIDER.
1. The BabyHALER®spacer device is intended for use with
the inhalation aerosol prescribed by your physician
(FLOVENT® HFA).
2. Refer to the inhalation aerosol instructions for proper use
of the medication.
3. Remove the mouthpiece cover. Gently fit the inhaler into
the BabyHALER®inhaler holder. The mouthpiece of the
inhaler should point into the BabyHALER®.

IMPORTANT: PLEASE READ
Page 2 of 4
Giving your baby the medicine
4. Your doctor will have told you how many doses of
medicine to give your baby. You should give one dose at a
time. Hold your baby and make sure he or she is settled.
5. Keep your BabyHALER®level as shown in the
photograph. With your thumb, press down once on the
inhaler to release a dose of medicine into the BabyHALER®,
as quickly as possible.
6. Place the facemask gently but securely over your baby’s
nose and mouth. (Hold the BabyHALER®at an angle that is
comfortable for both you and your baby.) Keep it there until
your baby has taken 5 to 10 breaths (about 15 seconds). You
can count the breaths by watching the valves move with
each breath. Then take the facemask away from your baby’s
face.
7. If your doctor has prescribed two doses, repeat steps 6
and 7.
8. Gently wash your baby’s face immediately after use.
9. Remove the inhaler from the BabyHALER®inhaler
holder.
10. Place the BabyHALER®back into the protective bag
after completing “How to clean your BabyHALER®” step.
If you find it difficult to use your BabyHALER®when
your baby is awake, you could try using it when he or
she is asleep. If you do this, remember that it’s important
to hold the BabyHALER®level when pressing down on
the inhaler to release a dose of medicine (see step 6).
How to clean your BabyHALER®
It is important to clean your BabyHALER®after each use.
Taking the BabyHALER®apart
It is important to clean your BabyHALER®after each use.
1. Check the inhaler is not in the BabyHALER®. Gently pull
off the soft facemask.
2. Remove the next section by pressing on the two grooved
clips with your thumb and fore finger and gently pulling the
plastic sections apart.
3. To separate the remaining two sections, press on the two
grooved clips and gently pull the sections apart.
4. To remove the inside blue valve, pinch it gently at the
centre with your thumb and forefinger and take it off its
post. To avoid damaging the valves, always handle them
very gently and hold them at the centre rather than the
edges.
5. To remove the outside blue valve, open the outside valve
cover, pinch the blue valve gently at the centre and take it
off its post.

IMPORTANT: PLEASE READ
Page 3 of 4
6. Clean all the parts using mild soapy water. Rinse the
mask thoroughly in warm water but do not rinse
BabyHALER®parts as this creates static.
The valves must be handled carefully.
7. Leave the parts at room temperature until they are
completely dry. Avoid excessive heat. Don’t rub the inside
of your BabyHALER®with a cloth or polish as this may
cause static which can affect how the BabyHALER®works.
The device must not be autoclaved.
Reassembling the BabyHALER®
8. Both valves are exactly the same, so it does not matter
which one goes where. Pick up one of the valves, holding it
at the centre between your thumb and forefinger. Put it on its
post on the central section.
9. Check that the valve is lying flat.
10. Put the other valve on its post. Check that it is lying flat.
Close the outside valve cover.
11. Put the two sections with the valves together. Make sure
they click shut.
12. Replace the section with the inhaler holder. The two
sections should click shut. Make sure that the inhaler holder
and the outside valve cover are both pointing upwards.
13. Replace the facemask. If you are not going to use the
BabyHALER®immediately, put the device back into its’
protective bag.
Looking after the valves
To ensure that your baby gets the correct dose of medicine
each time, you must check that the two blue valves in your
BabyHALER®are working properly each time you use it.
The section “Checking the valves” tells you how to do this.
If a valve is not working properly, it might be because:
• it is not correctly positioned in your BabyHALER®, or
• it has become worn or damaged and needs to be
replaced.
How to check that the valves are correctly positioned
1.To check the outside valve, lift the outside valve cover
and make sure that the valve is lying flat.
2.To check the inside valve, take off the top section of the
BabyHALER®by pressing on the grooved clips near the
inside blue valve and gently pulling the sections apart. Make
sure that the valve is lying flat. Then clip the two sections
back together again.
3. Check your BabyHALER®again (see “Checking the
valves”). If one of the valves is still not working properly,
you will need to replace it with a spare valve (see “How to
replace a valve”).
How to replace a valve
Two spare valves are included in your BabyHALER®box.
All the valves are exactly the same.
1. Remove the faulty valve.
2. Pick up a new valve by pinching it gently at centre with
your thumb and forefinger.

IMPORTANT: PLEASE READ
Page 4 of 4
3. Put the valve on its post. Check that it is lying flat.
4. Reassemble your BabyHALER®.
Handling the valves
Always handle the valves carefully. Hold them at the centre
rather than at the edges.
Do not expose them to heat or direct sunlight or frost. Do
not put them in hot water.
Protect the BabyHALER®from sunlight. You may need to
replace your BabyHALER®after 6 months of use.
MORE INFORMATION
This document can be found at:
http:/www.gsk.ca or by contacting the sponsor:
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
Last revised: September 9, 2015
©2015 GlaxoSmithKline Inc. All Rights Reserved
BabyHALER is a trademark of the GlaxoSmithKline group of
companies.
FLOVENT is a registered trademark of Glaxo Group Limited, used
under license by GlaxoSmithKline Inc.