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BRAMITOB 300MG/4ML NEBULISER SOLUTION

Active substance(s): TOBRAMYCIN

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TECHNICAL INFORMATION / INFORMAZIONI TECNICHE

CHIESI FARMACEUTICI S.p.A. - Parma - Italia

TECHNICAL WORKING

VIETATA LA MANOMISSIONE

1

DRAFT (Mac - ID cc )
08/07/2015

(1) DESCRIZIONE MATERIALE

F.E. BRAMITOB 300mg 4ml sol. da neb. CH. LTD

APPROVAL ARTWORK
1) ARTWORK LAB : (tecnichal part)

(signature)

Date:

2) ARTWORK LAB. HEAD

(signature)

Date:

3) MANUFACTURING DEPT. :

(signature)

Date:

(2) F.TO A.A.

Approved (OK for the print)

COLORI DI STAMPA N° 1

NAME (IN CAPITAL LETTERS):

150 x 62,5 mm

NERO + retino 50%

richiesta di codifica del 28/05/2015 - (6) Motivo:
- Regolatorio: - Chiesi UK address change
- Tecnico: modifica cod. Chiesi, cod. laetus, cod. UK

Date:

PDF OK per TVS

Final PDF Approved for Print

(signature)

Date:

(signature)

Date:

(signature)

Date:

87P48.06/01

(8) DATA A.A.

87P48.06/01
FUSTELLA

09/06/2015

(5) SOST. COD. 87P48.05/01

FONTS: in tracciati
CORPO: /
REPARTO: /

BIANCA

NOTE PER FORNITORE: Dopo piegatura deve risultare visibile su un lato il nome del prodotto e il codice testo e sull’altro lato il codice a barre

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(3) N˚ PHARMACODE 172 (COD. A BARRE)

Request for new draft
JOB TITLE

(Final check)

DIMENSIONI FOGLIO STESO

F049

4) I certify here by under my personal responsibility that the signed text is in full compliance with the official version approved
by the relevant regulatory Authority and in agreement with all regulations in force in the country, where the product will be
distributed.

5) ARTWORK LAB

D.Q.O.C. - Ufficio Grafico
Autore: RB/ChB
mail: r.boselli@chiesi.com

PDF per il fornitore e per Chiesi Farm.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bramitob 300mg/4ml Nebuliser Solution
Tobramycin

Read all of this leaflet carefully before you start taking this medicine.

- 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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Bramitob is and what it is used for
2. Before you use Bramitob
3. How to use Bramitob
4. Possible side effects
5. How to store Bramitob
6. Further information

1. What Bramitob is and what it is used for

Bramitob contains tobramycin which is an antibiotic belonging to a family called the
aminoglycosides. It fights infections caused by Pseudomonas aeruginosa.
Bramitob is used for treating chronic chest infections in patients with cystic fibrosis caused by
Pseudomonas bacteria. It kills the bacteria and helps to improve your breathing. Pseudomonas
is a very common bacterium that infects nearly all patients with cystic fibrosis at some time
during their lives. Some people do not get this infection until later on in their lives while others
get it very young. If infection is not properly controlled it will continue to damage the lungs
causing further problems. As Bramitob is breathed-in the antibiotic, tobramycin, can get straight
into your lungs to work against the bacteria causing the infection.
Bramitob is indicated only for patients aged 6 years and older.
To achieve the best results please make every effort to use your medicine as instructed.

2. Before you use Bramitob
Do not use Bramitob:
• If you are allergic (hypersensitive) to tobramycin, any of the other ingredients of
Bramitob or any other type of aminoglycoside antibiotic
• If you are taking any of the medicines listed in the section below, Taking other medicines
Take special care with Bramitob:
The tobramycin in Bramitob is one of a group of medicines that can occasionally cause hearing
loss, dizziness and kidney damage (see also Section 4 on the back of the leaflet, Possible
side effects). It is important that you tell your doctor if any of the following applies to you:
• If your chest becomes tight after using your Bramitob. Your doctor will supervise

your first dose of Bramitob and check your lung function before and after dosing. If
you are not already doing so, your doctor may ask you to use a bronchodilator, (e.g.
salbutamol), before using Bramitob.

• If you have ever suffered from any neuromuscular disorders such as parkinsonism

or other conditions characterised by muscle weakness, including myasthenia gravis.

• If you have ever experienced kidney problems in the past. Before you start to use

Bramitob, your doctor may check that your kidneys are working properly by testing a
blood or urine sample. Your doctor may re-check this regularly during treatment.

• If you have ever experienced in the past

- ringing in your ears
- any other problems with your hearing
- dizziness.

Your doctor may test your hearing before starting Bramitob or at any time during your Bramitob
treatment.
• If you are currently coughing up blood in your sputum. Inhaling medicines may cause

you to cough and your doctor may ask you to stop using Bramitob until little or no
blood appears in your sputum.

• If you are concerned that your Bramitob is not as effective as it should be. Bacteria

can sometimes develop resistance to antibiotic treatment.

Taking other medicines:
Before starting treatment, please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained without a prescription.
• Do not use Bramitob if you are taking diuretics (water tablets) containing furosemide

or ethacrynic acid, without discussing this with your doctor.

• Do not use Bramitob if you are taking urea or mannitol (these products are used to

treat serious conditions in hospitalised patients).

• Some other medicines can sometimes harm the kidneys or hearing and this could be

made worse by Bramitob treatment.

You may be receiving injections of tobramycin or other aminoglycosides as well as inhaling
Bramitob. Such injections, which may increase the very low body levels of aminoglycoside
caused by inhaling Bramitob, should be avoided when the following medicines are being taken:
• Amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins
• Platinum compounds (for example, carboplatin and cisplatin)
• Anticholinesterases (for example, neostigmine and pyridostigmine), botulinum toxin
If this applies to you, you should speak to your doctor.
Pregnancy and breast-feeding:
If you are pregnant or could become pregnant or you are breastfeeding, talk to your doctor
before using Bramitob.
Driving and using machines:
Bramitob has minor influence on the ability to drive and use machines.
In rare cases Bramitob may make you feel dizzy. It is therefore possible that Bramitob could
affect your ability to drive a car or operate machinery.
3. How to use Bramitob
Always use Bramitob exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. Instructions for using Bramitob are given after the dosage
section.
Do not mix or dilute your Bramitob with any other medicine in your nebuliser.
If you are taking several different treatments for cystic fibrosis you should take them in the
following order:
- bronchodilator (e.g. salbutamol), then
- chest physiotherapy, then
- other inhaled medicines, then
- Bramitob
Also check the order with your doctor.
Bramitob should be used with a clean, dry PARI LC PLUS or PARI LC SPRINT reusable
nebuliser (for your own personal use only) and a suitable compressor. Ask your doctor or
physiotherapist for advice on which compressor to use.)
The single-dose Bramitob container should be opened just before use. Any unused solution
that is not immediately used should be discarded.
Dosage:
• The dose (one 4 ml container) is the same for all persons aged 6 years and older.
• Use two single-dose containers per day for 28 days. Inhale the contents of one
container in the morning and one in the evening. There should be a 12 hour gap
between the doses.
• You then have 28 days without taking your medicine before starting another 28-day
treatment cycle again.
• It is important that you keep using the product twice each day during your 28 days on
treatment and that you keep to the 28-day on/28-day off cycle. Keep taking Bramitob
in this way until your doctor tells you to stop.
If you use more Bramitob than you should:
If you inhale too much Bramitob you may get a very hoarse voice. Make sure you tell your
doctor as soon as possible.
If you forget to use Bramitob:
• If there are more than 6 hours before you are due to use your next dose (container),
use Bramitob now.
• If there are less than 6 hours before you are due to use your next dose (container),
miss out the forgotten dose (container).
Then continue with your next dose as normal.
Please read back of leaflet

PAG. 1/2

TECHNICAL INFORMATION / INFORMAZIONI TECNICHE

CHIESI FARMACEUTICI S.p.A. - Parma - Italia

TECHNICAL WORKING

VIETATA LA MANOMISSIONE

1

DRAFT (Mac - ID cc )
08/07/2015

(1) DESCRIZIONE MATERIALE

F.E. BRAMITOB 300mg 4ml sol. da neb. CH. LTD

APPROVAL ARTWORK
1) ARTWORK LAB : (tecnichal part)

(signature)

Date:

2) ARTWORK LAB. HEAD

(signature)

Date:

3) MANUFACTURING DEPT. :

(signature)

Date:

(2) F.TO A.A.

Approved (OK for the print)

COLORI DI STAMPA N° 1

NAME (IN CAPITAL LETTERS):

150 x 62,5 mm

NERO + retino 50%

richiesta di codifica del 28/05/2015 - (6) Motivo:
- Regolatorio: - Chiesi UK address change
- Tecnico: modifica cod. Chiesi, cod. laetus, cod. UK

Date:

PDF OK per TVS

Final PDF Approved for Print

(signature)

Date:

(signature)

Date:

(signature)

Date:

PDF per il fornitore e per Chiesi Farm.

Instructions for use:
Bramitob
is intended
Instructions
for use:for use in a nebuliser, do not use it in any other way.

Bramitob
is your
intended
forthoroughly
use in a nebuliser,
notwater
use itbefore
in any opening
other way.
1. Wash
hands
with soapdoand
your single-dose
according
to the following
instructions.
1. container
Wash your
hands thoroughly
with soap
and water before opening your single-dose
2. Bend
the single-dose
backwards
and forwards (Figure A).
container
according tocontainer
the following
instructions.
3.
a new
container
from theand
strip,
firstly from
the A).
top, then in the middle
2. Carefully
Bend the separate
single-dose
container
backwards
forwards
(Figure
(Figure
B),
leaving
the
rest
in
the
foil
envelope.
3. Carefully separate a new container from the strip, firstly from the top, then in the middle
rotating
the flap as indicated by the arrow (Figure C).
4. Open
the
(Figure
B),single-dose
leaving thecontainer
rest in thebyfoil
envelope.
5.
squeeze
the contents
of the
container
(Figure
D). C).
by rotating
theinto
flapthe
asnebuliser
indicatedchamber
by the arrow
(Figure
4. Gently
Open the
single-dose
container
5. Gently squeeze the contents of the container into the nebuliser chamber (Figure D).


6.
7.
6.
8.
7.
9.
8.




Turn on the compressor.
Check
there
is a steady mist coming from the mouthpiece.
Turn onif the
compressor.
Sit
or
stand
in
an
so that
youthe
canmouthpiece.
breathe normally.
Check if there is aupright
steadyposition
mist coming
from
Place
the mouthpiece
between
your
andcan
on breathe
top of your
tongue. Breathe normally,
Sit or stand
in an upright
position
so teeth
that you
normally.
but
only
through
your
mouth
(you
may
find
noseclips
helpful).
Try not to
block the
end of
9. Place the mouthpiece between your teeth and on top of your tongue.
Breathe
normally,
the
tongue.
but mouthpiece
only throughwith
youryour
mouth
(you may find noseclips helpful). Try not to block the end of
10. Continue
until allwith
the your
Bramitob
is used up, this should take about 15 minutes.
the mouthpiece
tongue.
11.
you are until
interrupted,
or need to
or rest
turn off the
10. IfContinue
all the Bramitob
is cough
used up,
this during
should your
take treatment,
about 15 minutes.
compressor
to
save
your
medicine.
Turn
the
compressor
on
again
when
you
11. If you are interrupted, or need to cough or rest during your treatment, turn
offare
theready to
restart
your treatment.
compressor
to save your medicine. Turn the compressor on again when you are ready to

treatment.
If yourestart
have your
any further
questions on the use of this product, ask your doctor or pharmacist.

If you have
anyyour
further
questions
oncompressor:
the use of this product, ask your doctor or pharmacist.
Looking
after
nebuliser
and
Please
follow
the
manufacturer’s
instructions
for the care and use of your nebuliser and
Looking after your nebuliser and compressor:
compressor.
Please follow the manufacturer’s instructions for the care and use of your nebuliser and
compressor.
4.
Possible side effects

4. Possible
side effects
Like
all medicines,
Bramitob can cause side effects, although not everybody gets them.
medicines,
Bramitob
can effects
cause side
effects,
although
not everybody
IfLike
youallare
not sure what
the side
below
are, ask
your doctor
to explaingets
themthem.
to you.
If you
are common
not sure what
sideofeffects
below
are,may
ask your
explain
them
to you.
The
most
side the
effects
Bramitob
which
affectdoctor
more to
than
1 in 100
people
are:
Cough
and
hoarseness.
The most common side effects of Bramitob which may affect more than 1 in 100 people are:
Cough and hoarseness.
Uncommon
side effects of Bramitob which may affect more than 1 in 1,000 people are: thrush
infection),
vertigo,
lossmay
of hearing,
increased
quantities,
in
the mouth (candida
Uncommon
side effects
of Bramitob
which
affect more
than 1 saliva
in 1,000
people are: thrush
inflammation
of the tongue,
rash,vertigo,
sore throat,
enzymes
increased
the blood, noisy
infection),
loss hepatic
of hearing,
increased
saliva in
quantities,
in the mouth (candida
breathing,
nausea,
dry, coughing
up blood,
in the increased
throat (oropharyngitis)
chest,
inflammation
of themucosal
tongue, rash,
sore throat,
hepaticpain
enzymes
in the blood,or
noisy
loss
of
hearing,
headache,
shortness
of
breath,
weakness,
producing
more
sputum
(the
breathing, nausea, mucosal dry, coughing up blood, pain in the throat (oropharyngitis) or chest,
substance
you cough
up) than
normal,ofgastric
and fungal
infection.
loss of hearing,
headache,
shortness
breath,pain
weakness,
producing
more sputum (the

substance
you cough
up)
than
normal,
and fungal
infection.
Rare
side effects
which
may
affect
moregastric
than 1pain
in 10,000
people
are: loss of appetite, ringing in
the
ears,
tightness
or difficulty
breathing,
of voice,
noseare:
bleeds,
nose, ringing
mouth in
Rare
sidechest
effects
which may
affect more
than 1loss
in 10,000
people
loss runny
of appetite,
ulcers,
vomiting,
taste disturbances,
dizziness,
loss of
strength,
fever,
pain,
laryngitis
the ears,
chest tightness
or difficulty asthma,
breathing,
loss of voice,
nose
bleeds,
runny
nose,
mouth
(voice
throat and asthma,
difficulty dizziness,
swallowing).
ulcers,alteration
vomiting,with
tastesore
disturbances,
loss of strength, fever, pain, laryngitis
(voiceRare
alteration
with sore
throat
difficulty
swallowing).
Very
side effects
which
mayand
affect
less than
1 in 10,000 people are: swelling of lymph
glands,
drowsiness,
ear
problems,
ear
pain,
hyperventilation,
Very Rare side effects which may affect less than 1 in 10,000sinusitis,
people are: swelling of lymph
diarrhoea,
allergic reactions
including
and pruritus, deficiency
glands, drowsiness,
ear problems,
earurticaria
pain, hyperventilation,
sinusitis, of available oxygen in
the
blood and
bodily
tissues (hypoxia),
back pain,
pain and generally
feeling
unwell.
diarrhoea,
allergic
reactions
including urticaria
andabdominal
pruritus, deficiency
of available
oxygen
in

blood
and
bodily
tissues
pain,
abdominal
andnot
generally
unwell.
Ifthe
any
of the
side
effects
gets(hypoxia),
serious, orback
if you
notice
any sidepain
effects
listed infeeling
this leaflet,
please
tell
your
doctor
or
pharmacist.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
IfReporting
you get any
sideeffects
effects talk to your doctor, pharmacist or nurse. This includes any possible
of side
side
effects
not
listed
in this
leaflet.
You
can also
report side
effectsThis
directly
via: any possible
If you get any side effects
talk
to your
doctor,
pharmacist
or nurse.
includes
UK:
Scheme
at www.mhra.gov.uk/yellowcard.
sideYellow
effectsCard
not listed
in this
leaflet. You can also report side effects directly via:
HPRA Card
Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:
ROI:
UK: Yellow
Scheme at www.mhra.gov.uk/yellowcard.
+353
1 6762517.
Website: www.hpra.ie;
medsafety@hpra.ie.
ROI: HPRA
Pharmacovigilance,
EarlsfortE-mail:
Terrace,
IRL - Dublin 2; Tel: +353 1 6764971; Fax:
By
reporting
side effects
you
can help provide
more
information on the safety of this medicine.
+353
1 6762517.
Website:
www.hpra.ie;
E-mail:
medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bramitob
5. How to store Bramitob
• Keep out of the reach and sight of children
Keep
out of
theonly.
reach
of children
• For
single
use
Doand
not sight
use Bramitob
after the expiry date which is stated on the outer

and label
after Do
EXP.
date after
refers
to expiry
the last
daywhich
of thatismonth.
can
• pack
For single
use only.
notThe
useexpiry
Bramitob
the
date
stated You
on the
outer

use
if the
colour
of the date
solution
varies
packBramitob
and labelalso
after
EXP.
The expiry
refers
to the last day of that month. You can
use
Bramitob
also
if
the
colour
of
the
solution
varies
• In use shelf life: Bramitob bags (intact or opened)
may be stored for up to 3 months at
more
than
25ºC.
• not
In use
shelf
life:
Bramitob bags (intact or opened) may be stored for up to 3 months at
not more
25ºC. (2-8ºC). You can store the single-dose container for up to 3
• Store
in athan
refrigerator
months at not more than 25ºC., if you don’t have a refrigerator available and for
transporting purposes.
months at not more than 25ºC., if you don’t have a refrigerator available and for
transporting
purposes.in the original packaging in order to protect from light.
• Store
your containers

• Store in a refrigerator (2-8ºC). You can store the single-dose container for up to 3

Storefirst
youropening
containers
in the original
packaging
in immediately.
order to protect from light.
• After
the single-dose
container:
Use
opening
the single-dose
container:container
Use immediately.
• After first use:
Discard
the used single-dose
immediately.
• Medicines
After first use:
Discard
the
used single-dose
containerorimmediately.
should
not be
disposed
of via wastewater
household waste. Ask your

pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. Further information
• Medicines should not be disposed of via wastewater or household waste. Ask your

6. Further information
What Bramitob contains:
The
active
substance
is tobramycin. Each 4ml single-dose container contains tobramycin
What
Bramitob
contains:
300
The mg.
active substance is tobramycin. Each 4ml single-dose container contains tobramycin
The
300 other
mg. ingredients are sodium chloride, sulphuric acid and sodium hydroxide (for pH
adjustment),
water for are
injections.
The other ingredients
sodium chloride, sulphuric acid and sodium hydroxide (for pH

adjustment), water for injections.
What Bramitob looks like and contents of the pack:
Bramitob
appearslooks
as a clear,
yellowish
solution.
What Bramitob
like and
contents
of the pack:
Your
Bramitob
Nebuliser
Solution
comessolution.
in 4ml single-dose containers. There are 4 containers
Bramitob
appears
as a clear,
yellowish
in
each
sealed Nebuliser
bag, in boxSolution
sizes ofcomes
4, 16, in
284ml
or 56.
single-dose containers. There are 4 containers
Your
Bramitob
Not
all pack
sizes
may
be marketed.
in each
sealed
bag,
in box
sizes of 4, 16, 28 or 56.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing
Holder:
MarketingAuthorisation
Authorisation
Holder and Manufacturer:
Chiesi
Limited,
333
Styal
Road, Manchester, M22 5LG, United Kingdom.
Marketing Authorisation Holder:
Farmaceutici
S.p.A, 26/AM22
Via 5LG,
Palermo,
43122
Parma, Italy or
Manufacturer:
Chiesi Limited,Chiesi
333 Styal
Road, Manchester,
United
Kingdom.
Genetics
S.p.A.,
Contradad
Canfora,
84084
Fisciano
(Italy)
Manufacturer: Chiesi Farmaceutici S.p.A, 26/A Via Palermo, 43122 Parma, Italy or

Genetics S.p.A., Contradad Canfora, 84084 Fisciano (Italy)
This medicinal product is authorised in the Member States of the EEA under the following
names:
This medicinal product is authorised in the Member States of the EEA under the following
names:

Austria: Bramitob
Austria:
Bramitob
Czech
Republic:
Bramitob

(8) DATA A.A.

87P48.06/01
FUSTELLA

09/06/2015

(5) SOST. COD. 87P48.05/01

FONTS: in tracciati
CORPO: /
REPARTO: /

VOLTA

NOTE PER FORNITORE: Dopo piegatura deve risultare visibile su un lato il nome del prodotto e il codice testo e sull’altro lato il codice a barre

DEFINITIVO:
7) PDF TRANSFERRED IN TVS:

(4) CODICE

TOT. PAG. PDF: N.2

(7) Rif.

Signature

6) ARTW. DEVEL. MANAGER

150 x 500 mm

DIMENSIONI FOGLIO FINITO PIEGATO

(3) N˚ PHARMACODE 172 (COD. A BARRE)

Request for new draft
JOB TITLE

(Final check)

DIMENSIONI FOGLIO STESO

F049

4) I certify here by under my personal responsibility that the signed text is in full compliance with the official version approved
by the relevant regulatory Authority and in agreement with all regulations in force in the country, where the product will be
distributed.

5) ARTWORK LAB

D.Q.O.C. - Ufficio Grafico
Autore: RB/ChB
mail: r.boselli@chiesi.com

Netherlands: Bramitob
Netherlands:
Bramitob
Poland: Bramitob

Poland: Bramitob
Czech
Republic:
Bramitob
Germany:
Bramitob
Portugal:
Bramitob
Germany:
Bramitob
Portugal:
Bramitob
Greece: Bramitob
Slovak
Republic:
Bramitob
Greece: Bramitob
Slovak
Republic:
Bramitob
Hungary:
Bramitob
Spain:
Bramitob
Ireland:
Bramitob
United
Kingdom:
Bramitob
Hungary: Bramitob
Spain: Bramitob
Italy: Tobrineb
Ireland:
Bramitob
United Kingdom: Bramitob
Italy: Tobrineb
Is this leaflet hard to see or read? Phone for help: 0161 488 5555 (from UK)
+44161
488 5555
Is this leaflet
hard (from
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This leaflet was last approved in 07/2015

CP0005/9

This leaflet was last approved in 07/2015

CP0005/9

87P48.06/01

PAG. 2/2

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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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