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BUDELIN NOVOLIZER 400 MICROGRAMS PER ACTUATION INHALATION POWDER

Active substance(s): BUDESONIDE

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Cartridge

Sliding
cap

Dosage counter

Dosage
button

Package leaflet: Information for the user

Check that the colour of the control window has
changed back to red, also indicating a correct
inhalation. Replace the protective cap on the
­
mouthpiece – the inhalation procedure is now
complete.
The number in the top window indicates the
number of inhalations left. The numeric scale
200-60 is shown in steps of 20 and 60-0 in steps
of 10.If the click sound and change of the colour
did not appear, please repeat the procedure as
described above.

Budelin® Novolizer ®

400 micrograms per actuation inhalation powder
Budesonide

Read all of this leaflet carefully before
you start using 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 symp­
toms 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. See section 4.

NOTE: The coloured dosage button should only
be pressed immediately before inhalation.
Protective cap

Control window

1. PREPARATION:
The NOVOLIZER® Dry
Cap
Powder Inhaler makes
inhaling simple and reli­
able. Its straightforward
use, fast cartridge re­
placement and simple
cleaning are easy and
quickly done.
Place the NOVOLIZER® Dry Powder Inhaler in
front of you. Lightly press together the ribbed
surfaces on both sides of the cap, move the cap
forwards () and lift off ().
Remove the protective
Aluminium foil
aluminium foil from the
Cartridge
cartridge cylinder and
zylinder
take out the new car­
tridge. However, this
should only be done just
before using the car­
tridge. The colour coding on the cartridge must
correspond to the colour of the dosage button.
First filling:
Insert the cartridge into
the NOVOLIZER® Dry
Powder Inhaler with the
dosage counter facing
the mouthpiece (). Do
not press the dosage
button while inserting
the cartridge.

Cartridge

Refilling:
Note: The NOVOLIZER® Dry Powder Inhaler
should be cleaned every time the cartridge is
­exchanged after removal of empty cartridge.
If you have already used the NOVOLIZER® Dry
Powder Inhaler, first remove the empty cartridge
and then insert the new one (). Do not press
the dosage button while inserting the cartridge.
Replace the cap into the
side guides from above
() and push down flat
towards the coloured
dosage button until it
snaps into place ().

Cap
Dosage button

Flat

The NOVOLIZER® is now
filled and ready for use.
You can leave the
cartridge in the NOVO­
­
LIZER® Dry Powder In­
haler until it has been
used up or for up to
6 months after in­sertion. The cartridge is used up
if you see a hatched “0” in the middle of the dos­
age counter. Then a new cartridge has to be in­
serted. The cartridges may only be used in the
original dry powder inhaler.
2. USAGE:
Whenever possible, sit
or stand while inhaling.
When using the NOVO­
LIZER® always keep it
horizontal. First remove
the protective cap ().
Completely depress the
coloured dosage button.
A loud double click will
be heard and the colour
of the control window
will change from red to
green. Then release the
coloured button. The
colour green in the con­
trol window indicates
that the NOVOLIZER®
device is ready for use.

Protective cap

Dosage button

Green colour indicates
ready for use

Control window

Exhale (but not into
the NOVOLIZER® Dry
Powder Inhaler). Put your
lips tightly around the
mouthpiece, inhale the
powder steadily, deeply
and as rapidly as possi­
ble (to the maximum inhalation) and then hold
the breath for a few seconds. During this breath
a loud click should be heard, indicating correct
inhalation. Then continue with normal breathing.
1

Inadvertent overdosing is not possible with the
NOVOLIZER®. The click sound and the change
of the colour in the control window indicate that
inhalation has been performed correctly. If the
­
­colour of the control window does not change
back to red, the inhalation should be repeated.
If inhalation is not completed correctly after
­several a
­ ttempts, then you should consult your
doctor.
3. CLEANING:
The NOVOLIZER® Dry Powder Inhaler should be
cleaned at regular intervals, but at least every
time the cartridge is exchanged.

What is in this leaflet:
1. 
What Budelin Novolizer 400 micrograms
is and what it is used for
2. What you need to know before you use
Budelin Novolizer 400 micro­grams
3. How to use Budelin Novolizer 400 micro­
grams
4. Possible side effects
5. How to store Budelin Novolizer 400 micro­
grams
6. Contents of the pack and other information

Remove protective cap and mouthpiece
First remove the protec­
Mouthpiece
tive cap. Then grasp the
mouthpiece and turn it
briefly counter-clockwise
() until it becomes
loose. Then remove ().
Cleaning
Now turn the NOVO­
Dispensing slide
LIZER® upside down.
Grasp the loose dis­
pensing slide and move
it forwards () and up­
wards (). Any remain­
ing powder can be re­
moved by tapping lightly.
Clean the mouthpiece, the dispensing slide and
the powder inhaler with a soft and dry lint-free
cloth.
Do NOT use water or detergent.
Assembly – Insert dosage slide
After cleaning insert the
dosing slide by sliding
down at an angle ()
and press into position
().
Turn the inhaler back
over.

1. What Budelin Novolizer 400 micrograms
is and what it is used for
Budesonide, the active substance in Budelin
Novolizer 400 micrograms, is a glucocorti­
coid (corticosteroid) for inhalation.
Budelin Novolizer 400 micrograms is used
for regular treatment of persistent asthma.
NOTE:
Budelin Novolizer 400 micrograms should
not be used for treatment of a sudden attack
of respiratory distress (acute asthma attack
or Status asthmaticus (asthma a
­ttacks oc­
curring very frequently and/or persisting for
several days)).

Dispensing slide

2. What you need to know before you use
Budelin Novolizer 400 micrograms
Do not use Budelin Novolizer 400 micro­
grams if you are allergic to budesonide or to
milk proteins that are contained in small
amounts in the excipient lactose monohy­
drate (see section 6).

Assembly – Fit mouthpiece and protective cap
Insert the mouthpiece
Groove
Mouthpiece
with the pin into the
groove on the left and
turn to the right until it
snaps into place. Finish
Pin
by replacing the protec­
tive cap.

Warnings and precautions
Talk to your doctor or pharmacist before
­using Budelin Novolizer 400.

Notes

Contact your doctor if you experience
blurred vision or other visual disturbances.

• The Patient Information Leaflet describes how
the drug works. Please read it through care­
fully before using the inhaler for the first time.
• The NOVOLIZER® which comes with various
active substances does not use any pro­
pellants and is designed for refilling. This
makes the NOVOLIZER® a very environmen­
tally friendly product.
• 
It is not possible to overdose with the
­NOVOLIZER®. Even if the button is pressed
several times, no more powder is available for
inhalation. Only press the button when you
­really want to inhale. If you cannot manage to
inhale correctly after several attempts, consult
your doctor.
• The NOVOLIZER® can be refilled using new
cartridges* containing the active substance
and is thus ideally suited to long-term usage
(up to one year).
• Do not shake the filled NOVOLIZER®.
• 
Please support your children in proper
­handling of the device.
• 
Make sure your NOVOLIZER® is protected
from moisture and heat and kept clean at all
times.

Take special care in using Budelin Novolizer
400 micrograms, if you are suffering from lung
tuberculosis or fungal infection or from other
infection of the airways. This also applies if
you have been affected by these conditions in
the past. Ask your doctor for advice.
Budesonide is not suitable for treatment of
acute respiratory distress or severe continu­
ous spasm of the bronchial tubes (Status asthmaticus). Your doctor will advise you to use a
short‑acting inhaled bronchodilating agent
(bronchodilator) as rescue medication to re­
lieve the acute symptoms of your complaints.
If you have a severe liver disease, the elimi­
nation of Budesonide may be impaired. This
may lead to increased levels of Budesonide
in your blood.

*
Regarding corresponding medicines, please
ask your doctor.
MEDA Pharma GmbH & Co. KG
Benzstr. 1
61352 Bad Homburg (Germany)

Last Review October 2017
T5008784

Cartridge cylinder

Instructions for Use (Gebrauchsanleitung) in com­
pliance with the Medizinproduktegesetz (German Law
on Medical Devices)

Any inhaled glucocorticoids may cause side
effects, particularly when using high doses
for prolonged periods. These effects are
much less likely to occur with inhalation
treatment than with the intake of glucocorti­
coid tablets. Possible effects include disor­
ders in the function of the adrenal cortex,
Cushing’s syndrome, Cushingoid features
(hormone disorder caused by high levels of
cortisol in the blood with central obesitiy,
‘moon face’, thinning of the skin, hyperten­
sion, etc.), decrease in bone density, growth
retardation in children and adolescents as
well as eye disease (cataract and glaucoma),
and more rarely, a range of psychological or
behavioural effects including psychomotor
hyperactivity, sleep disorders, anxiety, de­
pression or aggression (particularly in chil­
dren). Therefore, it is important that the

l­owest dose is administered at which effec­
tive control of asthma is maintained.
Should periods of stress or emergencies
(e.g. severe infections, injuries and surgery)
occur within the first few months of switch­
ing from intake of tablets to inhalation treat­
ment, it may be necessary to resume sys­
temic administration of glucocorticoids in
form of tablets or infusions. This applies also
to patients who have received prolonged
treatment with high doses of inhaled gluco­
corticoids. They may also have impaired
adrenocortical function and may need sys­
temic glucocorticoid cover during periods of
stress and/or for elective surgery.
After switching to inhalation treatment,
symptoms may occur that had been sup­
pressed by the previous systemic treatment
with glucocorticoids, e.g. symptoms of aller­
gic rhinitis, allergic rash or rheumatic com­
plaints. These symptoms should be treated
in addition by suitable medication.
Some patients might feel generally unwell in
a non-specific way during the switching period
despite maintenance or even improvement
in respiratory function. In such a case, please,
consult your doctor. He/she will then decide
whether treatment can be continued as
planned or if you have - for instance - symp­
toms of an insufficient function of the adre­
nal cortex conflicting with such continuation.
Other medicines and Budelin Novolizer 400
micrograms
Please tell your doctor or pharmacist if you
are taking / using, have recently taken /
used or might take / use any other medi­
cines.
Some medicines may increase the effects of
Budelin Novolizer 400 micrograms and your
doctor may wish to monitor you carefully if
you are taking these medicines (including
some medicines for HIV, nelfinavir, ritonavir,
cobicstat and medicine for the treatment of
fungal disease, ketoconazole, itraconazole).
Therefore, this combination should be
avoided. If this is not possible the time
interval between administration of these
­
medicines and budesonide should be as
long as possible.
Raised plasma concentrations of cortico­
steroids and enhanced effects of cortico­
steroids have been observed in women also
treated with oestrogens and contraceptive
steroids, but no effect has been observed
with budesonide and concomitant intake of
low dose combination oral contraceptives.
Because adrenal function may be sup­
pressed, an ACTH stimulation test for diag­
nosing pituitary insufficiency might show
false results (low values).
Pregnancy and 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.
Pregnancy
Most results from prospective epidemiological
studies and world-wide post-marketing data
have not been able to detect an increased risk
for adverse effects for the foetus and newborn
child from the use of inhaled budesonide duri­
ng pregnancy. It is important for both foetus
and mother to maintain an adequate asthma
treatment during pregnancy. As with other
drugs administered during pregnancy, the be­
nefit of the administration of budesonide for
the mother should be weighed against the
risks to the foetus.
Breast-feeding
Budesonide is excreted in breast milk. How­
ever, at therapeutic doses no effects on the
suckling child are anticipated. Maintenance
treatment with inhaled budesonide (200 or
400 micrograms twice daily) in asthmatic nur­
sing women results in negligible systemic ex­
posure to budesonide in breast-fed infants.
Therefore, Budelin Novolizer 400 micrograms
can be used during breast feeding.
Driving and using machines
Budesonide has no influence on the ability to
drive and use machines.

T5008784_p01.indd 1

MEDA
SPECIFICATION BOX

Typopharma GmbH
Mühlestr. 57
D-79539 Lörrach
produktion@typopharma.com
www.typopharma.com
typopharma no:

# 129737

T5008784

INSTRUCTIONS FOR USE1 Novolizer®

15.02.18 10:48

Meda Manufacturing GmbH

Used template

N/A

Code (PZN, EAN, Datamatrix) N/A

Product
(+Pack Size)

PB BUDELIN 400 SC GB

Comments

Meda Code / no.

T5008784

black

Replaced no.

T5008425

p 490 c

Order no.

N/A

Country/ language

GB, english

Technical colours

Cutting

Component Size

247 x 340 mm

Corrections / No. of proofs

4

Release

Page no.

Page 1 of 2

1 15.02.2018 sm

5

Drawing no.

N/A

Correction Remark:
required

Laetus no. | SEM

N/A

Manufacturer

N/A
N/A

Colours used

| N/A

2

6

3

7

Fonts used

Helvetica Neue LT W1G

Min. font-­
size text

7,7 pt

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Date & sign.:

! PLEASE TURN OVERPRINTING ON !

Budelin Novolizer 400 micrograms contains
milk sugar (lactose), 10.5 mg of lactose mono­
hydrate/delivered dose.

Normally, the content of lactose in a single
dose does not cause any problems in peo­
ple with lactose intolerance. If you are con­
cerned that you may have an intolerance,
you must talk to your doctor.
Milk sugar (lactose) contains small amounts
of milk protein.
3. How to use Budelin Novolizer 400 micrograms
Always use this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Patients without previous treatment with
glucocorticoids and patients previously
treated with inhaled glucocorticoids
Unless otherwise prescribed by your doctor,
the following dosage is recommended for:
Adults (including older people) and children/
adolescents over 12 years of age:
Initial recommended
dose:
1 single dose
(400 micrograms)
once or twice daily
Maximum recom­
mended dose:
2 single doses
(800 micrograms)
twice daily (daily dose:
1600 micrograms)
Children aged 6 to 12 years:
Initial recommended
1 single dose ­
dose:
(400 micrograms)
once a day
Maximum recom­
mended dose:
1 single dose
(400 micrograms)
twice daily
(daily dose:
800 micrograms)
In case of once daily dosing, it is recom­
mended to take this dose in the evening.
Children below 6 years of age:
Budelin Novolizer 400 micrograms is not
re­
­
commended for use in children below
age 6 due to insufficient data on safety and
efficacy.
Please support your children in proper h
­ andling
of the Novolizer device.

Children
It is recommended that the growth of chil­
dren receiving prolonged treatment with
inhaled glucocorticoids at large doses is
­
regularly monitored.
Older people
Usually, no special dose adjustment is re­
quired. In general, the lowest effective dose
required for a sufficient control should be
used.
In case of deterioration of symptoms (recog­
nized by e.g. persistent respiratory distress
and increased use of other inhaled broncho­
dilating agents) you should seek advice from
a medical doctor as soon as possible. If you
have inhaled only once a day so far, it may
become required in such a case to use the
same dose twice daily now (in the morning
and in the evening). In any case, you doctor
should decide if your usual dose of Budelin
Novolizer 400 micrograms needs to be in­
creased.
Should you have the impression that the
effect of Budelin Novolizer 400 micrograms
is either too strong or too weak, discuss this
with your doctor or pharmacist.
For the relief of acute symptoms of asthma,
you should carry along a short acting in­
haled bronchodilating agent (beta-2-agonist,
such as Salbutamol) at all times.
When you switch from another Budesonide
inhaler to Budelin Novolizer 400 micrograms,
the treatment plan may have to be adjusted
by your doctor.
Method of Administration
Inhalation use.
Inhale as shown in the Instructions for Use.
Important information for use
To reduce the risk of fungal infection in
mouth and throat (oral candidiasis) and
hoarseness it is recommended that inhala­
tion be performed before meals and/or that
the mouth is rinsed with water or the teeth
are brushed after each inhalation.
Duration of treatment
Budelin Novolizer 400 micrograms is inten­

ded for long-term therapy. It should be used
regularly according to the recommended
treatment schedule even at times when no
symptoms are experienced.
If you have not used glucocorticoids pre­
viously or have been treated occasionally
only over a short period with glucocorticoids,
regular use of Budelin Novolizer 400 micro­­
grams as directed should lead to an im­
provement in breathing after approximately
10 days. However, extreme mucous con­
gestion and inflammatory processes may
obstruct the bronchial passages to such an
extent that Budesonide cannot fully exert its
effects in the lung. In such cases, initiation of
therapy should be supplemented with admini­
stration of cortisone products (systemic glu­
cocorticoids) in form of tablets. Later on, the
tablet dose should be reduced gradually but
inhalative therapy will be continued.
If you have used cortisone products for a
prolonged period already, you should be
­
switched to Budelin Novolizer 400 micro­
grams at a time when your symptoms are
completely under control. Normally, function
of the adrenal cortex is suppressed in this
situation and therefore, intake of cortisone
tablets (systemic corticoid administration)
should be reduced gradually and must not
be stopped abruptly. At the beginning of the
switchover period, Budelin Novolizer
400 micrograms should be given in addition
for approximately 10 days. Then, depending
on your response, the daily dose of the cor­
tisone tablets can be reduced gradually at
intervals of one to two weeks.
If you inhale more Budelin Novolizer
400 micrograms than you should
It is important that you take your dose as
stated on the pharmacist’s label or as
advised by your doctor. You should not
increase or decrease your dose without
seeking medical advice.

Rare (may affect up to 1 in 1,000 people):
Allergic reactions (hypersensitivity) and
swelling of the face, eyes, lips, mouth and
throat (angioneurotic oedema), anaphylactic
reaction; suppression of the function of the
adrenal cortex (adrenal suppression), growth
retardation in children and adolescents;
restlessnes, nervousnes, abnormal behav­
ior, over-excited or irritable (these effects
are more likely to occur in children); skin
reactions such as nettle rash (urticaria),
­
eczema, topical inflammation of the skin
­
(dermatitis), itching (pruritus), redness of the
skin by excessively filled blood vessels (ery­
thema), bruising, disturbance of and hoarse
voice (in children)
Very rare (may affect up to 1 in 10,000 peo­
ple):
Bone density is decreased
Frequency not known (frequency cannot be
estimated from the available data):
Sleeping problems, aggression, excessive
urge to be active accompanied by mental
restlessness (psychomotor hyperactivity);
glaucoma; Lactose-monohydrate contains
small amounts of milk proteins and can
therefore cause allergic reactions.
Occasionally, side effects may occur which
are typical for systemic glucocorticoste­
roids. These side effects depend on the
dosage, the period of treatment, concomi­
tant or previous treatment with other gluco­
corticosteroids and the individual sensitivity.
Reporting of side effects
If you get any side effects, talk to your ­doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help pro­
vide more information on the safety of this
medicine.

If you forget to use Budelin Novolizer
400 micrograms
Do not take a double dose to make up for a
forgotten dose.

5. How to store Budelin Novolizer
400 micro­grams

If you stop using Budelin Novolizer
400 micrograms
Do not stop treatment with the Budelin
Novolizer 400 micrograms without talking
­
to your doctor first because this could lead
to an aggravation of the disease.

Do not use this medicine after the expiry
date which is stated on the label, the carton
and the cartridge container. The expiry date
refers to the last day of that month.

If you have any further questions on the­
use of this product, ask your doctor or phar­
macist.
Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Most important side effects
Irritation of the oral mucosa (throat irritation)
accompanied by difficulty in swallowing,
hoarseness and cough may commonly
­occur.
Treatment with inhaled Budesonide may
­result in fungal disease in the mouth and the
throat (oropharyngeale candidiasis). Experi­
ence has shown that this fungal infection
occurs less often when inhalation is per­
formed before meals and/or when the mouth
is rinsed or the teeth are brushed after inha­
lation. In most cases this condition responds
to topical anti-fungal therapy without
discontinuing treatment with the Budelin
­
Novo­lizer 400.
As with other inhalation therapies, in rare
cases bronchial spasm (paradoxical bron­
chospasm) may occur, manifested by a tem­
porary exacerbation of the respiratory dis­
tress and a immediate increase in wheezing
after dosing. Only in such a case, you
should discontinue use of the Budelin
­Novolizer 400 without previous consultation
and you must contact your doctor imme­
diately.
Inhalation of larger doses over a prolonged
period may lead to increased susceptibility
to infection. The ability to adapt to stress
can be impaired.
List of all other side effects
Uncommon (may affect up to 1 in 100 people):
Depression, anxiety or feeling worried, cata­
ract, muscle spasm, shaking (tremor),
blurred vision.

Keep this medicine out of the sight and
reach of children.

Storage conditions
Store in the original package. This medicinal
product does not require any special tem­
perature storage conditions.
In-Use storage conditions: Keep the
Novolizer device tightly closed, in order
­
to protect from moisture.
Information concerning in-use shelf-life
Exchange the cartridge six months after first
opening.
Do not use the powder inhaler for more than
1 year.
Note: The Novolizer device has been shown
to function for at least 2000 single doses.
Therefore a maximum of 20 cartridges
containing 100 single doses each and/or
40 cartridges containing 50 single doses
each can be used with this device (within a
single year) prior to replacement.

Pack sizes:
Original sales packs:
1 cartridge containing 50/100 metered
doses and 1 Novolizer powder inhaler
device
2 cartridges containing 100 metered doses
each and 1 Novolizer powder inhaler device
Refill packs:
1 cartridge containing 50/100 metered
doses
2 cartridges containing 100 metered doses
each
Not all pack sizes may be marketed
Marketing Authorization Holder
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishops Stortford
CM22 6PU
UK
Manufacturer:
MEDA Manufacturing GmbH
Neurather Ring 1
51063 Cologne
Germany
Tel: (+49)-221-6472-0
Fax: (+49)-221-6472-696
or:
MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Germany
This medicinal product is authorized in the
Member States of the EEA under the
following names:
Austria
Novolizer® Budesonid Meda 400 Mikro­
gramm Pulver zur Inhalation
Belgium and Luxembourg:
Novolizer® Budesonide 400 microgrammes,
poudre pour inhalation
France:
Novopulmon® Novolizer® 400 micro­
grammes/dose, poudre pour inhalation
Germany:
Novopulmon® 400 Novolizer®, Pulver zur In­
halation
Ireland:

Novolizer® Budesonide 400 micrograms in­
halation powder
Italy:
Budesonide Viatris® Novolizer® 400 micro­
grammi polvere per inalazione
The Netherlands:
Budesonid Novolizer® 400 microgram, inha­
latiepoeder
Portugal:
Budesonido Novolizer® 400 microgramas pó
para inalação
Spain:
Novopulm® Novolizer® 400 microgramos,
polvo para inhalación
United Kingdom:
Budelin® Novolizer® 400 micrograms per
­actuation inhalation powder
This leaflet was last revised in October 2017.

Do not throw away any medicine via waste­
water or household waste. Ask your phar­
macist how to throw away medicines you no
longer use. These measures will help to pro­
tect the environment.
6. Contents of the pack and further
information
What Budelin Novolizer 400 micrograms
contains
The active substance is budesonide.
Each actuation (puff) contains 400 micro­
grams of budesonide.
The other ingredient is Lactose mono­hydrate.
What Budelin Novolizer 400 micrograms
looks like and contents of the pack
Budelin Novolizer 400 micrograms, inhala­
tion powder, contains a white powder (0.545
g or 1.09 g) in a cartridge containing 50 or
100 metered doses packed in a container
sealed by aluminium foil, plus a Novolizer
powder inhaler device.
All components are made of plastic ma­
terials.

T5008784_p01.indd 2

MEDA
SPECIFICATION BOX

Typopharma GmbH
Mühlestr. 57
D-79539 Lörrach
produktion@typopharma.com
www.typopharma.com
typopharma no:

# 129737

T5008784

15.02.18 10:48

Meda Manufacturing GmbH

Used template

N/A

Code (PZN, EAN, Datamatrix) N/A

Product
(+Pack Size)

PB BUDELIN 400 SC GB

Comments

Meda Code / no.

T5008784

black

Replaced no.

T5008425

p 490 c

Order no.

N/A

Country/ language

GB, english

Technical colours

Cutting

Component Size

247 x 340 mm

Corrections / No. of proofs

4

Release

Page no.

Page 2 of 2

1 15.02.2018 sm

5

Drawing no.

N/A

Correction Remark:
required

Laetus no. | SEM

N/A

Manufacturer

N/A
N/A

Colours used

| N/A

2

6

3

7

Fonts used

Helvetica Neue LT W1G

Min. font-­
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Dieses Korrektur-PDF wurde von uns mit größter Sorgfalt erstellt
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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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