Brochure LEVITRA®

Transcription

Brochure LEVITRA®

Erectile Dysfunction – LEVITRA®
Identifying genuine products of Bayer HealthCare
LEVITRA® brochure | Status: July 2013/Version 34-2011
Product presentation, packaging design, and selected security features
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www.beware-of-counterfeits.com
Identifying genuine products of Bayer HealthCare
LEVITRA® brochure
Status: July 2013 | Version: 34-2011
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Contents
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6 Protecting against counterfeits
7 LEVITRA® film-coated and orodispersible tablets
8 How can I identify genuine packages of film-coated tablets?
10 How can I identify genuine blister packs of film-coated tablets?
12 How can I identify genuine packages of orodispersible tablets?
14 How can I identify genuine pull-out blister packs of orodispersible tablets?
16 How can I identify genuine LEVITRA® pill bottles?
18 How can I identify counterfeit products?
20 Recognizing fake and pseudo-generic products
LEVITRA® brochure
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Protecting against counterfeits
In general, medicines in Germany
are pharmacy-only (i.e. patients can
buy them only in pharmacies). In
addition, many medicines may only
be handed out by the pharmacist
on presentation of a doctor’s prescription. This will be indicated on
the package (“pharmacy-only” or
“prescription-only”). The pharmacy
where patients buy their medicines
is thus the primary place of trust.
Germany can be rightly proud of the
safety and quality of its medicine
supplies.
How can I protect myself against counterfeit products?
Patients should only purchase
medicines from suppliers to whom
they can entrust their health to!
Patients should not trust suppliers
who break the law, for example,
• by marketing drug products in
contravention of legal regulations,
in particular outside legal retail
channels.
•b
y selling so-called generic
products that infringe intellectual
property rights (for example, marketing generic vardenafil that is
allegedly of a quality comparable
with LEVITRA® in Europe).
For this reason:
• Avoid purchasing pharmacy-only
medicinal products from private
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•
•
•
•
individuals, whether over the internet,
from acquaintances who bring back
apparently genuine products from
abroad, or in establishments such as
discos, body-building studios, etc.
Avoid offers for prescription-only
medicinal products that circumvent
the regulations requiring a doctor’s
prescription.
Avoid products in packaging that
is incomplete or not correctly con
figured for retail in Germany. (In case
of doubt, consult your physician or
pharmacist.)
Identify reputable internet pharmacies before purchasing drug
products online.
Obtain any medication you may
need on vacation before you travel
abroad.
In the case of suspect pharmaceuticals,
patients should always consult their doctor
or pharmacist, particularly if they think
that the product has had different effects
from the ones they are used to or if there
seems to be something wrong with the
packaging.
Patients should ensure that they are wellinformed before purchasing medicinal
products online.
Patients who buy products when they
are abroad should ensure that the
source they are buying from is trustworthy. They would do best to create
a personal “first-aid kit” before leaving
home, with the advice of a doctor or
pharmacist.
LEVITRA® film-coated and
orodispersible tablets
LEVITRA®: packaging with security features
Bayer HealthCare protects its product LEVITRA® (active ingredient: vardenafil) worldwide by means of various security features.
The following pages will show which features genuine products must display (page 7–17). Most of them are visible to the naked
eye and it would be extremely difficult to reproduce all of them. Please note that the depictions may not apply to parallel imports.
The LEVITRA® film-coated tablet is sold worldwide in three dosages of 5 mg, 10 mg, and 20 mg. German packaging is
different from packaging in other countries.
The new LEVITRA® orodispersible tablet is sold worldwide but only in a 10 mg dosage. In the USA and Canada,
the LEVITRA® orodispersible tablet is sold under the name of STAXYN™.
The LEVITRA® film-coated tablet is sold in the USA in pill bottles, in dosages of 2.5 mg, 5 mg, 10 mg, and 20 mg.
LEVITRA® brochure
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How can I identify genuine
packages of film-coated tablets?
Identifying characteristics of the packaging of LEVITRA® film-coated tablets
The following images and texts describe identifying characteristics of the German packaging of LEVITRA® film-coated tablets.
The packages may look different in other countries. As an example, a non-European package bearing the flame symbol is
shown at the bottom of page 9.
A
Dosage of the LEVITRA® film-coated
tablet
Dosages of the active ingredient vardenafil
in the LEVITRA® film-coated tablet in
Europe are 5 mg, 10 mg, and 20 mg.
The dosage is displayed at the top right
of the front of every package.
A
B
Embossed elements
The brand name LEVITRA® and a Braille
inscription are tangibly embossed on
the box.
B
C
C Number of tablets
The LEVITRA® film-coated tablets are sold in Europe in packages of 2, 4, 8, and
12 tablets. The number of tablets is printed in violet on the front of the package.
A dosage of 5 mg is printed in white within a violet frame. If the dosage is higher
than 5 mg, it is all printed in violet. The displayed number is made up of smaller
numbers, repeated continuously in microprinting, which become visible to the
human eye with the help of a magnifying glass.
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D Uncoated area
The entire surface of the LEVITRA®
folding box is coated, except for the
LEVITRA® lettering on the white part
of the box. This can be seen when the
box is tilted to the appropriate angle
under a light source.
Example of a
10 mg package
D
F
E
E
Variable data
Variable data (batch number, expiry
date) are printed on one side flap of
every folding box. The batch number is
a combination of letters and digits. The
expiry date has two digits showing the
month and four digits showing the year.
Package with variable data
F
Blue box*
On the back of the LEVITRA® folding
box, there is a colored frame (blue box)
which may contain (varying) countryspecific texts and symbols.
*Used only in the EU, Norway, and Iceland.
LEVITRA® brochure
Folding boxes bearing the flame symbol are sold
outside the EU.
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How can I identify genuine blister
packs of film-coated tablets?
Identifying characteristics of LEVITRA® film-coated tablet blisters
The following images and texts describe identifying characteristics of the German LEVITRA® film-coated tablet blister. The
printed texts can appear in different positions. They may look different in other countries. The examples shown at the bottom
of the page are earlier versions of the blister packs.
A
Variable data
date) are printed on every blister. The
batch number is a combination of letters
and digits. The expiry date has two
digits showing the month and four digits
showing the year.
A
A
Old blister variations that may still be available commercially, but are no
longer manufactured.
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B
B
Variable colors
The word LEVITRA® and the flame symbol
are repeated in a special color parallel
to the shorter edge of the blister. The
blister is moved (or, more precisely, when
the light falls on it from a different angle),
the color changes from violet to green
or vice versa.
C
D
D
The word LEVITRA®
The word LEVITRA® has been placed
on the inside surface of the transparent
plastic film. For this reason, it does not
look flat, but follows the shape of the
deformed blister foil and “moves” with it.
LEVITRA® brochure
C
Bayer cross on the aluminum foil
Light and dark Bayer crosses are continuously embossed in the aluminum foil of
every blister of film-coated tablets.
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packages of orodispersible tablets?
Identifying characteristics of the packaging of LEVITRA® orodispersible tablets
The following images and texts describe identifying characteristics of the German packaging of LEVITRA® package of
orodispersible tablets. The package may look different in other countries. Page 13, for example, shows a package of STAXYNTM
with the flame symbol that is available only in the USA and Canada.
A
Dosage of the LEVITRA®
orodispersible tablet
LEVITRA® orodispersible tablets are
sold worldwide but only in the dosage
of 10 mg of the active ingredient vardenafil. The dosage is always displayed
at the top right of the front package.
A
B
Embossed elements
The brand name LEVITRA® and a Braille
inscription are tangibly embossed on
the box.
B
C
C Number of tablets
LEVITRA® orodispersible tablets are sold worldwide in packages of 2, 4, and 8
tablets. The number of tablets is printed in violet on the front of the package. The
displayed number is made up of smaller numbers, repeated continuously in microprinting, which are visible to the human eye with the help of a magnifying glass.
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D Uncoated area
The entire surface of the LEVITRA®
folding box is coated, except for the
LEVITRA® lettering on the white part of
the box. This can be seen when the box
is tilted to the appropriate angle under
a light source.
D
F
E
F
Blue box
On the back of the LEVITRA® folding
box, there is a colored frame (blue box)
which may contain (varying) countryspecific texts and symbols.
E
Variable data
date) are printed on one side flap of
the package. The batch number is a
combination of letters and digits. The
expiry date has two digits showing the
month and four digits showing the year.
Package with variable data
In the USA and Canada, the orodispersible tablet
is sold under the product name STAXYN™.
LEVITRA® brochure
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How can I identify genuine pull-out
blister packs of orodispersible tablets?
Identifying characteristics of the LEVITRA® pull-out blister pack of orodispersible tablets
The following images and texts describe identifying characteristics of a European LEVITRA® pull-out blister pack of orodispersible
tablets. It is part of the LEVITRA® package of orodispersible tablets and may look different in other countries. For example, a
STAXYNTM pull-out blister pack of orodispersible tablets bearing the flame symbol, sold only in the USA and Canada, is shown
at the bottom of page 15.
A
Embossed elements
The product name LEVITRA® is tangibly
embossed on the black box.
A
B
B
Using the LEVITRA® pull-out
blister pack
When the orange flap with the arrow
is pulled, the blister emerges from the
opposite side of the package.
B
C
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C Embossed elements
The word LEVITRA® and the flame
symbol are continuously embossed in
diagonal lines on the aluminum foil of
every blister of orodispersible tablets.
E
D
D
D
D
Variable data on the LEVITRA® pull-out blister pack
Variable data (batch number, expiry date) are printed on the aluminum foil and on the package of every pull-out
blister pack. The batch number is a combination of letters and digits. The expiry date has two digits showing the
month and four digits showing the year. The details on the foil must match those on the box, as shown in the image.
E
Variable data on the outer folding box
The first batch number shown on the outer folding box is the batch number of the package as distributed
commercially.
In the USA and Canada, the blister displays an embossed flame symbol
instead of the word “LEVITRA®”.
LEVITRA® brochure
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LEVITRA® pill bottles?
The US packaging
In the USA, LEVITRA® is sold in four different dosages and is usually available in plastic bottles. Furthermore, and in contrast to
many other countries, it is common practice and quite legal for patients to obtain individual tablets from their pharmacist.
In Germany, such bottles may not be given to patients. Any patient who is offered such a bottle should refuse to touch it.
A
B
C
A
The LEVITRA® pill bottle
Every genuine LEVITRA® pill bottle is
white with an orange screwcap. It contains 30 tablets when first sold. Every
LEVITRA® pill bottle has an adhesive
label which displays the flame symbol,
the product name, and the number of
tablets contained in the bottle.
B
Dosage of the LEVITRA®
film-coated tablet
In the USA, the dosages of the active
ingredient vardenafil are 2.5 mg, 5 mg,
10 mg, and 20 mg. The dosages are
displayed in different colors on the
right, below the flame symbol on the
front of every pill bottle.
C Microprinting
Every adhesive label displays the
characteristic orange LEVITRA® microprinting, which extends over the entire
width of the label.
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D Patient information leaflet
The patient information leaflet is
attached to the back of the bottle.
F Aluminum seal
Every single LEVITRA® bottle is sealed.
The aluminum foil displays the Bayer
cross and the word Bayer.
D
F
E
E
Label
Variable data are imprinted on the black
part of the label.
Old package variation: On the bottle (left),
variable data are printed in a grey area; on the
aluminum seal (right) the flame symbol and the
word LEVITRA® are shown.
LEVITRA® brochure
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How can I identify
counterfeit products?
Counterfeits
The products shown here and on the following pages are either not registered anywhere in the world or, at least, not
registered in Europe, but they are available to patients in Europe over the internet and are used by European consumers.
Many patients in Germany who order this kind of product are not aware of, or ignore, the fact that by doing so, they are
not only endangering their health but may also be breaking the law. We strongly advise you not to take these drugs!
LEVITRA® packages and/or blisters
with the batch number BXB8551 are
always counterfeits!
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These packages and the tablets are counterfeit
• No genuine LEVITRA® pill bottle is sold by Bayer in a folding box.
• No genuine LEVITRA® pill bottle is sold by Bayer with a white screwcap.
• No genuine LEVITRA® pill bottle is sold by Bayer with a white label.
• No genuine LEVITRA® product is sold by Bayer with 100 mg of vardenafil per tablet.
• No genuine LEVITRA® product with the following batch numbers is sold by Bayer:
- 0027K79
- 2500K69
- 0026K69
- 0027K18
- 0027K81
Genuine LEVITRA® tablets by
Bayer are not supplied loosely
or in a plastic bag.
LEVITRA® brochure
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Recognizing fake and
pseudo-generic products
We strongly advise you not to take these drugs!
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We strongly advise you not to take these drugs!
LEVITRA® brochure
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Further addresses and links
European Alliance for Access to Safe Medicines
(EAASM)
Internet: www.eaasm.eu
National Association of Boards of Pharmacy (NABP)
1600 Feehanville Drive
Mount Prospect, IL 60056
USA
Phone: +1 847 391-4406
Fax: +1 847 391-4502
Internet: www.nabp.net
World Health Organization (WHO)
Avenue Appia 20
1211 Geneva 27
Switzerland
Phone: +41 22 791-2111
Fax: +41 22 791-3111
Internet: www.who.int
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Leopold Plaza Building
Rue du Trône 108
1050 Brussels
Belgium
Phone: +32 2 6262555
Fax: +32 2 6262566
Internet: www.efpia.eu
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LEVITRA® brochure
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Bayer Pharma AG
Packaging Technology
Building D 203
51368 Leverkusen, Germany
www.healthcare.bayer.com

Brochure LEVITRA®

Transcription

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