apo-dabigatran capsules 68891...take apo-dabigatran as prescribed. apo-dabigatran may be taken with...
TRANSCRIPT
Introducing
APO-DABIGATRAN CAPSULESThe first generic alternative to Pradaxa
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For more information or to place orders, please contact your Apotex Sales Representative or our National Order Desk at:
1.877.427.6839
For pharmacist use only.
ORDERING INFORMATION
PRODUCT PACKSIZE(S) UPC APO
CODEMCKESSONCODE
K&FCODE
Apo-Dabigatran 75 mg Caps* 30 BLS 65450 137470 161280
Apo-Dabigatran 110 mg Caps 60 BTL 65451 137469 161281
Apo-Dabigatran 150 mg Caps 60 BTL 65452 137468 161282
PRODUCT INFORMATION
PRODUCT DINBRAND REFERENCE
PRODUCT COMPARISON
Apo-Dabigatran 75 mg Caps 02468891 Pradaxa
Apo-Dabigatran 110 mg Caps 02468905 Pradaxa
Apo-Dabigatran 150 mg Caps 02468913 Pradaxa
771313245937
20170801R1 CART-1155
Code No. KR. DRUGS/KTK/25/521/2006
Pharmacien : Délivrer avec le feuillet de renseignements destinés aux consommateurs en pièce jointe. La monographie du produit est disponible sur demande.
Conserver entre 15 °C et 30 °C dans l’emballage d’origine. Protéger de l’humidité.
Important : Ne pas retirer la pellicule en aluminium de la plaquette alvéolée avant d’avoir besoin de prendre une capsule. Ne pas percer la pellicule en aluminium avec la capsules.
Des questions ou problèmes? 1-800-667-4708
AnticoagulantEach capsule contains 75 mg of dabigatran etexilate as dabigatran etexilate mesylate.
Adult Dose: Take APO-DABIGATRAN as prescribed. APO-DABIGATRAN may be taken with or without food. Swallow capsule whole with a glass of water. Do not chew, break or open the capsules. For more details refer to the enclosed Consumer Information leaflet.
Keep out of reach and sight of children.
AnticoagulantChaque capsule contient 75 mg de dabigatran etexilate sous forme de mésylate de dabigatran etexilate.
Dose pour adultes : Prendre APO-DABIGATRAN comme prescrit. APO-DABIGATRAN peut être pris avec ou sans nourriture. Avaler la capsule en entier avec un verre d’eau. Ne pas mâcher, briser ou ouvrir les capsules. Pour plus de détails, consulter la notice ci-incluse.
Tenir hors de la portée et de la vue des enfants.
Pharmacist: Dispense with enclosed Consumer Information leaflet. Product Monograph available on request.
Store between 15°C to 30°C in the original package. Protect from moisture.
Important: Do not peel off the blister foil until a capsule is required. Do not push the capsules through the blister foil.
Questions or concerns? 1-800-667-4708
30 (3X10) Capsules
30 (3
X10)
Cap
sule
s
DIN 02468891
DIN
0246
8891TORONTO
CANADA
Dabigatran Etexilate Capsules
Dabi
gatra
n Et
exila
te C
apsu
les
Dabigatran etexilate (as dabigatran etexilate mesylate)Dabigatran etexilate (sous forme de mésylate de dabigatran etexilate)
75 mg
75 m
g
APO-DABIGATRANAPOTEX INC.TORONTOCANADAM9L 1T9
APO-
DABI
GATR
AN
154 mm23 mm
35 mm
85 mm
11 mm
34.5 mm
85 mm
33.5 mm12 mm
Glue Area
Non-varnished area for track and trace details.
Non-varnish area (uncoated)Area for Lot/expiry imprint
PAGE 1 OF 1
NON VARNISH AREA DIELINEUV VARNISH/AQUEOUS COATING
See Material Specification Certificate of Analysis
ARPL CTN APO DABIGATRAN CAP 75MG 30 N/A
692174
N/A
N/A
389256
0
032 C300 CBLACK
9 PTMADHAVA CHARYAPR 16, 2018
MaterialCode:
PreviousCode:
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Bleed
012 C
85 mm x 35 mm x 154 mm20170801R1 CART-1155
771313245944
TORONTOC
AN
AD
A
Each capsule contains 110 mg of dabigatran etexilate as dabigatran etexilate m
esylate.
Adult Dose: Take APO-DABIGATRAN as prescribed. APO-DABIGATRAN may be taken with or without food.
Swallow capsule whole with a glass of water. Do not chew, break or open the capsules. For more details see
Product Monograph, available upon request.
Keep out of reach and sight of children. Pharmacist: Dispense with Consum
er Information.
Apotex Inc. Toronto,Canada M9L 1T9
Anticoagulant Conserver entre 15 °C et 30 °C dans l’em
ballage d’origine. Protéger de l’hum
idité. Une fois le flacon ouvert, le produit doit être utilisé dans les 4 prochains m
ois. Garder le flacon bien ferm
é. Des questions ou problèm
es? 1-800-667-4708
389110Code No. KR. DRUGS/KTK/25/521/2006
Anticoagulant Store between 15°C to 30°C in the original package. Protect from
m
oisture. Once opened, the product m
ust be used within 4 m
onths. Keep the bottle tightly closed. Questions or concerns? 1-800-667-4708
Chaque capsule contient 110 mg de dabigatran etexilate sous form
e de mésylate de dabigatran etexilate.
Dose pour adultes : Prendre APO-DABIGATRAN comm
e prescrit. APO-DABIGATRAN peut être pris avec ou sans nourriture. Avaler la capsule en entier avec un verre d’eau. Ne pas m
âcher, briser ou ouvrir les capsules. Pour plus de détails, voir la m
onographie du produit (disponible sur demande).
Tenir hors de la portée et de la vue des enfants.Pharmacien : Délivrer avec les renseignem
ents destinés aux consomm
ateurs.
Peel Here /
Tirez Ici
DIN 0246890560 Capsules
APO-DABIGATRAN
Dabigatran etexilate (as dabigatran etexilate mesylate)
Dabigatran etexilate (sous forme de m
ésylate de dabigatran etexilate)
Dabigatran Etexilate Capsules
110 mg
115.9 mm
(4.5629”)22.225 m
m.875”
138.125 mm
( 5.438”)
50.8 mm
2”
non-varnish area 22.225 m
m x 50.8 m
m
restricted area for Lot and Expiry encoding
3.175 mm
(.125”) C.R.Non Printing
Die Line
ALL COPY SHOULD BE 3.175 mm
(.125”) AW
AY FROM EDGE OF DIE LINE BUT GRAPHICS CAN BLEED OFF
PERMANENT GLUE HINGE
115.9 mm
(4.5629”)22.225 m
m.875”
138.125 mm
( 5.438”)
50.8 mm
2”
ALL COPY SHOULD BE 3.175 mm
(.125”) AW
AY FROM EDGE OF DIE LINE BUT GRAPHICS CAN BLEED OFF
115.9 mm
(4.5629”)22.225 m
m.875”
138.125 mm
( 5.438”)
50.8 mm
2”
PERMANENT GLUE HINGEView 1 / Front panel
View 2 / Back face of front panel
View 3 / Layer 2 032 C300 C
50.8 mm
x 138.125 mm
(2 Ply)
389110
UV VARNISH / AQUEOUS COATING
Black
N/A
See Material Specification Certificate of Analysis
N/A0
692174
Material
Code:
N/A
PreviousCode:
Minim
umFont Size:
Prepared by:
Date:
QA Rev#:
PantoneColours:
C of A:
Dimensions/Dieline#:
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Material
Code REF:
ECL Comm
onText#:
PAGE 1 OF 1
DIELINE
Description:ARPL LBL APO DABIGATRAN CAP 110M
G 60
MADHAVA CHARY
APR 10, 2018
Violet C
6.5 PT
771313245951
TORONTOC
AN
AD
A
Each capsule contains 150 mg of dabigatran etexilate as dabigatran etexilate m
esylate.
Adult Dose: Take APO-DABIGATRAN as prescribed. APO-DABIGATRAN may be taken with or without food.
Swallow capsule whole with a glass of water. Do not chew, break or open the capsules. For more details see
Product Monograph, available upon request.
Keep out of reach and sight of children. Pharmacist: Dispense with Consum
er Information.
Apotex Inc. Toronto,Canada M9L 1T9
DIN 02468913
60 Capsules
APO-DABIGATRANAnticoagulant Conserver entre 15 °C et 30 °C dans l’em
ballage d’origine. Protéger de l’hum
idité. Une fois le flacon ouvert, le produit doit être utilisé dans les 4 prochains m
ois. Garder le flacon bien ferm
é. Des questions ou problèm
es? 1-800-667-4708
389121Code No. KR. DRUGS/KTK/25/521/2006
Anticoagulant Store between 15°C to 30°C in the original package. Protect from
m
oisture. Once opened, the product m
ust be used within 4 m
onths. Keep the bottle tightly closed. Questions or concerns? 1-800-667-4708
Chaque capsule contient 150 mg de dabigatran etexilate sous form
e de mésylate de dabigatran etexilate.
Dose pour adultes : Prendre APO-DABIGATRAN comm
e prescrit. APO-DABIGATRAN peut être pris avec ou sans nourriture. Avaler la capsule en entier avec un verre d’eau. Ne pas m
âcher, briser ou ouvrir les capsules. Pour plus de détails, voir la m
onographie du produit (disponible sur demande).
Tenir hors de la portée et de la vue des enfants.Pharmacien : Délivrer avec les renseignem
ents destinés aux consomm
ateurs.
Dabigatran etexilate (as dabigatran etexilate mesylate)
Dabigatran etexilate (sous forme de m
ésylate de dabigatran etexilate)
Dabigatran Etexilate Capsules
150 mg
Peel Here /
Tirez Ici
115.9 mm
(4.5629”)22.225 m
m.875”
138.125 mm
( 5.438”)
50.8 mm
2”
non-varnish area 22.225 m
m x 50.8 m
m
restricted area for Lot and Expiry encoding
3.175 mm
(.125”) C.R.Non Printing
Die Line
ALL COPY SHOULD BE 3.175 mm
(.125”) AW
AY FROM EDGE OF DIE LINE BUT GRAPHICS CAN BLEED OFF
PERMANENT GLUE HINGE
115.9 mm
(4.5629”)22.225 m
m.875”
138.125 mm
( 5.438”)
50.8 mm
2”
ALL COPY SHOULD BE 3.175 mm
(.125”) AW
AY FROM EDGE OF DIE LINE BUT GRAPHICS CAN BLEED OFF
115.9 mm
(4.5629”)22.225 m
m.875”
138.125 mm
( 5.438”)
50.8 mm
2”
PERMANENT GLUE HINGE
View 1 / Front panel
View 2 / Back face of front panel
View 3 / Layer 2
50.8 mm
x 138.125 mm
(2 Ply)
389121
6.5 PT
N/A
See Material Specification Certificate of Analysis
N/A0
692174
Material
Code:
N/A
PreviousCode:
Minim
umFont Size:
Prepared by:
Date:
QA Rev#:
PantoneColours:
C of A:
Dimensions/Dieline#:
Change Control #:
Material
Code REF:
ECL Comm
onText#:
PAGE 1 OF 1
Description:ARPL LBL APO DABIGATRAN CAP 150M
G 60
MADHAVA CHARY
APR 10, 2018
032 C300 C
UV VARNISH / AQUEOUS COATING
Black
DIELINE
Apo-Dabigatran 110 mg Caps actual size Pradaxa 110 mg Caps
Apo-Dabigatran 150 mg Caps actual size
Pradaxa 150 mg Caps
Apo-Dabigatran 75 mg Caps actual size Pradaxa 75 mg Caps
*Inventory for the 75 mg strength will not be available at this time.
TM
PRODUCT PACKSIZE(S) DIN BRAND
REFERENCE1APOCODE
MCKESSON CODE
K&F CODE
Apo-Vardenafil 5 mg Tabs 4 BLS 02471647 Levitra 66929 135622 161059
Apo-Vardenafil 10 mg Tabs 4 BLS 02471655 Levitra 66930 135653 161060
Apo-Vardenafil 20 mg Tabs 4 BLS 02471663 Levitra 66931 135623 161061
Apo-Midodrine 2.5 mg Tabs 100 BTL 02278677 Amatine 48149 135687 119102
Apo-Midodrine 5 mg Tabs 100 BTL 02278685 Amatine 48148 135688 119103
Apo-Travoprost-Timop 0.004%/0.5% Ophthalmic Solution
5 mL 02415305 DuoTrav 61665 135545 161062
Apo-Ambrisentan 5 mg Tabs 30 BLS 02475375 Volibris 65773 135154 161016
Apo-Ambrisentan 10 mg Tabs 30 BLS 02475383 Volibris 65774 135155 161015
Melphalan for Injection 50 mg/vial 1 Kit 02468921 Alkeran 65119 135049 160996
Apo-HYDROmorphone CR 3 mg Caps 60 BTL 02476614 Hydromorph Contin 53046 132982 160783
Apo-HYDROmorphone CR 4.5 mg Caps 60 BTL 02476622 Hydromorph Contin 66644 133024 160787
Apo-HYDROmorphone CR 6 mg Caps 60 BTL 02476630 Hydromorph Contin 53050 132983 160789
Apo-HYDROmorphone CR 9 mg Caps 60 BTL 02476649 Hydromorph Contin 66689 132981 160790
Apo-HYDROmorphone CR 12 mg Caps 60 BTL 02476657 Hydromorph Contin 53051 133004 160780
Apo-HYDROmorphone CR 18 mg Caps 60 BTL 02476665 Hydromorph Contin 53052 133002 160782
Apo-HYDROmorphone CR 24 mg Caps 60 BTL 02476673 Hydromorph Contin 53053 133023 160792
Apo-HYDROmorphone CR 30 mg Caps 60 BTL 02476681 Hydromorph Contin 53054 133022 160785
Apo-Pinaverium 50 mg Tabs 100 BTL 02469677 Dicetel 47840 132066 160614
Apo-Pinaverium 100 mg Tabs 100 BTL 02469685 Dicetel 47839 132067 160617
Apo-Efavirenz-Emtricitabine- Tenofovir 600 mg / 200 mg / 300 mg Tabs
30 BTL 02468247 Atripla 65772 131683 160572
Apo-Solifenacin 5 mg Tabs 30 BTL 02423375 Vesicare 63893 130236 160334
Apo-Solifenacin 5 mg Tabs 100 BTL 02423375 Vesicare 63437 130243 160335
Apo-Solifenacin 10 mg Tabs 30 BTL 02423383 Vesicare 63894 130242 160332
Apo-Solifenacin 10 mg Tabs 100 BTL 02423383 Vesicare 63439 130244 160333
Apo-Lansoprazole- Amoxicillin-Clarithromycin 30 mg DR Caps, 500 mg Caps, 500 mg Tabs
56 BLS 02470780 Hp-PAC 62903 130474 160368
Apo-Clobetasol Spray 0.05 % w/w 59 mL 02475162 Clobex 65948 129771 160265
Apo-Latanoprost 50 mcg/mL Ophthalmic Solution
2.5 mL 02296527 Xalatan 66479 15293 160136
Cop
yrig
ht ©
201
9, A
pot
ex T
echn
olog
ies
Inc.
1B
rand
ref
eren
ces
are
the
trad
emar
ks o
f thi
rd p
arty
man
ufac
ture
rs.
For more information or to place orders, please contact your Apotex Sales Representative or our National Order Desk at:
1.877.427.6839
For pharmacist use only.
OTHER RECENT PRODUCT LAUNCHES