apo-dabigatran capsules 68891...take apo-dabigatran as prescribed. apo-dabigatran may be taken with...

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Introducing APO-DABIGATRAN CAPSULES The first generic alternative to Pradaxa Copyright © 2019 Apotex Technologies Inc. Pradaxa is a trademark of Boehringer Ingelheim Pharma GmbH & Co. KG 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 PACK SIZE(S) UPC APO CODE MCKESSON CODE K&F CODE 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 DIN BRAND 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 771313245944 771313245951 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.

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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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Date:

QA Rev#:

PantoneColours:

Description:

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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#:

Change Control #:

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

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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.

OTHER RECENT PRODUCT LAUNCHES