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TachoSil (Page 5 of 5)


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TachoSil is a registered trademark of Takeda Nycomed AS.

PRINCIPAL DISPLAY PANEL – 3.7 inch x 1.9 inch Patch Carton

NDC 0944-8701-01

Absorbable Fibrin
Sealant Patch
TachoSil®

1 patch of 3.7 inch x 1.9 inch
(9.5 cm × 4.8 cm)

Single use only

Topical use only
Do not use intravascularly

Store at 2°C to 25°C (36°F to 77°F)
Do not freeze

Directions for use: See package insert

Use immediately once the foil pouch is opened
Do not resterilize

Dispose of any unused product or waste materialin accordance with local requirements

Rx Only

Product Code 1144922

Baxter

8701.jpg
(click image for full-size original)
8701.jpg

PRINCIPAL DISPLAY PANEL – 1.9 inch x 1.9 inch Patch Carton

NDC 0944-8702-02

Absorbable Fibrin
Sealant Patch
TachoSil®

2 patches of 1.9 inch x 1.9 inch
(4.8 cm × 4.8 cm)

Single use only

Topical use only
Do not use intravascularly

Store at 2°C to 25°C (36°F to 77°F)
Do not freeze

Directions for use: See package insert

Use immediately once the foil pouch is opened
Do not resterilize

Dispose of any unused product or waste materialin accordance with local requirements

Rx Only

Product Code 1144923

Baxter

8702.jpg
(click image for full-size original)
8702.jpg

PRINCIPAL DISPLAY PANEL – 1.2 inch x 1.0 inch Patch Carton

NDC 0944-8703-01

Absorbable Fibrin
Sealant Patch
TachoSil®

1 patch of 1.2 inch x 1.0 inch
(3.0 cm × 2.5 cm

Single use only

Topical use only
Do not use intravascularly

Store at 2°C to 25°C (36°F to 77°F)
Do not freeze

Directions for use: See package insert

Use immediately once the foil pouch is opened
Do not resterilize

Dispose of any unused product or waste materialin accordance with local requirements

Rx Only

Product Code 0000000

Baxter

8703.jpg
(click image for full-size original)
8703.jpg
TACHOSIL thrombin human and fibrinogen patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0944-8701
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THROMBIN HUMAN (THROMBIN HUMAN) THROMBIN HUMAN 5.5 mg
FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 2.0 [USP'U]
Inactive Ingredients
Ingredient Name Strength
EQUINE COLLAGEN
ALBUMIN HUMAN
RIBOFLAVIN
SODIUM CHLORIDE
SODIUM CITRATE
ARGININE HYDROCHLORIDE
Product Characteristics
Color YELLOW (active side) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0944-8701-01 1 POUCH in 1 CARTON contains a POUCH
1 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0944-8701-01) and contains a BLISTER PACK
1 1 PATCH in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (0944-8701-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125351 04/05/2010
TACHOSIL thrombin human and fibrinogen patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0944-8702
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THROMBIN HUMAN (THROMBIN HUMAN) THROMBIN HUMAN 5.5 mg
FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 2.0 [USP'U]
Inactive Ingredients
Ingredient Name Strength
EQUINE COLLAGEN
ALBUMIN HUMAN
RIBOFLAVIN
SODIUM CHLORIDE
SODIUM CITRATE
ARGININE HYDROCHLORIDE
Product Characteristics
Color YELLOW (active side) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0944-8702-02 2 POUCH in 1 CARTON contains a POUCH
1 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0944-8702-02) and contains a BLISTER PACK
1 1 PATCH in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (0944-8702-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125351 04/05/2010
TACHOSIL thrombin human and fibrinogen patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0944-8703
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THROMBIN HUMAN (THROMBIN HUMAN) THROMBIN HUMAN 5.5 mg
FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 2.0 [USP'U]
Inactive Ingredients
Ingredient Name Strength
EQUINE COLLAGEN
ALBUMIN HUMAN
RIBOFLAVIN
SODIUM CHLORIDE
SODIUM CITRATE
ARGININE HYDROCHLORIDE
Product Characteristics
Color YELLOW (active side) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0944-8703-01 1 POUCH in 1 CARTON contains a POUCH
1 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0944-8703-01) and contains a BLISTER PACK
1 1 PATCH in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (0944-8703-01)
2 NDC:0944-8703-05 5 POUCH in 1 CARTON contains a POUCH
2 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0944-8703-05) and contains a BLISTER PACK
2 1 PATCH in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (0944-8703-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125351 04/05/2010
Labeler — Baxter Healthcare Corporation (039121363)

Revised: 09/2013 Baxter Healthcare Corporation

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