e vial.
Do not store any GATTEX you have mixed.
Keep GATTEX and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Hospira, Inc.
1776 N. Centennial Drive
McPherson, KS 67460
U.S.A.
Distributed by:
NPS Pharmaceuticals
550 Hills Drive, 3rd Floor
Bedminster, NJ 07921
U.S.A.
©2012 NPS Pharmaceuticals
Issued: December 2012
PRINCIPAL DISPLAY PANEL - 30 Vial Carton
NDC 68875-0101-2
Rx only
Gattex®
(Teduglutide [rDNA origin]) for Injection
5 mg per vial.
For subcutaneous use only.
nps
pharmaceuticals
PRINCIPAL DISPLAY PANEL - 30 Vial Kit Carton
Rx only
Pharmacy:
Apply Use By dating
sticker here
NDC 68875-0102-1
Gattex®
(Teduglutide [rDNA origin]) for Injection
5 mg per vial.
For subcutaneous use only.
Attention Patients: Store at room temperature up to 25°C (77°F). Do not freeze.
nps
pharmaceuticals
PRINCIPAL DISPLAY PANEL - Single Use Kit Carton
NDC 68875-0103-1
Gattex®
(Teduglutide [rDNA origin]) for Injection
5 mg per vial.
For subcutaneous use only.
Rx only
Pharmacy:
Apply Use By dating
sticker here
Attention Patients: Store at room temperature up to 25°C (77°F). Do not freeze.
nps
pharmaceuticals
GATTEX
teduglutide injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68875-0101
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
teduglutide (teduglutide) teduglutide 5 mg
Inactive Ingredients
Ingredient Name Strength
Histidine 3.88 mg
mannitol
sodium phosphate, monobasic, monohydrate
sodium phosphate, dibasic, heptahydrate
Packaging
# Item Code Package Description
1 NDC:68875-0101-2 30 VIAL in 1 CARTON
1 NDC:68875-0101-1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203441 12/21/2012
GATTEX
teduglutide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68875-0103
Packaging
# Item Code Package Description
1 NDC:68875-0103-1 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 1
Part 2 1 SYRINGE, PLASTIC 1
Part 1 of 2
GATTEX
teduglutide injection, powder, lyophilized, for solution
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
teduglutide (teduglutide) teduglutide 5 mg
Inactive Ingredients
Ingredient Name Strength
histidine 3.88 mg
mannitol 15 mg
sodium phosphate, monobasic, monohydrate 0.644 mg
sodium phosphate, dibasic, heptahydrate 3.434 mg
Packaging
# Item Code Package Description
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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