rate intact carton at 2º-8ºC
(36º-46ºF). DO NOT SEPARATE
CONTENTS OF CARTON PRIOR
TO USE.
DO NOT FREEZE
PRINCIPAL DISPLAY PANEL - 200 mg/mL Syringe Carton
NDC 50474-710-81
Rx ONLY
Do not accept if seals on top and
bottom of carton are missing.
Dispense the enclosed Medication Guide to
each patient.
cimzia®
(certolizumab pegol)
STARTER KIT
3 cartons of 2 × 200 mg/mL prefilled syringes
FOR SUBCUTANEOUS INJECTION USE ONLY
The entire carton is to be dispensed as one unit.
Each unit carton contains three individual
cartons (doses). Each individual carton (dose)
contains: 2 single-use prefilled syringes
(200 mg/1 mL) and 2 alcohol swabs.
store in refrigerator
ucb
STORE AT 36º- 46º F (2º-8º C)
DO NOT FREEZE
Protect from light
CIMZIA
certolizumab pegol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-700
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50474-700-62 2 KIT ( KIT) in 1 CARTON contains a KIT
1 1 KIT ( KIT) in 1 KIT This package is contained within the CARTON(50474-700-62)
2 NDC:50474-700-61 2 KIT ( KIT) in 1 CARTON contains a KIT
2 1 KIT ( KIT) in 1 KIT This package is contained within the CARTON(50474-700-61)
QUANTITY OF PARTS
Part# Package Quantity Total Product Quantity
Part1 1VIAL, GLASS 1mL
Part2 1VIAL, GLASS 1mL
Part 1of2
CIMZIA
certolizumab pegol injection, powder, lyophilized, for solution
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
certolizumab pegol (certolizumab pegol) certolizumab pegol 200mg in1mL
Inactive Ingredients
Ingredient Name Strength
sucrose 100mg in1mL
lactic acid 0.9mg in1mL
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125160 04/20/2008
Part 2of2
WATER
water injection, solution
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Water
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125160 04/20/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125160 04/20/2008
CIMZIA
certolizumab pegol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-710
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
certo
