uld be dry before you inject.
3.Lightly pinch the skin. Stick the needle in the way your child's doctor showed you. Release the skin (see figure A).
Figure A: Lightly pinch the skin and inject as instructed
4.Slowly push in the plunger of the syringe all the way, making sure you have injected all the liquid. Pull the needle straight out and gently press on the spot where you injected your child with gauze or a cotton ball for a few seconds. Do not rub the area (see figure B).
Figure B: Press (don't rub) with gauze or cotton
5.Follow your child's doctor's instructions for throwing away the needle and syringe. Do not recap the syringe. Used needle and syringe should be placed in a sharps container (such as a red biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can). Such containers should be sealed and disposed of properly.
For additional information, call 1-866-837-2422.
SPL UNCLASSIFIED SECTION
Manufactured for: Ipsen Biopharmaceuticals, Inc.
Basking Ridge, NJ 07920 USA
www.ipsenus.com
Issued: August 2005
Revised: June 2012
PRINCIPAL DISPLAY PANEL - 40 mg Carton
NDC 15054-1040-5
One multi-use vial
Rx only
increlex®
(mecasermin [rDNA origin]
injection)
40 mg/4 mL
(10 mg/mL)
For subcutaneous use only
Net wt. 40 mg
TN5UC-01
INGREDIENTS AND APPEARANCE
INCRELEX
mecasermin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15054-1040
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
mecasermin (UNII: 7GR9I2683O) (mecasermin - UNII:7GR9I2683O) mecasermin 40 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol (UNII: LKG8494WBH) 36 mg in 4 mL
sodium chloride (UNII: 451W47IQ8X) 23.4 mg in 4 mL
polysorbate 20 (UNII: 7T1F30V5YH) 8 mg in 4 mL
sodium acetate (UNII: 4550K0SC9B) 23.3 mg in 4 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:15054-1040-5 1 in 1 CARTON
1 4 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021839 01/03/2006
Labeler - Ipsen Biopharmaceuticals, Inc. (118461578)
Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 030606222 MANUFACTURE(15054-1040)
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