GATTEX- teduglutide injection, powder, for solution 
GATTEX- teduglutide   
NPS Pharmaceuticals

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Instructions for Use

GATTEX®(Ga'-tex)

(teduglutide [rDNA origin])

for injection

Read this Instructions for Use before you start using GATTEX and each time you get a refill. There may be new information. Your healthcare provider or nurse should show you how to prepare, measure your dose, and give your injection of GATTEX the right way.

If you cannot give yourself the injection:

Important information:

GATTEX kit
GATTEX kit
Gather the supplies you will need to prepare GATTEX and to give your injection. (See Figure A)

Figure A From your GATTEX kit you will need:
  • 5-mg vial of GATTEX with green cap
    Your healthcare provider will tell you how many vials of GATTEX you will need for your injection.
  • 2 alcohol swab pads
  • Diluent syringe. Your kit has only 1 type of Diluent syringe.
    • With a white snap-off cap OR
    • With a gray screw top
  • 22 gauge, 1½ inch needle
  • Plastic dosing syringe with needle attached
  • An FDA-cleared sharps disposal container. See "Step 7: Dispose of needles and syringes."

Step 1: Prepare the injection.
  • Choose a well-lit, clean, flat work surface.
  • Wash your hands with soap and water.
Step 2: Preparing the Diluent syringe.
  • Put the Diluent syringe and 22G 1½ inch needle in front of you on your work surface. (See Figure B1)
Figure B1
  • Hold the Diluent syringe by the barrel.
a.
If you have the Diluent syringe with the white snap-off cap: Snap or twist off the white cap (bend the cap sideways until the cap comes off). Only the top portion of the white cap should be snapped off. The lower portion of the cap will remain in place (See Figure B2). Throw the cap away.
Figure B2
b.
If you have the Diluent syringe with the gray screw top: Unscrew the top counter clockwise (to the left) (See Figure B3). Throw the top away.
Figure B3

Step 3: Mix GATTEX powder with Diluent.

Step 4: Check the mixed GATTEX.

Step 5: Draw up your dose of GATTEX.

Figure MFigure N

Step 6: Inject GATTEX.

Step 7: Dispose of syringes and needles.

How should I store GATTEX?

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

Revised: 01/2013
 
NPS Pharmaceuticals