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OMNITROPE (somatropin) injection, solution OMNITROPE (somatropin) kit [Sandoz Inc]


OMNITROPE (somatropin) injection, solution OMNITROPE (somatropin) kit [Sandoz Inc]

Read this Instructions for Use before you start using Omnitrope Pen 5 and each time you get a refill. There may be new information. This information does not take the place of talking to the healthcare provider about the medical condition or the treatment.

Note:

Omnitrope Pen 5, Single-Patient-Use cartridge containing Omnitrope, needle, alcohol swab and storage case:

Supplies you will need to give an Omnitrope Injection. See Figure A.

Steps you should follow to give an Omnitrope injection:

Step 5. Selecting the injection site and injecting the dose of Omnitrope

Step 6. Removing and throwing away the needle and empty cartridge

Note: Check that the cartridge holder is attached to the Pen body before each injection. One of the blue arrows on the cartridge should be lined up with the yellow mark on the Pen body. After you attach the needle, you may see a few drops of medicine at the tip of the needle.

Step 3. Priming a new cartridge

At least 2 drops of medicine must flow out of the needle for the Pen to be properly primed. See Figure M.

Step 4. Selecting the correct dose of Omnitrope

Do not count the clicks to measure the correct dose of medicine.

Instead, hold the Pen body with the needle pointing up and turn the dose knob in a clockwise direction until you see a bent arrow () in the dose dialing window. See Figure O. Now continue to turn the dose knob in a clockwise direction until you hear a click and the entire Pen body is fully extended.

The injection button can now be fully pressed, resetting the dial to "0" without giving medicine. The correct dose can now be redialed.

Step 5. Selecting the injection site and injecting the dose of Omnitrope

The best sites for injection are tissues with a layer of fat between skin and muscle such as the upper leg (thigh), buttocks, or stomach area (abdomen) as in the picture shown below. Do not inject near your belly button (navel) or waistline.

Change the injection site every day. See Figure P.

Step 6. Removing and throwing away the needle and empty cartridge

How should I store Omnitrope Pen 5?

Important information about possible problems you may have with the Omnitrope Pen 5

If the Omnitrope Pen 5 is damaged or does not work, call the pharmacy where you got the Omnitrope Pen 5. If you got your Omnitrope Pen 5 from OmniSource, call 1-877-456-6794.

For other questions or additional information, call OmniSource at 1-877-456-6794. Do not try to repair the Pen yourself.

Your Omnitrope Pen 5 is covered by a 2 year guarantee. Contact your Omnitrope Pen 5 provider after you have used the pen for 2 years to have it replaced by a new one.

This guarantee is invalid if your Omnitrope Pen 5 has not been used in accordance with the manufacturer's instruction leaflet or if the defect has been caused by neglect, misuse or accident.

BD and BD Logo are trademarks of Becton, Dickinson and Company © 2019 BD. All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

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