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OMNITROPE® PEN 5 INSTRUCTIONS FOR USE
For use with Omnitrope® (Somatropin [rDNA origin] Injection) 5 mg/1.5 mL cartridges
TABLE OF CONTENTS
Important Safety Information
DOs and DON'Ts
Pen Parts
Auto-positioning Feature
Pen Components
How to Use Your Omnitrope® Pen 5
Loading the Cartridge into the Pen
Attaching the Pen Needle
Priming
Dose Dialing
Making the Injection
Removing the Pen Needle
Trouble Shooting
Care and Storage
Guarantee
Important Personal Notes
Service Materials
READ FIRST: Important Safety Information
DOS AND DON'TS
DOs
DON'Ts
Never recap pen with pen needle on.
![]() |
Storing or carrying your Omnitrope® Pen 5 with a pen needle attached may lead to needle pricks and leaves an open passage for:
Both of these conditions can affect the dose of the injection.
5. Do not use your Omnitrope® Pen 5 if the cap or other parts are missing.
PEN PARTS
AUTO-POSITIONING FEATURE
The Omnitrope® Pen 5 has a black rod with an auto-positioning feature. This auto-positioning feature makes priming easier (fewer steps), especially when a new cartridge is used.
How it works
(Pictures are included only to demonstrate the auto-positioning feature. These steps are not necessary to operate pen).
![]() |
Notice that the black rod moves into the pen easily and returns to the fully extended position automatically. This automatic extension of the black rod positions it correctly against the cartridge plunger.
PEN PARTS
PEN CAP
1. Clip
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CARTRIDGE HOLDER
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PEN BODY
2. Black rod
3. Dose window with arrow indicator
4. White dose knob
5. Red injection button
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PEN NEEDLE UNIT
6. Outer pen needle shield
7. Inner pen needle shield
8. Pen needle
9. Hub
10. Paper tab
![]() |
Note - Pen Needle Unit is supplied assembled and sterile. Do not disassemble at this point.
CARTRIDGE
11. Rubber septum
12. Metal Cap
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13. Cartridge plunger
HOW TO USE YOUR OMNITROPE® PEN 5
LOADING THE CARTRIDGE INTO THE PEN
1. Remove the pen cap by pulling it off the pen.
2. Unscrew the cartridge holder from the pen body
![]() |
3. Insert the cartridge, metal cap first, into the cartridge holder
4. Lower the pen body onto the cartridge holder so that the black rod presses against the cartridge plunger. Screw the cartridge holder onto the pen body until no gap remains. One of the blue arrows must line-up with the yellow line mark on the pen body.
Note - Do not overtighten.
ATTACHING THE PEN NEEDLE
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5. Remove the paper tab from the back of a new pen needle.
6a. Holding the cartridge holder, push the pen needle unit onto the pen. Then screw the threaded hub of the pen needle onto the cartridge holder as shown.
6b. With a gentle pull, remove the outer pen needle shield. Save the outer shield. You will use it to remove the pen needle from the pen after your injection is finished.
6c. Do not remove the inner pen needle shield at this time.
6d. Check that the cartridge holder is attached to the pen body, with the blue arrow lined-up with the yellow mark on the pen body before each injection.
PRIMING
![]() |
Important - Before using a new cartridge, you must prime the Omnitrope® Pen 5.
For a New Cartridge Only
7. Hold the pen with the needle pointing upwards. Gently tap the cartridge holder with your finger to help air bubbles rise to the top of the cartridge. Set the dose to 0.05 mg (one click) by turning the dose knob.
8. Remove the inner pen needle shield. With the pen needle pointing up, firmly turn the dose knob back to the “0” position and hold for at least 5 seconds. At least 2 drops of medicine must flow out of the pen needle for the pen to be properly primed.
![]() |
If at least 2 drops do not flow out, set the dose to 0.05 mg and repeat the steps until at least 2 drops of medicine appear at the tip of the pen needle.
When medicine appears, the Omnitrope® Pen 5 is properly primed for injection and ready to use.
For a previously used Cartridge
No priming is needed. Remove the inner pen needle shield and continue with dose dialing.
DOSE DIALING
9. To set your dose, turn the dose knob until you see the number of mg for your dose in the middle of the dose window lined-up with the arrow. You will hear a click for each dose increment you dial. However, do not rely on counting these clicks to measure the right dose.
![]() |
Important - Dose Correction
If you turn the dose knob past your dose, do not dial backwards.
Hold the pen body and turn the dose knob until it is fully extended as shown
in picture 9a. You will see a bent arrow (
) in the dose dialing window. The injection
button can now be fully pressed, resetting the dial to “0” without
giving medicine. The right dose can now be redialed as described in step 9.
Note - Check that the cartridge holder is still attached to the pen body, with the blue arrow lined-up with the yellow mark on the pen body.
MAKING THE INJECTION
10. Insert the pen needle into the skin as instructed by your healthcare professional.
11. After inserting the pen needle, push the injection button in as far in as it will go and press firmly. A clicking sound will be heard while your dose is injecting. Continue to press firmly for at least 5 seconds, before you remove the pen needle from the skin.
![]() |
If medicine continues to drip from the pen needle after injection, hold the pen needle in your skin for a longer time the next time you inject.
If you cannot push the Injection button in as far in as it goes and the dose window does not read “0”, the cartridge is empty and the full dose of medicine has not been injected. The dose indicator window will show the amount of medicine still needed. Remove the pen needle from the skin and note the number. Reset the dose knob to “0” by holding the pen and turning the dose knob until it is fully extended as shown in picture 9a. The dose injection button can now be fully pressed to “0”. Remove the pen needle from the pen (see step 12 below) and remove the empty cartridge by unscrewing the cartridge holder. Insert a new cartridge and prime the pen as described in steps 7 and 8. Set the dose, which you noted, and inject. This completes your dose.
Important -Before replacing a cartridge, be sure that the pen needle unit is NOT attached to the Omnitrope® Pen 5.
REMOVING THE PEN NEEDLE
12. Carefully replace the outer pen needle shield. Hold the pen by the cartridge holder and unscrew the pen needle from the cartridge holder. Recap the pen.
![]() |
13. Store your Omnitrope® Pen 5 with attached Omnitrope cartridge in its pouch or refrigerator storage box. Store in a refrigerator between 36 and 46°F (2 and 8°C).
14. Dispose of used pen needles in a special container called a “sharps” container. Your healthcare professional can give you a sharps container or tell you how to make one. Do not dispose of used pen needles in the trash.
TROUBLESHOOTING
| PROBLEM | POSSIBLE CAUSE | HOW TO FIX |
| Dial unit does not turn easily. | Dust or dirt | Turn the dial beyond the highest setting on the scale. Wipe all exposed surfaces with a clean, damp cloth. Please also refer to the chapter “Care and Storage”. |
| You have dialed a higher dose than needed. | Correct dose as described in step 9, “Dose correction”. | |
| The injection button cannot be pushed or stops during injection. (Dose knob does not return to “0”). | Cartridge is empty and full dose has not been dispensed. | Remove the pen needle as per step 12 and replace the empty cartridge with a new cartridge. Refer to step 11, “If the injection button stops”. |
| Clogged pen needle. | Remove the pen needle as per step 12 and replace it with a new needle as described in step 5. | |
| No clicking is heard during the injection (Dose knob moves freely). | Pen is in dose correction mode. | Remove pen needle from skin. Press injection button all the way in so the dial returns to zero and repeat from step 9 to make the injection. |
| Medicine continues to drip from the pen needle after injection. | Pen needle was removed from the skin too early. | Hold the pen needle in your skin longer next time you inject. |
| Cartridge holder is not properly attached to the pen body. | Line-up blue arrow on cartridge holder with yellow mark on pen body. |
CARE AND STORAGE
Once your Omnitrope® Pen 5 contains a somatropin cartridge, it has to be stored in the refrigerator between 36 and 46°F (2 and 8°C).
Protect your Omnitrope® Pen 5 and cartridge from light by storing in its pouch or refrigerator storage box.
The Omnitrope cartridge must be discarded 28 days after the first injection. The Omnitrope® Pen 5 can be reloaded with a new cartridge and be used multiple times.
Your Omnitrope® Pen 5 must be properly cared for.
If your Omnitrope® Pen 5 is damaged or you cannot get it to work, contact the pharmacy that provided you the Omnitrope® Pen 5 or, if OmniSource provided you with your Omnitrope® Pen 5, call 1-877-456-6794. For other questions or additional information please call OmniSource at 1-877-456-6794. Do not attempt to repair the pen yourself.
GUARANTEE
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.
If your Omnitrope® Pen 5 is defective in materials or workmanship within the period of the guarantee, the provider of your Omnitrope® Pen 5 will replace your pen and/or rectify the fault at its own cost. If OmniSource provided your Omnitrope® Pen 5, call 1-877-456-6794. Otherwise call the pharmacy that provided the Omnitrope® Pen 5.
In case of complaints, please contact your Omnitrope® Pen 5 provider to report a complaint.
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.
ACCURACY - Omnitrope® Pen 5 complies with the accuracy requirements of the International Standard EN ISO11608-1/2000 Pen Injectors for medical use - Requirements and test methods.
IMPORTANT PERSONAL NOTES
Date I first used the Omnitrope® Pen 5: (dd/mm/yy)
Pen log no:
Additional Comments:
SERVICE MATERIALS*
![]() |
POUCH to store and protect your pen and other components, such as needles
![]() |
REFRIGERATOR STORAGE BOX to protect the drug from odors and accidental spills
![]() |
COOLBAG to help maintain Omnitrope® at refrigerator temperature when traveling
OMNITROPE® PEN 10 INSTRUCTIONS FOR USE
For use with Omnitrope® (Somatropin [rDNA origin] Injection) 10 mg/1.5 mL cartridges
TABLE OF CONTENTS
Important Safety Information
DOs and DON'Ts
Pen Parts
Auto-positioning Feature Pen Components
How to Use Your Omnitrope® Pen 10
Loading the Cartridge into the Pen
Attaching the Pen Needle
Priming
Dose Dialing
Making the Injection
Removing the Pen Needle
Trouble Shooting
Care and Storage
Guarantee Important
Personal Notes
Service Materials
READ FIRST: Important Safety Information
DOS AND DON'TS
DOs
DON'Ts
Never recap pen with pen needle on.
![]() |
Storing or carrying your Omnitrope® Pen 10 with a pen needle attached may lead to needle pricks and leaves an open passage for:
Both of these conditions can affect the dose of the injection.
5. Do not use your Omnitrope® Pen 10 if the cap or other parts are missing.
PEN PARTS
AUTO-POSITIONING FEATURE
The Omnitrope® Pen 10 has a black rod with an auto-positioning feature. This auto-positioning feature makes priming easier (fewer steps), especially when a new cartridge is used.
How it works
(Pictures are included only to demonstrate the auto-positioning feature. These steps are not necessary to operate pen).
![]() |
Notice that the black rod moves into the pen easily and returns to the fully extended position automatically. This automatic extension of the black rod positions it correctly against the cartridge plunger.
PEN PARTS
PEN CAP
1. Clip
![]() |
CARTRIDGE HOLDER
![]() |
PEN BODY
2. Black rod
3. Dose window with arrow indicator
4. White dose knob
5. Red injection button
![]() |
PEN NEEDLE UNIT
6. Outer pen needle shield
7. Inner pen needle shield
8. Pen needle
9. Hub
10. Paper tab
![]() |
Note - Pen Needle Unit is supplied assembled and sterile. Do not disassemble at this point.
CARTRIDGE
11. Rubber septum
12. Metal Cap
13. Cartridge plunger
![]() |
HOW TO USE YOUR OMNITROPE® PEN 10
LOADING THE CARTRIDGE INTO THE PEN
1. Remove the pen cap by pulling it off the pen.
2. Unscrew the cartridge holder from the pen body
![]() |
3. Insert the cartridge, metal cap first, into the cartridge holder
4. Lower the pen body onto the cartridge holder so that the black rod presses against the cartridge plunger. Screw the cartridge holder onto the pen body until no gap remains. One of the blue arrows must line-up with the white line mark on the pen body.
Note -Do not overtighten.
ATTACHING THE PEN NEEDLE
![]() |
5. Remove the paper tab from the back of a new pen needle.
6a. Holding the cartridge holder, push the pen needle unit onto the pen. Then screw the threaded hub of the pen needle onto the cartridge holder as shown.
6b. With a gentle pull, remove the outer pen needle shield. Save the outer shield. You will use it to remove the pen needle from the pen after your injection is finished.
6c. Do not remove the inner pen needle shield at this time.
6d. Check that the cartridge holder is attached to the pen body, with the blue arrow lined-up with the white mark on the pen body before each injection.
![]() |
PRIMING
Important - Before using a new cartridge, you must prime the Omnitrope® Pen 10.
For a New Cartridge Only
7. Hold the pen with the needle pointing upwards. Gently tap the cartridge holder with your finger to help air bubbles rise to the top of the cartridge. Set the dose to 0.1 mg (one click) by turning the dose knob.
8. Remove the inner pen needle shield. With the pen needle pointing up, firmly turn the dose knob back to the “0” position and hold for at least 5 seconds. At least 2 drops of medicine must flow out of the pen needle for the pen to be properly primed.
![]() |
If at least 2 drops do not flow out, set the dose to 0.1 mg and repeat the steps until at least 2 drops of medicine appear at the tip of the pen needle.
When medicine appears, the Omnitrope® Pen 10 is properly primed for injection and ready to use.
For a previously used Cartridge
No priming is needed. Remove the inner pen needle shield and continue with dose dialing.
DOSE DIALING
9. To set your dose, turn the dose knob until you see the number of mg for your dose in the middle of the dose window lined-up with the arrow. You will hear a click for each dose increment you dial. However, do not rely on counting these clicks to measure the right dose.
Important - Dose Correction
![]() |
If you turn the dose knob past your dose, do not dial backwards.
Hold the pen body and turn the dose knob until it is fully extended as shown
in picture 9a. You will see a bent arrow (
) in the dose dialing window.
The injection button can now be fully pressed, resetting the dial to “0”
without giving medicine. The right dose can now be redialed as described in
step 9.
Note - Check that the cartridge holder is still attached to the pen body, with the blue arrow lined-up with the white mark on the pen body.
MAKING THE INJECTION
10. Insert the pen needle into the skin as instructed by your healthcare professional.
11. After inserting the pen needle, push the injection button in as far in as it will go and press firmly. A clicking sound will be heard while your dose is injecting. Continue to press firmly for at least 5 seconds, before you remove the pen needle from the skin.
![]() |
If medicine continues to drip from the pen needle after injection, hold the pen needle in your skin for a longer time the next time you inject.
If you cannot push the Injection button in as far in as it goes and the dose window does not read “0”, the cartridge is empty and the full dose of medicine has not been injected. The dose indicator window will show the amount of medicine still needed. Remove the pen needle from the skin and note the number. Reset the dose knob to “0” by holding the pen and turning the dose knob until it is fully extended as shown in picture 9a. The dose injection button can now be fully pressed to “0”. Remove the pen needle from the pen (see step 12 below) and remove the empty cartridge by unscrewing the cartridge holder. Insert a new cartridge and prime the pen as described in steps 7 and 8. Set the dose, which you noted, and inject. This completes your dose.
Important - Before replacing a cartridge, be sure that the pen needle unit is NOT attached to the Omnitrope® Pen 10.
REMOVING THE PEN NEEDLE
12. Carefully replace the outer pen needle shield. Hold the pen by the cartridge holder and unscrew the pen needle from the cartridge holder. Recap the pen.
![]() |
13. Store your Omnitrope® Pen 10 with attached Omnitrope cartridge in its pouch or refrigerator storage box. Store in a refrigerator between 36 and 46°F (2 and 8°C).
14. Dispose of used pen needles in a special container called a “sharps” container. Your healthcare professional can give you a sharps container or tell you how to make one. Do not dispose of used pen needles in the trash.
TROUBLESHOOTING
| PROBLEM | POSSIBLE CAUSE | HOW TO FIX |
| Dial unit does not turn easily. | Dust or dirt | Turn the dial beyond the highest setting on the scale. Wipe all exposed surfaces with a clean, damp cloth. Please also refer to the chapter “Care and Storage”. |
| You have dialed a higher dose than needed. | Correct dose as described in step 9, “Dose correction”. | |
| The injection button cannot be pushed or stops during injection. (Dose knob does not return to “0”). | Cartridge is empty and full dose has not been dispensed. | Remove the pen needle as per step 12 and replace the empty cartridge with a new cartridge. Refer to step 11, “If the injection button stops”. |
| Clogged pen needle. | Remove the pen needle as per step 12 and replace it with a new needle as described in step 5. | |
| No clicking is heard during the injection (Dose knob moves freely). | Pen is in dose correction mode. | Remove pen needle from skin. Press injection button all the way in so the dial returns to zero and repeat from step 9 to make the injection. |
| Medicine continues to drip from the pen needle after injection. | Pen needle was removed from the skin too early. | Hold the pen needle in your skin longer next time you inject. |
| Cartridge holder is not properly attached to the pen body. | Line-up blue arrow on cartridge holder with yellow mark on pen body. |
CARE AND STORAGE
Once your Omnitrope® Pen 10 contains a somatropin cartridge, it has to be stored in the refrigerator between 36 and 46°F (2 and 8°C).
Protect your Omnitrope® Pen 10 and cartridge from light by storing in its pouch or refrigerator storage box.
The Omnitrope cartridge must be discarded 28 days after the first injection. The Omnitrope® Pen 10 can be reloaded with a new cartridge and be used multiple times.
Your Omnitrope® Pen 10 must be properly cared for.
If your Omnitrope® Pen 10 is damaged or you cannot get it to work, contact the pharmacy that provided you the Omnitrope® Pen 10 or, if OmniSource provided you with your Omnitrope® Pen 10, call 1-877-456-6794. For other questions or additional information please call OmniSource at 1-877-456-6794. Do not attempt to repair the pen yourself.
GUARANTEE
Your Omnitrope® Pen 10 is covered by a 2 year guarantee. Contact your Omnitrope® Pen 10 provider after you have used the pen for 2 years to have it replaced by a new one.
If your Omnitrope® Pen 10 is defective in materials or workmanship within the period of the guarantee, the provider of your Omnitrope® Pen 10 will replace your pen and/or rectify the fault at its own cost. If OmniSource provided your Omnitrope® Pen 10, call 1-877-456-6794. Otherwise call the pharmacy that provided the Omnitrope® Pen 10.
In case of complaints, please contact your Omnitrope® Pen 10 provider to report a complaint.
This guarantee is invalid if your Omnitrope® Pen 10 has not been used in accordance with the manufacturer`s instruction leaflet or if the defect has been caused by neglect, misuse or accident.
ACCURACY - Omnitrope® Pen 10 complies with the accuracy requirements of the International Standard EN ISO11608-1/2000 Pen Injectors for medical use - Requirements and test methods.
IMPORTANT PERSONAL NOTES
Date I first used the Omnitrope® Pen 10: (dd/mm/yy)
Pen log no:
Additional Comments:
SERVICE MATERIALS*
![]() |
POUCH to store and protect your pen and other components, such as needles
![]() |
REFRIGERATOR STORAGE BOX to protect the drug from odors and accidental spills
![]() |
COOLBAG to help maintain Omnitrope® at refrigerator temperature when traveling
*Optional; please check availability with your local Sandoz representative
INSTRUCTIONS FOR OMNITROPE® 5.8 MG/VIAL
The following instructions explain how to inject OMNITROPE® 5.8 mg. Do not inject OMNITROPE® yourself until your healthcare provider has taught you and you understand the instructions. Ask your healthcare provider or pharmacist if you have any questions about injecting OMNITROPE®.
Preparation
Collect necessary items before you begin:
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Wash your hands before you start with the next steps.
![]() |
Mixing OMNITROPE® 5.8 mg
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Measuring the Dose of OMNITROPE® 5.8 mg to Be Injected
![]() |
Injecting OMNITROPE® 5.8 mg
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After Injecting OMNITROPE® 5.8 mg
Last reviewed on RxList: 6/1/2011
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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