Omnitrope

PATIENT INFORMATION

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

  1. Read the following instructions before using the Omnitrope® Pen 5. Ask your healthcare professional if there is something you do not understand.
  2. The Omnitrope® Pen 5 is a pen injector. It is for use with Omnitrope® cartridges 5 mg/1.5 mL (15 IU) and BD® pen needles (29G x 12.7 mm or 31G x 8 mm or 31G x 5 mm).
  3. People with very poor vision should not use the Omnitrope® Pen 5 unless someone with good eyesight is able to help.

DOS AND DON'TS

DOs

  1. Always keep Omnitrope® cartridges refrigerated.
  2. After taking a cartridge out of the refrigerator, allow it to reach room temperature (about 30 minutes) before injecting the medicine.
  3. When starting a new cartridge, always ready (prime) the pen.
  4. When making an injection, insert the pen needle into the skin in the way that your healthcare professional teaches you. After pen needle insertion, push the injection button in as far as it will go and continue to press firmly for at least five 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 the skin longer the next time you inject.
  5. This device must not be shared with other patients even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection. However, if you are giving an injection to another person, be careful when removing the pen needle. Accidental pen needle sticks can transmit infections.
  6. For safety and injection comfort, use a new, sterile pen needle with each injection.

DON'Ts

  1. Do not share the Omnitrope® Pen 5 even if the needle is changed. It is made for only one person to use.
  2. The pen needle unit is sterile. To avoid contaminating the pen needle after opening, do not place it on a surface or touch exposed parts.
  3. Never dial your dose or attempt to correct a dialing error with the pen needle in your skin. This may result in a wrong dose.
  4. Never store or carry your Omnitrope® Pen 5 with a pen needle attached.

Never recap pen with pen needle on.

Never recap pen with pen needle on -  Illustration

Storing or carrying your Omnitrope® Pen 5 with a pen needle attached may lead to needle pricks and leaves an open passage for:

  • Air to enter the cartridge
  • medicine to leak out

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).

Auto-positioning feature  Illustration

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

Clip -  Illustration

CARTRIDGE HOLDER

Cartridge holder - Illustration

PEN BODY

2. Black rod

3. Dose window with arrow indicator

4. White dose knob

5. Red injection button

Pen body  Illustration

PEN NEEDLE UNIT

6. Outer pen needle shield

7. Inner pen needle shield

8. Pen needle

9. Hub

10. Paper tab

Pen needle unit -  Illustration

Note - Pen Needle Unit is supplied assembled and sterile. Do not disassemble at this point.

CARTRIDGE

11. Rubber septum

12. Metal Cap

Cartridge -  Illustration

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

Loading the cartridge -  Illustration

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

Attaching the pen needle -  Illustration

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

Priming the pen -  Illustration

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.

Priming the pen (new cartridge) -  Illustration

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.

Dose Dialling -  Illustration

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.

Making the injection -  Illustration

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.

Removing the pen needle -

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.

  • Only a clean, damp cloth should be used for routine cleaning. Never wash the pen in water or with strong surgical disinfectants.
  • Avoid exposure to dust, moisture and temperature extremes. Do not expose to heat or freeze.

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 -  Illustration

POUCH to store and protect your pen and other components, such as needles

Refrigerated storage box -  Illustration

REFRIGERATOR STORAGE BOX to protect the drug from odors and accidental spills

Cool bag -  Illustration

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

  1. Read the following instructions before using the Omnitrope® Pen 10. Ask your healthcare professional if there is something you do not understand.
  2. The Omnitrope® Pen 10 is a pen injector. It is for use with Omnitrope® cartridges 10 mg/1.5 mL (30 IU) and BD® pen needles (29G x 12.7 mm or 31G x 8 mm or 31G x 5 mm).
  3. People with very poor vision should not use the Omnitrope® Pen 10 unless someone with good eyesight is able to help.

DOS AND DON'TS

DOs

  1. Always keep Omnitrope® cartridges refrigerated.
  2. After taking a cartridge out of the refrigerator, allow it to reach room temperature (about 30 minutes) before injecting the medicine.
  3. When starting a new cartridge, always ready (prime) the pen.
  4. When making an injection, insert the pen needle into the skin in the way that your healthcare professional teaches you. After pen needle insertion, push the injection button in as far as it will go and continue to press firmly for at least five 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 the skin longer the next time you inject.
  5. This device must not be shared with other patients even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection. However, if you are giving an injection to another person, be careful when removing the pen needle. Accidental pen needle sticks can transmit infections.
  6. For safety and injection comfort, use a new, sterile pen needle with each injection.

DON'Ts

  1. Do not share the Omnitrope® Pen 10 even if he needle is changed. It is made for only one person to use.
  2. The pen needle unit is sterile. To avoid contaminating the pen needle after opening, do not place it on a surface or touch exposed parts.
  3. Never dial your dose or attempt to correct a dialing error with the pen needle in your skin. This may result in a wrong dose.
  4. Never store or carry your Omnitrope® Pen 10 with a pen needle attached.

Never recap pen with pen needle on.

Never recap pen with pen needle on -  Illustration

Storing or carrying your Omnitrope® Pen 10 with a pen needle attached may lead to needle pricks and leaves an open passage for:

  • Air to enter the cartridge
  • medicine to leak out

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).

Auto-positioning feature  Illustration

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

Clip -  Illustration

CARTRIDGE HOLDER

Cartridge holder -  Illustration

PEN BODY

2. Black rod

3. Dose window with arrow indicator

4. White dose knob

5. Red injection button

Pen body -  Illustration

PEN NEEDLE UNIT

6. Outer pen needle shield

7. Inner pen needle shield

8. Pen needle

9. Hub

10. Paper tab

Pen needle unit -  Illustration

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

Cartridge -  Illustration

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

Loading the cartridge -  Illustration

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

Attaching the pen needle -  Illustration

 

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.

Attaching the pen needle -  Illustration 2

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.

Priming -  Illustration

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

Dose dialing and correction -  Illustration

 

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.

Making the injection -  Illustration

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.

Removing the pen needle -  Illustration

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.

  • Only a clean, damp cloth should be used for routine cleaning. Never wash the pen in water or with strong surgical disinfectants.
  • Avoid exposure to dust, moisture and temperature extremes. Do not expose to heat or freeze.

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 -  Illustration

POUCH to store and protect your pen and other components, such as needles

Refrigerated storage box -  Illustration

REFRIGERATOR STORAGE BOX to protect the drug from odors and accidental spills

Coolbag -  Illustration

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®.

  • OMNITROPE® 5.8 mg is for multiple uses.
  • The concentration of OMNITROPE® after mixing is 5 mg/mL.
  • After mixing, OMNITROPE® 5.8 mg contains a preservative and should not be used in newborns.

Preparation

Collect necessary items before you begin:

Necessary items -  Illustration

  • a vial with OMNITROPE® 5.8 mg
  • a vial with diluent (mixing liquid - Bacteriostatic Water for Injection containing benzyl alcohol as preservative) for OMNITROPE® 5.8 mg
  • a sterile, disposable 3 mL syringe and needle for withdrawing the diluent from the vial (not supplied in the pack)
  • sterile disposable 1 mL syringes and needles for under the skin (subcutaneous) injection (not supplied in the pack)
  • 2 alcohol swabs (not supplied in the pack)

Wash your hands before you start with the next steps.

Wash your hands before you start -  Illustration

Mixing OMNITROPE® 5.8 mg

  • Remove the protective caps from the two vials. With one alcohol swab, clean both the rubber top of the vial that contains the powder and the rubber top of the vial that contains diluent.

Mixing Omnitrope -  Illustration

  • Use next the sterile diluent vial, the disposal 3 mL syringe and a needle.
  • Attach the needle to the syringe (if not attached already). Pull back the syringe plunger and fill the syringe with air. Push the needle fitted to the syringe through the rubber top of the diluent vial, push all the air from the syringe into the vial, turn the vial upside down, and withdraw all the diluent from the vial into the syringe. Remove the syringe and needle.

Mixing Omnitrope -  Illustration 2

  • Next take the syringe with the diluent in it and push the needle through the rubber stopper of the vial that contains the white powder. Inject the diluent slowly. Aim the stream of liquid against the glass wall in order to avoid foam. Remove the syringe and needle and dispose of them.

Mixing Omnitrope -  Illustration 3

  • Gently swirl the vial until the content is completely dissolved. Do not shake

Gently swirl the vial -  Illustration

  • If the medicine is cloudy or contains particles, it should not be used. The medicine must be clear and colorless after mixing.
  • After mixing the medicine, the medicine in the vial must be used within 3 weeks. Store the vial in a refrigerator at 2° to 8°C (36° to 46°F) after mixing and using it each time.

Measuring the Dose of OMNITROPE® 5.8 mg to Be Injected

  • Next use the sterile, disposable 1 mL (or similar) syringe and needle for subcutaneous injection. Push the needle through the rubber top of the vial that contains the medicine that you have just mixed.
  • Turn the vial and the syringe upside down.

Measuring the Dose -  Illustration

  • Be sure the tip of the syringe is in the OMNITROPE® mixed medicine.
  • Pull back on the plunger slowly and withdraw the dose prescribed by your doctor into the syringe.
  • Hold the syringe with the needle in the vial pointing up and remove the syringe from the vial.
  • Check for air bubbles in the syringe. If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubble disappears. Push the plunger slowly back up to the correct dose. If there is not enough medicine in the syringe after removing the air bubbles, draw more medicine into the syringe from the mixed medicine vial and repeat checking for bubbles.
  • Look at the mixed medicine in the syringe before using. Do not use if discolored or particles are present. You are now ready to inject the dose.

Injecting OMNITROPE® 5.8 mg

  • Choose the site of injection on your body. 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.

Choose the site of injection -  Illustration

  • Make sure you rotate the injection sites on your body. Inject at least ½ inch from the last injection. Change the places on your body where you inject, as you have been taught.
  • Before you make an injection, clean your skin well with an alcohol swab. Wait for the area to air dry.

Clean your skin well with an alcohol swab  Illustration

  • With one hand, pinch a fold of loose skin at the injection site. With your other hand, hold the syringe as you would a pencil. Insert the needle into the pinched skin straight in or at a slight angle (an angle of 45° to 90°). After the needle is in, remove the hand used to pinch the skin and use it to hold the syringe barrel. Pull back the plunger very slightly with one hand. If blood comes into the syringe, the needle has entered a blood vessel. Do not inject into this site; withdraw the needle and repeat the procedure at a different site. If no blood comes into the syringe, inject the solution by pushing the plunger all the way down gently.

Insert the needle into the pinched skin straight in or at a slight angle -  Illustration

  • Pull the needle straight out of the skin. After injection, press the injection site with a small bandage or sterile gauze if needed for bleeding, for several seconds. Do not massage or rub the injection site.

After Injecting OMNITROPE® 5.8 mg

  • Discard the injection materials.
  • Dispose the syringes safely in a closed container. You can ask your healthcare provider or pharmacist for a “sharps” container. A sharps container is a special container to put used needles and syringes in. You can return a full sharps container to your pharmacist or healthcare provider for disposal.
  • The vial of mixed medicine must be stored in the refrigerator in its carton at 2° to 8°C (36° to 46°F) and used within 3 weeks.
  • The solution should be clear after removal from the refrigerator. If the solution is cloudy or contains particles, discard the vial. Do not inject the medicine from this vial. Start over with a new vial of OMNITROPE® 5.8 mg. Call your pharmacist if you need a replacement.
  • Before each use disinfect the rubber top of the reconstituted vial with an alcohol swab. You must use a new disposable 1 mL syringe and needle for each injection.

Last reviewed on RxList: 6/1/2011
This monograph has been modified to include the generic and brand name in many instances.

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