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GENOTROPIN® (somatropin) for subcutaneous use Information for Patients

Instructions for Use
GENOTROPIN MINIQUICK (JEEN-o-tro-pin MIN-ee-kwik)
Growth Hormone Delivery Device containing Genotropin® Lyophilized powder (somatropin for injection)

Important Note
Please read these instructions completely before using GENOTROPIN MINIQUICK. If there is anything you do not understand or cannot do, call the Pfizer Bridge Program's toll-free number at 1-800-645-1280.
GENOTROPIN MINIQUICK is available in 10 dose strengths.
Check your GENOTROPIN MINIQUICK to be sure you have the dose your doctor prescribed.

GENOTROPIN MINIQUICK is a device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject a single dose of GENOTROPIN.

For each injection you will need:

  • 2 alcohol pads (not included)
  • the GENOTROPIN MINIQUICK device with the 2-chamber cartridge of GENOTROPIN inside it. The 2-chamber cartridge of GENOTROPIN contains the growth hormone powder in one chamber and the liquid in the other.
  • an injection needle. A needle for injection is provided with each device. If you need additional needles, ask for Becton Dickinson Ultra-Fine pen needles, either 29 gauge, 30 gauge or 31 gauge.
  • the reusable Needle Guard (optional, not included)
  • a proper disposal container (not included)

The diagram below identifies the different components of the GENOTROPIN MINIQUICK. (See Figure A)

FIGURE A

Figure A

Storage instructions for your GENOTROPIN MINIQUICK

  • Keep your GENOTROPIN MINIQUICK in the original carton to protect it from light.
  • Before you mix the growth hormone powder with the liquid in the syringe, you can store the GENOTROPIN MINIQUICK in the refrigerator [36°F to 46°F (2°C to 8°C)]. However, you can also store the GENOTROPIN MINIQUICK at room temperature [68°F to 77°F (20°C to 25°C)] for up to three months. Do not freeze.
  • Inject the GENOTROPIN right after you mix it. If that is not possible, you can keep the GENOTROPIN MINIQUICK in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 24 hours after mixing it. Do not freeze.

Using your GENOTROPIN MINIQUICK

Step 1.
Wash your hands well with soap and water before using the GENOTROPIN MINIQUICK.

Step 2.
Open the plastic bag that contains your GENOTROPIN MINIQUICK, by tearing the bag along the perforated line on the plastic.

Step 3.
Wipe the rubber stopper on the GENOTROPIN MINIQUICK with a pad or swab moistened with rubbing alcohol. (See Figure B)
FIGURE B
Figure B
Step 4.
Peel the seal from the back of the injection needle. Leave both needle covers (inner and outer) on the needle. (See Figure C)
FIGURE C
Figure C
Step 5.
  • Attach the needle onto the GENOTROPIN MINIQUICK by pushing it down and turning it clockwise (to the right) until it will no longer turn.
  • Make sure the needle is positioned squarely, not at an angle, onto the end of the rubber stopper before screwing it onto the GENOTROPIN MINIQUICK. (See Figure D)
FIGURE D
Figure D
Step 6.
  • Hold the GENOTROPIN MINIQUICK with the needle pointing up.To mix the growth hormone powder with the liquid, turn the plunger rod clockwise (to the right) until it will not go any further. (See Figure E)
  • When you turn the plunger rod clockwise (to the right), the GENOTROPIN MINIQUICK automatically mixes the growth hormone powder and the liquid.
  • Do not shake the GENOTROPIN MINIQUICK. Shaking may cause the growth hormone to not work as well.
  • Make sure the solution is clear, and that the growth hormone powder is completely dissolved. If you see particles in the solution, or if the solution is discolored, do not inject it. Call the toll-free number listed at the beginning of this leaflet.
FIGURE E
Figure E
Step 7.
  • Select your injection site and wipe that area of your skin with an alcohol pad, as instructed by your healthcare provider.
  • If you are using the reusable Needle Guard to hide the needle, go to Step 8.
  • If you are not using the reusable Needle Guard, go to Step 9.
Step 8. – With Needle Guard
  • Remove the outer needle cover from the needle, place the Needle Guard onto the GENOTROPIN MINIQUICK, and press gently until the Needle Guard snaps into place. Save the outer needle cover. (See Figure F)
  • Remove the inner needle cover from the needle.
  • Go to Step 10.
FIGURE F
Figure F
Step 9. – Without Needle Guard
  • Remove the outer and inner needle covers from the needle. Save the outer needle cover. (See Figure G)
  • Go to Step 10.
FIGURE G
Figure G
Step 10.
  • Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90-degree angle. (See Figure H)
  • If you are using the optional Needle Guard, the retractable plastic needle shield will push in as the GENOTROPIN MINIQUICK is pushed against your skin.
FIGURE H
Figure H
Step 11
  • Push the plunger rod in as far as it will go, to inject all the medicine in the GENOTROPIN MINIQUICK. (See Figure I)
  • Wait a few seconds to be sure that all the growth hormone has been injected. Pull out the needle.
FIGURE I
Figure I
Step 12.
  • If you are using the Needle Guard, remove the Needle Guard and then carefully replace the outer needle cover on the needle. Save the Needle Guard for future use. (See Figure J)
  • If you are not using the Needle Guard, carefully replace the outer needle cover on the needle.
FIGURE J
Figure J
Step 13. Disposing of your GENOTROPIN MINIQUICK
  • Your doctor or healthcare provider will instruct you on how to discard your used syringes and needles and other medical waste in an appropriate puncture resistant disposal container such as a sharps (medical waste) container. You may also contact your local health department for more information. There may be special state or local laws for properly disposing of used needles, syringes, other medical waste, and sharps containers.
  • Do not throw needles, syringes, or sharps containers in the household trash without first checking your state and local laws.
  • Do not recycle the sharps container.
  • Always keep your sharps container in a safe place and out of the reach of children.
Questions and Answers
Question Answer
Is it a problem if I see air bubbles in the syringe? No. There is no need to remove the air from the GENOTROPIN MINIQUICK. The small amount of air in the syringe does not affect your injection.
What should I do if I have problems turning the plunger rod (Step 6)? The problem could be because the needle has been inserted at an angle onto the rubber stopper.
Carefully replace the outer needle cover on the needle and unscrew counterclockwise to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle squarely on top of the device.
What should I do if I have problems pushing the plunger when making the injection (Step 11)? The problem could be because the needle has been inserted at an angle onto the rubber stopper.
Carefully replace the outer needle cover on the needle and unscrew counterclockwise to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle squarely on top of the device.
What should I do if the needle is damaged or bent? Throw away the needle and use a new needle with the GENOTROPIN MINIQUICK.
How do I care for my Needle Guard? Clean the Needle Guard by wiping with a damp cloth or alcohol swab. If your Needle Guard does not function properly, call the Pfizer Bridge Program at 1-800-645-1280.

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured by:
Vetter Pharma-Fertigung GmbH & Co. KG
Ravensburg, Germany

Logo

LAB-0227-6.0
September 2016

Logo


Logo

Instructions for Use
GENOTROPIN 12 (JEEN-o-tro-pin 12)
GENOTROPIN PEN 12 is a medical device used to mix and inject doses of reconstituted GENOTROPIN Lyophilized Powder (somatropin) for injection. Use this device only for administration of GENOTROPIN.

Important Note
Please read these instructions completely before using the GENOTROPIN PEN 12. Please do not use the GENOTROPIN PEN 12 unless your Healthcare provider has trained you.
If there is anything you do not understand or cannot do, call the Pfizer Bridge Programs toll-free number at 1-800-645-1280. If you have any questions about your dose or your treatment with GENOTROPIN, call your Healthcare provider.
Your pen should not be used near electrical or electronic equipment, including mobile phones. If your pen has been damaged, it should not be used and should be disposed of as instructed by your Healthcare provider.

GENOTROPIN PEN 12 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

For your injection you will need:

  • GENOTROPIN PEN 12 (pen)
  • 12 mg two-chamber cartridge of GENOTROPIN
  • 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31G) Becton Dickinson pen needle
  • Proper disposal container for used needles

The diagram below identifies the different components of the GENOTROPIN PEN 12 (See Figure A).

FIGURE A

Figure A

Storage instructions for your GENOTROPIN PEN 12

  • Between uses, store your pen (with cartridge) in the refrigerator [36°F to 46°F (2°C to 8°C)] in its protective case. Always remove the needle before storing.
  • Do not freeze. Protect from light. Throw away the cartridge within 28 days after reconstitution – even if the cartridge is not empty.
  • When travelling, keep your pen in its protective case and carry it in an insulated bag to protect it from heat or freezing. Put it back in the refrigerator as soon as possible.

Using your GENOTROPIN PEN 12

Step 1.
Wash your hands well with soap and water before using the GENOTROPIN PEN 12.

Step 2. Attach the Needle

FIGURE B

Figure B

FIGURE C

  • Unscrew the metal front part from the plastic body (See Figure C).
Figure C

FIGURE D

  • Peel off the foil from the needle.
  • Push and screw the needle onto the metal front part (See Figure D).
Figure D
Step 3. Insert the Two-Chamber Cartridge of GENOTROPIN

FIGURE E

Use only the 12mg cartridge.

  • Open the cartridge pack and take out a cartridge.
  • Check that the colour on the cartridge matches the colour around the plastic body window (See Figure E).
  • Hold the metal front part upright, and insert the cartridge—metal cap first—as shown (See Figure F).
  • Push the cartridge firmly into place.
Figure E

FIGURE F

Figure F
Step 4. Prepare the Pen

FIGURE G

  • Press the red release button; the injection button will pop-up (See Figure G).
Figure G

FIGURE H

  • Turn the injection button as far as it will go in the opposite way to the arrows on the injection button. This will draw back the plunger rod (See Figure H).
Figure H

FIGURE I

  • Check that the plunger rod is not visible through the window. Do not proceed if the plunger rod is visible, as the medication will not be properly mixed (See Figure I).
Figure I
Step 5. Mix your GENOTROPIN

FIGURE J

  • Make sure that a needle is attached to the metal front part.
  • While holding your pen upright, gently screw the metal front part and the plastic body back together. This mixes the liquid and the powder (See Figure J).
Figure J

FIGURE K

Step 6. Examine the Solution

  • Gently tip the pen from side to side to help dissolve the powder completely (See Figure K).
Figure K

FIGURE L

  • Do not shake your pen, as this might stop the growth hormone working. Check that the solution is clear in the cartridge window (See Figure L).

If you see particles, or if the solution is not clear, do not inject it. Instead, remove the cartridge and use a new one.

Figure L
Step 7. Release Trapped Air
  • Remove both the outer needle cover and inner needle cap. Dispose of the inner needle cap. Be careful not to touch the exposed needle.
  • Remove any trapped air from the solution as follows:
     
    a) Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (See Figure M).
     
    b) Hold your pen with the needle pointing upwards. Gently tap the metal front part with your finger to move any air bubbles to the top.
     
    c) Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (See Figure N).
     
    d) If no liquid appears, press the red release button. Then turn the injection button in the direction of the arrow until it clicks once and the display shows '0.2'. Repeat steps b) and c).

FIGURE M

Figure M

FIGURE N

Figure N
Step 8. Fit the Needle Guard (Optional)

FIGURE O

The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.

  • Grip the sides of the needle guard. Push it over the needle until it snaps in place (See Figure O). Never push the needle guard on the end.

Be careful not to touch the exposed needle.

Figure O

My daily dose is    display    mg (write in your daily dose)

FIGURE P

Step 9. Dial Your Prescribed Dose

  • Press the red release button to reset your pen.
  • The button will pop-up and the dose display window will read '0.0'.
  • Turn the injection button (in the direction of the arrow) until your prescribed dose is displayed (See Figure P).
  • If you turn the button too far, turn it back the other way until your correct dose is displayed.
Figure P
Step 10. Inject your GENOTROPIN

FIGURE Q

  • Choose and prepare an appropriate injection area, as directed by your Healthcare provider.
  • Firmly pinch a fold of skin at the injection area. Push needle fully into the skin fold at a 90° angle.
  • Push the injection button until it clicks. Wait at least 5 seconds, and then withdraw the needle from the skin. This makes sure the entire dose has been injected (See Figure Q).
Figure Q
Step 11. Discard the Needle and Store the GENOTROPIN PEN 12

FIGURE R

  • Pull off the needle guard, gripping the sides. Be careful not to push on the end (See Figure R).
  • Remove the needle as instructed by your Healthcare provider, and discard it in a proper disposal container. Never reuse a needle.
  • Push on the front cap, and put your pen back in its protective case.
  • Store your pen (with cartridge) in the refrigerator [36°F to 46°F (2°C to 8°C)] until your next injection.
Figure R
Step 12. Your Next Injection

FIGURE S

If you already have a cartridge in your pen, prepare the pen and give the injection as follows:

  •   Remove the front cap (See Figure S).
  •   Make sure there is enough growth hormone in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (See Figure T).
  •   Peel off the foil from a needle.
  •   Push and screw the needle onto the metal front part of your pen. Remove the outer needle cover and inner needle cap (See Figure U).
  •   Follow the instructions above, starting with Step 8: Fit the needle guard.
Figure S

FIGURE T

Figure T

FIGURE U

Figure U
Step 13. To Replace the Cartridge

FIGURE V

  •   Press the red release button to reset your pen (See Figure V).
Figure V

FIGURE W

  •   Turn the injection button (in the opposite direction to the arrow on the injection button) as far as it will go (See Figure W).This will draw back the plunger rod.
Figure W
  •   Unscrew the metal front part and remove the empty cartridge (See Figure X).
  • Discard the empty cartridge as instructed by your Healthcare provider.
  • To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with Step 1.

FIGURE X

Figure X

Step 14. Disposing of used Needles, cartridges and your GENOTROPIN PEN 12

  • Your Healthcare provider will instruct you on how to discard your used needles and other medical waste in an appropriate puncture resistant disposal container such as sharps (medical waste) container. You may also contact your local health department for more information. There may be special state or local laws for properly disposing of used needles, other medical waste and sharps containers.
  • Do not throw needles or sharps containers in the household trash without first checking your state and local laws.
  • Do not recycle the sharps container.
  • Always keep your sharps container in a safe place and out of reach of children.
Customizing your Pen

FIGURE Y

Your pen is supplied with two colored clip-on panels, enabling you to customize the look of your pen. To remove the clip-on panel from your pen, insert the lip of the front cap into the groove under the front end of the panel, and pry the panel off. The new panel simply clicks into place. A small hole near the dose display enables you to attach decorations or charms. Figure Y

Caring for your Pen

No special maintenance is required. To clean your pen, wipe the outside surface with a damp cloth. Do not immerse. Do not use alcohol or any other cleaning agents, as they may damage the plastic body. To clean the needle guard, wipe it with a damp cloth or alcohol swab.

Questions and Answers
Question Answer
How long is the use period of my pen? The pen has a use period of 2 year starting from the first use by the patient.
How can I tell how much GENOTROPIN is left in my pen? The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it can't go any further; the dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.
If the display doesn't work, can my pen still be used? Yes, but it is not recommended. When the display or the battery doesn't function any more, it is still possible to set the dose of your pen by counting the clicks (one click = '0.2' mg). Your pen can still be used while waiting for a new one. Contact your Healthcare provider.
What happens if I dial the injection button beyond the maximum dose ('4.0' mg)? Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.

Display Information

Steady display The selected dose size.
The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.
Steady display A dose is not set.
The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.
Flashing display The injection button is rotated too fast or too slow.
Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.
Flashing display The injection button is rotated too fast or too slow.
Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.
Flashing 1 month before the 2nd year use elapse.
(5 seconds) display This is normal. The dose can be set and read from the display. Contact your Healthcare provider.
Steady display Pen has reached the end of its use period of 2 years.
The display will continue to show display until the battery is
completely empty. This does not indicate a defect of your pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your Healthcare provider.
Flashing Battery charge is low and will be empty in one month's time.
(5 seconds) display Afterwards the dose can be set and your pen can be used correctly. Contact your Healthcare provider.
Steady display Battery power low.
The dose cannot be displayed. Contact your Healthcare provider.
Steady display Blank screen
To save the battery's energy, the dose display is activated for two minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery.

If you have any questions about your dose or your treatment with GENOTROPIN, call your Healthcare provider right away.

Use this device only for the person for whom it was prescribed.

These Instructions for use have been approved by the U.S. Food and Drug Administration.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium
Produced by Ypsomed AG, Burgdorf, Switzerland

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LAB-0224-8.0
September 2016


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Instructions for Use
GENOTROPIN 5 (JEEN-o-tro-pin 5)
GENOTROPIN PEN 5 is a medical device used to mix and inject doses of reconstituted GENOTROPIN Lyophilized Powder (somatropin) for injection. Use this device only for administration of GENOTROPIN.

Important Note
Please read these instructions completely before using the GENOTROPIN PEN 5. Please do not use the GENOTROPIN PEN 5 unless your Healthcare provider has trained you.
If there is anything you do not understand or cannot do, call the Pfizer Bridge Programs toll-free number at 1-800-645-1280. If you have any questions about your dose or your treatment with GENOTROPIN, call your Healthcare provider.
Your pen should not be used near electrical or electronic equipment, including mobile phones. If your pen has been damaged, it should not be used and should be disposed of as instructed by your Healthcare provider.

GENOTROPIN PEN 5 is a reusable multiple-use device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

For your injection you will need:

  • GENOTROPIN PEN 5 (pen)
  • 5 mg two-chamber cartridge of GENOTROPIN
  • 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle
  • Proper disposal container for used needles

The diagram below identifies the different components of the GENOTROPIN PEN 5 (See Figure A).

FIGURE A
Figure A

Storage instructions for your GENOTROPIN PEN 5

  • Between uses, store your pen (with cartridge) in the refrigerator [36°F to 46°F (2°C to 8°C)] in its protective case. Always remove the needle before storing.
  • Do not freeze. Protect from light. Throw away the cartridge within 28 days after reconstitution – even if the cartridge is not empty.
  • When travelling, keep your pen in its protective case and carry it in an insulated bag to protect it from heat or freezing. Put it back in the refrigerator as soon as possible.

Using your GENOTROPIN PEN 5

Step 1.

Wash your hands well with soap and water before using the GENOTROPIN PEN 5.

Step 2. Attach the Needle

FIGURE B

Figure B

FIGURE C

  • Unscrew the metal front part from the plastic body (See Figure C).
Figure C

FIGURE D

  • Peel off the foil from the needle.
  • Push and screw the needle onto the metal front part (See Figure D).
Figure D
Step 3. Insert the Two-Chamber Cartridge of GENOTROPIN

FIGURE E

Use only the 5 mg cartridge.

  • Open the cartridge pack and take out a cartridge.
  • Check that the colour on the cartridge matches the colour around the plastic body window (See Figure E).
Figure E

FIGURE F

  • Hold the metal front part upright, and insert the cartridge—metal cap first—as shown (See Figure F).
  • Push the cartridge firmly into place.
Figure F
Step 4. Prepare your Pen

FIGURE G

  • Press the red release button; the injection button will pop-up (See Figure G).
Figure G

FIGURE H

  • Turn the injection button as far as it will go in the opposite way to the arrows on the injection button. This will draw back the plunger rod (See Figure H).
Figure H

FIGURE I

  • Check that the plunger rod is not visible through the window. Do not proceed if the plunger rod is visible, as the medication will not be properly mixed (See Figure I).
Figure I
Step 5. Mix your GENOTROPIN

FIGURE J

  • Make sure that a needle is attached to the metal front part.
  • While holding your pen upright, gently screw the metal front part and the plastic body back together. This mixes the liquid and the powder (See Figure J).
Figure J
Step 6. Examine the Solution

FIGURE K

  • Gently tip your pen from side to side to help dissolve the powder completely (See Figure K).
Figure K
  • Do not shake your pen, as this might stop the growth hormone working. Check that the solution is clear in the cartridge window (See Figure L).
  • If you see particles, or if the solution is not clear, do not inject it. Instead, remove the cartridge and use a new one.

FIGURE L

Figure L

Step 7. Release Trapped Air

  • Remove both the outer needle cover and inner needle cap. Dispose of the inner needle cap. Be careful not to touch the exposed needle.
  • Remove any trapped air from the solution as follows:
 
a) Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (See Figure M).
 
b) Hold your pen with the needle pointing upwards. Gently tap the metal front part with your finger to move any air bubbles to the top.
 
c) Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (See Figure N).
 
d) If no liquid appears, press the red release button, then turn the injection button in the direction of the arrow until it clicks once and the display shows '0.1'. Repeat steps b) and c).

FIGURE M

Figure M

FIGURE N

Figure N

Step 8. Fit the Needle Guard (Optional)

The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.

  • Grip the sides of the needle guard. Push it over the needle until it snaps in place (See Figure O). Never push the needle guard on the end.

    Be careful not to touch the exposed needle.

FIGURE O

Figure O

My daily dose is    display   mg (write in your daily dose)

Step 9. Dial Your Prescribed Dose
  • Press the red release button to reset your pen.
  • The button will pop-up and the dose display window will read '0.0'.
  • Turn the injection button (in the direction of the arrow) until your prescribed dose is displayed (See Figure P).
  • If you turn the button too far, turn it back the other way until your correct dose is displayed.

FIGURE P

Figure P
Step 10. Inject your GENOTROPIN

FIGURE Q

  • Choose and prepare an appropriate injection area, as directed by your Healthcare provider.
  • Firmly pinch a fold of skin at the injection area. Push needle fully into the skin fold at a 90° angle.
  • Push the injection button until it clicks. Wait at least 5 seconds, and then withdraw the needle from the skin. This makes sure the entire dose has been injected (See Figure Q).
Figure Q
Step 11. Discard the Needle and Store your GENOTROPIN PEN 5

FIGURE R

  • Pull off the needle guard, gripping the sides. Be careful not to push on the end. (See Figure R).
  • Remove the needle as instructed by your Healthcare provider, and discard it in a proper disposal container. Never reuse a needle.
  • Push on the front cap, and put your pen back in its protective case.

Store your pen (with cartridge) in the refrigerator [36ºF to 46ºF (2ºC to 8ºC)] until your next injection.

Figure R
Step 12. Your Next Injection

If you already have a cartridge in your pen, prepare the pen and give the injection as follows:

  • Remove the front cap (See Figure S).
  • Make sure there is enough growth hormone in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (See Figure T).
  • Peel off the foil from a needle.
  • Push and screw the needle onto the metal front part of the pen. Remove the outer needle cover and inner needle cap (See Figure U).
  • Follow the instructions above, starting with Step 8: Fit the needle guard.

FIGURE S

Figure S

FIGURE T

Figure T

FIGURE U

Figure U
Step 13. To Replace the Cartridge

FIGURE V

  • Press the red release button to reset your pen (See Figure V).
Figure V
  • Turn the injection button (in the opposite direction to the arrow on the injection button) as far as it will go (See Figure W).This will draw back the plunger rod.
  • Unscrew the metal front part and remove the empty cartridge (See Figure X).
  • Discard the empty cartridge as instructed by your Healthcare provider.
  • To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with Step 1.

FIGURE W

Figure W

FIGURE X

Figure X

Step 14. Disposing of used needles, cartridges and your GENOTROPIN PEN 5

  • Your Healthcare provider will instruct you on how to discard your used needles and other medical waste in an appropriate puncture resistant disposal container such as sharps (medical waste) container. You may also contact your local health department for more information. There may be special state or local laws for properly disposing of used needles, other medical waste and sharps containers.
  • Do not throw needles or sharps containers in the household trash without first checking your state and local laws.
  • Do not recycle the sharps container.

Always keep your sharps container in a safe place and out of reach of children.

Customizing your Pen

FIGURE Y

Your pen is supplied with two coloured clip-on panels, enabling you to customize the look of your pen. To remove the clip-on panel from the pen, insert the lip of the front cap into the groove under the front end of the panel, and pry the panel off. The new panel simply clicks into place. A small hole near the dose display enables you to attach decorations or charms. Figure Y

Caring for your Pen

No special maintenance is required. To clean your pen, wipe the outside surface with a damp cloth. Do not immerse. Do not use alcohol or any other cleaning agents, as they may damage the plastic body. To clean the needle guard, wipe it with a damp cloth or alcohol swab.

Questions and Answers
Question Answer
How long is the use period of my pen? The pen has a use period of 2 year starting from the first use by the patient.
How can I tell how much GENOTROPIN is left in my pen? The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it can't go any further; the dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.
If the display doesn't work, can my pen still be used? Yes, but it is not recommended. When the display or the battery doesn't function any more, it is still possible to set the dose of your pen by counting the clicks (one click = '0.1'mg). Your pen can still be used while waiting for a new one. Contact your Healthcare provider.
What happens if I dial the injection button beyond the maximum dose ('2.0' mg)? Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.

Display Information:

Steady display The selected dose size.
The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.
Steady display A dose is not set.
The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.
Flashing display The injection button is rotated too fast or too slow.
Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.
Flashing display The injection button is rotated too fast or too slow.
Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.
Flashing 1 month before the 2nd year use elapse.
(5 seconds) display This is normal. The dose can be set and read from the display. Contact your Healthcare provider.
Steady display Pen has reached the end of its use period of 2 years.
The display will continue to show display until the battery
is completely empty.
This does not indicate a defect of the pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your Healthcare provider.
Flashing Battery charge is low and will be empty in one month's time. Afterwards the dose can be set and your pen can be used correctly. Contact your Healthcare provider.
(5 seconds) display
Steady display Battery power low.
The dose cannot be displayed. Contact your Healthcare provider.
Steady display Blank screen
To save the battery's energy, the dose display is activated for two minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery

If you have any questions about your dose or your treatment with GENOTROPIN, call your Healthcare provider right away.

Use this device only for the person for whom it was prescribed.

These Instructions for use have been approved by the U.S. Food and Drug Administration.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium
Produced by Ypsomed AG, Burgdorf, Switzerland

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LAB-0225-8.0
September 2016


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Instructions for Use
GENOTROPIN Mixer (JEEN-o-tro-pin MIX-er)
Growth Hormone Delivery Device for Mixing Genotropin® Lyophilized powder (somatropin) for injection

Important Note
Please read these instructions completely before using GENOTROPIN MIXER. If there is anything you do not understand or cannot do, call the Pfizer Bridge Program's toll-free number at 1-800-645-1280.

The GENOTROPIN MIXER is a device used to mix growth hormone that is provided in a 2-chamber cartridge of GENOTROPIN.

For each injection you will need:

  • GENOTROPIN MIXER
  • A pressure-release needle (also called dental needle) (not included).
  • One cartridge of GENOTROPIN® Lyophilized Powder (somatropin) for injection, which contains growth hormone powder in one chamber and the liquid in the other (not included).
  • Alcohol swab (not included).
  • Insulin syringe for injection (not included).
  • Proper disposal container (not included).

The diagram below identifies the different components of the GENOTROPIN MIXER. (See Figure A)

FIGURE A

Figure A

Storage instructions for your GENOTROPIN MIXER

  • Store your GENOTROPIN MIXER (with cartridge) in the refrigerator [36°F to 46°F (2°C to 8°C)]. Always remove the needle before storing.

Using your GENOTROPIN MIXER

Step 1. Before you begin

  • First, wash and dry your hands.
  • Completely unscrew the dark green plunger rod from the light green holder of the GENOTROPIN MIXER.
  • Remove the two-chamber cartridge of GENOTROPIN from its package.

FIGURE B

Step 2. Mixing GENOTROPIN

Insert the cartridge into the GENOTROPIN MIXER with the metallic/rubber tip of the cartridge facing into the open end of the holder. The metallic/rubber tip of the cartridge should be visible sticking out from the opening at the front of the holder.

  • Screw the plunger rod back into the holder. When the two halves are completely screwed together, the growth hormone and the diluent are automatically mixed. (See Figure B)

CAUTION: Look in the window of the GENOTROPIN MIXER to make sure the growth hormone is completely dissolved. If it is not, gently tip the GENOTROPIN MIXER from side to side until the liquid is clear. DO NOT SHAKE. The solution should be inspected visually for particulate matter and discoloration prior to administration. If the solution is still cloudy, do not inject it. Remove the cartridge and return it to your supplier. Repeat the procedure using a new cartridge.

Figure B

FIGURE C

Step 3. Releasing Pressure
  • Disinfect the metallic/rubber tip of the cartridge by wiping it with an alcohol swab.
  • Remove the protective cap from the pressure-release needle. Do not touch the exposed needle. With the metallic/rubber tip of the cartridge pointing upwards, pierce the rubber tip with the needle. This will release the excess pressure in the cartridge. Be sure the cartridge is vertical when pierced, to avoid spilling the growth hormone. (This step is only performed the first time you use a new cartridge.) (See Figure C)
  • Remove the pressure-release needle from the cartridge and discard the needle in a proper disposal container.
Figure C

FIGURE D

Step 4. Injecting GENOTROPIN

  • Disinfect the metallic/rubber tip of the cartridge by wiping it with an alcohol swab. This must be done each time before the solution is taken from the cartridge.
  • Take out an insulin syringe and remove its needle guard. Hold the GENOTROPIN MIXER upside down so that the metallic/rubber tip is pointing downwards.
  • Insert the needle of the syringe through the rubber tip of the cartridge contained in the GENOTROPIN MIXER, making sure that the needle tip always stays below the fluid level. This will minimize air from entering your syringe.
  • Holding the side of the syringe body and the end of the syringe plunger rod, pull the plunger of the syringe back slowly to draw out your prescribed dose of growth hormone.
  • Still holding the GENOTROPIN MIXER and syringe with its needle pointing upwards, gently tap the side of the syringe to move any air bubbles to the top of the syringe. Then push the syringe's plunger gently to force the air bubbles out of the syringe. Remove the syringe. It is now ready for your injection. (See Figure D)
  • Disinfect the area to be injected as directed by your healthcare provider. Pinch the skin firmly between your thumb and forefinger. Hold the syringe close to the needle—like a dart—and push it into the skin at a 45° to 90° angle with a quick, firm action.
  • Gently and smoothly inject the growth hormone until the syringe is empty. Withdraw the needle quickly, by pulling it straight out, and apply pressure over the injection site with a dry gauze pad.
  • Discard the needle in a proper disposal container.
  • The site of the injection should be changed each day.
Figure D

Step 5. Reusing the GENOTROPIN MIXER

The cartridge of GENOTROPIN can be reused for up to 28 days after reconstitution. Simply follow the instructions in the "Injecting GENOTROPIN" section. Additional pressure-release needles may be obtained by calling the Pfizer Bridge Program at 1-800-645-1280.

Step 6. Changing the cartridge

When the cartridge of GENOTROPIN is empty, you can reuse the GENOTROPIN MIXER with your next cartridge, as follows:

  • Unscrew the plunger rod from the GENOTROPIN MIXER.
  • Remove and discard the old cartridge.
  • Follow the steps beginning with the "Before You Begin" section.

Step 7. Disposing of used needles and cartridges

  • Your Healthcare provider will instruct you on how to discard your used needles and other medical waste in an appropriate puncture resistant disposal container such as sharps (medical waste) container. You may also contact your local health department for more information. There may be special state or local laws for properly disposing of used needles, other medical waste and sharps containers.
  • Do not throw needles or sharps containers in the household trash without first checking your state and local laws.
  • Do not recycle the sharps container.

Always keep your sharps container in a safe place and out of reach of children.

If you have any questions regarding the GENOTROPIN MIXER, contact your healthcare provider or call the Pfizer Bridge Program at 1-800-645-1280.

Use this device only for the person for whom it was prescribed.

These Instructions for use have been approved by the U.S. Food and Drug Administration.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium

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LAB-0228-4.0
September 2016

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Other Resources

PFIZER BRIDGE PROGRAM - Genotropin

To contact the Pfizer Bridge Program for device training, to address issues to avoid treatment interruptions or delays, for assistance with the insurance process, or for questions on the GENOTROPIN Savings Program, please call (800) 645-1280