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Instructions for Use:

Pushtronex

®

System for

Repatha

®

(ri-PAth-a) 

(evolocumab)

Single-Use On-Body Infusor and Prefilled Cartridge

Guide to parts

Prefilled Cartridge

White plunger

Cartridge top (Do not rotate)                                                                      

           

Cartridge bottom

                  

Medicine

Cartridge label

On-Body Infusor

Front view

Skin

adhesive

Status

light

Start button

(Do not press until ready to inject)

Cartridge door

(Do not close

without cartridge)

Medicine window

Pull tabs

Back view

Needle cover

Adhesive paper

Battery 

Strip

Left pull tab

Needle inside

(under cover)

Right pull tab

Important:

Needle is inside.

Summary of Contents for Pushtronex

Page 1: ...r Cartridge top Do not rotate Cartridge bottom Medicine Cartridge label On Body Infusor Front view Skin adhesive Status light Start button Do not press until ready to inject Cartridge door Do not close without cartridge Medicine window Pull tabs Back view Needle cover Adhesive paper Battery Strip Left pull tab Needle inside under cover Right pull tab Important Needle is inside ...

Page 2: ... 30 days Do not store the on body infusor and prefilled cartridge in temperatures above 77 F 25 C such as in your vehicle s glove box or trunk Do not freeze Using your on body infusor and prefilled cartridge Do not shake the on body infusor or prefilled cartridge Do not remove the on body infusor and prefilled cartridge from the box or clear tray until you are ready to inject Do not touch the star...

Page 3: ...epare 1A Remove the on body infusor and prefilled cartridge carton from the refrigerator Wait at least 45 minutes before injecting for the on body infusor and prefilled cartridge in the carton to naturally reach room temperature Do not try to warm the prefilled cartridge by using a heat source such as hot water or a microwave In any above cases use a new on body infusor and prefilled cartridge and...

Page 4: ...trim the area Use a firm and flat skin surface You can use Your thigh Stomach area abdomen except for a two inch area right around your navel Outer area of upper arm only if someone else is giving the injection Upper arm Stomach area abdomen Thigh Clean your injection site with an alcohol wipe Let your skin dry Do not touch this area again before injecting Do not inject into areas where the skin i...

Page 5: ...ady to inject 2B Inspect the cartridge Cartridge bottom White Medicine plunger Cartridge label Expiration date Cartridge top Do not rotate Check the expiration date do not use if this date has passed Make sure the medicine in the cartridge is clear and colorless to slightly yellow Do not use if the medicine is cloudy or discolored or contains flakes or particles Do not use if any part of the cartr...

Page 6: ...e into the on body infusor and firmly press on the top until it is secured in place Make sure that you give your injection within 5 minutes after loading the cartridge Do not insert the cartridge more than 5 minutes before injection This can dry out the medicine Load cartridge straight Press down firmly Inject within 5 minutes after loading the cartridge Insert the cartridge bottom first Do not to...

Page 7: ...nfusor before you close the door Do not close the door if the cartridge is missing or not fully inserted Do not touch the start button until you have placed the loaded on body infusor on your skin Important After you load the on body infusor go to the next step right away Step 3 Inject 3A Peel away both green pull tabs to show the adhesive The on body infusor is on when the blue status light flash...

Page 8: ...e is giving the injection Stomach area placement Thigh placement or Stretch method for stomach Do not stretch for thigh Important Adjust your body posture to avoid skin folds and bulges 3C When the blue light flashes the on body infusor is ready Keep the stretch stomach area method only Hold the loaded on body infusor with the blue light visible and place it on your skin You may hear beeps Stomach...

Page 9: ...njection has started Important If medication leaks from the on body infusor call 1 844 REPATHA 1 844 737 2842 or visit www REPATHA com 3E The injection takes about nine minutes to finish The status light turns solid green and the device beeps when done It is okay to hear a pumping sound start and stop during injection Injection is finished when The status light changes to solid green You hear seve...

Page 10: ...er you remove the used on body infusor 4B Throw away the used on body infusor in a sharps container The on body infusor contains batteries electronics and a needle Put the used on body infusor in a FDA cleared sharps disposal container right away after use Do not throw away dispose of the on body infusor in your household trash If you do not have a FDA cleared sharps disposal container you may use...

Page 11: ... your used sharps disposal container Do not recycle the on body infusor or sharps disposal container or throw them into household trash Important Always keep the sharps disposal container out of the reach of children 4C Check the injection site If there is blood press a cotton ball or gauze pad on your injection site Do not rub the injection site Apply an adhesive bandage if needed Troubleshooting...

Page 12: ...The on body infusor will stop Stop using the on body infusor call 1 844 REPATHA 1 844 737 2842 or visit www REPATHA com What if the on body infusor does not beep and the blue status light does not blink when I remove the pull tabs Check to see if both green pull tabs have been fully removed from the on body infusor including the adhesive paper over the battery strip and needle cover If both green ...

Page 13: ...rs to 3500 meters During injection keep the on body infusor a minimum of 4 inches 10 cm away from other electronics such as cellular phones Warning Do not modify the device On body infusor operating temperature range is 59 F to 104 F 15 C to 40 C www devicepatents com SYMBOL TABLE Do not re use Serial number Type BF Applied Part Do not use if packaging is damaged On Body Infusor containing 420 mg ...

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