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TERIPARATIDE TEVA 20 MICROGRAMS / 80 MICROLITRES SOLUTION FOR INJECTION IN PRE-FILLED PEN - patient leaflet, side effects, dosage

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Patient leaflet - TERIPARATIDE TEVA 20 MICROGRAMS / 80 MICROLITRES SOLUTION FOR INJECTION IN PRE-FILLED PEN

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Length: 397 mm

Width: 298 mm


Colours Used:


Template


C IMI Y MK


Teriparatide injection in pre-filled pen

User Manual

EAS3848a

Important: First read the Package leaflet that comes inside yourTeriparatide carton.

Before you use your new Teriparatide Teva Pen, please read the entire front and back of this User Manual completely. Follow the directions carefully when using the Teriparatide Teva Pen.

The Teriparatide Teva Pen contains 28 days of medicine. Th row away the Teri pa rat ide Teva Pen after 28 days, even if it is not completely empty. Do not inject more than one dose of Teriparatide in the same day.

Do not transfer Teriparatide to a syringe.


Set dose

Pull out black injection button until it stops.


If you cannot pull out the black injection button seeTroubleshooting, Problem E, on back page.


TeriparatideTeva Pen Parts*


Body Label Red Stripe

Blue Cap Medicine Cartridge Yellow Shaft Black Injection

Button



Large Needle Cover


Small Needle I

Protector Needle




* Needles not included. Becton, Dickinson and Company pen needles from 29 to 31 gauge can be used. Ask your doctor or pharmacist which needle gauge and length are best for you.


Wash your hands before every injection. Prepare the injection site as your doctor or pharmacist instructed.



Gently hold a fold of skin on your thigh or abdomen and insert needle straight into skin.


Check theTeri paratideTeva Pen label to make sure you have the right medicine and that it has not expired.


Do not use it if the Teri paratideTeva Pen looks damaged, the medicine in the cartridge is not clear and colourless, or if it has particles in it.


Pull off paper tab.



Push in black injection button until it stops. Hold it in and count to 5 slowly.You must wait until the count of 5 to make sure you receive the correct dose. Then pull the needle from skin.



Push needle straight onto medicine cartridge.


Confirm dose

IMPORTANT


After completing the injection:




Pull off large needle cover and save it.


Once the needle is removed from the skin, take your thumb off the black injection button. Check to make sure the black injection button is all the way in. If the yellow shaft does not show, you have finished the injection steps the right way.

You should NOT see any of the yellow shaft. If you do and have already injected the medicine, do not inject yourself a second time on the same day. Instead, you MUST reset the Teri pa rati de Teva Pen (seeTroublesho­oting, Problem A, on back page).

I ZINC Ref: EAS3848a GUIDE TERIPARATIDE 250mcg-ml SOL FOR INJ TUK 2.4ml <ZAG

Version: 3 16 october 2019

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Length:

397 mm

Colours Used:

Template | Y B

Width:

Depth:

298 mm

Remove needle

Put large needle cover on needle. Do not try to put the needle cover back on with your hands.

Unscrew the covered needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns.

Pull off needle and throw away as directed by your doctor or pharmacist.

Push blue cap back on. Right after use, pl ace Teri pa rati de Teva Pen in the refrigerator.

For more information, or if you have any questions, turn to the end of this page.

Teriparatide injection in pre-filled pen

Troubleshooting

Problem

Solution

A. The yellow shaft is still showing after I push in the black injection button. How do I reset my Teriparatide Teva Pen?

To reset theTeriparatideTeva Pen, follow the steps below.

  • 1) If you have already injected, DO NOT inject yourself a second time on the same day.

  • 2) Remove the needle.

  • 3) Attach a new needle, pull off the large needle cover and save it.

  • 4) Pull out the black injection button until it stops. Check to make sure the red stripe shows.

  • 5) Pull off the small needle protector and throw away.

  • 6) Point the needle down into an empty container. Push in the black injection button until it stops. Hold it in and slowly count to five. You may see a small stream or drop of fluid. When you have finished, the black injection button should be all the way in.

  • 7) If you still see the yellow shaft showing, contact your doctor or pharmacist.

  • 8) Put the large needle cover on needle. Unscrew the needle all the way by giving the needle cover 3 to 5 counter-clockwise turns. Pull off the covered needle and throw away as instructed by your healthcare provider. Push the blue cap back on, and put yourTeriparati­deTeva Pen in the refrigerator.

You can prevent this problem by always using a NEW needle for each injection, and by pushing the black injection button all the way in and slowly counting to five.

B. How can I tell if my TeriparatideTeva Pen works?

The black injection button should be all the way in to show that the full dose of medicine has been injected from theTeriparatideTeva Pen. Use a new needle every time you inject to be sure yourTeriparatide Teva Pen will work properly.

C. I can see an air bubble in my Teriparatide Teva Pen.

A small air bubble will not affect your dose and it will not harm you. You can continue to take your dose as usual.

D. I cannot get the needle off

  • 1) Put the large needle cover on the needle.

  • 2) Use the large needle cover to unscrew the needle.

  • 3) Unscrew the needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns.

  • 4) If you still cannot get the needle off, ask someone to help you.

E. What should I do if I have difficulty pulling out the black injection button?

Change to a newTeriparatideTeva Pen to take your dose as instructed by your healthcare provider. When the black injection button becomes hard to pull out, this means there is not enough medicine in your TeriparatideTeva Pen for another dose.You may still see some medicine left in the cartridge.


Cleaning and Storage

Cleaning Your Teri pa rati de Teva Pen

  • Wipe the outside of theTeriparatideTeva Pen with a damp cloth.
  • Do not place theTeriparatideTeva Pen in water, or wash or clean it with any liquid.

StoringYourTe­riparatideTeva Pen

  • After each use, refrigerate theTeriparatideTeva Pen right away. Read and follow the instructions in the Information for the Patient leaflet section ‚How to store Teriparatide Teva?‘.
  • Do not store theTeriparatideTeva Pen with the needle attached. Doing this may cause air bubbles to form in the medicine cartridge.
  • Store theTeriparatideTeva Pen with the blue cap on.
  • Do not freeze Teriparatide. If theTeriparatideTeva Pen has been frozen, throw the device away and use a newTeriparati­deTeva Pen.
  • If theTeriparatideTeva Pen has been left out of the refrigerator, do not throw theTeva Pen away. Place theTeva Pen back in the refrigerator and contact your doctor or pharmacist.

Other Important Notes

  • TheTeriparatideTeva Pen contains 28 days of medicine.
  • Do not transferTeripa­ratide to a syringe.This may result in you taking the wrong dose of medicine.
  • Write down your first injection date on a calendar.
  • Read and follow the instructions in the User Manual so that you use your TeriparatideTeva Pen the right way.
  • Check theTeriparatideTeva Pen label to make sure you have the right medicine and that it has not expired.
  • Do not use theTeriparatideTeva Pen if it looks damaged. Look at theTeriparatide medicine in the cartridge. If the medicine is not clear and colourless, or if it has particles, do not use it. Contact your doctor or pharmacist, if you notice any of these.
  • Use a new needle for each injection.
  • During the injection, you may hear one or more clicks – this is normal.
  • TheTeriparatideTeva Pen is not recommended for use by the blind or by those who have vision problems without help from a person trained in the proper use of the device.
  • Keep yourTeriparati­deTeva Pen and needles out of the reach of children.

Disposal of Pen Needles andTeva Pen

Disposal of Pen Needles and theTeriparatideTeva Pen

  • Before throwing away theTeriparatideTeva Pen, be sure to remove the pen needle.
  • Throw away yourTeriparati­deTeva Pen and used needles as directed by your doctor or pharmacist.