Forsteo 20 User Manual

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PEN USER MANUAL

Forsteo

FORSTEO 20 micrograms (µg)/ 80 microlitres solution for injection, in pre-filled pen

Instructions for use

Before you use your new pen, please read the sectio n Instructions for use completely. Follow the directions carefully when using the pen. Also read the package leaflet provided.

Do not share your pen or your needles as this may risk transmission of infectious agents.

Your pen contains 28 days of medicine.

Forsteo parts*

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

Yellow Shaft

Black

Injection

button

Red Stripe Blue Body Medicine Cartridge White Cap

Paper Tab Needle Large Needle Cover

Small Needle Protector

Always wash your hands before every injection. Prepare the injection site as directed by your doctor or pharmacist.

Pull off white cap

Attach new needle

Pull off paper

tab.

Push needle straight

onto medicine cartridge.

Screw on needle

until firmly attached.

Pull off large

needle cover

and save it.

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Set dose

Red

stripe

Small needle

protector

Pull out black

injection button until it stops.

If you cannot pull out the black injection button see

Troubleshooting,

Problem E.

Check to

make sure red stripe shows.

Pull off small

needle protector and throw away.

Inject dose

Gently hold a fold of skin from thigh or

abdomen and insert needle straight into skin.

Push in black injection button until

it stops. Hold it in and count to 5 s-l-o-w-l-y. Then pull the needle

from skin.

IMPORTANT

Confirm dose

After

completing the injection:

Once the needle is removed from the skin, check to make sure the black injection button is all the way in. If the yellow shaft does not show, you have completed the injection steps

correctly.

You should NOT see any of

the yellow shaft. If you do and have already injected, do not inject yourself a second time on the same day. Instead, you MUST reset FORSTEO (see Troubleshooting Problem A).

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Remove needle

Put large needle

cover on needle.

Unscrew the needle

all the way by giving the large needle cover 3 to 5 complete turns.

Pull off needle and

throw away as directed by your doctor or pharmacist.

Push white cap back

on. Place FORSTEO in the refrigerator immediately after use.

The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

Forsteo

FORSTEO, 20 microgram (µg) 80 microlitres solution for 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 FORSTEO?

To reset the FORSTEO, 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 count to 5 s-l-ow-l-y. 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,

please 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 complete turns. Pull off needle cover and throw away as directed by your doctor or pharmacist. Push the white cap back on, and place FORSTEO 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 counting

to 5 s-l-o-w-l-y.

B. How can I tell if my FORSTEO works?

The FORSTEO is designed to inject the full dose every time it is used according to the directions in the

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section Instructions for Use. The black injection

button will be all the way in to show that the full dose has been injected from the FORSTEO.

Remember to use a new needle every time you inject

to be sure your FORSTEO will work properly.

C. I see an air bubble in

my FORSTEO.

A small air bubble will not affect your dose nor will it

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 complete turns.

4) If you still cannot get the needle off, ask

someone to help you.

E. What should I do if I

cannot pull out the black injection button?

Change to a new FORSTEO to take your dose as

directed by your doctor or pharmacist.

This indicates th a t you have now used all the medicine that can be injected accurately even though you may still see some medicine left in the cartridge.

Cleaning and Storage

Cleaning Your FORSTEO

• Wipe the outside of the FORSTEO with a damp cloth.

• Do not place the FORSTEO in water, or wash or clean it with any liquid.

Storing Your FORSTEO

• Refrigerate the FORSTEO immediately after every use. Read and follow the instructions in

the Information for the Patient leaflet on how to store your pen.

• Do not store the FORSTEO with a needle attached as this may cause air bubbles to form in the

cartridge.

• Store the FORSTEO with the white cap on.

• Never store the FORSTEO in the freezer.

• If the medicine has been frozen, throw the device away and use a new FORSTEO.

• If the FORSTEO has been left out of the refrigerator, do not throw the pen away. Place the

pen back in the refrigerator and contact your do ctor or ph arm acis t.

Disposal of Pen Needles and Device

Disposal of Pen Needles and FORSTEO Device

• Before disposing of the FORSTEO device, be sure to remove the pen needle.

• Put used needles in a sharps container or a hard plastic container with a secure lid. Do not

throw needles directly into your household waste.

• Do not recycle the filled sharps container.

• Ask your healthcare professional about options to dispose of the pen and the sharps container

properly. The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

• Dispose of the device 28 days after first use.

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Other Important Notes

• The FORSTEO contains 28 days of medicine.

• Do not transfer the medicine into a syringe.

• Write down your first injection date on a calendar.

• Read and follow the in s tructions in the Information for the Patient leaflet for using the

product.

• Check the FORSTEO label to make sure you have the correct medicine. and that it has not

expired.

• Contact your doctor or pharmacist if you notice any of the following:

- The FORSTEO appears damaged

- The solution is NOT clear, colourless and free of particles

• Use a new needle for each injection.

• During injection, you may hear one or more clicks – this is a normal device operation.

• The FORSTEO is not recommended for use by the blind or visually impaired persons without

the assistance of a person trained in the proper use of the device.

• Keep the FORSTEO out of the sight and reach of children.

Manufactured by Lilly France, F-67640 Fegersheim, France for Eli Lilly and Company. This user manual was last revised in June 2018