Yorvipath 168 micrograms/0.56 ml solution for injection in pre-filled pen

Color

Strength

Blue

Yorvipath 168 micrograms/0.56 ml

Orange

Yorvipath 294 micrograms/0.98 ml

Garnet

Yorvipath 420 micrograms/1.4 ml

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Important information you need to know before starting to use your Yorvipath pen

Read and follow the package leaflet and these instructions for use carefully to ensure you inject Yorvipath correctly.

Make sure you have received training from your doctor or nurse before administering the injection. This is important to ensure you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and therefore may not get the full effect of your medicine.
• If you are blind or have visual impairment, or lack concentration, do not use your pen without help. Instead, ask someone who has been trained in the use of the Yorvipath pen to assist you.
• Keep out of sight and reach of children.
• The pen and needles are for use by a single patient only.
• Do not share your pen or needles with other people. This could cause infection (cross-contamination).
• Always dispose of your pen after 14 days, even if there is still medicine remaining. This is important to ensure you receive the correct effect of the medicine.
• Always use the needles provided with the Yorvipath pen for your injections.
• Remove the needle after each use. Do not store the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do not change the injection angle after inserting the needle into the skin. Changing the angle may cause the needle to bend or break. A bent or broken needle could become lodged in the body or remain completely under the skin. If a broken needle becomes lodged in the body or under the skin, seek medical attention immediately.
• Do not use needles if the needle cap or needle foil is damaged.

Caring for the pen

• Handle the pen carefully.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do not drop your pen or hit it against hard surfaces. If this happens, retest the pen flow (Section 2, Steps A–C) before the next use.
• Do not apply extra force to your pen. It may be empty, damaged, or no longer functioning properly.
• Do not attempt to repair a damaged pen yourself.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (Section 2) the first time you use a new pen (or if you suspect it may be damaged) to avoid wasting medication. The test checks that the medicine flows properly through the pen so you can receive the correct dose.

1. I do not see drops after testing the pen flow 5 times. What should I do?

If you do not see drops at the needle tip after 5 attempts, it may be because there is no flow through the pen and needle.

Change the needle (see Section 5, Step 13) and retest the pen flow (see Section 2, Steps A–C). You can confirm proper flow if you see a drop of medicine. If it still does not work, dispose of the pen and consult your healthcare professional.

1. How do I know when the injection is complete?

The injection is only complete when you press the injection button fully down, the dose selector has rotated back to the “?” symbol, and you have kept the pen in place on the skin for 5 seconds.

1. Why do I need to keep pressing the pen against the skin for 5 seconds?

Some of the medicine may flow back into the pen or leak from the injection site onto the skin. Pressing the pen against the skin for 5 seconds helps ensure that the full dose of medicine has been injected.

1. I cannot set the dose selector to the required dose. What should I do?

The pen does not allow you to set a dose greater than the amount remaining.

If your required dose is higher than the amount of medicine left in the pen, you will not be able to set the full dose. You must dispose of your pen and take the full dose using a new pen.

1. The red cap covers the needle before starting the injection. What should I do?

Unscrew and dispose of the used needle (see Section 5, Step 13). Take a new needle from the box and restart from Step 1. Each box contains one extra needle.

1 Preparation of the pen and needle

Step 1

Take your Yorvipath pen. Make sure it is the correct concentration and check the expiry date. Take a needle and check the expiry date on the needle (Figure C).

Note: Remove your pen from the refrigerator 20 minutes before first use.

Figure C

Step 2

Remove the pen cap and check the inspection window to ensure that the medicine inside the pen is clear and colourless (Figure D).

Important: If visible particles are present in the medicine, do not use the pen. Use a new pen instead.

Figure D

Step 3

Remove the needle seal (Figure E).

This needle can only be used once and will lock after use.

Always use a new needle for each injection.

Figure E

Step 4

Attach the needle straight onto your pen, then screw the needle onto the pen until secure (it will not tighten completely) (Figure F).

Figure F

Step 5

Remove the needle cap (Figure G) and discard it.

Important: Do not touch the blue cap, as it may block the needle.

Figure G

1. If the pen is new, test its flow

Test the pen flow (steps A – C) only the first time you use a new pen.

If your pen is already in use, go to section 3, "Prepare the injection and select the dose".

Step A

Turn the dose selector to the right 2 clicks until you see the drop symbol “” in the dose window (Figure H).

Note: You can always correct the selection by turning the dose selector.

Figure H

Step B

Bring air bubbles to the top of the pen by tapping the inspection window (Figure I). Hold the pen with the needle tip pointing upward.

Note: Small air bubbles are acceptable.

Figure I

Step C

Press the plunger and observe medicine droplets coming out from the needle tip.

While pressing, make sure the dose selector rotates back to the symbol

(Figure J).

Important: If you do not see medicine droplets, repeat this test (steps A – C) up to 5 times.

If no droplets appear, replace the needle and repeat the test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are two areas on your body where you can give the injection (Figure K).

Do not inject into areas of red, swollen, or scarred skin.

Choose a different injection site each time you give an injection.

Step 7

Wash your hands and clean the injection site with an alcohol swab

(Figure L).

Figure L

Step 8

Select your dose as prescribed by your doctor (6, 9, or 12 micrograms) by turning the dose selector to the right

(Figure M).

Important: Make sure not to press the button when selecting the dose, to avoid wasting the medicine.

Note: Always discard your pen and use a new one if you cannot set a full dose.

Figure M

4 Inject the dose

Use the injection technique recommended by your

doctor or nurse.

Read this entire section (Steps 9–12) before starting to inject.

Step 9

Hold the pen so that the blue cap is placed over the injection site. Make sure you can see the dose window (Figure N).

Figure N

Step 10

Push the pen straight into the skin until you hear a click and the blue cap is no longer visible (Figure O).

Figure O

Step 11

Press the button fully down and hold it firmly for 5 seconds. Make sure the dose selector turns back to the symbol . This means the full dose has been delivered

(Figure P).

Figure P

Step 12

Slowly remove the pen from the injection site. The blue cap will automatically lock over the needle and a red lockout will appear (Figure Q).

Figure Q

5 Dispose of the used needle

Step 13

Unscrew the needle and dispose of it safely according to local regulations (Figure R). Do not attempt to recap the needle, as you may get a needle stick from the back end.

Figure R

Step 14

Firmly attach the pen cap onto the pen to protect it between injections and to protect the medicine from light (Figure S).

Figure S

6 Dispose of the used pen

Important: Always dispose of the

pen 14 days after first use according to local regulations. To keep track of when 14 days have passed, it is recommended to cover the field "?Date of opening" on the inner packaging.

Always dispose of your pen and any additional needles after 14 days of use, even if there is still medication left (Figure T). This is important to ensure you receive the full effect of the medicine.

Figure T

Important information you must know before starting to use your Yorvipath pen

Read and follow the package leaflet and these instructions for use carefully to ensure you inject Yorvipath properly.

Make sure you have been trained by your doctor or nurse before administering the injection. This is important to ensure you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and therefore may not get the full effect of your medicine.
• If you are blind or have visual impairment, or difficulty concentrating, do not use your pen without help. Instead, ask someone who has been trained in the use of the Yorvipath pen to assist you.
• Keep out of sight and reach of children.
• The pen and needles are for use by a single patient only.
• Do not share your pen or needles with other people. This could cause infection (cross-contamination).
• Always dispose of your pen after 14 days, even if there is still medicine remaining. This is important to ensure you receive the correct effect of the medicine.
• Always use the needles supplied with the Yorvipath pen for your injections.
• Remove the needle after each use. Do not store the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do not change the injection angle after inserting the needle into the skin. Changing the angle may cause the needle to bend or break. A bent or broken needle could become lodged in the body or remain completely under the skin. If a broken needle becomes lodged in the body or under the skin, seek immediate medical attention.
• Do not use needles if the needle cap or needle shield is damaged.

Special instructions for doses greater than 30 micrograms

If your dose is greater than 30 micrograms/day:

• Administer two injections one after the other, into different injection sites (see the recommended schedule table in section 3 of the Package Leaflet).
• It is recommended to use a different Yorvipath pen for the second daily injection, even if both pens have the same color-coded button (same concentration).
• Follow the steps in the instructions for use for each injection.

Care of the pen

• Handle the pen carefully.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do not drop your pen or hit it against hard surfaces. If this happens, retest the pen flow (section 2, steps A–C) before the next use.
• Do not apply extra force to your pen. It may be empty, damaged, or no longer functioning correctly.
• Do not attempt to repair a damaged pen yourself.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (section 2) the first time you use a new pen (or if you suspect it may be damaged) to avoid wasting medication. The test checks that medicine flows properly through the pen so you can receive the correct dose.

1. I do not see drops after testing the pen flow 5 times. What should I do?

If you do not see drops at the needle tip after 5 attempts, it may mean there is no flow through the pen or needle.

Change the needle (see section 5, step 13) and retest the pen flow (see section 2, steps A–C). You can confirm proper flow if you see a drop of medicine.

If it still does not work, dispose of the pen and consult your healthcare professional.

1. How do I know when the injection is complete?

The injection is only complete when you press the button fully down, the dose selector has rotated back to the “?” mark, and you have kept the pen pressed against the skin for 5 seconds.

1. Why do I need to keep pressing the pen against the skin for 5 seconds?

Some of the medicine may flow back into the pen or leak out from the injection site onto the skin. Pressing the pen against the skin for 5 seconds helps ensure that all the medicine has been injected.

1. I cannot set the dose selector to the required dose. What should I do?

The pen does not allow you to set a dose greater than the amount of medicine remaining.

If your dose is higher than the amount of medicine left in the pen, you will not be able to set the full dose. You must dispose of your pen and administer the full dose using a new pen.

1. The red cap covers the needle before starting the injection. What should I do?

Unscrew and dispose of the used needle (see section 5, step 13). Take a new needle from the box and restart from step 1. Each box contains one additional needle.

1 Preparing the pen and needle

Step 1

Take your Yorvipath pen. Make sure it is the correct concentration and check the expiration date. Take a needle and check the expiration date on the needle (

Figure C).

Note: Remove your pen from the

refrigerator 20 minutes before first use.

Figure C

Step 2

Remove the pen cap and check the inspection window to make sure the medicine inside the pen is clear and

colorless (Figure D).

Important: If the medicine has

visible particles, do not use the pen. Use a

new pen.

Figure D

Step 3

Remove the tab from the needle (Figure E).

This needle can only be used once and will lock after use.

Always use a new needle for each injection.

Figure E

Step 4

Attach the needle straight onto your pen, then screw the needle onto the pen until secure (it will not tighten completely) (Figure F).

Figure F

Step 5

Remove the needle shield (Figure G) and discard it.

Important: Do not touch the blue cap as it may block the needle.

Figure G

1. If the pen is new, test its flow

Test the pen flow (steps A–C) only the first time you use a new pen.

If your pen is already in use, go to section 3 "Prepare the injection and

select the dose".

Step A

Turn the dose selector clockwise 2 clicks until you see the drop symbol “” in the dose window (Figure H).

Note: You can always correct the selection by turning the dose selector.

Figure H

Step B

Bring air bubbles to the top of the pen by tapping the inspection window (Figure I). Hold the pen with the needle tip pointing upward.

Note: Small air bubbles are acceptable.

Figure I

Step C

Press the injection button and watch for drops of medicine to appear at the needle tip. While pressing, ensure the dose selector rotates back to the symbol (Figure J).

Important: If you do not see drops of medicine, repeat this test (steps A–C) up to 5 times. If no drops appear, replace the needle and repeat the test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are two areas

on your body where you can administer the injection (Figure K).

Do not administer the injection into red, swollen, or scarred skin.

Choose a different injection site each time you give an injection.

Step 7

Wash your hands and clean the injection site

with an alcohol wipe

(Figure L).

Figure L

Step 8

Select your dose as prescribed by your doctor (15, 18, or 21 micrograms) by rotating

the dose selector clockwise

(Figure M).

Important: Make sure not to press the button while selecting the dose to avoid wasting the medication.

Note: Always discard your pen and use a new one if you cannot set a complete dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your

doctor or nurse.

Read the entire section (Steps 9–12) before beginning to inject.

Step 9

Hold the pen so that the blue cap is placed

on the injection site. Make sure you can

see the dose window (Figure N).

Figure N

Step 10

Push the pen straight into the skin until you

hear a click and the blue cap is no longer visible

(Figure O).

Figure O

Step 11

Press the button down fully and hold it

firmly for 5 seconds. Make sure the dose

selector rotates back to the symbol. This means

the full dose has been delivered

(Figure P).

Figure P

Step 12

Slowly remove the pen from the injection site.

The blue cap will automatically lock over the needle,

and a red shield will become visible (Figure Q).

Figure Q

5 Dispose of the used needle

Step 13

Unscrew the needle and dispose of it safely

according to local regulations (Figure R).

Do not attempt to recap the needle, as you may get a needlestick injury from the back end.

Figure R

Step 14

Firmly attach the pen cap

onto the pen to protect it between injections and to protect the

medication from light (Figure S).

Figure S

6 Dispose of the used pen

Important: Always dispose of the

pen 14 days after first use,

according to local regulations. To keep track

of when 14 days have passed, it is

recommended to cover the ?Date of

opening″ field on the inner packaging.

Always dispose of your pen and any

additional needles after 14 days of use,

even if there is still medication left

(Figure T).

This is important to ensure you receive

the full effect of the medicine.

Figure T

Important information you must know before starting to use your Yorvipath pen

Read and follow the package leaflet and these instructions for use carefully to ensure you inject Yorvipath properly.

Make sure you have received training from your doctor or nurse before administering the injection. This is important to ensure you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and therefore may not get the full effect of your medicine.
• If you are blind or have visual impairment, or difficulty concentrating, do not use your pen without assistance. Instead, ask someone who has been trained in the use of the Yorvipath pen to help you.
• Keep out of sight and reach of children.
• The pen and needles are for use by a single patient only.
• Do not share your pen or needles with other people. This could cause infection (cross-contamination).
• Always dispose of your pen after 14 days, even if there is still medicine remaining. This is important to ensure you receive the correct effect from the medicine.
• Always use the needles supplied with the Yorvipath pen for your injections.
• Remove the needle after each use. Do not store the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do not change the injection angle after inserting the needle into the skin. Changing the angle may cause the needle to bend or break. A bent or broken needle could become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do not use needles if the needle cover or needle shield is damaged.

Special instructions for doses greater than 30 micrograms/day

If your dose is greater than 30 micrograms/day:

• Administer two injections, one after the other, in different injection sites (see the recommended schedule table in section 3 of the Package Leaflet).
• It is recommended to use a different Yorvipath pen for the second daily injection, even if both pens have the same color dose button (same concentration).
• Follow the steps in the instructions for use for each injection.

Care of the pen

• Handle the pen carefully.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do not drop your pen or hit it against hard surfaces. If this happens, retest the pen flow (section 2, steps A–C) before the next use.
• Do not apply extra force to your pen. It may be empty, damaged, or no longer functioning correctly.
• Do not attempt to repair a damaged pen yourself.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (section 2) the first time you use a new pen (or if you suspect it may be damaged) to avoid wasting medication. The test checks that the medicine flows through the pen so that you can receive the correct doses.

1. I do not see drops after testing the pen flow 5 times. What should I do?

If you do not see drops at the tip of the needle after 5 attempts, it may be because there is no flow through the pen and needle.

Change the needle (see section 5, step 13) and retest the pen flow (see section 2, steps A–C). You can confirm proper flow if you see a drop of medicine.

If it still does not work, dispose of the pen and consult your healthcare professional.

1. How do I know when the injection is complete?

The injection is only complete when you press the dose button fully down, the dose selector has rotated back to the “?” and you have kept the pen pressed against the skin for 5 seconds.

1. Why must I continue pressing the pen against the skin for 5 seconds?

Some of the medicine may flow back into the pen or leak out from the injection site onto the skin. Pressing the pen against the skin for 5 seconds helps ensure that the full dose of medicine has been injected.

1. I cannot set the dose selector to the required dose. What should I do?

The pen does not allow you to set a dose greater than the amount remaining.

If your dose is higher than the amount of medicine left in the pen, you will not be able to set the full dose. You must dispose of your pen and take the full dose using a new pen.

1. The red cap covers the needle before starting the injection. What should I do?

Unscrew and dispose of the used needle (see section 5, step 13). Take a new needle from the box and restart from step 1. All boxes contain an extra needle.

1 Preparing the pen and needle

Step 1

Take your Yorvipath pen. Make sure it is the correct concentration and check the

expiration date. Take a needle and check

the expiration date on the needle

(Figure C).

Note: Remove your pen from

the refrigerator 20 minutes before first use.

Figure C

Step 2

Remove the closure cap from the pen and check the inspection window to ensure that the medicine inside the pen is clear and

colorless (Figure D).

Important: If the medicine contains

visible particles, do not use the pen. Use a

new pen.

Figure D

Step 3

Remove the tab from the needle (Figure E).

This needle can only be used once and will lock after use.

Always use a new needle for each injection.

Figure E

Step 4

Attach the needle directly onto your pen, and

then screw the needle onto the

pen until secure (it will not tighten completely) (Figure F).

Figure F

Step 5

Remove the needle cap (Figure G) and discard it.

Important: Do not touch the blue cap

as it may block the needle.

Figure G

1. If the pen is new, test its flow

Test the pen flow (steps A – C) only the first time you use

a new pen.

If your pen is already in use, go to section 3 "Prepare the injection and

select the dose".

Step A

Turn the dose selector to the right

2 clicks until you see the drop symbol “” in the dose window (Figure H).

Note: You can always correct the selection by turning the dose selector.

Figure H

Step B

Bring air bubbles to the top of the pen by tapping the inspection window (Figure I). Hold the pen with the needle tip pointing upward.

Note: Small air bubbles are acceptable.

Figure I

Step C

Press the push button and observe medication drops coming out from the needle tip. While pressing, ensure the dose selector rotates back to the symbol (Figure J).

Important: If you do not see medication drops, repeat this test (steps A – C) up to 5 times. If no drops appear, replace the needle and repeat the test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are two areas on your body where you can administer the injection (Figure K).

Do not inject into areas of red, swollen, or scarred skin.

Choose a different injection site each time you give an injection.

Step 7

Wash your hands and clean the injection site with an alcohol wipe

(Figure L).

Figure L

Step 8

Select your dose as prescribed by your doctor (24, 27, or 30 micrograms) by turning

the dose selector to the right

(Figure M).

Important: Make sure not to press the button while selecting the dose, to avoid wasting medication.

Note: Always discard your pen and use a new one if you are unable to set a full dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your

doctor or nurse.

Read this entire section (Steps 9–12) before beginning to inject.

Step 9

Hold the pen so that the blue cap is positioned over the injection site. Make sure you can see the dose window (Figure N).

Figure N

Step 10

Push the pen directly against the skin until you hear a click and the blue cap is no longer visible (Figure O).

Figure O

Step 11

Press the button down fully and hold it firmly for 5 seconds. Make sure the dose selector rotates back to the symbol . This indicates

that the full dose has been delivered

(Figure P).

Figure P

Step 12

Slowly remove the pen from the injection site. The blue cap will automatically lock over the needle and a

red lockout will be visible (Figure Q).

Figure Q

5 Dispose of the used needle

Step 13

Unscrew the needle and dispose of it safely according to local regulations (Figure R).

Do not attempt to recap the needle, as you may get a needlestick injury from the back end.

Figure R

Step 14

Firmly attach the pen cap onto the pen to protect it between injections and to protect the medication from light (Figure S).

Figure S

6 Dispose of the used pen

Important: Always dispose of the

pen 14 days after first use, according to local regulations. To keep track of when 14 days have passed, it is recommended to cover the “Date of opening” field on the inner packaging.

Always dispose of your pen and any remaining needles after 14 days of use,

even if there is still medication remaining (Figure T). This is important to ensure you receive the full therapeutic effect of the medication.

Figure T

Important information you must know before starting to use your Yorvipath pen

Read and follow the package leaflet and these instructions for use carefully to ensure you inject Yorvipath properly.

Make sure you have been trained by your doctor or nurse before administering the injection. This is important to ensure you receive the correct treatment.

For proper use

• If you do not follow these instructions, you may not receive the correct dose and therefore may not get the full effect of your medicine.
• If you are blind or have visual impairment, or lack concentration, do not use your pen without help. Instead, ask someone who has been trained in the use of the Yorvipath pen to assist you.
• Keep out of sight and reach of children.
• The pen and needles are for use by a single patient only.
• Do not share your pen or needles with other people. This could cause infection (cross-contamination).
• Always dispose of your pen after 14 days, even if there is still medicine remaining. This is important to ensure you receive the correct effect of the medicine.
• Always use the needles provided with the Yorvipath pen for your injections.
• Remove the needle after each use. Do not store the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do not change the injection angle after inserting the needle into the skin. Changing the angle may cause the needle to bend or break. A bent or broken needle could become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do not use needles if the needle cap or needle shield is damaged.

Caring for the pen

• Handle the pen carefully.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do not drop your pen or hit it against hard surfaces. If this happens, retest the pen flow (Section 2, steps A–C) before the next use.
• Do not apply extra force to your pen. It may be empty, damaged, or no longer functioning correctly.
• Do not attempt to repair a damaged pen yourself.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (Section 2) the first time you use a new pen (or if you suspect it may be damaged) to avoid wasting medication. The test checks that the medicine flows through the pen so you can receive the correct doses.

1. I do not see drops after testing the pen flow 5 times. What should I do?

If you do not see drops at the needle tip after 5 attempts, it may be because there is no flow through the pen and needle.

Change the needle (see Section 5, Step 12) and retest the pen flow (see Section 2, Steps A–C). You can confirm proper flow if you see a drop of medicine. If it still does not work, dispose of the pen and consult your healthcare professional.

1. How do I know when the injection is complete?

The injection is complete only when you press the injection button fully down and the dose selector has rotated back to the “?” and you have kept the needle in the skin for 5 seconds.

1. Why must I continue pressing the pen against the skin for 5 seconds?

Some of the medicine may flow back into the pen or leak out from the injection site onto the skin. Pressing the pen against the skin for 5 seconds helps ensure the full dose has been injected.

1. I cannot set the dose selector to the required dose. What should I do?

The pen does not allow you to set a dose larger than the amount remaining.

If your required dose is greater than the amount of medicine left in the pen, you will not be able to set the full dose. You must dispose of your pen and take the full dose using a new pen.

1 Preparing the pen and needle

Step 1

Take your Yorvipath pen. Make sure

it is the correct concentration and

check the expiration date. Take a

needle and check the expiration date on

the needle (Figure C).

Note: Remove your pen from the

refrigerator 20 minutes before first use.

Figure C

Step 2

Remove the pen cap and check the inspection window to ensure that the medication inside the pen is clear and colorless (Figure D).

Important: If the medication contains visible particles, do not use the pen. Use

a new pen.

Figure D

Step 3

Remove the tab from the needle (Figure E).

This needle can only be used once.

Always use a new needle for each injection.

Figure E

Step 4

Attach the needle straight onto your

pen, then screw the needle onto the

pen until it is secure (Figure F).

Figure F

Step 5

Remove the needle protector and the

inner needle cap (Figure G).

Important: Do not touch the blue cap, as it may block the needle.

Figure G

1. If the pen is new, test its flow

Test the pen flow (steps A – C) only the first time you use a new pen.

If your pen is already in use, go to section 3 "Prepare the injection and select the dose".

Step A

Turn the dose selector to the right 2 clicks until you see the drop symbol “” in the dose window (Figure H).

Note: You can always correct the selection by turning the dose selector.

Figure H

Step B

Bring air bubbles to the top of the pen by tapping the inspection window (Figure I). Hold the pen with the needle tip pointing upward.

Note: Small air bubbles are acceptable.

Figure I

Step C

Press the injection button and observe droplets of medication emerging from the needle tip. While pressing, ensure the dose selector rotates back toward the drop symbol (Figure J).

Important: If you do not see medication droplets, repeat this test (steps A – C) up to 5 times. If no droplets appear, replace the needle and repeat the test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are two

areas on your body where you can administer

the injection (Figure K).

Avoid injecting into red, swollen, or scarred

skin areas.

Choose a different injection site each

time you give an injection.

Step 7

Wash your hands and clean the injection site with an alcohol wipe

(Figure L).

Figure L

Step 8

Select your dose as prescribed by your doctor (6, 9, or 12 micrograms) by turning the dose selector to the right

(Figure M).

Important: Make sure not to press the button when selecting the dose

to avoid wasting the medication.

Note: Always discard your pen and use

a new one if you cannot set a full dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your

doctor or nurse.

Read this entire section (steps 9–11) before starting to inject.

Step 9

Make sure you can see the dose window. Insert the needle into the

skin (Figure N).

Figure N

Step 10

Press the button fully and hold it firmly

for 5 seconds. Ensure that the dose selector rotates back to the symbol . This indicates that the full dose has been delivered

(Figure O).

Figure O

Step 11

Slowly remove the pen from the injection site (Figure P).

Figure P

5 Dispose of the used needle

Step 12

Replace the needle cap to carefully remove the needle.

Insert the needle tip into the

cap and secure the cap onto the

needle (Figure Q).

Important: Always recap the needle before removing it to reduce the risk of needlestick injury

and cross-contamination.

Figure Q

Step 13

Unscrew the needle and dispose of it

safely according to local regulations

(Figure R).

Figure R

Step 14

Firmly attach the pen cap

onto the pen to protect it

between injections and to protect the

medication from light (Figure S).

Figure S

6 Dispose of the used pen

Important: Always dispose of the

pen 14 days after first use, in accordance with local regulations. To keep track of when 14 days have passed, it is recommended to cover the “Date of opening” field on the inner packaging.

Always discard your pen after

14 days of use, even if there is

medication remaining (Figure T). This is

important to ensure you receive

the full effect of the medication.

Note: If the pen package includes

needles, remember to discard the

additional needle when disposing of the pen.

Figure T

Important information you must know before starting to use your Yorvipath pen

Read and follow the package leaflet and these instructions for use carefully to ensure you inject Yorvipath correctly.

Make sure you have received training from your doctor or nurse before administering the injection. This is important to ensure you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and therefore may not get the full effect of your medicine.
• If you are blind or have visual impairment, or lack concentration, do not use your pen without assistance. Instead, ask someone who has been trained in the use of the Yorvipath pen to help you.
• Keep out of the sight and reach of children.
• The pen and needles are for single-patient use only.
• Do not share your pen or needles with other people. This could cause infection (cross-contamination).
• Always dispose of your pen after 14 days, even if there is still medicine left. This is important to ensure you receive the correct effect of the medicine.
• Always use the needles provided with the Yorvipath pen for your injections.
• Remove the needle after each use. Do not store the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do not change the injection angle after inserting the needle into the skin. Changing the angle may cause the needle to bend or break. A bent or broken needle could become stuck in the body or remain completely under the skin. If a broken needle becomes stuck in the body or under the skin, seek medical attention immediately.
• Do not use needles if the needle shield or needle foil is damaged.

Special instructions for doses greater than 30 micrograms/day

If your dose is greater than 30 micrograms/day:

• Administer two injections one after the other, in different injection sites (see the recommended schedule table in section 3 of the Package Leaflet).
• It is recommended to use a different Yorvipath pen for the second daily injection, even if both pens have the same color plunger (same concentration).
• Follow the steps in the instructions for use for each injection.

Pen care

• Handle the pen carefully.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do not drop your pen or hit it against hard surfaces. If this happens, test the pen flow again (section 2, steps A–C) before the next use.
• Do not apply extra force to your pen. It may be empty, damaged, or no longer functioning properly.
• Do not attempt to repair a damaged pen yourself.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (section 2) the first time you use a new pen (or if you suspect it may be damaged) to avoid wasting medication. The test checks that the medicine flows through the pen so you can receive the correct dose.

1. I do not see drops after testing the pen flow 5 times. What should I do?

If you do not see drops at the tip of the needle after 5 attempts, it may be because there is no flow through the pen and needle.

Change the needle (see section 5, step 12) and test the pen flow again (see section 2, steps A–C). You can confirm proper flow if you see a drop of medicine. If it still does not work, dispose of the pen and consult your healthcare professional.

1. How do I know when the injection is complete?

The injection is only complete when you press the plunger fully down and the dose selector has rotated back and you have kept the needle in the skin for 5 seconds.

1. Why must I continue pressing the pen against the skin for 5 seconds?

Some of the medicine may flow back into the pen or leak out from the injection site onto the skin. Pressing the pen against the skin for 5 seconds helps ensure that all the medicine has been injected.

1. I cannot set the dose selector to the required dose. What should I do?

The pen does not allow you to set a dose higher than the amount remaining.

If your dose is greater than the amount of medicine left in the pen, you will not be able to set a full dose. You must dispose of your pen and take the full dose using a new one.

1 Preparing the pen and needle

Step 1

Take your Yorvipath pen. Make sure it is the correct concentration and check the expiration date. Take a needle and check the expiration date on the needle (Figure C).

Note: Take your pen out of the

refrigerator 20 minutes before first use.

Figure C

Step 2

Remove the pen cap and check the inspection window to ensure that the medicine inside the pen is clear and colourless (Figure D).

Important: If the medicine has visible particles, do not use the pen. Use a new pen.

Figure D

Step 3

Remove the tab from the needle (Figure E).

This needle can only be used once.

Always use a new needle for each injection.

Figure E

Step 4

Place the needle directly onto your pen, then screw the needle onto the pen until secure

(Figure F).

Figure F

Step 5

Remove the needle protector and the inner needle cap (Figure G).

Immediately discard the inner needle cap and keep the needle protector for later use.

Figure G

1. If the pen is new, test its flow

Test the pen flow (steps A – C) only the first time you use a new pen.

If your pen is already in use, go to section 3 "Prepare the injection and select the dose".

Step A

Turn the dose selector to the right 2 clicks until you see the drop symbol “” in the dose window (Figure H).

Note: You can always correct the selection by turning the dose selector.

Figure H

Step B

Move air bubbles to the top of the pen by tapping the inspection window (Figure I). Keep the pen with the needle tip pointing upward.

Note: Small air bubbles are acceptable.

Figure I

Step C

Press the injection button and observe medication drops coming out from the needle tip. While pressing, make sure the dose selector rotates back to the symbol (Figure J).

Important: If you do not see medication drops, repeat this test (steps A – C) up to 5 times. If no drops appear, replace the needle and repeat the test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are two

areas on your body where you can administer

the injection (Figure K).

Avoid injecting into red, swollen, or scarred

skin areas.

Choose a different injection site each time you give the injection.

Step 7

Wash your hands and clean the injection site with an alcohol wipe (

Figure L).

Figure L

Step 8

Select your dose as prescribed by your doctor (15, 18, or 21 micrograms) by

turning the dose selector

to the right

(Figure M).

Important: Make sure not to press

the push-button when selecting the dose

to avoid wasting the medication.

Note: Always discard your pen and use

a new one if you cannot set a full dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your

doctor or nurse.

Read this entire section (Steps 9–11) before beginning to inject.

Step 9

Make sure you can see the dose window. Insert the needle into the

skin (Figure N).

Figure N

Step 10

Press the push-button fully down and

hold it firmly

for 5 seconds. Ensure that the

dose selector rotates back to the

symbol . This indicates that the

full dose has been delivered

(Figure O).

Figure O

Step 11

Slowly remove the pen from the injection site. (Figure P)

Figure P

5 Dispose of the used needle

Step 12

Replace the needle cap to carefully remove the needle.

Insert the needle tip into the cap and secure the cap onto the needle (Figure Q).

Important: Always replace the needle cap before removing the needle to reduce the risk of needlestick injury and cross-contamination.

Figure Q

Step 13

Unscrew the needle and dispose of it

safely according to local regulations (Figure R).

Figure R

Step 14

Firmly attach the pen cap onto the pen to protect it between injections and to shield the medication from light (Figure S).

Figure S

6 Dispose of the used pen

Important: Always dispose of the

pen 14 days after first use, according to local regulations. To keep track of when

14 days have passed, it is recommended to cover the “Date of opening” field on the packaging.

Always discard your pen after

14 days of use, even if there is still medication remaining (Figure T). This is

important to ensure you receive

the full therapeutic effect of the medication.

Figure T

Important information you must know before starting to use your Yorvipath pen

Read and follow the package leaflet and these instructions for use carefully to ensure you inject Yorvipath correctly.

Make sure you have received training from your doctor or nurse before administering the injection. This is important to ensure you receive the correct treatment.

For correct use

• If you do not follow these instructions, you may not receive the correct dose and therefore may not get the full effect of your medicine.
• If you are blind or have visual impairment, or difficulty concentrating, do not use your pen without assistance. Instead, ask someone who has been trained in the use of the Yorvipath pen to help you.
• Keep out of sight and reach of children.
• The pen and needles are for use by a single patient only.
• Do not share your pen or needles with other people. This could cause an infection (cross-contamination).
• Always dispose of your pen after 14 days, even if there is still medicine remaining. This is important to ensure you receive the correct effect of the medicine.
• Always use the needles provided with the Yorvipath pen for your injections.
• Remove the needle after each use. Do not store the pen with the needle attached.
• Avoid bending or breaking the pen needle.
• Do not change the injection angle after inserting the needle into the skin. Changing the angle may cause the needle to bend or break. A bent or broken needle could become lodged in the body or remain completely under the skin. If a broken needle becomes lodged in the body or under the skin, seek medical attention immediately.
• Do not use needles if the needle cover or needle shield is damaged.

Special instructions for doses greater than 30 micrograms/day

If your dose is greater than 30 micrograms/day:

• Administer two injections, one after the other, in different injection sites (see the recommended schedule table in section 3 of the Package Leaflet).
• It is recommended to use a different Yorvipath pen for the second daily injection, even if both pens have the same color dose button (same concentration).
• Follow the steps in the instructions for use for each injection.

Care of the pen

• Handle the pen carefully.
• Keep the pen dry.
• Use a damp cloth to clean the pen.
• Do not drop your pen or hit it against hard surfaces. If this happens, retest the pen flow (section 2, steps A–C) before the next use.
• Do not apply extra force to your pen. It may be empty, damaged, or no longer functioning properly.
• Do not attempt to repair a damaged pen yourself.
• Never use a damaged pen.

Troubleshooting

1. How often should I test the pen flow?

You should only test the pen flow (section 2) the first time you use a new pen (or if you suspect it may be damaged) to avoid wasting medication. The test checks that the medicine flows properly through the pen so you can receive the correct dose.

1. I do not see drops after testing the pen flow 5 times. What should I do?

If you do not see drops at the needle tip after 5 attempts, it may be because there is no flow through the pen and needle.

Change the needle (see section 5, step 12) and retest the pen flow (see section 2, steps A–C). You can confirm proper flow if you see a drop of medicine.

If it still does not work, dispose of the pen and consult your healthcare professional.

1. How do I know when the injection is complete?

The injection is only complete when you press the dose button fully down, the dose selector has rotated back to , and you have kept the needle in the skin for 5 seconds.

1. Why must I continue pressing the pen against the skin for 5 seconds?

Some of the medicine may flow back into the pen or leak from the injection site onto the skin. Pressing the pen against the skin for 5 seconds helps ensure that the full dose has been injected.

1. I cannot set the dose selector to the required dose. What should I do?

The pen does not allow you to set a dose greater than the amount remaining.

If your dose is higher than the amount of medicine left in the pen, you will not be able to set the full dose. You must dispose of your pen and take the full dose using a new pen.

1 Preparation of the pen and needle

Step 1

Take your Yorvipath pen. Make sure

it is the correct concentration and

check the expiration date. Take a

needle and check the expiration date on

the needle (Figure C).

Note: Remove your pen from the

refrigerator 20 minutes before first use.

Figure C

Step 2

Remove the closure cap from the pen and check the inspection window to ensure that the medicine

inside the pen is clear and colorless (Figure D).

Important: If visible particles are present in the medicine, do not use the pen. Use

a new pen.

Figure D

Step 3

Remove the tab from the needle (Figure E).

This needle can only be used once.

Always use a new needle for each injection.

Figure E

Step 4

Place the needle directly onto your

pen, then screw the needle onto the

pen until secure (Figure F).

Figure F

Step 5

Remove the needle cap—the inner

needle cover (Figure G).

Immediately discard the inner needle

cover and keep the outer needle cap

for later use.

Figure G

1. If the pen is new, test its flow

Test the pen flow (Steps A–C) only the first time you use

a new pen.

If your pen is already in use, go to Section 3 "Prepare the injection and

select the dose".

Step A

Turn the dose selector to the right by

2 clicks until you see the drop symbol “” in the dose window (Figure H).

Note: You can always correct the

selection by turning the dose selector.

Figure H

Step B

Move air bubbles to the top of the pen by tapping the

inspection window (Figure I). Hold the pen with the needle tip

pointing upward.

Note: Small air bubbles are acceptable.

Figure I

Step C

Press the injection button and observe medicine droplets coming out from the needle tip. While pressing, ensure that the dose selector returns

to the symbol (Figure J).

Important: If no medicine droplets are seen, repeat this test

(Steps A–C) up to 5 times. If still no droplets appear, change the needle and repeat the test.

Figure J

3 Prepare the injection and select the dose

Step 6

Choose the injection site. There are two

areas on your body where you can administer

the injection (Figure K).

Avoid injecting into areas of red, swollen, or scarred

skin.

Choose a different injection site each

time you give an injection.

Step 7

Wash your hands and clean the injection site with an alcohol wipe

(Figure L).

Figure L

Step 8

Select your dose as prescribed by your doctor (24, 27, or 30 micrograms)

by turning the dose selector to the

right

(Figure M).

Important: Make sure not to press the button while selecting the dose,

to avoid wasting the medication.

Note: Always discard your pen and use

a new one if you cannot set a full dose.

Figure M

4 Inject the dose

Use the injection administration technique recommended by your

doctor or nurse.

Read the entire section (Steps 9–11) before starting to inject.

Step 9

Ensure you can see the dose window. Insert the needle into the

skin (Figure N).

Figure N

Step 10

Press and hold the button fully down for 5 seconds. Make sure the dose selector rotates back to the symbol . This indicates that the full dose has been delivered

(Figure O).

Figure O

Step 11

Slowly remove the pen from the injection

site (Figure P).

Figure P

5 Dispose of the used needle

Step 12

Replace the needle cap to carefully remove the needle.

Place the needle tip into the cap and secure the cap onto the

needle (Figure Q).

Important: Always recap the needle before removing it from the pen to reduce the risk of needlestick injury

and cross-contamination.

Figure Q

Step 13

Unscrew the needle and dispose of it

safely according to local regulations

(Figure R).

Figure R

Step 14

Firmly attach the pen cap onto the pen to protect it

between injections and to protect the

medication from light (Figure S).

Figure S

6 Dispose of the used pen

Important: Always dispose of the

pen 14 days after first use, in accordance with local regulations. To keep track of when 14 days have passed, it is recommended to cover the “Date of Opening” field on the inner packaging.

Always discard your pen after

14 days of use, even if there is

medication remaining (Figure T). This is

important to ensure you receive

the full therapeutic effect of the medication.

Note: If the pen package includes

needles, remember to dispose of any unused

needles when discarding the pen.

Figure T