Ozempic 0.5 mg solution for injection in pre-filled pen

Instructions for Use of Ozempic 0.5 mg Solution for Injection in a Pre-filled Pen

Read these instructions carefully before using your pre-filled Ozempic pen. Ask your doctor, nurse, or pharmacist for guidance on how to correctly inject Ozempic.

Start by checking the pen to ensure it contains Ozempic 0.5 mg, then review the following images to become familiar with the different parts of the pen and the needle.

If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this pen without assistance. Seek help from someone with good eyesight who knows how to use the Ozempic pre-filled pen.

Your pen is a pre-filled, dose-adjusting pen. It contains 2 mg of semaglutide and allows you to select only 0.5 mg doses. An unused pen contains four doses of 0.5 mg.

Use the table inside the box lid to keep track of how many injections you have administered and when you administered them.

The pen is designed to be used with disposable 30G, 31G, and 32G needles up to 8 mm in length.

The package includes NovoFine Plus needles.

Please note: The size of the pen may differ from the pen shown in the image. These instructions apply to all Ozempic 0.5 mg pens.

Important Information

Pay special attention to these notes, as they are important for the safe use of the pen.

1. Preparing the Pen with a New Needle

• Check the name and color of the label on your pen to ensure it contains Ozempic 0.5 mg. This is especially important if you use more than one type of injectable medication. Using the wrong medication could be harmful to your health.
• Remove the pen cap.

• Check that the solution in the pen is clear and colorless. Look through the pen window. If the solution appears cloudy or discolored, do not use the pen.

• Take a new needle.

Check that the paper tab and the outer needle cap are undamaged, as damage could compromise sterility. If you notice any damage, use a new needle.

• Remove the paper tab.

Ensure the needle is properly attached.

• Place the needle straight onto the pen.
• Screw it on tightly.

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, no solution will be injected.

• Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.

• Remove the inner needle cap and discard it. If you attempt to reattach it, you risk accidentally pricking yourself with the needle.

A drop of solution may appear at the tip of the needle. This is normal, but even so, you must perform a flow check if this is a new pen and the first time you are using it. See step 2, “Flow Check with Each New Pen”.

Do not attach a new needle to the pen until you are ready to administer the injection.

Always use a new needle for each injection.

This helps prevent needle blockage, contamination, infection, and inaccurate dosing.

Never use a bent or damaged needle.

1. Flow Check with Each New Pen

• If the pen is already in use, go to step 3, “Dose Selection”. Perform the flow check only before the first injection with each new pen.

• Turn the dose selector to the flow check symbol () immediately after ‘0’. Ensure the flow check symbol aligns with the marker.

• Hold the pen with the needle pointing upward.

Press and hold the injection button until the dose counter returns to ‘0’. The ‘0’ must align with the dose marker.

A drop of solution should appear at the tip of the needle.

A small drop may remain at the needle tip, but it will not be injected.

If no drop appears, repeat step 2, “Flow Check with Each New Pen”, up to 6 times. If still no drop appears, change the needle and repeat step 2, “Flow Check with Each New Pen”, once more.

Discard the pen and use a new one if no drop of solution appears despite all attempts.

Always ensure a drop appears at the needle tip before first use of a new pen. This confirms that the solution is flowing.

If no drop appears, no medication will be injected, even if the dose counter moves. This may indicate that the needle is blocked or damaged.

If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and may not achieve the intended effect of Ozempic.

1. Dose Selection

• Turn the dose selector to select 0.5 mg.

Continue turning until the dose counter stops and displays 0.5 mg.

Only the dose counter and dose marker will indicate that 0.5 mg has been selected.

You can only select 0.5 mg per dose. When your pen contains less than 0.5 mg, the dose counter will stop before reaching 0.5.

The dose selector emits different clicks when turned forward, backward, or beyond 0.5 mg. Do not count the pen clicks.

Before injecting this medication, always use the dose counter and dose marker to confirm that 0.5 mg has been selected.

Do not count the pen clicks.

Only 0.5 mg doses should be selected using the dose selector. 0.5 mg must be exactly aligned with the dose marker to ensure you receive the correct dose.

How Much Solution Remains

• To determine how much solution remains, use the dose counter: turn the dose selector until the dose counter stops.

If it shows 0.5, there is at least 0.5 mg remaining in the pen.

If the dose counter stops before 0.5 mg, there is not enough solution left for a complete 0.5 mg dose.

If there is not enough solution in the pen for a complete dose, do not use it. Instead, use a new Ozempic pen.

1. Injecting the Dose

• Insert the needle under the skin as instructed by your doctor or nurse.
• Ensure you can see the dose counter. Do not cover it with your fingers, as this could interrupt the injection.

• Press and hold the injection button. Watch as the dose counter returns to ‘0’. The ‘0’ must align with the dose marker. At this point, you may hear or feel a click.

• Continue holding the button while keeping the needle under the skin.

•Count slowly to 6 while holding the button down.

• If you remove the needle too early, you may see solution leaking from the needle tip. In this case, the full dose will not have been administered.

• Remove the needle from the skin. Then release the button.

If bleeding occurs at the injection site, apply light pressure.

A drop of solution may appear at the needle tip after injection. This is normal and does not affect your dose.

Always observe the dose counter to confirm how many mg are injected. Hold the button down until the dose counter returns to ‘0’.

How to Detect a Blocked or Damaged Needle

• If the ‘0’ does not appear in the dose counter after continuously pressing the button, you may have used a blocked or damaged needle.
• In this case, you will not have received any medication, even if the dose counter moved from the original dose you set.

What to Do if the Needle is Blocked

Change the needle as described in step 5, “After Injection”, and repeat all steps from step 1, “Preparing the Pen with a New Needle”. Ensure you select the full dose required.

Never touch the dose counter during injection. This may interrupt the injection.

1. After Injection

Always discard the needle after each injection to ensure injections are administered correctly and to prevent needle blockage. If the needle is blocked, no medication will be injected.

• Place the needle tip into its outer cap, placed on a flat surface, without touching the needle or the outer cap.

• Once the needle is protected, carefully press the outer needle cap fully onto the needle.
• Unscrew the needle and dispose of it carefully according to instructions from your doctor, nurse, pharmacist, or local authorities.

• Replace the pen cap after each use to protect the solution from light.

When the pen is empty, discard it without the needle attached, following instructions from your doctor, nurse, pharmacist, or local authorities.

Never attempt to reattach the inner needle cap. You may accidentally prick yourself with the needle.

Always remove the needle from the pen immediately after each injection.

This helps prevent needle blockage, contamination, infection, solution leakage, and inaccurate dosing.

Additional Important Information

• Always keep the pen and needles out of sight and reach of others, especially children.
• Never share the pen or needles with other people.
• People caring for patients should be extremely careful when handling used needles to avoid accidental needlesticks and infections.

Maintaining Your Pen

Handle the pen with care. Rough handling or misuse may result in inaccurate dosing. If this occurs, you may not achieve the intended effect of this medication.

• Do not leave the pen in a car or in other places where it may become too hot or too cold.
• Do not inject Ozempic that has been frozen. If you do, you may not achieve the intended effect of this medication.
• Do not inject Ozempic that has been exposed to direct sunlight. If you do, you may not achieve the intended effect of this medication.
• Do not expose the pen to dust, dirt, or liquids.
• Do not wash, wet, or lubricate the pen. It may be cleaned with a soft cloth dampened with mild detergent.
• Ensure the pen does not fall or strike hard surfaces. If the pen is dropped or you suspect it may be damaged, attach a new needle and perform a flow check before injecting.
• Do not attempt to refill the pen. Once empty, it must be discarded.
• Do not attempt to repair or disassemble the pen.

Instructions for Use of Ozempic 0.5 mg Solution for Injection in a Pre-filled Pen

Read these instructions carefully before using your Ozempic pre-filled pen. Ask your doctor, nurse, or pharmacist for guidance on how to correctly inject Ozempic.

Begin by checking the pen to ensure it contains Ozempic 0.5 mg, then review the following images to become familiar with the different parts of the pen and the needle.

If you are blind or have low vision and cannot read the dose counter on the pen, do not use this pen without assistance. Seek help from someone with good eyesight who knows how to use the Ozempic pre-filled pen.

Your pen is a pre-filled, dose-dispensing pen. It contains 4 mg of semaglutide and allows only 0.5 mg doses to be selected. An unused pen contains eight 0.5 mg doses.

After administering the intended doses, some solution will remain in the pen. The pen must be discarded.

Use the table inside the box lid to record how many injections you have administered and when they were given.

The pen is designed to be used with disposable 30G, 31G, and 32G needles up to 8 mm in length.

The package includes NovoFine Plus needles.

Important Information

Pay close attention to these notes, as they are important for the safe use of the pen.

1. Preparing the Pen with a New Needle

• Check the name and color of the label on your pen to ensure it contains Ozempic 0.5 mg. This is especially important if you use more than one type of injectable medication. Using the wrong medication could be harmful to your health.
• Remove the pen cap.

• Check that the solution in the pen is clear and colorless. Look through the viewing window of the pen. If the solution appears cloudy or discolored, do not use the pen.

• Take a new needle.

Check that the paper tab and the outer needle cap are undamaged, as damage may compromise sterility. If any damage is observed, use a new needle.

• Remove the paper tab.

Ensure the needle is properly attached.

• Place the needle straight onto the pen.
• Screw it on tightly.

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, no solution will be injected.

• Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.

• Remove the inner needle cap and discard it. Attempting to reattach it may result in accidental needlestick injury.

A drop of solution may appear at the tip of the needle. This is normal, but you must still perform a flow check if this is a new pen and you are using it for the first time. See step 2, “Flow Check with Each New Pen”.

Do not attach a new needle to the pen until you are ready to administer the injection.

Always use a new needle for each injection.

This helps prevent needle clogging, contamination, infection, and inaccurate dosing.

Never use a bent or damaged needle.

1. Flow Check with Each New Pen

• If the pen is already in use, go to step 3, “Selecting the Dose”. Perform the flow check only before the first injection with each new pen.
• Turn the dose selector to the flow check symbol () immediately after the '0'. Ensure the flow check symbol aligns with the dose marker.

• Hold the pen with the needle pointing upward.

Press and hold the injection button until the dose counter returns to '0'. The '0' must align with the dose marker.

A drop of solution should appear at the needle tip.

A small drop may remain at the needle tip, but no medication will be injected.

If no drop appears, repeat step 2, “Flow Check with Each New Pen”, up to 6 times. If still no drop appears, change the needle and repeat step 2 once more.

Discard the pen and use a new one if no drop of solution appears despite these attempts.

Always ensure a drop appears at the needle tip before first use of a new pen. This confirms that the solution is flowing.

If no drop appears, no medication will be injected, even if the dose counter moves. This may indicate that the needle is blocked or damaged.

If you do not perform the flow check before the first injection with each new pen, you may not receive the prescribed dose and may not achieve the intended effect of Ozempic.

1. Selecting the Dose

• Turn the dose selector to select 0.5 mg.

Continue turning until the dose counter stops and displays 0.5 mg.

Only the dose counter and dose marker will indicate that 0.5 mg has been selected.

You can only select 0.5 mg per dose. When the pen contains less than 0.5 mg, the dose counter will stop before reaching 0.5 mg.

The dose selector makes different clicking sounds when turned forward, backward, or beyond 0.5 mg. Do not count the clicks of the pen.

Before injecting this medication, always use the dose counter and dose marker to confirm that 0.5 mg has been selected.

Do not count the clicks of the pen.

Only 0.5 mg doses should be selected using the dose selector. The 0.5 mg mark must align exactly with the dose marker to ensure you receive the correct dose.

How Much Solution Remains

• To determine how much solution remains, use the dose counter: turn the dose selector until the dose counter stops.

If it shows 0.5, there is at least 0.5 mg remaining in the pen.

If the dose counter stops before 0.5 mg, there is not enough solution left for a complete 0.5 mg dose.

If there is not enough solution in the pen for a complete dose, do not use it. Instead, use a new Ozempic pen.

1. Injecting the Dose

• Insert the needle under the skin as instructed by your doctor or nurse.
• Ensure you can see the dose counter. Do not cover it with your fingers, as this may interrupt the injection.

• Press and hold the injection button. Watch as the dose counter returns to '0'. The '0' must align with the dose marker. You may hear or feel a click at this point.

• Continue holding the button while keeping the needle under the skin.

• Count slowly to 6 while continuing to hold the button.

• If you remove the needle too early, you may see solution leaking from the tip. In this case, the full dose will not have been administered.

• Remove the needle from the skin. Then release the button.

If bleeding occurs at the injection site, apply light pressure.

A drop of solution may appear at the needle tip after injection. This is normal and does not affect your dose.

Always observe the dose counter to confirm how many mg are injected. Keep the button pressed until the dose counter returns to '0'.

How to Detect if the Needle is Blocked or Damaged

• If the '0' does not appear in the dose counter after continuously pressing the button, you may have used a blocked or damaged needle.
• In this case, no medication will have been delivered, even if the dose counter moved from the original dose set.

What to Do if the Needle is Blocked

Change the needle as described in step 5, “After Injection”, and repeat all steps starting from step 1, “Preparing the Pen with a New Needle”. Ensure you select the full dose required.

Never touch the dose counter during injection. This may interrupt the injection.

1. After Injection

Always discard the needle after each injection to ensure proper administration and to prevent needle clogging. If the needle is blocked, no medication will be injected.

• Place the needle tip into its outer cap, placed on a flat surface, without touching the needle or the outer cap.

• Once the needle is protected, carefully press the outer needle cap fully down.
• Unscrew the needle and dispose of it carefully according to instructions from your doctor, nurse, pharmacist, or local authorities.

• Replace the pen cap after each use to protect the solution from light.

When the pen is empty, discard it without the needle attached, following instructions from your doctor, nurse, pharmacist, or local authorities.

Never attempt to reattach the inner cap to the needle. You could be accidentally injured by the needle.

Always remove the needle from the pen immediately after each injection.

This helps prevent needle clogging, contamination, infection, solution leakage, and inaccurate dosing.

Additional Important Information

• Always keep the pen and needles out of sight and reach of others, especially children.
• Never share the pen or needles with other people.
• People caring for patients should be extremely careful when handling used needles to avoid accidental needlesticks and infections.

Maintaining Your Pen

Handle the pen with care. Rough handling or misuse may result in inaccurate dosing. If this occurs, you may not achieve the intended effect of this medication.

• Do not leave the pen in a car or other places where it may become too hot or too cold.
• Do not inject Ozempic that has been frozen. If you do, you may not achieve the intended effect of the medication.
• Do not inject Ozempic that has been exposed to direct sunlight. If you do, you may not achieve the intended effect of the medication.
• Do not expose the pen to dust, dirt, or liquids.
• Do not wash, wet, or lubricate the pen. It may be cleaned with a soft cloth dampened with mild detergent.
• Ensure the pen does not fall or strike hard surfaces. If the pen is dropped or you suspect it may be damaged, attach a new needle and perform a flow check before injecting.
• Do not attempt to refill the pen. Once empty, it must be discarded.
• Do not attempt to repair or disassemble the pen.