Amgevita

Amgevita Patient Counseling Information

adalimumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Full Prescribing Info
Patient Counseling Information
Instructions for use: AMGEVITA single use pre-filled syringe.
For subcutaneous use.
Important: Before you use an AMGEVITA pre-filled syringe, read this important information: Using your AMGEVITA pre-filled syringe: It is important that you do not try to give the injection unless you or your caregiver has received training.
Do not use an AMGEVITA pre-filled syringe if it has been dropped on a hard surface. Part of the AMGEVITA pre-filled syringe may be broken even if you cannot see the break. Use a new AMGEVITA pre-filled syringe.
Step 1: Prepare: A. Remove the number of AMGEVITA pre-filled syringes you need from the package.
Grab the syringe barrel to remove the syringe from the tray.
Place your finger or thumb on edge of tray to secure it while you remove the syringe.
Put the original package with any unused syringes back in the refrigerator.
For safety reasons: Do not grasp the plunger rod.
Do not grasp the needle cap.
Do not remove the needle cap until you are ready to inject.
Do not remove the finger flange. This is part of the syringe.
For a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting.
Do not put the syringe back in the refrigerator once it has reached room temperature.
Do not try to warm the syringe by using a heat source such as hot water or microwave.
Do not leave the syringe in direct sunlight.
Do not shake the syringe.
Important: Always hold the pre-filled syringe by the syringe barrel.
B. Inspect the AMGEVITA pre-filled syringe.
Always hold the syringe by the syringe barrel.
Make sure the medicine in the syringe is clear and colourless to slightly yellow.
Do not use the syringe if: The medicine is cloudy or discoloured or contains flakes, or particles; Any part appears cracked or broken; The needle cap is missing or not securely attached; The expiration date printed on the label has passed.
In all cases, use a new syringe.
C. Gather all materials needed for your injection(s).
Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place a new, pre-filled syringe.
You will also need these additional items, as they are not included in the carton: Alcohol wipes, Cotton ball or gauze pad, Plaster, Sharps disposal container.
D. Prepare and clean your injection site(s).
You can use: Your thigh; Belly, except for a 2 inch (5 centimetres) area around your belly button.
Clean your injection site with an alcohol wipe. Let your skin dry.
Do not touch this area again before injecting.
If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion.
Step 2: Get ready: E. Pull the needle cap straight out and away from your body when you are ready to inject.
It is normal to see a drop of liquid at the end of the needle.
Do not twist or bend the needle cap.
Do not put the needle cap back onto the syringe.
Do not remove the needle cap from the syringe until you are ready to inject.
Important: Throw the needle cap into the sharps disposal container provided.
F. Pinch your injection site to create a firm surface.
Pinch the skin firmly between your thumb and fingers, creating an area about 2 inch (5 centimetres) wide.
Important: Keep the skin pinched while injecting.
Step 3: Inject: G. Hold the pinch. With the needle cap off, insert the syringe into your skin at 45 to 90 degrees.
Do not place your finger on the plunger rod while inserting the needle.
H. Using slow and constant pressure, push the plunger rod all the way down until it stops moving.
I. When done, release your thumb, and gently lift the syringe off of your skin.
Step 4: Finish: J. Discard the used syringe and the needle cap.
Do not reuse the used syringe.
Do not use any medicine that is left in the used syringe.
Put the used AMGEVITA syringe in a sharps disposal container immediately after use. Do not throw away (dispose of) the syringe in your household waste.
Talk with your doctor or pharmacist about proper disposal. There may be local guidelines for disposal.
Do not recycle the syringe or sharps disposal container or throw them into the household waste.
Important: Always keep the sharps disposal container out of the sight and reach of children.
K. Examine 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 a plaster if needed.
Instructions for use: AMGEVITA single use SureClick pre-filled autoinjector.
For subcutaneous use.
Important: Before you use an AMGEVITA pre-filled autoinjector, read this important information: Using your AMGEVITA pre-filled autoinjector: It is important that you do not try to give the injection unless you or your caregiver has received training.
Do not use an AMGEVITA pre-filled autoinjector if it has been dropped on a hard surface. Part of the AMGEVITA pre-filled autoinjector may be broken even if you cannot see the break. Use a new AMGEVITA pre-filled autoinjector.
The needle cover of the AMGEVITA pre-filled autoinjector is made from dry natural rubber, which contains latex. Tell your healthcare provider if you are allergic to latex.
Step 1: Prepare: A. Remove one AMGEVITA pre-filled autoinjector from the package.
Carefully lift the pre-filled autoinjector straight up out of the box.
Put the original package with any unused pre-filled autoinjectors back in the refrigerator.
For a more comfortable injection, leave the pre-filled autoinjector at room temperature for 15 to 30 minutes before injecting.
Do not put the pre-filled autoinjector back in the refrigerator once it has reached room temperature.
Do not try to warm the pre-filled autoinjector by using a heat source such as hot water or microwave.
Do not shake the pre-filled autoinjector.
Do not remove the yellow cap from the pre-filled autoinjector yet.
B. Inspect the AMGEVITA pre-filled autoinjector.
Make sure the medicine in the window is clear and colourless to slightly yellow.
Do not use the pre-filled autoinjector if: The medicine is cloudy or discoloured, or contains flakes or particles; Any part appears cracked or broken; The pre-filled autoinjector has been dropped on a hard surface; The yellow cap is missing or not securely attached; The expiration date printed on the label has passed.
In all cases, use a new pre-filled autoinjector.
C. Gather all materials needed for your injection.
Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place a new, pre-filled autoinjector.
You will also need these additional items, as they are not included in the carton: Alcohol wipes, Cotton ball or gauze pad, Plaster, Sharps disposal container.
D. Prepare and clean your injection site.
You can use: Your thigh; Belly, except for a 2 inch (5 centimetre) area right around your belly button.
Clean your injection site with an alcohol wipe. Let your skin dry.
Do not touch this area again before injecting.
If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion.
Step 2: Get ready: E. Pull the yellow cap straight off when you are ready to inject.
It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Do not twist or bend the yellow cap.
Do not put the yellow cap back onto the pre-filled autoinjector.
Do not remove the yellow cap from the pre-filled autoinjector until you are ready to inject.
F. Stretch or pinch your injection site to create a firm surface.
Stretch method: Stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches (5 centimetres) wide.
Pinch method: Pinch the skin firmly between your thumb and fingers, creating an area about 2 inches (5 centimetres) wide.
Important: Keep the skin stretched or pinched while injecting.
Step 3: Inject: G. Hold the stretch or pinch. With the yellow cap off, place the pre-filled autoinjector on your skin at 90 degrees.
Important: Do not touch the blue start button yet.
H. Firmly push the pre-filled autoinjector down onto the skin until it stops moving.
Important: You must push all the way down but do not touch the blue start button until you are ready to inject.
I. When you are ready to inject, press the blue start button.
J. Keep pushing down on your skin. Your injection could take about 10 seconds.
The window turns yellow when the injection is done.
Note: After you remove the pre-filled autoinjector from your skin, the needle will be automatically covered.
Important: When you remove the pre-filled autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. Call your doctor immediately.
Step 4: Finish: K. Discard the used pre-filled autoinjector and the yellow cap.
Put the used pre-filled autoinjector in a sharps disposal container immediately after use. Do not throw away (dispose of) the pre-filled autoinjector in your household waste.
Talk with your doctor or pharmacist about proper disposal. There may be local guidelines for disposal.
Do not reuse the pre-filled autoinjector.
Do not recycle the pre-filled autoinjector or sharps disposal container or throw them into the household waste.
Important: Always keep the sharps disposal container out of the sight and reach of children.
L. Examine 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 a plaster if needed.
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