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Instructions For Instructions for Use Please see page 2 Instructions for Use Please see page 3 SIMPONI® (SIM-po-nee) (golimumab) SIMPONI® (SIM-po-nee) (golimumab) SmartJect® autoinjector Prefilled Syringe SINGLE-DOSE Important Important If your doctor decides that you or a caregiver may be able to give your SIMPONI® injections at home, you should SIMPONI® comes as a single-dose prefilled syringe containing one 50 mg or one 100 mg dose. Each SIMPONI® prefilled receive training on the right way to prepare and inject SIMPONI® using SmartJect®. syringe can only be used one time. Throw away (dispose of) the used prefilled syringe (See Step 3) after one dose, even Do not try to inject SIMPONI® yourself until you have been shown the right way to give the injections by your doctor if there is medicine left in it. Do not reuse your SIMPONI® prefilled syringe. or nurse. If your healthcare provider decides that you or a caregiver may be able to give your injections of SIMPONI® at home, Please read this Instructions for Use before using SIMPONI® SmartJect® and each time you get a refill. There may be you should receive training on the right way to prepare and inject SIMPONI® using the prefilled syringe before new information. This leaflet does not take the place of talking with your doctor about your medical condition or attempting to inject. Do not try to inject yourself until you have been shown the right way to give the injections by your your treatment. healthcare provider. Read this Instructions for Use before using your SIMPONI® prefilled syringe and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. This Instructions for Use has been approved by the U.S. Food and Drug Administration. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by: Manufactured by: Janssen Biotech, Inc. Janssen Biotech, Inc. Horsham, PA 19044 Horsham, PA 19044 US License No. 1864 US License No. 1864 Approved: MaySeptember 2018 2015 Revised May 2018 © Janssen Biotech, Inc. 2020 04/20 cp-26311v4 © Janssen Biotech, Inc. 2020 04/20 cp-66815v2 © Janssen Biotech, Inc. 2020 04/20 cp-74833v3 Important Your SmartJect® at-a-glance 1. Prepare for your injection If your doctor decides that you or a caregiver may be Cap able to give your SIMPONI® Do not remove the cap injections at home, you until you are ready to EXP should receive training on MM/YYYY inject (See Step 2). the right way to prepare SmartJec Use for Instructions SIMPONI® and inject SIMPONI® using Security seal SmartJect®. (on side of cap) Do not try to inject Green safety sleeve SIMPONI® yourself until you Clear cover have been shown the right Thin hidden needle security seal t way to give the injections ® (SIM-po-nee) (golimumab) (SIM-po-nee) by your doctor or nurse. autoinjector Take out SmartJect® Inspect SmartJect® Check liquid in the Choose injection site Clean injection site Please read this Instructions Take SmartJect® out of Check the expiration date SmartJect® Select from the following Wash your hands well for Use before using SIMPONI® (‘EXP’) on the back of areas for your injection: with soap and warm water. SmartJect® and each time you Viewing window the refrigerator and After 30 minutes, check remove it from the carton. SmartJect®. get a refill. There may be new the liquid in the viewing 1. Front of thighs Wipe your chosen injection Place on a flat surface information. This leaflet does Do not use SIMPONI® window. It should be clear (recommended) site with an alcohol swab out of reach of children. to slightly yellow and not take the place of talking SmartJect® if the expiration 2.Lower abdomen and allow it to dry. with your doctor about your Raised part of button SmartJect® should sit at date has passed. Call your may contain tiny white (do not use the 2-inch Do not touch, fan or blow medical condition or your Press here only when room temperature for at doctor or pharmacist for or clear particles. area around your on the injection site after treatment. SmartJect® is pushed least 30 minutes to ensure a refill. It is also normal to see navel (belly-button)) you have cleaned it. firmly against your skin proper injection. Store in refrigerator Check the security seal on a small air bubble. 3. Back of upper arms (if 36° to 46°F (2° to 8°C). and you are ready to inject (See Step 2). Do not warm any other way. the cap. Do not inject if the liquid a caregiver is giving If needed, store SIMPONI® at you the injection) Do not inject if the seal is cloudy or discolored, room temperature, up to 77°F Do not remove the cap yet. is broken. or has large particles. Choose a dierent site This Instructions for Use (25°C) for one period of time up to has been approved by within your preferred 30 days. Do not return it to the the U.S. Food and Drug area for each injection. refrigerator. Throw away (dispose Gather supplies Administration. of) if not used within 30 days at Expiration date (on back) Do not inject into skin Manufactured by: room temperature. While SmartJect® sits at that is tender, bruised, Janssen Biotech, Inc. room temperature for Do not freeze SmartJect®. Need help? red, scaly or hard. Horsham, PA 19044 30 minutes, gather your US License No. 1864 Do not shake SmartJect®. Call your doctor to talk supplies: Do not inject into areas about any questions you with scars or stretch marks. Approved: SeptemberMay 2018 2015 Keep SIMPONI® in the original • 1 Alcohol swab carton to protect from light may have. For additional © Janssen Biotech, Inc. 2020 before use. assistance or to share your • 1 Cotton ball or gauze pad 04/20 cp-26311v4 Keep SIMPONI® and all feedback call 800-JANSSEN • 1 Sharps container medicines out of the reach of (800-526-7736). (See Step 3) children. 2. Inject SIMPONI® using SmartJect® 3. After your injection Helpful tips Additional disposal information: If you are having If you do not have an FDA-cleared sharps disposal container, you Make sure the cap may use a household is removed. container that is: Make sure SmartJect® • made of a heavy-duty is pushed firmly plastic 1st 2nd against your skin. • can be closed with a CLICK! tight-fitting, puncture- CLICK! Make sure you are pressing the raised resistant lid, without green safety part of button. sharps being able to sleeve come out Remove cap Position Push fi rmly Press button and wait Listen for 2nd ‘click’ Check the viewing Dispose of your Check injection site Try pressing the • upright and stable Twist the cap to break the Hold SmartJect® comfortably Push SmartJect® firmly Keep holding SmartJect® Keep holding SmartJect® window SmartJect® There may be a small button a little harder. during use security seal, then pull it and position it straight onto against your skin so the firmly against your skin. firmly against your skin until After lifting SmartJect® Put your used SmartJect® amount of blood or liquid Try a dierent • leak-resistant straight o. Dispose of the your skin, as shown. green safety sleeve slides Use your other hand to you hear the 2nd ‘click’ from your skin, look for in an FDA-cleared sharps at the injection site. injection site. • properly labeled to warn cap right away. into the clear cover. press the raised part of (3–15 seconds). Make sure the green safety the yellow indicator in the disposal container right Hold pressure over your of hazardous waste the button to start It is important to inject sleeve is flat against your Do not touch or press The 2nd ‘click’ means the viewing window to confirm away after use. skin with a cotton ball inside the container your injection. SmartJect® worked within 5 minutes of skin and that your injection the button while pushing injection is complete and Do not throw away or gauze pad until any If you are pinching When your sharps disposal properly. The yellow removing the cap. site is as flat as possible. SmartJect® against your skin. You will hear a loud 1st you can lift SmartJect® (dispose of) loose needles bleeding stops. the skin to inject: container is almost full, you ‘click’ as you press the from your skin. indicator will fill about half Do not put the cap back Do not touch or press the and syringes in your Do not rub the injection will need to follow your button. This is normal, of the viewing window. Use 1 hand to both on, this may damage the button while positioning the If you have trouble hearing household trash. site. community guidelines for The green safety the medication is just If you do not see the yellow position SmartJect® the right way to dispose of hidden needle. SmartJect® onto your skin. the ‘clicks’, count to 15 Do not recycle your used sleeve helps prevent beginning to be delivered. indicator, call 800-JANSSEN If needed, cover injection against the skin and your sharps disposal after pressing the button, sharps disposal container. Do not inject if SmartJect® You may or may not feel site with a bandage. Your press the button. accidental injections. then lift the SmartJect® o (800-526-7736). container. There may be is dropped without the a needle prick. For more information, injection is now complete! state or local laws about You will not be able to your skin.
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