Recormon Patient Counseling Information

Instructions for Use: Epoetin beta (Recormon) pre-filled syringe: The following instructions explain how to give an injection of Epoetin beta (Recormon). Be sure that you read, understand and follow the Instructions for Use as well as the package leaflet before injecting Epoetin beta (Recormon). Your healthcare provider will show you how to prepare and inject Epoetin beta (Recormon) properly before you use it for the first time.
Do not inject yourself unless you have received training. Consult your healthcare provider if you require further information.
Always follow all directions in these Instructions for Use as they may differ from your experiences. These instructions will minimize risk such as accidental needle stick and prevent incorrect use.
Epoetin beta (Recormon) can be administered through two manners, your doctor will decide which way is right for you: Intravenous administration (into the vein or vein port), only to be performed by healthcare professionals.
Subcutaneous administration (under the skin).
Before you begin: Do not take the needle cap off until you are ready to inject Epoetin beta (Recormon).
Do not try to take the syringe apart at any time.
Do not reuse the same syringe.
Do not use if the syringe has been dropped or damaged.
Do not leave the syringe unattended.
Keep the syringe and needle and the puncture-resistant or sharps disposal container out of reach of children.
Contact your healthcare professional if you have any questions.
Storage Instructions: Keep your unused syringe(s) and needle(s) in the original carton and store in a refrigerator at 2°C to 8°C.
Keep your syringe and needle out of direct sunlight.
Do not freeze.
Do not use if the syringe has been frozen.
Always keep the syringe and needle dry.
Supplies needed to give your injection: Included in the box: Epoetin beta (Recormon) pre-filled syringe(s).
Injection needle(s) (27G 1/2 used for priming, setting the dose and injecting the medicine).
Note: Each Epoetin beta (Recormon) carton contains either 1 syringe/1 needle or 6 syringes/6 needles.
Package leaflet with Instructions For Use.
Not included in the box: 1 alcohol swab.
1 dry sterile pad.
1 puncture-resistant container or sharps container for safe disposal of rubber cap, needle cap and used syringe.
Preparing for injection: 1. Find a well-lighted, clean, flat, working surface.
Take the carton with the syringe(s) and needle(s) out of the refrigerator.
2. Check that the carton has not been damaged and check the expiration date on the carton has not passed.
Do not use if the expiration date has passed, if the syringe is dropped or damaged, or if the carton appears to be tampered with. In this case, proceed to step 17 and contact your healthcare provider.
3. Take one syringe out of the carton and one needle. Be careful when taking out the syringe. Make sure you always hold the syringe on the glass barrel.
Do not flip the carton upside down to remove the syringe.
Do not handle the syringe by holding the plunger or needle cap.
Remark: If you have a multipack, put the carton with the remaining syringe(s) and needle(s) back into the refrigerator.
4. Inspect the syringe and needle closely.
Check the syringe and needle for any damage. Do not use the syringe if you have dropped the syringe or if any part of the syringe appears to be damaged.
Check the expiration date on the syringe and the needle. Do not use the syringe or the needle if the expiration date has passed.
Check the liquid in the syringe. The liquid should be clear and colorless. Do not use the syringe if the liquid is cloudy, discolored, or has particles.
5. Place the syringe on a clean, flat surface.
Set aside the syringe for 30 minutes so it can warm up on its own to room temperature. Leave the needle cap on while it warms up.
Do not speed up the warming process in any way, and do not put the syringe in a microwave or in warm water.
Remark: If the syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger.
6. Attach the needle to the syringe.
Remove the needle from the blister.
Remove the outer packaging from the needle. Do not remove the needle cap.
Pull the rubber cap off the end of the syringe.
Dispose of the rubber cap in a puncture-resistant or sharps container immediately.
Do not touch the tip of the syringe.
Do not push or pull the plunger.
Hold the syringe by the barrel and push the needle onto the syringe.
Gently twist until it is fully attached.
7. Place the syringe on a clean, flat surface until ready for use.
8. Wash your hands with soap and water.
9. Choose an injection site: The recommended injection sites are the top of your thigh or the lower part of your abdomen below the belly button.
Do not inject within 5 cm (2 inches) area directly around your belly button.
Choose a different injection site for each new injection.
Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Do not inject into vein or into a muscle.
10. Wipe the injection site with an alcohol swab and let it air dry for 10 seconds.
Do not fan or blow on the cleaned area.
Do not touch the injection site again before giving the injection.
Administering the subcutaneous injection: 11. Hold the syringe and needle tightly at the hub and carefully pull the injection needle cap away from the syringe. Use the syringe within 5 minutes of removing the cap; otherwise, the needle may clog.
Do not hold the plunger while you remove the needle cap.
Do not touch the needle after removing the needle cap.
Do not re-cap the needle.
Do not straighten needle if needle is bent or damaged.
Throw away the needle cap in a sharps container immediately.
12. Hold the syringe with the needle pointing up. Remove the larger air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe. Then, slowly push the plunger up to push the air bubbles out of the syringe.
13. Adjust to your prescribed dose by slowly pushing the plunger.
14. Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action.
Do not touch the plunger while inserting the needle into the skin.
Do not insert the needle through clothing.
Once the needle is inserted, release the pinch and hold the syringe tightly in place.
15. Slowly inject your prescribed dose by gently pushing the plunger all the way down.
Remove the needle and syringe from the injection site at the same angle as inserted.
After the injection: 16. There may be a little bleeding at the injection site. You can press dry sterile pad over the injection site. Do not rub the injection site.
If needed, you may cover the injection site with a small bandage.
In case of skin contact with medicine, wash the area that touched the medicine with water.
17. Put your used syringe in a sharps disposal container right away after use.
Do not try to remove the used injection needle from the used syringe.
Do not recap the injection needle with the cap.
Do not throw away (dispose of) the syringe in your household trash.
Important: Always keep the sharps disposal container out of reach of children.
Instructions for Use for intravenous injection, intended for healthcare professional only: The following Instructions for Use explain how to give an intravenous injection of Epoetin beta (Recormon). Be sure that you read, understand and follow the Instructions for Use as well as the package leaflet before injecting Epoetin beta (Recormon).
Administering the intravenous injection (healthcare professional only): Preparing for injection: follow steps 1 to 8 of subcutaneous injection (previously).
9. Select a vein. Change vein with each injection to prevent soreness in one spot.
Do not inject into a red or swollen area.
Do not inject into a muscle.
Clean the skin above the vein with an alcohol swab and let dry.
Do not fan or blow on the cleaned area.
Do not touch the injection site again before giving the injection.
10. Prepare the syringe and needle: follow steps 11 to 14 of subcutaneous injection (previously).
15. Insert the needle into the vein.
Do not hold or push on the plunger while inserting needle.
16. Slowly inject the prescribed dose by gently pushing the plunger all the way down. Remove the needle and syringe from the injection site at the same angle as inserted.
After the intravenous injection: follow steps 16 to 17 of subcutaneous injection (previously).
Administering the intravenous injection via injection port (healthcare professional only): Preparing for injection: follow steps 1 to 8 of subcutaneous injection (previously).
9. Clean the skin above the injection port with an alcohol swab and let dry. Clean the injection port as instructed by the provider.
Do not fan or blow on the cleaned area.
Do not touch the injection site again before giving the injection.
10. Prepare the syringe and needle: follow steps 11 to 14 of subcutaneous injection (previously).
15. Insert the needle into the injection port (follow the instruction of the injection port provider).
Do not hold or push on the plunger while inserting needle.
16. Slowly inject the prescribed dose by gently pushing the plunger all the way down. Remove the needle and syringe from the injection port at the same angle as inserted.
After the intravenous injection via injection port: follow steps 16 to 17 of subcutaneous injection (previously).