Rebif 22 mcg Rebidose Instructions For Use Manual Download Page 28

Page: 28 / 28

This Instructions for Use has been approved by
the Food and Drug Administration.

Version: 18 Dec 2012
Manufacturer: EMD Serono, Inc.
Rockland, MA 02730 U.S. Lic. 1773
MS LifeLines: 1-877-477-3243

Summary of Contents for 22 mcg Rebidose

Page 1: ...1 Instructions For Use subcutaneous injection...

Page 2: ...the treatment of relapsing forms of multiple sclerosis Please read these instructions carefully before you start using the Rebif Rebidose and remember you must have received the appropriate training...

Page 3: ...nformation 8 How Supplied 10 Titration 12 Choosing an injection site 13 Step 1 Prepare for your injection 14 Examine syringe and expiration date 15 Step 2 Administer your injection 18 Step 3 Finish yo...

Page 4: ...4 Before injection Injector button Injector body Dose label area Syringe plunger Transparent syringe housing Needle cap containing the needle shield Rebif Rebidose features...

Page 5: ...5 After injection Safety guard Needle Needle cap containing the needle shield Syringe plunger...

Page 6: ...ot share the Rebidose with anyone Doing so may result in injury including the transmission of infectious blood borne diseases Adhere to strict safety and antiseptic precautions at all times Do not ins...

Page 7: ...llow Inspect for cracks or breakage in the syringe or other parts Do not use Rebidose if it is cracked or broken or if the liquid is cloudy discolored or contains particles If the Rebidose has been dr...

Page 8: ...tely and dispose of the Rebidose in an acceptable biohazard sharps container Injecting Rebif the medicine in the Rebidose autoinjector may cause skin reactions including soreness redness pain bruising...

Page 9: ...autoinjector contains a glass syringe In very rare cases the syringe may break during the injection If this happens immediately dispose of any broken glass and the damaged Rebidose autoinjector in th...

Page 10: ...r Rebidose autoinjectors are supplied in these 3 packaging presentations Titration Pack 6 Rebif 8 8 mcg Rebidose autoinjectors with a lime green injector button 6 Rebif 22 mcg Rebidose autoinjectors w...

Page 11: ...11 22 mcg yellow 8 8 mcg lime green 44 mcg teal green...

Page 12: ...a lime green injector button and six 22 mcg Rebidose autoinjectors with a yellow injector button The titration period lasts 4 weeks and during this time you will administer 12 injections Weeks 1 and 2...

Page 13: ...r surface of the upper arm the stomach and the buttocks Do not use the area near your waistline or within 2 inches of your navel Only choose one site for injection Use a different site each time you i...

Page 14: ...efrigerator at least 30 minutes prior to use Caution Do not heat or microwave a Rebidose autoinjector 1 2 Put all of the items listed below within easy reach on a table or other stable surface 1 Rebid...

Page 15: ...d roll off the table and become unsterile 1 5 Check the expiration date on the Rebidose autoinjector label and its carton If the medication has expired do not use it 1 6 Examine the contents of the sy...

Page 16: ...eedle cap to make sure you see a black needle shield inside the cap fig b 1 11 Dispose of the needle cap and proceed to the injection step without delay Warning If the Rebidose has been dropped more t...

Page 17: ...17 a b Needle shield...

Page 18: ...istance this action unlocks the injector button fig c 2 3 Keep the Rebidose pressed firmly against the skin and use your thumb to push the injector button fig d You will hear a click which means the i...

Page 19: ...oes not start release the injector button and make sure that the Rebidose is still pressed firmly against your skin Then push firmly on the injector button listening for the click that indicates the s...

Page 20: ...fety guard slides down and locks into place to protect you from the needle fig g If any liquid is left in the syringe or if you have any other problems contact your health care provider or MS LifeLine...

Page 21: ...21 g f before injection after injection Safety guard...

Page 22: ...ared sharps disposal container right away after use fig h Do not throw them away dispose of in your household trash 2 If you do not have a FDA cleared sharps disposal container you may use a household...

Page 23: ...to follow your community guidelines for the correct way to dispose of it There may be state or local laws about how you should throw away used needles and syringes For more information about safe shar...

Page 24: ...ght and reach of children Warning Do not insert your fingers into the opening of the safety guard Do not try to re use a Rebidose single use autoinjector that has already been used Adhere to proper di...

Page 25: ...lable Rebidose may be stored between 36 F and 77 F 2 C to 25 C for up to 30 days away from heat and light Do not put them in or near the freezer compartment Do not inject Rebif that you know or suspec...

Page 26: ...always carry Rebidose autoinjectors in your hand luggage because the aircraft luggage compartment can be very cold and the Rebif could freeze It is safe to pass Rebidose autoinjectors through x ray m...

Page 27: ...r Notes Week 1 Inj Site Date Time Site Reaction Inj 1 Yes No Inj 2 Yes No Inj 3 Yes No Week 2 Inj Site Date Time Site Reaction Inj 1 Yes No Inj 2 Yes No Inj 3 Yes No Week 3 Inj Site Date Time Site Rea...

Page 28: ...This Instructions for Use has been approved by the Food and Drug Administration Version 18 Dec 2012 Manufacturer EMD Serono Inc Rockland MA 02730 U S Lic 1773 MS LifeLines 1 877 477 3243...