What Ilaris contains
- The active substance is canakinumab. One vial of powder contains 150 mg canakinumab.- The other ingredients are:sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80.
What Ilaris looks like and contents of the pack
- Ilaris is supplied as a powder for solution for injection in a 150 mg glass vial. - Ilaris is available in packs containing one vial or multipacks comprising four intermediate packs, each containing one vial. Not all pack sizes may be marketed in your country. - The powder is white.
Marketing Authorisation Holder
Novartis Europharm Limited
West Sussex, RH12 5AB
Novartis Pharma GmbH
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11
Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00
eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217
Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111
Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00
Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570
Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888
España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600
France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01
Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439
Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 9 61 33 22 11
357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00
Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50
This leaflet was last approved in
This medicine has been authorised under ?Exceptional Circumstances?. This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
INSTRUCTIONS FOR USE OF ILARIS POWDER FOR SOLUTION FOR INJECTION
Please note that the preparation of the injection at room temperature takes about 30 minutes. See also section 3, ?Injecting Ilaris yourself?.
Read these instructions all the way through before beginning.
- Find a clean place in which to prepare and administer the injection.
- Wash your hands with soap and water.
- Check the expiry dates on the vial and syringes. Do not use after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. - Always use new, unopened needles and syringes. Avoid touching the needles and the tops of the vials.
Gather together the necessary items
Included in the pack
One vial of Ilaris powder for solution for injection (keep refrigerated)
Not included in the pack one vial or ampoule of sterile water for injection water do not refrigerate one 1.0 ml syringe one 18 G x 2 inch 50 mm needle for reconstituting the powder transfer needle one 27 G x 0.5 inch 13 mm needle for injecting injection needle alcohol swabs clean, dry cotton swabs an adhesive plaster a proper disposal container for used needles, syringe and vials sharps container
1. Remove the protective caps from the Ilaris and water vials. Do not touch the vial stoppers. Clean the stoppers with the alcohol swab. 2. Open the wrappers containing the syringe and the transfer needle bigger one and attach the needle to the syringe. 3. Carefully remove the cap from the transfer needle and set the cap aside. Pull the plunger all the way down to the 1.0 ml mark, filling the syringe with air. Insert the needle into the water vial through the centre of the rubber stopper Fig. 1. 4. Gently push the plunger all the way down until air is injected into the vial.
5. Invert the vial and syringe assembly and bring to eye level Fig. 2. 6. Make sure the tip of the transfer needle is covered by the water and slowly pull the syringe plunger down to slightly past the 1.0 ml mark. If you see bubbles in the syringe, remove bubbles as instructed by your healthcare provider or pharmacist. 7. Make sure 1.0 ml of water is in the syringe, then withdraw the needle from the vial. There will be water remaining in the vial. 8. Insert the transfer needle through the centre of the stopper of the vial of Ilaris powder, taking care not to touch the needle or the stopper. Slowly inject 1.0 ml of water in to the vial containing the Ilaris powder Fig. 3. 9. Carefully remove the syringe with the transfer needle from the vial and recap the needle as instructed by your healthcare provider or pharmacist. 10. Without touching the rubber stopper, swirl do not shake the vial slowly at an angle of about 45 degrees for approximately 1 minute Fig. 4a. Allow to stand for 5 minutes. 11. Now, gently turn the vial upside down and back again ten times, again taking care not to touch the rubber stopper Fig. 4b. 12. Allow to stand for about 15 minutes at room temperature to obtain a clear to opalescent solution. Do not shake. Do not use if particles are present in the solution. 13. Make sure all of the solution is in the bottom of the vial. If drops remain on the stopper, tap the side of the vial to remove them. The solution should be clear to opalescent and free of visible particles. If not used immediately after reconstitution, the solution should be stored in the refrigerator 2C to 8C and used within 24 hours.
Preparing the injection
14. Clean the rubber stopper of the vial containing the Ilaris solution with a new alcohol swab. 15. Uncap the transfer needle again. Pull the plunger of the syringe all the way down to the 1.0 ml mark, filling the syringe with air. Insert the syringe needle into the vial of Ilaris solution through the centre of the rubber stopper Fig. 5. Gently push the plunger all the way down until air is injected into the vial. Do not inject air into the medicine. 16. Do not invert the vial and syringe assembly Fig. 6a. Insert the needle all the way into the vial until it reaches the bottom edge. 17. Tip the vial to ensure that the required amount of solution can be drawn into the syringe Fig. 6b. NOTE The required amount depends on the dose to be administered 0.2 ml to 1.0 ml. Your healthcare provider will instruct you on the right amount for you. 18. Slowly pull the syringe plunger up to the correct mark 0.2 ml to 1.0 ml, filling the syringe with Ilaris solution. If there are air bubbles in the syringe, remove bubbles as instructed by your healthcare provider. Ensure that the correct amount of solution is in the syringe. 19. Remove the syringe and needle from the vial. There may be solution remaining in the vial. Recap the transfer needle as instructed by your healthcare provider or pharmacist. Remove the transfer needle from the syringe. Place the transfer needle in the sharps container. 20. Open the wrapper containing the injection needle and attach the needle to the syringe. Set the syringe aside.
Giving the injection
21. Choose an injection site on the upper thigh, abdomen, upper arm or buttocks. Do not use an area that has a rash or broken skin, or is bruised or lumpy. Avoid injecting into scar-tissue as this may lead to insufficient exposure to canakinumab. Avoid injecting in to a vein. 22. Clean the injection site with a new alcohol swab. Allow the area to dry. Uncap the injection needle. 23. Gently pinch the skin up at the injection site. Hold the syringe at a 90-degree angle and in a single, smooth motion, push the needle straight down completely into the skin Fig. 7. 24. Keep the needle all the way in the skin while slowly pushing the syringe plunger down until the barrel is empty Fig. 8. Release the pinched skin and pull the needle straight out. Dispose of the needle and syringe in the sharps container without recapping or removing the needle.
After the injection
25. Do not rub the injection area. If bleeding occurs, apply a clean, dry cotton swab over the area, and press gently for 1 to 2 minutes, or until bleeding stops Fig. 9. Then apply an adhesive plaster. 26. Safely dispose of needles and syringe in the sharps container or as directed by your healthcare provider or pharmacist Fig. 10. Never reuse syringes or needles. 27. Properly dispose of vials containing remaining water and Ilaris solution if any as directed by your healthcare provider or pharmacist. Any unused product or waste material should be disposed of in accordance with local requirements. Keep the sharps container out of reach of children. Dispose of it as directed by your healthcare provider or pharmacist.