What STELARA contains
-The active substance is ustekinumab. Each pre-filled syringe contains 90mg ustekinumab in 1ml.
-The other ingredients are sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 andwater for injections.
What STELARA looks like and contents of the pack
STELARA is a clear to slightly opalescent, colourless to light yellow solution for injection. The solutionmay contain a few small translucent or white particles of protein.It is supplied as a carton pack containing 1single-dose, glass 1ml pre-filled syringe. Each pre-filled syringe contains 90mg ustekinumab in 1ml of solution for injection.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
2340 Beerse
Belgium
Manufacturer
Janssen BiologicsB.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgienJANSSEN-CILAG NVAntwerpseweg 15-17B-2340 BeerseTélTel 32 14 649 411 LuxembourgLuxemburgJANSSEN-CILAG NVAntwerpseweg 15-17B-2340 BeerseBelgiqueBelgienTél 32 14 649 41
MagyarországJANSSEN-CILAG Kft.H-2045 Törökbálint, Tó ParkTel 36 23-510-919 Johnson Johnson d.o.o. , 4, 4, 3 1766. 359 2 489 94 0
eská republikaJANSSEN-CILAG s.r.o.Karla Englie 3201615000 Praha 5eská republikaTel 420 227 012 222 MaltaA.M. Mangion Ltd.Mangion BuildingTriq dida fi triq VallettaLuqa LQA 6000MaltaTEL 00356 2397 6000641
DanmarkJANSSEN-CILAG ASHammerbakken 19DK-3460 BirkerødTlf 45 45 94 82 82 NederlandJANSSEN-CILAG B.V.Dr. Paul Janssenweg 1505026 RH TilburgTel 31 13 583 73 7
DeutschlandJANSSEN-CILAG GmbHJohnson Johnson Platz 1D-41470 NeussTel 49 2137-955-955 NorgeJANSSEN-CILAG A.S.Drammensveien 288NO-0283 OsloTlf 47 24 12 65 00
ÖsterreichJANSSEN-CILAG Pharma GmbHVorgartenstraße 206BA-1020 WienTel 43 1 610 300 EestiJanssen-Cilag Polska Sp. z o.o.Eesti filiaalLõõtsa 2EE-11415 TallinnTel 372 617 741
JANSSEN-CILAG .... 56GR-151 21 T 30 210 80 90 000 PolskaJANSSENCILAGPOLSKA Sp. z o.o.ul.Iecka 2402135 WarszawaTel. 48 22 237 60 0
EspañaJANSSEN-CILAG, S.A.Paseo de las Doce Estrellas, 5-7Campo de las NacionesE-28042 MadridTel 34 91 722 81 00 PortugalJANSSEN-CILAG FARMACÊUTICA, LDA.Estrada Consiglieri Pedroso, 69 AQueluz de BaixoP-2734-503 BarcarenaTel 351 21 43 68 83
FranceJANSSEN-CILAG1, rue Camille DesmoulinsTSA 9100392787 Issy Les MoulineauxCedex 9Tél 0800 25 50 75 33 1 55 00 44 44 RomâniaJohnson Johnson d.o.o.Str. Tipografilor nr. 11-15,Cldirea S-Park,Corp A2, Etaj 5013714 BucuretiTel 40 21 207 18 0
SlovenijaJohnson Johnson d.o.o.martinska 53SI-1000, LjubljanaTel. 386 1 401 18 30IrelandJANSSEN-CILAG Ltd.50 -100 Holmers Farm Way,High Wycombe,Buckinghamshire, HP12 4EGTel 44 1 494 567 56
Slovenská republikaJohnson Johnson, s.r.o.Plynárenská 7B824 78 BratislavaTel 421 233 552 600ÍslandJANSSEN-CILAGco Vistor hf.Hörgatún 2IS-210 GarðabærSími 354 535 700
ItaliaJANSSEN-CILAG SpAVia M.Buonarroti, 23I-20093 Cologno Monzese MITel 39 022510.1 SuomiFinlandJANSSEN-CILAG OYVaisalantieVaisalavägen 2FI-02130 EspooEsboPuhTel 358 207 531 30
7 CY-1060 T 357 22 755 214 SverigeJANSSEN-CILAG ABBox 7073192 07 SollentunaTel 46 8 626 50 00
LatvijaJanssen-Cilag Polska Sp. z o.o.fille LatvijBauskas iela 58A-3LV-1004, RgaTel 371 678 93561 United KingdomJANSSEN-CILAG Ltd.50 -100 Holmers Farm Way,High Wycombe,Buckinghamshire, HP12 4EGTel 44 1 494 567 56
Lietuva
UAB ?Johnson & Johnson?
Gele-inio Vilko g. 18A
LT-08104 Vilnius
Tel: +370 5 278 68 88
This leaflet was last approved in {MM/YYYY}.
INSTRUCTIONS FOR ADMINISTRATION
At the start of treatment, your healthcare provider assists you with your first injection. However, you and your doctor may decide that you may inject STELARA yourself. If this happens, you will get training on how to inject STELARA. Talk to your doctor if you have any questions about giving yourself an injection.
-Do not mix STELARA with other liquids for injection
-Do not shake STELARA pre-filled syringes. This is because strong shaking may damage the medicine. Do not use the medicine if it has been shaken strongly.
Figure 1 shows whatthe pre-filled syringe looks like.
Figure 1
1. Check the number of pre-filled syringes and prepare the materialsPreparing for use of the pre-filled syringe Take the pre-filled syringes out of the refrigerator. Let the pre-filled syringe stand outside the box for about half an hour. This will let the liquid come to a comfortable temperature for injection room temperature. Do not remove the syringes needle cover while allowing it to reach room temperatureHold the pre-filled syringe by the body of the syringe with the covered needle pointing upwardDo not hold by the plunger head, plunger, needle guard wings, or needle coverDo not pull back on the plunger at any timeDo not remove the needle cover from the pre-filled syringe until instructed to do soDo not touch the needle guard activation clips as indicated by asterisks in Figure 1 to prevent prematurely covering the needle with the needle guard
Check the pre-filled syringe(s) to make sure
-the number of pre-filled syringes and strength is correct
- If your dose is 90mg you will get one 90mg pre-filled syringe of STELARA.-it is the right medicine-it has not passed its expiry date-the pre-filled syringe is not damaged-the solution in the pre-filled syringe is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow-the solution in the pre-filled syringe is not discoloured or cloudy and does not contain any foreign particles-the solution in the pre-filled syringe is not frozen.
Get everything together that you need and lay out on a clean surface. This includes antiseptic wipes, a cotton ball or gauze, and a sharps container
2. Choose and prepare the injection site:
Choose an injection site (see Figure 2)
STELARA is given by injection under your skin subcutaneouslyGood places for the injection are the upper thigh or around the belly abdomen at least 5 cm away from the navel belly buttonIf possible, do not use areas of skin that show signs of psoriasisIf someone will assist in giving you the injection, then he or she may also choose the upper arms as an injection site
*Areas in gray are recommended injection sites.
Figure 2
Prepare the injection site
-Wash your hands very well with soap and warm water
-Wipe the injection site on the skin with an antiseptic wipe
- Do nottouch thisarea again before giving the injection.
3. Remove the needle cover (see Figure 3):
-The needle cover should notbe removed until you are ready to inject the dose-Pick up the pre-filled syringe, hold the body of the syringe with one hand
-Pull the needle cover straight off and throw it away. Do nottouch the plunger while you do this
Figure 3
You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle. These are both normal and do not need to be removedDo not touch the needle or allow it to touch any surfaceDo not use the pre-filled syringe if it is dropped without the needle cover in place. If this happens, please contact your doctor or pharmacistInject the dose promptly after removing the needle cover
4. Inject the dose:
-Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly
Do not pull back on the plunger at any timeIn a single and swift motion, insert the needle through the skin as far as it will go see Figure 4
Figure 4
Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings see Figure 5
Figure 5
When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin see Figure 6
Figure 6
Slowly take your thumb off the plunger head to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by Figure 7
Figure 7
5. After the injectionPress an antiseptic wipe over the injection site for a few seconds after the injection.There may be a small amount of blood or liquid at the injection site. This is normal.You can press a cotton ball or gauze over the injection site and hold for 10 seconds.Do not rub your skin. You may cover the injection site with a small adhesive bandage, if necessary
6. Disposal:
-Used syringes should be placed in a puncture-resistant container, like a sharps container (see Figure 8). Do not ever re-use a syringe, for your safety and health and for the safety of others.Dispose of your sharps container according to your local regulations
-Antiseptic wipes and other supplies can be disposed of in your garbage.
Figure 8