Stelara amp. 45 mg. 1 JANSSEN CILAG
Stelara belongs to a group of medicines called "immunosuppressants". These drugs work by reducing the activity of the immune system.
Stelara amp. 45 mg. 1 JANSSEN - CILAG
What Stelara and what it is used
Stelara contains active substance " ustekinumab ", which is a monoclonal antibody . Monoclonal antibodies are proteins that recognize and bind certain particular proteins in the body.
Stelara belongs to a group of medicines called " immunosuppressants " . These drugs work by reducing the activity of the immune system .
Stelara is used in adults to treat the following inflammatory diseases:
Plaque psoriasis ;
Psoriatic arthritis .
" Plaque psoriasis " is a skin condition causing inflammation affecting the skin and nails. Stelara reducing inflammation and other symptoms of the disease.
Stelara is used in adults with moderate to severe plaque psoriasis who are unable to use ciclosporin, methotrexate and phototherapy , or when those treatments are not working.
Psoriatic arthritis is an inflammatory disease of the joints , usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines . If you do not respond well enough to these medicines , you may be prescribed Stelara, to :
reducing the signs and symptoms of your illness ;
Improve your physical condition.
2 . What you should know before using Stelara
Do not use Stelara:
If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in Section 6) ;
If you have an active infection which your doctor considers important .
If you are not sure if any of the above applies to you , ask your doctor or pharmacist before using Stelara.
Warnings and Precautions
Talk to your doctor or pharmacist before using Stelara. Your doctor will check your condition before each treatment . Inform your doctor about any illness you have before each treatment. Also tell your doctor if you have recently been in contact with someone who might have tuberculosis. Your doctor will examine you and make testing for tuberculosis before using Stelara. If your doctor thinks you are at risk for TB, you may be given medication to treat it
Watch for serious adverse reactions
Stelara can cause serious side effects, including allergic reactions and infections. You should watch for certain signs of illness while taking Stelara. See "After serious adverse effects" in section 4 for a full list of side effects .
Before using Stelara tell your doctor:
If you have ever had an allergic reaction to Stelara. If you are unsure , ask your doctor ;
If you have ever had any type of cancer - that is because immunosuppressants like Stelara weaken part of the immune system. This may increase the risk of cancer ;
If you have or have had a recent infection ;
If you have any new or changing lesions in areas with psoriasis or intact skin;
If you receive any other treatment for psoriasis and / or psoriatic arthritis - as other immunosuppressive agents or phototherapy ( when the body is treated with type ultraviolet (UV) light). This treatment can also weaken the part of the immune system . The use of these treatments with Stelara not studied . It is possible , however , it may increase the risk of diseases associated with a weakened immune system ;
If you receive or have ever received injections to treat allergies - it is not known if Stelara may affect them ;
If you're over 65 - you may be more prone to infections.
If you are not sure if any of these applies to you, talk to your doctor or pharmacist before using Stelara.
Children and adolescents
Stelara is not recommended for use in children and adolescents (under 18 years) because it has been studied in this age group.
Other medicines , vaccines and Stelara
Tell your doctor or pharmacist :
If you are taking , have recently taken or take any other medicines ;
If you have had or are planning to make your vaccination. While using Stelara, should not be given certain types of vaccines (live vaccines) .
Pregnancy and lactation :
It is preferable to avoid the use of Stelara pregnancies . The effects of this drug in pregnant women are unknown. If you are a woman of childbearing potential , it is desirable to avoid becoming pregnant and to use appropriate contraception while using Stelara and at least 15 weeks after the last administration of Stelara. Ask your doctor if you are pregnant, think you may be pregnant or planning to become pregnant ;
Ask your doctor if you are breast-feeding or plan to breast-feed . You and your doctor should decide if you will breastfeed or use Stelara. You should not do both.
Driving and using machines
Stelara no or negligible influence on the ability to drive and use machines.
3 . How to use Stelara
Stelara is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis and psoriatic arthritis. Always use this medicine exactly as your doctor tells you . If you are not sure, ask your doctor. Discuss with your doctor when you are the injections and when will be the next check.
How much Stelara is given
Your doctor will decide how much Stelara you need and for how long .
The recommended starting dose is 45 mg ustekinumab . Patients weighing more than 100 kg may be given 90 mg instead of 45 mg;
After the initial dose , the next dose will be your after 4 weeks, and then every 12 weeks. Subsequent doses are generally the same as the initial dose.
How to use Stelara
Stelara is given by injection under your skin (subcutaneously). Early Stelara can be injected by a doctor or nurse.
You and your doctor may decide that you yourself may inject Stelara. In that case you will get training on how to inject Stelara alone ;
For instructions on how to inject Stelara , see " Instructions for use " at the end of this leaflet.
Talk to your doctor if you have any questions about giving yourself an injection .
If you use more than the amount of Stelara
If you have used or been given an overdose of Stelara, immediately consult your doctor or pharmacist. Always keep with you the carton of the medicine , even if it is empty.
If you forget to use Stelara
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a missed dose.
If you stop using Stelara
It is not dangerous to stop using Stelara. However, if you stop , your psoriasis may return .
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Watch for serious adverse reactions
Some patients may have serious adverse reactions that having emergency treatment.
Allergic reactions - may require urgent treatment , so be sure to call your doctor or call for emergency medical attention if you notice any of these signs .
Serious allergic reactions (' anaphylaxis ') are rare in people taking Stelara ( may affect up to 1 in 1000 people). Signs include:
difficulty breathing or swallowing;
low blood pressure that can cause dizziness or lightheadedness ;
swelling of your face , lips, mouth or throat.
Common signs of an allergic reaction include rash and urticaria (may affect up to 1 in 10 people) .
If you experience a serious allergic reaction, your doctor may decide that you should not use Stelara again.
Infections - may require urgent treatment , so be sure to call your doctor if you notice any of these signs .
Stelara can reduce your ability to fight infections and certain infections can become serious .
infections of the nose or throat and colds are common ( may affect up to 1 in 10 people) ;
inflammation of the subcutaneous tissue ( cellulite ) is uncommon ( may affect up to 1 in 100 people)
herpes (type a painful rash with blisters ) are uncommon (may affect up to 1 in 100 people) .
While using Stelara, you should look for signs of infection. These include:
fever, flu-like symptoms , night sweats ;
fatigue, shortness of breath, persistent cough ;
hot, red and painful skin or painful skin rash with blisters
burning when urinating ;
Contact your doctor immediately if you notice any of these signs . Tell him also , if you have any persistent or recurrent infection. Your doctor may decide that you should not use Stelara, until the infection is cured. Tell your doctor if you have open wounds or injuries as it can become infected .
Other side effects
Common side effects (affects 1 in 10 people) :
itching ( pruritus) ;
back pain, muscle or joint pain ;
sore throat ;
infections of the teeth ;
redness and pain at the injection site .
Uncommon side effects (affects 1 in 100 people) :
stuffy or runny nose ;
bleeding, bruising , induration , swelling and itching at the injection site ;
Drooping Eyelid and distortion of the muscles of one side of the face ( " facial paralysis " or " Bell's palsy " ), which typically is temporary ;
change of psoriasis with redness and new small yellow or white blisters on the skin , sometimes accompanied by fever ( pustular psoriasis) .
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet . You can also report side effects directly through the national system of communication. As reported side effects , you can do your bit to get more information on the safety of this medicine.
5 . How to store Stelara
Keep out of reach of children.
Store in a refrigerator (2 ° C- 8 ° C). Do not freeze .
Keep the vial in the outer carton to protect from light.
Do not shake the vials Stelara. Prolonged vigorous shaking may damage the medicine .
Do not use this medicine:
after the expiry date stated on the label and carton after " EXP" . The expiry date refers to the last day of that month;
if the liquid is discolored , cloudy , or it can be seen floating foreign particles ( see section 6 " Stelara looks like and contents of the pack " ) ;
if you know or think you may have been exposed to extreme temperatures (such as accidentally frozen or heated ) ;
if the product has been shaken vigorously
if the seal is broken .
Stelara e for single use only . Any unused product remaining in the vial and the syringe should be discarded .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Stelara
The active substance is ustekinumab . Each vial contains 45 mg ustekinumab in 0,5 ml.
The other ingredients are sucrose , L-histidine , L-histidine monohydrochloride monohydrate, polysorbate 80 and water for injections.
Stelara looks like and contents of the pack
Stelara is a clear to slightly opalescent (having a pearl shine) , colorless to pale yellow solution for injection . It may contain a few small translucent or white particles of protein. Supplied in a carton containing a vial of 2 ml single dose. Each vial contains 45 mg ustekinumab in 0,5 ml of solution for injection .
Marketing Authorisation Holder:
Janssen-Cilag International NV, Belgium.
Janssen Biologies B.V., Netherlands.
Instructions for administration
At the beginning of treatment medical professional you your first injection . You and your doctor may decide that you yourself may inject Stelara. In that case you will get training on how to inject Stelara. Talk to your doctor if you have any questions about giving yourself an injection .
Stelara not mix with other liquids for injection .
Do not shake the vials Stelara. The reason for this is that strong shaking may damage the medicine . Do not use the medication if it has been badly shaken .
1. Check the number of vials and prepare the materials :
Remove vials ( vials ) from the refrigerator. Allow to stand for about half an hour . This will allow the fluid to reach a suitable temperature for injection (room temperature) .
Check vials ( vials ) to make sure that :
number of vials and the amount of active substance Strength are true :
If your dose is 45 mg, you will receive a 45 mg vial of Stelara;
If your dose is 90 mg, will receive two 45 mg vials of Stelara and will have to have two injections. Select two different injection sites (eg one shot in the right thigh and the other - on the left ) and make them one after another. Use a new needle and syringe for each injection ;
this is the right medicine ;
shelf life has not expired ;
vial is not damaged and the seal is not broken ;
the vial is clear to slightly opalescent (having a pearl shine) and colorless to pale yellow ;
the solution is discolored or cloudy and does not contain foreign matter ;
solution is not frozen .
Gather all the materials you need , and place them on a clean surface . These include the syringe , needle, antiseptic wipes, cotton ball or gauze , and a sharps container .
2 . Choose and prepare the injection site :
Select a inzhektirane :
Stelara is given by subcutaneous injection ;
Suitable sites for injection are the upper thigh or around the belly off at least 5 cm from the navel ;
If possible, no use of skin areas with signs of psoriasis ;
If someone helps with the injection, he / she can choose and upper arm as an injection site .
Prepare the injection site :
Wash your hands well with soap and warm water ;
Wash the skin at the injection site with an antiseptic cloth ;
Do not touch this area to inject.
3 . Prepare the dose:
Open the cap of the vial ;
Do not remove the stopper ;
Clean the stopper with antiseptic gauze ;
Place the vial on a flat surface;
Open the cap of the needle ;
Do not touch the needle or let it touch other objects ;
Insert the needle through the rubber stopper ;
Turn the vial and syringe upside down ;
Pull the plunger of the syringe until it is filled with all the liquid as prescribed by your doctor (0,5 ml);
It is important that the needle at all times be in the liquid. This prevents the formation of air bubbles in the syringe ;
Remove the needle from the vial ;
Hold the syringe with the needle pointing up , to see if the liquid air bubbles ;
If there are bubbles, gently tap the syringe with your finger until come to the surface ;
Then press the plunger until all the air (but not liquid) out ;
Do not inject in bed and not touch the needle in the other subjects.
4 . Inject the dose :
Gently pinch the cleaned skin between your thumb and forefinger. Do not squeeze ;
Insert the needle into the skin clenched ;
Push the plunger with your thumb so that all the liquid is injected . Push it slowly and evenly while gently squeezing the skin;
When the piston reaches the end , remove the needle and drop the skin.
5 . After injection:
Press an antiseptic wipe over the injection site for several seconds after the injection ;
It is possible that the site of injection, a small amount of blood or fluid . This is normal ;
You can press the injection site with a cotton ball or gauze and hold 10 seconds;
Do not rub the skin. If necessary, you can put a small sticker on the injection site.
6 . disposal
Used syringes and needles should be placed in a puncture-proof container such as a sharps . For your safety and the health and safety of others, never reuse needles and syringes . Dispose of your sharps container in accordance with local regulations ;
Empty vials, antiseptic wipes and other supplies can be disposed of in your garbage .