STELARA 1X45MG SYR. S-ARAB.

Product Description:

• Stelara contains the active substance USTEKINUMAB, a monoclonal antibody. 
• Monoclonal antibodies are proteins that recognize and bind to other specific proteins in the body.
• Stelara belongs to a group of medicines called immunosuppressants. 
• These are drugs that inhibit parts of the immune system.

Stelara is used to treat the following inflammatory diseases:

• Plaque psoriasis - in adults and children aged 6 years or older
• Psoriatic arthritis - in adults
• Moderate to severe Crohn's disease - in adults
• Moderate to severe ulcerative colitis - in adults
• Flapper:
• Plaque psoriasis is a skin disease that causes inflammation of the skin and nails. 
• Stelara suppresses inflammation and improves other symptoms of the disease.
• Stelara is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate or phototherapy, or where these treatments have not worked.
• Stelara is used in children and adolescents who are 6 years of age or older with moderate to severe plaque psoriasis, who cannot tolerate phototherapy or other systemic treatment, or where these treatments have not had an effect.

Psoriatic Arthritis:

• Psoriatic arthritis is an inflammatory disease of the joints that is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will be given other medicines. 

If you do not respond well enough to these medicines, you may be given Stelara to:

• Reduce the symptoms of your disease.
• Improve your physical function.
• Slow down your joint damage.

Crohn's disease:

• Crohn's disease is an inflammatory disease of the intestine.
• If you have Crohn's disease , you will first be given other medicines. 
• If you do not get a good enough effect or cannot tolerate these medicines, you can get Stelara to reduce the symptoms of your disease.

Ulcerative colitis:

• Ulcerative colitis is an inflammatory disease of the intestine. 
• If you have ulcerative colitis , you will first receive other medicines. 
• If you do not get a good enough effect or cannot tolerate these medicines, you can get Stelara to reduce the symptoms of your disease.

How To Use:

• Stelara is intended for use under the guidance and supervision of a doctor who has experience in the treatment of conditions for which Stelara is indicated.
• Always use this medicine exactly as your doctor has told you. 
• Contact a doctor if you are unsure. Ask your doctor about when you should take injections and when you should have follow-up appointments.

How much Stelara should be given:

• Your doctor will decide how much Stelara you need to use and how long to use it.

Adults who are 18 years of age or older:

Psoriasis or psoriatic arthritis:

• The recommended starting dose is 45 mg Stelara. 
• Patients who weigh more than 100 kilograms (kg) can start with a dose of 90 mg instead of 45 mg.
• After the initial dose, you will receive the next dose 4 weeks later, then every 12 weeks. The subsequent doses are usually the same as the starting dose.

Crohn's disease or ulcerative colitis:

• During treatment, the first dose with approx. 6 mg/kg Stelara will be given by your doctor through a drip into a vein in your arm ( intravenous infusion). 
• After the initial dose, you will receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks, as an injection under the skin ( subcutaneously ).
• In some patients, 90 mg of Stelara can be given every 8 weeks after the first subcutaneous injection. 
• Your doctor will decide when you should receive the next dose.
• Children and young people aged 6 or older

Psoriasis:

• Your doctor will find the right dose for you, including the amount (volume) of Stelara to inject to get the right dose. 
• The right dose for you depends on your body weight at the time the individual dose is given.
• There is a 45 mg vial if you need to get less than a full 45 mg dose.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg of body weight.
• If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.
• If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.
• After the initial dose, you will receive the next dose 4 weeks later, then every 12 weeks.

How Stelara is given:

• Stelara is given as an injection under the skin ( subcutaneously ). 
• At the start of treatment, your medical or nursing staff may inject Stelara for you.
• You and your doctor can still decide that you inject Stelara yourself. If so, you will receive training on how to inject Stelara yourself.
• Talk to your doctor if you have any questions about how to give yourself an injection.
• If you take too much Stelara
• If you have taken too much Stelara, contact your doctor or pharmacist immediately. Always take the outer packaging of the medicine with you, even if it is empty.

If you have forgotten to take 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 treatment with Stelara:

• It is not dangerous to stop using Stelara. If you stop, the symptoms may return.
• Ask your doctor or pharmacist if you have any questions about the use of this medicine.
• Do not shake the pre-filled syringe of Stelara. Prolonged shaking can damage the medicine.

Warnings And Precautions:

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 that your doctor considers important.
• If you are unsure whether any of the above apply to you, contact your doctor or pharmacist before taking stelara.
• Talk to your doctor or pharmacist before using Stelara.
• Your doctor will examine your health before each treatment.
• Make sure you tell your doctor about any medical conditions you have before each treatment. 
• Also tell your doctor if you have recently been close to someone who may have tuberculosis.
• Your doctor will examine you and take a test for tuberculosis before you receive Stelara. 
• If your doctor thinks you are at risk of getting tuberculosis , you may be given medicine to treat it.

Be aware of serious side effects:

• Stelara can cause serious side effects, including allergic reactions and infections.
• You must be aware of certain signs of illness when taking Stelara.

Before using Stelara, tell your doctor:

• If you have ever had an allergic reaction to Stelara. Talk to your doctor if you are unsure.
• If you have ever had some form of cancer - this is because immunosuppressive drugs such as Stelara inhibit parts of the immune system. 
• This can increase the risk of cancer .
• If you have or have recently had an infection .
• If you have any new sores or changing sores in psoriasis areas or on normal skin.
• If you have ever had an allergic reaction to latex or Stelara injection - the container of this medicine contains latex rubber, which can cause a severe allergic reaction in people who are sensitive to latex.
• If you receive another form of treatment for psoriasis and/or psoriatic arthritis - such as other immunosuppressive medicines or phototherapy (when your body is treated with a type of ultraviolet (UV) light).
• These treatments can also inhibit parts of the immune system.
• Use of these treatments at the same time as Stelara has not been studied. 
• It is nevertheless possible that the probability of diseases increases due to a weaker immune system.
• If you have or have had injections to treat allergies - it is not known whether Stelara can affect this.
• If you are 65 or older - you may be more likely to get infections .
• If you are unsure whether any of the above applies to you, contact your doctor or pharmacist before taking Stelara.

Children And Youth:

• Stelara is not recommended for use in children under 6 years of age with psoriasis, or for use in children under 18 years of age with psoriatic arthritis, Crohn's disease or ulcerative colitis as it has not been studied in this age group.

Other medicines, vaccines and Stelara:

Talk to your doctor or pharmacist:

• If you use, have recently used or plan to use other medicines.
• If you have recently had or are about to have a vaccination. Some vaccine types (live vaccines) should not be given during treatment with stelara.

Pregnancy and breastfeeding:

• It is preferable to avoid the use of Stelara during pregnancy.
• The effect of Stelara in pregnant women is not known.
• If you are a woman of childbearing age, you are advised not to become pregnant, and you must use safe contraception during treatment with Stelara and for at least 15 weeks after the last treatment.
• Talk to your doctor if you are pregnant, think you may be pregnant or plan to become pregnant.
• Ustekinumab can pass into breast milk. 
• Talk to your doctor if you are breastfeeding or plan to breastfeed. 
• You and your doctor must decide whether you should breastfeed or use Stelara. Don't do both.

Driving and using machines:

• Stelara has no or negligible influence on the ability to drive and use machines.

Ingredients:

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg ustekinumab in 0.5 ml.

What Stelara looks like and the contents of the pack:

• Stelara is a clear to slightly opaque (has a pearly sheen), colorless to pale yellow solution for injection. 
• The solution may contain a few small transparent or white protein particles. 
• It is supplied as a box with a single dose in a 1 ml pre-filled syringe.
• Each syringe contains 45 mg ustekinumab in 0.5 ml solution for injection.