SIMPONI 50 mg pen. 1 JANSSEN CILAG

SIMPONI 50 mg pen. 1 JANSSEN   CILAG
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Simponi contains an active ingredient called golimumab.
Simponi belongs to a group of medicines called "inhibitors of TNF". 

SIMPONI 50 mg pen. 1 JANSSEN - CILAG

 
 
 
 
 
What Simponi is and what it is used ?
Simponi contains an active ingredient called golimumab .
Simponi belongs to a group of medicines called " inhibitors of TNF". It is used in adults to treat the following inflammatory diseases :
Rheumatoid arthritis ;
Psoriatic arthritis ;
Ankylosing spondylitis ;
Ulcerative colitis.
Simponi works by blocking a protein called 'tumor necrosis factor alpha "(TNF?). This protein is involved in inflammatory processes and blocking it can reduce inflammation in your body.

rheumatoid arthritis
Rheumatoid arthritis is an inflammatory joint disease . If you have active rheumatoid arthritis you will first be given other medicines . If you do not respond well enough of them , you may be given Simponi, which will be given in combination with another medicine called methotrexate :
suppression of the signs and symptoms of your illness ;
delay the damage of bone and joint you ;
improve your physical condition.
psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by Psoriasis - inflammatory skin disease . If you have active psoriatic arthritis you will first be given other medicines . If you do not respond well enough of them , you may be given Simponi, for:
suppression of the signs and symptoms of your illness ;
delay damage to your bones and joints ;
improve your physical condition.
ankylosing spondylitis
Ankylosing spondylitis is an inflammatory disease of the spine . If you have ankylosing spondylitis, you will first be given other medicines . If you do not respond well enough of them , you may be given Simponi, for:
suppression of the signs and symptoms of your illness ;
improve your physical condition.
ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, initially you will be given other medicines. If these drugs do not have enough effect on you to treat your disease will prescribe Simponi.

2 . What you should know before using Simponi?
Do not use Simponi:
if you are allergic (hypersensitive) to golimumab or any of the other ingredients of this medicine (listed in Section 6) ;
if you have tuberculosis (TB) or other severe infection ;
if you have moderate or severe heart failure.
If you are not sure if any of these apply to you, talk to your doctor, pharmacist or nurse before using Simponi.

Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Simponi.
infections
Tell your doctor immediately if you already have or develop symptoms of infection during treatment with Simponi. Symptoms of infection include fever , cough, shortness of breath, flu-like symptoms , diarrhea, wounds , dental problems or burning during urination.
During treatment with Simponi may be more susceptible to infections.
Infections may develop faster and be more severe. In addition, some previous infections may reappear.
Tuberculosis (TB)
Tell your doctor immediately if during or after your treatment you develop symptoms of TB. Symptoms of TB include persistent cough , weight loss , fatigue, fever or night sweats .
Rarely reported cases of TB in patients treated with Simponi, including patients who were taking medication for TB. Your doctor will do tests to check that you have TB, it will record the results in your Patient Alert Card .
It is important to tell your doctor if you have ever had TB, or have been in close contact with sick or suffered from TB.
If your doctor feels that you are at increased risk of developing TB, before using Simponi can be treated with medicine for TB.
The virus of hepatitis B (HBV)
Tell your doctor if you are carriers of HBV or if you have or have had HBV, before you start treatment with Simponi.
Tell your doctor if you think you are at risk of infection with HBV.
Your doctor will test for HBV.
In patients who are carriers of HBV, treatment with inhibitors of TNF, as Simponi, can lead to reactivation of the virus, which in certain cases can be life-threatening.
Invasive fungal infections
If you have lived or traveled in areas where infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common , tell your doctor. These infections are caused by certain species of fungi, and may affect the lungs and other parts of the body. If you do not know if these infections are common in the area where you lived or traveled , ask your doctor.

Cancer and lymphoma
Before you start using Simponi, tell your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer ) or other cancers .
If you use Simponi or other inhibitors of TNF, the risk for developing lymphoma or other cancers may increase .
Patients with severe rheumatoid arthritis and other inflammatory disease of longer duration may be at higher than average risk of developing lymphoma .
In some children and adolescents treated with TNF- blockers have developed cancers including atypical cancers that have in some cases been fatal .
In rare cases, patients taking other TNF- blockers was observed peculiar and severe type of lymphoma called hepatosplenic T-cell lymphoma. The majority of these patients were adolescents or young men. This type of cancer usually leads to death. Almost all of these patients were also receiving drugs known as azathioprine or 6-mercaptopurine . Tell your doctor if you are taking azathioprine or 6-mercaptopurine concomitantly with Simponi.
Patients with severe persistent asthma , chronic obstructive pulmonary disease ( COPD), or heavy smokers may have a higher risk of developing cancer by treatment with Simponi. If you have severe persistent asthma , COPD or smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you .
Some patients treated with golimumab developed certain types of skin cancer. Tell your doctor if during or after therapy are any changes in the condition of the skin or growths on the skin.
heart failure
Tell your doctor if you have new or worsening symptoms of heart failure. Symptoms of heart failure include shortness of breath or swelling of the legs.
Reported are reports of new or worsening congestive heart failure during treatment with inhibitors of TNF.
If you have mild heart failure and you are being treated with Simponi, your doctor should monitor you closely.
Diseases of the Nervous System
Tell your doctor if you have ever been diagnosed with demyelinating disorders such as multiple sclerosis or symptoms thereof. Symptoms may include changes in vision , weakness in arms and legs , numbness or " pins and needles " in any part of the body. Your doctor will decide whether you should apply Simponi.

Operations or dental procedures
Tell your doctor if you have surgery or dental procedures.
Tell your surgeon or dentist performing the procedure that you are being treated with Simponi, showing them your Patient Alert Card .
autoimmune diseases
Tell your doctor if you develop symptoms of a disease called lupus . Symptoms include persistent rash , joint pain and fatigue.
Rare cases of development of lupus in humans treated with inhibitors of TNF.
Blood diseases
In some patients the body is unable to produce enough blood cells to help him fight infections and stop bleeding. Contact your doctor immediately if you develop a fever that does not go away easily bruise or bleed , you look very pale . Your doctor may decide to stop treatment .
If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Simponi.

vaccinations
Tell your doctor if you have had or will have a vaccine .
While treatment with Simponi, should not you be certain (live ) vaccines.
Some vaccinations may cause infections. If you received Simponi, while you were pregnant , your baby may be at increased risk of such infection for approximately six months after the last dose you received during pregnancy . It is important to tell your baby's doctor and other medical professionals for their treatment with Simponi, to enable them to decide when your baby can be vaccinated .

Therapeutic infectious agents
Tell your doctor if you have recently applied or will you apply the treatment with therapeutic infectious agent (such as infusion of BCG, used in the treatment of cancer).

allergic reactions
Tell your doctor immediately if you develop symptoms of an allergic reaction after your treatment with Simponi. Symptoms of allergy can include swelling of the face, lips , mouth, or throat, which may lead to difficulty in swallowing or breathing , skin rash , hives, swelling of the hands, feet or ankles .
Some of these reactions may be serious or life-threatening rare .
Some of these reactions occurred after the first administration of Simponi.
Children and adolescents
Not recommended the use of Simponi in children and adolescents (under 18 years), as it is studied in this age group.

Other medicines, Simponi
Tell your doctor or pharmacist if you are using or have recently used it is possible to use other medicines , including any other medicines for the treatment of rheumatoid arthritis , psoriatic arthritis or ankylosing spondylitis.
You should not use Simponi with medicines containing the active substance anakinra or abatacept . These drugs are used to treat rheumatic diseases.
Tell your doctor or pharmacist if you are taking other medicines that affect the immune system.
Should not receive certain (live ) vaccines while using Simponi.
If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Simponi.

Pregnancy and lactation
Before using Simponi, tell your doctor if:
are pregnant or plan to become pregnant while using Simponi. The effects of this drug in pregnant women are unknown. Not recommended the use of Simponi in pregnant women. If you are being treated with Simponi, should avoid becoming pregnant by using adequate contraception during treatment and for at least 6 months after the last injection of Simponi.
you are ( potential) nursing . Must have at least 6 months of the last of Simponi before breast-feeding. If you are treatment with Simponi, should stop breastfeeding.
If you received Simponi during pregnancy , your baby may be at increased risk of infection. It is important to tell your baby's doctor and other medical professionals for their treatment with Simponi, before your baby is vaccinated ( for more information see the point of vaccination).
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.

Driving and using machines
Simponi may have little impact on your ability to drive or operate any tools or machines . After administration of Simponi can get dizzy . If this happens , do not drive or use any tools or machines.
Simponi latex and sorbitol
Latex sensitivity
The needle cover of the prefilled syringe contains latex. Because latex can cause severe allergic reactions , contact your doctor if you or the person who takes care of you, you are allergic to latex.
Intolerance to sorbitol
Simponi contains sorbitol (E420). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 . How to use Simponi?
Always use this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

How much is applied Simponi?
Rheumatoid arthritis , psoriatic arthritis , ankylosing spondylitis
The recommended dose is 50 mg ( the contents of the prefilled syringe 1 ) administered once a month on the same date .
Before the fourth dose , contact your doctor . Your doctor will determine whether treatment with Simponi should continue.
If you weigh more than 100 kg, the dose may be increased to 100 mg ( the 2 pre-filled syringes ) given once a month on the same date.
ulcerative colitis
The table below shows how will normally take this medicine .
Start of treatment starting dose of 200 mg ( content 4 prefilled pens ) followed by 100 mg (the content of 2 pre -filled pens ) 2 weeks later .
maintenance treatment
• For patients weighing less than 80 kg, 50 mg ( the content of the pre-filled pen 1 ) 4 weeks after your last treatment , then every 4 weeks.
• For patients weighing 80 kg or more , 100 mg (the content of the pre-filled pens 2 ) 4 weeks after your last treatment , then every 4 weeks.
How to use Simponi?
Simponi is given by injection under the skin ( subcutaneously).
At first the doctor or nurse may inject Simponi. You and your doctor may decide that you are able to inject Simponi. In this case you will be taught how to self- inject Simponi.
Talk to your doctor if you have any questions about giving yourself an injection . At the end of this leaflet you will find detailed "Instructions for administration" .

If you use more than the amount of Simponi
If you have used or been given too much Simponi ( or by injection of a single high dose , or too often) , immediately contact your doctor or pharmacist. Always carry a cardboard box , even if it is empty.

If you forget to use Simponi
If you forget to use Simponi on the planned date , apply the missed dose as soon as you remember.
Do not use a double dose to make up for a missed dose.
When to inject your next dose:
If you were less than 2 weeks , inject the missed dose as soon as you remember and then continue on the original regimen.
If you miss more than two weeks , inject the missed dose as soon as you remember and contact your doctor or pharmacist to ask when you should inject the next dose .
If you are not sure, ask your doctor or pharmacist.

If you stop using Simponi
If you intend to stop using Simponi, discuss this with your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them . Some patients may develop serious side effects that require treatment . The risk of certain side effects is greater at the 100 mg dose compared to the dose of 50 mg. Adverse reactions may be up to several months after the last injection.
Tell your doctor immediately if you notice any of the following serious side effects , including:
allergic reactions that may be serious or life-threatening rare ( rare ) . Symptoms of an allergic reaction may include swelling of the face , lips , mouth or throat which may cause difficulty in swallowing or breathing , skin rash, hives, swelling of the hands , feet or ankles. Some of the reactions appear after the first administration of Simponi;
serious infections (including TB , bacterial infections including serious blood infections and pneumonia, severe fungal infections, and other opportunistic infections) (uncommon ) . Symptoms of infection may include fever, tiredness, (persistent) cough , shortness of breath , flu-like symptoms , weight loss , night sweats, diarrhea, wounds , dental problems and burning when urinating ;
reactivation of hepatitis B if you are a carrier or have suffered from hepatitis B ( rare). Symptoms can include yellowing of the skin and eyes, dark brown -colored urine , pain in the right side of the abdomen, fever, nausea , vomiting and fatigue ;
neurological disorders such as multiple sclerosis (uncommon ) . Symptoms of disease of the nervous system may include vision changes , weakness in the hands and knees , numbness or tingling of different parts of your body ;
cancer of the lymph nodes ( lymphoma) ( rare). The symptoms of lymphoma can include swelling of the lymph nodes , weight loss or fever ;
heart failure ( uncommon) . Symptoms of heart failure may include symptoms such as shortness of breath or swelling of your feet ;
signs of disorder of the immune system called lupus ( rare). Symptoms may include joint pain or rash on the cheeks or arms that is sensitive to the sun
blood disease . Symptoms of the disease may include blood neotminavashta temperature, easy bruising or bleeding , or very pale face .
Tell your doctor immediately if you notice any of these symptoms.
Administration of Simponi were observed following additional adverse reactions :
Very common side effects (likely to affect more than 1 in 10 patients):
Infections of the upper respiratory tract , sore throat , hoarseness , runny nose .
Common side effects ( may affect up to 1 in 10 patients):
Changes in liver function tests (increased liver enzymes) found in the blood tests done by your doctor ;
dizziness ;
headache ;
Superficial fungal infections ;
Bacterial infections ( such as cellulitis ) ;
Low red blood cells;
A positive blood test for lupus ;
Allergic raktsii ;
Indigestion ;
Stomach pain ;
nausea ;
flu ;
bronchitis ;
Sinus infection ;
herpes ;
Increase in blood pressure;
fever ;
Reactions at the injection site (including redness, hardness , pain, bruising, itching , tingling and irritation ) ;
Feeling weak .
Uncommon side effects ( may affect up to 1 in 100 patients):
abscess ;
Cancer , including skin cancer , and non-cancerous tumors and lumps , including moles ;
Psoriasis (including the hands and / or feet, and / or in the form of skin blisters ) ;
Low platelet count ;
Low white blood cells;
Overall low number of platelets, red and white blood cells;
Thyroid disorders ;
Increases in blood sugar levels ;
Increase in blood cholesterol levels ;
Sleep problems ;
Feeling depressed ;
Disequilibrium ;
Changes in taste ;
Tingling or " pins and needles " ;
Changes in vision ;
Sensation of irregular heart beat ;
Narrowing of the blood vessels of the heart ;
Blood clots ;
Pain and discoloration of the fingers or toes ;
Flushing ;
Asthma , shortness of breath , wheezing ;
constipation ;
Chronic inflammatory disease of the lungs ;
Disorders of the stomach and the intestine , including inflammation of the lining of the stomach and the colon, which may cause fever ;
acids;
Pain and mouth ulcers ;
Gallstones ;
hair loss ;
Rash and itching of the skin;
Liver ;
Bladder disorders ;
Renal ;
Breast disorders ;
Menstrual irregularities ;
Bone fractures ;
Discomfort in the chest ;
Inflammation of the blood vessels in the skin , causing a rash.
Rare side effects (may affect up to 1 in 1000 patients):
Infection of the joint or of the surrounding tissues ;
Kidney infection ;
Delayed wound healing ;
Inflammation of the blood vessels of the internal organs ;
leukemia;
Melanoma (a type of skin cancer) ;
Flaky , scaly skin ;
Disorders of the immune system that can affect the lung , skin and lymph nodes (often represented as sarcoidosis ) .
Side effects with unknown frequency:
Failure of the bone marrow to produce blood cells;
Merkel cell carcinoma (a type of skin cancer) ;
Rare type of blood cancer affecting mostly young people ( hepatosplenic T-cell lymphoma) .
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. 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 Simponi?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the label after "EXP" on the carton after " EXP" . The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze .
Keep the pre- filled pen in the outer carton to protect from light .
Do not use this medicine if you notice that the solution is not clear to pale yellow, it is cloudy or contains foreign particles.
Do not dispose of medications in wastewater or household waste . Ask your doctor or pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Additional information
What does Simponi?
The active substance is golimumab . One pre-filled syringe of 0,5 ml contains 50 mg golimumab .
Other ingredients are: sorbitol (E420), L- histidine , L-histidine monohydrochloride monohydrate, polysorbate 80 and water for injections.
Simponi looks like and contents of the pack ?
Simponi is supplied as a solution for injection in pre-filled disposable syringe . Simponi is supplied in packs containing 1 pre-filled syringe and multipacks containing 3 (3 packs of 1) pre -filled syringes. Not all pack sizes may be marketed .
The solution is clear to slightly opalescent (having a pearl shine) , colorless to light yellow and may contain a few small translucent or white particles of protein . Do not use Simponi, if the solution is discolored, cloudy, or contains foreign particles.
Marketing Authorisation Holder and Manufacturer
Janssen Biologies B.V., Netherlands.
Application Instructions
If you want to self inject Simponi, you must be trained by a healthcare professional on how to prepare an injection and give it to yourself . If you have not received such training , please contact your doctor , nurse or pharmacist to arrange a training meeting .

In these instructions:
1. Preparing to use the pen
2 . Choosing and preparing an injection site
3 . Injection drug
4 . after injection

1. Preparing to use the pen
Do not shake pen.
Do not remove the cap of the pen until instructed to do so.
Check the number of pre-filled pens
Check prefilled pen to make sure that:
number pre-filled pens and the amount of active substance per dose are correct
If your dose is 50 mg, will take a prefilled pen 50 mg;
If your dose is 100 mg, will take two pre-filled pens of 50 mg and will have to do two injections. Select two different sites for these injections ( eg one injection in the right thigh and the other in the left thigh ) by injecting one after another ;
If your dose is 200 mg, will take four pre-filled pens of 50 mg and will have to do four injections. Select different locations for these injections as injecting one after another.
Check the expiration date
Check the expiration date (after the word "EXP") of the pen.
You can also check the expiration date printed on the carton.
Do not use the pen if the expiration date has passed. The expiry date refers to the last day of that month. Please ask for help from your doctor or pharmacist.

Check the security seal
Check the security seal around the cap of the pen.
Do not use the pen if the seal is broken . Please contact your doctor or pharmacist.

Wait for 30 minutes to allow the pen to reach room temperature
To make sure that the proper injection , remove the pen from the box and let it sit at room temperature for 30 minutes , out of reach of children.
Do not heat the pen in any other way (eg in the microwave or in hot water) .
Do not remove the cap of the pen , while allowing it to reach room temperature.

Prepare the remaining funds necessary
While waiting , you can prepare your other necessary means, including swab with alcohol , cotton or gauze , and a sharps container .

Check the liquid in the pen
Look through the window to make sure that the liquid in the pen is clear or slightly opalescent (having a pearl shine) and colorless to light yellow . The solution may be used if it contains a small translucent or white particles of protein .
You will notice an air bubble , which is normal .
Do not use the pen if the liquid is colored , cloudy or contains larger particles . If this happens , contact your doctor or pharmacist.

2 . Choosing and preparing an injection site
The drug is usually injected in front of the middle part of the hips.
Can be injected in the abdomen below the navel , with the exception of the area approximately 5 cm below the navel .
Do not inject into areas where the skin is tender , bruised , red, scaly, hard or has scars or stretch marks.
If you require several injections , injections should be given at different body sites .
Choosing an injection site caregiver
If the injection you are a caregiver , it can use the outer surface of the upper arm .
In this case, the medicine can be injected to all locations indicated , regardless of your body type or size .
Preparing the injection site
Wash your hands thoroughly with soap and warm water.
Clean the injection site with a swab with alcohol.
Allow the skin to dry before injecting . Does not blow Veith over the cleaned area.
Do not touch this area again before giving the injection .
3 . Injection drug
The cap should not be removed until you are ready to inject . The drug should be injected within 5 minutes after removal of the cap.

Remove the cover
When you are ready to inject , twist the cap slightly to break the security seal .
Take off the cap and discard after injection.
Do not put the cap back because it can damage the needle in the pen . Do not use the pen if it is dropped without the cap is removed. If this happens , please contact your doctor or pharmacist.

Put your pen in the skin and squeeze well
Hold the pen comfortably in your hand. DO NOT press the button yet .
Choose one of two ways for injection. It is recommended that the injection without engaging a skin fold . However, if you prefer, you can pinch the skin to have a healthy injection surface .
Hold the open end of the pen to your skin at a right angle (90 degrees) and push the cylinder well as the safety slide completely transparent cover .
Click the button to inject
While pressing the pen to the skin , press with your fingers or thumb raised front part of the button . Will be able to press the button if the pen is pressed to the skin and the safety cylinder does not slide into the transparent cover .
Once pressed , the button will remain lost , so there is no need to keep pushing it .
You will hear a loud " click" - do not worry. This first " snap " indicates that the needle has been inserted and the injection has begun. You may feel or not feel the prick of the needle at this time.
Do not remove the pen from the skin. If you step away from the skin pen can not put the full dose of medicine.

Hold the pen until you hear a second "click ."
Continue pressing the stylus into the skin until you hear a second "click ." It usually takes 3-6 seconds, but can sometimes take up to 15 seconds until you hear the second "click" .
The second "click" means that the injection is finished and the needle is back in the pen .
Lift the pen from the injection site .
If you have a hearing problem , counted 15 seconds of pressing the button , and then lift the pen from the injection site.

4 . after injection
Use cotton or gauze
At the injection site can occur slight bleeding or a small amount of liquid. This is normal .
Press the injection site with cotton or gauze and hold for 10 seconds.
If necessary , you may cover the injection site with a small patch. Do not massage the skin.
Check window - yellow indicates that the application is correct.
If the yellow indicator is not visible in the window , or suspect you have not received the full dose , contact your doctor or pharmacist. Do not place a second dose without consulting your doctor.

Disposal of the pen
Immediately dispose of the pen in a special sharps container . Make sure you dispose of trash exactly as directed by your doctor or nurse.
If you think that injecting something went wrong or you are not sure , contact your doctor or pharmacist.
 
 
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