Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - simponi

Document Subject

Generated Narrative: MedicinalProductDefinition mpd2d145b277f24456eda5f7dbaa40b7cf

identifier: http://ema.europa.eu/identifier/EU/1/09/546/009 1 pre-filled pen

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d2d145b277f24456eda5f7dbaa40b7cf

identifier: http://ema.europa.eu/identifier/EU/1/09/546/009 1 pre-filled pen

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - simponi

Attesters

What is in this leaflet

1. What Simponi is and what it is used for
2. What you need to know before you use Simponi
3. How to use Simponi
4. Possible side effects
5. How to store Simponi
6. Contents of the pack and other information

Simponi contains the active substance called golimumab. Simponi belongs to a group of medicines called TNF blockers . It is used in children 2 years of age and older for the treatment of polyarticular juvenile idiopathic arthritis. Simponi works by blocking the action of a protein called tumour necrosis factor alpha (TNF- ). This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body. Polyarticular juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes joint pain and swelling in children. If you have polyarticular juvenile idiopathic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Simponi in combination with methotrexate to treat the disease.

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 any other severe infection.

If you have moderate or severe heart failure. If you are not sure if any of the above applies 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 straight away if you already have or get any symptoms of infection, during or after your treatment with Simponi. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems or a burning feeling when urinating.

You may get infections more easily while using Simponi.

Infections may progress more rapidly and may be more severe. In addition, some previous infections may reappear. Tuberculosis (TB) Tell your doctor straight away if symptoms of TB appear during or after your treatment. Symptoms of TB include persistent cough, weight loss, tiredness, fever or night sweats.

Cases of TB have been reported in patients treated with Simponi, in rare occasions even in patients who have been treated with medicines for TB. Your doctor will test you to see if you have TB. Your doctor will record these tests on your Patient Reminder Card.

It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had or has TB.

If your doctor feels that you are at risk of TB, you may be treated with medicines for TB before you begin using Simponi. Hepatitis B virus (HBV)

Tell your doctor if you are a carrier or if you have or have had HBV before you are given Simponi.

Tell your doctor if you think you might be at risk of contracting HBV

Your doctor should test you for HBV

Treatment with TNF blockers such as Simponi may result in reactivation of HBV in patients who carry this virus, which can be life-threatening in some cases. Invasive fungal infections If you have lived in or travelled to an area where infections caused by specific type of fungi that can affect the lungs or other parts of the body (called histoplasmosis, coccidioidomycosis, or blastomycosis), are common, tell your doctor straight away. Ask your doctor if you don t know if these fungal infections are common in the area in which you have lived or travelled. Cancer and lymphoma Tell your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer) or any other cancer before you use Simponi.

If you use Simponi or other TNF blockers, your risk for developing lymphoma or another cancer may increase.

Patients with severe rheumatoid arthritis and other inflammatory diseases, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.

There have been cases of cancers, including unusual types, in children and teenage patients taking TNF-blocking agents, which sometimes resulted in death.

On rare occasions, a specific and severe type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF-blockers. Most of these patients were adolescent or young adult males. This type of cancer has usually resulted in death. Almost all of these patients had also received medicines known as azathioprine or 6-mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.

Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or are heavy smokers may be at increased risk for cancer with Simponi treatment. If you have severe persistent asthma, COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Some patients treated with golimumab have developed certain kinds of skin cancer. If any changes in the appearance of the skin or growths on the skin occur during or after therapy, tell your doctor. Heart failure Tell your doctor straight away if you get new or worsening symptoms of heart failure. Symptoms of heart failure include shortness of breath or swelling of your feet.

New and worsening congestive heart failure has been reported with TNF blockers, including Simponi. Some of these patients died.

If you have mild heart failure and you are being treated with Simponi, you must be closely monitored by your doctor. Nervous system disease Tell your doctor straight away if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis. Symptoms may include changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body. Your doctor will decide if you should receive Simponi. Operations or dental procedures

Talk to your doctor if you are going to have any operations or dental procedures.

Tell your surgeon or dentist performing the procedure that you are having treatment with Simponi by showing them your Patient Reminder Card. Autoimmune disease Tell your doctor if you develop symptoms of a disease called lupus. Symptoms include persistent rash, fever, joint pain and tiredness.

On rare occasions, people treated with TNF blockers have developed lupus. Blood disease In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi. Vaccinations Talk to your doctor if you have had, or are due to have a vaccine.

You should not receive certain (live) vaccines while using Simponi.

Certain vaccinations may cause infections. If you received Simponi while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately six months after the last dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Simponi use so they can decide when your baby should receive any vaccine. Talk to your child s doctor regarding vaccinations for your child. If possible, your child should be up to date with all vaccinations before using Simponi. Therapeutic infectious agents Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer). Allergic reactions Tell your doctor straight away if you develop symptoms of an allergic reaction after your treatment with Simponi. 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 these reactions may be serious or, rarely, life-threatening.

Some of these reactions occurred after the first administration of Simponi. Children Simponi is not recommended for children less than 2 years of age with polyarticular juvenile idiopathic arthritis because it has not been studied in this group. Other medicines and Simponi

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat polyarticular juvenile idiopathic arthritis.

You should not take Simponi with medicines containing the active substance anakinra or abatacept. These medicines are used for the treatment of rheumatic diseases.

Tell your doctor or pharmacist if you are taking any other medicines that affect your immune system.

You should not receive certain (live) vaccines while using Simponi. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi. Pregnancy and breast-feeding Talk to your doctor before using Simponi if:

You are pregnant or are planning to become pregnant while using Simponi. There is limited information about the effects of this medicine in pregnant women. If you are being treated with Simponi, you must avoid becoming pregnant by using adequate contraception during your treatment and for at least 6 months after the last Simponi injection. Simponi should only be used during pregnancy if it is clearly necessary for you.

Before starting breast-feeding, your last treatment with Simponi must be at least 6 months ago. You must stop breast-feeding if you are to be given Simponi.

If you received Simponi during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby s doctors and other health care professionals about your Simponi use before the baby receives any vaccine (for more information see section on vaccination). If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Simponi has minor influence on your ability to ride bicycles, drive and use tools or machines. Dizziness may however occur after you take Simponi. If this happens, do not ride bicycles, drive or use any tools or machines. Simponi contains latex and sorbitol Latex sensitivity A part of the pre-filled pen, the needle cover, contains latex. Because latex may cause severe allergic reactions, talk to your doctor before using Simponi if you or your carer are allergic to latex. Sorbitol intolerance This medicine contains 18.45 mg sorbitol (E420) in each pre-filled pen. Each 0.05 mL medicine contains 2.05 mg sorbitol (E420).

Always use this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. How much Simponi is given Polyarticular juvenile idiopathic arthritis in children 2 years of age and older:

Children weighing less than 40 kg: The recommended dose of Simponi for children weighing less than 40 kg depends on their weight and height. Your doctor will tell you the correct dose to use. The dose should be given once a month, on the same date each month.

Children weighing at least 40 kg: For children with body weight of at least 40 kg, a fixed dose 50 mg pre-filled pen or pre-filled syringe is available. For the 50 mg dose, see section 3 How to use Simponi of the Simponi 50 mg pre-filled pen or pre-filled syringe package leaflet.

Talk to your doctor before you take the fourth dose. Your doctor will determine if you should continue Simponi treatment. How Simponi is given

Simponi is given by injection under the skin (subcutaneously).

At the start, your doctor or nurse may inject Simponi. However, you and your doctor may decide that you may inject Simponi to yourself or to your child. In this case you will get training on how to inject Simponi. Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed Instructions for Use included with this leaflet. If you use more Simponi than you should If you have used or been given too much Simponi (either by injecting too much on a single occasion, or by using it too often), talk to your doctor or pharmacist straight away. Always take the outer carton and this leaflet with you, even if it is empty. If you forget to use Simponi If you forget to use Simponi on your planned date, inject the forgotten dose as soon as you remember. Do not use a double dose to make up for a forgotten dose. When to inject your next dose:

If you are less than 2 weeks late, inject the forgotten dose as soon as you remember and stay on your original schedule.

If you are more than 2 weeks late, inject the forgotten dose as soon as you remember and talk to your doctor or pharmacist to ask when you need to take the next dose. If you are not sure what to do, talk to your doctor or pharmacist. If you stop using Simponi If you are considering stopping Simponi, talk to your doctor or pharmacist first. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience serious side effects and may require treatment. Side effects may appear up to several months after the last injection. Tell your doctor straight away if you notice any of the following serious side effects of Simponi which include:

allergic reactions which may be serious, or rarely, life-threatening (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 these reactions occurred 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) (common). Symptoms of an infection can include fever, tiredness, (persistent) cough, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning feeling when urinating.

reactivation of hepatitis B virus if you are a carrier or have had hepatitis B before (rare). Symptoms can include yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever, feeling sick, being sick, and feeling very tired.

nervous system disease such as multiple sclerosis (rare). Symptoms of nervous system disease can include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.

cancer of the lymph nodes (lymphoma) (rare). Symptoms of lymphoma can include swelling of the lymph nodes, weight loss, or fever.

heart failure (rare). Symptoms of heart failure can include shortness of breath or swelling of your feet.

signs of immune system disorders called:

lupus (rare). Symptoms can include joint pain or a rash on cheeks or arms that is sensitive to the sun.

sarcoidosis (rare). Symptoms can include a persistent cough, being short of breath, chest pain, fever, swelling of your lymph nodes, weight loss, skin rashes, and blurred vision.

swelling of small blood vessels (vasculitis) (rare). Symptoms can include fever, headache, weight loss, night sweats, rash, and nerve problems such as numbness and tingling.

skin cancer (uncommon). Symptoms of skin cancer can include changes in the appearance of your skin or growths on your skin.

blood disease (common). Symptoms of blood disease can include a fever that does not go away, bruising or bleeding very easily or looking very pale.

blood cancer (leukaemia) (rare). Symptoms of leukaemia can include fever, feeling tired, frequent infections, easy bruising, and night sweats. Tell your doctor straight away if you notice any of the above symptoms. The following additional side effects have been observed with Simponi: Very common side effects (may affect more than 1 in 10 people):

Upper respiratory tract infections, sore throat or hoarseness, runny nose Common side effects (may affect up to 1 in 10 people):

Abnormal liver tests (increased liver enzymes) found during blood tests done by your doctor

Feeling dizzy

Headache

Feeling numb or having a tingling feeling

Superficial fungal infections

Abscess

Bacterial infections (such as cellulitis)

Low red blood cell counts

Low white blood cell counts

Positive blood lupus test

Allergic reactions

Indigestion

Stomach pain

Feeling sick (nausea)

Flu

Bronchitis

Sinus infection

Cold sores

High blood pressure

Fever

Asthma, shortness of breath, wheezing

Stomach and bowel disorders which include inflammation of the stomach lining and colon which may cause fever

Pain and ulcers in the mouth

Injection site reactions (including redness, hardness, pain, bruising, itching, tingling and irritation)

Hair loss

Rash and itching of the skin

Difficulty sleeping

Depression

Feeling weak

Bone fractures

Chest discomfort Uncommon side effects (may affect up to 1 in 100 people):

Kidney infection

Cancers, including skin cancer and non-cancerous growths or lumps, including skin moles

Skin blisters

Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)

Psoriasis (including on the palms of your hand and/or the soles of your feet and/or in the form of skin blisters)

Low platelet count

Combined low platelet, red, and white blood cell count

Thyroid disorders

Increase in blood sugar levels

Increase in blood cholesterol levels

Balance disorders

Vision disturbances

Inflamed eye (conjunctivitis)

Eye allergy

Sensation of heart beating irregularly

Narrowing of the blood vessels in the heart

Blood clots

Flushing

Constipation

Chronic inflammatory condition of the lungs

Acid reflux

Gall stones

Liver disorders

Breast disorders

Menstrual disorders Rare side effects (may affect up to 1 in 1,000 people):

Failure of the bone marrow to produce blood cells

Severely decreased number of white blood cells

Infection of the joints or the tissue around them

Impaired healing

Inflammation of blood vessels in internal organs

Leukaemia

Melanoma (a type of skin cancer)

Merkel cell carcinoma (a type of skin cancer)

Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)

Scaly, peeling skin

Immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)

Pain and discolouration in the fingers or toes

Taste disturbances

Bladder disorders

Kidney disorders

Inflammation of the blood vessels in your skin which results in rash Side effects of which the frequency is not known:

A rare blood cancer affecting mostly young people (hepatosplenic T-cell lymphoma)

Kaposi s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi s sarcoma most commonly appears as purple lesions on the skin

Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and 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 in order to protect it from light.

This medicine can also be stored out of the refrigerator at temperatures up to a maximum of 25 C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton. Write the new expiry date on the carton including day/month/year (no more than 30 days after the medicine is removed from the refrigerator). Do not return this medicine to refrigerator if it has reached room temperature. Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.

Do not use this medicine if you notice that the liquid is not a clear to light yellow colour, cloudy, or contains foreign particles.

Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Simponi contains The active substance is golimumab. One 0.45 mL pre-filled pen contains 45 mg of golimumab. 1 mL contains 100 mg golimumab. The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80 and water for injections. For more information on sorbitol (E420), see Section 2. What Simponi looks like and contents of the pack Simponi is supplied as solution for injection in a single-use pre-filled pen, VarioJect. Simponi is available in packs containing 1 pre-filled pen. The solution is clear to slightly opalescent (having a pearl-like shine), colourless to light yellow and may contain a few small translucent or white particles of protein. Do not use Simponi if the solution is discoloured, cloudy or you can see foreign particles in it. Marketing Authorisation Holder and Manufacturer Janssen Biologics B.V. Einsteinweg 2333 CB Leiden The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com Lietuva UAB Merck Sharp & Dohme Tel. + 370 5 278 02 msd_lietuva@merck.com

.: +359 2 819 3info-msdbg@merck.com Luxembourg/Luxemburg MSD Belgium T l/Tel: (+32(0)27766211) dpoc_belux@merck.com esk republika Merck Sharp & Dohme s.r.o. Tel: +420 233 010 dpoc_czechslovak@merck.com Magyarorsz g MSD Pharma Hungary Kft. Tel.: +36 1 888 5hungary_msd@merck.com Danmark MSD Danmark ApS Tlf: + 45 4482 4dkmail@merck.com Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) e-mail@msd.de Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999(+31 23 5153153) medicalinfo.nl@merck.com Eesti Merck Sharp & Dohme O Tel.: +372 6144 msdeesti@merck.com Norge MSD (Norge) AS Tlf: +47 32 20 73 msdnorge@msd.no

MSD . . . . . : +30 210 98 97 dpoc_greece@merck.com sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 dpoc_austria@merck.com Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 msd_info@merck.com Polska MSD Polska Sp. z o.o. Tel: +48 22 549 51 msdpolska@merck.com France MSD France T l: + 33 (0) 1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465inform_pt@merck.com Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 croatia_info@merck.com Rom nia Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 msdromania@merck.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfo_ireland@merck.com Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 msd.slovenia@merck.com sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282dpoc_czechslovak@merck.com Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) medicalinformation.it@msd.com Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 info@msd.fi

Merck Sharp & Dohme Cyprus Limited .: 800 00 673 (+357 22866700) cyprus_info@merck.com Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700medicinskinfo@merck.com Latvija SIA Merck Sharp & Dohme Latvija Tel: + 371 67364msd_lv@merck.com United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +35312998medinfoNI@msd.com This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: