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Generated Narrative: Bundle TEST PURPOSES ONLY - erelzi

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Generated Narrative: MedicinalProductDefinition mp467d212176ff3f3172a5c049c6483dc0

identifier: http://ema.europa.eu/identifier/EU/1/17/1195/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Erelzi 25 mg solution for injection in pre-filled syringe

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

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-	Country	Jurisdiction	Language
*	EU	EU	en

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Generated Narrative: Composition composition-en-467d212176ff3f3172a5c049c6483dc0

identifier: http://ema.europa.eu/identifier/EU/1/17/1195/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - erelzi

Attesters

7. Instructions for Use of the Erelzi pre-filled syringe

What is in this leaflet

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

Erelzi is a medicine that is made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. Erelzi works by reducing the inflammation associated with certain diseases. In adults (aged 18 and over), Erelzi can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis in each case usually when other widely used treatments have not worked well enough or are not suitable for you. For rheumatoid arthritis, Erelzi is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you. Whether used alone or in combination with methotrexate, Erelzi can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities. For psoriatic arthritis patients with multiple joint involvement, Erelzi can improve your ability to do normal daily activities. For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), Erelzi can slow down the structural damage to those joints caused by the disease. Erelzi is also prescribed for the treatment of the following diseases in children and adolescents:

For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:

Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more.

Psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more.

For enthesitis-related arthritis in patients from the age of 12 years and weighing 62.5 kg or more when other widely used treatments have not worked well enough or are not suitable for them.

Severe psoriasis in patients from the age of 6 years and weighing 62.5 kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.

Do not use Erelzi

if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Erelzi (listed in section 6). If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Erelzi, and contact your doctor immediately.

if you or the child have, or are at risk of developing a serious blood infection called sepsis. If you are not sure, please contact your doctor.

if you or the child have an infection of any kind. If you are not sure, please talk to your doctor. Warnings and precautions Talk to your doctor before using Erelzi.

Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Erelzi, and contact your doctor immediately.

Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Erelzi.

Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.

Infections/monitoring: Tell your doctor of any recent travel outside the European region. If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately. Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Erelzi.

Tuberculosis: As cases of tuberculosis have been reported in patients treated with Erelzi, your doctor will check for signs and symptoms of tuberculosis before starting Erelzi. This may include a thorough medical history, a chest X-ray and a tuberculin test. The conduct of these tests should be recorded on the Patient Card. It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.

Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Erelzi. Treatment with Erelzi may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus. If this occurs, you should stop using Erelzi.

Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Erelzi in case the infection worsens.

Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Erelzi.

Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord). Your doctor will determine if Erelzi is an appropriate treatment.

Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Erelzi needs to be used with caution under these circumstances.

Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given Erelzi. Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma. Children and adults taking Erelzi may have an increased risk of developing lymphoma or another cancer. Some children and teenage patients who have received Erelzi or other medicines that work the same way as Erelzi have developed cancers, including unusual types, which sometimes resulted in death. Some patients receiving Erelzi have developed skin cancers. Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.

Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Erelzi. Your doctor will determine if preventive treatment for chickenpox is appropriate.

Alcohol abuse: Erelzi should not be used for the treatment of hepatitis related to alcohol abuse. Please tell your doctor if you or the child in your care have a history of alcohol abuse.

Wegener s granulomatosis: Erelzi is not recommended for the treatment of Wegener s granulomatosis, a rare inflammatory disease. If you or the child in your care have Wegener s granulomatosis, talk to your doctor.

Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor may decide if you or the child need less anti-diabetic medicine while using Erelzi. Children and adolescents Erelzi is not indicated for use in children and adolescents who weigh less than 62.5 kg.

Vaccinations: If possible, children should be up to date with all vaccinations before using Erelzi. Some vaccines, such as oral polio vaccine, should not be given while using Erelzi. Please consult your doctor before you or the child receive any vaccines. Erelzi should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years or weighing less than 62.5 kg, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years or weighing less than 62.5 kg, or in children with psoriasis below the age of 6 years or weighing less than 62.5 kg. Other medicines and Erelzi Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor. You or the child should not use Erelzi with medicines that contain the active substance anakinra or abatacept. Pregnancy and breast-feeding Erelzi should only be used during pregnancy if clearly needed. You should consult your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby. If you received Erelzi during pregnancy, your baby may have a higher risk of getting an infection. In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received etanercept or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported. Another study found no increased risk of birth defects when the mother had received etanercept in pregnancy. Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby. Talk to your doctor if you want to breastfeed while on Erelzi treatment. It is important that you tell your baby s doctors and other healthcare professionals about the use of Erelzi during pregnancy and breastfeeding before your baby receives any vaccine.. Driving and using machines The use of Erelzi is not expected to affect the ability to drive or use machines. Erelzi contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 25 mg or 50 mg, that is to say essentially sodium-free .

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you feel that the effect of Erelzi is too strong or too weak, talk to your doctor or pharmacist. Erelzi is available as 25 mg strength and 50 mg strength. Use in adult patients (aged 18 years or over) Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin. However, your doctor may determine an alternative frequency at which to inject Erelzi. Plaque psoriasis The usual dose is 25 mg twice a week or 50 mg once a week. Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week. Your doctor will decide how long you should use Erelzi and whether retreatment is needed based on your response. If Erelzi has no effect on your condition after 12 weeks, your doctor may tell you to stop using this medicine. Use in children and adolescents The appropriate dose and frequency of dosing for the child or adolescent will depend on body weight and disease. Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of etanercept. Paediatric patients weighing 62.5 kg or more can be dosed 25 mg given twice a week or 50 mg given once a week using a fixed-dose pre-filled syringe or pre-filled pen. Other etanercept products with appropriate dosage forms for children are available. For polyarthritis or extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more, the usual dose is 25 mg given twice a week or 50 mg given once a week. For psoriasis in patients from the age of 6 years and weighing 62.5 kg or more, the usual dose is 50 mg and should be given once weekly. If Erelzi has no effect on the child s condition after 12 weeks, your doctor may tell you to stop using this medicine. The doctor will provide you with detailed directions for preparing and measuring the appropriate dose. Method and route of administration Erelzi is administered by an injection under the skin (by subcutaneous injection). Detailed instructions on how to inject Erelzi are provided in section 7, Instructions for use of the Erelzi pre-filled syringe . Do not mix the Erelzi solution with any other medicine. To help you remember, it may be helpful to write in a diary which day(s) of the week Erelzi should be used. If you use more Erelzi than you should If you have used more Erelzi than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately. Always have the outer carton of the medicine with you, even if it is empty. If you forget to inject Erelzi If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose. Then continue to inject the medicine on the usual day(s). If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgotten dose. If you stop using Erelzi Your symptoms may return upon discontinuation. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions If any of the following happen, do not inject more Erelzi. Tell your doctor immediately, or go to the casualty department at your nearest hospital.

Trouble swallowing or breathing

Swelling of the face, throat, hands, or feet

Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling

Severe rash, itching, or hives (elevated patches of red or pale skin that often itch) Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Erelzi, so you should seek immediate medical attention. Serious side effects If you notice any of the following, you or the child may need urgent medical attention.

Signs of serious infections such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints;

Signs of blood disorders, such as bleeding, bruising, or paleness;

Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg;

Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips;

Signs of cancers: cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer. These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin;

Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;

Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;

Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching. These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal). If these signs occur, tell your doctor immediately, or visit the casualty department at your nearest hospital. The known side effects of Erelzi include the following in groups of decreasing frequency:

Very common (may affect more than 1 in 10 people) Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling) (these do not occur as often after the first month of treatment; some patients have developed a reaction at an injection site that was recently used); and headache.

Common (may affect up to 1 in 10 people) Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).

Uncommon (may affect up to 1 in 100 people) Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).

Rare (may affect up to 1 in 1,000 people) Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white- grey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).

Very rare (may affect up to 1 in 10,000 people) Failure of the bone marrow to produce crucial blood cells.

Not known (frequency cannot be estimated from the available data) Merkel cell carcinoma (a type of skin cancer); Kaposi s sarcoma (a rare cancer related to infection with human herpes virus 8. Kaposi s sarcoma most commonly appears as purple lesion on the skin); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); damage to the tiny filters inside your kidneys leading to poor kidney function (glomerulonephritis), worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash). Additional side effects in children and adolescents The side effects and their frequencies seen in children and adolescents are similar to those described above. 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 carton and the label of the pre-filled syringe 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 syringes in the outer carton in order to protect from light. After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the syringe to reach room temperature. Do not warm in any other way. Immediate use is then recommended. Erelzi may be stored outside of the refrigerator at temperatures up to a maximum of 25 C for a single period of up to four weeks; after which, it should not be refrigerated again. Erelzi should be discarded if not used within four weeks after removal from the refrigerator. It is recommended that you record the date that Erelzi is removed from the refrigerator and the date after which Erelzi should be discarded (no more than 4 weeks following the removal from the refrigerator). Inspect the solution in the syringe. It should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein. This appearance is normal for Erelzi. Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present. If you are concerned with the appearance of the solution, then contact your pharmacist for assistance. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Erelzi contains The active substance is etanercept. Each pre-filled syringe contains 25 mg of etanercept or 50 mg of etanercept. The other ingredients are citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections. What Erelzi looks like and contents of the pack Erelzi is supplied as a pre-filled syringe containing a clear or slightly opalescent, colourless to slightly yellowish solution for injection (injection). The pre-filled syringes are made of type I glass, a rubber plunger stopper (bromobutyl rubber), a plunger rod, an attached stainless steel 29 gauge needle and needle cap (thermoplastic elastomer). The syringes are provided with an automatic needle guard. Each pack contains 1, 2 or 4 pre-filled syringes with a needle guard, multipacks contain 12 (3 packs of 4) 25 mg or 50 mg pre-filled syringes with a needle guard or 8 (2 packs of 4) or 24 (6 packs of 4) 25 mg pre-filled syringes with a needle guard. Not all pack sizes may be marketed. Marketing Authorisation Holder Sandoz GmbH Biochemiestrasse 6250 Kundl Austria Manufacturer Sandoz GmbH Schaftenau Biochemiestrasse 6336 Langkampfen Austria Novartis Pharmaceutical Manufacturing GmbH Biochemiestrasse 6336 Langkampfen Austria For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Sandoz nv/sa T l/Tel: +32 2 722 97 Lietuva Sandoz Pharmaceuticals d.d filialas Tel: +370 5 2636

.: +359 2 970 47 Luxembourg/Luxemburg Sandoz nv/sa T l/Tel.: +32 2 722 97 esk republika Sandoz s.r.o. Tel: +420 225 775 Magyarorsz g Sandoz Hung ria Kft. Tel.: +36 1 430 2Danmark/Norge/ sland/Sverige Sandoz A/S Tlf/S mi/Tel: +45 63 95 10 Malta Sandoz Pharmaceuticals d.d. Tel: +35699644Deutschland Hexal AG Tel: +49 8024 908 0 Nederland Sandoz B.V. Tel: +31 36 52 41 Eesti Sandoz d.d. Eesti filiaal Tel: +372 665 2 sterreich Sandoz GmbH Tel: +43 5338 2 SANDOZ HELLAS . . : +30 216 600 5Polska Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 Espa a Sandoz Farmac utica, S.A. Tel: +34 900 456 Portugal Sandoz Farmac utica Lda. Tel: +351 21 000 86 France Sandoz SAS T l: +33 1 49 64 48 Rom nia Sandoz Pharmaceuticals SRL Tel: +40 21 407 51 Hrvatska Sandoz d.o.o. Tel: +385 1 23 53 Slovenija Sandoz farmacevtska dru ba d.d. Tel: +386 1 580 29 Ireland Rowex Ltd. Tel: + 353 27 50Slovensk republika Sandoz d.d. - organiza n zlo ka Tel: +421 2 50 70 6Italia Sandoz S.p.A. Tel: +39 02 96Suomi/Finland Sandoz A/S Puh/Tel: +358 10 6133
Sandoz Pharmaceuticals d.d. : +357 22 69 0United Kingdom (Northern Ireland) Sandoz GmbH Tel: +43 5338 2Latvija Sandoz d.d. Latvia fili le Tel: +371 67 892 This leaflet was last revised in {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency web site: