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Generated Narrative: Bundle TEST PURPOSES ONLY - avonex

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Generated Narrative: MedicinalProductDefinition mp36f1b29a7444210831ac7deab30ae673

identifier: http://ema.europa.eu/identifier/EU/1/97/033/003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: AVONEX 30 micrograms/0.5 ml solution for injection.

type: Full name

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part: nan

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-	Country	Jurisdiction	Language
*	EU	EU	en

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Generated Narrative: Composition composition-en-36f1b29a7444210831ac7deab30ae673

identifier: http://ema.europa.eu/identifier/EU/1/97/033/003

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - avonex

Attesters

7. How to inject AVONEX

What is in this leaflet

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

What AVONEX is The active substance in Avonex is a protein called interferon beta-1a. Interferons are natural substances made in your body to help protect you from infections and diseases. The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body. What AVONEX is used for Avonex is used to treat Multiple Sclerosis (MS). Treatment with Avonex can help to prevent you from getting worse, although it will not cure MS. Everyone has their own set of MS symptoms. These can include:

Feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness, numbness in the face, arms or legs

Acute or chronic pain, bladder and bowel problems, sexual problems and problems seeing things

Difficulty in thinking and concentrating, depression. MS also tends to flare up from time to time: this is called a relapse. (Notes information) Avonex works best when you use it:

at the same time

once a week

on a regular basis Do not stop your Avonex treatment without speaking to your doctor. Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS. Your doctor will advise you for how long you can use Avonex or when to stop. How AVONEX works Multiple sclerosis is linked to nerve (brain or spinal cord) damage. In MS, your body s defence system reacts against its own myelin the insulation that surrounds nerve fibres. When myelin is damaged, the messages between the brain and other parts of the body are disrupted. This is what causes the symptoms of MS. Avonex seems to work by stopping your body s defence system from attacking the myelin.

Do not use AVONEX

If you are allergic to interferon beta or any of the other ingredients of this medicine (listed in section 6)

If you have severe depression or think about committing suicide. Talk to a doctor straight away if any of these apply to you. (Notes information) Avonex and allergic reactions. Because Avonex is based on a protein, there is a small chance of an allergic reaction. More about depression. If you have severe depression or thoughts about suicide, you must not use Avonex. If you have depression, your doctor may still prescribe Avonex for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods. Warnings and precautions Talk to your doctor before using Avonex if you have or have had in the past:

Depression or problems affecting your moods

Thoughts about committing suicide. Changes to your mood, thoughts about suicide, feeling unusually sad, anxious or worthless, should be reported to your doctor immediately.

Epilepsy or other seizure disorders not controlled by medication

Serious kidney or liver problems

A low number of white blood cells or platelets, which can cause an increased risk of infection, bleeding or anaemia

Heart problems, which can cause symptoms such as chest pain (angina), particularly after any activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmias).

Irritation at an injection site, which can lead to skin and tissue damage (injection site necrosis). When you are ready to inject, carefully follow the instructions in section 7 How to inject AVONEX , at the end of this leaflet. This is to reduce the risk of injection site reactions. Talk to your doctor if you have any of these conditions, or if they worsen whilst taking Avonex. Blood clots in the small blood vessels may occur during your treatment. These blood clots could affect your kidneys. This might happen several weeks to several years after starting Avonex. Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidneys. Tell your doctor you are using Avonex:

If you are having a blood test. Avonex may interfere with the results. (Notes information) Sometimes you will need to remind other medical staff that you are being treated with Avonex. For example, if you are prescribed other medicines, or if you have a blood test, Avonex may affect the other medicines or the test result. Paediatric population Avonex is not recommended for use in children and adolescents because there is limited data on the use of Avonex in this population. Avonex should not be used in children below 10 years of age because it is yet to be established whether it would work for them and whether it would be safe. Other medicines and AVONEX Tell your doctor if you are using, have recently used or might use any other medicines, especially those used to treat epilepsy or depression. Avonex may affect other medicines or be affected by them. This includes any other medicines including medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. No harmful effects on the breastfed newborn/infant are anticipated. Avonex can be used during breast- feeding. Driving and using machines If you feel dizzy, do not drive. Avonex makes some people feel dizzy. If this happens to you, or if you get any other side effects that could affect your ability, do not drive or use machines. Important information about some of the ingredients of AVONEX This medicine is essentially sodium-free . It contains less than 23 mg (1 mmol) sodium in each weekly dose.

The recommended weekly dose One injection of Avonex, once a week. Try to use Avonex at the same time on the same day each week. If you have decided to start treatment with Avonex, your doctor may provide you with an Avostartclip titration kit. The Avostartclip attaches to the syringe and enables you to gradually increase your dose of Avonex when you first start treatment. This is to limit flu-like symptoms which some people experience when they start using Avonex. Your doctor or nurse will help you use the Avostartclip titration kit. (Notes information) Starting Avonex If you are new to Avonex, your doctor may advise you to gradually increase your dose so that you can adjust to the effects of Avonex before taking the full dose. You will be provided with an Avostartclip titration kit. Avostartclips can be attached onto the syringe enabling a reduced dose of Avonex to be injected at the start of treatment. Each Avostartclip should be used once and then discarded along with any remaining Avonex. For further details on use, speak with your doctor.
Injecting yourself You can inject Avonex yourself without the help of your doctor, if they have trained you to do this. The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX). If you have trouble handling the syringe, ask your doctor who may be able to help. (Notes information) There are more details on how to inject Avonex at the end of this leaflet. Alternate needle: Your pack of Avonex already includes a needle for injection. It may be possible for your doctor to prescribe you a shorter and thinner needle, depending on your body type. Talk to your doctor to see if this is appropriate for you. If you have problems handling the syringe, talk to your doctor about using a syringe grip. This is a specially designed holder to help you with injecting Avonex. How long to use AVONEX Your doctor will tell you how long you need to keep using Avonex. It is important to continue using Avonex regularly. Do not make changes unless your doctor tells you. If you inject more than you should You should only have one injection of Avonex, once a week. If you have used more than one injection of Avonex in a three-day period, contact your doctor or pharmacist straight away for advice. If you miss an injection If you miss your usual weekly dose, inject a dose as soon as you can. Then leave a week before using Avonex again. Continue injecting on this new day every week. If you have a preferred day for using Avonex, talk to your doctor about managing the dose, to get back to your preferred day. Do not use two injections to make up for a missed injection.

Like all medicines, this medicine can cause side effects, although not everybody gets them. (Notes information) Although the list of possible side effects can seem worrying, it s possible that you may not have any of them. Serious side effects: get medical help Serious allergic reactions If you get any of these:

Swelling of the face, lips or tongue

Difficulty breathing

A rash. Call a doctor immediately. Do not use any more Avonex until you have spoken to a doctor. Depression If you get any symptoms of depression:

Feeling unusually sad, anxious or worthless. Call a doctor immediately. Liver problems If you get any of these symptoms:

Yellowing of your skin or the whites of your eyes (jaundice)

Itching all over

Feeling sick, being sick (nausea and vomiting)

Easy bruising of the skin. Call a doctor immediately as they may be signs of a possible liver problem. Side effects seen in clinical trials (Notes information) Side effects seen in clinical trials. These are the side effects that people reported when Avonex was being tested. The figures are based on how many people said they d had them. It gives you an idea how likely you are to get similar side effects. Very common side effects (may affect more than 1 in 10 people)

Flu-like symptoms headache, muscle aches, chills or a fever: see Flu-like symptoms, below

Headache. Common side effects (may affect up to 1 in 10 people)

Loss of appetite

Feeling weak and tired

Difficulty sleeping

Depression

Flushing

Runny nose

Diarrhoea (loose stools)

Feeling or being sick (nausea or vomiting)

Numbness or tingling of skin

Rash, bruising of the skin

Increased sweating, night sweats

Pain in your muscles, joints, arms, legs or neck

Muscle cramps, stiffness in the joints and muscles

Pain, bruising and redness at the injection site

Changes to blood tests. Symptoms you might notice are tiredness, repeated infection, unexplained bruising or bleeding. Uncommon side effects (may affect up to 1 in 100 people)

Hair loss

Changes to your monthly period

Burning feeling at the site of injection. Rare side effects (may affect up to 1 in 1,000 people)

Difficulty breathing

Kidney problems including scarring that may reduce your kidney function If you get some or all of these symptoms:

Foamy urine

Fatigue

Swelling, particularly in the ankles and eyelids, and weight gain. Tell your doctor as they may be signs of a possible kidney problem.

Blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uremic syndrome). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness. Your doctor may find changes in your blood and the function of your kidneys. If any of the effects trouble you, talk to your doctor. Other side effects (Notes information) These effects have been seen in people using Avonex, but we do not know how likely they are to happen. If you feel dizzy, do not drive.

An underactive or overactive thyroid

Nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (seeing or hearing things that are not real), confusion or suicide

Numbness, dizziness, seizures or fits and migraines

An awareness of your heartbeat (palpitations), a rapid or irregular heartbeat, or heart problems which would have the following symptoms: a reduced ability to exercise, inability to lie flat in bed, shortness of breath or swollen ankles

Liver problems as described above

Nettle rash or blister-like rash, itching, worsening of psoriasis if you have it

Swelling or bleeding at the site of injection, tissue destruction (necrosis) or chest pain after an injection

Gaining or losing weight

Changes to test results, including changes to liver function tests

Pulmonary arterial hypertension: A disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with interferon beta-products. If any of the effects trouble you, talk to your doctor. Effects of the injection

Feeling faint: Your first injection of Avonex may be given by your doctor. It may make you feel faint. You may even actually faint. This is unlikely to happen again.

Just after an injection, your muscles may feel tense or very weak as though you are having a relapse. This is rare. It only happens when you inject and the effects soon pass. They may happen any time after starting on Avonex.

If you notice any irritation or skin problems after an injection, talk to your doctor. Flu-like symptoms (Notes information) Three simple ways to help reduce the impact of flu-like symptoms:

1. Use your Avonex injection just before bedtime. This may allow you to sleep through the effects.
2. Take paracetamol or ibuprofen half an hour before your Avonex injection and continue taking it for up to a day. Speak to your doctor or pharmacist about a suitable dose.
3. If you have a fever, drink plenty of water to keep you hydrated. Some people find that after injecting Avonex, they feel like they have flu. Signs are:

Headache

Muscle aches

Chills or a fever. These symptoms are not really flu You can t pass it on to anyone else. They are more common when you first start using Avonex. Your doctor may provide you with an Avostartclip titration kit which enables you to gradually increase your dose at the start of treatment to help limit flu-like symptoms. As you keep using your injections, the flu-like symptoms gradually decrease. Children (10 years of age and above) and adolescents In clinical trials, some side effects were reported more frequently in children and adolescents than in adults, e.g., muscle pain, pain in extremity, fatigue, and joint pain. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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. In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label. Store in the original package (sealed plastic tray) in order to protect from light. Store in a refrigerator (between 2 C and 8 C). Do not freeze. Avonex can also be stored at room temperature (between 15 C and 30 C) for up to one week. Do NOT use Avonex if you notice:

The pre-filled syringe is broken.

The sealed plastic tray is damaged or opened.

The solution is coloured or you can see particles floating in it.

The tamper evident cap has been broken. 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 AVONEX contains The active substanceis: Interferon beta-1a 30 micrograms/0.5 ml The other ingredients are: Sodium acetate, trihydrate; acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections. What AVONEX looks like and contents of the pack Avonex solution for injection comes as a ready to use injection In a box of Avonex there are four or twelve ready to use (pre-filled) syringes, each with 0.5 ml of a clear, colourless liquid inside. Not all pack sizes may be marketed. Each syringe is packed in a sealed plastic tray. A separate needle to give the injection is also included in the tray. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is: Biogen Netherlands B.V. Prins Mauritslaan 1171 LP Badhoevedorp The Netherlands Avonex is made by: FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek All 1, DK-3400 Hiller d, Denmark Biogen Netherlands B.V. Prins Mauritslaan 1171 LP Badhoevedorp The Netherlands You can get a larger print version of this leaflet by calling the local representatives. For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Belgi /Belgique/Belgien Biogen Belgium NV/SA +32 2 2191Lietuva Biogen Lithuania UAB +370 5 259 6

+359 2 962 12 Luxembourg/Luxemburg Biogen Belgium NV/SA +32 2 2191 esk republika Biogen (Czech Republic) s.r.o. +420 255 706 Magyarorsz g Biogen Hungary Kft. +36 1 899 9Danmark Biogen Denmark A/S +45 77 41 57 Malta Pharma. MT Ltd.. +356 21337Deutschland Biogen GmbH +49 (0) 89 99 6Nederland Biogen Netherlands B.V. +31 20 542 2Eesti Biogen Estonia O +372 618 9Norge Biogen Norway AS +47 23 40 01
Genesis Pharma SA +30 210 8771 sterreich Biogen Austria GmbH +43 1 484 46 Espa a Biogen Spain S.L. +34 91 310 7Polska Biogen Poland Sp. z o.o. +48 22 351 51 France Biogen France SAS +33 (0)1 41 37 9Portugal Biogen Portugal Sociedade Farmac utica, Unipessoal Lda. +351 21 318 8Hrvatska Biogen Pharma d.o.o. +385 1 775 73 Rom nia Johnson & Johnson Romania S.R.L. +40 21 207 18 Ireland Biogen Idec (Ireland) Ltd. +353 (0)1 463 7Slovenija Biogen Pharma d.o.o. +386 1 511 02 sland Icepharma hf +354 540 8Slovensk republika Biogen Slovakia s.r.o. +421 2 323 34Italia Biogen Italia s.r.l. +39 02 584 9Suomi/Finland Biogen Finland Oy +358 207 401
Genesis Pharma Cyprus Ltd +357 22 76 57 Sverige Biogen Sweden AB +46 8 594 113 Latvija Biogen Latvia SIA +371 68 688 United Kingdom (Northern Ireland) Biogen Idec (Ireland) Limited +44 (0) 1628 50 1This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: