AVONEX 30 MCG Proszek i rozpuszczalnik do roztworu do wstrzykiwań

Treść ulotki

1. AVONEX 30 micrograms/0.5 ml injectable solution
   1. What is AVONEX and what is it used for
   2. What you need to know before using AVONEX
   3. How to use AVONEX
   4. Possible side effects
   5. How to store AVONEX
   6. Contents of the pack and other information
   7. How to inject AVONEX
2. AVONEX 30 micrograms/0.5 ml injectable solution, in pre-filled pen
   1. What is AVONEX and what is it used for
   2. What you need to know before using AVONEX
   3. How to use AVONEX PEN
   4. Possible side effects
   5. How to store AVONEX PEN
   6. Package Contents and Other Information
   7. How to inject AVONEX PEN
   8. Take an Avonex Pen from the refrigerator
   9. Let Avonex Pen warm up.

AVONEX 30 micrograms/0.5 ml injectable solution

(interferon beta-1a)

Prefilled syringe
Read this leaflet carefully before using this medicine as it contains important
information for you.
Even if you have used AVONEX before, some of the information may have changed.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

(Supplementary information)
prescription.
If there is anything you are not sure about, ask your doctor or pharmacist.

Contents of 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
• 7. How to inject AVONEX

1. What is AVONEX and what is it used for

What is AVONEX
The active ingredient of Avonex is a protein called interferon beta-1a. Interferons are
natural substances that the body produces to protect itself from infections and diseases. The protein
contained in Avonex has exactly the same composition as interferon beta produced by the human
body.

What is AVONEX used for
Avonex is used to treat multiple sclerosis (MS).Treatment with Avonex may help you to
avoid worsening, although it cannot cure MS.

Each person experiences an individual variety of symptoms specific to MS.Among the possible symptoms are:

• Sense of imbalance or dizziness, walking problems, muscle stiffness and spasms, fatigue, numbness in the face, arms or legs
• Acute or chronic pain, bladder or bowel disorders, sexual problems and vision disturbances
• Difficulty thinking and concentrating, depression. MS also tends to relapse from time to time: this phenomenon is called a relapse (exacerbation).

(Additional information)

Avonex is most effective when taken:

• at the same time
• once a week
• regularlyDo not interrupt treatment with Avonex without first talking to your doctor.

Avonex may help reduce the number of relapses (exacerbations) you may have and slow down
the disabling effects of MS.Your doctor will tell you how long you should take Avonex or when
it will be time to stop.

How AVONEX works
Multiple sclerosis is associated with damage to nerves (brain or spinal cord). In MS, the
immune system reacts by attacking myelin – the "insulating" coating that surrounds nerve
fibers. Damage to myelin impairs the exchange of messages between the brain and other parts of the
body. This is what causes the symptoms of MS. The action of Avonex appears to consist
of preventing the body's immune system from attacking myelin.

2. What you need to know before using AVONEX

Do not use AVONEX:

• If you are allergicto interferon beta or any of the other ingredients of this medicine (listed in section 6)
• If you suffer from severe depressionor have thoughts of suicide.

Tell your doctor immediately if you are in any of these circumstances.
(Additional information)

Avonex and allergic reactions.Since Avonex contains a protein, there is a low possibility of
an allergic reaction.

More about depression.If you suffer from severe depression or have thoughts of suicide, you should not use
Avonex.
If you suffer from depression, your doctor may still prescribe Avonex, but it is important that you
inform your doctor if you have suffered from depression or other similar mood disorders.

Warnings and precautions
Talk to your doctor before using Avonex if you suffer from or have suffered in the past from the following
problems:

• Depressionor mood problems
• Thoughts of suicide.

You must immediately report any mood swings, thoughts of suicide, unusual
feelings of sadness, anxiety or worthlessness.

• Epilepsyor other uncontrolled seizure disorders
• Severe kidney or liver disorders
• Low white blood cell or platelet count,which may increase the risk of infections, bleeding or anemia
• Heart problems, which can cause symptoms such as chest pain (angina) especially after physical exertion, swelling of the ankles, shortness of breath (congestive heart failure) or irregular heartbeat (arrhythmias)
• Injection site irritation, which can cause damage to the skin and tissues (injection site necrosis). When you are ready for the injection, carefully follow the instructions in the

reduce the risk of reactions at the injection site.

Talk to your doctor if you have any of these conditions, or if they worsen during the use of Avonex.
During treatment, blood clots may form in the small blood
vessels. These clots could affect the kidneys. The formation of clots may
occur from several weeks to several years after starting treatment with Avonex.
Your doctor may decide to have you undergo blood pressure, blood (platelet count) and kidney function checks.

Tell your doctor that you are taking Avonex:

• If you need to have a blood test, because Avonex can alter the results.

(Additional information)

In some cases, you will need to inform healthcare professionals that you are using Avonex.
For example, if you are prescribed other medicines or if you need to have a blood test, Avonex
may alter the effect of the medicines or the test results.

Paediatric population
The use of Avonex is not recommended in children and adolescents because limited data are available on its use in this population. Avonex should not be used in children under 10 years of age because it has not yet been established whether it is effective and safe for them.

Other medicines and AVONEX
Tell your doctorif you are taking, have recently taken or might take any other medicines,
especially if they are medicines to treat epilepsy and depression. Avonex can influence
the action of other medicines or be influenced by them. This applies to any medicine, including those
available without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine.
No harmful effects on the breastfed infant are expected. Avonex can be used
during breastfeeding.

Driving and using machines
If you feel dizzy, do not drive.Some people experience dizziness with Avonex.
If this happens to you, or if you have other side effects that may affect your ability, do
not drive or use machines.

Important information about some of the other ingredients of AVONEX
This medicine is practically "sodium-free". It contains less than 23 mg (1 mmol) of sodium per
weekly dose.

3. How to use AVONEX

Recommended weekly dose
One Avonex injection per week.
Try to take Avonex every week, always on the same day and at the same time.
If you have decided to start treatment with Avonex, your doctor may provide you with a titration kit
Avostartclip. The Avostartclip attaches to the syringe and allows you to gradually increase the dose
of Avonex at the beginning of treatment. This limits flu-like symptoms to which some people
are susceptible when starting to use Avonex. Your doctor or nurse will teach you how to
use the Avostartclip titration kit.
(Additional information)

Starting therapy with Avonex
If you have never taken Avonex before, your doctor may advise you to gradually increase the
dose, to get used to the effects of Avonex before taking the full dose. You will probably
be provided with an Avostartclip titration kit, which is mounted on the syringe allowing the
administration of a reduced dose of Avonex at the beginning of therapy. Each Avostartclip must
be used only once and then disposed of with the remaining Avonex. For further
information on the use of this device, consult your doctor.

Self-administration of the injection
You can inject Avonex without the help of a doctor, if you have been shown how to do it. Instructions for

AVONEX).

If you have problemshandling the syringe, consult your doctor, who can help you.
(Additional information)

Alternative needle:
an injection needle is already included in the Avonex package. Your doctor may prescribe
a shorter and thinner needle depending on your physical characteristics. If you think this is the case, talk
to your doctor.

If you have problems handling the syringe, talk to your doctor about the possibility of using a
suitable tool. This tool consists of a support specifically designed to facilitate
the injection of Avonex.

How long to use AVONEX
The doctor will decide how long you should use Avonex. It is important to continue using Avonex
regularly. Do not make any changes unless directed by your doctor.

If you inject more Avonex than you should
You should have only one Avonex injection per week. If you have had more than one Avonex
injection within three days, seek immediate medical advice or contact your pharmacist.
If you forget an injection
If you miss your usual weekly dose, inject a dose as soon as possible. Then wait a
week before your next Avonex injection. Continue injections on this new day
every week. If there is a particular day of the week when you prefer to have the injection, you
should consult your doctor for the necessary instructions to return the injection to your preferred day. Do not
inject a double dose to make up for a missed injection.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
(Additional information)
Even if the list of possible side effects seems worrying, you may not experience any.

Serious side effects: contact your doctor
Severe allergic reactions
If you experience any of these symptoms:

• Swelling of the face, lips or tongue
• Difficulty breathing
• Redness. Call your doctor immediately. Do not continue to use Avonex until you have informed your doctor.

Depression
If you experience symptoms of depression:

• An unusual feeling of sadness, anxiety or sense of worthlessness. Call your doctor immediately.

Liver problems
If you experience any of these symptoms:

• Yellowing of the skin or whites of the eyes (jaundice)
• Widespread itching
• Nausea and vomiting
• Easy bruising. Call your doctor immediately,as this may be a sign of a liver problem.

Side effects detected in clinical studies
(Additional information)

Side effects detected in clinical studies.These are side effects reported during the period
in which Avonex was studied. The figures provided are based on the number of people who reported
the effect and are intended to give you an idea of the likelihood that you may also experience the side effect in
question.

Very common side effects

(may affect more than 1 in 10 people)

• Flu-like symptoms - headache, muscle pain, chills or fever: see Flu-like symptomsbelow
• 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
• Diarrhea (loose stools)
• Feeling unwell or sick (nausea or vomiting)
• Numbness or tingling of the skin
• Redness or bruising of the skin
• Increased sweating, night sweats
• Muscle or joint pain, pain in the arms, legs or neck
• Muscle cramps, muscle and joint stiffness
• Pain, bruising and redness at the injection site
• Changes in blood test results. Symptoms you may notice include fatigue, recurrent infections, unexplained bruising or bleeding.

Uncommon side effects

(may affect up to 1 in 100 people)

• Hair loss
• Changes in the menstrual cycle
• Burning sensation at the injection site.

Rare side effects
(may affect up to 1 in 1000)

• Difficulty breathing
• Kidney problems, including scarring, which may reduce kidney function. If you experience any or all of these symptoms:
• Foamy urine
• Fatigue
• Swelling, especially in the ankles and eyelids, and weight gain. Tell your doctor because these may be signs of a possible kidney problem.
• Blood clots inside the small blood vessels that can affect the kidneys (thrombotic thrombocytopenic purpura or hemolytic uremic syndrome). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or feeling lightheaded. Your doctor may find changes in your blood and kidney function.

If any of these side effects bother you, talk to your doctor.
Other side effects
(Additional information)

These effectshave been observed in people using Avonex, but it is not known what the probability
is that they will occur.

If you feel dizzy, do not drive.

• Hypo- or hyperthyroidism
• Nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (imaginary visions or sounds), confusion, suicidal ideation
• Numbness, dizziness, seizures and migraine
• Awareness of heartbeat (palpitations), rapid or irregular heartbeat, heart problems with the following symptoms: decreased ability to perform physical activity, inability to lie flat in bed, shortness of breath or swelling of the ankles
• Liver problems, as described above
• Hives or blistering rash, itching or worsening of psoriasis, if you suffer from it
• Swelling or bleeding at the injection site, tissue destruction (necrosis) or chest pain after injection
• Weight gain or loss
• Changes in laboratory test results, including liver function tests
• Pulmonary arterial hypertension: A disease that causes severe narrowing of the blood vessels in the lungs, leading to increased pressure in the vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension has been observed at various times during treatment, even years after starting treatment with interferon-beta products.

If any of these side effects bother you, talk to your doctor.
Injection side effects

• Feeling faint:the first injection of Avonex may be given by your doctor, as it may make you feel faint or actually faint. This is unlikely to happen more than once.
• You may experience hypertonia or muscle weakness immediately after the injection -an effect similar to a relapse of MS. This is rare, occurs only at the time of injection and passes shortly after. However, this side effect may occur at any time after starting therapy with Avonex.
• If you notice irritation or skin problemsafter the injection, talk to your doctor.

Flu-like symptoms
(Additional information)

Three simple ways to reduce the intensity of flu-like symptoms:

• 1.Give the Avonex injection just before going to bed. This way, when side effects occur, you will be asleep.
• 2.Take paracetamol or ibuprofenhalf an hourbefore the Avonex injection and continue to take it for up to a day. Ask your doctor or pharmacist for advice on a suitable dose.
• 3.If you develop a fever, drink plenty of waterto keep your body hydrated.

After injecting the dose of Avonex, some people feel as if they have the flu. The
symptoms are:

• Headache
• Muscle pain
• Chills or fever.

These symptoms are not due to a real flu
You cannot infect other people. These types of symptoms are more common at the beginning of therapy with
Avonex. Your doctor may provide you with an Avostartclip titration kit that allows you to gradually increase the dose
at the beginning of therapy, helping to limit flu-like symptoms.
Continuing with the injections, flu-like symptoms will gradually decrease.

Children (10 years of age and over) and adolescents
In clinical studies, some side effects have been reported more frequently in children and
adolescents compared to adults, such as muscle pain, limb pain, fatigue and
joint pain.

Reporting side effects
If you experience any side effect, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported 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 must record
the name and batch number of the medicine you are taking in your medical record.
It is advisable to possibly take note of these details in case you are requested
this information in the future.

5. How to store AVONEX

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.The expiry date
refers to the last day of that month.
Store in the original packaging (sealed plastic tray) to protect the medicine
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 no more than one
week.

DO NOT use AVONEXif you notice that:

• The pre-filled syringe is broken.
• The sealed plastic tray is damaged or open.
• The solution does not appear colourless or if particles in suspension are visible.
• The tamper-evident cap has been broken.

Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AVONEX contains
The active ingredientis: interferon beta-1a, 30 micrograms/0.5 ml

The other ingredients are:sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride,
polysorbate 20 and water for injections.

Description of the appearance of AVONEX and contents of the pack
Avonex injectable solution is supplied as a ready-to-use injection
A pack of Avonex contains four or twelve ready-to-use (pre-filled) syringes,
each containing 0.5 ml of clear and colourless liquid. Not all pack sizes may be marketed. Each syringe is packaged in a sealed plastic tray. Each
pack also includes an injection needle.

Marketing authorisation holder and manufacturer
The marketing authorisation holder is:
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands

Manufacturer
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1,
DK-3400 Hillerød,
Denmark.
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
local representative.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biogen Belgium NV/SA
 +32 2 2191218

Lietuva
Biogen Lithuania UAB
 +370 5 259 6176

България
ТП ЕВОФАРМА
 +359 2 962 12 00

Luxembourg/Luxemburg
Biogen Belgium NV/SA
 +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
 +420 255 706 200

Magyarország
Biogen Hungary Kft.
 +36 1 899 9883

Danmark
Biogen Denmark A/S
 +45 77 41 57 57

Malta
Pharma. MT Ltd..
 +356 21337008

Nederland
Biogen Netherlands B.V.
 +31 20 542 2000

Eesti
Biogen Estonia OÜ
 +372 618 9551

Deutschland
Biogen GmbH
 +49 (0) 89 99 6170

Norge
Biogen Norway AS
 +47 23 40 01 00

Ελλάδα
Genesis Pharma SA
 +30 210 8771500

Österreich
Biogen Austria GmbH
 +43 1 484 46 13

Polska
Biogen Poland Sp. z o.o.
 +48 22 351 51 00

France
Biogen France SAS
 +33 (0)1 41 37 9595

España
Biogen Spain S.L.
 +34 91 310 7110

Portugal
Biogen Portugal
Sociedade Farmacêutica, Unipessoal Lda.
 +351 21 318 8450

Hrvatska
Biogen Pharma d.o.o.
 +385 1 775 73 22

România
Johnson & Johnson Romania S.R.L.
 +40 21 207 18 00

Ireland
Biogen Idec (Ireland) Ltd.
 +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
 +386 1 511 02 90

Ísland
Icepharma hf
 +354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
 +421 2 323 34008

Italia
Biogen Italia s.r.l.
 +39 02 584 9901

Suomi/Finland
Biogen Finland Oy
 +358 207 401 200

Κύπρος
Genesis Pharma Cyprus Ltd
 +357 22 76 57 15

Sverige
Biogen Sweden AB
 +46 8 594 113 60

United Kingdom (Northern Ireland)
Biogen Idec (Ireland) Limited
 +44 (0) 1628 50 1000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency.

7. How to inject AVONEX

You must have already received instructions on how to inject Avonex.
These instructions are only a reminder. If you have any doubts, please contact your doctor or
pharmacist.

Choice of injection site

• Avonex is injected into a muscle, for example one of the muscles in the upper thigh. Injection of Avonex into the buttocks is not recommended.
• Choose a different injection site each week.This will reduce the risk of skin or muscle irritation.
• Do not chooseareas of skin with bruising, lesions or infections and do not inject into an open wound. LatvijaBiogen Latvia SIA  +371 68 688 158

Plunger

• A. Prepare
• 1. Take a sealed tray from the refrigerator
• Check the expiry date on the tray lid. Do not use the product if it is expired.
• Completely remove the paper lid. Check that the tray contains a prefilled syringe and an injection needle (see the figure “Contents of the plastic tray”).
• 2. Let the syringe warm up
• Leave the syringe at room temperature for half an hour. This will make the injection more comfortable than injecting it immediately after removal from the refrigerator. Tip:do not use external heat sources, such as warm water, to warm the syringe.
• 3. Wash your hands thoroughlywith soap and water and dry them.
• 4. Prepare cotton balls soaked in alcohol and plasters(not supplied) if needed.

Find a clean, hard surface to place the materialneeded for the injection.
Place the tray on it.

• B. Preparing the injection

Check the liquid in the syringe

It should appear clear and colourless.If the solution is cloudy or
coloured, or if particles are visible in suspension, do not use the prefilled
syringe.

Remove the syringe cap

The syringe has a white tamper-evident cap.

Make sure the cap is intact and has not been opened.
If it appears that the cap has been opened, do not use the syringe. Hold the
syringe with the white cap facing upwards.

Bend the cap at a right angle until it detaches.
Do not touch the hub.
Do not push the plunger.

3Attach the needle

Open the needle so as to expose the hub. Keep the protective cover
on the needle.

Push the needle onto the syringe.
Rotate it clockwise until it clicks into place.
Tip:make sure the needle is firmly inserted onto the syringe, otherwise
leakage may occur.
If you have been told to gradually increase the dose of Avonex,
you may need a titration kit Avostartclip provided by your
doctor. For further details, please contact your doctor.

Now remove the needle protective cover. Do not rotate it.

Tip: if you rotate the protective cover while removing it, you may
inadvertently remove the needle as well.

• C. Performing the injection

Clean and pinch the injection site

If desired, use a cotton ball soaked in alcohol to clean the skin at the
chosen injection site. Wait for the skin to dry.

With one hand, pinch the skin around the injection site.
Relax the muscle.

Perform the injection

Insert the needle into the muscle with a quick pushperpendicular to the skin .
The needle must penetrate completely.
Slowly press the plunger until the syringe is empty.
If you are using the syringe with Avostartclip, you will receive a lower dose of
Avonex.
The syringe will not empty.
3

Remove the needle

Remove the injection needle while holding the skin firmly stretched or compressed
around the injection site.
If you use alcohol cotton balls, place one on the injection site.
If desired, apply a plaster to the injection site.

Dispose of used material correctly
After performing the injection, place the needle and syringe in a special
container (a sharps container), and not in household waste.
If you have used Avostartclip, you must throw away the syringe (and Avostartclip) after
the injection. The unused portion of Avonex must notbe reused.
Paper and cotton balls can be placed in a normal waste bin.

AVONEX 30 micrograms/0.5 ml injectable solution, in pre-filled pen

(interferon beta-1a)

Pre-filled pen
Read this leaflet carefully before using this medicine, as it contains important
information for you.
Even if you have used Avonex before, some of the information may have changed.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

(Supplementary information)
prescription.
(Supplementary information)
If you have any questions, ask your doctor or pharmacist.

Contents of 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 PEN
• 4. Possible side effects
• 5. How to store AVONEX PEN
• 6. Contents of the pack and other information
• 7. How to self-inject AVONEX PEN

1. What is AVONEX and what is it used for

(Additional information)

Avonex is more effective when administered:

• at the same time
• once a week
• regularly. Do not stop treatment with Avonex without first consulting your doctor.

What is AVONEX
Avonex Pen is used to inject Avonex. The active ingredient of Avonex is a protein called

interferon beta-1a. Interferons are natural substances that the body produces to protect itself from
infections and diseases. The protein contained in Avonex has exactly the same composition
as the interferon beta produced by the human body.

What is AVONEX used for
Avonex is used to treat multiple sclerosis (MS). Treatment with Avonex may help you to
avoid worsening, although it cannot cure MS.

Each person experiences an individual variety of symptoms specific to MS. Possible symptoms include:

• Sense of imbalance or dizziness, walking problems, muscle stiffness and spasms, fatigue, numbness in the face, arms or legs
• Acute or chronic pain, bladder or bowel disorders, sexual problems and vision disturbances
• Difficulty thinking and concentrating, depression. MS also tends to flare up from time to time: this phenomenon is called a relapse (exacerbation).

Avonex can help reduce the number of relapses (exacerbations) you may have and slow down
the disabling effects of MS. Your doctor will tell you how long you should take Avonex or when
it will be time to stop.

How does AVONEX work
Multiple sclerosis is associated with damage to nerves (brain or spinal cord). In MS, the
immune system reacts by attacking myelin – the "insulating" coating that surrounds nerve
fibers. Damage to the myelin impairs the exchange of messages between the brain and other parts of
the body. This is what causes the symptoms of MS. The action of Avonex appears to consist
of preventing the body's immune system from attacking myelin.

2. What you need to know before using AVONEX

(Additional information)

Avonex and allergic reactions
Since Avonex contains a protein, there is a low possibility of an allergic reaction.

Further information on depression
If you suffer from severe depression or have suicidal thoughts, you should not use Avonex. If you suffer from
depression, your doctor may still prescribe Avonex, but it is important that you inform your
doctor if you have suffered from depression or other similar mood disorders.

Do not use AVONEX

• If you are allergicto interferon beta or any of the other ingredients of this medicine (listed in section 6)
• If you suffer from severe depressionor are thinking about suicide.

Immediately inform your doctor if you are in any of these circumstances.
Warnings and precautions
Talk to your doctor before using Avonexif you suffer or have suffered in the past from the following
problems:

• Depressionor mood problems
• Suicidal thoughts. You should immediately report any mood swings, suicidal thoughts, unusual feelings of sadness, anxiety or worthlessness.
• Epilepsyor other uncontrolled seizure disorders
• Severe kidney or liver disorders
• Low white blood cell or platelet count, which may increase the risk of infections, bleeding or anemia
• Heart disorders, which may cause symptoms such as chest pain (angina) especially after physical exertion, swelling of the ankles, shortness of breath (congestive heart failure) or irregular heartbeat (arrhythmias)
• Irritation at the injection site, which may cause damage to the skin and tissues (injection site necrosis). When you are ready for the injection, carefully follow the instructions provided in

to reduce the risk of reactions at the injection site.

Talk to your doctor if you suffer from any of these conditions, or if they worsen while using Avonex.
During treatment, blood clots (blood clots) may form within the small blood
vessels. These clots could have an effect on the kidneys. The formation of clots could
occur from several weeks to several years after starting treatment with Avonex.
Your doctor may decide to have you undergo blood pressure, blood (platelet count) and kidney function checks.

Inform your doctor that you are taking Avonex:

• if you need to have a blood test, because Avonex can alter the results.

(Additional information)

In some cases you will need to inform healthcare professionals that you are using Avonex.For
example, if you are prescribed other medicines or if you need to have a blood test, Avonex may
alter the effect of the medicines or the results of the analysis.

Paediatric population
The use of Avonex is not recommended in children and adolescents because limited data are available on its use in this population. Avonex should not be used in children under the age of
10 years because it has not yet been established whether it is effective and safe for them.

Other medicines and AVONEX
Tell your doctorif you are taking, have recently taken or might take any other
medicines, especially if they are medicines for treating epilepsy and depression. Avonex may
influence the action of other medicines or be influenced by them. This applies to any medicine,
including those available without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor
or pharmacist for advice before taking this medicine.
No harmful effects on the nursing infant are expected. Avonex can be used
during breastfeeding.

Driving and using machines
If you feel dizzy, do not drive. In some people Avonex causes a dizzying effect.
If this happens to you, or if you have other side effects that may impair your abilities, you should not
drive or operate machinery.

Important information about some of the other ingredients of Avonex
This medicine is practically "sodium-free". It contains less than 23 mg (1 mmol) of sodium per
weekly dose.

3. How to use AVONEX PEN

(Additional information)

There are further details on how to perform the injection using Avonex Pen on the back of this
The recommended weekly dose
One injection using Avonex Pen, once a week.
Try to take Avonex every week, always on the same day and at the same time.

Self-administer the injection
You can inject Avonex using Avonex Pen without the help of a doctor, if the doctor has provided you with the
(see section 7, How to inject Avonex Pen).

If you have difficulty handlingAvonex Pen, contact your doctor who can help you.

For how long to use AVONEX
The doctor will decide how long you should use Avonex. It is important to continue using Avonex
regularly. Do not make any changes unless directed by your doctor.

If you inject more Avonex than you should
You should only administer one injection of Avonex Pen, once a week. If you have used more than one
Avonex Pen within three days, seek immediate medical advice from your doctor or pharmacist.

If you forget an injection
If you miss your usual weekly dose, inject a dose as soon as possible. Then allow a
week to pass before using Avonex Pen again. Continue the injections on this new day
every week. If there is a particular day of the week when you prefer to administer the injection, you
should consult your doctor for the necessary instructions to return the injection to your preferred day. Do not
inject a double dose to compensate for a missed injection.

4. Possible side effects

(Additional information)
Although the list of possible side effects seems worrying, you may not experience any.
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects: see a doctor
Severe allergic reactions
If you experience any of these symptoms:

• Swelling of the face, lips or tongue
• Difficulty breathing
• Redness. Call your doctor immediately. Do not continue to use Avonex until you have informed your doctor.

Depression
If you experience symptoms of depression:

• Unusual feeling of sadness, anxiety or feeling of worthlessness. Call your doctor immediately.

Liver problems
If you experience any of these symptoms:

• Yellowing of the skin or whites of the eyes (jaundice)
• Widespread itching
• Nausea and vomiting
• Easy bruising. Call your doctor immediately, as this may be a sign of a liver problem.

Side effects detected in clinical studies
(Additional information)

Side effects detected in clinical studies.These are side effects reported during the period
in which Avonex was studied. The figures given are based on the number of people who reported
the effect and are intended to give you an idea of the probability that you may also experience the side effect in
question.

Very common side effects(may affect more than 1 in 10 people)

• Flu-like symptoms - headache, muscle aches, chills or fever: see Flu-like symptomsbelow
• 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
• Diarrhea (loose stools)
• Feeling unwell or sick (nausea or vomiting)
• Numbness or tingling of the skin
• Bruises or redness on the skin
• Increased sweating, night sweats
• Muscle or joint pain, pain in the arms, legs or neck
• Muscle cramps, muscle and joint stiffness
• Pain, bruising and redness at the injection site
• Changes in blood test results. Symptoms you may notice are fatigue, recurrent infections, unexplained bruising or bleeding.

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

• Hair loss
• Changes in the menstrual cycle
• Burning sensation at the injection site.

Rare side effects(may affect up to 1 in 1000 people)

• Difficulty breathing
• Kidney problems, including scarring, which may reduce kidney function If you experience any or all of these symptoms:
• Foamy urine
• Fatigue
• Swelling, especially around the ankles and eyelids, and weight gain. Tell your doctor because these may be signs of a possible kidney problem.
• Blood clots in the small blood vessels that can affect the kidneys (thrombotic thrombocytopenic purpura or hemolytic uremic syndrome). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or feeling lightheaded. Your doctor may find changes in your blood and kidney function.

If any of these side effects bother you, tell your doctor.

Other side effects
(Additional information)

These effectshave been observed in people using Avonex, but it is not known what the
probability is that they will occur.

If you feel dizzy, do not drive

• Hypo- or hyperthyroidism
• Nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (imaginary visions or sounds), confusion, suicidal thoughts
• Numbness, dizziness, seizures and migraine
• Awareness of heartbeat (palpitations), fast or irregular heartbeat, heart problems with the following symptoms: decreased ability to perform physical activity, inability to lie flat in bed, shortness of breath or swelling of the ankles
• Liver problems, as described above
• Hives or blistering rash, itching or worsening of psoriasis if you suffer from it
• Swelling or bleeding at the injection site, tissue destruction (necrosis) or chest pain after the injection
• Weight gain or loss
• Changes in laboratory test results, including liver function tests
• Pulmonary arterial hypertension: A disease that causes severe narrowing of the blood vessels in the lungs, leading to increased pressure in the vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension has been observed at various times during treatment, even years after starting treatment with interferon-beta products.

If any of these side effects bother you, tell your doctor.
Injection site side effects

• Feeling faint: the first injection of Avonex may be given by your doctor, because it may make you feel faint or actually faint. This is unlikely to happen more than once.
• You may experience hypertonia or muscle weakness immediately after the injection-an effect similar to an MS relapse. This is rare, occurs only at the time of the injection and passes shortly after.

This side effect can however occur at any time after starting therapy
with Avonex.

• If you notice irritation or skin problemsafter the injection, tell your doctor.

Flu-like symptoms
(Additional information)

Three simple ways to reduce the intensity of flu-like symptoms:

• 1. Use Avonex Pen in the evening, just before going to bed.This way you can sleep when these effects occur.
• 2. Take paracetamol or ibuprofen half an hour beforethe injection with Avonex Pen and continue to take it for up to a day. Ask your doctor or pharmacist for advice on a suitable dose.
• 3. If you develop a fever, drink plenty of waterto keep your body hydrated.

After using Avonex Pen, some people feel like they have the flu.
The signs are:

• Headache
• Muscle aches
• Chills or fever.

These symptoms are not due to a real flu
You cannot infect other people. Symptoms of this type are more frequent at the beginning of therapy with
Avonex, and with continuing injections they gradually decrease.

Children (10 years of age and over) and adolescents
In clinical studies, some side effects were reported more frequently in children and
adolescents compared to adults, such as muscle pain, limb pain, fatigue and
joint pain.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex 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 must record
the name and batch number of the medicine you are taking in your medical record.
It is advisable to possibly make a note of these details in case you are requested
this information in the future.

5. How to store AVONEX PEN

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. The expiry date refers to the last day of that month.
Avonex Pen contains a pre-filled syringe of Avonex. Store in the original package to
protect the medicine from light.
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
Avonex Pen can also be stored at room temperature (between 15°C and 30°C) for a maximum of
one week.

Do not use Avonex Pen if you notice that:

• The pen is broken.
• The solution is coloured or particles in suspension are visible.
• The tamper-evident cap has been broken.

Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What AVONEX PEN contains
The active substanceis: interferon beta-1a, 30 micrograms/0.5 ml

Other ingredientsare: sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride,
polysorbate 20 and water for injections.

Description of the appearance of AVONEX PEN and contents of the pack
Each individual pack contains an Avonex Pen, a needle and a pen cap that is tamper-evident.
Avonex Pen contains a pre-filled syringe of Avonex and must only be used after receiving adequate
instructions. Avonex Pens are supplied in packs of four or twelve for one or three months of injections.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
.

Manufacturer:
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1,
DK-3400 Hillerød,
Denmark.
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
local representative.
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Biogen Belgium NV/SA
 +32 2 2191218

Lietuva
Biogen Lithuania UAB
 +370 5 259 6176

България
ТП ЕВОФАРМА
 +359 2 962 12 00

Luxembourg/Luxemburg
Biogen Belgium NV/SA
 +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
 +420 255 706 200

Magyarország
Biogen Hungary Kft.
 +36 1 899 9883

Danmark
Biogen Denmark A/S
 +45 77 41 57 57

Malta
Pharma. MT Ltd..
 +356 21337008

Nederland
Biogen Netherlands B.V.
 +31 20 542 2000

Eesti
Biogen Estonia OÜ
 +372 618 9551

Deutschland
Biogen GmbH
 +49 (0) 89 99 6170

Norge
Biogen Norway AS
 +47 23 40 01 00

Ελλάδα
Genesis Pharma SA
 +30 210 8771500

Österreich
Biogen Austria GmbH
 +43 1 484 46 13

Polska
Biogen Poland Sp. z o.o.
 +48 22 351 51 00

France
Biogen France SAS
 +33 (0)1 41 37 9595

España
Biogen Spain S.L.
 +34 91 310 7110

Portugal
Biogen Portugal
Sociedade Farmacêutica, Unipessoal Lda.
 +351 21 318 8450

Hrvatska
Biogen Pharma d.o.o.
 +385 1 775 73 22

România
Johnson & Johnson Romania S.R.L.
 +40 21 207 18 00

Ireland
Biogen Idec (Ireland) Ltd.
 +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
 +386 1 511 02 90

Ísland
Icepharma hf
 +354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
 +421 2 323 34008

Italia
Biogen Italia s.r.l.
 +39 02 584 9901

Suomi/Finland
Biogen Finland Oy
 +358 207 401 200

Κύπρος
Genesis Pharma Cyprus Ltd
 +357 22 76 57 15

Sverige
Biogen Sweden AB
 +46 8 594 113 60

United Kingdom (Northern Ireland)
Biogen Idec (Ireland) Limited
 +44 (0) 1628 50 1000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency.

7. How to inject AVONEX PEN

Avonex Pen (single-use)
Package contents - Avonex Pen, needle and tamper-evident Avonex Pen cap
Latvia
Biogen Latvia SIA
 +371 68 688 158

Avonex Pen - ready for injection

Avonex Pen - after injection (ready for disposal)

You must have received instructions on how to use Avonex Pen.
These notes are just a reminder. If you have any doubts or problems, consult your doctor or
pharmacist.

Where to inject
Choose a different injection site each week
The best area is the outer muscle of the upper thigh.
Alternate between the right and left thigh.
Keep a record of where you perform the injection each week.

• Avonex is injected into a muscle; the best area is the outer muscle of the upper thigh,as illustrated in the image above. Injection into the buttocks is not recommended.
• Choose a different injection site each week. This reduces the risk of skin or muscle irritation.
• Do not useareas of skin with bruising, lesions or infections, or areas where there are open wounds.
• A. Preparation

1. Take an Avonex Pen from the refrigerator

Check that the package contains an Avonex Pen, a needle and a pen cap.
Do not shake Avonex Pen.
Check the expiry date on the Avonex Pen label.
Do not use it if it is expired.

2. Let Avonex Pen warm up.

Leave it at room temperature for half an hour.
This makes the injection more comfortable, rather than using it immediately after
removal from the refrigerator.

Tip:Do not use external heat sources, such as warm water, to warm Avonex Pen.

• 3.Wash your hands thoroughlywith soap and water and dry them.
• 4.Prepare disinfecting wipes and plasters(not supplied) if you need them.
• 5.Find a clean, hard surface to place the materialneeded for the injection.

• B. Preparation of Avonex Pen

1 Remove the tamper-evident cap.
Check that the cap is intact and has not been opened.
If it appears to have been opened, do not use that Avonex Pen.

• Hold Avonex Pen with the cap facing upwards.
• Bend the cap at a right angle, until itdetaches completely.
• Do not touch the exposed glass tip. Tip: Place the pen on the table before starting the procedure at point 2.

2 Attach the needle.

• Avonex Pen is designed to work exclusively with the supplied needle.
• Remove the aluminumfrom the needle cover.
• Attach the needle by pressing it onto the glass end of the pen. Keep the pen in a vertical position.
• Do not remove the needle cover.
• To avoid possible leakage from the needle, gently turn the needle clockwise until it is firmly inserted. If leakage occurs, you may not receive the entire dose of medication. Tip: The needle cover will detach automatically when performing the instructions at the next point 3.

3 Extend the injector guard.

• Hold the pen body firmly with one hand. Point the needle cover away from your body and other people.
• Using the other hand, with a quick movement move the injector guard (grooved area) overthe needle, until the needle is completely covered.
• The plastic needle cover will detach. Tip: Do not pressthe blue activation button at the same time.

4 Check that the injector guard is correctly
extended.

• Check that the injector guard is fully extended. A small rectangular area will be visible next to the oval viewing window: this is the safety lock.

5 Check the liquid

• Look through the oval viewing window. The liquid must be clear and colorless. If the solution is cloudy, colored, or if it contains suspended particles, do not use this pen. The presence of one or more air bubbles is normal.

• C. How to use Avonex Pen

1 Disinfect the injection site.

If necessary, use a cotton ball soaked in alcohol to
clean the skin at the chosen injection site. Wait for
the skin to dry.
Tip: The best area is the outer muscle of the upper
thigh.

2 Place Avonex Pen on the skin.

• With one hand, hold the pen body at a right angle to the injection site. Check that the pen windows are visible.
• Tip: Be careful not to press the blue activation button too soon.
• Press the pen body firmly against the skin to release the safety lock.
• Check that the safety lock is released. The small rectangular window will disappear. Now Avonex Pen is ready to administer the injection. Tip: Continue to hold the pen firmly against the skin.

3 Administer the injection

• To start the injection, press the blue activation button with your thumb. You will feel a click indicating that the injection process has started. Do not lift the pen from the skin.
• Continue to hold the pen on the skin and count slowly for 10 seconds.
• After 10 seconds, remove the pen to remove the needle from the injection site.
• Apply pressure to the injection site for a few seconds. If there is blood, wipe it off.

4 Confirmation of injection

• Check the oval viewing window. The window will appear yellowif the entire dose has been administered.
• Do not reuse Avonex Pen. The pen is for single use only.

5 Disposal

• Place the pen cap on a flat, hard surface. Tip: Do not hold the pen cap, you could prick yourself with the needle.
• Insert the needle directly into the pen cap.
• Press firmlyto seal the needle until you hear a click. You may need to use both hands. Once the pen is sealed, there is no risk of injury.
• Waste must be disposed of properly. Your doctor, nurse or pharmacist should provide you with instructions on disposing of the used Avonex Pen, for example in a sharps container.