AVONEX. 30 mcg. + P-solvent

LEAFLET: INFORMATION FOR THE USER
AVONEX 30 micrograms powder and solvent for solution for injection
(Interferon beta-1a) (Interteron beta-1a)
Packaging BIO-SET
Read this leaflet carefully before you start using this medicine.
WHAT AVONEX AND WHAT IT IS USED
What AVONEX
The active ingredient in Avonex is a protein called interferon beta -1a.
Interferons are natural substances in your body in order to help protect you from infections and diseases . The protein in Avonex is made up of exactly the same ingredients as interferon beta that exists in the human body.

What AVONEX is used
Avonex is used to treat multiple sclerosis (MS). Avonex treatment can help prevent worsening of your condition , although it will not cure MS .

The combination of MS symptoms is individually different for different people.
Symptoms may include:
feeling of loss of balance or instability, trouble walking , muscle stiffness and spasms of the muscles , fatigue , numbness in the face, arms or legs ;
acute or chronic pain , problems with bladder and bowel , sexual problems and problems seeing things ;
difficulty in thinking and concentrating , depression .
Furthermore, MS tends occasionally to flare it is called a relapse .

( Note )
Avonex works best when you use it at the same time , once a week regularly.
Do not stop treatment with Avonex, before talking to your neurologist.

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 how long you can use Avonex or when to stop .

How AVONEX
Multiple sclerosis is associated with damage to the nerves (brain or spinal cord) . In MS 's defense system reacts to your body 's own myelin - the 'insulation' that surrounds nerve fibers. When myelin is damaged interrupting the transmission of messages between the brain and other body parts. This is what causes the symptoms of MS . Avonex seems to work by stopping defense system of your body to attack myelin.

2 . BEFORE YOU USE AVONEX
Do not use AVONEX:
if you are allergic (hypersensitive ) to interferon beta, human serum albumin or any of the other ingredients of Avonex;
If you are pregnant , do not start using Avonex;
if you have severe depression or thoughts about suicide .
Immediately consult your doctor if any of these apply to you .

( Note )
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 depression or thoughts of suicide, you should not use Avonex.
If you have depression , your doctor may still prescribe Avonex, but it is very important to tell your doctor to give him / her know if you have depression or similar mood disorders .

Take special care with AVONEX
Talk to your doctor :
if you have or have had:
depression or problems affecting your mood;
thoughts about committing suicide.
Of changes in mood , thoughts of suicide , excessive feelings of sadness , anxiety or inferiority should immediately notify your doctor.
epilepsy or other seizure disorders not controlled by medication ;
severe kidney or liver problems ;
reduced numbers of white blood cells or platelets , which may cause an increased risk of infection , bleeding or anemia ;
heart problems that can cause symptoms such as chest pain (angina) , especially after exercise , swollen ankles , shortness of breath ( congestive heart failure ), or irregular heartbeat (arrhythmias ) .
Consult your doctor if you have any of these conditions, or if any of them get worse while using Avonex.

Tell your doctor if you are taking AVONEX:
if you have a blood test , Avonex may interfere with the results .
( Note ):
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 interfere with other medications or research results.

Using other medicines
If you are taking other medicines, especially those used to treat epilepsy or depression Avonex may affect them. This includes any other medicines , even those not prescribed.

Pregnancy and lactation
If you are pregnant, do not start treatment with Avonex;
If you could get pregnant should use contraception during treatment with Avonex;
If you are planning a baby or if you become pregnant while being treated with Avonex, tell your doctor. You and your doctor can discuss whether to continue treatment ;
If you become pregnant or think you may be pregnant , talk to your doctor as soon as possible ;
If you want to breastfeed , talk to your doctor.
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 some side effects that can affect your ability, you should not drive or operate machinery.

Important information about some of the ingredients of AVONEX
This medicine is virtually no sodium. It contains less than 23 mg ( 1 mmol) of sodium in each dose .

3 . HOW TO USE AVONEX
The usual dose for adults and adolescents over 12 years of age
One injection of Avonex once a week.
Try to use Avonex at the same time on the same day each week.
At the beginning of treatment, your doctor or nurse may gradually increase your dose of AVONEX. This will help limit the flu-like symptoms.

Not for children.
Avonex should not be used in children under the age of 12 years .

Injecting
You can inject yourself without the help of your doctor if he / she has trained you to do this. Instructions for 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. Will probably help .

( Note )
More details on how to inject Avonex at the end of this leaflet .

Replace needle :
Your pack contains Avonex injection needle . Your doctor can prescribe a shorter and thinner needle , depending on your body type . Talk to your doctor to see if this would be appropriate in your case .

If you have trouble handling the syringe , talk to your doctor about using a syringe grip . This is a specially designed holder to help you inject Avonex.

How long to use AVONEX
Your doctor will tell you how long you should continue to use Avonex. It is important to continue using Avonex regularly. Do not make changes unless your doctor tells you .

If you use more than the amount of AVONEX
You should only have one injection of Avonex, once a week. If you use more than one injection of Avonex in a period of three days , contact your doctor or pharmacist for advice.

If you forget to use AVONEX
If you miss your usual weekly dose , inject a dose as soon as you can. Then you have to leave a week before using Avonex. Continue to inject this " new day " each week. If you have a preferred day for the injection of Avonex, talk to your doctor about how to adjust the dose, to return to your preferred day.
Do not double the dose to make up for a missed injection .

4 . POSSIBLE SIDE EFFECTS
Like all medicines , Avonex can cause side effects, although not everybody gets them .
( Note )
Although the list of possible side effects can seem worrying, it 's possible that you do not have any of them.
Serious side effects , seek medical advice
Severe allergic reactions
If you get any of the following occur :
swelling of the face , lips or tongue ;
difficulty breathing ;
rash.
Call a doctor immediately . Do not use more Avonex until you have consulted a doctor.

depression
If you get any symptoms of depression :
feeling unusually sad, anxious or worthless .
Call a physician immediately .

Liver problems
If you get any of the following symptoms:
yellowing of the skin or the whites of your eyes ( jaundice) ;
itching all over ;
feeling of nausea and vomiting ( retching and vomiting ) ;
easy bruising of the skin.
Call a doctor immediately as these may be signs of a possible liver damage .

( Note )
Side effects seen in clinical trials. These are the side effects that people reported during testing of Avonex. The figures are based on how many people said they 'd had them . This gives an idea of how likely you are to get similar side effects .

Very common side effects
(affects at least 1 in 10 people):
flu-like symptoms - headache , muscle aches , chills or fever : see . below - Flu-like symptoms ;
headache.
Common side effects
( affects less than 1 in 10 people):
loss of appetite ;
a feeling of weakness and fatigue ;
sleep problems ;
depression ;
hot flashes ;
fever ;
diarrhea ( disorder) ;
feeling of nausea and vomiting ;
numbness and tingling of the skin;
rash, bruising ;
increased sweating , night sweats ;
aching muscles , joints, arms, legs, or neck ;
muscle cramps, stiffness of joints and muscles ;
pain , bruising ( hematoma ) , and redness at the injection site ;
change the results of the blood test. The symptoms that you might notice are tiredness, repeated infection, unexplained bruising ( bruises) and bleeding.
Uncommon side effects
( affects less than 1 in 100 people):
hair loss ;
changes in menstrual periods ;
burning sensation at the site of injection .
Rare side effects
(affects no- less than 1 in 1000 people):
difficulty breathing .
If you get experience any of these reactions , talk to your doctor.
Other side effects
( Note )
These effects are seen in people who apply Avonex, but we do not know how likely they are to occur .
underactive or overactive thyroid gland ;
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 ;
feel your heartbeat ( palpitations) , a rapid or irregular heartbeat, or heart problems, which have the following symptoms : decreased ability to exercise, inability to lie flat in bed , shortness of breath and swelling of the ankles ;
liver problems , sis as described above ;
hives or blister-like rash , itching, worsening of psoriasis if you have it;
swelling or bleeding at the site of injection , or chest pain after injection ;
gaining or losing weight ;
change research results , including changes in liver function tests .
If you suffer from any of these , talk to your doctor.

Effects of the injection
Malaise : The first injection of Avonex may be given by your doctor. It may make you feel faint . You may even actually faint. This is unlikely , however, to repeat ;
Immediately after the injection, you may experience a pronounced muscle weakness - like having a relapse . This is rare . It only happens during injection and the effect quickly disappears . May, however, occur at any time after the start of treatment with Avonex;
If you notice any irritation or skin problems after an injection, tell your doctor.
flu-like symptoms
( Note )
Three simple ways to help reduce flu-like symptoms:
1. Avonex injection just before bedtime . Can it help you sleep through the reactions.
2 . Take paracetamol or ibuprofen half an hour before your Avonex injection and continue to take it for a period of one day. Talk to your doctor or pharmacist to determine the appropriate dose.
3 . If you have a fever , drink plenty of water to you hydrated .

Some people find that after injecting Avonex, they feel like they have flu . Signs are :
headache ;
muscle pain ;
chills or fever .
These symptoms are not the flu. Since you can not infect anyone. They are more frequent at the beginning of treatment with Avonex. At the start of treatment, your doctor or nurse may gradually increase your dose of AVONEX With continued injections , flu-like symptoms gradually decrease .

5 . HOW TO STORE AVONEX
Keep out of reach of children.
Do not use Avonex after the expiry date stated on the label .
Do not store above 25 ° C.
Solution after preparation and drawn into the syringe should be administered as soon as possible . However, the prepared syringe to be stored in a refrigerator (2 ° C - 8 ° C) for a maximum of 6 hours prior to injection. Do not freeze. Bring it out half an hour before the injection.

DO NOT use AVONEX, if you notice that :
The bottle cap is broken.
The sealed plastic tray is damaged or opened.
After preparation of the injection , the liquid solution that you have prepared in the vial has a different color, but not colorless or slightly yellow, or if you can see it sail particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . ADDITIONAL INFORMATION
ingredients
The active substance (s) is: Interferon beta -1a 30 micrograms
Other ingredients are: Human serum albumin , sodium chloride , disodium hydrogenphosphate and sodium dihydrogenphosphate.

What Avonex pack
Each box Avonex Bioset has four doses of Avonex.
Each dose is in a sealed plastic tray and has a white to off- white powder in a glass container ( vial) and an injection syringe , which is filled with water. They are mixed to prepare the injection you take ( solution for injection) . The pack also provided separate needle for injection .

Marketing Authorisation Holder:
Biogen Idee Limited, United Kingdom.

Manufacturer of Avonex e:
Biogen Idee Denmark Manufacturing ApS, Denmark.

7 . How to inject AVONEX
You must have training in how to inject Avonex.
These notes are a reminder . If you are not sure , check with your doctor or pharmacist.

Where to inject
Avonex is injected into a muscle , such as the upper thigh muscle . Avonex injection in the buttocks is not recommended.
Each week, use a different location for the injection. This means less risk of irritation of the skin and muscle.
Do not use any area of skin that is bruised, sore or infection , or if there is an open wound .
A. Preparation
1. Remove the tray from the box.
Check the expiry date of the expiry date of the lid of the tray . Do not use if expired .
Peel and remove the lid completely . Check the tray :
a BIO-SET ( vial + Base + cap) ;
a syringe ;
one injection needle ( see picture " Contents of the plastic tray" ) .
2 . Wash hands thoroughly with soap and water and dry them .
3 . Prepare alcohol wipes and sticking plasters (not supplied) if required.
4 . Find a clean , hard surface on which to place things that you will need for your injection . Place the tray on it.

B. Preparing the injection
1. Remove the cap from the vial
Twist, then pull the cap.
Do not touch the connection .
2 . Pull the cap off the syringe
Hold the base of the syringe. Pull the fuse.
Do not touch the connection . Do not push the plunger.
3 . Align the syringe and vial
Place the Bio-Set on a flat surface .
Align the two binding sites , so as to be in a straight line.
Hold the syringe base her Screw her on the clockwise tight vial .
4 . Tap the syringe down until it locks
Keep Bio-Set on flat surface and hold the syringe for her foundation
Keep them in a straight line.
Tip: If the syringe is at an angle to the Bio-Set, it will leak . Push the syringe until it clicks .

5 . Mix water and powder
Slowly inject all the water from the syringe into the vial.
Tip: Do not push the plunger quickly . This results in the conversion of the solution into a foam, which can not be drawn into the syringe .
Push the plunger to expel air from the syringe .

6 . Dissolve the powder fully
Take the vial and syringe , keeping them attached and straight .
Gently swirl the vial until all the powder has dissolved .
Do not shake : this leads to the formation of foam .
7 . Fill the syringe
Take the syringe with the vial upside down, still in a straight line.
Tip: If the syringe at an angle to the Bio-Set, will leak.
Slowly pull the plunger until all the liquid in the syringe .

8 . Divide the syringe from the vial
Hold the syringe to the base. Turn it clockwise to remove it from the vial Bio-Set.
Do not touch the connection of the syringe.
C. Giving the injection
1. Check the liquid in the syringe
It should be clear and colorless. If the solution is any other color , and it is a colorless or pale yellow, or if you notice contains particles , do not inject .
2 . Inserting the needle
Unscrew the needle to expose the connection .
Fuse it should remain in place.
Push and twist the needle clockwise onto the syringe.
Now remove the fuse.
Do not twist .
Tip: If you twist the needle when you remove it , it may accidentally come off and the needle.

3 . Remove any air
To remove air, point the syringe up .
Pochuknete January gently to make any air bubbles go to the top.
Gently , gently press the plunger to expel the air. Do not allow to flow over a small drop of liquid.
4 . Clean and stretch the injection site .
If necessary , use an alcohol wipe to clean the skin at the injection site , which you have selected . Allow the skin to dry .
With one hand , stretch the skin around the injection site .
Relax your muscle .
5 . Place injection
Insert the injection needle with a quick motion, like pressing the arrow jerked right angle through the skin into the muscle.
You have to go all the way needle.
Slowly press the plunger until the syringe is empty .
At the beginning of treatment , to reduce flu-like symptoms , your doctor or nurse may increase your dose postapenno . Any unused Avonex should be discarded and should not be used.
6 . pull the needle
Keep the skin stretched tightly or squeeze the skin around the injection site , and pull out the needle.
Put a plaster over the injection site if you need to.
7 . Dispose of waste appropriately
After you have finished each injection, put the needle, syringe and vial container (eg sharps ) and not in ordinary rubbish .
Waste paper and used tampons can be disposed of in an ordinary household waste.