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Extavia 250 mcg. 15 vials

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What Extavia is
Extavia is a medicine known as interferon that is used to treat multiple sclerosis. Interferons are proteins synthesized by the body that help him fight attacks against the immune system, Viral infections.

How Extavia works
Multiple sclerosis (MO) is a chronic condition affecting the central nervous system (CNS) and especially the function of the brain and spinal cord. In MC, an inflammatory process destroys the protective shell (called myelin) of CNS nerves and stops their normal functioning. This process is called demyelination.
The exact cause of MS's appearance is unknown. It is believed that an abnormal response to the human immune system plays an important role in the process of CNS damage.
CNS damage can develop during an MS attack. It may cause temporary disabling, such as, for example, Difficulty walking. Symptoms may resolve completely or partially.
It has been shown that interferon beta-1b changes the response of the immune system and helps to reduce the activity of the disease.

How Extavia helps treat your illness:
Single clinical episode indicative of a high risk of developing multiple sclerosis: Extavia has been shown to delay progression to clinically defined multiple sclerosis.

Recurrent-remitting multiple sclerosis: Patients with relapsing-remitting MS have recurrent seizures during which symptoms are visibly impaired. Extavia has been shown to reduce the number of seizures and make them lighter. It reduces the number of hospitalizations due to the disease and prolongs the time without seizures.

Secondary progressive multiple sclerosis: In some cases, patients with relapsing-remitting MS have noticed enhancement of their symptoms and progression to another form of MS called secondary progressive MS. In these cases, patients find that their disability is increasing regardless of whether or not they have seizures. Extavia may reduce the number and severity of seizures and delay the progression of disability.

What Extavia is used for:
Extavia is used in patients:
Who for the first time have symptoms indicative of a high risk of developing multiple sclerosis. Before starting treatment, your doctor will exclude all other causes for which these symptoms are characteristic;
Who suffer from relapsing-remitting multiple sclerosis with at least two attacks over the last two years;
Who suffer from a secondary progressive form of multiple sclerosis with active disease, proven by seizures.

2. What you need to know before using Extavia
Do not use Extavia:
If you are allergic to natural or recombinant interferon beta, human albumin or any of the other ingredients of this medicine (listed in section 6);
If you are pregnant. In this case, you should not start treatment with Extavia (see section "Pregnancy" below);
If you become pregnant or planning a pregnancy. You must stop treatment with Extavia and tell your doctor (see section "Pregnancy" below);
If you suffer from severe depression and / or have suicidal thoughts (see "Warnings and precautions" and section 4. "Possible side effects");
If you have severe liver damage (see "Warnings and precautions", "Other medicines and Extavia" and section 4. "Possible side effects").
Please tell your doctor if any of the conditions listed above apply to you.

Warnings and precautions
Talk to your doctor before using Extavia:
If you have monoclonal gammopathy. This is a disorder of the immune system, in which an abnormal protein is found in the blood. When using medicines like Extavia, it is possible that problems with small blood vessels (capillaries) (systemic capillary leak syndrome) may occur. This can lead to shock (collapse) or even fatal;
If you have had a depression in the past, if you have depression or if you have been thinking about suicide in the past. Your doctor will monitor you closely during treatment. If your depression and / or your thoughts of suicide are severe, you will not be given Extavia (see also "Do not use Extavia");
If you have ever had seizures or if you are taking medicines for epilepsy (anti-epileptic medicines), your doctor will monitor your treatment carefully (see also "Other medicines and Extavia" and section 4 "Possible side effects");
If you suffer from serious kidney problems, your doctor may monitor your kidney function during treatment.
While using Extavia, your doctor should also know:
If you experience symptoms such as itching around the body, swelling of the face and / or tongue and sudden shortness of breath. These may be the symptoms of a severe allergic reaction that can become life-threatening;
If you feel noticeably more sad or depressed than the time before treatment with Extavia or if you think of suicidal thoughts. If you develop depression during treatment with Extavia, you may need special treatment and your doctor will carefully monitor you and may also suggest stopping your treatment. If you suffer from severe depression and / or suicidal thoughts, you will not be treated with Extavia (see also "Do not use Extavia");
If you notice unusual bruising, increased bleeding after trauma or if you often have infections. These may be symptoms of a decrease in the number of blood cells or the number of platelets (the cells responsible for blood clotting). You may need additional supervision from your doctor;
If you have a loss of appetite, fatigue, nausea, vomiting periodically and especially if you notice itchy skin, yellowing of the skin or eyes or easily occurring bruising. These symptoms may indicate problems with your liver. In clinical trials, changes in functional liver function parameters were observed in patients treated with Extavia. As with other interferons, rare hepatic impairment, including cases of hepatic failure, has been reported in patients receiving Extavia. The most severe of these have been seen in patients taking other medicines or suffering from diseases that may affect the liver (eg alcohol abuse, severe infection);
If you experience symptoms such as an irregular heartbeat, ankle or leg swelling or shortness of breath. These may be the symptoms of cardiac disease (cardiomyopathy) that has been observed in patients taking Extavia;
If you notice abdominal pain that spreads to your back and / or you feel sick or have fever. These may be symptoms of inflammation of the pancreas (pancreatitis), as reported with Extavia. Often this is accompanied by an increase in some blood fats (triglycerides).
Stop using Extavia and tell your doctor immediately if you experience any of these symptoms.

Other things to keep in mind when using Extavia:
You will need blood tests to determine the number of blood cells, biochemical parameters and liver enzymes. These will be done before you start using Extavia regularly after starting treatment with Extavia and then periodically during treatment even if you do not have any special symptoms. These will be additional blood tests, except those usually done for MS follow-up;
If you suffer from heart disease, flu-like symptoms that often occur at the beginning of treatment may be stressful for you. Extavia should be used with caution and your doctor will monitor your condition for a possible worsening of heart function, especially at the beginning of treatment. Extavia itself does not affect the heart directly;
Your thyroid function will be reviewed periodically or if your doctor thinks necessary for other reasons;
Extavia contains human albumin and therefore has a potential risk of transmission of viral infections. The risk of transmitting Creutzfeld-Jacob disease (BCA) can not be ruled out;
During treatment with Extavia, your body may be able to synthesize substances called neutralizing antibodies that can interact with Extavia. It is not yet known whether these neutralizing antibodies reduce the effectiveness of the treatment. Not neutralizing antibodies are synthesized in all patients. Currently, it is not possible to predict which patients fall within this group;
During treatment with Extavia, kidney problems may occur that may lead to decreased renal function, including fibrosis (glomerulosclerosis). Your doctor may have tests to evaluate your kidney function;
During the treatment, blood clots may appear in small blood vessels. These blood clots could affect the kidneys. This may happen from a few weeks to several years after starting treatment with Extavia. Your doctor may want to check your blood pressure, blood (platelet count) and kidney function.
Injection site reactions
During treatment with Extavia, it is expected that you will develop injection site reactions. Symptoms include redness, swelling, skin discolouration, inflammation, pain and hypersensitivity. Less commonly, disruption of skin integrity and tissue damage (necrosis) around the injection site has been reported. Usually, the frequency of reactions at the injection site decreases with time.
Disturbance of the integrity of the skin and the tissue at the site of injection may result in scarring. If these changes are severe
If you experience any disruption of the skin's integrity accompanied by swelling or leakage of the injection site:
Stop the injection of Extavia and consult your doctor.
If you have only one inflamed area of ​​injection (lesion) and tissue damage (necrosis) is not very severe, you can continue to use Extavia;
If more than one injection site is inflamed (multiple lesions), you should stop using Extavia to heal your skin.
Your doctor will periodically check for self-injection, especially if you have had reactions at the injection site.

Children and adolescents
No formal clinical trials have been conducted in children or adolescents.
However, there are some data available for adolescents between 12 and 17 years of age, suggesting that the safety profile of Extavia in this age group is the same as in adults.
Extavia should not be used in children below 12 years of age due to lack of information about this age group.

Other medicines and Extavia
Tell your doctor or pharmacist if you are using, have recently used or are likely to use other medicines.
No formal interaction studies have been conducted to ascertain whether Extavia affects other medicines or how far they affect them.
Concomitant administration of Extavia with medicines that affect the immune response of the body, with the exception of anti-inflammatory drugs called corticosteroids or ACTH, is not recommended.

Extavia should be used with caution with:
Medicines whose metabolism needs a certain liver enzyme system (known as the cytochrome P450 system) to remove them from the body, e.g. Medicines for epilepsy (such as phenytoin);
Medicines that affect the production of blood cells.
Extavia with food and drink
Extavia is injected subcutaneously so that Extavia is not expected to be affected by any of your drinks or foods.

Pregnancy
Women who may become pregnant should use appropriate contraception during treatment with Extavia.
If you are pregnant or suspect that you are pregnant, tell your doctor. Extavia treatment should not be started if you are pregnant (see also "Do not use Extavia");
If you intend to become pregnant, discuss this with your doctor first before starting treatment with Extavia;
If you become pregnant during treatment with Extavia, stop treatment and contact your doctor immediately. You and your doctor will decide together whether or not to continue treatment with Extavia.
Ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding
It is not known whether interferon beta-1b passes into human breast milk. However, there is a theoretical possibility of occurrence of serious adverse reactions to interferon beta-1b in infants.
Discuss with your doctor before starting treatment with Extavia whether or not you should stop breast-feeding so that you can be given Extavia.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Extavia may cause side effects of the central nervous system (see section 4. "Possible side effects"). If you are particularly sensitive, this may affect your ability to drive and use machines.

Extavia contains sodium
This medicinal product contains sodium less than 1 mmol (23 mg) per ml, ie. Practically does not contain sodium.

3. How to use Extavia
Treatment with Extavia should be initiated under the supervision of a physician experienced in the treatment of multiple sclerosis.
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one day (once every two days), 1.0 ml of the reconstituted solution of Extavia (see Annex "Single injection procedure" in the second part of the leaflet) is injected under the skin (subcutaneously). This is equivalent to 250 micrograms (8.0 million IU) of interferon beta-1b.
In general, treatment should be started at a low dose of 0.25 ml (62.5 micrograms). The dose will then be gradually increased to the full dose of 1.0 ml (250 micrograms). The dose should be increased every four times in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml). Your doctor may decide, together with you, to change the dose increments to increase the dose depending on the side effects that may occur with you at the start of treatment.
Preparation of the injection
Prior to injection, Extavia solution should be reconstituted from the Extavia powder vial and 1.2 ml of the liquid from the pre-filled syringe with solvent. All this will be done by your doctor or nurse or by yourself after you have been carefully trained.
Detailed instructions for subcutaneous self-injection of Extavia are provided in the Annex on the back of this leaflet. These instructions tell you how to make the solution for injection.
The injection site should be changed regularly. See section 2 "Warnings and precautions" and follow the instructions for "Changing the injection sites" in the application on the back of this leaflet.

Duration of treatment
It is currently not known how long Extavia treatment should be continued. The duration of treatment will be determined by your doctor with you.

If you use more Extavia than you should
The administration of Extavia doses repeatedly exceeding the recommended dose for the treatment of multiple sclerosis did not result in life-threatening conditions.
Ask your doctor if you have injected too much Extavia or too often.
If you forget to use Extavia
If you forget to put your injection at the right time, do it as soon as you remember and then put the next injection after 48 hours.
Do not inject a double dose to make up for a forgotten single dose.

If you stop using Extavia
Discuss with your doctor if you stop or want to stop treatment. It is not known that stopping treatment with Extavia will lead to acute withdrawal symptoms.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Extavia can cause serious side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.

Tell your doctor and stop using Extavia immediately:
If you experience symptoms such as itching all over the body, swelling of the face and / or tongue or sudden onset of breathlessness;
If you feel much more sad or discouraged than before starting treatment with Extavia or if you have thoughts about suicide;
If you notice abnormal bruising, increased bleeding after trauma, or if you often have infections;
If you have a loss of appetite, fatigue, nausea, vomiting periodically, especially if you notice itching all over the body, yellowing of the skin or the white part of the eyes or bruising;
If you experience symptoms such as irregular heart rhythm, swelling of your ankles or legs or shortness of breath;
If you have abdominal pain that spreads to the back and / or you feel sick or have fever.
Tell your doctor immediately:
If you get any or all of the symptoms: cloudy urine, fatigue, swelling, especially in the ankles and eyelids, and weight gain as there may be signs of a likely kidney problem.
At the beginning of treatment, side effects are common, but they usually decrease during the course of treatment.

The most common side effects are:
Flu-like symptoms such as fever, chills, soreness in the joints, malaise, sweating, headache or muscle pain. These symptoms can be reduced by taking paracetamol or non-steroidal anti-inflammatory drugs such as ibuprofen;
Injection site reactions. Symptoms may include redness, swelling, discoloration, inflammation, pain, hypersensitivity, tissue damage (necrosis). See "Warnings and precautions" in section 2 for more information about what to do if you experience side effects at the injection site. They can be reduced by using an auto-injector. Contact your doctor, pharmacist or nurse for more information.
To reduce side effects at the start of treatment, your doctor should start using a small dose of Extavia and gradually increase it (see section 3 "How to use Extavia").

The following list of side effects is based on reports from clinical trials with Extavia (List 1) and adverse reactions to the marketed product (List 2)

List 1:
Very common side effects seen in clinical trials with Extavia (may affect more than 1 in 10 people) and reactions with a frequency higher than placebo. The list also includes undesirable effects that are common (may affect up to 1 in 10 people) but which have a significant association with treatment:
Infection, abscess;
Decreased white blood cell count, enlarged lymph nodes (lymphadenopathy);
Reduction
In addition, during the post-marketing period the following side effects have been identified.
List 2:
Adverse reactions reported during product marketing (frequencies - where known - based on clinical trial data):
Very common (may affect more than 1 in 10 people):
Joint pain (arthralgia).
Common (may affect up to 1 in 10 people):
Decreasing the number of red blood cells in the blood (anemia);
The thyroid gland does not work properly (produces too little hormone) (hypothyroidism);
Increasing or decreasing weight;
Confusion;
Abnormally fast heart rhythm (tachycardia);
It is possible to increase the red-yellow pigment (bilirubin) that is produced by the liver (this will be determined by blood tests);
Swollen and usually itchy areas of the skin or mucous membranes (urticaria);
Itching (pruritus);
Hair loss (alopecia);
Menstrual disorders (menorrhagia).
Uncommon (may affect up to 1 in 100 people):
The number of platelets (which help the blood to clot) may decrease (thrombocytopenia);
Certain types of fats in the blood (triglycerides) may increase (to be determined by blood tests), see section 2 "Warnings and Precautions";
Suicide attempts;
Mood swings;
Seizure;
A specific hepatic enzyme (gamma GT) that is produced by the liver may increase (this will be determined by liver tests);
Inflammation of the liver (hepatitis);
Changing the color of the skin.
Rare (may affect up to 1 in 1,000 people):
Serious allergic (anaphylactic) reactions;
The thyroid gland is not working properly (thyroid disorders), more hormone is produced (hyperthyroidism);
Inflammation of the pancreas (pancreatitis), see section 2 "Warnings and Precautions";
Blood clots in small blood vessels that may affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome). Symptoms may include more frequent bruising, bleeding, fever, excessive weakness, headache, dizziness or vertigo. Your doctor may experience changes in your blood and kidney function.
Adverse reactions only obtained during the post-marketing period:
Kidney problems, including fibrosis (glomerulosclerosis), which may reduce renal function (uncommon);
Severe loss of appetite leading to weight loss (anorexia) (rare);
Cardiac disease (cardiomyopathy) (rare);
Sudden bronchospasm (rare);
Impaired liver function (liver damage [including hepatitis], hepatic failure) (rare);
Problems with small blood vessels (capillaries) may occur with the use of medicines similar to Extavia (systemic capillary leak syndrome) (not known).
How to store Extavia
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store above 25 ° C. Do not freeze.
Use the solution as soon as it is prepared. However, if this is not possible, the solution will remain in use for up to 3 hours if stored in a refrigerator at 2 ° C - 8 ° C.
Do not use this medicine if you notice it contains particles or if it is discolored.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Extavia contains
The active substance is: interferon beta-1b. Each vial contains 300 micrograms (9.6 million IU) of interferon beta-1b. After reconstitution, each milliliter contains 250 micrograms (8.0 million IU) of interferon beta-1b.

The other ingredients are:
In the powder: mannitol and human albumin;
In the solvent: sodium chloride, water for injection.
What Extavia looks like and contents of the pack
Extavia is a powder and solvent for solution for injection.
The powder is white to off-white in color.
Extavia powder is available in a 3 ml vial.
The solvent is a clear / colorless solution.
The solvent for Extavia is supplied in 1.2 ml pre-filled syringes and contains 1.2 ml of sodium chloride 5.4 mg / ml (0.54% w / v) sodium chloride solution for injection.

Extavia is available in packs of:
5 vials of interferon beta-1b and 5 pre-filled syringes containing solvent;
14 vials of interferon beta-1b and 14 pre-filled syringes containing solvent;
15 vials of interferon beta-1b and 15 pre-filled syringes containing solvent;
3-month group pack containing 42 (3x14) interferon beta-1b vials and 42 (3x14) pre-filled syringe with solvent;
3-month group pack containing 45 (3x15) vials of interferon beta-1b and 45 (3x15) pre-filled syringe with solvent.
Not all packs may be marketed.

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