12 mg concentrate for infusion solution
What LEMTRADA is and what it is used for
LEMTRADA contains the active substance alemtuzumab used to treat a form of multiple sclerosis (MS) in adults, called relapsing-remitting multiple sclerosis (RRMS, relapsing-remitting MS). LEMTRADA does not cure MS but can reduce the number of relapses of MS. LEMTRADA can also help slow down or reverse certain signs and symptoms of MS. In clinical trials, patients treated with LEMTRADA had fewer relapses and were less likely to have impaired function compared with patients treated with a beta-interferon injected several times a week.
LEMTRADA is used if your MS is highly active even though you have been treated with at least one other MS medicine or if your MS worsens rapidly.
What is multiple sclerosis?
Multiple sclerosis, MS, is an autoimmune disease that affects the central nervous system (brain and spinal cord). MS means that your immune system accidentally attacks the protective layer (myelin) around the nerve fibers and causes inflammation. When inflammation causes symptoms, it is often called an attack or a relapse. Patients with RRMS experience relapses that are followed by periods of recovery.
What symptoms you experience depends on which part of your central nervous system is affected. The damage that occurs to your nerves during this inflammation can go back, but as the disease progresses, the damage can build up and become permanent.
How LEMTRADA works
LEMTRADA regulates your immune system to limit attacks on the nervous system.
What you need to know before you get LEMTRADA
DO NOT use LEMTRADA:
- if you are allergic to alemtuzumab or any of the other ingredients of this medicine (listed in section 6)
- if you are infected with human immunodeficiency virus ( HIV ).
- if you suffer from a serious infection
- if you have any of the following conditions:
- other autoimmune disease besides multiple sclerosis
- untreated high blood pressure
- previously had ruptures in blood vessels that supply the brain
- previously had a stroke
- previously had a heart attack or chest pain
- previously had bleeding disorders
Warnings and cautions
Talk to your doctor before receiving LEMTRADA. After receiving treatment with LEMTRADA, you may be at greater risk of developing other autoimmune conditions or serious infections. It is important that you understand these risks and how to keep them under control. You will receive a patient warning card and a patient guide with additional information. It is important that you always carry the Patient Alert Card with you during treatment and for four years after your last infusion of LEMTRADA, as side effects may occur several years after treatment. You should always show the patient warning card to your doctor when receiving medical treatment, even if it is not for your MS.
Your doctor will take blood samples before you start treatment with LEMTRADA. The purpose of the tests is to find out if you can take LEMTRADA. Your doctor also wants to make sure that you do not have any medical conditions or diseases before starting treatment with LEMTRADA.
- Autoimmune conditions
Treatment with LEMTRADA may increase the risk of autoimmune conditions. Such conditions mean that the immune system accidentally attacks your body. Below you will find information on certain specific conditions that have been observed in MS patients who have been treated with LEMTRADA.
These autoimmune conditions can occur several years after treatment with LEMTRADA. Therefore, you must leave regular blood and urine tests for four years after your last infusion. These tests are needed even if you are feeling well and if your MS symptoms are under control. There are certain signs and symptoms that you should keep an eye out for. In addition, these conditions can occur later than 4 years after the end of treatment and you must therefore continuously look for signs and symptoms, even after you no longer need to leave monthly blood and urine tests. Detailed information on these signs and symptoms, the sampling, and measures you need to take can be found in sections 2 and 4 – autoimmune conditions.
Further useful information on these autoimmune conditions and how to test for them can be found in the LEMTRADA Patient Guide.
- Acquired haemophilia ( haemophilia A)In rare cases, patients have developed a bleeding disorder , which is caused by antibodies that act against factor VIII (a protein needed for normal blood coagulation), which is called acquired hemophilia ( hemophilia A). This condition needs to be diagnosed and treated immediately. Symptoms of acquired haemophilia are described in section 4.
Immunological thrombocytopenia (ITP)
A common side effect is that patients develop a bleeding disorder that is caused by a low level of platelets and is called immunological thrombocytopenia (ITP). This disease must be diagnosed and treated early, otherwise the effects can be serious or even fatal . A description of the signs and symptoms of ITP can be found in section 4.
Kidney disease (eg anti-GBM disease)
In rare cases, patients have experienced autoimmune reactions that have caused kidney problems , such as antiglomerular basement membrane disease (anti-GBM disease). A description of the signs and symptoms of kidney disease can be found in section 4. If left untreated, it can cause kidney failure that requires dialysis or transplantation, and can lead to death.
are very common that patients experienced an autoimmune disorder of the thyroid gland which affects its ability to form or to check hormone you that are important for metabolism.
LEMTRADA can cause various types of thyroid disorders, including:
- Overactive thyroid gland ( hyperthyroidism ), where the thyroid gland produces too much hormone
- Underactive thyroid gland ( hypothyroidism ), where the thyroid gland does not produce enough hormone .
A description of the signs and symptoms of thyroid disorders can be found in section 4.
If you develop a thyroid disorder, in most cases you will need to be treated for the rest of your life with drugs that control the thyroid disorder, and in some cases, the thyroid gland may need to be removed.
You must get the right treatment for thyroid disorders, especially if you become pregnant after using LEMTRADA. If you have an untreated thyroid disorder, this can harm the fetus or the newborn baby.
Liver inflammationSome patients have developed hepatitis after receiving LEMTRADA.Hepatitis can be diagnosed from the blood samples that you must take regularly after treatment with LEMTRADA. Tell your doctor if you develop one or more of the following symptoms: nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellow skin or eyes, dark urine or bleeding or if you get bruises more easily than normal.
Thrombotic thrombocytopenic purpura (TTP)A thrombotic disease called thrombotic thrombocytopenic purpura (TTP) can occur during treatment with LEMTRADA. Blood clots form in blood vessels and can occur throughout the body. Contact your healthcare provider immediately if you have any of the following symptoms: bruising of the skin or mouth that may appear as small red dots, with or without unexplained extreme fatigue, fever, confusion, speech changes, yellowing of the skin or eyes (jaundice), small amount of urine, dark-colored urine. It is recommended to seek medical attention immediately as TTP can be fatal (see section 4 “Possible side effects”).
SarcoidsThere have been reports of an immune system disease ( sarcoidosis ) in patients treated with LEMTRADA. Symptoms may include persistent dry cough, shortness of breath, chest pain, fever, swollen lymph nodes , weight loss, rash and blurred vision.
Other autoimmune conditions
In less common cases, patients have experienced autoimmune conditions involving red or white blood cells . This can be diagnosed from the blood samples that you need to take regularly after treatment with LEMTRADA. If you develop any of these conditions, your doctor will tell you and take appropriate action to treat the condition.
Most patients treated with LEMTRADA experience side effects during the infusion itself or within 24 hours after the infusion . To try to reduce the infusion reactions, your doctor will give you some medicine or other medicines (see section 4 – infusion reactions ).
- Other serious reactions that occur shortly after infusion one of LEMTRADASome people have had severe or life-threatening reactions after infusion of one of LEMTRADA, including bleeding in the lungs, heart attack, stroke or rupture of blood vessels that supply the brain. Reactions may occur after any of the doses during the treatment regimen. In a majority of cases, the reactions have occurred within 1-3 days after infusion one. Your doctor will monitor vital parameters, including blood pressure before and during infusion one. Get help immediately if you have any of the following symptoms: difficulty breathing, coughing up blood, chest pain, drooping face, sudden severe headache, weakness in one half of the body, difficulty speaking or neck pain.
- Hemophagocytic lymphohistiocytosisTreatment with LEMTRADA may increase the risk of excessive activation of white blood cells in association with inflammation (haemophagocytic lymphohistiocytosis), which may be fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands , bruising or rash, contact a doctor immediately.
Patients treated with LEMTRADA are at higher risk of developing a serious infection (see section 4 – Infection s ). In general, these infections can be treated with standard medicines .
To reduce the risk of you getting an infection, your doctor will check if other medicines you are taking can affect your immune system. Therefore, it is important that you tell your doctor about all the medicines you are taking.
Tell your doctor if you have a serious infection before starting treatment with LEMTRADA as your doctor will postpone treatment until the infection has passed.
Patients treated with LEMTRADA are at higher risk of developing a herpes infection (for example, a cold sore ). In general, a patient who has already had a herpes infection has a higher risk of developing a herpes infection again. It is also possible to develop a herpes infection for the first time. It is recommended that your doctor prescribe a medicine that reduces the risk of developing a herpes infection that you should take on the days when you receive treatment with LEMTRADA and for one month after treatment.
In addition, there is the risk of developing infection that may lead to changes in the cervix ( cervical ). Therefore, it is recommended that all female patients undergo an annual examination, such as cell samples. The doctor explains what tests are needed.
Infection with a virus called cytomegalovirus has been reported in patients treated with LEMTRADA. Most of the cases occurred within 2 months after the initial dosing of alemtuzumab. Contact a doctor immediately if you get symptoms of infection such as fever or swollen glands.
Patients who have been treated with LEMTRADA have had an infection due to a virus called Epstein-Barr virus ( EBV ), including cases of severe and sometimes fatal hepatitis. Contact a doctor immediately if you get symptoms of infection such as fever, swollen glands, or fatigue.
Patients treated with LEMTRADA are also at higher risk of developing listeria infection (a bacterial infection caused by eating contaminated food). Listeria infection can cause serious illness, including – meningitis ( meningitis ) but can be treated with appropriate medication. To reduce this risk, avoid eating raw or poorly cooked meat, mold and putty cheese, and unpasteurized dairy products two weeks before treatment, during treatment, and for at least one month after treatment with LEMTRADA.
If you live in an area where tuberculosis infection you are normal you may be at greater risk of infection with tuberculosis. Your doctor will arrange for tuberculosis checks.
If you are a carrier of hepatitis B or hepatitis C infection (these diseases affect the liver) extra care must be taken before you can receive treatment with LEMTRADA, as it is unknown if the treatment could lead to the hepatitis infection being activated, which in that case can damage your liver.
There have been cases of a rare brain infection called PML ( progressive multifocal leukoencephalopathy) in patients receiving LEMTRADA. PML has been reported in patients with other risk factors, especially previous treatment with MS drugs associated with PML.
PML can lead to severe disability for weeks or months and can be fatal.
The symptoms may resemble a relapse of MS and include progressive weakness or clumsiness in the extremities, visual disturbances, speech problems or changes in thinking, memory, and orientation that lead to confusion and personality changes. It is important to inform your relatives or caregivers about your treatment, as they may notice symptoms that you are not aware of. Contact a doctor immediately if you develop symptoms suggestive of PML.
- Pneumonitis and pericarditisPneumonitis ( inflammation of lung tissue) has been reported in patients treated with LEMTRADA. Most cases occurred within the first month after treatment with LEMTRADA. Cases of pericardial effusion (accumulation of fluid around the heart) and pericarditis (pericarditis) have also been reported in patients treated with LEMTRADA. You should report symptoms such as shortness of breath, cough, wheezing, chest pain or tightness in the chest and bloody cough to your doctor, as they may be caused by pneumonitis , pericardial effusion or pericarditis.
- Inflammation of the gallbladderLEMTRADA may increase your risk of getting gallbladder inflammation . This can be a serious medical condition that can be life threatening. You should contact your doctor if you have symptoms such as abdominal pain or discomfort, fever, nausea or vomiting.
Previous cancer diagnosis
Tell your doctor if you have previously been diagnosed with cancer.
It is not known if LEMTRADA affects your vaccine response. If you have not received the usual standard vaccinations, your doctor will consider whether you should receive them before you receive LEMTRADA treatment. In particular, your doctor will consider vaccinating you against chickenpox if you have never had it. Any vaccinations must be given at least six weeks before starting a treatment course with LEMTRADA.
You must NOT take certain types of vaccines ( live virus vaccines ) if you have recently received LEMTRADA.
Children and young people
LEMTRADA is not intended for use in children and adolescents under 18 years of age as it has not been studied in MS patients under 18 years of age.
Other medicines and LEMTRADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (including any vaccinations or herbal remedies).
In addition to LEMTRADA, there are other treatments, both for MS and for the treatment of other conditions, that can affect your immune system and therefore affect your ability to fight infection. If you are taking such medicine, your doctor may ask you to stop taking that medicine before starting treatment with LEMTRADA.
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Women of childbearing potential must use effective contraception during each course of treatment with LEMTRADA and for four months after each course of treatment.
If you become pregnant after treatment with LEMTRADA and suffer from a thyroid disorder during pregnancy, extra care is required. Thyroid disorders can harm the baby (see section 2 Warnings and precautions – autoimmune conditions).
It is not known whether LEMTRADA can be transmitted to infants via breast milk, but there is a risk that this may be the case. Therefore, it is recommended that you do not breastfeed during treatment with LEMTRADA and for four months after each course of treatment. At the same time, there may be benefits to breast milk that can help protect your baby from infection. Therefore, talk to your doctor if you are planning to breastfeed your baby for advice on what is best for you and your baby.
During treatment and for four months afterward, LEMTRADA may remain in your body. It is not known if LEMTRADA has any effect on fertility during this period. Talk to your doctor if you are planning to become pregnant. There is no evidence that LEMTRADA affects male fertility.
Driving and using machines
Many patients experience side effects when they receive infusion one or within 24 hours after infusion one with LEMTRADA, and some of these, such as dizziness, may make it unsafe to drive or use machines. If you experience this, stop these activities until you feel better.
LEMTRADA contains excipients
This medicine contains less than 1 mmol potassium (39 mg) per infusion, ie essentially ‘potassium free.
This medicine contains less than 1 mmol sodium (23 mg) per infusion, ie essentially ‘sodium-free.
3. How to get LEMTRADA
Your doctor will explain to you how to get LEMTRADA. If you have any further questions, ask your doctor.
The initial treatment you will receive will consist of one infusion per day for 5 days (course 1) and one infusion per day for 3 days one year later (course 2).
You will not receive any treatment with LEMTRADA between these two courses. Two treatment regimens can reduce MS activity for up to 6 years.
Some patients with symptoms or signs of MS after the first two courses may receive one or two additional courses of treatment, consisting of one infusion per day for 3 days. These additional treatment regimens can be administered after twelve months or more after the previous regimens.
The maximum daily dose is one infusion.
You will receive LEMTRADA as an infusion into a vein. Each infusion takes about four hours. Monitoring for adverse reactions and regular sampling must be continued for four years after the last infusion.
The diagram below can help you understand how long the effect of the treatment lasts and how long follow-up is required.
Follow-up after treatment with LEMTRADA
Once you have received LEMTRADA, you must undergo regular tests to ensure that any side effects can be diagnosed and treated as soon as possible. The tests must be continued for four years after the last infusion. See description in section 4 – the most important side effects are.
If you take more LEMTRADA than you should
Patients who have accidentally received too much LEMTRADA in an infusion have experienced severe reactions such as headache, rash, low blood pressure, or increased heart rate. Doses that are higher than the recommended dose may lead to more severe or prolonged infusion reactions (see section 4) or a more potent effect on the immune system. In overdose, cancel the administration of LEMTRADA and treat the symptoms.
Missed LEMTRADA dos er
Your dose is unlikely to be missed as it is administered by healthcare professionals. Note, however, that if a dose is missed, it should not be given on the same day as a scheduled dose.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The main side effects are the autoimmune conditions described in section 2, including:
- Acquired haemophilia A (a type of haemophilia ) , (less common – may affect up to 1 in 100 people): may manifest as rapid bruising, nosebleeds, pain or swelling in joints, other types of bleeding or bleeding from a cuts take longer to stop than usual.
- ITP (bleeding disorder) (common – may affect up to 1 in 10 people): may appear as small scattered red, pink or purple spots on the skin; that you get bruises more easily; that bleeding from wounds is more difficult to stop; heavier, more prolonged or frequent menstrual bleeding than usual; bleeding between periods; bleeding from the gums or nose that has occurred recently or takes longer than usual to stop; or coughing up blood.
- Thrombotic thrombocytope purpura (TTP), (rare – may affect up to 1 in 1,000 people): may appear as bruises on the skin or on the mouth, which may appear as small red dots, with or without unexplained extreme fatigue, fever, confusion, speech changes, yellowing of the skin or eyes (jaundice), small amount of urine, dark-colored urine.
- kidney disease (rare – may affect up to 1 in 1,000 people): may manifest as blood in the urine (your urine may be red or the same color as tea) or as swelling in the legs or feet. It can also lead to damage to the lungs, which can result in you coughing up blood
|If you experience any of these signs or symptoms of bleeding or kidney disease, contact your doctor immediately and tell them about the symptoms. If you cannot reach your regular doctor, you must seek immediate medical attention immediately.|
- thyroid disorders (very common – may affect more than 1 in 10 people): may manifest as excessive sweating; unexplained weight loss or weight gain; eye swelling; nervousness; fast heartbeat; that one freezes; fatigue that gets worse or recent constipation.
- disorders of red or white blood cells (uncommon – may affect up to 1 in 100 people): as a result of blood tests.
- sarcoidosis (uncommon – may affect up to 1 in 100 people): may manifest as persistent dry cough, shortness of breath, chest pain, fever, swollen lymph nodes , weight loss, rash and blurred vision.
|All of these serious side effects can occur several years after you have received LEMTRADA. If you experience any of these signs or symptoms, contact your doctor immediately and tell them about them. You will also have to take blood and urine samples regularly so that you can receive treatment quickly if you should suffer from any of these conditions.|
You will be given the following tests for autoimmune conditions:
(to diagnose all-important serious side effects listed above)
Before starting treatment and every month after treatment
Up to four years after your last LEMTRADA infusion
(additional test to diagnose kidney disease)
Before starting treatment and every month after treatment
Up to four years after your last LEMTRADA infusion
After this period, your doctor will perform more tests if you experience symptoms of ITP, acquired hemophilia A, TTP, kidney, or thyroid disorders. After four years, you should continue to pay attention to signs or symptoms of side effects as described in your patient guide, and you should continue to carry the patient warning card with you.
Another important side effect is the increased risk of infection (see below for details on how often patients suffer from infections s). These are usually mild, but the severe infection may occur.
|Tell your doctor immediately if you experience any of these signs of infection fever and / or chillsswollen glands|
To reduce the risk of certain infections, your doctor may consider giving you a chickenpox vaccination and/or other vaccinations that your doctor considers necessary for you (see section 2: What you need to know before you receive LEMTRADA – Vaccine). Your doctor may also prescribe cold sores (see section 2: What you need to know before you get LEMTRADA – Infections ).
The most common side effects are infusion reactions (see below for details on how often patients experience such), which may occur during the infusion, once or within 24 hours after the infusion a. These are usually mild but severe reactions that can occur. Sometimes allergic reactions can also occur.
To try to reduce the infusion reactions, your doctor will give you other medicines ( corticosteroids ) before the first three infusions of each LEMTRADA course of treatment. Other treatments can limit these reactions and that you can get before infusion one or when you experience symptoms. In addition, you will be monitored during infusion one and for two hours after the end of infusion one. If you get severe reactions, you can slow down the infusion or stop it completely.
More information on these reactions can be found in the LEMTRADA Patient Guide.
The side effect is that you may experience are the following:
Very common (may affect more than 1 user in 10):
- Infusion reactions that may occur during the infusion itself or within 24 hours after the infusion: changes in heart rate, headache, rash, rash on the body, fever, hives, chills, itching , redness of the face and throat, feeling tired, nausea
- Infection you : respiratory infections such as colds and sinusitis, urinary tract infection, herpes infection
- Decreased white blood cell count ( lymphocyte , leukocyte , neutrophil )
- Thyroid disorders such as overactive or underactive thyroid gland
Common (may affect up to 1 in 10 people):
- Infusion reactions that may occur during the infusion itself or within 24 hours after the infusion: indigestion, chest discomfort, pain, dizziness, taste changes, difficulty sleeping, difficulty breathing or shortness of breath, low blood pressure , pain at the infusion site.
- Infection you : cough, ear infection, flu-like disease, bronchitis , pneumonia , oral or vaginal sponge, shingles , cold sores, swollen or enlarged glands , flu , herpes zoster infection, tooth infection
- excessive immune response
- increased number of white blood cells such as neutrophil s, eosinophilic s (different types of white blood cells ), anemia ( anemia ), reduced the percent of red cells , easy to get or excessive amount of bruising or bleeding, swelling of lymph nodes
- pain in the back, neck, arms or legs, muscle aches, muscle cramps, joint pain, pain in the mouth or throat
- inflammation of the mouth / gums / tongue
- general discomfort, weakness, vomiting, diarrhea, abdominal pain, stomach flu, hiccups
- abnormal liver samples
- abnormalities that can be seen on examination: blood or protein in the urine, decreased heart rate, irregular or abnormal heart rhythm, high blood pressure , impaired kidney function, white blood cells in the urine
- bleeding in the skin
- MS- forest
- tremors, loss of sensation, burning or stinging sensation
- autoimmune overactive or underactive thyroid gland , thyroid gland – antibodies or goiter (enlargement of the thyroid gland, which is located on the neck)
- swollen arms and / or legs
- vision problems, inflammation of the conjunctiva of the eye ( conjunctivitis ), eye diseases that are linked to diseases of the thyroid gland
- tingling sensation or decreased balance, migraine
- anxiety, depression
- unusually heavy, prolonged or irregular menstrual bleeding
- acne , reddening of the skin, excessive sweating, discoloration of the skin, skin damage, inflammation of the skin ( dermatitis )
- nosebleeds, bruises
- hair loss
- skeletal and muscle pain, discomfort in the pectoral muscle
Uncommon (may affect up to 1 in 100 people):
- Infection you : upset stomach, inflamed gums, nail fungus, tonsillitis, acute sinusitis, bacterial skin infection, infection with cytomegalovirus
- athlete’s foot
- abnormal vaginal cell sample
- increased sensation, sensory disturbances such as numbness, tingling and pain, tension headache
- double vision
- pain in the ear
- difficulty swallowing, irritation of the throat, whooping cough
- weight loss, weight gain, decreased red blood cell count , elevated blood sugar, enlargement of red blood cells
- constipation, acid regurgitation, dry mouth
- bleeding from the rectum
- bleeding from the gums
- decreased appetite
- blisters, night sweats, swelling of the face, eczema
- stiffness, discomfort in arms and legs
- kidney stones , excretion of ketone bodies in urine, kidney disease
- weakened / weakened immune system
- inflammation of the gallbladder, with or without gallstones s
- autoimmune diseases characterized by bleeding (acquired hemophilia , hemophilia A)
Rare (may affect up to 1 in 1,000 people):
- excessive activation of white blood cells in connection with inflammation (haemophagocytic lymphohistiocytosis)
- autoimmune thrombotic disease (thrombotic thrombocytopenic purpura, TTP)
Has been reported (occurs in an unknown number of users):
- meningitis caused by listeria bacteria ( meningitis )
- bleeding in the lungs
- heart attack
- ruptures of carotid or vertebral arteries (blood vessels supplying the brain)
- infection due to a virus called Epstein-Barr
Show the patient warning card and this leaflet to all physicians involved in your treatment, not just the neurologist.
This information is also available on the patient warning card and in the patient guide provided to you by your doctor.
How to store LEMTRADA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Store in the original package. Sensitive to light.
It is recommended that the drug be used immediately after dilution, due to the possible risk of microbial contamination. If the medicine is not used immediately, it is the user’s responsibility to ensure that the storage time during use and the conditions before use do not exceed 8 hours at 2 till to 8 ºC, protected from light.
Contents of the pack and other information
The active substance is alemtuzumab.
Each vial contains 12 mg of alemtuzumab in 1.2 ml.
Other ingredients are:
- disodium phosphate dihydrate (E339)
- disodium edetate
- potassium chloride (E508)
- potassium dihydrogen phosphate (E340)
- polysorbate 80 (E433)
- sodium chloride
- water for injections
What the medicine looks like and contents of the pack
LEMTRADA is a clear, colorless to slightly yellow concentrate for solution for infusion (sterile concentrate) that is supplied in a glass vial with a stopper.
There is 1 vial in each carton.
Marketing Authorisation Holder
Leonardo Da Vincilaan 19
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, UK.
Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland.
Contact the representative of the marketing authorization holder if you want to know more about this medicine:
Tel: +46 (0) 8 634 50 00