Enbrel solution for injection 25 mg. 4 flacons
In adults (over 18 years) Enbrel can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis heavy
Enbrel solution for injection 25 mg. 4 flacons
What is Enbrel and what it is used?
Enbrel e medicament which is made up of two human proteins. It blocks the activity of another protein in the body that causes inflammation. Enbrel act by reducing inflammation associated with certain diseases .
In adults (over 18 years ) Enbrel can be used for moderate or severe rheumatoid arthritis , psoriatic arthritis, ankylosing spondylitis and severe moderate or severe psoriasis - in any case usually when other widely used treatments are not that good enough or they are not suitable for you.
In rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although can be used alone if the treatment with methotrexate is inappropriate for the search . Whether used alone or in combination with methotrexate , Enbrel can slow down the damage to your joints caused by rheumatoid arthritis, and improve your ability to do normal daily activities.
In patients with psoriatic arthritis with involvement of multiple joints Enbrel can improve your ability to perform normal daily activities. In patients with multiple symmetrical painful or swollen joints ( eg hands , wrists and feet ) Enbrel can slow down the damage to those joints caused by the disease.
Enbrel is also indicated for the treatment of these diseases in children and adolescents:
• The following types of juvenile idiopathic arthritis when methotrexate was not given enough good result or is not appropriate for them :
• Polyarthritis ( positive or negative rheumatoid factor) and extended oligoarthritis in patients aged 2 years and over
• Psoriatic arthritis in patients aged 12 years and over
• For enthesitis - related arthritis in patients aged 12 years and older , widely used when other treatments have not good enough or they are not suitable for them
• Severe psoriasis in patients aged 6 years and over who have had an inadequate response to (or are unable to accept ) phototherapy or other systemic therapy .
2 . What you should know before using Enbrel?
Do not use Enbrel
• if you or the child in your care , you are allergic to etanercept or any of the other ingredients of Enbrel. If you or your child experience allergic reactions such as chest tightness, wheezing, dizziness or rash , do not inject more Enbrel and immediately contact your doctor.
• if you or your child have, or are at risk of developing serious blood infection called sepsis. If you are unsure , please contact your doctor.
• if you or your child have any kind of infection . If you are unsure , please talk with your doctor.
Warnings and Precautions
• Allergic reactions: If you or your child experience allergic reactions such as chest tightness, wheezing, dizziness or rash , do not inject more Enbrel and immediately contact your doctor.
• Infections / surgery: If you or your child develop a new infection or have some major surgery , your doctor may want to monitor the treatment with Enbrel.
• Infections / diabetes: Tell your doctor if you or your child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
• Infections / monitoring : Tell your doctor about any upcoming travel outside the region. If you or your child develop symptoms of infection such as fever , chills or cough , tell your doctor. Your doctor may decide to continue to follow you or the child for the presence of infections after you or the child stop using Enbrel.
• Tuberculosis : As in patients treated with Enbrel, reported TB cases , your doctor will check for signs and symptoms of tuberculosis before they prescribe Enbrel. This may include a thorough medical history , chest X-ray and a tuberculin test. Conduct of these tests should be recorded in the Patient Alert Card . It is important to tell your doctor if you or your child ever had TB, or if you have been in close contact with someone who has had TB. If during or after your treatment symptoms of tuberculosis (eg persistent cough , weight loss , lethargy , mild fever ) , or any other infection , tell your doctor.
• Hepatitis B: Your doctor may decide to test for the presence of hepatitis B infection before you or your child to start treatment with Enbrel.
• Hepatitis C: Tell your doctor if you or your child have hepatitis C. Your doctor may wish to monitor the treatment with Enbrel, if the infection worsens.
• Blood disorders : Seek immediate medical advice if you or your child have any signs or symptoms such as persistent fever , sore throat , bruising , bleeding or paleness . Such symptoms may point to the existence of a potentially life-threatening blood disorders that may require discontinuation of Enbrel.
• Nervous system and eye: Tell your doctor if you or your child have multiple sclerosis , optic neuritis ( inflammation of the nerves of the eye) or transverse myelitis (inflammation of the spinal cord) . Your doctor will determine if Enbrel is an appropriate treatment .
• Congestive heart failure : Tell your doctor if you or your child have a history of congestive heart failure as Enbrel should be used with caution in these circumstances.
• Cancer : Tell your doctor if you have or have ever had lymphoma (a type of blood cancer ) or any other cancer before you are given Enbrel.
Patients with severe rheumatoid arthritis who have long been suffering from this disease may have a higher than average risk of developing lymphoma .
Children and adults taking Enbrel, may have an increased risk of developing lymphoma or other cancers .
Some children and adolescent patients who received Enbrel or other drugs acting in the same way as Enbrel, have developed a variety of cancers, including unusual species which sometimes leads to death .
Some patients receiving Enbrel, have developed a cancer of the skin. Tell your doctor if you or your child experience any change in the appearance of the skin or skin growths .
• Chickenpox: Tell your doctor if you or the child you are exposed to chicken pox while using Enbrel. Your doctor will determine the appropriate preventive treatment for chickenpox .
• Latex : The cover of the needle is made from latex (dry natural rubber ) . Contact your doctor before using Enbrel, if that works with the cover of the needle or the one who will apply Enbrel, have known or possible hypersensitivity ( allergy) to latex.
• Alcohol abuse : Enbrel should not be used for the treatment of hepatitis B associated with alcohol abuse. Please tell your doctor if you or the child you are caring for , have a history of alcohol abuse.
• Wegener's granulomatosis : Enbrel is not recommended for the treatment of Wegener's granulomatosis , a rare inflammatory disease. If you or the child you are caring for , have Wegener's granulomatosis , talk to your doctor.
• Antidiabetic medicines: Tell your doctor if you or your child have diabetes or are taking medicines to treat diabetes . Your doctor can decide whether you or the child you need less anti-diabetes medicines while taking Enbrel.
Children and adolescents
• Vaccinations : If possible , children should be conducted with all vaccinations before using Enbrel. Some vaccines such as oral polio vaccine should not be administered while using Enbrel. Please consult with your doctor before you or your child taking any vaccines.
• inflammatory bowel disease ( IBD ) in the patients with juvenile idiopathic arthritis ( JIA ) , treated with Enbrel, there are cases of IBD . Tell the doctor if your child get abdominal cramps and pain , diarrhea, weight loss or blood in the stool .
Usually Enbrel should not be used in children with arthritis or extended oligoarthritis under 2 years of age or in children with enthesitis - related arthritis and psoriatic arthritis under 12 years of age or in children with psoriasis under 6 years of age.
Other medicines and Enbrel
Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (including anakinra , abatacept or sulfasalazine ), including those not prescribed by a doctor. You or your child should not take Enbrel drug containing the active substance anakinra or abatacept .
Pregnancy and lactation
The effects of Enbrel in pregnant women are not known , so it is not recommended for use of Enbrel during pregnancy . Women using Enbrel, should not become pregnant . If the patient becomes pregnant should consult a doctor.
Women using Enbrel, should not breastfeed because Enbrel passes into human breast milk.
Driving and using machines
Not expected that the use of Enbrel to affect the ability to drive and use machines. 3 . How to use Enbrel
Always use Enbrel exactly as your doctor has told you . If you are not sure, ask your doctor or pharmacist.
If you feel that the effect of Enbrel is too strong or too weak, talk to your doctor or pharmacist.
Dosing for adult patients ( aged 18 years)
Rheumatoid arthritis , psoriatic arthritis and ankylosing spondylitis
The usual dose is 25 mg, administered twice weekly or 50 mg once weekly by subcutaneous injection. However, your doctor can determine another frequency with which to inject Enbrel.
The usual dose is 25 mg twice a week or 50 mg once a week.
In other instances, 50 mg may be administered twice a week for a maximum of 12 weeks followed by 25 mg twice a week or 50 mg once a week.
Your doctor will decide how long you should take Enbrel and if necessary re-treatment depending on your response . If Enbrel has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Use in children and adolescents
Appropriate dose and frequency of administration of the child or adolescent will depend on body weight and disease. The doctor will give you detailed instructions for preparing and measuring the appropriate dose.
For polyarthritis and extended oligoarthritis in patients aged 2 years or more and enthesitis - related arthritis and psoriatic arthritis in patients aged 12 years and older , the usual dose is 0,4 mg Enbrel per kg body weight ( maximum 25 mg) administered twice weekly or 0,8 mg Enbrel per kg body weight ( up to 50 mg) was administered once a week.
For psoriasis patients of age 6 years and over , the usual dose is 0,8 mg Enbrel per kg body weight (up to a maximum of 50 mg) and is to be administered once weekly . If Enbrel has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Method and route of administration
Enbrel is given by injection under the skin ( subcutaneous injection ) . Enbrel can be taken with or without food or drink .
The powder should be reconstituted before use. Detailed instructions on how to prepare and inject Enbrel are provided in section 7 , " Instructions for preparation and injection of Enbrel". • Do not mix with Enbrel solution to any other medicine.
To remember more easily , it may be helpful to write in a diary which day ( what days ) of the week should be used Enbrel.
If you use more than the amount of Enbrel
If you use more than the amount of Enbrel ( either by injecting too large dose once or too frequent use) , talk to a doctor or pharmacist. Always keep the carton of the medicine with you, even if it is empty.
If you forget to inject Enbrel
If you miss a dose , you should inject as soon as possible after you remember unless the next scheduled dose is not the next day, in which case you should skip the missed dose. Then proceed to inject the customary day (s) . If you do not remember until the day the next injection , do not take a double dose ( two doses on the same day) to make up the missed dose.
If you stop using Enbrel
Your symptoms may recur after discontinuation .
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines , Enbrel can cause side effects, although not everybody gets them .
There may be other side effects not listed in this leaflet. If you are worried about any side effects or if you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
The most common side effects with Enbrel were injection site reactions , infections , allergic reactions , formation of autoantibodies , itching and fever. For more details please see below .
If anything the following, do not inject more Enbrel. Tell your doctor or go to the casualty department at your nearest hospital :
• Difficulty swallowing or breathing .
• Swelling of the face , throat, hands or feet .
• Feeling nervous or anxious, palpitations, sudden reddening of the skin and / or a feeling of warmth.
• Severe rash, itching or hives ( raised red or white areas of the skin that often itch ) .
Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you should seek medical help immediately.
Serious side effects
If you notice any of the following , you or your child may need urgent medical attention :
• Signs of serious infection such as high fever that may be accompanied by cough , shortness of breath , chills , weakness or hot, red , painful inflamed area of skin or joints
• Signs of blood disorders such as bleeding , bruising or paleness
• Signs of nerve disorders such as numbness, tingling , changes in vision , eye pain , or onset of weakness in an arm or leg
• Signs of worsening heart failure such as fatigue or shortness of breath on exertion , swelling of the ankles, feeling of fullness in the throat or stomach , shortness of breath or cough night , bluish -colored fingernails or lips
• signs of cancer : Cancer may affect , to any part of the body, including skin and blood and possible signs depend on the type and location of the cancer. These effects can include weight loss , fever, swelling (with or without pain ) , persistent cough, the presence of sores or bumps on the skin
• Signs of autoimmune reactions (formation of antibodies that can damage normal tissues in the body) such as pain, itching , weakness and disturbances of breathing , thinking, feeling or vision
• Signs of lupus or lupus-like syndrome, with weight changes, persistent rash , fever , pain in the joints or muscles or fatigue
• Signs of inflammation of blood vessels such as pain , fever, redness or heat the skin or itching.
These are rare or uncommon but serious diseases ( some of which may rarely be fatal ) . If these signs occur , tell your doctor or go to the casualty department at your nearest hospital.
Famous following adverse reactions with Enbrel, grouped in descending frequency:
• Very common ( may affect more than 1 in 10 patients):
Infections ( including colds , sinusitis , bronchitis, urinary tract infections and skin infections ), injection site reactions ( including bleeding , bruising , redness, itching, pain and swelling) . Injection site reactions ( they do not occur so often , after the first month of therapy) . Some patients developed reactions at the injection site that was used before.
• Common ( may affect up to 1 in 10 patients):
Allergic reactions , fevers , itching, antibodies directed against normal tissues ( autoantibody formation ) .
• Uncommon ( may affect up to 1 in 100 patients):
Serious infections (including pneumonia , deep skin infections , joint infections, infections of the blood and in different places ), low platelet count , skin cancer (except for melanoma ), localized swelling of the skin ( angioedema) , urticaria ( raised red or white areas of the skin that often itch ), eye inflammation , psoriasis (new or worsening ), rash , inflammation or calcification of the lungs , inflammation of blood vessels that affects multiple organs .
• Rare (may affect up to 1 in 1000 patients):
Serious allergic reactions (including severe localized swelling of the skin and wheezing ), lymphoma ( cancer of the blood) , melanoma (a type of skin cancer ) combined low platelet , red blood cells and leukocytes , nervous system disorders ( severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord ), tuberculosis , worsening congestive heart failure, seizures, lupus or lupus -like syndrome (symptoms may include persistent rash , fever, joint pain and fatigue ), low number of red blood cells , low leukocyte count , low neutrophil counts ( white blood cells ), elevated liver blood tests , skin rash, which can cause severe blistering and peeling of the skin , inflammation of the liver caused by the body's own immune system of the body ( autoimmune hepatitis ), disorder of the immune system , which can affect the lungs , skin and lymph nodes ( sarcoidosis ) .
• Very rare (may affect up to 1 in 10,000 patients): failure of the bone marrow to produce blood cells essential .
• Not known ( data can not be estimated ): Leukemia ( cancer affecting the blood and bone marrow ), Merkel cell carcinoma (a type of skin cancer ), excessive activation of white blood cells associated with inflammation ( syndrome activation of macrophages ), recurrence of hepatitis B ( liver infection ) .
Additional side effects in children and adolescents:
Adverse reactions observed in children and adolescents and their frequencies are similar to those described above .
5 . How to store Enbrel?
Keep out of reach of children.
Do not use Enbrel after the expiry date stated on the carton and label after " EXP " and "EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze .
Before reconstitution Enbrel, Enbrel can be stored outside the refrigerator at a temperature up to 25 ° C for a single period of up to four weeks , then he should not be returned to the refrigerator . Enbrel should be discarded if not used within four weeks after removal from the refrigerator . It is recommended to record the date on which Enbrel is removed from the refrigerator and the date after which Enbrel should be discarded (no more than 4 weeks after removal from the refrigerator ) .
After reconstitution Enbrel immediate use is recommended . However, the solution can be used within 6 hours when stored at or below 25 ° C.
Do not use Enbrel, if you notice that the solution is not clear or if it contains particles . The solution should be clear, colorless or pale yellow , with no lumps , flakes , or particles.
Carefully discard the solution Enbrel, which is not injected within 6 hours.
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 . Package Contents and more information
What does Enbrel?
The active ingredient is etanercept Enbrel . Each vial of 25 mg of Enbrel contains 25 mg etanercept.
Other ingredients are:
Powder Mannitol (E421), sucrose and trometamol Solvent: Water for injections.
Enbrel looks like and contents of the pack ?
Enbrel 25 mg was provided as a white powder and solvent for solution for injection ( powder for injection). Each pack contains 4 single dose vials , 4 pre- filled syringes with water for injection and 8 wipes with alcohol.