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Composition : RITUXIMAB-100MG/10ML
Description : MABTAS 100MG INJ
Route Of Administration : PARENTERAL
Pack : 1

Drug Ingredient Information



Information for patients
Drug Information Rituximab contains an antibody (rituximab) which is a type of protein. Rituximab binds to the surface of a type of white blood cell, the B lymphocyte. When rituximab binds to the surface of this cell it causes the cell to die. Rituximab may be used for the treatment of three different conditions. Your doctor may prescribe Rituximab for the treatment of: a) Non-Hodgkin’s Lymphoma Non-Hodgkin’s lymphoma is a disease of the lymphatic system. B lymphocytes are involved in the cause of some of the symptoms you may have. Rituximab can be used alone or with other medicines your doctor may prescribe to induce remission of your disease. Rituximab may be used as a continuous (maintenance) treatment for 2 years in patients who have responded to induction treatment. b) Chronic lymphocytic leukaemia Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia. CLL affects a particular lymphocyte, the B cell, which originates from the bone marrow and develops in the lymph nodes. Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood. The proliferation of these abnormal B-lymphocytes is the cause of symptoms you may have. Rituximab in combination with chemotherapy destroys these cells which are gradulally removed from the body by biological processes. c) Rheumatoid arthritis Rituximab is used for the treatment of rheumatoid arthritis. Rheumatoid arthritis is a disease of the joints. B lymphocytes are involved in the cause of some of the symptoms you have. Rituximab is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects. Rituximab is usually taken together with another medicine called methotrexate. Rituximab slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities The best responses to Rituximab are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti- Cyclic Citrullinated Peptide (anti-CCP). Both tests are commonly positive in rheumatoid arthritis and aid in confirming the diagnosis.
Drug Alert
Alert if you are allergic to rituximab, to other similar proteins, or to any of the other ingredients in the solution if you have an active, severe infection or have a severely decreased immune system function. If you are not sure about this, you should ask your doctor who will inform you accordingly
Before Consuming the Medicine
Avoid Drug if you think you have hepatitis infection now or have had it in the past. In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal in very rare cases. Patients with a history of hepatitis B infection will be carefully checked by their doctor for signs of active hepatitis B. if you are taking treatment for high blood pressure. You may be asked not to take your medicines 12 hours before your infusion of Rituximab . Some people have a fall in their blood pressure during the infusion. if you have ever had heart disease (i.e. angina, palpitations, or heart failure) or a history of breathing problems Your doctor may need to take special care of you during your treatment with Rituximab (in any of the above cases).
Drug Special Care tell your doctor if you are taking or have previously taken medicines which may affect your immune system, such as chemotherapy or immunosuppressive agents. if you think you may have an infection, even a mild one like a cold. The cells that are affected by Rituximab help to fight infection and you should wait until the infection has passed before you are given Rituximab . Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections. if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries. Some vaccines should not be given at the same time as Rituximab or in the months after you receive Rituximab . Your doctor will check if you should have any vaccines before you receive Rituximab . At present, there is not very much information about Rituximab treatment in children and adolescents; if you are under 18 years of age, you or your parent/carer should ask your doctor if Rituximab is right for you
Drug Drug Interactions Before starting treatment, make sure your doctor knows if you are taking or have recently taken any other medicines (including those you have bought for yourself from a pharmacy, supermarket or health store). This is extremely important, as using more than one medicine at the same time can strengthen or weaken their effect. Rituximab should not be used with other drugs unless your doctor has told you it is safe to do so
Drug Pregnancy Interaction You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. This is because Rituximab is an antibody and can cross the placenta and affect your baby.If you can get pregnant, you must use an effective method of birth control during therapy with Rituximab and for 12 months after the last time you were treated with Rituximab
Drug Breast feeding Interaction Rituximab might also get into breast milk and so you should not breast-feed your baby during therapy with Rituximab and for 12 months after the last time you were treated with Rituximab
Drug Machinery Interaction It is not known whether Rituximab has an effect on your ability to drive a car or use machines.
Drug More Information no data available
How to take the Medicine
Consumption Info no data available
Drug quanitty a) If you are being treated for non-Hodgkin’s Lymphoma If you are treated with Rituximab alone you will receive infusions at weekly intervals for a total of four infusions (days 1, 8, 15 and 22), so that the a course of treatment usually lasts for 22 days. Repeated treatment courses with Rituximab are possible. If you are treated with Rituximab in combination with other medicines, you will receive an infusion of Rituximab on the same day as the other medicines, which are usually given 8 times at 3-week intervals. If you have responded to treatment and are further treated with Rituximab as continuous (maintenance) treatment, you will receive one infusion of Rituximab every 2 or 3 months (as directed by your doctor) for two years. Your doctor may change the number of infusions depending on your disease. b) If you are being treated for chronic lymphocytic leukemia When you are treated with Rituximab in combination with chemotherapy, you will receive Rituximab infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total. Each cycle has a duration of 28 days. The chemotherapy should be given after the Rituximab infusion. Your doctor will decide if you should receive concomitant supportive therapy. c) If you are being treated for rheumatoid arthritis Each course of treatment is made up of two separate infusions which are given 2 weeks apart.Repeated courses of treatment with Rituximab are possible. Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more Rituximab. This may be months from now.
Drug Dose Rituximab is an infusion (“drip”) which is given directly into your veins. You will be observed by a health care professional while you are being given Rituximab in case you have any side effects during the infusion. Before the infusion is given you will be given medicines to prevent or reduce possible reactions to Rituximab
Excess Drug Consumption no data available
Forgot Drug Consumption no data available
Stop Drug Consumption no data available
Possible Side Effects
General Information During or within the first 2 hours of the first infusion you may develop fever, chills and shivering. Less frequently, some patients may experience blisters, itching, sickness, tiredness, headache, breathing difficulties, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets. If you have heart disease or angina, these reactions might get worse. Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped for a while. You may require additional treatment such as an antihistamine or paracetamol. When these symptoms go away, or improve, the infusion can be continued. These reactions are less likely to happen after the second infusion. cough, sore throat, burning pain when passing urine, or you start to feel weak or generally unwell. You might get infections more easily following Rituximab therapy. Often these are colds, but there have been cases of pneumonia or urinary infections. Very rarely, some patients taking Rituximab have had a serious brain infection, which has been fatal. Tell your doctor immediately if you have memory loss, trouble thinking, difficulty with walking or loss of vision. If you are being treated for rheumatoid arthritis, you will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregiver
Common Drug Side Effects •infections such as sepsis and pneumonia (bacterial), herpes and hepatitis B (viral) or candidal (fungal) bronchial tube and sinuses inflammation, or other general infections of unknown origin •low number of red blood cells, low number of red and white blood cells and platelets •allergic reactions (hypersensitivity) •high sugar level in the blood, weight loss, excess fluid in the face and the body, increased blood levels of the enzyme (LDH), low blood level of calcium •abnormal sensations of the skin, such as numbness, tingling, pricking, burning, a creeping skin sensation, decreased sense of touch. Feeling restless, difficulty falling asleep, becoming red in the face and bruising of the skin as a consequence of dilation of the blood vessels, dizziness, anxiety •an increased production of tears, secretion and shedding disorders, inflammation of the eye (conjunctivitis) •ringing sound in the ears, ear pain •heart disorders (heart attack, irregular heart rate, abnormally fast heart rate) •high or low blood pressure, a decrease in blood pressure upon assuming an upright posture •inflammation, irritation and / or tightness of the lungs, throat and / or sinuses, shortness of breath, too little oxygen reaching the body organs, coughing •vomiting , diarrhoea, pain in the abdomen, irritation and /or ulceration of the throat and the mouth,difficulties in swallowing, constipation, indigestion. Eating disorders: decrease in the amount of food eaten with a consequential dangerous loss in weight •skin disorders, burning sensation of the skin, itching, increased perspiration, night sweats •musculoskeletal disorders, abnormal increase in tightness of muscle tone, pain, joint pain, muscle pain, back and neck pain •general disorders, tumour pain, becoming markedly red in the face and other areas of the skin, general discomfort or uneasiness, flu syndrome, fatigue, shaking, multi-organ dysfunction •Infections such as bronchial tube inflammation (bronchitis) •A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems •Fungal foot infection (athlete’s foot) •High cholesterol levels in the blood •Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica, migraine, dizziness •Loss of hair •Anxiety, depression •Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth •Pain in the tummy, back, muscles and/or joints
Rare Drug Side Effects • infections such as pneumonia (bacterial) and herpes (viral) or bronchial tube inflammation (bronchitis) • low number of white blood cells, with or without fever, low number of platelets in the blood • allergic reactions after infusion • nausea • skin rashes, itching ,bald spots on the scalp fever, chills, physical weakness, headache • decreased immunity (decreased IgG levels) •Excess fluid retention in the face and body •Inflammation, irritation and / or tightness of the lungs, and throat, coughing •Skin reactions including hives, itching and rash •Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue, collapse
Very Rare Drug Side Effects •abnormal clotting, decrease of blood cells production, autoimmune decrease of red blood cells, swollen/enlarged lymph nodes •low mood and loss of interest or pleasure in usual activities, nervousness •taste changes •heart disorder (heart attack, abnormally fast heart rate, reduced heart rate, irregular heart rate, chest pain) inflammation, irritation and/or thightness of the lungs, asthma, shortness of breath •enlargement of the abdomen •pain at the infusion site •A complex of symptoms occurring within a few weeks of an infusion of Rituximab including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
Drug Side Effects Symptoms •Infections such as pneumonia (bacterial) •Pain on passing water (urinary tract infection) •Allergic reactions after infusion •Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or block nose and sneezing, shaking, rapid heart beat, and tiredness •Headache
How to Store the Medicine
How to Store the Medicine Keep out of the reach and sight of children. Do not use MabThera after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month Store in a refrigerator (2 °C – 8 °C). Keep the container in the outer carton in order to protect from light.Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

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