Maball 100mg and Maball 500mg INJECTION ( Hetero ) | Rituximab

1. Maball 100mg/500mg INJECTION ( Hetero ) - Rituximab | apple pharmaceuticals Maball 100mg|Maball 500mg is a anticancer medicine which prevents the growth and spread of cancer cells in the body, the main ingredient which is used as rituximab. Maball 100mg will help to prevent the Non- Hodgkins lymphoma or chronic lymphocytic and with combination with another anticancer drugs like methotrexate is used for rheumatoid arthritis symptoms in adult treatment. Maball 100mg with steroid regimen combination is given for the treatment of some rare disorders which cause blood vessels and other tissues inflammation in the body INDICATION Maball 100mg|Maball 500mg and hyaluronidase human injection are given alone or combination with another drugs to treat certain types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia (cancer start in WBC). Maball 100mg injection combination with methotrexate (Otrexup, Rasuvo, Xatmep, others) is also indicated for the treatment rheumatoid arthritis symptoms in adults that have been already treated with a some type of regimen knowns as tumor necrosis factor (TNF) inhibitor. Maball 100mg is a type in a classification of drugs called monoclonal antibodies. Maball 100mg is used to killing cancer cells to treat NHL , CLL, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis by inhibiting the activity of the immune system parts that can injury the joints, veins, and other blood vessels and cause organs (heart and lungs) damage. DOSAGE: Maball 100mg|Maball 500mg injection is usually used to administrate only via intravenous infusion not by IV push or bolus. BEFORE EACH INFUSION THE DRUG IS PREMEDICATE : First infusion: Starting treatment rate of 50 mg/hr is administer , in not showing infusion toxicity, rate raised up to 50 mg/hr increments at intervals of 30 min and max of 400 mg/hr. Successive infusion: initial at rate of 100 mg/hr, in not showing infusion toxicity, rate raised upto 100 mg/hr increments at intervals of 30 min and max of 400 mg/hr. While combination with CHOP chemotherapy the injection Maball has not been given. Hence Premedication with corticosteroids must be considered. LOW GRADE OR FOLLICULAR NON-HODGKINS LYMPHOMA : The drug Dose is 375 mg/m2 as an IV infusion. Once weeks for 4 or 8 doses administrated for Relapsed treatment Once weekly for 4 doses administrated for Retreatment for relapsed. Previously untreated: administer on day 1 of each cycle of chemotherapy, up to 8 doses. In complete or partial response of patient, start with 8 weeks for maintenance following Maball 100mg in combination with chemotherapy

2. completed then administer 8weeks for 12 doses as a single agent. Once weekly for 4 doses at intervals of 6 months and max of 16 dose for Non – progression (following CVP chemotherapy completion 6 – 8 cycles): On day 1 each cycle of chemotherapy up to 8 infusions for Diffuse large B- cell NHL CHRONIC LYMPHOCYTIC LEUKEMIA : Before starting of FC chemotherapy, dose recommended is 375 mg/m2 followed 500 mg/m2 on day 1 of 2-6 cycles every 28 days. PHARMACOKINETICS Absorption: Not available Distribution: volume of distribution is 3.1 L There are no human plasma level Metabolism: Maball 100mg metabolized by human antimurine antibody production. Elimination : not available The drug elimination of half life of NHL is 22 days and for RA is 18.0 days, GPA and microscopic polyangitis is 23 days. MECHANISM OF ACTION Maball 100mg|Maball 500mg is a type of class called as monoclonal antibody. A new type of "targeted" cancer treatment and an integral part of the body's immune system. Naturally the body fused to antibodies in along with an antigen which has entered the body and attack the antigen for destruction by the immune system. Monoclonal antibiotics which only targeted by an essential cells only, they may cause less toxicity to healthy cell and it is prescribed treatment given only for cancers in which antigens (and the respective antibodies) have been already identified. Maball 100mg injection works by linking to the CD20 antigen on normal and malignant B-cells. Hence natural immune security of body are initiated to attach and kill the marked B-cells. Young cells (stem cells) in the bone marrow which will develop into the various cell types and do not have the CD20 antigen. After treatment CD20 antigen allows healthy B- cells to multiply.

3. ADMINISTRTION Take an amount Maball 100mg injection is administer and diluted to final concentration of 1 mg/ml upto 4 mg/ml as infusion (containing either 0.9% Nacl or 5% dextrose in water). Gently Invert the bag and mix the solution. Discard unused drug left in vial. OVERDOSAGE: If over dose occurs seek immediately to the emergency department or poison control help line. please consult the doctor for further clarification. DOSAGE COMPONENT OF ZEVALIN FOR TREATMENT OF NHL : The dose 250 mg/m2 of Maball injection within 4 hours prior to the administration of Indium-111-(In- 111-) Zevalin and Yttrium-90- (Y-90-) Zevalin. 7–9 days before to Rituxan and Y-90- Zevalin administrate Rituxan and In-111-Zevalin. RHEUMATOID ARTHRITIS : When combination of Maball injection with methotrexate is administrated. Maball injection given as two dose of 100mg IV infusion 2 weeks separated. When glucocorticoids administered as methylprednisolone 100mg IV Subsequent course based on clinical evaluation must administer every 24 weeks, but not early than every 16 weeks. GRANULOMATOSIS POLYANGITIS AND MICROSCOPIC POLYANGITIS : Maball injection administer Dose of 375 mg/m2 IV infusion weekly once for 4 weeks. When Glucocorticoids given with methylprednisolone by dose of 1000 mg IV/ day for 1- 3 days and purse by oral prednisone 1 mg/kg/day are recommended for the treatment of symptoms of serious vacuities This drug should initiate within 14 days before or with the starting of Maball injection and may continue during and after the 4 week course with treatment of Maball injection drug. Safety and not established for subsequent infusion. PRECAUTIONS Allgeric condition against Maball 100mg or any other medication inform your doctor. Information about past medical history used which include in prescription, non-prescription, vitamins &supplements , nutritional products just inform the doctor. While using Maball 100mg do not take any vaccination or immunization without taking advice from doctors. Avoid use of Maball 100mg if you are pregnant. It will harm the baby unborn, while using Maball 100mguse correct birth control to prevent pregnancy and for at least 2 weeks after your treatment ends. Maball 100mg may affect the ability to have children in

4. women. Inform your doctor if you planning to pregnant. It is unknown whether Maball 100mg passes into breast milk , avoid breast-feed while on Maball 100mg treatment. CONTRAINDICATION Hypersensitivity or murine proteins. Active severe infectons in rheumatoid arthritis Uncontrolled cardiac disease. MISSED DOSE If a dose missed then have the drug soon you remembered, if next dose time reach then leave the missed dose and follow the normal schedule. Do not have 2 dose at a same time. Please consult with doctor for further details. DRUG INTERACTION Maball 100mg drug interaction has limited data is available at present.Interation with fludarabine or cyclophosphamide have no effects in pharmacokinetics in CLL patients. Maball combination with methotrexate had no effects in pharmacokinetics. STORAGE Store the drug at 2℃– 3℃ Keep away from the childerns Use the drug before expiry date Protected from direct sunlight and Do not freeze or shake. Discard the unused drug by asking the advice from doctor or pharmacist. SIDE EFFECTS Common effects: fever and chills (flu lik symptoms) Less common side effects: Weakness; nausea ; headache; cough ; dyspnea ; pharyngitis