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TAJ PHARMA INDIA / Product / MEFISAR® (CYTARABINE 20MG/ML AND 100MG/ML SOLUTION FOR INFUSION OR INJECTION BP)
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MEFISAR® (CYTARABINE 20MG/ML AND 100MG/ML SOLUTION FOR INFUSION OR INJECTION BP)

Generic Name

CYTARABINE


Brand Name

MEFISAR


Dosage Form

Injection


Strength and Dosage

20MG/ML , 100MG/ML


Therapeutic Category


Patient Information Leaflet

Summary of Product Characteristics pdfIcon

Product Description


The active ingredient is cytarabine.
• Cytarabine is one of a group of the medicines known as cytotoxics, these medicines are used in the treatment of acute leukaemias (cancer of blood where you have too many white blood cells). Cytarabine interferes with the growth of cancer cells, which are eventually destroyed.
• Cytarabine is also used for the induction and maintenance of remission of leukaemia.
• Remission induction is an intensive treatment to force leukaemia into retreat. When it works, the balance of cells in your blood becomes more normal and your health improves. This relatively healthy spell is called a remission.
• Maintenance therapy is a milder treatment to make your remission last as long as possible. Quite low doses of Cytarabine are used to keep the leukaemia under control and stop it flaring up again.
You should consult your doctor if you are unsure why you have been given Cytarabine.


BEFORE YOU ARE GIVEN MEFISAR

Do not use MEFISAR if you:
• are allergic (hypersensitive) to cytarabine, or any of the other ingredients of MEFISAR
• are already taking medicines that have caused you to have a low blood count caused by suppression of your bone marrow.

Take special care with MEFISAR:
• Tell your doctor if your liver is not working properly. This will help your doctor decide if MEFISAR is suitable for you.
• If you have had or are due to have any vaccination including a live or live-attenuated vaccination.

Taking other medicines
Tell your doctor or pharmacist if you are:
• given medicines containing 5-Fluorocytosine (a medicine used to treat fungal infections).
• taking medicines containing digitoxin or beta-acetyldigoxin which are used to treat certain heart conditions.
• taking Gentamicin (an antibiotic used to treat bacterial infections).
• given medicines containing cyclophosphamide, vincristine and prednisone which are used in cancer treatment programmes.
• taking or have recently taken any other medicines, even those not prescribed.

Pregnancy
Avoid becoming pregnant while you or your partner is being treated with Cytarabine. If you are sexually active, you are advised to use effective birth control to prevent pregnancy during treatment, whether you are male or female. MEFISAR may cause birth defects, so it is important to tell your doctor if you think you are pregnant.

Breast-feeding
You should stop breast-feeding before starting treatment with MEFISAR because this medicine may be harmful to infants being breast-fed.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machinery
If feeling unwell following treatment with MEFISAR you should avoid driving or using machinery.
Ask your doctor or pharmacist for advice before taking any medicine.


HOW MEFISAR IS GIVEN TO YOU

MEFISAR will be given to you by infusion into a vein (through a ‘drip’) or by injection under the direction of specialists in hospital. Your doctor will decide what dose to give and the number of days’ treatment you will receive depending on your condition.
The dose of MEFISAR will be decided by your doctor based on your condition being treated for, whether you are in induction or maintenance therapy and your body surface area. Your body weight and height will be used to calculate your body surface area.

Regular Check-ups
During treatment you will need regular checks including blood tests. Your doctor will tell you how often this should be done. He/she will be making regular checks of:
• Your blood- to check for low blood cell counts that may need treatment.
• Your liver – again using blood tests – to check that MEFISAR is not affecting the way it functions in a harmful way.
• Your kidneys – again using blood tests – to check that MEFISAR is not affecting the way it functions in a harmful way.
• Blood uric acid levels – MEFISAR may increase uric acid levels in the blood. Another medicine may be given if your uric acid levels are too high.

If you receive high doses of MEFISAR:
High doses can worsen side effects like sores in the mouth or may decrease the number of white blood cells and platelets (these help the blood to clot) in the blood. Should this happen, you may need antibiotics or blood transfusions. Mouth ulcers can be treated to make them less uncomfortable as they heal.


POSSIBLE SIDE EFFECTS

Like all cytotoxic medicines, MEFISAR causes side effects, although these can vary from patient to patient.
Tell your doctor or nursing staff that will be monitoring you during this time immediately, if you suffer from the following symptoms after taking this medicine:
• An allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
• You are feeling tired and lethargic.
• You have flu like symptoms e.g. raised temperature or fever and chills.
• You bruise more easily or bleed more than usual if you hurt yourself. These are the symptoms of low numbers of blood cells. Tell your doctor or nursing staff immediately if you experience these symptoms.

Other side effects that may occur are:
If any of these side effects gets serious please tell your doctor or nursing staff immediately.
• Reactions at Injection site: inflammation to your veins (caused by a blood clot).
• Effects on your nervous system: Headaches or feeling dizzy, feeling of pins and needles, shaking and fits, drowsiness, experience problems in walking, speech problems, involuntary muscular movement, changes in your personality, tiredness, weakness, fainting.
• Effects on your skin and hair: Hair loss is common and may be quite severe. Hair normally re-grows when your treatment course ends. A rash or ulceration on your skin, peeling of the skin, itching or increased freckles. You may get an infection, including infection or inflammation at the site of your injection.
•Effects on your stomach, intestines: Feeling sick, being sick, diarrhoea, loss of appetite, abdominal pain.
•Effects on your mouth, gullet and anus: Inflammation of the gullet, causing heartburn may make you feel sick, and the appearance of sores in the mouth, lips, or on the anus (back passage).
•Effects on your pancreas: Pancreatitis (pain in the upper abdomen)often accompanied by feeling sick or vomiting. Tell your doctor if this happens to you.
•Effects on your liver: Liver damage (seen as yellowing of the skin and whites of the eye).
•Effects on your kidneys, bladder and urine: Difficulty or pain when passing urine. Blood in your urine and impaired kidney function.
•Effects on your hands, face and body: Feeling hot and feverish, conjunctivitis, and pain and numbness in joints, fingers, toes or face, swelling of the abdomen, legs, ankles and feet.
•Effects on respiratory system and chest: Shortness of breath, pneumonia, short or stabbing chest pain, build up of fluid in the lungs, sore throat.
•Effects on your muscles and bone: muscle pain, bone pain.
•Effects on your heart and circulation: fast heart beat, pericarditis (inflammation of the covering of the heart).
•Effects on your eyes and vision: eye infection, irritation, pain and blurred vision, visual loss.
“Cytarabine Syndrome”
Sometimes the following side effects can happen together 6 to 12 hours after receiving Cytarabine. Feeling generally unwell with a high temperature, pain in bone, muscle and sometimes the chest, blistery rash, sore eyes. This is called “Cytarabine Syndrome” and can be treated.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nursing staff immediately.


HOW TO STORE MEFISAR

Keep out of the reach and sight of children.
Hospital staff will store your medicine safely. The unopened vials should be stored in the original container between 15ºC and 25 ºC until ready for use.
MEFISAR should not be used after the expiry date which is stamped on the pack. The expiry date refers to the last day of that month.
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.


FURTHER INFORMATION

What MEFISAR contains
The active ingredient is cytarabine.
The other ingredients in Cytarabine 20mg/ml are hydrochloric acid, sodium hydroxide, nitrogen, water for injections and sodium chloride.
The other ingredients in Cytarabine 100mg/ml are hydrochloric acid, sodium hydroxide, nitrogen and water for injections.

What MEFISAR looks like and contents of the pack
MEFISAR is a solution available in two strengths: 20mg/ml and 100mg/ml.
MEFISAR containing 20mg/ml is supplied in plastic vials containing 100mg (5ml) or 500mg (25ml).
MEFISAR containing 100mg/ml is supplied in plastic vials 1000mg (10ml) or 2000mg (20ml).

Additional Information

If you are a distributor, please inquire with us about product , importing and/or marketing our products in your country or region. If you are a consumer, don’t hesitate to contact us about more information for this product.

To inquire more about cost effective Taj Brands products, hospital imports, non-available life saving products, please contact us.

The most common markets for this product include the following state . Please inquire with us if your state is not listed:

North India : Jammu & Kashmir ,Himachal Pradesh,Uttar Pradesh ,Uttaranchal , Punjab ,Haryana.
South India : Kerala, Karnataka ,Tamil Nadu,Andhra Pradesh.
East India : Assam ,Manipur, Meghalaya,West Bengal ,Orissa,Sikkim ,Mizoram, Tripura
West India : Goa ,Gujarat ,Rajasthan ,Maharashtra
Central India : Madhya Pradesh, Chattisgarh

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