\n\n100 mg \/ ml solution for injection \/ infusion
Cytarabine<\/p>\n\n\n\n
Take special care with Cytarabine Fresenius Kabi<\/p>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
Pregnancy<\/em> Breast-feeding<\/em> Ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n If you feel unwell after taking the cytarabine treatment, you should not drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. Cytarabine will be given to you by infusion into a vein (by a “drip”) or by injection, under the guidance of hospital specialists. Your doctor will decide what dose is given and for how long depending on your condition.<\/p>\n\n\n\n Regular checks<\/strong><\/p>\n\n\n\n During treatment, you will need regular check-ups, including blood tests. Your doctor will tell you how often these should be done. He\/she will regularly check:<\/p>\n\n\n\n High doses can aggravate side effects such as sores in the mouth or can reduce the number of white blood cells and platelets (this helps the blood to clot) in the blood. Should this occur, you may need antibiotics or blood transfusions. Sores in the mouth can be treated to make them less uncomfortable when they heal. If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell<\/strong> your doctor or nurse immediately<\/strong> if you get any of the following symptoms after treatment with this medicine:<\/p>\n\n\n\n Other side effects that may occur are:<\/strong><\/p>\n\n\n\n If any of these side effects gets serious, talk to your doctor or nurse immediately<\/strong>. Very common (may affect more than 1 user in 10):<\/strong><\/p>\n\n\n\n Common <\/strong>(may <\/strong>affect up to 1 in 10 <\/strong>people):<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people):<\/strong><\/p>\n\n\n\n Very rare (may affect up to 1 in 10,000 people):<\/strong><\/p>\n\n\n\n Has been reported (occurs in an unknown number of users):<\/strong><\/p>\n\n\n\n The following <\/strong>adverse reactions<\/strong> are <\/strong>reported at the high dose:<\/strong><\/strong><\/strong> Very common (may affect more than 1 user in 10):<\/strong><\/p>\n\n\n\n Common (may affect up to 1 in 10 people):<\/strong><\/p>\n\n\n\n Has been reported (occurs in an unknown number of users):<\/strong><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children. Store at 15 \u00b0 C – 25 \u00b0 C. Store in a cold place. Do not freeze. Do not use this medicine after the expiry date which is stated on the bottle or carton. The expiration date is the last day of the specified month. The product should be used immediately after opening. After dilution in the following diluents, sterile water for injections, glucose 50 mg\/ml solution for infusion, or sodium chloride 9 mg\/ml solution for infusion: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2-8 \u00b0 C, unless dilution has taken place under controlled and validated aseptic conditions. Do not use cytarabine if you notice that the solution is not clear, colorless, and free of particles. 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.<\/p>\n\n\n\n The medicine is a clear, colorless solution for injection or infusion. This medicine is supplied in a clear, colorless, type I glass vial with a bromobutyl rubber stopper and a flip-off cap consisting of an aluminum seal and a green (2 ml), blue (5 ml), red (10 ml), and yellow (20 ml) ) plastic disc. Each carton contains 1 vial of 1 ml, 5 ml, 10 ml, or 20 ml. Not all pack sizes may be marketed.<\/p>\n\n\n\n Fresenius Kabi AB<\/p>\n\n\n\n 751 74 Uppsala
Avoid getting pregnant while you or your partner are being treated with cytarabine. If you are sexually active, you should use effective contraception to prevent pregnancy during treatment, whether you are male or female. Cytarabine can cause birth defects, so it is important to tell your doctor if you think you may be pregnant. Men and women must use effective contraception during and up to 6 months after treatment.
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You should stop breast-feeding before starting treatment with cytarabine, as this medicine may be harmful to breast-fed infants.
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
<\/p>\n\n\n\nCytarabine Fresenius Kabi contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Cytarabine Fresenius Kabi<\/h2>\n\n\n\n
Based on your condition and body surface area, your doctor will determine the dose of cytarabine and whether you should receive induction or maintenance therapy. Your body weight and height will be used to calculate your body surface area.
<\/p>\n\n\n\nIf you use more Cytarabin Fresenius Kabi then you should<\/h2>\n\n\n\n
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<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Cytarabin Fresenius Kabi<\/h2>\n\n\n\n
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Chemical and physical in-use stability has been demonstrated for 8 days below 25 \u00b0 C.
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<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
Each ml of solution contains 100 mg of cytarabine.
Each 1 ml vial contains 100 mg of cytarabine. Each 5 ml vial contains 500 mg of cytarabine. Each 10 ml vial contains 1000 mg of cytarabine. Each 20 ml vial contains 2000 mg of cytarabine.<\/li>What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
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