CYTARABINE 100 MG/ML SOLUTION FOR INJECTION OR INFUSION
Active substance: CYTARABINE
View full screen / Print PDF » Download PDF ⇩
Transcript
Cytrabine - Pack Insert - Bordon - GBR+IRL
PACKAGE LEAFLET: INFORMATION FOR THE USER Cytarabine 100 mg/ml solution for injection or infusion Cytarabine Read all of this leaflet carefully before you start using this medicine. -- Keep this leaflet. You may need to read it again. -- If you have any further questions, please ask your doctor or pharmacist. -- 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 pharmacist. In this leaflet: 1.What Cytarabine is and what it is used for 2.Before you are given Cytarabine 3.How to use Cytarabine 4.Possible side effects 5.How to store Cytarabine 6.Further information 1. WHAT CYTARABINE IS AND WHAT IT IS USED FOR Cytarabine is used in adults and children. The active ingredient is cytarabine. Cytarabine is one of a group of 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. 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 period 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. 2. BEFORE YOU ARE GIVEN CYTARABINE Do not use cytarabine if you: are allergic (hypersensitive) to cytarabine, or any of the other ingredients of Cytarabine. If the cell count in your blood report is very low due to some cause other than cancer ,or as decided by your doctor If you are feeling increasing difficulties in body coordination after radiation treatment or treatment with another anticancer drug such as methotrexate. Take special care with cytarabine: if your bone marrow is in low state, therapy should be initiated under close medical supervision. if you have problem with your liver. Cytarabine strongly reduce blood cell production in the bone marrow. This can make you more prone to infection or bleeding. The blood cell numbers can continue to fall for up to a week after stopping treatment. Your doctor will test your blood regularly and examine your bone marrow if required. Serious and sometimes life-threatening side effects can occur in the central nervous system, the bowels or lungs. Your liver and kidney function should be monitored during cytarabine therapy. If your liver is not working well before treatment, cytarabine should be given only under strict control. The levels of uric acid (showing that the cancer cells are destroyed) in your blood (hyperuricaemia) may be high during treatment. Your doctor will tell you if you need to take any medicine to control this. During treatment with cytarabine administration of live or attenuated vaccine is not advised. If required, consult your doctor. Use of killed or inactivated vaccine may not have the desired effect due to suppressed immune system while on cytarabine. Do not forget to tell you doctor if you have received radiotherapy. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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. Pregnancy, breast-feeding and fertility 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. Cytarabine may cause birth defects, so it is important to tell your doctor if you think you are pregnant. Men and women have to use effective contraception during and up to 6 months after treatment. Breast-feeding You should stop breast-feeding before starting treatment with cytarabine because this medicine may be harmful to infants being breast-fed. Fertility Cytarabine may lead to suppression of menstrual cycles in females and lead to amenorrhea and may suppress sperm production in male patients. Male patients undergoing cytarabine treatment should use a reliable contraceptive method. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machinery Cytarabine does not affect your ability to drive or use machinery. However, cancer treatment in general can affect the ability of some patients to drive or operate machines. If you are affected, you should not drive or use machines. Important information about some of the ingredients of Cytarabine This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium- free. 3. HOW TO USE CYTARABINE Method and route of administrations Cytarabine 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. Dosage Based on your condition, your doctor will decide the dose of cytarabine, 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. 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 cytarabine is not affecting the way it functions in a harmful way. Your kidneys again using blood tests to check that cytarabine is not affecting the way it functions in a harmful way. Blood uric acid levels - cytarabine may increase uric acid levels in the blood. Another medicine may be given if your uric acid levels are too high. If your are on dialysis, the doctor may alter the time of drug administration as dialysis may decrease the effectiveness of the medicine. If you receive high doses of cytarabine: 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. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, cytarabine injection can cause side effects, although not everybody gets them. The side effects of cytarabine are dependent on the dose. The digestive tract is most commonly affected, but also the blood. Common : may affect up to 1 in 10 people fever not enough white and red blood cells or blood platelets, which may make you more prone to infection or bleeding - a fall in white blood cells can be accompanied by chills and fever that immediately require a medical opinion; - a fall in the platelet count can be accompanied by bleeding that immediately requires a medical opinion, abnormal blood cells (megaloblastosis) loss of appetite swallowing difficulty belly ache (abdominal pain) nausea (feeling sick) vomiting diarrhoea inflammation or ulceration of the mouth or anus reversible effects on the skin such as reddening (erythema), blistering, rash, hives, blood vessel inflammation (vasculitis), hair loss reversible effects on the liver such as increased enzyme levels reversible effects on the eyes such as sore eyes with bleeding (haemorrhagic conjunctivitis) with vision disturbance, sensitivity to light (photophobia), watery or burning eyes and inflammation of the cornea (keratitis) reduced consciousness (at high doses) speaking difficulties (at high doses) abnormal eye movements (nystagmus at high dose) inflammation of the vein at the site injection abnormal high blood uric acid levels (hyperuricaemia) Uncommon : may affect up to 1 in 100 people sore throat headache serious allergic reactions (anaphylaxis), causing for instance difficulty in breathing or dizziness blood-poisoning (sepsis) inflammation and ulcers of the gullet
[ Vinod Pal ] D:\FK-DATA\Europe\Cytarine\GBR+IRL\Bordon\May 2012\Cytrabine - Pack Insert - Bordon - GBR+IRL.indd
Dimension: 280 x 320 mm
Instruction for Use/Handling For single use only. Cytarabine is intended for intravenous or subcutaneous use only. The diluted solution should be clear, colourless solution free, from visible particles. Parenteral drugs should be inspected visually for particulate matter and discolouration, prior to administration, whenever solution and container permit. If the solution appears discoloured or contains visible particles, it should be discarded. Cytarabine injection can be diluted with sterile water for injections, glucose intravenous infusion (5 % w/v) or sodium chloride intravenous infusion (0.9 % w/v). The dilution compatibility study has been carried out in polyolefin infusion bags. The concentration over which the physico-chemical stability of cytarabine has been demonstrated is 0.04 - 4 mg/ml.
The following information is intended for medical or healthcare professionals only:
Prior to use, vials of Cytarabine 100 mg/ml must be warmed to 55C, for 30 minutes, with adequate shaking, and allowed to cool to room temperature. Once opened, the contents of each vial must be used immediately and not stored. Infusion fluids containing cytarabine should be used immediately.
Cytotoxic Handling Guidelines Administration: Should be administered by, or under the direct supervision of, a qualified physician who is experienced in the use of cancer chemotherapeutic agents.
Preparation (Guidelines): 1. Chemotherapeutic agents should be prepared for administration only by professionals trained in the safe use of the preparation. 2. Operations such as dilution and transfer to syringes should be carried out only in the designated area. 3. The personnel carrying out these procedures should be adequately protected with clothing, gloves and eye shield. 4. Pregnant personnel are advised not to handle chemotherapeutic agents.
Black
Times New Roman
9 pt
Draft: 1
Last modified: 16 May 2012 4:29 PM
Contamination: (a) In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat the transient stinging of skin. Medical
XXXXXX
V001
XXXXXXXXXX
Cytrabine - Pack Insert - Bordon - GBR+IRL
severe bowel inflammation (necrositing colitis) bowel cysts ulceration of the skin itching inflammation at the site of injection brown/black spots on the skin (lentigo) yellowish skin and eye balls (jaundice) lung infection (pneumonia) breathing difficulty paralysis of the legs and lower body can occur when cytarabine is given into the space surrounding the spinal cord muscle and joint pain inflammation of the lining that surrounds the heart (pericarditis) impaired kidney function inability to pass urine (urinary retention) chest pain burning pain of palms and soles Digestive tract: Especially in treatment with high doses of cytarabine more severe reactions may appear in addition to the common symptoms. Perforation, death (necrosis) and obstruction of the bowel and inflammation of the inner belly lining have been reported. Liver abcesses, liver enlargement, blockage of liver veins and inflammation of the pancreas have been observed after high-dose therapy. The side effects on the digestive tract are less if cytarabine is given by infusion. Lungs: Acute, distressing breathing difficulties and water in the lungs (pulmonary edema) have been observed particularly at high doses. Others: heart muscle disease (cardiomyopathy) abnormal muscle breakdown (rhabdomyolysis) 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 pharmacist. These disorders can occur even when treatment has a positive effect 5. HOW TO STORE CYTARABINE Keep out of the reach and sight of children. Do not store above 25C. Do not refrigerate or freeze. Do not use cytarabine injection after the expiry date which is stated on the vial or carton. The expiry date refers to the last day of that month. The product should be used immediately after opening the vial. After dilution in the following diluents, sterile water for injections, glucose intravenous infusion (5 % w/v) or sodium chloride intravenous infusion (0.9 % w/v): Chemical and physical in-use stability has been demonstrated for 8 days below 25 C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8C, unless dilution has taken place in controlled and validated aseptic conditions. Do not use cytarabine injection if you notice that the solution is not clear, colourless 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. 6. FURTHER INFORMATION What Cytarabine contains: The active ingredient is cytarabine. 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 1 g of cytarabine. Each 20 ml vial contains 2 g of cytarabine. The other ingredients are hydrochloric acid, sodium hydroxide and water for injections. What Cytarabine looks like and contents of the pack The medicinal product is presented as a clear, colourless solution for injection or infusion. This medicine is presented in a clear colourless, type I glass vials with bromobutyl rubber stopper and sealed with flip-off aluminium overseal Green (2 ml), blue (5 ml), red (10 ml) and yellow (20 ml). The package contains 1 vial of 1 ml, 5 ml, 10 ml and 20 ml, respectively. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom This medicinal product is authorised in the Member States of the EEA under the following names: Belgium Czech Republic Germany Denmark Estonia Spain Finland France Hungary Ireland Iceland Italy Latvia Malta Lithuania Luxemburg Netherlands Norway Poland Portugal Romania Sweden Slovak Republic United Kingdom Cytarabine Fresenius Kabi 100 mg/ml Oplossing voor injectie of infusie Cytarabin Kabi 100 mg/ml, Injekn a infuzn roztok Cytarabin Kabi 100 mg/ml Injektions-oder Infusionslsung Cytarabin Fresenius Kabi Cytarabine Kabi Citarabina 100 mg/ml solucin inyectable o para perfusin Cytarabin Fresenius Kabi 100 mg/ml injektio-/ infuusioneste, liuos Cytarabine Kabi 100 mg/ml, solution injectable ou pour perfusion Cytarabine Kabi 100 mg/ml oldatos injekci vagy infzi Cytarabine 100 mg/ml Solution for Injection or Infusion Cytarabin Fresenius Kabi 100 mg/ml stungulyf/ innrennslislyf, lausn Citarabina Kabi Cytarabine Kabi 100 mg/ml dums injekcijm vai infzijm Cytarabine 100 mg/ml Solution for Injection or Infusion Cytarabine Kabi 100 mg/ml injekcinis/ infuzinis tirpalas Cytarabin Kabi 100 mg/ml Injektions- oder Infusionslsung Cytarabine Fresenius Kabi 100 mg/ml Oplossing voor injectie of infusie Cytarabin "Fresenius Kabi" 100 mg/ml Injeksjons-/infusjonsvske, opplsning Cytarabine Kabi Citarabina Kabi Citarabina Kabi 100 mg/ml soluie injectabil sau perfuzabil Cytarabin Fresenius Kabi 100 mg/ml injektions-/ infusionsvtska, lsning Cytarabin Kabi 100 mg/ml, injekn a infzny roztok, Cytarabine 100 mg/ml Solution for Injection or Infusion
Very rare : may affect up to 1 in 10,000 people inflammation of sweat glands irregular heartbeat (arrhythmias) Other side effects: The cytarabine syndrome may occur 6-12 hours after the start of treatment. The symptoms include: fever bone and muscle pain occasional chest pain rash sore eyes (conjunctivitis) nausea (feeling sick) Your doctor may prescribe corticosteroids (anti-inflammatory medicines) to prevent or treat these symptoms. If they are effective, treatment with cytarabine may be continued. Central nervous system: The following symptoms, which are usually reversible, may develop in up to one third of patients after treatment with high cytarabine doses: personality changes changed alertness difficulty in speeking problems of coordination tremor abnormal eye movements (nystagmus) headache confusion sleepiness dizziness coma convulsions These side effects may occur more often: in elderly patients (>55 years of age) in patients with impaired liver and kidney function after previous cancer treatment to the brain and spinal cord for instance radiotherapy or injection of cytostatic with alcohol abuse The risk of nervous system damages increases if the cytarabine treatment is given at high doses or at short intervals is combined with other treatments that are toxic to the nerves system (such as radiotherapy or methotrexate)
[ Vinod Pal ] D:\FK-DATA\Europe\Cytarine\GBR+IRL\Bordon\May 2012\Cytrabine - Pack Insert - Bordon - GBR+IRL.indd
Dimension: 280 x 320 mm
This leaflet was last revised on 05/2012
Disposal: Syringes, container, absorbent materials, solution and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerated at 1100C. Any unused product or waste material should be disposed of in accordance with local requirements.
advice should be sought if the eyes are affected. (b) In the event of spillage, operators should put on gloves and mop up the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with w a t e r . Put all solutions and sponges into a plastic bag and seal it.
Black
Times New Roman
9 pt
Draft: 1
Last modified: 16 May 2012 4:29 PM
XXXXXX
V001
XXXXXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER Cytarabine 100 mg/ml solution for injection or infusion Cytarabine Read all of this leaflet carefully before you start using this medicine. -- Keep this leaflet. You may need to read it again. -- If you have any further questions, please ask your doctor or pharmacist. -- 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 pharmacist. In this leaflet: 1.What Cytarabine is and what it is used for 2.Before you are given Cytarabine 3.How to use Cytarabine 4.Possible side effects 5.How to store Cytarabine 6.Further information 1. WHAT CYTARABINE IS AND WHAT IT IS USED FOR Cytarabine is used in adults and children. The active ingredient is cytarabine. Cytarabine is one of a group of 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. 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 period 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. 2. BEFORE YOU ARE GIVEN CYTARABINE Do not use cytarabine if you: are allergic (hypersensitive) to cytarabine, or any of the other ingredients of Cytarabine. If the cell count in your blood report is very low due to some cause other than cancer ,or as decided by your doctor If you are feeling increasing difficulties in body coordination after radiation treatment or treatment with another anticancer drug such as methotrexate. Take special care with cytarabine: if your bone marrow is in low state, therapy should be initiated under close medical supervision. if you have problem with your liver. Cytarabine strongly reduce blood cell production in the bone marrow. This can make you more prone to infection or bleeding. The blood cell numbers can continue to fall for up to a week after stopping treatment. Your doctor will test your blood regularly and examine your bone marrow if required. Serious and sometimes life-threatening side effects can occur in the central nervous system, the bowels or lungs. Your liver and kidney function should be monitored during cytarabine therapy. If your liver is not working well before treatment, cytarabine should be given only under strict control. The levels of uric acid (showing that the cancer cells are destroyed) in your blood (hyperuricaemia) may be high during treatment. Your doctor will tell you if you need to take any medicine to control this. During treatment with cytarabine administration of live or attenuated vaccine is not advised. If required, consult your doctor. Use of killed or inactivated vaccine may not have the desired effect due to suppressed immune system while on cytarabine. Do not forget to tell you doctor if you have received radiotherapy. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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. Pregnancy, breast-feeding and fertility 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. Cytarabine may cause birth defects, so it is important to tell your doctor if you think you are pregnant. Men and women have to use effective contraception during and up to 6 months after treatment. Breast-feeding You should stop breast-feeding before starting treatment with cytarabine because this medicine may be harmful to infants being breast-fed. Fertility Cytarabine may lead to suppression of menstrual cycles in females and lead to amenorrhea and may suppress sperm production in male patients. Male patients undergoing cytarabine treatment should use a reliable contraceptive method. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machinery Cytarabine does not affect your ability to drive or use machinery. However, cancer treatment in general can affect the ability of some patients to drive or operate machines. If you are affected, you should not drive or use machines. Important information about some of the ingredients of Cytarabine This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium- free. 3. HOW TO USE CYTARABINE Method and route of administrations Cytarabine 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. Dosage Based on your condition, your doctor will decide the dose of cytarabine, 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. 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 cytarabine is not affecting the way it functions in a harmful way. Your kidneys again using blood tests to check that cytarabine is not affecting the way it functions in a harmful way. Blood uric acid levels - cytarabine may increase uric acid levels in the blood. Another medicine may be given if your uric acid levels are too high. If your are on dialysis, the doctor may alter the time of drug administration as dialysis may decrease the effectiveness of the medicine. If you receive high doses of cytarabine: 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. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, cytarabine injection can cause side effects, although not everybody gets them. The side effects of cytarabine are dependent on the dose. The digestive tract is most commonly affected, but also the blood. Common : may affect up to 1 in 10 people fever not enough white and red blood cells or blood platelets, which may make you more prone to infection or bleeding - a fall in white blood cells can be accompanied by chills and fever that immediately require a medical opinion; - a fall in the platelet count can be accompanied by bleeding that immediately requires a medical opinion, abnormal blood cells (megaloblastosis) loss of appetite swallowing difficulty belly ache (abdominal pain) nausea (feeling sick) vomiting diarrhoea inflammation or ulceration of the mouth or anus reversible effects on the skin such as reddening (erythema), blistering, rash, hives, blood vessel inflammation (vasculitis), hair loss reversible effects on the liver such as increased enzyme levels reversible effects on the eyes such as sore eyes with bleeding (haemorrhagic conjunctivitis) with vision disturbance, sensitivity to light (photophobia), watery or burning eyes and inflammation of the cornea (keratitis) reduced consciousness (at high doses) speaking difficulties (at high doses) abnormal eye movements (nystagmus at high dose) inflammation of the vein at the site injection abnormal high blood uric acid levels (hyperuricaemia) Uncommon : may affect up to 1 in 100 people sore throat headache serious allergic reactions (anaphylaxis), causing for instance difficulty in breathing or dizziness blood-poisoning (sepsis) inflammation and ulcers of the gullet
[ Vinod Pal ] D:\FK-DATA\Europe\Cytarine\GBR+IRL\Bordon\May 2012\Cytrabine - Pack Insert - Bordon - GBR+IRL.indd
Dimension: 280 x 320 mm
Instruction for Use/Handling For single use only. Cytarabine is intended for intravenous or subcutaneous use only. The diluted solution should be clear, colourless solution free, from visible particles. Parenteral drugs should be inspected visually for particulate matter and discolouration, prior to administration, whenever solution and container permit. If the solution appears discoloured or contains visible particles, it should be discarded. Cytarabine injection can be diluted with sterile water for injections, glucose intravenous infusion (5 % w/v) or sodium chloride intravenous infusion (0.9 % w/v). The dilution compatibility study has been carried out in polyolefin infusion bags. The concentration over which the physico-chemical stability of cytarabine has been demonstrated is 0.04 - 4 mg/ml.
The following information is intended for medical or healthcare professionals only:
Prior to use, vials of Cytarabine 100 mg/ml must be warmed to 55C, for 30 minutes, with adequate shaking, and allowed to cool to room temperature. Once opened, the contents of each vial must be used immediately and not stored. Infusion fluids containing cytarabine should be used immediately.
Cytotoxic Handling Guidelines Administration: Should be administered by, or under the direct supervision of, a qualified physician who is experienced in the use of cancer chemotherapeutic agents.
Preparation (Guidelines): 1. Chemotherapeutic agents should be prepared for administration only by professionals trained in the safe use of the preparation. 2. Operations such as dilution and transfer to syringes should be carried out only in the designated area. 3. The personnel carrying out these procedures should be adequately protected with clothing, gloves and eye shield. 4. Pregnant personnel are advised not to handle chemotherapeutic agents.
Black
Times New Roman
9 pt
Draft: 1
Last modified: 16 May 2012 4:29 PM
Contamination: (a) In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat the transient stinging of skin. Medical
XXXXXX
V001
XXXXXXXXXX
Cytrabine - Pack Insert - Bordon - GBR+IRL
severe bowel inflammation (necrositing colitis) bowel cysts ulceration of the skin itching inflammation at the site of injection brown/black spots on the skin (lentigo) yellowish skin and eye balls (jaundice) lung infection (pneumonia) breathing difficulty paralysis of the legs and lower body can occur when cytarabine is given into the space surrounding the spinal cord muscle and joint pain inflammation of the lining that surrounds the heart (pericarditis) impaired kidney function inability to pass urine (urinary retention) chest pain burning pain of palms and soles Digestive tract: Especially in treatment with high doses of cytarabine more severe reactions may appear in addition to the common symptoms. Perforation, death (necrosis) and obstruction of the bowel and inflammation of the inner belly lining have been reported. Liver abcesses, liver enlargement, blockage of liver veins and inflammation of the pancreas have been observed after high-dose therapy. The side effects on the digestive tract are less if cytarabine is given by infusion. Lungs: Acute, distressing breathing difficulties and water in the lungs (pulmonary edema) have been observed particularly at high doses. Others: heart muscle disease (cardiomyopathy) abnormal muscle breakdown (rhabdomyolysis) 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 pharmacist. These disorders can occur even when treatment has a positive effect 5. HOW TO STORE CYTARABINE Keep out of the reach and sight of children. Do not store above 25C. Do not refrigerate or freeze. Do not use cytarabine injection after the expiry date which is stated on the vial or carton. The expiry date refers to the last day of that month. The product should be used immediately after opening the vial. After dilution in the following diluents, sterile water for injections, glucose intravenous infusion (5 % w/v) or sodium chloride intravenous infusion (0.9 % w/v): Chemical and physical in-use stability has been demonstrated for 8 days below 25 C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8C, unless dilution has taken place in controlled and validated aseptic conditions. Do not use cytarabine injection if you notice that the solution is not clear, colourless 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. 6. FURTHER INFORMATION What Cytarabine contains: The active ingredient is cytarabine. 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 1 g of cytarabine. Each 20 ml vial contains 2 g of cytarabine. The other ingredients are hydrochloric acid, sodium hydroxide and water for injections. What Cytarabine looks like and contents of the pack The medicinal product is presented as a clear, colourless solution for injection or infusion. This medicine is presented in a clear colourless, type I glass vials with bromobutyl rubber stopper and sealed with flip-off aluminium overseal Green (2 ml), blue (5 ml), red (10 ml) and yellow (20 ml). The package contains 1 vial of 1 ml, 5 ml, 10 ml and 20 ml, respectively. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom This medicinal product is authorised in the Member States of the EEA under the following names: Belgium Czech Republic Germany Denmark Estonia Spain Finland France Hungary Ireland Iceland Italy Latvia Malta Lithuania Luxemburg Netherlands Norway Poland Portugal Romania Sweden Slovak Republic United Kingdom Cytarabine Fresenius Kabi 100 mg/ml Oplossing voor injectie of infusie Cytarabin Kabi 100 mg/ml, Injekn a infuzn roztok Cytarabin Kabi 100 mg/ml Injektions-oder Infusionslsung Cytarabin Fresenius Kabi Cytarabine Kabi Citarabina 100 mg/ml solucin inyectable o para perfusin Cytarabin Fresenius Kabi 100 mg/ml injektio-/ infuusioneste, liuos Cytarabine Kabi 100 mg/ml, solution injectable ou pour perfusion Cytarabine Kabi 100 mg/ml oldatos injekci vagy infzi Cytarabine 100 mg/ml Solution for Injection or Infusion Cytarabin Fresenius Kabi 100 mg/ml stungulyf/ innrennslislyf, lausn Citarabina Kabi Cytarabine Kabi 100 mg/ml dums injekcijm vai infzijm Cytarabine 100 mg/ml Solution for Injection or Infusion Cytarabine Kabi 100 mg/ml injekcinis/ infuzinis tirpalas Cytarabin Kabi 100 mg/ml Injektions- oder Infusionslsung Cytarabine Fresenius Kabi 100 mg/ml Oplossing voor injectie of infusie Cytarabin "Fresenius Kabi" 100 mg/ml Injeksjons-/infusjonsvske, opplsning Cytarabine Kabi Citarabina Kabi Citarabina Kabi 100 mg/ml soluie injectabil sau perfuzabil Cytarabin Fresenius Kabi 100 mg/ml injektions-/ infusionsvtska, lsning Cytarabin Kabi 100 mg/ml, injekn a infzny roztok, Cytarabine 100 mg/ml Solution for Injection or Infusion
Very rare : may affect up to 1 in 10,000 people inflammation of sweat glands irregular heartbeat (arrhythmias) Other side effects: The cytarabine syndrome may occur 6-12 hours after the start of treatment. The symptoms include: fever bone and muscle pain occasional chest pain rash sore eyes (conjunctivitis) nausea (feeling sick) Your doctor may prescribe corticosteroids (anti-inflammatory medicines) to prevent or treat these symptoms. If they are effective, treatment with cytarabine may be continued. Central nervous system: The following symptoms, which are usually reversible, may develop in up to one third of patients after treatment with high cytarabine doses: personality changes changed alertness difficulty in speeking problems of coordination tremor abnormal eye movements (nystagmus) headache confusion sleepiness dizziness coma convulsions These side effects may occur more often: in elderly patients (>55 years of age) in patients with impaired liver and kidney function after previous cancer treatment to the brain and spinal cord for instance radiotherapy or injection of cytostatic with alcohol abuse The risk of nervous system damages increases if the cytarabine treatment is given at high doses or at short intervals is combined with other treatments that are toxic to the nerves system (such as radiotherapy or methotrexate)
[ Vinod Pal ] D:\FK-DATA\Europe\Cytarine\GBR+IRL\Bordon\May 2012\Cytrabine - Pack Insert - Bordon - GBR+IRL.indd
Dimension: 280 x 320 mm
This leaflet was last revised on 05/2012
Disposal: Syringes, container, absorbent materials, solution and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerated at 1100C. Any unused product or waste material should be disposed of in accordance with local requirements.
advice should be sought if the eyes are affected. (b) In the event of spillage, operators should put on gloves and mop up the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with w a t e r . Put all solutions and sponges into a plastic bag and seal it.
Black
Times New Roman
9 pt
Draft: 1
Last modified: 16 May 2012 4:29 PM
XXXXXX
V001
XXXXXXXXXX
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
