CYTARABINE 100MG/ML INJECTION
Active substance: CYTARABINE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Cytarabine 100 mg/ml Injection
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, ask your doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Cytarabine Injection is and what it is used for 2. Before you use Cytarabine Injection 3. How to use Cytarabine Injection 4. Possible side effects 5. How to store Cytarabine Injection 6. Further information
1. WHAT CYTARABINE INJECTION IS AND WHAT IT IS USED FOR
Cytarabine Injection is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. Cytarabine Injection is used to treat some types of leukaemia (cancer affecting the blood) and lymphomas (cancer of the lymph glands). It may be used in combination with other anti-cancer medicines.
2. BEFORE YOU USE CYTARABINE INJECTION Do not use Cytarabine Injection
if you have shown signs of hypersensitivity (severe allergy) to cytarabine in the past if your bone marrow is still recovering from damage caused by other medicines (your doctor will check for this using blood tests and will only consider treatment with cytarabine if absolutely necessary) if your cancer is not spreading (your doctor will only consider treatment with cytarabine if absolutely necessary) Tell your doctor if you think any of the above applies to you before this medicine is used.
Take special care with Cytarabine Injection
if the number of cells in your blood (blood cell count) is low (your doctor will check this using blood tests) if you have any problems with your liver including jaundice (causes yellowing of the skin) Tell your doctor if either of the above applies to you before this medicine is used. Special care will be taken if cytarabine is to be given to a child.
Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could interact with cytarabine. The effectiveness of the following medicines may be reduced by cytarabine: digoxin tablets (heart medicine) gentamicin (an antibiotic) flucytosine (a medicine used to treat fungal infections) Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine. As there is a risk of birth defects, women of childbearing potential should use appropriate contraception methods during treatment with cytarabine. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines if you experience any side effect which may lessen your ability to do so.
3. HOW TO USE CYTARABINE INJECTION
This medicine may be given by injection (using a syringe) under the skin (subcutaneous) or into a vein (intravenous). It may also be given by infusion (drip) into a vein. If given as an infusion, Cytarabine Injection will be diluted first. Cytarabine 100 mg/ml Injection must not be injected intrathecally (into the spine).
Dose
Your doctor will work out the correct dose of cytarabine for you and how often it must be given. The dose will depend on your medical condition, your size and how well your liver is working. Your doctor will tell how well your liver is working using blood tests. You will have regular blood tests after your dose of cytarabine to check for side effects. These tests may be done more often if you are elderly, as you may be more likely to get side effects. Treatment may have to be stopped if your blood cell count drops too low.
If you are given too much or too little Cytarabine Injection
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.
Cytarabine 100 mg/ml Injection
The following information is intended for medical or healthcare professionals only Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here. Cytarabine 100 mg/ml Injection should not be administered by the intrathecal route due to the slight hypertonicity of this formulation.
Incompatibilities
Solutions of cytarabine have been reported to be incompatible with various drugs, i.e. carbenicillin sodium, cephalothin sodium, fluorouracil, gentamicin sulphate, heparin sodium, hydrocortisone sodium succinate, insulin-regular, methylprednisolone sodium succinate, nafacillin sodium, oxacillin sodium, penicillin G sodium. However, the incompatibility
Q62990 4XXXXX
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cytarabine Injection can cause side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint severe pain in the chest severe pain in the abdomen loss of vision, loss of sense of touch, mental disturbance or loss of ability to move normally (this medicine may cause side effects to the brain and eyes which are usually reversible but may be very serious) These are serious side effects. You may need urgent medical attention.
If you experience any of the following tell your doctor as soon as possible:
unexpected bleeding e.g. bleeding gums, blood in urine or vomit, unexpected bruises black tarry stools shortness of breath sore mouth or mouth ulcers symptoms of an infection, e.g. fever, chills, aches or soreness when swallowing skin rash or skin ulcers problems passing urine dizziness yellowing of the skin or yellowing of the whites of the eyes (jaundice) sore or itchy eyes pain in the joints or along nerves pain, infection, swelling or irritation at the injection site mild pain in the abdomen feeling sick or being sick (this side effect may be reduced if cytarabine is given as an infusion into a vein rather than a injection into a vein) diarrhoea loss of appetite hair loss Cytarabine may lead to changes in your blood cells. Your doctor will take blood samples to monitor for these and also to check how well your liver and kidneys are working. Sometimes the following side effects can occur together, usually 6-12 hours after receiving cytarabine: feeling generally unwell with a high temperature pain in bone, muscle and occasionally the chest rash sore eyes
This is known as cytarabine syndrome and it can be treated. If you experience these side effects please tell your doctor or nurse as soon as possible. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE CYTARABINE INJECTION
Keep out of the reach and sight of children
Expiry
This medicine must not be used after the expiry date which is stated on the vial and carton after EXP. Where only a month and year is stated, the expiry date refers to the last day of that month.
Storage
The vial should be kept in the outer carton, in order to protect from light, and stored at, or below, 25C.
6. FURTHER INFORMATION What Cytarabine Injection contains
The active substance is cytarabine. Each millilitre (ml) of solution contains 100 milligrams (mg) of cytarabine. The other ingredient is Water for Injections.
What Cytarabine Injection looks like and contents of the pack
Cytarabine Injection is a clear, colourless solution for injection which comes in glass containers called vials. It may be supplied in packs containing: 1, 1, 1, 1, 5, 5, 5, 5, 10 10 10 10 or or or or 20 20 20 20 x x x x 100 mg/1 500 mg/5 1 g/10 ml 2 g/20 ml ml vials ml vials vials vials
Not all packs may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release in Europe
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK
Manufacturer
Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170, Australia This leaflet was last approved in
11/2008
depends on several factors (e.g. concentrations of the drug, specific diluents used, resulting pH, temperature). Specialised references should be consulted for specific compatibility information.
Use and handling
Cytarabine 100 mg/ml Injection is a ready to use injection but it can be diluted with Sterile Water for Injections BP, Glucose Intravenous Infusion BP or Sodium Chloride Intravenous Infusion BP. Chemical and physical in-use stability has been demonstrated for 7 days at room temperature. 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.
Q62990 4XXXXX
Cytarabine 100 mg/ml Injection
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, ask your doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Cytarabine Injection is and what it is used for 2. Before you use Cytarabine Injection 3. How to use Cytarabine Injection 4. Possible side effects 5. How to store Cytarabine Injection 6. Further information
1. WHAT CYTARABINE INJECTION IS AND WHAT IT IS USED FOR
Cytarabine Injection is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. Cytarabine Injection is used to treat some types of leukaemia (cancer affecting the blood) and lymphomas (cancer of the lymph glands). It may be used in combination with other anti-cancer medicines.
2. BEFORE YOU USE CYTARABINE INJECTION Do not use Cytarabine Injection
if you have shown signs of hypersensitivity (severe allergy) to cytarabine in the past if your bone marrow is still recovering from damage caused by other medicines (your doctor will check for this using blood tests and will only consider treatment with cytarabine if absolutely necessary) if your cancer is not spreading (your doctor will only consider treatment with cytarabine if absolutely necessary) Tell your doctor if you think any of the above applies to you before this medicine is used.
Take special care with Cytarabine Injection
if the number of cells in your blood (blood cell count) is low (your doctor will check this using blood tests) if you have any problems with your liver including jaundice (causes yellowing of the skin) Tell your doctor if either of the above applies to you before this medicine is used. Special care will be taken if cytarabine is to be given to a child.
Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could interact with cytarabine. The effectiveness of the following medicines may be reduced by cytarabine: digoxin tablets (heart medicine) gentamicin (an antibiotic) flucytosine (a medicine used to treat fungal infections) Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine. As there is a risk of birth defects, women of childbearing potential should use appropriate contraception methods during treatment with cytarabine. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines if you experience any side effect which may lessen your ability to do so.
3. HOW TO USE CYTARABINE INJECTION
This medicine may be given by injection (using a syringe) under the skin (subcutaneous) or into a vein (intravenous). It may also be given by infusion (drip) into a vein. If given as an infusion, Cytarabine Injection will be diluted first. Cytarabine 100 mg/ml Injection must not be injected intrathecally (into the spine).
Dose
Your doctor will work out the correct dose of cytarabine for you and how often it must be given. The dose will depend on your medical condition, your size and how well your liver is working. Your doctor will tell how well your liver is working using blood tests. You will have regular blood tests after your dose of cytarabine to check for side effects. These tests may be done more often if you are elderly, as you may be more likely to get side effects. Treatment may have to be stopped if your blood cell count drops too low.
If you are given too much or too little Cytarabine Injection
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.
Cytarabine 100 mg/ml Injection
The following information is intended for medical or healthcare professionals only Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here. Cytarabine 100 mg/ml Injection should not be administered by the intrathecal route due to the slight hypertonicity of this formulation.
Incompatibilities
Solutions of cytarabine have been reported to be incompatible with various drugs, i.e. carbenicillin sodium, cephalothin sodium, fluorouracil, gentamicin sulphate, heparin sodium, hydrocortisone sodium succinate, insulin-regular, methylprednisolone sodium succinate, nafacillin sodium, oxacillin sodium, penicillin G sodium. However, the incompatibility
Q62990 4XXXXX
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cytarabine Injection can cause side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint severe pain in the chest severe pain in the abdomen loss of vision, loss of sense of touch, mental disturbance or loss of ability to move normally (this medicine may cause side effects to the brain and eyes which are usually reversible but may be very serious) These are serious side effects. You may need urgent medical attention.
If you experience any of the following tell your doctor as soon as possible:
unexpected bleeding e.g. bleeding gums, blood in urine or vomit, unexpected bruises black tarry stools shortness of breath sore mouth or mouth ulcers symptoms of an infection, e.g. fever, chills, aches or soreness when swallowing skin rash or skin ulcers problems passing urine dizziness yellowing of the skin or yellowing of the whites of the eyes (jaundice) sore or itchy eyes pain in the joints or along nerves pain, infection, swelling or irritation at the injection site mild pain in the abdomen feeling sick or being sick (this side effect may be reduced if cytarabine is given as an infusion into a vein rather than a injection into a vein) diarrhoea loss of appetite hair loss Cytarabine may lead to changes in your blood cells. Your doctor will take blood samples to monitor for these and also to check how well your liver and kidneys are working. Sometimes the following side effects can occur together, usually 6-12 hours after receiving cytarabine: feeling generally unwell with a high temperature pain in bone, muscle and occasionally the chest rash sore eyes
This is known as cytarabine syndrome and it can be treated. If you experience these side effects please tell your doctor or nurse as soon as possible. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE CYTARABINE INJECTION
Keep out of the reach and sight of children
Expiry
This medicine must not be used after the expiry date which is stated on the vial and carton after EXP. Where only a month and year is stated, the expiry date refers to the last day of that month.
Storage
The vial should be kept in the outer carton, in order to protect from light, and stored at, or below, 25C.
6. FURTHER INFORMATION What Cytarabine Injection contains
The active substance is cytarabine. Each millilitre (ml) of solution contains 100 milligrams (mg) of cytarabine. The other ingredient is Water for Injections.
What Cytarabine Injection looks like and contents of the pack
Cytarabine Injection is a clear, colourless solution for injection which comes in glass containers called vials. It may be supplied in packs containing: 1, 1, 1, 1, 5, 5, 5, 5, 10 10 10 10 or or or or 20 20 20 20 x x x x 100 mg/1 500 mg/5 1 g/10 ml 2 g/20 ml ml vials ml vials vials vials
Not all packs may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release in Europe
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK
Manufacturer
Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170, Australia This leaflet was last approved in
11/2008
depends on several factors (e.g. concentrations of the drug, specific diluents used, resulting pH, temperature). Specialised references should be consulted for specific compatibility information.
Use and handling
Cytarabine 100 mg/ml Injection is a ready to use injection but it can be diluted with Sterile Water for Injections BP, Glucose Intravenous Infusion BP or Sodium Chloride Intravenous Infusion BP. Chemical and physical in-use stability has been demonstrated for 7 days at room temperature. 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.
Q62990 4XXXXX
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.
