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Cytarabine Stada

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Package leaflet: Information for the user


Cytarabine STADA 100 mg/ml, concentrate for solution for 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, ask your doctor or pharmacist.

  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.


What is in this leaflet

1. What Cytarabine STADA is and what it is used for

2. What you need to know before you use Cytarabine STADA

3. How to use Cytarabine STADA

4. Possible side effects

5. How to store Cytarabine STADA

6. Contents of the pack and other information


1. What Cytarabine STADA is and what it is used for


Cytarabine STADA is an anti-cancer medicine and is used to treat acute leukaemia (blood cancer) in children and adults.


It is also used to prevent or treat leukaemia affecting the lining of brain and spinal cord (meningeal leukaemia).


2. What you need to know before you use Cytarabine STADA


DO NOT use Cytarabine STADA


Warnings and precautions

Talk to your doctor or pharmacist or nurse before using cytarabine. Especially:


Other medicines and Cytarabine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially


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 amenorrhoea 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 machines

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 machinery.


Cytarabine STADA 100 mg/ml contains sodium

This medicinal product contains 0.224 mmol (or 5.13 mg) sodium per 1 ml. To be taken into consideration by patients on a controlled sodium diet.


3. How to use CytarabineSTADA


Cytarabine STADA can only be given under supervision by a doctor with experience in cancer treatment. Your doctor will decide about the dose you will receive.


The solution of the medicine, which is prepared especially for you by specialised staff, is given slowly into a vein (intravenous infusion).


If you use more Cytarabine STADA than you should

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 question on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, this medicine 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.


Tell your doctor or nurse immediately, if you suffer from the following symptoms after taking this medicine:


These are serious side effects. You may need urgent medical attention.


Other reported side effects include:


Common (may affect up to 1 in 10 people):

fever

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)


Uncommon(may affect up to 1 in 100 people):


Very Rare(may affect up to 1 in 10,000 people):


Not Known (frequency cannot be estimated from the available data):


Other side effects:

The Cytarabine Syndrome may occur 6-12 h after the start of treatment. The symptoms include:

Your doctor may prescribe corticosteroids (anti-inflammatory medicines) to prevent or treat these symptoms. If they are effective, treatment with cytarabine may be continued.


The following symptoms may develop after intrathecal treatment (injection into the space around the spinal cord) with cytarabine:


Reactions observed with higher-dose therapy


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:


These side effects may occur more often:


The risk of nervous system damages increases if the cytarabine treatment:


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 abscesses, 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 oedema) have been observed, particularly at high doses.


Others:


Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Cytarabine STADA


Your medicine is stored in a pharmacy and is prepared especially for you by experienced staff based on your doctor´s prescription.


Keep out of the reach and sight of children.


Do not use Cytarabine STADA after the expiry date which is stated on the vial and outer carton.


Do not store above 25°C.


6. Contents of the pack and other information


What Cytarabine STADA contains

The active substanceis cytarabine.


1 ml concentrate for solution for infusion contains 100 mg cytarabine.

1 vial of 10 ml contains 1 g cytarabine.

1 vial of 50 ml contains 5 g cytarabine.


The other ingredients are sodium lactate solution and water for injections.


What Cytarabine STADA looks like and contents of the pack

This medicine is a concentrate for solution for infusion. The solution is clear and colourless, and is filled in clear glass vials sealed with rubber stoppers and aluminium caps.


The packages contain 1 vial of 10 ml and 50 ml, respectively.


Not all pack sizes may be marketed.


Marketing Authorisation Holder

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany


Manufacturer

cell pharm GmbH

Feodor-Lynen-Str. 35

D-30625 Hannover

Germany


This medicinal product is authorised in the Member States of the EEA under the following names:


Austria Cytarabin STADA 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Finland Cytarabine STADA 100 mg/ml, infuusiokonsentraatti, liuosta varten

Sweden Cytarabine STADA 100 mg/ml koncentrat till infusionsvätska, lösning

Netherlands Cytarabine CF 100 mg/ml, concentraat voor oplossing voor injectie


This leaflet was last approved 22015-04-24


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The following information is intended for medical or health care professionals only:


Incompatibilities

This medicinal product should not be mixed with other medicinal products except for those mentioned under “Handling”.


Incompatibilities include heparin, insulin, methotrexate, 5-fluorouracil, nafcillin, oxacillin, penicillin G, and methyl-prednisolone succinate.


Handling

Cytarabine STADA should for infusion be diluted with sodium chloride solution, 9 mg/ml, or glucose solution, 50 mg/ml. Use of the infusion solution with closed transmission systems is recommended. Solutions for dilution containing benzyl alcohol must not be used for intrathecal administration. The concentration must, however, not exceed 50 mg/ml.


If Cytarabine STADA comes in contact with skin, the exposed area should be rinsed with large amounts of water and then thoroughly washed with soap and water. If the solution gets into the eyes, rinse very carefully with large amounts of water, whereupon an eye specialist should be consulted immediately.


Pregnant staff should be excluded from working with this drug.


After use, bottles and injection materials, including gloves, should be disposed of according to the rules for cytostatics.


Inactivation of spilled or leaked drug can be obtained with 5% sodium hypochlorite solution. All cleaning materials should be disposed of as indicated previously.


Shelf-life:

No opened vial may be stored.


In-use stability

Chemical and physical in-use stability after dilution in sodium chloride solution 9 mg/ml or glucose solution 50 mg/ml has been demonstrated for 10 days when stored in a refrigerator or 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 prior to use are the responsibility of the user and should normally not be longer than 24 hours at 2-8°C, unless dilution has taken place under controlled and validated aseptic conditions.

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