100 mg / ml solution for injection / infusion 
Cytarabine

What Cytarabine Fresenius Kabi is and what it is used for

  • Cytarabine Fresenius Kabi is used in adults and children.
  • The active substance is cytarabine, which belongs to a group of medicines called cytostatics. These medicines are used to treat acute leukemias (cancer of the blood where you have too many white blood cells ). Cytarabine disrupts the growth of cancer cells, which are eventually destroyed.
  • Cytarabine is also used for induction of remission and maintenance treatment of leukemia.
  • Induction of remission is an intensive treatment to force back leukemia. When it works, the balance of cells in the blood becomes more normal and your health improves. This relatively healthy period is called remission.
  • Maintenance treatment is a milder treatment to prolong remission for as long as possible. Relatively low dose cytarabine is used to keep leukemia under control and prevent it from flaring up again.
  • Cytarabine contained in Cytarabine Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Cytarabin Fresenius Kabi

Do not use Cytarabine Fresenius Kabi

  • if you are allergic to cytarabine or any of the other ingredients of this medicine (listed in section 6).
  • if you have very low blood counts due to something other than cancer. Your doctor may not give you this medicine if you have any other less serious illness, apart from a weakened immune system.
  • if you have had severe brain damage ( encephalopathy ) after radiation therapy or from treatment with any other cancer medicine, such as methotrexate.

Warnings and cautions

Take special care with Cytarabine Fresenius Kabi

  • If your bone marrow function is impaired, treatment should be initiated under close medical supervision.
  • Your liver and kidney function should be monitored during cytarabine treatment. If your liver does not work well before treatment, cytarabine should only be given under close supervision
  • If you have received or plan to take any vaccination (including vaccination with live or attenuated vaccine)
  • Cytarabine strongly inhibits the production of blood cells in the bone marrow. This can make you more susceptible to infection or bleeding. Your blood levels may continue to fall for up to a week after stopping treatment. Your doctor will check your blood regularly and examine your bone marrow if necessary.
  • Serious and sometimes life-threatening side effects can occur in the central nervous system, intestines or lungs.
  • The levels of uric acid (indicating that cancer cells are being destroyed) in the blood may be high during treatment (hyperuricemia). Your doctor will tell you if you need to take any medicine to control this.

Other medicines and Cytarabine Fresenius Kabi

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

  • If you are taking medicines containing 5-fluorocytosine (a medicine used to treat fungal infections).
  • If you are taking medicines containing digitoxin or beta-acetyldigoxin, which are used to treat certain heart problems.
  • If you are taking gentamicin (an antibiotic used to treat bacterial infections ).
  • If you are taking medicines containing cyclophosphamide, vincristine, and prednisone used for cancer treatment.
  • If you are given cytarabine in combination with methotrexate given in the spine. Cases of headache, paralysis, coma, and stroke-like symptoms have been seen in children and adolescents given intravenous cytarabine in combination with methotrexate given in the spine.

Pregnancy and breastfeeding

Pregnancy 
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.

Breast-feeding 
You should stop breast-feeding before starting treatment with cytarabine, as this medicine may be harmful to breast-fed infants.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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.

Cytarabine Fresenius Kabi contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

How to use Cytarabine Fresenius Kabi

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.


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.

Regular checks

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:

  • Your blood, to see if you have low blood cell counts, which may require treatment.
  • Your liver – with blood tests – to check that cytarabine does not affect function.
  • Your kidneys – with blood tests – to check that cytarabine does not affect function.
  • Levels of uric acid in the blood – cytarabine may increase the level. Another medicine can be given if your uric acid levels are too high.

If you use more Cytarabin Fresenius Kabi then you should

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you get any of the following symptoms after treatment with this medicine:

  • An allergic reaction such as sudden wheezing, difficulty breathing, swelling of eyelids, face or lips, rash or itching (especially if it affects the whole body)
  • Fatigue and lethargy
  • Flu-like symptoms such as fever and chills
  • Easy to get bruises or bleeding more than usual in case of injuries. These are symptoms of low blood pressure.

Other side effects that may occur are:

If any of these side effects gets serious, talk to your doctor or nurse immediately.

Very common (may affect more than 1 user in 10):

  • Pneumonia, infection (which can become serious and lead to organ failure)
  • Too low production of red and white blood cells and platelets.
  • Inflammation or sores in mouth, lips, or anus, nausea, vomiting, diarrhea, abdominal pain
  • Liver damage (seen in blood tests)
  • Hair loss is common and can be serious. The hair normally grows back when the treatment is completed.
  • Rash
  • Cytarabine syndrome. Sometimes the following side effects are seen together, 6-12 hours after cytarabine treatment: General malaise with fever, pain in the skeleton, muscles and sometimes in the chest, blisters, sore eyes. This is called “cytarabine syndrome” and can be treated.
  • Fever
  • Abnormal results from bone marrow or blood tests.

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

  • Wounded skin
  • Abnormally high uric acid levels in the blood
  • Difficulty swallowing

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

  • Gas-filled cysts in the intestinal wall
  • Severe intestinal inflammation
  • Serious infection of the peritoneum

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

  • irregular heartbeat ( arrhythmia )
  • inflammation of the sweat glands

Has been reported (occurs in an unknown number of users):

  • Infection, including infection or inflammation at the injection site
  • Loss of appetite
  • Headache, dizziness, tingling sensation in the skin, tremors, and cramps, drowsiness
  • Sore and itchy eyes
  • Inflammation of the membrane surrounding the heart (pericarditis)
  • Slower heart rate or heart rate ( pulse ) than usual
  • Inflammation of the veins (caused by blood clots)
  • Shortness of breath, sore throat, pain when swallowing or difficulty swallowing
  • Upper abdominal pain and often also nausea or vomiting ( pancreatitis ), inflammation, or ulcers in the esophagus which can cause heartburn and malaise
  • Jaundice (causes yellowing of the skin and whites of the eyes)
  • Reddening of the skin (similar to sunburn), pain and numbness in joints, fingers, toes, and face, swelling of the abdomen, legs, ankles, and feet, tingling or burning sensation, tender and tight skin, thick calluses on the palms, and hands, itchy rash, itching, more freckles
  • Difficulty urinating or pain when urinating. Blood in the urine and impaired kidney function (seen in blood tests)

The following adverse reactions are reported at the high dose:

Very common (may affect more than 1 user in 10):

  • Affected alertness, speech difficulties, involuntary movements or coordination problems, involuntary eye movements, headaches, confusion, drowsiness, dizziness, etc. caused by brain effects.
  • Infection, irritation, and pain in the eyes as well as blurred vision and loss of vision
  • Chipping chest pain, fluid accumulation in the lungs

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

  • Scaly skin
  • Infection and inflammation of the intestine, most common in infants

Has been reported (occurs in an unknown number of users):

  • Accumulation of goods in the liver and enlarged liver
  • Personality changes
  • Coma, seizures, poor balance caused by nerve damage
  • High heart rate, impaired heart function, shortness of breath, dizziness, swelling of the legs, ankles, feet, and jugular veins ( cardiomyopathy ), which can be life-threatening
  • Blood in vomit or stool (due to tissue death or ulceration of the gastrointestinal tract), pain or tenderness in the stomach ( peritonitis ), blood clots in the hepatic veins (Budd-Chiari syndrome)
  • Muscle damage ( rhabdomyolysis ), missed periods in fertile women ( amenorrhea), absence of sperm in the semen ( azoospermia ).

5. How to store Cytarabin Fresenius Kabi

Keep this medicine out of the sight and reach of children.

Store at 15 ° C – 25 ° 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: 
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 before use are the responsibility of the user and would normally not be longer than 24 hours at 2-8 ° 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance 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 1000 mg of cytarabine. Each 20 ml vial contains 2000 mg of cytarabine.
  • The other ingredients are hydrochloric acid, sodium hydroxide, and water for injections.

What the medicine looks like and the contents of the pack

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.

Marketing Authorisation Holder

Fresenius Kabi AB

751 74 Uppsala

Manufacturer

Fresenius Kabi Deutschland GmbH

Pfingstweide 53

61169 Friedberg

Germany

This medicinal product is authorized under the European Economic Area under the names:
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Czech Republic Cytarabine Kabi 100 mg/ml, Injectable and infused drugs
Denmark Cytarabin Fresenius Kabi
Estonia Cytarabine Kabi
Spain Cytarabine 100 mg / ml injectable solution for perfusion
France Cytarabine Kabi 100 mg/ml, injectable solution or for perfusion
Hungary Cytarabine Kabi 100 mg / ml injectable vaginal infusion
Ireland Cytarabine 100 mg / ml Solution for Injection or Infusion
Iceland Cytarabine Fresenius Kabi 100 mg/ml solution for injection or infusion
Latvia Cytarabine Kabi 100 Mg / ml Injection injection or infusion
Lithuania Cytarabine Kabi 100 mg / ml injekcinis / infuzinis tirpalas
Netherlands Cytarabine Fresenius Kabi 100 mg/ml Solution for injection or infusion
Norway Cytarabine “Fresenius Kabi” 100 mg / ml Solution for injection / infusion
Poland Cytarabine Kabi
Portugal Cytarabine Kabi
Romania Cabana Kabi 100 mg/ml injectable solution for perfusion
Slovakia Cytarabine Kabi 100 mg/ml, injectable and infused drug,
UK Cytarabine 100 mg / ml Solution for Injection or Infusion

Muhammad Nadeem

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