2 mg / ml solution for injection / infusion 
epirubicin hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Epirubicin Teva is and what it is used for 
2. What you need to know before you use Epirubicin Teva 
3. How to use Epirubicin Teva 
4. Possible side effects 
5. How to store Epirubicin Teva 
6. Package contents and other information

What Epirubicin Teva is and what it is used for

Pharmaceutical
group Epirubicin belongs to the group of chemotherapy drugs. 
Epirubicin prevents cancer cells from growing, which eventually kills them.

Used for
Epirubicin is given for the treatment of:

  • breast cancer.
  • stomach cancer.
  • Epirubicin Teva is also used in the bladder (injected into the bladder) to treat early (superficial) bladder cancer and helps prevent the recurrence of bladder cancer after surgery.

Epirubicin is often used at the same time as other anticancer medicines (so-calpolychemotherapyrapy according to schedule).

2. What you need to know before you use Epirubicin Teva

You will not be treated with Epirubicin Teva

  • if you are allergic to epirubicin, similar medicines (called anthracyclines or anthracenediones, see below), or any of the other ingredients of this medicine (listed in section 6).
  • if you are breast-feeding

Depending on the route of administration, Epirubicin Teva will NOT be given to you in the following situations:

Intravenous (in a vein):

  • if you previously been treated with other cancer drugs in the high dose you including doxorubicin and daunorubicin which belong to the same class of drugs as Epirubicin Teva (called anthracycline s ). They have similar side effects(including effects on the heart).
  • if you suffer from or have had heart disease.
  • if you have low blood levels
  • if you have severe liver disease.
  • if you suffer from an acute severe infection.

Intravesical (directly in the bladder):

  • if cancer has penetrated the bladder wall.
  • if you have a urinary tract infection.
  • if you have pain or inflammation in the bladder.
  • if it is difficult to insert a catheter into your bladder.
  • if large amounts of urine remain in your bladder after you urinate
  • if there is blood in the urine
  • if you have a narrowed bladder.

Warnings and cautions

Talk to your doctor or pharmacist before using Epirubicin Teva:

  • if you are older or a child, as the risk of serious heart side effects is higher. Your heart function will be checked before and after treatment with epirubicin.
  • if you have or have had heart problems in the past. Inform your doctor. The dose of epirubicin needs to be adjusted. Your doctor will regularly check that your heart is functioning normally.
  • if you have been previously treated with anti-cancer drugs (such as doxorubicin or daunorubicin, anthracenedione derivatives, or trastuzumab) or if you have received radiation therapy over the chest area, as the risk of serious heart effects is greater. Tell your doctor as this is part of the assessment of the total dose of epirubicin you will receive.
  • if you have liver or kidney disease. This can cause more side effects. Both renal function and liver function will be checked regularly and the dose adjusted if necessary.
  • if you want to have children  Both men and women should use effective contraception both during and up to 6 months after treatment. Men are advised to ask for information about the possibility of freezing sperm before treatment.
  • if you have an infection or bleeding. Epirubicin may affect the bone marrow. The number of white blood cells in your blood will decrease, making you more susceptible to infection ( leukopenia ). Bleeding may occur more easily ( thrombocytopenia ). These side effects are temporary. The number of white blood cells is at least 10-14 days after the drug is given and usually returns to normal 21 days after the drug is given. The doctor will take regular samples.
  • if you have recently received or wish to receive any vaccination.

Take special care with Epirubicin Teva:

  • if the uric acid level in your blood needs to be checked. Your doctor will check this.
  • if blood clots form in your blood vessels ( thromboembolism ). This can lead to inflammation in a vein ( thrombophlebitis ) or blockage of the pulmonary artery ( pulmonary embolism )
  • if you get severe inflammation or sore mouth.
  • if you get a burning sensation where an injection is given. This may mean that epirubicin is leaking from the blood vessel. Make the doctor aware of this.

Other medicines and Epirubicin Teva

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

An interaction means that (drugs) used together can affect each other’s effect and/or side effects. An interaction may occur during concomitant use of this solution and:

  • previous or concomitant therapy with other agents related to epirubicin (called anthracyclines; (eg cancer drugs mitomycin C, dacarbazine, dactinomycin, and cyclophosphamide )), other medications that may affect the heart (for example, cancer drugs 5-fluorouracil, cyclophosphamide, cisplatin, taxanes, trastuzumab ); the harmfulness of the heart may increase. Extra control of the heart is then necessary.
  • epirubicin may increase the effects of radiation. Even quite a long time after the radiation, it can cause serious side effects over the radiated area.
  • rifampicin (an agent used in the treatment of tuberculosis ) and barbiturate s (an agent used for insomnia or epilepsy, such as phenobarbital); These agents reduce the amount of epirubicin in the blood, which can lead to a reduced effect of epirubicin.
  • paclitaxel and docetaxel (agents used to treat certain types of cancer); When paclitaxel is given before epirubicin or docetaxel is given immediately after epirubicin, the amount of epirubicin in the blood increases, which can lead to an increase in side effects. 
  • dexverapamil (a drug used to treat certain types of heart disease); when used with epirubicin it can harm the bone marrow.
  • interferon alfa-2b (a drug used in certain types of cancer and lymphoma and certain forms of hepatitis(jaundice)).
  • quinine (a drug used to treat malaria and leg cramps); Quinine can accelerate the rapid release of epirubicin into the body, which can have adverse effects on red blood cells.
  • dexrazoxane (a drug sometimes used with doxorubicin to reduce the risk of heart problems); epirubicin may not remain in the body for as long, which may lead to a reduced effect of epirubicin.
  • cimetidine (an agent that reduces the amount of stomach acid); the amount of epirubicin in the blood increases, which can lead to an increase in side effects.
  • previous or concomitant therapy with other agents affecting the bone marrow (for example, other anticancer drugs, sulfonamide, chloramphenicol, diphenylhydantoin, amidopyrinderivat, agents against certain viruses ); the formation of red blood cells can be disturbed.
  • agents that cause heart failure
  • agents that affect liver function; The breakdown of epirubicin in the liver can be affected, which can cause a reduced effect of epirubicin or an increase in side effects.
  • live vaccines; there is a risk of fatal disease, therefore this combination is not recommended.
  • ciclosporin ( an agent that inhibits the immune system); the immune system can be inhibited too much.

Epirubicin Teva with food and drink

You should not drink any fluid for 12 hours before the epirubicin treatment is given in the bladder.

Pregnancy, breastfeeding, and fertility

Pregnancy and fertility

Anti-cancer drugs are only given in extreme cases during pregnancy. The benefits to the mother must be weighed against the potential risk to the unborn child. In animal studies, epirubicin is harmful to the unborn baby and can cause birth defects. Both men and women should use effective contraception ( birth control pills, condoms) both during treatment and 6 months after the end of treatment to prevent pregnancy. 
You should also avoid getting pregnant if your partner is being treated with epirubicin. 
If a pregnancy occurs during treatment with epirubicin, genetic counseling is recommended. 
Men who wish to have children in the future should seek advice on sperm freezing before starting epirubicin treatment.

Breast-feeding 
It is unknown whether epirubicin is excreted in human milk. You should stop breast-feeding during treatment with Epirubicin Teva.

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

Driving and using machines

As many patients become very nauseous or have to vomit during treatment, driving and using machines can not be recommended.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Epirubicin Teva contains sodium

This medicine contains 18 mg of sodium (the main ingredient in baking soda) in each 5 ml vial. This corresponds to 0.9% of the recommended daily intake of sodium for an adult.

This medicine contains 35 mg sodium (the main ingredient in baking soda) in each 10 ml vial. This corresponds to 1.8% of the recommended daily sodium intake for an adult.

This medicine contains 89 mg of sodium (the main ingredient in baking soda) in each 25 ml vial. This corresponds to 4.4% of the recommended daily sodium intake for an adult.

This medicine contains 266 mg of sodium (the main ingredient in baking soda) in each 75 ml vial. This corresponds to 13.3% of the recommended daily sodium intake for an adult.

This medicine contains 354 mg of sodium (the main ingredient in baking soda) in each 100 ml vial. This corresponds to 17.7% of the recommended daily intake of sodium for an adult.

This medicine contains 3.5 mg (0.154 mmol) sodium per ml solution. This should be considered by patients on a low-salt diet.

3. How to use Epirubicin Teva

Epirubicin Teva will only be given to you under the supervision of a doctor specializing in this type of treatment. Ask your doctor or pharmacist if you are unsure.

The dose you receive depends on the type of cancer you have, your health, your age, how well your liver is working, and what other medications you are taking.

Venous administration ( intravenous administration )

The dosing schedule is adapted to your health and any previous treatments, and your height and weight are taken into account. The amounts in the dosing schedule are expressed in several milligrams per square meter of body surface area.

The medicine will be given as an injection into a vein for 3-5 minutes or as an infusion into a vein for a maximum of 30 minutes. 
If only epirubicin hydrochloride is given, ie without other cancer drugs, the recommended dose is 60-90 mg / m 2 body surface area. Dose one is given as a single dose or divided into 2-3 consecutive days. This is repeated every 21 days. In combination with other cancer drugs, dose one is reduced. 
The administration is via a catheter or by a side tap to the ongoing infusion of physiological saline or glucose (sugar solution). 
A higher dose er can be given in the treatment of breast cancer (100-120 mg / m 2 body surface area).

Administration via the bladder ( intravesical administration ) The
the drug can be given directly into the bladder (for the treatment of bladder cancer) using a catheter. If this method is used, do not drink any liquid for 12 hours before treatment so that the urine does not dilute the drug too much. The solution should remain in the bladder 1-2 hours after it is injected. You need to turn around a few times during treatment to make sure that all parts of the bladder come in contact with the medicine. 
When emptying your bladder after taking the medicine, be careful not to let the urine come in contact with your skin. In case of skin contact, wash with soap and water without scrubbing.

When epirubicin is given, your doctor will take blood samples to measure the effect of the medicine. Your doctor will also do checks to see how your heart is working. Both blood tests and cardiac function tests are performed before and during treatment with epirubicin.

If you take more Epirubicin Teva then you should

Because this medicine is given to you by healthcare professionals, the risk of an overdose is unlikely. Contact your doctor immediately if you suspect you have been given too much Epirubicin Teva.

If you forget to use Epirubicin Teva

As this medicine is given by healthcare professionals, it is unlikely that a dose will be missed. 
Check with your doctor if you are unsure.

If you stop taking Epirubicin Teva

Consult your doctor. 
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Adverse reactions are expected to occur in over 10 percent of patients treated with epirubicin. The most common side effects are bone marrow depression, gastrointestinal disorders, loss of appetite, hair loss, and infections.

The following side effects may include:

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

  • decreased production of blood cells (bone marrow inhibition; leading to a lack of white and red blood cells and platelets ), which leads to an increased susceptibility to infections and anemia.
  • hair loss ( alopecia in 60-90% of patients. This includes reduced beard growth in men. Hair loss is dose-related and transient in most patients).
  • red urine after administration for the following 1-2 days

Common (may affect up to 1 in 10 people)

  • infection is
  • hot flashes
  • loss of appetite ( anorexia ), dehydration
  • inflammation of the mucosa ( mucositis may appear 5-10 days after the start), inflammation of the esophagus mucosa ( esophagitis ) or oral mucosa ( stomatitis), vomiting, diarrhea (which may cause disturbance of the fluid balance in the body), nausea (nausea and vomiting, often within the first 24 hours, in almost all patients)
  • redness of the skin where the injection/infusion was given
  • inflammation of the bladder, sometimes with bleeding, local reactions such as burning, and an increased need to urinate if the drug has been given to the bladder

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

  • bleeding and an increased tendency to get bruises (due to lack of platelets[thrombocytopenia])
  • redness along the veins ( phlebitis ), vasculitis with the formation of a blood clot, often feels like a painful, slightly hard nucleus with redness over it ( thrombophlebitis )

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

  • certain forms of blood cancer ( acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML))
  • severe, immediate allergic reaction (anaphylactic/anaphylactoid reaction) with or without shock including rash and itching, fever, and chills
  • abnormally high level of uric acid in the blood (hyperuricemia)
  • dizziness
  • risk of the weakened heart resulting in blood overflow ( chronic heart failure ), heart failure (shortness of breath; accumulation of fluid throughout the body [edema]), liver enlargement, accumulation of fluid in the abdominal cavity ( ascites ), accumulation of fluid in the lungs ( pulmonary edema, pleural effusion), heart rhythm disorders [canter rhythm], cardiotoxicity (eg, abnormal ECG, arrhythmias, heart muscle disease [cardiomyopathy]) increased heart rate in chambers of the lower part of the heart (ventricular tachycardia), slow heartbeat ( bradycardia ), break impulse conduction in the heart ( AV block, branch block)
  • formation of small sips ( hives ) or severe itching  local flushing reactions in the vessel where the injection/infusion was given
  • missed menstruation, lack of sperm in the semen
  • feeling sick, a strong feeling of weakness, fever, chills
  • changes in the content of certain enzymes ( transaminases )

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

  • blood poisoning ( sepsis ) and shock as a result of a decrease in the production of blood ar (myelosuppression), pneumonia
  • bleeding, lack of oxygen in tissue are
  • certain nerve diseases ( peripheral neuropathy ), headache
  • inflammation of the eye ( conjunctivitis, keratitis )
  • shock, blood clot formation ( thromboembolism ), also in the lungs ( pulmonary embolism, in very rare cases with fatal outcome)
  • abrasion of the oral mucosa, sores in the mouth, pain in the mouth, burning sensation in the mucous membrane, bleeding in the mouth, staining of the oral cavity (cheek pigmentation)
  • local reactions, rash, itching, skin changes, redness, hot flashes, and burning in the skin, changes in the skin and on the nails (hyperpigmentation), photosensitivity, hypersensitivity of the skin to radiation (recall phenomena)
  • increased amounts of protein in the urine ( proteinuria ) of patients given high dose s
  • local pain, severe cellulite ( inflammation of cell tissue), tissue death (tissue necrosis), thickening or increased stiffness of the vessel wall (phlebosclerosis) after accidental injection outside the vein
  • the decrease in the amount of blood pumped from the ventricle at each heartbeat ( asymptomatic decrease in left ventricular ejection fraction )

Intravesical (in the bladder): When Epirubicin Teva has been given in the bladder, serious side effects throughout the body and allergic reactions have been rare.

5. How to store Epirubicin Teva

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

Do not use this medicine after the expiry date which is stated on the label/carton after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C-8 ° C). 
Store and transport cold (2 ° C-8 ° C). 
Do not freeze.

After opening, the product should be used immediately.

The chemical and physical durability after opening is as follows:

Viaflo (non-PVC) bag In the refrigerator 2–8 ° C At room temperature 15–25 ° C, in normal lighting
0.9% sodium chloride solution for injection 28 days 14 days
5% glucose solution for injection 28 days 28 days

Polypropylene syringe In the refrigerator 2–8 ° C At room temperature 15–25 ° C, in normal lighting
0.9% sodium chloride solution for injection 28 days 14 days
Water for injections 28 days 7 days
Undiluted 28 days 14 days

From a microbiological point of view, the medicine should be used immediately. If the solution is not used directly, the storage time and storage conditions before use are the responsibility of the user and should not normally be longer than 24 hours at 2 ° C-8 ° C.

Refrigerator storage of solution for injection may result in the formation of a jelly-like product. This gel returns to a slightly viscous to the free-flowing solution after two up to a maximum of four hours after the solution has reached room temperature (15 ° C-25 ° C).

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 epirubicin hydrochloride; a 1 ml solution contains 2 mg epirubicin hydrochloride.
  • The other ingredients are sodium chloride, hydrochloric acid, and water for injections.

What the medicine looks like and the contents of the pack

Epirubicin Teva is a clear red solution for injection or infusion. It is supplied in glass vials of 5 ml (10 mg), 10 ml (20 mg), 25 ml (50 mg), 75 ml (150 mg) or 100 ml (200 mg) solution for injection / infusion.

Not all pack sizes may be marketed.

Manufacturer: 
Pharmachemie BV, Swensweg 5, PO Box 552, 2003 RN Haarlem, The Netherlands

Muhammad Nadeem

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