2 mg / ml concentrate for solution for infusion solution 
doxorubicin 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 or pharmacist.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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

What Doxorubicin Actavis is and what it is used for

Doxorubicin Actavis belongs to a group of medicines called anthracyclines. Doxorubicin Actavis is used to treat the following types of cancer:

  • small cell lung cancer
  • bladder cancer
  • skeletal cancer
  • breast cancer
  • blood cancer
  • lymphatic system cancer (Hodgkin’s and Non-Hodgkin’s lymphoma )
  • cancer of the bone marrow one
  • thyroid cancer
  • cancer of the soft tissues (in adults)
  • recurrent cancer of the ovaries or uterine lining
  • certain types of kidney cancer that affect children (Wilms tumor )
  • certain types of advanced cancer of the nerve cells that affect children ( neuroblastoma ).

Doxorubicin Actavis is also used in combination with other anticancer medicines.

Doxorubicin hydrochloride contained in Doxorubicin Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Doxorubicin Actavis

Do not take Doxorubicin Actavis:

  • if you are allergic to doxorubicin or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to medicines in the class of anthracyclines or anthracendions
  • if you are breast-feeding.

Talk to your doctor if any of the above apply to you.

Do not take Doxorubicin Actavis intravenously

  • if after previous cancer treatment you were told that you had a persistent decrease in the production of blood cells (ie that the bone marrow is not working properly)
  • if after a previous cancer treatment you suffered from severe inflammation or sores in the mouth
  • if you have any type of heart problem
  • if you start to bleed easily
  • if you suffer from any type of general infection
  • if your liver is not working properly
  • if you have previously received doxorubicin or other anthracyclines you are up to the maximum total dose.

Talk to your doctor if any of the above apply to you.

Do not take Doxorubicin Actavis directly into the bladder

  • if you have a tumor that has grown into the wall of the bladder
  • if you have a urinary tract infection
  • if you have inflammation of the bladder
  • if you have blood in your urine
  • if you have problems inserting the catheter (eg blockages in the urethra).

Talk to your doctor if any of the above apply to you.

Warnings and cautions

Talk to a doctor

  • before taking Doxorubicin Actavis if you are or may be pregnant, see also the section on pregnancy and breast-feeding below
  • if you have previously received any type of radiation therapy
  • If you are trying to get pregnant, you will probably want to get pregnant in the future, or if you want to become a father
  • if you have kidney problems
  • if you have or have ever had any type of heart problem.

Doxorubicin severely reduces blood cell production in the bone marrow. It can make you more prone to infection or bleeding. Tell your doctor if you get a fever or other signs of infection or if you have any type of bleeding.

Vaccination is not recommended. Avoid contact with people who have recently been vaccinated against polio.

Doxorubicin Actavis should only be given under the supervision of a qualified doctor who has experience in cancer treatment. All patients must be checked carefully and often e.g. how the blood picture looks like and for how the heart, liver, and kidneys work.

Contact a doctor or other healthcare professional immediately if you feel a burning or burning sensation at the infusion site. Such pain can occur if the drug leaks out of the vein and you then need to receive appropriate treatment.

Other medicines and Doxorubicin Actavis

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This is especially important for:

  • other anti-cancer drugs, e.g. anthracyclines (daunorubicin, epirubicin, idarubicin, trastuzumab), cyclophosphamide, cytarabine, cisplatin, fluorouracil, taxanes (eg paclitaxel), mercaptopurine, methotrexate, streptozocin
  • cyclosporine (used in organ and tissue transplants)
  • medicines for heart disease (heart active medicines), e.g. calcium channel blockers and digoxin
  • drugs that lower uric acid levels in the blood
  • rifampicin ( antibiotic )
  • cimetidine (used to treat heartburn and stomach ulcers )
  • live vaccines (eg polio ( myelitis ))
  • phenytoin, carbamazepine, valproate, phenobarbital, and other barbiturates(used to treat epilepsy )
  • chloramphenicol and sulfonamides (medicines for infections )
  • amphotericin B (an antifungal medicine)
  • drugs against viral infections, e.g. ritonavir (used to treat HIV )
  • clozapine (a psychotropic drug)
  • amidopyrine derivatives (for pain and inflammation ).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is known from animal experiments that doxorubicin passes through the placenta and damages the fetus. Therefore, you should not use doxorubicin if you are pregnant. Tell your doctor immediately if you are or think you may be pregnant.

Women treated with Doxorubicin Actavis should not become pregnant during and up to 6 months after treatment. Men treated with doxorubicin should ensure that their partner does not become pregnant during and up to 6 months after treatment. Sexually active men and women should therefore use an effective method of contraception during and up to 6 months after treatment.

Doxorubicin can cause permanent infertility and men should therefore seek advice on storing (or freezing) semen before treatment. If you are considering having children after treatment, you should discuss it with your doctor.

The drug passes into breast milk. Do not breast-feed while you are being treated with Doxorubicin Actavis.

Driving and using machines

Due to frequent nausea and vomiting, you are advised not to 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.

Doxorubicin Actavis contains sodium

This medicine contains 18 mg of sodium (the main ingredient in table salt) in each 5 ml vial. This corresponds to 0.9% of the WHO’s recommended maximum intake for an adult.

This medicine contains 35 mg of sodium (the main ingredient in table salt) in each 10 ml vial. This corresponds to 1.8% of the WHO’s recommended maximum intake for an adult.

This medicine contains 88.5 mg of sodium (the main ingredient in table salt) in each 25 ml vial. This corresponds to 4.4% of the WHO’s recommended maximum intake for an adult.

This medicine contains 177 mg of sodium (the main ingredient in table salt) in each 50 ml vial. This corresponds to 8.9% of the WHO’s recommended maximum intake for an adult.

This medicine contains 266 mg of sodium (the main ingredient in table salt) in each 75 ml vial. This corresponds to 13.3% of the WHO’s recommended maximum intake for an adult.

This medicine contains 354 mg of sodium (the main ingredient in table salt) in each 100 ml vial This corresponds to 17.7% of the WHO recommended maximum intake for an adult.

How to take Doxorubicin Actavis

Doxorubicin Actavis should only be given under the supervision of a qualified doctor who has experience in cancer treatment.

Methods of administration and routes of administration

You will be given the drug by intravenous infusion into a blood vessel under the supervision of a specialist. Do not take the medicine yourself. You will be monitored regularly, both during and after treatment. If you have superficial bladder cancer, the drug may be administered directly into the bladder ( installation ). This medicine should be diluted before use.

Intravenous administration

Dose one is usually calculated based on body surface area. Doxorubicin Actavis can be given e.g. once a week, every three weeks, or even at longer intervals. Dosage one and how often the medicine should be given also depends on what other cancer medicines are used and on what disease you have and your general condition. Your doctor will decide what dose to take.

Installation in the bladder

Dose one is 30-50 mg doxorubicin in 25-50 ml saline solution. The solution should be kept in the bladder for 1-2 hours. During this period, you must turn 90 degrees every 15 minutes.

You should not drink anything for 12 hours before instilling one in the bladder to avoid diluting the drug with urine. Instillation one can be repeated at 1 week to 1-month intervals. Your doctor will determine how often installation is needed.

Use for children and adolescents

Dosage one should be reduced in children. Doctors will advise you on how much you need.

If you take more Doxorubicin Actavis then you should

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

Because a doctor will give you the medicine, it is unlikely that you will get an overdose. However, if you have any further questions, ask your doctor or nurse immediately.

In acute overdose, side effects such as sores in the mouth, reduced white blood cell counts, and platelets can worsen and can lead to heart problems. Your doctor will take appropriate action if you have an overdose. Heart problems can occur six months after an overdose.

If you forget to take Doxorubicin Actavis

Doctors decide how long you should be treated with Doxorubicin Actavis. If treatment is stopped before the planned treatment cycles have been completed, the treatment may have a worse effect. Ask your doctor if you want to stop treatment.

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.

Contact a doctor or healthcare professional immediately if you notice any of the following side effects:

  • Dizziness, fever, shortness of breath with chest and throat pain, or itchy rash. This can be a type of allergic reaction that can be very serious.
  • You feel tired and apathetic. This may be a sign of anemia (low red blood cell count ).
  • You have a fever or other symptoms of infection. This may be a sign of decreased white blood cell count.
  • You get lighter bruises or bleeding. This may be a sign that you have few platelets.

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

  • nausea, vomiting, stomach pain, digestive problems, diarrhea
  • inflammation of the mucous membranes, e.g. in the mouth or esophagus
  • hair loss (normally transient), reddening of the skin, the skin becomes sensitive to artificial or natural light (light hypersensitivity)
  • red urine for one or two days after administration. This is normal and nothing to worry about
  • bone marrow inhibition (anemia), including a decrease in the number of white blood cells (makes it easier to get infections ), platelets (makes it easier to bleed and get bruises), and red blood cells (anemia; which makes the skin pale and you can feel weak or short of breath)
  • severe cardiac complications (cardiac toxicity), e.g. damage to the heart muscle or fast, slow, or irregular heartbeat. Effects may occur shortly after starting a treatment or several years later
  • fever

Common (may affect up to 1 in 10 people)

  • bacterial infection
  • bacterial infection in the blood
  • cardiac arrhythmias (irregular heartbeat, faster heartbeat, slower heartbeat), decreased amount of blood pumped through the heart, impaired cardiac muscle function ( cardiomyopathy ) which can be life-threatening
  • bleeding
  • eating disorders ( anorexia )
  • local allergic reaction in areas treated with radiation
  • itching
  • difficulty urinating or pain when urinating, inflammation of the bladder after instillation into the bladder, sometimes with irritation of the bladder, blood in the urine, painful urination, more frequent urination, or decreased amount of urine

Uncommon (may affect up to 1 in 100 people)

  • acute blood cancer (certain types of leukemia )
  • inflammation in a friend
  • bleeding in the stomach or intestines
  • ulcers of the mucous membranes of the mouth, pharynx, esophagus, stomach, or intestines
  • ulcers and possible cell death or tissue death in the colon when Doxorubicin Actavis is given in combination with the drug cytarabine
  • dehydration

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

  • inflammation of the outermost layer of the eye (conjunctivitis)
  • hives; skin rash and redness
  • dark areas of skin and nails; loss of nails ( onycholysis )
  • severe allergic reactions with or without shock, including rash, itching, fever, and chills (anaphylactic reactions)
  • tremors
  • dizziness
  • secondary leukemia (blood cancer that develops after treatment against another cancer) when Doxorubicin Actavis is used in combination with other cancer drugs that damage DNA
  • tumor lysis syndrome (complications from chemotherapy due to degradation products from dying cancer cells, which can affect the blood and kidneys, for example)
  • injection site reactions, including redness, rash, and pain, inflammation of the vein ( phlebitis ), thickening or hardening of the vein wall (phlebosclerosis)
  • a burning or burning sensation at the site of administration in connection with the drug leaking from the vein. This can lead to the death of local tissue cells and this requires appropriate treatment, in some cases surgery

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

  • flushing
  • altered heart function (non-specific ECG changes), isolated cases of life-threatening irregular heartbeat ( arrhythmia ), heart failure, inflammation of the pericardium/myocardium, lost nerve impulses in the heart
  • formation of blood clots in a blood vessel
  • discoloration ( pigmentation ) of the oral mucosa
  • swelling and numbness in the hands and feet (acrylic erythema ), blistering, tissue damage, especially in the hands and feet, which cause redness, swelling, blisters, stinging or burning sensation where the drug leaks into the tissue (palmar-plantar erythrodysesthesia syndrome)
  • acute renal failure
  • abnormally high levels of uric acid in the blood
  • missed menstruation
  • fertility problems in men (decreases or lack of active semen)

Unknown (frequency can not be calculated from available data)

  • increased tear flow
  • cough or difficulty breathing due to sudden narrowing of the airways
  • pneumonia
  • liver toxicity that can sometimes lead to chronic liver tissue damage ( cirrhosis )
  • temporarily elevated liver values
  • oily, hairless, or scaly skin spots ( actinic keratosis )
  • severe pain and swelling in the joints
  • feeling weak
  • radiation damage (to the skin, lungs, pharynx, esophagus, gastrointestinal mucosa, heart) that may recur after administration of doxorubicin. Reporting of side effects if you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via the Medical Products Agency, Box 26, SE-751 03 Uppsala. Website: www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Doxorubicin Actavis

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial after EXP and the outer carton after EXP. dat. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Keep the vial in the outer carton. Sensitive to light.

Do not use this medicine unless it is clear, red, and free from particles.

Any unused product or waste material should be disposed of by local requirements. Follow guidelines for handling cytotoxic drugs.

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 in Doxorubicin Actavis is doxorubicin hydrochloride. Each vial contains 2 mg/ml doxorubicin hydrochloride.
  • The other ingredients are sodium chloride, hydrochloric acid, and water for injections.

What the medicine looks like and the contents of the pack

Doxorubicin Actavis concentrate for solution for infusion is a clear, red liquid.

Doxorubicin Actavis is packaged in clear glass vials with a rubber stopper and an aluminum seal with a polypropylene disc.

Pack sizes:

1 x 5 ml vial

10 x 5 ml vial

1 x 10 ml vial

10 x 10 ml vial

1x 25 ml vial

1 x 50 ml vial

1 x 75 ml vial

1 x 100 ml vial

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjörður

Iceland

Agent:

SanoSwiss UAB

Aukstaiciu str. 26A

LT-44169 Kaunas

Lithuania

+370 700 01320

info@sanoswiss.com

Muhammad Nadeem

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