10 mg / mL concentrate for infusion solution 
carboplatin

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 nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show signs of symptoms similar to yours.
  • If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Carboplatin Ebewe is and what it is used for 
2. What you need to know before you get Carboplatin Ebewe 
3. How to get Carboplatin Ebewe 
4. Possible side effects 
5. How to store Carboplatin Ebewe 
6. Contents of the packaging and other information 

1. What Carboplatin Ebewe is and what it is used for

Carboplatin Ebewe contains the active substance carboplatin. Carboplatin is a so-called cytotoxic drug and is used to treat certain types of cancer, such as ovarian cancer ( ovarian cancer ) and lung cancer.

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

2. What you need to know before you get Carboplatin Ebewe

Do not use Carboplatin Ebewe

  • if you are allergic to carboplatin, other platinum-containing medicines, or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe kidney disease (severe kidney failure ).
  • if you have impaired bone marrow function (impaired ability to produce blood cells in the bone marrow ).
  • if you have a bleeding cancerous tumor.
  • concomitant with the yellow fever vaccine (see “Other medicines and Carboplatin Ebewe” below).
  • if you are breast-feeding (see “Pregnancy, breast-feeding and fertility” below).

Warnings and cautions

Talk to your doctor or nurse before using Carboplatin Ebewe.

Carboplatin Ebewe should only be prescribed by a doctor with extensive experience in cancer treatment.

Your kidney function, liver function, and blood counts will be monitored before and during treatment with Carboplatin Ebewe. If you get deviating results from these tests, the treatment can be stopped until the test values ​​return to more normal results

Before treatment with Carboplatin Ebewe, you can get nausea medication to relieve the discomfort.

During treatment with carboplatin, you are given medicines to reduce the risk of a potentially life-threatening complication called tumor lysis syndrome, which is caused by a chemical imbalance in

the blood due to the breakdown of dying tumor cells that release their contents into the blood.

Tell your doctor:

  • if you experience headaches, seizures, changes in vision, from blurred vision to blindness, or experience mental disorders such as confusion.
  • if you experience extreme fatigue associated with decreased red blood cell count and shortness of breath ( hemolytic anemia ), alone or in combination with low platelet count, easy to get bruises ( thrombocytopenia ), and kidney disease that means you have reduced urine output or no urine at all. These are symptoms of hemolytic-uremic syndrome.
  • if you get a fever (body temperature of 38 ° C or more) or chills, which may be a sign of an infection. Tell your doctor immediately. There is a risk of infection spreading to the bloodstream.

Children:

This medicine is not recommended for children as there is not enough experience in administering Carboplatin Ebewe to this patient group. Children are at greater risk of hearing loss with carboplatin treatment. Long-term follow-up of hearing is recommended in children.

Other medicines and Carboplatin Ebewe

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

It is especially important that you tell your doctor if you are using:

  • Blood thinners. Coagulation needs to be checked more often during combination therapy with Carboplatin Ebewe.
  • Aminoglycoside is (a group of antibiotics ).
  • Ciclosporin, tacrolimus, sirolimus (medicines that inhibit the immune system).
  • Diuretics (increases urine output) used to lower blood pressure .
  • Phenytoin, fosphenytoin (medicines for epilepsy ).

When you are being treated with Carboplatin Ebewe, you must not be vaccinated against yellow fever.

If you are planning to be vaccinated with another vaccine at the same time as you are being treated with Carboplatin Ebewe, you should discuss this with your doctor before vaccination.

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 nurse for advice before taking this medicine.

Pregnancy

Carboplatin Ebewe should not be used during pregnancy unless clearly necessary, as there is a risk of serious birth defects. Women of childbearing potential are advised against becoming pregnant during treatment with Carboplatin Ebewe.

Breast-feeding

It is not known whether carboplatin is excreted in human milk. During treatment with Carboplatin Ebewe, breast-feeding should be discontinued.

Fertility

Carboplatin Ebewe can cause sterility and you should therefore discuss with your doctor if you plan to have children after treatment. Men treated with Carboplatin Ebewe are advised against having children during and at least 6 months after treatment. Men should also seek advice on sperm storage before starting treatment.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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, pharmacist, or nurse.

3. How to get Carboplatin Ebewe

Infusion one is always given by a nurse or doctor. It is usually given as a drip into a vein ( intravenously ) and usually takes between 15 and 60 minutes.

The dose of medicine you receive depends on the disease you are being treated for, your medical condition, age, body weight or body surface area, and how well your kidneys are functioning. The usual dose is 400 mg / m 2.

If you take more Carboplatin Ebewe than you should

You will receive this medicine in a hospital and it is unlikely that you will receive too much carboplatin. If you are worried that you have been given too high a dose or if you have any questions about the dose you have been given, talk to your doctor or nurse who will give you the medicine.

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

4. Possible side effects

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

If any of the following occur, contact your doctor immediately or seek medical advice:

  • Abnormal bruising, bleeding, or signs of infection, such as sore throat and fever. This can be a sign of blood effects such as anemia, decreased number of blood cells and platelets that have been reported as very common side effects (may affect more than 1 user in 10)
  • Severe allergic reactions ( hypersensitivity reactions ). Symptoms of an allergic reaction may include swelling of the eyelids, face, or lips, low blood pressure, palpitations, sudden itchy rash (hives), sudden wheezing, chest tightness, shortness of breath, and dizziness. Common side effects (may affect up to 1 in 10 people).

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

  • Vomiting, nausea, abdominal pain.
  • Altered results in tests of kidney and liver function, altered levels of salts in the blood.

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

  • Infection is, bleeding.
  • Decreased sensation, numbness, decreased tendon reflexes, taste disturbance.
  • Visual disturbances in rare cases loss of vision.
  • Hearing impairment such as tinnitus and hearing loss.
  • Cardiovascular disease.
  • Respiratory problems, lung disease, bronchospasm ( bronchospasm ) which causes shortness of breath.
  • Diarrhea and constipation.
  • Mucosal problems.
  • Hair loss, skin problems.
  • The disease of the skeleton and muscles.
  • The disease of the urinary and/or genital organs.
  • Extreme fatigue/weakness ( asthenia ).
  • Elevated bilirubin in the blood (may cause symptoms such as yellowing of the skin).
  • Elevated creatinine in the blood (signs of renal impairment).
  • The increased amount of uric acid in the blood.

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

  • Tumor disease due to treatment.
  • Severe bone marrow exposure (bone marrow failure).
  • A disease affecting the blood and kidneys (hemolytic-uremic syndrome-HUS).
  • Dehydration, decreased appetite, decreased sodium levels in the blood.
  • Vascular effects in the brain such as stroke or blood clot.
  • Heart failure, migratory blood clots (emboli), high or low blood pressure.
  • Inflammation of the oral mucosa.
  • Hives, rash, redness, and itching of the skin.
  • Injection site reactions.
  • Feeling sick.
  • Headaches, mental disorders such as confusion, seizures, and changes in vision, from blurred vision to blindness. These are symptoms of reversible posterior leukoencephalopathy syndrome, a rare disease that affects the nervous system.
  • Pancreatitis.
  • Pneumonia
  • Muscle cramps, muscle weakness, confusion, visual impairment or visual disturbances, irregular heartbeat, renal failure, or abnormal blood test results (symptoms of tumor lysis syndrome that can be caused by rapidly disintegrating tumor cells, see section 2).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Carboplatin Ebewe

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 carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Keep the vial in the outer carton. Sensitive to light.

Instructions for storage of the medicinal product and shelf life after dilution can be found in the section “The following information is only intended for healthcare professionals”.

Waste materials must be disposed of in accordance with the hospital’s instructions for cytotoxic drugs and in accordance with current laws on the disposal of hazardous waste.

6. Contents of the packaging and other information

Content declaration

  • The active substance is carboplatin. One ml concentrate for solution for infusion contains 10 mg carboplatin.
  • The other ingredients are water for injections

What the medicine looks like and the contents of the pack

Carboplatin Ebewe is available in the following pack sizes:

Bottles:

1 x 5 mL concentrate for infusion solution

5 x 5 ml concentrate for infusion solution

1 x 15 mL concentrate for infusion solution

1 x 45 mL concentrate for infusion solution

1 x 60 mL concentrate for infusion solution

1 x 100 mL concentrate for infusion solution

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

EBEWE Pharma Ges. Mb H Nfg. KG

Mondseestrasse 11

4866 Unterach

Austria

For more information on Carboplatin Ebewe, contact your local representative:

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Muhammad Nadeem

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