10 mg / ml concentrate for solution for infusion 
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.
  • 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.

This leaflet contains information about: 
1. What Carboplatin Rivopharm is and what it is used for 
2. What you need to know before you use Carboplatin Rivopharm 
3. How to use Carboplatin Rivopharm 
4. Possible side effects 
5. How to store Carboplatin Rivopharm 
6. Contents of the packaging and other information 

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

Carboplatin Rivopharm contains carboplatin which belongs to a group of medicines called platinum compounds which are used to treat cancer.

Carboplatin Rivopharm is used to treat advanced ovarian cancer.

Carboplatin contained in Carboplatin Rivopharm 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 you use Carboplatin Rivopharm

Do not use Carboplatin Rivopharm

  • if you are allergic to carboplatin or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe kidney problems. Carboplatin Rivopharm can in exceptional cases be used despite severe kidney problems.
  • if you have impaired bone marrow function (impaired ability to produce blood cells in the bone marrow ).
  • if you have a bleeding tumor s
  • when taking the yellow fever vaccine at the same time (see Other medicines and Carboplatin Rivopharm)
  • if you are breast-feeding (see Pregnancy, breast-feeding and fertility )

Tell your doctor if any of the above apply to you before you start using this medicine.

Warnings and cautions

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

Talk to your doctor or nurse before taking Carboplatin Rivopharm.

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

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 bloodstream.

Tell your doctor:

  • if you get symptoms such as confusion, cramps or changes in vision during treatment with this medicine.
  • if you experience extreme fatigue associated with decreased red blood cell countsand shortness of breath ( hemolytic anemia ), alone or in combination with low platelet counts , abnormal bruising ( thrombocytopenia ) and kidney disease when you have decreased urine output or no urine at all (symptoms of Hemolytic-uremic syndrome)
  • if you get a fever (temperature higher than or equal to 38 o C), or chills, which may be a sign of infection , contact a doctor immediately. There is a risk of blood infection.

Other medicines and Carboplatin Rivopharm

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

Tell your doctor if you are taking any of the following medicines as they may affect or be affected by Carboplatin Rivopharm:

  • blood-thinning drugs. Blood clotting ability needs to be checked more often during combination therapy with Carboplatin Rivopharm.
  • antibiotics of the type aminoglycoside s.
  • ciclosporin, tacrolimus, sirolimus (medicines that inhibit the immune system).
  • diuretics ( diuretics ) used to lower blood pressure et.
  • phenytoin and fosfenytoin (used to treat various types of seizures).

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

If you are planning to be vaccinated with another vaccine while you are being treated with Carboplatin Rivopharm, you should discuss this with your doctor before vaccination.

Carboplatin Rivopharm with alcohol

There is no known interaction between Carboplatin Rivopharm and alcohol. However, you should consult your doctor as Carboplatin Rivopharm may affect the liver’s ability to handle alcohol.

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 for advice before using this medicine.

If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do so as soon as possible and before receiving an infusion .

Pregnancy

You should not be treated with Carboplatin Rivopharm while you are pregnant unless your doctor considers it absolutely necessary.

Animal studies have shown that there is a risk of malformations in the fetus. If you are being treated with Carboplatin Rivopharm while you are pregnant, talk to your doctor about the possible risks for the unborn baby.

Women of childbearing potential must use effective contraception during treatment with carboplatin.

Breast-feeding

It is not known whether carboplatin is excreted in human milk. Therefore, you should not breast-feed while you are being treated with Carboplatin Rivopharm.

Fertility

Women of childbearing potential should avoid becoming pregnant by using effective contraception during treatment.

Men treated with carboplatin should refrain from becoming the father of a child during the treatment period and for at least six months after the end of treatment. Sperm storage should be considered before treatment due to the risk of persistent infertility .

Driving and using machines

Carboplatin Rivopharm can cause side effects that may affect your ability to drive or use machines. You should be especially careful if you feel dizzy or have an effect on your vision or hearing.

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.

How to use Carboplatin Rivopharm

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.

Ask the doctor or nurse who gives / has given the infusion one if you want more information.

How large a dose you receive depends on your height and weight, how good your blood formation is and on your kidney function. The doctor will choose the dose that is best for you. The infusion solution is diluted before use.

You may feel unwell while being treated with Carboplatin Rivopharm. Your doctor may give you another medicine to reduce nausea before you are treated with Carboplatin Rivopharm.

Dose limits of Carboplatin Rivopharm are normally given four weeks apart. Your doctor may want to take blood samples every week after you receive Carboplatin Rivopharm to determine the correct dose for your next infusion .

Adults

Usual dose is 400 mg / m² body surface area (calculated using your height and weight).

Older

For elderly patients, the dose may be adjusted depending on the general condition.

Kidney problems

The amount of medicine you receive may vary depending on how well your kidneys are working. If you have kidney problems, your doctor may reduce the dose one and also often want to take blood samples and monitor your kidney function.

Use for children and adolescents

Carboplatin has not been used in children sufficiently to provide recommendations for a specific dose .

If you take more Carboplatin Rivopharm than you should

It is unlikely that you are getting too much carboplatin. If this happens, you may suffer from certain kidney, liver, vision and hearing problems and impaired bone marrow function. 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 the doctor or nurse who is giving you the medicine.

If you forget to use Carboplatin Rivopharm

It is very unlikely that you will miss a dose because your doctor has instructions on when to get the medicine. If you think you have not been given a dose , talk to your doctor or nurse.

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, tell your doctor immediately :

  • you have difficulty breathing.
  • you get raised red spots that can feel hot and itchy.
  • the face swells.
  • infection and / or bleeding.
  • allergic reactions (eg rash, fever, itching )

The above side effects are very serious and can occur more often if you have been treated with platinum-containing medicines. You may need medical attention immediately.

The side effects below are also very serious and it is very important that your doctor finds out if they occur. If you experience any of the following, tell your doctor as soon as possible: 

Other side effects ar

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

  • Blood effects such as anemia , decreased blood cell counts and platelets .
  • 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):

  • Peripheral nerve disease (in nerve pathways outside the brain), abnormal sensation sensations in the skin (creeps, tingling, numbness), decreased tendon reflexes, taste disturbance.
  • Visual disturbances, in rare cases loss of vision.
  • Hearing impairment.
  • Cardiovascular disease.
  • Mucosal problems in the gastrointestinal tract.
  • Hair loss, skin problems.
  • Disease of the skeleton and muscles.
  • Disease of the urinary and / or genital organs.
  • Increased amount of bilirubin (slag product from the breakdown of red blood cells ) in the blood, increased level of creatinine (slag product from the muscles), increased amount of uric acid in the blood.

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

  • Tumor disease due to treatment.
  • Severe bone marrow exposure (bone marrow failure).
  • Disease that affects 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.
  • Headache, confusion, convulsions or changes in vision from blurring to loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome (RPLS), a rare neurological disease).
  • Heart failure , migratory blood clots (emboli), high or low blood pressure .
  • Inflammation of the oral mucosa .
  • Inflammation of the pancreas
  • Hives , rash, redness, itching .
  • Injection site reactions.
  • 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 arIf you get any side effects , talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. You can also report side effectsdirectly (see details below). By reporting side effects , you can help increase drug safety information. The Medical Products AgencyBox 26751 03 Uppsala www.lakemedelsverket.se

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 Rivopharm

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

Do not store above 25 ° C.

Store in the outer carton. Sensitive to light.

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 carboplatin. 1 ml contains 10 mg of carboplatin.
  • The other ingredients are mannitol 10 mg and water for injections. 

What the medicine looks like and contents of the pack

Vial of glass.

Pack size: 1 x 5 ml, 10 x 5 ml, 1 x 15 ml, 10 x 15 ml, 1 x 45 ml, 10 x 45 ml, 1 x 60 ml, 10 x 60 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Rivopharm Ltd.

17 Corrig Road

Sandyford, Dublin 18

Ireland

Agent

SanoSwiss UAB

Aukstaiciu str. 26A

LT-44169 Kaunas

Lithuania

+370 700 01320

info@sanoswiss.com

Manufacturer

Pharmachemie BV

Swensweg 5

2031 GA Haarlem

Netherlands

Muhammad Nadeem

Leave a Reply