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.
  • 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 Actavis is and what it is used for 
2. What you need to know before you get Carboplatin Actavis 
3. How to get Carboplatin Actavis 
4. Possible side effects 
5. How to store Carboplatin Actavis 
6. Contents of the packaging and other information 

What Carboplatin Actavis is and what it is used for

What Carboplatin Actavis is

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

What Carboplatin Actavis is used for

Carboplatin Actavis is used to treat advanced ovarian cancer and small cell lung cancer.

Carboplatin contained in Carboplatin 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.

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

Do not use Carboplatin Actavis

  • 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 ( creatinine clearance at or below 30 ml/min)
  • if you have impaired bone marrow function (impaired ability to produce blood cells in the bone marrow ).
  • if you have a bleeding tumor s
  • concomitant use of yellow fever vaccine

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.

Carboplatin Actavis is usually given to patients in hospitals. Under normal circumstances, do not use this medicine on your own. Your doctor or nurse will give you the medicine and will monitor you closely and often during and after treatment. Normally, blood samples are taken for analysis before each infusion.

Warnings and cautions

Talk to your doctor or nurse before receiving Carboplatin Actavis

  • if you are pregnant or think you may be pregnant
  • if you are breast-feeding
  • if you have headaches, altered mental function, seizures, and abnormal vision from blurring to vision loss, talk to your doctor
  • if you develop extreme fatigue and shortness of breath with decreased red blood cell count (symptoms of hemolytic anemia ), alone or with low platelet count, abnormal tendency to bruise ( thrombocytopenia ), and kidney disease where you urinate little or nothing at all (symptoms of the hemolytic uremic syndrome), talk to your doctor
  • if you have a fever (temperature above or equal to 38 ° C), or chills, which may be a sign of infection, talk to your doctor immediately. You may be at risk of getting a blood  infection
  • if you are likely to drink any alcoholic beverage while you are being treated with the medicine.

The effect of carboplatin on the blood-forming system may be increased or prolonged if you have poor kidney function compared to patients with normal kidney function.

Your doctor will want to check on you more often if you have poor kidney function.

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.

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.

The infusion solution may be diluted with another solution before administration. Talk to your doctor to make sure it is suitable for you.

Tell your doctor if you think your child has hearing problems, as hearing loss is more common in children who are being treated with this medicine.

Other medicines and Carboplatin Actavis

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 Actavis:

  • other drugs that reduce the activity of the immune system (eg ciclosporin, tacrolimus, sirolimus, and other anticancer medicines)
  • other drugs are known to be harmful to the kidneys (eg aminoglycoside antibiotics)
  • other medicines are known to impair the ear’s auditory or balance functions (eg aminoglycoside antibiotics, furosemide (used to treat heart failure and edema ))
  • chelating agents (substances that bind to carboplatin and thus reduce the effect of carboplatin)
  • phenytoin and fosphenytoin (used to treat various types of convulsions and seizures)
  • anticoagulants (used to prevent blood clots)
  • loop diuretics (used to treat high blood pressure and edema ).

You should not receive vaccines that contain live viruses during treatment with carboplatin.

Carboplatin Actavis with food, drink, and alcohol

There is no known interaction between Carboplatin Actavis and alcohol. However, you should consult your doctor as Carboplatin Actavis 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 Actavis 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 Actavis while you are pregnant, talk to your doctor about the possible risks to the unborn baby.

Women of childbearing potential must use effective contraception both before and during treatment with carboplatin. Because carboplatin can cause damage to the genome, genetic counseling is recommended if you become pregnant during treatment with carboplatin. Genetic counseling is also recommended for patients who want to have children after treatment with Carboplatin Actavis.

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 Actavis.

Fertility

Carboplatin can cause damage to the genome. Women of childbearing potential should avoid becoming pregnant by using effective contraception during treatment. Genetic counseling is recommended for women who are pregnant or become pregnant 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 does not affect your ability to drive or use machines. However, you should be especially careful when you receive your first infusion, especially if you feel dizzy or insecure.

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 or pharmacist.

How to get Carboplatin Actavis

An infusion 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.

The dose you receive depends on your height and weight, on 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.

Adults

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

Older

The usual dose for adults can be used, although the doctor may choose to use another dose.

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. Infusion is given by a doctor who has experience in cancer treatments.

Use for children and adolescents

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

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

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

If you take more Carboplatin Actavis than you should

It is unlikely that you are getting too much carboplatin. However, should this occur, you may have some kidney, liver, vision, and hearing problems and a low white blood cell, count . 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 Actavis

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.

Tell a doctor as soon as possible if you notice any of the following:

  • Abnormal bruising, bleeding, or signs of infection, such as sore throat and fever.
  • Severe itchy skin (with rash) or swelling of the face, lips, tongue, and/or pharynx, which may lead to difficulty swallowing or breathing ( angioedema ) and feeling dizzy.
  • Oral inflammation (eg sore lips or cold sores).

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

  • Bone marrow inhibition results in a sharp decrease in the number of white blood cells as a result, which makes infection more likely ( leukopenia, neutropenia )
  • Decreased platelet count, increasing the risk of bruising and bleeding ( thrombocytopenia )
  • Anemia (a condition with decreased red blood cell count, which makes you tired)
  • Elevated levels of uric acid in the blood, which can cause gout (h
  • Slightly impaired hearing (hearing loss at high frequencies)
  • Nausea and vomiting
  • Abdominal pain and cramps
  • Unusual tiredness or feeling of weakness
  • Abnormal liver values ​​and abnormal liver function tests. Your doctor may want to monitor this
  • Renal impairment (decreased renal creatinine – clearance, increased blood urea)
  • Decreased levels of salts in the blood ( sodium, potassium, calcium, magnesium). Your doctor may want to monitor this.

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

  • Infection is
  • Abnormal bruising or bleeding (bleeding complications) 
  • Allergic reactions, including rash, hives, redness, itching, fever
  • Weakness, tingling, and numbness ( peripheral neuropathy )
  • Tingling and tingling
  • Reduction of deep tendon reflexes (reflexes in muscles to contract when the tendon meets)
  • Emotional disorders
  • Taste changes
  • Impotence
  • Visual disturbances, including temporary loss of vision
  • Earring ( tinnitus ), hearing loss, and hearing loss 
  • Heart disease
  • Lung disease, scarring and thickening of the lungs with difficulty breathing, sometimes fatal (interstitial lung disease), difficulty breathing
  • Diarrhea, constipation
  • Problems in mucous membranes
  • Hair loss
  • Skin disease
  • Itchy rash ( hives )
  • Itching ( pruritus )
  • Red rash (erythematous rash)
  • Problems with pain in muscles, joints, tendons, ligaments, and nerves (musculoskeletal disease)
  • Impact on the condition of the urinary tract and genitals (urogenital disorders)
  • Flu-like symptoms
  • Increased levels of creatinine, bilirubin, and uric acid in the blood. Your doctor may want to monitor this.

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

  • Cancer caused by chemotherapy or radiation (secondary tumors )
  • Fever and chills without signs of infection
  • Redness, swelling, pain, or dead skin around the injection site

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

  • Feeling sick with high fever due to low white blood cell count (febrile neutropenia)
  • Severe allergic reactions (anaphylactic / anaphylactoid reactions). Symptoms of severe allergic reactions include sudden wheezing or pressure over the chest, swelling of the eyelids, face, or lips, flushing, drop in blood pressure, rapid heartbeat, hives, shortness of breath, dizziness, and anaphylactic shock.
  • Low levels of sodium in the blood ( hyponatremia )
  • Loss of appetite ( anorexia )
  • Inflammation of the optic nerve one that can cause a complete or partial loss of vision ( optic neuritis )
  • Severely impaired liver function, liver cells are damaged or die. Your doctor may want to monitor this. 

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

  • Bleeding in the brain, which can cause stroke or loss of consciousness
  • Heart failureSudden blockage of a blood vessel (embolism), high blood pressure, low blood pressure

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

  • Hemolytic uremic syndrome (a disease that manifests itself as acute renal failure / low urine output / no urine output, decreased red blood cell count[microangiopathic hemolytic anemia], and low platelet levels ).
  • Dehydration.
  • Sore lips or sores in the mouth ( stomatitis )
  • A group of symptoms such as headache, altered mental function, seizures, and abnormal vision from blurring to loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome, an unusual neurological disease).
  • Pancreatitis.
  • Lung infection
  • A group of symptoms, such as fatigue, bruising and bleeding, infections , fever, and unexplained weight loss (symptoms of promyelocytic leukemia, a form of cancer that affects blood-producing cells in the bone marrow ).
  • 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 Actavis

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. The expiration date is the last day of the specified month.

Unopened packaging: Do not store above 25 ° C. Store the bottle in the outer carton. Sensitive to light.

After dilution: Chemical and physical in-use stability of the reconstituted solution has been demonstrated at 25 ° C for 8 hours.

Given the risk of microbiological growth, the product should be used immediately, unless the method of dilution excludes the risk of microbial contamination. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

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 of concentrate contains 10 mg of carboplatin.
  • The other ingredients are water for injections.

What the medicine looks like and the contents of the pack

Carboplatin Actavis is a clear, colorless to pale yellow liquid.

Pack sizes: 1 x 5 ml, 5 x 5 ml, 1 x 15 ml, 1 x 45 ml, 1 x 60 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

This medicinal product is authorized under the European Economic Area under the names:

Bulgaria Carboplatin Actavis

Denmark Carboplatin Actavis

Estonia Carboplatin Actavis

Finland Carboplatin Actavis 10mg / ml, infusion concentrate, liuosta varten

Germany Carboplatin-Actavis 10 mg/ml concentrate for the preparation of an infusion solution

Iceland Carboplatin Actavis

Italy Carboplatino Aurobindo

Lithuania Carboplatin Actavis 10mg / ml concentrated infusion powder

Netherlands Carboplatin Aurobindo10 mg/ml, concentrate for solution for infusion

Norway Carboplatin Actavis

Poland Carboplatin Actavis

Slovakia Bopacatin 10 mg / ml

Slovenia Bopacatin 10 mg / ml

Hungary Bopacatin 10 mg / ml

Muhammad Nadeem

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