10 mg / ml concentrate for solution for infusion 
carboplatin

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

Carboplatin Accord contains carboplatin which is part of a group of medicines called platinum compounds. These are used to treat cancer.

Carboplatin Accord is used for advanced ovarian cancer and small cell lung cancer .

2. What you need to know before using Carboplatin Accord

Do not use Carboplatin Accord

  • if you are allergic to carboplatin or any of the other ingredients of this medicine (listed in section 6)
  • if you have severe kidney disease
  • if you have fewer blood cells than normal (your doctor will check this with a blood test)
  • if you have bleeding tumors
  • if you are planning to get vaccinated against yellow fever or have just done so.

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

Warnings and cautions

Talk to your doctor or pharmacist before using Carboplatin Accord

  • if you are pregnant or could be pregnant
  • if you are breast-feeding
  • if you have mild kidney disease. Your doctor will check on you more regularly
  • if you are older (over 65 years)
  • if you have previously been treated with cisplatin or similar anticancer medicines; Carboplatin can affect the nervous system and cause tingling or hearing or vision problems. Your doctor may want to assess you more regularly
  • if you get headaches, altered mental function, seizures and visual disturbances, from blurred vision to visual impairment
  • if you develop extreme fatigue and shortness of breath with decreased red blood cell count ( haemolytic anemia ), alone or in combination with low platelet count , abnormal bruising ( thrombocytopenia ) and kidney disease that causes you to urinate little or not at all (symptoms of haemolytic uremic syndrome )
  • if you get a fever (body temperature of at least 38 ° C) or chills, which may be a sign of infection . There is a risk that you will get an infection in the blood.

During treatment with carboplatin, you may in some cases be given medicines to reduce the risk of a life-threatening complication called tumor lysis syndrome, which is caused by chemical imbalances in the blood due to the breakdown of dying cancer cells that release their contents into the bloodstream.

Other medicines and Carboplatin Accord

Special care is required if you are taking / using other medicines as these may affect carboplatin, eg:

  • Drugs that can reduce the number of blood cells at the same time as carboplatin may require a dose change and the frequency of carboplatin treatment
  • Some antibiotics called aminoglycosides , vancomycin or capreomycin at the same time as carboplatin may increase the risk of kidney or hearing problems
  • water tablets ( diuretics ) simultaneously with carboplatin may increase the risk of kidney problems or hearing
  • live or live attenuated vaccines (for yellow fever vaccine, see section 2 Do not use Carboplatin Accord)
  • blood-thinning drugs, e.g. warfarin , together with carboplatin may require closer monitoring of blood coagulation capacity
  • Phenytoin or phosphenytoin (used to treat seizures and seizures) at the same time as carboplatin may increase the risk of seizures
  • other drugs that reduce the activity of the immune system (eg cyclosporine, tacrolimus, sirolimus).

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Carboplatin Accord with food and drink

There is no known interaction between carboplatin and alcohol. However, check with your doctor, as carboplatin 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 or pharmacist for advice before taking this medicine.

Pregnancy

Due to the potential risk of malformations, female patients who may become pregnant should use contraceptives before and during treatment with carboplatin.

Breast-feeding

It is unknown whether carboplatin is excreted in human milk. Thus, during treatment with Carboplatin Accord, you should stop breast-feeding.

Fertility

Men treated with this drug are advised against having children during and up to 6 months after treatment. There is a risk that the drug may cause permanent sterility and men should therefore seek advice on storing sperm before treatment.

Treatment with carboplatin may temporarily or permanently reduce fertility in men and women. Talk to your doctor if you are worried.

Driving and using machines

Do not drive or use machines if you experience side effects that may impair your ability to do so, such as nausea, vomiting, changes in vision or hearing. 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 .

The stopper of the vial of Carboplatin Accord contains natural rubber

The stopper of the vial contains dry natural rubber (a derivative of latex), which may cause allergic reactions.

3. How to use Carboplatin Accord

This medicine is given as an infusion (drip) into a vein for 15‑60 minutes.

Dose

Your doctor will determine which dose of carboplatin is right for you and how often you should get it.

Dose one depends on your medical condition, your size and how your kidneys are working. Your doctor will give you information on how your kidneys are working using blood and urine tests. After your dose of carboplatin, you should have regular blood tests. You may also undergo checks for nerve damage and hearing loss.

It normally takes 4 weeks between each dose of carboplatin.

If you use more Carboplatin Accord than you should 

As this medicine is given in a hospital under the supervision of a doctor, it is unlikely that you will get too much or too little, but talk to a doctor or healthcare professional if you are worried.

If you stop using Carboplatin Accord

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

4. Possible side effects

Like all medicines, Carboplatin Accord can cause side effects , although not everybody gets them.

If any of the following occur, tell your doctor immediately :

  • Abnormal bruising, bleeding, or signs of infection, such as sore throat and fever.
  • Severe allergic reaction (anaphylaxis / anaphylactic reactions) – you may suddenly experience itchy rash ( hives ) swelling of the hands, feet, ankles, face or throat (which may make it difficult to swallow or breathe) and you may have a feeling that you will faint.
  • Muscle cramps, muscle weakness, confusion, visual impairments or disorders, irregular heartbeat, renal failure or abnormal blood test results (symptoms of tumor lysis syndrome that may be caused by the rapid degradation of tumor cells (see section 2).

These are serious side effects . You may need urgent medical attention.

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

  • Changes in red and white blood cells and platelets (bone marrow inhibition).
  • Fatigue, shortness of breath and paleness caused by anemia (a condition that reduces the number of red blood cells ).
  • Increase in the level of urea in the blood.
  • Deviating content of liver enzymes.
  • Nausea or vomiting.
  • Stomach pain and stomach cramps.
  • Decreased levels of sodium , potassium , calcium and magnesium in the blood.
  • Decreased creatine clearance in the kidneys.

Common (may affect up to 1 in 10 people)

  • Diarrhea or constipation.
  • Rash and / or itching
  • Earring or hearing changes.
  • Hair loss.
  • Flu-like symptoms .
  • Signs of infection such as fever or sore throat.
  • Symptoms of severe allergic reaction including sudden wheezing and tightness of the chest, swelling of the eyelids, face or lips, flushing, low blood pressure , rapid heartbeat, shortness of breath, dizziness and anaphylactic shock .
  • Tingling or numbness in hands, feet, arms or legs.
  • Burning or stinging sensation.
  • Reduced tendon reflex.
  • Taste changes or loss of taste.
  • Temporary deterioration of vision or changes in vision.
  • Heart disease.
  • Chest tightness or wheezing.
  • Interstitial lung disease (a group of lung diseases that causes the deep lung tissue to become inflamed).
  • Sores on the lips or cold sores (mucous membrane diseases).
  • Pain or discomfort in the skeleton, joints, muscles or surrounding structures (musculoskeletal disease).
  • Kidney or urine problems.
  • Extreme fatigue/weakness ( asthenia ).
  • Increased levels of bilirubin and creatinine in the blood.
  • Increased levels of uric acid in the blood that can lead to gout .

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

  • Temporary vision loss.
  • Feeling sick with high fever due to low levels of white blood cells (febrile neutropenia ).

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

  • Scarring in the lungs leading to shortness of breath and / or cough ( pulmonary fibrosis ).

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

  • Cancer caused by treatment with carboplatin (secondary malignancy ).
  • Hemolytic uremic syndrome (a disease characterized by acute renal failure ).
  • Dry mouth , fatigue and headache due to severe fluid loss (dehydration).
  • Decreased appetite, anorexia .
  • Stroke .
  • Severe hepatic impairment, damaged or dead liver cells.
  • Heart failure .
  • Obstruction in blood vessels (emboli).
  • Changes in blood pressure ( hypertension or hypotension ).
  • Skin disease such as hives , rash, redness ( erythema ) and itching .
  • Swelling or tenderness at the injection site.
  • A group of symptoms such as headache, altered mental function, seizures and visual disturbances from blurred vision to visual impairment (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disease)
  • Pancreatitis .
  • Sores or information in the mouth ( stomatitis ).
  • Lung infection.

Carboplatin can lead to problems with blood, liver and kidneys. Your doctor will take blood samples to check for these problems.

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 Accord

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

Do not store above 25 ° C. Store in a cold place. Do not freeze. Keep the vial in the outer carton. Sensitive to light.

After reconstitution: Chemical and physical in-use stability of the product after reconstitution has been demonstrated for 24 hours at room temperature and for 30 hours at 2-8 ° C.

From a microbiological perspective, the product should be used immediately. If the reconstituted product is not used immediately, the user is responsible for the storage time and storage conditions before use. Normally the product should not be stored for longer than 24 hours at 2-8 ° C, unless dilution has taken place under controlled and validated antiseptic conditions.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance in Carboplatin Accord is carboplatin.

Each 1 ml concentrate for solution for infusion contains 10 mg carboplatin.

Each 5 ml vial contains 50 mg of carboplatin.

Each 15 ml vial contains 150 mg of carboplatin.

Each 45 ml vial contains 450 mg of carboplatin.

Each 60 ml vial contains 600 mg of carboplatin.

The other ingredients are water for injections.

What the medicine looks like and the contents of the pack

Concentrate for infusion solution

Carboplatin Accord is a clear colorless to pale yellow solution.

5 ml, 15 ml, 45 ml or 60 ml concentrate for solution for infusion is supplied in 5 ml / 15 ml / 45 ml / 60 ml amber vial of type I glass.

The vials are sealed with a gray chlorobutyl rubber stopper / gray Westar prewashed silicone rubber stopper with a tear-off aluminum seal.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited Sage House,

319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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