1 mg / mL concentrate for infusion solution 
cisplatin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

The medicine is called “Cisplatin Accord 1 mg/ml concentrate for solution for infusion ” but in the rest of the package leaflet it is called “Cisplatin Accord”.

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

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

What Cisplatin Accord is and what it is used for

Cisplatin belongs to a group of medicines called chemotherapy drugs , which are used to treat cancer. Cisplatin can be used alone but is usually used in combination with other chemotherapy drugs .

What is it used for?

Cisplatin can destroy cells in the body that can cause certain types of cancer ( tumorsin the testicles, ovaries and bladder, epithelial tumors in the head and neck area, lung cancer and, in combination with radiation, cervical cancer).

Cisplatin contained in the Cisplatin Accord may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Cisplatin Accord

Do not take Cisplatin Accord

  • if you are allergic to cisplatin or any of the other ingredients of this medicine (listed in section 6)
  • if you have a history of hypersensitivity to similar cancer medicines
  • if you have severe kidney disease
  • if you have a hearing impairment
  • If you have a low blood cell count (called “bone marrow suppression”), your doctor will check it with a blood test
  • if you suffer from dehydration
  • if you need to get the yellow fever vaccine
  • if you are breast-feeding.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using Cisplatin Accord:

  • if you have any symptoms of nerve damage ( peripheral neuropathy ) such as tingling, numbness or loss of sensation
  • if you have received radiation treatment to the head.

Other medicines and Cisplatin Accord

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, such as:

  • certain types of antibiotics such as cephalosporins , aminoglycosides and amphotericin B, and certain contrast agents (may be given in conjunction with X-ray examination) may aggravate side effects caused by cisplatin; especially kidney problems.
  • Certain diuretics (loop diuretics ), aminoglycosides ( antibiotics ) and ifosfamide (anticancer medicines) may aggravate the side effect of hearing loss caused by cisplatin.
  • bleomycin (anti-cancer drug), methotrexate (used to treat cancer or arthritis ) and paclitaxel (anti-cancer drug) in combination with cisplatin may cause more side effects .
  • Oral blood thinners ( anticoagulants ) may have a reduced effect in combination with cisplatin. Your doctor will monitor this with blood tests.
  • Some medicines for hypersensitivity ( antihistamines ) may mask symptoms of imbalance (eg dizziness or tinnitus ).
  • antispasmodics (anticonvulsants) e.g. phenytoin may have a reduced effect in combination with cisplatin
  • Side effects caused by ifosfamide (medicines for cancer) can be aggravated by cisplatin.

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.

Due to the risk of birth defects, male and female patients should take contraceptives both during treatment and for at least 6 months after stopping treatment.

Treatment with cisplatin may cause permanent ( irreversible ) infertility in men. It is recommended that men who wish to become fathers in the future seek advice regarding cryopreservation (freeze storage) of semen before treatment. Talk to your doctor if you have any concerns.

Driving and using machines

Do not drive or use machines if you experience any side effects that may affect your ability to do so.

Cisplatin Accord contains sodium

Cisplatin Accord contains 3.5 mg sodium per ml (main ingredient in cooking / table salt). This corresponds to 38.3% of the highest recommended daily intake of sodium for adults.

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

3. How to use Cisplatin Accord

Dosage and route of administration

Cisplatin should only be administered by a cancer treatment specialist.

The concentrate is diluted with a sodium chloride solution.

Emergency equipment must be available to deal with anaphylactic reactions.

Cisplatin is only administered as an injection into a vein ( intravenous infusion ) and should not come into contact with materials containing aluminum.

The recommended dose of cisplatin depends on your general condition, the expected effect of treatment and whether cisplatin is given alone ( monotherapy ) or in combination with other medicines ( combination therapy ).

Cisplatin ( monotherapy )

The following dose is recommended:

  • A single dose of 50-120 mg / m² body surface area every three to four weeks.
  • 15–20 mg / m² per day for a five-day period, every three to four weeks.

Cisplatin in combination with other chemotherapy ( combination therapy )

  • 20 mg / m² or more, once every three to four weeks.

Cisplatin is used in combination with radiation to treat cervical cancer.

A typical dose is 40 mg / m² per week for six weeks.

To prevent or reduce kidney problems, we recommend that you drink large amounts of water for 24 hours after cisplatin treatment. Cisplatin Accord should not be given more than once every three to four weeks.

If you take more Cisplatin Accord than you should

Your doctor will decide what dose you should take based on the conditions that apply to you. In case of overdose, the side effects may get worse. Your doctor may give you appropriate treatment for the side effects . Contact a doctor immediately if you think you have used too much cisplatin.

Always use this medicine exactly according to the instructions given to you by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately if you get any of the following:

  • severe allergic reaction – you experience a sudden itchy rash ( hives ), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing) and you may feel dizzy
  • severe chest pain that may radiate to the jaw or arm with sweating, shortness of breath and nausea (heart attack)
  • pain or swelling at the injection site during infusion one (may be due to the fact that infusion one does not enter the blood vessel properly, which can lead to serious damage to the tissue around the injection site)
  • stroke
  • disorders of brain function (confusion, slurred speech, sometimes vision loss, memory loss and paralysis).

These side effects are serious and you may need urgent care.

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

  • decreased bone marrow function (which may affect the production of blood cells)
  • reduction in the number of white blood cells , which increases the risk of infection ( leukopenia )
  • reduction in the number of platelets , which increases the risk of bruising and bleeding ( thrombocytopenia )
  • decrease in the number of red blood cells which may cause weakness or pale skin ( anemia )
  • decreased amount of sodium in the blood
  • fever.

Common (may affect up to 1 in 10 people)

  • severe pain or swelling in the legs, chest pain or difficulty breathing (may indicate a blood clot in a vein)
  • fast, irregular or slow heartbeat
  • sepsis (blood poisoning).

Uncommon (may affect up to 1 in 100 people)

  • severe allergic reaction (see description above)
  • damage to the ears (toxicity)
  • decreased amount of magnesium in the blood
  • abnormal sperm production.

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

  • increased risk of acute leukemia
  • seizures
  • fainting, headache, confusion and loss of vision
  • loss of certain types of brain function including brain dysfunction characterized by spasms and decreased consciousness
  • heart attack
  • inflammation of the mucous membranes of the mouth ( stomatitis )
  • peripheral neuropathy in the sensory nerves, characterized by tickling, itching or tingling without cause and sometimes by taste, sensory and visual disturbances, sudden cutting pain from the neck down to the back and legs when bending forward.

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

  • cardiac arrest.

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

  • signs of infection such as fever or sore throat
  • hemolytic anemia
  • inadequate secretion of the hormone et vasopressin ( ADH ) which can reduce the amount of sodium in the blood and which causes the body to retain fluid
  • increased level of amylase ( enzyme ) in the blood
  • dehydration
  • decreased amount of calcium , phosphate and potassium in the blood
  • increased amount of uric acid in the blood
  • muscle spasms
  • diseases of the spinal cord that can cause a feeling of electric shock going through the arms and legs
  • loss of taste
  • vision problems (blurred vision, impaired color perception, loss of vision or eye pain)
  • ringing in the ears or deafness
  • heart problems
  • unusually cold or pale hands and feet
  • tingling, numbness or trembling in the hands, feet, arms or legs
  • persistent headache
  • feels or is ill
  • loss of appetite, anorexia
  • hiccup
  • diarrhea
  • increased amount of liver enzymes, increased amount of bilirubin
  • breathing difficulties
  • kidney or urine problems
  • hair loss
  • rash
  • extreme fatigue / weakness
  • swelling or tenderness at the injection site
  • cramps or spasm are
  • burning or knitting sensation
  • bruising or bleeding
  • hemolytic-uremic syndrome that can cause changes in the kidneys and blood.

Cisplatin can cause problems in the blood, liver and kidneys. Your doctor will take blood samples to check this.

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 Cisplatin Accord

Keep this medicine out of the sight and reach of children.

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

Cisplatin Accord 1 mg / mL concentrate for infusion solution

Store in the outer carton. Sensitive to light. Store in a cold place. Do not freeze.

Do not use this medicine after the expiry date which is stated on the vial or outer carton after “EXP. that. ”. The expiration date is the last day of the specified month. Do not use this medicine if you notice any visible deterioration.

All materials used for preparation and administration or that have been in contact with cisplatin in any way should be discarded in accordance with local cytotoxic guidelines.

Discard the bottle if the solution is cloudy or contains a precipitate that does not dissolve.

6. Contents of the packaging and other information

Content declaration

The active substance in Cisplatin Accord is cisplatin.

Each milliliter (ml) of solution contains 1 milligram (mg) of cisplatin. The medicine is supplied in brown glass containers called vials.

Pack sizes 10 ml 25 ml 50 ml 100 ml
Cisplatin 10 mg 25 mg 50 mg 100 mg

The medicine is sold in packs of one vial (not all pack sizes may be marketed).

The other ingredients are water for injections, sodium chloride, hydrochloric acid (for pH adjustment) and / or sodium hydroxide (for pH adjustment).

What the medicine looks like and the contents of the pack

Cisplatin Accord is a clear, colorless to pale yellow solution in a brown vial , largely free of particles sealed with a snap cap with white clear seal.

1 pack of 1 vial of 10 ml contains 10 mg of cisplatin.

1 pack of 1 vial of 25 ml contains 25 mg of cisplatin.

1 pack of 1 vial of 50 ml contains 50 mg of cisplatin.

1 pack of 1 vial of 100 ml contains 100 mg of cisplatin.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV 
Winthontlaan 200 
3526 kV Utrecht The 
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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