Cisplatinum Accord

Leaflet accompanying the packaging: patient information

Cisplatinum Accord, 1 mg/ml, concentrate for solution for infusion

Cisplatinum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Cisplatinum Accord and what is it used for
• 2. Important information before using Cisplatinum Accord
• 3. How to use Cisplatinum Accord
• 4. Possible side effects
• 5. How to store Cisplatinum Accord
• 6. Contents of the packaging and other information

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

Cisplatinum Accord contains the active substance cisplatin, which belongs to a group of medicines called cytostatics, used to treat cancer. Cisplatin can be used alone, but it is often used in combination with other cytostatic medicines.
Cisplatin destroys cells in the body that can cause certain types of cancer (testicular cancer, ovarian cancer, bladder cancer, squamous cell carcinoma of the head and neck, lung cancer, and cervical cancer in combination with radiotherapy).
The doctor will be able to provide more information.
Patient should talk to their doctor if they do not feel better or feel worse.

2. Important information before using Cisplatinum Accord

When not to use Cisplatinum Accord

• if the patient is allergic to cisplatin, similar anti-cancer medicines, other platinum compounds, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has a very low number of blood cells (so-called "myelosuppression") (the doctor will check this through a blood test)
• if the patient is breastfeeding
• if the patient has severe kidney disease
• if the patient has hearing disorders
• if the patient is dehydrated
• if the patient needs to receive a yellow fever vaccine

If any of the above situations apply to the patient, they should contact their doctor before using this medicine.

Warnings and precautions

Before starting treatment with Cisplatinum Accord, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has any symptoms of nerve damage (peripheral neuropathy), such as tingling, numbness, and decreased sensation. The patient will be regularly examined for these symptoms, and if necessary, treatment may be discontinued.
• if the patient has undergone radiation therapy to the head.

The doctor will perform tests to determine the levels of calcium, sodium, potassium, and magnesium in the blood, as well as blood morphology, liver and kidney function, and the nervous system.
Cisplatin may affect the bone marrow, causing changes in blood cell production. The patient should tell their doctor if they experience unusual bleeding or bruising. The patient should not take aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or other medicines without consulting their doctor. The doctor will frequently order blood tests and check for signs of infection.
Cisplatin may cause hearing problems (ototoxicity) and kidney function disorders (nephrotoxicity). Kidney function and hearing will be monitored before and during treatment. If the patient experiences any changes in hearing, they should inform their doctor.
The patient should tell their doctor if they plan to get vaccinated during cisplatin treatment.
The patient should avoid certain live vaccines, as they may cause severe infections, and the response to other types of vaccines (inactivated) may be weakened.

Cisplatinum Accord and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, such as:

• certain antibiotics, such as cephalosporins, aminoglycosides, and amphotericin B, and certain substances used in imaging tests, which may increase the side effects of cisplatin, especially kidney function disorders
• certain diuretic medicines called loop diuretics, antibiotics called aminoglycosides, and the anti-cancer medicine ifosfamide, which may increase the side effects of cisplatin in the form of hearing loss
• bleomycin (an anti-cancer medicine), methotrexate (used to treat cancer or arthritis), and paclitaxel (an anti-cancer medicine), which may cause more side effects when used in combination with cisplatin
• cisplatin may reduce the effectiveness of anti-epileptic medicines (used to treat epilepsy); it may be necessary to determine the level of phenytoin in the blood
• the effectiveness of oral anticoagulant medicines (e.g., warfarin) may change. The doctor will monitor the results of blood tests.
• buclizine, cyclizine, and meclozine (anti-histamine medicines), loxapine, phenothiazines, and thioxanthenes (medicines used to treat mental disorders), and trimethobenzamide (medicines used to prevent nausea and vomiting) may mask symptoms of balance disorders (such as dizziness or ringing in the ears)
• cisplatin may increase the side effects of ifosfamide (an anti-cancer medicine)
• pyridoxine (vitamin B6) and altretamine (an anti-cancer medicine) used in combination with cisplatin in the treatment of advanced ovarian cancer may shorten the recovery time. The doctor will discuss this with the patient.
• bleomycin and etoposide (anti-cancer medicines) used in combination with cisplatin and lithium (used to treat mental disorders) may decrease the level of lithium in the blood. It is recommended to monitor the level of lithium.
• yellow fever vaccines should not be used in combination with cisplatin treatment due to the risk of death from vaccination. It is recommended to use an inactivated vaccine.
• medicines for gout, such as allopurinol, colchicine, probenecid, or sulfinpyrazone, reduce the level of uric acid in the blood. The doctor may change the dose of Cisplatinum Accord.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Due to the possibility of birth defects, patients should use contraceptive methods during cisplatin treatment and for at least six months after the end of treatment.
Cisplatin should not be used during pregnancy, unless the doctor explicitly recommends it.
Before using any medicine, the patient should consult their doctor or pharmacist.

Breastfeeding

This medicine should not be used if the patient is breastfeeding.

Fertility

Male patientstreated with cisplatin are advised not to father a child during treatment and for up to 6 months after the end of treatment. Cisplatin treatment may potentially cause permanent infertility in men. It is recommended that men who wish to become fathers in the future seek advice on storing sperm in a frozen state (cryopreservation) before starting treatment.

Driving and using machines

The patient should not drive or operate machines if they experience any side effects that may reduce their ability to do so.

Cisplatinum Accord contains sodium

This medicine contains 3.5 mg of sodium (the main component of common salt) per ml. This corresponds to 0.18% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine can be prepared using solutions containing sodium. This should be taken into account if the patient is on a low-sodium diet.

3. How to use Cisplatinum Accord

Dosage and administration

Cisplatinum Accord may only be administered by a specialist in oncology treatment.
The concentrate is diluted with a sodium chloride solution.
Cisplatin is usually administered by intravenous infusion lasting from 6 to 8 hours.
Equipment for controlling anaphylactic reactions should be available.
Cisplatin should not come into contact with materials containing aluminum.
The recommended dose of Cisplatinum Accord depends on the patient's condition, expected treatment outcomes, and whether cisplatin is administered alone (monotherapy) or in combination with other medicines (combination chemotherapy).

Recommended dose

Cisplatin (monotherapy):
the following dosing is recommended:

• a single dose of 50 to 120 mg/m2 body surface area, every 3 to 4 weeks.
• 15 to 20 mg/m2 per day for 5 days, every 3 to 4 weeks.

Cisplatin in combination with other chemotherapeutic medicines (combination chemotherapy):

• 20 mg/m2 or higher, once every 3 to 4 weeks.

In the treatment of cervical cancer, cisplatin is used in combination with radiotherapy or other anti-cancer medicines.
The typical dose is 40 mg/m2 per week for 6 weeks.
To avoid or alleviate kidney problems, it is recommended to drink plenty of water within 24 hours of using Cisplatinum Accord.

Using a higher dose of Cisplatinum Accord than recommended

The doctor will ensure that the correct dose is administered based on the patient's condition. In case of overdose, the patient may experience an increase in side effects. The doctor may use symptomatic treatment for these side effects. If the patient believes they have received too high a dose of Cisplatinum Accord, they should contact their doctor immediately.
In case of doubts about using this medicine, the patient should consult their doctor.

4. Possible side effects

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

If the patient experiences any of the following symptoms, they should immediately inform their doctor:

• severe allergic reaction - may cause sudden itching rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), sudden redness of the skin, and a feeling of fainting
• severe chest pain, which may radiate to the jaw or arm, sweating, shortness of breath, and nausea (heart attack)
• fainting or seizures
• hearing problems - may cause ringing in the ears or hearing loss (ototoxicity)
• kidney problems and urinary disorders
• excessive fatigue and general malaise, which may be symptoms of a decreased number of blood cells (myelosuppression). This will be confirmed by a blood test.

These are serious side effects. The patient may need urgent medical attention.
Very common (may affect more than 1 in 10 patients)

• decreased bone marrow function (may affect blood cell production)
• decreased white blood cell count, which increases the risk of infections (leukopenia)
• decreased platelet count, which increases the risk of bruising and bleeding (thrombocytopenia)
• decreased red blood cell count, which may cause weakness and pale skin (anemia)
• decreased sodium levels in the blood
• high fever

Common (may affect up to 1 in 10 patients)

• severe pain or swelling in the legs, chest pain, or difficulty breathing (which may indicate dangerous blood clots in a vein)
• fast, irregular, or slow heart rate
• sepsis (blood poisoning)

Uncommon (may affect up to 1 in 100 patients)

• severe allergic reaction (see above)
• hearing disorders (ototoxicity)
• decreased magnesium levels in the blood
• abnormal sperm production

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

• increased risk of acute leukemia
• seizures (epileptic fits)
• fainting, headache, disorientation, and loss of vision
• loss of certain brain functions, including brain dysfunction characterized by seizures and decreased level of consciousness
• brain dysfunction (disorientation, slurred speech, sometimes blindness, memory loss, and paralysis)
• heart attack
• mouth ulcers
• kidney problems or urinary disorders
• hair loss
• rash
• extreme fatigue or weakness
• swelling or pain at the injection site
• muscle spasms
• burning or stinging sensation
• unexpected bleeding or bruising
• hemolytic-uremic syndrome, which can cause kidney and blood changes.

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

• cardiac arrest

Frequency not known (cannot be estimated from the available data)

• infection symptoms, such as fever or sore throat
• hemolytic anemia
• inappropriate release of antidiuretic hormone (ADH), which can lead to low sodium levels in the blood and water retention in the body
• increased amylase activity in the blood
• dehydration
• decreased levels of calcium, phosphates, and potassium in the blood
• high levels of uric acid in the blood
• muscle spasms
• spinal cord disease that can cause a sensation of "electric shock" in the limbs
• loss of taste
• vision problems (blurred vision, strange colors, loss of vision, or eye pain)
• ringing in the ears or deafness
• heart problems
• unusual feeling of cold or white hands and feet
• tingling, numbness, or trembling of hands, feet, arms, or legs
• persistent headache
• nausea or vomiting
• loss of appetite, anorexia
• hiccups
• diarrhea
• increased activity of liver enzymes, increased bilirubin levels
• breathing difficulties
• shortness of breath, chest pain, especially when inhaling, coughing up blood
• kidney problems or urinary disorders
• hair loss
• rash
• extreme fatigue or weakness
• swelling or pain at the injection site
• muscle spasms

Cisplatin can cause blood, liver, and kidney disorders. The doctor will order blood tests to check for these disorders and monitor electrolyte levels.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Cisplatinum Accord

Store out of sight and reach of children.

Store the vial in the outer packaging to protect it from light.
Do not store in the refrigerator or freeze.
If the solution remains cloudy or a precipitate forms, the product should not be used.
The product should be discarded if the solution does not become clear after vigorous shaking.
Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of the month.
Do not use this medicine if visible signs of deterioration are observed.
Any materials used to prepare and administer or materials that have come into contact with cisplatin should be disposed of in accordance with local regulations for the disposal of cytotoxic waste.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cisplatinum Accord contains

The active substance of Cisplatinum Accord is cisplatin.
Each milliliter (ml) of solution contains 1 milligram (mg) of cisplatin. The medicine is in orange glass vials.

The medicine is available in packs containing single vials (not all vial sizes may be marketed).
The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

What Cisplatinum Accord looks like and contents of the pack

Cisplatinum Accord is a clear, colorless to pale yellow solution, free from particulate matter, in an orange glass vial with a clear flip-off seal.
Each 10 ml vial contains 10 mg of cisplatin.
Each 25 ml vial contains 25 mg of cisplatin.
Each 50 ml vial contains 50 mg of cisplatin.
Each 100 ml vial contains 100 mg of cisplatin.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, 32009, Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Member State

Medicine name

Austria
Cisplatin Accord 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium
Cisplatin Accord Healthcare 1 mg/ml solution à Diluer pour Perfusion / concentraat voor oplossing voor infusie / Konzentrat zur Herstellung einer Infusionslösung
Bulgaria
Cisplatin Accord 1mg/ml Concentrate for Solution for Infusion
Denmark
Cisplatin Accord
Estonia
Cisplatin Accord 1 mg/ml
Finland
Cisplatin Accord 1 mg/ml infuusiokonsentraatti, Liuosta Varten
Germany
Cisplatin Accord 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Hungary
Cisplatin Accord 1 mg/ml Concentrate for Solution for Infusion
Ireland
Cisplatin 1 mg/ml Concentrate for Solution for Infusion
Italy
Cisplatin Accord Healthcare 1 mg/ml concentrato per soluzione per infusione
Latvia
Cisplatin Accord
Lithuania
Cisplatin Accord 1 mg/ml koncentratas infuziniam tirpalui

Netherlands
Cisplatin Accord 1 mg/ml Concentraat voor Oplossing voor Infusie
Norway
Cisplatin Accord 1 mg/ml Konsentrat til infusjonsvæke
Poland
Cisplatinum Accord
Portugal
Cisplatin Accord
Romania
Cisplatină Accord 1 mg / ml concentrat pentru soluţie perfuzabilă
Slovenia
Cisplatin Accord 1 mg/ml koncentrat za raztopino za infundiranje
Spain
Cisplatino Accord 1 mg/ml concentrado para solución para perfusión
Sweden
Cisplatin Accord 1 mg/ml Koncentrat till Infusionsvätska, Lösning
United Kingdom (Northern Ireland)
Cisplatin 1 mg/ml Concentrate for Solution for Infusion

Date of last revision of the leaflet: October 2024 -------------------------------------------------------------------------------------------------------------- (Note: This is a Patient Leaflet, not a Summary of Product Characteristics. For details of the product, see the SPC.)

Information intended for healthcare professionals only

Instructions for preparation and handling of the medicinal product

As with other anti-cancer medicines, caution should be exercised when handling cisplatin. Dilution should be performed under aseptic conditions by trained personnel in a designated area. Protective gloves should be worn. Precautions should be taken to avoid contact between the medicinal product and the skin and mucous membranes. If the solution comes into contact with the skin, the affected area should be washed immediately with soap and water. If the solution comes into contact with the mucous membranes, they should be rinsed immediately with plenty of water. After inhalation of the solution, shortness of breath, chest pain, throat irritation, and nausea have been reported. Pregnant women should avoid contact with cytotoxic medicines. Cisplatin should not be used during pregnancy, unless the doctor considers the risk associated with the administration of the medicinal product to be clinically justified.
Particular care should be taken when disposing of excreta and vomit. If the solution remains cloudy or a precipitate forms, the vial should be discarded. Damaged vials should be treated with the same caution as contaminated waste. Contaminated waste should be stored in properly labeled waste containers. See "Disposal of unused medicinal product".

Preparation for intravenous administration

The required amount of solution should be drawn from the vial and then diluted in at least 1 liter of the following solutions:

• 0.9% sodium chloride
• mixture of 0.9% sodium chloride and 5% glucose (1:1) (final concentrations: 0.45% sodium chloride solution, 2.5% glucose solution)
• 0.9% sodium chloride and 1.875% mannitol for injection
• 0.45% sodium chloride, 2.5% glucose, and 1.875% mannitol for injection

Before use, the solution should always be inspected. Only clear solutions free from particulate matter should be used.
If a precipitate forms inside the vial, the vial should be stored at room temperature (20-25°C) until a clear solution is obtained. The unopened container should be protected from light. The medicinal product should be discarded if the solution does not become clear after vigorous shaking.
Cisplatin should not come into contact with aluminum-containing materials. Cisplatin may react with metal (aluminum) to form a black platinum precipitate. All materials containing aluminum, such as infusion sets, needles, cannulae, and syringes, should not be used.
Cisplatin decomposes in solutions containing a small amount of chloride. The chloride concentration should be at least 0.45% sodium chloride solution.
Due to the lack of compatibility studies, cisplatin should not be mixed with other medicinal products.
Antioxidants (such as sodium metabisulfite), bicarbonates (sodium bicarbonate), sulfites, fluorouracil, and paclitaxel may inactivate cisplatin in infusion sets.

Special precautions for storage

Medicinal product in the packaging for sale

Concentrate for solution for infusion, 1 mg/ml

Undiluted solution: store the container in the outer packaging to protect it from light. Do not store in the refrigerator or freeze. If the solution remains cloudy or a precipitate forms, the solution should not be used.

Diluted solution

For information on the storage conditions of the medicinal product after dilution, see below "Concentrate for solution for infusion after dilution":
Do not store in the refrigerator or freeze.

Concentrate for solution for infusion after dilution

After dilution
Chemical and physical stability of Cisplatinum Accord after dilution in the recommended infusion solutions described in the section "Instructions for preparation and handling of the medicinal product" has been demonstrated for 24 hours at room temperature 20-25°C.
From a microbiological point of view, the diluted solution should be used immediately. If the product is not used immediately, the responsibility for the storage conditions and duration of the prepared solution lies with the user. Dilution should be performed under controlled and validated aseptic conditions.