1 mg / mL concentrate for infusion solution
Read all of this leaflet carefully before you start taking 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, pharmacist, or nurse.
- 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 you will find information about:
1. What Cisplatin Ebewe is and what it is used for
2. What you need to know before you use Cisplatin Ebewe
3. How to use Cisplatin Ebewe
4. Possible side effects
5. How to store Cisplatin Ebewe 6. Contents of the pack
and other information
What Cisplatin Ebewe is and what it is used for
Cisplatin Ebewe is part of a group of medicines called chemotherapy drugs used in cancer treatment. Cisplatin Ebewe can be used alone but is most often used in combination with other chemotherapy drugs .
Cisplatin destroys cells in the body that can cause various types of cancer (testicular cancer, ovarian cancer, cancer of the head and neck ( tumor that attacks the outer layer of the skin), lung cancer). Your doctor can provide you with more information.
Cisplatin contained in Cisplatin Ebewe 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 use Cisplatin Ebewe
Do not use Cisplatin Ebewe
- if you are allergic to cisplatin or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to any other platinum-containing medicine
- if have kidney problems
- if you suffer from dehydration
- if you suffer from a decreased number of blood cells
- if you have a hearing loss
- if you are pregnant or breastfeeding
- together with a vaccine against yellow fever or phenytoin (see “Other medicines and Cisplatin Ebewe” below).
Warnings and cautions
Talk to your doctor, pharmacist or nurse before using Cisplatin Ebewe.
- Your doctor will perform tests to determine the levels of calcium , sodium , potassium and magnesium in your blood, check your blood count and liver and kidney capacity.
- Cisplatin Ebewe should only be administered under the strict supervision of a specialist experienced in the administration of chemotherapy.
- your hearing will be tested before starting treatment with Cisplatin Ebewe.
- if you suffer from nerve disease that is not caused by cisplatin.
- if you are planning to have a baby (see “Pregnancy, breast-feeding and fertility”).
Other medicines and Cisplatin Ebewe
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Please note that the information below also applies to products that have been used some time ago or that you will use in the future.
- The toxic effects of cisplatin may be increased with concomitant use of other chemotherapy drugs (medicines used to treat cancer), such as bleomycin and methotrexate.
- Cisplatin can have serious effects on the kidneys when co-administered with medicines that can cause side effects in the kidneys, such as medicines used to treat and prevent infections (antibiotics: cephalosporins , aminoglycosides , and / or amphotericin B) and contrast agents. .
- Cisplatin can damage your hearing when co-administered with medicines that have hearing side effects, such as aminoglycosides .
- Concomitant use of drugs that increase urinary excretion (loop diuretics) and cisplatin (cisplatin dose: more than 60 mg / m 2 , urine secretion: less than 1000 ml per day) may result in adverse effects on the kidneys and hearing.
- The first signs of hearing damage (dizziness and / or tinnitus ) may not be detected during cisplatin treatment if hypersensitivity drugs are co-administered ( antihistamines such as buclizine, cyclizine, loxapine, meclozin, phenothiazines, thioxanthenes and / or trimethobenzamides).
- Cisplatin given in combination with ifosfamide may cause hearing loss.
- The effects of cisplatin treatment can be reduced through the concomitant use of peroxide and hexamethylmelamine.
- Use of cisplatin in combination with paclitaxel or docetaxel may result in severe nerve damage.
- Concomitant use of cisplatin with bleomycin and etoposide may reduce lithium levels in the blood. Therefore, lithium levels should be checked at regular intervals.
- Cisplatin may reduce the effect of medicines used to treat epilepsy.
- Cisplatin may affect the effect of blood thinners. Therefore, coagulation should be monitored more frequently in combination with cisplatin.
- You should not be vaccinated with live virus vaccines for three months after treatment with 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.
Cisplatin Ebewe must not be used during pregnancy .
YOU MUST USE PREVENTIVE TREATMENT DURING CISPLATIN EBEWE AND AT LEAST SIX MONTHS AFTER.
Cisplatin Ebewe must not be used during breast-feeding.
MALE PATIENTS TREATED WITH CISPLATIN EBEWE ADVICE NOT TO GET CHILDREN DURING TREATMENT WITH CISPLATIN EBEWE AND AT LEAST SIX MONTHS AFTER. Men are also advised to seek advice on sperm storage before starting treatment.
Driving and using machines
Do not drive or use any tools or machines that require your full attention as Cisplatin Ebewe may make you feel sleepy and / or nauseous.
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.
Cisplatin Ebewe contains sodium
This medicine contains 35 mg sodium (the main ingredient in table salt / table salt) per 10 ml vial . This corresponds to 1.75% of the highest recommended daily intake of sodium for adults.
This medicine contains 71 mg of sodium (the main ingredient in table salt / table salt) per 20 ml vial . This corresponds to 3.55% of the highest recommended daily intake of sodium for adults.
This medicine contains 177 mg of sodium (the main ingredient in table salt / table salt) per 50 ml vial . This corresponds to 8.85% of the highest recommended daily intake of sodium for adults.
This medicine contains 354 mg of sodium (the main ingredient in table salt / table salt) per 100 ml vial . This corresponds to 17.7% of the highest recommended daily intake of sodium for adults.
How to use Cisplatin Ebewe
Dosage and route of administration
Cisplatin Ebewe should only be given by a specialist in cancer treatment. The concentrate is diluted with sodium chloride solution, or a sodium chloride solution containing glucose, or a sodium chloride solution containing mannitol.
Cisplatin Ebewe is only given by injection into a vein (an intravenous infusion ).
Cisplatin Ebewe should not come in contact with any materials that contain aluminum.
The recommended dose of Cisplatin Ebewe depends on your general condition, the expected effects of the treatment and whether ciplatin is given alone or in combination with other anticancer medicines.
Cisplatin Ebewe (as treatment alone):
The following dosage is recommended:
- a single dose of 50-120 mg / m 2 body surface area, every 3-4 weeks.
- 15-20 mg / m 2 per day for a 5-day period, every 3-4 weeks.
Cisplatin Ebewe in combination with other cancer drugs:
- The usual dose is 20 mg / m 2 or more, every 3-4 weeks.
- The usual dose for treating tumors in the lungs is 80 mg / m 2 .
To avoid or reduce kidney problems, you are advised to drink large amounts of water over a 24-hour period after treatment with Cisplatin Ebewe.
If you suspect you have received more Cisplatin Ebewe than you should
Your doctor will make sure you get the right dose for your condition. In case of overdose, you may experience increased side effects . Your doctor may prescribe treatment for these side effects.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Contact a doctor as soon as possible if:
- you have persistent or severe diarrhea or vomiting
- you have inflammation of the oral mucosa (may cause sore lips or sores in the mouth)
- you have swelling of the face, lips, mouth or throat
- you have unexplained respiratory symptoms such as unproductive cough, difficulty breathing or wheezing.
- you have difficulty swallowing
- you have numbness or tingling in your fingers or toes
- you have extreme fatigue
- you have an increased tendency to get bruises or bleeding
- you have signs of infection , such as sore throat and fever
- you have discomfort on or near the injection site during the infusion a
- you have severe pain or swelling in one of the legs, chest pain or difficulty breathing (may indicate harmful blood clots in a blood vessel) (common: may affect up to 1 in 10 people).
Very common (may affect more than 1 user in 10):
- reduction in the number of white blood cells , which increases the risk of infections
- reduction in the number of platelets , which increases the risk of bruising / bleeding
- reduction in the number of red blood cells which can make the skin pale and cause fatigue and shortness of breath
- hearing loss combined with tinnitus
- decreased appetite ( anorexia ), nausea, vomiting, diarrhea
- renal impairment, such as difficulty producing urine and urinary intoxication of the blood and increased uric acid levels in the blood (eg gout )
Common (may affect up to 1 in 10 people):
- infection and blood poisoning
- decreased number of white blood cells (approximately 14 days after treatment), decreased number of platelets (approximately 21 days after treatment) and decreased number of red blood cells (may occur later than decrease in white blood cells and platelets )
- peripheral neuropathy characterized by impaired taste, sensation and vision and also disorders of brain function (confusion, slurred speech, sometimes blindness, memory loss and paralysis). Radiant pain from the neck via the back to the legs when bending forward, spinal cord disease
- deafness and dizziness
- arrhythmias, including slow heart rate, increased heart rate
- inflammation of veins
- difficulty breathing, pneumonia and respiratory failure
- hepatic impairment
- redness and inflammation in the injection site.
- swelling, pain.
Uncommon (may affect up to 1 in 100 people):
- hypersensitivity reaction , including rash, eczema with severe itching , hives , skin inflammation or itching
- metal deposits on the gums
- hair loss
- disorders of spermatogenesis and ovulation, painful breast enlargement in men.
Rare (may affect up to 1 in 1,000 people):
- increased degradation of the number of red blood cells , bone marrow inhibition characterized by a sharp decrease in the number of white blood cells , combined with high fever, severe sore throat and cold sores ( agranulocytosis ), and anemia caused by reduced blood cell production
- severe hypersensitivity with low blood pressure ( hypotension ), increased heart rate ( tachycardia ), difficulty breathing, muscle cramps in the airways, swelling of the face and fever, inhibition of the immune system
- decreased levels of salts ( calcium , magnesium , sodium , phosphate , potassium ) in the blood with muscle cramps and / or changes seen on the ECG , very high cholesterol levels in the blood, increased levels of amylase (an enzyme ) in the blood
- loss of certain brain functions, including brain effects characterized by seizures and decreased degree of consciousness ( encephalopathy ), as well as occlusion of the carotid artery
- vision loss (blindness), impaired color perception, and eye movement
- inability to maintain normal conversation, hearing loss (especially among children and elderly patients)
- high blood pressure and heart attacks
- inflammation of the oral mucosa ( stomatitis )
- decreased blood protein levels (albumin)
- cisplatin, like other similar medicines, increases the risk of leukemia (secondary leukemia ).
Very rare (may affect up to 1 in 10,000 people):
- insufficient production of the hormone et vasopressin in the brain
- increased iron levels in the blood
- swelling, inflammation of the eye nerve combined with pain and impaired nerve function, blindness caused by brain disease
- cardiac arrest
- decreased blood flow, e.g. in the brain, but also in the fingers and toes
- baldness caused by hair loss.
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 Ebewe
Keep out of sight and reach of children.
Do not store above 25 ° C.
Store in a cold place. Do not freeze.
Store in the outer carton (photosensitive).
Expiry date: Use before the expiry date which is stated on the carton and vial after EXP. or EXP.
Do not use Cisplatin Ebewe if you notice any visible deterioration.
6. Contents of the packaging and other information
Each milliliter (ml) of solution contains 1 milligram (mg) of cisplatin. The vial contains 10 ml, contains 10 mg cisplatin, the vial contains 20 ml, contains 20 mg cisplatin, the vial contains 50 ml, contains 50 mg cisplatin, the vial contains 100 ml, contains 100 mg cisplatin
- The active substance is cisplatin
- The other ingredients are sodium chloride, dilute hydrochloric acid and water for injections.
What the medicine looks like and the contents of the pack
Cisplatin Ebewe is a clear and colorless to yellowish solution for infusion in glass vials.
1 pack of 1, 5 or 10 vials / vials of 10 ml concentrate for solution for infusion(contains 10 mg cisplatin).
1 pack of 1, 5 or 10 vials / vials of 20 ml concentrate for solution for infusion(contains 20 mg cisplatin).
1 pack of 1, 5 or 10 vials / vials of 50 ml concentrate for solution for infusion(contains 50 mg cisplatin).
1 pack of 1, 5 or 10 vials / vials of 100 ml concentrate for solution for infusion(contains 100 mg cisplatin)
Not all pack sizes may be marketed.
The vials are packaged with or without protective plastic coating (OncoSafe®).
Marketing Authorization Holder and Manufacturer
Ebewe Pharma Ges.mbH Nfg. KG, Mondseestrasse 11, A-4866 Unterach, Austria
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark