Cisplatin 1 Mg/Ml Concentrate For Solution For Infusion
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Package Leaflet: Information For The User
Cisplatin 1 mg/ml concentrate for solution for infusion
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist._
In this leaflet:
1. What Cisplatin 1 mg/ml concentrate for solution for infusion is and what it is used for
2. Before you use Cisplatin 1 mg/ml concentrate for solution for infusion
3. How you use Cisplatin 1 mg/ml concentrate for solution for infusion
4. Possible side effects
5. How to store Cisplatin 1 mg/ml concentrate for solution for infusion
6. Further information
Cisplatin 1 mg/ml concentrate for solution for infusion is given only by healthcare personnel, who can reply to any questions, which you may have after reading this package leaflet.
1. What Cisplatin 1 mg/ml concentrate for solution for infusion is and what it is used for
Cisplatin forms part of a group of medicines called cytostatics, which are used in the treatment of cancer. Cisplatin can be used alone but more commonly Cisplatin is used in combination with other cytostatics.
What is it used for?
Cisplatin can destroy cells in your body that may cause certain types of cancer (tumor of testis, tumor of ovary, tumor of the bladder, head and neck epithelial tumor, lung cancer and for cervical cancer in combination with radiotherapy).
Your doctor will be able to provide you with more information.
2. Before you use Cisplatin 1 mg/ml concentrate for solution for infusion
Do not take Cisplatin 1 mg/ml concentrate for solution for infusion if:
• you are allergic (hypersensitive) to cisplatin or to any of the other ingredients of Cisplatin 1 mg/ml concentrate for solution for infusion;
• you are allergic (hypersensitive) to any other medicine that contains platina compounds;
• you have kidney problems (renal dysfunction);
• you suffer from dehydration;
• you suffer from severe suppression of bone marrow
functionality, symptoms may be: extreme tiredness, easy bruising or bleeding, occurrence of infections;
• your hearing is impaired;
• you suffer from nervous disorders caused by cisplatin;
• you are breast-feeding;
• combined with yellow vaccine and phenytoin (see "Use of Cisplatin 1 mg/ml concentrate for solution for infusion with other medicines" below).
Take special care with Cisplatin 1 mg/ml concentrate for solution for infusion:
• Your doctor will carry out tests in order to determine the levels of calcium, sodium, potassium and magnesium in your blood, as well as to check your blood picture and your liver and kidney functionality and neurological function.
• Cisplatin 1 mg/ml concentrate for solution for infusion should only be administered under the strict supervision of a specialist doctor experienced in administrating chemotherapy.
• Your hearing will be tested prior to each treatment with Cisplatin 1 mg/ml concentrate for solution for infusion.
• If you suffer from a nervous disorder not caused by Cisplatin 1 mg/ml concentrate for solution for infusion.
• If you suffer from an infection. Please consult your doctor.
• If you intend to have children (see Pregnancy, breastfeeding and fathering children).
• With spillage of cisplatin the contaminated skin must immediately be washed with water and soap. If cisplatin is injected outside the blood vessels the administration must be stopped immediately. Infiltration of cisplatin in the skin can result in tissue damage (cellulitis, fibrosis and necrosis).
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Taking other medicines
Please note that these statements may also apply to products used some time ago or at some time in the future.
Please inform your doctor or pharmacist if you are taking, of have recently taken, any other medicines obtained without a prescription.
• Simultaneous use of medicines that inhibit the bone marrow function or radiation can potentiate the adverse effects of cisplatin on the bone marrow.
• Cisplatin toxicity may increase when administered simultaneously with other cytostatics (medicine for cancer treatment), such as bleomycin and methotrexate.
• Agents to treat high blood pressure (antihypertensives containing furosemide, hydralazine, diazoxide, and propanolol) may increase the toxic effect of Cisplatin 1 mg/ml concentrate for solution for infusion on kidneys.
• Cisplatin toxicity may severely affect the kidneys when administered simultaneously with agents that may cause side effects in the kidneys, such as those for the prevention/ treatment of certain infections (antibiotics: cephalosporins, aminoglycosides, and/or amphotericin B) and contrast agents.
• Cisplatin toxicity may affect hearing faculties when administered simultaneously with agents that may have a side effect on hearing faculties, such as aminoglycosides.
• If you use agents to treat gout during your treatment with cisplatin, then the dosage of such agents may need to be adjusted (e.g. allopurinol, cholchicine, probenecid and/or sulfinpyrazone).
• Administration of drugs that elevate your rate of bodily urine excretion (loop diuretics) combined with cisplatin (cisplatin dose: more than 60mg/m1 2, urine secretion: less than 1000 ml per 24 hours) may result in toxic effects on kidneys and hearing.
• The first signs of hearing damage (dizziness and/ or tinnitus) may remain hidden when - during your treatment with cisplatin - you are also being administered agents to treat hypersensitivity (antihistamines, such as buclizine, cyclizine, loxapine, meclozine, phenothiazines, thioxanthenes and/or trimethobenzamides).
• Cisplatin given in combination with ifosphamide may result in hearing impairment.
• The effects of treatment with cisplatin can be reduced through simultaneous administration of pyridoxine and hexamethylmelamine.
• Cisplatin given in combination with bleomycin and vinblastin may result in paleness or flue coloration of the fingers and/or toes (Raynaud's phenomenon).
• Administration of cisplatin prior to treatment with paclitaxel or in combination with docetaxel may result in severe nerve damage.
• The combined use of cisplatin with bleomycin and etoposide may decrease lithium levels in the blood. Therefore, lithium levels should be checked on a regular basis.
• Cisplatin reduces the effects of phenytoin on the treatment of epilepsy.
• Penicillamine may reduce the effectiveness of Cisplatin 1 mg/ml concentrate for solution for infusion.
• Cisplatin may have an adverse impact on the effectivity of agents preventing coagulation (anticoagulants). Therefore, coagulation should be checked more often during combined use.
• Cisplatin and ciclosporin may result in suppression of the immune system with the risk of increased production of white blood cells (lymphocytes).
• You should not receive any vaccinations containing live viruses within three months after the end of treatment with cisplatin.
• When undergoing treatment with cisplatin, you should not receive yellow fever vaccinations (also see "Do not take Cisplatin 1 mg/ml concentrate for solution for infusion").
Pregnancy, breast-feeding and fathering children
Ask your doctor or pharmacist for advice before you begin to use, or are administered, Cisplatin 1 mg/ml concentrate for solution for infusion.
Cisplatin must not be used during pregnancy unless clearly indicated by your doctor.
You must use effective contraception during and at least 6 months after treatment with Cisplatin 1 mg/ml concentrate for solution for infusion.
You must not breast-feed while you are treated with Cisplatin 1 mg/ml concentrate for solution for infusion.
Male patients treated with Cisplatin 1 mg/ml concentrate for solution for infusion are advised not to father a child during treatment and for up to 6 months after treatment. Further, men are advised to seek counseling on sperm preservation before starting treatment.
Driving and using machines
Cisplatin may cause side effects such as feeling sleepy and/or vomiting. If you suffer from either of these conditions, then you should not operate any machines that require your full attention.
Important information about some of the ingredients of Cisplatin 1 mg/ml concentrate for solution for infusion
Cisplatin 1 mg/ml concentrate for solution for infusion contains 9 mg sodium per ml. This should be considered if you have to keep a low sodium diet.
3. How you use Cisplatin 1 mg/ml concentrate for solution for infusion
Dosage and method of administration
Cisplatin 1 mg/ml concentrate for solution for infusion should only be given by a specialist in cancer treatment. The concentrate is diluted with a sodium chloride solution that contains glucose.
Cisplatin 1 mg/ml concentrate for solution for infusion is only given by injection into a vein (an intravenous infusion).
Cisplatin 1 mg/ml concentrate for solution for infusion should not come into contact with any materials that contain aluminium.
The recommended dosage of Cisplatin 1 mg/ml concentrate for solution for infusion depends on your well-being, the anticipated effects of the treatment, and whether or not cisplatin is given on its own (monotherapy) or in combination with other agents (combination chemotherapy).
Cisplatin 1 mg/ml concentrate for solution for infusion (monotherapy):
The following dosages are recommended:
• A single dosage of 50 to 120 mg/m2 body surface, every 3 to 4 weeks.
• 15 to 20 mg/m2 per day over a 5-day period, every 3 to 4 weeks.
Cisplatin 1 mg/ml concentrate for solution for infusion in combination with other chemotherapeutical agents (combination chemotherapy):
• 20 mg/m2 or more, once every 3 to 4 weeks.
For treatment of cervical cancer cisplatin is used in combination with radiotherapy.
A typical dose is 40 mg/m2 weekly for 6 weeks.
In order to avoid, or reduce, kidney problems, you are advised to drink copious amounts of water for a period of 24 hours following treatment with Cisplatin 1 mg/ml concentrate for solution for infusion.
If you believe you have received more Cisplatin 1 mg/ml concentrate for solution for infusion than you should
Your doctor will ensure that the correct dose for your condition is given. In case of overdose, you may experience increased side effects. Your doctor may give you symptomatic treatment for these side effects. If you think you received too much Cisplatin 1 mg/ml concentrate for solution for infusion, immediately contact your doctor.
If you have any further questions on the use of this product, ask your doctor.
The following information is intended for medical or healthcare professionals only:
Preparation and handling of the product
For single use only.
Refer to local cytotoxic guidelines.
Like with all anti-neoplastic products caution is needed with the processing of cisplatin. Dilution should take place under aseptic conditions in a safety box, by trained personnel in an area specifically intended for this, and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses. Precautions should be taken to avoid contact with the skin and mucous membranes. If skin contact did occur anyway, the skin should be washed with soap and water immediately. With skin contact tingling, burns and redness have been observed. In case of contact with the mucous membranes they should be copiously rinsed with water. After inhalation dyspnoea, pain in the chest, throat irritation and nausea have been reported.
In the event of spillage, operators should put on gloves and mop up the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with water. Put all solutions and sponges into a plastic bag and seal it.
Pregnant women must avoid contact with cytostatic drugs.
Bodily waste matter and vomit should be disposed with care.
If the solution is cloudy or a deposit that does not dissolve is noticed, the bottle should be discarded.
A damaged bottle must be regarded and treated with the same precautions as contaminated waste. Contaminated waste must be stored in waste containers specifically marked for this. See section "Disposal".
Preparation of the intravenous administration
Take the quantity of the solution that is needed from the bottle and dilute with at least 1 litre of the following solutions:
• sodium chloride 9mg/ml (0.9%);
• mixture of sodium chloride 9mg/ml (0.9%)/ glucose 50mg/ml (5%) (1:1), (resulting final concentrations: sodium chloride 4.5mg/ml (0.45%), glucose 25mg/ml (2.5%));
• sodium chloride 9mg/ml (0.9%) and 18.75mg/ml (1.875%) mannitol, for injection;
• sodium chloride 4.5mg/ml (0.45%), glucose 25mg/ml (2.5%) and 18.75mg/ml (1.875%) mannitol, for injection.
Always look at the injection before use. Only a clear solution, free from particles should be administered.
|
Description |
Cisplatin 1 mg / ml / 50 ml,100 ml | ||
|
Component Type |
Leaflet |
Pharma Code |
TBC |
|
Affiliate Item Code |
545197 |
SAP No. |
N/A |
|
Superceded Affiliate Item Code |
N/A |
Vendor Job No. |
242879 |
|
TrackWise PR No. |
545197 |
Proof No. |
3 |
|
MA No. |
N/A |
Client Market |
UK |
|
Packing Site/Printer |
N/A |
Keyline/Drawing No. |
N/A |
|
Supplier Code |
N/A |
Barcode Info |
N/A |
No. of colours
1
Page Count
1/2
Colours Black
Non-Print
Colours
Equate CMYK with
Main Font
Dimensions
Myriad Pro
Body Text Size
11 pt
560x320 mm
DO NOT bring in contact with injection material that contains aluminium.
DO NOT administer undiluted.
With respect to chemical and physical stability with use of the undiluted solutions, see section "Special precautions for storage - undiluted solution"
Disposal
All materials that have been used for the preparation and administration, or which have been in contact with cisplatin in any way, must be disposed of according to local cytotoxic guidelines. Remnants of the medicinal products as well as all materials that have been used for dilution and administration must be destroyed according to hospital standard procedures applicable to cytotoxic agents and in accordance with local requirements related to the disposal of hazardous waste.
Incompatibilities
Do not bring in contact with aluminium. Cisplatin reacts with metal aluminium to form a black precipitate of platinum. All aluminium-containing IV sets, needles, catheters and syringes should be avoided. Cisplatin decomposes with solution in media with low chloride content; the chloride concentration should at least be equivalent to 0.45% of sodium chloride.
Antioxidants (such as sodium metabisulphite), bicarbonates (sodium bicarbonate), sulfates, fluorouracil and paclitaxel may inactivate cisplatin in infusion systems.
This medicinal product must not be mixed with other medicinal products except those mentioned in above mentioned section "Preparation of the intravenous administration".
Special precautions for storage Medicinal product as packaged for sale:
Concentrate for solution for infusion 1 mg/ml Undiluted solution: Do not store above 25°C. Do not refrigerate or freeze. Keep the vial in the outer carton in order to protect from light. If the solution is not clear or an undissolvable precipitate is formed the solution must not be used.
Diluted solution:
Do not store diluted solutions in the refrigerator or freezer.
After dilution in infusion fluids mentioned above: Chemical and physical in-use stability has been demonstrated for 14 days at 15-25°C under protection from light.
From a microbiological point of view, the product should always be used immediately.
TBC
4. Possible side effects
Like all medicines, Cisplatin 1 mg/ml concentrate for solution for infusion can have side effects although not everybody gets them.
If you experience any side effect it is important that you inform your doctor before your next treatment.
Tell your doctor immediately, if you notice any of the following:
• persistent or severe diarrohea or vomiting;
• stomatitis/mucositis (sore lips or mouth ulcer);
• swelling of the face, lips mouth or throat;
• unexplained respiratory symptoms such as non-productive cough, difficulty in breathing or crackles;
• difficulty in swallowing;
• numbness or tingling in your fingers or toes;
• extreme tiredness;
• abnormal bruising or bleeding;
• signs of infection, such as sore throat and high temperature;
• sensation of discomfort close to or at the injection site during the infusion.
Side effects may appear
very common affects more than 1 user in 10;
common affects 1 to 10 users in 100;
uncommon affects 1 to 10 users in 1,000;
rare affects 1 to 10 users in 10,000;
very rare affects less than 1 user in 10,000;
not known: frequency cannot be estimated from the
available data
The following side effects may occur:
Very common
Blood and lymphatic system: reduction in the number of white blood cells, which makes infections more likely (leukopenia), reduction in blood platelets, which increases the risk of bruising and bleeding (thrombocytopenia), as well as reduction in red blood cells, which can make the skin pale and cause weakness or breathlessness (anaemia).
Kidneys and urinary tracts: renal dysfunction, such as failure to produce urine (anuria) and urine poisoning of the blood (uraemia)
Common
Infections: blood-poisoning (sepsis).
Nervous system: damage to the nervous system (neurotoxicity). Heart: arrhythmia, including reduced heartbeat (bradycardia), accelerated heartbeat (tachycardia).
Blood vessels: inflammation of a vein (phlebitis).
Respiratory disorders: difficulty of breathing (dyspnoea), inflammation of the lungs (pneumonia) and respiratory failure. Skin: redness and inflammation of the skin (erythema, skin ulcer) in the area of the injection, swelling (oedema), pain at the area of injection.
Uncommon
Immune system: severe hypersensitivity (anaphylactic reactions) Hearing: loss of hearing (ototoxicity).
Reproductive system and breasts: dysfunctional spermatogenesis and ovulation, and painful breast growth in men (gynaecomastia)
Rare
Neoplasms: increases the risk of leukaemia (acute leukaemia). Immune system: suppression of the immune system (immunosuppression).
Nutrition and metabolism: excessive cholesterol levels in the blood
Nervous system: peripheral neuropathy of the sensory nerves (bilateral, sensory neuropathy), characterised by tickling, itching or tingling without cause and sometimes characterised by a loss of taste, touch, sight, as well as brain dysfunction (confusion, slurred speech, sometimes blindness, memory loss, and paralysis); sudden shooting pains from the neck through the back into the legs when bending forwards, spinal disease, convulsions, loss of certain types of brain function, including brain dysfunction characterised by spasms and reduced levels of consciousness (encephalopathy), as well as closure of the carotid artery.
Eyes: inflammation of the eye nerve combined with pain and reduced nerve function (optic neuritis), eye movement dysfunction.
Heart: coronary artery disease
Blood vessels: increased blood pressure levels (hypertension). Gastrointestinal tract: inflammation of mucous membranes of the mouth (stomatitis).
Very rare
Nutrition and metabolism: increased iron levels in the blood. Nervous system: attacks (seizures).
Heart: heart failure
Not known
Infections: Infections
Hormones: increased blood amylase (enzyme) levels.
Nutrition and metabolism: reduced level of electrolytes (magnesium, calcium, sodium, phosphate, potassium) in the blood with muscle cramping and/or changes in an electrocardiogram (ECG), dehydration, involuntary contraction of muscles (tetany).
Nervous system: stroke (cerebrovascular accident)
Eyes: loss of sight (blindness), difficulties in colour perception, blurred vision, swelling (papilloedema)
Hearing and balance function: deafness, tinnitus Heart: cardiac disorder
Blood vessels: blood flow dysfunction, e.g. in the brain, but also in the fingers and toes (Raynaud's syndrome).
Respiratory disorders: pulmonary embolism.
Gastrointestinal tract: loss of appetite (anorexia), nausea, vomiting, diarrhoea, hiccups.
Skin: loss of hair (alopecia), rash.
General symptoms: fever, weakness (asthenia), malaise.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Cisplatin 1 mg/ml concentrate for solution for infusion
Keep Cisplatin 1 mg/ml concentrate for solution for infusion out of the reach and sight of children.
Do not use Cisplatin 1 mg/ ml concentrate for solution for infusion after the expiry date which is stated on the vial and the outer carton after 'exp'. The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
Do not store above 25°C.
Do not refrigerate or freeze.
If the solution is cloudy or a deposit that does not dissolve is noticed, the bottle should be discarded.
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.
After dilution:
Chemical and physical in-use stability has been demonstrated for 14 days at 15-25°C under protection from light.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
6. Further information
What Cisplatin 1 mg/ml concentrate for solution for
infusion contains
The active substance is cisplatin.
1 ml of concentrate for solution for infusion contains 1 mg of cisplatin.
One vial of 50 ml concentrate for solution for infusion contains 50 mg cisplatin.
One vial of 100 ml concentrate for solution for infusion contains 100 mg cisplatin.
Other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.
What Cisplatin 1 mg/ml concentrate for solution for infusion looks like and contents of the pack
Cisplatin 1 mg/ml concentrate for solution for infusion is a clear, colourless to pale yellow concentrate for solution for infusion free from visible particles in glass injection vials.
Packaging with 1 vial of 50 ml of concentrate, the vial containing 50 mg cisplatin.
Packaging with 1 vial of 100 ml of concentrate, the vial containing 100 mg cisplatin.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer
Agila Specialties Polska Sp.z.o.o.
10, Daniszewska Str 03-230 Warsaw Poland
Mylan S.A.S.
117 Allee des Parcs 69800 Saint-Priest France
KR/DRUGS/KTK/28/381/2008
This leaflet was last approved in 03/2015
545197
|
Description |
Cisplatin 1 mg / ml / 50 ml,100 ml | ||
|
Component Type |
Leaflet |
Pharma Code |
TBC |
|
Affiliate Item Code |
545197 |
SAP No. |
N/A |
|
Superceded Affiliate Item Code |
N/A |
Vendor Job No. |
242879 |
|
TrackWise PR No. |
545197 |
Proof No. |
3 |
|
MA No. |
N/A |
Client Market |
UK |
|
Packing Site/Printer |
N/A |
Keyline/Drawing No. |
N/A |
|
Supplier Code |
N/A |
Barcode Info |
N/A |
No. of colours
1
Page Count
2/2
Colours Black
Non-Print
Colours
Equate CMYK with
Main Font
Dimensions
Myriad Pro
Body Text Size
11 pt
560x320 mm
Sign-offs
1111111 I
mini