Cisplatin 1 Mg/Ml Concentrate For Solution For Infusion

Document: leaflet SANDOZ_PL 14510-0017 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cisplatin 1 mg/ml

Concentrate for solution for infusion

cisplatin

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 further questions, please ask your doctor or your pharmacist.

• 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 is and what it is used for

2. Before you are given Cisplatin 1 mg/ml

3. How you are given Cisplatin 1 mg/ml ^ SANDOZ

4. Possible side effects

5. How to store Cisplatin 1 mg/ml

6. Further information

1. WHAT CISPLATIN 1 MG/ML 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.

Cisplatin can destroy cells in your body that may cause certain types of cancer (tumour of testis, tumour of ovary, head and neck epithelial tumour (tumour affecting the outer tissue layer of the skin), tumour in the lung).

Your doctor will be able to provide you with more information.

2. BEFORE YOU ARE GIVEN CISPLATIN 1 MG/ML Do not take Cisplatin if:

• you are allergic (hypersensitive) to cisplatin or to any of the other ingredients of Cisplatin

• you are allergic (hypersensitive) to any other medicine that contains platin

• you have kidney problems (renal dysfunction)

• you suffer from dehydration

• you suffer from decrease in blood cell count

• your hearing is impaired

• you are pregnant or breastfeeding

• combined with yellow fever vaccine and phenytoin (see “Use of Cisplatin with other medicines” below).

Take special care with Cisplatin:

• 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 cell count and your liver and kidney function.

• Cisplatin 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.

• If you suffer from a nervous disorder not caused by Cisplatin.

• If you suffer from an infection. Please consult your doctor.

• If you intend to have children (see Pregnancy, breast-feeding and fathering children).

Please consult your doctor, even if these statements were applicable to you at any time in the past.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Please note that these statements may also apply to products used some time ago or at some time in the future.

• Cisplatin toxicity may increase when administered simultaneously with other cytostatics (medicine for cancer treatment), such as bleomycin, methotrexate and paclitaxel.

• 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 abilities when administered simultaneously with agents that may cause hearing loss, such as aminoglycosides.

• Administration of drugs that elevate your rate of bodily urine excretion (loop diuretics) combined with cisplatin (cisplatin dose: more than 60mg/m², 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 blue coloration of the fingers and/or toes (Raynaud’s phenomenon).

• Administration of cisplatin for 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.

• Cisplatin may have an adverse impact on the effectivity of agents preventing coagulation (anticoagulants). Therefore, coagulation should be checked more often during combined use.

• You should not receive any vaccinations containing live viruses within three months of treatment with cisplatin.

Pregnancy, breast-feeding and fathering children

Ask your doctor or pharmacist for advice before you begin to use, or are

administered, Cisplatin.

Cisplatin must not be used during pregnancy.

YOU MUST USE EFFECTIVE CONTRACEPTION DURING AND AT LEAST 6 MONTHS AFTER TREATMENT WITH CISPLATIN.

Cisplatin must not be used while breast-feeding.

MALE PATIENTS TREATED WITH CISPLATIN 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

Do not drive or use any tools or machinery that require your full attention, because cisplatin may make you feel sleepy and/or cause vomiting.

Important information about some of the ingredients of Cisplatin

Cisplatin contains 3.5 mg sodium per ml. This should be considered if you have to keep low sodium diet.

3. HOW YOU ARE GIVEN CISPLATIN 1 MG/ML Dosage and method of administration

Cisplatin should only be given by a specialist in cancer treatment. The concentrate is diluted with a sodium chloride solution, or a sodium chloride solution that contains glucose, or a sodium chloride solution that contains mannitol.

Cisplatin is only given by injection into a vein (an intravenous infusion).

Cisplatin should not come into contact with any materials that contain aluminium. The recommended dosage of Cisplatin 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 (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 in combination

with other chemotherapeutical agents (combination chemotherapy):

• The typical dosage is 20 mg/m2 or more, every 3 to 4 weeks

• In the treatment of tumours in the lung the typical dosage is 80 mg/m2

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.

If you believe you have received more Cisplatin 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 have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cisplatin 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.

The following information is intended for medical or healthcare professionals only:

Special precautions for disposal and other handling

Cisplatin is to be diluted before use. For preparation of solution for infusion, any device containing aluminium that may come in contact with cisplatin (sets for intravenous infusion, needles, catheters, syringes) must be avoided.

Preparation of solution for infusion must take place in aseptic conditions.

For dilution of the concentrate, one of the following solutions should be used:

• sodium chloride solution 0.9%;

• mixture of sodium chloride solution 0.9% and glucose solution 5% (1:1) (resulting final concentrations: sodium chloride 0.45%, glucose 2.5%).

• Should hydration prior to the treatment with cisplatin be impossible, the concentrate may be diluted with:

mixture of sodium chloride solution 0.9% and mannitol solution 5% (1:1) (resulting final concentrations: sodium chloride 0.45%, mannitol 2.5%). Preparation of cisplatin solution for infusion:

The required amount (dose) of the cisplatin should be diluted in 1-2 litres of one of the above mentioned solutions.

The diluted solution should be administered only by intravenous infusion.

Only clear and colourless to yellowish solutions without visible particles should be used.

For single use only.

Cytotoxic agents should be prepared for administration only by personnel who have been trained in the safe handling of the preparation.

Refer to local cytotoxic handling guidelines.

As for any other cytotoxic agent, cisplatin should be used with extreme caution: gloves, face masks and protective clothing are required and vital. Cisplatin should be processed under a protective hood, if possible. Contact with skin and/or mucous membranes must be avoided. Pregnant hospital employees should not work with cisplatin.

Skin contact: Rinse with large quantities of water. Apply an ointment if you have a temporary burning feeling. (Note: Some persons are sensitive to platinum and may experience a skin reaction).

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. SZ00000LT000

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If any of the following side effects occur, stop taking Cisplatin and tell your doctor straight away

• persistent or severe diarrhoea 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.

The following side effects may occur:

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

• Reduction in the number of white blood cells (leukopenia) which make infections more likely.

• Reduction in blood platelets (thrombocytopenia) which increases the risk of bruising and bleeding.

• Reduction in red blood cells (anaemia) which can make the skin pale and cause weakness or breathlessness.

• Reduction of sodium in the blood.

Common (may affect up to 1 in 10 people)

• Blood poisoning.

• Irregular heartbeat, including slow or fast heartbeat.

Uncommon (may affect up to 1 in 100 people)

• Leukaemia.

• Reduction of magnesium levels in the blood.

• Hearing loss.

• Abnormal sperm production.

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

• Uncontrollable shaking.

• Nerve damage.

• Brain dysfunction characterised by headache, spasms and reduced levels of consciousness.

• Heart attack.

• Inflammation in the mouth.

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

• Stopping of the heart.

Not known (frequency cannot be estimated from the available data)

• Increased levels of enzymes and bilirubin in the blood.

• Decrease in urine production.

• Dehydration.

• Reduction of potassium, phosphate or calcium in the blood.

• Increased urine in the blood.

• Muscle cramps.

• Stroke.

• Spinal disease.

• Nerve damage characterised by a loss of taste, touch, sight, as well as brain dysfunction (confusion, slurred speech, sometimes blindness, memory loss, and paralysis).

• Damage to blood vessels in the brain.

• Sudden shooting pains from the neck to the legs when bending forwards.

• Blindness, blurred vision, decreased ability to see colour

• Ringing in the ears.

• Blood clot.

• Nausea, vomiting, diarrhoea.

• Loss of appetite.

• Hiccups.

• Skin rash.

• Hair loss.

• Muscle spasms.

• Kidney failure.

• Feeling weak or tired.

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 via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CISPLATIN 1 MG/ML

Keep Cisplatin out of the reach and sight of children.

Do not store above 25°C.

Do not refrigerate or freeze.

Keep the vial in the outer carton (to avoid exposure of Cisplatin to light).

Use by date: Do not use Cisplatin after the expiry, which is stated on the carton and vial after “EXP”.

Do not use Cisplatin if you notice visible signs of deterioration.

6. FURTHER INFORMATION

Each millilitre (ml) of solution contains 1 milligram (mg) of cisplatin.

The 10 ml vial contains 10 mg cisplatin, the 20 ml vial contains 20 mg cisplatin, the 50 ml vial contains 50 mg cisplatin and the 100 ml vial contains 100 mg cisplatin.

What Cisplatin contains

• The active substance is cisplatin.

• Other ingredients are sodium chloride, dilute hydrochloric acid and water for injections

What Cisplatin looks like and contents of the pack

Cisplatin is a clear and colourless to yellowish solution for infusion in glass injection vials.

Packaging with 1,5 or 10 injection vial(s) of 10 ml, each injection vial containing 10 mg cisplatin.

Packaging with 1,5 or 10 injection vial(s) of 20 ml, each injection vial containing 20 mg cisplatin.

Packaging with 1,5 or 10 injection vial(s) of 50 ml, each injection vial containing 50 mg cisplatin.

Packaging with 1,5 or 10 injection vial(s) of 100 ml, each injection vial containing 100 mg cisplatin.

Some of the packaging sizes will not be for sale.

The vials are packed with or without a protective plastic overwrap (OncoSafe®).

Marketing authorisation holder and manufacturer:

Marketing authorisation holder: EBEWE Pharma Ges.m.b.H. Nfg.KG, Mondseestrasse 11,4866 Unterach, Austria.

Manufacturer: EBEWE Pharma Ges.m.b.H. Nfg.KG, Mondseestrasse 11,

4866 Unterach, Austria.

Distributor: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

This leaflet was last revised in 03/2014

Rinse the area twice with water. Put all solutions and sponges into a plastic bag and seal it. In the case of spillage all items coming into contact with Cisplatin should be handled and disposed in accordance to local cytotoxic guidelines.

Any unused product or waste material should be disposed of in accordance with local requirements.

Incompatibilities

Cisplatin reacts with aluminium which results in production of a black platinum precipitate. Therefore any device containing aluminium that may come in contact with cisplatin (sets for intravenous infusion, needles, catheters, syringes) must be avoided.

This medicinal product must not be mixed with other medicinal products except those mentioned above.

The cisplatin must not be diluted with glucose solution 5% alone or mannitol solution 5% alone, but only with the mixtures containing additional sodium chloride as stated above.

Antioxidants (such as sodium metabisulphite), bicarbonates (sodium bicarbonate), sulfates, fluorouracil and paclitaxel may inactivate cisplatin in infusion systems.

Special precautions for storage Medicinal product as packaged for sale:

Do not store above 25°C. Do not refrigerate or freeze. Keep the vial in the outer carton.

Solution for infusion after dilution:

Chemical and physical in-use stability has been demonstrated for 48 hours at 2 to 8°C when protected from light for solutions with a final cisplatin concentration of 0.1 mg/ml after dilution of the cisplatin concentrate with one of the following solutions:

• sodium chloride solution 0.9%;

• mixture of sodium chloride solution 0.9% and glucose solution 5% (1:1);

• mixture of sodium chloride solution 0.9% and mannitol solution 5% (1:1).

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 / dilution (etc) has taken place in controlled and validated aseptic conditions. s_Z00000lt₀₀0

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Proof no. Date prepared: 002.1 21/03/2014	Font size: 8pt
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cisplatin 1 mg/ml

Concentrate for solution for infusion

cisplatin

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 further questions, please ask your doctor or your pharmacist.

• 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 is and what it is used for

2. Before you are given Cisplatin 1 mg/ml

3. How you are given Cisplatin 1 mg/ml

4. Possible side effects

5. How to store Cisplatin 1 mg/ml

6. Further information

1. WHAT CISPLATIN 1 MG/ML IS AND WHAT IT IS USED FOR

Your doctor will be able to provide you with more information.

2. BEFORE YOU ARE GIVEN CISPLATIN 1 MG/ML Do not take Cisplatin if:

• you are allergic (hypersensitive) to cisplatin or to any of the other ingredients of Cisplatin

• you are allergic (hypersensitive) to any other medicine that contains platin

• you have kidney problems (renal dysfunction)

• you suffer from dehydration

• you suffer from decrease in blood cell count

• your hearing is impaired

• you are pregnant or breastfeeding

• combined with yellow fever vaccine and phenytoin (see “Use of Cisplatin with other medicines” below).

Take special care with Cisplatin:

• Cisplatin 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.

• If you suffer from a nervous disorder not caused by Cisplatin.

• If you suffer from an infection. Please consult your doctor.

• If you intend to have children (see Pregnancy, breast-feeding and fathering children).

Please consult your doctor, even if these statements were applicable to you at any time in the past. Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Please note that these statements may also apply to products used some time ago or at some time in the future.

• Cisplatin toxicity may increase when administered simultaneously with other cytostatics (medicine for cancer treatment), such as bleomycin, methotrexate and paclitaxel.

• Cisplatin toxicity may affect hearing abilities when administered simultaneously with agents that may cause hearing loss, such as aminoglycosides.

• 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).