PACKAGE LEAFLET: INFORMATION FOR THE USER

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Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

Oxaliplatin

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or nurse.

•    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Oxaliplatin 5 mg/ml is and what it is used for

2.    What you need to know before you are given Oxaliplatin 5 mg/ml

3.    How Oxaliplatin 5 mg/ml is used

4.    Possible side effects

5 How to store Oxaliplatin 5 mg/ml

6. Contents of the pack and other information

Driving and using machines

Oxaliplatin treatment may result in an increase risk of dizziness, nausea and vomiting, and other neurological symptoms that affect walking and balance. If this happens you should not drive or operate machinery. If you have vision problems while taking Oxaliplatin, do not drive, operate heavy machines, or engage in dangerous activities.

What Oxaliplatin 5 mg/ml is and what it is ^_    3 How Oxaliplatin 5 mg/ml is used

used for

Oxaliplatin 5 mg/ml is an anticancer medicine and contains the active substance oxaliplatin.

Oxaliplatin 5 mg/ml is used for treating bowel cancer after it has been removed by surgery or when it has already spread.

Oxaliplatin 5 mg/ml is used in combination with other anticancer medicines called 5-fluorouracil (5-FU) and folinic acid (FA).

What you need to know before you are given Oxaliplatin 5 mg/ml

You should not be given Oxaliplatin 5 mg/ml:

1.    if you are allergic to oxaliplatin.

2.    if you are breast-feeding.

3.    if you already have a reduced number of blood cells.

4.    if you already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks,

such as buttoning clothes.

5.    if you have severe kidney problems.

Warnings and precautions:

Talk to your doctor before you are given Oxaliplatin 5 mg/ml

•    if you have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin, cisplatin. Allergic reactions can occur during any oxaliplatin infusion.

•    if you have mild or moderate kidney problems

•    if you have any liver problems or abnormal liver function test results during your treatment

If any of the following applies to you at any time, tell your doctor immediately. Your doctor may need to treat you for these events. Your doctor may need to reduce the dose of Oxaliplatin 5 mg/ml, or delay or stop your treatment with Oxaliplatin 5 mg/ml

•    If you have an unpleasant sensation in the throat, in particular when swallowing, and have a sensation of shortness of breath, during the treatment, tell your doctor.

•    If you have nerve problems in your hands or feet, such as numbness or tingling, or decreased sensations in your hands or feet, tell your doctor.

•    If you have headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss, tell your doctor.

•    If you feel or are sick (nausea or vomiting), tell your doctor.

•    If you have severe diarrhoea, tell your doctor.

•    If you have sore lips or mouth ulcers (mucositis/ stomatitis), tell your doctor.

•    If you have diarrhoea, or a reduction in white blood cells or platelets, tell your doctor. Your doctor may reduce the dose of Oxaliplatin 5 mg/ml or postpone your treatment with Oxaliplatin 5 mg/ml

•    If you have unexplained respiratory symptoms such as cough, or any difficulties in breathing, tell your doctor. Your doctor may stop your treatment with Oxaliplatin 5 mg/ml

•    If you develop an extreme tiredness, shortness of breath, or kidney disease where you pass little or no urine (symptoms of acute renal failure), tell your doctor.

•    If you have fever (temperature greater than or equal to 38°C), or chills, which could be signs of infection, tell your doctor immediately. You may be at risk of getting an infection of the blood.

Other medicines and Oxaliplatin 5 mg/ml

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility

Pregnancy

•    It is not recommended that you become pregnant during treatment with oxaliplatin and must use an effective method of contraception. Female patients should take appropriate contraceptive measures during and after cessation of therapy continuing for 4 months.

•    If you are pregnant or planning a pregnancy it is very important that you discuss this with your doctor before you receive any treatment.

•    If you get pregnant during your treatment, you must immediately inform your doctor.

Breast-feeding

•    You must not breast-feed while you are treated with oxaliplatin. Fertility

•    Oxaliplatin may have an anti-fertility effect, which could be irreversible. Male patients should seek advice on conservation of sperm prior to treatment.

•    Male patients are advised not to father a child during treatment and until 6 months after treatment, and to take appropriate contraceptive measures during this time.

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 being given this medicine.

This medicine will be administered by medical personnel; do not take it yourself.

Oxaliplatin 5 mg/ml is intended in adults only.

Dosage

The dose of Oxaliplatin 5 mg/ml is based on your body surface area. This is calculated from your height and weight.

The usual dose for adults including the elderly is 85 mg/m² of body surface area. The dose you receive will also depend on results of blood tests and whether you have previously experienced side effects with Oxaliplatin 5 mg/ml.

Method and route of administration

•    Oxaliplatin 5 mg/ml will be prescribed for you by a specialist in cancer treatment.

•    You will be treated by a healthcare professional, who will have made up the required dose of Oxaliplatin 5 mg/ml. Oxaliplatin 5 mg/ml is given by slow injection into one of your veins (an intravenous infusion) over a 2 to 6 hour period.

•    If feelings of discomfort or pain arise at the injection site inform the healthcare professionals immediately.

•    Oxaliplatin 5 mg/ml will be given to you at the same time as folinic acid and before the infusion of 5 fluorouracil.

Frequency of administration

You should usually receive your infusion once every 2 weeks. Duration of treatment

The duration of the treatment will be determined by your doctor.

Your treatment will last a maximum of 6 months when used after complete resection of your tumour.

If you received more Oxaliplatin 5 mg/ml than you should

This medicine will be administered by a medical personnel; do not administer it yourself.

As this medicine is administered by a healthcare professional it is highly unlikely that you will be given too much or too little.

In case of overdose you may experience increased side effects. Your doctor may give you appropriate treatment for these side effects.

If administration of Oxaliplatin 5 mg/ml is forgotten

Your doctor will decide on what time you will receive this medicine. If you think you missed a dose, please contact your doctor as soon as possible.

If you have any questions about your treatment ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause 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 serious side effects:

•    Symptoms of an allergic or anaphylactic reaction with sudden signs such as rash, itching or hives on the skin, difficulties in swallowing, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing, extreme tiredness (you may feel you are going to faint). In the majority of cases, these symptoms occurred during the infusion or immediately after but delayed allergic reactions have also been observed hours or even days after the infusion.

•    Abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature

•    Persistent or severe diarrhoea or vomiting

•    Presence of blood or dark brown coffee-coloured particles in your vomit

•    Stomatitis/mucositis (sore lips or mouth ulcers)

•    Unexplained respiratory symptoms such as dry cough, difficulties in breathing or crackles

•    a group of symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder).

•    Stomatitis/mucositis (sore lips or mouth ulcers)

•    Extreme tiredness with decreased number of red blood cells, and shortness of breath (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome).

Other side effects

Very common: may affect more than 1 in 10 people:

•    Oxaliplatin 5 mg/ml can affect the nerves (peripheral neuropathy). You may feel a tingling and/or numbness in the fingers, toes, around the mouth or in the throat which may

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

Instructions for use CYTOSTATIC

HANDLING Oxaliplatin 5 mg/ml

As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.

Instructions for Handling

The handling of this cytotoxic agent by nursing or medical personnel requires every precaution to guarantee the protection of the handler and his surroundings.

The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicinal products used. The conditions must guarantee the integrity of the product, the protection of the environment and particularly the protection of the personnel handling the medicines, in accordance with the hospital policy. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area.

Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area, containers and collection bags for waste.

Excreta and vomit must be handled with care.

Pregnant women must be warned to avoid handling cytotoxic agents.

Any broken container must be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in suitably labelled rigid containers. See below chapter “Disposal”.

If oxaliplatin concentrate or solution for infusion should come into contact with skin, wash immediately and thoroughly with water.

If oxaliplatin concentrate or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.

Special precautions for administration

•    DO NOT use injection equipment containing aluminium.

•    DO NOT administer undiluted.

•    Only glucose 50 mg/ml (5 %) solution for infusion is to be used as a diluent. DO NOT dilute for infusion with sodium chloride or chloride containing solutions.

•    DO NOT mix with any other medicinal products in the same infusion bag or administer simultaneously by the same infusion line.

•    DO NOT mix with alkaline medicinal products or solutions, in particular 5-fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of others medicinal products active substances. Alkaline medicinal products or solutions will adversely affect the stability of oxaliplatin.

Instruction for use with folinic acid (as calcium folinate or disodium folinate)

Oxaliplatin 85mg/m² intravenous infusion in 250 to 500 ml of glucose 50 mg/ml (5 %) solution for infusion is given at the same time as folinic acid (FA) intravenous infusion in glucose 50 mg/ml (5 %) solution for infusion, over 2 to 6 hours, using a Y-line placed immediately before the site of infusion. These two medicinal products should not be combined in the same infusion bag. Folinic acid must not contain trometamol as an excipient and must only be diluted using isotonic glucose 50 mg/ml (5 %) solution for infusion, never in alkaline solutions or sodium chloride or chloride containing solutions.

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sometimes occur in association with cramps.

These effects are often triggered by exposure to cold e.g. opening a refrigerator or holding a cold drink. You may also have difficulty in performing delicate tasks, such as buttoning clothes. Although in the majority of cases these symptoms resolve completely themselves there is a possibility of persistent symptoms of peripheral sensory neuropathy after the end of the treatment

•    Some people have experienced a tingling, shock-like sensation passing down the arms or trunk when the neck is flexed. Oxaliplatin 5 mg/ml can sometimes cause an unpleasant sensation in the throat, in particular when swallowing, and give the sensation of shortness of breath. This sensation, if it happens, usually occurs during or within hours of the infusion and may be triggered by exposure to the cold. Although unpleasant, it will not last long and goes away without the need for any treatment. Your doctor may decide to alter your treatment as a result

•    Oxaliplatin 5 mg/ml may cause diarrhea, mild nausea (feeling sick) and vomiting (being sick). However, medication to prevent the sickness is usually given to you by your doctor before treatment and may be continued after treatment.

•    Oxaliplatin 5 mg/ml causes temporary reduction in the number of blood cells. The reduction of red cells may cause anaemia (a reduction of red cells), abnormal bleeding or bruising (due to a reduction in platelets). The reduction in white blood cells may make you prone to infections. Your doctor will take blood to check that you have sufficient blood cells before you start treatment and before each subsequent course.

•    Sensation of discomfort close to or at the injection site during the infusion.

•    Fever, rigors (tremors), mild or severe tiredness, body pain

•    Weight changes, loss or lack of appetite, taste disorders, constipation

•    Headache, back pain

•    Swelling of the nerves to your muscles, neck stiffness, abnormal tongue sensation possibly altering speech, stomatitis, mucositis (sore lips or mouth ulcers)

•    Stomach pain

•    Abnormal bleeding including nose bleeds

•    Coughing, difficulty in breathing,

•    Allergic reactions, skin rash which may be red and itchy, mild hair loss (alopecia),

•    Alteration in blood tests including those relating to abnormalities in liver function.

Common: may affect up to 1 in 10 people:

•    Infection due to a reduction in white blood cells,

•    Serious infection of the blood in addition to a reduction in white blood cells (neutropenic sepsis), which may be fatal,

•    Indigestion and heart burn, flushing, hiccups and dizziness

•    Increased sweating and nail disorders, flaking skin

•    Chest pain

•    Runny nose and lung disorders

•    Joint pain and bone pain

•    Pain on passing urine and changes in kidney function, changes of frequency of urination, dehydration

•    Blood in the urine/stools, swelling of the veins, clots in the lung

•    High blood pressure

•    Depression and insomnia

•    Conjunctivitis and visual problems

Uncommon: may affect up to 1 in 100 people:

•    Serious infection of the blood(sepsis), which may be fatal

•    Blockage or swelling of the bowel

•    Nervousness

Rare: may affect up to 1 in 1,000 people:

•    Loss of hearing

•    Scarring and thickening in the lungs with difficulties in breathing, sometimes fatal (interstitial lung disease)

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

•    Vascular disorders of liver.

•    Kidney disease where you pass little or no urine (symptoms of acute renal failure)

•    Presence of blood or dark brown coffee-coloured particles in your vomit.

Not known: frequency cannot be estimated from the available data

•    Convulsion (uncontrolled shaking of the body)

•    Serious infection of the blood and low blood pressure (septic shock), which may be fatal,

•    Spasm of the throat causing difficulty in breathing,

•    Extreme tiredness with decreased number of red blood cells, and shortness of breath (haemolytic anaemia), alone or combined with low platelet count and kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome), which may be fatal, have been reported.

•    Allergic vasculitis (inflammation of blood vessels)

•    Auto-immune reaction leading to reduction of all blood cell lines (autoimmune pancytopenia).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Contents of the pack and other information

What Oxaliplatin 5 mg/ml contains

•    The active substance is oxaliplatin. 1 ml of concentrate for solution for infusion contains 5 mg of oxaliplatin.

•    The other ingredient is water for injections.

What Oxaliplatin 5 mg/ml looks like and contents of the pack

Oxaliplatin 5 mg/ml is a clear colourless liquid.

The medicinal product comes in plastic containers called vials. 50 mg vial:

each vial contains 10 ml concentrate for solution for infusion. 100 mg vial:

each vial contains 20 ml concentrate for solution for infusion. 150 mg vial:

each vial contains 30 ml concentrate for solution for infusion. 200 mg vial:

each vial contains 40 ml concentrate for solution for infusion. Pack sizes: 1, 5 and 10 vial(s).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,39179 Barleben,

Germany

or

Lek Pharmaceuticals d.d.,

Verovskova 57, 1526 Ljubljana,

Slovenia.

This leaflet was last revised in 04/2016.

5

How to store Oxaliplatin 5 mg/ml

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

Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP The expiry date refers to the last day of that month.

Do not freeze.

Solution for infusion:

After dilution in glucose 50 mg/ml (5%) solution for infusion, chemical and physical in-use stability has been demonstrated for 48 hours at 2 - 8°C and for 6 hours at 15 - 25°C.

From a microbiological point of view, the infusion preparation 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°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.

Inspect visually prior to use. Do not use this medicine if you

notice particles in the diluted solution.    _Sz₀₀₀₀₀lt₀₀₀

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Instruction for use with 5-FU

Oxaliplatin should always be administered before fluoropyrimidines - i.e. 5-fluorouracil (5-FU).

After oxaliplatin administration, flush the line and then administer 5-fluorouracil (5-FU).

For additional information on medicinal products combined with oxaliplatin, see the corresponding summary of product characteristics.

USE ONLY the recommended solvents (see below).

Concentrate for solution for infusion

Inspect visually prior to use. Only clear solutions without

particles should be used.

Dilution before infusion

Withdraw the required amount of concentrate from the vial(s) and then dilute with 250 ml to 500 ml of a glucose 50 mg/ml (5%) solution for infusion to give an oxaliplatin concentration between 0.2 mg/ml and 0.7 mg/ml. The concentration range over which the physico-chemical stability of oxaliplatin has been demonstrated is 0.2 mg/ml to 2 mg/ml.

Administer by intravenous infusion.

After dilution in glucose 50 mg/ml (5%) solution for infusion, chemical and physical in-use stability has been demonstrated for 48 hours at 2 - 8°C and for 6 hours at 15 - 25°C.

From a microbiological point of view, this infusion preparation should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Inspect visually prior to use. Only clear solutions without particles should be used.

The medicinal product is for single use only. Any unused infusion solution should be discarded.

NEVER use sodium chloride or chloride containing solutions for dilution.

The compatibility of Oxaliplatin solution for infusion has been tested with representative, PVC-based, administration sets.

Infusion

The administration of oxaliplatin does not require prehydration.

Oxaliplatin diluted in 250 to 500 ml of a glucose 50 mg/ml (5%) solution for infusion to give a concentration not less than 0.2 mg/ml must be infused either by peripheral vein or central venous line over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil the oxaliplatin infusion must precede the administration of 5-fluorouracil.

Incompatibilities

The medicinal product should not be mixed with other medicinal products in the same infusion bag or infusion line.

•    DO NOT mix the concentrate for solution for infusion and the diluted medicinal product with any other medication in the same infusion bag or administer simultaneously by the same infusion line in the absence of compatibility studies. Under instructions for use described in section “Instruction for use with folinic acid (as calcium folinate or disodium folinate)” oxaliplatin can be co-administered with folinic acid via a Y-line.

•    DO NOT mix with alkaline medicines or solutions, in particular 5-fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of other medicines. Alkaline medicines or solutions will adversely affect the stability of oxaliplatin.

•    DO NOT dilute oxaliplatin with saline or other solutions containing chloride ions (including calcium, potassium or sodium chlorides). Only glucose 50 mg/ml (5%) solution for infusion is to be used as a diluent.

•    DO NOT use injection equipment containing aluminium.

Disposal

Remnants of the medicinal product 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 with due regard to current laws related to the disposal of hazardous waste.

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