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Oxaliplatin 5 Mg/Ml Concentrate For Solution For Infusion

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The following information is intended for healthcare professionals only:

SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

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 and medical personnel requires every precaution to guarantee the protection of the handler and his surroundings.

The preparations of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used, in conditions that guarantee the integrity of the medicinal product, the protection of the environment and in particular 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.

Faeces 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 precaution s and considered as contaminated waste. Contaminated waste should be incinerated in suitably labelled rigid containers. See below section“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 5% infusion solution 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 drugs in the same infusion bag or administer simultaneously by the same infusion line.

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

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

Oxaliplatin 85 mg/m² intravenous infusion in 250 to 500 ml of 5°o glucose solution is given at the same time as folinic acid intravenous infusion in 5° o glucose solution, over 2 to 6 hours, using a Y-line placed immediately before the site of infusion. These two drugs 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 5 °o solution, never in alkaline solutions or sodium chloride or chloride containing solutions.

Instruction for use with 5-ftuorouracil (5-FU)

Oxaliplatin should always be administered before fluoropyrimidines - i.e. 5-fluorouracil. After oxaliplatin administration, flush the line and then administer 5-fluorouracil.

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For additional information on drugs combined with oxaliplatin, see the corresponding manufacturer's summary of product characteristics.

- USE ONLY the recommended solvents (see below).

- Any concentrate that shows evidence of precipitation should not be used and should be destroyed with due regard to legal requirements for disposal of hazardous waste (see below).

Concentrate for solution for infusion

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.

Dilution before infusion

Withdraw the required amount of concentrate from the vial(s) and then dilute with 250 ml to 500 ml of a 5° o glucose solution to give an oxaliplatin concentration between 0.2 mg/ml and 0.7 mg/ml. The concentration range over which the physicochemical stability of oxaliplatin has been demonstrated is 0.2 mg/ml to 2.0 mg/ml.

Administer by intravenous infusion.

After dilution in 5° o glucose solution, chemical and physical in-use stability has been demonstrated for 24 hours at 2^:C to 8 C and 6 hours at 15 C to 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 and would normally not be longer than 24 hours at 2°C to 8 ^: C and 6 hours at 15 ^:C to 25 ^:C unless dilution has taken place in controlled and validated aseptic conditions.

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 5° o glucose solution 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.

Disposal

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

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Package leaflet: Information for the user

Oxaliplatin 5 mg/ml concentrate for solution for infusion

Oxaliplatin

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What Oxaliplatin is and what it is used for

2. What you need to know before you use Oxaliplatin

3. How to use Oxaliplatin

4. Possible side effects

5. How to store Oxaliplatin

6. Contents of the pack and other information

1. What Oxaliplatin is and what it is used for

The active ingredient of oxaliplatin concentrate for solution for infusion is oxaliplatin.

Oxaliplatin is an anti-cancer drug and is used to treat metastatic (advanced) cancer of the colon (large bowel) or rectum (back passage), or as additional treatment following surgery to remove a tumour (growth) in the colon. It is used in combination with other anti-cancer medicines called 5-fluorouracil (5-FU) and folinic acid (FA).

2. What you need to know before you use Oxaliplatin Do not use Oxaliplatin:

• if you are allergic to Oxaliplatin or any of the other ingredients of this medicine (listed in section 6).

• if you are breastfeeding

• if you already have a reduced number of blood cells

• if you already have tingling and numbness in the fingers and/ or toes, and have difficulty performing delicate tasks, such as buttoning clothes

• if you have a severe kidney problem.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Oxaliplatin

• if you have mild or moderate kidney problems.

• if you have ever suffered an allergic reaction to other platinum-containing medicines such as carboplatin or cisplatin.

• if you have symptoms of nerve damage such as weakness, numbness, disturbance of feeling after previous oxaliplatin treatment. These effects are often triggered by exposure to cold. If you notice such symptoms tell your doctor, especially if they are troublesome and/or last longer than 7 days. Your doctor will regularly carry out neurological examinations, before and regularly during treatment, especially if you are given other drugs which may cause nerve damage. Symptoms of nerve damage can persist after the end of the treatment.

• if you have any liver problems.

• if your blood cell counts are too low after previous infusions of oxaliplatin. Your doctor will regularly take blood to check you have sufficient blood cells.

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

--------------------------_X------------------------------

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• if you also receive 5-fluorouracil, because the risk of diarrhoea, vomiting, sore mouth and blood abnormalities is increased.

• if you experience 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).

Other medicines and Oxaliplatin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking this medicine.

You must not become pregnant during treatment with oxaliplatin and must use an effective method of contraception. If pregnancy occurs during your treatment, you must immediately inform your doctor. You should take appropriate contraceptive measures during and after cessation of therapy continuing for 4 months for women and 6 months for men.

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 are therefore advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment. Male patients should take appropriate contraceptive measures during and after cessation of therapy continuing for 6 months.

Driving and using machines:

Oxaliplatin treatment may result in an increased risk of dizziness, nausea and vomiting, and other neurologic symptoms that affect gait 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.

3. How to use Oxaliplatin

Oxaliplatin is intended only for adults.

Dosage

The dose of Oxaliplatin 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.

Method and route of administration

• Oxaliplatin 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.

• Oxaliplatin is given by slow injection into one of your veins (an intravenous infusion) over a 2 to 6 hour period.

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

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Frequency of administration

You should usually receive your infusion once every 2 weeks.

Duration of treatment

The duration of 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 are given more Oxaliplatin than you should

As this medicine is administered by a healthcare professional, it is highly unlikely that you will be given too little or too much. In case of overdose, you may experience increased side effects. Your doctor may give you appropriate treatment for these side effects.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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.

You will find described below the side effects that you could experience.

Tell your doctor immediately if you notice any of the following:

• 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 a dry cough, difficulty 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).

Other known side effects of Oxaliplatin are:

Very common: may affect more than 1 in 10 people

• Oxaliplatin 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 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 themselves completely, 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 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 may cause diarrhoea, mild nausea (feeling sick) and vomiting (being sick); however medication to prevent the

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For additional information on drugs combined with oxaliplatin, see the corresponding manufacturer's summary of product characteristics.

- USE ONLY the recommended solvents (see below).

- Any concentrate that shows evidence of precipitation should not be used and should be destroyed with due regard to legal requirements for disposal of hazardous waste (see below).

Concentrate for solution for infusion

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.

Dilution before infusion

Administer by intravenous infusion.

After dilution in 5° o glucose solution, chemical and physical in-use stability has been demonstrated for 24 hours at 2^:C to 8 C and 6 hours at 15 C to 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 and would normally not be longer than 24 hours at 2^: C to 8^: C and 6 hours at 15 ^:C to 25 ^:C unless dilution has taken place in controlled and validated aseptic conditions.

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

Disposal

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

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