Oxaliplatin Teva 5 mg/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Oxaliplatin Teva 5 mg/ml Concentrate for solution for infusion EFG

oxaliplatin

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion is and what it is used for.
2. What you need to know before being given Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion.
3. How Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion is administered.
4. Possible side effects.
5. How to store Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion.
6. Contents of the pack and other information.

1. What Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion is and what it is used for

The active substance of Oxaliplatin Teva 5 mg/ml is oxaliplatin.

Oxaliplatin Teva 5 mg/ml is used for the treatment of colorectal cancer (treatment of stage III colon cancer after complete resection of the primary tumour, metastatic colon cancer, and rectal cancer). Oxaliplatin is used in combination with other anticancer medicines, such as 5-fluorouracil and folinic acid.

Oxaliplatin is an antineoplastic or anticancer agent containing platinum.

2. What you need to know before Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion is administered to you

Do not receive Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion:

• if you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding (see also section “Pregnancy, breastfeeding and fertility”).
• if you already have a low number of blood cells.
• if you already have tingling and numbness in your fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes.
• if you have severe kidney problems.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion

• If you have ever had an allergic reaction to medicines containing platinum, such as carboplatin or cisplatin. Allergic reactions may 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.
• If you have or have had heart disorders, such as an abnormal electrical signal known as QT interval prolongation, irregular heartbeat, or a family history of heart problems.
• If you have recently received or plan to receive any vaccine. During treatment with oxaliplatin, you should not be vaccinated with “live” or “attenuated” vaccines, such as the yellow fever vaccine.

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

• If you have an unpleasant sensation in your throat, especially when swallowing, and feel short of breath, during treatment.
• If you have nerve problems in your hands or feet, such as tingling and numbness, or reduced sensation in your hands or feet.
• If you have headache, altered mental function, seizures, or abnormal vision, ranging from blurred vision to loss of vision.
• If you feel unwell (nausea and vomiting).
• If you have severe diarrhoea.
• If you have pain in your lips or mouth ulcers (mucositis/stomatitis).
• If you have diarrhoea or a decrease in white blood cells or platelets. Your doctor may need to reduce the dose of Oxaliplatin Teva 5 mg/ml or postpone your treatment with Oxaliplatin Teva 5 mg/ml.
• If you have unexplained respiratory symptoms such as cough or difficulty breathing. Your doctor may stop your treatment with Oxaliplatin Teva 5 mg/ml.
• If you develop extreme tiredness, shortness of breath, or kidney problems causing you to pass little or no urine (symptoms of acute kidney failure).
• If you have fever (temperature greater than or equal to 38°C) or chills, which may be signs of infection. You may be at risk of developing a blood infection.
• If you have fever > 38°C. Your doctor may determine whether you also have a decrease in white blood cells.
• If you unexpectedly experience bleeding or bruising (disseminated intravascular coagulation). These may be signs of blood clots forming throughout the small blood vessels in your body.
• If you feel dizzy (loss of consciousness) or have an irregular heartbeat while taking Oxaliplatin Teva 5 mg/ml. This may be a sign of a serious heart disorder.
• If you develop muscle pain and swelling, along with weakness, fever, and red-brown urine. These could be signs of muscle damage (rhabdomyolysis) and could lead to kidney problems or other complications.
• If you have abdominal pain, nausea, vomiting blood or coffee-ground-like vomit, or dark stools, which may be signs of an intestinal ulcer (gastrointestinal ulcer with potential for haemorrhage or perforation).
• If you have abdominal pain (around the navel), bloody diarrhoea, nausea and/or vomiting, which may be caused by reduced blood flow to the walls of your intestine (intestinal ischaemia).

Using Oxaliplatin Teva 5 mg/ml with other medicines

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

Pregnancy, breastfeeding and fertility

Pregnancy

• It is not advisable to become pregnant during treatment with oxaliplatin, and you should use an effective method of contraception. Female patients should use appropriate contraceptive measures during treatment and for 4 months after completion of treatment.
• If you are pregnant or planning to become pregnant, it is very important that you discuss this with your doctor before receiving any treatment.
• If you become pregnant during treatment, you must inform your doctor immediately.

Breastfeeding

• You must not breastfeed during treatment with oxaliplatin.

Fertility

• Oxaliplatin may have an anti-fertility effect which could be irreversible. Male patients should seek advice on sperm preservation before treatment.
• Male patients are advised not to father a child during treatment and for 6 months after treatment, and to use appropriate contraceptive measures during this time.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Treatment with oxaliplatin may increase the risk of dizziness, nausea, vomiting, and other neurological symptoms affecting gait and balance. If this occurs, you should not drive or operate machinery. If you have vision problems while being administered Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion, do not drive, operate heavy machinery, or participate in hazardous activities.

3. How Oxaliplatino Teva 5 mg/ml concentrate for solution for infusion is administered

Oxaliplatino Teva 5 mg/ml is only administered to adults.

For single use only.

Dosage

The dosage of Oxaliplatino Teva 5 mg/ml is based on your body surface area, which is calculated from your weight and height. The recommended dose for adults, including elderly patients, is 85 mg/m² of body surface area. The dose you receive may also depend on blood test results and whether you have previously experienced adverse effects with Oxaliplatino Teva 5 mg/ml.

Method and route of administration

• Oxaliplatino Teva 5 mg/ml will be prescribed by a specialist in cancer treatment.
• You will be treated by a healthcare professional who will have prepared the appropriate dose of Oxaliplatino Teva 5 mg/ml.
• Oxaliplatino Teva 5 mg/ml is administered by slow injection into a vein (intravenous infusion) over a period of 2 to 6 hours.
• You will receive Oxaliplatino Teva 5 mg/ml at the same time as folinic acid and before the infusion of 5-fluorouracil.

Frequency of administration

You will normally receive the infusion every 2 weeks.

Duration of treatment

Your doctor will determine how long your treatment will last.

Your treatment will last a maximum of 6 months when used after complete removal of the tumor.

If you are given more Oxaliplatino Teva 5 mg/ml concentrate for solution for infusion than recommended:

Since this medicine is administered by a healthcare professional, it is highly unlikely that you will receive too much or too little.

In case of overdose, you may experience worsening of adverse reactions. Your doctor can provide appropriate treatment for these adverse effects.

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

If administration of Oxaliplatino Teva 5 mg/ml concentrate for solution for infusion was missed

Your doctor will decide when you should receive the medicine. If you think you may not have received a dose, contact your doctor as soon as possible.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If you experience any adverse effect, it is important that you inform your doctor before the next treatment.

Below are the effects you may experience.

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

• Signs of an allergic or anaphylactic reaction such as sudden rash, itching or hives, difficulty swallowing, swelling of the face, lips, tongue or other body parts, shortness of breath, wheezing or breathing difficulties, or extreme fatigue (feeling faint). In most cases, these symptoms occurred during or immediately after the infusion, but delayed allergic reactions have also been observed, occurring hours or even days after infusion.

• Unusual bruising, bleeding, or signs of infection such as sore throat and high temperature.

• Persistent or severe diarrhea or vomiting.

• Presence of blood or dark brown, coffee-ground-like particles in your vomit.

• Painful lips or mouth ulcers (mucositis/stomatitis).

• Unexplained respiratory symptoms such as dry cough, difficulty breathing, or crackling sounds.

• A group of symptoms including headache, altered mental function, seizures, and vision changes ranging from blurred vision to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder).

• Severe fatigue with a drop in red blood cell count and shortness of breath (hemolytic anemia), either alone or in combination with low platelet count, unusual bruising (thrombocytopenia), and kidney problems causing reduced or no urine output (symptoms of hemolytic uremic syndrome).

Other known adverse effects of Oxaliplatin Teva 5 mg/ml are:

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

• Oxaliplatin Teva 5 mg/ml can affect the nerves (peripheral neuropathy). You may experience tingling and/or numbness in the fingers, toes, around the mouth, or in the throat, which may sometimes be accompanied by muscle cramps.

These adverse effects are often triggered by exposure to cold, such as opening a refrigerator or holding a cold drink. You may also have difficulty performing fine motor tasks, such as buttoning clothes. Although in most cases these symptoms resolve completely on their own, there is a possibility that symptoms of peripheral sensory neuropathy may persist after treatment has ended. Some people may experience a sudden tingling sensation running down the arms or trunk when bending the neck.

• Oxaliplatin Teva 5 mg/ml may sometimes cause an unpleasant sensation in the throat, especially when swallowing, and you may feel short of breath. If this occurs, it usually happens during or shortly after the infusion and may be triggered by exposure to cold. Although unpleasant, this sensation is temporary and resolves without treatment. Your doctor may decide to modify your treatment as a result.

• Oxaliplatin Teva 5 mg/ml may cause diarrhea, mild nausea (feeling of queasiness), and vomiting (feeling unwell); however, your doctor will usually prescribe preventive treatment before starting therapy, which should be continued afterward.

• Oxaliplatin Teva 5 mg/ml causes a temporary reduction in blood cell counts.

A decrease in red blood cells may lead to anemia (reduced number of red blood cells), abnormal bleeding, or bruising (due to reduced platelet count). A reduction in white blood cells may increase susceptibility to infections.

Before starting treatment and before each session, your doctor will perform a blood test to ensure you have sufficient blood cells.

• Discomfort or irritation at or near the infusion site during administration.

• Fever, chills (shivering), moderate or severe fatigue, body pain.

• Weight changes, loss of appetite or appetite loss, taste disturbances, constipation.

• Headache, back pain.

• Inflammation of muscular nerves, neck stiffness, unusual sensation on the tongue possibly affecting speech, stomatitis/mucositis (sores on the lips and mouth ulcers).

• Stomach pain.

• Abnormal bleeding, including nosebleeds.

• Cough, difficulty breathing.

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

• Blood test abnormalities indicating changes in liver function.

Common (may affect up to 1 in 10 people)

• Infection due to reduced white blood cells.

• Severe blood infection (septicemia) along with reduced white blood cells (septic neutropenia), which may be fatal.

• Reduction in white blood cells accompanied by fever > 38.3°C or prolonged fever > 38°C lasting more than one hour (febrile neutropenia).

• Indigestion and heartburn, hiccups, hot flushes, dizziness.

• Increased sweating and nail changes, skin peeling.

• Chest pain.

• Pulmonary disorders and runny nose.

• Joint pain and bone pain.

• Pain during urination and kidney function disturbances, changes in urination frequency, dehydration.

• Blood in urine or stools, vein inflammation, blood clots in the lung (pulmonary embolism).

• High blood pressure.

• Depression and insomnia.

• Conjunctivitis and vision problems.

• Decreased blood calcium levels.

• Falls.

Uncommon (may affect up to 1 in 100 people)

• Severe blood infection (sepsis), which may be fatal.

• Intestinal obstruction or inflammation.

• Restlessness.

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

• Hearing loss.

• Scarring formation. Lung thickening causing breathing difficulties, sometimes fatal (pulmonary interstitial disease).

• Short-term reversible vision loss.

• Unexpected bleeding or bruising due to widespread blood clotting in small blood vessels throughout the body (disseminated intravascular coagulation), which may be life-threatening.

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

• Presence of blood or dark brown, coffee-ground-like particles in vomit.

• Kidney problems causing reduced or no urine output (symptoms of acute renal failure).

• Vascular disorders of the liver.

Frequency not known (cannot be estimated from available data)

• Allergic vasculitis (inflammation of blood vessels).

• Autoimmune reaction causing reduction in all blood cell lines (autoimmune pancytopenia).

• Severe blood infection and low blood pressure (septic shock), which may be fatal.

• Seizures (uncontrolled body movements).

• Throat spasm that may cause breathing difficulties.

• Extreme fatigue with reduced red blood cell count and shortness of breath (hemolytic anemia), alone or in combination with low platelet count, unusual bruising (thrombocytopenia), and/or kidney problems causing reduced or no urine output (symptoms of hemolytic uremic syndrome), which may be fatal.

• Abnormal heart rhythm (QT prolongation), detectable on an electrocardiogram (ECG), which may be life-threatening.

• Muscle pain and swelling accompanied by weakness, fever, or red-brown colored urine (symptoms of muscle damage known as rhabdomyolysis), which may be fatal.

• Abdominal pain, nausea, vomiting with blood or coffee-ground-like vomit, dark stools (symptoms of gastrointestinal ulcer with potential hemorrhage or perforation), which may be fatal.

• Reduced blood flow to the intestine (intestinal ischemia), which may be fatal.

• Myocardial infarction (heart attack), angina pectoris (chest pain or discomfort).

• Esophagitis (inflammation of the inner lining of the esophagus—the tube connecting the mouth to the stomach—causing pain and difficulty swallowing).

• Blood cancer at the end of treatment (secondary leukemia).

• Reduction in all types of blood cells (pancytopenia).

• Disorder or disruption of blood supply to the brain (ischemic and hemorrhagic cerebrovascular disorders).

• Lung infection (pneumonia) possibly causing breathing difficulties (bronchopneumonia), which may be fatal.

• Non-cancerous abnormal liver nodules (focal nodular hyperplasia).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion

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

Store below 25 °C. Keep the vial in the outer packaging to protect it from light.

Do not use this medicine after the expiry date stated on the carton and on the label of the vial after “EXP”. The expiry date refers to the last day of the month indicated.

Oxaliplatin Teva 5 mg/ml must not come into contact with the eyes or skin. If accidental spillage occurs, inform the doctor or nurse immediately.

After the infusion is complete, any remaining Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion will be carefully disposed of by your doctor or nurse.

6. Contents of the pack and other information

Composition of Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion

• The active substance is oxaliplatin. 1 ml of concentrate for solution for infusion contains 5 mg of oxaliplatin.
• The other components are lactose monohydrate and water for injections.

Appearance of the product and contents of the container

Oxaliplatin Teva 5 mg/ml concentrate for solution for infusion is a clear, colourless or almost colourless solution in a colourless glass vial with a bromobutyl rubber stopper, aluminium seal and polypropylene snap cap.

4 ml of concentrate for solution for infusion contain 20 mg of oxaliplatin.

10 ml of concentrate for solution for infusion contain 50 mg of oxaliplatin.

20 ml of concentrate for solution for infusion contain 100 mg of oxaliplatin.

40 ml of concentrate for solution for infusion contain 200 mg of oxaliplatin.

Vials are supplied in cardboard packs, each containing one vial. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Manufacturer

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem

The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names

Belgium	Oxaliplatine TEVA 5 mg/ml concentrate for solution for infusion
Czech Republic	Oxaliplatin - Teva 5 mg/ml
France	Oxaliplatine TEVA 5 mg/ml, solution to be diluted for perfusion
Germany	Oxaliplatin-GRY® 5 mg / ml concentrate for the preparation of an infusion solution
Greece	Oxaliplatin Teva 5 mg/ml, πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Italy	OXALIPLATINO TEVA 5 mg/ ml concentrate for solution for infusion
Luxembourg	Oxaliplatine TEVA 5 mg/ml solution to be diluted for perfusion
Netherlands	Oxalisin 5 mg/ml, concentrate for solution for infusion
Slovenia	Oksaliplatin Teva 5 mg/ml concentrate for infusion solution
Spain	Oxaliplatino TEVA 5 mg/ml concentrate for infusion solution EFG
Sweden	Oxaliplatin Teva 5 mg/ml, concentrate for infusion liquid, solution

Date of last revision of this leaflet: August 2022

This information is intended for healthcare professionals only

GUIDE FOR THE PREPARATION AND USE OF OXALIPLATIN TEVA 5 mg/ml CONCENTRATE FOR INFUSION SOLUTION EFG

It is important that you read the entire content of this procedure before preparing Oxaliplatin Teva 5 mg/ml concentrate for infusion solution.

1. Composition

Oxaliplatin Teva 5 mg/ml concentrate for infusion solution is a clear, colorless or almost colorless liquid containing 5 mg/ml of oxaliplatin and 45 mg/ml of monohydrate lactose in water for injection.

2. Presentation

Oxaliplatin Teva 5 mg/ml concentrate for infusion solution is supplied as single-dose vials.

Oxaliplatin Teva 5 mg/ml concentrate for infusion solution is a clear, colorless or almost colorless solution in a colorless glass vial with a bromobutyl rubber stopper, aluminum seal, and snap cap.

4 ml of concentrate for infusion solution contain 20 mg of oxaliplatin.

10 ml of concentrate for infusion solution contain 50 mg of oxaliplatin.

20 ml of concentrate for infusion solution contain 100 mg of oxaliplatin.

40 ml of concentrate for infusion solution contain 200 mg of oxaliplatin.

Each carton contains one vial of Oxaliplatin Teva 5 mg/ml concentrate for infusion solution.

Only certain pack sizes may be marketed.

Oxaliplatin Teva 5 mg/ml concentrate for infusion solution packaged for sale

Store below 25°C. Keep the vial in the outer packaging to protect from light.

Infusion solution

After dilution of the concentrate for infusion solution in 5% glucose (50 mg/ml), physical and chemical stability has been demonstrated for use for 24 hours at 2°C–8°C and for 6 hours at 25°C.

From a microbiological standpoint, the prepared infusion should be used immediately.

If not used immediately, the storage time and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C unless the dilution was carried out under controlled and validated aseptic conditions.

Visually inspect before use. Only clear solutions free from particles should be used.

The medicine is for single use only. Any unused solution must be discarded.

3. Safe handling recommendations

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

Handling instructions

Handling this cytotoxic agent by healthcare personnel requires precautions to ensure the protection of the handler and the surrounding environment.

Preparation of injectable solutions of cytotoxic agents should be performed by personnel specialized in handling such drugs, under conditions that ensure product integrity, environmental protection, and particularly the protection of personnel handling these medications, in accordance with hospital guidelines. A designated and prepared area is required for this purpose. Smoking, eating, or drinking in this area is prohibited.

Personnel must be equipped with appropriate materials for handling, including sleeves, mask, cap, goggles, sterile disposable gloves, protective gown for the work area, and containers and bags for collecting waste.

Feces and vomit should be handled with care.

Pregnant women should avoid handling cytotoxic agents.

Any broken container must be handled with the same precautions and considerations as contaminated waste. Contaminated waste must be incinerated in appropriate rigid containers, properly labeled. See section “Disposal” below.

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

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

4. Preparation for intravenous administration

Special precautions for administration

• NEVER use infusion devices containing aluminum.
• NEVER administer undiluted.
• Only 5% glucose solution (50 mg/ml) for infusion may be used as diluent. NEVER use sodium chloride solutions or solutions containing chloride.
• NEVER mix with other medicines in the same infusion bag or administer simultaneously through the same infusion line with other medicines.
• NEVER mix with alkaline medicines or solutions, particularly 5-fluorouracil or folinic acid containing trometamol as excipient and trometamol salts of other medicines. Alkaline medicines or solutions will negatively affect the stability of oxaliplatin.

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

Intravenous infusion of oxaliplatin 85 mg/m² in 250 to 500 ml of 5% glucose solution (50 mg/ml) is administered simultaneously with folinic acid in 5% glucose solution (50 mg/ml) over 2 to 6 hours, using a Y-line placed immediately before the injection site. These two medicines must not be combined in the same infusion bag. Folinic acid must not contain trometamol as excipient and should only be diluted using 5% isotonic glucose solution (50 mg/ml), and NEVER in alkaline solutions, sodium chloride solutions, or solutions containing chloride.

Instructions for use with 5-fluorouracil

Oxaliplatin must always be administered before fluoropyrimidines, e.g., 5-fluorouracil.

After administration of oxaliplatin, flush the line and then administer 5-fluorouracil.

For additional information regarding this medicine in combination with oxaliplatin, refer to the corresponding Summary of Product Characteristics.

• USE ONLY the recommended diluents (see below).
• Only clear, particle-free solutions should be used.

4.1 Preparation of the infusion solution

Withdraw the required amount of concentrate from the vial(s) and then dilute with 250 ml to 500 ml of 5% glucose solution (50 mg/ml) to achieve an oxaliplatin concentration between 0.2 mg/ml and 0.7 mg/ml. The concentration range for which physico-chemical stability has been demonstrated is 0.2 mg/ml to 2.0 mg/ml.

Administer by intravenous infusion.

After dilution of the concentrate for infusion solution in 5% glucose solution (50 mg/ml), physical and chemical stability is maintained for 48 hours at a temperature between +2°C and +8°C and for 24 hours at +25°C.

From a microbiological standpoint, the prepared infusion should be used immediately.

If not used immediately, the storage time and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at +2°C to +8°C unless the dilution was carried out under controlled and validated aseptic conditions (not exceeding 48 hours).

Visually inspect before use. Only clear, particle-free solutions should be used.

This medicine is for single use only. Any unused infusion solution must be discarded (see section “Disposal” below).

NEVER use sodium chloride or chloride-containing solutions for dilution.

Compatibility of the oxaliplatin solution has been verified for administration systems with PVC components.

4.2 Infusion of the solution

Administration of oxaliplatin does not require prehydration.

Oxaliplatin, diluted in 250 ml to 500 ml of 5% glucose solution (50 mg/ml) to achieve a concentration of not less than 0.2 mg/ml, should be infused either via central or peripheral venous route over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion must precede that of 5-fluorouracil.

4.3 Disposal

Any remaining medicine and materials used for dilution and administration must be destroyed in accordance with hospital procedures for cytotoxic agents, taking into account legal requirements for the disposal of hazardous waste.