Oxaliplatin-ebeve

Leaflet attached to the packaging: information for the user

Oxaliplatin-Ebewe, 5 mg/ml, concentrate for solution for infusion

Oxaliplatinum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or nurse.
If the patient experiences any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Oxaliplatin-Ebewe and what is it used for
• 2. Important information before using Oxaliplatin-Ebewe
• 3. How to use Oxaliplatin-Ebewe
• 4. Possible side effects
• 5. How to store Oxaliplatin-Ebewe
• 6. Contents of the pack and other information

1. What is Oxaliplatin-Ebewe and what is it used for

Oxaliplatin-Ebewe is an anticancer medicine. It contains the active substance oxaliplatin.
Oxaliplatin-Ebewe is used to treat colon cancer after surgery to remove the tumor or to treat cancer that has spread.
Oxaliplatin-Ebewe is used in combination with other anticancer medicines: 5-fluorouracil (5-FU) and folinic acid (FA).

2. Important information before using Oxaliplatin-Ebewe

When not to use Oxaliplatin-Ebewe

if the patient is allergicto oxaliplatin
if the patient is breast-feeding
if before starting treatment the patient's blood contains a reduced number of blood cells
if before starting treatment the patient experiences tingling and numbness of the fingers and (or)
toes making it difficult to perform precise actions, such as buttoning up
if the patient has severe kidney function disorders.

Warnings and precautions

Before receiving Oxaliplatin-Ebewe, discuss with your doctor if:
the patient has had an allergic reaction to platinum-containing medicines in the past (such as carboplatin, cisplatin), as allergic reactions may also occur during oxaliplatin infusion.
the patient has mild or moderate kidney function disorders.
the patient has any liver function disorders or abnormal liver function test results during treatment.
the patient has or has had heart problems, such as abnormal heart rhythm (so-called QT interval prolongation), irregular heart rhythm, or heart problems in the family history.
if the patient has recently received or plans to receive any vaccines. During oxaliplatin treatment, "live" or "attenuated" vaccines, such as yellow fever vaccine, should not be administered.

Oxaliplatin-Ebewe and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breast-feeding and fertility

Pregnancy
During oxaliplatin treatment, it is not recommended to become pregnant and effective contraception methods should be used. Female patients should use appropriate contraception methods during treatment and for 9 months after its completion.
Men are not recommended to father a child during treatment and for 6 months after its completion and should use appropriate contraception methods during this time.
If the patient is pregnant or plans to become pregnant, it is very important to discuss this with the doctor beforereceiving the medicine.
If the patient becomes pregnant during treatment, they must immediately inform the doctor.
Breast-feeding
During oxaliplatin treatment, breast-feeding is not allowed.
Fertility
Oxaliplatin may cause infertility, which may be irreversible. Before starting treatment, men should seek advice on the possibility of storing sperm.
After completing oxaliplatin treatment, female patients planning to become pregnant are advised to seek advice from a genetics specialist.
Before using any medicine, consult a doctor or pharmacist.

Driving and using machines

Oxaliplatin treatment may increase the risk of dizziness, nausea, vomiting, and other neurological symptoms that affect movement and balance. If such symptoms occur, do not drive vehicles or operate machines. If the patient experiences vision disturbances while using Oxaliplatin-Ebewe, they should not drive vehicles, operate machines, or perform potentially hazardous activities.

3. How to use Oxaliplatin-Ebewe

The medicine is administered by medical staff. It must not be used by itself.
Oxaliplatin-Ebewe is intended for adults only.

Dosage

The dose of Oxaliplatin-Ebewe is determined by the doctor based on the patient's body surface area, calculated from their height and weight.
The usual dose in adults (including the elderly) is 85 mg/m2 of body surface area. The dose also depends on the results of blood tests and the occurrence of side effects after the previous administration of Oxaliplatin-Ebewe.

Method and route of administration

Oxaliplatin-Ebewe is prescribed by an oncologist.
Treatment is carried out by a specialist who determines the dose suitable for the patient.
Oxaliplatin-Ebewe is administered into a vein in a slow infusion (intravenous infusion) lasting 2 to 6 hours. If the patient experiences discomfort or pain at the injection site, they should immediately inform the medical staff.
Oxaliplatin-Ebewe is administered to the patient at the same time as folinic acid, but before the infusion of 5-fluorouracil.

Frequency of administration

The medicine is usually administered once every 2 weeks.

Duration of treatment

The duration of treatment is determined by the doctor.
If the medicine is administered after complete removal of the tumor, treatment lasts for a maximum of 6 months.

Use of a higher than recommended dose of Oxaliplatin-Ebewe

Since the medicine is administered by medical staff, the use of too much or too little of it is unlikely.
In case of overdose, severe side effects may occur. In such a case, the doctor will use appropriate treatment.

Missed administration of Oxaliplatin-Ebewe

The doctor decides when the patient should receive the medicine. In case of doubt as to whether a dose of the medicine has been missed, consult the doctor as soon as possible.
In case of any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any side effect, it is important to inform the doctor before starting the next treatment cycle.

Immediately inform the doctor if the patient experiences any of the following symptoms:

tingling and (or) numbness of the fingers and toes, mouth, or throat, sometimes with muscle spasms, which can also cause difficulty in performing precise movements, such as buttoning up (symptoms of peripheral neuropathy) (very common)
symptoms of an allergic or anaphylactic reaction, such as skin rash, itching, or hives, difficulty swallowing, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing, very severe fatigue (feeling of fainting). In most cases, symptoms occurred during infusion or immediately after it, but delayed allergic reactions were also observed, which occurred after a few hours or even days after infusion (very common)
abnormal bruising, bleeding, or signs of infection, such as sore throat and high temperature (due to a decrease in the number of platelets or white blood cells) (very common)
persistent or severe diarrhea or vomiting (very common)
unexplained respiratory symptoms, such as dry cough, difficulty breathing, or crackling in the airways (very common)
mouth sores/mucositis (ulcers on the lips or mouth) (very common)
blood in vomit or black, tarry stools (symptoms of gastrointestinal bleeding) (common)
a set of symptoms such as headache, mental disorders, seizures, and vision disturbances (from blurred vision to loss of vision) - symptoms of a rare neurological disorder, called reversible posterior leukoencephalopathy syndrome (rare)
extreme fatigue only with a decrease in the number of red blood cells and shortness of breath (hemolytic anemia) (rare) or in combination with a decrease in the number of platelets, abnormal bruising (thrombocytopenia) (rare) and kidney disease, in which the patient urinates little or no urine (hemolytic-uremic syndrome) (frequency not known)

Other known side effects of Oxaliplatin-Ebewe

Very common(may occur more often than in 1 in 10 people)
Occurring in some people, tingling and a sensation similar to an electric shock, running along the arms or torso, caused by bending the neck
Sometimes caused by the medicine, an unpleasant sensation in the throat, especially when swallowing, felt as shortness of breath. This side effect usually occurs during infusion or within a few hours after its completion, and may be caused by cold. Although it is unpleasant, it does not last long and usually resolves without treatment. The doctor may decide to change the treatment regimen.
Diarrhea, mild nausea, and vomiting. Before treatment, the doctor usually recommends an anti-emetic medicine that can be taken afterwards.
Periodic decrease in the number of blood cells. A decrease in the number of red blood cells can cause pale skin, weakness, and shortness of breath (anemia). Before starting treatment and before each subsequent cycle, the doctor will check if the patient's blood contains a sufficient number of cells
A feeling of discomfort in the area or at the injection site during infusion.
Fever, chills, fatigue, weakness, pain.
Changes in weight, decreased or absent appetite, taste disorders, constipation
Headache, back pain
Numbness of the nerves, stiffness of the neck, abnormal sensation of the tongue with possible speech disorders
Stomach pain
Abnormal bleeding, including nosebleeds
Cough, difficulty breathing
Allergic reactions, skin rash, which may be red and itchy, mild hair loss (alopecia)
Changes in blood test results, including tests detecting abnormal liver function
Skin disorders
High glucose (sugar) levels in the blood, which can cause severe thirst, dry mouth, or frequent urination
Low potassium levels in the blood, which can cause abnormal heart rhythm and may be manifested by muscle spasms, muscle weakness, or fatigue
High sodium levels in the blood, which can cause confusion, muscle tremors, or heart rhythm disorders
Common(may occur less often than in 1 in 10 people):
Infection due to a decrease in the number of white blood cells
Severe blood infection, accompanied by a decrease in the number of white blood cells (sepsis with neutropenia) - a condition that can lead to death
Indigestion and heartburn, sudden flushing of the skin, hiccups, and dizziness
Excessive sweating and nail disorders, skin peeling
Chest pain
Common cold and upper respiratory tract infection
Joint pain and bone pain
Pain when urinating and changes in kidney function, changes in urination frequency, dehydration
Blood in urine and stool
High blood pressure
Depression, sleep disorders
Conjunctivitis, vision disturbances
Dizziness
Nerve inflammation leading to muscle spasms and loss of certain reflexes
Neck stiffness, intolerance to bright light, and headache
Blood clots, usually in the leg, causing pain, swelling, or redness.
Blood clots in the lungs, which cause chest pain and shortness of breath
Weight loss
Rash
Low calcium levels in the blood
Uncommon(may occur less often than in 1 in 100 people):
Severe blood infection (sepsis), which can lead to death
Nervousness
Hearing disorders (ototoxicity)
Impaired movement of food through the intestines
Disorders of acid-base balance in the body
Rare(may occur less often than in 1 in 1000 people):
Decreased platelet count due to an allergic reaction, associated with bruising and abnormal bleeding (immune-mediated thrombocytopenia)
Decrease in the number of red blood cells due to their breakdown
Speech disorders
Periodic decrease in visual acuity, visual field disorders, transient, short-term vision loss, optic neuritis
Deafness (hearing loss)
Scarring and thickening of lung tissue with breathing difficulties, sometimes fatal (interstitial lung disease)
Inflammation of the intestines causing pain or diarrhea, including severe bacterial infection (caused by Clostridium difficile)
Pancreatitis
Sudden, unexpected bleeding or bruising due to the formation of numerous blood clots in small blood vessels (disseminated intravascular coagulation), which can lead to death
Very rare(may occur less often than in 1 in 10,000 people):
Vascular diseases of the liver
Disorders of kidney function, kidney disease, in which the patient does not urinate or urinates little (symptoms of acute kidney failure)
Frequency not known(cannot be estimated from the available data):
Seizures (uncontrolled body shaking)
Severe blood infection with low blood pressure (septic shock), which can lead to death
Laryngospasm causing difficulty breathing
Allergic inflammation of blood vessels
An autoimmune reaction that causes a decrease in the production of all cell lines (pancytopenia associated with autoimmune disorders)
Abnormal heart rhythm (QT interval prolongation) visible on an electrocardiogram (ECG), which can lead to death
Pain and swelling of the muscles, accompanied by weakness, fever, or brownish discoloration of the urine (symptoms of muscle damage called rhabdomyolysis), which can lead to death
Abdominal pain, nausea, bloody vomiting, or vomiting with coffee grounds-like material or black, tarry stools (symptoms of stomach or intestinal ulcers with possible bleeding or perforation), which can lead to death
Decreased blood flow to the intestines (intestinal ischemia), which can lead to death
Non-cancerous, abnormal liver tumors (focal nodular hyperplasia)

Reporting side effects

If side effects occur, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Oxaliplatin-Ebewe

Store the medicine out of sight and reach of children.

Avoid contact of Oxaliplatin-Ebewe with eyes or skin. In case of accidental spillage, immediately inform the doctor or nurse.

Before dilution, store the medicine in its original outer packaging to protect it from light. Do not freeze.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and label after EXP.
The expiry date refers to the last day of the month stated.
After completion of the infusion, Oxaliplatin-Ebewe will be carefully disposed of by the doctor or nurse.

6. Contents of the pack and other information

What Oxaliplatin-Ebewe contains

The active substance is oxaliplatin.
Other ingredients are water for injections.

What Oxaliplatin-Ebewe looks like and contents of the pack

Oxaliplatin-Ebewe is a clear, colorless solution, free from visible particles.
1 ml of solution contains 5 mg of the active substance - oxaliplatin.
The medicine is a concentrate for solution for infusion.
10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatin.
20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatin.
30 ml of concentrate for solution for infusion contains 150 mg of oxaliplatin.
40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin.
50 ml of concentrate for solution for infusion contains 250 mg of oxaliplatin.
Pack sizes:
1, 5, or 10 vials of 10 ml
1 vial of 20 ml
1 vial of 30 ml
1 vial of 40 ml
1 vial of 50 ml
The vial may be placed in a protective plastic packaging ("OncoSafe" or "Sleeving"). "Onco-Safe" and "Sleeving" do not come into contact with the medicine and provide additional protection during transport, thus increasing the safety of medical and pharmaceutical personnel.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
EBEWE Pharma Ges.m.b.H. Nfg. KG
Mondseestrasse 11
A-4866 Unterach, Austria
Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg. KG
Mondseestrasse 11
A-4866 Unterach, Austria
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben, Germany
Fareva Unterach GmbH
Mondseestraße 11
4866 Unterach, Austria

For more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00
Date of revision of the leaflet:05/2025
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Information intended for healthcare professionals only

Special precautions for disposal and preparation of the medicinal product

As with other potentially toxic substances, caution should be exercised when handling and preparing oxaliplatin solutions.
Instructions for use
Handling this cytotoxic medicine by nursing and medical staff requires the exercise of all possible precautions to ensure protection of the person handling the medicine and their environment.
Solutions of cytotoxic medicines for injection or infusion must be prepared by appropriately trained, specialized personnel with knowledge of the medicines used, in conditions ensuring product purity, environmental protection, and above all, the safety of personnel handling the medicines, in accordance with hospital rules.
This requires the preparation of a dedicated area. In the designated area, smoking, eating, and drinking are not allowed.
Personnel must be equipped with appropriate protective equipment, in particular, long-sleeved gowns, protective masks, caps, protective glasses, sterile single-use gloves, protective covers for workstations, containers, and bags for waste.
Care should be taken when handling the patient's excreta and vomit.
Pregnant women should be warned against contact with cytotoxic medicines.
All damaged containers should be handled with the same precautions and treated as contaminated waste. Contaminated waste should be incinerated in appropriately labeled, rigid containers. Disposal - see below.
In case of contact of the oxaliplatin concentrate or infusion solution with the skin, wash the contaminated area thoroughly with water immediately.
In case of contact of the oxaliplatin concentrate or infusion solution with mucous membranes, rinse the contaminated area thoroughly with water immediately.
Special precautions for administration of the medicinal product

• DO NOT use injection equipment containing aluminum.
• DO NOT administer undiluted concentrate.
• Only 5% glucose solution for infusion can be used as a diluent. DO NOT dilute with sodium chloride solutions or other solutions containing chloride ions.
• DO NOT mix with other medicinal products in the same infusion bag or administer simultaneously through the same infusion line.
• DO NOT mix with medicinal products or solutions with an alkaline pH, in particular 5-fluorouracil preparations and folinic acid preparations containing trometamol as an excipient, as well as trometamol salts of other medicinal products. Alkaline medicinal products or solutions have an adverse effect on the stability of oxaliplatin.

Instructions for use with folinic acid (in the form of calcium or disodium salt)
Oxaliplatin at a dose of 85 mg/m2 in intravenous infusion, diluted in 250 to 500 ml of 5% glucose solution for infusion, is administered simultaneously with intravenous infusion of folinic acid, diluted in 5% glucose solution for infusion. The infusion lasts from 2 to 6 hours and is administered through a Y-connector placed directly before the injection site. These two medicinal products must not be mixed in the same infusion bag. Folinic acid must not contain trometamol as an excipient and can only be diluted with isotonic 5% glucose solution for infusion.
Never use alkaline solutions or sodium chloride solutions or other solutions containing chloride ions.
Instructions for use with 5-fluorouracil

Oxaliplatin should always be administered before fluoropyrimidines, i.e. 5-fluorouracil.

After administration of oxaliplatin, flush the intravenous line, and then administer 5-fluorouracil.
Additional information on medicinal products used in combination with oxaliplatin - see the relevant summary of product characteristics.
Concentrate for solution for infusion
Inspect before use. Only clear solutions free from particles can be used.
The medicinal product is for single use only. Unused concentrate should be discarded.
Dilution before infusion
Take the required amount of concentrate from the vial (vials) and then dilute in 250 to 500 ml of 5% glucose solution for infusion to obtain an oxaliplatin concentration of not less than 0.2 mg/ml.
Administer intravenously.
From a microbiological point of view, the product should be used immediately.
If the product is not used immediately, the user is responsible for the storage time and conditions. The storage time should not exceed 24 hours at a temperature of 2 to 8°C, unless dilution is performed in controlled and validated aseptic conditions.
It has been demonstrated that the solution diluted with 5% glucose solution for infusion to a concentration of 0.2 mg/ml and 2.0 mg/ml remains chemically and physically stable for 48 hours at a temperature of 2 to 8°C and for 6 hours at a temperature of 20 to 25°C.
Inspect the solution before use. Only clear solutions free from particles can be used.
The medicinal product is for single use only. Unused infusion solution should be discarded (see below under "Disposal").
Never use sodium chloride solution for dilution.
Infusion

Administration of oxaliplatin does not require prior hydration of the patient.
Oxaliplatin diluted in 250 to 500 ml of 5% glucose solution for infusion to obtain a concentration of not less than 0.2 mg/ml should be administered intravenously into a peripheral vein or through a central venous catheter over 2 to 6 hours. If oxaliplatin is administered with 5-fluorouracil, the following sequence should be followed: oxaliplatin should be administered first in infusion, followed by 5-fluorouracil.
Disposal

Residual medicinal product, as well as all materials used for dilution and administration of the solution, must be disposed of in accordance with standard hospital procedures for cytotoxic medicines, taking into account current regulations for the disposal of hazardous waste.

Administration

FOR USE ONLY IN ADULTS
The recommended dose of oxaliplatin is 85 mg/m2 intravenously, administered every 2 weeks for 12 cycles (6 months) as adjuvant treatment.
The recommended dose of oxaliplatin is 85 mg/m2 intravenously, administered every 2 weeks, until disease progression or unacceptable toxicity.
The administered dose should be adjusted according to the patient's tolerance to the medicine (see section 4.4 of the Summary of Product Characteristics).
Oxaliplatin should alwaysbe administered beforefluoropyrimidines, i.e. 5-fluorouracil.
Oxaliplatin is administered in intravenous infusion over 2 to 6 hours, prepared in 250 to 500 ml of 5% glucose solution for infusion 50 mg/ml, to obtain a concentration ranging from 0.2 mg/ml to 0.7 mg/ml. The concentration of 0.7 mg/ml is the highest concentration used in clinical practice for an oxaliplatin dose of 85 mg/m2.

Shelf life

Marketing authorization holder's product: 2 years
Stability after dilution
From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage time and conditions. The storage time should not exceed 24 hours at a temperature of 2 to 8°C, unless dilution is performed in controlled and validated aseptic conditions.
It has been demonstrated that the solution diluted with 5% glucose solution for infusion to a concentration of 0.2 mg/ml and 2.0 mg/ml remains chemically and physically stable for 48 hours at a temperature of 2 to 8°C and for 6 hours at a temperature of 20 to 25°C.

Special precautions for storage

Store the vial in the outer packaging to protect it from light.
Do not freeze.
Do not store above 25°C.