Prospecto: information for the user

Oxaliplatino Aurovit 5 mg/ml concentrate for infusion solution EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Oxaliplatino Aurovit and what it is used for

2.What you need to know before starting to use Oxaliplatino Aurovit

3.How to use Oxaliplatino Aurovit

4.Possible side effects

5.Storage of Oxaliplatino Aurovit

6.Contents of the package and additional information

Oxaliplatino Aurovit contains the active ingredient oxaliplatino, which belongs to the group of platinum-based medications used to treat cancer.

Oxaliplatino is used to treat advanced colorectal cancer (especially after complete resection of the primary tumor), metastatic (cancer cells that spread to other parts of the body) colon and rectal cancer.Oxaliplatino is used in combination with other anticancer medications called 5-fluorouracil and folinic acid.

No useOxaliplatino Aurovit si

•is allergic to oxaliplatino.

•is breastfeeding.

•has a reduced number of blood cells.

•has numbness and tingling in the fingers of the hands and/or feet and has difficulty performing delicate tasks, such as dressing.

•has severe kidney problems.

Advertencias y precauciones

Consult your doctor or pharmacist before starting to use oxaliplatino:

•If you have ever had an allergic reaction to medications containing platinum, such as carboplatino or cisplatino. Allergic reactions may occur during any oxaliplatino infusion.

•If you have mild or moderate kidney problems.

•If you have low blood counts after a previous treatment with oxaliplatino. Your doctor will have to perform tests to investigate if you have sufficient blood counts before starting treatment.

•If you have symptoms of nerve damage, such as weakness, numbness, altered taste, or abnormal sensations after a previous treatment with oxaliplatino. These symptoms may be caused by a cold. Inform your doctor if you notice any of the symptoms, especially if they are uncomfortable and/or last more than 7 days. Your doctor will perform neurological exams before and during treatment, especially if you receive other medications that may cause nerve damage. Nerve damage symptoms may persist after treatment completion.

•If you are also receiving 5-fluorouracilo, due to the increased risk of diarrhea, vomiting, mouth ulcers, and abnormal blood parameters.

•If you have liver problems.

•If you have or have had heart problems, such as an abnormal electrical signal, called QT interval prolongation, an irregular heartbeat, or a family history of heart problems.

•If you have recently received or plan to receive any vaccine. During oxaliplatino treatment, do not vaccinate with "live" or "attenuated" vaccines, such as the yellow fever vaccine.

•If you are pregnant or plan to become pregnant (see Pregnancy, breastfeeding, and fertility).

•Read the section on fertility even if you are a man.

Otros medicamentos yOxaliplatino Aurovit

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

Embarazo, lactancia y fertilidad

Embarazo

•It is not recommended to become pregnant during oxaliplatino treatment and you should use an effective contraceptive method. Patients should take appropriate contraceptive measures during treatment and for up to 4 months after its completion.

•If you are pregnant or plan to become pregnant, it is very important that you talk to your doctorbeforereceiving any treatment.

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

Lactancia

•You should not breastfeed while on oxaliplatino treatment.

Fertilidad

•Oxaliplatino may cause infertility, which could be irreversible. Male patients should seek advice on sperm conservation before treatment.

•It is recommended that male patients do not have children during treatment and for up to 6 months after treatment, and take appropriate contraceptive measures during this time.

Consult your doctor or pharmacist before using any medication.

Conducción y uso de máquinas

The treatment with oxaliplatino may increase the risk of dizziness, nausea, and vomiting and other neurological symptoms that may affect walking and balance. If this occurs, do not drive or operate machinery. If you have vision problems while using oxaliplatino, do not drive, operate heavy machinery, or participate in hazardous activities.

Oxaliplatino is only indicated for adults.

Dose

The dose ofoxaliplatinodepends on your body surface area. This is calculated from your weight and height.

The usual dose for adults, including elderly individuals, is 85 mg/m2of body surface area. The dose you receive will also depend on blood test results and whether you have previously experienced adverse effects withoxaliplatino.

Form and route of administration

•Oxaliplatino 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.

•Oxaliplatino is administered by slow intravenous injection over a period of 2 to 6 hours.

•This medication will be administered at the same time as folinic acid and before the infusion of 5-fluorouracil.

Administration frequency

Generally, you should receive an infusion every 2 weeks.

Treatment duration

Your doctor will determine the duration of treatment.

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

If you are given more Oxaliplatino Aurovit than you should

Since this medication is administered by a healthcare professional, it is very unlikely that you will receive too little or too much of the medication.

In the event of an overdose, you may experience an increase in adverse effects. Your doctor may provide appropriate treatment for these adverse effects.

In the event of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at91 562 04 20, indicating the medication and the amount administered.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any side effect, it is important to inform your doctor before the next treatment.

Seek immediate medical attentionif you notice any of the following symptoms:

•Signs of an allergic reaction with sudden symptoms such as skin rash, itching, or hives, difficulty swallowing, swelling in the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing, extreme fatigue (you may feel like you are going to faint).Most cases occurred during infusion or immediately after, but delayed allergic reactions have also been observed hours or even days after infusion. Very common (may affect more than 1 in 10 people).

•Abnormal bruises or bleeding.Very common (may affect more than 1 in 10 people).

•Signs of infection, such as sore throat and high temperature.Common (may affect up to 1 in 10 people).

•Persistent or severe diarrhea or vomiting.Very common (may affect more than 1 in 10 people).

•Presence of blood or dark brown coffee-colored particles in your vomit. Very rare (may affect up to 1 in 10,000 people).

•Mouth sores or ulcers.Very common (may affect more than 1 in 10 people).

•Unexplained respiratory symptoms, such as dry or productive cough, difficulty breathing, or wheezing, shortness of breath, and wheezing.Very common (may affect more than 1 in 10 people).

•A group of symptoms such as headache, altered mental function, seizures, and abnormal vision, which can range from blurred vision to loss of vision (posterior reversible encephalopathy syndrome, a rare neurological disorder).Rare (may affect up to 1 in 1,000 people).

•Extreme fatigue with a decrease in red blood cell count and shortness of breath (hemolytic anemia), alone or in combination with a decrease in platelets, abnormal bruises (thrombocytopenia), and kidney problems that cause little or no urine to be produced (uremic hemolytic syndrome). Unknown frequency (cannot be estimated from available data).

Other known side effects of oxaliplatin

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

•Oxaliplatin can affect the nerves (peripheral neuropathy). You may feel tingling and/or numbness in your fingers and toes, around your mouth or throat, which may be accompanied by cramps.

These effects are usually triggered by exposure to cold, for example, when opening the refrigerator or holding a cold drink. You may also have difficulty performing delicate tasks, such as buttoning your clothes. Although in most cases these symptoms resolve completely on their own, there is a possibility that the symptoms of peripheral sensory neuropathy may persist after completing treatment.

•Some people have experienced a tingling sensation in their arms or torso when flexing their neck.

•Oxaliplatin can sometimes cause an unpleasant sensation in the throat, particularly when swallowing, and give the sensation of difficulty breathing. This sensation, if it occurs, usually appears during or in the hours following infusion and can be triggered by exposure to cold. Although it is unpleasant, it will not last long and will resolve without the need for treatment. As a result, your doctor may decide to modify your treatment.

•Oxaliplatin can cause diarrhea, mild nausea, and vomiting; however, your doctor will usually give you medication to prevent dizziness before treatment and may continue to use them after treatment.

•Oxaliplatin causes a temporary reduction in the number of blood cells. The decrease in red blood cells can cause anemia (reduction in the number of red blood cells), abnormal bleeding, or the appearance of bruises (due to a decrease in platelets). The decrease in white blood cells can facilitate the appearance of infections. Before starting treatment and before each cycle of treatment, your doctor will perform a blood test to check that you have a sufficient number of cells in your blood.

•Sensation of discomfort near or at the site of administration during infusion.

•Chills (shivering), mild to intense fatigue, body pain.

•Weight changes, loss or lack of appetite, taste alterations, constipation.

•Headache, back pain.

•Muscle nerve inflammation, neck stiffness, abnormal sensation in the tongue that may make it difficult to speak.

•Stomach pain

•Modest hair loss (alopecia).

•Changes in blood tests that show changes in liver function.

Common(may affect up to 1 in 10 people)

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

•Increased sweating and nail changes, skin peeling.

•Chest pain.

•Runny nose.

•Joint pain and bone pain.

•Urination pain and changes in kidney function, changes in urination frequency, dehydration.

•Blood in urine/stool, vein inflammation, pulmonary embolism.

•High blood pressure.

•Depression and insomnia.

•Conjunctivitis, vision problems.

•Decreased calcium levels in the blood.

•Fall.

Rare(may affect up to 1 in 100 people)

•Intestinal obstruction or inflammation.

•Nervousness.

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

•Loss of hearing.

•Pulmonary fibrosis with difficulty breathing, which may be fatal (interstitial lung disease).

•Temporary and reversible loss of vision.

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

•Kidney problems that cause little or no urine to be produced (acute renal failure symptoms).

•Liver vascular disorders.

Unknown frequency(cannot be estimated from available data)

•Allergic vasculitis (inflammation of blood vessels).

•Seizures (uncontrolled body agitation).

•Throat spasm that may cause difficulty breathing.

•Abnormal heart rhythm (prolonged QT), which can be seen on an electrocardiogram (ECG) and may be fatal.

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

•Esophageal inflammation (inflammation of the inner lining of the esophagus - the tube that connects the mouth to the stomach - which causes pain and difficulty swallowing).

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

•Risk of new cancers. Leukemia, a type of blood cancer, has been reported in patients after using oxaliplatin in combination with other medications. Consult your doctor about the possible increased risk of this type of cancer when oxaliplatin is used with certain medications.

•Abnormal liver nodules, non-cancerous (focal nodular hyperplasia).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Oxaliplatino should not come into contact with the eyes or skin. If any accidental spill occurs, report immediately to the doctor or nurse.

When the infusion has finished, oxaliplatino should be eliminated with caution by the doctor or nurse.

Do not use this medicationafter the expiration date that appears on the box and vials after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

After dilution in 5% glucose, chemical and physical stability has been demonstrated for use during 48 hours at 2-8°C and during 24 hours at 25°C. From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, storage times and conditions before use are the responsibility of the user and should normally not exceed 24 hours at 2-8°C, unless the dilution was made in validated and controlled aseptic conditions.

Do not use this medicationif you observe that the solution is not transparent and particle-free.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition ofOxaliplatino Aurovit

-The active ingredient is oxaliplatino. Each vial contains 50 mg, 100 mg or 200 mg of oxaliplatino.

-The other component is water for injection.

Aspect of the productand content of the package

Concentrate for solution for infusion.

Clear and colorless solution, essentially free of visible particles. Each vial contains 50 mg, 100 mg or 200 mg of oxaliplatino in water for injection. The vials are supplied in boxes with one vial.

1 vial with 10 ml of concentrated solution for infusion contains 50 mg of oxaliplatino.

1 vial with 20 ml of concentrated solution for infusion contains 100 mg of oxaliplatino.

1 vial with 40 ml of concentrated solution for infusion contains 200 mg of oxaliplatino.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Germany:Oxaliplatin PUREN 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Belgium:Oxaliplatin Eugia 5 mg/ml concentraat voor oplossing voor infusie / solution à diluer pour perfusion / Konzentrat zur Herstellung einer Infusionslösung

Spain:Oxaliplatino Aurovit 5 mg/ml concentrado para solución para perfusión EFG

France:OXALIPLATINE ARROW LAB 5mg/ml, solution à diluer pour perfusion

Italy:Oxaliplatino Aurobindo Italia

Poland:Oxaliplatin Eugia

Portugal:Oxaliplatina Generis

Sweden:Oxaliplatin Eugia

Last review date of this leaflet: January 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended only for doctors or healthcare professionals.

GUIDE FOR PREPARATION FOR USE OF OXALIPLATINO AUROVIT 5 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION EFG

It is essential to read the entire content of this procedure before preparing the oxaliplatino infusion solution.

1. FORMULATION

Oxaliplatino Aurovit 5 mg/ml concentrate for solution for infusion is a clear and colorless liquid, containing 5 mg/ml of oxaliplatino in water for injection.

2. PRESENTATION

Oxaliplatino Aurovit is supplied as single-dose vials. Each box contains 1 vial of oxaliplatino (50 mg, 100 mg or 200 mg).

The 10 ml vial of Oxaliplatino Aurovit is a type I transparent glass vial with 50 mg of oxaliplatino concentrate for solution for infusion, with a bromobutyl rubber stopper.

The 20 ml vial of Oxaliplatino Aurovit is a type I transparent glass vial with 100 mg of oxaliplatino concentrate for solution for infusion, with a bromobutyl rubber stopper.

The 40 ml vial of Oxaliplatino Aurovit is a type I transparent glass vial with 200 mg of oxaliplatino concentrate for solution for infusion, with a bromobutyl rubber stopper.

Oxaliplatino Aurovit packaged for sale

This medication does not require special storage conditions.

Solution for infusion

After dilution in 5% glucose solution, the chemical and physical stability has been demonstrated for 48 hours at 2-8°C and for 24 hours at +25°C. From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the dilution has been performed in validated and controlled aseptic conditions (not exceeding 48 hours).

Visually inspect before use. Only clear solutions without particles should be used.

The medication is for single use only. The unused solution should be discarded.

3. SAFE HANDLING RECOMMENDATIONS

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

Handling instructions

The handling of this cytotoxic agent by healthcare personnel requires taking precautions to ensure the protection of the handler and their environment.

The preparation of injectable solutions of cytotoxic agents should be performed by specialized personnel in this class of medications, in conditions that ensure the integrity of the product, environmental protection, and above all, the protection of personnel handling these medications, in accordance with hospital regulations. A prepared and reserved area is required for this purpose. Smoking, eating, or drinking is prohibited in this area.

Personal should be provided with suitable materials for handling, especially long-sleeved gowns, masks, caps, protective glasses, sterile single-use gloves, protective clothing for the work area, containers, and waste bags for disposal of materials.

Feces and vomit should be handled with care.

Pregnant women should be advised to avoid handling cytotoxic agents.

Any broken container should be treated with the same precautions and considerations as contaminated waste. Contaminated waste should be incinerated in rigid containers suitable for the purpose, properly labeled. See the "Disposal" section below.

If the concentrate for solution for infusion or the oxaliplatino infusion solution comes into contact with the skin, wash immediately with abundant water.

If the concentrate for solution for infusion or the oxaliplatino infusion solution comes into contact with mucous membranes, wash immediately with abundant water.

4. PREPARATION FOR INTRAVENOUS ADMINISTRATION

Special precautions for administration

•Do not use aluminum-containing injection devices.

•Do not administer without dilution.

•Only 5% glucose solution (50 mg/ml) can be used as a solvent. Do not dilute for infusion with sodium chloride or solutions containing sodium chloride.

•Do not mix with other medications in the same infusion bag or administer simultaneously in the same infusion line with other medications.

•Do not mix with alkaline solutions, particularly 5-fluorouracil, folinic acid preparations containing trometamol as an excipient, and trometamol salts of other medications. Alkaline solutions may negatively affect the stability of oxaliplatino.

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

The intravenous infusion of 85 mg/m2of oxaliplatino in 250 to 500 ml of 5% glucose solution (50 mg/ml) is administered at the same time as an intravenous infusion of folinic acid in 5% glucose solution (50 mg/ml), over 2 to 6 hours, using a Y-connector placed immediately before the injection site. These two medications should not be combined in the same infusion bag. Folinic acid should not contain trometamol as an excipient and should only be diluted with isotonic glucose solutions, never with alkaline or sodium chloride solutions or solutions containing sodium chloride.

Instructions for use with 5-fluorouracil

Oxaliplatino should always be administered before fluoropyrimidines, i.e., 5-fluorouracil. After administering oxaliplatino, wash the infusion site and then administer 5-fluorouracil.

For additional information on medications combined with oxaliplatino, see the corresponding technical data sheet.

•Only use the recommended solvents (see below).

•Only use clear solutions without particles.

4.1 Preparation of the infusion solution

Extract the required amount of concentrate from the vial or vials and dilute with 250 to 500 ml of a 5% glucose solution (50 mg/ml) to administer a concentration of oxaliplatino between 0.2 mg/ml and 0.7 mg/ml. The concentration range for which physical-chemical stability has been demonstrated is 0.2 mg/ml to 2.0 mg/ml.

Administer by intravenous infusion.

After dilution in 5% glucose solution (50 mg/ml), the chemical and physical stability has been demonstrated for 48 hours at 2-8°C and for 24 hours at +25°C.

From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the dilution has been performed in validated and controlled aseptic conditions (not exceeding 48 hours).

Visually inspect before use. Only clear solutions without particles should be used.

The medication is for single use only. The unused solution should be discarded (see the "Disposal" section below).

NEVERuse sodium chloride or solutions containing sodium chloride for dilution.

The compatibility of the oxaliplatino solution has been verified for PVC infusion systems.

4.2 Infusion of the solution

The administration of oxaliplatino does not require prehydration.

Oxaliplatino, diluted in 250 to 500 ml of 5% glucose solution (50 mg/ml) to administer a concentration not less than 0.2 mg/ml, will be infused via a central or peripheral vein over 2 to 6 hours. When oxaliplatino is administered with 5-fluorouracil, the infusion of oxaliplatino should precede that of 5-fluorouracil.

4.3 Disposal

The disposal of unused medication and materials used for dilution and administration will be carried out in accordance with hospital procedures for cytotoxic agents, taking into account local regulations for the disposal of hazardous waste.