ONDANSETRON 2 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Ondansetron Accord 2 mg/ml, solution for injection or infusion
   1. You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ondansetron Accord and what is it used for
4. Important information before using Ondansetron Accord
   1. When not to use Ondansetron Accord:
   2. Warnings and precautions
   3. Ondansetron Accord and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. It is not recommended to breastfeed while using Ondansetron Accord.
   6. Driving and using machines:
   7. Ondansetron Accord contains sodium.
5. How to use Ondansetron Accord
   1. Prevention of nausea and vomiting caused by chemotherapy or radiotherapy
   2. Prevention of nausea and vomiting caused by chemotherapy:
   3. Patients with moderate or severe liver disease
   4. If the patient continues to experience nausea or vomiting
   5. Using a higher dose of Ondansetron Accord than recommended
6. Possible side effects
   1. SEVERE SIDE EFFECTS
   2. Allergic reactions
   3. Other side effects include:
   4. Very common (may affect more than 1 in 10 people)
   5. Common (may affect up to 1 in 10 people)
   6. Uncommon (may affect up to 1 in 100 people)
   7. Rare (may affect up to 1 in 1,000 people)
   8. Very rare (may affect up to 1 in 10,000 people)
   9. Frequency not known (cannot be estimated from the available data)
   10. Reporting side effects
7. How to store Ondansetron Accord
8. Contents of the packaging and other information
   1. What Ondansetron Accord contains
   2. What Ondansetron Accord looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer:
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet: February 2025
   7. The following information is intended for medical personnel or healthcare professionals only
   8. Instructions for use:
   9. Nausea and vomiting caused by chemotherapy and radiotherapy:
   10. Nausea and vomiting in the postoperative period:
   11. Children (over 1 month of age) and adolescents:
   12. Incompatibilities:
   13. Shelf life and storage

Leaflet accompanying the packaging: information for the user

Ondansetron Accord 2 mg/ml, solution for injection or infusion

Ondansetron

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

The medicine is called Ondansetron Accord 2 mg/ml, solution for injection or infusion, and will be referred to as Ondansetron Accord throughout the rest of this leaflet.

Table of contents of the leaflet

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

1. What is Ondansetron Accord and what is it used for

Ondansetron Accord contains the active substance ondansetron, which belongs to a group of anti-emetic medicines. Some treatments may cause nausea or vomiting. Anti-emetic medicines can prevent nausea and vomiting after treatment.

In adults, Ondansetron Accord is used:

• to prevent nausea and vomiting that may occur during chemotherapy (a course of chemotherapy) or radiotherapy for the treatment of cancer,
• to prevent and treat nausea and vomiting that may occur after surgery under general anesthesia.

In children over 1 month of age, Ondansetron Accord may be used to prevent and treat nausea and vomiting after surgery.

In children over 6 months of age, Ondansetron Accord may also be used to treat nausea and vomiting during chemotherapy.

2. Important information before using Ondansetron Accord

When not to use Ondansetron Accord:

• if the adult or child is taking apomorphine (used to treat Parkinson's disease);
• if the adult or child is allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).

If the patient thinks that any of the above applies to them, they should consult their doctor before taking Ondansetron Accord.

Warnings and precautions

Before starting treatment with Ondansetron Accord, the patient should tell their doctor or pharmacist:

• if they are allergic to medicines similar to ondansetron, such as granisetron or palonosetron,
• if they have ever had heart problems, such as irregular heartbeat (arrhythmia),
• if they have had problems with their intestines,
• if their liver is not working properly, the doctor may reduce the dose of Ondansetron Accord. If any of the above applies to the patient, they should inform their doctor.

Ondansetron Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those available without a prescription.

• phenytoin, carbamazepine (medicines used to treat epilepsy) may affect the level of ondansetron in the body,
• rifampicin (a medicine used to treat itching, tuberculosis, and leprosy) may affect the level of ondansetron in the body,
• concomitant use of ondansetron may affect the action of tramadol (a medicine used to relieve pain),
• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram (SSRIs) (selective serotonin reuptake inhibitors) (medicines used to treat depression and/or anxiety) may cause a change in mental state,
• venlafaxine, duloxetine (SNRIs) (serotonin and norepinephrine reuptake inhibitors) (medicines used to treat depression and/or anxiety) may cause a change in mental state,
• concomitant use of ondansetron with medicines that affect the heart (e.g., anthracyclines, such as doxorubicin, daunorubicin, or trastuzumab), antibiotics (e.g., erythromycin or ketoconazole), anti-arrhythmic medicines (e.g., amiodarone), and beta-blockers (e.g., atenolol or timolol) may increase the risk of heart rhythm disturbances. The patient should inform their doctor if they are taking any of these medicines.

Pregnancy, breastfeeding, and fertility

Ondansetron Accord should not be used during the first trimester of pregnancy. This is because Ondansetron Accord may slightly increase the risk of the baby having a cleft lip and/or palate (an opening or split in the upper lip and/or the roof of the mouth). If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. If the patient is a woman of childbearing age, they may be advised to use effective contraception.

It is not recommended to breastfeed while using Ondansetron Accord.

Animal studies have shown that ondansetron can pass into breast milk. This may affect the baby. The patient should discuss this with their doctor.

Driving and using machines:

Ondansetron Accord does not affect the ability to drive or use machines.

Ondansetron Accord contains sodium.

The medicine contains 3.62 mg of sodium (the main component of common salt) per milliliter. This corresponds to 0.18% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ondansetron Accord

This medicine should always be used as directed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.

Ondansetron Accord is usually given by a doctor or nurse.

The prescribed dose of the medicine will depend on the type of treatment.

Prevention of nausea and vomiting caused by chemotherapy or radiotherapy

Adults:

On the day of chemotherapy or radiotherapy, the recommended dose for adults is 8 mg, given as an intravenous or intramuscular injection, immediately before chemotherapy or radiotherapy, and then another 8 mg dose after 12 hours. The usual intravenous dose for adults should not exceed 8 mg.

In subsequent days:

• after chemotherapy, the medicine will be given orally, in the form of an ondansetron tablet (8 mg) or 10 ml syrup (8 mg),
• oral administration can be started 12 hours after the last intravenous dose and continued for up to 5 days.

If the patient continues to experience nausea or vomiting, they should inform their doctor or nurse.

Prevention of nausea and vomiting caused by chemotherapy:

Children over 6 months of age and adolescents:

The dose of the medicine will be determined by the doctor based on the patient's weight or body surface area.

On the day of chemotherapy:

• the first dose is given as an intravenous injection, immediately before treatment. After chemotherapy, the medicine is usually given orally to children in the form of a tablet or syrup.

In subsequent days, oral administration can be started 12 hours after the last intravenous dose and continued for up to 5 days.

Prevention and treatment of nausea and vomiting in the postoperative period:

Adults:

• the usual dose for adults is 4 mg, given as an intravenous or intramuscular injection. To prevent vomiting, the medicine will be given immediately before surgery.

Children:

• the doctor will determine the dose of the medicine to be used in children over 1 month of age and adolescents. The maximum dose of 4 mg will be given as a slow intravenous injection. To prevent vomiting, the medicine will be given immediately before surgery.

Patients with moderate or severe liver disease

The dose should not exceed 8 mg per day.

If the patient continues to experience nausea or vomiting

The medicine should start working soon after administration. If the patient continues to experience nausea or vomiting, they should inform their doctor or nurse.

Using a higher dose of Ondansetron Accord than recommended

The medicine will be given to the patient by a doctor or nurse, so it is unlikely that the patient will receive too much medicine. If it is thought that the patient has received too much medicine or missed a dose, they should tell their doctor or nurse.

4. Possible side effects

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

SEVERE SIDE EFFECTS

Allergic reactions

If the patient experiences an allergic reaction, they should immediately tell their doctor or medical staff.Symptoms may include:

• sudden wheezing, pain, or tightness in the chest,
• swelling of the eyelids, face, lips, mouth, or tongue, which may make breathing difficult,
• a rash - red spots or patches under the skin anywhere on the body (hives),
• fainting.

If the patient experiences these symptoms, they should immediately contact their doctor. They should stop taking this medicine.

Other side effects include:

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

Headache

Common (may affect up to 1 in 10 people)

Sudden flushing of the face, hot flushes
Constipation
Changes in liver function test results (if the patient is taking Ondansetron Accord with cisplatin chemotherapy, otherwise this side effect is uncommon)
Irritation at the injection site, such as pain, burning, swelling, redness, or itching

Uncommon (may affect up to 1 in 100 people)

Seizures (fits)
Abnormal body movements or spasms (dyskinesia)
Motor disorders (including persistent muscle contractions and/or repetitive movements, dystonia)
Irregular or slow heartbeat
Chest pain with or without a decrease in the ST segment on the ECG
Sudden, forced, upward gaze
Low blood pressure, which may lead to fainting or dizziness
Hiccups
Increased levels of substances (enzymes) produced by the liver (which may be detected in blood tests). These symptoms were often reported in patients receiving cisplatin (a medicine used in chemotherapy).

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

Severe allergic reactions
Dizziness or feeling faint during rapid intravenous administration
Temporary vision disturbances (such as blurred or double vision), mainly during intravenous administration
Heart rhythm disturbances (sometimes leading to sudden loss of consciousness)
Diarrhea and abdominal pain

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

Severe, sudden allergic reaction with symptoms such as fever, blisters, and skin peeling (toxic epidermal necrolysis; Lyell's syndrome) and severe allergic reaction with high fever, blisters, joint pain, and/or eye inflammation (Stevens-Johnson syndrome)
Poor vision or temporary loss of vision, usually lasting no longer than 20 minutes. Most patients were receiving chemotherapy, including cisplatin. In some cases, it was reported that temporary blindness was caused by brain-related conditions.

Frequency not known (cannot be estimated from the available data)

Fluid retention (swelling)
Rash and itching
Myocardial ischemia Symptoms include: sudden chest pain or tightness

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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
Phone: +48 22 49 21 201
Fax: +48 22 49 21 209
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.

5. How to store Ondansetron Accord

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the ampoule or carton after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.

The medicinal product does not require any special storage conditions regarding temperature. Ampoules should be stored in the outer packaging to protect them from light.

Do not use this medicine if the container is damaged or if particles and/or crystals are visible.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ondansetron Accord contains

The active substance of Ondansetron Accord is ondansetron (in the form of dihydrochloride dihydrate).

1 ml of the solution for injection or infusion contains 2 mg of ondansetron (in the form of dihydrochloride dihydrate).

Each 2 ml ampoule contains 4 mg of ondansetron (in the form of dihydrochloride dihydrate).

Each 4 ml ampoule contains 8 mg of ondansetron (in the form of dihydrochloride dihydrate).

The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide, and/or concentrated hydrochloric acid to adjust the pH and water for injections.

What Ondansetron Accord looks like and contents of the pack

Ondansetron Accord is a clear and colorless solution for injection or infusion, contained in an ampoule made of clear or orange glass.

Ondansetron Accord 2 mg/ml solution for injection is available in packs containing 5 ampoules of 2 ml, 5 ampoules of 4 ml, and 10 ampoules of 2 ml and 10 ampoules of 4 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer:

Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens
Schimatari, 32009 Lamia
Greece

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: February 2025

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

Instructions for use:

For intravenous or intramuscular injection or intravenous infusion after dilution.

The doctor prescribing ondansetron to prevent nausea and vomiting associated with radiotherapy or chemotherapy in adults, adolescents, and children should consider the relevant guidelines for the use of the medicine and the practical principles of its use.

Nausea and vomiting caused by chemotherapy and radiotherapy:

Adults: The severity of vomiting caused by cancer treatment varies depending on the dose of the medicine and the combination of chemotherapy and radiotherapy in the treatment regimens used. The route of administration and dose of ondansetron should be chosen flexibly, within the range of 8 mg to 32 mg per day, according to the following recommendations.

Chemotherapy and radiotherapy with emetic potential:

Ondansetron may be given rectally, orally (tablet or syrup), intravenously, or intramuscularly.

In most patients undergoing chemotherapy or radiotherapy with emetic potential, ondansetron should be given in a dose of 8 mg, as a slow intravenous injection (lasting at least 30 seconds) or intramuscularly, immediately before treatment, and then 8 mg orally, every 12 hours.

To prevent delayed or prolonged vomiting after the first 24 hours, oral or rectal treatment with ondansetron should be continued for up to 5 days after the end of the treatment cycle.

Chemotherapy with high emetic potential: Patients receiving chemotherapy with high emetic potential, e.g., high-dose cisplatin, may receive ondansetron orally, rectally, intravenously, or intramuscularly. Ondansetron given in the following dose regimens during the first 24 hours after the start of chemotherapy showed comparable efficacy:

• A single dose of 8 mg, given as a slow intravenous injection (lasting at least 30 seconds) or intramuscularly, immediately before chemotherapy.
• Two doses of 8 mg, given 2 to 4 hours apart, as a slow intravenous injection (lasting at least 30 seconds) or intramuscularly, or as a continuous intravenous infusion of 1 mg/hour for 24 hours.
• An initial dose of 16 mg, diluted in 50 to 100 ml of 0.9% sodium chloride injection or other suitable infusion fluid (see section 6.6), given as an infusion lasting at least 15 minutes, immediately before chemotherapy. After the initial dose of ondansetron, two additional doses of 8 mg may be given intravenously (as an injection lasting at least 30 seconds) or intramuscularly, 4 hours apart.
• The choice of dose regimen should depend on the severity of the vomiting.

A single dose greater than 16 mg should not be given due to the dose-dependent increase in the risk of QT interval prolongation (see sections 4.4, 4.8, and 5.1 of the Summary of Product Characteristics).

The efficacy of ondansetron in chemotherapy with high emetic potential may be enhanced by the addition of a single intravenous dose of 20 mg of sodium phosphate dexamethasone before chemotherapy.

To prevent delayed or prolonged vomiting after the first 24 hours, oral or rectal treatment with ondansetron should be continued for up to 5 days after the end of the treatment cycle.

Children and adolescents:

Treatment of nausea and vomiting caused by chemotherapy in children aged ≥ 6 months and adolescents.

The dose of the medicine used to treat nausea and vomiting caused by chemotherapy is calculated based on the patient's body surface area (BSA) or weight.

Calculation of the dose based on body surface area (BSA):

Ondansetron Accord should be given intravenously in a single dose of 5 mg/m², immediately before chemotherapy. The single intravenous dose should not exceed 8 mg.

Oral administration can be started 12 hours later and continued for up to 5 days (see Dosage Tables in the Summary of Product Characteristics).

The total daily dose given over 24 hours (in divided doses) should not exceed 32 mg (the dose used in adults).

Calculation of the dose based on body weight:

The total daily doses based on body weight are higher than those calculated based on body surface area (BSA). Ondansetron Accord should be given intravenously in a single dose of 0.15 mg/kg, immediately before chemotherapy. The single intravenous dose should not exceed 8 mg.

Two additional intravenous doses of 8 mg may be given, 4 hours apart.

Oral administration can be started 12 hours later and continued for up to 5 days (see Summary of Product Characteristics for further information).

Ondansetron Accord should be diluted in 5% glucose solution or 0.9% sodium chloride solution or other suitable infusion fluid (see section 6.6 of the Summary of Product Characteristics) and given as an intravenous infusion lasting at least 15 minutes.

There are no data from clinical trials with a control group on the use of Ondansetron Accord to prevent delayed or prolonged nausea and vomiting caused by chemotherapy.

There are no data from clinical trials with a control group on the use of Ondansetron Accord to treat nausea and vomiting caused by radiotherapy in children.

Nausea and vomiting in the postoperative period:

Adults:

Ondansetron can be given orally or as an intravenous or intramuscular injection.

Ondansetron can be used in a single dose of 4 mg, given intramuscularly or as a slow intravenous injection, immediately before anesthesia.

In the treatment of nausea and vomiting in the postoperative period, a single dose of 4 mg is recommended, given intramuscularly or as a slow intravenous injection.

Children (over 1 month of age) and adolescents:

Oral administration: No studies have been conducted on the oral use of ondansetron to prevent or treat nausea and vomiting in the postoperative period. In such cases, a slow intravenous injection is recommended.

Injection:

To prevent postoperative nausea and vomiting (PONV) in pediatric patients undergoing general anesthesia during surgery, ondansetron can be given as a slow intravenous injection (lasting at least 30 seconds) in a single dose of 0.1 mg/kg, up to a maximum of 4 mg, before, during, or after the induction of anesthesia.

To treat nausea and vomiting in pediatric patients after surgery under general anesthesia, ondansetron can be given as a slow intravenous injection (lasting at least 30 seconds) in a single dose of 0.1 mg/kg, up to a maximum of 4 mg.

There are no data on the use of Ondansetron Accord to treat nausea and vomiting in the postoperative period in children under 2 years of age.

Elderly patients: Data on the use of ondansetron to prevent and treat PONV in elderly patients are limited, but ondansetron is well tolerated by patients over 65 years of age receiving chemotherapy.

Patients with renal impairment: No dose adjustment is required.

Patients with hepatic impairment: The clearance of ondansetron is significantly reduced and the half-life significantly prolonged in patients with moderate or severe hepatic impairment. In such patients, the total daily dose should not exceed 8 mg, and oral or rectal administration is recommended.

Patients with slow metabolism of sparteine and debrisoquine: The half-life of ondansetron in the elimination phase is not changed in patients classified as slow metabolizers of sparteine and debrisoquine. Consequently, in such patients, multiple doses will result in the same level of exposure as in other patients. No dose adjustment is required.

Incompatibilities:

This medicine must not be mixed with other medicinal products except those mentioned below.

The solution should not be sterilized by autoclaving.

Ondansetron Accord should only be mixed with the following recommended solutions:

0.9% sodium chloride injection for intravenous infusions (BP) (0.9% w/v)

5% glucose injection for intravenous infusions (BP) (5% w/v)

10% mannitol injection for intravenous infusions (BP) (10% w/v)

Ringer's solution for intravenous infusions

0.3% potassium chloride solution (0.3% w/v) and 0.9% sodium chloride solution (0.9% w/v) for intravenous infusions (BP)

0.3% potassium chloride solution (0.3% w/v) and 5% glucose solution (5% w/v) for intravenous infusions (BP)

The stability of Ondansetron Accord after dilution with the recommended solutions has been demonstrated for concentrations of 0.016 mg/ml and 0.64 mg/ml.

Only clear and colorless solutions should be used.

Diluted solutions should be stored protected from light.

Shelf life and storage

In the unopened packaging

3 years.

The medicinal product does not require any special storage conditions regarding temperature. Ampoules should be stored in the outer packaging to protect them from light.

Injection

The medicine should be used immediately after opening.

Infusion

The chemical and physical stability of the diluted solution with the recommended diluents has been demonstrated at 25°C and 2-8°C for 7 days.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. The solution should not be stored for longer than 24 hours at 2-8°C, unless the dilution has been made in controlled and validated aseptic conditions.