ONDANSETRON 8 mg Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ondansetron Accord, 4 mg, solution for injection/infusion in a pre-filled syringe
3. Ondansetron Accord, 8 mg, solution for injection/infusion in a pre-filled syringe
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Ondansetron Accord and what is it used for
5. Important information before using Ondansetron Accord
   1. When not to use Ondansetron Accord:
   2. Warnings and precautions
   3. Ondansetron Accord with other medicines
   4. Ondansetron Accord with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Ondansetron Accord contains sodium
6. How to use Ondansetron Accord
   1. Dose
   2. Nausea and vomiting caused by chemotherapy or radiation therapy
   3. Nausea and vomiting caused by chemotherapy
   4. Nausea and vomiting after surgery
   5. Prevention of nausea and vomiting after surgery
   6. Treatment of nausea and vomiting after surgery
   7. Dose adjustment
   8. Patient with moderate or severe liver disease
   9. Patient with advanced age, renal impairment, and poor metabolizers of sparteine and debrisoquine
   10. Duration of treatment
   11. Overdose of Ondansetron Accord
7. Possible side effects
   1. Inform the doctor or nurse immediately if any of the following symptoms occur:
   2. Frequency not known (frequency cannot be estimated from the available data)
   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. Reporting side effects
8. How to store Ondansetron Accord
   1. Expiry date
   2. Storage
9. 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/Importer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: February 2025
   7. The following information is intended for healthcare professionals only

Leaflet accompanying the packaging: patient information

Ondansetron Accord, 4 mg, solution for injection/infusion in a pre-filled syringe

Ondansetron Accord, 8 mg, solution for injection/infusion in a pre-filled syringe

Ondansetron

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, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

The medicine is called Ondansetron Accord, 4 mg or 8 mg, solution for injection/infusion in a pre-filled syringe and is referred to as Ondansetron Accord in the rest of the 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 and belongs to a group of anti-emetic medicines. Ondansetron is a 5HT3 receptor antagonist. It works by blocking the action of 5HT3 receptors located in the central and peripheral nervous system.
Ondansetron Accord is used:

• to prevent nausea and vomiting caused by
• cancer chemotherapy in adults and children aged ≥ 6 months;
• cancer radiation therapy in adults;
• to prevent and treat nausea and vomiting in the post-operative period in adults and children aged ≥ 1 month.

Consult a doctor, nurse, or pharmacist if additional information on the use of the medicine is needed.

2. Important information before using Ondansetron Accord

When not to use Ondansetron Accord:

• if the patient is allergic to ondansetron or other medicines in the group of selective 5HT3 receptor antagonists (e.g., granisetron, dolasetron) or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking apomorphine (a medicine used to treat Parkinson's disease).

Warnings and precautions

Before starting treatment with Ondansetron Accord, discuss with a doctor, pharmacist, or nurse:
• if the patient has ever had an allergy to other anti-emetic or anti-vomiting medicines, such as granisetron or palonosetron.
• if the patient has intestinal obstruction or severe constipation. This medicine may affect the movement of the lower part of the digestive tract
• if the patient has liver function disorders or is taking any medicines that may be harmful to the liver (hepatotoxic medicines used in chemotherapy). In such cases, liver function will be closely monitored, especially in children and adolescents.
• if the patient has ever had heart rhythm disorders, including irregular heartbeat (arrhythmia). Ondansetron prolongs the QT interval (a segment measured in the ECG, indicating delayed repolarization of the heart with a risk of life-threatening heart rhythm disorders) in a dose-dependent manner.
• if the patient is going to have a tonsillectomy. In this case, they must be closely monitored, as ondansetron treatment may mask the symptoms of internal bleeding.
• if the patient has electrolyte imbalances, such as low levels of potassium and magnesium in the blood.
• if the patient is going to have any diagnostic tests (including blood, urine, skin tests with allergens, etc.). Inform the doctor about taking this medicine, as it may affect the results of the tests.
Inform the doctor or pharmacist immediately if any of these symptoms occur during or after treatment.

• If the patient experiences sudden chest pain or tightness (myocardial ischemia).

Ondansetron Accord with other medicines

Tell the doctor, pharmacist, or nurse about all medicines the patient is taking, has recently taken, or might take, including those available without a prescription.
Particularly, inform the doctor, pharmacist, or nurse if the patient is taking any of the following medicines:
phenytoin (used to treat epilepsy and heart rhythm disorders). The effect of ondansetron may be reduced;
carbamazepine (used to treat epilepsy and neuralgic pain). The effect of ondansetron may be reduced;

• rifampicin (used to treat infections such as tuberculosis). The effect of ondansetron may be reduced; antibiotics such as erythromycin; ketoconazole (used to treat patients with Cushing's syndrome); anti-arrhythmic medicines (used to treat irregular heartbeat), such as amiodarone; beta-blockers, used to treat certain heart diseases, eye diseases, anxiety disorders, or to prevent migraines, such as atenolol or timolol; tramadol (used to treat pain). The pain-relieving effect of tramadol may be reduced; medicines affecting the heart (haloperidol, methadone); anticancer medicines (especially anthracyclines, such as doxorubicin, daunorubicin, or trastuzumab); SSRIs (selective serotonin reuptake inhibitors), used to treat depression and/or anxiety, including: fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• SNRIs (serotonin and norepinephrine reuptake inhibitors), used to treat depression and/or anxiety, including venlafaxine, duloxetine.

Ondansetron Accord with food, drink, and alcohol

Ondansetron Accord can be taken with or without food and drink.

Pregnancy, breastfeeding, and fertility

Pregnancy
Do not use Ondansetron Accord during the first trimester of pregnancy. This is because Ondansetron Accord may slightly increase the risk of cleft lip and/or cleft palate [an opening or gap 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 a doctor or pharmacist before using this medicine.
If the patient can become pregnant, they will be advised on effective contraception.
Breastfeeding
Ondansetron passes into breast milk. Therefore, mothers taking ondansetron SHOULD NOT breastfeed.
Before using any medicine, consult a doctor.

Driving and using machines

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

Ondansetron Accord contains sodium

This medicine contains 3.6 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 administered by intravenous infusion after prior dilution or by injection (intravenous or intramuscular) by qualified medical personnel, usually a doctor or nurse, and never by the patient themselves.

Dose

The doctor will determine the appropriate dose of ondansetron for the patient.
The dose depends on the treatment (chemotherapy or surgical procedure), liver function, and whether the medicine is administered by intravenous injection or infusion.

Nausea and vomiting caused by chemotherapy or radiation therapy

Adults
On the day of chemotherapy or radiation therapy, it is recommended to use a dose of 8 mg, administered by slow intravenous injection or intramuscularly, directly before chemotherapy or radiation therapy, and then another dose of 8 mg after 12 hours.
In subsequent days

• Usually, the intravenous dose used in adults should not exceed 8 mg. Oral administration can be started 12 hours after chemotherapy or radiation therapy and can be continued for up to 5 days. Usually, the dose used is 8 mg twice a day.

If chemotherapy or radiation therapy causes severe nausea and vomiting, a higher dose of this medicine may be necessary for the patient.
The doctor will decide whether a dose adjustment is necessary.
A single dose should not exceed 16 mg due to the increased risk of heart rhythm disorders (see section 2).

Nausea and vomiting caused by chemotherapy

Children over 6 months 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 administered intravenously, directly before treatment. After chemotherapy, the medicine is usually administered orally to children 12 hours later, in the form of a tablet or syrup. The usual dose is 4 mg twice a day and can be administered for up to 5 days.

Nausea and vomiting after surgery

Prevention of nausea and vomiting after surgery

Adults:

• Usually, the dose used in adults is 4 mg, administered intramuscularly or by slow intravenous injection, directly before the surgical procedure.

Children over 1 month and adolescents
The doctor will determine the dose of the medicine. The maximum dose of 4 mg is administered by slow intravenous injection, directly before the surgical procedure.

Treatment of nausea and vomiting after surgery

Adults:

• Usually, the dose used in adults is 4 mg, administered intramuscularly or by slow intravenous injection.

Children over 1 month and adolescents
The doctor will determine the dose of the medicine. The maximum dose is 4 mg, administered by slow intravenous injection.

Dose adjustment

Patient with moderate or severe liver disease

The dose should not exceed 8 mg per day.

Patient with advanced age, renal impairment, and poor metabolizers of sparteine and debrisoquine

No dose adjustment of the daily dose, frequency, or route of administration is necessary.

Duration of treatment

The doctor will determine the duration of treatment with ondansetron. Treatment should not be stopped prematurely.
Ondansetron Accord should start working soon after injection. If the patient still has nausea or vomiting, inform the doctor or nurse.

Overdose of Ondansetron Accord

This medicine will be administered to the patient by a doctor or nurse, so it is unlikely that the patient will receive too much of the medicine. If it is thought that the patient has received too much of the medicine or missed a dose of the medicine, inform the doctor or nurse.
Little is known about the overdose of ondansetron. In most patients, the symptoms were similar to those already reported in patients receiving the recommended doses of this medicine (see section "Possible side effects").
After overdose, the following symptoms have been observed: vision disturbances, severe constipation, low blood pressure, and loss of consciousness. In all cases, the symptoms resolved completely.
This medicine may affect heart rhythm, especially in the case of overdose. In this case, the doctor will monitor the heart's action.
There is no specific antidote for ondansetron. Therefore, in case of suspected overdose, only symptomatic treatment should be used.
Inform the doctor if any of these symptoms occur.
In case of any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

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

Inform the doctor or nurse immediately if any of the following symptoms occur:

Uncommon(may affect up to 1 in 100 people)
• Chest pain, irregular heartbeat (arrhythmia, which can be life-threatening in individual cases) and slow heartbeat (bradycardia)
Rare(may affect up to 1 in 1,000 people)
• Immediate allergic reactions, including life-threatening allergic reactions (anaphylaxis)
This may be: itchy rash, swelling of the eyelids, face, lips, mouth, and tongue

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

• Sudden chest pain or tightness (myocardial ischemia)
If any of these symptoms occur, stop taking the medicine and contact a doctor.

Other side effects include:

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

• Headache

Common (may affect up to 1 in 10 people)

Flushing of the face, hot flushes
Constipation
Irritation and redness at the injection site

Uncommon (may affect up to 1 in 100 people)

Seizures (convulsions)
Abnormal body movements or tremors
Irregular heartbeat
Chest pain
Low blood pressure, which can lead to fainting or dizziness
Hiccups
Changes in liver function test results (this side effect occurs when the patient is taking Ondansetron Accord with a medicine called cisplatin, otherwise, it is uncommon)

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

• Dizziness or feeling of emptiness in the head
• Blurred vision
• Heart rhythm disorders (sometimes leading to sudden loss of consciousness)

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

• Poor vision or temporary loss of vision, usually lasting no longer than 20 minutes
• Widespread skin rash with blisters and peeling, covering a large area of the body (toxic epidermal necrolysis).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ondansetron Accord

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

Expiry date

Do not use this medicine after the expiry date stated on the pre-filled syringe or carton after: EXP. The expiry date refers to the last day of the month stated.

Storage

No special storage precautions for the medicine are necessary.
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. Ask the pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ondansetron Accord contains

The active substance of the medicine is ondansetron (in the form of ondansetron hydrochloride dihydrate).
1 ml of the solution for injection/infusion in a pre-filled syringe contains 2 mg of ondansetron (in the form of ondansetron hydrochloride dihydrate).
Each 2 ml pre-filled syringe contains 4 mg of ondansetron (in the form of ondansetron hydrochloride dihydrate).
Each 4 ml pre-filled syringe contains 8 mg of ondansetron (in the form of ondansetron hydrochloride dihydrate).
Other ingredients are: citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide, and/or concentrated hydrochloric acid (to adjust pH) and water for injections.

What Ondansetron Accord looks like and contents of the pack

Ondansetron is a clear and colorless solution in a pre-filled syringe made of orange glass.
The medicine is available in packs containing 1, 5, and 10 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer/Importer:

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
95-200 Pabianice
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA3000
Malta
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Accord Healthcare single member S.A.
64th Km National Road Athens
32009 Lamia, Schimatari
Greece

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

Date of last revision of the leaflet: February 2025

The following information is intended for healthcare professionals only

Instructions for use
For intravenous injection or infusion after prior dilution.
The doctor prescribing ondansetron to prevent nausea and vomiting associated with radiation therapy or chemotherapy in adults, adolescents, and children should take into account the relevant guidelines for the use of the medicine and the practically accepted principles of its use.
Compatibility with other medicinal products
The following active substances may be administered through a three-way infusion set of ondansetron at concentrations of ondansetron from 16 to 160 micrograms/ml (8 mg/500 ml and 8 mg/50 ml):
Nausea and vomiting caused by chemotherapy and radiation therapy
Adults: The severity of vomiting caused by cancer treatment varies depending on the dose of the medicine and the combination of chemotherapy and radiation therapy in the treatment regimens used. The route of administration of Ondansetron Accord and its dose should be chosen flexibly, within the range of 8 mg to 32 mg per day, according to the following recommendations.
Chemotherapy and radiation therapy with emetogenic potential:
Directly before treatment, ondansetron should be administered in a dose of 8 mg by slow intravenous injection (lasting at least 30 seconds) or intramuscularly, and then 8 mg of the medicine should be administered orally, 12 hours later.

To prevent delayed or prolonged nausea and vomiting after the first 24 hours, continue oral or rectal treatment with ondansetron for up to 5 days after the end of the chemotherapy cycle.
Chemotherapy with high emetogenic potential:
Patients receiving chemotherapy with high emetogenic potential, e.g., high-dose cisplatin, may receive ondansetron orally, rectally, intravenously, or intramuscularly. Ondansetron used in the following dosage regimens during the first 24 hours of chemotherapy showed comparable efficacy:

• A single dose of 8 mg, administered by slow intravenous injection (lasting at least 30 seconds) or intramuscularly, directly before chemotherapy.
• A dose of 8 mg, administered by slow intravenous injection (lasting at least 30 seconds) or intramuscularly, directly before the start of chemotherapy. Two additional doses of 8 mg should be administered by intravenous injection (lasting at least 30 seconds) or intramuscularly at 4-hour intervals or up to 24 hours by continuous infusion at a rate of 1 mg/hour.
• The maximum initial dose is 16 mg, diluted in 50 to 100 ml of sodium chloride 0.9% solution for intravenous infusion or another suitable infusion fluid (see section 6.6 of the Summary of Product Characteristics) and administered by intravenous infusion over at least 15 minutes, directly before chemotherapy. After the initial dose of Ondansetron Accord, two additional doses of 8 mg may be administered by intravenous injection (lasting at least 30 seconds) or intramuscularly at 4-hour intervals.
• A single dose should not exceed 16 mg due to the dose-dependent increased risk of heart rhythm disorders (see sections 4.4, 4.8, and 5.1 of the Summary of Product Characteristics).

The choice of dosage regimen should depend on the degree of nausea and vomiting.
The efficacy of ondansetron in chemotherapy with high emetogenic potential may be enhanced by the addition of a single intravenous dose of 20 mg of dexamethasone sodium phosphate before chemotherapy.
To prevent delayed or prolonged nausea and vomiting after the first 24 hours, continue oral or rectal treatment with ondansetron for up to 5 days after the end of the chemotherapy 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 body weight.
Dose calculation based on body surface area (BSA):
Ondansetron Accord should be administered intravenously in a single dose of 5 mg/m², directly 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 the dosage tables in the Summary of Product Characteristics.
The total dose administered over 24 hours (in divided doses) should not exceed 32 mg (the dose used in adults).
Dose calculation based on body weight:
Total daily doses based on body weight are higher than doses calculated based on body surface area (BSA). Ondansetron Accord should be administered intravenously in a single dose of 0.15 mg/kg, directly before chemotherapy. The single intravenous dose should not exceed 8 mg. Two additional intravenous doses of 8 mg may be administered at 4-hour intervals. Oral administration can be started 12 hours later and continued for up to 5 days (see the Summary of Product Characteristics for further information).
Ondansetron Accord should be diluted in glucose 5% solution for intravenous infusion or sodium chloride 0.9% solution for intravenous infusion (9 mg/ml), or another compatible infusion fluid (see section 6.6 of the Summary of Product Characteristics) and administered by intravenous infusion over 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 radiation therapy in children.
Nausea and vomiting after surgery
Adults:For the prevention of nausea and vomiting, ondansetron can be used in a single dose of 4 mg, administered intramuscularly or by slow intravenous injection, directly before the surgical procedure.
For the treatment of nausea and vomiting after surgery, a single dose of 4 mg is recommended, administered intramuscularly or by slow intravenous injection.
Children (over 1 month) and adolescents
Oral administration:
No studies have been conducted on the oral use of ondansetron to prevent or treat nausea and vomiting after surgery. In this case, it is recommended to use slow intravenous injection.
Injection:
For the prevention of post-operative nausea and vomiting (PONV) in pediatric patients undergoing general anesthesia during surgery, ondansetron can be administered by 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.
For the treatment of nausea and vomiting in pediatric patients after surgery under general anesthesia, ondansetron can be administered by 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 to treat nausea and vomiting after surgery 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; however, ondansetron is well tolerated by patients over 65 years of age receiving chemotherapy.
Patients with renal impairment:No dose adjustment of the daily dose, frequency, or route of administration of Ondansetron Accord is necessary.
Patients with liver impairment:The clearance of ondansetron is significantly reduced, and the half-life in serum is significantly prolonged in patients with moderate or severe liver function disorders. In such patients, the total daily dose should not exceed 8 mg. Therefore, oral or parenteral administration is recommended.
Patients with poor metabolism of sparteine and debrisoquine:The half-life of ondansetron in the elimination phase does not change in patients classified as poor metabolizers of sparteine and debrisoquine. Consequently, in such patients, multiple doses will result in the same level of exposure as in other patient groups. No dose adjustment of the daily dose or frequency of administration is necessary.
Incompatibilities
The solution should not be sterilized in an autoclave.
Ondansetron Accord should only be mixed with the recommended solutions listed below:
sodium chloride 0.9% solution for intravenous infusion (BP) (9 mg/ml)
glucose 5% solution for intravenous infusion (BP) (5% w/v)
mannitol 10% solution for intravenous infusion (BP) (10% w/v)
Ringer's solution for intravenous infusion
sodium chloride 0.9% solution (9 mg/ml) and potassium chloride 0.3% (0.3% w/v) for intravenous infusion (BP)
sodium chloride 0.9% solution (9 mg/ml) and glucose 5% (5% w/v) for intravenous infusion (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

3 years
No special storage precautions for the medicinal product are necessary.
Injection
The medicinal product should be used immediately after opening.
Infusion
After dilution with the recommended diluents, the chemical and physical in-use stability has been demonstrated for 7 days at 25°C and 2-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has been made in controlled and validated aseptic conditions.