Ondansetron Kalceks

Package leaflet: Information for the user

Ondansetron Kalceks 2 mg/ml solution for injection/infusion

ondansetron
Equivalent medicine
Please read all of this leaflet carefully before you are given this medicine as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

1. What Ondansetron Kalceks is and what it is used for
2. What you need to know before you are given Ondansetron Kalceks
3. How Ondansetron Kalceks is given
4. Possible side effects
5. How to store Ondansetron Kalceks
6. Contents of the pack and other information

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

Ondansetron Kalceks contains a medicine called ondansetron. Ondansetron belongs to a group of medicines called antiemetics, which relieve nausea and vomiting.
Adults
Ondansetron is used to treat nausea and vomiting caused by chemotherapy and radiotherapy, and to prevent and treat nausea and vomiting after surgery.
Children and adolescents
Ondansetron is used to treat nausea and vomiting caused by chemotherapy in children from 6 months of age and in adolescents.
Ondansetron is used to prevent and treat nausea and vomiting after surgery in children from 1 month of age and in adolescents.

2. What you need to know before you are given Ondansetron Kalceks

Do not be given Ondansetron Kalceks:

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

If any of the situations listed above apply to you, you will not be given Ondansetron Kalceks. If you have any doubts, consult your doctor or nurse before receiving this medicine.

Warnings and precautions

Consult your doctor or nurse before you are given Ondansetron Kalceks if:

• you experience symptoms of an allergic reaction, such as itching, difficulty breathing, or swelling of the face, lips, throat, or tongue;
• you have previously had an allergic reaction to other medicines used to treat nausea and vomiting (such as granisetron or palonosetron);
• you have heart problems; a temporary change in the electrocardiogram (ECG) may occur;
• you are taking medicines to treat heart rhythm disorders (antiarrhythmics) or medicines to lower blood pressure and resting heart rate (beta-blockers);
• you suffer from constipation or have an intestinal disease that may cause constipation;
• you have liver problems or are taking medicines that could damage the liver (hepatotoxic chemotherapeutic agents). In these cases, liver function will be closely monitored, especially in children and adolescents;
• you have had a blood test to check liver function values (ondansetron may affect these values);
• you have problems with blood electrolyte levels, such as potassium or magnesium;
• you are scheduled for a tonsillectomy. In this case, you will need to be closely monitored.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or nurse before being given this medicine.

Other medicines and Ondansetron Kalceks

Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or nurse if you are taking any of the following medicines:

• apomorphine (see "Do not be given Ondansetron Kalceks");
• carbamazepine or phenytoin (used to treat epilepsy);
• rifampicin (used to treat infections such as tuberculosis);
• tramadol (a painkiller);
• medicines used to treat depression and/or anxiety:
  • SSRIs (selective serotonin reuptake inhibitors), including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
  • SNRIs (serotonin-noradrenaline reuptake inhibitors), including venlafaxine and duloxetine.

When administered together with medicines used to treat certain heart conditions, changes in the ECG may occur. Concurrent use of medicines that damage the heart (e.g. anthracyclines (such as doxorubicin, daunorubicin) or trastuzumab), antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (such as amiodarone), and beta-blockers (such as atenolol or timolol) may increase the risk of heart rhythm disturbances.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Pregnancy

You must not use Ondansetron Kalceks during the first trimester of pregnancy. Ondansetron Kalceks may slightly increase the risk of cleft lip and/or cleft palate (openings or splits in the upper lip and/or palate) in the unborn child. If you are already pregnant, suspect you are pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using Ondansetron Kalceks.

Women of childbearing potential

If you are a woman of childbearing age, you may be advised to use effective contraceptive methods.

Breastfeeding

Breastfeeding must be discontinued before starting treatment with ondansetron.

Fertility

Ondansetron has no effect on fertility.

Driving and using machines

Ondansetron does not impair or impairs negligibly the ability to drive vehicles or operate machinery.

Ondansetron Kalceks contains sodium

This medicine contains 3.52 mg of sodium (a main component of table salt) per ml of solution. This corresponds to 0.18% of the maximum recommended daily dietary intake of sodium for an adult.

3. How Ondansetron Kalceks is administered

Ondansetron will be administered to you by a doctor or nurse via injection or slow infusion into a vein, or via injection into a muscle.
Ondansetron is also available in pharmaceutical forms suitable for rectal and/or oral administration, allowing individual dose adjustment. However, Ondansetron Kalceks is intended for administration only into a vein or a muscle.
The dose prescribed for you will depend on the treatment you are undergoing.

Adults
To prevent nausea and vomiting caused by chemotherapy or radiotherapy

• On the day of chemotherapy or radiotherapy
  Ondansetron will be administered just before chemotherapy or radiotherapy. The usual dose in adults is 8 mg, given by slow injection into a vein or muscle, or by slow infusion into a vein.

• Following days
  After the first treatment, your doctor may prescribe oral ondansetron or rectally administered ondansetron. Follow the instructions provided in the respective package leaflet as needed. Always take this medicine exactly as instructed by your doctor.

If necessary, the dose may be increased up to 32 mg per day.

To prevent and treat nausea and vomiting after surgery
The usual dose in adults is 4 mg, administered by slow injection into a vein or muscle.

Paediatric population
To prevent nausea and vomiting caused by chemotherapy in children from 6 months of age and adolescents
In children, this medicine is administered slowly into a vein (intravenously) just before chemotherapy (recommended dose: 5 mg/m² or 0.15 mg/kg). The intravenous dose must not exceed 8 mg. Oral administration may begin 12 hours later. This treatment may be continued for 5 days after chemotherapy. The oral dose is calculated based on body weight or body surface area. The total daily dose must not exceed the adult maximum dose of 32 mg.

To prevent and treat nausea and vomiting after surgery in children from 1 month of age and adolescents
In children, the dose is calculated based on body weight or body surface area. The total daily dose must not exceed the adult maximum dose of 32 mg. The dose is administered by slow intravenous injection before, during, or after induction of anaesthesia.

Elderly (aged over 65 years)
Ondansetron is well tolerated in patients over 65 years of age.

Nausea and vomiting induced by chemotherapy and radiotherapy
In patients aged 65 years or older, all intravenous doses must be diluted and infused over 15 minutes. If repeated administration is required, subsequent doses must be spaced at least 4 hours apart.
In patients aged between 65 and 74 years, the initial dose is 8 mg or 16 mg. In patients over 75 years of age, the initial dose must not exceed 8 mg.

For prevention and treatment of postoperative nausea and vomiting
Experience in elderly patients is limited.

Patients with hepatic impairment
In patients with moderate or severe liver problems, the total daily dose must not exceed 8 mg.

Patients with renal impairment
Dose adjustment or changes in frequency of administration are not required, nor is there any need to modify the route of administration.

If you have been given more Ondansetron Kalceks than you should have
Since Ondansetron Kalceks will be administered by a doctor or nurse, it is unlikely that an overdose will occur. If you think that you or your child have received too much or have missed a dose, contact your doctor or nurse.

The following symptoms may occur: visual disturbances, severe constipation, low blood pressure, and slow heart rate.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects in children and adolescents are similar to those observed in adults.
Severe allergic reactions. These occur rarely in people taking ondansetron. Reported symptoms include:

• raised, itchy skin rash (urticaria)
• swelling, sometimes of the face or mouth (angioedema), with difficulty breathing
• brief loss of consciousness

Contact your doctor immediately if you experience any of these symptoms. Stop using this medicine.

Very common side effects (may affect more than 1 in 10 patients)

• Headache

Common side effects (may affect up to 1 in 10 patients)

• Feeling of warmth or hot flushes
• Constipation
• Flushing
• Irritation at the injection site (after intravenous injection)

Uncommon side effects (may affect up to 1 in 100 patients)

• Seizures
• Involuntary muscle movements or spasms
• Irregular or slow heartbeat
• Chest pain
• Low blood pressure
• Hiccups
• Increased liver enzymes

Rare side effects (may affect up to 1 in 1,000 patients)

• Heart rhythm disorders (sometimes causing sudden loss of consciousness)
• Dizziness
• Blurred vision or transient visual disturbances

Very rare side effects (may affect up to 1 in 10,000 patients)

• Widespread rash, with blistering and peeling of the skin over large areas of the body (toxic epidermal necrolysis)
• Temporary loss of vision

Not known (frequency cannot be determined from available data)

• Dry mouth
• Myocardial ischemia (signs include: sudden chest pain or chest tightness)

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ondansetron Kalceks

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature conditions.
Keep the vials in their outer packaging to protect the medicine from light.

After opening the vial
Once opened, the product must be used immediately.

Period of validity after dilution
Chemical and physical stability during use has been demonstrated for 7 days at 25 °C and at 2-8 °C.
From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2-8 °C, unless the dilution was carried out under controlled and validated aseptic conditions.

Do not use this medicine after the expiry date which is stated on the label of the vial and on the carton after "Exp". The expiry date refers to the last day of that month.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ondansetron Kalceks injection contains

• The active substance is ondansetron. Each ml of solution contains ondansetron hydrochloride dihydrate equivalent to 2 mg of ondansetron. Each 2 ml vial contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 4 ml vial contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron.
• The other components are sodium chloride, citric acid monohydrate, sodium citrate dihydrate, water for injections.

Description of the appearance of Ondansetron Kalceks and contents of the pack
Clear, colourless solution free from visible particles.
2 ml or 4 ml solution in colourless glass OPC vials (One Point Cut).
The vials are packed in a tray. The tray is placed inside the outer carton.
Pack sizes:
5, 10 or 25 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Latvia Ondansetron Kalceks 2 mg/ml solution for injection/infusion
Austria, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Lithuania, Norway, Slovakia, Sweden: Ondansetron Kalceks
Belgium Ondansetron Kalceks 2 mg/ml, solution for injection/for infusion
Ondansetron Kalceks 2 mg/ml, oplossing voor injectie/infusie
Ondansetron Kalceks 2 mg/ml, Injektions-/Infusionslösung
Greece ONDANSETRON/KALCEKS
Ireland, United Kingdom (Northern Ireland) Ondansetron 2 mg/ml solution for injection/infusion
Italy Ondansetron Kalceks
Netherlands Ondansetron Kalceks 2 mg/ml, oplossing voor injectie/infusie
Poland ONDANSETRON KALCEKS
Romania Ondansetron Kalceks 2 mg/ml solution for injection/perfusion
Slovenia Ondansetron Kalceks 2 mg/ml raztopina za injiciranje/infundiranje
Spain Ondansetron Kalceks 2 mg/ml inyectable y para perfusión solución

The following information is intended exclusively for healthcare professionals:

Refer to the product characteristics summary (SmPC) for further information on this
medicinal product.
Overdose
Symptoms and signs
Experience with ondansetron overdose is limited, but the following symptoms of intoxication may be expected in case of accidental overdose: visual disturbances, severe constipation, hypotension, and vasovagal episode with transient second-degree AV block. In all reported cases, these events resolved completely. Ondansetron prolongs the QT interval in a dose-dependent manner.
Paediatric population
Paediatric cases consistent with serotonin syndrome have been reported following accidental oral overdoses of ondansetron (estimated ingestion greater than 4 mg/kg) in infants and children aged between 12 months and 2 years.
Management
There is no specific antidote for ondansetron. In cases of suspected overdose, symptomatic and supportive treatment should be administered as appropriate. ECG monitoring is recommended. Further management should be based on clinical indication or recommendations from the national poison control centre, where available.
The use of ipecacuanha to treat overdose is not recommended, as patient response is unlikely due to the antiemetic action of ondansetron itself.
Incompatibilities
Ondansetron Kalceks for injection or infusion must not be administered in the same syringe or same infusion set as another medicinal product.
This medicinal product must not be mixed with other medicinal products except those mentioned below.
Instructions for use, disposal and handling
For single use only.
The medicinal product should be inspected visually prior to use. The product must not be used if visible signs of degradation are present (e.g. particulate matter or discoloration).
Ondansetron Kalceks must not be autoclaved for sterilization.
It may be diluted with the following intravenous infusion solutions:

• Sodium chloride 9 mg/ml (0.9%) solution;
• Glucose 50 mg/ml (5%) solution;
• Mannitol 100 mg/ml (10%) solution;
• Ringer's solution;
• Potassium chloride 3 mg/ml (0.3%) and sodium chloride 9 mg/ml (0.9%) solution;
• Potassium chloride 3 mg/ml (0.3%) and glucose 50 mg/ml (5%) solution;
• Ringer's lactate solution.

Compatibility of Ondansetron Kalceks has been demonstrated with polypropylene (PP) syringes, type I glass vials, polypropylene (PE), polyvinyl chloride (PVC), and ethyl vinyl acetate (EVA) infusion bags, and PVC and PE tubing when diluted with the infusion solutions listed above. Compatibility of undiluted Ondansetron Kalceks for injection or infusion has been demonstrated with PP syringes.
Compatibility with other drugs
Ondansetron may be administered by intravenous infusion (at a rate of 1 mg/hour). The following medicinal products may be administered via the Y-site of the ondansetron infusion set at ondansetron concentrations between 16 and 160 mcg/ml (e.g. 8 mg/500 ml and 8 mg/50 ml, respectively):

• Cisplatin
• 5-Fluorouracil
• Carboplatin
• Etoposide
• Ceftazidime
• Cyclophosphamide
• Doxorubicin
• Dexamethasone

Instructions for opening the ampoule

1. Position the ampoule with the coloured mark facing upwards. If solution is present in the upper part of the ampoule, gently tap with the finger to allow all the solution to flow down to the lower part.
2. Use both hands to open; hold the lower part of the ampoule with one hand and, with the other, break off the upper part in the direction opposite to the coloured mark (see images below).

Any unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.