Ondansetron Noridem

PACKAGE LEAFLET

Package leaflet: INFORMATION FOR THE USER

Ondansetron Noridem 2 mg/mL solution for injection

Ondansetron
Generic Medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet:

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

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

Ondansetron Noridem contains ondansetron, which belongs to a class of medicines called
antiemetics.
Ondansetron Noridem is used for:

• preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer in adults;
• preventing and treating postoperative nausea and vomiting in adults;
• preventing nausea and vomiting caused by anti-tumour chemotherapy in children and adolescents aged 6 months to 17 years;
• preventing postoperative nausea and vomiting in children and adolescents aged 1 month to 17 years.

Consult your doctor, pharmacist, or nurse if you need further explanation about these
uses.
Ondansetron Noridem should start working immediately after the injection is administered.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Ondansetron Noridem

Do not take Ondansetron Noridem:

• if you are allergic to apomorphine (a medicine used to treat Parkinson's disease);
• if you are allergic to ondansetron or to any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor, pharmacist, or nurse before being administered Ondansetron Noridem.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Ondansetron Noridem:

• if you have ever had heart problems;
• if you have an irregular heartbeat (arrhythmia);
• if you are allergic to medicines similar to ondansetron, such as granisetron (known as “Kytril”);
• if you have liver problems;
• if you have intestinal blockage;
• if you have problems with blood electrolyte levels, such as potassium, sodium, and magnesium.

If you are unsure whether any of these conditions apply to you, consult your doctor, pharmacist, or nurse before using Ondansetron Noridem.
Contact your doctor or pharmacist immediately if you develop any of the following symptoms during or after treatment with Ondansetron Noridem:

• If you experience sudden chest pain or chest tightness (myocardial ischemia).

Other medicines and Ondansetron Noridem
Inform your doctor, pharmacist, or nurse if you are currently taking, have recently taken, or might take any other medicines. This includes medicines without a prescription and herbal medicines. This is because Ondansetron Noridem may affect how some medicines work. Other medicines may also affect the action of Ondansetron Noridem.
In particular, consult your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• carbamazepine or phenytoin, medicines used to treat epilepsy, which may reduce the effect of Ondansetron Noridem;
• rifampicin, a medicine used to treat infections such as tuberculosis (TB), which may reduce the effect of Ondansetron Noridem;
• antibiotics (such as erythromycin) or antifungals (such as ketoconazole);
• antiarrhythmics, medicines used to treat irregular heartbeat, which may interact with Ondansetron Noridem and affect heart rate;
• beta-blockers, medicines used to treat certain heart or eye conditions, anxiety, or to prevent migraine, which may interact with Ondansetron Noridem and affect heart rate;
• tramadol, a painkiller, as Ondansetron Noridem may reduce its effect;
• medicines that affect the heart (such as haloperidol or methadone);
• anticancer medicines (especially anthracyclines), which may interact with Ondansetron Noridem and cause cardiac arrhythmias;
• medicines used to treat depression and/or anxiety:
• SSRIs (selective serotonin reuptake inhibitors), such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram;
• SNRIs (serotonin-norepinephrine reuptake inhibitors), such as venlafaxine and duloxetine.
  If you are unsure whether any of these conditions apply to you, consult your doctor, pharmacist, or nurse before using Ondansetron Noridem. Ondansetron Noridem must not be administered in the same syringe or infusion (intravenous drip) as other medicines.

Pregnancy, breastfeeding, and fertility
You must not use Ondansetron Noridem during the first trimester of pregnancy. This is because Ondansetron Noridem may slightly increase the risk of cleft lip and/or cleft palate (openings or splits in the upper lip and/or roof of the mouth) in the unborn child. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking Ondansetron Noridem. Women of childbearing potential should use an effective method of contraception.
You must not breastfeed while using Ondansetron Noridem. This is because a small amount may pass into breast milk. Consult your doctor or midwife for advice.

Driving and using machines
Ondansetron Noridem is not expected to affect the ability to drive or operate machinery. However, it is advisable to exercise caution if you experience any of the side effects listed in section 4 (e.g., dizziness or blurred vision). Do not drive or operate machinery if you do not feel well.

Ondansetron Noridem contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., it is essentially "sodium-free".

3. How to take Ondansetron Noridem

Ondansetron Noridem is normally administered by a doctor or nurse. The prescribed dose will depend on the type of treatment.

Prevention of nausea and vomiting induced by chemotherapy or radiotherapy

Adults
On the day of chemotherapy or radiotherapy

• A single dose must not exceed 16 mg;
• The usual dose in adults is 8 mg given by intravenous injection over at least 30 seconds or by intramuscular injection, immediately before treatment, and possibly two additional 8 mg doses given by intravenous injection over at least 30 seconds or by intramuscular injection, 4 hours apart, depending on the intensity of the chemotherapy or radiotherapy. After chemotherapy, the medicine is generally administered orally as Ondansetron Noridem 8 mg tablets or Ondansetron Noridem syrup 10 mL (8 mg).

In the following days

• The usual adult dose is one 8 mg tablet or 10 mL syrup (8 mg) taken twice daily;
• The maximum duration of treatment is 5 days.

If your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you may be given a higher than usual dose of Ondansetron Noridem. Your doctor will decide this.

Elderly
If you are over 65 years of age, your doctor will adjust the dosage as necessary.

Children and adolescents (aged between 6 months and 17 years)
Only for the prevention of nausea and vomiting caused by chemotherapy.
Your doctor will determine the dose based on the child's body size (body surface area) or weight.

On the day of chemotherapy

• The first dose is given by intravenous injection (up to 8 mg), immediately before the child's treatment. After chemotherapy, 12 hours after the initial injection, the medicine is generally given orally as Ondansetron Noridem tablets up to 4 mg twice daily or syrup 5 mL (4 mg).

In the following days

• One tablet up to 4 mg or 5 mL syrup (4 mg) every 12 hours;
• These doses may be administered for up to 5 days.

Prevention of nausea and vomiting after surgery

• The usual dose for adults is 4 mg given by intravenous or intramuscular injection. The medicine will be administered immediately before surgery.
• For children over 1 month of age and adolescents, the dose will be determined by the doctor. The maximum dose is 4 mg given by intravenous injection. The medicine will be administered immediately before surgery.

Treatment of nausea and vomiting after surgery

• The usual dose for adults is 4 mg given by intravenous or intramuscular injection.
• For children over 1 month of age and adolescents, the dose will be determined by the doctor. The maximum dose is 4 mg given by intravenous injection.

Patients with moderate or severe liver problems
The total daily dose must not exceed 8 mg. If you are undergoing blood tests to monitor liver function, this medicine may alter the results.

If you take more Ondansetron Noridem than you should
Ondansetron Noridem will be administered to you or to the child by a doctor or nurse, so it is unlikely that you or the child will receive too much. If you think that you or the child has received an excessive dose or has missed a dose, inform your doctor or nurse.

If you have any doubts about how to use 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.
Some side effects can be serious
STOP taking ondansetron and contact your doctor immediately if you or the child experience any of the following symptoms:
Allergic reactions
These reactions are rare in people taking ondansetron. If you develop an allergic reaction, inform your doctor or a healthcare professional immediately. Signs may include:

• sudden wheezing and chest pain or tightness in the chest
• swelling of the eyelids, face, lips, mouth or tongue
• skin rash: red spots or lumps under the skin (urticaria) anywhere on the body
• collapse

Myocardial ischemia: signs include:

• sudden chest pain or
• chest tightness

Other possible side effects are listed below. If any of these effects become severe, inform your
doctor, pharmacist or nurse:
Very common (may affect more than 1 in 10 people)

• headache

Common (may affect up to 1 in 10 people)

• feeling of warmth or hot flushes
• constipation
• changes in liver function test results (if you are using Ondansetron Noridem together with a medicine called cisplatin; otherwise this side effect is uncommon)
• irritation and redness at the injection site

Uncommon (may affect up to 1 in 100 people)

• hiccups
• low blood pressure which may cause weakness or dizziness
• irregular heartbeat
• slow heartbeat
• chest pain
• seizures
• unusual body movements or tremor

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

• feeling dizzy or lightheaded during intravenous injection
• blurred vision
• heart rhythm disorders (which sometimes cause sudden loss of consciousness)

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

• widespread rash with blisters and peeling of the skin over large areas of the body (toxic epidermal necrolysis)
• blurred vision or temporary loss of vision, which usually resolves within 20 minutes

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

5. How to store Ondansetron Noridem

Keep this medicine out of the sight and reach of children.
Use this medicine within 4 months after opening the protective pouch.
Do not use this medicine if you notice signs of deterioration, such as loss of colour.
Store below 25 °C. Keep in the original packaging to protect the medicine from light.

After opening the protective pouch:

• record the date of opening;
• add 4 months to that date. This will be the “use by after” date;
• write the “use by after” date in the designated space on the pouch;
• do not use any remaining vials from that pouch after the “use by after” date and return them to the pharmacist, who will dispose of them appropriately;
• if the pouch has not been opened, do not use this medicine after the expiry date stated on the label of the vial, the box or the leaflets/pouch after “Exp”. The expiry date refers to the last day of that month;
• if you have been told to stop taking this medicine, return any unused Ondansetron Noridem to the pharmacist for disposal. Do not dispose of any medicine 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 Noridem contains

• The active substance is ondansetron (as hydrochloride dihydrate). Each 1 mL vial contains 2 mg (milligrams) of ondansetron. Each 2 mL vial contains 4 mg of ondansetron. Each 4 mL vial contains 8 mg of ondansetron.
• The other components are: citric acid monohydrate, sodium citrate dihydrate, sodium chloride and water for injections.

Description of the appearance of Ondansetron Noridem and contents of the pack
Ondansetron Noridem is a clear, colourless injectable solution which may be diluted before use.
Each glass or plastic vial (container) contains 2 mL (millilitres) or 4 mL of this medicinal product.
Glass vials are contained in plastic packaging within cardboard boxes. Packs of 5 glass vials are available.
Plastic vials are individually wrapped in aluminium foil blisters and contained in cardboard boxes. Alternatively, plastic vials are packaged in strips of 5 inside a bag and contained in cardboard boxes. Packs of 5, 10 or 50 plastic vials are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Noridem Enterprises Limited.
Evagorou And Makariou,
Mitsi Building 3, Office 115,
Nicosia 1065, Cyprus

Manufacturer
DEMO S.A. PHARMACEUTICAL INDUSTRY
National Road Athens-Lamia 21 km
14568 Greece
T: +30 210 8161802

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Ireland: Ondansetron 2 mg / mL solution for injection
Germany: Ondansetron Noridem 2 mg/ml Injektionslösung
Austria: Ondansetron Noridem 2 mg/ml Injektionslösung
Greece: ONDANSETRON/NORIDEM ενέσιμο διάλυμα 2 mg / mL
Belgium (BE): Ondansetron Noridem 2 mg/ml solution injectable/oplossing voor injectie/Injektionslösung
Cyprus (CY): Ondansetron Noridem 2 mg/mL, Solution for injection
Czech Republic (CZ): Ondansetron Noridem
Denmark (DK): Ondansetron Noridem
Hungary (HU): Ondansetron Noridem 2 mg/ml oldatos injekció
Finland (FI): Ondansetron Noridem
Italy (IT): Ondansetron Noridem
Netherlands (NL): Ondansetron Noridem 2 mg/ml, oplossing voor injectie
Norway (NO): Ondansetron Noridem
Portugal (PT): Ondansetrón Noridem 2 mg/ml Solução injetável
Poland (PL): Ondansetronum Noridem
Romania (RO): Ondansetron Noridem 2 mg/ml soluție injectabilă
Slovakia (SK): Ondansetron Noridem 2 mg/ml injekčný roztok
Spain (ES): Ondansetrón Noridem 2 mg/ml solución inyectable
Sweden (SE): Ondansetron Noridem
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The following information is intended exclusively for healthcare professionals:
For further details on this medicinal product, please read the Summary of Product Characteristics (SmPC).
Each 1 mL vial contains ondansetron hydrochloride dihydrate equivalent to 2 mg of ondansetron.
Each 2 mL vial contains 4 mg of ondansetron.
Each 4 mL vial contains 8 mg of ondansetron.

Pharmaceutical form
Injectable solution. Clear, colourless aqueous solution.

Dosage and method of administration
Nausea and vomiting induced by chemotherapy and radiotherapy (CINV and RINV)
The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The choice of dosage regimen should be based on the severity of emesis.

CINV and RINV in adults
The dosage range for Ondansetron Noridem is 8–32 mg per day and should be selected according to the following scheme.

Chemotherapy and radiotherapy with emetogenic potential:
In most patients undergoing emetogenic chemotherapy or radiotherapy, ondansetron 8 mg should be administered as a slow intravenous injection (over not less than 30 seconds) or intramuscular injection, immediately before treatment, followed by 8 mg orally after 12 hours.

Highly emetogenic chemotherapy: In patients undergoing highly emetogenic chemotherapy, the maximum initial dose of ondansetron of 16 mg may be administered via intravenous infusion over 15 minutes. A single intravenous dose greater than 16 mg should not be administered due to the dose-dependent risk of QT interval prolongation (see sections 4.4, 4.8 and 5.1 of the SmPC).

Ondansetron has been shown to be equally effective during the first 24 hours of chemotherapy with the following dosage regimens:

• A single dose of 8 mg administered as a slow intravenous injection (over not less than 30 seconds) or intramuscular injection immediately before chemotherapy.
• A dose of 8 mg administered as a slow intravenous injection (over not less than 30 seconds) or intramuscular injection immediately before chemotherapy, followed by two additional intravenous injections (over not less than 30 seconds) or intramuscular doses of 8 mg given at 4-hour intervals, or by continuous infusion of 1 mg/hour up to 24 hours.
• • A maximum initial dose of 16 mg diluted in 50–100 mL of 0.9% w/v sodium chloride injection solution or another compatible infusion fluid (see section 6.6 of the SmPC), administered by infusion over not less than 15 minutes immediately before chemotherapy. The initial dose of Ondansetron Noridem may be followed by two additional 8 mg intravenous doses (over not less than 30 seconds) or intramuscular doses given 4 hours apart.

The efficacy of Ondansetron Noridem in highly emetogenic chemotherapy may be enhanced by administration of a single intravenous dose of 20 mg of sodium phosphate dexamethasone given before chemotherapy.
Oral treatment is recommended after the first 24 hours to prevent delayed or prolonged emesis.
The recommended oral dose is 8 mg taken twice daily.
The choice of dosage regimen should be based on the severity of emesis.

Paediatric population
CINV in children and adolescents (aged 6 months to 17 years)
The dose for CINV may be calculated based on body surface area (BSA) or body weight. Dosing based on body weight results in a higher total daily dose compared to BSA-based dosing (see sections 4.4 and 5.1 of the prescribing information).
In clinical studies in the paediatric population, ondansetron was administered by intravenous infusion, diluted in 25–50 mL of 0.9% w/v sodium chloride injection solution or another compatible infusion fluid (see section 6.6 of the SmPC), administered over not less than 15 minutes.
There are no data from controlled clinical studies on the use of ondansetron in radiotherapy-induced nausea and vomiting in children.

Dosing based on BSA
Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m². The intravenous dose must not exceed 8 mg.
Oral dosing may begin 12 hours later and may continue for up to 5 days (see Table 1).
The total dose within 24 hours (administered as separate doses) must not exceed the adult maximum of 32 mg.

Table 1: Dosing for CINV based on BSA (age 6 months to 17 years)

The intravenous dose must not exceed 8 mg.
The total daily dose within 24 hours must not exceed the adult dose of 32 mg.
Dosing based on body weight
Body weight-based dosing results in a higher total daily dose compared to
BSA-based dosing (see sections 4.4 and 5.1 of the SmPC).
Ondansetron should be administered intravenously as a single dose of 0.15 mg/kg immediately before chemotherapy. The intravenous dose must not exceed 8 mg.
On day 1, two additional intravenous doses may be administered at 4-hour intervals.
Oral dosing may begin 12 hours later and may continue for up to 5 days (see Table 2).
The total dose within 24 hours (administered as separate doses) must not exceed the adult dose of 32 mg.
Table 2: Dosing for CINV based on body weight (from ≥6 months to 17 years of age)

The intravenous dose must not exceed 8 mg.
The total dose within 24 hours must not exceed the adult dose of 32 mg.
CINV and RINV in adults
In patients aged between 65 and 74 years, the adult dosing regimen may be followed. All
intravenous doses must be diluted in 50–100 mL of 0.9% sodium chloride solution or other
compatible infusion fluids (see section 6.6 of the SmPC) and infused over 15 minutes.
In patients aged 75 years and older, the initial intravenous dose of Ondansetron Noridem
must not exceed 8 mg. All intravenous doses must be diluted in 50–100 mL of 0.9% sodium
chloride solution or other compatible infusion fluids (see section 6.6 of the SmPC) and infused
over 15 minutes. The initial 8 mg dose may be followed by two additional intravenous doses of
8 mg each, infused over 15 minutes and administered at intervals of not less than 4 hours (see
section 5.2 of the SmPC).

Postoperative nausea and vomiting (PONV)
Adults
For the prevention of PONV, the recommended dose of ondansetron is a single 4 mg dose
administered by slow intramuscular or intravenous injection at the induction of anaesthesia.
For the treatment of established PONV, a single 4 mg dose administered by slow intramuscular or intravenous injection is recommended.

Paediatric population
Children and adolescents (aged 1 month to 17 years)
For the prevention of PONV in paediatric patients undergoing surgery under general anaesthesia, Ondansetron Noridem may be administered as a single dose by slow intravenous injection (over not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum dose of 4 mg, either before, during, or after induction of anaesthesia.
For the treatment of postoperative PONV in paediatric patients undergoing surgery under general anaesthesia, Ondansetron Noridem may be administered as a single dose by slow intravenous injection (over not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum dose of 4 mg.
There are no data on the use of Ondansetron Noridem for the treatment of PONV in children under 2 years of age.

Elderly
Experience with ondansetron in the prevention and treatment of PONV in elderly patients is limited. However, ondansetron is well tolerated in patients over 65 years of age receiving chemotherapy.

Patients with renal impairment
No adjustment of daily dose, frequency, or route of administration is required.

Patients with hepatic impairment
In patients with moderate or severe hepatic impairment, ondansetron clearance is significantly reduced and serum half-life significantly prolonged. In such patients, the total daily dose must not exceed 8 mg.

Patients who are poor metabolizers of sparteine/debrisoquine
The elimination half-life of ondansetron is not altered in patients who are poor metabolizers of sparteine/debrisoquine. Therefore, repeated doses in these patients will result in drug exposure levels not different from those in the general population. No adjustments to the daily dose or frequency of administration are required.

Overdose
Signs and symptoms
Experience with ondansetron overdose is limited. In most cases, symptoms were similar to those reported in patients receiving recommended doses (see section 4.8 of the SmPC). Reported manifestations include visual disturbances, severe constipation, hypotension, and a vasovagal episode with transient second-degree atrioventricular block. Ondansetron prolongs the QT interval in a dose-dependent manner.
ECG monitoring is recommended in cases of overdose. After oral overdose, cases consistent with serotonin syndrome have been reported in children.

Treatment
There is no specific antidote for ondansetron; therefore, appropriate symptomatic and supportive therapy should be administered in cases of suspected overdose. Further treatment should be in accordance with clinical indications or as recommended by the national poison control centre, where available. The use of ipecacuanha for the treatment of ondansetron overdose is not recommended, as patient response is unlikely due to the antiemetic action of ondansetron itself.

Special precautions for disposal and handling
Ondansetron must not be sterilized by autoclaving.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

Reconstitution and dilution of Ondansetron Noridem
Compatibility with intravenous infusion fluids
Ondansetron Noridem must be mixed only with the following recommended infusion solutions:

Diluent
Sodium chloride 0.9% w/v for intravenous infusion
Glucose 5% w/v for intravenous infusion
Mannitol 10% w/v for intravenous infusion
Ringer's solution for intravenous infusion
Potassium chloride 0.3% w/v and sodium chloride 0.9% w/v for intravenous infusion
Potassium chloride 0.3% w/v and glucose 5% w/v for intravenous infusion

In accordance with good pharmaceutical practice, dilutions of ondansetron injection in infusion fluids should be prepared immediately before infusion. However, dilutions of ondansetron in polyethylene bottles with the following intravenous infusion fluids have been shown to be stable for 24 hours at room temperature (25 ± 2 °C) or for 36 hours under refrigeration (2–8 °C).

Compatibility with other medicines
Ondansetron may be administered by intravenous infusion at a rate of 1 mg/hour, e.g., using an infusion bag or syringe pump. Administration of the following drugs is compatible with ondansetron at concentrations from 16 to 160 micrograms/mL (e.g., 8 mg in 500 mL and 8 mg in 50 mL, respectively) using a Y-set:

Cisplatin
Concentrations up to 0.48 mg/mL (e.g., 240 mg in 500 mL) administered over 1 to 8 hours.

5-fluorouracil
Concentrations up to 0.8 mg/mL (e.g., 2.4 g in 3 litres or 400 mg in 500 mL) administered at a rate of at least 20 mL per hour (480 mL over 24 hours). Higher concentrations of 5-fluorouracil may cause precipitation of ondansetron. The 5-fluorouracil infusion solution may contain up to 0.045% w/v magnesium chloride in addition to other excipients proven to be compatible.

Carboplatin
Concentrations ranging from 0.18 mg/mL to 9.9 mg/mL (e.g., 90 mg in 500 mL up to 990 mg in 100 mL) may be administered over a period of 10 minutes to 1 hour.

Etoposide
Concentrations ranging from 0.14 mg/mL to 0.25 mg/mL (e.g., 70 mg in 500 mL up to 250 mg in 1 litre) may be administered over 30 minutes to 1 hour.

Ceftazidime
Doses ranging from 250 mg to 2,000 mg reconstituted with water for injection, as recommended by the manufacturer (2.5 mL for 250 mg and 10 mL for 2 g of ceftazidime), may be administered as an intravenous bolus over approximately 5 minutes.

Cyclophosphamide
Doses ranging from 100 mg to 1 g, reconstituted with water for injection, 5 mL per 100 mg of cyclophosphamide, as recommended by the manufacturer, may be administered as an intravenous bolus over approximately 5 minutes.

Doxorubicin
Doses ranging from 10 mg to 100 mg, reconstituted with water for injection, 5 mL per 10 mg of doxorubicin, as recommended by the manufacturer, may be administered as an intravenous bolus over approximately 5 minutes.

Dexamethasone
20 mg of dexamethasone sodium phosphate may be administered by slow intravenous injection over 2–5 minutes using a Y-infusion set delivering 8 or 16 mg of ondansetron diluted in 50–100 mL of one of the following infusion fluids:

• Sodium chloride 0.9% w/v for intravenous infusion
• Glucose 5% w/v for intravenous infusion
• Sodium chloride 0.9% w/v and glucose 5% w/v for intravenous infusion over approximately 15 minutes. Compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated, supporting the administration of these drugs through the same infusion set, with in-line concentrations of 32 micrograms–2.5 mg/mL for dexamethasone sodium phosphate and 8 micrograms–1 mg/mL for ondansetron.

Ondansetron Noridem must not be administered in the same infusion syringe as other
medicines.

Special precautions for storage
Store below 25 °C. Keep in the original packaging to protect from light.
Ondansetron Noridem diluted in intravenous infusion fluids is stable under normal lighting conditions or in sunlight for at least 24 hours; therefore, protection from light during infusion is not required.