ONDANSETRON 2 mg /Ml Injectable Solution

Зміст інструкції

1. Ondansetron Noridem 2 mg/mL injectable solution
   1. What is Ondansetron Noridem and what is it used for
   2. What you need to know before you take Ondansetron Noridem
   3. How to take Ondansetron Noridem
   4. Possible side effects
   5. How to store Ondansetron Noridem
   6. Content of the pack and other information

Ondansetron Noridem 2 mg/mL injectable solution

Ondansetron

Equivalent Medicinal Product

Read this leaflet carefully before taking 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take Ondansetron Noridem
• 3. How to take Ondansetron Noridem
• 4. Possible side effects
• 5. How to store Ondansetron Noridem
• 6. Contents of the pack and other information

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

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

• the prevention of nausea and vomiting caused by chemotherapy or radiotherapy for cancer in adults;
• the prevention and treatment of postoperative nausea and vomiting in adults;
• the prevention of nausea and vomiting caused by anticancer chemotherapy in children and adolescents aged between 6 months and 17 years;
• the prevention of postoperative nausea and vomiting in children and adolescents aged between 1 month and 17 years.

Please ask your doctor, pharmacist or nurse if you need further explanation regarding these
uses.
Ondansetron Noridem should start to work shortly 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 you take 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 any of the other ingredients of this medicine (listed in section 6). If you are unsure, ask your doctor, pharmacist or nurse before you are given 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 problems with your liver;
• if you have a bowel obstruction;
• if you have problems with salt levels in your blood, such as potassium, sodium and magnesium.

If you are not sure whether any of these conditions apply to you, ask your doctor, pharmacist or nurse before using Ondansetron Noridem.

Contact your doctor or pharmacist immediately if you develop any of these symptoms during and after treatment with Ondansetron Noridem

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

Other medicines and Ondansetron Noridem
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription and herbal medicines. This is because Ondansetron Noridem can affect how some medicines work. Other medicines can also affect how Ondansetron Noridem works.
In particular, talk to your doctor, pharmacist or nurse if you are taking any of the following medicines:

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

Pregnancy, breastfeeding and fertility
You should 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 palate (openings or splits in the upper lip and/or palate) in the unborn baby. If you are pregnant, suspect you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking Ondansetron Noridem. Women of childbearing potential should use effective contraception.
You should not breastfeed while using Ondansetron Noridem. This is because a small amount can pass into breast milk. Ask your doctor or midwife.

Driving and using machines
It is not expected that Ondansetron Noridem will affect your ability to drive or use machines. However, you should use 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. essentially “sodium-free”.

3. How to take Ondansetron Noridem

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

Prevention of chemotherapy or radiotherapy-induced nausea and vomiting

Adults
On the day of chemotherapy or radiotherapy

• a single dose should not exceed 16 mg;
• the usual dose in adults is 8 mg administered by an injection into a vein in at least 30 seconds or into the muscle, immediately before treatment, and, possibly, two further doses of 8 mg by injection into a vein in at least 30 seconds or into the muscle at intervals of 4 hours, depending on the intensity of the chemotherapy or radiotherapy. After chemotherapy, the medicine will generally be administered orally as Ondansetron Noridem 8 mg tablets or Ondansetron Noridem 10 mL syrup (8 mg).

On subsequent days

• the usual dose for adults is one 8 mg tablet or 10 mL syrup (8 mg) taken twice a day;
• the maximum duration of therapy is 5 days.

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

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

Children and adolescents (aged between 6 months and 17 years)
Only for the prevention of nausea and vomiting caused by chemotherapy.
The 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 administered by injection into a vein (up to 8 mg), immediately before the child's treatment. After chemotherapy, 12 hours after the initial injection, the medicine will generally be administered orally in the form of a tablet up to 4 mg twice a day or syrup of 5 mL (4 mg).

On subsequent days

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

Prevention of nausea and vomiting after surgery

• The usual dose for adults is 4 mg administered by injection into a vein or into the muscle. The medicine will be administered immediately before surgery.
• For children over 1 month of age and adolescents, the doctor will determine the dose. The maximum dose is 4 mg administered through an injection into a vein. The medicine will be administered immediately before surgery.

Treatment of nausea and vomiting after surgery

• The usual dose for adults is 4 mg administered by injection into a vein or into the muscle.
• For children over 1 month of age and adolescents, the doctor will determine the dose. The maximum dose is 4 mg administered through an injection into a vein.

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

If you take more Ondansetron Noridem than you should
The doctor or nurse will administer Ondansetron Noridem to you or the child, therefore it is
unlikely that you or the child will receive too much. If you think you have taken an excessive dose or
forgotten a dose, inform the doctor or nurse.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

Some side effects can be serious
STOP treatment with ondansetron and contact your doctor immediately if you or your
child experience any of the following symptoms:

Allergic reactions
These reactions are rare in people taking ondansetron. If you develop an allergic reaction,
tell your doctor or healthcare professional immediately. Signs may include:

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

Myocardial ischemia:signs include:

• sudden chest pain or
• chest tightness

Other possible side effects are listed below. If these effects become severe, tell 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 flushing
• constipation
• changes in liver function test results (if you use 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 feeling weak or dizzy
• 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 the injection into a vein
• blurred vision
• heart rhythm disturbances (which sometimes cause sudden loss of consciousness)

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

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system located at
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 within 4 months of opening the protective sachet.
Do not use this medicine if you notice signs of deterioration such as discoloration.
Store at a temperature below 25 °C. Store in the original packaging to protect the
medicine from light.
Once the protective sachet has been opened:

• record the date of opening;
• add 4 months to that date. This will be the “expiry after” date;
• write the “expiry after” date in the designated space on the sachet;
• do not use any remaining vials from that sachet after the “expiry after” date and return them to the pharmacist who will dispose of them;
• if the sachet has not been opened, do not use this medicine after the expiry date which is stated on the vial label, the carton, or the leaflets/sachet 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 in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Ondansetron Noridem contains

• The active ingredient is ondansetron (as dihydrochloride dihydrate). Each 1 mL (millilitre) 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 ingredients are: citric acid monohydrate, disodium 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 and colourless injectable solution that can be diluted before
use.
Each glass or plastic vial (container) contains 2 mL (millilitres) or 4 mL of this medicine.
The glass vials are contained in plastic packs inside cardboard boxes. Packs of 5 glass vials are
available.
The plastic vials are wrapped in individual aluminium foil blisters and contained in
cardboard boxes. Alternatively, the 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 Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
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): Ondansetrom 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 for healthcare professionals:
For more details on this medicine, read the Summary of Product Characteristics
(SmPC).
Each 1 mL vial contains ondansetron dihydrochloride 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
Solution for injection. Clear and colourless aqueous solution.

Posology 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 determined by
the severity of the emesis.

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

Chemotherapy-induced and radiotherapy-induced nausea and vomiting:
In most patients undergoing chemotherapy or radiotherapy, ondansetron 8
mg should be administered as a slow intravenous injection (over no 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 used administered by
intravenous infusion over 15 minutes. A single intravenous dose greater than 16 mg should not be administered due to the increased risk of dose-dependent prolongation
of the QT interval (see sections 4.4, 4.8 and 5.1 of the SmPC).
Ondansetron has been shown to be equally effective in the first 24 hours of chemotherapy according to the
dosages indicated below:

• A single dose of 8 mg by slow intravenous injection (over no less than 30 seconds) or intramuscularly immediately before chemotherapy.
• A dose of 8 mg by slow intravenous injection (over no less than 30 seconds) or intramuscularly immediately before chemotherapy, followed by two further intravenous injections (over no less than 30 seconds) or intramuscular doses of 8 mg at four-hour intervals, or with a constant infusion of 1 mg/hour for up to 24 hours.
• - An initial maximum dose of 16 mg diluted in 50-100 mL of 0.9% p/v sodium chloride solution or other compatible infusion fluid (see section 6.6 of the SmPC) and administered by infusion, over no less than 15 minutes immediately before chemotherapeutic treatment. The initial dose of Ondansetron Noridem may be followed by two further doses of 8 mg intravenously (over no less than 30 seconds) or intramuscularly at 4-hour intervals.

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

Paediatric population

CINV in children and adolescents (aged from 6 months to 17 years)
The dose for CINV can be calculated based on body surface area (BSA) or based on weight. Weight-based dosing results in a higher total daily dose compared to BSA dosing (see sections 4.4 and 5.1 of the SmPC).
In clinical studies in the paediatric population, ondansetron was administered by intravenous infusion diluted in 25-50 mL of 0.9% p/v sodium chloride solution or other compatible infusion fluid (see section 6.6 of the SmPC) and administered by infusion over no less than
15 minutes.
There are no data from controlled clinical studies on the use of ondansetron in nausea and vomiting induced
by radiotherapy in children.

Dosage based on BSA
Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m². The intravenous dose should 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 in 24 hours (administered in separate doses) should not exceed the adult dose of 32
mg.
Table 1: Dosage for CINV based on BSA (from 6 months to 17 years of age)
The intravenous dose should not exceed 8 mg.
The total dose in 24 hours should not exceed the adult dose of 32 mg.

Dosage based on body weight
Weight-based dosing results in a higher total daily dose compared to BSA dosing (see sections 4.4 and 5.1 of the SmPC).
Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The intravenous dose should not exceed 8 mg.
On day 1, up to three doses of 0.15 mg/kg intravenously 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 in 24 hours (administered in separate doses) should not exceed the adult dose of 32
mg.
Table 2: Dosage for CINV based on body weight (from ≥6 months to 17 years of age)

The intravenous dose should not exceed 8 mg.
The total dose in 24 hours should not exceed the adult dose of 32 mg.

CINV and RINV in adults
In patients aged between 65 and 74 years, the adult dosing scheme may be followed. All
intravenous doses should 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 or older, the initial intravenous dose of Ondansetron Noridem
should not exceed 8 mg. All intravenous doses should 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 dose of 8 mg may be followed by two further intravenous doses of
8 mg each, infused over 15 minutes and at intervals of not less than 4 hours (see
section 5.2 of the SmPC).
Post-operative nausea and vomiting (PONV)

Adults
For the prevention of PONV, the recommended dose of ondansetron is a single dose of 4 mg
administered by intramuscular or slow intravenous injection at induction of anaesthesia.
For the treatment of PONV, when it has already occurred, a single dose of 4 mg is recommended
administered by intramuscular or slow intravenous injection.

Paediatric population

Children and adolescents (aged from 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 (no 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 post-operative nausea and vomiting in paediatric patients undergoing surgery
under general anaesthesia, Ondansetron Noridem may be administered as a single dose, by
slow intravenous injection (no less than 30 seconds), at a dose of 0.1 mg/kg up to a dose
of 4 mg.
There are no data on the use of Ondansetron Noridem in the treatment of PONV in children
under 2 years of age.

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

Patients with renal impairment
No adjustment of the daily dose or frequency or route of administration is necessary.

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

Patients with impaired sparteine/debrisochine oxidative metabolic capacity
The elimination half-life of ondansetron is not altered in subjects with impaired
sparteine/debrisochine oxidative metabolic capacity. Therefore, in such patients repeated doses
will determine exposure levels that do not differ from those of the general population. No changes in daily dosage or frequency of administration are therefore required.

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

Treatment
There is no specific antidote for ondansetron; therefore, in cases of suspected overdose, appropriate symptomatic and supportive therapy should be administered. Further treatments should
be in accordance with clinical guidelines or as recommended by the National Poisons Centre, where
available. The use of ipecacuanha for the treatment of ondansetron overdose is not
recommended as a response from patients is unlikely due to ondansetron’s own antiemetic
action.

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

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

Diluent
Sodium chloride for intravenous infusion 0.9% w/v
Glucose solution for intravenous infusion 5% w/v
Mannitol for intravenous infusion 10% w/v
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 liquids must be prepared at the time of infusion. However, dilutions of ondansetron in polyethylene bottles with the following intravenous infusion liquids have been shown to be stable for 24 hours at room temperature (25 ± 2  C) or for 36 hours in the refrigerator (2–8  C).
Compatibility with other medicines
Ondansetron can be administered by intravenous infusion at a dosage of 1 mg/hour, for example, with an infusion bag or a syringe pump. The administration of the following drugs is compatible with ondansetron at concentrations of 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 a variable time from 1 to 8 hours.

5-fluorouracil
Concentrations up to 0.8 mg/mL (e.g. 2.4 g in 3 liters or 400 mg in 500 mL) administered at a rate of at least 20 mL per hour (480 mL per 24 hours). Higher concentrations of 5-fluorouracil may cause ondansetron to precipitate. The 5-fluorouracil infusion solution may contain up to 0.045% w/v of magnesium chloride in addition to other excipients that have 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) can be administered over a period ranging from 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 liter) can be administered over a time ranging from 30 minutes to 1 hour.

Ceftazidime
Dosages 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), can be administered as a rapid intravenous bolus in about 5 minutes.

Cyclophosphamide
Dosages between 100 mg and 1 g, reconstituted with water for injection, 5 mL for 100 mg of cyclophosphamide, as recommended by the manufacturer, can be administered as a rapid intravenous bolus in about 5 minutes.

Doxorubicin
Dosages between 10 mg and 100 g, reconstituted with water for injection, 5 mL for 10 mg of doxorubicin, as recommended by the manufacturer, can be administered as a rapid intravenous bolus in about 5 minutes.

Dexamethasone
20 mg of dexamethasone sodium phosphate can be administered by slow intravenous injection in 2-5 minutes using a Y-set that delivers 8 or 16 mg of ondansetron diluted in 50-100 ml of one of the following infusion liquids:

• Sodium chloride for intravenous infusion 0.9% w/v
• Glucose solution for intravenous infusion 5% w/v
• Sodium chloride for intravenous infusion 0.9% w/v and glucose solution for intravenous infusion 5% w/v in about 15 minutes. Compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated, supporting the administration of these drugs through the same infusion set, with concentrations in line 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 at a temperature below 25 °C. Store in the original package to protect the medicine from light.
Ondansetron Noridem diluted in intravenous infusion liquids is stable under normal ambient lighting conditions or sunlight for at least 24 hours, therefore it is not necessary to protect it from light during infusion.