ONDANSETRONE 4 mg /2 Ml Roztwór Do Wstrzykiwań

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1. Ondansetrone Hikma 4 mg/2 ml injectable solution, 8 mg/4 ml injectable solution
   1. What is Ondansetrone Hikma and what is it used for
   2. What you need to know before using Ondansetrone Hikma
   3. How to use Ondansetrone Hikma
   4. Possible side effects
   5. How to store Ondansetrone Hikma
   6. Content of the pack and other information

Ondansetrone Hikma 4 mg/2 ml injectable solution, 8 mg/4 ml injectable solution

Ondansetrone

Read this leaflet carefully before you use 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, nurse or pharmacist.
• 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ondansetrone Hikma and what is it used for

Ondansetrone Hikma contains a substance belonging to a group of medicines called
antiemetics
Ondansetrone Hikma is used for:

• the prevention of nausea and vomiting induced by chemotherapy (in adults and children) and radiotherapy (adults only);
• the prevention of nausea and vomiting after surgery.

Ask your doctor, nurse or pharmacist if you would like further explanations regarding these uses.

2. What you need to know before using Ondansetrone Hikma

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

If you are not sure, talk to your doctor, nurse or pharmacist before taking
Ondansetrone Hikma.
Before taking Ondansetrone Hikma tell your doctor, pharmacist or nurse if:

• you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swelling of the ankles)
• you have an irregular heartbeat (arrhythmias)
• you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
• you have liver problems
• you have a bowel obstruction
• you have problems with the levels of certain salts in your blood, such as potassium, sodium and magnesium. If you are not sure if any of the above conditions apply to you, talk to your doctor, nurse or pharmacist before receiving Ondansetron Hikma. Other medicines and Ondansetrone HikmaTell your doctor or pharmacist 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 Ondansetrone Hikma can affect how some medicines work. Also some other medicines can affect how Ondansetrone Hikma works. In particular, tell your doctor, nurse or pharmacist if you are taking any of the medicines listed below:
• carbamazepine or phenytoin used to treat epilepsy
• rifampicin used to treat infections such as tuberculosis (TB)
• antibiotics such as erythromycin or ketoconazole
• antiarrhythmic medicines used to treat irregular heartbeat
• beta-blocker medicines used to treat some heart or eye problems, for anxiety or to prevent migraine
• tramadol, a painkiller
• medicines that affect the heart (haloperidol or methadone)
• cancer medicines (in particular anthracyclines and trastuzumab)
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• SNRIs (serotonin and noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine If you are not sure if any of the above conditions apply to you, talk to your doctor, nurse or pharmacist before receiving Ondansetron Hikma. Ondansetrone Hikma, should not be administered in the same syringe or infusion fluid, as any other medicine.

Pregnancy and breastfeeding
It is not known whether Ondansetrone Hikma is safe during pregnancy.
If you are pregnant, or breastfeeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Do not breastfeed if you are taking Ondansetrone Hikma. This is because small amounts pass into breast
milk. Ask your doctor or midwife for advice.

Ondansetrone Hikma containsa small amount of sodium citrate and sodium chloride.
This medicine contains 6.4 mmol (or 148 mg) of sodium per maximum daily dose of 23 mg .
This must be taken into consideration by patients on a controlled sodium diet.

3. How to use Ondansetrone Hikma

Ondansetrone Hikma is normally given by a nurse or a doctor. The dosage that has been prescribed to you depends on the treatment you are receiving.

To prevent nausea and vomiting following chemotherapy or radiotherapy in adults
On the day of chemotherapy or radiotherapy

• The recommended dose for adults is 8 mg given by injection into a vein, just before treatment, and another 8mg twelve hours later. After chemotherapy, your medicine will generally be given orally via an 8 mg tablet or 10 ml (8 mg) of ondansetrone syrup. In the following days
• The recommended dose for adults is one 8mg tablet or 10 ml (8 mg) of syrup taken twice a day.
• This administration can continue for up to 5 days. If your chemotherapy or radiotherapy causes severe nausea and vomiting, you may be given a higher dose of ondansetrone. Your doctor will decide on this.

Management of nausea and vomiting following chemotherapy in adolescents and children over 6 months of age
Your doctor will decide the dose based on the child's size (body surface area) or
weight.
On the day of chemotherapy

• The first dose is given by injection into a vein, just before your child's treatment. After chemotherapy, the medicine will generally be given orally twelve hours later, as ondansetrone syrup or ondansetrone tablets. In the following days
• 2.5 ml (2 mg) of syrup 2 times a day for small children and those weighing 10kg or less.
• one 4mg tablet or 5 ml (4 mg) of syrup twice a day for larger children and weighing more than 10 kg.
• two 4mg tablets or 10 ml (8 mg) of syrup twice a day for adolescents (or with extensive body surface area)
• these dosages can be given for up to 5 days.

To prevent nausea and vomiting after surgery
Adults:

• The usual dosage for adults is 4 mg given by slow injection into a vein. This will be given to you as a preventative measure just before surgery. Children:
• For children over 1 month of age and for adolescents, the doctor will decide the dosage. The maximum dose is 4 mg given by injection into a vein. This will be given just before surgery. Patients with moderate or severe liver problemsThe total daily dose should not exceed 8 mg.

If you continue to feel sick or start to feel sick
Ondansetrone Hikma should start to work soon after the injection. If you continue to feel sick or
feel unwell, inform your doctor or nurse.

If you use more Ondansetrone Hikma than you should
The doctor or nurse will give you or your child Ondansetrone Hikma, so it is unlikely that you
or your child will receive too much. If you think that you or your child have received too much or
have forgotten a dose, inform your doctor or nurse.

4. Possible side effects

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

Allergic reactions
If you have an allergic reaction, tell your doctor or hospital staff straight away. The symptoms can 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 bumps on the skin (hives) anywhere on your body
collapse.

Other side effects include:
Very common(may affect more than 1 in 10 people)

• headache

Common(may affect up to 1 in 10 people)

• a feeling of warmth or hot flushes
• constipation
• changes in liver function tests (if you are taking ondansetron with a medicine called cisplatin, otherwise this effect is uncommon)
• irritation and redness at the injection site Uncommonmay affect up to 1 in 100 people)
• hiccups
• low blood pressure, which may make you feel weak or dizzy
• irregular heartbeat
• chest pain
• convulsions
• unusual body movements or tremors

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

• feelings of dizziness or lightheadedness
• blurred vision
• heart rhythm problems (sometimes causing sudden loss of consciousness)

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

• poor vision or temporary loss of vision, which usually returns within 20 minutes

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects
Website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ondansetrone Hikma

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Diluted solutions are chemically stable for 24 hours if stored at 2–8 ºC.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
the abbreviation EXP (month) / (year).
The expiry date refers to the last day of that month.

6. Content of the pack and other information

What Ondansetrone Hikma contains

• The active ingredient is ondansetron, in the form of dihydrochloride dihydrate. Each ml of solution contains 2 mg of ondansetron. Each 2 ml vial contains 4 mg of ondansetron and each 4 ml vial contains 8 mg of ondansetron.
• The other ingredients are: sodium chloride, citric acid monohydrate, sodium citrate and water for injections.

Description of the appearance of Ondansetrone Hikma and contents of the pack
Ondansetrone Hikma is a clear and colourless injectable solution, packaged in colourless glass vials
.
Ondansetrone Hikma 4 mg/2 ml injectable solution

Each vial contains 2 ml of solution.

• Pack size: 5 vials

Ondansetrone Hikma 8 mg/4 ml, injectable solution

Each vial contains 4 ml of solution.

• Pack size: 5 vials

Marketing Authorisation Holder and manufacturer responsible for batch release

Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n,º 8, 8A e 8B – Fervença
2705-906 Terrugem SNT
Portugal
Tel.: +351 219 608 410
Fax: +351 219 615 102
[email protected]

Manufacturer responsible for batch release
Hikma Italia S.p.A.
Viale Certosa, 10
27100 Pavia
Italy
Wholesale Licence Holder for Italy
Hikma Italia SpA
Viale Certosa 10
27100 Pavia – Italy
This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Austria: Ondansetron Hikma 4 mg/2 ml & 8 mg/4 ml Injektionslösung
Belgium: Ondansetron Hikma 4 mg/2 ml & 8 mg/4 ml Solution injectable
Germany: Ondansetron Hikma 4 mg/2 ml & 8 mg/4 ml Injektionslösung
Italy: Ondansetrone Hikma 4 mg/2 ml & 8 mg/4 ml Soluzione iniettabile
Netherlands: Ondansetron Hikma 4 mg/2 ml & 8 mg/4 ml Oplossing voor injectie
Portugal: Ondansetron Hikma 4 mg/2 ml & 8 mg/4 ml Solução injetável

This leaflet was last updated on
The following information is intended exclusively for healthcare professionals

Ondansetrone Hikma 4 mg/2 ml injectable solution
Ondansetrone Hikma 8 mg/4 ml injectable solution
Ondansetrone (as dihydrochloride dihydrate)
See the Summary of Product Characteristics (SPC) for further details on this product

Medicinal product name
Ondansetrone Hikma injectable solution

Qualitative and quantitative composition
Ondansetrone Hikma 2 mg/ml
each 2 ml vial contains 4 mg of ondansetron (as dihydrochloride dihydrate) in aqueous solution for
intravenous administration
each 4 ml vial contains 8 mg of ondansetron (as dihydrochloride dihydrate) in aqueous solution for
intravenous administration

Posology and method of administration
Nausea and vomiting induced by chemotherapy and radiotherapy
Adults
The emetogenic potential of antineoplastic therapies varies depending on the doses administered and the type of
combination between the chemotherapy and radiotherapy regimens used. The route of administration and the
dose of Ondansetrone Hikma should be flexible, ranging from 8 to 32 mg/day and chosen as
indicated below,

Emetogenic chemotherapy and radiotherapy:Ondansetrone can be administered by rectal,
oral (tablets or syrup), intravenous or intramuscular injection. However, Ondansetrone
Hikma is only approved for intravenous administration.
In most patients undergoing emetogenic chemotherapy or radiotherapy, Ondansetrone
Hikma 8 mg should be administered by slow intravenous injection (over no less than 30
seconds), immediately before treatment, followed by 8 mg orally every twelve hours.
To prevent delayed or prolonged emesis beyond the first 24 hours, continue oral or rectal treatment
with ondansetron for up to 5 days after the treatment cycle.

Highly emetogenic chemotherapy: in patients receiving highly
emetogenic chemotherapy, e.g. high-dose cisplatin, ondansetron can be administered orally,
rectally, intravenously or intramuscularly. However, Ondansetrone Hikma is only approved for
intravenous administration.
Ondansetrone Hikma has been shown to have the same efficacy in the following regimens for the
first 24 hours of chemotherapy:

• single dose of 8 mg by slow intravenous injection (over no less than 30 seconds) immediately before chemotherapy;
• dose of 8 mg by slow intravenous injection (over no less than 30 seconds) immediately before chemotherapy, followed by two further intravenous administrations of 8 mg at four-hour intervals, or by constant infusion of 1 mg/hour for up to 24 hours;
• maximum initial intravenous dose of 16 mg, diluted in 50-100 ml of physiological saline or other compatible infusion solution (see instructions for use / handling) and infused over a period of not less than 15 minutes, immediately before chemotherapy. An initial dose of ondansetron may be followed by two further doses of 8mg intravenously (over no less than 30 seconds) at four-hour intervals. A single higher dose of more than 16 mg should not be administered due to the dose-dependent increase in the risk of QT interval prolongation (see sections 4.4, 4.8 and 5.1 of the SPC). The choice of therapeutic regimen should be made based on the severity of the emetogenic stimulus. The efficacy of Ondansetrone Hikma in highly emetogenic chemotherapy can be increased by adding a single intravenous dose of 20 mg of desamethasone sodium phosphate, administered before chemotherapy. To prevent delayed or prolonged emesis beyond the first 24 hours, continue oral or rectal treatment with ondansetron for up to 5 days after the treatment cycle.

Paediatric population
CINV in children aged ≥ 6 months and adolescents
The dosage for CINV can be calculated based on body surface area (BSA) or based on
weight – see below.
In paediatric clinical studies, ondansetron was administered via intravenous infusion diluted
in 25- 50 ml of saline or other compatible infusion fluid and infused over no less than 15 minutes.
The dosage based on weight results in higher total doses compared to dosage based on BSA
(see sections 4.4 and 5.1 of the SPC).
Ondansetrone Hikma should be diluted in 5% dextrose or 0.9% sodium chloride solution or other
compatible infusion fluid (see instructions for use / handling) and infused intravenously
over a period of not less than 15 minutes.
There are no data from controlled clinical studies on the use of ondansetron in the prevention of delayed or
prolonged CINV. There are no data from controlled clinical studies on the use of ondansetron for nausea
and vomiting induced by radiotherapy in children.
Dosage by BSA:
Ondansetrone Hikma should be administered immediately before chemotherapy as
a single intravenous dose of 5mg/m². The intravenous dose should not exceed 8 mg.
Oral dosage can start 12 hours later and can be continued for up to 5 days (see SPC for
dosage tables).
The total daily dose for 24 hours (given in divided doses) should not exceed the adult dosage of
32mg.
Dosage based on body weight:
The dosage resulting from body weight leads to higher total daily doses compared to
dosage based on
Ondansetrone Hikma should be administered immediately before chemotherapy as
a single intravenous dose of 0.15 mg/kg. The single intravenous dose should not exceed 8 mg.
Two further intravenous doses may be administered at four-hour intervals. Oral dosage
can start 12 hours later and can be continued for up to 5 days.
The total dosage in 24 hours (given in separate doses) should not exceed the adult dose of 32 mg
(see SPC for further details).

Elderly
In patients aged 65 to 74 years, the adult dosage may be followed. All intravenous doses should be diluted in 50-100ml of saline or other compatible infusion fluid
(see instructions for use / handling) and infused for over 15 minutes.

In patients aged 75 years and over, the initial intravenous dose of Ondansetrone Hikma should not
exceed 8 mg. All administrations must be diluted in 50-100 ml of saline or
other compatible infusion fluid (see instructions for use / handling) and infused for over 15
minutes. The initial dose of 8 mg may be followed by two further intravenous doses of 8 mg, infused
for over 15 minutes and given at intervals of not less than 4 hours (see SPC).

Post-operative nausea and vomiting (PONV)
Adults
For the prevention of PONV, Ondansetrone Hikma can be administered orally or by
intravenous injection.
However, Ondansetrone Hikma is only approved for intravenous administration.
Ondansetrone Hikma can be administered as a single dose of 4 mg by slow intravenous injection at the time of induction of anaesthesia.
For the treatment of manifest PONV: a single dose of 4 mg by slow intravenous injection is recommended.

Paediatric population
PONV in children aged ≥ 1 month and adolescents
For the prevention of PONV in children undergoing surgery under general anaesthesia, a
single dose of Ondansetrone Hikma can be administered by slow intravenous injection
(no less than 30 seconds) at a dose of 0.1 mg/kg, up to a maximum of 4 mg, before, during or
after induction of anaesthesia. For the treatment of PONV after surgery in children who have
undergone surgical operation under general anaesthesia, a single dose of ondansetron can be
administered by slow intravenous injection (no less than 30 seconds) at a dosage of

• 0.1mg/kg up to a maximum of 4mg. There are no data relating to the use of Ondansetrone Hikma for the treatment of PONV in children under 2 years of age. ElderlyExperience with the use of Ondansetrone Hikma for the prevention and treatment of PONV in the elderly is limited; however, Ondansetrone Hikma is well tolerated in patients over 65 years of age undergoing chemotherapy.

For all indications:

Special precautions for disposal and other handling
Single-use. Unused medicinal product and waste materials derived from such medicinal product must be disposed of in
accordance with local regulations.
Visually inspect the solution before use. Use only solutions that are clear, practically
free of particles.

Compatibility with solutions for intravenous administration
Ondansetron Hikma can only be mixed with solutions that are recommended:

• 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) solution for intravenous infusion
• potassium chloride 0.3% (w/v) and glucose 5% (w/v) solution for intravenous infusion

For good pharmaceutical practice, dilutions of Ondansetron Hikma injectable in liquids for
intravenous administration should be prepared at the time of infusion or stored at
2-8 ° C for no more than 24 hours before the start of administration
Compatibility with other medicines
Ondansetron can be administered via intravenous infusion at 1 mg/hour, for example from
an infusion bag or a syringe pump. The following medicines can only be
administered through the Y-piece of an infusion set for Ondansetron Hikma with
ondansetron concentrations between 16 and 160 µg/ml (i.e. 8 mg/500 ml and 8 mg/50 ml,
respectively).

Cisplatin –Concentrations up to 0.48 mg/ml (i.e. 240 mg in 500 ml) administered over

• 1 - 8 hours.

5-Fluorouracil –Concentrations up to 0.8 mg/ml (i.e. 2.4 g in 3 liters or 400 mg in 500 ml)
administered at a rate of at least 20 ml/h (500 ml/24 h). Higher concentrations of
5-fluorouracil may cause precipitation of ondansetron. The infusion of
5-fluorouracil may contain up to 0.045% w/v of magnesium chloride, in addition to other compatible excipients.

Carboplatin –Concentrations between 0.18 mg/ml and 9.9 mg/ml (i.e. from 90 mg in 500 ml to
990 mg in 100 ml), administered over 10 minutes-1 hour.

Etoposide –Concentrations between 0.144 mg/ml and 0.250 mg/ml (i.e. from 72 mg in 500 ml to
250 mg in 1 liter), administered over 30 minutes - 1 hour.

Ceftazidime –Doses between 250 mg and 2000 mg, reconstituted with water for injections
as recommended by the manufacturer (i.e. 2.5 ml for 250 mg and 10 ml for 2 g of
ceftazidime) and administered as an intravenous bolus over approximately 5 minutes.

Cyclophosphamide –Doses between 100 mg and 1 g, reconstituted with water for injections,
5 ml per 100 mg of cyclophosphamide, as recommended by the manufacturer and administered
as an intravenous bolus over approximately 5 minutes.

Doxorubicin -Doses between 10 mg and 100 mg, reconstituted with water for injections,
5 ml per 10 mg of doxorubicin, as recommended by the manufacturer and administered
as an intravenous bolus over approximately 5 minutes.

Dexamethasone -Dexamethasone sodium phosphate 20 mg can be administered via slow intravenous injection for 2-5 minutes through the Y-piece of an infusion set releasing 8 or 16
mg of ondansetron diluted in 50-100 ml of a compatible infusion solution over a
period of approximately 15 minutes.
The compatibility between dexamethasone sodium phosphate and ondansetron has been shown to support the
administration of these drugs through the same administration set resulting in
concentrations of 32 micrograms – 2.5mg/ml for dexamethasone sodium phosphate and 8 micrograms –
1mg/ml for ondansetron.

Period of validity
3 years

Special precautions for storage
This medicine does not require any particular storage conditions.