ONDANSETRONE 2 mg /Ml Injectable Or Infusion Solution

Зміст інструкції

1. Ondansetrone Aurobindo 2 mg/ml injectable solution or infusion
   1. What is Ondansetrone Aurobindo and what it is used for
   2. What you need to know before you are given Ondansetrone Aurobindo
   3. How to use Ondansetrone Aurobindo
   4. Possible side effects
   5. How to store Ondansetrone Aurobindo
   6. Contents of the pack and other information
2. Ondansetrone Aurobindo 2 mg/ml is available in filling volumes in vials of 2 ml and

Ondansetrone Aurobindo 2 mg/ml injectable solution or infusion

Generic medicine

Read this leaflet carefully before you start to use 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 or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

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

Ondansetrone injection contains the active ingredient ondansetrone, which belongs to a
group of medicines called antiemetics.
Ondansetrone injection is used:

• to prevent nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only);
• to prevent nausea and vomiting after surgery in adults and children aged ≥ 1 month. If you would like more information on these uses, please contact your doctor, nurse or pharmacist.

2. What you need to know before you are given Ondansetrone Aurobindo

Do not use Ondansetrone Aurobindo:

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

If you have any doubts, ask your doctor, nurse or pharmacist before you are
given an injection of Ondansetron Aurobindo.

Warnings and precautions
Talk to your doctor or nurse before using Ondansetrone Aurobindo:

• If you have liver problems.
• If you have ever suffered from heart problems (e.g. congestive heart failure causing shortness of breath and swollen ankles).
• If you have an irregular heartbeat (arrhythmia).
• If you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron (Do not use Ondansetrone Aurobindo).
• If you suffer from chronic constipation.
• If you have a bowel obstruction.
• If you suffer from disorders in the levels of salts in your blood, such as potassium, sodium and magnesium.
• Preventing nausea and vomiting with ondansetron may mask occult bleeding after tonsillectomy surgery. Therefore, these patients must be carefully monitored after the administration of ondansetron.

If you are not sure if any of the above applies to you, ask your doctor, nurse or
pharmacist before you are given an injection of Ondansetron Aurobindo.

Other medicines and Ondansetrone Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines, including medicines you buy without a prescription and
herbal medicines. Indeed, ondansetron can affect the way some
medicines work. Also, some other medicines can affect the way
ondansetron works.
In particular, it is important that you tell your doctor, nurse and pharmacist if you are

• carbamazepine or phenytoin 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-blockers used to treat some heart or eye problems, anxiety or to prevent migraine;
• tramadol, a painkiller;
• medicines that have effects on the heart (such as haloperidol or methadone);
• cancer medicines (especially anthracyclines and trastuzumab);
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression including venlafaxine, duloxetine;
• You must not use ondansetron if you are taking apomorphine for Parkinson's disease.

If you are not sure if any of the above applies to you, ask your doctor, nurse
or pharmacist before you are given an injection of Ondansetron Aurobindo.
The injection of Ondansetron Aurobindo must not be administered in the same syringe or
infusion (drip) with other medicines.

Pregnancy and breastfeeding
Pregnancy:
Ondansetrone Aurobindo should not be used during the first trimester of
pregnancy, because Ondansetrone Aurobindo may slightly increase the risk that the
baby is born with cleft lip and/or cleft palate (splits or openings in the upper lip
and/or palate). If you are already pregnant, think you might be pregnant or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking Ondansetrone
Aurobindo. if you are a woman of childbearing potential, you may be advised to use effective
contraceptive measures.

Breastfeeding:
Do not breastfeed if you have been treated with Ondansetrone Aurobindo, as small amounts
pass into breast milk. Ask your doctor or midwife for advice.

Fertility:
No data are available on the effects of ondansetron on fertility in humans.

Driving and using machines
Ondansetron does not alter or alters negligibly the ability to drive vehicles or
use machines.

Ondansetrone Aurobindo contains sodium
This medicine contains 2.5 mmol (or 57.0 mg) of sodium per maximum daily dose
of 32 mg. To be taken into consideration in people who are on a low sodium diet.

3. How to use Ondansetrone Aurobindo

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor, pharmacist or nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
It is usually administered by a doctor or a nurse. The prescribed dose will depend on the treatment you are undergoing.

To prevent nausea and vomiting due to chemotherapy or radiotherapy
On the day of chemotherapy or radiotherapy

• The usual dose in adults is 8 mg administered by injection into a vein or into the muscle, just before treatment and another dose of 8 mg 12 hours later.

On subsequent days

• The intravenous dose in adults should not exceed 8 mg.
• This may be administered for a period of up to 5 days.

If it is expected that chemotherapy or radiotherapy will cause severe nausea and vomiting, you may be given a higher dose of Ondansetrone Aurobindo than usual. Your doctor will decide this.

To prevent nausea and vomiting due to chemotherapy in children over 6 months of age and in adolescents
The 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 administered as a slow injection into a vein, just before treatment of your child. After chemotherapy, the medicine of your child will be administered orally. The usual dose is 4 mg.

To prevent nausea and vomiting after surgery
Adults:

• The usual dose in adults is 4 mg administered by slow injection into a vein or by injection into the muscle. For prevention, it will be administered just before surgery.

Children (over 1 month of age) and adolescents:
The doctor will decide the dose for children over 1 month of age and for adolescents. The maximum dose is 4 mg administered as a slow injection into a vein. For prevention, it will be administered just before surgery.

Patients with impaired renal function
No dose adjustment is required.

Patients with moderate or severe liver problems
The total dose should not exceed 8 mg.

If you continue to have nausea or vomiting
The injection of Ondansetrone Aurobindo should start to take effect immediately after the injection. If you continue to have nausea or vomiting, inform your doctor or nurse.

If you take more Ondansetrone Aurobindo than you should
Because the doctor or nurse will administer the ondansetron injection to you or your child, it is unlikely that you or your child will receive an excessive dose. If you believe that you or your child has received an excessive dose or has missed one, inform your doctor or nurse. In some patients, the following effects have been observed after overdose: visual disturbances, severe constipation, low blood pressure, heart rhythm disturbances and loss of consciousness.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Allergic reactions
If you have an allergic reaction, inform your doctor or a member of the medical staff immediately. The
signs include:

• sudden shortness of breath and chest pain or tightness;
• swelling of eyelids, face, lips, mouth or tongue;
• skin rash - red spots and bumps under the skin (hives) all over the 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):

• Feelings of flushing or warmth.
• Constipation.
• Changes in liver function test results (if you have been given ondansetron injection 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):

• Convulsions.
• Unusual body movements or tremor.
• Irregular heartbeat.
• Chest pain.
• Low blood pressure which may cause you to faint or feel dizzy.
• Hiccups.
• Hypersensitivity reactions around the administration site (e.g. rash, hives, itching) which sometimes extends along the vein into which the medicine was administered.
• Abnormal blood test results to check liver function.

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

• Feeling dizzy or confused.
• Blurred vision.
• Heart rhythm disorders (which sometimes cause a sudden loss of consciousness).
• Diarrhoea and abdominal pain.

Very rare (may affect up to 1 in 10,000), including isolated cases:

• Vision disturbances or temporary loss of vision, which usually returns within 20 minutes.
• Depression.
• Widespread rash with blisters and peeling of the skin on large areas of the body (toxic epidermal necrolysis).

Not known (frequency cannot be estimated from the available data)
Myocardial ischemia
The signs include:

• sudden chest pain or
• chest tightness.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects
directly through the national reporting system at
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 Ondansetrone Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store the vials in the package to protect the medicine from light.
Do not use this medicine if you notice the presence of particles or changes in color.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ondansetrone Aurobindo contains
The active ingredient is ondansetron (as dihydrochloride dihydrate).
Each ml of injectable or infusion solution contains 2 mg of ondansetron (as
ondansetron dihydrochloride dihydrate).

• Each 2 ml vial contains 4 mg of ondansetron (as ondansetron dihydrochloride dihydrate).
• Each 4 ml vial contains 8 mg of ondansetron (as ondansetron dihydrochloride dihydrate).
• The other components are citric acid monohydrate, sodium citrate, sodium chloride, water for injections.

Description of the appearance of Ondansetrone Aurobindo and contents of the pack
Injectable or infusion solution.
Clear and transparent solution free from visible particles.
Ondansetrone Aurobindo is a clear, colorless injectable or infusion solution
contained in transparent type I glass vials. To facilitate breakage, the vials may
have a pre-break point (One-Point cut (OPC) opening system) or may be
“scored”.

Ondansetrone Aurobindo 2 mg/ml is available in filling volumes in vials of 2 ml and

4 ml packaged in boxes of 1, 5 or 10 vials.
It is possible that not all packages are marketed.

Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1914, Malta

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Belgium: Ondansetron Eugia 2 mg/ml solution for injection or infusion/solution
injectable ou pour perfusion/Injektions-/Infusionslösung
Germany: Ondansetron Aurobindo 2 mg/ml Injektions-/Infusionslösung
Italy: Ondansetrone Aurobindo
Luxembourg: Ondansetron Eugia 2 mg/ ml solution injectable ou pour perfusion
Portugal: Ondansetrom Aurovitas
Spain: Ondansetrón Aurovitas 2 mg/ml solución inyectable y para perfusión
EFG

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The following information is intended exclusively for physicians or healthcare professionals:
Chemotherapy- and radiotherapy-induced nausea and vomiting:

Adults:The emetogenic potential of the anticancer treatment varies depending on the doses and
combinations of chemotherapy and radiotherapy regimens used. The route of
administration and the dose of ondansetron must be flexible within the range of 8-32
mg/day and selected as described below.

Emetogenic chemotherapy and radiotherapy:
For most patients undergoing emetogenic chemotherapy or radiotherapy,
ondansetron 8 mg should be administered as a slow intravenous (over no
less than 30 seconds) or intramuscular injection or via other routes of administration within
at least 15 minutes before treatment. However, this medicinal product is
exclusively for injection or for infusion.
To protect against delayed or prolonged vomiting after the first 24 hours, oral treatment with
ondansetron should be continued for up to 5 days after a treatment cycle.
Highly emetogenic chemotherapy: For patients undergoing highly
emetogenic chemotherapy, for example high-dose cisplatin, ondansetron may be administered
by intravenous or intramuscular route.
Ondansetron has been shown to be equally effective after the first 24 hours of
chemotherapy in the following dosage regimen:

• A single dose of 8 mg via a slow intravenous injection (over no less than 30 seconds) or intramuscular injection within at least 15 minutes before chemotherapy.
• A dose of 8 mg via a slow intravenous injection (over no less than 30 seconds) or intramuscular injection within at least 15 minutes before chemotherapy, followed by two further intravenous (over no less than 30 seconds) or intramuscular doses of 8 mg at intervals of not less than four hours or a constant infusion of 1 mg/hour for up to 24 hours.
• Doses greater than 8 mg and up to a maximum of 16 mg diluted in 50-100 ml of physiological saline or another compatible liquid infusion solution (see Instructions for use/handling) and infused over no less than 15 minutes before chemotherapy.
• Single doses greater 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 SmPC).

The selection of the dosage regimen should be determined based on the severity of the emetogenic
potential.
The efficacy of ondansetron in highly emetogenic chemotherapy may be
increased by the addition of an intravenous dose of sodium desamethasone phosphate, 20 mg
administered before chemotherapy.
To protect against delayed or prolonged vomiting after the first 24 hours, oral treatment with
ondansetron should be continued for up to 5 days after a treatment cycle.

Paediatric population:
CINV in children ≥ 6 months and adolescents
The dose for CINV can be calculated based on body surface area (BSA) or
weight - see below.
In paediatric clinical studies, ondansetron was administered by IV infusion
diluted in 25-50 ml of physiological saline or other compatible infusion fluid and infused in
a period of no less than 15 minutes.
The weight-based dose involves higher total daily doses if compared to the BSA-based dose – see sections 4.4 and 5.1.
Ondansetron hydrochloride should be diluted in 5% glucose or 0.9% sodium chloride or in
another compatible infusion fluid (see Instructions for use/handling) and infused
intravenously for no less than 15 minutes.
There are no data from controlled clinical studies on the use of injectable ondansetron in
the prevention of chemotherapy-induced delayed or prolonged nausea and vomiting. There are no
data from controlled clinical studies on the use of injectable ondansetron for radiotherapy-induced nausea and
vomiting in children.
Dosage with BSA:
Ondansetron should be administered immediately before chemotherapy in
a single intravenous dose of 5 mg/m². The intravenous dose should not exceed 8 mg. The
oral dosage may start twelve hours later and may be continued for up to 5 days (see
the SmPC for dosage tables). The total daily dose should not exceed the adult dose of 32 mg.
Dosage with body weight:
The weight-based dosage involves higher daily doses if compared to the
dosage based on BSA. Injectable ondansetron should be administered
immediately before chemotherapy with a single intravenous dose of 0.15 mg/kg. The
intravenous dose should not exceed 8 mg. Two further intravenous doses may be administered
at intervals of 4 hours. Oral dosage may start twelve hours later and may be
continued for up to 5 days. The total dose in 24 hours (administered in separate doses) should
not exceed the adult dose of 32 mg (see the SmPC for further details).

Elderly
In patients aged between 65 and 74 yearsthe intended dose schedule for adults can be followed.
All intravenous doses must be diluted in 50-100 ml of physiological saline or another compatible infusion fluid (see Instructions for
use/handling) and infused over a period of 15 minutes.

In patients aged 75 years or over, the initial intravenous dose of ondansetron
should not exceed 8 mg. All intravenous doses must be diluted in 50-100 ml of
physiological saline or another compatible infusion fluid (see Instructions for
use/handling) and infused over a period of 15 minutes. The initial dose of 8 mg may be
followed by two further intravenous doses of 8 mg, infused for 15 minutes and administered at
intervals of not less than four hours (see SmPC).
Post-operative nausea and vomiting (PONV):

Adults:For the prevention of PONV, ondansetron can be administered orally
or by intravenous or intramuscular injection .
Ondansetron Aurobindo can be administered as a single dose of 4 mg by slow intravenous or intramuscular injection at the time of anaesthesia.
For the treatment of already established PONV, a single dose of 4 mg is recommended
via an intramuscular or slow intravenous injection.

Children (age ≥1 month and adolescents)

Injection
For the prevention of PONV in paediatric patients undergoing surgery
performed under general anaesthesia, a single dose of ondansetron may 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 paediatric patients undergoing surgery
performed under general anaesthesia, a single dose of ondansetron may 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. There are no data on the use of injectable ondansetron for the
treatment of post-operative vomiting in children under 2 years of age.
Elderly :There is limited experience with the use of ondansetron in the prevention and
treatment of PONV in the elderly, however ondansetron is well tolerated in patients over 65 years of age undergoing chemotherapy.

For all indications:

Patients with renal impairment:no alteration of the daily dose or
frequency of doses or route of administration is required.

Patients with hepatic impairment:the clearance of ondansetron is significantly
reduced and the serum half-life is significantly prolonged in subjects with moderate to severe hepatic impairment. In these patients, the total daily dosage
should not exceed 8 mg.

Patients with reduced sparteine/debrisochine metabolism:the elimination half-life
of ondansetron is not altered in subjects classified as poor metabolisers of
sparteine and debrisochine. Consequently, in these patients a repeated dose will provide
exposure levels that are not different from those of the general population. No
modification of the daily dose or frequency of doses is required.
The ondansetron injection/infusion solution should not be autoclaved.

Incompatibilities
The ondansetron injection/infusion solution is physically compatible and
chemically stable when mixed with the following infusion solutions
within the concentration range of 0.016-0.64 mg/ml:

• 0.9% w/v Sodium chloride
• 5% w/v Glucose
• 10% w/v Mannitol
• Ringer's solution
• 0.3% w/v Potassium chloride and 0.9% w/v Sodium chloride
• 0.3% w/v Potassium chloride and 5% w/v Glucose

Compatibility studies with the aforementioned diluents have been conducted in polyvinyl chloride infusion bags and polyvinyl chloride administration kits. Adequate stability is also believed to be conferred by the use of polyethylene infusion bags or type I glass vials. Dilutions of ondansetron injection/infusion solutions in 0.9% w/v Sodium Chloride intravenous infusion or 5% w/v
Glucose intravenous infusion have been shown to be stable in polypropylene syringes. Solutions of ondansetron injection/infusion diluted with other compatible infusion fluids are believed to be stable in polypropylene syringes.

Shelf life and storage
Unopened: 3 years.
Injection: After first opening, the medicinal product must be used immediately.
Infusion: Chemical and physical stability during use has been demonstrated for 7 days at 15-25°C and
at 2-8°C.
From a microbiological point of view, the product must be used immediately. If
not used immediately, storage times in use and conditions before use
are the responsibility of the user and generally should not exceed 24
hours at 2-8°C, unless the dilution has been carried out in controlled and validated aseptic conditions.