PALONOSETRON 250 MICROGRAMS Инъекционный раствор

Содержание инструкции

1. Palonosetron Fresenius Kabi 250 micrograms injectable solution
   1. What is Palonosetron and what is it used for
   2. What you need to know before you use Palonosetron
   3. How to use Palonosetron
   4. Possible side effects
   5. How to store Palonosetron
   6. Package Contents and Other Information
2. Palonosetron Fresenius Kabi 250 micrograms injectable solution in pre-filled syringe
   1. What is Palonosetron and what is it used for?
   2. What you need to know before you use Palonosetron
   3. How to use Palonosetron
   4. Possible side effects
   5. How to store Palonosetron
   6. Contents of the pack and other information

Palonosetron Fresenius Kabi 250 micrograms injectable solution

Generic medicine

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

The name of the medicine is Palonosetron Fresenius Kabi 250 micrograms solution
Contents of this leaflet

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

1. What is Palonosetron and what is it used for

Palonosetron belongs to a category of medicines known as serotonin antagonists
(5HT ).
These medicines have the ability to block the action of serotonin, a chemical substance, which
can cause nausea and vomiting.
Palonosetron is used for the prevention of nausea and vomiting associated with oncological chemotherapy
in adults, adolescents and children over one month of age.

2. What you need to know before you use Palonosetron

Do not use Palonosetron:

• If you are allergic to palonosetron or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Palonosetron:

• if you have acute intestinal obstruction or a history of repeated constipation;
• if you use Palonosetron in addition to other medicines that can cause an abnormal heart rhythm, such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone;
• if you have a personal or family history of heart rhythm disturbances (prolongation of the QT interval);
• if you have other heart problems;
• if you have an imbalance of certain minerals in the blood, such as potassium and magnesium, which has not been treated.

The use of Palonosetron is not recommended in the days following chemotherapy, unless
you need to undergo another cycle of chemotherapy.

Other medicines and Palonosetron
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including:

• • SSRIs (selective serotonin reuptake inhibitors) used for the treatment of depression and/or anxiety, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• SNRIs (serotonin-noradrenaline reuptake inhibitors) used for the treatment of depression and/or anxiety, including venlafaxine, duloxetine.

Pregnancy and breastfeeding
If you are pregnant or suspect you are pregnant, your doctor will not give you
Palonosetron unless it is absolutely necessary.
It is not known whether Palonosetron causes harmful effects if used during pregnancy.
It is not known whether Palonosetron passes into breast milk.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Palonosetron can cause dizziness or fatigue. If you experience these symptoms, do not drive vehicles and
do not use tools or machinery.

Palonosetron contains sodium
This medicine contains 0.04 mmol (or 0.91 mg) of sodium per ml. The maximum dose for children
contains 1.19 mmol (or 27.3 mg) of sodium. To be taken into consideration for patients on a
controlled sodium diet.

3. How to use Palonosetron

The doctor or nurse will normally inject Palonosetron approximately 30 minutes before the start of
chemotherapy.

Adults
The recommended dose of Palonosetron in adults is 250 micrograms administered as a
rapid injection into a vein.

Children and adolescents (from 1 month to 17 years of age):
The doctor will decide the dose based on body weight, however the maximum dose is 1500 micrograms.
Palonosetron Fresenius Kabi will be administered as a slow infusion into a vein.
If you have any doubts about the use of this medicine, please consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects and their frequencies are listed below:

Adults
Common(may affect up to 1 in 10 people):

• headache
• dizziness
• constipation and diarrhoea

Uncommon(may affect up to 1 in 100 people):

• low or high blood pressure
• abnormal heart rate or lack of blood flow to the heart
• alteration of the vein colour and/or enlargement of the veins
• exceptionally high or low potassium levels in the blood
• high blood sugar levels or presence of sugar in the urine
• low calcium levels in the blood
• high levels of the pigment bilirubin in the blood
• high levels of certain liver enzymes
• euphoric mood or feelings of anxiety
• sleepiness or difficulty sleeping
• decreased or loss of appetite
• weakness, fatigue, fever or flu-like symptoms
• sensations of numbness, burning, itching or tingling on the skin
• itchy rash
• altered vision or eye irritation
• motion sickness
• ringing in the ears
• hiccups, flatulence (intestinal gas), dry mouth or indigestion
• abdominal (stomach) pain
• difficulty urinating
• joint pain
• • abnormalities in the electrocardiogram (QT prolongation)

Very rare(may affect up to 1 in 10,000):
Allergic reactions to Palonosetron (signs may include swelling of the lips, face,
tongue or throat, difficulty breathing or collapse, you may also notice a rash
with the formation of nodules and itching (urticaria)), burning or pain at the injection site.

Children and adolescents
Common(may affect up to 1 in 10 people):

• headache

Uncommon(may affect up to 1 in 100 people):

• dizziness
• jerky body movements
• irregular heart rate
• cough or shortness of breath
• nosebleed
• itchy rash or urticaria
• fever
• pain at the infusion site

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store Palonosetron

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 label. The expiry date refers to the last day of that month.
Do not use this medicine if the solution is not clear or has visible particles.
This medicine does not require any particular storage conditions.
Single use only, any unused solution should be discarded.
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. Package Contents and Other Information

What Palonosetron Contains

• The active ingredient is palonosetron (as hydrochloride). Each ml of solution contains 50 micrograms of palonosetron. Each vial containing 5 ml of solution contains 250 micrograms of palonosetron.
• The other ingredients are mannitol (E421), sodium edetate dihydrate, sodium citrate dihydrate (E331), anhydrous citric acid (E330) and water for injections, sodium hydroxide (to adjust the pH), hydrochloric acid (to adjust the pH).

Description of Palonosetron and Package Contents
Palonosetron injectable solution is a clear, colorless solution and is supplied in glass vials
for single use, closed with a halobutyl rubber stopper and an aluminum crimp and a plastic
tear-off cap.
Pack sizes
1 or 10 vials
Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala
Verona

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36 A-8055 Graz, Austria

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:

-----------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:

Dosage and Administration

Adults
250 micrograms of palonosetron administered as a single intravenous bolus, approximately 30 minutes
before the start of chemotherapy. Palonosetron Fresenius Kabi should be injected over
30 seconds.

Elderly
No dose adjustment is necessary for the elderly.

Children and adolescents (from 1 month to 17 years of age):
20 micrograms/kg (the total maximum dose should not exceed 1500 micrograms) of palonosetron,
administered as a single 15-minute intravenous infusion starting approximately 30 minutes
before the start of chemotherapy.

Incompatibilities
This medicinal product must not be mixed with other medicinal products.

Special Precautions for Storage
This medicinal product does not require any special storage conditions.

Special Precautions for Disposal and Handling
For single use only, unused solution must be discarded.
Unused medicinal product and waste materials derived from such medicinal product should be disposed of
in accordance with local regulations.

Palonosetron Fresenius Kabi 250 micrograms injectable solution in pre-filled syringe

Read this leaflet carefully before you 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

The name of the medicine is Palonosetron Fresenius Kabi 250 micrograms solution
Contents of this leaflet

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

2. What is Palonosetron and what is it used for?

Palonosetron belongs to a category of medicines known as serotonin antagonists
(5HT).
These medicines have the ability to block the action of serotonin, a chemical substance, which
can cause nausea and vomiting.
Palonosetron is used for the prevention of nausea and vomiting associated with oncological chemotherapy
in adults.

4. What you need to know before you use Palonosetron

Do not use Palonosetron:

• If you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you use Palonosetron:

• if you have acute intestinal obstruction or a history of recurrent constipation;
• if you use Palonosetron in addition to other medicines that can cause an abnormal heart rhythm, such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone;
• if you have a personal or family history of heart rhythm disturbances (QT prolongation);
• if you have other heart problems;
• if you have an imbalance of certain minerals in the blood, such as potassium and magnesium, which has not been treated. Palonosetron is not recommended in the days following chemotherapy, unless you are to undergo another cycle of chemotherapy.

Children and adolescents
The use of Palonosetron Fresenius Kabi in prefilled syringes is not recommended in children
and adolescents. Palonosetron Fresenius Kabi in
glass vials can be used for this population.

Other medicines and Palonosetron
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including:

• • SSRIs (selective serotonin reuptake inhibitors) used for the treatment of depression and/or anxiety, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• SNRIs (serotonin-norepinephrine reuptake inhibitors) used for the treatment of depression and/or anxiety, including venlafaxine, duloxetine.

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, your doctor will not give you
Palonosetron unless it is absolutely necessary.
It is not known whether Palonosetron causes harmful effects when used during pregnancy.
It is not known whether Palonosetron passes into breast milk.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Palonosetron can cause dizziness or fatigue. If you experience these symptoms, do not drive vehicles and
do not use tools or machinery.

Palonosetron contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per prefilled syringe, therefore it is
essentially ‘sodium-free’.

5. How to use Palonosetron

The doctor or nurse will normally inject Palonosetron approximately 30 minutes before the start of
chemotherapy.
The recommended dose of Palonosetron in adults is 250 micrograms administered as a
rapid injection into a vein.
For children and adolescents, Palonosetron Fresenius Kabi in vials must be used.
If you have any doubts about the use of this medicine, please consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone
experiences them.
Possible side effects and their frequencies are listed below:

Common(may affect up to 1 in 10 people):

• headache
• dizziness
• constipation and diarrhoea

Uncommon(may affect up to 1 in 100 people):

• low or high blood pressure
• abnormal heart rate or lack of blood flow to the heart
• alteration of the colour of the vein and/or enlargement of the veins
• exceptionally high or low potassium levels in the blood
• high blood sugar levels or presence of sugar in the urine
• low calcium levels in the blood
• high levels of the pigment bilirubin in the blood
• high levels of some liver enzymes
• euphoric mood or feelings of anxiety
• sleepiness or difficulty sleeping
• decreased or loss of appetite
• weakness, fatigue, fever or flu-like symptoms
• sensations of numbness, burning, itching or tingling on the skin
• itchy rash
• altered vision or eye irritation
• motion sickness
• ringing in the ears
• hiccups, flatulence (intestinal gas), dry mouth or indigestion
• abdominal (stomach) pain
• difficulty urinating
• joint pain
• • abnormalities in the electrocardiogram (prolongation of the QT interval)

Very rare(may affect up to 1 in 10,000):
Allergic reactions to Palonosetron (signs may include swelling of the lips, face,
tongue or throat, difficulty breathing or collapse, you may also notice a rash
with the formation of nodules and itching (urticaria)), burning or pain at the injection site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Palonosetron

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 label. The expiry date refers to the last day of that month.
Do not use this medicine if the solution is not clear or has visible particles.
This medicine does not require any particular storage conditions.
Single use only, any unused solution should be discarded.
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. Contents of the pack and other information

What Palonosetron contains

• The active substance is palonosetron (as hydrochloride). Each ml of solution contains 50 micrograms of palonosetron. Each pre-filled syringe of 5 ml of solution contains 250 micrograms of palonosetron.
• The other ingredients are mannitol (E421), sodium edetate dihydrate, sodium citrate dihydrate (E331), anhydrous citric acid (E330) and water for injections, sodium hydroxide (to adjust the pH), hydrochloric acid (to adjust the pH).

Description of Palonosetron and contents of the pack
Palonosetron solution for injection in a pre-filled syringe is a clear, colourless solution and is supplied
in a plastic syringe pre-filled with a chamber made of cycloolefin copolymer material
and a rubber plunger and cap of halobutyl rubber.
Pack sizes
1 or 10 pre-filled syringes
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala
Verona

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36 A-8055 Graz, Austria

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

-----------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals:

Posology and method of administration

Adults
250 micrograms of palonosetron administered as a single intravenous bolus, approximately 30 minutes
before the start of chemotherapy. Palonosetron Fresenius Kabi should be injected
over 30 seconds.

Elderly population
No dose adjustment is necessary for the elderly.

Incompatibilities
This medicine must not be mixed with other medicines.

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

Special precautions for disposal and handling
For single use only, unused solution must be discarded.
Unused medicinal product and waste materials derived from such medicinal product should be disposed of
in accordance with local regulations.

Use of pre-filled syringes:
Sterility must be ensured. The outer surface of the syringe and the plunger are not sterile!

• 1) Take the syringe from the packaging
• 2) Remove the cap from the syringe and connect the infusion line, needle or cannula to the syringe. Remove the air bubble (a small bubble may remain) and the syringe ready for use will be administered manually.