250 micrograms solution for injection
palonosetron
What Palonosetron is and what it is used for
Palonosetron contains the active substance palonosetron. It belongs to a group of medicines called serotonin – ( 5HT 3 ) antagonist er.
Palonosetron is used in adults, adolescents, and children over one month of age to prevent nausea and vomiting during so-called chemotherapy ( chemotherapy ) against cancer.
It works by blocking the activity of the chemical substance serotonin, which can make you feel sick or vomit.
Palonosetron contained in Palonosetron Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Palonosetron
Do not use Palonosetron
- you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
You will not receive Palonosetron if any of the above apply to you. If you are not sure, talk to your doctor or nurse before taking this medicine.
Warnings and cautions
Talk to your doctor or nurse before using Palonosetron if:
- you have an obstruction in the intestine or have had constipation repeatedly in the past.
- you have had heart problems or if there are heart problems in the family, such as a change in heart rate (“extended QT interval”).
- You have an imbalance of certain minerals in the blood that has not been treated, such as potassium and magnesium.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before taking Palonosetron.
Other medicines and Palonosetron
Tell your doctor if you are taking, have recently taken, or might take any other medicines. You must tell us if you are taking the following medicines:
Medicines for depression or anxiety
Tell your doctor or nurse if you are taking any medicines for depression or anxiety, for example:
- so-called SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine , sertraline, fluvoxamine, citalopram, escitalopram
- so-called SNRIs (serotonin noradrenaline reuptake inhibitors) such as venlafaxine, duloxetine (may lead to the development of serotonin syndrome and should be used with caution).
Drugs that can affect the heartbeat
Tell your doctor or nurse if you are taking any other medicines that may affect your heart rate – you may have heart problems if you take them with Palonosetron. These are:
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before taking Palonosetron – you may have heart problems if you take these medicines with Palonosetron.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
The reason is that it is not known whether Palonosetron can harm the baby.
It is not known if Palonosetron passes into breast milk.
Driving and using machines
You may feel dizzy or tired after taking this medicine. If this happens, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Palonosetron contains sodium
This medicine contains 4.55 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 0.23% of the highest recommended daily intake of sodium for adults.
How to use Palonosetron
Palonosetron is usually given by a doctor or nurse.
- You will receive the medicine about 30 minutes before the start of chemotherapy.
Adults
- The recommended dose of Palonosetron is 250 micrograms.
- It is given as an injection to a friend.
Children and adolescents (from 1 month to 17 years of age)
- The doctor calculates the correct dose based on body weight.
- The maximum dose is 1500 micrograms.
- Palonosetron is given as a drip (a slow infusion into a vein).
You should not receive Palonosetron in the next few days after a chemotherapy treatment unless you are to receive another round of chemotherapy.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may be caused by this medicine:
Serious side effects are
Tell your doctor immediately if you get any of the following serious side effects:
Tell your doctor immediately if you get any of the side effects listed above.
Other side effects ar
Tell your doctor if you get any of the following side effects:
Common: may affect up to 1 in 10 users
- headache, dizziness
- constipation, diarrhea
Uncommon: may affect up to 1 in 100 people
- high or low blood pressure
- abnormal heart rate or insufficient blood supply to the heart
- abnormally high or low levels of potassium in the blood
- high levels of sugar in the blood or sugar in the urine
- low levels of calcium in the blood
- high levels of the pigment bilirubin in the blood
- high levels of certain liver enzymes
- abnormal ECG ( electrocardiogram ) ( QT prolongation).
Very rare: may affect up to 1 in 10,000 people
- burning, pain, or redness at the injection site.
Additional side effects are in children and adolescents
Common: may affect up to 1 in 10 users
- headache
Uncommon: may affect up to 1 in 100 people
- dizziness
- jerky body movements
- abnormal heart rate
- cough or shortness of breath
- nosebleeds
- itchy skin rash or hives
- fever
- pain at the infusion site
Tell your doctor if you get any of the side effects listed above.
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 vial and carton after EXP. day. or EXP. The expiration date is the last day of the specified month.
Do not use this medicine if the solution is not clear or if it has visible particles.
This medicine does not require any special storage instructions.
For single use only, any remaining solution is discarded.
Contents of the pack and other information
Content declaration
- The active substance is palonosetron (as hydrochloride)
- Each ml of solution contains 50 micrograms of palonosetron. Each vial of 5 ml solution contains 250 micrograms of palonosetron.
- The other ingredients are mannitol (E421), disodium edetate, sodium citrate (E331), citric acid (E330) and water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).
What the medicine looks like and the contents of the pack
Palonosetron solution for injection is a clear, colorless solution and is supplied in disposable glass vials with halobutyl rubber stoppers and closed with a removable aluminum plastic cap.
Pack sizes:
1 or 10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria