250 micrograms solution for injection
palonosetron
What Palonosetron Accord is and what it is used for
Palonosetron Accord belongs to a group of medicines called serotonin ( 5HT 3 ) antagonists.
They can block the action of the chemical serotonin which can cause nausea and vomiting.
Palonosetron Accord is used for the prevention of nausea and vomiting in adults, adolescents, and children over one month of age in connection with chemotherapy for cancer.
What you need to know before using Palonosetron Accord
Do not use Palonosetron Accord
- if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before you are given Palonosetron Accord
- if you have an acute intestinal obstruction or have previously had constipation repeatedly,
- if you are taking Palonosetron Accord with other medicines that may trigger abnormal heart rhythms such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone,
- if you or someone in your family has or has had changes in your heart rhythm (extended QT interval ),
- if you have other heart problems,
- if you have an imbalance in certain minerals in the blood, e.g. potassium and magnesium, which have not been treated.
The use of Palonosetron Accord in the next few days after chemotherapy is only recommended if a new chemotherapy cycle is to be started.
Other medicines and Palonosetron Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:
Selective serotonin reuptake inhibitors ( SSRIs ) including fluoxetine, paroxetine , sertraline, fluvoxamine, citalopram, and escitalopram used to treat depression and/or anxiety.
SNRIs ( serotonin and norepinephrine reuptake inhibitors) including venlafaxine and duloxetine are used to treat depression and/or anxiety.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or think you may be, your doctor will prescribe treatment with Palonosetron Accord only when necessary.
It is not known if Palonosetron Accord can cause harmful effects when used during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or think you may be.
Breast-feeding
It is not known if Palonosetron Accord passes into breast milk.
If you are breastfeeding, talk to your doctor or pharmacist before using Palonosetron Accord.
Driving and using machines
Palonosetron Accord may cause dizziness or tiredness. If this happens, do not drive or use any tools or machines.
Palonosetron Accord contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Palonosetron Accord
As a rule, it is a doctor or nurse who gives an injection with Palonosetron Accord about 30 minutes before the start of chemotherapy.
Adults
The recommended dose of Palonosetron Accord is 250 micrograms, given as a rapid injection into a vein.
Use in children and adolescents (aged 1 month to 17 years)
Your doctor will decide on a dose depending on your body weight, but the highest dose is 1,500 micrograms.
Palonosetron Accord will be given as a slow infusion into a vein.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adults
Common (may affect up to 1 in 10 people):
- headache
- dizziness
- constipation and 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
- color changes and/or magnification
- abnormally high or low amount of potassium in the blood
- high blood sugar or sugar in the urine
- low calcium in the blood
- high levels of the pigment bilirubin in the blood
- high levels of certain liver enzymes
- elation or anxiety
- drowsiness or insomnia
- loss of appetite or loss of appetite
- weakness, fatigue, fever, or flu-like symptoms
- numbness, burning, tingling, or ant crawling on the skin
- skin rash with itching
- impaired vision or eye irritation
- motion sickness
- tinnitus
- hiccups, gas, dry mouth, or indigestion
- abdominal pain
- urination difficulties
- joint pain
- ECG abnormalities (prolonged QT interval ).
Very rare (may affect up to 1 in 10,000 people):
- allergic reactions to Palonosetron Accord:
swelling of the lips, face, tongue, or throat, difficulty breathing, collapse, rash ( hives ) with bumps and itching, burning, or pain at the injection site.
Children and young people
Common (may affect up to 1 in 10 people):
- headache.
Uncommon (may affect up to 1 in 100 people):
- dizziness
- jerky body movements
- abnormal heart rate
- cough and shortness of breath
- nosebleeds
- itchy rash or hives
- fever
- pain at the infusion site.
How to store Palonosetron Accord
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 carton and vial after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
For single use only, discard any remaining solution.
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 of solution contains 250 micrograms of palonosetron.
- The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, sodium hydroxide (for pH adjustment), hydrochloric acid, concentrated (for pH adjustment), and water for injections (see section 2 Palonosetron Accord contains sodium ).
What the medicine looks like and the contents of the pack
Palonosetron Accord solution for injection is a clear, colorless solution delivered in a 6 ml vial, closed with a chlorobutyl rubber stopper, and sealed with a flip-off aluminum seal. One vial contains one dose.
Pack size: one vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare BV,
Winthontlaan 200,
3526 kV Utrecht,
Netherlands
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Polan