250 micrograms solution for injection
palonosetron
What Palonosetron Reig Jofre is and what it is used for
Palonosetron Reig Jofre belongs to a group of medicines called serotonin (5HT3) antagonists.
They can block the action of the chemical serotonin which can cause nausea and vomiting.
Palonosetron Reig Jofre is used to prevent nausea and vomiting in adults, adolescents, and children over one month of age in connection with chemotherapy for cancer.
Palonosetron contained in Palonosetron Reig Jofre may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Palonosetron Reig Jofre
Do not use Palonosetron Reig Jofre
- 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 or pharmacist before using Palonosetron Reig Jofre
- if you have an acute intestinal obstruction or have previously had constipation repeatedly,
- if you are taking Palonosetron Reig Jofre with other medicines that can 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.
Use of Palonosetron Reig Jofre in the next few days after chemotherapy is only recommended if a new chemotherapy cycle is to be started.
Other medicines and Palonosetron Reig Jofre
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including SSRIs (selective serotonin reuptake inhibitors) 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, breastfeeding, and fertility
Pregnancy
If you are pregnant or think you may be, your doctor will prescribe treatment with Palonosetron Reig Jofre only when necessary.
It is not known if Palonosetron Reig Jofre 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 Reig Jofre passes into breast milk.
If you are breastfeeding, ask your doctor or pharmacist for advice before using Palonosetron Reig Jofre.
Driving and using machines
Palonosetron Reig Jofre may cause dizziness or tiredness. 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.
How to use Palonosetron Reig Jofre
As a rule, it is a doctor or nurse who gives an injection of Palonosetron Reig Jofre about 30 minutes before the start of chemotherapy.
Adults
The recommended dose of Palonosetron Reig Jofre is 250 micrograms, given as a rapid injection into a vein.
Use for children and adolescents
Your doctor will decide on a dose depending on your body weight, but the highest dose is 1,500 micrograms.
Palonosetron Reig Jofre 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any side effects and their frequencies are listed below:
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 enlargement of the veins
- 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 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 Reig Jofre:
swelling of the lips, face, tongue, or throat, difficulty breathing, collapse, rash ( hives ) with bumps and itching, burning, or pain at the injection site.
Additional side effects in 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
- abnormal heart rate
- cough or shortness of breath
- nosebleeds
- itchy rash or hives
- fever
- pain at the infusion site
How to store Palonosetron Reig Jofre
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. The expiration date is the last day of the specified month.
No special storage instructions.
For single use only, any remaining solution should be discarded.
Contents of the pack and other information
Content declaration
- The active substance is palonosetron (as hydrochloride). One ml solution contains 50 micrograms of palonosetron. One vial of 5 ml solution contains 250 micrograms of palonosetron.
- The other ingredients are mannitol, disodium edetate (dihydrate), sodium citrate (dihydrate), citric acid monohydrate, and water for injections.
What the medicine looks like and the contents of the pack
Palonosetron Reig Jofre solution for injection is a clear, colorless solution and is supplied in a pack with a type I glass vial with silicone fluorotic stopper of chlorobutyl rubber and an aluminum cap. The vial contains 5 ml of solution, which is a dose.
Available in packs of 1 vial containing 5 ml solution.
Marketing Authorization Holder and Manufacturer
Laboratory Reig Jofre SA
Grand Captain, 10
08970 Sant Joan Despí (Barcelona)
Spain
Local representative:
Bioglan AB
Box 50310
202 13 Malmö
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Palonosetron Reig Jofre
Finland: Palonosetron Reig Jofre 250 micrograms, injection test, limos
Norway: Palonosetron Reig Jofre
Spain: Palonosetron Sala 250 micrograms solution for EFG injection
Sweden: Palonosetron Reig Jofre
United Kingdom: Palonosetron 250 micrograms solution for injection