250 micrograms solution for injection
palonosetron
What Palonosetron STADA is and what it is used for
Palonosetron Stada belongs to a group of medicines called serotonin ( 5HT 3 ) antagonists.
They can block the action of the substance serotonin which can cause nausea and vomiting.
Palonosetron Stada 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 Stada 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 STADA
Do not use Palonosetron STADA
- 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 Stada.
- If you have an acute intestinal obstruction or have previously had constipation repeatedly.
- If you are taking Palonosetron Stada with other medicines that may cause abnormal heart rhythm 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 Stada in the next few days after chemotherapy is only recommended if a new chemotherapy cycle is to be started.
Other medicines and Palonosetron STADA
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 are 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
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant or think you may be, your doctor will prescribe treatment with Palonosetron Stada only when necessary.
It is not known if Palonosetron Stada can cause harmful effects when used during pregnancy.
Breast-feeding
It is not known if Palonosetron Stada passes into breast milk.
Driving and using machines
Palonosetron Stada 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.
Palonosetron STADA contains sodium
This medicine contains 4.65 mg sodium (less than 1 mmol sodium (23 mg)) per vial, ie is essential ‘sodium-free’, but if the maximum dose for children (6 bottles) is administered, the sodium content is 1.2 mmol. sodium (28 mg).
How to use Palonosetron STADA
As a rule, it is a doctor or nurse who gives an injection of Palonosetron Stada about 30 minutes before the start of chemotherapy.
Adults
The recommended dose of Palonosetron Stada is 250 micrograms, given as a rapid injection into a vein.
Use for children and adolescents
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 Stada 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.
Common (may affect up to 1 in 10 people):
- 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
- 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 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 Stada.
Signs may include 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 STADA
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.
Do not use Palonosetron Stada if you notice discoloration, turbidity, or particles, it should be a clear, colorless solution.
For single use only, any remaining solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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. One vial of 5 ml solution contains 250 micrograms of palonosetron.
The other ingredients are mannitol (E421), disodium edetate, sodium citrate (E331), citric acid monohydrate (E330), water for injections, sodium hydroxide, and hydrochloric acid (E507).
What the medicine looks like and the contents of the pack
Palonosetron Stada solution for injection is a clear, colorless solution, free from visible particles with a pH value of 4.5-5.5, and is delivered in a package with a type I glass vial with a gray rubber stopper and aluminum cap, which contains 5 ml of solution which is a dose.
Available in packs of 1 vial containing 5 ml solution.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Haupt Pharma Wolfratshausen GmbH
Pfaffenrieder Strasse 5, 82515 Wolfratshausen
Germany
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark