1 mg / ml injection solution
1. What Granisetron Fresenius Kabi is and what it is used for
Granisetron Fresenius Kabi contains the active substance granisetron. It belongs to a group of medicines called “5-HT 3 receptor antagonists” or “antiemetics” (medicines that prevent nausea and vomiting).
Granisetron Fresenius Kabi is used to prevent and treat nausea and vomiting caused by other medical treatments, such as chemotherapy and radiation therapy for cancer and surgery.
Solution for injection is used for adults and children aged 2 years and older.
What you need to know before you use Granisetron Fresenius Kabi
Do not use Granisetron Fresenius Kabi
- If you are allergic to granisetron or any of the other ingredients of this medicine (listed in section 6).
If you are not sure, talk to a doctor, pharmacist, or nurse before getting an injection.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Granisetron Fresenius Kabi if you:
- have problems with your bowel movements due to blockages in the intestines.
- have heart problems, are treated for cancer with a drug that is known to be harmful to the heart or have problems with salt levels in the body, such as potassium , sodium or calcium (electrolyte changes).
- take another medicine that is “5-HT 3 receptor antagonists”. This includes dolasetron, ondansetron which is used in the same way as Granisetron Fresenius Kabi to treat and prevent nausea and vomiting.
Serotonin syndrome is a less common but possibly life-threatening reaction that may occur with the use of granisetron (see section 4). The reaction may occur if you take granisetron alone but are more likely if you take granisetron with certain other medicines (especially fluoxetine , paroxetine , sertraline , fluvoxamine, citalopram , escitalopram, venlaflaxine, duloxetine).
Other medicines and Granisetron Fresenius Kabi
Tell your doctor or pharmacist if you have recently taken or might take any other medicines. This is because Granisetron Fresenius Kabi can affect the way some medicines work. Some other medicines may also affect the way Granisetron Fresenius Kabi injection works.
In particular, tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:
- drugs used to treat irregular heartbeats
- other medicines that are “5-HT 3 receptor antagonists” such as dolasetron or ondansetron (see “Warnings and Precautions” above)
- phenobarbital, a drug used to treat epilepsy
- a drug called ketoconazole used to treat fungal infections
- the antibiotic erythromycin used to treat bacterial infections
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and / or anxiety. For example fluoxetine , paroxetine , sertraline , fluvoxamine, citalopram , escitalopram
- SNRIs ( serotonin noradrenaline uptake inhibitors) used to treat depression and / or anxiety. For example venlaflaxine, duloxetine
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Driving and using machines
Granisetron Fresenius Kabi is unlikely to affect your ability to drive and use tools or machines.
Granisetron Fresenius Kabi contains sodium chloride
This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free.
How to use Granisetron Fresenius Kabi
A doctor or nurse will give you an injection. Dosage one varies from one patient to another. It depends on your age, weight, and whether you are receiving the medicine to prevent or treat nausea and vomiting. Your doctor will calculate the dose you should receive.
Granisetron Fresenius Kabi is given as an injection into the veins ( intravenously ).
To prevent nausea or vomiting after radiation or chemotherapy
You will receive an injection before the radiation or chemotherapy treatment is started. Injection one into the veins will take between 30 seconds and 5 minutes and dose one will usually be between 1 and 3 mg. The drug will be diluted before being injected.
Treatment for nausea or vomiting after radiotherapy or chemotherapy
Injection one will take between 30 seconds and 5 minutes and dose one will usually be between 1 and 3 mg. The medicine will be diluted before being injected into your veins. After receiving the first dose, you may be given more injections to stop nausea. There will be at least 10 minutes between each injection. The highest dose of Granisetron Fresenius Kabi that you receive is 9 mg per day.
Combination with steroids is
The effect of injection can be enhanced by the use of drugs called corticosteroids. Steroid one can either be given with a dose between 8 and 20 mg dexamethasone before the radiation or chemotherapy treatment starts or as 250 mg methylprednisolone which will be given both before and after your radiation or chemotherapy treatment.
Treatment of nausea or vomiting after surgery
Injection one into the veins will take between 30 seconds and 5 minutes and dose one is usually 1 mg. The highest dose of Granisetron Fresenius Kabi that will be given is 3 mg per day.
Use in children
Use in children to prevent or treat nausea or vomiting after radiotherapy or chemotherapy
Children will receive Granisetron Fresenius Kabi by injection into their vein as described above. Dose one depends on the weight of the child. The solution for injection will be diluted and given before starting radiation therapy or chemotherapy. Injection one will take 5 minutes. Children will receive a maximum of 2 doses per day at least 10 minutes apart.
Use in children to prevent or treat nausea or vomiting after surgery
Children should not be given this injection to treat nausea or vomiting after surgery.
If you use more Granisetron Fresenius Kabi than you should
As an injection is given to you by a doctor or nurse, it is unlikely that you will receive an overdose. Talk to your doctor or nurse if you are worried. The symptoms of overdose are a mild headache. You will be treated depending on your symptoms.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following problems, see a doctor immediately :
- allergic reactions ( anaphylaxis ). Signs of this may be swelling of the throat, face, lips and mouth, difficulty breathing and swallowing.
Other side effects that may occur when you take this medicine are:
Very common: may affect more than 1 in 10 people:
- constipation. Your doctor will examine you.
Common: may affect up to 1 to 10 people:
- sleep problems (insomnia)
- Changes in the way your liver works are shown by blood tests
Uncommon: may affect up to 1 in 100 people:
- skin rash or an allergic skin reaction or hives ( urticaria ). Signs of this may be red, raised itchy rashes.
- altered heartbeat (rhythm) and changes seen on ECG (electrical recording of the heart)
- abnormal involuntary movements such as tremors, muscle stiffness and muscle contractions.
- Serotonin syndrome. Symptoms may include diarrhea, nausea, vomiting, fever, high blood pressure , excessive sweating and rapid heartbeat , agitation, confusion, hallucinations, chills, muscle tremors, twitching or stiffness, loss of coordination and restlessness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
5. How to store Granisetron Fresenius Kabi
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/or ampoule label after EXP. date. The expiration date is the last day of the specified month.
Store in the outer carton. Sensitive to light.
Do not freeze.
Once Granisetron Fresenius Kabi has been opened, it should be used immediately.
When Granisetron Fresenius Kabi has been diluted, it should be used immediately. If the reconstituted solution is not used immediately, it should be stored at 25 ° C, protected from sunlight, and used within 24 hours.
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.
6. Contents of the packaging and other information
- The active substance is granisetron (as hydrochloride).Each ml of solution for injection contains 1 mg of granisetron (as hydrochloride).
- The other ingredients are citric acid monohydrate, hydrochloric acid , sodium chloride, water for injections and sodium hydroxide for pH regulation .
What the medicine looks like and contents of the pack
Granisetron Fresenius Kabi is a clear, colorless liquid.
The package may contain 5 or 10 ampoules in clear glass. The ampoules contain either 1 ml or 3 ml Granisetron Fresenius Kabi 1 mg/ml solution for injection.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi AB
751 74 Uppsala
Labesfal – Laboratories Almiro SA (Fresenius Kabi Group)
Lagedo Industrial Zone
3465-157 Santiago de Besteiros
Fresenius Kabi Austria GmbH