Patient leaflet - Granisetron 3 mg / 3 ml concentrate for solution for infusion or injection
1. What Granisetron infusion/injection is and what it is used for
Granisetron infusion/injection contains a medicine called granisetron. This belongs to a group of medicines called ‘5-HT3 receptor antagonists’ or ‘anti-emetics’.
Granisetron infusion/injection is used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer, and by surgery.
The solution for infusion or injection is for use in adults and children from 2 years old.
2. What you need to know before Granisetron infusion/injection is given to you
Do not use Granisetron infusion/injection:
- 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 your doctor, nurse or pharmacist before having the infusion or injection.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before Granisetron infusion/injection is given to you:
| − | if you are having problems with your bowel movements because of a blockage of your gut (intestines) |
|---|---|
| − | if you have heart problems, are being treated for cancer with a medicine that is known to damage your heart or have problems with levels of salts, such as potassium, sodium or calcium, in your body (electrolyte abnormalities) |
| − | if you are taking other ‘5-HT3 receptor antagonist’ medicines. These include dolasetron, ondansetron used like granisetron in the treatment and prevention of nausea and vomiting. |
Serotonin syndrome is an uncommon but potentially life-threatening reaction that can occur with granisetron (see section 4). It can cause serious changes in how your brain, muscles, and digestive system work. The reaction can occur if you take granisetron alone but it is more likely to occur if you take granisetron with certain other medicines (in particular fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).
Other medicines and Granisetron infusion/injection
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Granisetron infusion/injection can affect the way some medicines work. Also some other medicines can affect the way this infusion/injection works.
In particular, tell your doctor, nurse or pharmacist if you are taking the following medicines:
| − | medicines used to treat an irregular heartbeat other ‘5-HT3 receptor antagonist’ medicines such as dolasetron or ondansetron (see “Warnings and precautions” above) |
|---|---|
| − | phenobarbital, a medicine used to treat epilepsy |
| − | a medicine called ketoconazole used in the treatment of fungal infections |
| − | the antibiotic erythromycin used to treat bacterial infections. |
| − | SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. Examples are fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram. |
| − | SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety. Examples are venlafaxine, duloxetine. |
Pregnancy and breast-feeding
You should not have this injection or infusion if you are pregnant, trying to get pregnant or are breast-feeding, unless your doctor has decided that it is absolutely necessary.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before Granisetron infusion/injection is given to you.
Driving and using machines
Granisetron is not likely to affect your ability to drive or use any tools or machines.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
3. How Granisetron infusion/injection will be given to you
The infusion/injection will be given to you by a doctor or nurse. The dose of granisetron varies from one patient to another. It depends on your age, weight, and whether you are being given the medicine to prevent, or treat, nausea and vomiting. The doctor will work out how much to give you.
Granisetron can be given as an injection or infusion into the veins (intravenous).
Prevention of feeling or being sick following radio- or chemotherapy
You will be given the injection or infusion before your radio- or chemotherapy starts. The injection or infusion into your veins will take between 30 seconds (injection) and 5 minutes (infusion) and the dose will usually be between 1 and 3 mg. The medicine may be diluted before it is injected or infused.
Treatment of feeling or being sick following radio- or chemotherapy
The injection or infusion will take between 30 seconds (injection) and 5 minutes (infusion) and the dose will usually be between 1 and 3 mg. The medicine may be diluted before it is injected or infused into your veins. You may be given more injections or infusions to stop your sickness after the first dose. There will be at least 10 minutes between each dose. The most granisetron you will be given is 9 mg a day.
Combination with steroids
The effect of the injection may be improved by the use of medicines called adrenocortical steroids. The steroid will be given either as a dose between 8 and 20 mg dexamethasone before your radio- or chemotherapy or as 250 mg methyl-prednisolone, which will be given both before and after your radio- or chemotherapy.
Use in children in the prevention or treatment of feeling or being sick following radio- or chemotherapy
Children will be given granisetron by infusion into the vein as described above with the dose depending on the child’s weight. The infusions will be diluted and be given before radio- or chemotherapy and will take 5 minutes. Children will be given a maximum of 2 doses a day, at least 10 minutes apart.
Treatment of feeling or being sick following surgery
The injection or infusion into your veins will take between 30 seconds (injection) and 5 minutes (infusion) and the dose will usually be 1 mg. The most granisetron you will be given is 3 mg a day.
Use in children in the prevention or treatment of feeling or being sick following surgery
Children should not be given this injection to treat sickness or the feeling of sickness after surgery.
If you are given more Granisetron than you should
Because the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. However, if you are worried talk to your doctor or nurse. Symptoms of overdose include mild headaches. You will be treated depending on your symptoms.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice the following problem you must tell your doctor or nurse immediately: allergic reactions (anaphylaxis). The signs may include swelling of the throat, face, lips and mouth, difficulty in breathing or swallowing.
Other side effects that may be experienced while taking this medicine are:
Very common: affects more than 1 user in 10 − headache
- constipation. Your doctor will monitor your condition.
Common: affects 1 to 10 users in 100
- problems sleeping (insomnia)
- changes in how your liver is working shown by blood tests
- diarrhoea
Uncommon: affects up to 1 to 10 users in 1,000
| − | skin rashes or an allergic skin reaction or “nettle-rash” or “hives” (urticaria). The signs may include red, raised itchy bumps |
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| − | changes in the heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the heart) |
| − | abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions. |
| − | Serotonin Syndrome. The signs may include diarrhoea, nausea, vomiting, high temperature and blood pressure, excessive sweating and rapid heartbeat, agitation, confusion, hallucination, shivering, muscles shakes, jerks or stiffness, loss of coordination and restlessness. |
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Granisetron infusion/injection
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 ampoule label. The expiry date refers to the last day of that month.
The doctor or nurse will check that this date has not been passed.
Keep the ampoules in the outer carton. Do not freeze.
Once opened, the ampoules have a shelf life of 24 hours.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Granisetron infusion/injection contains
- The active substance is granisetron (as hydrochloride) 1mg/1ml.
The other ingredients are: Sodium Chloride
Hydrochloric Acid Sodium Hydroxide Water for Injections
What Granisetron infusion/injection look like and contents of the pack
Granisetron concentrate for solution for infusion or injection is a clear, colourless or slightly straw-coloured solution.
Pack sizes:
5 x 3ml ampoules (3mg/3ml)
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd. 3rd Floor, Nexus Building 4 Gatwick Road
Crawley West Sussex RH10 9BG
United Kingdom
Manufacturer
Hameln Pharmaceuticals GmbH Langes Feld 13
31789 Hameln Hannover Germany
This leaflet was last revised in 07/2023
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The following information is intended for healthcare professionals only. PREPARATION GUIDE FOR:
Granisetron 1 mg/ml concentrate for solution for injection or infusion
(Please note that this information is NOT the SPC. For full details regarding this product, please refer to the SPC.)
It is important that you read the entire contents of this guide prior to the preparation of this medicinal product.
PREPARATION FOR THE INTRAVENOUS ADMINISTRATION:
Adults: To prepare a dose of 3mg, 3ml is withdrawn from the ampoule and diluted either to 15ml with 0.9% w/v Sodium Chloride Injection BP (for bolus administration) or in infusion fluid to a total volume of 20 to 50ml.
The dose should be administered as a slow intravenous injection (15ml given over 30 seconds) or as an intravenous infusion (20 to 50ml given over 5 minutes).
Children: To prepare the dose of 40μg/kg the appropriate volume (up to 3ml) is withdrawn from the ampoule and diluted with infusion fluid to a total volume of 10 to 30ml. The dose should be administered as an intravenous infusion (10 to 30ml given over 5 minutes).
For infusion: any of the following solutions may be used:
| − | 0.9% w/v Sodium Chloride solution; |
|---|---|
| − | 0.18% w/v Sodium Chloride and 4% w/v Glucose solution; |
| − | 5% w/v Glucose solution; |
| − | Hartmann's Solution for Injection; |
| − | Sodium Lactate solution; |
| − | 10% Mannitol solution. |
No other diluents should be used.
For single use only. Ideally, intravenous infusions of granisetron should be prepared at the time of administration. After dilution (see above), or when the container is opened for the first time, the shelf-life is 24 hours when stored at ambient temperature in normal indoor illumination protected from direct sunlight. It must not be used after 24 hours. If to be stored after preparation, granisetron infusions must be prepared under appropriate aseptic conditions.
As a general precaution, granisetron should not be mixed in solution with other drugs.