Granisetron 3mg/3ml Concentrate For Solution For Infusion Or Injection
Package leaflet: Information for the user
Granisetron 3mg/3ml Concentrate for solution for infusion or injection
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Granisetron injection is and what it is used for
2. What you need to know before you use Granisetron injection
3. How to use Granisetron injection
4. Possible side effects
5. How to store Granisetron injection
6. Contents of the pack and other information
1 What Granisetron injection is and what it is used for
Granisetron injection contains a medicine called granisetron. This belongs to a group of medicines called ‘5-HT3 receptor antagonists’ or ‘anti-emetics’.
Granisetron 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 injection is for use in adults and children from 2 years old.
2 What you need to know before you use Granisetron injection
Do not use Granisetron 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 injection.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before using Granisetron injection:
- 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 Kytril in the treatment and prevention of nausea and vomiting.
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Granisetron injection can affect the way some medicines work. Also some other medicines can affect the way this 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 “Take special care with Kytril” 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.
Pregnancy and breast-feeding
You should not have this injection if you are pregnant, trying to get pregnant or are breast-feeding, unless your doctor has told you to.
Ask your doctor, nurse or pharmacist for advice before taking any medicine.
Driving and using machines
Granisetron is not likely to affect your ability to drive or use any tools or machines.
3 How to use Granisetron injection
The 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 into the veins (intravenous).
Prevention of feeling or being sick following radio- or chemotherapy
You will be given the injection before your radio- or chemotherapy starts. The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be between 1 and 3 mg. The medicine may be diluted before it is injected.
Treatment of feeling or being sick following radio- or chemotherapy
The injection will take between 30 seconds and 5 minutes and the dose will usually be between 1 and 3 mg. The medicine may be diluted before it is injected into your veins. You may be given more injections to stop your sickness after the first dose. There will be at least 10 minutes between each injection. 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 injections into the vein as described above with the dose depending on the child’s weight. The injections 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 into your veins will take between 30 seconds and 5 minutes 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 too much Granisetron
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 see a doctor straight away:
- 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
- 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.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not listed in this leaflet.
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 Content of the pack and other information What Granisetron injection contains
- The active substance is Granisetron (as hydrochloride) 3mg/3ml.
- The other ingredients are:
Sodium Chloride Hydrochloric Acid Sodium Hydroxide Water for Injections
What Granisetron injection looks 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 1ml ampoules (3mg/3ml)
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturer:
Hameln Pharmaceuticals GmbH Langes Feld 13 31789 Hameln Hannover
Germany
This leaflet was last revised in 01/2012
Granisetron 3mg/3ml Concentrate for solution for infusion or injection
The following information is intended for healthcare professionals only.
(Please note that this information is NOT the SPC. For full details regarding this product, please refer to the SPC.)
Instructions for preparing the infusion:
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 in any of the following solutions: 0.9% w/v Sodium Chloride Injection BP; 0.18% w/v Sodium Chloride and 4% w/v Glucose Injection BP; 5% w/v Glucose Injection BP; Hartmann's Solution for Injection BP; Sodium Lactate Injection BP; or 10% Mannitol Injection BP (for infusion). No other diluents should be used.
Children: To prepare the dose of 40pg/kg the appropriate volume (up to 3ml) is withdrawn from the ampoule and diluted with infusion fluid (as for adults) to a total volume of 10 to 30ml.
Ideally, intravenous infusions of Granisetron should be prepared at the time of administration. After dilution (see above) 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.