Granisetron 1mg/1ml Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Granisetron 1mg/1ml Concentrate for Solution for Infusion
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse or pharmacist.
• This medicine has been prescribed to you. Do not pass it on to others. 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. See section 4.
IN THIS LEAFLET:
1. What Granisetron is and what it is used for
2. Before you are given Granisetron
3. How Granisetron will be given
4. Possible side effects
5. How to store Granisetron
6. Further information
1. What Granisetron is and what it is used for
a group of medicines called ‘5-
Granisetron contains a medicine called granisetron. This belongs to HT receptor antagonists’ or ‘anti-emetics’.
and being sick) caused by other
Granisetron is used to prevent or treat nausea and vomiting (feeling 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. Before you receive Granisetron
Do not use Granisetron:
• If you are allergic (hypersensitive) to granisetron or any of the other ingredients of granisetron (listed in Section 6: Further information).
If you are not sure, talk to your doctor, nurse or pharmacist before having the injection.
Take special care with Granisetron:
Check with your doctor, nurse or pharmacist before using granisetron if you:
• are having problems with your bowel movements because of a blockage of your gut (intestines)
• 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)
• are taking other ‘5-HT receptor antagonist’ medicines. These include dolasetron, ondansetron used like Granisetron in the treatment and prevention of nausea and vomiting.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Granisetron 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-HT receptor antagonist’ medicines such as dolasetron or ondansetron (see “Take special care with Granisetron” 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.
Important information about some of the ingredients of Granisetron
This medicinal product contains 0.15mmol (3.5mg) sodium per ml. To be taken into consideration by patients on a controlled sodium diet, if the dose exceeds 6.6ml.
3. How to use Granisetron
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 Gransietron you will be given is 9 mg in a day.
Combination with steroids
Teh effect of the injection maybe 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 a 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, Granisetron can cause side effects, although not everybody gets them. If you notice the following you must see a doctor straight away.
• allergic reactions (anaphylaxis). The signs may include swelling of the throat, face, lips and mouth, difficultly 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 1
abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Granisetron Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
Do not freeze. Keep the container in the outer carton in order to protect from light.
Do not use this product if you notice that the solution is brown.
The product should be used immediately after opening and dilution.
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. Further information
What Granisetron contains:
• The active ingredient is granisetron. Oneml of concentrate for solution for infusion or injection contains 1mg granisetron (as hydrochloride). Each ampoule or vial contains 1mg granisetron (as hydrochloride).
• The other ingredients are sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.
What Granisetron looks like and contents of the pack:
• Concentrate for solution for infusion or injection
• Sterile, clear, colourless solution
• 1 ml in clear glass type I ampoules Pack sizes: 1, 5 or 10 ampoules.
• 1 ml in clear glass type I vials, sealed with rubber stopper and green cap Pack sizes: 1, 5 or 10 vials.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom .
OR 1
Marketing Authorisation holder: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex,
BN22 9AG, United Kingdom. Company responsible for manufacture: Pharmachemie B.V., Swensweg 5, 2031
GA Haarlem, The Netherlands.
OR 1
Marketing Authorisation holder: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom. Company responsible for manufacture: Teva Pharmaceutical Works Private Limited Company, Tancsics Mihaly ut 82, H-2100 Godollo, Hungary.
OR *
Marketing Authorisation holder: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom. Company responsible for manufacture: GALIEN LPS 98 Rue Bellocier, 89100 Sens, France.
This leaflet was last revised in August 2016
PL 00289/1035
PREPARATION GUIDE FOR USE WITH GRANISETRON 3MG/3ML CONCENTRATE FOR
SOLUTION FOR INFUSION
(Please note this is a Prescriber Information Leaflet NOT the SPC. For full details regarding this product please refer to the SPC.)
The following information is intended for medical or healthcare professionals only: Incompatibilities
As a general safety rule, Granisetron should never be mixed in solution with other drugs. Prophylactic infusion of Granisetron should be completed before the start of cytostatic therapy.
Preparation and administration of Granisetron solution _ for infusion
Prevention and treatment of post-operative nausea and vomiting:
Adults:
A 1 mg dose is prepared by withdrawing 1 ml from the ampoule and diluting it to 5 ml with 0.9% w/v sodium chloride solution. No other solutions should be used.
The dose should be administered as a slow intravenous injection given over 30 seconds.
Children:
There is no experience in the use of granisetron in the prevention and treatment of post-operative nausea and vomiting in children, therefore it is not recommended for this indication in this age group,
Children and teenagers aged 2 to 16 years
A 40 pg/kg dose is prepared by withdrawing the appropriate amount and diluting with infusion fluid to a total volume between 10 and 30 ml. 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 solutions should be used.
The dose should be administered as an intravenous infusion given over 5 minutes.
changes in the heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the heart)