Granisetron 1 Mg/Ml Concentrate For Solution For Injection Or Infusion
PACKAGE LEAFLET INFORMATION FOR THE USER SZ00000LT000
Granisetron 1 mg/ml Concentrate for Solution for Injection or Infusion
A SANDOZ
Granisetron hydrochloride
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.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Granisetron is and what it is used for
2. What you need to know before you use Granisetron
3. How to use Granisetron
4. Possible side effects
5. How to store Granisetron
6. Contents of the pack and other information
What Granisetron is and what it is ■ used for
Granisetron belongs to a group of medicines called anti-emetics. It 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.
This solution for injection is for use in adults and children from 2 years old.
2 What you need to know before you ■ use Granisetron
Do not use Granisetron:
• 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 having the 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 Granisetron in the treatment and prevention of nausea and vomiting.
Other medicines and Granisetron
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. 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-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.
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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking any medicine.
Driving and using machines
Granisetron has no or negligible effect on the ability to drive or use machines.
Granisetron contains sodium
This medicinal product contains 1.4 mmol (or 31.5 mg) sodium per maximum daily dosage (9 mg granisetron). To be taken into consideration by patients on a controlled sodium diet.
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 Granisetron you will be given is 9 mg a day.
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The following information is intended for healthcare professionals only:
Dilute before use. For single use only. Any unused portion should be discarded.
Preparing the injection
Adults: To prepare a dose of 1 mg, 1 ml is withdrawn from the vial and diluted to 5 ml with 0.9% w/v Sodium Chloride Injection BP.
To prepare a dose of 3 mg, 3 ml is withdrawn from the vial and diluted to 15 ml with 0.9% w/v Sodium Chloride Injection BP (for bolus administration)
Preparing the infusion SZ00000LT000
Adults: To prepare a dose of 1 mg or 3 mg, 1 ml or 3 ml is withdrawn from the vial and diluted in infusion fluid to a total volume of 20 to 50 ml 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. No other diluents should be used.
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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.
side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Granisetron after the expiry date which is stated on the vial and carton after Exp. The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
Do not freeze.
Diluted solution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately.
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 protect the environment.
6 Contents of the pack and other ■ information
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 (may affect more than 1 in 10 people):
• headache
• constipation. Your doctor will monitor your condition.
Common (may affect up to 1 in 10 people):
• problems sleeping (insomnia)
• changes in how your liver is working shown by blood tests
• diarrhoea.
Uncommon (may affect up to 1 in 100 people):
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor 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 (www.mhra.gov.uk/yellowcard). By reporting
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Paediatric population: To prepare the dose of 40 pig/kg the appropriate volume (up to 3 ml) is withdrawn from the vial and diluted with infusion fluid (as for adults) to a total volume of 10 to 30 ml
Intravenous injections and infusions of Granisetron should be prepared at the time of administration and used immediately from a microbiological point of view. In-use storage times and conditions prior to use are not supported by microbiological data and are the responsibility of the user.
The diluted injections and infusions are to be inspected visually for particulate matter prior to administration. They should only be used if the solution is clear and free from particles.
What Granisetron contains
- The active substance is granisetron (as hydrochloride).
- Each vial with 1 ml concentrate for solution for injection or infusion contains granisetron hydrochloride equivalent to 1 mg granisetron.
- Each vial with 3 ml concentrate for solution for injection or infusion contains granisetron hydrochloride equivalent to 3 mg granisetron.
- The other ingredients are citric acid, monohydrate, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injection.
What Granisetron looks like and contents of the pack
Granisetron is a concentrate for solution for injection or infusion. The solution is clear, colourless to slightly yellow solution.
- 1 ml of concentrate for solution for injection or infusion is contained in 2 ml clear type I glass vial with a 13 mm rubber stopper and an aluminium seal with a dark blue flip-off button.
- Pack sizes: 1 and 5 vials.
- 3 ml of concentrate for solution for injection or infusion is contained in 5 ml clear type I glass vial with a 13 mm rubber stopper and an aluminium seal with a dark blue flip-off button or infusion or 6 ml clear type I glass vial with a 20 mm rubber stopper and an aluminium seal with a dark blue flip-off button.
- Pack sizes: 1,5 and 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisaion Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia.
This leaflet was last revised in 01/2014.
D1007005 SZ00000LT000
Diluted solution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately.
This medicinal product should not be mixed with other medicinal products.
Prophylactic administration of Granisetron should be completed prior to the start of cytostatic therapy.
D1007005 SZ00000LT000
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A Artwork Proof Box Ref: V008-update SPC&PIL | ||
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Proof no. |
Date prepared: |
Font size: |
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005.0 |
10/01/2014 |
7pt |
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Colours: |
Fonts: | |
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| Black |
□ |
Helvetica |
|
□ |
□ | |
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Dimensions: |
136 x 296 mm |
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