Granisetron 1mg/Ml Solution For Injection
Anexo 6.00 do PT.G.087
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CODIGO: XXXXXX Code |
DESIGNACA°: LITiGRANISE1-Ron fkuk Name |
ELABORADO POR: JD0686 Made by |
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VERSA0: /xx Version |
PROVA: Q7 Proof |
DATA: 14 Jul.2015 Date |
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FICHA TECNICA: XXXXXX Technical Sheet |
ESCALA: ..... Scale 1'1 |
Sizes: 9 pts |
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CORES: |
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150 mm
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, pharmacist or nurse.
• 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, pharmacist or nurse. 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
1. What Granisetron is and what it is used for
Granisetron 1mg/ml solution for injection contains the active substance granisetron. This belongs to a group of medicines called “5-HT3 receptor antagonists” or “anti-emetics”.
Granisetron 1mg/ml solution for injection is used to prevent or treat nausea or vomiting (feeling sick 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 aged 2 years and above.
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, pharmacist or
nurse before having the injection.
Warnings and precautions
Talk to your doctor, pharmacist or nurse 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-HT3 receptor antagonisf medicines.
These include dolasetron, ondansetron used like Granisetron in the treatment and prevention of nausea and vomiting.
Other medicines and Granisetron
Tell your doctor 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 pharmacist or nurse if you are taking the following medicines:
• medicines used to treat an irregular heartbeat other ‘5-HT3 receptor antagonisf 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor tor advice before using this medicine.
Driving and using machines
Granisetron is not likely to affect your ability to drive and use any tools or machines.
Granisetron contains sodium chloride
Granisetron contains 31.5 mg (1.37 mmol) of sodium per maximum daily dose of 9 mg. 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.
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.
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
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.
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 use 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, pharmacist or nurse.
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, difficultly 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly:
The following information is intended for healthcare professionals only:
Instructions for dilution:
For single use only. Any unused portion should be discarded.
The diluted injections and infusions are to be inspected visually tor particulate matter prior to administration. They should only be used if the solution is clear and free from particles.
Adults: The contents of a 1 ml ampoule can be diluted to a volume of 5 ml; the contents of a 3 ml ampoule can be diluted to a volume of 15 ml.
infusion fluid and then given over five minutes as an intravenous infusion in any of the following solutions:
0.9 % w/v sodium chloride injection 5 % w/v glucose injection Lactated Ringer's Solution;
No other diluents should be used.
Use in the paediatric population
Children 2 years of age and older: To prepare the dose of 10-40 pg/kg, the appropriate volume is withdrawn and diluted with infusion fluid (as tor adults) to a total volume of 10 to 30 ml.
Granisetron can also be diluted in 20 to 50 ml compatible As a general precaution, Granisetron should not be
Manufacturers:
For UK - via the Yellow Card Scheme at: www.mhra. gov.uk/yellowcard Labesfal -Laboratories Almira S.A (Fresenius Kabi
By reporting side effects you can help provide more Group)
information on the safety of this medicine. Zona Industrial do Lagedo, 3465-157 Santiago de
Besteiros, Portugal
5. How to store Granisetron and
Keep this medicine out of the sight and reach of children. Fresenius Kabi Austria GmbH, Hafnerstrasse 36, A-8055
Graz, Austria
Do not use this medicine after the expiry date which is stated on the carton and/or ampoule after EXP. The expiry date refers to the last day of that month.
This leaflet was last revised in July 2015
Keep in the outer carton and protect from light.
Do not freeze.
Once opened, Granisetron should be used immediately.
Once diluted, Granisetron should be used immediately.
If not used immediately, the ready to use solution should be stored at 25 °C, protected from sunlight and used within 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 protect the environment.
6. Contents of the pack and other information
What Granisetron contains:
The active substance is Granisetron (as Hydrochloride). Each ml of Granisetron solution for injection contains 1 mg of granisetron (as hydrochloride). The other ingredients are citric acid monohydrate, hydrochloric acid, sodium chloride, water for injections, sodium for pH (acidity) adjustment.
What Granisetron looks like and contents of the pack: Granisetron is a clear colourless solution.
The pack may contain 5 or 10 clear glass ampoules. The ampoules contain either 1 ml or 3 ml Granisetron 1 mg/ ml solution for injection. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park
Runcorn, Cheshire, WA7 1 NT, UK
VO 03
xxxxxx/xx
mixed in solution with other drugs.
Granisetron 1 mg / ml is compatible with Dexamethason dihydrogenphosphate dinatrium in a concentration of 10-60 pg/ml of Granisetron and 80-480 pg/ml Dexamethasonphosphate diluted in sodium chloride 0.9 % or Glucose 5 % solution over a period of 24 hours.
Shelf life of the finished medicinal product:
3 years
Once opened the product should be used immediately. Ideally, intravenous infusions of Granisetron should be prepared at the time of administration. After dilution, or when the container is opened for the first time, the shelf life is 24 hours when stored at ambient temperature (25°C) 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.
Special precautions for storage
Keep the ampoules in the outer carton in order to protect
from light. Do not freeze.
Any unused product or waste material should be disposed of in accordance with local requirements.
