Granisetron Kabi

Granisetron Kabi

granisetron

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
/
The Glory Medicina
Full Prescribing Info
Contents
Granisetron HCl.
Description
Each ml of Granisetron solution for injection contains 1 mg of granisetron (as hydrochloride).
Excipients/Inactive Ingredients: The other ingredients are citric acid monohydrate, hydrochloric acid, sodium chloride, water for injections, sodium hydroxide for pH (acidity) adjustment.
Action
Granisetron Kabi contains a medicine called granisetron. This belongs to a group of medicines called "5-HT3 receptor antagonists" or "anti-emetics".
Indications/Uses
Granisetron Kabi 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 from 2 years old.
Dosage/Direction for Use
The injection will be given by a doctor or nurse. The dose of Granisetron Kabi varies from one patient to another. It depends on age, weight, and whether the patient is being given the medicine to prevent, or treat, nausea and vomiting. The doctor will work out how much to give the patient.
Granisetron Kabi can be given as an injection into the veins (intravenous).
Prevention of feeling or being sick following radio- or chemotherapy: The injection will be given before the radio- or chemotherapy starts. The injection into the 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 the veins. More injections may be given to stop the sickness after the first dose. There will be at least 10 minutes between each injection. The most Granisetron Kabi the patient 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 the radio- or chemotherapy or as 250 mg methyl-prednisolone, which will be given both before and after the 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 Kabi by injections into the vein as described previously 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 the veins will take between 30 seconds and 5 minutes and the dose will usually be 1 mg. The most Granisetron Kabi the patient 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.
Overdosage
Because the injection will be given by a doctor or a nurse, it is unlikely that the patient will be given too much. However, if the patient is worried he/she must talk to the doctor or nurse. Symptoms of overdose include mild headaches. The patient will be treated depending on the symptoms.
If the patient has any further questions on the use of this medicine, ask the doctor, nurse or pharmacist.
Contraindications
Do not use Granisetron Kabi: If the patient is allergic (hypersensitive) to granisetron or any of the other ingredients of this medicine (listed in Description).
If the patient is not sure, talk to the doctor, nurse or pharmacist before having the injection.
Special Precautions
Take special care with Granisetron Kabi: The patient must check with the doctor, nurse or pharmacist before using Granisetron Kabi if he/she: is having problems with bowel movements because of a blockage of the gut (intestines).
If the patient has heart problems, is being treated for cancer with a medicine that is known to damage the heart or has problems with levels of salts, such as potassium, sodium or calcium, in the body (electrolyte abnormalities).
If the patient is taking other '5-HT3 receptor antagonist' medicines. These include dolasetron, ondansetron used like Granisetron Kabi in the treatment and prevention of nausea and vomiting. Cases of life-threatening serotonin syndrome have been reported with 5-HT3 receptor antagonist anti-emetics, particularly when given in combination with other serotonergic and/or neuroleptic drugs. Treatment should be discontinued if such events occur and supportive symptomatic treatment should be initiated. If concomitant treatment of Granisetron Kabi with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observations of the patient is advised, particularly during treatment initiation and dose increases.
Important information about some of the ingredients of Granisetron Kabi: Sodium: Granisetron Kabi 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.
Driving and using machines: Granisetron Kabi is not likely to affect the patient's ability to drive or use any tools or machines.
Use In Pregnancy & Lactation
The patient should not have this injection if she is pregnant, trying to get pregnant or is breast-feeding, unless advised by the doctor.
The doctor, nurse or pharmacist must be asked for advice before taking any medicine.
Side Effects
Like all medicines Granisetron Kabi can cause side effects, although not everybody gets them. If the patient notices the following problem he/she 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. The doctor will monitor the condition.
Common: affects 1 to 10 users in 100: Problem sleeping (insomnia); Changes in how the 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 any of the side effects gets serious, or if the patient notices any side effects not listed, tell the doctor, nurse or pharmacist.
Drug Interactions
Taking other medicines: Advise the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription. This is because Granisetron Kabi can affect the way some medicines work. Also some other medicines can affect the way this injection works.
In particular, advise the doctor, nurse or pharmacist if the patient is taking the following medicines: medicines used to treat an irregular heartbeat; other '5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see Precautions); 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.
Caution For Usage
Instructions for dilution: For single use only. Any unused portion should be discarded.
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.
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.
Granisetron Kabi can also be diluted in 20 to 50 ml compatible infusion fluid and then given over five minutes as an intravenous infusion.
Granisetron Kabi can only be diluted with 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.
Children 2 years of age and older: To prepare the dose of 10 - 40 μg/kg, the appropriate volume is withdrawn and diluted with infusion fluid (as for adults) to a total volume of 10 to 30 ml.
As a general precaution, Granisetron Kabi should not be mixed in solution with other drugs.
Storage
Keep in the outer carton and protect from light.
Do not freeze.
Once opened, Granisetron Kabi should be used immediately.
Once diluted Granisetron Kabi 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.
Medicines should not be disposed via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Any unused product or waste material should be disposed of in accordance with local requirements.
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.
Granisetron Kabi 1 mg/ml is compatible with Dexamethasone dihydrogen phosphate dinatrium in a concentration of 10-60 μg/ml of Granisetron and 80-480 μg/ml Dexamethasone phosphate diluted in sodium chloride 0.9 % or Glucose 5 % solution over a period of 24 hours.
ATC Classification
A04AA02 - granisetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Presentation/Packing
Soln for inj (amp) (clear colourless solution) 1 mg/1 mL x 5's. 3 mg/3 mL x 5's.
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