Granisetron Hydrochloride solution for injection USP 1mg/1ml in Pre-filled Syringe
Granisetron Hydrochloride solution for injection USP 3mg/3ml in Pre-filled Syringe
Granisetron Hydrochloride solution for injection USP 4mg/4ml in Pre-filled Syringe
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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.
Active substance: Granisetron Hydrochloride Pre-filled Syringe
What is in this leaflet:
1. What Granisetron Hydrochloride Pre-filled Syringe is and what it is used for
2. What you need to know before you are given Granisetron Hydrochloride Pre-filled Syringe
3. How Granisetron Hydrochloride Pre-filled Syringe will be given
4. Possible side effects
5. How to store Granisetron Hydrochloride Pre-filled Syringe
6. Contents of the pack and other information
1. WHAT GRANISETRON HYDROCHLORIDE PRE-FILLED SYRINGE IS AND WHAT IT IS USED FOR
Granisetron Hydrochloride Pre-filled Syringe contains a medicine called granisetron. This belongs to a group of medicines called ?5-HT3 receptor antagonists? or ?antiemetics?.
Granisetron Hydrochloride Pre-filled Syringe is used to prevent or treat nausea (feeling sick) and vomiting (being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer, and by surgery.
The solution for injection or infusion is for use in adults, adolescents and children from 2 years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GRANISETRON HYDROCHLORIDE PRE-FILLED SYRINGE
Do not use Granisetron Hydrochloride Pre-filled Syringe
– if you are allergic (hypersensitive) to granisetron or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, nurse or pharmacist before using Granisetron
Check with your doctor, nurse or pharmacist before using Granisetron Hydrochloride Pre-filled Syringe if you:
– have problems with your bowel movements because of a blockade 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 antagonist? medicines. These include dolasetron and ondansetron used like Granisetron Hydrochloride Pre-filled Syringe in the treatment and prevention of nausea and vomiting.
Serotonin syndrome is an uncommon but potentially life-threatening reaction that can occur with granisetron (see section 4). The reaction can occur if you take granisetron
alone but it is more likely to occur if you take granisetron with certain other medicines (in particular fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).
Other medicines and Granisetron
Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Granisetron Hydrochloride Pre-filled Syringe can affect the way some medicines work. Also, some other medicines can affect the way this injection or infusion works.
In particular, tell your doctor, nurse or pharmacist if you are taking the following medicines:
– medicines used to treat an irregular heartbeat or other ?5-HT3 receptor antagonist? medicines such as dolasetron or ondansetron (see ?Warnings and precautions? above)
– phenobarbital, a medicine used to treat epilepsy.
– SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. Examples are fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
– SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety. Examples are venlafaxine, duloxetine.
Pregnancy and breastfeeding
You should not have this injection or infusion if you are pregnant, trying to get pregnant or are breastfeeding unless your doctor has told you to.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.
Driving and using machines
Granisetron Hydrochloride Pre-filled Syringe is not likely to affect your ability to drive or use any tools or machines.
Granisetron Hydrochloride Pre-filled Syringe contains sodium
This medicine contains:
– a maximum of 27.7 mg (or 1.2 mmol) sodium (the main component of cooking/table salt) per 1 ml Pre-filled Syringes.
This is equivalent to 1.4% of the recommended maximum daily dietary intake of sodium for an adult
– a maximum of 83.1 mg (or 3.6 mmol) sodium (the main component of cooking/table salt) per 3 ml Pre-filled Syringes.
This is equivalent to 4.2% of the recommended maximum daily dietary intake of sodium for an adult
3. HOW GRANISETRON HYDROCHLORIDE PRE-FILLED SYRINGE WILL BE GIVEN
The injection or infusion will be given to you by a doctor or nurse. The dose of Granisetron Hydrochloride Pre-filled Syringe 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 Hydrochloride Pre-filled Syringe can be given as an injection or infusion into the veins (intravenous).
Dosage
The usual doses are:
Prevention of feeling or being sick following radio- or chemotherapy
You will be given the injection or infusion before your radio- or chemotherapy starts. The injection or infusion into your veins will take between 30 seconds (injection) and 5 minutes (infusion) 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 or infusion will take between 30 seconds (injection) and 5 minutes (infusion) and the dose will usually be between 1 and 3 mg. The medicine may be diluted before it is injected or infused into your veins.
You may be given more injections or infusions to stop
your sickness after the first dose. There will be at least 10 minutes between each dose. The most Granisetron Hydrochloride Pre-filled Syringe you will be given is 9 mg a day.
Combination with steroids
The effect of the injection or infusion 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 chemotherapy
Children will be given Granisetron Hydrochloride Pre-filled Syringe by infusions into a vein as described above with the dose depending on the child?s weight. The infusions will be diluted and be given before 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 Hydrochloride Pre-filled Syringe 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 more Granisetron Hydrochloride Pre-filled Syringe than you should
Because the injection or infusion 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.
For information intended for healthcare professionals please see the accordant section below.
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 up to 1 in 10 users):
? Difficulty in sleeping (insomnia)
? Diarrhoea
? Changes in how your liver is working shown by blood tests
Uncommon (affects up to 1 in 100 users):
? Skin rashes or an allergic skin reaction or ?nettle rash? or ?hives? (urticaria). The signs may include red, raised itchy bumps.
? Abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions
? Changes in the heartbeat (rhythm) and changes are seen on ECG readings (electrical recordings of the heart)
Serotonin Syndrome. The signs may include
diarrhoea, nausea, vomiting, high temperature and blood pressure, excessive sweating and rapid heartbeat, agitation, confusion, hallucination, shivering, muscles shake, jerks or stiffness, loss of coordination and restlessness.
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE GRANISETRON HYDROCHLORIDE PRE-FILLED SYRINGE
Keep this medicine out of the sight and reach of children.
This product does not require any special temperature storage conditions.
Keep the Pre-filled Syringes in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the Pre-filled Syringes label and the outer carton after ?EXP.?. The expiry date refers to the last day of that month.
Do not use this medicine if you notice the solution is not clear or free from particles.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Granisetron Hydrochloride Pre-filled Syringe contains
The active substance is granisetron hydrochloride
Each 1 ml Pre-filled Syringes contains a total content of 1 mg granisetron as the hydrochloride in 1 ml of a sterile solution.
Each 3 ml Pre-filled Syringes contains a total content of 3 mg granisetron as the hydrochloride in 3 ml of a sterile solution.
Each 4 ml Pre-filled Syringes contains a total content of 4 mg granisetron as the hydrochloride in 4 ml of a sterile solution.
The other ingredients are sodium chloride, citric acid monohydrate, sodium hydroxide and water for injections.
What Granisetron Hydrochloride Pre-filled Syringe looks like and contents of the pack
Granisetron Hydrochloride Pre-filled Syringe is a clear, colourless concentrate for solution for injection or infusion.
Pack size:
Granisetron Hydrochloride
Pre-filled Syringe is available in packs of five or ten Pre-filled Syringes
filled with 1 ml, 3 ml or
4 ml of the solution.
Not all pack sizes may be marketed.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222825)