Granisetron Kabi 1 mg/ml concentrate for injection solution EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Granisetron Kabi 1 mg/ml solution for injection EFG
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 questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- What Granisetron Kabi is and what it is used for
- What you need to know before using Granisetron Kabi
- How to use Granisetron Kabi
- Possible side effects
- How to store Granisetron Kabi
- Contents of the pack and other information
1. What Granisetron Kabi is and what it is used for
Granisetron Kabi contains the active substance granisetron. It belongs to a group of medicines called serotonin 5-HT3 receptor antagonists, or antiemetics, which means they prevent or treat nausea and vomiting.
Granisetron Kabi is indicated for the prevention and treatment of nausea and vomiting (feeling of discomfort) caused by certain treatments, such as chemotherapy or radiotherapy in anticancer therapy, as well as for the treatment and prevention of postoperative nausea and vomiting.
The injectable solution is indicated in adults and children aged 2 years and older.
2. What you need to know before using Granisetron Kabi
Do not use Granisetron Kabi
- if you are allergic to granisetron or to any of the other ingredients of this medicine (see section 6).
If you are unsure, consult your doctor, pharmacist, or nurse before receiving the injection.
Warnings and precautions
Before using Granisetron Kabi, talk to your doctor, pharmacist, or nurse if:
- you have constipation due to intestinal obstruction.
- you have heart problems, are receiving anticancer medicines that may be harmful to your heart, and/or have disorders affecting your electrolyte levels such as
potassium, sodium, or calcium (electrolyte imbalances).
- you are taking another medicine from the group of “5-HT3 receptor antagonists”.
Included in this group are dolasetron and ondansetron, which, like Granisetron Kabi, are used for the prevention and treatment of nausea and vomiting.
Serotonin syndrome is a rare but potentially life-threatening reaction that may occur with granisetron (see section 4). This reaction may occur when taking granisetron alone, but is more likely to occur if you take granisetron together with certain other medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).
Use of Granisetron Kabi with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Granisetron Kabi
may interact with certain medicines. Also, some medicines may
interact with this injection.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicine:
- medicines used to treat irregular heartbeats, other
5-HT3 receptor antagonists such as dolasetron or
ondansetron (see “Warnings and precautions”)
- phenobarbital, a medicine used to treat epilepsy
- ketoconazole, a medicine used to treat fungal infections
- erythromycin, an antibiotic used to treat bacterial infections
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
- SNRIs (serotonin and noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Driving and using machines
Granisetron Kabi is not expected to affect your ability to drive or operate machinery.
Granisetron Kabi contains sodium chloride
This medicine contains less than 1 mmol (23 mg) of sodium per vial, and is therefore considered essentially “sodium-free”.
3. How to use Granisetron Kabi
Granisetron Kabi will be administered to you by your doctor or nurse.
The dose of Granisetron Kabi varies from patient to patient. It depends on your age, body weight, and whether you are taking other medications to prevent or treat nausea and vomiting. Your doctor will decide how much you should be given.
Granisetron Kabi may be given as an intravenous injection (into a vein).
Prevention of nausea or vomiting following radiotherapy or chemotherapy
The injection will be given before your radiotherapy or chemotherapy begins. The intravenous injection will last between 30 seconds and 5 minutes, and the usual dose ranges from 1 to 3 mg. The medication may be diluted before injection.
Treatment of nausea or vomiting following radiotherapy or chemotherapy
The intravenous injection lasts between 30 seconds and 5 minutes, and the usual dose ranges from 1 to 3 mg. The medication may be diluted before intravenous injection. To control nausea, you may receive additional injections after the first dose, with at least 10 minutes between each dose. The maximum daily dose of Granisetron Kabi is 9 mg.
Combination with corticosteroids
The effect of the injection may be enhanced by using other medications called corticosteroids. This may include 8–20 mg of dexamethasone, administered before the start of radiotherapy or chemotherapy, or 250 mg of methylprednisolone administered before the start of chemotherapy and again immediately after its completion.
Treatment of nausea or vomiting following surgery
The intravenous injection lasts between 30 seconds and 5 minutes, and the usual dose is 1 mg. The maximum daily dose of Granisetron Kabi is 3 mg.
Use in children
Use in children for the prevention or treatment of nausea or vomiting following radiotherapy or chemotherapy
Granisetron Kabi is administered by intravenous injection as described above, with the dose adjusted according to the child's body weight. The injections are diluted and administered before radiotherapy or chemotherapy, lasting 5 minutes. Children may receive up to a maximum of 2 doses per day, with at least 10 minutes between doses.
Use in children for the prevention or treatment of nausea or vomiting following surgery
This injection should not be administered for the treatment of nausea or feeling unwell after surgery.
If you use more Granisetron Kabi than you should
Since this injection is administered by a doctor or nurse, it is unlikely that you will receive more than the intended dose. However, if you are concerned, consult your doctor or nurse. Symptoms of overdose may include mild headache (cephalalgia). You will be treated according to your symptoms.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you notice any of the following adverse effects, you must immediately consult your doctor:
- Allergic reactions (anaphylaxis). Signs may include swelling of the throat, or swelling of the face, lips, and mouth, and difficulty breathing or swallowing.
Other adverse effects that may occur 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
- Difficulty falling asleep (insomnia)
- Blood tests show changes in liver function
- Diarrhea
Uncommon: may affect up to 1 in 100 people
- Skin rashes or an allergic reaction or urticaria. Signs may include itchy red spots
- Changes in heart rhythm (rhythm) and changes in the ECG (electrocardiogram)
- Abnormal involuntary movements, such as tremors, muscle rigidity, and muscle contractions
- Serotonin Syndrome. Signs may include fever, sweating, chills, diarrhea, nausea, vomiting, muscle spasms, twitching, spasms or stiffness, hyperactive reflexes, loss of coordination, rapid heart rate, changes in blood pressure, confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Granisetron Kabi
Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the packaging
after “EXP”. The expiry date refers to the last day of the month indicated.
- Store in the original packaging to protect from light.
- Do not freeze.
- Once opened, Granisetron Kabi must be used immediately.
- After dilution, Granisetron Kabi must be used immediately. If not used
immediately, the ready-to-use solution should be stored at 25°C, protected from direct sunlight, and used within the following 24 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Granisetron Kabi
- The active substance is granisetron (as hydrochloride).
Each ml of Granisetron Kabi injectable solution contains 1 mg of granisetron (as hydrochloride).
- Other ingredients are citric acid (monohydrate), hydrochloric acid, sodium chloride, water for injections, and sodium hydroxide to adjust the pH (acidity).
Appearance of the product and contents of the container
Granisetron Kabi is a clear, colourless solution.
The carton may contain 5 or 10 clear glass ampoules. The ampoules contain 1 ml or 3 ml of Granisetron Kabi 1 mg/ml injectable solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
FRESENIUS KABI ESPAÑA, S.A.U.
Marina, 16-18 - 08005 (Barcelona)
Spain
Manufacturer:
Labesfal – Laboratórios Almiro S.A. (Fresenius Kabi Group)
Zona Industrial do Lagedo, 3465-157 Santiago de Besteiros
Portugal
This medicine is authorised in the European Economic Area member states under the following names:
Belgium Granisetron Fresenius Kabi 1mg/ml, oplossing voor injectie / solution injectable / Injektionslösung
Czech Republic Granisetron Kabi 1 mg/ml, injekcní roztok
Germany Granisetron Kabi 1 mg/ml Injektionslösung
Finland Granisetron Fresenius Kabi 1 mg/ml injektioneste, liuos
Italy Granisetron Kabi 1 mg/ml soluzione iniettabile
Luxembourg Granisetron Kabi 1 mg/ml Injektionslösung
Netherlands Granisetron Fresenius Kabi 1mg/ml, oplossing voor injectie
Portugal Granisetron Kabi
Romania Granisetron Kabi 1 mg/ml solutie injectabila
Sweden Granisetron Fresenius Kabi 1 mg/ml injektionsvätska, lösning
Slovakia Granisetron Kabi 1 mg/ml, injekcný roztok
United Kingdom Granisetron 1 mg/ml solution for injection
This leaflet was last reviewed in September 2020
“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS)
www.aemps.gob.es.”
This information is intended for healthcare professionals only:
Instructions for dilution:
For single use only. Any unused portion must be discarded.
Diluted injections and infusions should be inspected visually for particulate matter prior to administration. Only solutions that are clear and free of particles should be used.
Adults: The contents of a 1 ml ampoule may be diluted up to a total volume of 5 ml; the contents of a 3 ml ampoule may be diluted up to a total volume of 15 ml.
Granisetron Kabi may also be diluted in 20 - 50 ml of a compatible infusion fluid and administered over 5 minutes as an intravenous infusion using any of the following solutions:
0.9% w/v Sodium chloride solution
5% w/v Glucose solution
Ringer lactate solution
Other diluents must not be used.
Use in the paediatric population
Children aged two years and older: To prepare a dose of 10 - 40 μg/kg, withdraw the appropriate volume and dilute in an infusion fluid (as for adults) to a total volume of 10 to 30 ml.
As a general precaution, Granisetron Kabi must not be mixed in the same solution with other medicines.
Granisetron Kabi 1 mg/ml is compatible with dexamethasone sodium phosphate at a concentration of 10–60 µg/ml of Granisetron and 80–480 µg/ml of dexamethasone phosphate diluted in 0.9% Sodium chloride or 5% Glucose solution for a period of 24 hours.
Expiry date:
3 years
Once opened, the medicine must be used immediately.
Ideally, intravenous infusions of Granisetron Kabi should be prepared at the time of administration. After dilution or when the container is first opened, the solution is stable for 24 hours if stored at room temperature (25°C) under normal indoor lighting and protected from direct sunlight. Do not use after 24 hours. If storage after preparation is required, Granisetron Kabi infusions must be prepared under appropriate aseptic conditions.
Special storage precautions
Store the ampoules in the outer packaging to protect from light. Do not freeze.
Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.