GRANISETRON KABI 1 mg/ml CONCENTRATE FOR INJECTION SOLUTION

2. What you need to know before you use Granisetron Kabi

Do not use Granisetron Kabi

• if you are allergic to granisetron or any of the other ingredients of this medicine (see section 6).

If you are not sure, 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 problems with constipation due to intestinal obstruction.
• you have heart problems, are receiving anticancer medications that can be harmful to your heart, and/or have some disorder of salt levels such as potassium, sodium, or calcium (electrolyte disturbances).

you are taking another medicine from the group of "5-HT3 receptor antagonists".

This group includes dolasetron and ondansetron, used, like Granisetron Kabi, for the treatment and prevention of nausea and vomiting.

Serotonin Syndrome is a rare but potentially life-threatening reaction that can occur with granisetron (see section 4). The reaction can occur if you take granisetron alone but is more likely to occur if you take granisetron with other certain medications (in particular fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).

Using Granisetron Kabi with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is because Granisetron Kabi may interact with some medicines. Also, some medicines may interact with this injection.

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine:

• medicines used to treat irregular heartbeats, other

medicines "antagonists of the 5-HT3 receptors" 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 norepinephrine 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 have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

Granisetron Kabi is not expected to affect your ability to drive or use machines.

Granisetron Kabi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, so it is essentially "sodium-free".

3. How to use Granisetron Kabi

The injection will be given to you by your doctor or nurse.

The dose of Granisetron Kabi varies from one patient to another. It depends on age, weight, and whether you are taking other medicines to prevent or treat nausea and vomiting. Your doctor will decide how much to administer.

Granisetron Kabi can be given as an injection into the veins (intravenously).

Prevention of nausea or vomiting after radiotherapy or chemotherapy

You will be given the injection before starting radiotherapy or chemotherapy. The injection into the veins (intravenously) will last between 30 seconds and 5 minutes, and the usual dose is between 1 and 3 mg. The medicine can be diluted before injection.

Treatment of nausea or vomiting after radiotherapy or chemotherapy

The injection will last between 30 seconds and 5 minutes, and the usual dose is between 1 and 3 mg. The medicine can be diluted before injection into the veins (intravenously). To stop the discomfort, you may receive more injections after the first dose. There must be at least 10 minutes between each dose. The maximum dose of Granisetron Kabi will be 9 mg per day.

Combination with corticosteroids

The effect of the injection may be increased with the use of other medicines, called corticosteroids. It can be 8-20 mg of dexamethasone, administered before the start of radiotherapy or chemotherapy treatment, or 250 mg of methylprednisolone administered before the start of chemotherapy and again immediately after finishing it.

Treatment of nausea or vomiting after an operation

The injection into the veins (intravenously) will last between 30 seconds and 5 minutes, and the usual dose is 1 mg. The maximum dose of Granisetron Kabi is 3 mg per day.

Use in children

Use in children for the prevention or treatment of nausea or vomiting after radiotherapy or chemotherapy

Granisetron Kabi is given by injection into the veins (intravenously) as described above, with the dose adjusted according to the child's weight. The injections are diluted and administered before radiotherapy or chemotherapy and last 5 minutes. Children may receive a maximum of 2 doses per day, with at least 10 minutes between each dose.

Use in children for the prevention or treatment of nausea or vomiting after an operation

This injection should not be given for the treatment of nausea or discomfort after an operation.

If you use more Granisetron Kabi than you should

Because this injection is given by a doctor or nurse, it is unlikely that you will receive more than the dose you should. However, if you are concerned, talk to your doctor or nurse. Symptoms of overdose include a mild headache (cephalalgia). You will be treated according to your symptoms.

If you have any further questions on the use of this product, 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 any of the following side effects, you should see your doctor immediately:

• allergic reactions (anaphylaxis). The signs can include swelling of the throat, or your face, lips, and mouth, and difficulty breathing or swallowing.

Other side 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 sleeping (insomnia)
• through blood tests, changes in liver function are shown

Uncommon: may affect up to 1 in 100 people

• skin rash or an allergic reaction or hives. The signs can include red spots that itch
• changes in heartbeats (rhythm) and changes in the ECG (electrocardiogram)

Rare: may affect up to 1 in 1,000 people

• abnormal involuntary movements, such as tremors, muscle stiffness, and muscle contractions
• Serotonin Syndrome. The signs could include fever, sweating, chills, diarrhea, nausea, vomiting, muscle spasms, tremors, or stiffness, hyperactive reflexes, loss of coordination, rapid heartbeat, changes in blood pressure, confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Reporting of side effects

If you experience 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 to the Spanish Medicines Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Granisetron Kabi

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

Store in the original packaging to 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 the next 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 solution for injection contains 1 mg of granisetron (as hydrochloride).

• Other ingredients are citric acid (monohydrate), hydrochloric acid, sodium chloride, water for injections, sodium hydroxide to adjust the pH (acidity).

Appearance and packaging

Granisetron Kabi is a clear and colorless solution.

The box may contain 5 or 10 glass ampoules. The ampoules contain 1 ml or 3 ml of Granisetron Kabi 1 mg/ml solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicinal product is authorized in the Member States of the European Economic Area 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 Granissetrom 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 revised inSeptember 2020

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

www.aemps.gob.es.”

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This information is intended only for healthcare professionals:

Instructions for dilution:

For single use. The unused quantity should be discarded.

The injections and infusions diluted should be inspected visually for particles before administration. They should only be used if the solution is clear and free of particles.

Adults:The contents of a 1 ml ampoule can be diluted up to a volume of 5 ml; the contents of a 3 ml ampoule can be diluted up to a volume of 15 ml.

Granisetron Kabi can also be diluted in 20 - 50 ml of compatible infusion fluid and administered over 5 minutes as an intravenous infusion in any of the following solutions:

Sodium chloride 0.9% p/v solution

Glucose 5% p/v solution

Ringer's lactate solution

No other diluents should be used.

Use in pediatric population

Children from 2 years of age or older:To prepare the dose of 10 - 40 μg/kg, the appropriate volume is withdrawn and diluted in an infusion fluid (as for adults) up to a total volume of 10 to 30 ml.

As a general precaution, Granisetron Kabi should not be mixed in the solution with other medicines.

Granisetron Kabi 1 mg/ml is compatible with Dexamethasone dihydrogen phosphate at a concentration of 10-60 µg/ml of Granisetron and 80-480 µg/ml of Dexamethasone phosphate diluted in Sodium chloride 0.9% or Glucose 5% solution for 24 hours.

Shelf life of the medicinal product:

3 years

Once the medicinal product is opened, it should 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 shelf life is 24 hours if stored at room temperature (25°C) under normal indoor lighting protected from direct sunlight. It should not be used after 24 hours. If it is to be stored after preparation, the infusions of Granisetron Kabi should be prepared under appropriate aseptic conditions.

Special precautions for storage

Store the ampoules in the outer packaging to protect from light. Do not freeze.

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.