PROSPECTO : INFORMATION FOR THE USER

Granisetron Kabi 1 mg/ml injectable solution EFG

Read this prospectus carefully before starting to use the medication because it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

1.What is Granisetron Kabi and for what it is used

2.What you need to know before using Granisetron Kabi

3.How to use Granisetron Kabi

4.Possible adverse effects

5Storage of Granisetron Kabi

6.Contents of the package and additional information

Granisetron Kabi contains the active ingredient granisetron. This belongs to a group of medicines called 5-HT3 receptor antagonists, or antiemetics, which prevent or treat nausea and vomiting.3,

Granisetron Kabi is indicated for the prevention and treatment of nausea and vomiting (feeling of discomfort) caused by certain treatments, such as chemotherapy or radiation therapy in cancer therapy, as well as for treating and preventing postoperative nausea and vomiting.

The injectable solution is indicated for adults and children 2 years of age and older.

No use Granisetron Kabi

-if you are allergic to granisetron or any of the other components of this medication (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 bowel obstruction causing constipation.

-you have heart problems, are receiving cancer medications that may be harmful to your heart, and/or have any electrolyte imbalances such as potassium, sodium, or calcium (electrolyte disturbances).

-you are taking another medication from the group of “5-HT3 receptor antagonists.”

Within this group are dolasetron and ondansetron, used, like Granisetron Kabi, for the treatment and prevention of nausea and vomiting.

The Serotonin Syndrome is a rare but potentially fatal 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 other certain medications (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).

Use of Granisetron Kabi with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is because Granisetron Kabi may interact with some medications. Also, some medications may interact with this injection.

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication:

•medications used to treat irregular heartbeats, other “5-HT3 receptor antagonists” such as dolasetron or ondansetron (see “Warnings and precautions”)

•phenobarbital, medication used to treat epilepsy

•ketoconazole, medication used to treat fungal infections

•erythromycin, 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 (selective serotonin and noradrenaline reuptake inhibitors) used to treat depression and/or anxiety, including venlafaxine, duloxetine.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Driving and operating machinery

It is not expected that Granisetron Kabi will affect your ability to drive or operate machinery.

Granisetron Kabi contains sodium chloride

This medication contains less than 1 mmol (23 mg) of sodium per ampoule, making it essentially “sodium-free.”

The injection will be administered by your doctor or nurse.

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

Granisetron Kabi can be administered as an injection into a vein (intravenous).

Prevention of nausea or vomiting after radiation or chemotherapy

The injection will be administered before the start of radiation or chemotherapy. The intravenous injection will last between 30 seconds to 5 minutes, and the usual dose is between 1 and 3 mg. The medication can be diluted before injection.

Treatment of nausea or vomiting after radiation or chemotherapy

The injection will last between 30 seconds to 5 minutes, and the usual dose is between 1 and 3 mg. The medication can be diluted before intravenous injection. To stop the discomfort, you may receive additional injections after the first dose. There should be at least 10 minutes between each injection. The maximum dose of Granisetron Kabi will be 9 mg per day.

Combination with corticosteroids

The effect of the injection can be increased with the use of other medications, known as corticosteroids. This may include 8-20 mg of dexamethasone, administered before the start of radiation or chemotherapy treatment, or 250 mg of methylprednisolone administered before the start of chemotherapy and again immediately after its completion.

Treatment of nausea or vomiting after surgery

The intravenous injection will last between 30 seconds to 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

radiation or chemotherapy

Granisetron Kabi is administered by intravenous injection, as described earlier, with the dose adjusted according to the child's weight. The injections are diluted and administered before radiation or chemotherapy, lasting 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 surgery

This injection should not be administered for the treatment of nausea or discomfort 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 doses than you should. However, if you are concerned, consult your doctor or nurse. Symptoms of overdose may include a mild headache (cephalgia). You will be treated according to your symptoms.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If you observe any of the following adverse effects, you must immediately consult your doctor:

•allergic reactions (anaphylaxis). The signs may include throat inflammation, or

swelling of the face, lips, and mouth, and difficulty breathing or swallowing.

Other adverse effects that may occur while taking this medication are:

Very frequent: may affect more than 1 in 10 people

•headache

•constipation. Your doctor will monitor your condition.

Frequent: may affect up to 1 in 10 people

•difficulty falling asleep (insomnia)

•through blood tests, changes in liver function are shown

•diarrhea.

Rare: may affect up to 1 in 100 people

•skin eruptions or an allergic reaction or urticaria. The signs may include

red itchy patches

•changes in heartbeats (rhythm) and changes in the ECG

(electrocardiogram)

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

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or nurse, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

•Do not use this medication after the expiration date that appears on the packaging

after “CAD”. The expiration date is the last day of the month indicated.

•Store in the original packaging to protect it from light.

•Do not freeze.

•Once opened, Granisetron Kabi must be used immediately.

•Once diluted, Granisetron Kabi must be used immediately. If not used

immediately, the ready-to-use solution must be stored at 25°C, protected from sunlight

and must be used within the next 24 hours.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Granisetron Kabi

• The active ingredient 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 injection, sodium hydroxide for pH adjustment (acidity).

Aspect of the product and contents of the package

Granisetron Kabi is a transparent and colorless solution.

The box may contain 5 or 10 glass vials. The vials contain 1 ml or 3 ml of Granisetron Kabi 1 mg/ml injectable solution.

Not all package sizes may be marketed.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

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 authorized in the member states of the European Economic Area with the following names:

BelgiumGranisetron Fresenius Kabi 1mg/ml, solution for injection /solution injectable / Injektionslösung

Czech RepublicGranisetron Kabi 1 mg/ml, injekční roztok

GermanyGranisetron Kabi 1 mg/ml Injektionslösung

FinlandGranisetron Fresenius Kabi 1 mg/ml injection solution, solution

ItalyGranisetron Kabi 1 mg/ml injectable solution

LuxembourgGranisetron Kabi 1 mg/ml Injektionslösung

NetherlandsGranisetron Fresenius Kabi 1mg/ml, solution for injection

PortugalGranissetrom Kabi

RomaniaGranisetron Kabi 1 mg/ml injectable solution

SwedenGranisetron Fresenius Kabi 1 mg/ml injection solution, solution

SlovakiaGranisetron Kabi 1 mg/ml, injekční roztok

United Kingdom Granisetron 1 mg/ml solution for injection

This leaflet has been revised inSeptember 2020

“Detailed and updated information on this medicineis available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

www.aemps.gob.es.”

-----------------------------------------------------------------------------------------------------------------------

This information is intended solely for doctors or healthcare professionals:

Instructions for dilution:

For single use. The unused amount must be discarded.

Injected and perfused solutions must be visually inspected for particles before administration. Only use if the solution is transparent and free of particles.

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

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

Sodium chloride 0.9% w/v solution

Glucose 5% w/v solution

Ringer lactate solution

Do not use other diluents.

Use in pediatric population

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

As a general precaution, Granisetron Kabi should not be mixed with other

medicines.

Granisetron Kabi 1 mg/ml is compatible with Dexametasona dihidrógenofosfato disódico at a concentration of 10-60 µg/ml of Granisetrón and 80-480µg/ml of Dexametasona fosfato diluted in Sodium chloride 0.9% or Glucose 5% solution for a period of 24 hours.

Expiration date of the medicine:

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 package is opened for the first time, the expiration date is 24 hours if stored at room temperature (25°C) under normal interior lighting, protected from direct sunlight. Do not use after 24 hours. If it is to be stored after preparation, Granisetron Kabi infusions must be prepared under appropriate aseptic conditions.

Special precautions for storage:

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

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.