Kaiselon Injection (Granisetron Hydrochloride)

Adult administration

1. Adults 1) Nausea and vomiting caused by chemotherapy or radiotherapy <Directions> To prepare an intravenous infusion solution, withdraw 3 mL (3 mg) of granisetron from the ampoule and dilute it in one of the infusion solutions listed below to a total volume of 20 ∼ 50 mL or 15 mL. Do not use any other diluent. - For dilution to 20 ∼ 50 mL: normal saline injection, 0.18 % w/v sodium chloride + 4.0 % w/v glucose injection, 5 % w/v glucose injection, Hartmann's injection, sodium lactate injection, 10 % w.v mannitol injection - For dilution to 15 mL: normal saline injection <Dose> Dilute 40 μg/kg of granisetron (usually 3 mg) in 20 ∼ 50 mL of infusion solution and administer over at least 5 minutes, or dilute in 15 mL of infusion solution and administer intravenously (over at least 30 seconds). A single dose of this medicine controls nausea and vomiting, but up to 2 additional doses of 3 mg may be administered at intervals of at least 10 minutes within 24 hours. Maximum daily dose: This medicine may be administered up to 3 times at 3 mg per dose within 24 hours. The total dose administered over 24 hours must not exceed 9 mg. 2) Postoperative nausea and vomiting Dilute 1 mL (1 mg) of this medicine in normal saline injection to a total volume of 5 mL (do not use any other diluent), then administer slowly intravenously (over at least 30 seconds). Maximum daily dose: Up to 2 mL (2 mg) of this medicine may be administered within 24 hours. 3. Older adults No specific dosage adjustment is necessary. 4. Patients with renal or hepatic impairment No specific dosage adjustment is necessary.

Child administration

2. Children (2 years and older) 1) Nausea and vomiting induced by chemotherapy <Directions> Dilute a dose of 40 μg/kg of this medicine in infusion solution (see the directions for adults) to a total volume of 10 ∼ 30 mL. <Dose> Dilute 40 μg/kg of this medicine (maximum 3 mg) in 10 ∼ 30 mL of infusion solution and administer over at least 5 minutes. A single dose of this medicine controls nausea and vomiting, but 1 additional dose of 40 μg/kg (maximum 3 mg) may be administered at an interval of at least 10 minutes within 24 hours. 2) Since this medicine has not been used for postoperative nausea and vomiting in children, it is preferable not to administer it.

This medication is provided in ampule form, and care must be taken when opening the container as glass fragments may be present. Special caution is necessary when used by children or the elderly. People who have allergic reactions to this medication or its components should not use it. As it can suppress bowel motility, patients suspected of having bowel obstruction symptoms should be closely monitored after administration of this medication. It may affect cardiac electrical activity, so caution is needed when used by patients with arrhythmias or heart diseases. Headaches and constipation may occur frequently, and liver function tests may show a temporary increase but are usually not severe. Allergic reactions such as rashes or anaphylaxis may occur, so it is essential to inform medical staff immediately if symptoms arise. This medication may affect driving or operating machinery, so caution is needed while using it. Using this medication in conjunction with other serotonergic drugs can result in serious side effects known as serotonin syndrome; therefore, patients must be closely monitored if combined. Pregnant or breastfeeding women should generally avoid using this medication unless in special circumstances and should discontinue breastfeeding while using it. Safety in children, especially in premature infants or infants, has not been adequately confirmed, necessitating cautious use. In the case of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms, and care must be taken not to exceed the recommended dosage. This medication should not be mixed with other drugs, and after dilution, it should be used as soon as possible. Keep this medication out of the reach of children and do not transfer it to other containers.

• hypersensitivity
• urticaria
• headache
• serotonin syndrome
• QT prolongation
• constipation
• increased liver aminotransferases
• rash
• diarrhea
• nausea

This medication should be stored in a sealed container to protect it from air and light, preferably at temperatures between 1 to 30 degrees Celsius at room temperature. This helps maintain the medication's efficacy and prevents deterioration.

Appearance

Colorless and transparent injection solution in a colorless and transparent ampule

Package unit

1mL, 3mL x 5 ampules