Canitron Injection (Granisetron Hydrochloride)

Adult administration

1. Adults 1) Nausea and vomiting caused by chemotherapy or radiotherapy <Preparation> To prepare an intravenous infusion solution, withdraw 3 mL (3 mg) of granisetron from the ampoule and dilute it with one of the infusion solutions 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 Dextrose Injection, 5 % w/v Dextrose 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). Nausea and vomiting are controlled with a single dose of this medicine, 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: Up to 3 doses of 3 mg of this medicine may be administered within 24 hours. The total dose administered over 24 hours should 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 special dosage adjustment is required. 4. Patients with renal or hepatic impairment No special dosage adjustment is required.

Child administration

2. Children (2 years and older) 1) Nausea and vomiting induced by chemotherapy <Preparation> Dilute a dose of 40 μg/kg of this medicine in an infusion solution (see the adult preparation instructions) to a total volume of 10 ∼ 30 mL. <Dose> Dilute 40 μg/kg (maximum 3 mg) of this medicine in 10 ∼ 30 mL of infusion solution and administer over at least 5 minutes. Nausea and vomiting are controlled with a single dose of this medicine, but one 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 there is no experience with the use of this medicine for postoperative nausea and vomiting in children, it is preferable not to administer it.

This medication is provided as an injectable ampoule, and extreme care must be taken when cutting the container to avoid glass fragments. Caution is particularly necessary when using it for children or the elderly. It should not be used in patients who have allergic reactions to any ingredients contained in this medication. This medication can suppress bowel movements, so patients with intestinal obstruction symptoms must be closely monitored after administration. Additionally, it may affect heart rhythm, so patients with heart disease or existing ECG abnormalities should use it cautiously. Common side effects may include headaches and constipation, and rare allergic reactions or rashes may occur. Liver function tests may show temporarily elevated values, but this rarely leads to serious issues. This medication can cause serotonin syndrome, which induces changes in mental status or neurological abnormalities, so patients taking serotonin-related medications should be monitored closely. There is insufficient data regarding its effect on driving or machinery operation, but drowsiness may occur, so caution is advised. This medication has relatively few interactions with other medications, but caution is necessary when used in combination with certain analgesics or antibiotics, especially with respect to their effects on the heart, so patients with heart conditions should be cautious. Use during pregnancy should be avoided except in special cases, and it is recommended to discontinue breastfeeding during the treatment period if nursing. Safety for children and neonates has not been adequately verified, so caution is required when administering to children. In case of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms, and it should be ensured that the recommended dose is not significantly exceeded. This medication should not be mixed with other drugs and should be stored in a tightly closed container that protects it from light and is kept out of reach of children. Diluted solutions should be used as soon as possible, and they should be prepared and stored in a sterile manner.

• Hypersensitivity
• urticaria
• headache
• serotonin syndrome
• QT prolongation
• constipation
• increased hepatic aminotransferases
• rash
• anaphylaxis

This medication is sensitive to light, so it should be stored in a container that does not allow light to enter. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

A colorless, transparent injection solution contained in a colorless, transparent ampoule.

Package unit

1mL/ampoule × 5, 3mL/ampoule × 5