Samsung Palonosetron Injection (Palonosetron Hydrochloride)

Adult administration

1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.25 mg intravenously once over at least 30 seconds, 30 minutes before starting chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg intravenously once over at least 10 seconds immediately before induction of anesthesia. As with other antiemetics, routine administration is not recommended in patients expected to have a low likelihood of postoperative nausea and vomiting. Administration of this medicine is recommended for patients in whom postoperative nausea and vomiting should be avoided, even if the likelihood of its occurrence is low. 3) Treatment of postoperative nausea and vomiting: As soon as nausea and vomiting occur, administer 0.075 mg intravenously once over at least 10 seconds. No dose adjustment is required for elderly patients or patients with hepatic or renal impairment. There are no clinical data for patients with end-stage renal disease undergoing dialysis. This medicine should not be mixed with other medicines. Flush the infusion line with normal saline before and after administering this medicine.

Child administration

Children (2 months of age and older): Prevention of acute nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.02mg/kg (maximum 1.5mg) once by intravenous infusion over at least 15 minutes, 30 minutes before starting chemotherapy. Neonates: The safety and efficacy of this medicine have not been established (no data are available). Infants (under 24 months): Data on the use of this medicine for the prevention of nausea and vomiting induced by anticancer chemotherapy are limited.

This medication should not be used by individuals who are allergic to it or its ingredients. Those who have previously had allergic reactions to similar medications should take extra caution while using this drug. This medication may slow down bowel movements, potentially worsening constipation, so individuals with severe constipation or symptoms of intestinal obstruction should use it carefully under the supervision of a doctor. Additionally, using this drug with other serotonin-related medications may rarely lead to serious side effects known as serotonin syndrome, so it is essential to consult with a doctor if taking such medications. This drug may cause dizziness, drowsiness, and fatigue, requiring caution while driving or operating machinery. Since it may affect heart rhythm, individuals with heart disease or prolonged QT intervals should consult a doctor before using this medication. The effects of this medication on the fetus or infant during pregnancy or breastfeeding have not been thoroughly studied, so it should only be used under a doctor’s judgment when necessary. Special caution is needed when administering this drug to children or elderly individuals, particularly in children, as safety and efficacy have yet to be established. In case of overdose, there is no specific antidote, and immediate medical attention should be sought for appropriate treatment. This drug should be stored in a cool place away from direct sunlight, and it is crucial to check for discoloration or foreign substances before administration. Any leftover medication after use should be disposed of, and it should not be shared with others.

• Headache
• constipation
• diarrhea
• dizziness
• fatigue
• abdominal pain
• insomnia
• severe constipation
• non-sustained tachycardia
• bradycardia

This medication should be stored at room temperature between 1 to 30 degrees Celsius, and it is important to keep it in a sealed container to prevent air exposure. It should also be kept in a dark place to protect it from light exposure, which helps maintain its effectiveness.

Appearance

A colorless and transparent solution contained in a colorless and transparent prefilled syringe

Package unit

5 prefilled syringes/box [(1.5 mL/syringe)], 1 prefilled syringe/box [(5 mL/syringe)]