PALONOSETRON KABI SOLUTION FOR INJECTION 50MCG/ML [SIN17591P]

Product Info

PALONOSETRON KABI SOLUTION FOR INJECTION 50MCG/ML

[SIN17591P]

Indication

4.1 Therapeutic indications
Chemotherapy-Induced Nausea and Vomiting in Adults
Palonosetron is indicated for:

• Moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses

• Highly emetogenic cancer chemotherapy – prevention of acute nausea and vomiting associated with initial and repeat courses

Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
Palonosetron is indicated for:

• Prevention of acute nausea and vomiting associated with initial and repeat courses of moderately or highly emetogenic cancer chemotherapy

Postoperative Nausea and Vomiting in Adults

• Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.

As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, Palonosetron is recommended even where the incidence of postoperative nausea and/or vomiting is low.

Dosing

4.2 Posology and method of administration

Posology
Chemotherapy-Induced Nausea and Vomiting
Palonosetron should be used only before chemotherapy administration. This medicinal product should be administered by a healthcare professional under appropriate medical supervision.
Adult
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. Palonosetron Fresenius Kabi should be injected over 30 seconds.

The efficacy of Palonosetron Kabi in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.

Pediatric population
Children and Adolescents (aged 1 month to less than 17 years):
20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy.

The safety and efficacy of Palonosetron in children aged less than 1 month have not been established. No data are available. There are limited data on the use of Palonosetron in the prevention of nausea and vomiting in children under 2 years of age.

Postoperative Nausea and Vomiting
Adult
75 micrograms palonosetron administered as a single intravenous bolus administered over 10 seconds immediately before the induction of anesthesia.

Method of administration
For intravenous use.

Palonosetron Kabi is supplied ready for intravenous administration at a concentration of 0.05 mg/ml (50 mcg/ ml). Palonosetron Kabi should not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of Palonosetron Kabi. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.

Contraindications

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.