Active Ingredient and Strength	PALONOSETRON HYDROCHLORIDE EQV PALONOSETRON - 0.25 MG/5 ML
Dosage Form	INJECTION, SOLUTION
Manufacturer and Country	QILU PHARMACEUTICAL (HAINAN), CO., LTD. - CHINA
Registration Number	SIN16959P
Licence Holder	APEX PHARMA MARKETING PTE. LTD.
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	A04AA05

4.1 THERAPEUTIC INDICATIONS

Chemotherapy-induced nausea and vomiting in adults

Palonosetron-AFT 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 paediatric patients aged 1 month to less than 17 years

Palonosetron-AFT is indicated for:

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

Postoperative nausea or vomiting in adults

Palonosetron-AFT is indicated for:

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-AFT is recommended even where the incidence of postoperative nausea and/or vomiting is low.

4.2 DOSE AND METHOD OF ADMINISTRATION

Recommended dosing

Chemotherapy-induced nausea and vomiting

The safety and efficacy of palonosetron in children aged less than 1 month have not been established. No data are available. There is 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

Dosage for adults – a single dose of 0.075 mg I.V. dose administered over 10 seconds immediately before the induction of anaesthesia.

Instructions for IV administration

Palonosetron-AFT is supplied ready for intravenous injection at a concentration of 0.05 mg/mL (50 mcg/mL).

This medicinal product must not be mixed with other medicinal products.

Flush the infusion line with normal saline before and after administration of Palonosetron-AFT.

Contains no antimicrobial agent. Palonosetron-AFT is for single use in one patient only.
Discard any residue.

4.3 CONTRAINDICATIONS

Palonosetron-AFT is contraindicated in patients with known hypersensitivity to the drug or to any of its components.