Palonosetron 250 micrograms Solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Palonosetron hydrochloride

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

A04AA; A04AA05

INN (International Name):

Palonosetron hydrochloride

Dosage:

250 microgram(s)

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Serotonin (5HT3) antagonists; palonosetron

Authorization status:

Marketed

Authorization date:

2016-10-28

Summary of Product characteristics

Health Products Regulatory Authority
30 April 2021
CRN009X4X
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Palonosetron 250 micrograms Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms palonosetron (as
hydrochloride).
Each vial of 5 ml of solution contains 250 micrograms palonosetron (as
hydrochloride).
Excipient with known effect
This medicinal product contains 0.2 mmol sodium per vial.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution, free from visible particles.
pH 4.7 – 5.3
Osmolality 270 – 330 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Palonosetron is indicated in adults for:

the prevention of acute nausea and vomiting associated with highly
emetogenic cancer chemotherapy,

the prevention of nausea and vomiting associated with moderately
emetogenic cancer chemotherapy.
Palonosetron is indicated in paediatric patients 1 month of age and
older for:

the prevention of acute nausea and vomiting associated with highly
emetogenic cancer chemotherapy and
prevention of nausea and vomiting associated with moderately
emetogenic cancer chemotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Palonosetron should be used only before chemotherapy administration.
This medicinal product should be administered by a
healthcare professional under appropriate medical supervision.
Posology
_Adults_
250 micrograms palonosetron administered as a single intravenous bolus
approximately 30 minutes before the start of
chemotherapy. Palonosetron should be injected over 30 seconds.
The efficacy of Palonosetron 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.
_Elderly people_
No dose adjustment is necessary for the elderly.
Health Products Regulatory Authority
30 April 2021
CRN009X4X
Page 2 of 13
_Paediatric population_
_Chi