Aloxi
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
05-09-2017
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Active ingredient:
Palonosetron hydrochloride 50 µg/mL
Available from:
Mundipharma New Zealand Ltd
INN (International Name):
Palonosetron hydrochloride 50 µg/mL
Dosage:
250µg/5mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Palonosetron hydrochloride 50 µg/mL Excipient: Citric acid monohydrate Disodium edetate dihydrate Hydrochloric acid Mannitol Sodium citrate dihydrate Sodium hydroxide Water for injection
Units in package:
Vial, glass, single dose, 5 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Helsinn Advanced Synthesis SA
Therapeutic indications:
Aloxi is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.
Product summary:
Package - Contents - Shelf Life: Vial, glass, single dose, - 5 mL - 60 months from date of manufacture stored at or below 25°C protect from light
Authorization date:
2004-10-13
Summary of Product characteristics
ALX_PI_AUNZ_SRR-CCSI update_Final_10Jun14
Page 1 of 9
PRODUCT INFORMATION
ALOXI
PALONOSETRON HCL INJECTION
NAME OF THE DRUG
ALOXI Injection
(palonosetron hydrochloride)
STRUCTURAL FORMULA
DESCRIPTION
Palonosetron hydrochloride is a white to off-white crystalline powder.
It is freely soluble in water,
soluble in propylene glycol, and slightly soluble in ethanol and
2-propanol.
Chemically, palonosetron hydrochloride is:
(3aS)-2-[(S)-1-Azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-
hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The empirical
formula is C
19
H
24
N
2
O.HCl, with
a molecular weight of 332.87. Palonosetron hydrochloride exists as a
single isomer.
_CHEMICAL ABSTRACTS SERVICE (CAS) REGISTRY NUMBER: _
135729-61-2 Palonosetron
135729-62-3 Palonosetron Hydrochloride
ALOXI injection is a sterile, clear, colourless, non-pyrogenic,
isotonic, buffered solution for intravenous
administration. Each 5 ml vial of ALOXI injection contains 250 µg
equivalent palonosetron base
as hydrochloride.
_INACTIVE INGREDIENTS: _
Mannitol 207.5 mg, disodium edetate and citrate buffer in water for
intravenous administration. The
pH of the solution is 4.5 to 5.5.
PHARMACOLOGY
Palonosetron hydrochloride is an antiemetic and antinauseant agent. It
is a selective serotonin
subtype 3 (5-HT
3
) receptor antagonist with a strong binding affinity for this
receptor.
_PHARMACODYNAMICS _
Cancer chemotherapy may be associated with a high incidence of nausea
and vomiting, particularly
when certain agents, such as cisplatin, are used. 5-HT
3
receptors are located on the nerve terminals
of the vagus in the periphery and centrally in the chemoreceptor
trigger zone of the area postrema. It
is thought that chemotherapeutic agents produce nausea and vomiting by
releasing serotonin from
the enterochromaffin cells of the small intestine and that the
released serotonin then activates 5-HT
3
receptors located on vagal afferents to initiate the vomiting reflex.
ALX_PI_AUNZ_SRR-CCSI update_Final_10Jun14
Page 2 of 9
The effect of palonosetron on blood pr
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