Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Palonosetron hydrochloride 50 µg/mL
Mundipharma New Zealand Ltd
Palonosetron hydrochloride 50 µg/mL
250µg/5mL
Solution for injection
Active: Palonosetron hydrochloride 50 µg/mL Excipient: Citric acid monohydrate Disodium edetate dihydrate Hydrochloric acid Mannitol Sodium citrate dihydrate Sodium hydroxide Water for injection
Vial, glass, single dose, 5 mL
Prescription
Prescription
Helsinn Advanced Synthesis SA
Aloxi is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.
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
2004-10-13
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 Přečtěte si celý dokument