PALONOSETRON HYDROCHLORIDE injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

PALONOSETRON HYDROCHLORIDE (UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R)

Mevcut itibaren:

Teva Parenteral Medicines, Inc.

INN (International Adı):

PALONOSETRON HYDROCHLORIDE

Kompozisyon:

PALONOSETRON 0.25 mg in 5 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC). - 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 hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial

Ürün özeti:

NDC 0703-4094-01, Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-dose vial individually packaged in a carton. Storage

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

PALONOSETRON HYDROCHLORIDE- PALONOSETRON HYDROCHLORIDE INJECTION,
SOLUTION
TEVA PARENTERAL MEDICINES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE
ALL THE INFORMATION NEEDED
TO USE PALONOSETRON HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR PALONOSETRON HYDROCHLORIDE INJECTION.
PALONOSETRON HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Palonosetron is a serotonin-3 (5-HT ) receptor antagonist indicated
in:
Adults for prevention of:
acute and delayed nausea and vomiting associated with initial and
repeat courses of moderately emetogenic cancer
chemotherapy (MEC). (1)
acute nausea and vomiting associated with initial and repeat courses
of highly emetogenic cancer chemotherapy (HEC).
(1)
postoperative nausea and vomiting (PONV) for up to 24 hours following
surgery. Efficacy beyond 24 hours has not
been demonstrated (1)
Pediatric patients aged 1 month to less than 17 years for prevention
of:
acute nausea and vomiting associated with initial and repeat courses
of emetogenic cancer chemotherapy, including
highly emetogenic cancer chemotherapy (HEC). (1)
DOSAGE AND ADMINISTRATION
Chemotherapy-Induced Nausea and Vomiting (2.1)
Age
Dose*
Infusion Time
Adults
0.25 MG as a single dose
Infuse over 30 SECONDS beginning approximately 30 minutes
before the start of chemotherapy
Pediatrics
(1 month to less than
17 years)
20 MICROGRAMS PER
KILOGRAM (maximum 1.5 mg) as
a single dose
Infuse over 15 MINUTES beginning approximately 30 minutes
before the start of chemotherapy
*Note different dosing units in pediatrics
Postoperative Nausea and Vomiting (2.1)
The recommended adult dosage is 0.075 mg as a single intravenous dose
administered over 10 seconds immediately
before the induction of anesthesia.
DOSAGE FORMS AND STRENGTHS
Inje ction:
0.25 mg/5 mL (free base) in a single-dose vial (3)
CONTRAINDICATIONS
Hypersensitivity to palonosetron or any of its components (4)
WAR