PALONOSETRON injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Fresenius Kabi USA, LLC

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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). 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 and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. Palonosetron Hydrochloride Injection is contraindicated in patients known to have hypersensitivity to palonosetron [see Warnings and Precautions (5.1)] . Risk Summary There are no available data on palonosetron HCl use in pregnant women to inform a drug-associated risk. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron HCl during

পণ্য সারাংশ:

Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-dose prefilled syringe is available as follows: Storage

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

PALONOSETRON - PALONOSETRON INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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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 Hydrochloride Injection 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)
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)
*Note different dosing units in pediatrics
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
Pe diatrics
(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
Instructions for Intravenous Administration
For a dose of 0.25 mg, use the entire contents (5 mL) of the prefilled
syringe. Do not use the prefilled syringe to
administer a dose of less than 0.25 mg (5 mL). (2.2)
DOSAGE FORMS AND STRENGTHS
0.25 mg (free base) per 5 mL (concentration: 0.05 mg per mL, 50 mcg
per mL) single-dose prefilled syringe (3)
CONTRAINDICATIONS
Hypersensitivity to palonosetron or any of its components (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions, including anaphylaxis and anaphylactic
shock: reported in p