PALONOSETRON HYDROCHLORIDE injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Meitheal Pharmaceuticals Inc.

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). - 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

পণ্য সারাংশ:

Palonosetron Hydrochloride Injection is a sterile, clear and colorless solution, and is supplied as follows: Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Do not freeze. Protect from light. Discard unused portion.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

PALONOSETRON HYDROCHLORIDE- PALONOSETRON HYDROCHLORIDE INJECTION,
SOLUTION
MEITHEAL PHARMACEUTICALS INC.
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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)
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
(max 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
Injection:
0.25 mg palonosetron in 5 mL (0.05 mg per mL) in a single-dose vial
(3)
CONTRAINDICATIONS
Hypersensitivity to palonosetron or any of its components (4)
WAR