PENTETATE ZINC TRISODIUM injection, solution, concentrate

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Pentetate zinc trisodium (UNII: NXU65IC8PG) (pentetic acid - UNII:7A314HQM0I)

MAH:

hameln pharma gmbh

INN:

Pentetate zinc trisodium

composition:

Pentetate zinc trisodium 1000 mg in 5 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Zn-DTPA is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination. None. Pregnancy Category B Risk Summary There are no adequate and well-controlled studies of Zn-DTPA use in pregnant women. Chelation treatment of pregnant women should begin and continue with Zn-DTPA. Reproduction studies have been performed in pregnant mice at doses up to 31 times (11.5 mmol/kg) the recommended daily human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Zn-DTPA. There was a slight reduction in the average birth weight. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known whether Zn-DTPA is excreted in human milk. Radiocontaminants are known to be excreted in breast milk. Women with known or suspected internal contamination with radiocontaminants should not breast feed, whether

leaflet_short:

Zn-DTPA is supplied as a sterile solution in 5 mL single-use clear glass ampoules at a concentration of 200 mg/mL for intravenous use. Each ampoule contains the equivalent of 1000 mg of pentetate zinc trisodium. NDC 70651-002-03: 5 mL single-dose ampoules, package of 10 Store between 15-30°C (59-86°F). Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product may be filtered using a sterile filter if particles are seen subsequent to opening of the ampoule. OPC ampoule: to open, turn so that the point faces upward and break off the neck with a downward movement.

authorization_status:

New Drug Application

SPC

PENTETATE ZINC TRISODIUM- PENTETATE ZINC TRISODIUM INJECTION,
SOLUTION, CONCENTRATE
HAMELN PHARMA GMBH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PENTETATE ZINC TRISODIUM
INJECTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR PENTETATE ZINC TRISODIUM
INJECTION.
PENTETATE ZINC TRISODIUM INJECTION (ZN-DTPA)
FOR INTRAVENOUS OR INHALATION ADMINISTRATION
INITIAL U.S. APPROVAL: 2004
WARNING: ASTHMA EXACERBATION WITH NEBULIZATION AND DEPLETION OF TRACE
METALS
DURING THERAPY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Nebulized Zn-DTPA may be associated with asthma exacerbation. (5.1)
Zn-DTPA is associated with depletion of trace metals. The risk for
depletion increases when Zn-DTPA is
administered over several months. Monitor serum zinc levels, serum
creatinine, BUN, electrolytes, urinalysis and
blood cell counts during Ca-DTPA or Zn-DTPA therapy. (2.4, 5.2)
INDICATIONS AND USAGE
Pentetate zinc trisodium injection is a radiomitigation chelator
indicated for treatment of individuals with known or
suspected internal contamination with plutonium, americium, or curium
to increase the rates of elimination. (1)
DOSAGE AND ADMINISTRATION
Chelation treatment is most effective if administered within the first
24 hours. Administer Ca-DTPA, if available, as the
initial dose. (2.1, 2.2)
If Ca-DTPA is not available during the first 24 hours,
in adults and adolescents, administer intravenously a single 1.0 gram
Zn-DTPA initial dose. (2.1)
in children less than 12 years of age, administer intravenously a
single 14 mg/kg Zn-DTPA initial dose, not to exceed 1.0
gram. (2.1)
After the first 24 hours, continue chelation therapy with Zn-DTPA:
in adults and adolescents, administer intravenously 1.0 gram Zn-DTPA
once daily. (2.1)
in children less than 12 years of age, administer intravenously 14
mg/kg Zn-DTPA once daily, not to exceed 1.0 gram
daily. (2.1)
See Full Prescribing Information for dose (2.1) and nebulized
chelation therapy. (