PENTETATE CALCIUM TRISODIUM injection, solution, concentrate

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

pentetate calcium trisodium (UNII: G79YN26H5B) (pentetic acid - UNII:7A314HQM0I)

Dostępny od:

hameln pharma gmbh

INN (International Nazwa):

pentetate calcium trisodium

Skład:

pentetate calcium trisodium 1000 mg in 5 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Ca-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 C Risk Summary There are no adequate and well-controlled studies of Ca-DTPA use in pregnant women. Ca-DTPA chelation therapy causes depletion of body stores of zinc, a trace metal essential for fetal development [see Warnings and Precautions (5.2)] . The consequences of zinc depletion and results of animal studies suggest a teratogenic risk in humans. Ca-DTPA was teratogenic and embryotoxic in mice at daily doses 2 to 8 times the recommended daily human dose, based on body surface area (BSA), with a dose-dependent increase in the frequency of gross malformations. Ca-DTPA was teratogenic in dogs at approximately half the recommended daily human dose based on BSA, as described below. There are no animal or human data evaluating the teratogenic effect of a single dose of Ca-DTPA. Ca-DTPA should be used during pregnancy

Podsumowanie produktu:

Ca-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 calcium trisodium. 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.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

PENTETATE CALCIUM TRISODIUM- PENTETATE CALCIUM 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 CALCIUM TRISODIUM
INJECTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR PENTETATE CALCIUM TRISODIUM
INJECTION.
PENTETATE CALCIUM TRISODIUM INJECTION (CA-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 Ca-DTPA may be associated with asthma exacerbation. (5.1)
Ca-DTPA is associated with depletion of trace metals such as zinc. The
magnitude of depletion increases with split
daily dosing, with increasing dose and with increased treatment
duration. Only a single dose of Ca-DTPA is
recommended. Use Zn-DTPA if additional chelation therapy is indicated.
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 calcium 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. (2.1, 2.2)
In adults and adolescents, administer intravenously a single 1.0 gram
Ca-DTPA dose. (2.1)
In children less than 12 years of age, administer intravenously, a
single 14 mg/kg Ca-DTPA dose, not to exceed 1.0 gram.
(2.1)
Zn-DTPA is recommended for maintenance chelation therapy after the
first 24 hours. If Zn-DTPA is unavailable, chelation
therapy may continue with Ca-DTPA. (2.1)
See Full Prescribing Information for dose (2.1) and nebulized
chelation therapy (2.3)
DOSAGE FORMS AND STRENGTHS
1000 mg / 5 mL single-use ampoules (3)
CON