pentetate calcium trisodium- 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 Pharmaceuticals

INN (International Nazwa):

pentetate calcium trisodium

Forma farmaceutyczna:

INJECTION, SOLUTION, CONCENTRATE

Skład:

200 mg in 1 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 known.

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. NDC 52919-001-03, 5 mL single-use ampoules, package of 10. Store between 15 - 30°C (59 - 86°F).

Charakterystyka produktu

PENTETATE CALCIUM TRISODIUM- PENTETATE CALCIUM TRISODIUM INJECTION,
SOLUTION,
CONCENTRATE
HAMELN PHARMACEUTICALS
----------
PENTETATE CALCIUM TRISODIUM INJECTION
1000 mg
For Intravenous or Inhalation Administration
PACKAGE INSERT - INSTRUCTION FOR USE
DESCRIPTION
Pentetate calcium trisodium injection contains the sodium salt of
calcium diethylenetriaminepentaacetate.
Pentetate calcium trisodium is also known as trisodium calcium
diethylenetriaminepentaacetate and is
commonly referred to as Ca-DTPA. It has a molecular formula of Na CaC
H N O and a molecular
weight of 497.4 Daltons. It is represented by the following structural
formula:
Ca-DTPA is supplied as a clear, colorless, hyperosmolar (1260
mOsmol/kg) solution in a colorless
ampoule containing 5 mL. The ampoule contents are sterile,
non-pyrogenic and suitable for intravenous
administration. Each mL of solution contains the equivalent of 200 mg
pentetate calcium trisodium
(obtained from 158.17 mg pentetic acid, 40.24 mg calcium carbonate and
NaOH) in water for injection,
USP. The pH of the solution is adjusted with NaOH and is between 7.3 -
8.3.
CLINICAL PHARMACOLOGY
GENERAL
Ca-DTPA forms stable chelates with metal ions by exchanging calcium
for a metal of greater binding
capacity. The radioactive chelates are then excreted by glomerular
filtration into the urine. In animal
studies, Ca-DTPA forms less stable chelates with uranium and neptunium
_in vivo_ resulting in the
deposition of these elements in tissues including the bone. Ca-DTPA
treatments are not expected to be
effective for uranium and neptunium. Radioactive iodine is not bound
by DTPA.
PHARMACODYNAMICS
In a study of rodents internally contaminated with plutonium, the rate
of plutonium elimination was
measured after treatment with Ca-DTPA and Zn-DTPA given intravenously
as a single dose of 10 to
1,000 µmol/kg (0.54 – 54 × maximum human dose, MHD). When treated
within one hour of internal
contamination, Ca-DTPA resulted in about a 10-fold higher rate of
elimination of plutonium in the urine
as co