Edetate Disodium USP

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Disodium edetate 150 mg/mL (Added as disodium edetate hydrous 166mg)

から入手可能:

Centre for Advanced Medicine

INN（国際名）:

Disodium edetate 150 mg/mL (Added as disodium edetate hydrous 166mg)

投薬量:

150 mg/mL

医薬品形態:

Solution for injection

構図:

Active: Disodium edetate 150 mg/mL (Added as disodium edetate hydrous 166mg) Excipient: Hydrochloric acid Sodium hydroxide Water for injection

パッケージ内のユニット:

Ampoule, glass, Type 1 (not marketed), 20 mL

クラス:

Prescription

処方タイプ:

Prescription

製:

Akzo Nobel Chemicals bv

製品概要:

Package - Contents - Shelf Life: Ampoule, glass, Type 1 - 20 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, crimp seal - 100 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, screw cap - 100 mL - 36 months from date of manufacture stored at or below 25°C

承認日:

1984-04-18

製品の特徴

NEW ZEALAND DATASHEET
NAME OF MEDICINE
EDETATE DISODIUM INJECTION, USP
PRESENTATION
Edetate Disodium
Injection, USP
is a sterile, non-pyrogenic, concentrated solution of edetate
disodium in water for injection, which, as a result of pH adjustment
with sodium hydroxide, contains
varying amounts of disodium and trisodium salts. Each ml contains:
Edetate Disodium anhydrous
150mg,
in Water
for
Injection
q.s.
pH
is
adjusted
with
Sodium
Hydroxide
and
if
necessary
Hydrochloric Acid. Approximate pH is 7 (range
6.5 –
7.
5
).
USES
ACTIONS
Edetate disodium is classified as a clinical chelating agent for
emergency lowering of serum calcium
in hypercalcemia.
Edetate
disodium,
USP
is
chemically
designated
disodium
(ethylene-dinitrilo)
tetra-acetate
dihydrate, a white crystalline powder soluble in water. It is also
described as the disodium salt of
ethylenediamine-tetra-acetic acid (EDTA).
Edetate disodium injection forms chelates with the cations of calcium
and many divalent and trivalent
metals. Because of its affinity for calcium, edetate disodium will
produce a lowering of the serum
calcium level during intravenous infusion. Slow infusion over a
protracted period may cause
mobilization of extracirculatory calcium stores. Edetate disodium
exerts a negative inotropic effect
upon the heart.
PHARMACOKINETICS
After intravenous administration, the chelate formed is excreted in
the urine with 50% appearing in 1
hour and over 95% in 24 hours.
Edetate disodium likewise forms chelates with other polyvalent metals
and produces increases in
urinary excretion of magnesium, zinc and other trace elements. It does
not form a chelate with
potassium but may reduce the serum level and increase urinary loss of
potassium.
INDICATIONS
Edetate
Disodium
injection
is
indicated
in
selected
patients
for
the
emergency
treatment
of
hypercalcemia and for the control of ventricular arrhythmias
associated with digitalis toxicity.
DOSAGE AND ADMINISTRATION
Edetate Disodium injection is administered by intravenous infusion
only after dilution. The solutio