Edetate Disodium USP

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

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

Tilgængelig fra:

Centre for Advanced Medicine

INN (International Name):

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

Dosering:

150 mg/mL

Lægemiddelform:

Solution for injection

Sammensætning:

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

Enheder i pakken:

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

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Akzo Nobel Chemicals bv

Produkt oversigt:

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

Autorisation dato:

1984-04-18

Produktets egenskaber

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