Disodium Edetate 3g + Sodium Ascorbate 5g

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

Disodium edetate; Sodium ascorbate

Produkta apraksts

DISODIUM EDETATE 3G + SODIUM ASCORBATE 5G IN 50ML SOLUTION

_CONCENTRATED INJECTION FOR INTRAVENOUS INFUSION _
Biological Therapies  
 Product Information – Disodium Edetate 3g + Sodium Ascorbate 5g
in 50mL Concentrated Injection  – pi34s1002 
Page 1 of 4 
PRODUCT INFORMATION 
AUST R 22289 
NAME OF THE DRUG: 
Disodium Edetate is the Disodium salt of 
EDTA (ethylenediamine tetra-acetic acid) 
dihydrate. 
CHEMICAL STRUCTURE:
(18)

NaOOCCH
CH  COONa
HOOCCH
CH  COOH
NCH  CH  N
2
2
2
2
2
2
2 H  O
2

DESCRIPTION: 
Biological Therapies supplies Disodium 
Edetate with or without sodium ascorbate 
as a sterile, non-pyrogenic, concentrated 
Solution.  Further dilution and pH 
adjustment of the solution MUST occur 
before infusion (refer to "_Dosage and _
_Administration_"). 
Disodium Edetate has a molecular 
weight of 372.2.  It is a white odourless 
crystalline powder soluble 1 in 11 of 
water; slightly soluble in alcohol.
(17)
  The 
BP specifies that a 5% solution in water 
has a pH of 4.0 to 5.5.
(15)
  Various 
injectable preparations of Disodium 
Edetate are described in the "Handbook 
of Injectable Drugs"
(17)
, Martindale
(15)

"The Merck Index"
(18)
, and the USP
(23)
. 
As a result of pH adjustment, the 
administering infusion will contain varying 
amounts of the disodium and trisodium 
salts
(23)
.  Also, the inclusion of MgSO
4
 in 
the infusion solution (as described in 
"_Dosage and Administration_") will 
produce some Magnesium Disodium 
Edetate which helps reduce the pain of 
administering EDTA.  
PHARMACOLOGY: 
EDTA is a chelating agent, that is, it 
incorporates a heavy metal ion into a ring 
structure.  The biological half-life of 
EDTA in humans is about one hour.
(28)

About 1-2% remains in the body after 24 
hours and 0.5% after 48 hours.  The 
chelated EDTA passes through the 
bloodstream and is mostly excreted 
through the kidneys (95%) into the urine.  
The remainder of the EDTA passes 
through the liver and