BIOLOGICAL THERAPIES DISODIUM EDETATE SOLUTION 3g/100mL injection vial

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

disodium edetate, Quantity: 30 mg/mL

Commercializzato da:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

Forma farmaceutica:

Injection, concentrated

Composizione:

Excipient Ingredients: water for injections

Via di somministrazione:

Intravenous

Confezione:

1 x 100mL vial

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old code) 1. Disodium Edetate is particularly effective in treating lead accumulation and lead poisoning. This is especially so where there is a concomitant hypercalcaemic problem (refer "Indications (2)"). However it must be noted that Disodium Edetate is equally effective with Calcium Disodium Edetate in removing heavy metals, even in the absence of hypercalcaemia. For patients with elevated serum calcium or hypermobility of their body pools of calcium where there may be transiently or prolonged raised serum calcium (see "Indications (2)"), the EDTA of choice for removing heavy metals may be Disodium Edetate. There are no recognised safe limits for lead intoxication. Lead poisoning may occur by ingestion or inhalation of lead dust or fumes. Poisoning is manifested by a metallic taste, anorexia, irritability, apathy, abdominal colic, vomiting, diarrhoea, cons

Dettagli prodotto:

Visual Identification: Clear solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

1991-10-08

Foglio illustrativo

DISODIUM EDETATE SOLUTION
3G IN 100ML _CONCENTRATED INJECTION FOR INTRAVENOUS INFUSION _
_CONSUMER MEDICINE INFORMATION _
_Biological Therapies _
_ _
_CMI – Disodium Edetate Solution 3g in 100mL Concentrated Injection
– cmi31s1002 _
_page 1 of 3 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Disodium Edetate Solution 3g in
100mL Concentrated Injection for Intravenous
Infusion.
It does not contain all the available
information.
It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your
doctor has weighed the risks of giving
Disodium Edetate Injection against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET. You may need to read it
again.
WHAT DISODIUM EDETATE INJECTION
IS USED FOR
DISODIUM EDETATE SOLUTION 3G IN 100ML
CONCENTRATED INJECTION MUST BE DILUTED
BEFORE IT IS USED.
Disodium Edetate Solution 3g in 100mL
Concentrated Injection contains the active
ingredient Disodium Edetate.
Disodium Edetate belongs to a group of
substances called chelating agents.
Chelating agents are used to remove high
levels of mineral deposits from the body.
They work by tightly binding on to the mineral
so that it can be excreted from the body,
usually in the urine.
This medicine may be used to remove small
amounts of lead from the body if the lead is
causing problems in the body.
Since Disodium Edetate will bind to a wide
range of metals, it will also bind with various
toxic and radioactive metals that you may
have ingested or inhaled, such as radioactive
calcium, strontium, radium cobalt and
plutonium. Disodium Edetate will not treat
radiation poisoning; it is used only to remove
metals, which may be radioactive.
Too much calcium in the blood is called
hypercalcaemia. Disodium Edetate Injection
can also be used to remove excess calcium
from the blood if the excess calcium is
causing problems in the body. Disodium
Edetate works by binding with th

Scheda tecnica

DISODIUM EDETATE SOLUTION
_3G IN 100ML CONCENTRATED INJECTION FOR INTRAVENOUS INFUSION _
Biological Therapies
Product Information - Disodium Edetate Solution 3g in 100mL -
pi31s1002
page 1 of 4
PRODUCT INFORMATION
AUST R 22279
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 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 is
excreted in the bile and through the
intestinal tract (5%). Metal ions,
forming more stable complexes with
EDTA, compete with ions forming less
stable complexes. The order of
strength of complex of metal ions with
EDTA is as follows:
Co
+++
MOST STABLE
Fe
+++