BIOLOGICAL THERAPIES DISODIUM EDETATE 3g + SODIUM ASCORBATE 5g 50mL injection vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

sodium ascorbate, Quantity: 100 mg/mL; disodium edetate, Quantity: 60 mg/mL

Saadav alates:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

Ravimvorm:

Injection, concentrated

Koostis:

Excipient Ingredients: water for injections; sodium hydroxide

Manustamisviis:

Intravenous

Ühikuid pakis:

1 x 50mL vial

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

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, constipation, headache, leg cramps, black stools, oliguria, stupor, convulsions, palsies and coma. Chronic lead poisoning causes variable involvement of the Central N

Toote kokkuvõte:

Visual Identification: Clear and colourless to straw coloured solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

1991-10-08

Infovoldik

BIOLOGICAL THERAPIES DISODIUM EDETATE 3 G + SODIUM ASCORBATE 5 G
SOLUTION 50 ML INJECTION
_CONCENTRATED INJECTION FOR INTRAVENOUS INFUSION _
_CONSUMER MEDICINE INFORMATION _
_Biological Therapies Disodium Edetate 3 g + Sodium Ascorbate 5 g
Solution 50mL Injection Version ID: cmi34s1907 _
_page 1 of 3 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Biological Therapies Disodium Edetate
3 g + Sodium Ascorbate 5 g Solution in
50 mL 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 + Sodium Ascorbate
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 BIOLOGICAL THERAPIES
DISODIUM EDETATE + SODIUM
ASCORBATE INJECTION IS USED FOR
DISODIUM EDETATE + SODIUM ASCORBATE
CONCENTRATED INJECTION MUST BE DILUTED
BEFORE IT IS INJECTED.
Disodium Edetate + Sodium Ascorbate
Injection contains the active ingredients
Disodium Edetate and Sodium Ascorbate.
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. Sodium Ascorbate also
has mild chelating properties.
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 i

Toote omadused

AUSTRALIAN PRODUCT INFORMATION
BIOLOGICAL THERAPIES DISODIUM EDETATE 3 G + SODIUM ASCORBATE 5 G
SOLUTION 50 ML INJECTION
_ _
Biological Therapies
Page 1 of 7 Version ID: pi34S1902
AUST R 22289
1. NAME OF THE MEDICINE
Disodium edetate
Sodium ascorbate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Biological Therapies Disodium Edetate Solution 3 g + Sodium Ascorbate
5 g in 50 mL Concentrated Injection is presented in a clear
glass vial containing 3 g Disodium Edetate and 5 g Sodium Ascorbate in
Water for injections.
Disodium Edetate is the Disodium salt of EDTA (ethylenediamine
tetra-acetic acid) dihydrate.
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 Section 4.2 Dose and Method
of Administration) will produce some
Magnesium Disodium Edetate which helps reduce the pain of
administering EDTA.
For the full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
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 Section 4.2 Dose and Method of
Administration).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
DISODIUM EDETATE IS PARTICULARLY EFFECTIVE IN TREATING LOW LEVEL LEAD
ACCUMULATION AND LOW LEVEL LEAD POISONING.
This is especially so where there is a concomitant hypercalcaemic
problem (refer to "_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.
(27)
For patients with elevated serum calcium or hy