Calcium Disodium Versenate

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Calcium carbonate 42.4 mg/mL; Edetic acid 123.7 mg/mL; Sodium hydroxide 33.9 mg/mL

Prieinama:

iNova Pharmaceuticals (New Zealand) Limited

INN (Tarptautinis Pavadinimas):

Calcium carbonate 42.4 mg/mL

Dozė:

1g/5mL

Vaisto forma:

Solution for injection

Sudėtis:

Active: Calcium carbonate 42.4 mg/mL Edetic acid 123.7 mg/mL Sodium hydroxide 33.9 mg/mL Excipient: Water for injection

Vienetai pakuotėje:

Ampoule, glass, 6 x 5ml ampoule, 6 dose units

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Hospira Inc

Produkto santrauka:

Package - Contents - Shelf Life: Ampoule, glass, 6 x 5ml ampoule - 6 dose units - 60 months from date of manufacture stored at or below 30°C

Leidimo data:

1969-12-31

Prekės savybės

DATA SHEET 
CALCIUM DISODIUM VERSENATE 
_EDETATE CALCIUM DISODIUM _
WARNINGS: Calcium Disodium Versenate is capable of producing toxic
effects 
which can be fatal. Lead encephalopathy is relatively rare in adults,
but occurs 
more often in paediatric patients in whom it may be incipient and
thus 
overlooked. The mortality rate in paediatric patients has been high.
Patients with 
lead encephalopathy and cerebral oedema may experience a lethal
increase in 
intracranial pressure following intravenous infusion; the
intramuscular route is 
preferred for these patients. In cases where the intravenous route is
necessary, 
avoid rapid infusion. The dosage schedule should be followed and at no
time 
should the recommended daily dose be exceeded. 
NAME OF THE MEDICINE 
Edetate calcium disodium 
DESCRIPTION 
Calcium Disodium Versenate (edetate calcium disodium injection, USP)
is a 
sterile, injectable, chelating agent in concentrated solution for
intravenous 
infusion or intramuscular injection. Each 5 ml ampoule contains 1000
mg of 
edetate calcium disodium (equivalent to 200 mg/ml) in water for
injection. 
Chemically, this product is called
[[N,N'-1,2-ethanediyl-bis[N-(carboxymethyl)-
glycinato]](4-)-N,N',O,O',O
N
,O
N
']-,disodium, hydrate, (OC-6-21)-Calciate(2-). 
STRUCTURAL FORMULA: 

C
10
H
10
CaN
2
Na
2
O
8
 . xH
2
O 
Molecular weight 374.27 (anhydrous) 
PHARMACOLOGY 
The pharmacologic effects of edetate calcium disodium are due to the
formation 
of chelates with divalent and trivalent metals. A stable chelate will
form with any 
metal that has the ability to displace calcium from the molecule, a
feature shared 
by lead, zinc, cadmium, manganese, iron and mercury. The amounts of 
manganese and iron mobilised are not significant. Copper is not
mobilised and 
mercury is unavailable for chelation because it is too tightly bound
to body 
ligands or it is stored in inaccessible body compartments. The
excretion of 
calcium by the body is not increased following intravenous
a