ATELVIA COMBI D risedronate sodium 35mg tablet / supplemental 2500 mg calcium carbonate/22 microgram colecalciferol sachet compo

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

calcium carbonate,colecalciferol,risedronate sodium

Dostupné s:

Theramex Australia Pty Ltd

INN (Mezinárodní Name):

colecalciferol,Calcium carbonate,Risedronate sodium

Stav Autorizace:

Registered

Charakteristika produktu

Theramex Australia Pty Ltd Version 1.0 1
PRODUCT INFORMATION
ATELVIA
®
, ATELVIA
® COMBI & ATELVIA
® COMBI D
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Risedronate, Calcium carbonate, Cholecalciferol
NON-PROPRIETARY NAME
Risedronate
Each ATELVIA
®
tablet contains the equivalent of 5, 30, 35, 75 or 150 mg of
risedronate sodium.
The empirical formula for risedronate sodium is C
7
H
10
NO
7
P
2
Na. The chemical name of risedronate
sodium is [1-hydroxy-2-(3- pyridinyl)ethylidene]bis(phosphonic acid)
monosodium salt.
Calcium Carbonate Tablet
Also contains 1250 mg calcium carbonate tablets. Each calcium tablet
contains 1250 mg calcium
carbonate, which is equivalent to 500 mg elemental calcium.
Calcium Carbonate/Cholecalciferol Sachet
Each sachet contains 2500 mg calcium carbonate and 22
µ
g (880 IU) cholecalciferol, which is
equivalent to 1000 mg elemental calcium and 22
µ
g (880 IU) vitamin D3. The terms cholecalciferol
and vitamin D3 are equivalent. The chemical name of cholecalciferol is
(5Z,7E)-9,10-secocholesta-
5,7,10(19)-trien-3β-ol. Molecular formula: C
27
H
44
O.
CHEMICAL STRUCTURE
The chemical structure of risedronate sodium is the following:
Molecular Weight: 305.10
The CAS registry number is 115436-72-1
The chemical structure of cholecalciferol:
Molecular Weight: 384.6
The CAS registry number is 67-97-0
Theramex Australia Pty Ltd Version 1.0 2
DESCRIPTION
Risedronate sodium is a fine, white to off-white, odourless,
crystalline powder. It is soluble in water
and in aqueous solutions and essentially insoluble in common organic
solvents.
Calcium carbonate is a white powder, practically insoluble in water,
with a relative molecular
weight of 100.1.
Cholecalciferol is a secosterol that is a natural precursor of the
calcium-regulating hormone
calcitriol (1,25-dihydroxyvitamin).
Risedronate
Each ATELVIA
®
tablet contains risedronate sodium (5, 30, 35, 75 or 150 mg), lactose
(5, 30 or 35
mg tablets only), crospovidone, magnesium stearate, microcrystalline
cellulose, hydroxypropyl
cellulose, hypromellose,