Risedronate Sanofi-Aventis

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Risedronate sodium; Calcium carbonate; Colecalciferol; cholecalciferol

Saadav alates:

Sanofi-Aventis Australia Pty Ltd

Klass:

Medicine Registered

Infovoldik

 
_Risedronate sanofi-aventis CMI REG _
_#_
_ _
_102970_
_ _
_Page 1 _
_ _
Risedronate sanofi-aventis


_RISEDRONATE SODIUM _
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Risedronate sanofi-
aventis. 
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 
you taking Risedronate sanofi-aventis 
against the benefits this medicine is 
expected to have for you. 
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
WHAT RISEDRONATE 
SANOFI-AVENTIS IS USED 
FOR 
Risedronate sanofi-aventis is used to 
treat bone disease and belongs to a 
group of medicines called 
bisphosphonates. 
Risedronate sanofi-aventis works 
directly on your bones to make them 
stronger and therefore less likely to 
break or fracture. 
Risedronate sanofi-aventis 5mg daily, 
35mg Once-a-Week and 150mg Once-
a-Month tablets are used to treat: 
  osteoporosis (brittle or fragile 
bones that may fracture easily) 
  osteoporosis caused by taking 
steroids  
Risedronate sanofi-aventis 30mg 
tablets are used to treat: 
  Paget's disease of the bone.  
These conditions are caused by 
changes in the way bone is normally 
maintained. 
_UNDERSTANDING BONE _
Bone is a living tissue consisting of 
calcium and other minerals.  
Throughout life, old bone is constantly 
broken down and replaced with new 
bone.  After the age of 35, bone loss 
may occur faster than your body can 
replace it. If you lose too much bone 
then they become weaker and are more 
likely to break. 
_OSTEOPOROSIS _
Osteoporosis (brittle bone disease) is a 
disease that causes bones to become 
w

Toote omadused

_Risedronate sanofi-aventis  _
_#_
102898 v2.0
_ _
_Page 1 _

PRODUCT INFORMATION 
RISEDRONATE SANOFI-AVENTIS
®
, RISEDRONATE SANOFI-AVENTIS COMBI & 
RISEDRONATE SANOFI-AVENTIS COMBI D 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Risedronate 
Each Risedronate sanofi-aventis tablet contains the equivalent of
5, 30, 35 or 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 
g (880 IU) cholecalciferol, which is 
equivalent to 1000 mg elemental calcium and 22 
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  
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 
_Risedronate sanofi-aventis  _
_#_
102898 v2.0
_ _
_Page 2 _

weight of 100.1.   
Cholecalciferol is a secosterol that is a natural precursor
of the calcium-regulating hormone 
calcitriol (1,25-dihydroxy