Protos

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

Strontium ranelate

Disponible desde:

Servier Laboratories (Australia) Pty Ltd

clase:

Medicine Registered

Información para el usuario

PROTOS
®
 2G

_Strontium ranelate (pronounced stron-tee-um ran-ell-ate)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROTOS. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medications have risks and
benefits. Your doctor has considered
this before prescribing PROTOS for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICATION, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PROTOS IS
The name of your medicine is
PROTOS. The medicine contains the
active ingredient strontium ranelate.
PROTOS does not contain any
hormones.
WHAT PROTOS IS USED
FOR
PROTOS is usually prescribed for
severe (established) osteoporosis.
Osteoporosis is a disease of older
people.
PROTOS is not recommended for
children, or pregnant women.
PROTOS is available only with a
doctor's prescription.
There is no evidence that PROTOS is
addictive.
_WHY PROTOS IS USED FOR_
_OSTEOPOROSIS_
Bone is a living tissue just like most
other parts of your body. Your body
is constantly breaking down old bone
and making new bone tissue to keep
your skeleton healthy and strong.
When you have osteoporosis, your
body breaks down more bone than it
forms. Bone loss then gradually
occurs making your bones thinner
and more fragile.
PROTOS helps by increasing new
bone formation and slowing bone
breakdown. Osteoporosis is
especially common in women after
the menopause (change of life). The
menopause occurs when the ovaries
stop producing the female hormone
oestrogen, or are removed
(sometimes with a hysterectomy).
The earlier a woman reaches
menopause, the greater the risk of
osteoporosis.
Osteoporosis can also occur in men.
Many people with osteoporosis have
no symptoms so you may not even
have been aware that you have it.
However, osteoporosis makes you
more likely to have fractures (break
bones), especially in your spine, hips
and wrists. A fracture may even
occu

Ficha técnica

PROTOS
_®_
 2G 
– PRODUCT INFORMATION   

        1 (13) 

Version 14 
PROTOS
®

NAME OF THE DRUG 

_PROTOS_
_®_
_ _
strontium ranelate 2g  

DESCRIPTION 

Description  of  substance  and  solubility:  Strontium  ranelate  is  a  yellowish-white  non-
hygroscopic  powder.    It  crystallises  as  a  nonahydrate  form  but  one  water  molecule  is 
particularly labile and this leads to a compound containing either 8 or  9 water molecules per 
strontium ranelate molecule.  Strontium ranelate is slightly soluble in purified water (3.7mg/mL 
at saturation point) and practically insoluble
in organic solvents (eg, methanol). 

_Excipients: _Aspartame (E951, a source of phenylalanine), maltodextrin, mannitol. 

_Chemical name: strontium ranelate _
_ _
_CAS Registry Number: 135459-90-4 _

_Molecular formula:_ C
12
H
6
N
2
O
8
SSr
2

_Chemical structure: _
_ _
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PHARMACOLOGY 
_ _
_S_trontium ranelate has a dual effect on bone metabolism. _In
vitro_ it increases bone formation 
by increasing osteoblast precursor replication
and collagen synthesis, and reduces bone 
resorption by altering osteoclast ultrastructure and decreasing
resorbing activity in bone cell 
culture. The activity of strontium ranelate on both long
bones and vertebral bodies was studied 
in various
animal models. Strontium ranelate generally increased bone formation
and 
decreased bone resorption and
improved bone biomechanical properties such as bone 
strength.  

In bone tissue, strontium is adsorbed
onto the crystal surface and substitutes for calcium in the 
apatite crystal of the newly formed bone, up to
a ratio of 1 strontium atom to 10 calcium atoms. 
Strontium ranelate does not modify the crystal characteristics.  In animals,