PROTOS Granules for Oral Suspension 2g

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Viambatanisho vya kazi:

Strontium ranelate (as anhydrous form)

Inapatikana kutoka:

SERVIER (S) PTE LTD

ATC kanuni:

M05BX03

Kipimo:

2000 mg

Dawa fomu:

GRANULE, FOR SUSPENSION

Tungo:

Strontium ranelate (as anhydrous form) 2000 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

Prescription Only

Viwandani na:

Les Laboratoires Servier Industrie

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

2006-07-14

Taarifa za kipeperushi

 
1

1. 
NAME OF THE MEDICINAL PRODUCT 

PROTOS 2 g granules for oral suspension 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each sachet contains 2 g of strontium ranelate. 

Excipient with known effect:
Each sachet also contains 20 mg of aspartame (E951). 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Granules for oral suspension 
Yellow granules 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Treatment of severe osteoporosis in postmenopausal
women at high risk for fracture, for whom 
treatment with other medicinal products approved for
the treatment of osteoporosis is not possible due 
to, for example, contraindications
or intolerance. In postmenopausal women, strontium ranelate 
reduces the risk of vertebral
and hip fractures (see section 5.1).  
The
decision to prescribe strontium ranelate should be based on an assessment of the individual 
patient’s overall risks (see sections 4.3 and 4.4). 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

Treatment should only be initiated by a physician with
experience in the treatment of osteoporosis. 

Posology 
The recommended dose is one 2 g sachet once
daily by oral administration. 

Due to the nature of the treated disease, strontium ranelate
is intended for long-term use. 

The absorption of strontium ranelate is reduced by food,
milk and derivative products and therefore, 
PROTOS should be administered in-between meals. Given the
slow absorption, PROTOS should be 
taken at bedtime, preferably at least two
hours after eating (see sections 4.5 and 5.2)._ _

_ _
Patients treated with strontium ranelate
should receive vitamin D and calcium supplements if dietary 
intake is inadequate. 

_Elderly patients _
The efficacy and safety of strontium
ranelate have been established in a broad age range (up

Tabia za bidhaa

1
1.
NAME OF THE MEDICINAL PRODUCT
PROTOS 2 g granules for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 2 g of strontium ranelate.
Excipient with known effect: Each sachet also contains 20 mg of
aspartame (E951).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral suspension
Yellow granules
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of severe osteoporosis in postmenopausal women at high risk
for fracture, for whom
treatment with other medicinal products approved for the treatment of
osteoporosis is not possible due
to, for example, contraindications or intolerance. In postmenopausal
women, strontium ranelate
reduces the risk of vertebral and hip fractures (see section 5.1).
The decision to prescribe strontium ranelate should be based on an
assessment of the individual
patient’s overall risks (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be initiated by a physician with experience in
the treatment of osteoporosis.
Posology
The recommended dose is one 2 g sachet once daily by oral
administration.
Due to the nature of the treated disease, strontium ranelate is
intended for long-term use.
The absorption of strontium ranelate is reduced by food, milk and
derivative products and therefore,
PROTOS should be administered in-between meals. Given the slow
absorption, PROTOS should be
taken at bedtime, preferably at least two hours after eating (see
sections 4.5 and 5.2).
_ _
_ _
Patients treated with strontium ranelate should receive vitamin D and
calcium supplements if dietary
intake is inadequate.
_Elderly _
The efficacy and safety of strontium ranelate have been established in
a broad age range (up to
100 years at inclusion) of postmenopausal women with osteoporosis. No
dose adjustment is required
in relation to age.
_Renal impairment _
2
Strontium ranelate is not recommended for patients with severe renal
impairment (creatinine clearance
below 30 ml/min) (see sections 4.4 and 5.2