Actonel® Once -a-Month Film Coated Tablet 150mg

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Risedronic acid 139.2mg equivalent to Risedronate Sodium

Commercializzato da:

ZUELLIG PHARMA PTE. LTD.

Codice ATC:

M05BA07

Dosaggio:

150mg

Forma farmaceutica:

TABLET, FILM COATED

Composizione:

Risedronic acid 139.2mg equivalent to Risedronate Sodium 150mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Balkanpharma-Dupnitsa AD

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2011-04-18

Foglio illustrativo

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ACTONEL
®
 ONCE-A-MONTH 150MG TABLET 
_Risedronate _
Tablet 
[sanofi logo] 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Risedronate 
Each Actonel tablet contains 150mg of risedronate sodium equivalent
to 139.2mg of risedronic 
acid. 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.   
CHEMICAL STRUCTURE 
The chemical structure of risedronate sodium is the following: 
Molecular Weight: 305.10 
The CAS registry number is 115436-72-1  
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.   
Each Actonel tablet contains risedronate sodium 150
mg, crospovidone, magnesium stearate, 
microcrystalline cellulose, hydroxypropyl cellulose,
hypromellose, macrogol 400, macrogol 8000, 
silicon dioxide, indigo carmine CI73015 and titanium dioxide.  
PHARMACOLOGY 
Risedronate is a potent pyridinyl bisphosphonate that binds to
bone hydroxyapatite and inhibits 
osteoclast-mediated bone resorption.  Risedronate is a third
generation bisphosphonate. In 
preclinical studies risedronate demonstrated potent
anti-osteoclast and anti-resorptive activity, 
increasing bone mass and biomechanical strength dose-dependently.
 The activity of risedronate 
was confirmed by bone marker measurements during pharmacodynamic
and clinical studies. With 
risedronate 5 mg daily, decreases in biochemical markers of bone
turnover were observed within 1 
month of treatment and reached a maximum decrease in 3-6
months, remaining stable during the 
course of therapy.  This data demonstrates that risedronate
causes a moderate reduction in bone 
resorption and bone turnover.  The new steady state
approximates the rate of bone�

Scheda tecnica

AAAA09817-RISE IR THE 150-SG/L
4129247
190x600
Black
126774
Magenta
4129247
AAAA09817-RISE IR THE 150-SG/L
№
Parameter
PIL
1
Paper weight g/m
2
45
2 Pack line type
C80
3 Old AW ID
AAAK2724
4 New AW ID
AAAA09817
5 Old item code
4128424
6 New item code
4129247
7 Pharmcode
126774
8 Note
SUPPLIER INFORMATION TABLE
AAAA09817-RISE IR THE 150-SG/L
4129247
190x600
Black
Magenta
4129247
AAAA09817-RISE IR THE 150-SG/L