ACTONEL ONCE-A-WEEK TABLET 35 mg

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

RISEDRONATE SODIUM

Disponible depuis:

ZUELLIG PHARMA PTE. LTD.

Code ATC:

M05BA07

Dosage:

35 mg

forme pharmaceutique:

TABLET, FILM COATED

Composition:

RISEDRONATE SODIUM 35 mg

Mode d'administration:

ORAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

Balkanpharma-Dupnitsa AD

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2003-04-30

Notice patient

ACTONEL
®

                  35MG 
ONCE-A -WEEK 

(risedronate sodium) 
film-coated tablets

[sanofi logo] 

NAME OF THE DRUG 
Actonel is risedronate sodium. 
Each Actonel tablet contains the equivalent of 35mg 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. 
The chemical structure of risedronate sodium is the following: 

Molecular Weight: 305.10 

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 (Once-a-Week 35mg) tablet contains risedronate sodium,
lactose, crospovidone, 
magnesium stearate, microcrystalline cellulose, hydroxypropyl
cellulose, hypromellose, macrogol 
400, macrogol 8000, silicon dioxide, iron oxide yellow E172,
iron oxide red E172 and titanium 
oxide E171. 

PHARMACOLOGY 
Actonel is a potent pyridinyl bisphosphonate that binds to bone
hydroxyapatite and inhibits 
osteoclast-mediated bone resorption. Actonel is a third
generation bisphosphonate. 

In preclinical studies Actonel demonstrated potent anti-osteoclast
and anti-resorptive activity, 
increasing bone mass and biomechanical strength dose-dependently. The
activity of Actonel was 
confirmed by bone marker measurements during
pharmacodynamic and clinical studies. 

With Actonel 5mg 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 Actonel
causes a moderate reduction 
in bone resorption and bone turnover. The new steady state
approximates the rate of bone 
turnover seen in pre-men

Résumé des caractéristiques du produit

AAAA09813-RISE IR THE 35-SG/L
4129243
190x600
Black
126778
Magenta
4129243
AAAA09813-RISE IR THE 35-SG/L
№
Parameter
PIL
1
Paper weight g/m
2
45
2 Pack line type
C80
3 Old AW ID
AAAK0351
4 New AW ID
AAAA09813
5 Old item code
4128775
6 New item code
4129243
7 Pharmcode
126778
8 Note
SUPPLIER INFORMATION TABLE
AAAA09813-RISE IR THE 35-SG/L
4129243
190x600
Black
Magenta
4129243
AAAA09813-RISE IR THE 35-SG/L