FONATPLUS 70 mg/70 ug alendronate (as sodium) and colecalciferol 70 mg/70 microgram (2800 IU) tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

alendronate sodium, Quantity: 91.37 mg (Equivalent: alendronic acid, Qty 70 mg); colecalciferol, Quantity: 0.07 mg

Disponible depuis:

Dr Reddys Laboratories Australia Pty Ltd

DCI (Dénomination commune internationale):

alendronate sodium,colecalciferol

forme pharmaceutique:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; povidone; magnesium stearate; butylated hydroxytoluene; Gelatin; medium chain triglycerides; sucrose

Mode d'administration:

Oral

Unités en paquet:

1 Tablet, 4 Tablets

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

TRADENAMES are indicated for the treatment of: ? Osteoporosis* in select patients where vitamin D supplementation is recommended,* Prior to treatment, osteoporosis must be confirmed by: - the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by - the presence of osteoporotic fracture

Descriptif du produit:

Visual Identification: White to off-white, modified capsule-shaped uncoated tablet, debossed with ADC on one side and 28 on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2013-12-16

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION
FONATPLUS 70 MG/70 ΜG (ALENDRONATE SODIUM AND
COLECALCIFEROL)
FONATPLUS 70 MG/140 ΜG (ALENDRONATE SODIUM AND
COLECALCIFEROL)
1
NAME OF THE MEDICINE
Alendronate sodium and colecalciferol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of FonatPlus 70 mg/70 µg contains 91.37 mg of alendronate
sodium, which is the
molar equivalent to 70 mg of alendronic acid, and 70 mcg of
colecalciferol equivalent to 2800
IU vitamin D.
Each tablet of FonatPlus 70 mg/140 µg contains 91.37 mg of
alendronate sodium, which is the
molar equivalent to 70 mg of alendronic acid, and 140 mcg of
colecalciferol equivalent to 5600
IU vitamin D.
EXCIPIENTS WITH KNOWN EFFECT
Sucrose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
FonatPlus 70 mg/ 70 µg once weekly tablet is a white to off-white,
modified capsule- shaped
uncoated tablet, debossed with 'ADC' on one side and '28' on the other
side.
FonatPlus 70 mg/ 140 µg once weekly tablet is a white to off-white,
modified capsule- shaped
uncoated tablet, debossed with 'ADC' on one side and '56' on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FonatPlus 70 mg/70 µg and FonatPlus 70 mg/140 µg are indicated for
the treatment of:
•
Osteoporosis in select patients where vitamin D supplementation is
recommended
Prior to treatment, osteoporosis must be confirmed by:
•
the finding of low bone mass of at least 2 standard deviations below
the gender
specific mean for young adults or by
•
the presence of osteoporotic fracture
4.2
DOSE AND METHOD OF ADMINISTRATION
FonatPlus (70 mg/70 µg or 70 mg/140 µg)
Treatment of osteoporosis in patients where vitamin D
3
supplementation is recommended
1
The recommended dose is one tablet of Alendronate Plus D3 (70 mg/70
µg or 70 mg/140 µg)
once weekly.
The optimal duration of use has not been determined. All patients on
bisphosphonate therapy
should have the need for continued therapy re-evaluated on a periodic
basis. (see 5.1
PHARMACODYNAMIC PROPERTIES �