ALENDRONATE PLUS D3

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

colecalciferol, Quantity: 0.14 mg; alendronate sodium, Quantity: 91.37 mg (Equivalent: alendronic acid, Qty 70 mg)

Διαθέσιμο από:

Dr Reddys Laboratories Australia Pty Ltd

INN (Διεθνής Όνομα):

alendronate sodium,colecalciferol

Φαρμακοτεχνική μορφή:

Tablet, uncoated

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

4 Tablets, 1 Tablet

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Visual Identification: White to off-white, modified capsule-shaped uncoated tablet, debossed with ADC on one side and 56 on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2013-12-16

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
ALENDRONATE PLUS D3-DRLA 70 MG/70 MCG
(ALENDRONATE SODIUM AND COLECALCIFEROL)
ALENDRONATE PLUS D3-DRLA 70 MG/140 MCG
(ALENDRONATE SODIUM AND COLECALCIFEROL)
1
NAME OF THE MEDICINE
Alendronate sodium and colecalciferol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Alendronate Plus D3-DRLA 70 mg/70 mcg contains 91.37 mg
of alendronate
sodium, which is the molar equivalent to 70 mg of alendronic acid, and
70 microgram of
colecalciferol equivalent to 2800 IU vitamin D.
Each tablet of Alendronate Plus D3-DRLA 70 mg/140 mcg contains 91.37
mg of alendronate
sodium, which is the molar equivalent to 70 mg of alendronic acid, and
140 microgram 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
Alendronate Plus D3-DRLA 70 mg/ 70 mcg 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.
Alendronate Plus D3-DRLA 70 mg/ 140 mcg 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
Alendronate Plus D3-DRLA 70 mg/70 mcg and Alendronate Plus D3-DRLA 70
mg/140 mcg
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
Alendronate Plus D3-DRLA (70 mg/70 mcg or 70 mg/140 mcg)
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
mcg or 70 mg/140
mcg) once weekly.
The optimal duration of use has not been determined. All pa