Bonasol Once Weekly 70 mg Oral Solution

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Alendronic acid

Disponibbli minn:

Xeolas Pharmaceuticals Limited

Kodiċi ATC:

M05BA; M05BA04

INN (Isem Internazzjonali):

Alendronic acid

Dożaġġ:

70 milligram(s)

Għamla farmaċewtika:

Oral solution

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Bisphosphonates; alendronic acid

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2011-02-25

Karatteristiċi tal-prodott

Health┴Products┴Regulatory┴Authority
19┴November┴2021
CRN00CNRN
Page┴1┴of┴9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bonasol┴Once┴Weekly┴70┴mg┴Oral┴Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each┴100┴ml┴single-dose┴contains┴70┴mg┴alendronic┴acid
(as┴91.35┴mg┴sodium┴alendronate┴trihydrate)
Excipients:
Each┴dose┴(100┴ml)┴contains┴80┴mg┴methyl┴parahydroxybenzoate┴(E218),┴20┴mg┴propyl┴parahydroxybenzoate┴(E216)┴and┴6┴mg┴
Sunset┴Yellow┴(E110).┴
For┴a┴full┴list┴of┴excipients,┴see┴section┴6.1.
3 PHARMACEUTICAL FORM
Oral┴solution.
Orange┴coloured┴opalescent┴solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment┴of┴post-menopausal┴osteoporosis.
Alendronic┴acid┴reduces┴the┴risk┴of┴vertebral┴and┴hip┴fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For┴oral┴administration.
The┴recommended┴dosage┴is┴one┴70mg┴unit-dose┴(100┴ml)┴once┴weekly.
The┴optimal┴duration┴of┴bisphosphonate┴treatment┴for┴osteoporosis┴has┴not┴been┴established.
┴The┴need┴for┴continued┴
treatment┴should┴be┴re-evaluated┴periodically┴based┴on┴the┴benefits┴and┴potential┴risks┴of┴Bonasol┴Once┴weekly┴70┴mg┴Oral┴
Solution┴on┴an┴individual┴patient┴basis,┴particularly┴after┴5┴or┴more┴years┴of┴use.
Method of Administration
_To permit adequate absorption of alendronic acid_
┴
_Bonasol Once Weekly 70 mg Oral
Solution_┴must┴be┴taken┴at┴least┴30┴minutes┴before┴the┴first┴food,┴beverage,┴or┴medicinal┴
product┴of┴the┴day┴with┴plain┴water┴only.┴Other┴beverages┴(including┴mineral┴water),┴food┴and┴some┴medicinal┴products┴are┴
likely┴to┴reduce┴the┴absorption┴of┴alendronic┴acid┴(see┴Section┴4.5).
_To facilitate delivery to the stomach and thus reduce the potential
for