Source: Marketing Authorisation Holder Revision Year: 2023 Publisher: Tzamal Bio-Pharma Ltd., 20 Hamagshimim St., Petach-Tikva. Manufacturer: SwissCo Services AG, Sisseln, Switzerland.
Binosto.
| Pharmaceutical Form |
|---|
|
Effervescent Tablet. White to off-white round effervescent tablets of 25 mm diameter, flat faced with bevelled edges. After dissolution the solution has a pH of 4.8-5.4. |
Each effervescent tablet contains sodium alendronate trihydrate equivalent to 70 mg Alendronic acid.
Excipient(s) with known effect: The total amount of sodium from both the active substance and excipients in each effervescent tablet is 603mg.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Alendronic acid |
Alendronic acid is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. The bone formed during treatment with alendronic acid is of normal quality. |
| List of Excipients |
|---|
|
Monosodium citrate anhydrous |
The effervescent tablets are provided in strips of composite foil (paper/polyethylene/aluminium/Znionomer), with 2 effervescent tablets packed in individual units per strip.
Packs with 4, 12 or 24 effervescent tablets.
Not all pack sizes may be marketed.
The appearance of the product after dissolution is a clear to slightly cloudy solution.
Tzamal Bio-Pharma Ltd., 20 Hamagshimim St., Petach-Tikva.
Manufacturer: SwissCo Services AG, Sisseln, Switzerland.
158-96-34539-00
| Drug | Countries | |
|---|---|---|
| BINOSTO | Cyprus, Germany, Estonia, Finland, Ireland, Israel, Malta, Romania, Singapore, United Kingdom, United States |
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