- Approval Id
- 296e379d364a8fce
- Drug Name
- Bonviva Pre-Filled Syringe 3mg/3ml
- Product Name
- Bonviva Pre-Filled Syringe 3mg/3ml
- Approval Number
- SIN13328P
- Approval Date
- 2007-08-02
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>For intravenous use.</p>
<p><u>Posology</u><br>
The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 15 – 30 seconds, every three months.</p>
<p>Strict adherence to the intravenous administration route is required (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
If a dose is missed, the injection should be administered as soon as convenient. Thereafter, injections should be scheduled every 3 months from the date of the last injection.</p>
<p><u>Special populations</u><br>
<em>Patients with renal impairment</em><br>
No dosage adjustment is necessary for patients with mild or moderate renal impairment where serum creatinine is equal or below 200 micromole/l (2.3 mg/dl) or where creatinine clearance (measured or estimated) is equal or greater than 30 ml/min.</p>
<p>Bonviva injection is not recommended for use in patients who have a serum creatinine above 200 micromole/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Patients with hepatic impairment</em><br>
No dosage adjustment is required (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Elderly population (≥ 65 years)</em><br>
No dosage adjustment is required (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Children and adolescents</em><br>
Safety and efficacy have not been established in patients less than 18 years old.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.</p>
<p>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 benefit and potential risks of Bonviva on an individual patient basis, particularly after 5 or more years of use.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Patients with uncorrected hypocalcaemia (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
</ul>
- Atc Code
- M05BA06
- Atc Item Name
- ibandronic acid
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
