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BONVIVA PRE-FILLED SYRINGE 3MG/3ML [SIN13328P]
Active ingredients: BONVIVA PRE-FILLED SYRINGE 3MG/3ML
Last updated 26 October 2025
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Product Info
BONVIVA PRE-FILLED SYRINGE 3MG/3ML
[SIN13328P]
Product information
Active Ingredient and Strength | IBANDRONIC ACID (AS MONOSODIUM MONOHYDRATE 3.375 MG) - 3 MG/3 ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | VETTER PHARMA-FERTIGUNG GMBH & CO. KG - GERMANY |
Registration Number | SIN13328P |
Licence Holder | DCH AURIGA SINGAPORE |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | M05BA06 |
4.1 Therapeutic indications
Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
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.
4.2 Posology and method of administration
For intravenous use.
Posology
The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 15 – 30 seconds, every three months.
Strict adherence to the intravenous administration route is required (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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.
Special populations
Patients with renal impairment
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.
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Patients with hepatic impairment
No dosage adjustment is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Elderly population (≥ 65 years)
No dosage adjustment is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Children and adolescents
Safety and efficacy have not been established in patients less than 18 years old.
4.3 Contraindications
Patients with uncorrected hypocalcaemia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.