Regulatory Information
DKSH SINGAPORE PTE. LTD.
DKSH SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION, SOLUTION
**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.
INTRAVENOUS
Medical Information
**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.
**4.3 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_.
M05BA06
ibandronic acid
Manufacturer Information
DKSH SINGAPORE PTE. LTD.
Vetter Pharma-Fertigung GmbH & Co. KG
Active Ingredients
Documents
Package Inserts
Bonviva Pre-Filled Syringe 3mg PI.pdf
Approved: March 21, 2018