Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
Ibandronic acid (as monosodium monohydrate 3.375mg)
DKSH SINGAPORE PTE. LTD.
M05BA06
3mg/3ml
INJECTION, SOLUTION
Ibandronic acid (as monosodium monohydrate 3.375mg) 3mg/3ml
INTRAVENOUS
Prescription Only
Vetter Pharma-Fertigung GmbH & Co. KG
ACTIVE
2007-08-02
PRE-FILLED SYRINGE 3MG/3ML 1. NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg/3ml solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as 3.375 mg ibandronic acid, monosodium salt, monohydrate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection, pre-filled syringe. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous use. 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). Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5) 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. _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 μmol/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 μmol/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) _Patients with hepatic impairment _ No dosage adjustment is required (see section 5.2). _Elderly _ No dosage adj Les hele dokumentet
Black Guides Text Free Current code Flat Size: Finished style: Folded Size: Paper GSM: Atnahs code Version 15 Notes Date 30-09-22 Update 703-6148 703-6148 Size Description Page 1 0f 2 BONVIVA 3 MG 3ML LEAFLET Tech drawing Colour PMS Coated Non printable colours 16-05-23 10-02-23 05-10-22 Laetus code N/A Previous ref. Font size 9 pt Please DO NOT use this proof as artwork until the “APPROVAL TO PRINT” box has been signed and dated. APPROVAL TO PRINT Date Signature PDF 1.7 SG 630X480 MM 630X480 MM XXXX 00X00MM 40 GSM 000000000000000 1. NAME OF THE MEDICINAL PRODUCT Bonviva 3 mg/3ml solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as 3.375 mg ibandronic acid, monosodium salt, monohydrate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection, pre-filled syringe. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). 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). Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5) If a dose is missed, the injection should be administered as soon as convenient. Thereafter, injections should be scheduled every 3 months f Les hele dokumentet