Bonviva Pre-Filled Syringe 3mg3ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ibandronic acid (as monosodium monohydrate 3.375mg)

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

M05BA06

Dosage:

3mg/3ml

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Ibandronic acid (as monosodium monohydrate 3.375mg) 3mg/3ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Vetter Pharma-Fertigung GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2007-08-02

Patient Information leaflet

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

Summary of Product characteristics

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Date 30-09-22
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BONVIVA 3 MG 3ML LEAFLET
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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