BONVIVA 3 MG3ML SOLUTION FOR IV INJECTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

IBANDRONIC ACID

Available from:

DKSH MALAYSIA SDN BHD

INN (International Name):

IBANDRONIC ACID

Units in package:

3ml1Units mL; 3ml4Units mL

Manufactured by:

VETTER PHARMA-FERTIGUNG GMBH & CO KG

Summary of Product characteristics

8 PT
7 PT
CMO Code
Pharmanovia Code
Version
Notes
Date
739-3440
739-3440
N/A
Size
Description
Page 1 of 2
Tech. Drawing
Printable Colours
Non Printable Colours
Previous Ref.
6031644-L
Min. Font Size
MY
580X360MM
BONVIVA 3MG 3ML 580X360 CORRECT
FOLDING LEAFLET GUIDE
Black
Guides
Cutter
Guides
Manufacturer
WAYMADE
Min. Code Size
19
21-09 -22
Laetus Code
N/A
Edge Marks
N/A
Pharmanovia Previous Code
BONVIVA 3MG 3ML MY
BIPHOSPHONATE – DRUGS FOR TREATMENT OF BONE DISEASES (M05)
1. DESCRIPTION
1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Bonviva is a nitrogen-containing biphosphonate.
1.2 TYPE OF DOSAGE FORM
Pre-filled syringe.
1.3 ROUTE OF ADMINISTRATION
Intravenous
1.4 STERILE / RADIOACTIVE STATEMENT
Sterile product.
1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
ibandronic acid, monosodium salt, monohydrate Solution for injection:
Each pre-filled
syringe contains 3.375 mg ibandronic acid, monosodium salt,
monohydrate equivalent to 3 mg of ibandronic
acid in 3 ml of solution.
1.6 PRODUCT DESCRIPTION
Clear, colorless, solution
2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATION(S)
Bonviva is indicated for the treatment of postmenopausal osteoporosis,
to reduce the risk of fractures. Efficacy
on femoral neck fractures has not been established.
_TREATMENT OF OSTEOPOROSIS:_
Osteoporosis may be confirmed by the finding of low bone mass (T
score < - 2.0 SD)
and the presence or history of osteoporotic fracture, or a low bone
mass (T-score < - 2.5 SD) in the absence of
documented pre-existing osteoporotic fracture.
2.2 DOSAGE AND ADMINISTRATION
The recommended dose of Bonviva for treatment is 3 mg intravenous
injection (administered as an
intravenous injection over 15-30 seconds) every three months.
For intravenous use. Strict adherence to the intravenous route is
required. Patients must receive supplemental
calcium and vitamin D.
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 injecti