BONDRONAT FOR INFUSION 1 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IBANDRONIC ACID, monosodium salt, monohydrate eqv. to Ibandronic Acid

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

M05BA06

Dosage:

1mg/ml

Pharmaceutical form:

INJECTION

Composition:

IBANDRONIC ACID, monosodium salt, monohydrate eqv. to Ibandronic Acid 1mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Universal Farma, S.L.

Authorization status:

ACTIVE

Authorization date:

1999-10-29

Patient Information leaflet

BONDRONAT
  
Ibandronic acid 
______________________________________________________________________________ 
1. 
P
HARMACEUTICAL 
F
ORM

Concentrate for solution for infusion. 

2. 
Q
UALITATIVE AND 
Q
UANTITATIVE 
C
OMPOSITION

_Active ingredient_: ibandronic acid. 
Ampoules  with 1 ml of concentrate for infusion. Vials with 2 ml
or 6ml of concentrate for 
solution for infusion. 

Ampoules of 1 ml contain 1.125 mg
ibandronic acid, monosodium salt, monohydrate 
corresponding to 1
mg ibandronic acid; vials  of 2 ml contain 2.25 mg ibandronic acid, 
monosodium salt, monohydrate corresponding to 2 mg ibandronic acid; vials of 6 ml contain 6.75 
mg ibandronic acid, monosodium salt, monohydrate, corresponding
to 6 mg ibandronic acid. 

3. 
C
LINICAL 
P
ARTICULARS

3.1 
THERAPEUTIC INDICATIONS 
-  Prevention of skeletal events associated with metastatic
bone disease due to breast cancer. 
-  Treatment of pathologically (abnormally) elevated serum calcium levels (hypercalcemia) as a 
result of tumours. _ _
_ _
3.2 
DOSAGE AND METHOD OF ADMINISTRATION 
TREATMENT OF METASTATIC BONE DISEASE 
The recommended dose for metastatic bone
disease is 6 mg IV given every 3-4 weeks. The dose 
should
be infused over at least 15 minutes. For infusion, the contents of the ampoule(s)/vials(s) 
should be added
to 100 ml isotonic sodium chloride solution (or 100
ml 5% dextrose solution). 

A shorter (i.e 15 min) infusion
time should only be used for patients with
normal renal function or 
mild renal impairment. There are no data available
characterizing the use of a shorter infusion 
time in patients with creatinine
clearance below 50ml/min. Prescribers should consult the
section 
_Patients with renal impairment_  for recommendations on dosing
and administration in this patient 
group. 
 

Summary of Product characteristics

5mm
5mm
95 mm
175 mm
45 mm
45 mm
370 mm
66 mm
5mm
679 mm
750 mm
ONLY FOR POSITION
ONLY FOR POSITION
LAETUS CENTERED WITHIN 35 MM ON THE VISIBLE FINAL SIZE AFTER FOLDED
Notes
Printable Colours
Non Printable Colours
PAGE 1 OF 2
SG 705-8530 UNI 02
Date 07-12-23 Previous NA
BONDRONAT 2MG2ML 6MG6ML 1 VIAL
Size
750X370MM
Black
Guides
Guides
Barcdes
SG 705-8530 UNI 02
BONDRONAT
®
Ibandronic acid
DOSAGE /
INFUSION TIME
1
6 mg / 15 minutes
4 mg / 1 hour
2 mg / 1 hour
INFUSION VOLUME
2
100 mL
500 mL
500 mL
SMPR per patient
Reduction in
Rate compared
to placebo
Treatment
0.29
Treatment
Intravenous
Infusion (6mg
every 3 to 4
weeks
SREs
Risk Reduction
compared to
placebo (%)
40
p-value
0.004
p-value
0.003
CREATININE
CLEARANCE (ML/MIN)
≥50 CLcr <80
≥30 CLcr <50
<30
1.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_ ibandronic acid.
Ampoules with 1 ml of concentrate for infusion. Vials with 2 ml or 6ml
of concentrate for solution for infusion.
Ampoules of 1 ml contain 1.125 mg ibandronic acid, monosodium salt,
monohydrate corresponding to
1 mg ibandronic acid; vials of 2 ml contain
2.25 mg ibandronic acid, monosodium salt, monohydrate corresponding to
2 mg ibandronic acid; vials of 6 ml
contain 6.75 mg ibandronic acid, monosodium salt, monohydrate,
corresponding to 6 mg ibandronic acid.
3.
CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
-
Prevention of skeletal events associated with metastatic bone disease
due to breast cancer.
-
Treatment of pathologically (abnormally) elevated serum calcium levels
(hypercalcemia) as a result
of tumours.
3.2 DOSAGE AND METHOD OF ADMINISTRATION
TREATMENT OF METASTATIC BONE DISEASE
The recommended dose for metastatic bone disease is 6 mg IV given
every 3-4 weeks. The dose should be
infused over at least 15 minutes. For infusion, the contents of the
ampoule(s)/vials(s) should be added to
100 ml isotonic sodium chloride solution (or 100 ml 5% dextrose
solution).
A shorter (i.e 15 min) infusion time should only be us