BONDRONAT LIQUID

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

IBANDRONIC ACID (IBANDRONATE SODIUM)

Tilgængelig fra:

HOFFMANN-LA ROCHE LIMITED

ATC-kode:

M05BA06

INN (International Name):

IBANDRONIC ACID

Dosering:

1MG

Lægemiddelform:

LIQUID

Sammensætning:

IBANDRONIC ACID (IBANDRONATE SODIUM) 1MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

2ML

Recept type:

Prescription

Terapeutisk område:

BONE RESORPTION INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0132573001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2006-05-17

Produktets egenskaber

IBANDRONATE (BM 21.0955)
- 1 -
PRODUCT MONOGRAPH
Pr
BONDRONAT
®
(ibandronate sodium injection)
1 mg/mL of ibandronic acid, 1mL, 2mL Ampoules
Bone Metabolism Regulator
(Bisphosphonate)
Hoffmann-La Roche Ltd./Ltee
DATE OF PREPARATION:
2455 Meadowpine Boulevard June 3, 1998
Mississauga, Ontario
L5N 6L7
DATE OF REVISION:
February 13, 2004
Control Number: 088161,088162,088163
™ Trade Mark of F. Hoffmann-La Roche AG used under license
© Copyright 1998 - Hoffmann-La Roche Limited
IBANDRONATE (BM 21.0955)
- 2 -
NAME OF DRUG
PR BONDRONAT
®
(IBANDRONATE SODIUM INJECTION)
1 MG/ML OF IBANDRONIC ACID, 1ML, 2ML AMPOULES
THERAPEUTIC CLASSIFICATION
BONE METABOLISM REGULATOR
(BISPHOSPHONATE)
ACTIONS AND CLINICAL PHARMACOLOGY
Bondronat
®
(ibandronate) belongs to the class of bisphosphonates which act
primarily on bone.
This tissue specificity is based upon the high affinity of
bisphosphonates for bone mineral. The
major effect of ibandronate is to inhibit osteoclast-mediated bone
resorption without any
inhibitory effect on mineralization, although the precise mechanism is
not clear.
In patients with bone metastases, the inhibitory effect of ibandronate
on tumor induced
osteolysis, and specifically on tumor-induced hypercalcemia, is
characterized by a decrease in
serum calcium and urinary calcium excretion. Normalization of serum
calcium levels was
achieved in 75 percent of patients with doses ranging from 2 to 4 mg
ibandronate administered
as an intravenous infusion over 2 hours.
Several variables interfere with a precise assessment of the duration
of the effect. Variations in
the tumor load, in the amount and type of osteolytic mediators
produced by the tumor cells,
concomitant anticancer therapy and the renal handling of calcium can
influence the duration of
action
_._
Prior to initiation of therapy with ibandronate, the state of negative
fluid balance requires
vigorous and adequate hydration with isotonic saline (0.9% w/v).
Normalization of blood calcium levels by ibandronate in adequately
hydrated patients may also
norma