Bonviva

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

ibandronic acid

Commercializzato da:

Roche Diagnostics GmbH

INN (Nome Internazionale):

ibandronic acid

Dosaggio:

1mg/ml

Forma farmaceutica:

solution for i/v injection

Tipo di ricetta:

Prescription

Foglio illustrativo

10174402 FE
GENISYS-NO.
10174402
DATA MATRIX:
(92)10174402
PRINTING COLOURS:
PANTONE 281
FORMAT:
594X420 MM
FOLDING FORMAT:
99X35 MM
REPLACES GENISYS-NO.
10164035
TYPE SIZE:
9 PT
DRAWING NORM
01.07.14, VERSION C
®
Ibandronic acid
BISPHOSPHONATES – DRUGS FOR TREATMENT OF BONE DISEASES (M05)
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Bonviva is a nitrogen-containing bisphosphonate.
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.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Bonviva is indicated for the treatment of postmenopausal osteoporosis,
to reduce the
risk of fractures.
_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.
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 injection.
2.2.1
SPECIAL DOSAGE INSTRUCTIONS
_Patients with hepatic impairment_
No dosage adjustment is necessary (see section 3.2.4 Pharmacokinetics
in Special
Populations).
_Patients with renal impairment _
No dosage adjustment is necessary for patients with serum creatinine
≤ 200 μmol/l
(2.3 mg/dl) or where creatinine clearance (measured or estimated) ≥
30 ml/min.
Bonv

Scheda tecnica

December 2015
Summary of Product Characteristics
Ro 200-5450
Bonviva pre-filled syringes
December 2015
1
BONVIVA
®
Ibandronic acid
BISPHOSPHONATES – DRUGS FOR TREATMENT OF BONE DISEASES (M05)
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Bonviva is a nitrogen-containing bisphosphonate.
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.
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Bonviva is indicated for the treatment of postmenopausal osteoporosis,
to reduce the risk
of fractures.
_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.
December 2015
Summary of Product Characteristics
Ro 200-5450
Bonviva pre-filled syringes
December 2015
2
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
injection.
2.2.1
SPECIAL DOSAGE INSTRUCTIONS
_Patients with hepatic impairment _
No
dosage
adjustment
is
necessary
(see
section
3.2.4
Pharmacokinetics
in
Special
Populations).
_Patients with renal impairment _
No dosage adjustment is necessary for patients with serum creatinine
≤ 200 μmol/l
(2.3

mg/dl) or where creatinine clearance (measured or estimated) ≥ 30
ml