Bonviva solution for i/v injection

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

ibandronic acid

Disponible desde:

Roche Diagnostics GmbH

Código ATC:

M05BA06

Designación común internacional (DCI):

ibandronic acid

Dosis:

1mg/ml

formulario farmacéutico:

solution for i/v injection

Unidades en paquete:

(1) pre-filled glass syringe 3ml and (1) needle

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2019-07-30

Información para el usuario

10174402 FE
®
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
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:_
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:_
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.
Bonviva 3 mg every 3 months i.v. is not recommended for use in
patients who have
a serum creatinine >200 μmol/l (2.3 mg/dl) or who have a creatinine
clearance
(measured or estimated) < 30 ml/min because no clinical data are
available
from studies including such patients (see section 3.2.4
Pharmacokinetics in
Special Populations).
_Elderly_
No dosage adjus

Ficha técnica

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
16
1.
NAME OF THE MEDICINAL PRODUCT
Bonviva 3 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid
(as sodium monohydrate).
The concentration of ibandronic acid in the solution for injection is
1mg per ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
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
Patients treated with Bonviva should be given the package leaflet and
the patient reminder card.
Posology
The recommended dose of ibandronic acid is 3 mg, administered as an
intravenous injection over 15 -
30 seconds, every three months.
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.
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 benefits and potential risks of
Bonviva on an individual patient basis, particularly after 5 or more
years of use.
_Special populations _
_Patients with renal impairment _
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).
No dose adjustment is necessary for patients with mild or moderate
renal impairment where serum
cre