Bonviva solution for i/v injection

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

ibandronic acid (ibandronic acid monosodium monohydrate)

Disponible desde:

WAYMADE PLC

Código ATC:

M05BA06

Designación común internacional (DCI):

ibandronic acid (ibandronic acid monosodium monohydrate)

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:

2020-12-11

Información para el usuario

49
PACKAGE LEAFLET: INFORMATION FOR THE USER
BONVIVA 3 MG SOLUTION FOR INJECTION
ibandronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bonviva is and what it is used for
2.
What you need to know before you receive Bonviva
3.
How to receive Bonviva
4.
Possible side effects
5.
How to store Bonviva
6.
Content of the pack and other information
1.
WHAT BONVIVA IS AND WHAT IT IS USED FOR
Bonviva belongs to a group of medicines called bisphosphonates. It
contains the active substance
ibandronic acid.
Bonviva may reverse bone loss by stopping more loss of bone and
increasing bone mass in most
women who take it, even though they won’t be able to see or feel a
difference. Bonviva may help
lower the chances of breaking bones (fractures). This reduction in
fractures was shown for the spine
but not for the hip.
BONVIVA IS PRESCRIBED TO YOU TO TREAT POSTMENOPAUSAL OSTEOPOROSIS
BECAUSE YOU HAVE AN
INCREASED RISK OF FRACTURES. Osteoporosis is a thinning and weakening
of the bones, which is common
in women after the menopause. At the menopause, a woman’s ovaries
stop producing the female
hormone, oestrogen, which helps to keep her skeleton healthy. The
earlier a woman reaches the
menopause, the greater her risk of fractures in osteoporosis.
Other things that can increase the risk of fractures include:

not enough calcium and vitamin D in the diet

smoking cigarettes, or drinking too much alcohol

not enough walking or other weight-bearing exercise

a family history of osteoporosis
A HEALTHY LIFESTYLE will also help you to get the most benefit from
your treatment. This includes:

eating a balanced diet rich in cal

Ficha técnica

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
creatinine is equal or below 200 μmol/l (2.3 mg/dl)