Ibandroninezuur Teva 3 mg, oplossing voor injectie in voorgevulde spuit

Nazione: Paesi Bassi

Lingua: olandese

Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Principio attivo:

NATRIUMIBANDRONAAT 1-WATER 1,125 mg/ml SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR 1 mg/l

Commercializzato da:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

Codice ATC:

M05BA06

INN (Nome Internazionale):

NATRIUMIBANDRONAAT 1-WATER 1,125 mg/ml SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR 1 mg/l

Forma farmaceutica:

Oplossing voor injectie

Composizione:

AZIJNZUUR (E 260), GECONCENTREERD ; NATRIUMACETAAT 3-WATER (E 262) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE,

Via di somministrazione:

Intraveneus gebruik

Area terapeutica:

Ibandronic Acid

Dettagli prodotto:

Hulpstoffen: AZIJNZUUR (E 260), GECONCENTREERD; NATRIUMACETAAT 3-WATER (E 262); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); WATER VOOR INJECTIE;

Data dell'autorizzazione:

1900-01-01

Foglio illustrativo

Ibandronic acid, NL/H/2362/003, 05.09.22
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BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
IBANDRONINEZUUR TEVA 3 MG, OPLOSSING VOOR INJECTIE IN VOORGEVULDE
SPUIT
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 <[Ibandronic acid]> is and what it is used for
2.
What you need to know before you receive <[Ibandronic acid]>
3.
How to receive < Ibandronic acid 3 mg solution for injection>
4.
Possible side effects
5.
How to store <[Ibandronic acid]>
6.
Contents of the pack and other information
1.
WHAT <[IBANDRONIC ACID]> IS AND WHAT IT IS USED FOR
Ibandronic acid belongs to a group of medicines called
BISPHOSPHONATES
. It contains the active substance
ibandronic acid.
Ibandronic acid 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. Ibandronic acid may help
lower the chances of breaking bones (fractures). This reduction in
fractures was shown for the spine but not
for the hip.
IBANDRONIC ACID 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

Scheda tecnica

Ibandronic acid, NL/H/2362/003, 05.09.22
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rvg 109743 EU SPC IA-021 met NL info-clean
1.
NAAM VAN HET GENEESMIDDEL
Ibandroninezuur Teva 3 mg, oplossing voor injectie in voorgevulde
spuit
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe of 3 ml solution for injection contains 3 mg
ibandronic acid (as 3.375 mg
ibandronic acid, monosodium salt, monohydrate).
The concentration of ibandronic acid in the solution for injection is
1 mg per ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, colourless solution.
The pH of the solution is 4.9 – 5.5.
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 ibandronic acid 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
ibandronic acid on an individual patient basis, particularly after 5
or more years of use.
_ _
_Special populations _
_Patients with renal impairment _
Ibandronic acid 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