Ibandroninezuur STADA 3 mg/3 ml, oplossing voor injectie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NATRIUMIBANDRONAAT 1-WATER SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR

Beschikbaar vanaf:

Stada Arzneimittel AG

ATC-code:

M05BA06

INN (Algemene Internationale Benaming):

NATRIUMIBANDRONAAT 1-WATER COMPOSITION corresponding to ; IBANDRONINEZUUR

farmaceutische vorm:

Oplossing voor injectie

Samenstelling:

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

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Ibandronic Acid

Product samenvatting:

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

Autorisatie datum:

2012-09-03

Bijsluiter

PL Ibandronic acid NL2127 (3 mg)
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBANDRONINEZUUR STADA 3 MG/3 ML, OPLOSSING VOOR INJECTIE
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. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Ibandroninezuur STADA 3mg/3ml oplossing voor injectie is and
what it is used for
2. What you need to know before you receive Ibandroninezuur STADA
3mg/3ml oplossing
voor injectie
3. How to receive Ibandroninezuur STADA 3mg/3ml oplossing voor
injectie
4. Possible side effects
5. How to store Ibandroninezuur STADA 3mg/3ml oplossing voor injectie
6. Contents of the pack and other information
1. WHAT IBANDRONINEZUUR STADA 3MG/3ML OPLOSSING VOOR INJECTIE IS AND
WHAT IT IS USED
FOR
Ibandronic acid belongs to a group of medicines called
bisphosphonates. Ibandroninezuur
STADA 3mg/3ml oplossing voor injectie 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 fractur

Productkenmerken

NL SmPC Ibandronic acid NL2127 (3 mg)
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ibandroninezuur STADA 3 mg/3 ml, oplossing voor injectie
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.
Excipient(s) with known effect
Sodium (less than 1 mmol per dose)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
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 solution for injection 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 _
NL SmPC Ibandronic acid NL2127 (3 mg)
_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 cre