Ibandroninezuur Teva 6 mg, concentraat voor oplossing voor infusie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NATRIUMIBANDRONAAT 1-WATER SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR

Beschikbaar vanaf:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ATC-code:

M05BA06

INN (Algemene Internationale Benaming):

NATRIUMIBANDRONAAT 1-WATER COMPOSITION corresponding to ; IBANDRONINEZUUR

farmaceutische vorm:

Concentraat voor oplossing voor infusie

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:

2012-05-07

Bijsluiter

1
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
IBANDRONINEZUUR TEVA 6 MG, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
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]>
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]> contains the active substance ibandronic acid.
This belongs to a group of medicines
called bisphosphonates.
Ibandronic acid is used in adults and prescribed to you if you have
breast cancer that has spread to your
bones (called bone ‘metastases’)

It helps to prevent your bones from breaking (fractures)

It helps to prevent other bone problems that may need surgery or
radiotherapy
Ibandronic acid can also be prescribed if you have a raised calcium
level in your blood due to a tumour.
Ibandronic acid works by reducing the amount of calcium that is lost
from your bones. This helps to stop
your bones from getting weaker.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE <[IBANDRONIC ACID]>
DO NOT RECEIVE <[IBANDRONIC ACID]>:

if you are
ALLERGIC
to ibandronic acid or any of the other ingredients of this medicine
that are listed in
section 6

IF YOU HAVE, OR HAVE EVER HAD LOW LEVELS OF CALCIUM
in your blood
Do not receive this medicine if any of the above apply to you. If you
are not sure, talk to your doctor or
pharmacist before having ibandronic acid.
WARNINGS AND PRECAUTIONS
A side effect called osteonecrosis of the jaw

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Ibandroninezuur Teva 2 mg, concentraat voor oplossing voor infusie
Ibandroninezuur Teva 6 mg, concentraat voor oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 2 ml concentrate for solution for infusion contains 2 mg
ibandronic acid (as 2.25 mg
ibandronic acid, monosodium salt, monohydrate).
One vial with 6 ml concentrate for solution for infusion contains 6 mg
ibandronic acid, (as 6.75 mg
ibandronic acid monosodium salt, monohydrate)
One ml concentrate for solution for infusion contains 1 mg ibandronic
acid (as 1.13 mg ibandronic acid,
monosodium salt, monohydrate).
Excipient with known effect:
Sodium (less than 1 mmol per dose).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless solution.
pH of the undiluted product: 4.9-5.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ibandronic acid is indicated in adults for

Prevention of skeletal events (pathological fractures, bone
complications requiring radiotherapy or
surgery) in patients with breast cancer and bone metastases.

Treatment of tumour-induced hypercalcaemia with or without metastases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Patients treated with ibandronic acid should be given the package
leaflet and the patient reminder card.
Ibandronic acid therapy should only be initiated by physicians
experienced in the treatment of cancer.
Posology
_ _
_Prevention of skeletal events in patients with breast cancer and bone
metastases_
The recommended dose for prevention of skeletal events in patients
with breast cancer and bone metastases
is 6 mg intravenous injection given every 3-4 weeks. The dose should
be infused over at least 15 minutes.
2
A shorter (i.e. 15 min) infusion time should only be used for patients
with normal renal function or mild
renal impairment. There are no data available characterising the use
of a shorter infusion time in patients
with creatinine clearance