Ibandroninezuur STADA 2 mg/2 ml, concentraat voor oplossing voor infusie

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

NATRIUMIBANDRONAAT 1-WATER SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR

Disponible depuis:

Stada Arzneimittel AG

Code ATC:

M05BA06

DCI (Dénomination commune internationale):

NATRIUMIBANDRONAAT 1-WATER COMPOSITION corresponding to ; IBANDRONINEZUUR

forme pharmaceutique:

Concentraat voor oplossing voor infusie

Composition:

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

Mode d'administration:

Intraveneus gebruik

Domaine thérapeutique:

Ibandronic Acid

Descriptif du produit:

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

Date de l'autorisation:

2012-09-03

Notice patient

PL Ibandronic acid NL2126 (2+6 mg)
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBANDRONINEZUUR STADA 2 MG/2 ML, CONCENTRAAT VOOR OPLOSSING VOOR
INFUSIE
IBANDRONINEZUUR STADA 6 MG/6 ML, 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 or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Ibandroninezuur STADA 2 mg and 6 mg is and what it is used for
2. What you need to know before you receive Ibandroninezuur STADA 2 mg
and 6 mg
3. How to receive Ibandroninezuur STADA 2 mg and 6 mg
4. Possible side effects
5. How to store Ibandroninezuur STADA 2 mg and 6 mg
6. Contents of the pack and other information
1. WHAT IBANDRONINEZUUR STADA 2 MG AND 6 MG IS AND WHAT IT IS USED FOR
Ibandroninezuur STADA 2 mg and 6 mg concentrate for solution for
infusion 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 IBANDRONINEZUUR STADA 2 MG
AND 6 MG
DO NOT RECEIVE IBANDRONINEZUUR STADA 2 MG AND 6 MG

if you are allergic to ibandronic acid or any of the other ingredients
of this medicine (listed
in section 6)

if you have, or have ever

Résumé des caractéristiques du produit

NL SmPC Ibandronic acid 2+6 mg CSI, NL2126
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ibandroninezuur STADA 2 mg/2 ml, concentraat voor oplossing voor
infusie
Ibandroninezuur STADA 6 mg/6 ml, 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(s) 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 concentrate for solution for
infusion 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.
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 availab