Ibandroninezuur STADA 50 mg, filmomhulde tabletten

Ülke: Hollanda

Dil: Hollandaca

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

Aktif bileşen:

NATRIUMIBANDRONAAT 1-WATER SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR

Mevcut itibaren:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC kodu:

M05BA06

INN (International Adı):

NATRIUMIBANDRONAAT 1-WATER COMPOSITION corresponding to ; IBANDRONINEZUUR

Farmasötik formu:

Filmomhulde tablet

Kompozisyon:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Uygulama yolu:

Oraal gebruik

Terapötik alanı:

Ibandronic Acid

Ürün özeti:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); LACTOSE 1-WATER; MACROGOL 3350; NATRIUMSTEARYLFUMARAAT; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Yetkilendirme tarihi:

2010-12-31

Bilgilendirme broşürü

NL_PL Ibandronic acid NL1835-001
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBANDRONINEZUUR STADA 50 MG, FILMOMHULDE TABLETTEN
ibandronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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 50 mg, filmomhulde tabletten is and what
it is used for.
2. What you need to know before you take Ibandroninezuur STADA 50 mg,
filmomhulde
tabletten.
3. How to take Ibandroninezuur STADA 50 mg, filmomhulde tabletten.
4. Possible side effects.
5. How to store Ibandroninezuur STADA 50 mg, filmomhulde tabletten
6. Contents of the pack and other information.
1. WHAT IBANDRONINEZUUR STADA 50 MG, FILMOMHULDE TABLETTEN IS AND WHAT
IT IS USED FOR
Ibandroninezuur STADA 50 mg, filmomhulde tabletten contains the active
substance ibandronic
acid. This belongs to a group of medicines called bisphosphonates.
Ibandroninezuur STADA 50 mg, filmomhulde tabletten 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 also helps to prevent other bone problems that may need surgery or
radiotherapy
Ibandroninezuur STADA 50 mg, filmomhulde tabletten 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 TAKE IBANDRONINEZUUR STADA 50 MG,
FILMOMHULDE
TABLETTEN
DO NOT TAKE IBANDRONINEZUUR STADA 50 MG, FILMOMHULDE TABLETTEN
•
if you are allergic to ibandronic acid or any

Ürün özellikleri

NL_SmPC Ibandronic acid NL1835-001
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ibandroninezuur STADA 50 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of ibandronic acid (as
ibandronic acid sodium
monohydrate).
Excipient(s) with known effect
Each film-coated tablet contains 54.25 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
White to off-white, oblong, biconvex film-coated tablets, 9 mm in
length and debossed with
"I9BE" on one side and on the other side with "50".
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ibandronic acid is indicated in adults for the prevention of skeletal
events (pathological
fractures, bone complications requiring radiotherapy or surgery) in
patients with breast cancer
and bone metastases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ibandronic acid therapy should only be initiated by physicians
experienced in the treatment of
cancer.
Posology
The recommended dose is one 50 mg film-coated tablet daily.
_Hepatic impairment _
No dose adjustment is required (see section 5.2).
_Renal impairment _
No dose adjustment is necessary for patients with mild renal
impairment (CLcr ≥ 50 and
< 80 ml/min).
For patients with moderate renal impairment (CLcr ≥ 30 and < 50
ml/min) a dosage adjustment
to one 50 mg film-coated tablet every second day is recommended (see
section 5.2).
For patients with severe renal impairment (CLcr < 30 ml/min) the
recommended dose is one
50 mg film-coated tablet once weekly. See dosing instructions, above.
_Elderly (> 65 years) _
No dose adjustment is necessary (see section 5.2).
_Paediatric population _
NL_SmPC Ibandronic acid NL1835-001
The safety and efficacy of ibandronic acid in children and adolescents
below 18 years have
not been established. No data are available (see section 5.1 and 5.2).
Method of administration
For oral use.
Ibandronic acid tablets should be taken after an overnight fast (at
least 6 hou