Bondenza (previously Ibandronic Acid Roche)

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-05-2013
Summary of Product characteristics Summary of Product characteristics (SPC)
13-05-2013
Public Assessment Report Public Assessment Report (PAR)
13-05-2013

Active ingredient:

ibandronska kislina

Available from:

Roche Registration Ltd.

ATC code:

M05BA06

INN (International Name):

ibandronic acid

Therapeutic group:

Zdravila za zdravljenje bolezni kosti

Therapeutic area:

Osteoporoza, postmenopavz

Therapeutic indications:

Zdravljenje osteoporoze pri ženskah po menopavzi z večjim tveganjem zloma. Zmanjšanje tveganja za zlome vretenc je bilo dokazano,. Učinkovitost na femoralne-vrat zlomi ni bila ugotovljena.

Product summary:

Revision: 16

Authorization status:

Umaknjeno

Authorization date:

2004-02-23

Patient Information leaflet

                                9.
POSEBNA NAVODILA ZA SHRANJEVANJE
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZD
RAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
Velika Britanija
12.
ŠTEVILKA(E) DOVOLJENJA ZA PROMET
EU/1/03/266/003 1 filmsko obložena tableta
EU/1/03/266/004 3 filmsko obložene tablete
13.
ŠTEVILKA SERIJE
Serija
14.
NAČIN I
ZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Bondenza 150 mg
34
Zdravilo nima veā dovoljenja za promet
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
DVOJN
EM TRAKU
PRETISNI OMOT
1.
IME ZDRAVILA
Bondenza 150 mg filmsko obložene tablete
ibandronska kislina
2.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Roche Registration Ltd.
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
DRUGI PODATKI
35
Zdravilo nima veā dovoljenja za promet
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Bondenza 3 mg raztopina za injiciranje
ibandronska kislina
2.
NAVEDBA ENE ALI VEČ ZD
RAVILNIH UČINKOVIN
Ena napolnjena injekcijska brizga vsebuje 3 mg ibandronske kisline (v
obliki natrijevega monohidrata)
v 3 ml raztopine.
3.
SEZNAM POMOŽNIH SNOVI
Zdravilo vsebuje tudi natrijev klorid, koncentrirano ocetno kislino
(ledocet), natrijev acetat trihidrat in
vodo za injekcije. Za nadaljnje informacije glejte navodilo za
uporabo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
raztopina za injiciranje
1 napolnjena injekcijska brizga + 1 injekcijska igla
4 napolnjene injekcijske brizge + 4 injekcijske igle
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo
Samo za intravensko uporabo
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGL
EDA OTROK
Zdravilo shranjujte nedosegljivo otrokom
7.
DRUGA POSEBNA OPOZORILA, ČE SO POT
REBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do
9.
POSEBNA NAVODILA ZA SHRANJEVANJ
                                
                                Read the complete document

Summary of Product characteristics

                                PRILOGA I
POVZETEK GLAVNIH ZNAČI
LNOSTI ZDRAVILA
1
Zdravilo nima veā dovoljenja za promet
1.
IME ZDRAVILA
Bondenza 150 mg filmsko obložene tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
_ _
Ena filmsko obložena tableta vsebuje 150 mg ibandronske kisline
(v obliki natrijevega monohidrata).
Pomožne snovi z znanim uč
inkom:
vsebuje 162,75 mg laktoze monohidrata (enakovredno 154,6 mg brezvodne
laktoze).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
filmsko obložena tableta
Filmsko obložene tablete so bele do sivo bele barve, p
odolgovate oblike z oznako “BNVA” na eni
strani in “150” na drugi strani.
4.
KLINIČNI PODA
TKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravljenje osteoporoze pri postmenopavznih ženskah s poveč
anim tveganjem za zlome (glejte
poglavje 5.1).
Dokazano je bilo zmanjšanje tveganja za vretenčne zlome,
učinkovitosti pri zlomih stegneničnega
vratu pa niso ugotovili.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Priporočeni odmerek je ena 150-mg filmsko obložena tableta na mesec.
Tableto je priporočeno vzeti
na isti datum v mesecu.
Zdravilo Bondenza je treba vzeti zjutraj na prazen žel
odec (najmanj 6 ur brez obroka) in 1 uro pred
prvim dnevnim obrokom hrane ali pijače, ki ni voda (glejte poglavje
4.5), ali zaužitjem drugih
peroralnih zdravil ali dodatkov (vključno s kalcijem).
Če bolnik
odmerek izpusti, mu je treba svetovati, naj vzame eno 150-mg tableto
zdravila Bondenza
naslednje jutro potem, ko se spomni, razen če je do naslednjega
načrtovanega odmerka manj kot 7 dni.
Bolnik naj nadaljuje jemanje odmerka enkrat na mesec na prvotno
izbrani dan.
Če je do naslednjega načrtovanega odmerka manj kot 7 dni, naj bolnik
počaka do tega odmerka in
nadaljuje jemanje ene tablete enkrat na mesec po prvotnem načrtu.
Bolnik ne sme vzeti dveh tablet v enem tednu.
Če vnos s hrano ni zadoste
n, morajo bolniki prejemati dodatke kalcija, vitamina D ali obojega
(glejte
poglavje 4.4 in poglavje 4.5).
Optimalno trajanje zdravljenja osteoporoze z difosfonati še ni
dolo
                                
                                Read the complete document

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Active ingredient ibandronska kislina

ibandronska kislina

ATC code M05BA06

M05BA06

Marketed by Roche Registration Ltd.

Roche Registration Ltd.

INN (International Name) ibandronic acid

ibandronic acid

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Bondenza (previously Ibandronic Acid Roche)