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ZOLEDRONIC ACID SEACROSS 4MG/100ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoledronic Acid 4 mg/100 ml solution for infusion
Zoledronic acid
ReDd Dll of tKis leDÀet cDrefull\ Eefore \ou Dre giYen tKis
medicine EecDuse it contDins imSortDnt informDtion for \ou
 .eeS WKiV leaÀeW  ,I \oX KaYe an\ IXrWKer TXeVWionV aVN \oXr docWor
SKarPaciVW or nXrVe
 ,I \oX JeW an\ Vide eIIecWV WalN Wo \oXr docWor SKarPaciVW
or nXrVe 7KiV inclXdeV an\ SoVViEle Vide eIIecWV noW liVWed
in WKiV leaÀeW 6ee VecWion 
:KDt is in tKis leDÀet:
 :KaW Zoledronic $cid iV and ZKaW iW iV XVed Ior
 :KaW \oX need Wo NnoZ EeIore \oX are JiYen Zoledronic
$cid
 +oZ Zoledronic $cid iV XVed
 3oVViEle Vide eIIecWV
 +oZ Wo VWore Zoledronic $cid
 &onWenWV oI WKe SacN and oWKer inIorPaWion
1 :HAT ZOLE'RONIC ACI' IS AN' :HAT IT IS USE'
FOR
7Ke acWiYe VXEVWance in Zoledronic $cid iV ]oledronic
acid ZKicK EelonJV Wo a JroXS oI VXEVWanceV called
EiVSKoVSKonaWeV Zoledronic acid ZorNV E\ aWWacKinJ iWVelI
Wo WKe Eone and VloZinJ doZn WKe raWe oI Eone cKanJe ,W iV
XVed
‡ To SreYent Eone comSlicDtions eJ IracWXreV in adXlW
SaWienWV ZiWK Eone PeWaVWaVeV VSread oI cancer IroP
SriPar\ ViWe Wo WKe Eone 
• To reduce the amount of calcium in WKe Elood in adXlW
SaWienWV ZKere iW iV Woo KiJK dXe Wo WKe SreVence oI a
WXPoXr 7XPoXrV can acceleraWe norPal Eone cKanJe
in VXcK a Za\ WKaW WKe releaVe oI calciXP IroP Eone
iV increaVed 7KiV condiWion iV NnoZn aV WXPoXrindXced
K\SercalcaePia 7,+ 
 :HAT GI9EN ZOLE'RONIC ACI'
)olloZ careIXll\ all inVWrXcWionV JiYen Wo \oX E\ \oXr docWor
WreaWPenW ZiWK Zoledronic $cid and Zill cKecN \oXr reVSonVe
Wo WreaWPenW aW reJXlar inWerYalV
‡ iI \oX are EreaVWIeedinJ
‡ iI \oX are allerJic Wo ]oledronic acid anoWKer
EiVSKoVSKonaWe WKe JroXS oI VXEVWanceV Wo ZKicK
Zoledronic $cid EelonJV  or an\ oI WKe oWKer inJredienWV
oI WKiV Pedicine liVWed in VecWion 
:arnings and Srecautions
7alN Wo \oXr docWor SKarPaciVW or nXrVe EeIore \oX are
JiYen Zoledronic $cid
‡ iI \oX KaYe or KaYe Kad a Nidne\ SroElem
‡ iI \oX KaYe or KaYe Kad Sain sZelling or numEness of
WKe MaZ a feelinJ of KeaYineVV in WKe MaZ or looVeninJ of a
WooWK
‡ if \oX are KaYinJ dental treatment or are dXe Wo XnderJo
denWal VXrJer\ Well \oXr denWiVW WKaW \oX are EeinJ WreaWed
ZiWK Zoledronic $cid
5edXced leYelV of calciXP in WKe Elood K\SocalcaePia
VoPeWiPeV leadinJ Wo PXVcle craPSV dr\ VNin EXrninJ
VenVaWion KaYe Eeen reSorWed in SaWienWV WreaWed ZiWK
Zoledronic $cid
,rreJXlar KearW EeaW cardiac arrK\WKPia  Vei]XreV
VSaVP and WZiWcKinJ WeWan\ KaYe Eeen reSorWed aV
Vecondar\ Wo VeYere K\SocalcaePia ,n VoPe inVWanceV WKe
K\SocalcaePia Pa\ Ee lifeWKreaWeninJ ,f an\ of WKeVe aSSl\
Wo \oX Well \oXr docWor VWraiJKW aZa\
Patients aged  \ears and oYer
Zoledronic $cid can Ee JiYen Wo SeoSle aJed  \earV
and oYer 7Kere iV no eYidence Wo VXJJeVW WKaW an\ e[Wra
SrecaXWionV are needed
Children and adolescents
Zoledronic $cid iV noW recoPPended for XVe in adoleVcenWV
and cKildren EeloZ WKe aJe of  \earV

Other medicines and Zoledronic Acid
7ell \oXr docWor if \oX are WaNinJ KaYe recenWl\ WaNen or
PiJKW WaNe an\ oWKer PedicineV ,W iV eVSeciall\ iPSorWanW
WKaW \oX Well \oXr docWor if \oX are alVo WaNinJ
‡ $PinoJl\coVideV PedicineV XVed Wo WreaW VeYere
infecWionV  Vince WKe coPEinaWion of WKeVe ZiWK
EiVSKoVSKonaWeV Pa\ caXVe WKe calciXP leYel in WKe
Elood Wo EecoPe Woo loZ
‡ 7KalidoPide a Pedicine XVed Wo WreaW a cerWain W\Se of
Elood cancer inYolYinJ WKe Eone or an\ oWKer PedicineV
ZKicK Pa\ KarP \oXr Nidne\V
‡ 2WKer PedicineV WKaW alVo conWain ]oledronic acid and are
XVed Wo WreaW oVWeoSoroViV and oWKer noncancer diVeaVeV
of WKe Eone or an\ oWKer EiVSKoVSKonaWe Vince WKe
coPEined effecWV of WKeVe PedicineV WaNen WoJeWKer ZiWK
Zoledronic $cid are XnNnoZn
‡ $nWianJioJenic PedicineV XVed Wo WreaW cancer  Vince
WKe coPEinaWion of WKeVe ZiWK Zoledronic $cid KaV Eeen
aVVociaWed ZiWK an increaVed riVN of oVWeonecroViV of WKe
MaZ 21- 
Pregnanc\ and Ereastfeeding
7ell \oXr docWor if \oX are or WKinN WKaW \oX Pa\ Ee SreJnanW
feedinJ
,f \oX are SreJnanW or EreaVWfeedinJ WKinN \oX Pa\ Ee
SreJnanW or are SlanninJ Wo KaYe a EaE\ aVN \oXr docWor or
SKarPaciVW for adYice Eefore WaNinJ an\ Pedicine
'riYing and using machines
7Kere KaYe Eeen Yer\ rare caVeV of droZVineVV and
VleeSineVV ZiWK WKe XVe of ]oledronic acid WKerefore Ee carefXl ZKen driYinJ XVinJ PacKiner\ or
SerforPinJ oWKer WaVNV WKaW need fXll aWWenWion
Zoledronic Acid contains sodium citrate
7KiV Pedicinal SrodXcW conWainV leVV WKan  PPol VodiXP
 PJ Ser doVe  Pl  ie eVVenWiall\ µVodiXPfree¶
 HO: ZOLE'RONIC ACI' IS USE'
‡ Zoledronic $cid PXVW onl\ Ee JiYen E\ KealWKcare
SrofeVVionalV Wrained in adPiniVWerinJ EiVSKoVSKonaWeV
inWraYenoXVl\ ie WKroXJK a Yein
‡ Eefore eacK WreaWPenW Wo KelS SreYenW deK\draWion
‡ &arefXll\ folloZ all WKe oWKer inVWrXcWionV JiYen Wo \oX E\
\oXr docWor SKarPaciVW or nXrVe
HoZ much Zoledronic Acid is giYen
‡ 7Ke XVXal VinJle doVe JiYen iV  PJ
,f \oX KaYe a Nidne\ SroEleP \oXr docWor Zill JiYe \oX a
loZer doVe deSendinJ on WKe VeYeriW\ of \oXr Nidne\ SroEleP
HoZ often Zoledronic Acid is giYen
‡ ,f \oX are EeinJ WreaWed for WKe SreYenWion of Eone
coPSlicaWionV dXe Wo Eone PeWaVWaVeV \oX Zill Ee JiYen
one infXVion of Zoledronic $cid eYer\ WKree Wo foXr ZeeNV
‡ ,f \oX are EeinJ WreaWed Wo redXce WKe aPoXnW of calciXP
in \oXr Elood \oX Zill norPall\ onl\ Ee JiYen one infXVion
of Zoledronic $cid
HoZ Zoledronic Acid is giYen
‡ Zoledronic $cid iV JiYen aV a driS infXVion inWo a
Yein ZKicK VKoXld WaNe aW leaVW  PinXWeV and VKoXld Ee
adPiniVWered aV a VinJle inWraYenoXV VolXWion in a
VeSaraWe infXVion line
3aWienWV ZKoVe Elood calciXP leYelV are noW Woo KiJK Zill
alVo Ee SreVcriEed calciXP and YiWaPin ' VXSSlePenWV Wo Ee
WaNen eacK da\
If \ou are giYen more Zoledronic Acid than \ou should Ee
,f \oX KaYe receiYed doVeV KiJKer WKan WKoVe
recoPPended \oX PXVW Ee carefXll\ PoniWored E\ \oXr
docWor 7KiV iV EecaXVe \oX Pa\ deYeloS VerXP elecWrol\We
aEnorPaliWieV eJ aEnorPal leYelV of calciXP SKoVSKorXV
and PaJneViXP andor cKanJeV in Nidne\ fXncWion
inclXdinJ VeYere Nidne\ iPSairPenW ,f \oXr leYel of calciXP
fallV Woo loZ \oX Pa\ KaYe Wo Ee JiYen VXSSlePenWal
calciXP E\ infXVion




The folloZing information is intended for healthcare Srofessionals onl\:
HoZ to SreSare and administer Zoledronic Acid

‡ Zoledronic $cid conWainV  PJ of ]oledronic acid in  Pl of infXVion VolXWion for iPPediaWe XVe in SaWienWV ZiWK norPal renal
fXncWion
‡ )or VinJle XVe onl\ $n\ XnXVed VolXWion VKoXld Ee diVcarded 2nl\ clear VolXWion free froP SarWicleV and diVcoloXraWion
VKoXld Ee XVed $VeSWic WecKniTXeV PXVW Ee folloZed dXrinJ WKe SreSaraWion of WKe infXVion
‡ &KePical and SK\Vical VWaEiliW\ KaV Eeen dePonVWraWed for  KoXrV aW ƒ&  ƒ& and aW ƒ& )roP a PicroEioloJical SoinW of
YieZ WKe dilXWed VolXWion for infXVion VKoXld Ee XVed iPPediaWel\ ,f noW XVed iPPediaWel\ inXVe VWoraJe WiPeV and
condiWionV Srior Wo XVe are WKe reVSonViEiliW\ of WKe XVer and ZoXld norPall\ noW Ee lonJer WKan  KoXrV aW ƒ& ± ƒ&
7Ke refriJeraWed VolXWion VKoXld Ee eTXiliEraWed Wo rooP WePSeraWXre Srior Wo adPiniVWraWion
‡ 7Ke VolXWion conWaininJ ]oledronic acid PXVW noW Ee fXrWKer dilXWed or Pi[ed ZiWK oWKer infXVion VolXWionV ,W iV JiYen aV a
VinJle PinXWe inWraYenoXV infXVion in a VeSaraWe infXVion line 7Ke K\draWion VWaWXV of SaWienWV PXVW Ee aVVeVVed Srior Wo
and folloZinJ adPiniVWraWion of Zoledronic $cid Wo aVVXre WKaW WKe\ are adeTXaWel\ K\draWed
‡ Zoledronic $cid  PJ Pl VolXWion for infXVion can Ee XVed iPPediaWel\ ZiWKoXW fXrWKer SreSaraWion for SaWienWV ZiWK
norPal renal fXncWion ,n SaWienWV ZiWK Pild Wo PoderaWe renal iPSairPenW redXced doVeV VKoXld Ee SreSared aV inVWrXcWed
EeloZ 7o SreSare redXced doVeV for SaWienWV ZiWK EaVeline &/cr ”  PlPin refer Wo 7aEle  EeloZ
5ePoYe WKe YolXPe of Zoledronic $cid VolXWion indicaWed froP WKe Yial and reSlace ZiWK an eTXal YolXPe of VWerile VodiXP
cKloride  PJPl  VolXWion for inMecWion or  JlXcoVe VolXWion for inMecWion

4 POSSI%LE SI'E EFFECTS
/iNe all PedicineV WKiV Pedicine can caXVe Vide effecWV
alWKoXJK noW eYer\Eod\ JeWV WKeP 7Ke PoVW coPPon oneV
are XVXall\ Pild and Zill SroEaEl\ diVaSSear afWer a VKorW
WiPe
Tell \our doctor aEout an\ of the folloZing serious side
effects straight aZa\:
Common Pa\ affecW XS Wo  in  SeoSle
‡ 6eYere Nidne\ iPSairPenW Zill norPall\ Ee deWerPined E\
\oXr docWor ZiWK cerWain VSeci¿c Elood WeVWV 
‡ /oZ leYel of calciXP in WKe Elood
Uncommon Pa\ affecW XS Wo  in  SeoSle
‡ 3ain in WKe PoXWK WeeWK andor MaZ VZellinJ or VoreV
inVide WKe PoXWK nXPEneVV or a feelinJ of KeaYineVV
in WKe MaZ or looVeninJ of a WooWK 7KeVe coXld Ee ViJnV
of Eone daPaJe in WKe MaZ oVWeonecroViV  7ell \oXr
docWor and denWiVW iPPediaWel\ if \oX e[Serience VXcK
V\PSWoPV
‡ ,rreJXlar KearW rK\WKP aWrial ¿ErillaWion KaV Eeen Veen
in SaWienWV receiYinJ ]oledronic acid for SoVWPenoSaXVal
oVWeoSoroViV ,W iV cXrrenWl\ Xnclear ZKeWKer ]oledronic
acid caXVeV WKiV irreJXlar KearW rK\WKP EXW \oX VKoXld
reSorW iW Wo \oXr docWor if \oX e[Serience VXcK V\PSWoPV
afWer \oX KaYe receiYed ]oledronic acid
‡ 6eYere allerJic reacWion VKorWneVV of EreaWK VZellinJ
Painl\ of WKe face and WKroaW
9er\ rare Pa\ affecW XS Wo  in  SeoSle
‡ $V a conVeTXence of loZ calciXP YalXeV irreJXlar KearW
EeaW cardiac arrK\WKPia Vecondar\ Wo K\SocalcaePia 
Vei]XreV nXPEneVV and WeWan\ Vecondar\ Wo
K\SocalcaePia 
Tell \our doctor aEout an\ of the folloZing side effects
as soon as SossiEle:
9er\ common Pa\ affecW Pore WKan  in  SeoSle
‡ /oZ leYel of SKoVSKaWe in WKe Elood
Common Pa\ affecW XS Wo  in  SeoSle
‡ +eadacKe and a ÀXliNe V\ndroPe conViVWinJ of feYer
faWiJXe ZeaNneVV droZVineVV cKillV and Eone MoinW
andor PXVcle acKe ,n PoVW caVeV no VSeci¿c WreaWPenW
iV reTXired and WKe V\PSWoPV diVaSSear afWer a VKorW WiPe
coXSle of KoXrV or da\V 
‡ *aVWroinWeVWinal reacWionV VXcK aV naXVea and YoPiWinJ
aV Zell aV loVV of aSSeWiWe
‡ &onMXncWiYiWiV
‡ /oZ leYel of red Elood cellV anaePia 

ReSorting of side effects
,f \oX JeW an\ Vide effecWV WalN Wo \oXr docWor SKarPaciVW or
nXrVe 7KiV inclXdeV an\ SoVViEle Vide effecWV noW liVWed in
WKiV leaÀeW $lVo \oX can KelS PaNe VXre PedicineV rePain
aV Vafe aV SoVViEle E\ reSorWinJ an\ XnZanWed Vide effecWV
Yia WKe inWerneW aW ZZZPKraJoYXN\elloZcard $lWernaWiYel\
\oX can call )reeSKone    aYailaEle EeWZeen
aPSP 0onda\ ± )rida\ or ¿ll in a SaSer forP aYailaEle
froP \oXr local SKarPac\ %\ reSorWinJ Vide effecWV \oX can
KelS SroYide Pore inforPaWion on WKe VafeW\ of WKiV Pedicine
 HO: TO STORE ZOLE'RONIC ACI'
Zoledronic $cid SroSerl\ Vee VecWion  
$fWer ¿rVW oSeninJ Zoledronic $cid VKoXld Ee XVed
iPPediaWel\ ,f WKe VolXWion iV noW XVed iPPediaWel\ iW VKoXld
Ee VWored in a refriJeraWor aW ƒ& ± ƒ& EXW no lonJer WKan
 KoXrV
 CONTENTS OF THE PACK AN' OTHER
INFORMATION
What Zoledronic Acid contains:
‡ 7Ke acWiYe VXEVWance iV ]oledronic acid 2ne Yial conWainV
 PJ ]oledronic acid correVSondinJ Wo  PJ
]oledronic acid PonoK\draWe
‡ 7Ke oWKer inJredienWV are
PanniWol (
VodiXP ciWraWe (
ZaWer for inMecWionV
What Zoledronic Acid looks like and contents of the
Sack:
Zoledronic $cid VolXWion for infXVion iV a clear coloXrleVV
VolXWion free froP YiViEle SarWicleV
Zoledronic $cid iV VXSSlied aV a VolXWion in a Yial 2ne Yial
conWainV  PJ of ]oledronic acid
(acK SacN conWainV WKe Yial ZiWK VolXWion
Zoledronic $cid iV VXSSlied aV SacNV conWaininJ
 Yial of  Pl
 YialV of  Pl
1oW all SacN Vi]eV Pa\ Ee ParNeWed
Marketing Authorisation Holder and Manufacturer:
The Marketing Authorisation Holder is:
6eacroVV 3KarPaceXWicalV /iPiWed
 +anoYer 6TXare 0a\fair /ondon :6 +8 8.

Uncommon Pa\ affecW XS Wo  in  SeoSle
‡ +\SerVenViWiYiW\ reacWionV
‡ /oZ Elood SreVVXre
‡ &KeVW Sain
‡ 6Nin reacWionV redneVV and VZellinJ aW WKe infXVion ViWe
raVK iWcKinJ
‡ +iJK Elood SreVVXre VKorWneVV of EreaWK di]]ineVV VleeS
diVWXrEanceV WinJlinJ or nXPEneVV of WKe KandV or feeW
diarrKoea
‡ /oZ coXnWV of ZKiWe Elood cellV and Elood SlaWeleWV
‡ /oZ leYel of PaJneViXP and SoWaVViXP in WKe Elood docWor Zill PoniWor WKiV and WaNe an\ neceVVar\ PeaVXreV
‡ 6leeSineVV
‡ 7earinJ of WKe e\e e\e VenViWiYiW\ Wo liJKW
‡ 6Xdden coldneVV ZiWK fainWinJ liPSneVV or collaSVe
‡ 'if¿cXlW\ in EreaWKinJ ZiWK ZKee]inJ or coXJKinJ
‡ 8rWicaria

The Manufacturer is:
,3* 3KarPa /iPiWed $WriXP &oXrW 7Ke 5inJ %racNnell
5* %: 8.
or
$Jila 6SecialWieV 3olVNa 6S Zoo  'aniV]eZVNa 6Wr
 :arVaZ 3oland
or
6anocKePia 3KarPa]eXWica $* /andeJJerVWraVVe  
1eXfeld an der /eiWKa $XVWria

Rare Pa\ affecW XS Wo  in  SeoSle
‡ 6loZ KearWEeaW
‡ &onfXVion
‡ 8nXVXal fracWXre of WKe WKiJK Eone SarWicXlarl\ in SaWienWV
on lonJWerP WreaWPenW for oVWeoSoroViV Pa\ occXr rarel\
&onWacW \oXr docWor if \oX e[Serience Sain ZeaNneVV or
diVcoPforW in \oXr WKiJK KiS or Jroin aV WKiV Pa\ Ee an
earl\ indicaWion of a SoVViEle fracWXre of WKe WKiJK Eone
‡ ,nWerVWiWial lXnJ diVeaVe inÀaPPaWion of WKe WiVVXe aroXnd
WKe air VacNV of WKe lXnJV 
‡ )lXliNe V\PSWoPV inclXdinJ arWKriWiV and MoinW VZellinJ

Ital\
Netherlands

This medicinal Sroduct is authorised in the MemEer
States of the EEA under the folloZing names:
'enmark
Finland
German\

NorZa\
SZeden

ZoledronV\re 6eacroVV
Zoledronic acid 6eacroVV PJPl
,nfXXVioneVWe liXoV
ZoledronVlXre 6eacroVV PJPl
,nfXVionVl|VXnJ
$cido Zoledronico 6eacroVV
Zoledronine]XXr 6eacroVV PJPl
2SloVVinJ Yoor infXVie
ZoledronV\re 6eacroVV
ZoledronV\ra 6eacroVV PJPl
,nfXVionVYlWVNa l|VninJ

This leaÀet Zas last reYised in 0/014

9er\ rare Pa\ affecW XS Wo  in  SeoSle
‡ )ainWinJ dXe Wo loZ Elood SreVVXre
‡ 6eYere Eone MoinW andor PXVcle Sain occaVionall\
incaSaciWaWinJ
‡ 3ainfXl redneVV andor VZellinJ of WKe e\e

$'8.





TaEle 1: 3reSaraWion of redXced doVeV of Zoledronic $cid  PJ Pl VolXWion for infXVion
%aVeline creaWinine
clearance PlPin

5ePoYe WKe folloZinJ
aPoXnW of Zoledronic $cid
VolXWion for infXVion Pl

5eSlace ZiWK WKe folloZinJ
YolXPe of VWerile VodiXP
cKloride  PJPl 
or  JlXcoVe VolXWion for
inMecWion Pl

$dMXVWed doVe PJ
]oledronic acid in  Pl

























'oVeV KaYe Eeen calcXlaWed aVVXPinJ WarJeW $8& of  PJ‡Krl &/cr  PlPin 
7Ke redXced doVeV for SaWienWV ZiWK renal iPSairPenW are e[SecWed Wo acKieYe WKe VaPe $8& aV WKaW Veen in SaWienWV ZiWK
creaWinine clearance of  PlPin
‡ 6WXdieV ZiWK VeYeral W\SeV of infXVion lineV Pade froP Sol\Yin\lcKloride Sol\eWK\lene and Sol\SroS\lene VKoZed no
incoPSaWiEiliW\ ZiWK ]oledronic acid
‡ 6ince no daWa are aYailaEle on WKe coPSaWiEiliW\ of ]oledronic acid ZiWK oWKer inWraYenoXVl\ adPiniVWered VXEVWanceV
Zoledronic $cid PXVW noW Ee Pi[ed ZiWK oWKer PedicaWionVVXEVWanceV and VKoXld alZa\V Ee JiYen WKroXJK a VeSaraWe infXVion line
HoZ to store Zoledronic Acid
‡ .eeS Zoledronic $cid oXW of WKe reacK and ViJKW of cKildren
‡ 'o noW XVe Zoledronic $cid afWer WKe e[Sir\ daWe VWaWed on WKe SacN
‡ 7KiV Pedicinal SrodXcW doeV noW reTXire an\ VSecial VWoraJe condiWionV
7Ke dilXWed Zoledronic $cid infXVion VolXWion VKoXld Ee XVed iPPediaWel\ in order Wo aYoid PicroEial conWaPinaWion

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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