Skip to Content

PENTOSTAM INJECTION

Active substance(s): SODIUM STIBOGLUCONATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

2



10000000123828

Package Leaflet: Information for the Healthcare Professional
sodium stibogluconate
HTXLYDOHQWWRPJSHQWDYDOHQWDQWLPRQ\LQHDFKPO

DOSAGE AND ADMINISTRATION INFORMATION ONLY
3OHDVHUHIHUWRWKHFXUUHQW6XPPDU\RI3URGXFW&KDUDFWHULVWLFVIRU3HQWRVWDP
,QMHFWLRQ3/5IRUFRPSOHWHSUHVFULELQJLQIRUPDWLRQ

Posology and method of administration
Route of administration
Filter immediately prior to administration
'XHWRWKHSUHVHQFHRISDUWLFXODWHV VL]HUDQJHWRPLFURQV 3HQWRVWDPVROXWLRQ
VKRXOGEHGUDZQXSWKURXJKDILOWHULPPHGLDWHO\SULRUWRDGPLQLVWUDWLRQ7KHVHSDUWLFXODWHVDUH
LQVROXEOHFRPSOH[HVIRUPHGE\DQLQWHUDFWLRQEHWZHHQSURGXFWSUHVHUYDWLYHDQGWKHDQWLR[LGDQW
LQWKHUXEEHUVWRSSHU)LOWHUVRISRUHVL]HPLFURQRUOHVVDQGPHPEUDQHW\SHVSRO\YLQ\OLGHQH
GLIOXRULGHSRO\HWKHUVXOIRQHSRO\VXOIRQHQ\ORQVXUIDFWDQWIUHHFHOOXORVHDFHWDWHDQGPL[HG
FHOOXORVHHVWHUVKDYHEHHQVKRZQWREHVXLWDEOH:KHUHVWHULOHILOWHUVDUHQRWDYDLODEOHWKHULVNV
DQGEHQHILWVRIDGPLQLVWHULQJXQILOWHUHG3HQWRVWDPWKHUDS\VKRXOGEHDVVHVVHGE\WKHFOLQLFLDQRQ
DQLQGLYLGXDOEDVLV
Dosage recommendations
$OOGRVDJHUHFRPPHQGDWLRQVDUHEDVHGRQWKHILQGLQJVRIWKH:+2([SHUW&RPPLWWHHRQ
OHLVKPDQLDVLVZKLFKPHWLQ7KHUHDUHQRVSHFLDOUHFRPPHQGDWLRQVIRUGLIIHUHQWDJHJURXSV
Ě 9LVFHUDOOHLVKPDQLDVLV
PJSHQWDYDOHQWDQWLPRQ\ PO3HQWRVWDP SHUNJERG\ZHLJKWLQWUDPXVFXODUO\RU
LQWUDYHQRXVO\GDLO\IRUGD\V RUGD\VIRU/,QIDQWXP 3DWLHQWVVKRXOGEHH[DPLQHGIRU
HYLGHQFHRIUHODSVHDIWHUDQGPRQWKVDQGLQ$IULFDDIWHUPRQWKV
Ě &XWDQHRXVOHLVKPDQLDVLVFDXVHGE\2OG:RUOGVSHFLHV
)RUOHVLRQVUHTXLULQJORFDOWKHUDS\
Ě PJPJLQWUDOHVLRQDOSHQWDYDOHQWDQWLPRQ\ POVRGLXPVWLERJOXFRQDWHLQMHFWLRQ 
SHUVHVVLRQHYHU\GD\VIRUVHVVLRQV
)RUOHVLRQVUHTXLULQJV\VWHPLFWKHUDS\
Ě PJNJSHQWDYDOHQWDQWLPRQ\ POVRGLXPVWLERJOXFRQDWHLQMHFWLRQ LQWUDPXVFXODUO\RU
LQWUDYHQRXVO\IRUGD\V
0RQRWKHUDS\ZLWKVRGLXPVWLERJOXFRQDWHLVQRWUHFRPPHQGHGIRUWKHWUHDWPHQWRIFXWDQHRXV
OHLVKPDQLDVLVFDXVHGE\L. aethiopcia.3OHDVHUHIHUWR:+2WUHDWPHQWUHFRPPHQGDWLRQVIRU
OHLVKPDQLDVLV
Ě &XWDQHRXVOHLVKPDQLDVLVFDXVHGE\1HZ:RUOGVSHFLHV
)RUOHVLRQVUHTXLULQJORFDOWKHUDS\
Ě PJPJLQWUDOHVLRQDOSHQWDYDOHQWDQWLPRQ\ POVRGLXPVWLERJOXFRQDWHLQMHFWLRQ 
SHUVHVVLRQHYHU\GD\VIRUVHVVLRQV
)RUOHVLRQVUHTXLULQJV\VWHPLFWKHUDS\
Ě PJNJSHQWDYDOHQWDQWLPRQ\ POVRGLXPVWLERJOXFRQDWHLQMHFWLRQ LQWUDPXVFXODUO\RU
LQWUDYHQRXVO\IRUGD\V
0RQRWKHUDS\ZLWKVRGLXPVWLERJOXFRQDWHLVQRWUHFRPPHQGHGIRUUHODSVHWUHDWPHQW3OHDVHUHIHU
WR:+2WUHDWPHQWUHFRPPHQGDWLRQVIRUOHLVKPDQLDVLV
Ě 0XFRFXWDQHRXVOHLVKPDQLDVLV
3DWLHQWVVKRXOGEHWUHDWHGZLWKPJSHQWDYDOHQWDQWLPRQ\ PO3HQWRVWDP SHUNJERG\
ZHLJKWGDLO\LQWUDPXVFXODUO\RULQWUDYHQRXVO\IRUGD\V/LWWOHGDWDDUHDYDLODEOHIRUWKHWKHUDS\
RI0&/GXHWRL. aethiopica.
Ě 'LIIXVHFXWDQHRXVOHLVKPDQLDVLVLQWKH1HZ:RUOGDQGOHLVKPDQLDVLVUHFLGLYDQV
)RUGLIIXVHFXWDQHRXVOHLVKPDQLDVLVLQWKH1HZ:RUOGDQGOHLVKPDQLDVLVUHFLGLYDQVFRPELQDWLRQ
WKHUDS\VKRXOGEHFRQVLGHUHG3OHDVHUHIHUWR:+2WUHDWPHQWUHFRPPHQGDWLRQVIRUOHLVKPDQLDVLV
Ě 8VHLQWKHHOGHUO\
7KHUHLVOLWWOHLQIRUPDWLRQRQWKHHIIHFWVRI3HQWRVWDPRQHOGHUO\LQGLYLGXDOV,IWUHDWPHQWRI
FXWDQHRXVOHLVKPDQLDVLVLVQHFHVVDU\WKHQORFDOLQILOWUDWLRQLVSUHIHUUHG7KHQRUPDOSUHFDXWLRQV
VKRXOGEHVWULFWO\DGKHUHGWRZKHQWUHDWLQJROGHUSDWLHQWVIRUYLVFHUDOOHLVKPDQLDVLV

Pharma Code Ref: 159

Pentostam® Injection
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR

Pentostam

Not applicable
JMF293

Not available

Not available
1
K

0

0

Contra-indications
3HQWRVWDPVKRXOGnotEHJLYHQWRDQ\SDWLHQW
Ě ZLWKVLJQLILFDQWO\LPSDLUHGUHQDOIXQFWLRQ
Ě ZKRKDVH[SHULHQFHGDVHULRXVDGYHUVHUHDFWLRQWRDSUHYLRXVGRVH




,I\RXDUHQRWVXUHLIDQ\RIWKHDERYHDSSO\WR
\RXWDONWR\RXUGRFWRUSKDUPDFLVWRUQXUVH
EHIRUH\RXKDYH3HQWRVWDP

Package Leaflet: Information for the User

Pentostam® Injection
sodium stibogluconate
Read all of this leaflet carefully before you
are given this medicine because it contains
important information for you.
Ě .HHSWKLVOHDIOHW DJDLQ
Ě ,I\RXKDYHDQ\IXUWKHUTXHVWLRQVDVN\RXU
GRFWRUSKDUPDFLVWRUQXUVH
Ě ,I\RXJHWDQ\VLGHHIIHFWVWDONWR\RXU
GRFWRUSKDUPDFLVWRUQXUVH7KLVLQFOXGHV
DQ\SRVVLEOHVLGHHIIHFWVQRWOLVWHGLQWKLV
OHDIOHW6HHVHFWLRQ
What is in this leaflet:
1. :KDW3HQWRVWDPLVDQGZKDWLWLVXVHGIRU
2. :KDW\RXQHHGWRNQRZEHIRUH\RXKDYH
3HQWRVWDP
3. +RZ3HQWRVWDPLVJLYHQ
4. 3RVVLEOHVLGHHIIHFWV
5. +RZWRVWRUH3HQWRVWDP
6. &RQWHQWVRIWKHSDFNDQGRWKHULQIRUPDWLRQ

1 What Pentostam is and what it is
used for
7KHQDPHRI\RXULQMHFWLRQLV3HQWRVWDP
,WFRQWDLQVDPHGLFLQHFDOOHGVRGLXP
VWLERJOXFRQDWH
3HQWRVWDPNLOOVSDUDVLWHVZKLFKFDXVHDGLVHDVH
FDOOHGOHLVKPDQLDVLV7KHVHSDUDVLWHVDUHVSUHDG
E\ELWHVIURPVDQGIOLHV
7KHUHDUHPDLQZD\VLQZKLFKOHLVKPDQLDVLV
FDQVKRZLWVHOI
Ě E\VRUHVRQ\RXUVNLQ FXWDQHRXV
Ě E\VRUHVLQ\RXUQRVHPRXWKDQGWKURDW
PXFRFXWDQHRXV
Ě E\DIIHFWLQJ\RXULQWHUQDORUJDQVOLNHWKH
OLYHU YLVFHUDO 

2 What you need to know before you
have Pentostam
You should not have Pentostam if you:
Ě DUHDOOHUJLFWRVRGLXPVWLERJOXFRQDWHRUDQ\
RIWKHRWKHULQJUHGLHQWVRIWKLVPHGLFLQH
OLVWHGLQVHFWLRQ
Ě KDYHVHULRXVNLGQH\GLVHDVH
'RQRWKDYH3HQWRVWDPLIDQ\RIWKHDERYH
DSSO\WR\RX,Ib\RXDUHQRWVXUHWDONWR\RXU
GRFWRUSKDUPDFLVWRUQXUVHEHIRUHKDYLQJ
3HQWRVWDP
Warnings and precautions
7DNHVSHFLDOFDUHZLWK3HQWRVWDPLI\RXKDYH
Ě OLYHUSUREOHPV
Ě KHDUWSUREOHPVDQXQXVXDOKHDUWUK\WKPRU
EHDW
Ě EHHQWUHDWHGIRUOHLVKPDQLDVLVGLVHDVHEHIRUH
Ě VRUHVLQ\RXUQRVHPRXWKRUWKURDW

KHDUWUK\WKPDQGEHDWEHIRUHDQGGXULQJ\RXU
3HQWRVWDPWUHDWPHQW7KHGRFWRURUQXUVHZLOO
XVHDQHOHFWURFDUGLRJUDP (&* WRFKHFNKRZ
ZHOO\RXUKHDUWZRUNV

9pt
10pt
100%
9pt
No

,I\RXDUHKDYLQJEORRGWHVWVWRFKHFNIRU
FKDQJHVWRWKHEORRGSDQFUHDVRUOLYHU
IXQFWLRQOHW\RXUGRFWRUSKDUPDFLVWRUQXUVH
NQRZWKDW\RXDUHRQ3HQWRVWDP7KLVLV
EHFDXVH3HQWRVWDPFDQDIIHFWWKHUHVXOWVRI
WKHVHW\SHVRIWHVWV
Other medicines and Pentostam
3OHDVHWHOO\RXUGRFWRUSKDUPDFLVWRUQXUVHLI
\RXDUHWDNLQJKDYHUHFHQWO\WDNHQRUPLJKW
XVHDQ\RWKHUPHGLFLQHVLQFOXGLQJPHGLFLQHV
REWDLQHGZLWKRXWDSUHVFULSWLRQ
VSHFLDOFDUHLI\RXKDYHPHGLFLQHVIRU
DQXQXVXDOKHDUWUK\WKPRUEHDW DQWL
DUUKWK\PLFV OLNHDPLRGDURQHDQGVRWDORO
7KLVLVEHFDXVH3HQWRVWDPFDQFKDQJH\RXU
KHDUWUK\WKPDQGLQFUHDVHWKHHIIHFWVRIWKHVH
PHGLFLQHV
,I\RXUGRFWRUUHFRPPHQGVWKDW\RXWDNH
DPSKRWHULFLQ%WKH\PD\ZLVKWRGHOD\VWDUWLQJ
WKLVWUHDWPHQWDQGFKHFN\RXUHOHFWURO\WH
OHYHOVEHIRUHXVH7KLVLVEHFDXVHDPSKRWHULFLQ
%JLYHQVKRUWO\DIWHU3HQWRVWDPFDQFDXVH
DEQRUPDOKHDUWEHDWV
Pregnancy and breast-feeding
7DONWR\RXUGRFWRUSKDUPDFLVWRUQXUVHEHIRUH
KDYLQJWKLVPHGLFLQHLI\RXDUHSUHJQDQW
SODQQLQJWRJHWSUHJQDQWRUEUHDVWIHHGLQJ,I
\RXDUH\RXVKRXOGQRWKDYH3HQWRVWDP

3 How Pentostam is given
$bTXDOLILHGSHUVRQOLNHDGRFWRURUDQXUVHZLOO
JLYH\RXWKLVPHGLFLQH
3HQWRVWDPFDQEHJLYHQDVDQLQMHFWLRQLQWRDYHLQ
LQWUDYHQRXV RUDPXVFOH LQWUDPXVFXODU  GRFWRUZLOOGHFLGHZKLFKRQHLVEHVWIRU\RX
The dose and how long you will have this
treatment
Ě 7KHGRVHWKDW\RXZLOOKDYHLVGLIIHUHQWIRU
HDFKW\SHRIOHLVKPDQLDVLV GHFLGHWKHGRVHDQGKRZORQJ\RXU
WUHDWPHQWZLOOODVW
Ě 7UHDWPHQWLVXVXDOO\RQHLQMHFWLRQGDLO\IRU
GD\V
,WLVUHFRPPHQGHGWKDW\RXUHWXUQWR\RXU
GRFWRUDIWHUPRQWKVDQGDJDLQDIWHUbPRQWKV
VRWKDW\RXUFRQGLWLRQFDQEHDVVHVVHG
If more Pentostam is given to you than
recommended
,I\RXWKLQN\RXKDYHEHHQJLYHQWRRPXFK
3HQWRVWDPtell your doctor immediately.
Ě IHHOLQJVLFN QDXVHD EHLQJVLFN YRPLWLQJ 
VHYHUHGLDUUKRHD
Ě \RXUVNLQRUWKHZKLWHVRI\RXUH\HVPD\
WXUQ\HOORZ MDXQGLFH

3DJHRI

2
Special warnings and precautions for use
Intravenous injection should be filtered immediately before use VHH3RVRORJ\DQGPHWKRGRI
DGPLQLVWUDWLRQ Administer very slowly over 5 minutesWRUHGXFHWKHULVNRIORFDOWKURPERVLV
,QbWKHXQOLNHO\HYHQWRIFRXJKLQJYRPLWLQJRUVXEVWHUQDOSDLQRFFXUULQJDGPLQLVWUDWLRQVKRXOG
EHGLVFRQWLQXHGLPPHGLDWHO\,QVXFKFDVHVH[WUHPHFDUHVKRXOGEHWDNHQLI3HQWRVWDPLV
UHDGPLQLVWHUHGE\WKLVURXWH
6XFFHVVIXOWUHDWPHQWRIPXFRFXWDQHRXVOHLVKPDQLDVLVPD\LQGXFHVHYHUHLQIODPPDWLRQ
DURXQGWKHOHVLRQ,QFDVHVRISKDU\QJHDORUWUDFKHDOLQYROYHPHQWWKLVPD\EHOLIH
WKUHDWHQLQJ8QGHUVXFKFLUFXPVWDQFHVFRUWLFRVWHURLGVPD\EHXVHG
9HU\UDUHO\DQDSK\ODFWLFVKRFNPD\GHYHORSGXULQJWUHDWPHQWIRUZKLFKDGUHQDOLQH
LQMHFWLRQDQGDSSURSULDWHVXSSRUWLYHPHDVXUHVVKRXOGEHJLYHQLPPHGLDWHO\

10000000123828

GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR

Pentostam

3URORQJDWLRQRIWKH47FLQWHUYDOKDVEHHQREVHUYHGLQVRPHSDWLHQWVWDNLQJVRGLXP
VWLERJOXFRQDWHDQGDSSHDUVWREHGRVHUHODWHG7KHUHKDYHDOVREHHQUHSRUWVRI
IDWDOFDUGLDFDUUK\WKPLDVLQSDWLHQWVUHFHLYLQJKLJKHUGRVHDQWLPRQLDOWKHUDS\IRUYLVFHUDO
OHLVKPDQLDVLV7KHUHIRUH(&*PRQLWRULQJLVUHFRPPHQGHGEHIRUHDQGGXULQJWKHUDS\ZLWK
VRGLXPVWLERJOXFRQDWH:KHUH(&*PRQLWRULQJLVQRWDYDLODEOHWKHULVNVDQGEHQHILWVRIVRGLXP
VWLERJOXFRQDWHWKHUDS\VKRXOGEHDVVHVVHGRQDQLQGLYLGXDOEDVLV
,IFOLQLFDOO\VLJQLILFDQWSURORQJDWLRQRI47FLQWHUYDORFFXUVVRGLXPVWLERJOXFRQDWHVKRXOGEH
GLVFRQWLQXHG(OHFWURFDUGLRJUDSKLFFKDQJHVQRWDEO\DOWHUDWLRQVLQ7ZDYHDPSOLWXGHPD\EH
H[SHFWHGLQWKHPDMRULW\RISDWLHQWVJLYHQVRGLXPVWLERJOXFRQDWHWKHVHDSSHDUWREHUHYHUVLEOH
RQFHVVDWLRQRIWKHUDS\DQGDUHQRWRIVHULRXVVLJQLILFDQFH
6RGLXPVWLERJOXFRQDWHVKRXOGEHXVHGZLWKFDXWLRQLQSDWLHQWVZLWKFDUGLRYDVFXODUGLVHDVHDKLVWRU\
RIYHQWULFXODUDUUK\WKPLDVRURWKHUULVNIDFWRUVNQRZQWRSUHGLVSRVHWRZDUGV47SURORQJDWLRQ
IRUH[DPSOHWKRVHZLWKFRQJHQLWDO47FSURORQJDWLRQRUWDNLQJFRQFRPLWDQWGUXJVNQRZQWR
VLJQLILFDQWO\SURORQJWKH47LQWHUYDO HJFODVV,,,DQWLDUUK\WKPLFVVXFKDVVRWDORODQGDPLRGDURQH 
$VWKHUHDSSHDUVWREHDGRVHUHODWLRQVKLSLQWKHGHYHORSPHQWRI(&*DEQRUPDOLWLHVSULRU
H[SRVXUHWRDQWLPRQLDOWKHUDS\VKRXOGEHFRQVLGHUHGZKHQDVVHVVLQJDSDWLHQWďVVXLWDELOLW\IRU
LQLWLDWLQJRUFRQWLQXLQJWKHUDS\ZLWKVRGLXPVWLERJOXFRQDWH
3DWLHQWVZKRKDYHUHFHQWO\UHFHLYHGRWKHUDQWLPRQLDOGUXJVVKRXOGEHPRQLWRUHGFORVHO\IRUVLJQV
RIDQWLPRQ\LQWR[LFDWLRQVXFKDVEUDG\FDUGLDDQGFDUGLDFDUUK\WKPLDVGXULQJDGPLQLVWUDWLRQRI
VRGLXPVWLERJOXFRQDWH
7KHUHKDYHEHHQVRPHUHSRUWVRIFDUGLDFDUUK\WKPLDVDQGVXGGHQGHDWKZKHQDPSKRWHULFLQ
%GHR[\FKRODWHLVDGPLQLVWHUHGVRRQDIWHUVRGLXPVWLERJOXFRQDWHIRUUHWUHDWPHQWRIYLVFHUDO
OHLVKPDQLDVLV(OHFWURO\WHLPEDODQFHVVKRXOGEHFRUUHFWHGSULRUWRDGPLQLVWUDWLRQRIDPSKRWHULFLQ
%GHR[\FKRODWHDQGSDWLHQWVDSSURSULDWHO\PRQLWRUHG

Not applicable
JMF293

Not available

Not available
1
K

0

0

,QWHUFXUUHQWLQIHFWLRQVVXFKDVSQHXPRQLDVKRXOGEHVRXJKWDQGWUHDWHGFRQFRPLWDQWO\
+LJKFRQFHQWUDWLRQVRIDQWLPRQ\DUHIRXQGLQWKHOLYHUVRIDQLPDOVDIWHUUHSHDWHGGRVDJHZLWK
SHQWDYDOHQWDQWLPRQ\3HQWRVWDPVKRXOGWKHUHIRUHEHXVHGZLWKFDXWLRQLQSDWLHQWVZLWKKHSDWLF
GLVHDVH+RZHYHUVRPHDEQRUPDOLWLHVRIOLYHUIXQFWLRQPD\EHH[SHFWHGLQFDVHVRIYLVFHUDO
OHLVKPDQLDVLV,QVXFKSDWLHQWVWKHEHQHILWRISHQWDYDOHQWDQWLPRQ\WUHDWPHQWRXWZHLJKVWKHULVN
3HQWRVWDPPD\LQGXFHPLOGHOHYDWLRQRIKHSDWLFHQ]\PHVLQVHUXPZKLFKODWHUUHWXUQWRQRUPDO

Fertility, pregnancy and lactation
$OWKRXJKQRHIIHFWVRQWKHIRHWXVKDYHEHHQUHSRUWHG3HQWRVWDPVKRXOGEHZLWKKHOGGXULQJ
SUHJQDQF\XQOHVVWKHSRWHQWLDOEHQHILWVWRWKHSDWLHQWRXWZHLJKWKHSRVVLEOHULVNWRWKHIRHWXV
&KLOGUHQVKRXOGQRWEHEUHDVWIHGE\PRWKHUVUHFHLYLQJ3HQWRVWDP

Storage, use and handling
Special precautions for storage
Ě 6WRUHEHORZŃ&
Ě 'RQRWIUHH]H
Ě 3URWHFWIURPOLJKW
Ě 1RWEHXVHGPRUHWKDQPRQWKDIWHUUHPRYLQJWKHILUVWGRVH
Instructions for disposal and other handling
Ě 3HQWRVWDPVROXWLRQVKRXOGEHILOWHUHGLPPHGLDWHO\SULRUWRXVH VHH3RVRORJ\DQGPHWKRGRI
DGPLQLVWUDWLRQ 
/HDIOHWGDWH)HEUXDU\
3HQWRVWDPLVDUHJLVWHUHGWUDGHPDUNRIWKH*OD[R6PLWK.OLQHJURXSRIFRPSDQLHV
Ģ*OD[R6PLWK.OLQHJURXSRIFRPSDQLHV$OOULJKWVUHVHUYHG





Ě \RXUXULQHPD\EHFRPHGDUNHURU\RXU
VWRROVPD\EHFRPHSDOHU

Ě 6KRUWWHUPFKDQJHVLQEORRGFKHPLVWU\
3OHDVHDOVRVHHVHFWLRQ

KHOS\RXUUHFRYHU\

Reporting of side effects

,I\RXKDYHDQ\IXUWKHUTXHVWLRQVDERXW
KRZWKLVSURGXFWLVJLYHQDVN\RXUGRFWRU
SKDUPDFLVWRUQXUVH

4 Possible side effects
/LNHDOOPHGLFLQHVWKLVPHGLFLQHFDQFDXVHVLGH
HIIHFWVDOWKRXJKQRWHYHU\ERG\JHWVWKHP
9HU\UDUHO\DVXGGHQDQGVHYHUHDOOHUJLF
UHDFWLRQWR3HQWRVWDPFDQRFFXU,I\RXJHWDQ\
RIWKHIROORZLQJV\PSWRPVtell your doctor,
pharmacist or nurse immediately:
Ě 5DVKLWFKLQJRUKLYHVRQWKHVNLQ
Ě 6ZHOOLQJRIWKHIDFHOLSVWRQJXHRURWKHU
SDUWVRIWKHERG\
Ě 6KRUWQHVVRIEUHDWKZKHH]LQJRUWURXEOH
EUHDWKLQJ
6RPHSDWLHQWVFDQJHWSQHXPRQLD,I\RX
JHWDQ\RIWKHIROORZLQJtell your doctor,
pharmacist or nurse as soon as possible:
Ě )HYHUDQGFKLOOV
Ě &RXJKZLWKSKOHJPRUEORRG
7KHSQHXPRQLDPD\EHFDXVHGE\3HQWRVWDP
RUWKHOHLVKPDQLDVLVGLVHDVHLWVHOI
2WKHUVLGHHIIHFWVLQFOXGH
Common PD\DIIHFWXSWRLQSDWLHQWV
Ě )HHOLQJVLFN QDXVHD EHLQJVLFN YRPLWLQJ 
GLDUUKRHDRUVWRPDFKSDLQ
Ě *HQHUDOIHHOLQJRIWLUHGQHVVGURZVLQHVVRU
ODFNRIHQHUJ\
Ě 0XVFOHSDLQ
Ě -RLQWSDLQV
Ě +HDGDFKH
Ě :HLJKWORVVRUODFNRIDSSHWLWH
Rare PD\DIIHFWXSWRLQSDWLHQWV
Ě WXUQ\HOORZ
Ě +LJKWHPSHUDWXUHVZHDWLQJDQGIOXVKLQJRI
\RXUIDFH
Ě %OHHGLQJIURP\RXUQRVHRUJXP
Ě 'L]]LQHVVRUDVSLQQLQJIHHOLQJDOVRFDOOHG
YHUWLJR
Ě 5DVKRUZRUVHQLQJRI\RXUVRUHV
Ě &KHVWSDLQ
7KHIROORZLQJVLGHHIIHFWVPD\RFFXUEXWWKH
IUHTXHQF\ZLWKZKLFKWKHVHPD\RFFXULVQRW
NQRZQ
Ě 3DLQZKHUH\RXKDGWKHLQMHFWLRQ,I\RX
KDYHWKHLQMHFWLRQVLQWR\RXUYHLQ LQWUDYHQRXV 
\RXPD\IHHOEULHISDLQDORQJWKHYHLQRU
JHWDEORRGFORWLQWKHYHLQGXHWRWKH
LQMHFWLRQ WKURPERVLV 
Ě &RXJKLQJVWUDLJKWDIWHU\RXKDYHWKH
LQMHFWLRQ
Ě 6HYHUHVWRPDFKSDLQZKLFKPD\VSUHDGWR
WKHEDFN DVVRFLDWHGZLWKWKHLQIODPPDWLRQ
RIWKHSDQFUHDV RIWHQZLWKIHHOLQJVLFN
QDXVHD DQGEHLQJVLFN YRPLWLQJ 

,I\RXJHWDQ\VLGHHIIHFWVWDONWR\RXUGRFWRU
SKDUPDFLVWRUQXUVH7KLVLQFOXGHVDQ\SRVVLEOH
VLGHHIIHFWVQRWOLVWHGLQWKLVOHDIOHW DOVRUHSRUWVLGHHIIHFWVGLUHFWO\YLDWKH &DUG6FKHPHDWZZZPKUDJRYXN\HOORZFDUG

9pt
10pt
100%
9pt
No

%\UHSRUWLQJVLGHHIIHFWV\RXFDQKHOSSURYLGH
PRUHLQIRUPDWLRQRQWKHVDIHW\RIWKLV
PHGLFLQH

5 How to store Pentostam
Ě .HHSWKLVPHGLFLQHRXWRIWKHVLJKWDQG
UHDFKRIFKLOGUHQ
Ě 'RQRWXVHWKLVPHGLFLQHDIWHUWKHH[SLU\
GDWHZKLFKLVSULQWHGRQWKHFDUWRQDQGWKH
ERWWOHODEHO7KLVH[SLU\GDWH ([S UHIHUVWR
WKHODVWGD\RIWKDWPRQWK
Ě 6WRUHEHORZŃ&DQGGRQRWIUHH]H
Ě 3HQWRVWDPVKRXOGEHVWRUHGLQWKHFDUWRQWR
SURWHFWIURPOLJKW

6 Contents of the pack and other
information
What Pentostam contains
Ě 7KHDFWLYHVXEVWDQFHLVVRGLXPVWLERJOXFRQDWH
Ě 7KHRWKHULQJUHGLHQWVDUHFKORURFUHVRO
JOXFRQRGHOWDODFWRQHDQG:DWHUIRU
,QMHFWLRQV
What Pentostam looks like and contents of
the pack
(DFKFDUWRQFRQWDLQVDQDPEHUJODVVERWWOH
FRQWDLQLQJbPORIVROXWLRQ
Marketing Authorisation Holder and
Manufacturer
0DUNHWLQJ$XWKRULVDWLRQ+ROGHU
7KH:HOOFRPH)RXQGDWLRQ/WG
6WRFNOH\3DUN:HVW8[EULGJH
0LGGOHVH[8%%7
0DQXIDFWXUHU*OD[R:HOOFRPH2SHUDWLRQV
%DUQDUG&DVWOH'XUKDP'/'7
Other formats
7ROLVWHQWRRUUHTXHVWDFRS\RIWKLVOHDIOHWLQ
%UDLOOHODUJHSULQWRUDXGLRSOHDVHFDOOIUHHRI
charge:

 8.2QO\
3OHDVHEHUHDG\WRJLYHWKHIROORZLQJ
LQIRUPDWLRQ
Product name
5HIHUHQFHQXPEHU

Pentostam Injection
5

7KLVLVDVHUYLFHSURYLGHGE\WKH5R\DO1DWLRQDO
,QVWLWXWHRI%OLQG3HRSOH
/HDIOHWGDWH)HEUXDU\
3HQWRVWDPLVDUHJLVWHUHGWUDGHPDUNRIWKH
*OD[R6PLWK.OLQHJURXSRIFRPSDQLHV
Ģ*OD[R6PLWK.OLQHJURXSRIFRPSDQLHV
$OOULJKWVUHVHUYHG



3DJHRI

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide