qanastek/EMEA-V3 huggingface dataset:
In toxicology studies abacavir was shown to increase liver weights in rats and monkeys.
Studji tossikoloġiċi wrew li abacavir żied il- piż tal- fwied fil- firien u x- xadini.
The clinical relevance of this is unknown.
Ir- relevanza klinika ta` dan mhix magħrufa.
There is no evidence from clinical studies that abacavir is hepatotoxic.
M`hemm l- ebda evidenza minn studji kliniċi li abacavir jagħmel ħsara fil- fwied.
Additionally, autoinduction of abacavir metabolism or induction of the metabolism of other medicinal products hepatically metabolised has not been observed in man.
Minbarra hekk, awto- induzzjoni tal- metaboliżmu ta ’ abacavir jew l- induzzjoni tal- metaboliżmu ta` xi prodotti mediċinali oħra ma ġewx osservati fil- bniedem.
Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Deġenerazzjoni mijokardjali ħafifa fil- qalb tal- ġrieden u l- firien dehret wara li abacavir ingħata għal sentejn.
The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans.
L- esponimenti sistemiċi kienu ekwivalenti għal minn 7 sa 24 darba aktar mill- esponiment sistemiku li jkun mistenni fil- bnedmin.
The clinical relevance of this finding has not been determined.
Ir- relevanza klinika ta`dan l- istħarriġ ma ġietx determinata.
Reproductive toxicology
Tossiċita fis- sistema riproduttiva
In reproductive toxicity studies in animals, lamivudine and abacavir were shown to cross the placenta.
Fi studji dwar it- tossiċita fis- sistema riproduttiva fl- annimali, lamivudine u abacavir jidher li qasmu l - plaċenta.
Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in rabbits at relatively low systemic exposures, comparable to those achieved in humans.
Lamivudine ma kienx teratoġeniku fi studji fuq annimali iżda kien hemm indikazzjonijiet ta ’ żjieda fi mwiet embrijoniċi tal- fniek f’ esponimenti relattivament baxxi, komparabbli ma ’ dawk fil- bniedem.
A similar effect was not seen in rats even at very high systemic exposure.
Effett simili ma deherx fil- każ tal- firien anke f’ esponiment sistemiku għoli ħafna.
Abacavir demonstrated toxicity to the developing embryo and foetus in rats, but not in rabbits.
Abacavir wera effett tossiku fuq l- embriju u l- fetu fl- istat ta ’ żvilupp fil- firien iżda mhux fil- fniek.
These findings included decreased foetal body weight, foetal oedema, and an increase in skeletal variations/ malformations, early intra-uterine deaths and still births.
Dawn is- sejbiet kienu jinkludu tnaqqis fil- piż tal- fetu, edima tal- fetu, u żieda f’ varjazzjonijiet/ malformazzjonijiet skeletriċi, imwiet prematuri fil- ġuf u trabi li jitwieldu mejta.
No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Ma tista tittieħed l- ebda konklużjoni fuq il- potenzjal teratoġeniku ta ’ abacavir minħabba dawn l- effetti tossiċi fuq l- embriju u l- fetu.
17 A fertility study in rats has shown that abacavir and lamivudine had no effect on male or female fertility.
Fi studju fuq il- fertilità tal- firien ntwera li abacavir ma kellu l- ebda effett fuq il- fertilita` ta ’ l- annimali maskili u femminili.
Core: magnesium stearate microcrystalline cellulose sodium starch glycollate.
Magnesium stearate microcrystalline cellulose, sodium starch glycollate.
Opadry Orange YS-1-13065-A containing: hypromellose titanium dioxide (E171) macrogol 400, polysorbate 80 sunset yellow aluminium lake (E110).
Opadry Orange YS- 1- 13065- A li fih: hypromellose titanium dioxide (E171) macrogol 400, polysorbate 80 sunset yellow aluminium lake (E110).
Do not store above 30ºC.
Taħżinx f`temperatura `l fuq minn 30°C
90 (3x30) tablets in opaque white (PVC/ PVDC/ Aluminium) blister packs.
30 pillola f’ folji bojod opaki (PVC/ PVDC/ Aluminju) u fliexken bojod (HDPE) b’ għatu li ma jinfetaħx mit- tfal 90 (3x30) pillola f’ pakkett blister (PVC/ PVDC/ Aluminium) abjad li ma jgħaddix dawl minnu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu /.
19 ANNEX II
20 ANNESS II
20 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street Ware Hertfordshire SG12 0DJ United Kingdom
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street Ware Hertfordshire SG12 0DJ Renju Unit
OUTER CARTON BLISTER PACK (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
KARTUNA TA ’ BARRA PAKKETT BLISTER (B’ KAXXA BLU) (ESKLUŻI L- MULTIPACKS)
Kivexa 600 mg/ 300 mg film-coated tablets abacavir/ lamivudine
Kivexa 600 mg/ 300 mg pilloli miksija b’ rita abacavir/ lamivudine
Each film-coated tablet contains: abacavir 600 mg (as sulfate) lamivudine 300 mg
Kull pillola miksija b’ rita fiha: abacavir 600 mg (bħala sulfat) lamivudine 300 mg
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Contains sunset yellow (E110), see package leaflet for further information
Fih sunset yellow (E110), ara l- fuljett ta ’ tagħrif għal aktar informazzjoni
Detach enclosed Alert Card, it contains important safety information
Neħħi l- Kartuna ta ’ twissija li tinsab fuq ġewwa, fiha informazzjoni importanti dwar is- sigurta` tal- mediċina
WARNING!
TWISSIJA!
In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY
Fil- każ li jkollok xi sintomi ta ’ reazzjonijiet ta ’ sensittivita` eċċessiva, agħmel kuntatt mat- tabib IMMEDJATAMENT
“ Pull here”
“ Iġbed hawn ”
Do not store above 30°C
Taħżinx f’ temeperatura ‘ l fuq minn 30°C
MULTIPACKS ONLY OUTER LABEL (WITH BLUE BOX) 3x30 TABLETS WRAPPED IN CLEAR PLASTIC
MULTIPACKS BISS TIKKETTA TA ’ BARRA (B’ KAXXA BLU) 3x30 PILLOLI ISSIĠILLATI F’ PLASTIK LI JGĦADDI D- DAWL MINNU
Kivexa 600 mg/ 300 mg film-coated tablets abacavir/ lamivudine
Kivexa 600 mg/ 300 mg film- coated tablets abacavir/ lamivudine
Each film-coated tablet contains: abacavir 600 mg (as sulfate) lamivudine 300 mg
Kull pillola miksija b’ rita fiha: abacavir 600 mg (as sulfate) lamivudine 300 mg
LIST OF EXCIPIENTS
LISTA TAS- SUSTANZI MHUX ATTIVI
Multipack containing 3 packs each containing 30 film-coated tablets
Multipack li fih 3 pakketti li kull wieħed fih 30 pillola miksija b’ rita
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
MOD TA ’ KIF U MNEJN JINGĦATA Aqra l- fuljett ta ’ tagħrif qabel l- użu
In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY
F’ każ ta ’ xi sintomi li jissuġerixxu reazzjonijiet ta ’ sensittività eċċessiva, ikkuntatja lit - tabib tiegħek IMMEDJATAMENT
26 Do not store above 30°C
Taħżinx f’ temperatura il- fuq minn 30˚C
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTT MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTT MEDIĊINALI, JEKK HEMM BŻONN
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
28 TAGĦRIF LI JIDHER FUQ IL- PAKKETT TA 'BARRA
MULTIPACKS ONLY OUTER CARTON BLISTER PACK (WITHOUT BLUE BOX) 30 TABLETS
MULTIPACKS BISS KARTUNA TA ’ BARRA PAKKETT BLISTER (MINGĦAJR KAXXA BLU) 30 PILLOLA
Kivexa 600 mg/ 300 mg film-coated tablets abacavir/ lamivudine
Kivexa 600 mg/ 300 mg pilloli miksijin b’ rita abacavir/ lamivudine
PHARMACEUTICAL FORM AND CONTENTS 30 film coated tablets Component of a multipack comprising 3 packs each containing 30 film-coated tablets, not to be sold separately
GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola miksija b’ rita Il- kontenut ta ’ multipack li fih 3 pakketti li kull wieħed fih 30 pillola miksijin b’ rita, li m’ għandhomx jinbiegħu separatament
Detach enclosed Alert Card, it contains important safety information
Aqla 'l- Alert Card li jkun hemm ġewwa l- pakkett, fiha informazzjoni importanti fuq sigurtà
EXP 28 9.
29 9.
Do not store above 30°C
Taħżinx f’ temperatura il- fuq minn 30˚C
29 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Kivexa 600 mg/ 300 mg tablets. abacavir/ lamivudine
Kivexa pilloli ta ’ 600 mg/ 300 mg. abacavir/ lamivudine
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON BOTTLE AND LABEL
KARTUNA TA ’ BARRA FLIXKUN U TIKKETTA
The Alert Card enclosed contains important safety information
Il- Kartuna ta ’ Twissija li tinsab fuq ġewwa fiha informazzjoni importanti dwar is- sigurta` tal - mediċina
32 KIVEXA TABLETS ALERT CARD (blister and bottle pack)
33 KARTUNA TA ’ TWISSIJA GĦALL- PILLOLI KIVEXA (folji u flixkun)
SIDE 1
NAĦA 1
IMPORTANT - ALERT CARD Kivexa (abacavir sulfate / lamivudine) Tablets Carry this card with you at all times
IMPORTANTI – KARTUNA TA ’ TWISSIJA Pilloli Kivexa (abacavir sulphate/ lamivudine) Dejjem żomm din il- kartuna fuqek
Since Kivexa contains abacavir some patients taking Kivexa may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Kivexa is continued.
Billi Kivexa fih abacavir xi pazjenti li jieħdu Kivexa jistgħu jiżviluppaw reazzjoni ta ’ sensitivita` eċċessiva (reazzjoni allerġika serja) li tista ’ tipperikola l- ħajja jekk Kivexa tibqa ’ tittieħed.
CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Kivexa if:
STAQSI LIT- TABIB TIEGĦEK IMMEDJATAMENT għal parir biex tara jekk għandekx tieqaf tieħu Kivexa f’ każ li:
1) you get a skin rash OR 2) you get one or more symptoms from at least TWO of the following groups
1) ikollok raxx fil- ġilda JEW 2) ikollok wieħed jew aktar sintomi ta ’ mill- anqas TNEJN minn dawn il- gruppi li ġejjin:
- shortness of breath, sore throat or cough
- qtugħ ta ’ nifs, uġigħ fil- griżmejn jew sogħla
- nausea or vomiting or diarrhoea or abdominal pain
- nawżeja jew remettar jew dijarreja jew uġigħ addominali
- severe tiredness or achiness or generally feeling ill
- għeja kbira jew jaqbduk weġgħat jew ma tħossokx tiflaħ
If you have discontinued Kivexa due to this reaction, YOU MUST NEVER TAKE Kivexa, or any medicine containing abacavir (Ziagen or Trizivir) again as within hours you may experience a life- threatening lowering of your blood pressure or death.
Jekk waqft tieħu Kivexa minħabba din ir- reazzjoni, QATT M’ GĦANDEK TERĠA ’ TIEĦU Kivexa jew xi mediċina li fiha abacavir (Ziagen jew Trizivir) minħabba li fi ftit sigħat tista ’ titbaxxilek il - pressjoni f’ daqqa u tkun ta ’ periklu għall- ħajtek, jew tmut.
(see reverse of card)
(ara fuq wara tal- kartuna)
SIDE 2
NAĦA 2
You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Kivexa.
Għandek tgħid mill- ewwel lit- tabib tiegħek jekk taħseb li għandek xi reazzjoni ta ’ sensittivita` eċċessiva għal Kivexa.
Write your doctor's details below:
Ikteb id- dettalji tat- tabib tiegħek hawn taħt:
Doctor:...................... .……………………
ISEM TAT- TABIB................................... TEL...........................................
If your doctor is not available, you must urgently seek alternative medical advice (e. g. the emergency unit of the nearest hospital).
Jekk it- tabib tiegħek ma jkunx dispost, għandek tfittex għajnuna medika oħra immedjatament (e. g. id- dipartiment ta ’ l- emerġenza fl- eqreb sptar).
For general Kivexa information enquiries, contact ………
Għal informazzjoni ġenerali fuq Kivexa, kellem lil.................
Kivexa 600 mg/ 300 mg film-coated tablets abacavir/ lamivudine
Kivexa 600 mg/ 300 mg Pilloli miksija b’ rita abacavir/ lamivudine
- Keep this leaflet, you may need to read it again.
Jista jkollok bżonn terġa ’ taqrah.
HYPERSENSITIVITY REACTION
REAZZJONI TA ’ SENSITTIVITA` EĊĊESSIVA
Since Kivexa contains abacavir some patients taking Kivexa may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if you continue to take Kivexa.
Billi Kivexa fih abacavir xi pazjenti li jieħdu Kivexa jistgħu jiżviluppaw reazzjoni ta ’ sensitivita` eċċessiva (reazzjoni allerġika serja) li tista ’ tipperikola l- ħajja jekk tibqa ’ tieħu Kivexa.
It is essential you read the information on this reaction under “ Take special care with Kivexa” in section 2 of this leaflet.
Hu essenzjali li taqra l- informazzjoni dwar din ir- reazzjoni taħt “ Oqgħod attent ħafna b’ Kivexa ” fis - sezzjoni 2 ta ’ dan il- fuljett.
There is also an Alert Card included in the Kivexa pack, to remind you and medical staff about abacavir hypersensitivity.
Hemm ukoll kartuna ta ’ twissija inkluża fil- pakkett ta ’ Kivexa, biex ifakkar lilek u lill- istaff mediku dwar dan l- effett ta ’ sensittivita` eċċessiva għal abacavir.
This card should be removed and kept with you at all times.
Din il - kartuna għandha titneħħa u tinżamm fuqek f’ kull ħin.
- severe tiredness or achiness or generally feeling ill
- għeja kbira jew jaqbduk weġgħat jew ġeneralment ma tħossokx tiflaħ
If you have discontinued Kivexa due to a hypersensitivity reaction, YOU MUST NEVER TAKE Kivexa, or any other medicine containing abacavir (Ziagen or Trizivir) again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Jekk waqft tieħu Kivexa minħabba din ir- reazzjoni ta ’ sensittivita` eċċessiva, QATT M’ GĦANDEK TERĠA ’ TIEĦU Kivexa jew xi mediċina li fiha abacavir (Ziagen jew Trizivir) minħabba li fi ftit sigħat tista ’ titbaxxilek il- pressjoni f’ daqqa u tkun ta ’ periklu għall- ħajtek, jew tmut.
If you are hypersensitive to abacavir you should return all of your unused Kivexa tablets for disposal.
Jekk int sensittiv eċċessivament għal abacavir għandek tieħu lura il- pilloli ta ’ Kivexa li ma wżajtx biex jintremew.
Ask your doctor or pharmacist for advice.
Staqsi lit- tabib jew lill- ispiżjar tiegħek għall- parir.
What Kivexa is and what it is used for 2.
X’ inhu Kivexa u għalxiex jintuża 2.
Before you take Kivexa 3.
Qabel ma tieħu Kivexa 3.
How to take Kivexa 4.
Kif għandek tieħu Kivexa 4.
How to store Kivexa 6.
Kif taħżen Kivexa 6.
WHAT KIVEXA IS AND WHAT IT IS USED FOR
X’ INHU KIVEXA U GĦALXIEX JINTUŻA
Kivexa contains abacavir and lamivudine.
Kivexa fih abacavir u lamivudune.
These are also available as separate medicines.
Dawn huma wkoll disponibbli bħala mediċini separatament.
They belong to a group of antiretrovirals, which are medicines used to treat Human Immunodeficiency Virus (HIV) infection, called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Jiffurmaw parti minn grupp ta ’ mediċini antiretrovirali, li huma mediċini wżati fil- kura ta ’ l- infezzjoni tal- Virus ta ’ l- Immunodefiċjenza Umana (HIV), imsejħa inibituri tal- analogi tan- nucleoside reverse transcriptase (NRTIs).
They are used in combination with other antiretrovirals to treat HIV infection.
Dawn jintużaw flimkien ma ’ antiretrovirali oħra għall- kura ta ’ l- infezzjoni HIV.
35 Kivexa reduces the amount of HIV in the blood (viral load), and keeps it low.
36 Kivexa tnaqqas l- ammont ta ’ HIV fid- demm l- ammont ta ’ viri, u żżommu baxx.
It also increases the number of CD4 blood cells.
Iżżid ukoll in- numru ta ’ ċelluli tad- demm CD4.
CD4 cells are a type of white blood cell that play an important role in keeping the immune system healthy to help fight infection.
Iċ- ċelluli CD4 huma tip ta ’ ċelluli tad- demm bojod li għandhom rwol importanti fiż- żamma ta ’ sistema immuni f’ saħħitha biex tiġġieled kontra l- infezzjoni.
Response to treatment with Kivexa varies between patients.
Ir- rispons għall- kura b’ Kivexa tvarja bejn pazjent u ieħor.
Your doctor will be monitoring the effectiveness of your treatment.
It- tabib tiegħek ser jevalwa l- effettivita` tat- trattament tiegħek.
BEFORE YOU TAKE KIVEXA
QABEL MA TIEĦU KIVEXA
Do not take Kivexa:
Tieħux KIVEXA
- if you are allergic (hypersensitive) to the active substance abacavir, which is also included in
- jekk inti allerġiku (sensittivita` eċċessiva) għas- sustanza attiva abacavir, li tinsab ukoll fil -
medicines called Trizivir and Ziagen
mediċini msejħa Trizivir u Ziagen
- if you are allergic to the active substance lamivudine or any of the other ingredients in Kivexa
- jekk inti allerġiku għas- sustanza attiva lamivudine jew għal xi ingredjenti oħra f’ Kivexa
- if you have serious liver disease
- jekk inti għandek xi mard tal- fwied gravi
If you are not sure whether you should be taking Kivexa, please discuss with your doctor before taking this medicine.
Jekk għandek xi dubji dwar jekk għandekx tieħu Kivexa, jekk jogħġbok tkellem mat- tabib tiegħek qabel tieħu din il- mediċina.
Take special care with Kivexa
Oqgħod attent ħafna b’ KIVEXA
Hypersensitivity reaction (serious allergic reaction):
Reazzjoni ta ’ sensittività eċċessiva (reazzjoni allerġika serja):
About 5 in every 100 patients, who are treated with abacavir, develop a hypersensitivity reaction.
Xi 5 minn kull 100 pazjent, li jieħdu abacavir, jiżviluppaw reazzjoni ta ’ sensittivita` eċċessiva.
Research has found that people with a gene called HLA-B (type 5701) are more likely to have a hypersensitivity reaction to abacavir.
Skond riċerka nstab li nies b' ġene li jissejjaħ HLA- B (tip 5701) aktar għandhom ċans li jkollhom reazzjoni ta ’ sensittività eċċessiva għal abacavir.
However, even if you do not have this gene type it is still possible for you to get this reaction.
Madankollu, anke jekk m’ għandekx dan il- ġene, xorta huwa possibli li jkollok din ir- reazzjoni.
If you know you have this gene type, be sure to tell your doctor before you take abacavir.
Jekk taf li għandek dan it- tip ta ’ ġene, kun żgur li tgħid lit- tabib tiegħek qabel tieħu abacavir.
The most common symptoms of this reaction are high temperature (fever) and a skin rash.
L- iżjed sintomi komuni ta ’ din ir- reazzjoni huwa deni għoli u raxx fil- ġilda.
Other frequently observed signs are nausea, vomiting, diarrhoea, abdominal pain and severe tiredness.
Sintomi komuni oħra huma dardir, remettar, dijarreja, uġigħ addominali u għeja kbira.
Other symptoms may include joint or muscle pain, swelling of the neck, shortness of breath, sore throat, cough and headache.
Sintomi oħra jistgħu jinkludu uġigħ fil- ġogi jew fil- muskoli, nefħa fl- għonq, qtugħ ta ’ nifs, uġigħ fil- gerżuma, sogħla u uġigħ ta ’ ras.
Occasionally inflammation of the eye (conjunctivitis), mouth ulcers or low blood pressure may occur.
Kultant jista ’ jkun hemm infjammazzjoni fl- għajnejn (konġuntivite), ulċeri fil- ħalq jew pressjoni baxxa.
The symptoms of this allergic reaction can occur at any time during treatment with abacavir.
Is- sintomi ta ’ din ir- reazzjoni allerġika jistgħu jidhru f’ kull ħin waqt kura b’ abacavir.
However they usually occur in the first six weeks of treatment.
Madankollu normalment dawn iseħħu fl- ewwel sitt ġimgħat tal- kura.
The symptoms worsen with continued treatment and may be life-threatening if treatment is continued.
Is- sintomi jiħżienu jekk il- kura titkompla u jistgħu ikunu ta ’ perikolu għall- ħajja jekk it- trattament jitkompla.
- nausea or vomiting or diarrhoea or abdominal pain
deni qtugħ ta ’ nifs, uġigħ fil- griżmejn jew sogħla nawżeja jew remettar jew dijarreja jew uġigħ addominali għeja kbira jew jaqbduk weġgħat jew ġeneralment ma tħossokx tiflaħ
If you have discontinued Kivexa due to a hypersensitivity reaction, YOU MUST NEVER TAKE Kivexa or any other medicine containing abacavir (Ziagen or Trizivir) again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Jekk waqaft tieħu Kivexa minħabba din ir- reazzjoni, QATT M’ GĦANDEK TERĠA ’ TIEĦU Kivexa jew xi mediċina li fiha abacavir (Ziagen jew Trizivir) minħabba li fi ftit sigħat tista ’ titbaxxilek il- pressjoni f’ daqqa u tkun ta ’ periklu għall- ħajtek, jew tmut.
If you have stopped taking Kivexa for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting.
Jekk waqaft tieħu Kivexa għal xi raġuni, l- aktar għax taħseb li għandek xi effetti sekondarji jew għax għandek xi mard ieħor, huwa importanti li tkellem lit- tabib tiegħek qabel ma terġa ’ tibda l- kura.
Your doctor will check whether any symptoms you had may be related to this hypersensitivity reaction.
Jekk it- tabib tiegħek jaħseb li hemm il- possibilta` li dawn kienu relatati, hu jwissik biex
If your doctor thinks there is a possibility that they were related, you will be instructed never to take Kivexa or any other abacavir containing medicine (Ziagen or Trizivir) again.
37 qatt ma terġa ’ tieħu Kivexa jew xi mediċina oħra li fiha abacavir (Ziagen jew Trizivir).
It is important that you follow this advice.
Hu importanti li inti timxi fuq dan il- parir.
36 Occasionally life-threatening hypersensitivity reactions have occurred when abacavir was restarted in patients who reported only one of the symptoms on the Alert Card before stopping.
Xi drabi reazzjonijiet ta ’ sensittivita` eċċessiva ta ’ periklu għall- ħajja seħħew f’ pazjenti li reġgħu ħadu abacavir wara li kienu waqqfuh minħabba li kellhom wieħed biss mis- sintomi li jidhru fuq il- kartuna ta ’ twissija qabel ma waqqfuh.
On very rare occasions hypersensitivity has been reported when abacavir was restarted in patients who had no symptoms of hypersensitivity before stopping.
F’ każijiet rari ħafna, sensittivita` eċċessiva ġiet rappurtata meta abacavir reġa ’ ngħata lil pazjenti li ma kellhom ebda sintomi ta ’ sensittivita` eċċessiva qabel ma waqqfuh.
If you are hypersensitive to abacavir, return all of your unused Kivexa tablets for disposal.
Jekk inti għandek sensittivita` eċċessiva għal abacavir, ħu lura l- pilloli kollha ta ’ Kivexa li ma wżajtx biex jintremew.
Ask your doctor or pharmacist for advice.
Staqsi lit- tabib jew spiżjar tiegħek għal parir.
Lactic acidosis: the class of medicines to which Kivexa belongs (NRTIs) can cause a condition called lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver.
Aċidożi lattika: il- grupp ta ’ mediċini li jifforma parti minnu Kivexa (NRTIs) jista ’ jikkawża kondizzjoni msejħa Aċidożi lattika (eċċess ta ’ aċidu lattiku fid- demm tiegħek), flimkien ma ’ tkabbir tal- fwied.
Lactic acidosis, if it occurs, usually develops after a few months of treatment.
Aċidożi lattika, jekk isseħħ, normalment tiżviluppa fi żmien ftit xhur wara li tibda l- kura.
Deep, rapid breathing, drowsiness, and non-specific symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis.
Nifs fil- fond u frekwenti, sensazzjoni ta ’ ngħas, u sintomi mhux speċifiċi bħal dardir, remettar, u wġigħ fl- istonku jistgħu jindikaw l- iżvilupp ta ’ aċidożi lattika.
This rare but serious side effect occurs more often in women, particularly if very overweight.
Din il- kondizzjoni rari, iżda serja, hi iżjed komuni fin- nisa, partikolarment jekk għandhom piż żejjed.
If you have liver disease you may also be more at risk of getting this condition.
Jekk issofri minn xi mard tal- fwied, għandek riskju akbar li jkollok din il- kondizzjoni.
While you are being treated with Kivexa, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Waqt li tkun qed tieħu Kivexa, it- tabib tiegħek ser iżommok taħt osservazzjoni bir- reqqa sabiex jinduna b’ xi sintomi li jindikaw l- iżvilupp ta ’ aċidożi lattika.
Fat distribution: redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
Jista ’ jkun hemm ukoll tnaqqis, żjieda jew tibdil fid- ditribuzzjoni tax - xaħam tal- ġisem waqt li pazjenti jkunu fuq terapija kombinata antiretrovirali.
Contact your doctor if you notice changes in body fat.
Jekk tinduna b’ xi bidla fix- xaħam tal- ġisem, għarraf lit- tabib tiegħek.
Liver disease/ hepatitis: please speak with your doctor if you have a history of liver disease.
Mard tal- fwied/ epatite: jekk jogħġbok kellem lit- tabib tiegħek jekk għandek xi passat mediku ta ’ mard tal- fwied.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.
Pazjenti b’ epatite B jew Ċ kronika u li qed jingħataw kura b’ mediċini antiretrovirali huma f’ riskju akbar li jsofru minn reazzjonijiet avversi serji tal- fwied u anke fatali, u jista ’ jkun hemm bżonn ta ’ testijiet tad- demm biex tkun monitorjata l- funzjoni tal- fwied.
If you have hepatitis B infection, you should not stop Kivexa without instructions from your doctor, as you may have a recurrence of your hepatitis.
Jekk għandek l- infezzjoni ta ’ l- epatite B, m’ għandekx twaqqaf Kivexa mingħajr l- istruzzjonijiet tat - tabib għax tista ’ terġa ’ taqbdek l- epatite.
This may occur due to you suddenly stopping lamivudine.
Dan jista ’ jiġri għax tkun waqqaft lamivudine f’ daqqa.
This recurrence may be more severe in patients with serious liver disease.
Din ir- rikorrenza tista ’ tkun aktar gravi f’ pazjenti b’ mard tal- fwied.
Pancreatitis: inflammation of the pancreas (pancreatitis) has been reported in some patients treated with abacavir and lamivudine, although it was not clear whether this was due to these medicines or the HIV infection itself.
Pankreatite: infjammazzjoni tal- frixa (pankreatite) ġiet rappurtata f’ xi pazjenti li kienu fuq il- kura ta ’ abacavir u lamivudine, għalkemm mhuwiex ċar jekk dan kienx dovut għal dawn il- mediċini jew għall - infezzjoni HIV innifisha.
Immune Reactivation Syndrome:
Sindromu ta ’ Riattivazzjoni Immuni:
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Jaħsbu li dawn is- sintomi huma dovuti għat- titjib fir- rispons immuni tal- ġisem, li jgħin lill- ġisem jiġġieled kontra infezzjonijiet li seta ’ kien hemm bla ma jidhru s- sintomi.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Xi pazjenti li jkunu fuq terapija antiretrovirali kombinata jistgħu jiżviluppaw marda fl- għadam imsejħa osteonekrożi (mewt tat- tessuti ta ’ l- għadam kawżata min nuqqas ta ’ demm fl- għadam).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul ta ’ terapija antiretrovirali kombinata, l- użu ta ’ kortikosterojdi, il- konsum ta ’ l - alkoħol, immunosoppressjoni gravi, indiċi ogħla tal- piż tal- ġisem, fost affarijiet oħra, jistgħu jkunu ftit mill- ħafna fatturi ta ’ riskju ta ’ l- iżvilupp ta ’ din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ osteonekrożi huma ebusija fil - ġogi, uġigħ (speċjalment fl- għadam tal- ġenbejn, fl- irkobbtejn u fl- ispalel) u diffikulta` fil- moviment.
General:
38 Ġenerali:
Kivexa helps to control your condition but is not a cure for HIV infection.
Kivexa jgħinek tikkontrolla l- kondizzjoni iżda mhuwiex fejqan mill- infezzjoni ta ’ l- HIV.
Treatment with antiretroviral medicines has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Trattament b’ mediċini antiretrovirali ma deherx li jnaqqas ir- riskju ta ’ tixrid ta ’ l- infezzjoni ta ’ l- HIV b’ kuntatt sesswali jew bid- demm.
You should continue to use appropriate precautions to prevent this.
Int għandek tibqa ’ tieħu l- prekawzjonijiet meħtieġa sabiex twaqqaf dan milli jseħħ.
You may continue to develop other infections and other illnesses associated with HIV disease.
Tista ’ tkompli tiżviluppa infezzjonijiet u mard ieħor assoċjat mal- marda HIV.
You should therefore keep in regular contact with your doctor while taking Kivexa.
Int għalhekk, għandek tibqa ’ f’ kuntatt regolari mat- tabib tiegħek waqt li tkun tieħu Kivexa.
37 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Abacavir or lamivudine in Kivexa may interact with certain other medicines.
Abacavir jew lamivudine f’ Kivexa jistgħu jfixklu l- effett ta ’ xi mediċini oħra.
Kivexa should not be taken with zalcitabine (used to treat HIV), high doses of co-trimoxazole (for infections caused by Pneumocystis carinii), injections of ganciclovir or foscarnet (used to treat infections caused by cytomegalo virus).
Kivexa m’ għandhiex tittieħed ma ’ zalcitabine (jintuża fit- trattament ta ’ l- HIV), dożi għolja ta ’ cotrimoxazole (għal infezzjonijet kawżati minn Pneumocystis carinii), injezzjonijiet ta ’ ganciclovir jew foscarnet (jintużaw fit- trattament ta ’ infezzjonijiet kawżati mill- virus cytomegalo)
Alcohol does increase the amount of abacavir in your blood.
L- alkoħol iżid l- ammont ta ’ abacavir fid- demm.
As abacavir increases the rate at which methadone is removed from the body, patients taking methadone will be checked for any withdrawal symptoms, and may have their methadone dose changed.
Billi abacavir iżid ir- rata li biha methadone jitneħħa mill- ġisem, pazjenti li jieħdu methadone jiġu ċċekkjati għal xi sintomi li s- soltu jidhru meta d- doża ta ’ methadone titnaqqas f’ daqqa, u jista’ jkun hemm bżonn tibdil fid- doża ta ’ methadone.
Pregnancy and breast feeding Kivexa is not recommended during pregnancy.
Tqala u Treddigħ Kivexa mhux rakkomandat waqt t- tqala.
If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.
Jekk toħroġ tqila jew qed tippjana biex toħroġ tqila, għandek tkellem lit- tabib tiegħek biex tiddiskuti l- effetti avversi li jista ’ jkollok u l- benefiċċji u r- riskji tat - terapija antiretrovirali fuqek u fuq it- tarbija.
If you have taken Kivexa during your pregnancy, your doctor may request regular visits to monitor the development of your child.
Jekk ħadt Kivexa waqt it- tqala, it- tabib jista ’ jagħtik parir biex tibda tmur regolarment għal visti biex jeżaminalek l- iżvilupp tat- tarbija.
Such visits may include blood tests and other diagnostic tests.
Dawn il- visti jistgħu jinkludu testijiet tad- demm u testijiet dijanjostiċi oħra.
In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.
Fi tfal li ommhom tkun ħadet analogi tan- nukleosidi u tan- nukleotidi waqt it- tqala, il- benefiċċju tat - tnaqqis tar- riskju ta ’ infezzjoni bl- HIVhuwa ikbar mir- riskju ta ’ l- effetti mhux mixtieqa.
If you are breast-feeding you must inform your doctor.
Jekk qed tredda ’ għandek tgħid lit- tabib.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV from mother to child.
Hu rakkomandat li nisa nfettati bl- HIV ma jreddgħux lit - trabi tagħhom fi kwalunkwe ċirkostanza biex tiġi evitata li l- HIV tgħaddi mill- omm għat- tarbija.
Driving and using machines No studies on the effects of Kivexa on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma saru ebda studji dwar l- effetti ta ’ Kivexa fuq il- ħila biex issuq u tħaddem makkinarju.
However, you should take into account the state of your health and the possible side effects of Kivexa before considering driving or using machines.
Madankollu, għandek tikkunsidra l- istat ta ’ saħħtek u l- effetti possibbli mhux mixtieqa ta ’ Kivexa qabel tiddeċiedi għandekx issuq jew tħaddem xi makkinarju.
Important information about some of the other ingredients of Kivexa tablets Kivexa contains a colouring called sunset yellow (E110), this may cause allergic reactions in some people.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ KIVEXA Kivexa fih kolorant imsejjaħ sunset yellow( E110); dan jista ’ jikkawża reazzjonijiet allerġiċi f’ xi wħud.
Always take Kivexa exactly as your doctor has told you.
KIF GĦANDEK TIEĦU KIVEXA Dejjem għandek tieħu Kivexa skond il- parir tat- tabib.
Take great care not to miss any doses if at all possible.
Kun żgur li possibbilment ma tinsa ’ qatt tieħu xi doża.
The usual dose in adults and adolescents from 12 years of age is one tablet once a day.
Id- doża li ssoltu tingħata għal adulti u adolexxenti ’ l fuq minn 12- il sena hija ta ’ pillola waħda darba kuljum.
Swallow the tablet whole with water.
Ibla ’ l- pillola sħiħa ma ’ l- ilma.
Kivexa can be taken with or without food.
Kivexa tista ’ tittieħed ma ’ l- ikel u anki mhux ma ’ l- ikel.
If you take more Kivexa than you should If you accidentally take too much you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Jekk tieħu KIVEXA aktar milli suppost Jekk aċċidentalment tieħu l- mediċina aktar milli suppost għandek tgħid b’ dan lit- tabib jew lill- ispiżjar tiegħek, jew tikkuntattja l- eqreb dipartiment ta ’ emerġenza ta ’ l- eqreb sptar biex tingħata parir.
If you forget to take Kivexa It is important to take Kivexa as prescribed to ensure you get maximum benefit.
Jekk tinsa tieħu KIVEXA Hu importanti li tieħu Kivexa skond ir- riċetta li għandek biex tkun żgur li tieħu l- benefiċċju kollu tiegħu.
If you forget to take a dose, take it as soon as you remember, and then continue as before.
Jekk tinsa tieħu doża, ħudha malli tiftakar, u mbagħad kompli kif suppost.
Do not take a double dose to make up for forgotten individual doses.
M’ għandekx tieħu doża doppja biex tpatti għal xi dożi li tkun insejt tieħu.
It is important to take Kivexa regularly because irregular intake may increase the risk of hypersensitivity reactions.
Hu importanti li tieħu Kivexa regolarment għaliex jekk ma teħdux regolari jista ’ jiżdiedlek ir- riskju ta ’ reazzjonijiet ta ’ sensittivita` eċċessiva.
38 If you stop taking Kivexa If you have stopped taking Kivexa for any reason, particularly if you think you are having side effects or for other illness, you must contact your doctor before restarting.
39 Jekk tieqaf tieħu KIVEXA Jekk waqaft tieħu Kivexa għal xi raġuni, b’ mod partikolari għaliex taħseb li qed ikollok xi effetti sekondarji jew minħabba xi mard ieħor, għandek tkellem lit- tabib qabel ma terġa ’ tibda.
In some cases your doctor will ask you to restart Kivexa in a place where you will be able to get ready access to medical care if needed.
F’ xi każijiet it- tabib jgħidlek biex terġa ’ tibda tieħu Kivexa f’ post fejn tkun tista ’ tingħata kura medika fil- pront f’ każ ta ’ bżonn.
Like all medicines, Kivexa can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra Kivexa jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
When treating HIV infection, it is not always possible to tell whether some of the side effects that occur are caused by Kivexa, by other medicines you are taking at the same time or by the HIV disease.
Meta tkun qed tingħata kura għall- infezzjoni HIV, mhux dejjem ikun possibbli li tgħid jekk xi wħud mill- effetti sekondarji li jidhru humiex kawżati minn Kivexa, minn mediċini oħra li tkun qed tieħu fl - istess ħin jew mill- marda ta ’ l- HIV innifisha.
For this reason it is very important that you inform your doctor about any changes in your health.
Għal din ir- raġuni huwa importanti ħafna li tgħid lit - tabib jekk tħoss xi tibdiliet f’ saħħtek.
Do not be alarmed by this list of possible side effects of Kivexa, you may not experience them.
Tallarmax ruħek b’ din il- lista ta ’ effetti sekondarji; tista ’ ma tħoss xejn minnhom.
Kivexa contains both abacavir and lamivudine, the side effects reported for each of these medicines are listed below.
Kivexa fih kemm abacavir kif ukoll lamivudine; l- effetti sekondarji rappurtati dwar kull waħda minn dawn il- mediċini huma mniżżlin hawn taħt.
A hypersensitivity reaction (serious allergic reaction) has been reported in about 5 in every 100 patients who have been treated with abacavir.
Reazzjoni ta ’ sensittivita` eċċessiva (reazzjoni ta ’ allerġija serja) ġiet irrappurtata f’ 5 każijiet minn kull 100 pazjent li ngħataw kura b’ abacavir.
This is described in section 2 of this leaflet under “ Take special care with Kivexa”.
Id- dettalji jidhru fis- sezzjoni 2 “ Oqgħod attent ħafna b’ Kivexa ” f’ dan il- fuljett.
It is important that you read and understand the information about this serious reaction.
Hu importanti li int taqra u tifhem sew it- tagħrif dwar din ir - reazzjoni serja.
Common side effects (reported in 1 to 10 out of 100 patients)
Effetti komuni sekondarji (rappurtati f’ każ wieħed sa 10 minn kull 100 pazjent)
- abacavir hypersensitivity, skin rash (without any other illness)
- sensittivita` eċċessiva għal abacavir, raxx fil- ġilda (bla mard ieħor)
- nausea, vomiting, diarrhoea, stomach pain
- nawżeja, remettar, dijarreja, uġigħ fl- istonku
- headache, joint pain, muscle disorders
- uġigħ ta ’ ras, uġigħ fil- ġogi, disturbi fil- muskoli
- cough, nasal symptoms (irritation, runny nose), high temperature
- sogħla, sintomi fl- imnieħer (irritazzjoni, imnieħer inixxi), deni għoli
- increases in enzymes produced by the liver
- letarġija, għeja, nuqqas ta ’ ngħas, tħossok ma tiflaħx, nuqqas t’ aptit, xagħar jaqa ’.
- anaemia (low red blood cell count), neutropenia (low white blood cell count) and reduction in the
Effetti sekondarji li mhumiex komuni (rappurtati f’ wieħed sa 10 minn kull 1000 pazjent) - żjidiet ta ’ enzimi li jagħmilhom il- fwied - anemija (nuqqas ta ’ ċelluli tad- demm ħomor), newtropenja (nuqqas ta ’ ċelluli tad- demm bojod) u tnaqqis fin- numru ta ’ plejtlits (ċelluli tad- demm importanti għat- tagħqid tad- demm)
If the production of red blood cells is reduced, you may have symptoms of tiredness or breathlessness.
Jekk il- produzzjoni ta ’ ċelluli tad- demm ħomor tonqos, jista ’ jkollok sintomi ta ’ għeja jew qtugħ ta ’ nifs.
A reduction in your white blood cell count can make you more prone to infection.
Nuqqas ta ’ ċelluli tad- demm bojod jista ’ jikkawżalek tendenza għal infezzjonijiet.
If you have a low platelet count, you may notice that you bruise more easily.
Jekk ikollok nuqqas ta ’ plejtlits, għandek mnejn tinduna li qed titbenġel malajr.
Rare side effects (reported in less than 1 in 1,000 patients)
Effetti sekondarji rari (rappurtati f’ inqas minn każ wieħed minn kull 1000 paz - kollass tat- tessuti muskolari
- increases of an enzyme called amylase
- żjieda ta ’ l- enzima msejħa amylase
- inflammation of the pancreas (pancreatitis).
- infjammazzjoni tal- frixa (pankreatite)
Very rare side effects (reported in less than 1 in 10,000 patients)
Effetti mhux mixtieqa u li huma rari ħafna (rappurtati f’ inqas minn każ wieħed minn kull 10, 000 pazjent)
- serious skin reactions
- reazzjonijiet serji tal- ġilda
- numbness, tingling sensation or sensation of weakness in the limbs
- titrix, sensazzjoni ta ’ tingiż jew sensazzjoni ta ’ debbolezza fid- dirgħajn u s- saqajn
- severe anaemia and neutropenia.
- anemija qawwija u newtropenja
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Terapija antiretrovirali kombinata tista ’ tikkawża tibdil fil- forma tal- ġisem minħabba r- ridistribuzzjoni tax- xaħam.
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck ('buffalo hump ').
Dawn jistgħu jinkludu tnaqqis ta ’ xaħam fis- saqajn, dirgħajn u l- wiċċ, żjieda ta ’ xaħam fl - addome (żaqq) u organi interni oħra, tkabbir tas- sider u boċoċ ta ’ xaħam fuq wara ta ’ l- għonq (‘ buffalo lump ’).
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża u l- effetti fit- tul fuq is- saħħa ta ’ dawn il- kondizzjonijiet mhumiex magħrufa preżentement.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
40 Terapija antiretrovirali kombinata tista ’ wkoll tikkawża żjieda ta ’ aċidu lattiku u zokkor fid- demm, iperlipimja (żjieda ta ’ xaħam fid- demm) u reżistenza għall- insulina.
39 Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body have been reported in some patients taking NRTIs (see “ Take special care with Kivexa” under section 2 for more information).
Każijiet ta ’ kondizzjoni msejħa aċidożi lattika, li hi formazzjoni ta ’ aċidu lattiku fil- ġisem, ġew rappurtati f’ xi pazjenti li jieħdu NRTIs (ara ‘ Oqgħod attent ħafna b’ Kivexa ” taħt sezzjoni 2 għal aktar tagħrif)
HOW TO STORE KIVEXA
KIF TAĦŻEN KIVEXA
Keep Kivexa out of the reach and sight of children.
Żomm KIVEXA fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Kivexa after the expiry date stated on the packaging.
Tużax Kivexa wara id- data ta ’ skadenza li tidher fuq il- pakkett.
FURTHER INFORMATION
X’ fih KIVEXA:
What Kivexa contains − The active substances are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine. − The other ingredients are magnesium stearate, microcrystalline cellulose, sodium starch glycollate, Opadry Orange YS-1-13065-A containing hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80 and sunset yellow aluminium lake (E110).
Opadry Orange YS- 1- 13065- A li fih hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80 u sunset yellow aluminium lake (E110).
What Kivexa looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
The tablets are orange, film-coated, capsule shaped, engraved with GS FC2 on one side.
Il- pilloli huma ta ’ kulur oranġjo, miksijin b’ rita, f’ għamla ta ’ kapsula, b’ GS FC2 minquxin fuq naħa waħda.
They are provided in bottles or blister packs containing 30 tablets and blister packs containing 90 (3x30) tablets.
Huma disponibbli fi fliexken jew pakketti blister ta ’ 30 pillola jew pakketti blister ta ’ 90 (3x30) pillola.
Marketing authorisation holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat - tqegħid fis- suq
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street Ware Hertfordshire SG12 0DJ United Kingdom
Glaxo Operations UK Ltd (fil- kummerċ Glaxo Wellcome Operations) Priory Street Ware Hertfordshire SG12 0DJ Renju Unit
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad -
Italia GlaxoSmithKline S. p. A.
42 Italia GlaxoSmithKline S. p. A.
This leaflet was approved in {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
What is KOGENATE Bayer?
X’ inhu KOGENATE Bayer?
KOGENATE Bayer is a powder and solvent that are mixed together to make a solution for injection.
KOGENATE Bayer huwa trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni.
KOGENATE Bayer contains the active substance octocog alfa (recombinant coagulation factor VIII).
KOGENATE Bayer fih is- sustanza attiva octocog alfa (fattur tal- koagulazzjoni VIII rikombinanti).
What is KOGENATE Bayer used for?
Għalxiex jintuża KOGENATE Bayer?
KOGENATE Bayer is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
KOGENATE Bayer jintuża għall- kura u l- prevenzjoni ta ’ fsada f’ pazjenti b’ emofilja A (disturb ta ’ fsada ereditarju kkawżat min- nuqqas ta ’ fattur VIII).
KOGENATE Bayer is intended for either short-term or long-term use.
KOGENATE Bayer huwa maħsub għal użu fuq perjodu fit- tul jew qasir.
How is KOGENATE Bayer used?
Kif jintuża KOGENATE Bayer?
KOGENATE Bayer should be started by a doctor who has experience in the treatment of haemophilia.
KOGENATE Bayer għandu jinbeda minn tabib li jkollu esperjenza fil- kura ta ’ l- emofilja.
KOGENATE Bayer is given by intravenous injection (into a vein) over several minutes, up to a rate of 2 ml per minute.
KOGENATE Bayer jingħata b’ injezzjoni fil- vini fuq diversi minuti, sa rata massima ta ’ 2 ml fil - minuta.
The dose and frequency depend on whether KOGENATE Bayer is used to treat haemorrhage (bleeding) or prevent it during surgery.
Id- doża u l- frekwenza jiddependu fuq jekk KOGENATE Bayer jintużax biex tiġi kkurata l - emorraġija (fsada) jew biex jimpediha waqt il- kirurġija.
The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery.
Id- doża tiġi aġġustata wkoll skond il- gravità ta ’ l- emorraġija jew it- tip ta ’ kirurġija.
KOGENATE Bayer can also be given as a continuous infusion (drip into a vein) for at least seven days in patients undergoing major surgery.
KOGENATE Bayer jista ’ jingħata wkoll bħala infużjoni kontinwa (dripp ġo vina) għal mill- anqas sebat ijiem f’ pazjenti sottoposti għal operazzjoni maġġuri.
How does KOGENATE Bayer work?
Kif jaħdem KOGENATE Bayer?
The active substance in KOGENATE Bayer, octocog alfa, is a blood coagulation factor protein.
Is- sustanza attiva f’ KOGENATE Bayer, octocog alfa, hija proteina tal- fattur tal- koagulazzjoni tad - demm.
In the body, factor VIII is one of the substances (factors) involved in blood coagulation (clotting).
Fil- ġisem, il- fattur VIII hu waħda mis- sustanzi (fatturi) involuti fil- koagulazzjoni (tagħqid) tad- demm.
KOGENATE Bayer is used to replace the missing factor VIII.
KOGENATE Bayer jintuża biex jissostitwixxi l- fattur VIII nieqes.
(44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged KOGENATE Bayer given as an intravenous injection has been studied in 66 patients who had been previously treated with recombinant coagulation factor VIII and 61 children who had not.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 85 45 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat KOGENATE Bayer?
The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
KOGENATE Bayer huwa simili għall- mediċina KOGENATE, iżda huwa ppreparat b’ mod differenti sabiex ma hemm l- ebda proteini derivati mill- bniedem fil- mediċina.
KOGENATE Bayer has also been studied as a continuous infusion in 15 patients with haemophilia A undergoing major surgery.
Minħabba dan, l- istudji li saru b’ KOGENATE Bayer ġew imqabbla ma ’ KOGENATE biex juru li ż- żewġ mediċini huma ekwivalenti.
The main measure of effectiveness was the doctor’ s assessment of how well bleeding was stopped.
Il- kejl prinċipali ta ’ l- effikaċja kienet l- evalwazzjoni tat- tabib dwar kemm twaqqfet sewwa l- fsada.
What benefit has KOGENATE Bayer shown during the studies?
X’ benefiċċju wera KOGENATE Bayer matul l- istudji?
In the previously treated patients, overall, 95% of bleeds responded to one or two intravenous injections of KOGENATE Bayer.
Fil- pazjenti li rċevew kura qabel, globalment, 95% tal- fsid irrisponda għal injezzjoni waħda jew żewġ injezzjonijiet ġol- vina ta ’ KOGENATE Bayer.
What is the risk associated with KOGENATE Bayer?
X’ inhu r- riskju assoċjat ma ’ KOGENATE Bayer?
In clinical trials with KOGENATE Bayer, this happened in 14% of previously untreated patients and in 17% of children who had been treated for less than five days in the past.
Fi provi kliniċi b’ Kogenate, dan ġara fi 14% tal- pazjenti li ma kinux ingħataw kura qabel u fi 17% tat- tfal li ġew ittrattati għal anqas minn ħamest ijiem fil- passat.
However, it is seen in less than 0.2% of patients treated for more than 100 days.
Minkejja dan, dan jidher f’ anqas minn 0. 2% tal- pazjenti ittrattati għal aktar minn 100 ġurnata.
If antibodies develop, KOGENATE Bayer will not work effectively.
Jekk jiżviluppaw antikorpi, il- KOGENATE Bayer ma jaħdimx b’ mod effettiv.