qanastek/EMEA-V3 huggingface dataset:
LABELLING AND PACKAGE LEAFLET
SOLUZZJONI ORALI - TIKKETTA TAL- FLIXKUN
LABELLING
ISEM TAL- PRODOTT MEDIĊINALI
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Kaletra (80 mg + 20 mg) / ml soluzzjoni orali (lopinavir + ritonavir)
Each soft capsule contains: lopinavir 133.3 mg and ritonavir 33.3 mg (pharmacokinetic enhancer).
Kull ml fih: lopinavir 80 mg u ritonavir 20 mg (qanqiel farmakokinetiku).
Includes: propylene glycol, polyoxyl 35 castor oil, anhydrized liquid sorbitol (mixture of sorbitol, sorbitol anhydrides and mannitol), glycerol and sunset yellow (E110).
Fih fost oħrajn: alkoħol (42% v/ v ara l- fuljett), high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassju (bħala axesulfame potassium)
180 soft capsules (2 bottles of 90 capsules each)
60 ml ta ’ soluzzjoni
Oral use Read the package leaflet before use
Jittieħed mill- ħalq Aqra il- fuljett ta ’ tagħrif qabel l- użu Importanti li tiftħu
Child resistant closure.
Għatu li ma jinfetaħx mit- tfal
{MM/ YYYY}
JIS: {XX/ SS}
Store in a refrigerator In use storage:
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN Aħżen f’ temperatura ta ’ bejn 2°C – 8°C (fil- friġġ) Ħażna waqt l- użu:
It is advised to write the date of removal from the refrigerator on the package.
Huwa rrikmandat li tikteb id- data tat- tneħħija mill - friġġ fuq il- pakkett ta ’ barra.
90 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
114 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CAPSULES - BOTTLE
PILLOLI 200 mg/ 50 mg - PAKKETT TA ’ FLIXKUN WIEĦED
Kaletra 133.3 mg/ 33.3 mg soft capsules lopinavir/ ritonavir
Kaletra 200 mg/ 50 mg pilloli miksija b’ rita lopinavir/ ritonavir
Each soft capsule contains: lopinavir 133.3 mg and ritonavir 33.3 mg (pharmacokinetic enhancer).
Kull pillola miksija b’ rita fiha: lopinavir 200 mg u ritonavir 50 mg (qanqiel farmakokinetiku).
90 soft capsules
120 pillola miksija b’ rita
Oral use Read the package leaflet before use
Jittieħed mill- ħalq Aqra il- fuljett ta ’ tagħrif qabel l- użu
Store in a refrigerator In use storage:
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN
EU/ 1/ 01/ 172/ 001
EU/ 1/ 01/ 172/ 004
92 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
116 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
CAPSULES - PACK OF 180 (5 CARTONS OF 6 BLISTERS OF 6 CAPSULES)
PILLOLI 200 mg/ 50 mg - FLIXKUN
180 soft capsules (5 cartons of 6 foil blisters of 6 capsules)
120 pillola miksija b’ rita
{MM/ YYY}
JIS: {XX/ SS}
93 10.
117 10.
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
118 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CAPSULES - CARTON OF 36 CAPSULES (6 BLISTERS OF 6 CAPSULES)
PILLOLI 200 mg/ 50 mg - PAKKETT TA ’ 120 (3 KAXXI TA ’ 5 FOLJI BI 8 PILLOLI MIKSIJA B’ RITA)
Contains:
Fih:
36 soft capsules (6 foil blisters of 6 capsules)
120 pillola miksija b’ rita (3 kaxxi ta ’ 5 folji bi 8 pilloli)
95 10.
119 10.
EU/ 1/ 01/ 172/ 002
EU/ 1/ 01/ 172/ 005
96 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
120 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CAPSULES - BLISTER OF 6 CAPSULES
PILLOLI 200 mg/ 50 mg - KARTUNA TA ’ ĠEWWA B’ 40 PILLOLA MIKSIJA B’ RITA (5 FOLJI BI 8 PILLOLI MIKSIJA B’ RITA)
NAME OF THE MARKETING AUTHORISATION HOLDER
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
Abbott Laboratories Limited
LISTA TA ’ SUSTANZI MHUX ATTIVI
EXPIRY DATE
GĦAMLA FARMAĊEWTIKA U KONTENUT
EXP:
Fih:
{MM/ YYYY}
40 pillola miksija b’ rita (5 folji bi 8 pilloli miksija b’ rita).
{number}
Jittieħed mill- ħalq Aqra il- fuljett ta ’ tagħrif qabel l- użu
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
ORAL SOLUTION CARTON - 300 ML OF SOLUTION (5 BOTTLES OF 60 ML EACH)
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal
NAME OF THE MEDICINAL PRODUCT
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)
Għatu li ma jinfetaħx mit- tfal
STATEMENT OF ACTIVE SUBSTANCE(S)
DATA TA ’ META JISKADI
Each ml contains: lopinavir 80 mg and ritonavir 20 mg (pharmacokinetic enhancer).
JIS: {XX/ SS}
LIST OF EXCIPIENTS
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN
Includes: alcohol (42% v/ v see leaflet), high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
PHARMACEUTICAL FORM AND CONTENTS
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
300 ml of solution (5 bottles of 60 ml each).
Abbott Laboratories Limited Queenborough Kent ME11 5EL Renju Unit
METHOD AND ROUTE(S) OF ADMINISTRATION
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Oral use Read the package leaflet before use
EU/ 1/ 01/ 172/ 005
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
NUMRU TAL- LOTT
Keep out of the reach and sight of children
Lott:
OTHER SPECIAL WARNING(S), IF NECESSARY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
Child resistant closure.
Prodott mediċinali jingħata bir- riċetta tat- tabib.
EXPIRY DATE
STRUZZJONIJIET DWAR L- UŻU
{MM/ YYYY}
INFORMAZZJONI BIL- BRAILLE
SPECIAL STORAGE CONDITIONS
Pilloli Kaletra 200 mg/ 50 mg
It is advised to write the date of removal from the refrigerator on the package.
122 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PILLOLI 200 mg/ 50 mg - FOLJA BI 8 PILLOLI MIKSIJA B’ RITA
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM TAL- PRODOTT MEDIĊINALI
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
Kaletra 200 mg/ 50 mg pilloli miksija b’ rita lopinavir/ ritonavir
MARKETING AUTHORISATION NUMBER(S)
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/ 1/ 01/ 172/ 003
Abbott Laboratories Limited
BATCH NUMBER
DATA TA ’ META JISKADI
{number]
JIS: {XX/ SS}
GENERAL CLASSIFICATION FOR SUPPLY
NUMRU TAL- LOTT
15.
Lott:
Kaletra
OĦRAJN
99 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
123 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ORAL SOLUTION - BOTTLE LABEL
PILLOLI 100 mg/ 25 mg – PAKKETT TA ’ FLIXKUN
Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)
Kaletra 100 mg/ 25 mg pilloli miksija b’ rita lopinavir/ ritonavir
Each ml contains lopinavir 80 mg and ritonavir 20 mg (pharmacokinetic enhancer).
Kull pillola miksija b’ rita fiha 100 mg lopinavir imħallat ma ’ 25 mg ritonavir biex iżid il - farmakokinetika.
60 ml of solution
60 pillola miksija b’ rita
Important to open
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Abbott Laboratories Limited Queenborough Kent ME11 5EL Renju Unit
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PILLOLI 100 mg/ 25 mg – TEST TAT- TABELLA TAL- FLIXKUN
Kaletra 200 mg/ 50 mg film-coated tablets lopinavir/ ritonavir
Kaletra 100 mg/ 25 mg pilloli miksija b’ rita lopinavir/ ritonavir
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
Kull pillola miksija b’ rita fiha 100 mg lopinavir imħallat ma ’ 25 mg ritonavir biex iżid il - farmakokinetika.
120 film-coated tablets
60 pillola miksija b’ rita
Oral use Read the package leaflet before use
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
102 11.
126 11.
Kaletra 200 mg/ 50 mg tablets
KALETRA 133. 3 mg/ 33. 3 mg kapsuli rotob lopinavir/ ritonavir
103 PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
200 MG/ 50 MG TABLETS - BOTTLE
- Żomm dan il- fuljett.
NAME OF THE MEDICINAL PRODUCT
Tista ’ tagħmlilhom il- ħsara,
Kaletra 200 mg/ 50 mg film-coated tablets lopinavir/ ritonavir
anki jekk ikollom l- istess sintomi bħal tiegħek.
STATEMENT OF ACTIVE SUBSTANCE(S)
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew l- ispiżjar tiegħek.
LIST OF EXCIPIENTS
Aktar tagħrif
PHARMACEUTICAL FORM AND CONTENTS
X’ INHU KALETRA U GĦALXIEX JINTUŻA
120 film-coated tablets
It- tabib tiegħek jiddetermina liema huma l- aħjar mediċini għalik.
METHOD AND ROUTE(S) OF ADMINISTRATION
QABEL MA TIEĦU KALETRA
Oral use Read the package leaflet before use
Tieħux Kaletra
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
- jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal lopinavir, ritonavir jew sustanzi oħra
Keep out of the reach and sight of children
- jekk int għandek problemi serji ħafna tal- fwied
OTHER SPECIAL WARNING(S), IF NECESSARY
midazolam orali (mittieħed mill- ħalq), triazolam (użati għas- soljiev ta ’ ansjetà u/ jew problemi ta ’ l- irqad);
8.
- -
EXPIRY DATE
pimozide (użati biex jittrattaw skizofrenija); cisapride (użati għas- soljiev ta’ ċerti problemi ta ’ l- istonku);
SPECIAL STORAGE CONDITIONS
ergotamine, dihydroergotamine, ergonovine, methylergonovine (użati biex jittrattaw l- uġigħ ta ’ ras);
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
amiodarone (użat biex jittratta taħbita mhux normali tal- qalb); vardenafil (użat biex jittratta disfunzjoni erettili).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pazjenti li qed jiehdu Kaletra m’ għandhomx jieħdu prodotti li fihom St. John’ s wort (Hypericum perforatum) għaliex dan jista ’ jwaqqaf lil Kaletra milli jaħdem kif suppost.
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
Jekk f’ dan il- waqt qed tieħu kwalinkwe minn dawn il- mediċini, saqsi lit- tabib tiegħek biex taqleb għall - mediċina oħra waqt li qed tieħu Kaletra.
MARKETING AUTHORISATION NUMBER(S)
Oqgħod attent ħafna b’ Kaletra
EU/ 1/ 01/ 172/ 004
L- użu tal- mediċini
BATCH NUMBER
li jmiss flimkien ma ’ Kaletra għandu jsir biss taħt parir mediku: mediċini użati biex inaqssu l- kolesterol fid- demm (eż. lovastatin, simvastatin, rosuvastatin jew atorvastatin), xi mediċini li jaffetwaw is- sistema immunitarja (eż. cyclosporin, sirolimus (rapamycin), tacrolimus), sterojdi varji (eż. dexamethasone, fluticasone propionate, ethinyl oestradiol), inibituri tal- protease oħra, ċerti mediċini tal- qalb bħal: antagonisti tal- kanali tal - kalċju (eż. felodipine, nifedipine, nicardipine) u mediċini użati biex jikkoreġu r- ritmu/ it- taħbita tal- qalb (eż. bepridil, systemic lidocaine, quinidine), mediċini għal kontra l- fungu (eż. ketoconazole, itraconazole), mediċini jixbħu lill- morfina (eż. methadone), antikonvulżivi (eż. carbamazepine, phenytoin, phenobarbital), warfarin, ċerti antibijotiċi (eż. rifampicin, rifabutin, clarithromycin), ċertu antidepressanti (eż. trazodone, bupropion), voriconazole, aġenti sedattivi (eż. midazolam mgħoti permezz ta ’ injezzjoni), aġenti għal kontra l- kanċer (eż. vincristine, vinblastine), mediċini użati biex wieħed jieqaf mit- tipjip (eż. bupropion).
Lot:
- Kaletra jista ’ jirreaġixxi ma ’ aġenti għal disfunzjoni erettili, (eż. sildenafil, tadalafil).
{number}
It- tabib
GENERAL CLASSIFICATION FOR SUPPLY
tiegħek għandu jiktiblek dożi iktar baxxi ta ’ dawn il- mediċini jekk qed tieħu Kaletra.
Medicinal product subject to medical prescription.
- Kaletra jista ’ jirreaġixxi ma ’ digoxin (mediċina tal- qalb).
INSTRUCTIONS ON USE
jekk qed tieħu digoxin u Kaletra.
16.
- Jekk jgħoġbok kellem lit- tabib tiegħek jekk għandek storja ta ’ mard tal- fwied.
INFORMATION IN BRAILLE
Pazjenti b’ epatite
105 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
- Redistribuzzjoni, akkumulazzjoni jew telf ta ’ xaħam tal- ġisem jistgħu iseħħ f’ pazjenti li qed
200 MG/ 50 MG TABLETS - PACK OF 120 (3 CARTONS OF 5 FOIL BLISTERS OF 8 FILM- COATED TABLETS)
Kellem lit- tabib tiegħek jekk tinnota tibdil fix- xaħam tal- ġisem.
Kaletra 200 mg/ 50 mg film-coated tablets lopinavir/ ritonavir
- Nisa tqal jew li qed ireddgħu m’ għandhomx jieħdu Kaletra sakemm mhux speċifikament diretti
STATEMENT OF ACTIVE SUBSTANCE(S)
mit- tabib tagħhom (ara ukoll ‘ Tqala u effetti fuq il- ħalib tas- sider ’).
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
- Kaletra m’ ghandux jigi somministrat lit- tfal ta ’ taħt is- sentejn sakemm mhux speċifikament
LIST OF EXCIPIENTS
diretti mit- tabib tagħhom.
PHARMACEUTICAL FORM AND CONTENTS
Nies li qed jieħdu Kaletra jistgħu xorta
Contains:
jiżvillupaw infezzjonjijiet jew mard assoċjat mall- marda ta ’ l- HIV u AIDS. Ma tnaqqasx ir- riskju li tgħaddi l- HIV lill- oħrajn minn kuntatt sesswali jew kontaminazzjoni tad- demm.
120 film-coated tablets (3 cartons of 5 foil blisters of 8 tablets).
Il - prekawzjonijiet apposta għandhom jittieħdu.
METHOD AND ROUTE(S) OF ADMINISTRATION
- F’ xi pazjenti b’ infezzjoni HIV avvanzata (AIDS) u storja ta ’ infezzjonijiet opportunistiċi, sinjali u
Oral use Read the package leaflet before use
Jekk tinnota xi sintomi ta ’ infezzjonijiet, informa lit- tabib tiegħek mill- ewwel.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
marda fl- għadam, ostjonekrożi (mewt ta ’ l- għadam ikkawżat minn nuqqas ta ’ provvista ta ’ demm).
Keep out of the reach and sight of children
Meta tieħu mediċini oħra
7.
Għandek tavża lit- tabib tiegħek dwar kwalinkwe mediċina, inklużi dawk il- mediċini li tista tixtri mingħajr riċetta, li qed tieħu jew li qed tippjana li tieħu, qabel ma tieħu Kaletra.
OTHER SPECIAL WARNING(S), IF NECESSARY
Ara sezzjoni 2, QABEL MA TIEĦU KALETRA, għall- iktar informazzjoni.
EXPIRY DATE
Kaletra jista ’ jittieħed ma ’ aġenti li jnaqqsu l- aċidu (bħal omeprazole u ranitidine) mingħajr aġġustament fid- doża.
{MM/ YYY}
Il- formulazzjoni gastroreżistenti ta ’ didanosine għandha tiġi somministrata mill- inqas sagħtejn wara l- ikel.
SPECIAL STORAGE CONDITIONS
It- tabib tiegħek jista jispjegalek dawn is- sintomi.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Jekk qed tieħu kontraċettivi mill- ħalq biex tipprevjeni t- tqala, għandek tuża kontraċettiv addizjonali jew ta ’ tip differenti minħabba li Kaletra jista ’ jnaqqas l- effettività ta ’ kontraċettivi li tieħu mill- ħalq.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Jekk joġgħbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
131 Meta tieħu Kaletra ma ’ l- ikel u max- xorb
MARKETING AUTHORISATION NUMBER(S)
Huwa importanti li tieħu Kaletra ma ’ l- ikel.
EU/ 1/ 01/ 172/ 005
Tqala u Treddigħ
BATCH NUMBER
Sewqan u tħaddim ta ’ magni
{number}
Kaletra ma ġiex studjat speċifikament għall- effetti possibli fuq il- ħila li ssuq karozza jew tħaddem magni.
GENERAL CLASSIFICATION FOR SUPPLY
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Kaletra
Medicinal product subject to medical prescription.
Allergija hija iżjed komuni f’ nies li huma allerġici għall- aspirina.
INSTRUCTIONS ON USE
KIF GĦANDEK TIEĦU KALETRA
INFORMATION IN BRAILLE
Huwa importanti li dejjem għandek tieħu Kaletra kuljum skond il- parir tat- tabib.
Kaletra 200 mg/ 50 mg tablets
Kif u meta għandek tieħu Kaletra
107 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Dejjem għandek tieħu Kaletra skond il- parir tat- tabib.
200 MG/ 50 MG TABLETS - INNER CARTON OF 40 FILM-COATED TABLETS (5 FOIL BLISTERS OF 8 FILM-COATED TABLETS)
Talterax jew twaqqafx id- doża ta ’ kuljum ta ’ Kaletra mingħajr ma tkellem lit- tabib tiegħek.
NAME OF THE MEDICINAL PRODUCT
Dejjem żomm biżżejjed Kaletra maħżuna biex ma tispiċċax b’ xejn.
Kaletra 200 mg/ 50 mg film-coated tablets lopinavir/ ritonavir
Kompli ħu din il- mediċina sakemm jgħidlek it- tabib il- kuntrarju.
STATEMENT OF ACTIVE SUBSTANCE(S)
Jekk tieħu Kaletra aktar milli suppost
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
Jekk tirrealliżża li ħadt iżjed Kaletra milli suppost għandek tieħu, kellem lit- tabib tiegħek minnufih.
LIST OF EXCIPIENTS
132 Jekk tinsa tieħu Kaletra
PHARMACEUTICAL FORM AND CONTENTS
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
40 film-coated tablets (5 foil blisters of 8 film-coated tablets).
Kompli bid- doża normali bi skeda regolari kif kitiblek it- tabib tiegħek.
METHOD AND ROUTE(S) OF ADMINISTRATION
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
Oral use Read the package leaflet before use
X’ effetti sekondarji jista ’ jkolli b’ Kaletra
6.
Bħal kull mediċina oħra, Kaletra jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd. Tista tkun diffiċli li tinnota liema effetti oħra huma ikkawżati minn Kaletra u dawk li jistgħu iseħħu minħabba mediċini oħra li qed tieħu fl- istess ħin jew minn kumplikazzjonjiet ta ’ l- infezzjoni ta ’ l- HIV.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Huwa importanti li tavża lit- tabib tiegħek bit- tibdiliet f’ saħħtek.
Keep out of the reach and sight of children
Il- frekwenza ta ’ l- effetti sekondarji hija klassifikata kif isegwi:
OTHER SPECIAL WARNING(S), IF NECESSARY
L- iżjed effetti sekondarji komuni ta ’ Kaletra (> 1/ 10) huma diareja, u żieda fi trigliċeridi, żieda fil - kolesterol totali u żieda fil- GGT.
EXPIRY DATE
Il- kawża u l- effetti fit- tul fuq is- saħħa ta ’ dawn il- kundizzjonijiet mhuwiex magħruf bħal issa.
{MM/ YYYY}
Jekk tesperjenza dawn is - sintomi għid lit- tabib tiegħek.
SPECIAL STORAGE CONDITIONS
Jekk dan jiġri lilek, itlob parir immedjat mit- tabib tiegħek.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
133 Każi ta ’ dijabete mellitus jew żidiet fiz- zokkor tad- demm ġew irrappurtati f’ pazjenti li qed jingħataw Kaletra.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Xi nies kellhom mard ieħor jew kienu qed jieħdu mediċini oħra.
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
F’ okkażjonijiet rari dawn il - problemi fil- muskoli kienu serji (rabdomilożi).
MARKETING AUTHORISATION NUMBER(S)
Effetti sekondarji mhux komuni (> 1/ 1000 u < 1/ 100 pazjenti) li jistgħu jiġru b’ Kaletra:
EU/ 1/ 01/ 172/ 005
Infezzjonijiet u infestazzjonijiet:
BATCH NUMBER
Neoplażma beninja tal- ġilda, ċesta;
Lot:
Disturbi fid- demm:
{number}
Anemija, lewkopenija u limfadenopatija;
GENERAL CLASSIFICATION FOR SUPPLY
Disturbi fis- sistema endokrinarja:
Medicinal product subject to medical prescription.
Disturbi fil- metaboliżmu u n- nutrizzjoni:
INSTRUCTIONS ON USE
Disturbi psikjatriċi:
INFORMATION IN BRAILLE
Disturbi fis- sistema nervuża:
Kaletra 200 mg/ 50 mg tablets
Disturbi fl- għajnejn:
109 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Tisfir tal- widnejn;
200 MG/ 50 MG TABLETS - BLISTER OF 8 FILM-COATED TABLETS
Disturbi fil- qalb: palpitazzjonijiet, akkumulazzjoni ta ’ ilma fil- pulmun, infart mijokardjali;
NAME OF THE MEDICINAL PRODUCT
Distrubi vaskulari: pressjoni għolja, tromboflebite, vaskulite, vini varikożi, tromboflebite fonda, disturbi vaskulari;
Kaletra 200 mg/ 50 mg film-coated tablets lopinavir/ ritonavir
Disturbi respiratorji, toraċiċi u medjastinali:
NAME OF THE MARKETING AUTHORISATION HOLDER
Disturbi Gastro- intestinali:
Abbott Laboratories Limited
Disturbi fil- fwied:
EXPIRY DATE
Disturbi fil- ġilda:
EXP:
134 Disturbi fil- muskoli:
{MM/ YYYY}
Disturbi fil- kliewi u fis- sistema urinarja:
BATCH NUMBER
Disturbi fis- sistema riproduttiva:
Lot:
Disturbi ġenerali:
{number}
Uġiegħ fis- sider, uġiegħ fis- sider substernali, dehxiet, deni, sindromu ta ’ l- influenza, tħossok mintix f’ siktek, edema periferali, interazzjoni ma ’ mediċini oħra;
OTHER
Investigazzjonijiet:
110 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Informa lit- tabib tiegħek b’ dawn l- effetti jew b’ xi effetti oħra.
100 MG/ 25 MG TABLETS - CARTON OF 1 BOTTLE
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xieffetti sekondarji li mhumiex imsemmija f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
NAME OF THE MEDICINAL PRODUCT
KIF TAĦŻEN KALETRA
Kaletra 100 mg/ 25 mg film-coated tablets lopinavir/ ritonavir
Tużax Kaletra wara d- data ta ’ skadenza li tidher fuq il- pakkett.
STATEMENT OF ACTIVE SUBSTANCE(S)
Aħżen fi friġġ (2°C – 8°C).
Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg of ritonavir as a pharmacokinetic enhancer.
Titrasferihx għal kontenitur ieħor.
LIST OF EXCIPIENTS
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjent.
PHARMACEUTICAL FORM AND CONTENTS
AKTAR TAGĦRIF
60 film-coated tablets
X’ fih Kaletra:
METHOD AND ROUTE(S) OF ADMINISTRATION
- Is- sustanza attiva hi lopinavir, il- kapsula fiha anke ritonavir li jaħdem billi jżid il- livelli fid- demm
Oral use Read the package leaflet before use
ta ’ lopinavir billi jinibixi enżimi li jimmetaboliżawh.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Kull kapsula ta ’ Kaletra fiha lopinavir 133. 3 mg u ritonavir 33. 3 mg (qanqiel farmakokinetiku).
Keep out of the reach and sight of children
- Is- sustanzi l- oħra huma: oleic acid, propylene glycol, polyoxyl 35 castor oil, ilma ppurifikat.
7.
135
OTHER SPECIAL WARNING(S), IF NECESSARY
- Il- qoxra tal- kapsula hi magħmula minn dawn: ġelatina, anhydrized liquid sorbitol (taħlita ta ’
EXPIRY DATE
Id- dehra tal- prodott u d- daqs tal- pakket:
{MM/ YYYY}
Żewġ fliexken ta ’ 90 kapsula huma pprovduti f’ pakkett wieħed.
SPECIAL STORAGE CONDITIONS
Kull pakkett fih 5 kartuniet (180 kapsula).
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Kaletra huwa supplit anke bħala soluzzjoni orali u bħala pilloli miksija b’ rita.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
MARKETING AUTHORISATION NUMBER(S)
Aesica Queenborough Ltd Queenborough Kent ME11 5EL Renju Unit
EU/ 1/ 01/ 172/ 006
België/ Belgique/ Belgien Abbott SA Parc Scientifique Rue du Bosquet, 2 B- 1348 Louvain- la- Neuve Tél/ Tel: + 32 10 475311
BATCH NUMBER
Luxembourg/ Luxemburg Abbott SA Parc Scientifique Rue du Bosquet, 2 B- 1348 Louvain- la- Neuve Belgique/ Belgien Tél/ Tel: + 32 10 475311
SPECIAL STORAGE CONDITIONS
137 Κύπρος Lifepharma (Z. A. M.) Ltd Aγ.
MARKETING AUTHORISATION NUMBER(S)
Lietuva Abbott Laboratories Baltics Vienības 87h Rīga, LV- 1004 Latvia Tel: + 371 67605580
EU/ 1/ 01/ 172/ 006
Dan il- fuljett kien approvat l- aħħar f ’ [data]
BATCH NUMBER
138 FULJETT TA ’ TAGĦRIF:
{number}
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
GENERAL CLASSIFICATION FOR SUPPLY
KALETRA (80 mg + 20 mg) / ml soluzzjoni orali (lopinavir + ritonavir)
Medicinal product subject to medical prescription.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
INSTRUCTIONS ON USE
- Żomm dan il- fuljett.
INFORMATION IN BRAILLE
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
PACKAGE LEAFLET
- Din il- mediċina ġiet mogħtija lilek.
115 PACKAGE LEAFLET:
TAGĦTIHIEX lil persuni oħra.
INFORMATION FOR THE USER
Tista ’ tagħmlilhom il- ħsara,
KALETRA 133.3 mg/ 33.3 mg soft capsules lopinavir/ ritonavir
anki jekk ikollom l- istess sintomi bħal tiegħek.
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew l- ispiżjar tiegħek.
What Kaletra is and what it is used for 2.
X’ inhu Kaletra u għalxiex jintuża 2.
Before you take Kaletra 3.
Qabel ma tieħu Kaletra 3.
How to take Kaletra 4.
Kif għandek tieħu Kaletra 4.
How to store Kaletra 6.
Kif taħżen Kaletra 6.
WHAT KALETRA IS AND WHAT IT IS USED FOR
X’ INHU KALETRA U GĦALXIEX JINTUŻA
Kaletra is an inhibitor of the human immunodeficiency virus (HIV) protease enzyme.
(HIV) tiġi kontrollata.
It helps control HIV infection by inhibiting or interfering with the protease enzyme that HIV needs to multiply.
Kaletra jagħmel dan billi jnaqqas ir- rittmu li bih tinfirex l- infezzjoni f’ ġismek..
Kaletra is used by adults and children 2 years of age or older who are infected with HIV, the virus which causes AIDS.
- Kaletra jintuża minn tfal ta ’ sentejn jew ikbar u minn adulti li huma infettati bl- HIV, il- virus li
Your doctor has prescribed Kaletra to help control your HIV infection.
Kaletra m’ għandux jingħata lil tfal li għandhom inqas minn sentejn sakemm it - tabib tagħhom ma jkunx ordna dan speċifikament.
Kaletra does this by slowing down the spread of the infection in your body.
Dan jagħmel parti minn grupp ta ’ mediċini li jissejħu
Kaletra is prescribed for use in combination with other antiviral medicines.
It- tabib tiegħek
Your doctor will determine which medicines are best for you.
jiddeċiedi dwar liema mediċini huma l- aħjar għalik.
BEFORE YOU TAKE KALETRA
QABEL MA TIEĦU KALETRA
Do not take Kaletra
Tieħux Kaletra
− if you are allergic (hypersensitive) to lopinavir, ritonavir or any of the other ingredients of Kaletra.
- jekk int allerġiku/ a (għandek sensittività eċċessiva) għal lopinavir, ritonavir jew sustanzi oħra ta ’
− if you have severe liver problems.
- jekk int għandek problemi serji ħafna tal- fwied.
− if you are currently taking any of the following medicines:
Tieħux Kaletra ma ’ xi waħda mill- mediċini li ġejjin:
−
l- irqad);
astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription);
- Ergotamine, dihydroergotamine, ergonovine, methylergonovine (użati biex jittrattaw l- uġigħ ta ’
−
139
oral (taken by mouth) midazolam, triazolam (used to relieve anxiety and/or trouble sleeping);
- Amiodarone (użat biex jittratta taħbita mhux normali tal- qalb);
− − − − −
- Vardenafil (użat biex jittratta disfunzjoni erettili);
pimozide (used to treat schizophrenia); cisapride (used to relieve certain stomach problems); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); amiodarone (used to treat abnormal heart beat); vardenafil (used to treat erectile dysfunction).
- Prodotti li fihom il- fexfiex tar- raba ’ (St John’ s Wort) (Hypericum perforatum).
116 Patients taking Kaletra must not take products containing St John’s wort (Hypericum perforatum) as this may stop Kaletra from working properly.
Għal tagħrif dwar ċerti mediċini oħra li jeħtieġu attenzjoni speċjali qabel tibda toħodhom, aqra l- lista ta ’ mediċini li ssib taħt ‘ Meta tieħu mediċini oħra ’.
If you are currently taking any of these medicines, ask your doctor about switching to another medicine while you are taking Kaletra.
Jekk f’ dan il- waqt qed tieħu kwalinkwe minn dawn il- mediċini, saqsi lit- tabib tiegħek biex taqleb għall - mediċina oħra waqt li qed tieħu Kaletra.
Take special care with Kaletra
Oqgħod attent ħafna b’ Kaletra
− Kaletra may interact with certain other medications with possible clinical effects.
- Kaletra mhuwiex kura għall- infezzjoni ta ’ l- HIV jew għall- AIDS.
− Kaletra may interact with erectile dysfunction agents (eg, sildenafil and tadalafil).
- Persuni li jkunu qegħdin jieħdu Kaletra xorta jistgħu jiżviluppaw infezzjonijiet jew mard ieħor
Your doctor should prescribe lower doses of these medicines if you are also taking Kaletra.
Għalhekk, huwa importanti li int tibqa ’ taħt l - osservazzjoni tat- tabib tiegħek waqt li tkun qiegħed tieħu Kaletra.
- Kaletra may interact with digoxin (heart medicine).
- Kaletra ma jnaqqasx ir- riskju li inti tgħaddi l- HIV lil ħaddieħor.
Your doctor should monitor you if you are
Għandhom jittieħdu l -
taking digoxin and Kaletra.
Għid lit- tabib tiegħek jekk inti għandek/ kellek:
− Taking certain medicines with Kaletra may result in increased levels in the body of these other medicines and could increase or prolong their effect and/or adverse reactions.
- Emofilja tip A u B, peress li Kaletra jista ’ iżid ir- riskju ta- telf ta ’ demm.
You must tell your doctor about all the medicines, including those medicines you can buy without a prescription, you are taking or are planning to take before you take Kaletra.
- Dijabete, peress li kien hemm rapporti ta ’ żieda fiz- zokkor fid- demm f’ pazjenti li jirċievu
This is because taking Kaletra with some medicines can result in serious or life threatening problems.
- Storja ta ’ problemi tal- fwied, peress li pazjenti bi storja ta ’ mard tal- fwied, inkluża l- epatite
− If you are taking an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception since Kaletra may reduce the effectiveness of oral and patch contraceptives.
kronika tat- tip B u Ċ huma f’ riskju akbar ta ’ effetti sekondarji serji ħafna u li jistgħu jkunu fatali.
− Please speak with your doctor if you have a history of liver disease.
Għid lit- tabib tiegħek jekk tesperjenza:
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
- Nawseja, rimettar, uġigħ addominali, diffikultà biex tieħu n- nifs u dgħjufija severa fil- muskoli fir -
− Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
riġlejn u fid- dirgħajn għax dawn is- sintomi jistgħu jindikaw żieda fil- livelli ta ’ l- aċidu laktiku.
Contact your doctor if you notice changes in body fat.
jindika żieda fil- livelli taz- zokkor fid- demm.
− Pregnant or nursing mothers should not take Kaletra unless specifically directed by their doctor (see also ‘Pregnancy and breast-feeding’).
ikkunsidrati bħala fattur ta ’ riskju għall- pankreatite (infjammazzjoni tal- frixa) u dawn is- sintomi jistgħu jissuġġerixxu din il- kondizzjoni.
− Kaletra should not be administered to children younger than 2 years of age unless specifically directed by their doctor.
Il - kawża u l- effetti dejjiema ta ’ dawn il- kundizzjonijiet fuq is- saħħa għadhom m’ humiex magħrufa.
− Kaletra is not a cure for HIV infection or AIDS.
kontra l- HIV.
People taking Kaletra may still develop infections or other illnesses associated with HIV disease and AIDS.
- Ebusija fil- ġogi, weġgħat u uġigħ (speċjalment tal- ġenbejn, ta ’ l- irkoppa u ta ’ l- ispallejn) u
It is therefore important that you remain under the supervision of your doctor while taking Kaletra.
- Uġigħ fil- muskoli, sensittività jew dgħjufija, partikolarment meta jkunu qegħdin jittieħdu dawn
Kaletra does not reduce the risk of passing HIV to others through sexual contact or contamination with blood.
F’ każi rari, dawn id- disturbi fil- muskoli kienu serji.
117 You should use appropriate precautions.
Meta tieħu mediċini oħra
− In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Għid lit- tabib tiegħek jekk qiegħed tieħu xi waħda mill- mediċini mniżżla hawn taħt, peress li għandha tingħata attenzjoni speċjali:
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.
- Mediċini għal kontra l- epilessija (eż. carbamazepine, phenytoin, phenobarbital);
If you notice any symptoms of infection, please inform your doctor immediately.
- Mediċini ġħad- disfunzjoni erettili (eż. sildenafil and tadalafil);
− Bone problems: 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).
Digoxin; Mediċini li huma antagonisti tal- kanali tal- kalċju (eż. felodipine, nifedipine, nicardipine); Mediċini użati biex jirregolarizzaw ir- rittmu tal- qalb (eż. bepridil, systemic lidocaine, quinidine);
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.
- Mediċini użati biex ibaxxu l- kolesterol fid- demm (eż. atorvastatin, lovastatin, rosuvastatin jew
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
- Mediċini li jaffetwaw is- sistema immunitarja (eż. cyclosporin, sirolimus (rapamycin),
If you notice any of these symptoms please inform your doctor.
- Mediċini użati biex wieħed iwaqqaf it- tipjip (eż. bupropion);
Taking other medicines
- Mediċini bħall- morfina (eż. methadone);
Kaletra may interact with other medicines, including those you take without a prescription.
biex tiġi evitata t- tqala (ara s- sezzjoni bl- isem Kontraċettivi imniżżla hawn taħt);
It is possible that your doctor may increase or decrease the dose of other medicines when you are also taking Kaletra.
- Inibituri protejaż (eż. amprenavir, fosamprenavir, indinavir, nelfinavir, ritonanvir, saquinavir);
You should tell your doctor about any medicines, including those medicines you can buy without a prescription, you are taking or planning to take, before you take Kaletra.
- Sterojdi (eż. dexamethasone, fluticasone propionate, ethinyl oestradiol);
See Section 2, BEFORE YOU TAKE KALETRA, for further information.
- Mediċini li jikkawżaw reazzjoni ma ’ l- alkoħol (eż. disulfiram).
Kaletra can be taken with acid reducing agents (such as omeprazole and ranitidine) with no dose adjustment.
Għal tagħrif fuq mediċini li m’ għandekx tieħu ma ’ Kaletra, aqra l- lista tal- mediċini taħt ‘ Tieħux Kaletra ma ’ xi waħda mill- mediċini li ġejjin ’.
If you are taking didanosine, it should be taken one hour before or at least two hours after taking Kaletra (with food).
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
The gastroresistant formulation of didanosine should be administered at least two hours after a meal.
Mediċini għad- disfunzjoni erettili (vardenafil, sildenafil, tadalafil)
If you are taking sildenafil or tadalafil with Kaletra talk to your doctor about possible interactions with other medicines and side effects.
- Jekk inti tieħu sildenafil jew tadalafil u Kaletra flimkien, int tista ’ tkun qiegħed f’ riskju ta ’ effetti
If you take sildenafil or tadalafil and Kaletra together, you may be at risk of side effects such as low blood pressure, passing out, visual changes and penile erection lasting more than 4 hours.
sekondarji bħal pressjoni baxxa, tintilef minn sensik, tibdil viżwali u erezzjoni tal- pene li ddum aktar minn 4 siegħat.
If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Jekk erezzjoni tal- pene ddum aktar minn 4 siegħat, għandek tfittex l - għajnuna medika immedjatament biex tevita dannu permanenti fil- pene.
If you are taking an oral contraceptive to prevent pregnancy, you should use an additional or different type of contraception since Kaletra may reduce the effectiveness of oral contraceptives.
f’ forma ta ’ garża li terħi l- mediċina biex tevita t- tqala, għandek tibda tuża kontraċettiv addizzjonali jew tip differenti ta ’ kontraċettiv (eż. kondom) għax Kaletra jista ’ jnaqqas l - effettività tal- kontraċettivi li jittieħdu mill- ħalq jew dawk f’ forma ta ’ garża li terħi l- mediċina.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
prekawzjonijiet xierqa (eż. agħmel użu mill- kondom) biex jiġi evitat li l- marda tgħaddiha lil ħaddieħor permezz ta ’ kuntatt sesswali.
Taking Kaletra with food and drink
Meta tieħu Kaletra ma ’ l- ikel u max- xorb
It is important that Kaletra is taken with food.
Huwa importanti li Kaletra jittieħed ma ’ l- ikel.
Pregnant or breast-feeding mothers should not take Kaletra unless specifically directed by the doctor.
- Nisa tqal jew ommijiet li jkunu qegħdin ireddgħu ma jistgħux jieħdu Kaletra, sakemm ma jkunx
Be sure to tell you doctor immediately if you are or may be pregnant or if you are breast-feeding a baby.
- Huwa rrakkomandat li nisa nfettati bl- HIV ma jreddgħux lit- trabi tagħhom minħabba l- possibilità
It is recommended that HIV-infected women should not breast-feed their infants because of the possibility your baby can be infected with HIV through your breast milk.
Kaletra fih 42% v/ v alcoħol.
118 Driving or using machines
Kaletra fih 42% v/ v alkoħol.
Kaletra has not specifically been tested for its possible effects on the ability to drive a car or operate machines.
Jista ’ jikkawża uġigħ ta ’ ras u taqlib fl- istonku u dijarea.
Important information about some of the ingredients of Kaletra
Kaletra fih polyoxyl 40 hydrogenated castor oil.
Sunset yellow [E110], a component of Kaletra soft capsules, can cause allergic-type reactions including asthma.
Kaletra fih il- potassju bħala acesulfame potassium, li jista ’ jikkawża ħsara f’ persuni li jkunu qegħdin fuq dieta li fiha ammont baxx ta ’ potassju.
Allergy is more common in those people who are allergic to aspirin.
Livell għoli ta ’ potassju fid- demm jista ’ jikkawża taqlib fl - istonku u dijarea.
HOW TO TAKE KALETRA
KIF GĦANDEK TIEĦU KALETRA
It is important that you take Kaletra every day exactly as your doctor prescribed it.
Kaletra huwa rrakkomandat għall- użu minn adulti u tfal ta ’ sentejn jew akbar li huma nfettati bl- HIV.
Even if you feel better, do not stop taking Kaletra without talking to your doctor.
Oqgħod attent meta tkun qiegħed tagħti d- dożaġġ lit- tfal.
Using Kaletra as recommended should give you the best chance to delay the development of resistance to the product.
- Huwa importanti li d- dożi kollha tas- soluzzjoni orali Kaletra jittieħdu ma ’ l- ikel.
How and when should Kaletra be taken
- Dejjem ħu Kaletra eżatt kif qallek it- tabib tiegħek.
Always take Kaletra exactly as your doctor has told you.
Kemm għandek tieħu Kaletra u fi x’ ħin?
You should check with your doctor or pharmacist if you are not sure.
12 - il siegħa, flimkien ma ’ mediċini oħra għal kontra l- HIV.
The usual adult dose is 3 capsules twice a day i.e. every 12 hours, in combination with other anti-HIV medicines.
- Fil- każ tat- tfal, it- tabib tiegħek jiddeċiedi d- doża t- tajba li għandha tingħata bbażata fuq it- tul u l -
For children, your doctor will decide the right dose based on the child’s height and weight.
- Kaletra jiġi fornut ukoll bħala pilloli miksija b’ rita li fihom 200 mg lopinavir u 50 mg ritonavir u
It is important that all doses of Kaletra are taken with food.
Nista ’ nieqaf nieħu Kaletra jew inbiddel id- doża?
Do not alter or discontinue the daily dose of Kaletra without first consulting with your doctor.
- Twaqqafx Kaletra u tbiddilx id- doża ta ’ Kaletra li tieħu kuljum qabel ma l- ewwel tikkonsulta
Kaletra should be taken twice every day to help control your HIV, no matter how much better you feel.
- Dejjem għandek tieħu Kaletra darbtejn kuljum biex il- mediċina tgħin biex tikkontrollalek l -
If a side effect is preventing you from taking Kaletra as directed tell your doctor right away.
- Bl- użu ta ’ Kaletra kif irrakkomandat għalik, int għandek l- aħjar ċans li tnaqqas ir- rittmu li bih
Always keep enough Kaletra on hand so you don’t run out.
tiżviluppa r- reżistenza għall- prodott.
When you travel or need to stay in the hospital make sure you will have enough Kaletra to last until you can get a new supply.
- Jekk inti m’ intix tieħu Kaletra kif qallek it- tabib tiegħek minħabba li qiegħed tesperjenza xi effett
Continue to take this medicine until your doctor tells you otherwise.
sekondarju, informa lit- tabib tiegħek immedjatament.
If you take more Kaletra than you should
- Dejjem żomm biżżejjed Kaletra biex ma tispiċċax mingħajr il- mediċina.
If you realise you have taken more Kaletra than you were supposed to, contact you doctor right away.
ikollok bżonn tmur l- isptar, kun ċert li għandek biżżejjed Kaletra biex iservik sakemm tkun tista ’ terġa tixtri.
If you cannot reach your doctor, go to the hospital.
- Kompli ħu din il- mediċina sakemm it- tabib tiegħek jindikalek mod ieħor.
If you forget to take Kaletra
Kif għandi nkejjel id- doża korretta tas- soluzzjoni?
It is important to take the total daily dose prescribed to ensure you get maximum benefit.
Kellem lill- ispiżjar tiegħek jekk għandek diffikultà biex tiftaħ il- flixkun.
If you miss a dose, take the missed dose as soon as possible together with some food, and then continue as before.
143 5 siringi ta ’ dożaġġ huma inklużi f’ kull kartuna ta ’ Kaletra soluzzjoni orali.
Do not take a double dose to make up for a forgotten dose.
Laħlaħ is - siringa u l- planġer b’ ilma nadif.
Continue on with your normal dose on the regular schedule as prescribed by your doctor.
Erġa agħqqad is- siringa u iġbed u armi l- ilma tal- vit għal xi ftit drabi biex tlaħlaħ.
POSSIBLE SIDE EFFECTS
Jekk tieħu Kaletra aktar milli suppost
What side effects might I have with Kaletra
Jekk tinsa tieħu Kaletra
Like all medicines, Kaletra can cause side effects, although not everybody gets them.
- Jekk tinsa tieħu doża, ħu d- doża li qbist mill- aktar fis possibbli ma ’ ftit ikel, u mbagħad kompli
It may be difficult to differentiate between side effects caused by Kaletra and those which may arise due to other medicines you take at the same time or by the complications of the HIV infection.
bid- doża normali skond l- iskeda regolari, kif qallek it- tabib tiegħek.
It is important that you inform your doctor of any change in your health.
- M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
The frequency of side effects is classified as follows:
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
Very common: more than 1 out of 10 persons treated;
Effetti sekondarji KOMUNI ĦAFNA (jaffetwaw aktar minn persuna 1 minn kull 10 persuni li jieħdu Kaletra):
119 Common: less than 1 out of 10, but more than 1 out of 100 persons treated; Uncommon: less than 1 out of 100, but more that 1 out of 1,000 persons treated; Rare: less than 1 out of 1,000, but more that 1 out of 10,000 persons treated.
- Ir- riskji dejjiema li jistgħu jwasslu għall- kumplikazzjonijiet, bħal attakki tal- qalb jew attakk ta ’
The most common side effects (> 1/10) of Kaletra are diarrhoea and increased triglycerides, increased total cholesterol, and increased GGT.
puplesija minħabba żieda fit- trigliċeridi u fil- kolesterol, għadhom m’ humiex magħrufa.
Other common side effects (> 1/100 and < 1/10) of Kaletra are: insomnia; headache, paresthesia; nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence, gastrointestinal disorder; rash, lipodystrophy, acne; asthenia, pain; increased glucose, increased amylase, increased SGOT/AST, increased SGPT/ALT, liver function tests abnormal.
- It- tabib tiegħek iżommok taħt osservazzjoni, u jista ’ jagħtik mediċini oħra jekk ikun hemm il -
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
- Żidiet kbar fl- ammont tat- trigliċeridi (xaħmijiet fid- demm) ġew ikkunsidrati bħala fattur ta ’ riskju
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’).
Effetti sekondarji KOMUNI (jaffetwaw minn 1 sa 10 persuni minn kull 100 persuna li jieħdu Kaletra):
The cause and long-term health effects of these conditions are not known at this time.
- Tibdil fil- forma tal- ġisem minħabba tibdil fid- distribuzzjoni tax- xaħam;
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
- Żieda fil- glukosju, żieda fl- amylase (enżima fis- sistema diġestiva), żieda fl- enżimi tal- fwied;
The long-term risks for complication such as heart attacks or stroke due to increases in triglycerides and cholesterol are not known at this time.
- Nawseja, rimettar, uġigħ addominali, skart tal- ġisem mhux normali, indiġestjoni, gass, problemi
Your doctor will monitor you and may prescribe other medicines if needed.
- Tnemnim, tingiż jew tittarrax il- ġilda.
In addition, large increases in the amount of triglycerides (fats in the blood) have also been considered a risk factor for pancreatitis.
Aktar tagħrif dwar in- nawseja, rimettar, u uġigħ addominali Għarraf lit- tabib tiegħek jekk tesperjenza nawseja, rimettar jew uġigħ addominali għax dawn jistgħu jkunu sinjali ta ’ pankreatite.
Pancreatitis should be considered if you experience clinical symptoms (nausea, vomiting, abdominal pain) which may be suggestive of this condition.
Tibdil fil- forma tal- ġisem minħabba tibdil fid- distribuzzjoni tax- xaħam It- terapija antiretrovirali kombinata tista ’ tikkawża tibdil fil- forma tal- ġisem minħabba tibdil fid - distribuzzjoni tax- xaħam.
If you experience these symptoms, tell your doctor.
Il- kawża u l- effetti dejjiema fuq is- saħħa ta ’ dawn il- kundizzjonijiet għadhom m’ humiex magħrufa.
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this treatment or another protease inhibitor.
Effetti sekondarji MHUX KOMUNI (jaffetwaw minn 1 sa 10 persuni minn kull 1, 000 persuna li jieħdu Kaletra):
Should this happen to you, seek immediate advice from your doctor.
- Numru baxx ta ’ ċelloli ħomor tad- demm, numru baxx ta ’ ċelloli bojod tad- demm, żieda fid- daqs
Cases of diabetes mellitus or increased blood sugars have been reported in patients receiving Kaletra.
- Tisma ’ ħsejjes f’ widna waħda jew fiż- żewġ widnejn, bħal żanżin, ċempil jew tisfir;
Abnormal liver function tests, hepatitis, and rarely jaundice, have been reported in patients taking Kaletra.
- Tħoss qalbek tgħaġġel, tħoss qalbek tieqaf jew tħabbat ħafna, attakk ta ’ qalb, nefħa u/ jew
Some people had other illnesses or were taking other medicines.
akkumulazzjoni ta ’ fluwidu fil- pulmuni;
People with pre-existing liver disease or hepatitis may have worsening of liver disease.
- Nefħa fiż- żaqq, stitikezza, nixfa fil- ħalq, diffikultà biex tibla ’, infjammazzjoni tal- musrana ż -
There have been reports of muscle pain, tenderness or weakness, particularly in combination with antiretroviral therapy including protease inhibitors and nucleoside analogues.
żgħira u l- kbira, tifwiq, infjammazzjoni tal- pajp ta ’ l- ikel, ma tkunx tista ’ tikkontrolla l- għamil ta ’ l- awrina, infjammazzjoni ta ’ l- istonku u l- musrana, dijarea bid- demm, tiġriħ fil- ħalq, infjammazzjoni tal- frixa, infjammazzjoni tal- glandola tal- bżieq, infjammazzjoni fil- ħalq, ulċeri fil- ħalq, infjammazzjoni tal- ħanek;
On rare occasions these muscle disorders have been serious (rhabdomyolysis).
- Uġigħ fis- sider, uġigħ fis- sider taħt l- isternu, tħoss id- dehxiet, deni, sintomi li jixbhu lil dawk ta ’
Uncommon side effects (> 1/1000 and < 1/100 patients) that may occur with Kaletra:
l- influwenza, tħossok m’ intix f’ sikktek, akkumulazzjoni ta ’ fluwidu f’ riġlejk jew madwar l - għekieżi, interazzjoni ma ’ mediċini oħra;
Infection and infestation: otitis media, bronchitis, sinusitis, furunculosis, bacterial infection, viral infection;
- Nuqqas ta ’ funzjoni tat- testikoli, is- sindromu Cushing (Cushing syndrome) (kundizzjoni
Neoplasms benign, malignant and unspecified: skin benign neoplasm, cyst;
kkawżata minn livell għoli ta ’ cortisol fid- demm), il- glandola tat- tirojde ma taħdimx kemm sippost;
Blood disorders: anaemia, leucopenia and lymphadenopathy;
- Infjammazzjoni tal- widna tan- nofs, infjammazzjoni tal- bronki, infjammazzjoni tas- sinus,
Endocrine disorders: hypogonadism male, Cushing syndrome, hypothyroidism;
imsiemer li jerġgħu ifeġġu, infezzjoniji tal- batterji, infezzjoni virali;
Metabolic and nutritional disorders: avitaminosis, dehydration, oedema, increased appetite, lactic acidosis, obesity, anorexia, diabetes mellitus, hyperglycaemia, hypocholesteremia;
- Tnaqqis fit- tolleranza tal- glukosju, żieda fil- piż, tnaqqis fil- piż, żieda fil- bilirubin (kulur tal -