qanastek/EMEA-V3 huggingface dataset:
Preliminary clinical data suggest the adefovir-associated resistance mutation rtA181V may confer a reduced susceptibility to lamivudine, and the lamivudine-associated mutation rtA181T may confer a reduced susceptibility to adefovir dipivoxil.
Informazzjoni klinika preliminarja tissuġġerixxi l- mutazzjoni rtA181V assoċjata mar - reżistenza għal adefovir tista ’ tikkawża tnaqqis fis- suxxettibilità għal lamivudine, u l- mutazzjoni rtA181T assoċjata ma ’ lamivudine tista ’ tikkawża tnaqqis fis- suxxettibbilità għal adefovir dipivoxil.
Adefovir dipivoxil is a dipivaloyloxymethyl ester prodrug of the active substance adefovir.
Adefovir dipivoxil hu prodrug dipivaloyloxymethyl ester tas- sustanza attiva adefovir.
The oral bioavailability of adefovir from 10 mg adefovir dipivoxil is 59%.
Il - biodisponibilità mill- ħalq ta ’ adefovir minn 10 mg ta ’ adefovir dipivoxil hi ta ’ 59%.
Following oral administration of a single dose of 10 mg adefovir dipivoxil to chronic hepatitis B patients, the median (range) peak serum concentration (Cmax) was achieved after 1.75 h (0.58-4.0 h).
Wara l- għoti mill - ħalq ta ’ doża waħda ta ’ 10 mg ta ’ adefovir dipivoxil lill- pazjenti b’ epatite B kronika, il- medjan (medda) ta ’ l- ogħla konċentrazzjonijietjiet fis- serum (Cmax) intlaħaq wara 1. 75 siegħa (0. 58- 4. 0 sigħat).
Median Cmax and AUC0-∞ values were 16.70 (9.66-30.56) ng/ ml and 204.40 (109.75-356.05) ng·h/ ml, respectively.
Il- valuri medjani ta ’ Cmax u AUC0- ∞ kienu ta ’ 16. 70 (9. 66- 30. 56) ng/ ml u ta ’ 204. 40 (109. 75- 356. 05) ng· h/ ml, rispettivament.
Systemic exposure to adefovir was not affected when 10 mg adefovir dipivoxil was taken with a high fat meal.
L- esponiment sistemiku għal adefovir ma kienx affettwat meta 10 mg ta ’ adefovir dipivoxil ittieħdu ma ’ ikla b’ kontenut għoli ta ’ xaħam.
The tmax was delayed by two hours.
It - tmax ittardja b’ sagħtejn.
11 Distribution:
Distribuzzjoni:
Preclinical studies show that after oral administration of adefovir dipivoxil, adefovir is distributed to most tissues with the highest concentrations occurring in kidney, liver and intestinal tissues.
Studji prekliniċi juru li wara li adefovir dipivoxil jittieħed mill- ħalq, adefovir jinfirex fil- biċċa l- kbira tat- tessuti bl- ogħla konċentrazzjonijiet li jintlaħqu fil- kliewi, fil- fwied u fit- tessut intestinali.
In vitro binding of adefovir to human plasma or human serum proteins is ≤ 4%, over the adefovir concentration range of 0.1 to 25 μ g/ ml.
It- twaħħil in vitro ta ’ adefovir mal- plażma tal- bniedem jew ma ’ proteini fis- serum tal - bniedem hi ta ’ ≤ 4%, fuq il- medda ta ’ konċentrazzjonijiet ta ’ adefovir ta ’ 0. 1 sa 25 μg/ ml.
The volume of distribution at steady-state following intravenous administration of 1.0 or 3.0 mg/ kg/ day is 392±75 and 352±9 ml/ kg, respectively.
Il- volum tad- distribuzzjoni fiss wara l- għoti ġol- vini ta ’ 1. 0 jew ta ’ 3. 0 mg/ kg/ kuljum hu ta ’ 392±75 u ta ’ 352±9 ml/ kg, rispettivament.
Following oral administration, adefovir dipivoxil is rapidly converted to adefovir.
Wara li jittieħed mill- ħalq, adefovir dipivoxil jinbidel malajr f’ adefovir.
At concentrations substantially higher (> 4,000-fold) than those observed in vivo, adefovir did not inhibit any of the following human CYP450 isoforms, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
F’ konċentrazzjonijiet sostanzjalment ogħla (> 4, 000- darba) minn dawk osservati in vivo, adefovir ma jimpedixxi l- ebda wieħed mill- iżoformi ta ’ CYP450 umani li ġejjin, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
Based on the results of these in vitro experiments and the known elimination pathway of adefovir, the potential for CYP450 mediated interactions involving adefovir with other medicinal products is low.
Ibbażat fuq dawn ir- riżultati ta ’ esperimenti in vitro u r- rotta ta ’ eliminazzjoni magħrufa ta ’ adefovir, il- potenzjal għal interazzjonijiet medjati ta ’ CYP450 li jinvolvu adefovir ma ’ prodotti mediċinali oħra huwa baxx.
Adefovir is excreted renally by a combination of glomerular filtration and active tubular secretion.
Adefovir jitneħħa mill- ġisem permezz tal- kliewi b’ kumbinazzjoni ta ’ filtrazzjoni glomerulari u sekrezzjoni tubulari attiva.
The median (min-max) renal clearance of adefovir in subjects with normal renal function (Clcr > 80 ml/ min) is 211 ml/ min (172-316 ml/ min), approximately twice calculated creatinine clearance (Cockroft-Gault method).
It- tneħħija mill- kliewi medjana (minima- massima) ta ’ adefovir f’ suġġetti b’ funzjoni renali normali (Clcr > 80 ml/ min) hi ta ’ 211 ml/ min (172- 316 ml/ min), bejn wieħed u ieħor darbtejn ir- rata mkejla ta ’ tneħħija tal- krejatinina (metodu ta ’ Cockroft- Gault).
After repeated administration of 10 mg adefovir dipivoxil, 45% of the dose is recovered as adefovir in the urine over 24 hours.
Wara l- għoti ripetut ta ’ 10 mg ta ’ adefovir dipivoxil, 45% mid- doża tinġabar bħala adefovir fl- awrina
Plasma adefovir concentrations declined in a biexponential manner with a median terminal elimination half-life of 7.22 h (4.72-10.70 h).
Il- konċentrazzjonijiet ta ’ adefovir fil- plażma naqsu b’ mod bi- esponentali bil - medjan tal- half- life ta ’ l- eliminazzjoni jkun ta ’ 7. 22 sigħat (4. 72- 10. 70 sigħat).
The pharmacokinetics of adefovir are proportional to dose when given as adefovir dipivoxil over the dose range of 10 to 60 mg.
Il- farmakokinetiċi ta ’ adefovir huma proporzjonali għad- doża meta mogħtija bħala adefovir dipivoxil fuq il- medda tad- doża ta ’ bejn 10 u 60 mg.
Repeated dosing of adefovir dipivoxil 10 mg daily did not influence the pharmacokinetics of adefovir.
Dożaġġ ripetut ta ’ 10 mg ta ’ adefovir dipivoxil kuljum ma influwenzax il- farmakokinetiċi ta ’ adefovir.
Gender, age and ethnicity:
Sess, età u etniċità:
The pharmacokinetics of adefovir were similar in male and female patients.
Il- farmakokinetiċi ta ’ adefovir kienu simili fl- irġiel u fin- nisa.
Pharmacokinetic studies have not been conducted in children or in the elderly.
Ma sarux studji farmakokinetiċi fit- tfal u fl- anzjani.
Pharmacokinetic studies were principally conducted in Caucasian patients.
L- istudji farmakokinetiċi saru prinċipalment fuq pazjenti Kawkasi.
The available data do not appear to indicate any difference in pharmacokinetics with regard to race.
L- informazzjoni disponibbli ma tidhirx li tindika xi differenza fil- farmakokinetiċi f’ dak li jirrigwarda r- razza.
The pharmacokinetics of adefovir dipivoxil were studied in an efficacy and safety study of a daily dose of 0.25 mg/ kg to 10 mg adefovir dipivoxil in children (aged 2 to < 18 years).
Il- farmakokinetiċi ta ’ adefovir dipivoxil ġew studjati fi studju dwar l- effikaċja u s - sigurtà ta ’ doża kuljum ta ’ 0. 25 mg/ kg sa 10 mg ta ’ adefovir dipivoxil fit- tfal (ta ’ bejn 2 sa < 18- il sena).
Pharmacokinetic analysis revealed that adefovir exposure was comparable among 3 age groups, 2 to 6 years (0.3 mg/ kg), 7 to 11 years (0.25 mg/ kg) and 12 to 17 years (10 mg) and all age groups achieved adefovir exposure in the target range (for efficacy results see section 5.1), which was based on adefovir plasma concentrations in adult patients with chronic hepatitis B with established safety and efficacy profiles.
It- targit tfassal abbażi ta ’ konċentrazzjonijiet ta ’ adefovir fil- plażma f’ pazjenti adulti b’ epatite B kronika li għandhom profil ta ’ sigurtà u effikaċja magħruf.
The mean (± SD) pharmacokinetic parameters of adefovir following administration of a single dose of 10 mg adefovir dipivoxil to patients with varying degrees of renal impairment are described in the table below:
Il- parametri farmakokinetiċi medji (± SD) ta ’ adefovir wara l- għoti ta ’ doża waħda ta ’ 10 mg ta ’ adefovir dipivoxil lill- pazjenti b’ rati varjabbli ta ’ indeboliment renali, huma deskritti fit- tabella t’ hawn taħt:
Renal Function Group
Grupp ta ’ Funzjoni Renali
Unimpaired
Bla indeboliment
Mild
Ħafif
Baseline Creatinine
Linja Bażi tat -
Clearance (ml/ min)
Tneħħija tal - Krejatinina (ml/ min)
(n=7) (n=8) (n=7)
(n=7)
17.8±3.2
17. 8±3. 2
22.4±4.0
22. 4±4. 0
28.5±8.6
28. 5±8. 6
51.6±10.3
51. 6±10. 3
201±40.8 469±99.0 231±48.9
201±40. 8 469±99. 0 231±48. 9
266±55.7 356±85.6 148±39.3
266±55. 7 356±85. 6 148±39. 3
455±176 237±118 83.9±27.5
455±176 237±118 83. 9±27. 5
1240±629 91.7±51.3 37.0±18.4
1, 240±629 91. 7±51. 3 37. 0±18. 4
A four-hour period of haemodialysis removed approximately 35% of the adefovir dose.
Perijodu ta ’ erba sigħat ta ’ dijaliżi tad- demm neħħa bejn wieħed u ieħor 35% tad- doża ta ’ adefovir.
The effect of peritoneal dialysis on adefovir removal has not been evaluated.
L- effett ta ’ dijaliżi peritoneali fuq it- tneħħija ta ’ adefovir ma ġiex evalwat.
12 It is recommended that the dosing interval of 10 mg adefovir dipivoxil is modified in patients with creatinine clearance between 30 and 49 ml/ min.
Hu rrakkomandat li l- intervall tad- dożaġġ ta ’ 10 mg ta ’ adefovir dipivoxil jinbidel f’ pazjenti li għandhom rata ta ’ tneħħija tal- krejatinina ta ’ bejn 30 u 49 ml/ min.
Adefovir dipivoxil is not recommended in patients with creatinine clearance of < 30 ml/ min or in patients on dialysis (see section 4.2 and 4.4).
Adefovir dipivoxil mhux rakkomandat f’ pazjenti bi tneħħija tal- krejatinina ta ’ < 30 ml/ min jew f’ pazjenti li qegħdin fuq id - dijaliżi (ara sezzjonijiet 4. 2 u 4. 4).
Pharmacokinetic properties were similar in patients with moderate and severe hepatic impairment compared to healthy volunteers (see section 4.2).
Il- karatteristiċi farmakokinetiċi kienu simili f’ pazjenti b’ indeboliment epatiku moderat jew sever meta mqabbla ma ’ voluntiera f’ saħħithom (ara sezzjoni 4. 2).
The primary dose-limiting toxic effect associated with administration of adefovir dipivoxil in animals (mice, rats and monkeys) was renal tubular nephropathy characterised by histological alterations and/ or increases in blood urea nitrogen and serum creatinine.
L- effett tossiku primarju li jillimita d- doża assoċjat ma ’ l- użu ta ’ adefovir dipivoxil f’ annimali (ġrieden, firien u xadini) kien in- nefropatija tubulari renali kkaratterizzata minn alterazzjonijiet istoloġiċi u/ jew żieda ta ’ nitroġenu ta ’ l- ureja fid- demm u serum tal- krejatinina.
Nephrotoxicity was observed in animals at systemic exposures at least 3-10 times higher than those achieved in humans at the recommended therapeutic dose of 10 mg/ day.
In- nefrotossiċità ġiet innutata f’ annimali waqt esponimenti sistemiċi li kienu mill- anqas 3- 10 darbiet ogħla minn dawk li ntlaħqu fil- bniedem fid- doża terapewtika rakkomandata ta ’ 10 mg/ kuljum.
No effects on male or female fertility, or reproductive performance, occurred in rats and there was no embryotoxicity or teratogenicity in rats or rabbits administered adefovir dipivoxil orally.
Ma kien hemm l- ebda effett fuq il- fertilità maskili jew femminili, jew fil- kapaċità riproduttiva fil - firien, u ma ’ kien hemm l- ebda embrijutossiċità jew teratoġeniċità fil- firien jew fil- fniek li ngħataw adefovir dipivoxil mill- ħalq.
When adefovir was administered intravenously to pregnant rats at doses associated with notable maternal toxicity (systemic exposure 38 times that achieved in humans at the therapeutic dose) embryotoxicity and an increased incidence of foetal malformations (anasarca, depressed eye bulge, umbilical hernia and kinked tail) were observed.
13 Meta adefovir ingħata ġol- vini lill- firien tqal f’ dożi assoċjati ma ’ tossiċità materna notevoli (esponiment sistemiku ta ’ 38 darba aktar minn dak li ntlaħaq fil- bniedem bid- doża terapewtika) ġew innutati l- embrijutossiċità u żieda fl- inċidenza ta ’ malformazzjonijiet fetali (anasarka, nefħa ta ’ l- għajn fil- ħofra, ernja ta ’ l- umbeliku u denb mgħawweġ).
No adverse effects on development were seen at systemic exposures approximately 12 times that achieved in humans at the therapeutic dose.
Ma dehrux effetti avversi fuq l- iżvilupp f’ esponiment sistemiku ta ’ bejn wieħed u ieħor 12- il darba ta ’ dak li ntlaħaq fil- bniedem bid- doża terapewtika.
Adefovir dipivoxil was mutagenic in the in vitro mouse lymphoma cell assay (with or without metabolic activation), but was not clastogenic in the in vivo mouse micronucleus assay.
Adefovir dipivoxil kien mutaġeniku fl- analiżi in vitro taċ- ċellula tal- limfoma tal- ġrieden (kemm bl- attivazzjoni metabolika u kemm mingħajrha) iżda ma kienx klastoġeniku fl- analiżi mikronuklejari in vivo tal- ġrieden.
Adefovir was not mutagenic in microbial mutagenicity assays involving Salmonella typhimurium (Ames) and Escherichia coli in the presence and absence of metabolic activation.
Adefovir ma ’ kienx mutaġeniku fl- analiżi ta ’ mutaġeniċità mikrobjali li jinvolvu Salmonella typhimurium (Ames) u Escherichia coli, kemm fil- preżenza u kemm fl- assenza ta ’ l- attivazzjoni metabolika.
Adefovir induced chromosomal aberrations in the in vitro human peripheral blood lymphocyte assay without metabolic activation.
Adefovir wassal għall- aberrazzjonijet kromożomali fl- analiżi in vitro tal- limfoċiti tad - demm periferali tal- bniedem mingħajr attivazzjoni metabolika.
In long-term carcinogenicity studies in rats and mice with adefovir dipivoxil, no treatment-related increase in tumour incidence was found in mice or rats (systemic exposures approximately 10 and 4 times those achieved in humans at the therapeutic dose of 10 mg/ day, respectively).
Fi studji fit- tul ta ’ karċinoġeniċità fil- firien u fil- ġrieden b’ adefovir dipivoxil, l- ebda żieda ta ’ inċidenza ta ’ tumuri konnessa mat- trattament ma nstabet fil- ġrieden jew fil- firien (esponimenti sistemiċi ta ’ madwar 10 u 4 darbiet aktar ta ’ dawk li ntlaħqu fil- bniedem bid- doża terapewtika ta ’ 10 mg/ kuljum, rispettivament).
Pregelatinised starch Croscarmellose sodium Lactose monohydrate Talc Magnesium stearate
Pregelatinised starch Croscarmellose sodium Lactose monohydrate Talc Magnesium stearate
13 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali ghall- ħazna
Keep the bottle tightly closed.
Żomm il- flixkun magħluq sewwa.
Hepsera is supplied in high-density polyethylene (HDPE) bottles with a child-resistant closure.
Hepsera huwa pprovdut fi fliexken piknometri tal- politin (HDPE) b’ għatu li ma jinfetaħx mit- tfal.
Each bottle contains 30 tablets, silica gel desiccant and fibre packing material.
Kull flixkun fih 30 pillola, ġel dessikant tas- silika u materjal ta ’ l- ippakkjar tal- fibra.
The following pack sizes are available: outer cartons containing 1 x 30 tablet and 3 x 30 tablet bottles.
Id- daqsijiet tal- pakketti li ġejjin huma disponibbli: kartun ta ’ barra li fihom fliexkun ta ’ 30 pillola u kartun ta ’ barra li fihom 3 fliexken ta ’ 30 pillola.
6.6 Special precautions for disposal
14 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
06 March 2003 Date of last renewal:
6 ta ’ Marzu 2003 Data ta ’ l- aħħar tiġdid ta ’ l- awtorizzazzjoni:
06 March 2008
6 ta ’ Marzu 2008
Name and address of the manufacturer(s) responsible for batch release
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta ’ tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli għal- ħruġ tal- lott konċernat.
The Marketing Authorisation Holder will submit the PSURs on a yearly basis.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq ser jibgħat il- PSURs fuq bażi annwali.
17 A.
17 ANNESS III
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
CARTON AND BOTTLE LABELLING
IL- KITBA TA ’ FUQ IL - KARTUNA U T- TIKKETTA TAL- FLIXKUN
Hepsera 10 mg tablets Adefovir dipivoxil
Hepsera 10 mg pilloli Adefovir dipivoxil
Contains lactose monohydrate, see package leaflet for further information.
Fih lactose monohydrate, ara l- fuljett ta ’ tagħrif għal iktar informazzjoni.
30 tablets.
30 pillola.
3 x 30 tablets.
3 x 30 pillola.
EU/ 1/ 03/ 251/ 001 30 tablets EU/ 1/ 03/ 251/ 002 3 x 30 tablets
EU/ 1/ 03/ 251/ 001 30 pillola EU/ 1/ 03/ 251/ 002 3 x 30 pillola
Lot {number}
Lott [numru]
Hepsera [outer packaging only]
Hepsera [pakkett ta ’ barra biss]
21 PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF
Never pass it on to others.
M’ għandek qatt tgħaddiha lil persuni oħra.
if their symptoms seem the same as yours.
tagħmlilhom il- ħsara, anki jekk jidhru li jkollhom l- istess sintomi bhal tiegħek.
- If you notice any side effects that you are worried about, whether they are listed in this leaflet or
- Jekk tinnota xi effetti sekondarji tli qed tinkwieta fuqhom, kemm jekk huma msemmijin f’ dan
not, talk to your doctor or pharmacist.
il- fuljett jew le, kellem lit- tabib jew lill- ispiżjar tiegħek.
What Hepsera is and what it is used for 2.
X’ inhi Hepsera u għalxiex tintuża 2.
Before you take Hepsera 3.
Qabel ma tieħu Hepsera 3.
How to take Hepsera 4.
Kif għandek tieħu Hepsera 4.
How to store Hepsera 6.
Kif taħżen Hepsera 6.
WHAT HEPSERA IS AND WHAT IT IS USED FOR
X’ INHI HEPSERA U GĦALXIEX TINTUŻA
What Hepsera is Hepsera belongs to a group of medicines called antiviral medicines.
X’ inhi Hepsera Hepsera hija parti minn grupp ta ’ mediċini magħrufa bħala mediċini antivirali.
What it is used for Hepsera is used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults.
Għalxiex tintuża Hepsera tintuża fit- trattament ta ’ l- epatite B kronika, infezzjoni bil- virus ta ’ l- epatite B (HBV), fl - adulti.
Infection with the hepatitis B virus leads to damage to the liver.
Infezzjoni bil- virus ta ’ l- epatite B twassal għall- ħsara fil- fwied.
Hepsera reduces the amount of the virus in your body, and has been shown to reduce liver damage.
Hepsera tnaqqas l- ammont ta ’ virus f’ ġismek, u ntwera li tnaqqas il- ħsara fil- fwied.
BEFORE YOU TAKE HEPSERA
QABEL MA TIEĦU HEPSERA
Do not take Hepsera
Tieħux Hepsera
• If you are allergic (hypersensitive) to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal adefovir, adefovir dipivoxil jew sustanzi oħra ta ’ Hepsera.
Tell your doctor at once if you could be allergic (hypersensitive) to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera.
Għid lit- tabib tiegħek immedjatament jekk inti tista ’ tkun allerġiku/ a (tbati minn sensittività eċċessiva) għal adefovir, adefovir dipivoxil jew sustanzi oħra ta ’ Hepsera.
Take special care with Hepsera
Oqgħod attent/ a ħafna b’ Hepsera
• Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
• Għid lit- tabib tiegħek jekk inti kellek mard fil- kliewi, jew jekk testijiet urew li hemm problemi fil- kliewi tiegħek.
Hepsera can affect the way your kidneys work.
Hepsera tista ’ taffettwa l- mod li bih jaħdmu l- kliewi tiegħek.
Your doctor should run tests to check your kidneys and liver are working properly, before and during your treatment.
It - tabib tiegħek għandu jagħmel testijiet biex jiċċekkja jekk il- kliewi u l- fwied tiegħek hux qed jaħdmu kif suppost, qabel u matul it- trattament tiegħek.
Depending on the results, your doctor may change how often you take Hepsera.
Skond ir- riżultati, it- tabib tiegħek jista ’ jibdel kemm inti tieħu Hepsera ta ’ spiss.
• Do not use Hepsera in children or adolescents under 18 years of age.
• Tużax Hepsera fit- tfal jew f’ adolexxenti ta ’ taħt it- 18- il sena.
If you are over 65 years of age your doctor may monitor your health more closely.
Jekk għandek iktar minn 65 sena, it- tabib tiegħek jista ’ jimmonitorja s- saħħa tiegħek iktar mill- qrib.
• Don’ t stop taking Hepsera without your doctor’ s advice.
• Tieqafx tieħu Hepsera mingħajr il- parir tat- tabib tiegħek.
22 • After stopping Hepsera tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment.
23 • Wara li tieqaf tieħu Hepsera għid it- tabib tiegħek immedjatament dwar kwalunkwe sintomi ġodda, mhux tas- soltu jew li jmorru għall- agħar li tinnota wara li twaqqaf it- trattament.
Some patients have had symptoms or blood tests indicating that their hepatitis has worsened after stopping treatment with Hepsera.
Xi pazjenti kellhom sintomi jew testijiet tad- demm li jindikaw li l- epatite tagħhom marret għall - agħar wara li waqqfu t- trattament b’ Hepsera.
It’ s best for your doctor to monitor your health after stopping treatment with Hepsera.
Ikun aħjar jekk it- tabib tiegħek jimmonitorjalek saħħtek wara li twaqqaf it- trattament b’ Hepsera.
You may need blood tests for several months after treatment.
Jista ’ jkollok bżonn ta ’ testijiet tad- demm għal bosta xhur wara li t- trattament.
• Once you start taking Hepsera:
• Ġaladarba tibda tieħu Hepsera:
look out for possible signs of lactic acidosis – see section 4, Possible side effects. your doctor should order blood tests every three months to check your medicine is keeping your chronic hepatitis B infection under control.
oqgħod attent/ a għal sinjali possibbli ta ’ aċidożi lattika – ara sezzjoni 4, Effetti sekondarji li jista ’ jkollha.
• Take care not to infect other people.
Hepsera ma tnaqqasx ir- riskju li tgħaddi
Hepsera does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
l- HBV lill- oħrajn minn kuntatt sesswali jew b’ kontaminazzjoni tad- demm.
You must continue to take precautions to avoid this.
Għandek tibqa ’ tieħu l- prekawzjonijiet biex tevita li dan iseħħ.
A vaccine is available to protect those at risk from becoming infected with HBV.
Hemm tilqima disponibbli biex tipproteġi lil dawk li huma f’ riskju li jiġu infettati bl- HBV.
• If you are HIV positive this medicine will not control your HIV infection.
• Jekk inti pożittiv/ a għall- HIV, din il- mediċina mhix ser tikkontrolla l- infezzjoni ta ’ l- HIV tiegħek.
• Tell your doctor or pharmacist if you are taking any other medicines or have recently taken any, including medicines and herbal products obtained without a prescription.
• Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, li jinkludi mediċini u prodotti mediċinali li ġejjin mill- ħxejjex, anki dawk mingħajr riċetta.
• It is especially important to tell your doctor if you are taking or have recently taken any of the following medicines which may damage your kidneys, or interact with Hepsera:
• B’ mod speċjali hu importanti li tgħid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar kwalunkwe mill- mediċini li ġejjin, li jistgħu jagħmlu ħsara lill- kliewi tiegħek, jew ikollhom azzjoni reċiproka ma ’ Hepsera:
vancomycin and aminoglycosides, used for bacterial infections amphotericin B, for fungal infections foscarnet, cidofovir or tenofovir disoproxil fumarate, for viral infections pentamidine, for other types of infection.
vancomycin u aminoglycosides, li jintużaw għall- infezzjonijiet batterjali amphotericin B, għall- infezzjonijiet fungali foscarnet, cidofovir jew tenofovir disoproxil fumarate, għall- infezzjonijiet virali pentamidine, għal tipi oħrajn ta ’ infezzjoni.
Taking Hepsera with food and drink
Meta tieħu Hepsera ma ’ l- ikel u max- xorb
Hepsera can be taken with or without food.
Hepsera tista ’ tittieħed ma ’ l- ikel jew mingħajr l- ikel.
• Tell your doctor immediately if you are pregnant or planning to become pregnant.
• Għid lit- tabib tiegħek immedjatament jekk inti tqila jew jekk qed tippjana li toħroġ tqila.
It is not known whether Hepsera is safe to use during human pregnancy.
Mhux magħruf jekk Hepsera hiex sigura biex tintuża matul it- tqala fil- bniedem.
• Use an effective method of contraception to avoid becoming pregnant if you are a woman of child-bearing age taking Hepsera.
• Uża metodu effettiv ta ’ kontraċezzjoni biex tevita li toħroġ tqila jekk inti mara f’ età li jista ’ jkollok it- tfal li qed tieħu Hepsera.
• Do not breast-feed while taking Hepsera.
• M’ għandekx tredda ’ waqt li tkun qed tieħu Hepsera.
It is not known whether the active substance in this medicine passes into breast milk.
Mhux magħruf jekk is- sustanza attiva f’ din il- mediċina tgħaddix fil- ħalib tas- sider.
Hepsera contains lactose If you are lactose-intolerant, or if you have been told that you have an intolerance to some sugars, talk to your doctor before taking Hepsera.
24 Hepsera fiha lactose Jekk għandek intolleranza għal lactose, jew jekk qalulek li għandek intolleranza għal xi tipi ta ’ zokkor, kellem lit- tabib tiegħek qabel ma tieħu Hepsera.
HOW TO TAKE HEPSERA
KIF GĦANDEK TIEĦU HEPSERA
It is important to take Hepsera exactly as your doctor has told you to make sure that your medicine is fully effective and to reduce the development of resistance to the treatment.
Hu importanti li tieħu Hepsera skond il- parir tat- tabib tiegħek biex tiżgura li l- mediċina tiegħek tkun effettiva b’ mod sħiħ u tnaqqas l- iżvilupp tar- reżistenza għat- trattament.
Check with your doctor or pharmacist if you are not sure how to take Hepsera.
Aċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju dwar kif tieħu Hepsera.
• The usual dose is one 10 mg tablet each day, taken with or without food.
• Id- doża li ssoltu tingħata hija ta ’ pillola waħda ta ’ 10 mg kuljum, li tittieħed ma ’ l- ikel jew mingħajr l- ikel.
• A different dose may be given to patients with kidney problems.
• Doża differenti tista ’ tingħata lill- pazjenti bi problemi tal- kliewi.
If you take more Hepsera than you should
Jekk tieħu Hepsera aktar milli suppost
If you accidentally take too many Hepsera tablets, contact your doctor or nearest hospital immediately.
Jekk aċċidentalment tieħu pilloli Hepsera żejda, ikkuntattja lit- tabib tiegħek jew l- eqreb sptar immedjatament.
If you miss a dose or you vomit
Jekk tinsa tieħu doża jew tirremetti
It is important not to miss a dose.
Huwa importanti li ma tinsa tieħu doża.
• If you do miss a dose of Hepsera, take it as soon as you can, and then take your next scheduled dose at its regular time.
• Jekk tinsa tieħu doża ta ’ Hepsera, ħudha malli tkun tista ’, imbagħad ħu d- doża li jmiss fil- ħin regolari tagħha.
• If it is nearly time for your next dose, skip the missed dose.
• Jekk ikun kważi wasal il- ħin għad- doża li jmiss, tieħux id- doża li tkun qbiżt.
Do not take a double dose (two doses close together).
M’ għandekx tieħu doża doppja (żewġ dożi qrib xulxin).
• If you are sick (vomit) less than 1 hour after taking Hepsera take another tablet.
• Jekk tirremetti inqas minn siegħa wara li tkun ħadt Hepsera, ħu pillola oħra.
You do not need to take another tablet if you are sick more than 1 hour after taking Hepsera.
M’ hemmx bżonn li tieħu pillola oħra jekk tirremetti iktar minn siegħa wara li tkun ħadt Hepsera.
Effects when Hepsera is stopped
Effetti meta Hepsera titwaqqaf
Don’t stop taking Hepsera without your doctor’s advice.
Tieqafx tieħu Hepsera mingħajr il- parir tat- tabib tiegħek.
Tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment.
Għid it- tabib tiegħek immedjatament dwar kwalunkwe sintomi ġodda, mhux tas- soltu jew li jmorru għall- agħar li tinnota wara li twaqqaf it- trattament.
See section 2 for more details.
Ara sezzjoni 2 għal iktar dettalji.
If you have any questions on how to use Hepsera, ask your pharmacist or doctor.
Jekk għandek xi mistoqsijiet dwar l- użu ta ’ Hepsera, staqsi lill- ispiżjar jew lit- tabib tiegħek.
Like all medicines, Hepsera can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Hepsera jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very rare side effects (These can affect less than 1 in 10,000 people taking Hepsera)
Effetti sekondarji rari ħafna (Dawn jistgħu jaffettwaw inqas minn 1 minn kull 10, 000 pazjent li jieħdu Hepsera)
• Lactic acidosis is a serious but very rare side effect of taking Hepsera.
• L- aċidożi lattika hi effett sekondarju serju iżda rari ħafna li jseħħ meta tkun qed tieħu Hepsera.
It can cause too much lactic acid in the blood and enlargement of the liver.
Tista ’ tikkawża lactic acid iżżejjed fid- demm u tkabbir tal- fwied.
People with liver disease may also be at risk.
Nies b’ mard tal- fwied jistgħu jkunu f’ riskju wkoll.
Some of the signs of lactic acidosis are:
25 Xi sinjali ta ’ l- aċidożi lattika huma:
• Feeling sick (nausea) and sickness (vomiting)
• Tħossok imdardar (tqalligħ) u tirremetti (rimettar)
• Stomach pain
• Uġigħ addominali (żaqq)
24 Contact your doctor at once if you get any of these symptoms.
Ikkuntattja it- tabib tiegħek immedjatament jekk ikollok xi wieħed minn dawn is- sintomi.
They are the same as some of the common side effects of Hepsera.
Dawn huma l- istess bħal xi effetti sekondarji komuni ta ’ Hepsera.
If you do get any of them, it is unlikely to be serious, but you need to check.
Jekk ikollok xi wieħed minnhom, mhux mistenni li jkun serju, iżda jeħtieġ li tiċċekkja.
Your doctor will monitor you regularly while you take Hepsera.
It- tabib tiegħek ser jimmonitorjak regolarment meta tkun qed tieħu Hepsera.
Common side effects (These can affect 1 to 10 in every 100 people taking Hepsera)
Effetti sekondarji komuni (Dawn jistgħu jaffettwaw minn 1 sa 10 minn kull 100 pazjent li jieħdu Hepsera)
• Headache
• Uġigħ ta ’ ras
• Feeling sick (nausea)
• Tħossok imdardar (tqalligħ)
• Diarrhoea
• Dijarea
• Digestive problems including wind or discomfort after eating meals
• Problemi diġestivi li jinkludi gass jew skonfort wara li tiekol xi ikla
• Kidney problems, as shown by blood tests
• Problemi fil- kliewi, kif muri mit- testijiet tad- demm
Tell a doctor or pharmacist if you are worried about any of these.
Għid lil tabib jew spiżjar jekk qed tinkwieta dwar xi effett sekondarju minn dawn.
Very common side effects (These can affect more than 10 in every 100 people taking Hepsera)
Effetti sekondarji komuni ħafna (Dawn jistgħu jaffettwaw iktar minn 10 minn kull 100 pazjent li jieħdu Hepsera)
• Weakness
• Dgħjufija
Tell a doctor or pharmacist if you are worried about this.
Għid lil tabib jew spiżjar jekk qed tinkwieta dwar dan.
Side effects before or after having a liver transplant
Effetti sekondarji qabel jew wara trapjant tal- fwied
Some patients have experienced: • Rash and itching – common
Xi pazjenti kellhom: • Raxx u ħakk - komuni
• Feeling sick (nausea) or being sick (vomiting) – common
• Tħossok imdardar (tqalligħ) jew tibda tirremetti (rimettar) - komuni
• Kidney failure – common
• Kollass tal- kliewi - komuni
• Kidney problems – very common
• Problemi fil- kliewi - komuni ħafna
• Also tests may show decreases in phosphate (common) or increases in creatinine (very common) in the blood.
• Flimkien ma ’ dan, it- testijiet jistgħu juru tnaqqis fil- phosphate (komuni) jew żidiet fil - krejatinina (komuni ħafna) fid- demm.
Other possible side effects
Effetti sekondarji oħra possibbli
Some patients may also experience: • Kidney failure
Xi pazjenti jista ’ jkollhom ukoll: • Kollass tal- kliewi
• Damage to kidney tubule cells
26 • Ħsara liċ- ċelluli tubuli tal- kliewi
• Muscle pain or weakness and softening of the bones (both associated with kidney problems)
• Uġigħ jew dgħjufija tal- muskoli u rtubija ta ’ l- għadam (it- tnejn marbuta ma ’ problemi tal - kliewi)
• Inflammation of the pancreas (pancreatitis)
• Infjammazzjoni tal- frixa (pankreatite)
If you notice any other effects, even ones not listed in this leaflet tell your doctor or pharmacist.
Jekk inti tinnota kwalunkwe effetti oħrajn, anki dawk li m’ humiex imsemmijin f’ dan il- fuljett, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE HEPSERA
KIF TAĦŻEN HEPSERA
Do not use after the expiry date stated on the bottle and carton after {EXP}.
Tużax wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kartuna wara {JIS}.
Do not store above 30ºC (86ºF).
Taħżinx f’ temperatura ’ l fuq minn 30ºC (86ºF).
Return any left over tablets to your pharmacist.
Ħu lura kwalunkwe pilloli li jibqa ’ għand l- ispiżjar tiegħek.
Only keep them if your doctor tells you to.
Żommhom biss jekk it- tabib tiegħek jgħidlek biex tagħmel hekk.
Medicines should not be disposed of via wastewater or household waste – this helps protect the environment.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku – dan jgħin għall- protezzjoni ta ’ l- ambjent.
What Hepsera contains
X’ fiha Hepsera
• The active substance in Hepsera is adefovir dipivoxil.
• Is- sustanza attiva f’ Hepsera hi adefovir dipivoxil.
• The other ingredients are: pregelatinised starch, croscarmellose sodium, lactose monohydrate, talc and magnesium stearate.
• Is- sustanzi l- oħra huma: pregelatinised starch, croscarmellose sodium, lactose monohydrate, talc u magnesium stearate.
What Hepsera looks like and contents of the pack
Id- dehra ta ’ Hepsera u l- kontenuti tal- pakkett
Hepsera 10 mg tablets are round, white to off-white tablets.
Il- pilloli ta ’ Hepsera 10 mg huma tondi, bojod għal abjad jagħti fil- griz.
The tablets are marked with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Il- pilloli huma mmarkati b ’ “ GILEAD ” u “ 10 ” fuq naħa waħda u b’ forma stilizzata ta ’ fwied fuq in- naħa l- oħra.
Hepsera 10 mg tablets are supplied in bottles of 30 tablets with silica gel desiccant.
Il- pilloli ta ’ Hepsera 10 mg huma pprovduti fi fliexken ta ’ 30 pillola b’ ġel dessikant tas- silika.
The silica gel desiccant is contained in either a separate sachet or a small canister and should not be swallowed.
Il- ġel dessikant tas - silika jinsab jew f’ qartas separat jew f’ kontenitur żgħir u m’ għandhux jinbela ’.
Manufacturer:
27 Manifattur:
Gilead Sciences Limited 13 Stillorgan Industrial Park Blackrock County Dublin Ireland
Gilead Sciences Limited 13 Stillorgan Industrial Park Blackrock County Dublin L- Irlanda
26 Gilead Sciences Limited IDA Business & Technology Park Carrigtohill County Cork Ireland
Gilead Sciences Limited IDA Business & Technology Park Carrigtohill County Cork L- Irlanda
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Herceptin?
X’ inhu Herceptin?
Herceptin is a powder that is made up into a solution for infusion (drip into a vein).
Herceptin huwa trab li huwa magħmul f’ soluzzjoni għal infużjoni (drip ġol- vina).
It contains the active substance trastuzumab.
Fiha s- sustanza attiva trastuzumab.
What is Herceptin used for?
Għal x’ hiex jintuża Herceptin?
Herceptin is used to treat breast cancer.
Herceptin jintuża biex jittratta l- kanċer tas- sider.
It can only be used when the cancer has been shown to ‘ express ’ HER2: this means that the cancer produces a specific protein called HER2 in large quantities on the surface of the tumour cells.
Huwa jista ’ jintuża biss meta l- kanċer jiġi muri li huwa ‘ jesprimi ’ HER2: dan ifisser li l- kanċer jipproduċi proteina speċifika, HER2, fi kwantitajiet kbar fil- wiċċ taċ- ċelloli tat- tumur.
Herceptin is used in metastatic breast cancer (when the cancer has spread to other parts of the body) and in early breast cancer (which has spread within the breast or to the glands under the arm but not to other parts of the body).
Herceptin jintuża f’ kanċer tas- sider metastatiku (meta l- kanċer ikun infirex għal partijiet oħra tal- ġisem) u f’ kanċer tas- sider bikri (li nfirex fis- sider jew fil- glandoli taħt id- driegħ iżda mhux fil- partijiet l- oħra tal- ġisem).
In metastatic breast cancer, Herceptin can be used in the following ways: • on its own in patients who have failed on at least two previous treatments; • in combination with paclitaxel or docetaxel (other anticancer medicines); • in combination with an aromatase inhibitor (another type of anticancer medicine), in women who have been through the menopause and whose cancer also expresses receptors for hormones such as oestrogen or progesterone on its surface.
F’ kanċer tas- sider metastatiku, Herceptin jista ’ jintuża f’ dawn il- modi li ġejjin: • waħidha f’ pazjenti li minn ta ’ l- anqas żewġ trattamenti oħra li ħadu qabel ma rnexxewx fuqhom; • f’ kumbinazzjoni ma ’ paclitaxel jew docetaxel (mediċini kontra l- kanċer oħra); • f’ kumbinazzjoni ma ’ inibitur aromatase (tip ieħor ta ’ mediċina kontra l- kanċer), f’ nisa li għaddew mill- menopawża u li l- kanċer tagħhom jesprimi ukoll riċevituri għal ormoni bħal ma ’ huma l - estroġenu u l- proġesteron fil- wiċċ tiegħu.
In early breast cancer, Herceptin is used after surgery, chemotherapy and radiotherapy (if applicable).
F’ kanċer tas- sider bikri, Herceptin huwa wżat wara l- kirurġija, kemoterapija u radjuterapija (fejn applikabbli).
How is Herceptin used?
Kif inhu użat Herceptin?
Herceptin treatment should only be started by a doctor who has experience in the use of anticancer medicines.
Trattament b’ Herceptin għandu jinbeda biss minn tabib li għandu esperjenza fl- użu ta ’ mediċini kontra l- kanċer.
The infusion can be associated with allergic reactions, so the patient should be monitored during and after the infusion.
L- infużjoni tista ’ tkun assoċjata ma ’ reazzjonijiet allerġiċi, għalhekk il- pazjent għandu jkun sorveljat waqt u wara l- infużjoni.
For metastatic cancer, Herceptin is given every week or every three weeks, and the treatment is continued for as long as it remains effective.
F’ każ ta ’ kanċer metastatiku, Herceptin jingħata kull ġimgħa, u t- trattament jitkompla sakemm idum effettiv.
For early cancer, Herceptin is given every three weeks for a year or until it stops being effective.
Fit- trattament ta ’ kanċer bikri, Herceptin jingħata kull tliet ġimgħat għal sena sakemm idum effettiv.
Herceptin can also be given weekly when used in combination with other anticancer medicines.
Herceptin jista ’ jingħata wkoll kull ġimgħa meta użat f’ kumbinazzjoni ma ’ mediċini oħra kontra l- kanċer.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
Għal dettalji sħaħ dwar id- dożaġġ, ara s- Sommarju tal- Karatteristiċi tal- Prodott (kif ukoll parti mill - EPAR)
HER2, a receptor for epidermal growth factor, which is found on the surface of certain tumour cells.
Is- sustanza attiva f’ Herceptin, trastuzumab, hija antikorp monoklonali.
By binding to the receptor, trastuzumab activates certain cells of the immune system (the body ’ s natural defences), which then kill the tumour cells.
Antikorp monoklonali huwa antikorp (tip ta ’ proteina) li ġie iddisinnjat biex jagħraf u jorbot struttura speċifika (imsejħa antiġen) li tinstab fuq ċertu ċelloli fil- ġisem.
Trastuzumab also prevents HER2 from breaking, which otherwise leads to a signal for the tumour cells to grow.
Trastuzumab ġie iddisinnjat biex jorbot ma ’ HER2, riċevitur għal fattur ta ’ l- iżvilupp epidermali, li jinstab fil- wiċċ ta ’ ċerti ċelloli tat- tumur.
About a quarter of breast cancers express large amounts of HER2.
Madwar kwart tal- kanċers tas- sider jesprimu f’ ammonti kbar ta ’ HER2.
How has Herceptin been studied?
Kif ġie studjat Herceptin?
All studies of Herceptin have been in cancers that express HER2.
L- istudji kollha ta ’ Herceptin kienu f’ kanċers li jesprimu HER2.
In metastatic breast cancer, Herceptin given once a week has been studied in four main studies.
F’ kanċer metastatiku tas- sider, Herceptin ġie mogħti darba kull ġimgħa u ġie studjat f’ erba ’ studji ewlenin.
One study looked at the use of Herceptin on its own in 222 patients who had failed on other types of chemotherapy before, and two looked at the use of Herceptin in combination with two other anticancer medicines (paclitaxel in 469 patients and docetaxel in 188 patients).
Studju minnhom ħares lejn l- użu waħdu ta ’ Herceptin f’ 222 pazjenti li ma rnexxewx qabel fuq tipi ta ’ kemoterapiji oħra, u tnejn ħarsu lejn l- użu ta ’ Herceptin f’ kumbinazzjoni ma ’ żewġ mediċini kontra l- kanċer oħra (paclitaxel f’ 469 pazjenti u docetaxel f’ 188 pazjenti).
These studies measured how many patients responded to treatment.
Dawn l- istudji kejlu kif il- pazjenti rrispondew għat- trattament.
The fourth study compared the combination of Herceptin and anastrozole (an aromatase inhibitor) with anastrozole alone in 208 patients.
Ir- raba ’ studju (f’ 208 pazjenti) qabbel il - kumbinazzjoni ta ’ Herceptin u anastrozole (impeditur aromatase) ma ’ anastrozole waħdu.
The main measure of effectiveness was the ‘ median progression-free survival’ (the length of time until 50% of the patients had experienced a worsening of their disease or had died).
Il- kejl ewlenija ta ’ l- effikaċja kienet is - “ sopravivenza medja ħielsa mill- progressjoni ” (it- tul ta ’ żmien sakemm 50% tal- pazjenti kienu esperjenzaw deterjorament tal- marda tagħhom jew kienu mietu).
Four additional studies looked at the response to Herceptin given once every three weeks, either on its own (two studies in a total of 177 patients), in combination with paclitaxel (in 32 patients) or in combination with docetaxel, with or without capecitabine (another anticancer medicine) in 225 patients.
Erba ’ studji addizzjonali oħra ħarsu lejn ir- rispons ta ’ Herceptin mogħti darba kull tliet ġimgħat, jew waħdu (żewġ studji f’ total ta ’ 177 pazjent, flimkien ma ’ paclitaxel (f’ 32 pazjent) jew flimkien ma ’ docetaxel, ma ’ capecitabine jew mingħajr (mediċina oħra kontra l- kanċer) f’ 225 pazjent.
In early breast cancer, Herceptin has been studied over one to two years in one main study that involved over 3,000 patients who had been first treated with surgery, chemotherapy or radiotherapy.
F’ kanċer tas- sider bikri, Herceptin ġie studjat fuq sena sa sentejn fi studju li jinvolvi 3, 000 pazjent li ġew ittrattati l- ewwel b’ kirurġija, kemoterapija jew radjoterapija.
Half of the patients received Herceptin, while the other half did not receive it.
Nofs il- pazjenti rċievew il- mediċina, waqt li n- nofs l- ieħor ma rċievewhiex.
The study measured the time until the cancer re-appeared anywhere in the body.
L- istudju kejjel iż- żmien sakemm il- kanċer reġa ’ tfaċċa x’ imkien fil- ġisem.
What benefit has Herceptin shown during the studies?
X’ benefiċċju wera Herceptin waqt l- istudji?
In metastatic breast cancer, the first study showed that 15% of the patients who had failed on other types of chemotherapy responded to Herceptin.
F’ kanċer tas- sider metastatiku, l- ewwel studju wera li 15% tal- pazjenti li ma rnexxewx fuq kemoterapiji oħra irrispondew għal Herceptin.
When Herceptin was used in addition to paclitaxel, the response rate was 48%, compared with 17% for paclitaxel on its own.
Meta Herceptin intuża flimkien ma ’ paclitaxel, ir- rata ta ’ rispons kienet ta ’ 48% imqabbla ma ’ 17% għal paclitaxel waħdu.
With docetaxel, 61% of the patients responded, compared with 34% for docetaxel on its own.
Ma ’ docetaxel, 61% tal- pazjenti rrispondew, meta mqabbel ma ’ 34% għal docetaxel waħdu.
When Herceptin was used in combination with anastrozole, the median progression-free survival was 4.8 months, compared with 2.4 months in the patients taking anastrozole on its own.
Meta Herceptin intuża f’ kumbinazzjoni ma ’ anastrozole, is- sopravivenza medja ħielsa mill- progressjoni kienet ta ’ 4. 8 xhur, meta mqabbla ma ’ 2. 4 xhur fil- pazjenti li kienu qed jieħdu anastrozole waħdu.
The additional studies showed that the effectiveness of three-weekly Herceptin was similar to that seen in studies of once-weekly Herceptin.
L- istudji addizzjonali wrew li l- effikaċja ta ’ Herceptin tliet darbiet fil- ġimgħa kien simili għal dak fi studji ta ’ Herceptin darba fil- ġimgħa.
8% of the patients who received Herceptin experienced a re-appearance of their cancer (127 out of 1,693), compared with 13% of the patients who did not receive it (219 out of 1,693).
Fl- istudju f’ kanċer tas- sider bikri, ir- riskju li l- kanċer jerġa ’ jfeġġ fl- ewwel sena kien imnaqqas b’ madwar nofs: fi 8% tal- pazjenti li rċievew Herceptin il- kanċer reġgħa feġġ mill- ġdid (127 minn 1, 693), meta mqabbel mat- 13% tal- pazjenti li ma rċevewx il- mediċina (219 minn 1, 693).
What is the risk associated with Herceptin?
X’ inhu r- riskju assoċjat ma ’ Herceptin?
Herceptin can cause cardiotoxicity (harm to the heart), including heart failure.
Herceptin jista ’ jikkaġuna kardjotossiċità (ħsara lill- qalb), inkluż kollass tal- qalb.
Care should be taken if it is given to patients who already have heart problems, and all patients need to be monitored during treatment to check their heart.
Għandha tingħata attenzjoni jekk Herceptin jingħata lill- pazjenti li diġà għandhom problemi tal- qalb, u l- pazjenti kollha għandhom jiġu sorveljati waqt it- trattament biex jiċċekkjaw il- funzjoni ta ’ qalbhom.
The most common side effects with Herceptin (seen in more than 1 patient in 10) are abdominal (tummy) pain, asthenia (weakness), chest pain, chills, fever, headache, pain, diarrhoea, nausea (feeling sick), vomiting, arthralgia (joint pain), myalgia (muscle pain) and skin rashes.
L- aktar effetti sekondarji komuni (jidhru f’ aktar minn pazjent 1 f’ 10) huma uġigħ (ta ’ żaqq) addominali, astenija (dgħjufija), uġigħ fis- sider, tertir, deni, uġigħ ta ’ ras, uġigħ, dijarea, nawsja (dardir), remettar, artralġja (uġigħ fil- ġoġi), majalġja (uġigħ fil- muskoli) u raxxijiet fil- ġilda.
For the full list of all side effects reported with Herceptin, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b ’ Herceptin, ara l- Fuljett tal- Pakkett.
Herceptin should not be used in people who are hypersensitive (allergic) to trastuzumab or to any of the other ingredients.
Herceptin m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal trastuzumab jew għal xi ingredjenti oħra.
It should also not be used in patients who have serious breathing problems when they are at rest because of their cancer, or who need oxygen therapy.
Ma għandux jintuża wkoll f’ pazjenti li għandhom problemi serji biex jieħdu n- nifs waqt il- mistrieħ minħabba l- kanċer tagħhom, jew li jeħtieġu terapija bl- ossiġenu.
Why has Herceptin been approved?
Għaliex ġie approvat Herceptin?
The Committee for Medicinal Products for Human Use (CHMP) decided that Herceptin’ s benefits are greater than its risks for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and patients with HER2 positive early breast cancer.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Herceptin huma akbar mir- riskji tiegħu fit- trattament ta ’ pazjenti b’ kanċer tas- sider metastatiku li t - tumuri tiegħu jesprimu sew HER2 u f’ pazjenti b’ kanċer tas- sider bikri HER2 pożittiv.
The Committee recommended that Herceptin be given marketing authorisation.
Il- Kumitat irrakkomanda li Herceptin jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Other information about Herceptin:
2/ 3 X’ miżuri qed jittieħdu biex jassiguraw l- użu sikur ta ’ Herceptin?
The European Commission granted a marketing authorisation valid throughout the European Union for Herceptin to Roche Registration Limited on 28 August 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Herceptin lil Roche Registration Limited fit- 28 ta ’ Awwissu 2000.
The marketing authorisation was renewed on 28 August 2005.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fit- 28 ta ’ Awwissu 2005.
The full EPAR for Herceptin can be found here.
L- EPAR sħiħ għal Herceptin jista ’ jiġi kkonsultat hawnhekk.
This summary was last updated in 09-2008.
Dan is- sommarju ġie aġġornat fi: 09- 2008.
EU/ 1/ 96/ 007/ 002
Numru ta ’ l- EU EU/ 1/ 96/ 007/ 002
Humalog
Isem inventat Humalog
100 U/ ml
Qawwa 100 U/ ml
Solution for injection
Għamla farmaċewtika Soluzzjoni għall- injezzjoni
vial (glass)
Il- pakkett kunjett (ħġieġ)
10 ml (3.5 mg/ ml)
Kontenut 10 ml (3. 5 mg/ ml)
1 vial
Daqs tal- pakkett kunjett 1
5 cartridges
5 skrataċ
Humalog HumaJect
Humalog Humaject
cartridge (glass) in pre-filled pen
skartoċċ (ħġieġ) ġo pinna mimlija għal- lest
5 pens
5 pinen
Humalog Pen
Humalog Pinna
Humalog Mix25 Pen
Humalog Mix25 Pinna
Humalog Mix50 Pen
Humalog Mix50 Pinna
Humalog NPL Pen
Humalog NPL Pinna
1 vial
kunjett 1
5 x 1 vial
5 x kunjett 1
2 x 5 cartridges
2 x 5 skrataċ
EU/ 1/ 96/ 007/ 024
1/ 2 EU/ 1/ 96/ 007/ 024
2x 5 pens
2 x 5 pinen
2 x 5 pens
2 x 5 pinen
2 x 5 cartridges
5 skrataċ
Humalog NPL Pen
Humalog Pinna
2 x 5 pens
5 pinen
Humalog 100 U/ ml, solution for injection in vial
Humalog 100 U/ ml, soluzzjoni għall- injezzjoni f’ kunjett
One ml contains 100U (equivalent to 3.5mg) insulin lispro (recombinant DNA origin produced in E. coli).
1 ml fih 100 U (ekwivalenti għal 3. 5mg) t' insulina lispro (ta ’ oriġini rikombinanti tad- DNA magħmul minn E. coli).