qanastek/EMEA-V3 huggingface dataset:
Baraclude oral solution contains the preservatives methylhydroxybenzoate and propylhydroxybenzoate, that may cause allergic reactions (possibly delayed).
Baraclude soluzzjoni orali fiha l- preservattivi methylhydroxybenzoate u propylhydroxybenzoate, li jistgħu jikkawżaw reazzjonijiet allerġiċi (possibbilment imdewmin).
Entecavir is not a substrate, an inducer or an inhibitor of cytochrome P450 (CYP450) enzymes (see section 5.2).
Enetcavir m’ huwiex sottostrat, inducer jew impeditur ta ’ enżimi ta ’ cytochrome P450 (CYP450) (ara sezzjoni 5. 2).
4.6 Pregnancy and lactation
37 4. 6 Tqala u Treddigħ
Given that the potential risks to the developing foetus are unknown, women of child-bearing potential should use effective contraception.
Minħabba li r- riskji potenzjali fuq il- fetu li jkun qed jiżviluppa m’ humiex magħrufa, nisa li għandhom il- potenzjal li jkollhom it- tfal iridu jużaw kontraċezzjoni effettiva.
Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
Għalhekk għandhom jintużaw interventi xierqa biex jipprevjenu li t- tarbija li tkun għadha kif twieldet tieħu l- HBV.
35 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Assessment of adverse reactions is based on four clinical studies in which 1,720 patients with chronic hepatitis B infection received double-blind treatment with entecavir 0.5 mg/ day (n = 679), entecavir 1 mg/ day (n = 183), or lamivudine (n = 858) for up to 107 weeks.
Il- valutazzjoni ta ’ l- effetti negattivi hija bbażata fuq erba ’ studji kliniċi, fejn 1, 720 pazjent b’ infezzjoni kronika ta ’ l- epatite B irċevew trattament double blind b’ 0. 5 mg/ jum (n= 679) ta ’ entecavir, b’ 1 mg/ jum (n= 183) ta ’ entecavir jew lamivudine (n= 858) sa 107 ġimgħat.
The safety profiles of entecavir and lamivudine, including laboratory test abnormalities, were comparable in these studies.
Il- profili tas- sigurtà ta ’ entecavir u lamivudine, inkluż anomaliji tat- testijiet tal- laboratorju, kienu komparabbli f’ dawn l - istudji.
The safety profile is based on treatment exposure to entecavir 0.5 mg once daily for a median of 53 weeks.
Il- profil tas- sigurtà huwa bbażat fuq studju ta ’ pazjenti li ħadu 0. 5 mg ta ’ entacavir darba kuljum għal medja ta ’ 53 ġimgħa.
Albumin levels < 2.5 g/ dl occurred in < 1% of patients, amylase levels > 3 times basel ine in 2%, lipase levels > 3 times baseline in 11% and platelets < 50,000/mm3 in < 1%.
38 Livelli ta ’ l- albumina ta ’ < 2. 5 g/ dl instabu f ’ < 1% tal- pazjenti, livelli ta ’ amylase > 3 darbiet iktar mil - linja bażi fi 2%, livelli ta ’ lipase > 3 drabi l- linja bażi fi 11% u platelets < 50, 000/ mm3 fi < 1%.
Treatment beyond 48 weeks: continued treatment with entecavir for a median duration of 96 weeks did not reveal any new safety signals.
Trattament itwal minn 48 gimgha: kontinwazzjoni ta ’ trattament b’ entecavir għal tul medju ta ’ 96 ġimgħa ma wrietx sinjali ġodda dwar is- sigurtà tiegħu.
Experience in lamivudine-refractory patients:
Esperjenza f’ pazjenti li huma refrattarji għal lamivudine:
36 Laboratory test abnormalities:
Anomaliji fit- testijiet tal- laboratorju:
Experience in patients co-infected with HIV: the safety profile of entecavir in a limited number of HIV/ HBV co-infected patients on lamivudine-containing HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4).
Esperjenza f’ pazjenti infettati fl- istess ħin bl- HIV: il- profil tas- sigurtà ta’ entecavir f’ numru limitat ta ’ pazjenti infettati bl- HIV/ HBV li kienu fuq lamivudine bħala parti mit- terapija HAART (terapija
Decompensated cirrhosis: a higher rate of serious hepatic adverse events has been observed in patients with decompensated cirrhosis compared with rates in patients with compensated liver function.
Ċirrożi di- kumpensata: rata ogħla ta ’ avvenimenti avversi epatiċi serji ġiet osservata f’ pazjenti b’ ċirrożi di- kumpensata meta mqabbla ma ’ rati f’ pazjenti b’ funzjoni tal- fwied ikkumpensata.
Pharmacotherapeutic group: nucleoside and nucleotide reverse transcriptase inhibitors ATC code:
Kategorija farmakoterapewtika: nucleoside u nucleotide reverse transcriptase inhibitors Kodiċi ATC:
In HBV combination assays in cell culture, abacavir, didanosine, lamivudine, stavudine, tenofovir or zidovudine were not antagonistic to the anti-HBV activity of entecavir over a wide range of concentrations.
40 F’ assaġġi ta ’ kombinazzjoni ta ’ HBV f’ kultura ta ’ ċelloli, abacavir, didanosine, lamivudine, stavudine, tenefovir u zidovudine ma kienux antagonistiċi għall- attività ta ’ entecavir kontra HBV fuq medda wiesgħa ta ’ konċentrazzjonijiet.
Resistance in cell culture: relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.
Reżistenza f’ kultura ta ’ ċelloli: fir- rigward ta ’ HBV wild- type, virusijiet LVDr li fihom sostituzzjonijiet ta ’ rtM204V u rtL180M fir- reverse transcriptase juru suxxettibilità ta ’ 8 darbiet inqas għal entecavir.
Incorporation of additional ETVr amino acid changes rtT184, rtS202 or rtM250 decreases entecavir susceptibility in cell culture.
L- inkorporazzjoni ta ’ aċidu amminiku addizzjonali ETVr tbiddel l- rtT184, rtS202 u/ jew l- rtM250 tnaqqas is- suxxettibilità għal entecavir f’ kultura ta ’ ċelloli.
Substitutions observed in clinical isolates (rtT184A, C, F, G, I, L, M or S; rtS202 C, G or I; and/ or rtM250I, L or V) further decreased entecavir susceptibility 16- to 741-fold relative to wild-type virus.
Is- sostituzzjonijiet osservati fl- iżolati kliniċi (rtT184A, C, F, G, I, L, M jew S; rtS202 C, G jew I; jew rtM250I, L jew V) komplew inaqqsu s- suxxettibilità għal entecavir bejn 16 u 741 darba relattiv għall- virus wild- type.
Baseline ALT levels ≥ 2 x ULN and baseline HBV DNA ≤ 9.0 log10 copies/ ml were
Linji bażi għoljin ta ’ Knodell necro- nflammatory scores (> 10) ġew assoċjati ma ’ titjib ikbar fl- istoloġija f’ pazjenti li huma nucleoside naïve.
38 both associated with higher rates of virologic response (Week 48 HBV DNA < 400 copies/ ml) in nucleoside-naive HBeAg-positive patients.
Livelli ta ’ ALT ta ’ linja bażi ta ’ ≥ 2 x l- ULN u DNA ta ’ HBV ta ’ linja bażi ≤ 9. 0 log10 kopji/ ml kienu t- tnejn li huma assoċjati ma ’ rati ogħla ta ’ titjib viroloġiku (Ġimgħa 48 DNA ta ’ HBV < 400 kopja/ ml) f’ pazjenti li huma nucleoside naïve u pożittivi għal HBeAg.
Results at 48 weeks of randomised, double blind studies comparing entecavir (ETV) to lamivudine (LVD) in HBeAg positive (022) and HBeAg negative (027) patients are presented in the table.
Ir- riżultati wara 48 ġimgħa ta ’ studji magħmulin b’ mod każwali, double blind li jqabblu entecavir (ETV) ma ’ lamivudine (LVD) f’ pazjenti pożittivi għal HBeAg (022) u f’ pazjenti negattivi għal HBeAg (027) jidhru fit- tabella.
Nucleoside Naive
Nucleoside Naive
HBeAg Positive (study 022)
Pożittivi għal (studju 022)
HBeAg Negative (study 027)
Negattivi għal HBeAg (studju 027)
ETV LVD ETV
ETV 0. 5 mg darba kuljum
LVD 100 mg
LVD 100 mg darba kuljum
100 mg 0.5 mg
ETV LVD 100 mg 0. 5 mg darba kuljum darba kuljum
n Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
n Titijib istoloġikub Ishak fibrosis score aħjar f’ Ishak fibrosis score agħar n Tnaqqis fil- viral load (log10 kopji/ ml) c DNA ta ’ HBV ma jistax jiġi osservat (< 300 kopja/ ml skond PCR) c
314a 314a 72%* 62% 39% 35% 8% 10% 354 355
314a 72% * 39% 8% 354 - 6. 86 * 67% *
296a 70%* 36% 12% 325
314a 62% 35% 10% 355 - 5. 39 36%
287a 61% 38% 15% 313
296a 287a 70% * 61% 36% 38% 12% 15% 325 313 - 5. 04 * - 4. 53 90% * 72%
HBeAg Seroconversion *p value vs lamivudine < 0.05 a
Sirokonversjoni ta ’ HBeAg
patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ ml)
41 * valur p vs lamivudine < 0. 05 a pazjenti b’ istoloġija ta ’ linja bażi li tista ’ tiġi evalwata (Knodell Necroinflammatory Score ta ’ linja bażi ≥ 2) b punt aħħari primarju c Roche Cobas Amplicor PCR assay (LLOQ = 300 kopja/ ml)
Lamivudine-refractory HBeAg positive (study 026) n
Rifrattorji għal Lamivudine Pożittivi għal HBeAg (studju 026)
ETV 1.0
ETV 1. 0 mg darba kuljum
LVD 100 mg once daily 116a
LVD 100 mg darba kuljum
Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
n Titijib istoloġikub Ishak fibrosis score aħjar f’ Ishak fibrosis score agħar n Tnaqqis fil- viral load (log10 kopji/ ml) c DNA ta ’ HBV ma jistax jiġi osservat (< 300 kopja/ ml skond PCR) c
55%* 34%* 11% 141
124a 55% * 34% * 11% 141 - 5. 11 * 19% *
28% 16% 26% 145
116a 28% 16% 26% 145 - 0. 48 1%
39 Results beyond 48 weeks of treatment:
Riżultati wara 48 ġimgħa ta ’ trattament:
Patients in response were followed for an additional 24 weeks off- treatment.
Pazjenti b’ rispons pożittiv ġew segwiti għal 24 ġimgħa oħra bla trattament.
For 26 entecavir-treated and 28 lamivudine-treated patients who continued treatment beyond 52 weeks (median 96 weeks), 96% of entecavir-treated and 64% of lamivudine-treated patients had HBV DNA < 300 copies/ ml by PCR at end of dosing.
42 Għal 26 pazjent li ġew ittrattati b’ entecavir u 28 pazjent li ġew ittrattati għal iktar minn 52 ġimgħa (medja ta ’ 96 ġimgħa), 96% ta ’ dawk il- pazjenti ittrattati b’ entecavir u 64% ta ’ dawk il- pazjenti ttrattati b’ lamivudine kellhom DNA ta ’ HBV < 300 kopja/ ml skond il- PCR fl- aħħar tad- dożi.
For patients who met protocol-defined response criteria, response was sustained throughout the 24-week post-treatment follow-up in 75% (83/ 111) of entecavir responders vs 73% (68/ 93) for lamivudine responders in study 022 and 46% (131/ 286) of entecavir responders vs 31% (79/ 253) for lamivudine responders in study 027.
Għal pazjenti li ssodisfaw il- kriterji li ġew definiti fi protokoll, it- titjib kompla matul il- follow- up ta ’ 24 ġimgħa wara t- trattament f’ 75% (83/ 111) tal- pazjenti li rrispondew għal entecavir kontra 73% (68/ 93) għal dawk li rrispondew għal lamivudine fi studju 022 u 46% (131/ 286) ta ’ dawk li rrispondew għal entecavir meta mqabbel ma ’ 31% (79/ 253) għal pazjenti li rrispondew għal lamivudine fi studju 027.
Patients had stable controlled HIV (HIV RNA < 400 copies/ ml) with recurrence of HBV viraemia on a lamivudine-containing HAART regimen. HAART regimens did not include emtricitabine or tenofovir disoproxil fumarate.
Ir- reġimen ta ’ HAART ma nkludewx emtricitabine jew tenofovir disoproxil fumarate.
At 24 weeks the reduction in HBV viral load was significantly greater with entecavir (-3.65
Fl- 24 ġimgħa, it- tnaqqis fil- viral load ta ’ l- HBV kien ferm ogħla b’ entecavir (- 3. 65 meta mqabbel ma ’ żjieda ta ’ 0. 11 log10 kopji/ ml).
HIV/ HBV co-infected patients not receiving concomitant HAART: entecavir has not been evaluated in HIV/ HBV co-infected patients not concurrently receiving effective HIV treatment.
Pazjenti ko- infettati bl- HIV/ HBV li ma jkunux qed jingħataw HAART fl- istess ħin: entecavir ma ġiex evalwat f’ pazjenti infettati fl- istess ħin bl- HIV/ HBV li ma kinux qegħdin jirċievu fl- istess ħin kura effettiva kontra l- HIV.
Through Week 240 in nucleoside-naive studies, genotypic evidence of ETVr substitutions at rtT184, rtS202, or rtM250 was identified in 3 patients treated with entecavir, 2 of whom experienced virologic breakthrough (see table).
43 Sa Ġimgħa 240 fi studji dwar pazjenti li qatt ma ħadu nukleoside, evidenza ġenotipika ta ’ sostituzzjonijiet ETVr f’ rtT184, rtS202, jew rtM250 kienet identifikati fi 3 pazjenti kkurati b’ entecavir, u 2 minnhom kellhom breakthrough viroloġiku (ara t- tabella).
These substitutions were observed only in the presence of LVDr substitutions (rtM204Vand rtL180M).
Dawn is- sostituzzjonijiet kienu osservati biss fil- preżenza ta ’ sostituzzjonijiet LVDr (rtM204V u rtL180M).
Emerging Genotypic Entecavir Resistance Through Year 5, Nucleoside-Naive Studies a
Reżistenza Ġenotipika Ġdida għal Entecavir Sa Sena 5, Studji dwar Pazjenti li Qatt ma Ħadu Nukleoside a
41 Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies
44 Reżistenza Ġenotipika għal Entecavir Sa Sena 5, Studji dwar Pazjenti Refrattarji għal Lamivudine
Also, lamivudine-refractory patients who achieved HBV DNA < 104 log10 copies/ ml by PCR at Week 24 had a lower rate of resistance than those who did not (5-year cumulative probability 17.6% [n=50] versus 60.5% [n=135], respectively).
Dawn l- 14- il pazjent kellhom rata iktar baxxa ta ’ reżistenza għal entecavir ġenotipiku (probabbiltà kumulattiva ta ’ 18. 8% sa 5 snin ta ’ follow - up) milli fil- popolazzjoni totali tal- istudju (ara t- tabella) Flimkien ma ’ dan, pazjenti refrattarji għal lamivudine li kisbu DNA tal- HBV ta ’ < 104 log10 kopji/ ml minn PCR f’ Ġimgħa 24, kellhom rata ta ’ reżistenza iktar baxxa minn f’ dawk li ma kisbuhiex (probabbiltà kumulattiva wara 5 sena ta ’ 17. 6% [n=50] kontra 60. 5% [n=135], rispettivament).
Metabolism: entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
45 Metaboliżmu: entecavir mhuwiex sottostrat, inibitur jew inducer tas- sistema ta ’ enżimi CYP450.
42 Elimination: entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady-state of about 75% of the dose.
Eliminazzjoni: entecavir huwa eliminat b’ mod predominanti mill- kliewi b’ irkupru tad- droga mhux mibdula mill- awrina f’ konċentrazzjoni fissa ta ’ madwar 75% tad- doża.
Baseline Creatinine Clearance (ml/ min)
Clearance tal- Kreatinina ta ’ Linja Bażi (ml/ min)
Altered renal function contributed to the increase in entecavir exposure in these patients (see section 4.4).
(ara sezzjoni 4. 4)
Race: the population pharmacokinetic analysis did not identify race as significantly influencing entecavir pharmacokinetics.
46 Razza: l- analiżi farmakokinetika tal- popolazzjoni ma wrietx li r- razza għandha effett b’ mod sinifikanti fuq il- farmakokinetika ta ’ entecavir.
43 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Maltitol liquid (E965) Sodium citrate Citric acid, anhydrous Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Orange flavour (acacia and natural flavours) Sodium hydroxide to adjust pH to approximately 6 Hydrochloric acid to adjust pH to approximately 6 Purified water
Maltitol liquid (E965) Sodium citrate Citric acid, anhydrous Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Orange flavour (togħma ta ’ akaċja u togħma naturali) Sodium hydroxide għall- aġġustament tal- pH għal madwar 6 Hydrochloric acid għall- aġġustament tal- pH għal madwar 6
This medicinal product must not be mixed with water, other solvents or other medicinal products.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
44 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
2 years After opening, the solution can be used up to the expiry date on the bottle.
sentejn Wara li tinfetaħ, is- soluzzjoni tista ’ tintuża sad- data ta ’ skadenza li tidher fuq il- flixkun.
Keep the bottle in the outer carton in order to protect from light.
Żomm il- flixkun fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
210 ml oral solution in a HDPE bottles with child-resistant closures (polypropylene).
210 ml soluzzjoni orali fi fliexken ta ’ l- HDPE b’ tapp magħmul apposta biex it- tfal ma jkunux jistgħu jiftħuh (polypropylene).
Each carton includes a measuring spoon (polypropylene) with milliliter marks from 1 up to 10 ml
Kull kartuna tinkludi mgħarfa għall- qies (polypropylene) b’ marki millilitriċi minn 1 sa 10 ml
46 A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Bristol-Myers Squibb, Rue du Docteur André Gilles, 28230 Epernon, France
Bristol- Myers Squibb, Rue du Docteur André Gilles, 28230 Epernon, Franza
Bristol-Myers Squibb, La Goualle B. P.6, 19250 Meymac, France
Bristol- Myers Squibb, La Goualle B. P. 6, 19250 Meymac, Franza
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is placed on the market.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH), irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 3. 0 ippreżentata f’ Modulu 1. 8. 1. tal- Applikazzjoni għat - Tqegħid fis- Suq, tkun implimentata u taħdem qabel ma l- prodott jibda jinbiegħ.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq irid ikun obbligat li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 2. 0 tal - Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f’ Modulu 1. 8. 2 tal - Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal - RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perijodiku dwar l - Aġġornament tas- Sigurtà (Periodic Safety Update Report - PSUR) li jkun imiss.
In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached, At the request of the EMEA.
Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju), Fuq talba tal- EMEA.
OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT
KLIEM FUQ IT- TIKKETTA TA ’ BARRA (PREŻENTAZZJONIJIET TAL- FLIXKUN U TAL- FOLJI) U L- KLIEM FUQ IT- TIKKETTA TAL- FLIXKUN
Baraclude 0.5 mg film-coated tablets entecavir
Baraclude 0. 5 mg pilloli miksijin b’ rita entecavir
Each film-coated tablet contains 0.5 mg of entecavir.
Kull pillola miksija b’ rita fiha 0. 5 mg ta ’ entecavir.
30 x 1 film-coated tablets 90 x 1 film-coated tablets
30 x 1 pillola miksija b’ rita 90 x 1 pillola miksija b’ rita
50 Bottle pack:
53 Pakkett tal- flixkun:
Do not store above 25°C.
Taħżinx f' temperatura ’ l fuq minn 25°C.
Outer carton:
Kartuna ta ’ barra:
Baraclude 0.5 mg
Baraclude 0. 5 mg
51 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
54 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Baraclude 0.5 mg tablets entecavir
Baraclude 0. 5 mg pilloli entecavir
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Baraclude 1 mg film-coated tablets entecavir
Baraclude 1 mg pilloli miksijin b’ rita entecavir
Each film-coated tablet contains 1 mg of entecavir.
Kull pillola miksija b’ rita fiha 1 mg ta ’ entecavir.
53 Bottle pack:
56 Pakkett tal- flixkun:
Baraclude 1 mg tablets entecavir
Baraclude 1 mg pilloli entecavir
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
58 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND BOTTLE LABEL TEXT
KLIEM FUQ IL- KARTUNA TA ’ BARRA U FUQ IT- TIKKETTA TAL- FLIXKUN
Baraclude 0.05 mg/ ml oral solution entecavir
Baraclude 0. 05 mg/ ml soluzzjoni orali entecavir
Each ml contains 0.05 mg entecavir.
Kull ml fih 0. 05 mg ta ’ entecavir.
Also contains: maltitol, preservatives E216, E218.
Fih ukoll: maltitol, preservatives E216, E218.
210 ml oral solution with a measuring spoon.
210 ml ta ’ soluzzjoni orali b’ mgħarfa tal- kejl.
Baraclude 0.05 mg/ ml
Baraclude 0. 05 mg/ ml
58 PACKAGE LEAFLET:
61 FULJETT TA 'TAGĦRIF:
Baraclude 0.5 mg film-coated tablets Entecavir
Baraclude 0. 5 mg pilloli miksijin b’ rita Entecavir
What Baraclude is and what it is used for 2.
X’ inhu Baraclude u għalxiex jintuża 2.
Before you take Baraclude 3.
Qabel ma tieħu Baraclude 3.
How to take Baraclude 4.
Kif għandek tieħu Baraclude 4.
How to store Baraclude 6.
Kif taħżen Baraclude 6.
WHAT BARACLUDE IS AND WHAT IT IS USED FOR
X’ INHU BARACLUDE U GĦALXIEX JINTUŻA
Baraclude tablets are anti-viral medicines, used to treat chronic hepatitis B virus (HBV) infection in adults.
Il- pilloli Baraclude huma mediċini kontra virusijiet, użati sabiex jittrattaw infezzjoni kronika bil- virus ta ’ l- epatite B (HBV) fl- adulti.
Infection by the hepatitis B virus can lead to damage to the liver.
Infezzjoni bil- virus ta ’ epatite B tista ’ twassal għal ħsara fil- fwied.
Baraclude reduces the amount of virus in your body, and improves the condition of the liver.
Baraclude inaqqas l- ammont tal - virus f’ ġismek, u jtejjeb il- kundizzjoni tal- fwied.
BEFORE YOU TAKE BARACLUDE
QABEL MA TIEĦU BARACLUDE
Do not take Baraclude if you are allergic (hypersensitive) to entecavir or any of the other ingredients of Baraclude.
Tiħux Baraclude jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal entecavir jew sustanzi oħra ta ’ Baraclude.
Take special care with Baraclude if you have ever had problems with your kidneys, tell your doctor.
Oqgħod attent ħafna b’ Baraclude jekk qatt kellek xi problemi fil- kliewi, għid lit- tabib tiegħek.
This is important because Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
Dan huwa importanti minħabba li Baraclude jiġi eliminat mill- ġisem permezz tal- kliewi u jista ’ jkollok bżonn aġġustament tad - doża jew ta ’ l- iskeda ta ’ dożaġġ.
do not stop taking Baraclude without your doctor’ s advice since your hepatitis may worsen after stopping treatment.
tiqafx tieħu Baraclude mingħajr il- parir tat- tabib tiegħek minħabba li l- epatite tiegħek tista ’ tiggrava wara li twaqqaf it- trattament.
When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months.
Meta t- trattament tiegħek bi Baraclude jitwaqqaf, it- tabib tiegħek ikompli jimmonitorjak u jeħodlok it- testijiet tad- demm għal bosta xhur.
discuss with your doctor whether you have liver cirrhosis and what the possible effects on your Baraclude treatment may be.
iddiskuti mat- tabib tiegħek jekk għandekx ċirrożi tal- fwied u x’ jista ’ jiġri jekk tieħu Baraclude.
if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor.
jekk inti infettat/ a wkoll bl- HIV (virus ta ’ l- immunodefiċjenza umana) kun ċert li tgħid lit - tabib tiegħek.
You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced.
M’ għandekx tieħu Baraclude jekk għandek infezzjoni bl- epatite B sakemm ma tkunx qed tieħu mediċini għall- HIV fl- istess ħin, billi l- effikaċja ta ’ trattament futur kontra l - HIV tista ’ tonqos.
Baraclude will not control your HIV infection.
Baraclude ma jikkontrollax l- infezzjoni ta ’ l- HIV tiegħek.
taking Baraclude will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination).
Għalhekk, huwa
So, it is important to take appropriate precautions to prevent others from becoming infected with HBV.
62 importanti li jittieħdu prekawzjonijiet xierqa sabiex oħrajn ma jiġux infettati bl- HBV.
A vaccine is available to protect those at risk from becoming infected with HBV.
Hemm vaċċin disponibbli biex jipproteġi lil dawk f’ riskju li jiġu infettati bl- HBV.
59 Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Baraclude jappartjeni għal kategorija ta ’ mediċini li jistgħu jikkawżaw aċidożi lattika (eċċess ta ’ aċidu lattiku f’ demmek) u tkabbir tal- fwied.
Symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis.
Sintomi bħal dardir, rimettar u uġigħ fl - istonku jistgħu jindikaw l- iżvilupp ta ’ aċidożi lattika.
This rare but serious side effect has occasionally been fatal.
Dan l- effett sekondarju rari iżda serju, xi kultant kien fatali.
Lactic acidosis occurs more often in women, particularly if they are very overweight.
Aċidożi lattika sseħħ aktar spiss fin- nisa, b’ mod partikolari jekk huma ħoxnin ħafna.
Your doctor will monitor you regularly while you are receiving Baraclude.
It- tabib tiegħek sejjer jimmonitorjak regolarment meta tkun qed tirċievi Baraclude.
Pregnancy and breastfeeding Tell your doctor if you are pregnant or planning to become pregnant.
Tqala u treddigħ Għid lit- tabib tiegħek jekk inti tqila jew qed tippjana li tinqabad tqila.
It has not been demonstrated that Baraclude is safe to use during human pregnancy.
Ma ntweriex li Baraclude huwa bla periklu biex jintuża matul it- tqala.
Baraclude must not be used during pregnancy unless specifically directed by your doctor.
Baraclude ma għandux jintuża matul tqala sakemm dan ma jiġix speċifikament issuġġerit mit- tabib tiegħek.
It is important that women of childbearing age receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.
Huwa importanti li n- nisa, li qegħdin f’ età li jkollhom it - tfal, u li jkunu qegħdin jirċievu t- trattament bi Baraclude jużaw metodu effettiv ta ’ kontraċezzjoni sabiex jevitaw li jinqabdu tqal.
You should not breast-feed during treatment with Baraclude.
It- treddigħ m’ huwiex irrakkomandat waqt trattament bi Baraclude.
Tell your doctor if you are breastfeeding.
Avża lit- tabib tiegħek jekk inti qiegħda tredda ’.
It is not known whether entecavir, the active ingredient in Baraclude, is excreted in human breast milk.
M’ huwiex magħruf jekk entecavir, is- sustanza attiva fi Baraclude, joħroġx fil- ħalib tas- sider tal- omm.
Driving and using machines Baraclude is unlikely to affect your ability to drive or operate machines.
Sewqan u tħaddim ta 'magni Baraclude m’ huwiex mistenni li jaffettwa l- abbiltà tiegħek li ssuq jew tħaddem magni.
Dizziness, fatigue and somnolence are common side effects which may impair your ability to drive and use machines.
Sturdament, għeja u ngħas tqil huma effetti sekondarji komuni, u dawn jistgħu jfixklu l- ħila biex issuq u tħaddem magni.
If you have any concerns consult your doctor.
Jekk għandek xi dubju ikkonsulta lit- tabib tiegħek.
Important information about some of the ingredients of Baraclude tablets This medicinal product contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Baraclude Dan il- prodott mediċinali fih lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib qallek li għandek intolleranza għal xi tip ta ’ zokkor, ikkuntattjah qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE BARACLUDE
KIF GĦANDEK TIEĦU BARACLUDE
Not all patients need to take the same dose of Baraclude.
Mhux il- pazjenti kollha jistgħu jieħdu l- istess doża ta ’ Baraclude.
Always take Baraclude exactly as your doctor has told you.
Dejjem għandek tieħu Baraclude skond il- parir tat- tabib.
The usual dose is either 0.5 mg or 1 mg once daily orally (by mouth).
Id- doża li s- soltu tingħata hija jew 0. 5 mg jew 1 mg darba kuljum li tittieħed oralment (mill- ħalq).
Your dose will depend on: whether you have been treated for HBV infection before, and what medicine you received. whether you have kidney problems.
Id- doża tiegħek tiddependi fuq: jekk inti ġejtx ittrattat għal infezzjoni b’ HBV qabel, u liema mediċina ħadt. jekk għandekx problemi fil- kliewi.
Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.
It- tabib tiegħek jista ’ jippreskrivi doża inqas għalik jew jordnalek teħodha anqas ta ’ spiss minn darba kuljum.
Your doctor will advise you on the dose that is right for you.
It- tabib tiegħek jagħtik parir fuq id- doża li hija tajba għalik.
Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment.
Dejjem ħu d- doża rrakkomandata mit - tabib tiegħek sabiex tkun żgur li l- mediċina tiegħek hija effettiva għal kollox u sabiex tnaqqas l - iżvilupp ta ’ reżistenza għat- trattament.
Take Baraclude as long as your doctor has told you.
Ħu Baraclude għal kemm jgħidlek it- tabib tiegħek.
Your doctor will tell you if and when you should stop the treatment.
It- tabib tiegħek jgħidlek jekk u meta għandek twaqqaf it- trattament.
Taking Baraclude with food and drink In most cases you may take Baraclude with or without food.
Meta tieħu Baraclude ma ’ l- ikel u max- xorb Ħafna drabi tista ’ tieħu Baraclude kemm ma ’ l- ikel kif ukoll mhux ma ’ l- ikel.
However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following.
Madankollu, jekk qabel kellek trattament, b’ lamivudine għandek tqis dan li ġej.
Empty stomach means at least 2 hours after a meal or at least 2 hours before your next meal.
Jekk qlibt għal Baraclude minħabba li t - trattament b’ lamivudine ma kienx qiegħed jaħdem, għandek tieħu Baraclude fuq stonku vojt darba kuljum, jiġifieri għallinqas sagħtejn wara ikla jew għallinqas sagħtejn qabel l- ikla li jmiss tiegħek.
If you take more Baraclude than you should Contact your doctor at once.
63 Jekk tieħu Baraclude aktar milli suppost Ikkuntattja lit- tabib tiegħek minnufih.
60 If you forget to take Baraclude It is important that you do not miss any doses.
Jekk tinsa tieħu Baraclude Huwa importanti li ma taqbeż ebda doża.
If you miss a dose of Baraclude, take it as soon as possible, and then take your next scheduled dose at its regular time.
Jekk taqbeż doża ta ’ Baraclude, ħudha malajr kemm jista ’ jkun, u mbagħad ħu d- doża li jkun imissek skond il- programm fil- ħin regolari tagħha.
If it is almost time for your next dose, do not take the missed dose.
Jekk ikun wasal il- ħin tad- doża l- oħra li jkun imissek, tiħux id- doża li tkun insejt tieħu.
Wait and take the next dose at the regular time.
Stenna u ħu d- doża skedata ta ’ wara, fil- ħin li jkun imissek toħodha.
Do not stop Baraclude without your doctor’ s advice Some people get very serious hepatitis symptoms when they stop taking Baraclude.
Twaqqafx Baraclude mingħajr il- parir tat- tabib tiegħek Xi nies isofru minn sintomi ta ’ epatite serji ħafna meta jieqfu jieħdu Baraclude.
Tell your doctor immediately about any changes in symptoms that you notice after stopping treatment.
Għid lit- tabib tiegħek minnufih b’ kull bidla fis- sintomi li jkollok wara li tkun waqqaft it- trattament.
Like all medicines, Baraclude can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Baraclude jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Patients treated with Baraclude in clinical studies have reported the following side effects: very common (at least 1 in 10 patients): headache common (at least 1 in 100 patients): insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea and dyspepsia (indigestion).
Pazjenti ttrattati bi Baraclude fi studji kliniċi rrapportaw l- effetti sekondarji li ġejjin: komuni ħafna (għallinqas pazjent 1 minn kull 10): uġigħ ta 'ras komuni (għallinqas pazjent 1 minn kull 100): insomnja (diffikultà biex wieħed jorqod), għeja (għeja kbira), sturdament, ngħas (ħedla), rimettar, dijarea, dardir u dispepsja (indiġestjoni).
Some patients may also experience rash.
Xi pazjenti jista ’ wkoll ikollhom raxx.
HOW TO STORE BARACLUDE
KIF TAĦŻEN BARACLUDE
Do not use Baraclude after the expiry date which is stated on the bottle, blister or carton after EXP.
Tużax Baraclude wara d- data ta ’ skadenza li tidher fuq il- flixkun, folja jew kaxxa wara JIS.
That expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
Blister packs: do not store above 30°C.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
Store in the original carton.
Pakkett tal- flixkun:
Bottle packs: do not store above 25°C.
Taħżinx f’ temperatura ’ l fuq minn 25°C.
What Baraclude contains The active substance is entecavir.
X’ fih Baraclude Is- sustanza attiva hi entecavir.
Each film-coated tablet contains 0.5 mg entecavir.
Kull pillola miksija b’ rita fiha 0. 5 mg ta ’ entecavir.
Tablet core: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline and povidone.
Qalba tal- pillola: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline u povidone.
Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433).
Kisja tal- pillola: hypromellose, macrogol 400, titanium dioxide (E171), u polysorbate 80 (E433).
What Baraclude looks like and contents of the pack The film-coated tablets (tablets) are white to off-white and triangular-shaped.
64 Id- dehra ta 'Baraclude u l- kontenuti tal- pakkett Il- pilloli miksijin b’ rita (pilloli) huma ta ’ lewn abjad għal abjad fl- isfar u għandhom għamla trijangulari.
They are marked with “ BMS ” on one side and “ 1611” on the other.
Huma mmarkati b ’ “ BMS ” fuq naħa u “ 1611 ” fuq in- naħa l- oħra.
Baraclude 0.5 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablets (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Baraclude 0. 5 mg pilloli miksijin b’ rita jiġu f’ kaxex tal- kartun li kull kaxxa fiha 30 x 1 jew 90 x 1 pillola miksijin b’ rita (f’ folji ta ’ doża waħda) u fi fliexken li fihom 30 pillola miksijin b’ rita.
61 Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Bristol-Myers Squibb La Goualle B. P.6 19250 Meymac France
Bristol- Myers Squibb La Goualle B. P. 6 19250 Meymac Franza
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
65 Eesti Österreich BRISTOL- MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni ddettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
63 PACKAGE LEAFLET:
66 FULJETT TA 'TAGĦRIF:
Baraclude 1 mg film-coated tablets Entecavir
Baraclude 1 mg pilloli miksijin b’ rita Entecavir
So, it is important to take appropriate precautions to prevent others from becoming infected with HBV.
67 importanti li jittieħdu prekawzjonijiet xierqa sabiex oħrajn ma jiġux infettati bl- HBV.
64 Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Baraclude jappartjeni għal kategorija ta ’ mediċini li jistgħu jikkawżaw aċidożi lattika (eċċess ta ’ aċidu lattiku f’ demmek) u tkabbir tal- fwied.
If you take more Baraclude than you should Contact your doctor at once.
68 Jekk tieħu Baraclude aktar milli suppost Ikkuntattja lit- tabib tiegħek minnufih.
65 If you forget to take Baraclude It is important that you do not miss any doses.
Jekk tinsa tieħu Baraclude Huwa importanti li ma taqbeż ebda doża.
Each film-coated tablet contains 1 mg entecavir.
Kull pillola miksija b’ rita fiha 1 mg ta ’ entecavir.
Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and iron oxide red.
Kisja tal- pillola: hypromellose, macrogol 400, titanium dioxide (E171), u iron oxide red.
What Baraclude looks like and contents of the pack The film-coated tablets (tablets) are pink and triangular-shaped.
69 Id- dehra ta 'Baraclude u l- kontenuti tal- pakkett Il- pilloli miksijin b’ rita (pilloli) huma ta ’ lewn roża u għandhom għamla trijangulari.
They are marked with “ BMS” on one side and “ 1612” on the other.
Huma mmarkati b ’ “ BMS ” fuq naħa u “ 1612 ” fuq in- naħa l- oħra.
Baraclude 1 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablets (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Baraclude 1 mg pilloli miksijin b’ rita jiġu f’ kaxex tal - kartun li kull kaxxa fiha 30 x 1 jew 90 x 1 pillola miksijin b’ rita (f’ folji ta ’ doża waħda) u fi fliexken li fihom 30 pillola miksijin b’ rita.
66 Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
70 Eesti Österreich BRISTOL- MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
68 PACKAGE LEAFLET:
71 FULJETT TA 'TAGĦRIF:
Baraclude 0.05 mg/ ml oral solution Entecavir
Baraclude 0. 05 mg/ ml soluzzjoni orali Entecavir
Baraclude oral solution is an anti-viral medicine, used to treat chronic hepatitis B virus (HBV) infection in adults.
Is- soluzzjoni orali Baraclude hija mediċina kontra virusijiet, użata sabiex tittratta infezzjoni kronika bil- virus ta ’ l- epatite B (HBV) fl- adulti.
Infection by the hepatitis B virus can lead to damage to the liver.
Infezzjoni bil- virus ta ’ l- epatite B tista ’ twassal għal ħsara fil- fwied.
discuss with your doctor whether you have liver cirrhosis and what the possible effects on your Baraclude treatment may be.
iddiskuti mat- tabib tiegħek jekk għandekx ċirrożi tal- fwied u x’ jistgħu jkunu l- effetti possibbli ta ’ x’ jista ’ jiġri jekk tieħu Baraclude fuq it- trattament tiegħek.
So, it is important to take appropriate precautions to prevent others from becoming infected with HBV.
72 importanti li jittieħdu prekawzjonijiet xierqa sabiex oħrajn ma jiġux infettati bl- HBV.
69 Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Baraclude jappartjeni għal kategorija ta ’ mediċini li jistgħu jikkawżaw aċidożi lattika (eċċess ta ’ aċidu lattiku f’ demmek) u tkabbir tal- fwied.
Important information about some of the ingredients of Baraclude oral solution This medicinal product contains maltitol which may have a mild laxative effect (13 g maltitol liquid per 20 ml dose).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Baraclude soluzzjoni orali Dan il- prodott mediċinali fih maltitol li jista ’ jkollu effett lassattiv ħafif (13 g maltitol likwidu għal doża ta ’ 20 ml).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkor, ikkuntattjah qabel tieħu dan il- prodott mediċinali.
This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).
Dan il- prodott fih methylhydroxybenzoate (E218) u propylhydroxybenzoate (E216) li jistgħu jikkawżaw reazzjonijiet allerġiċi (possibbilment mhux mill- ewwel).
The usual dose is either 0.5 mg (10 ml) or 1 mg (20 ml) once daily orally (by mouth).
Id- doża li s- soltu tingħata hija jew 0. 5 mg (10 ml) jew 1 mg (20 ml) darba kuljum li tittieħed oralment (mill- ħalq).
Entecavir oral solution is designed as a ready-to-use product.
Entecavir soluzzjoni orali hija mfassla bħala prodott lest biex jintuża.
Do not dilute or mix this solution with water or anything else.
Tiddilwix jew tħallat din is - soluzzjoni ma ’ l- ilma jew ma ’ xi ħaġa oħra.
Baraclude oral solution comes with a measuring spoon with milliliter marks from 1 up to 10 milliliters.
73 Baraclude soluzzjoni orali tiġi b’ mgħarfa ta ’ dożaġġ b’ marki minn 1 sa 10 millilitri.
Use the spoon as follows:
Uża l- imgħarfa hekk:
Hold the spoon in a vertical (upright) position and fill it gradually to the mark corresponding to the prescribed dose.
Żomm l- imgħarfa f’ pożizzjoni vertikali (wieqfa) u imlieha ftit ftit sal- marka li tikkorrespondi għad- doża li trid tieħu.
Holding the spoon with the volume marks facing you, check that it has been filled to the proper mark.
Dawwar l- imgħarfa lejk biex tkun tista ’ tiċċekkja li mlejtha sad- doża li tkun trid.
Swallow the medicine directly from the measuring spoon.
Ibla ’ l- mediċina direttament mill- imgħarfa tad- dożaġġ.
After each use, rinse the spoon with water and allow it to air dry.
Wara kull użu, laħlaħ l- imgħarfa bl- ilma u ħalliha tinxef f’ arja xotta.
However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following.
Madankollu, jekk qabel kellek trattament b’ lamivudine għandek tqis dan li ġej.
Empty stomach means at least 2 hours after a meal or at least 2 hours before your next meal.
Jekk qlibt għal Baraclude minħabba li t - trattament b’ lamivudine ma kienx qiegħed jaħdem, għandek tieħu Baraclude fuq stonku vojt darba kuljum, jiġifieri, għallinqas sagħtejn wara ikla jew għallinqas sagħtejn qabel l- ikla li jmiss tiegħek.
If you take more Baraclude than you should Contact your doctor at once.
Jekk tieħu Baraclude aktar milli suppost Ikkuntattja lit- tabib tiegħek minnufih.
If you forget to take Baraclude It is important that you do not miss any doses.
Jekk tinsa tieħu Baraclude Huwa importanti li ma taqbeż ebda doża.
71 Do not use Baraclude after the expiry date which is stated on bottle or carton after EXP.
Tużax Baraclude wara d- data ta ’ skadenza li tidher fuq il- flixkun jew fuq il- kaxxa wara JIS.
Each ml of oral solution contains 0.05 mg entecavir.
Kull ml ta ’ soluzzjoni orali fih 0. 05 mg ta ’ entecavir.
The other ingredients are: citric acid anhydrous, maltitol liquid (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), orange flavour (acacia and natural flavours), sodium citrate, sodium hydroxide, hydrochloric acid and purified water.
Is- sustanzi l- oħra huma: citric acid anhydrous, maltitol liquid (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), togħma ta ’ larinġ (togħma ta ’ akaċja u togħma naturali), sodium citrate, sodium hydroxide, hydrochloric acid u ilma ppurifikat.
What Baraclude looks like and contents of the pack The oral solution is a clear, colorless to pale yellow solution.
Id- dehra ta 'Baraclude u l- kontenuti tal- pakkett Is- soluzzjoni orali hija ċara, bla kulur għal isfar ċar.
Baraclude 0.05 mg/ ml oral solution is supplied in a bottle containing 210 ml oral solution.
Baraclude 0. 05 mg/ ml soluzzjoni orali tiġi fi flixkun li fih 210 ml ta ’ soluzzjoni orali.
Belgique/ België/ Belgien BRISTOL-MYERS SQUIBB BELGIUM S. A. / N. V.
75 Belgique/ België/ Belgien BRISTOL- MYERS SQUIBB BELGIUM S. A. / N. V.
Latvija BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
76 Latvija BRISTOL- MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
The measuring spoon is manufactured by:
L- imgħarfa tad- dożi hija ffabbrikata minn:
Authorised Representative in the EEA for Comar Plastics:
Rappreżentat Awtorizzat fiż- ŻEE għal Comar Plastics:
MDSS, Burckhardstrasse 1, 30163 Hannover, Germany
MDSS, Burckhardstrasse 1, 30163 Hannover, Ġermanja
ANNEX A EU Number
ANNESS A
Invented name
Mnejn
Pharmaceutical Form
Numru ta ’
Route
Qawwa
of
Daqs
Packaging
Isem Inventat
Content
jingħata
Package size
farmaċewtika
Administration
tal- pakkett
powder: vial (glass), solvent: vial (glass)
trab: kunjett (ħġieġ), solvent: kunjett (ħġieġ)
250 IU; solvent:
250 IU; solvent:
1 vial + 1 vial + 1 injection set
kunjett 1 + kunjett 1 + sett ta ’ l- injezzjoni 1
500 IU; solvent:
500 IU; solvent:
Powder and solvent for
Trab u solvent għal soluzzjoni għall- injezzjoni
powder: vial (glass); sol
trab: kunjett (ħġieġ), solvent: kunjett (ħġieġ)
1000 IU Powder and solvent for Intravenous use powder: vial (glass); solvent: powder:
trab:
1000
1000 IU; solvent:
1 vial + 1 vial + 1
kunjett 1 + kunjett 1 + sett ta ’ l- injezzjoni 1
powder: vial (glass), solvent: pre-filled syringe (glass)
trab: kunjett (ħġieġ), solvent: siringa mimlija għal- lest (ħġieġ)
1 vial + 1 pre- filled syringe + 1 injection set
kunjett 1 + siringa mimlija għal- lest 1 + sett ta ’ l- injezzjoni 1
powder: vial (glass),
trab: kunjett (ħġieġ), solvent: siringa mimlija għal- lest (ħġieġ)
1000 IU Powder and solvent for Intravenous use powder: vial (glass), solvent: powder:
trab:
filled syringe + 1 injection set
kunjett 1 + siringa mimlija għal- lest 1 + sett ta ’ l- injezzjoni 1
1 vial + 1 pre- filled syringe + 1 injection set
kunjett 1 + siringa mimlija għal - lest 1 + sett ta ’ l - injezzjoni 1
BeneFIX 250 IU powder and solvent for solution for injection.
BeneFIX 250 IU trab u solvent għal soluzzjoni għall- injezzjoni
Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX).
Kull kunjett nominalment fih 250 IU nonacog alfa (fattur IX tal- koagulazzjoni rikombinanti).
After reconstitution with the accompanying 5 ml water for injection, each ml of the solution contains approximately 50 IU nonacog alfa.
Wara r - rikostituzzjoni bil- 5 ml ta ’ ilma għall- injezzjonijiet li hu pprovdut miegħu, kull 1 ml tas- soluzzjoni jkun fih madwar 50 IU nonacog alfa..
The potency (IU) is determined using the European Pharmacopoeia one-stage clotting assay.
Il- qawwa (IU) hi stabbilita bl- użu ta ’ l- assay ta ’ t- tagħqid tad- demm fi stadju wieħed kif deskritt skond il- Farmakopea Ewropea.
The specific activity of BeneFIX is not less than 200 IU/ mg protein.
L- attività speċifika ta ’ BeneFIX hija ta ’ mhux anqas minn 200 IU/ mg ta ’ proteina.
BeneFIX contains recombinant coagulation factor IX, (INN = nonacog alfa).
BeneFIX fih il- fattur IX rikombinanti tal- koagulazzjoni, (INN = nonacog alfa).
Nonacog alfa is a purified protein that has 415 amino acids in a single chain.
Nonacog alfa hi proteina ppurifikata li għandha 415- il amino acid f’ katina waħda.
It has a primary amino acid sequence that is comparable to the Ala148 allelic form of plasma-derived factor IX, and some post-translational modifications of the recombinant molecule are different from those of the plasma-derived molecule.
Għandha sekwenza primarja ta ’ amino acids li tista ’ tqabbilha ma ’ l- għamla allelika Ala148 tal- fattur IX derivat mill- plażma, u xi modifiki ta ’ wara t- translazzjonali tal- molekula rikombinanti huma differenti minn dawk tal- molekula li hi derivata mill- plażma.
Recombinant coagulation factor IX is a glycoprotein that is secreted by genetically engineered mammalian cells derived from a Chinese hamster ovary (CHO) cell line.
Il- fattur IX rikombinanti tal- koagulazzjoni huwa glikoproteina, miksub permezz ta ’ l- inġinerija ġenetika ta ’ ċelluli mammiferi derivat mir- razza ta ’ ċelluli ta ’ l- ovarji ta ’ ħamster ċiniż (CHO).
Each vial contains 25 mg sucrose.
Kull kunjett fih 25 mg ta ’ sucrose.
White/ almost white powder and clear and colourless solvent for solution for injection.
Trab abjad/ kważi abjad, u solvent ċar u mingħajr kulur għas- soluzzjoni għall- injezzjoni.
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Kura u profilassi tal- fsada (ħruġ ta ’ demm) li għandhom l- emofilja B (nuqqas tal- fattur IX konġenitali).
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Il- kura għandha tinbeda taħt is- superviżjoni ta ’ tabib li għandu l- esperjenza fil- kura ta ’ l- emofilja.
The dosage and duration of the substitution therapy depends on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition.
Id- doża u t- tul tat- terapija ta’ sostituzzjoni jiddependu fuq is- severità tad- defiċjenza tal- fattur IX, il- lok u l- ammont ta ’ fsada, u l- kondizzjoni klinika tal- pazjent.