FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Maltese: jinħtieġux doża ta' rinforz billi fl-assenza ta' antikorpi evidenti jista jkun li l-protezzjoni tiġi assigurata bil memorja immunoloġika.
English: In a clinical trial where Twinrix Adult was administered according to this schedule, 82% and 85% of vaccinees had seroprotective levels of anti-HBV antibodies at 1 and 5 weeks respectively following the third dose (i.e. at months 1 and 2 after the initial dose).
Maltese: Fi provi kliniċi fejn Twinrix Adult ingħatat fuq din l-iskeda, 82% u 85% tal persuni mlaqqma kellhom livelli seroprotettivi ta' antikorpi kontra l-epatite B fi żmien ġimgħa u ħames ġimgħat rispettivament mit-teħid tat-tielet doża (i.e. fl-ewwel u fit-tieni xahar wara l-ewwel doża).
English: Twinrix Adult is a white, slightly milky liquid presented in a glass pre-filled syringe (1 ml).
Maltese: Twinrix Adult huwa likwidu abjad qisu ħalib, preżentat ġo siringa tal-ħġieġ mimlija għal-lest (1ml).
English: The seropositivity rate for anti-HAV antibodies after Twinrix Adult was 97% at both 7 and 48 months versus 99% and 93% after the GlaxoSmithKline Biologicals monovalent hepatitis A vaccine and 99% and 97% after another licensed monovalent hepatitis A vaccine.
Maltese: Twinrix Adult kienet ta' 97% kemm fix-xahar 7 kif ukoll fix-xahar 48 kontra 99% u 93% wara l-vaċċin indipendenti kontra l-epatite A ta' GlaxoSmithKline
English: • Abnormal laboratory liver test results
Maltese: • Riżultati tat-testijiet tal-laboratorju tal-fwied abnormali
English: Specific humoral antibodies against hepatitis B were observed in 70% of the adults after the first dose and approximately 99% after the third dose.
Maltese: Antikorpi speċifiċi kontra l-epatite B ġew osservati f' madwar 70%
English: Protection against hepatitis A and hepatitis B develops within 2-4 weeks.
Maltese: Il-protezzjoni kontra l-epatite A u B tiżviluppa f'perjodu ta' bejn 2 u 4 ġimgħat.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Twinrix Adult, suspension for injection
Maltese: Twinrix Adult, suspensjoni għall-injezzjoni
English: Twinrix Adult confers immunity against HAV and HBV infection by inducing specific anti-HAV and anti-HBs antibodies.
Maltese: Twinrix Adult tagħti immunita' kontra l-infezzjoni ta' HAV u HBV billi tinduċi antikorpi speċifiċi kontra
English: Re-suspension of the vaccine to obtain a uniform hazy white suspension
Maltese: Suspensjoni mill-ġdid tal-vaċċin sabiex tinkiseb suspensjoni bajda mċajpra uniformi
English: The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Maltese: Il-virus jinstab fil-fluwidi tal-ġisem bħal demm, semen, tisfija tal- vaġina, jew saliva (bżiq) ta' nies infettati.
English: The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Maltese: Il-livelli tal-antikorpi anti-HBs u anti-HAV osservati wara kors primarju ta' vaċċinazzjoni bil vaċċin kombinat huma fl-istess saff ta' dawk wara t-tilqima bil-vaċċini individwali.
English: Lymphadenopathy
Maltese: Limfadenopatija
English: • Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme), hives
Maltese: • Ħotob vjola jew ħomor għal vjola fuq il-ġilda (lichen planus), raxx serja tal-ġilda (eritema multiforme), tip ta' raxx
English: NAME OF THE MEDICINAL PRODUCT Twinrix Adult, suspension for injection Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Maltese: Vaċċin (adsorbit) tal-epatite A (inattivat) u epatite B (rDNA) (HAB).
English: - Dosage
Maltese: Treddigħ
English: CLINICAL PARTICULARS
Maltese: Provi kliniċi
English: Rare (These may occur in up to 1 in 1,000 doses of the vaccine):
Maltese: Rari (Dawn jistgħu jseħħu f'sa 1 minn kull 1,000 doża tal-vaċċin):
English: Each injection is given on a separate visit.
Maltese: Kull injezzjoni tiġi mogħtija waqt żjara separata.
English: • Swelling of the face, mouth or throat (angioneurotic oedema)
Maltese: • Nefħa tal-wiċċ, ħalq jew tal-gerżuma (edema angjonewrotika)
English: What Twinrix Adult looks like and contents of the pack
Maltese: Kif jidher Twinrix Adult u l-kontenut tal-pakkett:
English: 0.05 milligrams Al3+ 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology Adsorbed on aluminium phosphate
Maltese: 3Manifatturat fuq ċelluli tal-ħmira (Saccharomyces cerevisiae) b'teknoloġija rikombinanti tad-DNA
English: 7 days later
Maltese: 7 ijiem wara
English: 25 pre-filled syringes
Maltese: Tagħmlux fil-friża
English: HBsAg is produced by culture, in a selective medium, of genetically engineered yeast cells.
Maltese: HBsAg huwa prodott b'kultura f'taħlita selettiva, ta' ċelluli tal-ħmira mfassla ġenetikament.
English: EXPIRY DATE EXP: MM/YYYY
Maltese: • L-ewwel doża: fid-data magħżula
English: Rash, pruritus
Maltese: • R-raba doża
English: Hypotension
Maltese: Artralġja
English: One month after the fourth dose, all vaccinees demonstrated seroprotective levels of anti-HBs antibodies and were seropositive for anti-HAV antibodies.
Maltese: HBs u kienu seroposittivi għall-antikorpi anti-HAV.
English: Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Maltese: Twinrix Adult huwa vaċċin li jintuża fl-Adulti w adoloxxenti minn 16 il-sena l-fuq sabiex jipproteġi minn żewġ mardiet: epatite A u epatite B.
English: The vaccine may contain traces of neomycin which is used during the manufacturing process (see section 4.3).
Maltese: Il-vaċċin jista' jkun fih traċċi ta' neomycin li jintuża waqt il-proċess ta' manifattura (ara sezzjoni 4.3).
English: While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection.
Maltese: Waqt li mhux mistenni li l-antiġen tassuperfiċje ta' l-epatite B rekombinanti jkollu effetti avversi fuq it-tqala jew fuq il-fetu, hu rakkomandat li t tilqim jiġi pospost għal wara l-ħlas, sakemm ma jkunx hemm bżonn urġenti li tipproteġi l-omm kontra infezzjoni ta' l-epatite B.
English: • Fever equal to or greater than 37.5°C
Maltese: Mhux komuni Deni (≥ 37.5°C)
English: • Inflammation of some blood vessels (vasculitis)
Maltese: • Infjammazzjoni ta' xi vini w arterji (vaskulite)
English: Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the paediatric formulation
Maltese: * jirreferi għal effetti mhux mixtieqa li ġew osservati fi provi kliniċi li saru bil-preparazzjoni pedjatrika
English: Adverse events reported following overdosage were similar to those reported with normal vaccine administration.
Maltese: Effetti mhux mixtieqa li ġew rrappurtati wara doża eċċessiva kienu simili għal dawk irrappurtati wara t-tilqim normali.
English: A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with Twinrix Adult should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Adult therapy to the woman.
Maltese: Id-deċiżjoni fuq jekk wieħed għandux ikompli/jwaqqaf it-treddigħ jew ikompli/jwaqqaf it-terapija bi Twinrix Adult għandha tiġi bbażata fuq il-benefiċju tat-treddigħ għat-tarbija u l-benefiċju tat-terapija bi Twinrix Adult għall-mara.
English: What Twinrix Adult is and what it is used for What you need to know before you receive Twinrix Adult How Twinrix Adult is given
Maltese: X'għandek tkun taf qabel ma tieħu Twinrix Adult Kif għandek tieħu Twinrix Adult
English: In exceptional circumstances in adults, when travel is anticipated within one month or more after initiating the vaccination course, but where insufficient time is available to allow the standard 0, 1, 6 month schedule to be completed, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used.
Maltese: Wara r-raba doża li ngħatat fix-xahar 12, l-inċidenza ta' reazzjonijiet fis-sistema u lokali kienet komparabbli ma dik ta' wara t tilqim li ngħata ta' 0, 7, 21 ġurnata.
English: Twinrix Adult contains neomycin Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Maltese: Twinrix Adult mhux irrakkomandat għal prevenzjoni ta' wara l-esposizzjoni għall-virus (eż.tniggist b'labbra użata).
English: Norge GlaxoSmithKline AS
Maltese: B ta' GlaxoSmithKline:
English: Frequencies are reported as: Very common: ≥ 1/10 Common:
Maltese: Komuni ħafna ≥ 1/10 Komuni
English: Side effects occurred very rarely during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines include:
Maltese: Effetti mhux mixtieqa li seħħu rarament ħafna waqt provi kliniċi jew wara l-użu ġenerali tal-vaċċin jew wara l-użu ta' vaċċini separate tal-epatite A u B jinkludu:
English: Eesti GlaxoSmithKline Eesti OÜ
Maltese: Magyarország GlaxoSmithKline Kft. Tel.:
English: Very rare (These may occur in up to 1 in 10,000 doses of the vaccine):
Maltese: Rari ħafna (Dawn jistgħu jseħħu f'sa 1 minn kull 10,000 dożi tal-vaċċin):
English: It is important that procedures are in place to avoid injury from faints.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: • Official batch release
Maltese: • Nuqqas ta' aptit • Pressjoni baxxa
English: The seroprotection rate against hepatitis B increased to 95.1% by three months after the first dose.
Maltese: seroprotezzjoni kontra l-epatite B żdiedet għal 95.
English: Adult achieved seroprotective levels of anti-HBV antibodies (≥ 10 mIU/ml) and Geometric Mean
Maltese: Xahar wara din id-doża, 95% tas-suġġetti li tlaqqmu b'Twinrix Adult laħqu livelli seroprotettivi talantikorpi anti-HBV (≥ 10 mIU/ml) u l-Medja Ġeometrika tal-Konċentrazzjoni (GMC) żdiedet b'179-il darba (GMC ta' 7234 mIU/ml) u dan juri rispons fil-memorja mmunitarja.
English: Turbid white suspension.
Maltese: Is-suspensjoni hija bajda u mdardra.
English: Twinrix Adult is for intramuscular injection, preferably in the deltoid region.
Maltese: Twinrix Adult jingħata b' injezzjoni fil-muskolu, l-aħjar fil-muskolu deltoid .
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 25 PRE-FILLED SYRINGES WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 25 PRE-FILLED SYRINGES WITH 25 NEEDLES
Maltese: F'każijiet speċjali fl-adulti, meta qieghed jiġi ppjanat xi vjaġġar fi żmien xahar jew aktar mill-bidu tal- kors tal-vaċċinazzjoni, iżda fejn ma hemmx żmien biżżejjed sabiex tinżamm l-iskeda bażika ta' 0,1,6 xhur tiġi kompluta, tista tingħata skeda ta'tliet injezzjonijiet għal ġol-muskoli fi żmien 0, 7 u 21 ġurnata.
English: • Rash, itching
Maltese: • Dijarrea, dardir
English: • Swollen glands in the neck armpit or groin (lymphadenopathy)
Maltese: • Nuqqas ta' sensazzjoni jew dgħjufija fid-dirgħajn u s-saqajn (newropatija), paraliżi
English: Guidelines for boosting are based on the assumption that antibodies are required for protection; anti-HAV antibodies have been predicted to persist for at least 10 years.
Maltese: Huwa maħsub li l-antikorpi anti-HAV jippersistu minn ta' l-anqas 10 snin.
English: In comparative studies, it was noted that the frequency of solicited adverse events following the administration of Twinrix Adult is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines.
Maltese: F'studji komparattivi ntwera li l-frekwenza ta' effetti avversi dokumentati wara tilqima bi Twinrix Adult ma kienitx differenti minn dik ta' wara tilqima bil-vaċċini separati.
English: Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: Subjects, % (no.)
Maltese: Suġġetti, % (no.)
English: YMDD1 Non-YMDD1
Maltese: Non-YMDD1
English: Date of latest renewal: 23 June 2014
Maltese: Data tal-aħħar tiġdid: 23 ta' Ġunju 2014
English: The risk for developing YMDD mutant was 63% versus 13% with a cut off of 1000 copies/ml (NUCB3009 and NUCB3018).
Maltese: Ir-riskju li jiżviluppa l-mutant YMDD kien ta' 63% kontra 13% b'limitu ta' 1000 copies/ml (NUCB3009 u NUCB3018).
English: 3 Abbott Genostics solution hybridisation assay (LLOD < 1.6 pg/ml 4 Chiron Quantiplex assay (LLOD 0.7 Meq/ml)
Maltese: 3 Soluzzjoni Abbott Genostics hybridisation assay (LLOD < 1.6 pg/ml 4 Chiron Quantiplex assay (LLOD 0.7 Meq/ml)
English: The other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic yellow and red iron oxide.
Maltese: Is-sustanzi l-oħra huma: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic yellow u red iron oxide.
English: 8 Repeat steps 3 to 7 in the same way until you have taken your whole dose.
Maltese: 8 Irrepeti passi 3 sa 7 bl-istess mod sakemm tkun ħadt id-doża sħiħa tiegħek.
English: Immunosuppressive treatments
Maltese: Kuri immunosoppressivi
English: United Kingdom or
Maltese: United Kingdom
English: Remove the applicator from the adapter.
Maltese: Neħħi l-applikatur mill-adapter.
English: Elevations of CPK
Maltese: Żieda ta' CPK
English: Lamivudine-TP does not interfere with normal cellular deoxynucleotide metabolism.
Maltese: Lamivudine-TP ma jfixkilx il-metaboliżmu deoxynucleotide ċellulari normali.
English: YMDD mutant HBV status
Maltese: Status tal-mutant YMDD talHBV
English: ALT elevations (see section 4.4)
Maltese: Żieda ta' ALT (ara sezzjoni 4.4)
English: EU/1/99/114/002 84 tablets
Maltese: EU/1/99/114/001 28 pillola EU/1/99/114/002 84 pillola
English: See Section 4 for more information about the risks.
Maltese: Ara Sezzjoni 4 għal aktar informazzjoni dwar ir-riskji.
English: Boxes containing 28 or 84 film-coated tablets in double foil blisters, laminated with polyvinyl chloride.
Maltese: Kaxxi li fihom 28 jew 84 pilloli miksija ġo double foil blisters, laminati bi klorur tal-polyvinyl.
English: Administration of trimethoprim/sulphamethoxazole 160 mg/800 mg increased lamivudine exposure by about 40 %.
Maltese: L-amministrazzjoni ta' trimethoprim/sulphamethoxazole 160 mg/800 mg żiedet l-esponiment ta' lamivudine kważi b'40%.
English: Do not take Zeffix:
Maltese: Tieħux Zeffix:
English: ALT normalisation
Maltese: Normalizzazzjoni ta' ALT
English: 84 film-coated tablets
Maltese: jew 84 pillola.
English: Delta hepatitis or hepatitis C
Maltese: Epatite delta jew epatite Ċ
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Maltese: Glaxo Operations UK Limited (fil-kummerċ bħala Glaxo Wellcome Operations)
English: - Baseline 3
Maltese: ANNESS III
English: The oral solution contains propyl and methyl parahydroxybenzoate.
Maltese: Is-soluzzjoni orali fiha propyl and methyl parahydroxybenzoate.
English: Butterscotch coloured, film-coated, capsule shaped, biconvex, approximate dimensions 11mm x 5mm and engraved “GX CG5” on one face.
Maltese: Lewn it-tofi (butterscotch), miksija b'rita, forma ta' kapsula, ibbuzzata fuq iż-żewġ naħat, daqs bejn wieħed u ieħor 11mm x 5mm u mnaqqxa bi “GX CG5” fuq naħa waħda.
English: When full, the applicator contains 10 ml of solution.
Maltese: Meta mimlija, l-applikatur fih 10 ml ta' soluzzjoni.
English: ULN = Upper limit of normal.
Maltese: ULN=Il-limitu ta' fuq tan-normal.
English: Synthetic yellow and red iron oxides
Maltese: Iron oxides, sintetiċi, sofor u ħomor
English: - Baseline ALT  1 x ULN2 - Baseline ALT > 2 x ULN
Maltese: ALT ≤ 1 x ULN2 - Linja bażi
English: Creatinine clearance ml/min
Maltese: Tneħħija ta' kreatinina ml/min
English: A very rare side effect (these may affect up to 1 in 10,000 people) is:
Maltese: Effett sekondarju rari ħafna (dan jista' jaffettwa sa persuna waħda minn kull 10,000) huwa:
English: - Week 260 normal above normal < baseline above normal > baseline
Maltese: normal fuq in-normal < linja bażi fuq in-normal > linja bażi
English: Zeffix contains sucrose.
Maltese: Zeffix fih sucrose.
English: Co-administration of sorbitol solution (3.2 g, 10.2 g, 13.4 g) with a single 300 mg dose (Adult HIV daily dose) of lamivudine oral solution resulted in dose-dependent decreases of 14%, 32%, and 36% in lamivudine exposure (AUC) and 28%, 52%, and 55% in the Cmax of lamivudine in adults.
Maltese: It-teħid tas-soluzzjoni ta' sorbitol (3.2 g, 10.2 g, 13.4 g) ma' doża waħda ta' 300 mg (doża ta' kuljum għall-HIV fl-Adulti) ta' soluzzjoni orali ta' lamivudine rriżulta fi tnaqqis dipendenti fuq id-doża ta' 14 %, 32 %, u 36 % fl-esponiment ta' lamivudine (AUC∞) u ta' 28 %, 52 %, u 55 % fis-Cmax ta' lamivudine fl-adulti.
English: 12 Riverwalk
Maltese: TAGĦRIF
English: The active substance is lamivudine.
Maltese: Is-sustanza attiva hija lamivudine.
English: Pharmacotherapeutic group - Antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC Code: J05AF05.
Maltese: Antivirali għall-użu sistemiku, inibituri ta' nucleoside u nucleotide reverse transcriptase, Kodiċi ATC:
English: It is also only a weak inhibitor of mammalian DNA polymerases alpha and beta.
Maltese: Hu wkoll inibitur verament dgħajjef tad-DNA polymerases mammiferi alfa u beta.
English: Herts SG12 0DJ United Kingdom or
Maltese: Herts SG 12 0DJ Ir-Renju Unit jew
English: Reduction of erythrocytes and neutrophil counts were identified as the effects most likely to be of clinical relevance.
Maltese: It-tnaqqis ta' eritroċiti u ta' newtrofili ġew identifikati bħala l-effetti l-iktar probabbli ta' relevanza klinika.
English: Experience in CHB patients with advanced fibrosis or cirrhosis In a placebo-controlled study in 651 patients with clinically compensated chronic hepatitis B and histologically confirmed fibrosis or cirrhosis, lamivudine treatment (median duration 32 months) significantly reduced the rate of overall disease progression (34/436, 7.8 % for lamivudine versus 38/215, 17.7 % for placebo, p=0.001), demonstrated by a significant reduction in the proportion of patients having increased Child-Pugh scores (15/436, 3.4 % versus 19/215, 8.8 %, p=0.023) or developing hepatocellular carcinoma (17/436, 3.9 % versus 16/215, 7.4 %, p=0.047).
Maltese: xahar) naqqas sinifikament ir-rata ta' l-iżvilupp totali tal-marda (34/436, 7.8 % għal lamivudine kontra 38/215, 17.7 % għal plaċebo, p=0.001), u dan intwera bi tnaqqis sostanzjali fil-proporzjon ta' pazjenti b'żieda fil-Child-Pugh scores (15/436, 3.4 % kontra 19/215, 8.8 %, p=0.023) jew dawk li żviluppaw karċinoma epatoċellulari (17/436, 3.9 % kontra 16/215, 7.4 %, p=0.047).
English: The difference in the HBeAg seroconversion rates (HBeAg and HBV DNA loss with HBeAb detection) between placebo and lamivudine was not statistically significant in this population (rates after one year were 13 % (12/95) for placebo versus 22 % (42/191) for lamivudine; p=0.057).
Maltese: Id-differenza bejn ir-rati ta' serokonverżjoni (telf ta' HBV DNA bi skoperta ta' HbcAb) bejn plaċebo u lamivudine ma kienitx statistikament sinifikanti f'din il-popolazzjoni (ir-rati wara sena kienu 13% (12/95) għal plaċebo kontra 22% (42/191) għal lamivudine; p=0.057).
English: Zidovudine had no effect on the pharmacokinetics of lamivudine (see section 5.2).
Maltese: Zidovudine ma kellu ebda effett fuq il farmakokinetika ta' lamivudine (ara sezzjoni 5.2).
English: 2 Upper limit of normal
Maltese: 2 Limitu ta' fuq tan-normal
English: There have been reports of mitochondrial dysfunction in infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).
Maltese: Kien hemm rapporti ta' disfunzjoni tal-mitokondrija fi trabi li kienu esposti in utero u/jew wara t-twelid għall-analogi nukleosidi (ara sezzjoni 4.4).
English: When possible, avoid chronic co-administration of Zeffix with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Maltese: prodotti mediċinali li fihom sorbitol jew polialkoħol ieħor b'azzjoni ożmotika jew alkoħol monosakkaridu (eż. xylitol, mannitol, lactitol, maltitol).
English: Lamivudine is metabolised by both infected and uninfected cells to the triphosphate (TP) derivative which is the active form of the parent compound.
Maltese: Lamivudine hu mmetabolizzat b'ċelluli infettati jew mhux infettati lid-derivattiv trifosfat (TP) li huwa l-forma attiva tat-taħlita parentali.
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue:
English: Sodium starch glycolate
Maltese: Microcrystalline cellulose Sodium starch glycolate Magnesium stearate
English: • lactic acidosis (excess lactic acid in the blood).
Maltese: • aċidożi lattika (aċidu lattiku żejjed fid-demm).
English: Zeffix is an antiviral medicine that suppresses the hepatitis B virus and belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Maltese: mediċini msejħa inibituri nucleoside analogue reverse transcriptase (NRTIs).
English: †Comparable to a Grade 3 toxicity in accordance with modified WHO criteria.
Maltese: † Paragunabbli ma' tossiċita' ta' Grad 3 skont kriterji modifikati tal-WHO
English: In an extended treatment study in Asian patients (NUCB3018) the HBeAg seroconversion rate and ALT normalisation rate at the end of the 5 year treatment period was 48 % (28/58) and 47 % (15/32), respectively.
Maltese: HbeAg u r-rata ta' normalizzazzjoni ta' l-ALT fl-aħħar tal-perijodu ta' ħames snin trattament kienet ta' 48% (28/58) u 47% (15/32) rispettivament.
English: - Baseline normal above normal
Maltese: - Linja bażi normal fuq in-normal
English: INFORMATION IN BRAILLE zeffix 5 mg/ml
Maltese: zeffix 5mg/mL
English: Undetectable HBV DNA
Maltese: Il-livelli ta' ALT u HBV DNA
English: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and/or fibrosis.
Maltese: mard ikkumpensat tal-fwied b'evidenza ta' replikazzjoni virali attiva, b'livelli elevati b'persistenza ta' alanine aminotransferase (ALT) fis-serum u evidenza istoloġika ta'
English: Other medicines and Zeffix
Maltese: Mediċini oħra u Zeffix
English: These events were seen infrequently in clinical studies.
Maltese: Dawn il-każi rarament dehru fi studji kliniċi.
English: Laboratory parameters to be monitored should include (as a minimum) serum ALT, bilirubin, albumin, blood urea nitrogen, creatinine, and virological status: HBV antigen/antibody, and serum HBV DNA concentrations when possible.
Maltese: Ilparametri tal-laboratorju li għandhom jiġu mmonitorjati għandhom jinkludu (mill-inqas) is-serum ALT, bilirubin, albumin, nitroġenu ta' l-urea fid-demm, kreatinina, u status viroloġiku:
English: The likelihood of metabolic substance interactions with lamivudine is low due to the small (5-10 %) extent of hepatic metabolism and the low plasma protein binding.
Maltese: Ftit hemm probabbilta' ta' azzjoni metabolika reċiproka mal-lamivudine minħabba l-okkorrenza baxxa (5-10%) ta' metaboliżmu tal-fwied u t-tagħqid baxx tal-proteina fil-plażma.
English: You may need extra check-ups, including blood tests, while you're taking your medication.
Maltese: Jista' jkollok bżonn visti ekstra, inkluż testijiet tad-demm, waqt li tkun qed tieħu il-medikazzjoni tiegħek.
English: INFORMATION IN BRAILLE zeffix 100 mg
Maltese: zeffix 100mg
English: The active ingredient in Zeffix is lamivudine.
Maltese: Is-sustanza attiva ta'Zeffix hija lamivudine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR TABLETS: 28 tablet box, 84 tablet box
Maltese: IL-KARTUNA TA' BARRA GĦALL-PILLOLI : kaxxa ta' 28 pillola, kaxxa ta' 84 pillola