FrancophonIA/ELRC3.0 huggingface dataset:
English: Ulipristal acetate 10 mg/day N=95
Maltese: Ulipristal acetate 10 mg/ju m N=95
English: Drug hypersensitivity*
Maltese: Sensittività eċċessiva għallmediċina*
English: Rare (may affect up to 1 in 1,000 people) side effects: - nosebleed - indigestion, bloating - break of sac of fluid within the ovaries (ovarian cyst ruptured) - breast swelling.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000): - fsada mill-imnieħer - indiġestjoni, nefħa - ksur tal-borża tal-fluwidu fi ħdan l-ovarji (ċista tal-ovarji) - nefħa tas-sider.
English: In case of repeated treatment courses, endometrial thickening was less frequently observed (4.9% of patients after second treatment course and 3.5% after fourth treatment course).
Maltese: F'każ ta' korsijiet ta' kura ripetuti, tħaxxin endometrijali kien osservat b'mod inqas frekwenti (4.9% tal-pazjenti wara t-tieni kors ta' kura u 3.5% wara r-raba' kors ta' kura).
English: If a patient during treatment shows signs or symptoms compatible with liver injury (fatigue, asthenia, nausea, vomiting, right hypochondrial pain, anorexia, jaundice), treatment should be stopped and the patient should be investigated immediately, and liver function tests performed.
Maltese: Jekk pazjent waqt it-trattament juri sinjali jew sintomi kompatibbli ma' ħsara fil-fwied (għeja, astenja, dardir, rimettar, uġigħ ipokondrijali fin-naħa tal-lemin, anoreksja, suffejra), it-trattament għandu jitwaqqaf u l-pazjent għandu jiġi investigat immedjatament, u għandhom isiru testijiet tal-funzjoni talfwied.
English: Other medicines and Esmya
Maltese: Kif taħżen Esmya
English: 3 years.
Maltese: Tqala u treddigħ.
English: • in addition, liver testing should be performed within 2-4 weeks after treatment has stopped.
Maltese: • barra minn hekk, għandhom isiru testijiet tal-fwied 2-4 ġimgħat wara li jkun waqaf ittrattament.
English: • recommendation of a periodic monitoring of the endometrium in case of repeated intermittent treatment.
Maltese: • rakkomandazzjoni ta' monitoraġġ perjodiku biex jiġi ssorveljat l-endometriju f'każ ta' kura intermittenti ripetuta.
English: White to off-white, round biconvex tablet of 7 mm engraved with “ES5” on one face.
Maltese: Pillola bajda li tagħti fl-offwajt, tonda bikonvessa ta' 7 mm imnaqqxa b'“ES5” fuq wiċċ wieħed.
English: a a In Study 1, change from baseline in total myoma volume was measured by MRI.
Maltese: a a Fl-istudju 1, il-bidla mil-linja bażi fil-volum totali tal-mijoma ġiet imkejla permezz ta' MRI.
English: • the posology: 5 mg tablet once daily for treatment courses of up to 3 months each.
Maltese: • il-pożoloġija: pillola ta' 5 mg darba kuljum għal korsijiet ta' kura sa 3 xhur kull wieħed.
English: Headache*
Maltese: Tista'
English: If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted (see section "Bleeding pattern" below), investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Maltese: Jekk jiġi osservat tħaxxin tal-endometriju, li jippersisti wara r-ritorn tal-mestrwazzjoni matul perjodi mingħajr kura jew lil hinn minn 3 xhur wara t-tmiem tal-korsijiet ta' kura u/jew jiġi osservat mudell ta' fsada mibdul (ara s-sezzjoni "Mudell ta' fsada" taħt), għandha titwettaq investigazzjoni inkluż bijopsija endometrijali sabiex jiġu esklużi kundizzjonijiet sottostanti oħrajn, inkluż tumur malinn endometrijali.
English: Concomitant treatments
Maltese: TAL-PRODOTT MEDIĊINALI
English: Most patients treated with ulipristal acetate stopped bleeding within the first week of treatment (amenorrhea).
Maltese: Ħafna mill-pazjenti li rċevew kura bi ulipristal acetate waqfu jnixxu d-demm matul l-ewwel ġimgħa ta' kura (amenorreja).
English: Esmya 5 mg tablets
Maltese: IL-PRODOTT MEDIĊINALI Esmya 5 mg pilloli
English: Anxiety Emotional disorder
Maltese: Ansjetà Disturb emozzjonali
English: For further treatment courses, liver function must be tested once before each new treatment course and when clinically indicated.
Maltese: Qabel jinbeda t-trattament, għandhom isiru testijiet tal-funzjoni tal-fwied.
English: • Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Esmya
Maltese: • Materjal edukattiv għal dawk li jagħtu l-prodott fuq riċetta (ġinekologi) li huwa magħmul minn:
English: Amenorrhea Endometrial thickening*
Maltese: Tħaxxin tal-endometriju
English: Administration of ulipristal acetate (30 mg tablet) together with a high-fat breakfast resulted in approximately 45% lower mean Cmax, a delayed tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean AUC0-∞ compared with administration in the fasted state.
Maltese: L-għoti ta' ulipristal acetate (pillola ta' 30 mg) flimkien ma' kolazzjoni b'kontenut għoli ta' xaħam irriżulta f'madwar medja ta' Cmax li kienet 45% aktar baxxa, tmax ittardjat (minn medjan ta' 0.75 siegħat għal 3 sigħat) u medja ta' AUC0-∞ li kienet 25% ogħla meta mqabbla mal-għoti f'persuna sajma Inkisbu riżultati simili għall-metabolit mono-N-demethylated attiv.
English: One tablet contains 5 mg of ulipristal acetate.
Maltese: Kull pillola fiha 5 mg ta' ulipristal acetate.
English: Esmya is likely to make some hormonal contraceptives less effective.
Maltese: Esmya huwa mistenni li jagħmel xi kontraċettivi ormonali inqas effettivi.
English: - Certain medicines used to prevent strokes and blood clots (e.g. dabigatran etexilate).
Maltese: - Ċerti mediċini użati għall-prevenzjoni ta' puplesiji u emboli tad-demm (eż. dabigatran etexilate).
English: Ulipristal acetate may interfere with the action of hormonal contraceptive medicinal products (progestagen only, progestagen releasing devices or combined oral contraceptive pills) and progestagen administered for other reasons.
Maltese: Ulipristal acetate jista' jinterferixxi mal-azzjoni ta' prodotti mediċinali kontraċettivi ormonali (pilloli bbażati fuq proġestaġen biss, apparat li jirrilaxxa l-proġestaġen jew kontraċettivi kkombinati orali) u proġestaġen li jingħata għal raġunijiet oħra.
English: • itching
Maltese: • rimettar
English: Uncommon (may affect up to 1 in 100 people) side effects: - drug allergy - anxiety - mood swings - dizziness - dry mouth, constipation - hair loss, dry skin, increased sweating - back pain - leakage of urine - bleeding from the womb (uterine bleeding), vaginal discharge, abnormal vaginal bleeding,
Maltese: - allerġija għall-mediċina - ansjetà - tibdil fil-burdata - sturdament - ħalq xott, stitikezza - telf ta' xagħar, ġilda xotta, żieda fl-ammont ta' għaraq - uġigħ fid-dahar - tnixxija ta' awrina - fsada mill-ġuf (fsada fl-utru), tnixxija vaġinali, fsada vaġinali mhux normali - skumdità fis-sider - nefħa minħabba żamma ta' fluwidu (edema) - għejja estrema (astenja) - żieda fil-kolesterol fid-demm li tidher fit-testijiet tad-demm, żieda fix-xaħmijiet fid-demm
English: In subsequent treatment courses, endometrial thickening was less frequently observed (4.9% and 3.5% of patients by the end of second and fourth treatment course, respectively).
Maltese: F'korsijiet ta' kura sussegwenti, it-tħaxxin endometrijali kien osservat b'mod inqas frekwenti (4.9% u 3.5% talpazjenti sat-tmiem it-tieni u r-raba' kors ta' kura, rispettivament).
English: In study 1, a statistically significant difference was observed in reduction in menstrual blood loss in favour of the patients treated with ulipristal acetate compared to placebo (see Table 1 below), resulting in faster and more efficient correction of anaemia than iron alone.
Maltese: Fl-istudju 1, kienet osservata differenza statistikament sinifikanti fit-tnaqqis ta' telf ta' demm mestrwali favur il-pazjenti li kienu rċevew kura bi ulipristal acetate meta mqabbla ma' plaċebo (ara Tabella 1 hawn taħt), li rriżulta f'korrezzjoni aktar mgħaġġla u aktar effiċjenti tal-anemija milli bilħadid waħdu.
English: • reminder of the effect of ulipristal acetate on the endometrium.
Maltese: • tfakkira tal-effett ta' ulipristal acetate fuq l-endometriju
English: Ovarian cyst ruptured* Breast swelling
Maltese: Qsim ta' ċista talovarji* Nefħa tassider
English: Hot flushes were reported by 8.1% of patients but the rates varied across trials.
Maltese: Il-fwawar ġew irrapportati minn 8.1% tal-pazjenti, iżda r-rati kienu jvarjaw bejn il-provi.
English: Ulipristal acetate exerts a direct action on fibroids reducing their size through inhibition of cell proliferation and induction of apoptosis.
Maltese: Ulipristal acetate jeżerċita azzjoni diretta fuq il-fibrojdi u jnaqqas id-daqs tagħhom permezz ta' inibizzjoni tal-proliferazzjoni taċ-ċelluli u l-induzzjoni ta' apoptożi.
English: When comparing repeated treatment courses, overall adverse reactions rate was less frequent in subsequent treatment courses than during the first one and each adverse reaction was less frequent or remained in the same frequency category (except for dyspepsia which was classified as uncommon in treatment course 3 based on one patient occurence).
Maltese: Meta wieħed iqabbel korsijiet ta' kura ripetuti, ir-rata globali ta' reazzjonijiet avversi kienet inqas frekwenti f'korsijiet ta' kura sussegwenti milli matul l-ewwel wieħed u kull reazzjoni avversa kienet inqas frekwenti jew baqgħet fl-istess kategorija ta' frekwenza (ħlief għad-dispepsija li kienet ikklassifikata bħala mhux komuni fil-kors ta' kura 3 abbażi ta' okkorrenza f'pazjent wieħed).
English: Very common (may affect more than 1 in 10 people) side effects: - reduction or absence of menstrual bleeding (amenorrhea) - thickening of the lining of the womb (endometrial thickening).
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10): - tnaqqis jew nuqqas ta' fsada mestrwali (amenorrea) - ħxuna tar-rita tal-ġuf (ħxuna endometrijali).
English: There is no relevant use of ulipristal acetate in the paediatric population.
Maltese: Ulipristal acetate m'għadux użu rilevanti fil-popolazzjoni pedjatrika.
English: These histological changes are denoted as “Progesterone Receptor Modulator Associated Endometrial Changes” (PAEC) and should not be mistaken for endometrial hyperplasia (see sections 4.8 and 5.1).
Maltese: Dawn il-bidliet istoloġiċi huma indikati bħala “Bidliet Endometrijali Assoċjati mal-Modulatur tarRiċettur tal-Proġesteron” (PAEC) u ma għandhomx jiġu mitfixkla ma' iperplażja endometrijali (ara sezzjonijiet 4.8 u 5.1).
English: - Medicines used to treat certain bacterial infections (e.g. rifampicin, telithromycin,
Maltese: - Mediċini użati għall-kura ta' ċerti infezzjonijiet batterjali (eż. rifampicin, telithromycin,
English: Esmya should not be taken by children under 18 years of age since safety and efficacy of ulipristal acetate has not been established in this age group.
Maltese: Esmya ma għandux jittieħed minn tfal li għandhom inqas minn 18-il sena peress li s-sigurtà u leffikaċja ta' ulipristal acetate ma ġewx determinati f'dan il-grupp tal-età.
English: Mechanism of action Ulipristal acetate exerts a direct effect on the endometrium.
Maltese: Mekkaniżmu ta' azzjoni Ulipristal acetate jeżerċita effett dirett fuq l-endometriju.
English: If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted, investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Maltese: Jekk, matul kura intermittenti ripetuta, wara t-tnaqqis inizjali fil-fsada jew amenorreja, isseħħ fsada mhux mistennija jew persistenti mibdul, bħal fsada matul il-mestrwazzjoni, għandha titwettaq investigazzjoni tal-endometriju inkluż bijopsija endometrijali sabiex jiġu esklużi l-kundizzjonijiet sottostanti l-oħra, inkluż tumur malinn endometrijali.
English: nausea or vomiting, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache.
Maltese: nefħa tal-wiċċ, ilsien jew griżmejn; diffikultà biex tibla'; ħorriqija u diffikultà biex tieħu n-nifs.
English: The main route of elimination is through faeces and less than 10% is excreted in the urine.
Maltese: Ir-rotta ewlenija ta' eliminazzjoni hija permezz talippurgar u inqas minn 10% jitneħħa fl-awrina.
English: The efficacy of fixed doses of ulipristal acetate 5 mg and 10 mg once daily was evaluated in two Phase 3 randomised, double-blind, 13 week studies recruiting patients with very heavy menstrual bleeding associated with uterine fibroids.
Maltese: L-effikaċja ta' dożi fissi ta' ulipristal acetate ta' 5 mg u ta' 10 mg darba kuljum ġiet evalwata f'żewġ studji double blind, randomised, tal-Fażi 3, li damu għaddejjin 13-il ġimgħa li fihom ħadu sehem pazjenti li kellhom tnixxija mestrwali qawwija ħafna assoċjata mal-fibrojdi fl-utru.
English: Oedema Asthenia
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI 5
English: 2nd TEST (4 weeks after starting treatment) 3rd TEST (8 weeks after starting treatment) 4th TEST (12 weeks after starting treatment) 5th TEST (2- 4 weeks after stopping Esmya treatment)
Maltese: Il-Ħames TEST (2-4 ġimgħat wara t-twaqqif tat-trattament b'Esmya)
English: In about 10-15% of patients treated with ulipristal acetate the endometrium may thicken (> 16 mm) during the first 3-month treatment course.
Maltese: F'madwar 10-15% tal-pazjenti kkurati b'ulipristal acetate l-endometriju jista' jeħxien (> 16 mm) matul l-ewwel kors ta' kura ta' 3 xhur.
English: In case of atypical hyperplasia, investigation and management as per usual clinical practice should be performed.
Maltese: Fil-każ ta' iperplażja atipika, għandha titwettaq investigazzjoni u ġestjoni skont il-prattika klinika normali.
English: A daily dose of ulipristal acetate 5 mg partially suppresses FSH levels but serum oestradiol levels are maintained in the mid-follicular range in the majority of patients and are similar to levels in patients who received placebo.
Maltese: Doża ta' ulipristal acetate ta' 5 mg kuljum trażżan parzjalment il-livelli tal-FSH iżda fil-maġġoranza tal-pazjenti, il-livelli ta' estradajol fis-serum jinżammu fil-medda mid-follikulari u huma simili għallivelli f'pazjenti li rċevew plaċebo.
English: No dose adjustment is considered necessary for administration of ulipristal acetate to patients receiving concomitant mild CYP3A4 inhibitors.
Maltese: L-użu konkomittanti ta' ulipristal acetate u indutturi qawwija ta' CYP3A4
English: Abdominal pain Nausea
Maltese: Uġigħ addominali Nawsea
English: Table 2: Results of primary and selected secondary efficacy assessments in long term Phase III studies Parameter
Maltese: Tabella 2: Riżultati tal-valutazzjonijiet primarji u sekondarji magħżula tal-effikaċja fi studji fit-tul talFażi
English: • nausea (feeling sick)
Maltese: • dardir (tħossok se tirremetti)
English: • inform the patients about potential adverse reactions related to liver that could be caused by the use of Esmya.
Maltese: • tgħarraf lill-pazjenti dwar reazzjonijiet avversi potenzjali relatati mal-fwied li jistgħu jiġu kkawżati mill-użu ta' Esmya.
English: Cmax (g/ml) AUC0-∞ (g•h/ml) CLRENAL (ml/min)
Maltese: Cmax (g/ml) AUC0-∞ (g•h/ml) CLRENALI (ml/min)
English: Creatine kinase elevation
Maltese: Elevazzjoni tal-creatine kinase
English: N/A 14/26 (54)
Maltese: Ma japplikax 14/26 (54)
English: Muscular effects
Maltese: Effetti muskolari
English: HBeAg-negative (n = 446)
Maltese: HBeAg-negattivi (n = 446)
English: The most common HBV genotypes were B (26%) and C (51%).
Maltese: L-aktar ġenotipi komuni ta' HBV kienu B (26%) u C (51%).
English: Table 2 Adverse reactions
Maltese: Tabella 2 Reazzjonijiet avversi
English: Benzoic acid (E210) Sodium saccharin Passion fruit flavouring Sodium hydroxide Citric acid anhydrous Water, purified
Maltese: Benzoic acid (E210) Sodium saccharin Passion fruit flavouring Sodium hydroxide Citrc acid anhydrous Ilma, ppurifikat
English: Telbivudine is a synthetic thymidine nucleoside analogue with activity against HBV DNA polymerase.
Maltese: Telbivudine huwa analogu ta' thymidine nucleoside sintetiku attiv kontra HBV DNA polymerase.
English: HBeAg-positive (n = 921)
Maltese: HBeAg-posittivi (n = 921)
English: Metabolism and nutrition disorders Rare*
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Rari*
English: Telbivudine-5'-triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'-triphosphate.
Maltese: Telbivudine-5'-triphosphate jinibixxi HBV DNA polymerase (reverse transcriptase) billi jikkompeti mas-sustrat naturali, thymidine-5'-triphosphate.
English: SEM: Standard error of mean Roche COBAS Amplicor
Maltese: Telf ta' HbeAg SEM: Żball standard tal-medja Roche COBAS Amplicor
English: Severe (< 30) (n = 6) 200 mg
Maltese: Severa (<30) (n = 6) 200 mg
English: Study NV-02B-015
Maltese: NV-02B-015
English: to 1.4 (SD 0.9) with a mean change of -6.3 (SD 2.8).
Maltese: għal 1.4 (SD 0.9) b'bidla medja ta' -6.3 (SD 2.8).
English: Sebivo contains the active substance telbivudine.
Maltese: Sebivo fih is-sustanza attiva telbivudine.
English: HBeAg-positive n = 443 and 444, HBeAg-negative n = 219 and 219, for both telbivudine and lamivudine groups, respectively.
Maltese: HBeAg-posittivi n = 443 and 444, HBeAg-negattivi n = 219 and 219, għaż-żewġ gruppi telbivudine u lamivudine, rispettivament.
English: ≥ 3 log10 copies/ml
Maltese: ≥3 log10 kopji/ml
English: Cross-resistance has been observed among HBV nucleoside analogues (see section 4.4).
Maltese: Cross-resistance dehret fost l-analogi ta' HBV nucleoside (ara sezzjoni 4.4).
English: 600 mg (30 ml) once daily 600 mg once daily 400 mg (20 ml) once daily 600 mg once every 48 hours
Maltese: 600 mg (30 ml) darba kuljum 600 mg darba kuljum 400 mg (20 ml) darba kuljum 600 mg darba kull 48 siegħa
English: HBeAg-positive n = 440 and 446, HBeAg-negative n = 203 and 207, for telbivudine and lamivudine groups, respectively.
Maltese: HBeAg-posittivi n = 440 and 446, HBeAg-negattivi n = 203 and 207, għall-gruppi ta' telbivudine u lamivudine, rispettivament.
English: Study NV-02B-007 (GLOBE)
Maltese: Studju NV-02B-007 (GLOBE)
English: Table 9 Pharmacokinetic parameters (mean  SD) of telbivudine in subjects with various degrees of renal function
Maltese: Tabella 9 Parametri tal-farmakokinetiċi (medja  SD) ta' telbivudine f'individwi bi gradi varji ta' funzjoni renali
English: n = 432 and 442, for telbivudine and lamivudine groups, respectively.
Maltese: n = 432 u 442, għall-gruppi ta' telbivudine u lamivudine, rispettivament.
English: Telbivudine is not a substrate, inhibitor or inducer of the cytochrome P450 (CYP450) enzyme system.
Maltese: Telbivudine mhuwiex sustrat, inibitur jew induttur tas-sistema ta' enzimi cytochrome P450 (CYP450).
English: ESRD/ Haemodialysis (n = 6) 200 mg
Maltese: ESRD/ Ħemodijaliżi (n = 6) 200 mg
English: Genotypic mutation pattern and cross-resistance
Maltese: It-tip ta' mutazzjoni ġenotipika u cross-resistance
English: Sebivo may also cause other side effects:
Maltese: Sebivo jista' wkoll jikkawża effetti sekondarji oħra:
English: Date of first authorisation: 24 April 2007 Date of latest renewal: 16 December 2016
Maltese: Data tal-aħħar tiġdid: 16 Diċembru 2016
English: • Risk Management plan (RMP)
Maltese: Pjan tal-Ġestjoni tar-Riskju (RMP)
English: HBeAg-negative < 300 copies/ml
Maltese: HBeAg-negattivi <300 kopja/ml
English: • The mean Knodell necroinflammatory score of 7.6 (SD 2.9) at baseline improved (p < 0.0001)
Maltese: • Ir-riżultat Knodell nekroinfjammatorju medju ta' 7.6 (SD 2.9) fil-linja bażi tjieb (p < 0.0001)
English: A trend towards higher rates of HBeAg loss (35% vs 29%) and seroconversion (30% vs 25%) was also observed for telbivudine.
Maltese: Tendenza lejn rati ogħla ta' telf ta' HBeAg (35% vs 29%) u serokonverżjoni (30% vs 25%) kien osservat ukoll għal telbivudine.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to telbivudine in clinical trials (n = 8,914).
Maltese: Il-kategorija ta' frekwenza kienet stimata skont kalkolu statistiku msejjes fuq l-għadd sħiħ ta' pazjenti esposti għal telbivudine waqt provi kliniċi (n = 8,914).
English: Telbivudine is not a substrate, inhibitor or inducer of the cytochrome P450 (CYP450) enzyme system (see section 5.2).
Maltese: Telbivudine mhux sustrat, inibitur jew induttur tas-sistema ta' l-enzima cytochrome P450 (CYP450) (ara sezzjoni 5.2).
English: Table 2 lists the adverse reactions according to MedDRA system organ class and frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Tabella 2 telenka r-reazzjonijiet avversi skond il-klassi tas-sistema ta' l-organi u l-frekwenza MedDRA billi ntużat il-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • The mean Ishak score of 2.2 (SD 1.1) at baseline improved (p < 0.0001) to 0.9 (SD 1.0) with a mean change of -1.3 (SD 1.3).
Maltese: Ishak medju ta' 2.2 (SD 1.1) fil-linja bażi tjieb (p < 0.0001) għal 0.9 (SD 1.0) b'bidla medja ta' -1.3 (SD 1.3).
English: PCR Assay (lower limit of quantification  300 copies/ml).
Maltese: PCR Assay (L-anqas li jista' jaqra ≤300 kopji/ml).
English: Peripheral neuropathy, dysgeusia, hypoaesthesia, paresthesia, sciatica
Maltese: Newropatija periferali, disgewżja, ipoestesija, parestesija, xjatika
English: Clinical and virological efficacy endpoints were evaluated separately in the HBeAg-positive and HBeAg-negative patient populations.
Maltese: Endpoints ta' l-effikaċja klinika u viroloġika kienu evalwati b'mod separat fil-popolazzjonijiet ta' pazjenti HBeAg-posittivi u HBeAg-negattivi.
English: Exacerbations of hepatitis B after discontinuation of treatment Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued antihepatitis B therapy including telbivudine (see section 4.4).
Maltese: Każijiet fejn epatite B ħraxet f'daqqa b'mod sever kienu rrappurtati f'pazjenti li waqqfu it-terapija kontra l-epatite B inkluż telbivudine (ara sezzjoni 4.4).
English: HBV DNA at week 24
Maltese: HBV DNA fl24 ġimgħa
English: UNIQUE IDENTIFIER - 2D BARCODE [folding box only]
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D [kaxxa li tintlewa biss]
English: 300 copies/ml to < 3 log10 copies/ml
Maltese: 300 kopja/ml sa <3 log10 kopji/ml
English: Genotypic resistance test was performed in study NV-02B-007 (GLOBE; n = 680) in patients with virological rebound (confirmed increase of ≥ 1 log10 copies/ml HBV DNA from nadir).
Maltese: Sar studju ta' reżistenza ġenotipika waqt l-istudju NV-02B-007 (GLOBE; n = 680) fost pazjenti b'rikaduta viroloġika (żieda kkonfermata ta' ≥1 log10 copies/ml HBV DNA min-nadir).
English: Also contains sodium.
Maltese: TA' EĊĊIPJENTI Fih ukoll sodium.
English: 200 mg (10 ml) once daily 600 mg once every 72 hours
Maltese: 200 mg (10 ml) darba kuljum 600 mg darba kull 72 siegħa
English: Telbivudine is an inhibitor of both HBV first strand (EC50 = 0.4-1.3 M) and second strand (EC50 = 0.12-0.24 M) synthesis, and shows a distinct preference for inhibiting second strand production.
Maltese: Telbivudine jinibixxi s-sinteżi kemm ta' l-ewwel strand (EC50 = 0.4-1.3 M) kif ukoll tat-tieni (EC50 = 0.12-0.24 M), u juri preferenza distinta għall-inibizzjoni tal-produzzjoni tat-tieni strand.
English: Combination of telbivudine with pegylated or standard interferon alfa (see sections 4.4 and 4.5).
Maltese: It-taħlita ta' telbivudine ma' pegilat jew ma' interferon alfa standard (ara sezzjonijiet 4.4 u 4.5).
English: Film-coated tablets containing 600 mg telbivudine are bioequivalent to 30 ml telbivudine oral solution (20 mg/ml).
Maltese: Pilloli miksijin b'rita li fihom 600 mg telbivudine huma bijoekwivalenti għal 30 ml ta' soluzzjoni orali ta' telbivudine (20 mg/ml).