FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant submitted Cmax, AUCt and AUCinf values for all the volunteers and stated that the design of the study included sampling times in the absorption and late elimination phases in order to use results not exceeding the limit of quantification.
Maltese: L-Applikant issottometta l-valuri tas-Cmax, AUCt u AUCinf għall-voluntieri kollha u ddikjara li d-disinn tal-istudju kien jinkludi ħinijiet ta' teħid ta' kampjuni fil-fażijiet ta' assorbiment u eliminazzjoni tard sabiex jintużaw riżultati li ma jaqbżux il-limitu ta' kwantifikazzjoni.
English: No volunteers had to be removed by misinterpretation or an incorrect use of values below the LOQ and furthermore, the Applicant provided the calculated 90% confidence intervals for all 36 subjects and by exclusion of subject 24.
Maltese: L-ebda voluntier ma kellu jitneħħa minħabba interpretazzjoni ħażina jew użu ħażin ta' valuri taħt l-LOQ u barra minn hekk, l-Applikant ipprovda l-intervalli ta' kunfidenza ta' 90% kkalkolati għas-36 suġġett kollha bl-esklużjoni tas-suġġett 24.
English: (Invented) Name
Maltese: ANNESS I LISTA
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Further information on Defitelio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Defitelio contains the active substance defibrotide.
Maltese: Defitelio fih is-sustanza attiva defibrotide.
English: This overview was last updated in 10-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'10-2019.
English: Benefits of Defitelio were also seen in data from a United States patient registry (information about patients collected in a standard way), where patients with severe VOD after blood stem cell transplantation who received Defitelio plus standard care had better outcomes than those given standard care alone, including a higher 100-day survival rate (39% versus 31%) and a higher proportion of patients whose VOD resolved (51% versus 29%).
Maltese: Il-benefiċċji ta' Defitelio dehru wkoll f'data minn reġistru tal-pazjenti fl-Istati Uniti (l-informazzjoni dwar il-pazjenti nġabret b'mod standard), fejn pazjenti b'VOD severa wara trapjant taċ-ċelloli staminali tad-demm li rċivew Defitelio flimkien ma' kura standard kellhom riżultati aħjar minn dawk li ngħataw kura standard biss, inkluż rata ogħla ta' sopravivenza wara 100 jum (39 % kontra 31 %) u proporzjon ogħla ta' pazjenti li l-VOD tagħhom fieqet (51 % kontra 29 %).
English: Defitelio received a marketing authorisation valid throughout the European Union on 18 October 2013.
Maltese: Defitelio rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fit18 ta' Ottubru 2013.
English: Severe VOD has a high mortality rate of 75% or higher.
Maltese: VOD severa għandha rata ta' mortalità ta' 75 % jew għola.
English: Defitelio lowered the mortality rate to 62% at 100 days after transplantation, and 24% of patients had no symptoms of severe VOD after 100 days.
Maltese: Defitelio baxxa rata ta' mortalità għal 62 % fil-100 jum wara t-trapjant, u 24 % tal-pazjenti ma kellhom l-ebda sintomu ta' VOD severa wara 100 jum.
English: VOD is rare, and Defitelio was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 July 2004.
Maltese: VOD hija rari, u Defitelio ġie denominat bħala "mediċina orfni" (mediċina li tintuża f'mard rari) fid29 ta' Lulju 2004.
English: Other information about Defitelio
Maltese: Informazzjoni oħra dwar Defitelio
English: In one main study involving 102 patients with severe VOD following blood stem cell transplantation, Defitelio was compared with past records of patients who had received standard supportive care.
Maltese: Fi studju ewlieni wieħed li involva 102 pazjenti b'VOD severa wara trapjant taċ-ċelloli staminali tad-demm, Defitelio tqabbel ma' rekords tal-passat ta' pazjenti li kienu rċivew kura ta' sostenn standard.
English: What are the risks associated with Defitelio?
Maltese: X'inhuma r-riskji assoċjati ma' Defitelio?
English: The most common side effects with Defitelio are hypotension (low blood pressure) and bleeding.
Maltese: L-effetti sekondarji l-aktar komuni b'Defitelio huma ipotensjoni (pressjoni tad-demm baxxa) u fsada.
English: Defitelio is a medicine used to treat severe veno-occlusive disease (VOD) in patients undergoing haematopoietic (blood) stem cell transplantation.
Maltese: Defitelio huwa mediċina li tintuża biex tikkura marda venookklużiva (VOD) severa f'pazjenti li qiegħed isirilhom trapjant taċ-ċelloli staminali ematopojetiċi (tad-demm).
English: Treatment should last for at least 3 weeks and continue until the patient no longer has symptoms.
Maltese: Il-kura għandha ddum għal tal-inqas 3 ġimgħat u għandha tkompli sakemm ilpazjent ma jibqax ikollu sintomi.
English: Although it was not possible to conduct a study directly comparing Defitelio with placebo (dummy treatment), the company had provided sufficient data to show that patients treated with the medicine had improved chances of survival.
Maltese: Għalkemm ma kienx possibbli jsir studju li jqabbel direttament Defitelio ma' plaċebo (kura finta), ilkumpanija kienet ipprovdiet biżżejjed data biex turi li l-pazjenti kkurati bil-mediċina kienu tejbu lprobabbiltà ta' sopravivenza.
English: It is given by infusion (drip) into a vein over 2 hours 4 times a day.
Maltese: Jingħata permezz ta' infużjoni (dripp) fil-vina tul sagħtejn 4 darbiet kuljum.
English: The active substance in Defitelio, defibrotide, works by increasing the breakdown of clots in the blood.
Maltese: Is-sustanza attiva f'Defitelio, id-defibrotide, taħdem billi żżid it-tkissir tal-emboli fid-demm.
English: As for all medicines, data on the use of Defitelio are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Defitelio hija ssorveljata kontinwament.
English: Defitelio (defibrotide)
Maltese: Kif jintuża Defitelio?
English: How is Defitelio used?
Maltese: Kif jaħdem Defitelio?
English: Since Defitelio has been authorised under exceptional circumstances, the company that markets the medicine is required to provide results of an ongoing study on safety of the medicine when used for prevention of VOD in adults and children undergoing hematopoietic stem cell transplantation.
Maltese: Minħabba li Defitelio ġie awtorizzat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed il-mediċina fis-suq hija meħtieġa li tipprovdi riżultati ta' studju li għadu għaddej dwar is-sigurtà tal-mediċina meta tintuża għall-prevenzjoni ta' VOD f'adulti u tfal li qiegħed isirilhom trapjant taċ-ċelloli staminali ematopojetiċi.
English: The side effects seen, such as bleeding, were considered manageable and it was not possible to determine with certainty whether they were caused by Defitelio.
Maltese: L-effetti sekondarji li dehru, bħal fsada, tqiesu bħala li jistgħu jiġu mmaniġġjati u ma kienx possibbli li jiġi determinat b'ċertezza jekk ġewx ikkawżati minn Defitelio.
English: The European Medicines Agency decided that Defitelio's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Defitelio huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: What information is still awaited for Defitelio?
Maltese: Liema informazzjoni għadha mistennija għal Defitelio?
English: VOD is a condition in which the veins in the liver become blocked and stop the liver working properly.
Maltese: Barra minn hekk, id-defibrotide tista' tipproteġi ċ-ċelloli li jiksu l-vażi tad-demm.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PROCOMVAX
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) PROCOMVAX
English: This summary was last updated in 02-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 02-2008.
English: PROCOMVAX is a vaccine.
Maltese: PROCOMVAX huwa vaċċin.
English: The marketing authorisation was renewed on 7 May 2004.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fis-7 ta' Mejju 2004.
English: Other common side effects are fever, anorexia (loss of appetite), vomiting, diarrhoea, irritability, somnolence (sleepiness), crying (including unusual highpitched crying and prolonged crying) and otitis media (infection of the middle ear).
Maltese: Effetti sekondarji oħra huma d-deni, l-anoressija (nuqqas ta' aptit), remettar, dijarea, irritabilità, somnolenza (ħafna ngħas), biki (inkluż biki werżieqi u fit-tul), u infezzjonijiet fil-parti nofsanija tal-widna.
English: • surface antigen (proteins from the surface) of the hepatitis B virus.
Maltese: • antiġenu tas-superfiċje (proteini mill-wiċċ) tal-virus ta' l-epatite B.
English: In both groups, the infants were vaccinated at two, four, and 12 to 15 months of age.
Maltese: Fiżżewġ gruppi, it-tfal tlaqqmu fl-età ta' xahrejn, erba' xhur, u bejn 12 u 15-il xahar.
English: PROCOMVAX has been studied in one main study involving 882 infants.
Maltese: PROCOMVAX ġie studjat fi studju wieħed ewlieni li fih ħadu sehem 882 tifel u tifla żgħar.
English: • a protein purified from Hib, attached to a carrier (a protein purified from the outer membrane of
Maltese: • proteina ppurifikata mill-Hib, imwaħħla ma' carrier (proteina ppurifikata mill-membrana ta' barra
English: It contains proteins from Haemophilus influenzae type b (‘Hib', a bacterium that can cause meningitis) and parts of the hepatitis B virus as active substances.
Maltese: Fih proteini mill-Haemophilus influenzae tip b (‘Hib', batterju li jista' jikkawża l-meninġite) u partijiet mill-virus ta' l-epatite B bħala
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: PROCOMVAX is a combination of components that have been available in the European Union (EU) in other vaccines for a number of years.
Maltese: PROCOMVAX huwa kombinazzjoni ta' komponenti li ilhom disponibbli fl-Unjoni Ewropea (UE) f'vaċċini oħra għal ħafna snin.
English: How has PROCOMVAX been studied?
Maltese: Kif ġie studjat PROCOMVAX ?
English: This conclusion was confirmed with the results from seven additional studies supplied by the company.
Maltese: Din il-konklużjoni ġiet ikkonfermata mar-riżultati minn seba' studji addizzjonali
English: The vaccination schedule is three doses of PROCOMVAX, ideally at two, four, and 12 to 15 months of age.
Maltese: L-iskeda ta' tilqim hija ta' tliet dożi ta' PROCOMVAX, idealment meta t-tfal ikollhom xahrejn, erba' xhur, u bejn 12 u 15-il xahar.
English: The main study also showed that PROCOMVAX produced adequate levels of protection against hepatitis B virus.
Maltese: L-istudju ewlieni wera wkoll li PROCOMVAX ipproduċa livelli adegwati ta' protezzjoni kontra lvirus ta' l-epatite B.
English: The active substances are ‘adsorbed', meaning that they are fixed onto aluminium compounds, and the vaccine contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Maltese: Is-sustanzi attivi huma ‘adsorbiti', jiġifieri jeħlu ma' komposti ta' l-aluminju, u l-vaċċin ikun fih ‘adjuvant' (kompost li jkun fih l-aluminju) biex jistimula rispons aħjar.
English: PROCOMVAX is not recommended for infants younger than six weeks of age, because of a risk of a reduced protective response to Hib.
Maltese: PROCOMVAX mhux rakkomandat għal tfal ta' inqas minn sitt ġimgħat, minħabba riskju ta' rispons protettiv imnaqqas għall-Hib.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that PROCOMVAX's benefits are greater than its risks for vaccination against invasive disease caused by Hib and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' PROCOMVAX huma ikbar mir-riskji tiegħu għat-tilqim kontra mard invażiv ikkawżat mill-Hib u kontra infezzjonijiet ikkawżati mis-subtipi kollha magħrufin tal-virus ta' l-epatite B fit-tfal li jkollhom bejn sitt ġimgħat u 15-il xahar.
English: PROCOMVAX is used to vaccinate infants aged between six weeks and 15 months against ‘invasive' disease caused by Hib (such as bacterial meningitis) and infection with the hepatitis B virus.
Maltese: PROCOMVAX jintuża fit-tlaqqim ta' tfal żgħar li jkollhom bejn sitt ġimgħat u 15-il xahar kontra lmard ‘invażiv' ikkawżat mill-Hib (bħall-meninġite batterika) u l-infezzjoni bil-virus ta' l-epatite B.
English: The most common side effects seen with PROCOMVAX are reactions at the injection site, including pain, soreness, erythema (redness) and swelling.
Maltese: L-iktar effetti sekondarji komuni li dehru bi PROCOMVAX huma reazzjonijiet fis-sit ta' l-injezzjoni, inkluż uġigħ, sliħ, ħmura u nefħa.
English: These are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Maltese: Dawn jiġu prodotti b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': isir minn batterju li jkun irċieva ġene (DNA),
English: The European Commission granted a marketing authorisation valid throughout the EU to Sanofi Pasteur MSD S.N.C.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq madwar l-Unjoni Ewropea, għal PROCOMVAX lil Sanofi Pasteur MSD S.N.C. fis-7 ta' Mejju 1999.
English: The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Maltese: Is-sistema immunitarja mbagħad tkun tista' tipproduċi antikorpi iktar malajr meta l-persuna tiġi naturalment esposta għall-batterji u l-vajrusis.
English: Infants who show signs of hypersensitivity (allergic reaction) after an injection should not receive further injections of the vaccine.
Maltese: Tfal żgħar li juru sinjali ta' sensittività eċċessiva (reazzjoni allerġika) wara injezzjoni ma għandhomx jingħataw iktar injezzjonijiet tat-tilqima.
English: What is the risk associated with PROCOMVAX?
Maltese: Liema benefiċċju wera PROCOMVAX waqt l-istudji mwettqa?
English: In the main study, the responses both to PROCOMVAX and to the separate vaccines were low in terms of levels of antibodies against Hib.
Maltese: Fl-istudju ewlieni, ir-rispons kemm għal PROCOMVAX kif ukoll għall-vaċċini separati kienu baxxi f'termini ta' antikorpi kontra l-Hib.
English: County Cork, T45 DP77 Ireland
Maltese: County Cork, T45 DP77 L-Irlanda
English: 30 tablets.
Maltese: 30 pillola.
English: Tablet.
Maltese: Pillola.
English: 90 (3 bottles of 30) tablets.
Maltese: 90 (3 fliexken ta' 30) pillola.
English: EU/1/03/251/001 30 tablets EU/1/03/251/002 90 (3 bottles of 30) tablets
Maltese: EU/1/03/251/001 30 pillola EU/1/03/251/002 90 (3 fliexken ta' 30) pillola
English: Renal Function Group
Maltese: Grupp ta' Funzjoni Renali
English: Hepsera contains lactose monohydrate.
Maltese: Hepsera fiha lactose monohydrate.
English: Hepsera 10 mg tablets
Maltese: Hepsera 10 mg pilloli
English: • amphotericin B, for fungal infections
Maltese: • amphotericin B, għall-infezzjonijiet fungali
English: Clinical efficacy and safety:
Maltese: Effikaċja klinika u sigurtà:
English: Hepsera [outer packaging only]
Maltese: Hepsera [pakkett ta' barra biss]
English: Hepsera 10 mg tablets Adefovir dipivoxil
Maltese: Hepsera 10 mg pilloli Adefovir dipivoxil
English: {MM/YYYY}
Maltese: {XX/SSSS}
English: • look out for possible signs of lactic acidosis - see section 4, Possible side effects.
Maltese: • oqgħod attent/a għal sinjali possibbli ta' aċidożi lattika - ara sezzjoni 4, Effetti sekondarji possibbli.
English: • Inflammation of the pancreas (pancreatitis)
Maltese: • Infjammazzjoni tal-frixa (pankreatite)
English: • foscarnet, cidofovir or tenofovir disoproxil fumarate, for viral infections
Maltese: • foscarnet, cidofovir jew tenofovir disoproxil fumarate, għall-infezzjonijiet virali
English: Date of first authorisation: 06 March 2003 Date of latest renewal: 06 March 2008
Maltese: Data tal-aħħar tiġdid: 6 ta' Marzu 2008
English: In patients at risk for renal impairment, consideration should be given to more frequent monitoring of renal function.
Maltese: F'pazjenti f'riskju ta' indeboliment renali, għandha tingħata konsiderazzjoni għal monitoraġġ iktar frekwenti tal-funzjoni renali.
English: After 96, 144, 192 and 240 weeks of treatment with adefovir dipivoxil, resistance surveillance was performed for 293, 221, 116 and 64 patients, respectively.
Maltese: Wara 96, 144, 192 u 240 ġimgħa ta' trattament b'adefovir dipivoxil, sorveljanza tar-reżistenza twettqet fuq 293, 221, 116 u 64 pazjenti rispettivament.
English: Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0
Maltese: Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0
English: Each tablet contains 113 mg lactose monohydrate.
Maltese: Kull pillola fiha 113 mg ta' lactose monohydrate.
English: Renal failure, abnormal renal function, hypophosphatemia
Maltese: Kollass tal-kliewi, funzjoni renali anormali, ipofosfatimja
English: At concentrations substantially higher (> 4,000-fold) than those observed in vivo, adefovir did not inhibit any of the following human CYP450 isoforms, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
Maltese: F'konċentrazzjonijiet sostanzjalment ogħla (> 4,000-darba) minn dawk osservati in vivo, adefovir ma jimpedixxi l-ebda wieħed mill-iżoformi ta' CYP450 umani li ġejjin, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
English: Plasma adefovir concentrations declined in a biexponential manner with a median terminal elimination half-life of 7.22 h (4.72-10.70 h).
Maltese: Il-konċentrazzjonijiet ta' adefovir fil-plażma naqsu b'mod bi-esponentali bilmedjan tal-half-life ta' l-eliminazzjoni jkun ta' 7.22 sigħat (4.72-10.70 sigħat).
English: How to store Hepsera
Maltese: Tiħux Hepsera
English: • The active substance in Hepsera is adefovir dipivoxil.
Maltese: • Is-sustanza attiva f'Hepsera hi adefovir dipivoxil.
English: Improvements or stabilisation were seen in Child-Pugh-Turcotte score.
Maltese: Titjib jew stabilizzazzjoni ġew innutati fir-riżultati tal-punteġġ ta' Child-Pugh-Turcotte.
English: Exacerbation of hepatitis:
Maltese: Indeboliment epatiku:
English: • Diarrhoea
Maltese: • Dijarea
English: Hepsera is used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults.
Maltese: Hepsera jintuża fit-trattament tal-epatite B kronika, infezzjoni bil-virus tal-epatite B (HBV), fl-adulti.
English: Gilead Sciences Ltd Tel: + 44 (0) 8000 113 700
Maltese: United Kingdom Gilead Sciences Ltd Tel: + 44 (0) 8000 113 700
English: Median Cmax and AUC0-∞ values were 16.70 (9.66-30.56) ng/ml and 204.40 (109.75-356.05) ng·h/ml, respectively.
Maltese: Il-valuri medjani ta' Cmax u AUC0-∞ kienu ta' 16.70 (9.66-30.56) ng/ml u ta' 204.40
English: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co. Cork Ireland
Maltese: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co. Cork L-Irlanda
English: Pancreatitis
Maltese: Pankreatite
English: • The other ingredients are: pregelatinised starch, croscarmellose sodium, lactose monohydrate, talc and magnesium stearate.
Maltese: • Is-sustanzi mhux attivi l-oħra huma: pregelatinised starch, croscarmellose sodium, lactose monohydrate, talc u magnesium stearate.
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Normalisation of ALT, albumin, bilirubin and prothrombin time was seen at week 48 in 51-85 % of the patients.
Maltese: Kien hemm normalizzazzjoni ta' l-ALT, ta' l-albumina, bilirubina u tal-ħin tal-prothrombin raw fil-Ġimgħa 48 51-85% mill-pazjenti.
English: Nonetheless, there is a potential risk of selection of HIV strains resistant to adefovir with possible cross-resistance to other antiviral medicinal products.
Maltese: Madankollu hemm riskju potenzjali ta' selezzjoni ta' strejns tal-HIV reżistenti għal adefovir bil-possibbiltà ta' cross-resistance għall-prodotti mediċinali antivirali oħra.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 tablets and outer cartons containing 90 (3 bottles of 30) tablets.
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli: kartun ta' barra li fihom flixkun wieħed ta' 30 pillola u kartun ta' barra li fihom 90 (3 fliexken ta' 30) pillola.
English: Very rare side effects
Maltese: Effetti sekondarji rari ħafna
English: • Rash and itching - common
Maltese: • Raxx u ħakk - komuni
English: Gastrointestinal disorders: Common:
Maltese: Disturbi gastro-intestinali:
English: The median (min-max) renal clearance of adefovir in subjects with normal renal function (Clcr > 80 ml/min) is 211 ml/min (172-316 ml/min), approximately twice calculated creatinine clearance (Cockroft-Gault method).
Maltese: It-tneħħija mill-kliewi medjana (minima-massima) ta' adefovir f'suġġetti b'funzjoni renali normali (Clcr > 80 ml/min) hi ta' 211 ml/min (172-316 ml/min), bejn wieħed u ieħor darbtejn ir-rata mkejla ta' tneħħija tal-krejatinina (metodu ta' Cockroft-Gault).
English: Hepsera is indicated for the treatment of chronic hepatitis B in adults with:
Maltese: Hepsera hija indikata għat-trattament ta' epatite B kronika f'adulti b':
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 24 01 35 50
Maltese: België/Belgique/Belgien Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 24 01 35 50
English: Do not store above 30ºC (86ºF).
Maltese: Taħżinx f'temperatura 'l fuq minn 30ºC (86ºF).
English: In a second open-label, one-arm study, 10 mg adefovir dipivoxil and pegylated interferon alpha-2a were added to ongoing lamivudine therapy in 18 HIV/HBV co-infected patients with lamivudine-resistant HBV.
Maltese: Fit-tieni studju open-label, one-arm, 10 mg ta' adefovir dipivoxil u pegylated interferon alpha-2a kienu miżjuda ma' terapija kurrenti b'lamivudine fi 18-il pazjent infettati ukoll bl-HIV/HBV b'HBV reżistenti għal lamivudine.
English: • Do not take Hepsera if you are taking any medicines containing tenofovir.
Maltese: • Tieħux Hepsera jekk qed tieħu kwalunkwe mediċini li fihom tenofovir.
English: Gilead Sciences Slovakia s.r.o.
Maltese: Slovenská republika Gilead Sciences Slovakia s.r.o.
English: In HBeAg positive patients, the incidence of adefovir-associated resistance mutations was 3 % (2/65), 17 % (11/65) and 20 % (13/65) after a median duration exposure of 135, 189 and 235 weeks respectively.
Maltese: F'pazjenti pożittivi għal HBeAg, l-inċidenza ta' mutazzjonijiet assoċjati marreżistenza għal adefovir kienet ta' 3% (2/65), 17% (11/65) u 20% (13/65) wara tul medjan ta' esponiment ta' 135, 189 u 235 ġimgħa rispettivament.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: The volume of distribution at steady-state following intravenous administration of 1.0 or 3.0 mg/kg/day is 392±75 and 352±9 ml/kg, respectively.
Maltese: Il-volum tad-distribuzzjoni fiss wara l-għoti ġol-vini ta' 1.0 jew ta' 3.0 mg/kg/kuljum hu ta' 392±75 u ta' 352±9 ml/kg, rispettivament.
English: b. Tabulated summary of adverse reactions
Maltese: Sommarju tabulat ta' reazzjonijiet avversi
English: On the basis of an algorithm defining possible proximal renal tubulopathy and/or Fanconi syndrome as confirmed abnormalities, 28 cases of proximal renal tubulopathy (including possible Fanconi syndrome) were retrieved in the clinical safety dataset.
Maltese: Abbażi ta' algoritmu li jiddefinixxi l-possibiltà ta' tubulopatija prossimali renali u/jew sindrome ta' Fanconi bħala anormalitajiet ikkonfermati, 28 każ ta' tubulopatija prossimali renali (li tinkludi l-possibiltà ta' sindrome ta' Fanconi) ġew irkuprati fis-sett ta' data dwar is-sigurtà klinika.