FrancophonIA/ELRC3.0 huggingface dataset:
English: Following vaccination with Ervebo, individuals may test positive for Ebola glycoprotein (GP) nucleic acids, antigens, or antibodies against Ebola GP, which are targets for certain Ebola diagnostic tests.
Maltese: Wara t-tilqim b'Ervebo, l-individwi jista' jkollhom riżultat pożittiv għat-test tal-aċidi nukleiċi talglikoproteina (GP, glycoprotein) tal-Ebola, antiġeni jew antikorpi kontra l-GP tal-Ebola, li huma l-miri ta' ċerti testijiet dijanjostiċi għall-Ebola.
English: GMT (n) [95% CI]
Maltese: [CI ta' 95%]
English: Additional side effects in children and adolescents The vaccine has been studied in a small number of children and adolescents who were 6 to 17 years of age.
Maltese: Effetti sekondarji addizzjonali fit-tfal u l-adolexxenti It-tilqima ġiet studjata f'numru żgħir ta' tfal u adolexxenti b'età minn 6 snin sa 17-il sena.
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine, ATC code: J07BX02
Maltese: Tilqim, Tilqima Virali, Kodiċi ATC:
English: Individuals who develop vesicular rash after receiving the vaccine should cover the vesicles until they heal to minimize the risk of possible transmission of vaccine virus through open vesicles.
Maltese: Individwi li jiżviluppaw raxx bl-infafet wara li jirċievu t-tilqima għandhom jgħattu l-infafet sakemm dawn ifiequ biex inaqqsu r-riskju ta' trasmissjoni possibbli tal-virus tat-tilqima mill-infafet miftuħa.
English: Do not inject the vaccine intravascularly.
Maltese: Tinjettax it-tilqima b'mod intravaskulari.
English: Viral shedding was observed more frequently in children and adolescents (28/39) compared to adults.
Maltese: It-tixrid tal-virus kien osservat b'mod aktar frekwenti fi tfal u adolexxenti (28/39) meta mqabbel maladulti.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: This vaccine will not protect you against the other types of Ebola virus.
Maltese: Din it-tilqima mhijiex se tipproteġik kontra t-tipi loħra tal-virus tal-Ebola.
English: Because this vaccine is based on VSV, a known pathogen in livestock (e.g. horses, cattle, pigs), the risk assessment included species that are relevant for the wild type (wt) VSV backbone of this vaccine.
Maltese: Minħabba li din it-tilqima hija bbażata fuq VSV, patoġenu magħruf filbhejjem tal-irżiezet (eż. żwiemel, baqar, qżieqeż), il-valutazzjoi tar-riskju inkludiet speċi li huma rilevanti għall-qafas tal-VSV li jinstab fin-natura (wt, wild type) ta' din it-tilqima.
English: • Stomach pain,
Maltese: • Uġigħ fl-istonku,
English: • Headache,
Maltese: • Uġigħ ta' ras,
English: Although the clinical relevance of the GPELISA GMT as well as seroresponse is currently not known, based on available data it is expected that vaccine efficacy would apply to subjects from Guinea, Liberia, Sierra Leone, the United States, Canada, Europe, or other parts of the world.
Maltese: Għalkemm ir-rilevanza klinika ta' GMT ta' GP-ELISA kif ukoll is-serorispons mhumiex magħrufa attwalment, abbażi tad-data disponibbli hija mistennija li l-effikaċja tat-tilqima tapplika għal individwi mill-Guinea, Liberja, Sierra Leone, l-Istati Uniti, il-Kanada, l-Ewropa jew partijiet oħra tad-dinja.
English: The safety, immunogenicity and efficacy of Ervebo in children aged 1 to 17 years have not yet been established (see sections 4.8 and 5.1).
Maltese: Is-sigurtà, l-immunoġeniċità u l-effikaċja ta' Ervebo fi tfal li għandhom minn sena sa 17-il sena għadhom ma ġewx determinati s'issa (ara sezzjonijiet 4.8 u 5.1).
English: For precautions to be taken before administering the vaccine, see section 4.4.
Maltese: Għal prekawzjonjiet li għandhom jittieħdu qabel tagħti t-tilqima, ara sezzjoni 4.4.
English: • Joint pain,
Maltese: • Uġigħ fil-ġogi,
English: • Safe burial practices
Maltese: • Proċeduri sikuri tad-dfin
English: The MAH should provide additional data to confirm that the active substance (AS) process is properly validated.
Maltese: L-MAH għandu jipprovdi data addizzjonali biex jiġi kkonfermat li l-proċess tassustanza attiva (AS, active substance) huwa validat kif suppost.
English: • Ervebo is stored frozen at -80°C to -60°C and should be removed from the freezer and thawed in less than 4 hours until no visible ice is present.
Maltese: • Ervebo jinħażen iffriżat f'temperatura minn -80°C sa -60°C u għandu jitneħħa mill-friża u ssoluzzjoni titħalla tinħall mill-friża f'inqas minn 4 sigħat sakemm ma jkun jidher l-ebda silġ.
English: This does not mean that you have Ebola.
Maltese: Dan ma jfissirx li inti għandek l-Ebola.
English: The final primary analysis was to assess efficacy against laboratory confirmed EVD by comparing incidence of cases occurring 10 to 31 days post-randomization for those vaccinated in the immediate vaccination rings versus incidence of cases for subjects who consented on Day 0 in the delayed vaccination rings.
Maltese: L-analiżi primarja finali kienet biex tiġi stmata l-effikaċja kontra EVD kkonfermata fil-laboratorju billi ġiet imqabbla l-inċidenza ta' każijiet li seħħew 10 ijiem sa 31 jum wara l-għażla arbitrarja għal dawk li tlaqqmu fiċ-ċrieki ta' tilqim immedjat versus l-inċidenza ta' każijiet f'individwi li f'Jum 0 taw ilkunsens tagħhom biex jitlaqqmu fiċ-ċrieki ta' tilqim imdewwem.
English: Arthralgia Myalgia
Maltese: Il-Ġermanja
English: Vaccine efficacy has been established in the period ≥10 to ≤31 days after vaccination, however the duration of protection is not known (see section 5.1).
Maltese: L-effikaċja tattilqima ġiet stabbilita fil-perjodu ta' ≥10 sa ≤31 jum wara t-tilqim, madankollu t-tul ta' żmien talprotezzjoni mhuwiex magħruf (ara sezzjoni 5.1).
English: EXP
Maltese: GMT
English: In different trials, rash was reported with median onsets of 7.5 to 10.5 days (range from 0 to 47 days).
Maltese: Fi provi differenti, ġie rrappurtat raxx b'bidu medjan ta' 7.5 sa 10.
English: This exemption is subject to annual review and in any case ceases to be valid on 31 July 2022.
Maltese: Din l-eżenzjoni hija suġġetta għal reviżjoni annwali u fi kwalunkwe każ tieqaf tkun valida fil-31 ta' Lulju 2022.
English: Summary of Geometric Mean Titers for the PRNT from Protocols 009, 011 and 012 Clinical Trials
Maltese: Tabella 3. Sommarju tat-Titres Ġeometriċi Medji għall-PRNT mill-Provi Kliniċi tal-Protokolli 009, 011 u 012
English: Month 6 GMT (n) [95% CI]
Maltese: f'Xahar 6 (n)
English: Arthritis (arthritis, joint effusion, joint swelling, osteoarthritis, monoarthritis or polyarthritis) was generally reported within the first few weeks following vaccination.
Maltese: Artrite (artrite, effużjoni mill-ġogi, nefħa fil-ġogi, osteoartrite, monoartrite jew poliartrite) ġeneralment kienet irrappurtata fi żmien l-ewwel ftit ġimgħat wara t-tilqim.
English: When Ervebo was administered to female rats, antibodies against the vaccine virus were detected in foetuses and offspring, likely due to trans-placental transfer during gestation and with the acquisition of maternal antibodies during lactation, respectively (see section 4.6).
Maltese: Meta Ervebo ingħata lill-firien nisa, ġew osservati antikorpi kontra l-virus tat-tilqima fil-feti u fil-frieħ, x'aktarx minħabba trasferiment minn ġol-plaċenta waqt it-tqala u bl-akkwist ta' antikorpi tal-omm waqt it-treddigħ, rispettivament (ara sezzjoni 4.6).
English: • you are taking certain medicines that make your immune system weak such as immunosuppressants or corticosteroids,
Maltese: • inti qed tieħu ċerti mediċini li jagħmlu s-sistema immuni tiegħek dgħajfa bħal immunosoppressanti jew kortikosterojdi,
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to rice protein listed in section 2.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1 jew għal proteina tar-ross elenkata fis-sezzjoni 2.
English: Vaccine virus RNA has been detected by PCR in the plasma of most of the adult subjects.
Maltese: L-RNA tal-virus tat-tilqima ġiet osservata permezz ta' PCR fil-plasma tal-biċċa l-kbira tal-individwi adulti.
English: However, once thawed, the vaccine can be stored for up to 14 days at 2°C to 8°C before use.
Maltese: Madankollu, ladarba, tinħall il-friża t-tilqima tista' tinħażen sa 14-il jum f'temperatura minn 2°C sa 8°C qabel tintuża.
English: Baseline GMT (n) [95% CI]
Maltese: f'Xahar 24 (n)
English: For precautions regarding thawing, handling and disposal of the vaccine, see section 6.6.
Maltese: Għal prekawzjonijiet dwar kif iddewweb, timmaniġġja u tarmi t-tilqima, ara sezzjoni 6.6.
English: Justification for not including Braille accepted
Maltese: Grupp talLottijiet ta' Konsistenza Ikkombinati
English: There are no data on fertility effects in humans.
Maltese: M'hemmx data dwar effetti fuq il-fertilità fil-bniedem.
English: • Ebola is a serious disease caused by a virus.
Maltese: • L-Ebola hija marda serja kkawżata minn virus.
English: Warnings and precautions
Maltese: Reazzjonijiet Avversi
English: Vaccine virus might be present in biological fluids such as blood, urine, saliva, semen, vaginal fluids, aqueous humor, breast milk, faeces, sweat, amniotic fluid, and placenta.
Maltese: Il-virus tat-tilqima jista' jkun preżenti fi fluwidi bijoloġiċi bħad-demm, l-awrina, il-bżieq, is-semen, ilfluwidi tal-vaġina, il-fluwidu ċar fil-boċċa tal-għajn quddiem il-lenti, il-ħalib tas-sider, l-ippurgar, lgħaraq, il-fluwidu amnijotiku, u l-plaċenta.
English: Month 1 GMT (n) [95% CI]
Maltese: f'Xahar 1 (n)
English: Very common
Maltese: Konsistenza Ikkombinati
English: Testing for Ebola after you receive Ervebo
Maltese: Ittestjar għall-Ebola wara li inti tirċievi Ervebo
English: Protocol 010 (Ring vaccination study) was a Phase 3 open-label cluster-randomized trial of ring vaccination (vaccinating contacts and contacts of contacts [CCCs] of index Ebola cases) which evaluated efficacy and safety of Ervebo in Guinea.
Maltese: Il-protokoll 010 (Studju ta' tilqim ta' ċirku ta' persuni) kien prova ta' Fażi 3, arbitrarja għal ġemgħat ta' individwi, fejn kemm l-individwi kif ukoll l-investigaturi kienu jafu liema tilqima qed tintuża, ta' tilqim ta' ċirku ta' persuni (tilqim tal-kuntatti u tal-kuntatti tal-kuntatti [CCCs, contacts and contacts of contacts] tal-ewwel każ tal-Ebola identifikat minn grupp) li evalwat l-effikaċja u s-sigurtà ta' Ervebo fil-Guinea.
English: The relative contributions of innate, humoral and cell-mediated immunity to protection from Zaire Ebola virus are unknown.
Maltese: Il-kontribuzzjonijiet relattivi tal-immunità naturali, umorali u medjata miċ-ċelluli għall-protezzjoni mill-virus taż-Zaire Ebola mhumiex magħrufa.
English: Transmission of vaccine virus through close personal contact is accepted as a theoretical possibility.
Maltese: Trasmissjoni tal-virus tat-tilqima permezz ta' kuntatt personali mill-qrib hija aċċettata bħala possibbiltà teoretika.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, and is considered to be essentially sodium-free.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, u huwa meqjus li huwa essenzjalment ħieles mis-sodium.
English: • The vaccine is stored frozen at -80°C to -60°C and should be removed from the freezer and thawed in less than 4 hours until no visible ice is present.
Maltese: • It-tilqima tinħażen iffriżata f'temperatura ta' -80°C sa -60°C u għandha titneħħa mill-friża u titħallha tinħall mill-friża f'inqas minn 4 sigħat sakemm ma jkun jidher l-ebda silġ.
English: The MAH should provide comprehensive comparability data confirming that the commercial product manufactured at the Burgwedel site is representative of the material used in the clinical trials.
Maltese: L-MAH għandu jipprovdi data komprensiva ta' komparabilità li tikkonferma li lprodott kummerċjali manifatturat fis-sit ta' Burgwedel huwa rappreżentattiv talmaterjal li ntuża fil-provi kliniċi.
English: The median durations reported were between 6 to 18 days.
Maltese: It-tulijiet ta' żmien medjana rrappurtati kienu bejn 6 u 18-il jum.
English: EU/1/19/1392/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1392/001
English: • You can catch Ebola from blood and body fluids like urine, stools, saliva, vomit, sweat, breast milk, semen and vaginal fluids of people who are infected with Ebola virus.
Maltese: • Inti tista' taqbdek l-Ebola mid-demm u l-fluwidi tal-ġisem bħall-awrina, l-ippurgar, il-bżieq, irrimettar, l-għaraq, il-ħalib tas-sider, u s-semen u fluwidi tal-vaġina ta' persuni infettati bil-virus tal-Ebola.
English: The vaccine virus RNA was detected in a skin vesicle at 12 days post-vaccination in one of the four subjects.
Maltese: L-RNA tal-virus tattilqima kienet osservata f'nuffata fil-ġilda 12-il jum wara t-tilqim f'wieħed mill-erba' individwi.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32 (0) 27766211 dpoc_belux@merck.com
Maltese: +32 (0) 27766211 dpoc_belux@merck.com
English: • Contact with blood and body fluids (such as urine, faeces, saliva, sweat, vomit, breast milk,
Maltese: • Kuntatt mad-demm u mal-fluwidi tal-ġisem (bħall-awrina, l-ippurgar, il-bżieq, l-għaraq, irrimettar, il-ħalib tas-sider, is-semen, u l-fluwidi tal-vaġina).
English: Transient decreases in counts of lymphocytes, neutrophils and total white blood cells in the first 3 days following vaccination have been observed very commonly in Phase 1/2 studies; these events generally resolved after the first week post-vaccination.
Maltese: Tnaqqis temporanju fl-għadd ta' limfoċiti, newtrofili, u fit-total taċ-ċelluli tad-demm bojod fl-ewwel 3 ijiem wara t-tilqim kien osservat b'mod komuni ħafna fl-istudji ta' Fażi 1/2; dawn l-avvenimenti ġeneralment għaddew wara l-ewwel ġimgħa wara t-tilqim.
English: Ervebo solution for injection rVSVΔG-ZEBOV-GP, live IM
Maltese: U MNEJN GĦANDU JINGĦATA Ervebo soluzzjoni għall-injezzjoni rVSVΔG-ZEBOV-GP, ħaj
English: • Funeral or burial rituals that require handling the body of someone who died from Ebola.
Maltese: • Ritwali funebri jew tad-dfin li jeħtieġu li tmiss il-ġisem ta' xi ħadd li miet bl-Ebola.
English: • you have HIV infection or AIDS,
Maltese: • inti għandek infezzjoni tal-HIV jew l-AIDS,
English: Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ixxahar.
English: • Withdraw the entire content of Ervebo from the vial using a sterile needle and syringe.
Maltese: • Tużax din it-tilqima jekk tinnota frak fil-likwidu.
English: The vaccine virus is a Genetically Modified Organism (GMO).
Maltese: Il-virus tat-tilqima huwa Organiżmu Modifikat b'mod Ġenetiku (GMO, Genetically Modified Organism).
English: Of the 10 cases, 7 were in contacts, and 3 in contacts-of-contacts.
Maltese: Mill-10 każijiet, 7 kienu f'kuntatti, u 3 f'kuntatti tal-kuntatti.
English: Protection against filovirus disease
Maltese: Protezzjoni kontra mard ikkawżat mill-filovirus
English: Injection site pain Injection site erythema Injection site swelling
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni
English: Immune globulin (IG), blood or plasma transfusions should not be given concomitantly with Ervebo.
Maltese: Immunoglobulini (IG, immune globulin), trasfużjonijiet tad-demm jew tal-plażma m'għandhomx jingħataw flimkien ma' Ervebo.
English: Chills Hyperhidrosis (sweats)
Maltese: Tkexkix ta' bard Iperidrosi (għaraq)
English: The vaccine will not prevent disease caused by Filoviruses other than Zaire Ebola virus.
Maltese: It-tilqima ma tilqax kontra mard ikkawżat mill-Filoviruses ħlief għall-virus Zaire Ebola.
English: Therefore, diagnostic testing for Ebola should target non-GP sections of the Ebola virus.
Maltese: biex tinkludi wkoll testijiet għal virusis speċifikati.
English: Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla Farmaċewtika
English: Blisters made of polychlorotrifluorethylene (PCTFE) / polyethylene (PE) / polyvinylchloride (PVC) / aluminium.
Maltese: Folja ta' polychlorotrifluorethylene (PCTFE)/polyethylene (PE)/polyvinylchloride (PVC)/aluminju.
English: • The active substance is emtricitabine.
Maltese: • Is-sustanza attiva hi emtricitabine.
English: Emtricitabine is active in vitro against HBV.
Maltese: Emtricitabine hija attiva in vitro kontra l-HBV.
English: Emtricitabine dose (mg)
Maltese: Doża ta' emtricitabine (mg)
English: Sunset yellow (E110) may cause allergic reactions.
Maltese: Sunset yellow (E110) jista' jikkawża reazzjonijiet allerġiċi.
English: 30 hard capsules.
Maltese: 30 kapsula iebsin.
English: The systemic clearance of emtricitabine averaged 307 mL/min (4.03 mL/min/kg).
Maltese: It-tneħħija sistemika ta' emtricitabine kienet medja ta' 307 mL/min (4.03 mL/min/kg).
English: Emtriva [outer packaging only]
Maltese: Emtriva [pakkett ta' barra biss]
English: County Cork
Maltese: Carrigtohill County Cork
English: Emtriva oral solution contains:
Maltese: Emtriva soluzzjoni orali fiha:
English: 1 See section 4.8, Description of selected adverse reactions for more details.
Maltese: 1 Ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula għal aktar dettalji.
English: Contains E110, E216, E218, sodium and propylene glycol, see leaflet for further information.
Maltese: TA' EĊĊIPJENTI Fiha E110, E216, E218, sodium u propylene glycol, ara l-fuljett għal iktar informazzjoni.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenza hija deskritta bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) jew mhux komuni (≥ 1/1,000 sa < 1/100).
English: This HIV-1 mutation was observed in vitro and in HIV-1 infected patients.
Maltese: Din il-mutazzjoni tal-HIV-1 ġiet osservata in vitro u f'pazjenti infettati bl
English: Capsule contents Crospovidone
Maltese: Kontenut tal-kapsula
English: • The other ingredients are: cotton candy flavouring, disodium edetate, hydrochloric acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sodium phosphate monobasic hydrate, sunset yellow (E110), purified water, xylitol (E967).
Maltese: • Is-sustanzi l-oħra huma: cotton candy flavouring, disodium edetate, hydrochloric acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sodium phosphate monobasic hydrate, sunset yellow (E110), purified water, xylitol (E967).
English: Ethnicity No clinically important pharmacokinetic difference due to ethnicity has been identified.
Maltese: Etniċità L-ebda differenza farmakokinetika klinikament importanti minħabba l-etniċità ma ġiet identifikata.
English: The systemic emtricitabine exposure (mean ± standard deviation) increased from 11.8 ± 2.9 µg·h/mL in subjects with normal renal function to 19.9 ± 1.1, 25.0 ± 5.7 and 34.0 ± 2.1 µg·h/mL, in patients with mild, moderate and severe renal impairment, respectively.
Maltese: L-esponiment sistemiku ta' emtricitabine (medja ± devjazzjoni standard) żdiedet minn 11.8 ± 2.9 µg·h/mL f'individwi b'funzjoni renali normali, għal 19.9 ± 1.1, 25.0 ± 5.7 u 34.0 ± 2.1 µg·h/mL, f'pazjenti b'indeboliment ħafif, moderat u sever rispettivament.
English: < 15 (functionally anephric, requiring intermittent haemodialysis)*
Maltese: < 15 (funzjonalità anefrika, teħtieġ dijaliżi tad-demm intermittenti)*
English: Each dose (24 mL) contains 36 mg methyl parahydroxybenzoate (E218), 3.6 mg propyl parahydroxybenzoate (E216), 1.2 mg sunset yellow (E110), 480 mg propylene glycol and has a sodium content of 36 mg.
Maltese: Kull doża (24 mL) fiha 36 mg ta' methyl parahydroxybenzoate (E218), 3.6 mg propyl parahydroxybenzoate (E216), 1.2 mg sunset yellow (E110), 480 mg propylene glycol u għandha kontenut ta' sodium ta' 36 mg.
English: 170 mL oral solution.
Maltese: Il-flixkun fih 170 mL ta' soluzzjoni orali.
English: Pack size: 30 hard capsules.
Maltese: Daqs tal-pakkett: 30 kapsula iebsin.
English: The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563).
Maltese: Ilkategorija ta' frekwenza ta' mhux komuni kienet stmata mill-kalkulazzjoni statistika bbażata fuq in-numru totali ta' pazjenti esposti għal emtricitabine f'dawn l-istudji kliniċi (n = 1,563).
English: There was no evidence of toxicity to mitochondria in vitro or in vivo.
Maltese: Ma kienx hemm evidenza ta' tossiċità lill-mitokondrija in vitro jew in vivo.
English: Emtricitabine did not inhibit in vitro drug metabolism mediated by the following human CYP450 isoenzymes: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 and 3A4.
Maltese: Emtricitabine ma impedixxix in vitro l-metaboliżmu tal-mediċina medjat bl-iżoenzimi CYP450 umani li ġejjin: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 u 3A4.
English: In vitro, emtricitabine did not inhibit metabolism mediated by any of the following human CYP450 isoforms: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 and 3A4.
Maltese: In vitro, emtricitabine ma impedixxix il-metaboliżmu medjat mill-iżoformi CYP450 umani li ġejjin: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6 u 3A4.
English: Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF09
Maltese: Impedituri ta' nucleoside u nucleotide reverse transcriptase, Kodiċi ATC:
English: Patients co-infected with HBV
Maltese: Pazjenti infettati ukoll bl-HBV
English: Emtricitabine-resistant viruses were cross-resistant to lamivudine, but retained sensitivity to other nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine, stavudine, tenofovir, abacavir and didanosine), all non-nucleoside reverse transcriptase inhibitors (NNRTIs) and all PIs.
Maltese: Il-viri reżistenti għal emtricitabine kienu cross-resistant għal lamivudine, iżda żammew is-sensittività għall-impedituri ta' nucleoside reverse transcriptase oħra (NRTI) (zidovudine, stavudine, tenofovir, abacavir u didanosine), l-impedituri ta' non-nucleoside reverse transcriptase kollha (NNRTI) u l-PIs kollha.
English: Viruses resistant to zidovudine, didanosine and NNRTIs retained their sensitivity to emtricitabine (IC50 = 0.002 µmol/l to 0.08 µmol/l).
Maltese: Il-viri reżistenti għal zidovudine, didanosine u l-NNRTIs żammew is-sensittività għal emtricitabine (IC50 = 0.002 µmol/l sa 0.08 µmol/l).
English: PC: {number} SN: {number} NN: {number}
Maltese: • M'għandekx tredda' jekk qed tieħu Emtriva.
English: Adults with renal insufficiency
Maltese: Adulti b'insuffiċjenza renali
English: Emtriva 10 mg/mL oral solution
Maltese: Emtriva 10 mg/mL soluzzjoni orali
English: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill
Maltese: Gilead Sciences Ireland UC IDA Business & Technology Park
English: In combination studies of emtricitabine with protease inhibitors (PIs), nucleoside, nucleotide and non-nucleoside analogue inhibitors of HIV reverse transcriptase, additive to synergistic effects were observed.
Maltese: Fi studji kombinati ta' emtricitabine flimkien ma' impedituri tal-protease (PIs, protease inhibitors), impedituri ta' l-analogi tan-nukleosidi, nukleotidi u mhux nukleosidi tar-reverse transcriptase ta' l-HIV, żidiet ma' l-effetti sinerġistiċi ġew osservati.
English: Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over.
Maltese: Emtriva hija indikata flimkien ma' prodotti mediċinali antiretrovirali oħra għat-trattament ta' adulti u tfal infettati bil-virus tal-immunodefiċjenza umana-1 (HIV-1, human immunodeficiency virus-1) minn età ta' 4 xhur u aktar.
English: vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)1,2
Maltese: raxx vesikulobullożu, raxx bil-ponot, raxx makulari bl-imfafet, raxx, ħakk, urtikarja, telf tal-kulur tal-ġilda (żieda fil-pigmentazzjoni)1,2