FrancophonIA/ELRC3.0 huggingface dataset:
English: When used with cisplatin in cervical cancer, Hycamtin is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Maltese: Meta Hycamtin jintuża ma' ċisplatin fil-kanċer taċ-ċerviċi, jingħata bħala infużjoni fil-jiem 1, 2 u 3 (biċċisplatin jingħata fil-jum 1).
English: Hycamtin as an infusion has been studied in 293 women with advanced cervical cancer, where the effectiveness of a combination of Hycamtin and cisplatin was compared with that of cisplatin alone.
Maltese: Hycamtin mogħti bħala infużjoni ġie studjat f'293 mara b'kanċer taċ-ċerviċi avvanzat, fejn l-effikaċja ta' kombinazzjoni ta' Hycamtin u ċ-ċisplatin tqabblet ma' dik taċ-ċisplatinu waħdu.
English: 10 September 2012
Maltese: 10 ta' Settembru 2012
English: • Intra-abdominal infections.
Maltese: • Infezzjonijiet intra-addominali.
English: What is Zinacef?
Maltese: X'inhu Zinacef?
English: It is also available under other trade names: Curocef, Curoxim, Curoxime, Zinnat.
Maltese: Huwa wkoll disponibbli taħt ismijiet kummerċjali oħra: Curocef, Curoxim, Curoxime, Zinnat.
English: • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic,
Maltese: • Profilassi kontra infezzjoni f'kirurġija gastrointestinali (inkluż esofagali), ortopedika,
English: • Complicated urinary tract infections, including pyelonephritis (kidney infection).
Maltese: • Infezzjonijiet ikkumplikati tal-apparat urinarju, inkluż pajelonefrite (infezzjoni fil-kliewi).
English: On 24 May 2012, the European Medicines Agency completed a review of Zinacef.
Maltese: Fl-24 ta' Mejju 2012, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Zinacef.
English: The active substance, cefuroxime sodium, belongs to the group ‘cephalosporins'.
Maltese: Is-sustanza attiva, cefuroxime sodium, tagħmel parti mill-grupp ta' ‘kefalosporini'.
English: Zinacef is an antibiotic used to treat certain bacterial infections, including pneumonia (infection of the lungs), urinary tract infections (infections of the structures that carry urine), soft-tissue infections (infections of tissues just below the skin), infections within the abdomen, as well as to prevent infections during surgery.
Maltese: Zinacef huwa antibijotiku li jintuża fil-kura ta' ċerti infezzjonijiet batteriċi, inkluż pulmonite (infezzjoni tal-pulmuni), infezzjonijiet tal-apparat urinarju (infezzjonijiet tal-istrutturi li jġorru l-awrina), infezzjonijiet tat-tessut artab (infezzjonijiet tat-tessut eżatt taħt il-ġilda), infezzjonijiet fl-addome, kif ukoll fil-prevenzjoni ta' infezzjonijiet matul kirurġija.
English: Zinacef was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Zinacef ġie identifikat li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproki u Deċentralizzati - Umani (CMD(h)).
English: The company that markets these medicines is GlaxoSmithKline.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija GlaxoSmithKline.
English: Zinacef is authorised in the EU via national procedures.
Maltese: Zinacef huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The CHMP also harmonised other sections of the SmPC including sections 4.3 (contra-indications) and 4.4 (special warnings and precautions for use).
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħra tal-SmPC inkluż sezzjonijiet 4.3 (kontra-indikazzjonijiet) u 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu).
English: cardiovascular, and gynaecological surgery (including caesarean section).
Maltese: kardjovaskulari, u ġinekoloġika (inkluż ċesarja).
English: Zinacef is marketed in all EU Member States (except Germany, Latvia, Slovakia and Spain), as well as Iceland and Norway.
Maltese: Zinacef jitqiegħed fis-suq fl-Istati Membri kollha tal-UE (ħlief fil-Ġermanja, fil-Latvja, fis-Slovakkja u fi Spanja), kif ukoll fl-Islanda u fin-Norveġja.
English: • Acute exacerbations (flares-up) of chronic bronchitis.
Maltese: • Taħrix akut (rikaduta) ta' bronkite kronika.
English: On 20 April 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Zinacef in the EU.
Maltese: Fl-20 ta' April 2010, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP biex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Zinacef fl-UE.
English: The CHMP agreed that Zinacef should no longer be used to treat severe ear, nose and throat infections as well as bone and joint infections and gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae), because not enough clinical data are available to support these indications.
Maltese: Is-CHMP qabel li Zinacef ma għandux jibqa' jintuża fil-kura ta' infezzjonijiet severi tal-widnejn, talimnieħer u tal-griżmejn kif ukoll infezzjonijiet tal-għadam u tal-ġogi u ta' gonorrea (infezzjoni trażmessa sesswalment ikkawżata minn batterji magħrufa bħala Neisseria gonorrhoeae), minħabba li ma hemmx biżżejjed dejta klinika disponibbli biex tappoġġa dawn l-indikazzjonijiet.
English: The CHMP also decided that Zinacef should no longer be used in sequential therapy (when switching patients from an injectable to an oral treatment) due to a significant reduction in exposure to the active substance when switching to the oral formulation.
Maltese: Is-CHMP iddeċieda wkoll li Zinacef ma għandux jibqa' jintuża f'terapija sekwenzjali (meta pazjenti jinqelbu minn kura injettabbli għal waħda orali) minħabba tnaqqis sinifikanti fl-espożizzjoni għassustanza attiva meta jaqilbu għall-formulazzjoni orali.
English: • Soft-tissue infections: cellulitis, erysipelas and wound infections.
Maltese: • Infezzjonijiet tat-tessut artab: ċellulite, erysipelas u infezzjonijiet tal-ġrieħi.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Zinacef in adults and children and in patients with reduced kidney and liver function.
Maltese: Wara li armonizza l-indikazzjonijiet, is-CHMP armonizza wkoll ir-rakkomandazzjonijiet dwar l-użu ta' Zinacef fuq l-adulti u fuq it-tfal u fuq pazjenti b'funzjoni indebolita tal-kliewi u tal-fwied.
English: Zinacef should be given by injection into a vein over a period of 3 to 5 minutes, by infusion over 30 to 60 minutes, or by deep intramuscular injection, at different doses depending on the condition it is used to treat.
Maltese: Zinacef għandu jingħata permezz ta' injezzjoni ġo vina fuq perjodu ta' 3 sa 5 minuti, permezz ta' infużjoni fuq nofs siegħa sa siegħa, jew permezz ta' injezzjoni fil-fond ġol muskolu, f'dożi differenti skont ilkundizzjoni li għaliha qiegħed jintuża biex jikkura.
English: The CHMP concluded that Zinacef should be used in adults and children from birth for the following conditions:
Maltese: Is-CHMP ikkonkluda li Zinacef għandu jintuża fuq adulti u fuq tfal mit-twelid għall-kundizzjonijiet li ġejjin:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Zinacef in the European Union (EU).
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jeħtieġ li l-informazzjoni dwar il-preskrizzjoni għal Zinacef tiġi armonizzata fl-Unjoni Ewropea (UE).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tat-tagħrif sottomess u d-diskussjoni xjentifika fil-Kumitat, kien tal-opinjoni li lSmPCs, it-tikketti u l-fuljetti ta' tagħrif għandhom jiġu armonizzati fl-UE kollha.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Maltese: Dan wassal għal diverġenzi fost l-Istati Membri fil-mod ta' kif il-mediċina tista' tintuża, kif jidher fid-differenzi fis-sommarji tal-karatteristiċi talprodott (SmPCs), it-tikketti u l-fuljetti ta' tagħrif fil-pajjiżi fejn il-mediċina titqiegħed fis-suq.
English: Overdose (symptoms, emergency procedures, antidotes):
Maltese: Doża żejda (sintomi, proċeduri ta' emerġenza, antidoti):
English: ATCvet code: QI06AA01.
Maltese: QI06AA01
English: Date of last renewal: 12/06/2014.
Maltese: Data tal-aħħar tiġdid : 12/06/2014.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija ddefinita bl-użu tal-konvenzjoni li ġejja: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: VIRBAC Hungary KFT Szent Istvàn krt.11.II/21.
Maltese: VIRBAC Hungary KFT Szent Istvàn krt.11.II/21. 1055 Budapest Magyarország
English: Αθηνών - Λαμίας,
Maltese: 13o χλμ Ε.Ο. Αθηνών - Λαμίας,
English: 3% aluminium hydroxide gel expressed as mg Al3+
Maltese: 3 % ġel idrossidu tal-aluminjum rappreżentat bħala mg Al3+:
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2 °C - 8 °C) Tiffriżax.
English: Pharmacotherapeutic group: immunologicals for Felidae, inactivated viral vaccines for cats.
Maltese: Grupp farmakoterapewtiku: immunoloġiċi għall-Felidae vaċċin virali inattivat għall-qtates.
English: Sodium chloride Disodium phosphate anhydrous Potassium dihydrogen phosphate Aluminium hydroxide gel Quillaja saponaria Water for injections
Maltese: Klorur tas-sodju Fosfat anidru tad-dissodju Fosfat di-idroġenu tal-potassju Gell idrossidu tal-aluminju Kwillaja saponarja
English: Minimum quantity of purified p45 FeLV-envelope antigen: 102 µg
Maltese: Kwantità minima tal-antiġen p 45FeLV-envelop ippurifikat: 102 µg
English: Date of first authorisation: 17/06/2009.
Maltese: Data tal-ewwel awtorizzazzjoni : 17/06/2009.
English: Opalescent liquid.
Maltese: Likwidu opalexxenti
English: Buffered isotonic solution to
Maltese: Soluzzjoni isotonika newtralizzata sa
English: Interaction with other medicinal products and other forms of interaction:
Maltese: Interazzjonijiet ma' prodotti mediċinali oħrajn u forom oħra ta' interazzjoni:
English: No adverse reactions were observed after an overdose administration (2 doses) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
Maltese: (2 dożi) tal-prodott mediċinali veterinarju barra minn dawk imsemmija f'sezzjoni 4.6 b'eċċezzjoni ta' reazzjonijiet lokali li jistgħu jdumu aktar (5 sa 6 ġimgħat l-iżjed).
English: In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
Maltese: għandha tingħata l-kura sintomatika addattata.
English: Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Maltese: Immunizzazzjoni attiva tal-qtates minn età ta' tmien ġimgħat kontra Leucemia felina għall-prevenzjoni ta' viremija persistenti u sinjali kliniċi tal-marda relatata.
English: Minimum quantity of purified p45 FeLV-envelope antigen
Maltese: Kwantità minima ta' antiġen p 45FeLV-envelop ippurifikat
English: Plastic or cardboard box of 10 vials.
Maltese: Kaxxa tal-plastik jew tal-kartun ta' 10 kunjetti.
English: Plastic or cardboard box of 50 vials.
Maltese: Kaxxa tal-plastik jew tal-kartun ta' 50 kunjett.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).
English: The antigenic suspension is adjuvanted with an aluminium hydroxide gel and with a purified extract of Quillaja saponaria.
Maltese: Is-suspensjoni antiġenika hi megħjuna minn ġel idrossidu tal-aluminju u b'estratt purifikat ta' Kwillaja saponarja.
English: Only feline leukaemia virus (FeLV) negative cats should be vaccinated.
Maltese: Qtates negattivi għall-virus tal- Leucemia felina (FeLV) biss għandhom ikunu imlaqqma.
English: Buffered isotonic solution to 1 ml.
Maltese: Soluzzjoni isotonika newtralizzata sa millilitru Likwidu opalexxenti.
English: The vaccine contains the purified p45 FeLV-envelope antigen, obtained by genetic recombination of the E. coli strain.
Maltese: Il-vaċċin jikkuntieni l-antiġen p 45FeLV-envelop ippurifikat, miksub mir-rikumbinazzjoni ġenetika tar-razza E.
English: VIRBAC
Maltese: FARMAĊEWTIKU
English: Type I glass vials containing one dose (1 ml) of the vaccine closed with a 13 mm-diameter butyl elastomer stopper and aluminium capsule.
Maltese: Kunjetti tal-ħġieġ ta' tip I li fihom doża waħda (1 ml) tal-vaċċin magħluq b'tapp tal-lastku tal-butil b'dijametru ta' 13mm u kapsula tal-aluminjum.
English: Protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
Maltese: Protezzjoni kontra l-viraemija persistenti hija osservata fi 73% tal-qtates tliet ġimgħat wara lewwel injezzjoni bil-vaċċin.
English: Do not mix with any other veterinary medicinal product except FELIGEN RCP or FELIGEN CRP.
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor ħlief ma' FELIGEN CRP jew FELIGEN RCP.
English: The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed, Pain at palpation, sneezing or conjunctivitis may be noted in rare cases.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn L-ebda reazzjonijiet mhux mixtieqa ma kienu osservati wara amministrazzjoni ta' doża eċċessiva
English: LEUCOGEN suspension for injection for cats
Maltese: VETERINARJU LEUCOGEN suspensjoni għal injezzjoni
English: The onset of immunity has been demonstrated from 3 weeks after the primary vaccination.
Maltese: Il-bidu tal-immunità kien dimostrat minn 3 ġimgħat wara t-tilqima primarja.
English: Excipients:
Maltese: LT:
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea għallMediċini (http://www.ema.europa.eu).
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Maltese: Prodott mediċinali veterinarju jingħata biss bi preskrizzjoni.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP and FELIGEN RCP.
Maltese: Hemm informazzjoni disponibbli dwar is-sigurtà u l-effikaċja li turi li dan il-vaċċin jista' jiġi mħallat u mogħti ma' FELIGEN CRP jew FELIGEN RCP.
English: None.
Maltese: NO:
English: Vaccine against feline leukaemia.
Maltese: Ippakkjar ewlieni:
English: Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated.
Maltese: Wara l-ewwel tilqima li ssaħħaħ dik ta' qabilha sena wara l-ewwel kors ta' tilqim, kien dimostrat tul ta' immunità ta' 3 snin.
English: Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Maltese: Amministra doża waħda (1 ml) tal-prodott mediċinali veterinarju taħt il-ġilda skont ir-regoli tat-tilqim li ġejjin.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tas-sustanzi mhux attivi, ara sezzjoni 6.1.
English: Shake the vial gently and administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Maltese: Ħawwad il-kunjett b'mod ġentili u amministra doża waħda (1 ml) tal-prodott mediċinali veterinarju taħt il-ġilda skont ir-regoli tat-tilqim li ġejjin.
English: It is a ‘generic medicine'.
Maltese: Huwa “mediċina ġenerika”.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Maltese: Tenofovir hija inibitur nukleosidiku tat-transkrittażi inversa.
English: Emtricitabine/Tenofovir disoproxil Krka is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil).
Maltese: Emtricitabine/Tenofovir disoproxil Krka huwa disponibbli f'pilloli (200 mg emtricitabine u 245 mg tenofovir disoproxil).
English: Further information on Emtricitabine/Tenofovir disoproxil Krka can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/EmtricitabineTenofovir-disoproxil-Krka.
Maltese: Aktar informazzjoni dwar Emtricitabine/Tenofovir disoproxil Krka tista' tinstab fis-sit elettroniku talAġenzija: www.ema.europa.eu/medicines/human/EPAR/EmtricitabineTenofovir-disoproxil-Krka.
English: Emtricitabine/Tenofovir disoproxil Krka received a marketing authorisation valid throughout the EU on 9 December 2016.
Maltese: Emtricitabine/Tenofovir disoproxil Krka irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fid-9 ta' Diċembru 2016.
English: Emtricitabine/Tenofovir disoproxil Krka contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Maltese: Emtricitabine/Tenofovir disoproxil Krka fih żewġ sustanzi attivi: emtricitabine, li hija inibitur nukleosidiku tat-transkrittażi inversa; u tenofovir disoproxil li hija “prodroga” tat-tenofovir.
English: Emtricitabine/Tenofovir disoproxil Krka is an HIV medicine that is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Emtricitabine/Tenofovir disoproxil Krka huwa mediċina tal-HIV li tintuża f'kombinazzjoni ma' mill-anqas mediċina oħra tal-HIV għall-kura ta' adulti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: Emtricitabine/Tenofovir disoproxil Krka contains two active substances, emtricitabine and tenofovir disoproxil.
Maltese: Emtricitabine/Tenofovir disoproxil Krka fih żewġ sustanzi attivi, emtricitabine u tenofovir disoproxil.
English: Other information about Emtricitabine/Tenofovir disoproxil Krka
Maltese: Informazzjoni oħra dwar Emtricitabine/Tenofovir disoproxil Krka
English: The company that markets Emtricitabine/Tenofovir disoproxil Krka will provide an information pack to doctors which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Krka on kidney function, and information about use for pre-exposure prophylaxis.
Maltese: Il-kumpanija li tqiegħed lil Emtricitrabine/Tenofovir disoproxil Krka fis-suq se tipprovdi pakkett ta' informazzjoni lit-tobba li jkopri l-effetti potenzjali ta' ħsara ta' Emtricitabine/Tenofovir disoproxil Krka fuq il-funzjoni tal-kliewi, u informazzjoni dwar l-użu għall-profilassi ta' qabel l-esponiment.
English: Emtricitabine/Tenofovir disoproxil Krka is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Maltese: Emtricitabine/Tenofovir disoproxil Krka jintuża wkoll biex jgħin fil-prevenzjoni tal-infezzjoni tal-HIV-1 trażmessa sesswalment f'adulti u f'adoloxxenti li jkunu f'riskju għoli li jiġu infettati (profilassi ta' qabel l-esponiment jew PrEP).
English: For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Krka in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Maltese: Għall-profilassi ta' qabel l-esponiment tal-infezzjoni tal-HIV-1, huwa mistenni li Emtricitabine/Tenofovir disoproxil Krka fid-demm iwaqqaf il-virus milli jimmultiplika u jinfirex mis-sit tal-infezzjoni f'każ li lindividwu jkun espost għall-virus.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija wettqet ukoll studju li wera li hija “bijoekwivalenti” għall-mediċina ta' referenza.
English: How is Emtricitabine/Tenofovir disoproxil Krka used?
Maltese: Emtricitabine/Tenofovir disoproxil Krka?
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument bil-mistoqsijiet u t-tweġibiet hawnhekk.
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Maltese: Kemm emtricitabine kif ukoll tenofovir jaħdmu b'mod simili billi jimblokkaw l-attività tat-transkrittażi inversa, enzima prodotta mill-HIV li jħalliha timmultiplika lilha nnifisha fiċ-ċelloli li infettat.
English: Because Emtricitabine/Tenofovir disoproxil Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Emtricitabine/Tenofovir disoproxil Krka huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: For the treatment of HIV-1 infection, Emtricitabine/Tenofovir disoproxil Krka, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Għall-kura ta' infezzjoni tal-HIV 1, Emtricitabine/Tenofovir disoproxil Krka, meħud flimkien ma' minn tal-anqas mediċina antivirali oħra, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Krka.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanzi attivi fl-użi approvati bil-mediċina ta' referenza, Truvada, u m'għandhomx għalfejn jiġu ripetuti għal Emtricitabine/Tenofovir disoproxil Krka.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Krka has been shown to have comparable quality and to be bioequivalent to Truvada.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Emtricitabine/Tenofovir disoproxil Krka ntwera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Truvada.
English: Emtricitabine/Tenofovir disoproxil Krka does not cure HIV infection or AIDS, but it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Emtricitabine/Tenofovir disoproxil Krka ma jfejjaqx l-infezzjoni tal-HIV jew tal-AIDS, iżda jista' jittardja l-ħsara li ssir lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Krka are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Emtricitabine/Tenofovir disoproxil Krka tiġi ssorveljata kontinwament.