FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from clinical studies also showed differences in the safety profile of the two active substances.
Maltese: Data minn studji kliniċi wriet ukoll differenzi fil-profil tassigurtà taż-żewġ sustanzi attivi.
English: This means that Cabazitaxel Teva was intended to be similar to a ‘reference medicine' containing the same active substance and already authorised in the European Union.
Maltese: Dan ifisser li Cabazitaxel Teva kien maħsub biex ikun simili għal “mediċina ta' referenza” li fiha l-istess sustanza attiva u li diġà hija awtorizzata flUnjoni Ewropea.
English: The company claimed that cabazitaxel is a derivative of docetaxel, and that the active substances do not differ significantly in their safety and effectiveness.
Maltese: Il-kumpanija sostniet li cabazitaxel huwa derivattiv ta' docetaxel, u li s-sustanzi attivi ma jvarjawx b'mod sinifikanti fis-sigurtà u l-effettività tagħhom.
English: Thus Taxotere cannot be used to support the application for Cabazitaxel Teva and the CHMP recommended that Cabazitaxel Teva be refused marketing authorisation.
Maltese: Sabiex tappoġġja din it-talba, il-kumpanija rreferiet għal data ppubblikata u pprovdiet opinjoni esperta.
English: Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Maltese: Cabazitaxel jaħdem billi jimblokka l-kapaċità taċ-ċelloli tal-kanċer li jkissru l-“iskeletru” intern tagħhom li jippermettilhom jinqasmu u jimmultiplikaw.
English: This is because Cabazitaxel Teva is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Maltese: Dan għaliex Cabazitaxel Teva jingħata permezz ta' infużjoni ġo vina, sabiex is-sustanza attiva titwassal direttament fil-fluss tad-demm.
English: Cabazitaxel belongs to the group of cancer medicines known as ‘taxanes'.
Maltese: Cabazitaxel jappartjeni għall-grupp ta' mediċini kontra l-kanċer magħrufa bħala “tassani”.
English: Additionally, laboratory data suggest that cabazitaxel can be effective at treating cancer that is resistant to docetaxel.
Maltese: Barra minn hekk, id-data tal-laboratorju tissuġġerixxi li cabazitaxel jista' jkun effettiv fil-kura ta' kanċer li huwa reżistenti għal docetaxel.
English: The full EPAR for Exzolt can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinarymedicines/European public assessment reports.
English: Exzolt contains the active substance fluralaner.
Maltese: Exzolt fih is-sustanza attiva fluralaner.
English: Exzolt reduced the number of mites by more than 99% in pullets and breeders and more than 98% in layers.
Maltese: Exzolt naqqas in-numru ta' dud b'aktar minn 99 % fl-għawwietaq u fit-tiġieġ għat-tnissil u b'aktar minn 98 % fit-tiġieġ tal-bajd.
English: Other information about Exzolt?
Maltese: Informazzjoni oħra dwar Exzolt?
English: The active substance in Exzolt, fluralaner, acts as an ‘ectoparasiticide'.
Maltese: Is-sustanza attiva f'Exzolt, il-fluralaner, taġixxi bħala ‘ektoparassitiċida'.
English: Exzolt has been studied in a field study involving 9 farms with poultry red mite infestation, each with two similar houses with 550 to 100,000 chickens per house.
Maltese: Exzolt ġie studjat fi studju fuq il-post li involva 9 irziezet b'infestazzjoni b'dud aħmar tat-tjur, kull wieħed b'żewġt idjar simili b'550 sa 100,000 tiġieġa għal kull dar.
English: This is a summary of the European public assessment report (EPAR) for Exzolt.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Exzolt.
English: Exzolt is a veterinary medicine used to treat poultry red mite (Dermanyssus gallinae) infestation in pullets (young female chickens), breeders and layer hens.
Maltese: Exzolt huwa mediċina veterinarja li tintuża għall-kura ta' infestazzjoni b'dud aħmar tat-tjur (Dermanyssus gallinae) fl-għawwietaq (tiġieġ nisa żgħar), fit-tiġieġ għat-tnissil u fit-tiġieġ tal-bajd.
English: The duration of effectiveness was between 6 weeks and 8 months, depending on the length of the production cycle and how effectively the farms prevented re-introduction of new mites into their houses.
Maltese: Id-durata tal-effikaċja kienet bejn 6 ġimgħat u 8 xhur, skont it-tul taċ-ċiklu tal-produzzjoni u kemm l-irziezet ipprevjenew b'mod effettiv l-introduzzjoni mill-ġdid ta' dud ġdid fid-djar tagħhom.
English: What are the risks associated with Exzolt?
Maltese: -riskji asso ċjati ma' Exzolt?
English: Why is Exzolt approved?
Maltese: Għaliex ġie approvat Exzolt?
English: Fluralaner kills mites by acting on their nervous system after they have ingested the chicken's blood.
Maltese: Il-fluralaner toqtol id-dud billi taġixxi fuq is-sistema nervuża tagħhom wara li dawn ikunu inġestew id-demm tat-tiġieġa.
English: Red mite infestations can cause irritation and restlessness of the bird, feather pecking and anaemia (low red blood cell counts).
Maltese: L-infestazzjonijiet b'dud aħmar jistgħu jikkawżaw irritazzjoni u aġitazzjoni tal-għasfur, tnaqqir tar-rix u anemija (għadd baxx taċ-ċelloli ħomor tad-demm).
English: If another course of treatment is required, the interval between the two courses of treatment should be at least 3 months.
Maltese: Jekk ikun meħtieġ kors ieħor ta' kura, l-intervall bejn iż-żewġ korsijiet ta' kura għandu jkun tal-inqas 3 xhur.
English: How is Exzolt used?
Maltese: Kif jaħdem Exzolt?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Exzolt's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Exzolt huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: It works by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the mites.
Maltese: Din taħdem billi tinterferixxi fil-mod ta' kif jgħaddu s-sinjali bejn iċ-ċelloli tan-nervituri (newrotrażmissjoni) fis-sistema nervuża tal-parassiti, u dan jirriżulta f'paraliżi u l-mewt tad-dud.
English: EMEA/V/C/056
Maltese: EMEA/V/C/056 RAPPORT TAL-VALUTAZZJONI
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu© EMEA European Medicines Agency, 2008.
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu© EMEA European Medicines Agency, 2008.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREVAX FELV EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) PUREVAX FELV Sommarju ta' l-EPAR għall-pubbliku
English: The marketing authorisation was renewed on 18 April 2005.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-18 ta' April 2005.
English: Immunisation against FeLV sub-group A provides full protection against all three sub-groups of the virus: A, B and C.
Maltese: Tilqim kontra FeLV sotto-grupp A jagħti protezzjoni sħiħa kontra t-tliet sotto-gruppi tal-virus: A, B u Ċ.
English: Purevax FeLV is a vaccine containing feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Maltese: Purevax FeLV huwa vaċċin li fih vajrus tal-lewkimja tal-qtates (FeLV) vajrus rekombinanti canarypox (vCP97).
English: Purevax FeLV contains genes from the FeLV sub-group A called env and gag which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology'.
Maltese: Purevax FeLV fih ġeni mill-FeLV sotto-grupp A imsejjaħ env u gag li ddaħħlu f'vajrus vektor (carrier) imsejjaħ canarypox bl-użu ta' ‘teknoloġija rekombinanti tad-DNA'.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax FeLV exceed the risks for active immunisation of cats eight weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease, and recommended that Purevax FeLV be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benfiċċji ta' Purevax FeLV jegħlbu r-riskji ta' tilqim attiv ta' qtates ta' tmien ġimgħat jew akbar kontra l-lewkimja tal-qtates għall-prevenzjoni ta' vajrimja persistenti u sinjali kliniċi ta' mard relatat, u irrakomanda li Purevax FeLV jingħata l-awtorizzazzjoni għat-tqegħid fis-suq.
English: Purevax FeLV is used to vaccinate cats from the age of eight weeks against feline leukaemia, an illness affecting the immune system caused by a type of virus known as a retrovirus.
Maltese: Purevax FeLV jintuża biex jitlaqqmu qtates mill-età ta' tmien ġimgħat kontra l-lewkimja talqtates, marda li taffettwa s-sistema immunitarja ikkaġunata minn tip ta' vajrus magħruf bħala retrovirus.
English: What is Purevax FeLV?
Maltese: Kif jaħdem Purevax FeLV?
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn ir-riskju u l-benefiċċju jista' jinstab f'modulu 6 ta' dan l-EPAR.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax FeLV to MERIAL on 13 April 2000.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Purevax FeLV valida fl-Unjoni Ewropea kollha lil MERIAL fit-13 ta' April 2000.
English: The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Maltese: Il-vajrusijiet canarypox ma jinfirxux jew ma jimmultiplikawx fil-qattus iżda jipproduċu proteini mill-ġeni
English: The vaccinated kittens were housed for up to 28 weeks with a group of kittens who were infected with FeLV.
Maltese: Il-frieħ tal-qtates imlaqqma inżammu għal sa 28 ġimgħa ma' grupp ta' frieħ tal-qtates li kienu infettati b'FeLV.
English: Why has Purevax FeLV been approved?
Maltese: Għaliex ġie approvat Purevax FeLV?
English: Purevax FeLV vaccine provided protection against FeLV infection.
Maltese: Purevax FeLV huwa vaċċin.
English: Other information about Purevax FeLV:
Maltese: Tagħrif ieħor dwar Purevax FeLV:
English: The effectiveness of Purevax FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with FeLV.
Maltese: L-effikaċja tà ta' Purevax FeLV ġiet studjata f'diversi provi f'kondizzjonijiet tal-laboratorju fejn qtates kienu mlaqqma u infettati b'FeLV.
English: Purevax FeLV is a vaccine.
Maltese: Il-vaċċin Purevax FeLV ipprovda protezzjoni kontra infezzjoni FeLV.
English: A 1 ml dose of Purevax FeLV is injected under the skin.
Maltese: Doża ta' 1 ml ta' Purevax FeLV hija injettata taħt il-ġilda.
English: For a full list of all side effects reported with Purevax FeLV, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha irrapportati b'Purevax FeLV, ara l-Fuljett ta' Tagħrif.
English: What is the risk associated with Purevax FeLV?
Maltese: X'inhu r-riskju assoċjat ma' Purevax FeLV?
English: Pregelatinized starch Croscarmellose sodium Lactose monohydrate Microcrystalline cellulose Sodium stearyl fumarate Stearic acid
Maltese: Il-qalba tal-pillola Pregelatinized starch Croscarmellose sodium Lactose monohydrate Microcristalline cellulose Sodium stearyl fumarate Stearic acid
English: Tablet core: pregelatinized starch, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, stearic acid.
Maltese: Il-qalba tal-pillola: pregelatinized starch, croscarmellose sodium, lactose monohydrate, microcristalline cellulose, sodium stearyl fumarate, stearic acid.
English: Date of first authorisation: 28 April 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 28 april 2017
English: Titanum dioxide (E171) Macrogol
Maltese: Hypromellose 5 cp Titanum dioxide (E171) Macrogol
English: with other antiretroviral medicines.
Maltese: ANTI-INFETTIVI Antiretrovirali
English: At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/mL) and CD4 counts (233 and 241 cells/mm
Maltese: Fil-linja bażi, il-gruppi randomised kellhom medjan simili ta' l-RNA tal-HIV-1 talplażma (5.02 u 5.00 log10 kopja/mL) u ta' l- għadd tas-CD4 (233 u 241 ċelluli/mm
English: vancomycin (for bacterial infection) interleukin-2 (to treat cancer) cidofovir (for viral infection) non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Maltese: - vancomycin (għal infezzjoni batterjali) - interleukin-2 (għat-trattament tal-kanċer) - cidofovir (għal infezzjoni virali) - mediċini anti-infjammatorji mhux sterojdi (NSAIDs, għas-serħan mill-uġigħ fl-għadam jew fil muskoli)
English: HIV-1 RNA < 400 copies/mL (TLOVR)
Maltese: RNA tal-HIV-1 < 400 kopja/mL (TLOVR) Valur p % differenza
English: As of week 144: - The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil /efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine+tenofovir disoproxil group to the lamivudine/zidovudine group among all patients).
Maltese: - Il-mutazzjoni M184V/I żviluppat fi 2/19 (10.5%) iżolati analizzati minn pazjenti fil-grupp ta' emtricitabine/tenofovir disoproxil/efavirenz u f'10/29 (34.5%) iżolati analizzati fil-grupp ta' lamivudine/zidovudine/efavirenz (valur p ta' < 0.05, it-Test Exact ta' Fisher li qabbel il-grupp ta'emtricitabine+tenofovir disoproxil mal- grupp ta' lamivudine/zidovudine fost il-pazjenti kollha).
English: Emtricitabine-resistant viruses with the M184V/I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
Maltese: Il-viri reżistenti għal emtricitabine bil-mutazzjoni M184V/I kienu cross-resistant għal lamivudine, iżda żammew is sensittività għal didanosine, stavudine, tenofovir u zidovudine.
English: Table 2: Interactions between the individual components of emtricitabine/tenofovir disoproxil and other medicinal products
Maltese: Tabella 2: Interazzjonijiet bejn il-komponenti individwali ta' emtricitabine/tenofovir disoproxil u prodotti mediċinali oħra
English: The most frequently reported adverse reactions considered possibly or probably related to emtricitabine and/or tenofovir disoproxil were nausea (12%) and diarrhoea (7%) in an open-label randomised clinical study in adults (GS-01-934, see section 5.1).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti u li kienu kkunsidrati bħala possibbilment jew probabbilment relatati ma' emtricitabine u/jew tenofovir disoproxil, kienu t-tqalligħ (12%) u d-dijarea (7%) fi studju kliniku open-label u randomised fl-adulti (GS-01-934, ara sezzjoni 5.1).
English: AUC: ↑ 45% Cmax: ↑ 60% Cmin: ↔
Maltese: AUC: ↑ 45% Cmax: ↑ 60%
English: - Risk management plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: In an open-label randomised clinical study (GS-01-934), antiretroviral-naïve HIV-1 infected adult patients received either a once daily regimen of emtricitabine, tenofovir disoproxil and efavirenz (n = 255) or a fixed combination of lamivudine and zidovudineadministered twice daily and efavirenz once daily (n = 254).
Maltese: Fi studju kliniku open-label u randomised (GS-01-934), pazjenti adulti infettati bl-HIV-1 li qatt ma' kienu ngħataw mediċini antiretrovirali qabel irċievew jew kors ta' darba kuljum ta' emtricitabine, tenofovir disoproxil u efavirenz (n=255), jew kumbinazzjoni fissa ta' lamivudine u zidovudine mogħti darbtejn kuljum, u efavirenz mogħti darba kuljum (n=254).
English: 30 film-coated tablets: EU/1/17/1182/002 90 (3 x 30) film-coated tablets: EU/1/17/1182/004
Maltese: EU/1/17/1182/002 90 (3 x 30) pillola miksija b'rita:
English: Additive to synergistic effects were observed in combination studies with protease inhibitors, and with nucleoside and non-nucleoside analogue inhibitors of HIV reverse transcriptase.
Maltese: Żidiet ma' l-effetti sinerġistiċi dehru fi studji kombinati b'impedituri tal-protease, u b'impedituri tal-analogi tan-nukleosidi u mhux nukleosidi tar-reverse transcriptase ta' l-HIV.
English: 200 mg/245 mg film-coated tablets emtricitabine/tenofovir disoproxil
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d. 200 mg/245 mg pilloli miksija b'rita Emtricitabine/Tenofovir disoproxil
English: to treat HIV
Maltese: Trasmissjoni tal-HIV
English: Patients in the emtricitabine and tenofovir disoproxil group were given emtricitabine/tenofovir disoproxil and efavirenz from week 96 to week 144.
Maltese: Il-pazjenti fil-grupp ta' emtricitabine u tenofovir disoproxil ingħataw emtricitabine/tenofovir disoproxil u efavirenz minn ġimgħa 96 sa ġimgħa 144.
English: contains two active substances, emtricitabine and tenofovir disoproxil.
Maltese: - Is-sustanzi attivi huma emtricitabine u tenofovir disoproxil.
English: AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑ 197)
Maltese: AUC: ↑ 98% (↑ 77 sa ↑ 123) Cmax: ↑ 79% (↑ 56 sa ↑ 104) Cmin: ↑ 163% (↑ 137 sa ↑ 197)
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Z score was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Maltese: F'pazjenti li rċevew trattament b'tenofovir disoproxil jew plaċebo, il-punteġġ Z medju tal-BMD talispina lumbari kien -1.004 u -0.809, il-punteġġ Z medju tal-BMD tal-ġisem totali kien -0.866 u -0.584,
English: 28 film-coated tablets: EU/1/17/1182/001 84 film-coated tablets: EU/1/17/1182/003
Maltese: EU/1/17/1182/001 84 pillola miksija b'rita:
English: The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/mL and 2,050 (50.8%) ng•h/mL, respectively, in normal subjects compared with 289 (46.0%) ng/mL and 2,310 (43.5%) ng•h/mL in subjects with moderate hepatic impairment, and 305 (24.8%) ng/mL and 2,740 (44.0%) ng•h/mL in subjects with severe hepatic impairment.
Maltese: 289 (46.0%) ng/mL u 2,310 (43.5%) ng•h/mL f'individwi b'indeboliment epatiku moderat, u 305 (24.8%) ng/mL u 2,740 (44.0%) ng•h/mL f'individwi b'indeboliment epatiku sever.
English: Adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.
Maltese: Adulti u adolexxenti li għandhom 12-il sena u aktar, u li jiżnu tal-anqas 35 kg: Pillola waħda, darba kuljum.
English: in patients with creatinine clearance decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Maltese: Għandha titqies l-interruzzjoni tat-trattament bi Emtricitabine/Tenofovir disoproxil Krka d.d. f'pazjenti bi tneħħija tal-kreatinina mnaqqsa għal < 50 mL/min jew tnaqqis filphosphate fis-serum għal < 1.0 mg/dL (0.32 mmol/L).
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in HIV-1 infected patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Maltese: Każijiet ta' falliment akut tal-kliewi wara l-bidu ta' doża għolja jew diversi mediċini kontra l infjammazzjoni mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs) kienu rrappurtatif'pazjenti infettati bl-HIV-1 ittrattati b'tenofovir disoproxil u b'fatturi ta' riskju għal disfunzjoni talkliewi.
English: film coated tablets are blue, oval, biconvex tablets, of dimensions 20 mm x 10 mm.
Maltese: Il-pillolia miksija b'rita ta' Emtricitabine/Tenofovir disoproxil Krka d.d. huma blu, ovali, mżaqqa fuq żewġ naħat, b'daqs ta' 20 mm x 10 mm.
English: HIV-1infected patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Maltese: Pazjenti infettati bl-HIV-1 b'disfunzjoni tal-fwied li kienet teżisti minn qabel, inkluż epatite attiva kronika, għandhom frekwenza miżjuda ta' anormalitajiet tal-funzjoni tal-fwied matul terapija antiretrovirali kombinata (CART) u għandhom ikunu mmonitorjati skont il-prattika standard.
English: is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d. huwa indikat f'terapija antiretrovirali kombinata għal trattament ta' adulti infettati b'HIV-1 (ara sezzjoni 5.1).
English: AUC: ↓ 4% (↓ 15 to ↑ 8)
Maltese: AUC: ↓ 4% (↓ 32 sa ↑ 34)
English: film coated tablets (tablets) are blue, oval, biconvex tablets, of dimensions 20 mm x 10 mm.
Maltese: Il-pilloli miksija b'rita (pilloli) ta' Emtricitabine/Tenofovir disoproxil Krka d.d. huma blu, ovali, mżaqqin fuq żewġ naħat u b'dimensjonijiet ta' 20 mm x 10 mm
English: should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d. għandu jiġi evitat f'pazjenti li ngħataw antiretrovirali filpassat li għandhom l-HIV-1 bil-mutazzjoni K65R (ara sezzjoni 5.1).
English: HIV-1 RNA < 50 copies/mL (TLOVR)
Maltese: (95%CI) RNA tal-HIV-1 < 50 kopja/mL (TLOVR) Valur p % differenza (95%CI)
English: Emtricitabine: AUC: ↔ Cmax: ↔
Maltese: AUC: ↔ Cmax: ↔
English: with other medicines that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including aminoglycosides (for bacterial infection) amphotericin B (for fungal infection) foscarnet (for viral infection) ganciclovir (for viral infection) pentamidine (for infections)
Maltese: Jekk tieħu Emtricitabine/Tenofovir disoproxil Krka d.d. ma' mediċini oħra li jistgħu jagħmlu ħsara lill-kliewi tiegħek: b'mod speċjali hu importanti li tgħid lit-tabib tiegħek jekk qed tieħu kwalunkwe minn dawn il-mediċini, li jinkludu - aminoglycosides (għal infezzjoni batterjali) - amphotericin B (għal infezzjoni fungali) - foscarnet (għal infezzjoni virali) - ganciclovir (għal infezzjoni virali) - pentamidine (għall-infezzjonijiet)
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 50 mL/min in any patient receiving Emtricitabine/Tenofovir disoproxil Krka d.d., renal function should be reevaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk il-phosphate fis-serum huwa < 1.5 mg/dL (0.48 mmol/L) jew it-tneħħija tal-kreatinina tonqos għal < 50 mL/min fi kwalunkwe pazjent li jingħata Emtricitabine/Tenofovir disoproxil Krka d.d., ilfunzjoni tal-kliewi għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl talkonċentrazzjonijiet tal-glukożju fid-demm, il-potassium fid-demm u l-glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: HIV paediatric renal educational brochure:
Maltese: Opuskolu edukattiv dwar il-kliewi u l-HIV fit-tfal:
English: Renal function should be closely monitored (see section 4.4).
Maltese: Il-funzjoni renali għandha tkun immonitorjata millqrib (ara sezzjoni 4.4).
English: In study GS-US-104-0352, 89 HIV-1 infected paediatric patients with a median age of 7 years (range
Maltese: Fl-istudju GS-US-104-0352, 89 pazjent pedjatriku infettati bl-HIV-1 b'eta medjana ta' 7 snin (firxa bejn sentejn sa 15-il sena) kienu esposti għal tenofovir għal medjan ta' 331 ġimgħa.
English: is:
Maltese: A.
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24) Cmin: NC
Maltese: AUC: ↓ 3% (↓ 8% sa ↑ 15) Cmax: ↓ 24% (↓ 44 sa ↓ 12) Cmin: NC
English: - HIV pediatric renal educational brochure
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: Do not take Emtricitabine/Tenofovir disoproxil Krka d.d.if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Emtricitabine/Tenofovir disoproxil Krka d.d. jekk inti allerġiku għal emtricitabine, tenofovir, tenofovir disoproxil, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).