FrancophonIA/ELRC3.0 huggingface dataset:
English: If ZEPATIER is co-administered with ribavirin, the information for ribavirin with regard to contraception, pregnancy testing, pregnancy, breast-feeding, and fertility also applies to this combination regimen (refer to the Summary of Product Characteristics for the co-administered medicinal product for additional information).
Maltese: Jekk ZEPATIER jingħata flimkien ma' ribavirin, l-informazzjoni għal ribavirin dwar ilkontraċezzjoni, l-ittestjar għat-tqala, it-tqala, it-treddigħ u l-fertilità tapplika ukoll għall-iskeda ta' din il-kombinazzjoni ta' mediċini (irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott tal-prodott mediċinali mogħti flimkien miegħu għal aktar informazzjoni).
English: HIV ANTIVIRAL AGENTS: OTHER
Maltese: GĦALL-HIV:
English: No dose adjustment of ZEPATIER is required in patients with mild hepatic impairment (Child-Pugh A).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża ta' ZEPATIER f'pazjenti b'indeboliment ħafif talfwied (Child-Pugh A).
English: • have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely
Maltese: • bħalissa għandek infezzjoni jew kellek infezzjoni preċedenti bil-virus tal-epatite B, minħabba li t-tabib tiegħek jista' jkun irid jimmonitorjak aktar mill-qrib
English: Co-administration of inducers of CYP3A or P-gp with ZEPATIER is contraindicated because it may decrease elbasvir and grazoprevir plasma concentrations, which may lead to reduced therapeutic effect of ZEPATIER (see sections 4.3 and 4.4).
Maltese: L-għoti ta' indutturi ta' CYP3A jew P-gp flimkien ma' ZEPATIER huwa kontraindikat minħabba li jista' jnaqqas il-konċentrazzjonijiet ta' elbasvir u grazoprevir fil-plażma, u dan jista' jwassal għal tnaqqis fl-effett terapewtiku ta' ZEPATIER (ara sezzjonijiet 4.3 u 4.4).
English: • you are allergic to elbasvir, grazoprevir or any of the other ingredients of this medicine (listed in section 6)
Maltese: • inti allerġiku għal elbasvir, grazoprevir jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Co-administration with ZEPATIER is contraindicated.
Maltese: L-għoti tagħhom flimkien ma' ZEPATIER huwa kontraindikat.
English: Grazoprevir is active in vitro against the following genotype 1b NS3 substitutions conferring resistance to other NS3/4A protease inhibitors: V36A/I/L/M, Q41L/R, F43S, T54A/C/G/S, V55A/I, Y56F, Q80L/R, V107I, S122A/G/R, R155E/K/N/Q/S, A156G/S, D168E/N/S, V170A/I/T.
Maltese: V36A/I/L/M, Q41L/R, F43S, T54A/C/G/S, V55A/I, Y56F, Q80L/R, V107I, S122A/G/R, R155E/K/N/Q/S, A156G/S, D168E/N/S, V170A/I/T.
English: TN subjects with GT 1 infection with or without cirrhosis (with or without HCV/HIV1 co-infection) or who were peg-IFN + RBV null responders, were randomised to EBR + GZR with or without RBV for 8, 12 or 18 weeks.
Maltese: TN b'infezzjoni GT 1 b'ċirrożi jew mingħajrha (b'koinfezzjoni ta' HCV/HIV-1 jew mingħajrha) jew li ma kienu rrispondew xejn għal peg-IFN + RBV, intgħażlu b'mod każwali biex jieħdu EBR + GZR b'RBV jew mingħajru għal 8, 12 jew 18-il ġimgħa.
English: ZEPATIER combines two direct-acting antiviral agents with distinct mechanisms of action and nonoverlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Maltese: ZEPATIER jikkombina flimkien żewġ sustanzi antivirali li jaħdmu b'mod dirett b'mekkaniżmi ta' azzjoni distinti u profili ta' reżistenza li ma jikkoinċidux biex jattakka HCV fi stadji multipli taċ-ċiklu tal-ħajja tal-virus.
English: (600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Maltese: (600 mg darbtejn kuljum)/ ritonavir (100 mg darbtejn kuljum/ grazoprevir (200 mg darba kuljum)
English: ENDOTHELIN ANTAGONIST
Maltese: IL-PRODOTT MEDIĊINALI
English: Co-administration of ZEPATIER with P-gp inhibitors is expected to have a minimal effect on the plasma concentrations of ZEPATIER.
Maltese: Esperjenza ta' doża eċċessiva b'ZEPATIER fil-bniedem hija limitata.
English: Available pharmacokinetic data in animals has shown excretion of elbasvir and grazoprevir in milk.
Maltese: Dejta farmakokinetika disponibbli fl-annimali uriet eliminazzjoni ta' elbasvir u grazoprevir fil-ħalib.
English: Includes subjects with virologic breakthrough.
Maltese: *Jinkludi individwi b'avvanz viroloġiku.
English: Table 9: SVR in genotype 1b †-infected subjects Baseline Characteristics
Maltese: SVR f'individwi¶ infettati bil-ġenotip 1b†
English: Therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on weight/BMI (see section 4.4).
Maltese: Għalhekk, ma huwa rakkomandat l-ebda aġġustament fid-doża ta' elbasvir/grazoprevir abbażi tal-piż/BMI (ara sezzjoni 4.4).
English: (300 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: (300 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: Prednisone (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Maltese: Prednisone (doża waħda ta' 40 mg)/ elbasvir (50 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: The tablets are packaged into a carton containing two cardboard cards, each cardboard card containing two 7-count aluminium blisters.
Maltese: Il-pilloli huma ppakkjati f'kartuna li fiha żewġ kards tal-kartun, kull kard tal-kartun fija 2 folji talaluminju b'għadd ta' 7 pilloli l-waħda.
English: Table 10: SVR in genotype 1a-infected subjects Baseline Characteristics
Maltese: SVR f'individwi¶ infettati bil-ġenotip 1a Karatteristiċi fil-Linja Bażi
English: Pravastatin (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: Pravastatin (doża waħda ta' 40 mg)/ elbasvir (50 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin had serious adverse reactions (abdominal pain, transient ischaemic attack and anaemia).
Maltese: Anqas minn 1 % tal-individwi ttrattati b'ZEPATIER b'ribavirin jew mingħajru kellhom reazzjonijiet avversi serji (uġigħ fl-addome, attakk iskemiku temporanju u anemija).
English: Co-administration of ZEPATIER and CYP3A or P-gp inducers is contraindicated because it may significantly decrease elbasvir and grazoprevir plasma concentrations and may lead to a reduced therapeutic effect of ZEPATIER (see sections 4.3, 4.5 and 5.2).
Maltese: L-għoti ta' ZEPATIER flimkien ma' indutturi ta' CYP3A jew P-gp huwa kontraindikat minħabba li jista' jnaqqas b'mod sinifikanti l-konċentrazzjonijiet ta' elbasvir u grazoprevir fil-plażma u jista' jwassal għal tnaqqis fl-effett terapewtiku ta' ZEPATIER (ara sezzjonijiet 4.3, 4.5 u 5.2).
English: ↑ Simvastatin (primarily due to intestinal BCRP inhibition and CYP3A inhibition)
Maltese: ↑ Simvastatin (primarjament minħabba inibizzjoni ta' BCRP tal-musrana u inibizzjoni ta' CYP3A)
English: What ZEPATIER is used for ZEPATIER is used to treat long-term hepatitis C infection in adults aged 18 years and older.
Maltese: ZEPATIER jintuża għat-trattament ta' infezzjoni tal-epatite Ċ fit-tul f'adulti li għandhom 18-il sena u aktar.
English: (400 mg twice daily)/ grazoprevir (200 mg once daily)
Maltese: (400 mg darbtejn kuljum)/ grazoprevir (200 mg darba kuljum)
English: Tablet core
Maltese: Parametri tal-Laboratorju
English: Overall prevalence of GT4-infected subjects with baseline NS3 polymorphisms in the pooled analyses was
Maltese: ♯Il-prevalenza globali ta' individwi infettati b'GT4 b'polimorfiżmi ta' NS3 fil-linja bażi fl-analiżi kollettiva kienet 19% (7/36)
English: Grazoprevir oral exposures are approximately 2-fold greater in HCV-infected subjects as compared to healthy subjects.
Maltese: Esponimenti orali għal grazoprevir huma madwar darbtejn aktar f'individwi infettati b'HCV meta mqabbla ma' individwi f'saħħithom.
English: PHOSPHATE BINDERS
Maltese: X'fih ZEPATIER
English: The EC50 values of elbasvir and grazoprevir against full-length or chimeric replicons encoding NS5A or NS3 sequences from reference sequences and clinical isolates are presented in Table 5.
Maltese: Il-valuri EC50 ta' elbasvir u grazoprevir kontra replikoni b'tul sħiħ jew kimeriċi li jikkonvertu f'kowd is-sekwenzi ta' NS5A jew NS3 minn sekwenzi ta' referenza u iżolati kliniċi huma ppreżentati f'Tabella 5.
English: (600 mg once daily)/ grazoprevir (200 mg once daily)
Maltese: (600 mg PO darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: • EBR* + GZR* + RBV† for 8, 12, or 18 weeks (N=60, 152, and 65, respectively)
Maltese: • EBR* + GZR* + RBV† għal 8, 12, jew
English: • It is very important that you read the information concerning pregnancy and contraception in the ribavirin package leaflet very carefully.
Maltese: • Huwa importanti ħafna li inti taqra l-informazzjoni dwar tqala u kontraċezzjoni fil-fuljett ta' tagħrif ta' ribavirin.
English: Co-administration with grazoprevir did not result in clinically relevant increases in exposures of CYP3A substrates.
Maltese: L-għoti flimkien ma' grazoprevir ma wassalx għal żidiet rilevanti b'mod kliniku fl-esponimenti għal sustrati ta' CYP3A.
English: (600 mg IV single dose)/ grazoprevir (200 mg single dose)
Maltese: (600 mg darba kuljum)/ grazoprevir (200 mg darba kuljum)
English: Clinical and laboratory monitoring is recommended.
Maltese: Huwa rakkomandat monitoraġġ kliniku u tal-laboratorju.
English: In general, in HCV genotype 1a, 1b or 4 combinations of elbasvir resistance-associated substitutions further reduced elbasvir antiviral activity.
Maltese: B'mod ġenerali, il kombinazzjonijiet tal-ġenotipi 1a, 1b jew 4 ta' HCV ta' sostituzzjonijiet assoċjati ma' reżistenza għalelbasvir komplew inaqqsu aktar l-attività antivirali ta' elbasvir.
English: • itching
Maltese: C-EDGE
English: AUC 1.13 (1.05, 1.21) Cmax 0.87 (0.78, 0.96) C24 1.53 (1.43, 1.63)
Maltese: 87 (0.78, 0.96) C24 1.53 (1.43, 1.63)
English: Table 7: SVR in GT1a-, GT1b- or treatment-experienced GT4-infected subjects bearing baseline NS5A or NS3 polymorphisms SVR12 by Treatment Regimen ZEPATIER, 12 Weeks
Maltese: SVR f'individwi infettati b'GT1a, GT1b jew GT4 li jkunu ħadu trattament qabel li jkollhom polimorfiżmi ta' NS5A jew NS3 fil-linja bażi SVR12 Skont l-Iskeda ta' Għoti tat-Trattament
English: Do not use the medicine after the expiry date which is stated on the carton and blister packaging after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-ippakkjar tal-folja wara ‘JIS'.
English: Film-coated tablet.
Maltese: kolesterol fid-demm.
English: Elbasvir pharmacokinetics were approximately dose-proportional over the range of 5-100 mg once daily.
Maltese: Il-farmakokinetika ta' elbasvir kienet bejn wieħed u ieħor fi proporzjon mad-doża fuq il-firxa ta' 5100 mg darba kuljum.
English: Animal studies do not indicate harmful effects of elbasvir or grazoprevir on fertility at elbasvir and grazoprevir exposures higher than the exposure in humans at the recommended clinical dose (see section 5.3).
Maltese: Studji flannimali ma juru l-ebda effetti ħżiena ta' elbasvir jew grazoprevir fuq il-fertilità b'esponimenti għal elbasvir u grazoprevir ogħla mill-esponiment fil-bniedem bid-doża klinika rakkomandata (ara sezzjoni 5.3).
English: GT 1, 4, 6 TN with or without cirrhosis
Maltese: GT 1, 4, 6
English: C-EDGE TE (open-label)
Maltese: C-EDGE TN (la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża)
English: During clinical studies with ZEPATIER with or without ribavirin, regardless of treatment duration, < 1 % (13/1,690) of subjects experienced elevations of ALT from normal levels to greater than 5 times the ULN, generally at or after treatment week 8 (mean onset time 10 weeks, range 6-12 weeks).
Maltese: Matul l-istudji kliniċi b'ZEPATIER ma' ribavirin jew mingħajru, irrispettivament minn kemm dam ittrattament, < 1 % (13/1,690) tal-individwi kellhom żidiet fil-livell tal-ALT minn livelli normali għal aktar minn 5 darbiet il-ULN, ġeneralment waqt jew wara ġimgħa 8 ta' trattament (medja taż-żmien meta jibdew 10 ġimgħat, firxa 6 ġimgħat-12-il ġimgħa).
English: The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Maltese: Id-doża ta' atorvastatin m'għandhiex taqbeż id-doża ta' 20 mg kuljum meta jingħata flimkien ma' ZEPATIER.
English: Placebo-controlled study in which subjects were randomised in a 3:1 ratio to: EBR/GZR for 12 weeks (immediate treatment group [ITG]) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (deferred treatment group (DTG)).
Maltese: Studju kkontrollat bi plaċebo li fih lindividwi ntgħażlu b'mod każwali fi proporzjon ta' 3:1 għal: EBR/GZR għal 12-il ġimgħa (grupp bi trattament immedjat [ITG - immediate treatment group]) jew plaċebo għal 12-il ġimgħa segwit minn trattament fejn kemm linvestigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża b'EBR/GZR għal 12-il ġimgħa (grupp bi trattament ddiferit (DTG - deferred treatment group))
English: ANTICONVULSANTS
Maltese: SUSTANZI ANTIVIRALI
English: GT 4, 6 TN without cirrhosis
Maltese: GT 4, 6
English: Close monitoring of INR is recommended with all vitamin K antagonists.
Maltese: Huwa rrakkomandat monitoraġġ mill-qrib ta' INR bl-antagonisiti kollha tal-vitamina K.
English: (OATP1B inhibition and CYP3A induction)
Maltese: (inibizzjoni ta' OATP1B u induzzjoni ta' CYP3A)
English: • Keep this leaflet.
Maltese: Popolazzjoni ta' Pazjenti
English: No clinically relevant change in exposure is represented by a horizontal arrow “↔”.
Maltese: Ma hija rrapreżentata l-ebda bidla rilevanti b'mod kliniku fl-esponiment permezz talvleġġa orizzontali “↔”.
English: The dose of rosuvastatin should not exceed a daily dose of 10 mg when co-administered with ZEPATIER.
Maltese: Id-doża ta' rosuvastatin m'għandhiex taqbeż id-doża ta' 10 mg kuljum meta jingħata flimkien ma' ZEPATIER.
English: (600 mg PO once daily)/ grazoprevir (200 mg once daily)
Maltese: (doża waħda ta' 600 mg PO)/ grazoprevir (200 mg darba kuljum)
English: Diabetics may experience improved glucose control potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral (DAA) treatment.
Maltese: Pazjenti bid-dijabete jistgħu jesperjenzaw kontroll aħjar tal-glukożju, li potenzjalment jirriżulta f'ipogliċemija sintomatika, wara li tinbeda l-kura għall-HCV b'mediċina antivirali li taġixxi direttament (DAA).
English: Treatment outcomes in genotype 4-infected subjects treated with elbasvir/grazoprevir for 12 weeks or elbasvir/grazoprevir with ribavirin for 16 weeks are presented in Table 11.
Maltese: Ir-riżultati tat-trattament f'individwi infettatti bil-ġenotip 4 ttrattati b'elbasvir/grazoprevir għal 12-il ġimgħa jew elbasvir/grazoprevir ma' ribavirin għal 16-il ġimgħa huma ppreżentati f'Tabella 11.
English: NS5A substitutions conferring resistance to elbasvir may reduce the antiviral activity of other NS5A inhibitors.
Maltese: Issostituzzjonijiet ta' NS5A li jagħtu reżistenza għal elbasvir jistgħu jnaqqsu l-attività antivirali ta' inibituri oħra ta' NS5A.
English: (due in part to OATP1B and CYP3A inhibition)
Maltese: (parzjalment minħabba inibizzjoni ta' OATP1B u CYP3A)
English: GT 1, 4, 6 TN with or without cirrhosis HCV/HIV-1 co-infection
Maltese: TN b'ċirrożi jew mingħajrha Koinfezzjoni b'HCV/HIV-1
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Maltese: L-effetti fi studji mhux kliniċi kienu osservati biss f'espożizzjonijiet ikkunsidrati li kienu ogħla b'mod suffiċjenti mill-espożizzjoni massima umana li jindika ftit rilevanza għall-użu kliniku.
English: ANTIARRHYTHMICS
Maltese: FARMAĊEWTIKU
English: GT 1 TE with HCV protease inhibitor regimen
Maltese: X'inhu ZEPATIER u għalxiex jintuża
English: Cardboard box containing 5, 10, 50, 100 or 200 pipettes.
Maltese: Kaxxa tal-kartun fiha 5, 10, 50, 100 or 200 pipetta.
English: A white suspension.
Maltese: Suspensjoni bajda.
English: [Single-dose container:]
Maltese: [Kontenitur ta' doża waħda:]
English: PACKAGE SIZE 10 ml (10 doses).
Maltese: DAQS TAL-PAKKETT 10 ml (10 dożi)
English: Date of first renewal: 11/11/2013.
Maltese: Data tal- ewwel tiġdid: 11/11/2013
English: Do not store above 25 °C.
Maltese: Taħżnux f'temperatura ogħla minn 25°C.
English: 76505 Saue/Harjumaa Tel: + 372 6 709 006
Maltese: 76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006
English: Gentamicin resistant bacteria isolated from the field between 2008 and 2010 in canine otitis before treatment (determined according to CLSI guideline breakpoint ≥ 8 for all isolates except for Staphylococci ≥ 16 μg/ml) were low: 4.7%, 2.9% and 12.5% for Staphylococcus spp., Pseudomonas and Proteus spp.
Maltese: Batterji reżistenti għall-ġentamiċina iżolati barra bejn l-2008 u l-2010 f'otite kanina qabel il-kura (iddeterminat skont il-linja gwida CLSI breakpoint ≥ 8 għall-iżolati kollha ħlief għall-iStafilokokki ≥ 16 μg/ml) kienu baxxi: 4.7%, 2.9% u 12.5% għall-iStafilokokkus spp., Psewdomonas u Proteus spp. rispettivament.
English: 3001 Leuven
Maltese: B-3001 Leuven IL-BELĠJU
English: Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity.
Maltese: Mikonażol (bħala nitrat) hu derivattiv imidażol sintetiku b'attività pronunzjata antifungali.
English: Hydrocortisone aceponate
Maltese: Idrokortiżon aċeponat
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20/11/2008.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 20/11/2008
English: Liquid paraffin.
Maltese: Paraffin, Likwidu
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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 definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: See section 4.5 of the SPC.
Maltese: Ara t-taqsima 4.5 tal-SPC.
English: Hydrocortisone aceponate belongs to the diesters' class of glucocorticosteroids.
Maltese: Idrokortiżon aċeponat jappartjeni għall-klassi dijesteri ta' glukokortikosterojdi.
English: PHARMACEUTICAL FORM Ear drops, suspension.
Maltese: GĦAMLA FARMAĊEWTIKA Qtar għal widnejn, sospensjoni.
English: Multi-dose container composed of two extruded parts, one external white polypropylene rigid tube and one internal (ethylene-methacrylic acid)-zinc copolymer (Surlyn) flexible pouch containing a steel ball, closed with a 1 ml dosing airless pump equipped with a flexible atraumatic cannula and covered by a plastic cap.
Maltese: Kontenitur ta' multidożi magħmul minn żewġ partijiet li joħorġu 'l barra, wieħed tubu riġidu abjad estern tal-polipropilin u powċ wieħed flessibbli intern (aċidu etilin-metakriliku)-żingu kopolimer (Surlin) li fih ballun tal-azzar magħluq b'pompa mingħajr arja tad-dożaġġ ta' 1 ml attrezzat b'kanula atrawmatika flessibbli u mgħottija b'kappa tal-plastik.
English: France VIRBAC 13ème rue - L.I.D - BP 27 06517 Carros Hrvatska VIRBAC
Maltese: France VIRBAC 13ème rue - L.I.D - BP 27 F-06517 Carros
English: EU/2/08/085/001-006
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/085/001-006
English: No standardised in-vitro susceptibility breakpoints have been defined for miconazole; however, using the method by Diagnostics Pasteur, no resistant strains were found.
Maltese: Għal mikonażol, ma ġewx identifikati punti ta'effikaċja standard, in vitro, ta' suxxetibilita; madankollu jekk jintuża l-metodu ta' Diagnostics Pasteur, ma nstabu l-ebda strejns reżistenti.
English: Gentamicin as sulphate
Maltese: Gentamiċina bħala sulfat
English: Miconazole as nitrate
Maltese: Mikonażol bħala nitrat
English: Multi-dose container:
Maltese: TIKKETTA TAL-KONTENITUR TAL-MULTIDOŻI
English: Papules were observed uncommonly (less than 1% of treated dogs).
Maltese: Papuli kienu osservati mhux komunement (f'inqas minn 1% tal-klieb ikkurati).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/085/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/085/001
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):
Maltese: Il-prodott mediċinali veterinarju hu taħlita fissa ta' tlIet sustanzi attivi (kortikosterojdi, antifungali u antibijotiku):
English: ATCvet code: QS02CA03.
Maltese: QSO2 CA03
English: One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1,505 IU gentamicin (as sulphate).
Maltese: Millilitru fih 1.11 mg idrokortiżon aċeponat, 15.1 mg mikonażol (bħala nitrat) u 1,505 IU ġentamiċina (bħala sulfat).
English: Co-resistance has been described, i.e. gentamicin resistance genes are found to be physically linked to other antimicrobial resistance genes that are transferred between pathogens due to transferable genetic elements such as plasmids, integrons and transposons.
Maltese: Ko-reżistenza ġiet deskritta, i.e. ġeni ta' reżistenza għal ġentamiċina nstabu li kienu fiżikament illinkjati ma' ġeni oħra ta' reżistenza antimikrobjali li huma ttrasferiti bejn patoġeni minħabba elementi ġenetiċi transferibbli bħal plasmidi, integroni u transposoni.
English: Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis.
Maltese: Ilmikonażol jostakola b'mod selettiv is-sintesi ta' ergosterol, li hu komponiment essenzjali talmembrana tal-ħmira u fungi inklużi Malassezia pakidermatite.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs Hydrocortisone aceponate - Miconazole - Gentamicin
Maltese: VETERINARJU Qtar għal widnejn easotic, sospensjoni għall-klieb Idrokortiżon aċeponat- Mikonażol - Ġentamiċina
English: The bacterial resistance phenotypes to gentamicin are mainly based on three mechanisms: enzymatic modification of aminoglycosides, failure of intracellular penetration of the active substance and alteration of the aminoglycoside target.
Maltese: Il-fenotipi tar-reżistenza batterjali għal ġentamiċina huma primarjament ibbażati fuq tliet mekkaniżmi: modifikazzjoni enżimatika tal-aminoglukosidi, falliment ta' penetrazzjoni intraċellulari ta' sustanza attiva u tibdil tal-mira aminoglikosid.
English: Box containing 1 multi-dose container (the content of 10 ml is equivalent to 10 doses).
Maltese: Kaxxa li fiha kontenitur wieħed ta' multidoża (il-kontenut ta' 10 ml hu ekwivalenti għal 10 dożi).
English: Tel: + 372 6 709 006 E-mail: zoovet@zoovet.ee
Maltese: E-mail: zoovet@zoovet.ee
English: In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Maltese: F'każ ta' otite parasitika, għandha tingħata kura akariċidali adegwata.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml (10 doses).
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 10 ml (10 dożi)
English: Hydrocortisone aceponate 1.11 mg/ml, Miconazole as nitrate 15.1 mg/ml, Gentamicin as sulphate 1,505 IU/ml.
Maltese: Millilitru fih 1.11 mg idrokortiżon aċeponat, 15.1 mg mikonażol (bħala nitrat) u 1505
English: To be supplied only on veterinary prescription.
Maltese: M'għandux jitħallat ma' kull prodott mediċinal veterinarju ieħor.
English: WITHDRAWAL PERIOD(S)
Maltese: PERIJODU(I) TA' TIŻMIM
English: The veterinary medicinal product is a fixed combination of three active substances: antibiotic, antifungal and corticosteroid.
Maltese: Il-prodott mediċinali veterinarju hu taħlita fissa ta' tliet sustanzi attivi: kortikosterojdi, antifungali u antibijotiku.