FrancophonIA/ELRC3.0 huggingface dataset:
English: Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Icelandic: Rilpivirin (25 mg einu sinni á dag)/ elbasvir (50 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: MON
Icelandic: MÁN
English: (combination of OATP1B and CYP3A inhibition)
Icelandic: (sambland af OATP1B og CYP3A hömlun)
English: Placebo-controlled study in which subjects were randomised in a 2:1 ratio to EBR/GZR for 12 weeks (ITG) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (DTG).
Icelandic: Samanburðarrannsókn með lyfleysu þar sem sjúklingum var slembiraðað 2:1 og fengu EBR/GZR í 12 vikur (hópur sem fékk meðferð strax) eða lyfleysu í 12 vikur sem fylgt var eftir með opinni meðferð með EBR/GZR í 12 vikur (hópur sem fékk ekki meðferð strax).
English: Grazoprevir oral exposures are approximately 2-fold greater in HCV-infected subjects as compared to healthy subjects.
Icelandic: 2-falt meiri hjá sjúklingum með lifrarbólgu C samanborið við heilbrigða einstaklinga.
English: These changes are not clinically relevant; therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on sex (see section 4.4).
Icelandic: Þessar breytingar skipta ekki máli klínískt því er ekki ráðlagt að breyta skömmtum elbasvir/grazoprevir út frá kyni (sjá kafla 4.4).
English: Co-administration with grazoprevir did not result in clinically relevant increases in exposures of CYP3A substrates.
Icelandic: Samhliða gjöf grazoprevirs olli ekki aukinni útsetningu fyrir CYP3A hvarfefnum sem skiptir máli klínískt.
English: Microcrystalline cellulose Mannitol
Icelandic: KRAMPASTILLANDI LYF Carbamazepin
English: SEDATIVES
Icelandic: Sjúklingaþýði
English: Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Icelandic: Tacrolimus (2 mg stakur skammtur)/ elbasvir (50 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: (300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
Icelandic: (300 mg einu sinni á dag)/ ritonavir (100 mg einu sinni á dag/ elbasvir (50 mg einu sinni á dag)
English: Table 8: Studies conducted with ZEPATIER
Icelandic: Rannsóknir með ZEPATIER
English: (due in part to OATP1B and CYP3A inhibition)
Icelandic: (að hluta til vegna OATP1B og CYP3A hömlunar)
English: (300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Icelandic: (300 mg einu sinni á dag)/ ritonavir (100 mg einu sinni á dag/ grazoprevir (200 mg einu sinni á dag)
English: In genotype 1b replicons, single NS5A substitutions L31F and Y93H reduced elbasvir antiviral activity by 17-fold.
Icelandic: Stakt NS5A skiptihvarf L31F og Y93H í arfritum af arfgerð 1b dró 17-falt úr veiruvirkni elbasvirs.
English: Laboratory abnormalities
Icelandic: Klínískir stofnar
English: For specific dosage instructions for ribavirin, including dose modification, refer to the ribavirin Summary of Product Characteristics.
Icelandic: Varðandi sérstakar skammtaleiðbeiningar fyrir ribavirin, þ.m.t. aðlögun skammta er vísað í samantekt á eiginleikum lyfs fyrir ribavirin.
English: • have diabetes.
Icelandic: • ert með sykursýki.
English: Table 5: Activities of elbasvir and grazoprevir in GT1a, GT1b and GT4 reference sequences and clinical isolates in replicon cells
Icelandic: Virkni elbasvirs og grazoprevirs í viðmiðunarröðum og klínískum stofnum af arfgerð 1a, 1b og 4 í afrituðum frumum
English: GT 1, 4, 6 TN with or without cirrhosis Opiate agonist therapy
Icelandic: Arfgerð 1, 4, 6 TN með eða án skorpulifrar Meðferð með ópíati
English: (400 mg PO once daily)/ grazoprevir (100 mg single dose)
Icelandic: (400 mg til inntöku einu sinni á dag)/ grazoprevir (100 mg stakur skammtur)
English: SVR by cirrhosis status Non-cirrhotic
Icelandic: Varanleg veirusvörun eftir stöðu skorpulifrar Án skorpulifrar
English: Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Icelandic: HCV VEIRULYF Sofosbuvir (400 mg stakur skammtur sofosbuvir)/elbasvir (50 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: (600 mg IV single dose)/ grazoprevir (200 mg single dose)
Icelandic: (600 mg i.v. stakur skammtur)/ grazoprevir (200 mg stakur skammtur)
English: (400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Icelandic: (400 mg tvisvar á dag)/ ritonavir (100 mg tvisvar á dag)/ grazoprevir (200 mg einu sinni á dag)
English: (10 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Icelandic: (10 mg stakur skammtur)/ elbasvir (50 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: (400 mg twice daily)/ grazoprevir (200 mg once daily)
Icelandic: (400 mg tvisvar á dag)/ grazoprevir (200 mg einu sinni á dag)
English: (300 mg once daily)/ grazoprevir (200 mg once daily)
Icelandic: (300 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: Grazoprevir is active in vitro against the following genotype 1a NS3 substitutions which confer resistance to other NS3/4A protease inhibitors: V36A/L/M, Q41R, F43L, T54A/S, V55A/I, Y56F, Q80K/R, V107I, S122A/G/R/T, I132V, R155K, A156S, D168N/S, I170T/V.
Icelandic: V36A/L/M, Q41R, F43L, T54A/S, V55A/I, Y56F, Q80K/R, V107I, S122A/G/R/T, I132V, R155K, A156S, D168N/S, I170T/V.
English: (600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Icelandic: (600 mg tvisvar á dag)/ ritonavir (100 mg tvisvar á dag/ grazoprevir (200 mg einu sinni á dag)
English: HIV ANTIVIRAL AGENTS: OTHER
Icelandic: HIV VEIRULYF:
English: ANTIFUNGALS
Icelandic: Aukaverkanir
English: What ZEPATIER contains
Icelandic: ZEPATIER inniheldur
English: Outcome for subjects without SVR On-treatment virologic failure Relapse
Icelandic: Niðurstöður hjá þeim sem eru án varanlegrar veirusvörunar Veirufræðilegur brestur á meðferðartíma Bakslag
English: Grazoprevir is not a P-gp inhibitor based on in vitro data.
Icelandic: Byggt á upplýsingum in vitro er grazoprevir ekki P-gp hemill.
English: Proton pump inhibitors Pantoprazole (40 mg once daily)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Icelandic: Prótonpumpuhemlar Pantoprazol (40 mg einu sinni á dag)/ elbasvir (50 mg stakur skammtur)/ grazoprevir (100 mg stakur skammtur)
English: Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Icelandic: RÓANDI LYF Midazolam (2 mg stakur skammtur)/ grazoprevir (200 mg einu sinni á dag)
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.
Icelandic: 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: EBR with GZR
Icelandic: Varanleg veirusvörun EBR með GZR
English: Genotype 1b N = 8 % (n)
Icelandic: N = 8 % (n)
English: Prednisone (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Icelandic: Prednison (40 mg stakur skammtur)/ elbasvir (50 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: GT 1 TN or TE with or without cirrhosis Chronic Kidney Disease
Icelandic: Arfgerð 1 TN eða TE með eða án skorpulifrar Langvinnur nýrnasjúkdómur
English: Recommendation concerning coadministration with ZEPATIER
Icelandic: Upplýsingar um ZEPATIER
English: Relative to fasting conditions, the administration of a single dose of elbasvir/grazoprevir with a highfat (900 kcal, 500 kcal from fat) meal to healthy subjects resulted in decreases in elbasvir AUC0-inf and Cmax of approximately 11 % and 15 %, respectively, and increases in grazoprevir AUC0-inf and Cmax of approximately 1.5-fold and 2.8-fold, respectively.
Icelandic: 11% lækkun á AUC0-inf fyrir elbasvir og u.þ.b. 15% lækkun á Cmax og jók AUC0-inf fyrir grazoprevir u.þ.b. 1,5-falt og Cmax u.þ.b. 2,8-falt.
English: Bosentan
Icelandic: Dreifing
English: The safety and efficacy of ZEPATIER have not been established in liver transplant recipients.
Icelandic: ZEPATIER hefur ekki verið staðfest hjá lifrarþegum.
English: Antacids
Icelandic: Digoxin
English: Excretion
Icelandic: Upphafseinkenni
English: † for
Icelandic: Viðmið
English: In general, in HCV genotype 1a, 1b or 4 combinations of elbasvir resistance-associated substitutions further reduced elbasvir antiviral activity.
Icelandic: Yfirleitt dregur blanda skiptihvarfa sem tengjast ónæmi gegn elbasviri enn frekar úr veiruvirkni elbasvirs gegn HCV af arfgerð 1a, 1b og 4.
English: Following administration of elbasvir/grazoprevir to HCV-infected subjects, elbasvir peak plasma concentrations occur at a median Tmax of 3 hours (range of 3 to 6 hours); grazoprevir peak plasma concentrations occur at a median Tmax of 2 hours (range of 30 minutes to 3 hours).
Icelandic: C höfðu fengið elbasvir/grazoprevir var miðgildistími Tmax þar til hámarksplasmaþéttni elbasvirs var náð, 3 klst. (á bilinu 3 til 6 klst.); miðgildistími Tmax þar til hámarksplasmaþéttni grazoprevirs var náð, var 2 klst. (á bilinu 30 mín. til 3 klst.).
English: PHARMACEUTICAL PARTICULARS
Icelandic: LYFJAFRÆÐILEGAR UPPLÝSINGAR
English: • EBR* + GZR* + RBV† for 8, 12, or 18 weeks (N=60, 152, and 65, respectively)
Icelandic: † í 8, 12 eða 18 vikur (N=60, 152, og 65)
English: ↔ Elvitegravir AUC 1.10 (1.00, 1.21) Cmax 1.02 (0.93, 1.11) C24 1.31 (1.11, 1.55)
Icelandic: Cmax 1,02 (0,93; 1,11) C24 1,31 (1,11; 1,55)
English: (600 mg once daily)/ grazoprevir (200 mg once daily)
Icelandic: (600 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: Table 3: Adverse reactions identified with ZEPATIER Frequency
Icelandic: Aukaverkanir sem hafa komið fram með ZEPATIER* Tíðni
English: ACID REDUCING AGENTS H2-receptor antagonists Famotidine (20 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Icelandic: Famotidin (20 mg stakur skammtur)/ elbasvir (50 mg stakur skammtur)/ grazoprevir (100 mg stakur skammtur)
English: Common asthenia, irritability
Icelandic: Algengar þróttleysi, pirringur
English: Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose)
Icelandic: LYF VIÐ ASTMA Montelukast (10 mg stakur skammtur)/ grazoprevir (200 mg stakur skammtur)
English: Pravastatin (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Icelandic: Pravastatin (40 mg stakur skammtur)/ elbasvir (50 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: Elbasvir and grazoprevir are not expected to be removed by peritoneal dialysis.
Icelandic: Ekki er gert ráð fyrir að hægt sé að fjarlægja elbasvir og grazoprevir með kviðskilun.
English: Talk to your doctor about different contraception methods that are suitable for you.
Icelandic: Leitið ráða hjá lækninum um hentuga getnaðarvörn.
English: PHOSPHATE BINDERS
Icelandic: SVEPPALYF Ketoconazol
English: Overall prevalence of GT1a-infected subjects with baseline NS5A polymorphisms in the pooled analyses was
Icelandic: GT1a NS5A fjölbreytni:
English: • You must not become pregnant if you are taking ZEPATIER with ribavirin.
Icelandic: Forðast verður þungun ef ZEPATIER er notað ásamt ribavirini.
English: Dolutegravir (50 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Icelandic: SAMRUNAHEMLAR Dolutegravir (50 mg stakur skammtur)/ elbasvir (50 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Lýsing á útliti ZEPATIER og pakkningastærðir
English: STIMULANTS
Icelandic: hægðatregða
English: (10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
Icelandic: (10 mg stakur skammtur)/ elbasvir (50 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag
English: Gastrointestinal disorders: Common nausea, diarrhoea, constipation, upper abdominal pain, abdominal pain, dry mouth, vomiting Skin and subcutaneous tissue disorders: Common pruritus, alopecia
Icelandic: Algengar ógleði, niðurgangur, hægðatregða, verkur ofarlega í kvið, kviðverkur, munnþurrkur, uppköst
English: Modafinil
Icelandic: sundl
English: How ZEPATIER works
Icelandic: Hvernig nota á ZEPATIER
English: Efavirenz (600 mg once daily)/ elbasvir (50 mg once daily)
Icelandic: BAKRITAHEMLAR SEM EKKI ERU NÚKLEÓSÍÐ Efavirenz (600 mg einu sinni á dag)/ elbasvir (50 mg einu sinni á dag)
English: To be taken into consideration by patients on a controlled sodium diet.
Icelandic: Í greiningu á lyfjahvörfum hjá sjúklingum með lifrarbólgu
English: Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Icelandic: ÓNÆMISBÆLANDI LYF Ciclosporin (400 mg stakur skammtur)/ elbasvir (50 mg einu sinni á dag)/ grazoprevir (200 mg einu sinni á dag)
English: Rifampicin (600 mg IV single dose)/ elbasvir (50 mg single dose)
Icelandic: (CYP3A hömlun) LYF VIÐ MYKOBAKTERÍUM Rifampicin (600 mg i.v. stakur skammtur)/ elbasvir (50 mg stakur skammtur)
English: Medicinal product by therapeutic areas
Icelandic: Lyf eftir meðferðarsviði
English: OPIOID-SUBSTITUTION THERAPY
Icelandic: ÖRVANDI LYF Modafinil
English: ↔ S-Methadone AUC 1.23 (1.12, 1.35) Cmax 1.15 (1.07, 1.25)
Icelandic: AUC 1,23 (1,12; 1,35)
English: (600 mg PO single dose)/ grazoprevir (200 mg once daily)
Icelandic: (600 mg stakur skammtur til inntöku)/ grazoprevir (200 mg einu sinni á dag)
English: WED
Icelandic: Notkun
English: Excipients
Icelandic: Simvastatin
English: There are no adequate and well-controlled studies with ZEPATIER in pregnant women.
Icelandic: Fullnægjandi samanburðarrannsóknir liggja ekki fyrir um notkun ZEPATIER á meðgöngu.
English: Co-administration with ZEPATIER is contraindicated.
Icelandic: Íhuga á að stöðva meðferð með ZEPATIER ef staðfest
English: Less than 1% of subjects treated with ZEPATIER with or without ribavirin experienced ALT elevations >2.5 - 5 times the ULN during treatment; there were no treatment discontinuations due to these ALT elevations.
Icelandic: ALT hækkun >2.5 - 5 föld eðlileg efri mörk kom fram hjá innan við 1% þeirra sem fengu
English: Cirrhotic
Icelandic: Töflukjarni
English: FRI
Icelandic: Frásog
English: HBV AND HIV ANTIVIRAL AGENTS: NUCLEOS(T)IDE REVERSE TRANSCRIPTASE INHIBITORS
Icelandic: HBV OG HIV VEIRULYF:
English: Based on pooled data from patients treated with ZEPATIER for 12 weeks without ribavirin ULN: Upper limit of normal according to testing laboratory.
Icelandic: Á grundvelli sameinaðra upplýsinga frá sjúklingum sem voru meðhöndlaðir með ZEPATIER í 12 vikur án ríbavírins.
English: A should be considered in patients with baseline HCV RNA level >800,000 IU/ml and/or the presence of specific NS5A polymorphisms causing at least a 5-fold reduction in activity of elbasvir to minimise the risk of treatment failure (see section 5.1).
Icelandic: A hjá sjúklingum með upphafsgildi HCV RNA >800.000 a.e./ml og/eða sértæka fjölbreytni NS5A sem dregur a.m.k.
English: Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
Icelandic: LYF VIÐ HJARTSLÁTTARTRUFLUNUM Digoxin (0,25 mg stakur skammtur)/ elbasvir (50 mg einu sinni á dag)
English: (combination of mechanisms including CYP3A inhibition)
Icelandic: (sambland verkunarmáta þ.m.t. CYP3A hömlun)
English: Includes subjects with baseline sequencing data and who either achieved SVR12 or met criteria for virologic failure.
Icelandic: Felur í sér sjúklinga þar sem upplýsingar um raðir við upphaf liggja fyrir og sem náðu varanlegri veirusvörun í 12 vikur eða lengur eða skilmerkjum veirufræðilegs brests.
English: Atorvastatin (20 mg single dose)/ grazoprevir (200 mg once daily)
Icelandic: HMG-CoA REDÚKTASAHEMLAR Atorvastatin (20 mg stakur skammtur)/ grazoprevir (200 mg einu sinni á dag)
English: GT1b
Icelandic: Arfgerð 1b
English: GT 1 TE with HCV protease inhibitor regimen
Icelandic: LYF SEM DRAGA ÚR SÝRUMYNDUN H2-viðtakablokkar
English: Table 4: Selected treatment emergent laboratory abnormalities Laboratory Parameters
Icelandic: Valdar óeðlilegar rannsóknaniðurstöður sem komu fram við meðferð Rannsóknaniðurstöður
English: Retreatment
Icelandic: Lyfjagjöf
English: ANTICOAGULANTS
Icelandic: SEGAVARNARLYF
English: ATCvet code: QS02CA03.
Icelandic: QS02 CA03.
English: If this occurs, treatment should be stopped.
Icelandic: Ef þetta kemur fyrir skal hætta meðferð.
English: 1 dose / ear / day for 5 days
Icelandic: ins 1 skammtur/ eyra / dagur, í 5 daga
English: • To open: hold up the pipette upright and break the top of the cannula.
Icelandic: Til að opna: haltu pípettunni uppréttri og brjóttu toppinn af sprotanum.
English: Tel.: 0033/4.92.08.73.00 Fax: 0033/4.92.08.73.48 E-mail: dar@virbac.fr
Icelandic: Sími : 0033/4.92.08.73.00 Fax : 0033/4.92.08.73.48 Tölvupóstfang: dar@virbac.fr
English: Do not store above 25 °C.
Icelandic: Geymið við lægra hitastig en 25 °C.
English: See also “Special precautions for use in animals”.
Icelandic: Sjá einnig „Sérstakar varúðarreglur við notkun hjá dýrum“.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið við lægra hitastig en 25 °C
English: Mild to moderate redness of the ear was common (2.4% of treated dogs).
Icelandic: Vægur til í meðallagi mikill roði í eyra var algengur (2,4% þeirra hunda sem fengu meðferð).
English: In dogs treated at the therapeutic dose for ten consecutive days, serum cortisol levels decreased from five days onward and returned to normal values within ten days after the end of treatment.
Icelandic: Hjá hundum sem fengu meðferð með ráðlögðum skammti tíu daga í röð, fór sermisþéttni kortisóls lækkandi frá fimmta degi og hafði náð eðlilegu gildi innan tíu daga frá því að meðferð lauk.
English: In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
Icelandic: Í öllum tilfellum var meðferð með dýralyfinu haldið áfram og allir hundarnir náðu fullum bata án sértækrar meðferðar.
English: Gentamicin as sulphate
Icelandic: Gentamicin sem súlfat
English: 76505 Saue/Harjumaa, ESTONIA
Icelandic: 76505 Saue/Harjumaa, ESTONIA Tel:
English: Shake the pipette thoroughly before use.
Icelandic: Hristu pípettuna vandlega fyrir notkun.
English: PACKAGE SIZE 10 ml (10 doses).
Icelandic: PAKKNINGASTÆRÐ 10 ml (10 skammtar)
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Icelandic: Ítarlegar upplýsingar um dýralyfið eru birtar á vef Lyfjastofnunar Evrópu http://www.ema.europa.eu.
English: All Escherichia coli isolates were fully susceptible to gentamicin.
Icelandic: Allir einangraðir kóligerlastofnar voru fullkomlega næmir fyrir gentamisíni.
English: Cardboard box containing 5, 10, 50, 100 or 200 pipettes.
Icelandic: ASKJA MEÐ 5, 10, 50, 100 eða 200 PÍPETTUR
English: Squeeze gently but firmly in the middle of the body of the pipette.
Icelandic: Kreistu ákveðið en varlega miðju pípettunnar.
English: • Take out one pipette from the box.
Icelandic: Taktu eina pípettu úr öskjunni.
English: [Single-dose container:]
Icelandic: [Fjölskammta ílát:]
English: Since many bacterial strains may be involved in otitis externa in dogs, the mechanisms of resistance can vary.
Icelandic: Vegna þess að margir bakteríustofnar geta komið við sögu í hlustarbólgu hunda, getur orsök ónæmis verið mismunandi.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/085/001
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/08/085/001
English: In very rare cases, the use of the veterinary medicinal product has been associated with hearing impairment (partial hearing loss or deafness), usually temporary, and primarily in geriatric dogs.
Icelandic: Í mjög sjaldgæfum tilfellum hefur notkun dýralyfsins verið tengd við heyrnarskerðingu (að hluta til eða heyrnaleysi), yfirleitt tímabundna og fyrst og fremst hjá öldruðum hundum.
English: Do not use concurrently with substances known to cause ototoxicity.
Icelandic: Notið ekki samhliða lyfjum sem vitað er að geta valdið eiturverkun á heyrn.
English: MATERIALS, IF ANY
Icelandic: EÐA ÚRGANGI, EF VIÐ Á
English: Whatever the size
Icelandic: Óháð stærð
English: - 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.
Icelandic: - Mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum 10 dýrum sem fá meðferð) - Algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100 dýrum sem fá meðferð) - Sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 1.000 dýrum sem fá meðferð) - Mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 10.000 dýrum sem fá meðferð)
English: See section 4.5 of the SPC.
Icelandic: Sjá kafla 4.5 í samantektinni á eiginleikum lyfsins.
English: Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Icelandic: Þekkt er að gentamicin tengist eiturverkunum á heyrn þegar það er gefið óstaðbundið (systemic use) í stórum skömmtum.
English: Hydrocortisone aceponate belongs to the diesters' class of glucocorticosteroids.
Icelandic: Hýdrókortisonaceponat tilheyrir diesterflokki sykurstera.
English: Do not use in dogs with generalised demodecosis.
Icelandic: Ekki má nota lyfið handa hundum með útbreidda sýkingu af völdum hársekkjamaurs (demodicosis).
English: Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Icelandic: Áður en notkun þessa dýralyfs hefst skal skoða eyrnagöngin vandlega til að ganga úr skugga um að ekki sé gat á hljóðhimnunni, til að forðast hættu á að sýkingin berist inn í miðeyrað og til að koma í veg fyrir skemmdir á snigli og jafnvægiskerfi.
English: In case of accidental skin contact, it is recommended to wash thoroughly with water.
Icelandic: Ef dýralyfið berst á húð fyrir slysni, er mælt með því að þvo svæðið vandlega með vatni.
English: Papules were observed uncommonly (less than 1% of treated dogs).
Icelandic: Nabbar komu fyrir en voru sjaldgæfir (innan við 1% þeirra hunda sem fengu meðferð).
English: No standardised in-vitro susceptibility breakpoints have been defined for miconazole; however, using the method by Diagnostics Pasteur, no resistant strains were found.
Icelandic: Engin stöðluð in vitro næmismörk hafa verið skilgreind fyrir miconazol, en engir ónæmir stofnar hafa fundist þegar Diagnostics Pasteur aðferð hefur verið beitt.
English: To administer one dose (1 ml) of the product in the affected ear:
Icelandic: Til að gefa einn skammt (1 ml) af lyfinu í sýkta eyrað:
English: The recommended dosage is 1 ml of the veterinary medicinal product per ear once a day for five consecutive days.
Icelandic: Ráðlagður skammtur er 1 ml af dýralyfinu í sýkt eyra, einu sinni á dag, fimm daga í röð.
English: It is recommended that the external ear canal should be cleaned and dried before treatment and excess hair around the treatment area be cut.
Icelandic: Mælt er með að eyrnagöngin séu hreinsuð og þurrkuð fyrir meðferð og klippa hár ef meðferðarsvæðið er mjög loðið.
English: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted.
Icelandic: Ef ofnæmi fyrir einhverju af innihaldsefnum lyfsins kemur fram, skal hætt notkun lyfsins og hefja viðeigandi meðferð.
English: A white suspension.
Icelandic: Hvít dreifa.
English: Hydrocortisone aceponate - Miconazole - Gentamicin
Icelandic: Easotic eyrnadropar, dreifa handa hundum Hýdrókortisonaceponat - Miconazol - Gentamicin
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml (10 doses).
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI SKAMMTA 10 ml (10 skammtar)
English: Overdose (symptoms, emergency procedures, antidotes):
Icelandic: Ofskömmtun (einkenni, neyðarráðstafanir, mótefni):