FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptomatic, supportive therapy is recommended and should consist of administration of gastrointestinal protective agents and infusion of isotonic saline.
Slovenian: Posebnega antidota ni. Priporočljiva je podporna simptomatska terapija, ki naj vključuje zdravila za zaščito želodčne in črevesne sluznice ter infuzijo izotonične fiziološke raztopine.
English: Co-administration of robenacoxib tablets with the entire daily food ration produced no delay in Tmax (0.5 h), but a lower Cmax (691 ng/ml)
Slovenian: Pri vnosu tablet robenakoksiba s celotnim dnevnim obrokom hrane ni prišlo do podaljšanja pri Tmax (0,5 h), ampak nižje Cmax (691 ng/ml) in rahlo nižje AUC (1069 ng·h/ml).
English: Do not use in cats suffering from ulceration in the digestive tract.
Slovenian: Ne uporabite pri mačkah z razjedami na prebavilih.
English: The interchangeable use of Onsior tablets and Onsior solution for injection in 4-months old cats at overdoses of up to 3 times the maximum recommended dose (2.4 mg, 4.8 mg, 7.2 mg robenacoxib/kg orally and 2.0 mg, 4.0 mg and 6.0 mg robenacoxib/kg subcutaneously) resulted in a dose-dependent increase of sporadic oedema at the injection site and minimal to mild subacute/chronic inflammation of the subcutaneous tissue.
Slovenian: Kot rezultat zamenljive uporabe zdravila Onsior tablete in zdravila Onsior raztopina za injiciranje sta se pri mačkah, starih 4 mesece, pri prevelikem odmerku do 3-kratnih najvišjih priporočljivih odmerkov (2,4 mg, 4,8 mg, 7,2 mg robenakoksiba na kg telesne mase peroralno in 2,0 mg, 4,0 mg in
English: EXPIRY DATE EXP {month/year} Once broached, use by …
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {mesec/leto}
English: Robenacoxib had analgesic and anti-inflammatory actions in an inflammation model in dogs with single oral doses ranging from 0.5 to 8 mg/kg, with an ID50 of 0.8 mg/kg and a rapid onset of action (0.5 h).
Slovenian: Pri vnetnem modelu pri psih so enkratni peroralni odmerki robenakoksiba od 0,5 do 8 mg/kg telesne mase z ID50 0,8 mg/kg učinkovali hitro (0,5 h) protibolečinsko in protivnetno.
English: Apart from one lactam metabolite, the identity of other metabolites is not known in cats.
Slovenian: Z izjemo enega laktamskega presnovka ostali presnovki pri mačkah niso znani.
English: NATURE/TYPE: Blister foil
Slovenian: OVOJNINAH VRSTA/TIP: Steklena viala
English: In cats robenacoxib is extensively metabolised by the liver.
Slovenian: Robenakoksib se pri mačkah presnavlja v veliki meri v jetrih.
English: Onsior tablets for cats are available in cardboard boxes containing 6 x 1, 12 x 1, 30 x 1 or 60 x 1 tablets in Alu/Alu perforated unit dose blisters.. Not all pack sizes may be marketed.
Slovenian: Zdravilo Onsior tablete za mačke je na voljo v kartonskih škatlah s 6 x 1, 12 x 1, 30 x 1 ali 60 x 1 tableto v perforiranem Alu/Alu deljivem pretisnem omotu s posameznimi odmerki.
English: Onsior tablets for dogs are available in cardboard boxes containing 7, 14, 28 or 70 tablets in Alu/Alu blisters, 30 x 1 tablets in Alu/Alu perforated unit dose blisters or 60 x 1 tablets in Alu/Alu perforated unit dose blisters.. Not all pack sizes may be marketed.
Slovenian: Zdravilo Onsior tablete za pse je na voljo v kartonskih škatlah s 7, 14, 28 ali 70 tabletami v Alu/Alu pretisnem omotu, 30 x 1 tableto v perforiranem Alu/Alu deljivem pretisnem omotu s posameznimi odmerki ali 60 x 1 tableto v perforiranem Alu/Alu deljivem pretisnem omotu s posameznimi odmerki.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Slovenian: BESEDILO "ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
English: Repeated oral administration of robenacoxib to dogs at dosages of 2-10 mg/kg for 6 months produced no change in the blood profile, with neither accumulation of robenacoxib nor enzyme induction.
Slovenian: Ponavljajoče se 6 mesecev trajajoče peroralno prejemanje robenakoksiba v priporočenih odmerkih 2-10 mg/kg telesne mase pri psih ni povzročilo sprememb v krvni sliki,
English: The safety of the veterinary medicinal product has not been established in cats less than 4 months of age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini ni bila dokazana pri mačkah, mlajših od 4 mesecev, in psih, mlajših od 2 mesecev, oziroma pri mačkah ali psih, lažjih od 2,5 kg telesne mase.
English: Use in cats with impaired cardiac, renal or hepatic function or in cats that are dehydrated, hypovolaemic or hypotensive may involve additional risks.
Slovenian: Uporaba pri mačkah z oslabljenim srčnim, ledvičnim ali jetrnim delovanjem oziroma pri dehidriranih, hipovolemičnih ali hipotenzivnih mačkah predstavlja dodatno tveganje.
English: In artificially induced inflammation in dogs, robenacoxib reduced pain and inflammation with single oral doses ranging from 0.5 to 8 mg/kg and a rapid onset of action (0.5 h).
Slovenian: (0,5 h) in zmanjšal bolečino in vnetje z enkratnimi peroralnimi odmerki od 0,5 do 8 mg/kg.
English: Therapy should be discontinued if liver enzyme activities increase markedly or the dog shows clinical signs such as anorexia, apathy or vomiting in combination with elevated liver enzymes.
Slovenian: V primeru vidnega porasta aktivnosti jetrnih encimov oziroma kadar so pri psu vidni klinični znaki anoreksije, apatije ali bruhanja v kombinaciji s povišanimi jetrnimi encimi, je treba zdravljenje prekiniti.
English: Robenacoxib is excreted predominantly via the biliary route (∼70%) rather than via the kidneys (∼30%).
Slovenian: Pretežno se izloča z žolčem (∼ 70 %), v približno 30 % pa preko ledvic.
English: Do not use in animals suffering from gastrointestinal ulceration.
Slovenian: Ne uporabite pri živalih z razjedami na prebavilih.
English: Adverse reactions of the digestive tract (such as vomiting) were commonly reported but most cases were mild and recovered without treatment.
Slovenian: Neželeni učinki na prebavilih (kot je bruhanje) so bili opisani pogosto, vendar so bili v večini primerov blagi in so izzveneli brez zdravljenja.
English: Use in animals with impaired cardiac, renal or hepatic function or those are dehydrated, hypovolaemic or hypotensive may involve additional risks.
Slovenian: Uporaba pri živalih z oslabljenim srčnim, ledvičnim ali jetrnim delovanjem oziroma pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih predstavlja dodatno tveganje.
English: In dogs, robenacoxib was in vitro approximately 140 fold selective for COX-2 (IC50 0.04 μM) as compared to COX-1 (IC50 7.9 μM).
Slovenian: Pri psih je bila selektivnost robenakoksiba in vitro približno 140-krat večja za COX-2 (IC50 0,04 μM)
English: Onsior 5 mg tablets for dogs:
Slovenian: Onsior 5 mg tablete za pse:
English: In healthy young cats aged 7- 8 months, oral robenacoxib administered at overdoses of up to 5 times the maximum recommended dose (2.4 mg, 7.2 mg, 12 mg robenacoxib/kg bodyweight) for 6 months was well tolerated.
Slovenian: mesecev v prevelikih odmerkih do 5-kratnih najvišjih priporočljivih odmerkov (2,4 mg, 7,2 mg, 12 mg robenakoksiba na kg telesne mase), dobro prenašale.
English: Do not use in pregnant or lactating cats or cats used for breeding because the safety of this product has not been established in these animals.
Slovenian: Ne uporabite pri mačkah v obdobju brejosti in laktacije ali pri mačkah, namenjenih za vzrejo, ker varnost robenakoksiba pri teh živalih ni bila ugotovljena.
English: Do not use in case of hypersensitivity to robenacoxib or to any ingredients of the solution.
Slovenian: Ne uporabite v primerih preobčutljivosti na robenakoksib ali na katerokoli sestavino raztopine.
English: For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs.
Slovenian: Za zdravljenje bolečine in vnetja v povezavi z ortopedskimi operativnimi posegi ali z operativnimi posegi na mehkih tkivih pri psih.
English: Mild and transient diarrhoea, soft faeces or vomiting were commonly reported in clinical trials with treatment up to 6 days.
Slovenian: V kliničnih preizkusih z zdravljenjem do 6 dni so bili pogosto opisani blaga in prehodna diareja, mehko blato ali bruhanje.
English: Robenacoxib is extensively metabolised by the liver in cats and dogs.
Slovenian: Robenakoksib se pri mačkah in psih presnavlja v veliki meri v jetrih.
English: Onsior 20 mg tablets for dogs:
Slovenian: Onsior 20 mg tablete za pse:
English: Solution for injection: Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue FRANCE
Slovenian: 26 Rue de la Chapelle 68330 Huningue FRANCIJA
English: EU/2/08/089/001 (6 x 1 tablets) EU/2/08/089/002 (12 x 1 tablets) EU/2/08/089/021 (30 x 1 tablets) EU/2/08/089/003 (60 x 1 tablets)
Slovenian: EU/2/08/089/001 (6 x 1 tableta) EU/2/08/089/002 (12 x 1 tableta) EU/2/08/089/021 (30 x 1 tableta) EU/2/08/089/003 (60 x 1 tableta)
English: Use in dogs with impaired cardiac or renal function or dogs that are dehydrated, hypovolaemic or hypotensive may involve additional risks.
Slovenian: Uporaba pri psih z oslabljenim srčnim, ledvičnim delovanjem oziroma pri dehidriranih, hipovolemičnih ali hipotenzivnih psih predstavlja dodatno tveganje.
English: Robenacoxib is extensively metabolised by the liver in dogs.
Slovenian: Robenakoksib se pri psih presnavlja v veliki meri v jetrih.
English: For pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk of premature closure of the ductus arteriosus in the foetus.
Slovenian: Dolgotrajnejše izpostavljanje kože zdravilu pri nosečnicah, zlasti blizu roka poroda, poveča tveganje za predčasno zaprtje duktusa arteriozusa pri plodu.
English: No changes in the QT interval were observed after a single intravenous administration of 2 or 4 mg/kg robenacoxib to anaesthetised healthy cats.
Slovenian: Po enkratnem intravenskem dajanju 2 ali 4 mg/kg robenakoksiba anesteziranim zdravim mačkam niso opazili sprememb v QT intervalu.
English: Onsior 40 mg tablets for dogs:
Slovenian: Onsior 40 mg tablete za pse:
English: For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in cats.
Slovenian: Za zdravljenje bolečine in vnetja v povezavi z ortopedskimi operativnimi posegi ali z operativnimi posegi na mehkih tkivih pri mačkah.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use of the veterinary medicinal product.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po uporabi zdravila si umijte roke.
English: The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini ni bila dokazana pri psih, lažjih od 2,5 kg telesne mase oziroma mlajših od 3 mesecev.
English: Onsior 10 mg tablets for dogs:
Slovenian: Onsior 10 mg tablete za pse:
English: PACKAGE LEAFLET: Onsior 6 mg tablets for cats
Slovenian: Onsior 6 mg tablete za mačke
English: None.
Slovenian: Ga ni.
English: The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini ni bila dokazana pri mačkah, lažjih od 2,5 kg telesne mase oziroma mlajših od 4 mesecev.
English: Adverse reactions of the digestive tract were reported very commonly, but most cases were mild and recovered without treatment.
Slovenian: Zelo pogosto so bili opisani neželeni učinki na prebavilih, ki pa so bili v večini primerov blagi in so izzveneli brez zdravljenja.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravilo Onsior se ne sme uporabljati skupaj z drugimi zdravili iz skupine NSAID.
English: Robenacoxib
Slovenian: robenakoksib
English: As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised cats.
Slovenian: Pri občutljivih ali ogroženih mačkah je lahko prevelik odmerek, tako kot pri drugih zdravilih iz skupine NSAID, toksičen za prebavila, ledvice ali jetra.
English: EU/2/08/089/016 (7 tablets) EU/2/08/089/017 (14 tablets) EU/2/08/089/018 (28 tablets) EU/2/08/089/019 (70 tablets) EU/2/08/089/028 (30 x 1 tablets) EU/2/08/089/029 (60 x 1 tablets)
Slovenian: EU/2/08/089/016 (7 tablet) EU/2/08/089/017 (14 tablet) EU/2/08/089/018 (28 tablet) EU/2/08/089/019 (70 tablet) EU/2/08/089/028 (30 x 1 tableta) EU/2/08/089/029 (60 x 1 tableta)
English: EU/2/08/089/012 (7 tablets) EU/2/08/089/013 (14 tablets) EU/2/08/089/014 (28 tablets) EU/2/08/089/015 (70 tablets) EU/2/08/089/026 (30 x 1 tablets) EU/2/08/089/027 (60 x 1 tablets)
Slovenian: EU/2/08/089/012 (7 tablet) EU/2/08/089/013 (14 tablet) EU/2/08/089/014 (28 tablet) EU/2/08/089/015 (70 tablet) EU/2/08/089/026 (30 x 1 tableta) EU/2/08/089/027 (60 x 1 tableta)
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 20 mg/ml
Slovenian: 20 mg/ml
English: Robenacoxib produced marked inhibition of
Slovenian: akumulacije robenakoksiba ali indukcije encimov.
English: As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised animals.
Slovenian: Pri občutljivih ali ogroženih živalih je lahko prevelik odmerek, tako kot pri drugih zdravilih iz skupine NSAID, toksičen za prebavila, ledvice ali jetra.
English: EU/2/08/089/008 (7 tablets) EU/2/08/089/009 (14 tablets) EU/2/08/089/010 (28 tablets) EU/2/08/089/011 (70 tablets) EU/2/08/089/024 (30 x 1 tablets) EU/2/08/089/025 (60 x 1 tablets)
Slovenian: EU/2/08/089/008 (7 tablet) EU/2/08/089/009 (14 tablet) EU/2/08/089/010 (28 tablet) EU/2/08/089/011 (70 tablet) EU/2/08/089/024 (30 x 1 tableta) EU/2/08/089/025 (60 x 1 tableta)
English: EU/2/08/089/004 (7 tablets) EU/2/08/089/005 (14 tablets) EU/2/08/089/006 (28 tablets) EU/2/08/089/007 (70 tablets) EU/2/08/089/022 (30 x 1 tablets) EU/2/08/089/023 (60 x 1 tablets)
Slovenian: EU/2/08/089/004 (7 tablet) EU/2/08/089/005 (14 tablet) EU/2/08/089/006 (28 tablet) EU/2/08/089/007 (70 tablet) EU/2/08/089/022 (30 x 1 tableta) EU/2/08/089/023 (60 x 1 tableta)
English: Use this veterinary medicinal product under strict veterinary monitoring in animals at risk of ulceration of the digestive tract, or if the animal previously displayed intolerance to other NSAIDs.
Slovenian: Pri živalih s tveganjem za nastanek razjed na prebavilih oziroma z znano preobčutljivostjo na druga zdravila iz skupine NSAID uporabite to zdravilo pod strogim veterinarskim nadzorom.
English: For pregnant women, particularly near term pregnant women, accidental injection and prolonged dermal exposure might increase the risk to the foetus.
Slovenian: Nenamerno injiciranje in dolgotrajnejše izpostavljanje kože zdravilu pri nosečnicah, zlasti blizu roka poroda, lahko poveča tveganje za plod.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Slovenian: 4.9 Odmerjanje in pot uporabe Subkutana uporaba.
English: Use this veterinary medicinal product under strict veterinary monitoring in cats with a risk of gastrointestinal ulcers, or if the cat previously displayed intolerance to other NSAIDs.
Slovenian: Pri mačkah s tveganjem za nastanek razjed na prebavilih oziroma z znano preobčutljivostjo na druga zdravila iz skupine NSAID uporabite to zdravilo pod strogim veterinarskim nadzorom.
English: 26 Rue de la Chapelle
Slovenian: 26 Rue de la Chapelle 68330 Huningue
English: For pregnant women, particularly near term pregnant women, prolonged dermal exposure may increase the risk to the foetus.
Slovenian: Dolgotrajnejše izpostavljanje kože zdravilu pri nosečnicah, zlasti blizu roka poroda, poveča tveganje za plod.
English: Use this product under strict veterinary monitoring in dogs with a risk of gastrointestinal ulcers, or if the dog previously displayed intolerance to other NSAIDs.
Slovenian: Pri psih s tveganjem za nastanek razjed na prebavilih oziroma z znano preobčutljivostjo na druga zdravila iz skupine NSAID uporabite to zdravilo pod strogim veterinarskim nadzorom.
English: In clinical trials at the recommended dose (2 mg/kg), robenacoxib reduced pain and inflammation in dogs undergoing orthopaedic or soft tissue surgery.
Slovenian: (2 mg/kg) zmanjšal bolečino in vnetje pri psih, podvrženih ortopedskim operativnim posegom ali operativnim posegom na mehkih tkivih.
English: Do not use after the expiry date stated on the label after EXP. After first broaching of the vial, the product may be stored for 28 days.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini za oznako »EXP«.
English: In healthy young dogs aged 5-6 months, oral robenacoxib administered at high overdoses (4, 6 or 10 mg/kg/day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Slovenian: (4, 6 ali 10 mg/kg/dan) niso pojavili znaki toksičnosti na prebavilih, ledvicah ali jetrih, prav tako ni bilo vpliva na čas krvavitve.
English: In healthy young cats aged 7-8 months, oral robenacoxib administered at high overdoses (4, 12 or 20 mg/kg/day for 6 weeks) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Slovenian: (4, 12 ali 20 mg/kg/dan) niso pojavili znaki toksičnosti na prebavilih, ledvicah ali jetrih, prav tako ni bilo vpliva na čas krvavitve.
English: Do not use in pregnant or lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding.
Slovenian: Ne uporabite pri mačkah in psicah v obdobju brejosti ali laktacije ter pri mačkah in psih, namenjenih za vzrejo, ker varnost robenakoksiba pri teh živalih ni bila ugotovljena.
English: Ribavirin can harm your unborn baby.
Slovenian: Ribavirin lahko škoduje vašemu nerojenemu otroku.
English: Date of first authorisation: 06 July 2016
Slovenian: Datum prve odobritve: 06. julij 2016
English: It is therefore very important that you (or your partner) do not become pregnant during this treatment or for a period of time after completing treatment.
Slovenian: Zato je zelo pomembno, da vi (ali vaša partnerica) med tem zdravljenjem ali za določen čas po zaključku zdravljenja ne zanosite.
English: • If you are currently taking any of the following medicines:
Slovenian: • Če trenutno jemljete katero od naslednjih zdravil:
English: Recommended dose The recommended dose is one tablet once a day for 12 weeks.
Slovenian: Priporočeni odmerek Priporočeni odmerek je ena tableta enkrat na dan 12 tednov.
English: The human relevance of this finding is not known.
Slovenian: Pomembnost tega odkritja za ljudi ni znana.
English: • have liver problems other than from hepatitis C, for instance
Slovenian: • imate težave z jetri razen hepatitisa C, na primer
English: The tablet is 20 mm long and 10 mm wide.
Slovenian: Tableta je dolga 20 mm in široka 10 mm.
English: • Your doctor can decide if you should take Epclusa and for how long;
Slovenian: • da se lahko odloči, ali naj jemljete zdravilo Epclusa in kako dolgo;
English: Medicinal product by therapeutic areas/Possible Mechanism of Interaction
Slovenian: Zdravila po terapevtskih področjih/možni mehanizem interakcije
English: Study arms (Number of patients treated)
Slovenian: Skupine v študiji (število zdravljenih bolnikov)
English: f Bioequivalence/Equivalence boundary 80-125%.
Slovenian: f. Meja bioekvivalence/ekvivalence 80-125 %.
English: Clinical studies in patients with Renal Impairment - study 4062
Slovenian: Klinične študije pri bolnikih z ledvično okvaro - študija 4062
English: The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Slovenian: Učinkovini v zdravilu delujeta skupaj tako, da zavirata dve različni beljakovini, ki ju virus potrebuje za svojo rast in razmnoževanje, kar omogoča, da se okužba trajno odstrani iz telesa.
English: Skin disorders Frequency not known: Stevens-Johnson syndrome
Slovenian: Neznana pogostnost: Stevens-Johnsonov sindrom
English: Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
Slovenian: Zaradi grenkega okusa je priporočljivo, da se filmsko obložene tablete ne žveči in ne drobi.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: ENOLIČNI IDENTIFIKATOR - PODATKI V ČLOVEKU BERLJIVI OBLIKI
English: Mean ratio (90% confidence interval)a,b
Slovenian: Povprečno razmerje (90-odstotni interval zaupanja)a, b
English: • rosuvastatin or other statins used to treat high cholesterol.
Slovenian: • rosuvastatin ali druge statine, ki se uporabljajo za zdravljenje visokih ravni holesterola.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake „EXP“.
English: This change could be to Epclusa or another medicine you are taking.
Slovenian: Ta sprememba se lahko nanaša na zdravilo Epclusa ali drugo zdravilo, ki ga jemljete.
English: The following dosing is recommended where ribavirin is divided in two daily doses and given with food:
Slovenian: Naslednje odmerjanje je priporočeno, če ribavirin razdelimo na dva dnevna odmerka in dajemo s hrano:
English: No effect = 1.00. b All interaction studies conducted in healthy volunteers.
Slovenian: b. Vse študije interakcij so opravili pri zdravih prostovoljcih.
English: • If you are allergic to sofosbuvir, velpatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Slovenian: • če ste alergični na sofosbuvir, velpatasvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
English: NA = Not available a Mean value from multiple experiments of same laboratory replicon.
Slovenian: NA = podatkov ni na voljo a. Povprečna vrednost v več poskusih istega laboratorijskega replikona.
English: Virologic failure (relapse and on-treatment failure) Genotype 1a
Slovenian: Virološki neuspeh (relaps in neuspeh med zdravljenjem) Genotip 1a
English: In this limited clinical safety data set, the rate of adverse events and deaths was not clearly elevated from what is expected in ESRD patients.
Slovenian: V tem omejenem naboru podatkov klinične varnosti stopnja neželenih učinkov in smrti ni bila očitno večja od tiste, ki je pričakovana pri bolnikih z ESRD.
English: SVR12 for selected subgroups are presented in Table 13.
Slovenian: SVR12 za izbrane podskupine so predstavljene v preglednici 13.
English: These medicines can decrease the amount of velpatasvir in your blood.
Slovenian: Ta zdravila lahko zmanjšajo količino velpatasvirja v krvi.
English: These data indicate that renal clearance is the major elimination pathway for GS-331007.
Slovenian: Ti podatki kažejo, da je ledvični očistek glavna pot izločanja za GS-331007.
English: The effects of higher doses/exposures are not known.
Slovenian: Učinki višjih odmerkov/izpostavljenosti so neznani.
English: If you do miss a dose, work out how long it is since you last took your Epclusa:
Slovenian: Če pozabite vzeti odmerek, določite, koliko časa je minilo od takrat, ko ste zdravilo Epclusa nazadnje vzeli:
English: Variants were selected at NS5A resistance associated positions 24, 28, 30, 31, 32, 58, 92 and 93.
Slovenian: Različice so bile izbrane na položajih NS5A, povezanih z odpornostjo, 24, 28, 30, 31, 32, 58, 92 in 93.
English: If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take that medicine.
Slovenian: Če jemljete katero od teh zdravil, vam bo zdravnik predpisal drugo zdravilo za razjede želodca, zgago ali refluks kisline ali priporočil, kako in kdaj naj zdravilo vzamete.
English: It is very important that you also read the leaflets for the other medicines that you will be taking with Epclusa.
Slovenian: Zelo pomembno je, da preberete tudi navodila za uporabo drugih zdravil, ki jih boste jemali skupaj z zdravilom Epclusa.