natgillin/translations-raw huggingface dataset:
The pharmacokinetics of robenacoxib do not differ between male and female dogs, and are linear over the range 0.5-8 mg/kg. 
Nema razlike između farmakokinetike robenakoksiba između ženki i mužjaka pasa te su u oba slučaja linearne u rasponu od 0,5 do 8 mg/kg.
Imprints 
INDIKACIJE
Use in animals with impaired cardiac, renal or hepatic function or those are dehydrated, hypovolaemic or hypotensive may involve additional risks. 
Primjena na životinjama s oštećenom funkcijom srca, bubrega ili jetre ili na životinjama koje su dehidrirane, hipovolemične ili hipotenzivne može uključivati dodatne rizike.
Use in cats with impaired cardiac, renal or hepatic function or in cats that are dehydrated, hypovolaemic or hypotensive may involve additional risks. 
Primjena na mačkama s oštećenom funkcijom srca, bubrega ili jetre ili na mačkama koje su dehidrirane, hipovolemične ili hipotenzivne može uključivati dodatne rizike.
Gastrointestinal adverse events (such as vomiting) were commonly reported but most cases were mild and recovered without treatment. 
Gastrointestinalne nuspojave (poput povraćanja) prijavljivane su često, ali većina slučajeva bila je blaga i prošla je bez liječenja.
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. 
Nakon prvog otvaranja bočice proizvod se može čuvati 28 dana.
Tablets are round, beige to brown, non-divisible and with imprints “NA” on one side and “AK” on the other side. 
Okrugle bež do smeđe tablete bez razdjelne crte, s utisnutom oznakom NA na jednoj strani i AK na drugoj strani.
For the treatment of pain and inflammation associated with acute or chronic musculoskeletal disorders in cats. 
Za liječenje bola i upale povezanih s akutnim ili kroničnim mišićno-koštanim poremećajima u mačaka.
Symptomatic supportive therapy is recommended and should consist of administration of gastrointestinal protective agents and infusion of isotonic saline. 
Preporučuje se simptomatska potporna terapija koja se treba sastojati od primjene lijekova za zaštitu probavnog sustava i infuzije izotonične fiziološke otopine.
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) 
Istodobna primjena tableta robenakoksiba s cijelom dnevnom porcijom hrane nije uzrokovala odgodu u Tmax (0,5 h), ali Cmax (691 ng/ml) bio je niži, a AUC (1,069 ng·h/ml) nešto niži.
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 6 mg Robenacoxib 
SASTAV DJELATNIH TVARI Jedna tableta sadržava 6 mg robenakoksiba.
As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised cats. 
Kao i s bilo kojim nesteroidnim protuupalnim lijekom, predoziranje može uzrokovati gastrointestinalnu, bubrežnu ili jetrenu toksičnost u osjetljivih mačaka ili mačaka oslabljene imunosti.
Robenacoxib 
Elanco
For the treatment of pain and inflammation associated with acute and chronic musculoskeletal disorders in cats. 
Za liječenje bola i upale povezanih s akutnim i kroničnim mišićno-koštanim poremećajima u mačaka.
The following number of tablets should be given once daily at the same time every day: 
Sljedeći broj tableta treba davati jednom na dan u isto vrijeme svaki dan: Tjelesna težina (kg)
For cats, Onsior solution for injection or tablets may be used interchangeably in accordance with the indications and duration of use approved for each pharmaceutical form. 
U mačaka se otopina za injekcije ili tablete Onsior mogu naizmjenično upotrebljavati u skladu s indikacijama i trajanjem uporabe odobrenim za svaki farmaceutski oblik.
In the in vitro whole blood assay in cats, the selectivity of robenacoxib was approximately 500 fold higher for COX-2 (IC50 0.058 μM) as compared to COX-1 (IC50 28.9 μM). 
U in vitro ispitivanjima pune krvi u mačaka selektivnost robenakoksiba pokazala se približno 500 puta većom na COX-2 (IC50 0,058 μM) u usporedbi s COX-1 (IC50 28,9 μM).
Robenacoxib is extensively metabolised by the liver in dogs. 
Robenakoksib se u velikoj mjeri metabolizira u jetri pasa.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains the following amount of robenacoxib and bears the imprint “NA” on one side and the following imprint on the other side: 
Jedna tableta sadržava sljedeću količinu robenakoksiba i nosi utisnutu oznaku NA na jednoj strani i sljedeću oznaku na drugoj strani:
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. 
primijenjen kroz usta u prekomjernim dozama koje su bile do 5 puta veće od maksimalne preporučene doze (2,4 mg, 7,2 mg, 12 mg robenakoksiba/kg tjelesne mase) u razdoblju od 6 mjeseci.
Onsior 5 mg tablets for dogs Onsior 10 mg tablets for dogs Onsior 20 mg tablets for dogs Onsior 40 mg tablets for dogs Robenacoxib 
Onsior 5 mg, tablete za pse Onsior 10 mg, tablete za pse Onsior 20 mg, tablete za pse Onsior 40 mg, tablete za pse Robenakoksib
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). 
U in vitro ispitivanjima pune krvi u pasa selektivnost robenakoksiba pokazala se približno 140 puta većom na COX-2 (IC50 0,04 μM) u usporedbi s COX-1 (IC50 7,9 μM).
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. 
7,2 mg robenakoksiba/kg kroz usta i 2,0 mg, 4,0 mg i 6,0 mg robenakoksiba/kg subkutana) rezultirala je povećanom pojavom sporadičnih edema na mjestu injekcije koja je ovisila o doziranju i minimalnom do blagom subakutnom/kroničnom upalom subkutanog tkiva.
This product reduced in clinical trials the lameness and inflammation of dogs with chronic osteoarthritis. 
U kliničkim ispitivanjima proizvod je ublažio šepanje i upalu u pasa s kroničnim osteoartritisom.
Apart from one lactam metabolite, the identity of other metabolites is not known in cats. 
Nije poznat identitet ostalih metabolita u mačaka osim jednog laktamskog metabolita.
For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs. 
Za liječenje bola i upale povezanih s ortopedskim kirurškim zahvatima ili zahvatima na mekom tkivu u pasa.
In healthy young cats aged 10 months, once daily subcutaneous administration of robenacoxib at doses of 4 mg/kg (twice RTD) for 2 consecutive days and 10 mg/kg (5 times RTD) for 3 consecutive days did not produce any signs of toxicity, including signs of gastrointestinal, kidney or liver toxicity and had no effect on bleeding time. 
U zdravih mladih mačaka u dobi od 10 mjeseci supkutana primjena robenakoksiba jedanput na dan u dozama od 4 mg/kg (dva puta PTD) tijekom dva uzastopna dana i 10 mg/kg (5 puta PTD) tijekom tri uzastopna dana nije uzrokovala nikakve znakove toksičnosti, uključujući gastrointestinalnu toksičnost,
Yeast powder Cellulose, microcrystalline Povidone (K-30) Crospovidone Silica, colloidal anhydrous Magnesium stearate 
Silikagel, koloidni bezvodni Magnezijev stearat
In healthy young cats aged 7- 8 months, oral robenacoxib (Onsior tablets) 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. 
U zdravih mladih mačaka u dobi od 7 do 8 mjeseci robenakoksib (tablete Onsior) primijenjen kroz usta u prekomjernim dozama, koje su bile do 5 puta veće od maksimalne preporučene doze (2,4 mg,
Do not use in cats suffering from ulceration in the digestive tract. 
Ne primjenjivati na mačkama koje pate od ulceracija u probavnom sustavu.
Round, beige to brown tablets with imprints “NA” on one side and “AK” on the other side. 
Okrugle bež do smeđe tablete s utisnutom oznakom NA na jednoj strani i AK na drugoj strani.
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. 
Tablete za pse Onsior dostupne su u kartonskim kutijama koje sadržavaju 7, 14, 28 ili 70 tableta u Alu / Alu blisteru, 30 x 1 tableta u Alu / Alu perforiranim blisterima s jediničnim dozama ili 60 x 1 tableta u Alu / Alu perforiranim blisterima s jediničnim dozama.
Apart from one lactam metabolite, the identity of other metabolites is not known in dogs. 
Nije poznat identitet ostalih metabolita u pasa osim jednog laktamskog metabolita.
For pregnant women, particularly near term pregnant women, accidental injection and prolonged dermal exposure might increase the risk to the foetus. 
U trudnica, posebice onih koje će uskoro roditi, slučajno ubrizgavanje i produljena dermalna izloženost mogu povećati rizik za fetus.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET
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. 
Tablete za mačke Onsior dostupne su u kartonskim kutijama koje sadržavaju 6 x 1, 12 x 1, 30 x 1 ili 60 x 1 tableta u Alu / Alu perforiranim blisterima s jediničnim dozama.
For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in cats. 
Za liječenje bola i upale povezanih s ortopedskim kirurškim zahvatima ili zahvatima na mekom tkivu u mačaka.
4.8 Interaction with other medicinal products and other forms of interaction 
4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija Onsior se ne smije primjenjivati u kombinaciji s drugim nesteroidnim protuupalnim lijekovima.
Do not use in animals suffering from gastrointestinal ulceration. 
Ne primjenjivati na životinjama koje pate od ulceracija u probavnom sustavu.
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. 
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena u mačaka mlađih od četiri mjeseca i u pasa mlađih od dva mjeseca, ili u mačaka ili pasa koji teže manje od 2,5 kg.
In pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus. 
U trudnica, posebice onih koje će uskoro roditi, produljena dermalna izloženost proizvodu povećava rizik od prijevremenog zatvaranja ductusa arteriosusa u fetusa.
Onsior 5 mg tablets for dogs: 
Onsior 5 mg, tablete za pse:
Onsior must not be administered in conjunction with other NSAIDs or glucocorticosteroids. 
4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija Onsior se ne smije primjenjivati u kombinaciji s drugim nesteroidnim protuupalnim lijekovima ili glukokortikosteroidima.
Do not use in case of hypersensitivity to robenacoxib or to any of the ingredients of the tablets. 
Ne primjenjivati u životinja koje su preosjetljive na robenakoksib ili bilo koji sastojak tableta.
For pregnant women, particularly near term pregnant women, accidental injection and prolonged dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus. 
U trudnica, posebice onih koje će uskoro roditi, slučajno ubrizgavanje i produljena dermalna izloženost proizvodu povećavaju rizik od prijevremenog zatvaranja ductusa arteriosusa u fetusa.
Onsior 20 mg tablets for dogs: 
Onsior 20 mg, tablete za pse:
The safety of this 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. 
Neškodljivost ovog veterinarsko-medicinskog proizvoda nije utvrđena u mačaka mlađih od četiri mjeseca i u pasa mlađih od dva mjeseca, ili u mačaka ili pasa koji teže manje od 2,5 kg.
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. 
Predoziranje (simptomi, hitni postupci, antidoti): U zdravih mladih mačaka u dobi od 7 do 8 mjeseci robenakoksib primijenjen kroz usta u izrazito prekomjernim dozama (4, 12 ili 20 mg/kg/na dan tijekom 6 tjedana) nije pokazao znakove toksičnosti, uključujući nepostojanje dokaza o bilo kakvoj gastrointestinalnoj, bubrežnoj ili jetrenoj toksičnosti, te nije utjecao na vrijeme krvarenja.
Apart from one lactam metabolite, the identity of other metabolites is not known in cats or dogs. 
Nije poznat identitet ostalih metabolita u pasa i mačaka osim jednog laktamskog metabolita.
Onsior 40 mg tablets for dogs: 
Onsior 40 mg, tablete za pse:
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) 
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)
For pregnant women, particularly near term pregnant women, prolonged dermal exposure might increase the risk to the foetus. 
U trudnica, posebice onih koje će uskoro roditi, produljena dermalna izloženost može povećati rizik za fetus.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE 
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
Onsior 10 mg tablets for dogs: 
Onsior 10 mg, tablete za pse:
Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany 
Elanco GmbH Heinz-Lohmann-Str.
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. 
4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno U zdravih mladih pasa u dobi od 5 do 6 mjeseci robenakoksib primijenjen kroz usta u izrazito prekomjernim dozama (4, 6 ili 10 mg/kg/na dan tijekom 6 mjeseci) nije pokazao znakove toksičnosti, uključujući nepostojanje dokaza o bilo kakvoj gastrointestinalnoj, bubrežnoj ili jetrenoj toksičnosti, te nije imao utjecaj na vrijeme krvarenja.
Round, beige to brown tablets with the imprint “NA” on one side and the following imprint on the other side: 
Okrugle bež do smeđe tablete s utisnutom oznakom NA na jednoj strani i sa sljedećom oznakom na drugoj strani: tablete od 5 mg:
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. 
Ne primjenjivati na gravidnim životinjama ili životinjama u laktaciji jer neškodljivost robenakoksiba nije utvrđena tijekom graviditeta i laktacije ili u rasplodnih mačaka i pasa.
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. 
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena u pasa koji teže manje od 2,5 kg ili u pasa mlađih od tri mjeseca.
Do not use in pregnant or lactating bitches because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding. 
Ne primjenjivati na gravidnim kujama ili kujama u laktaciji jer sigurnost robenakoksiba nije utvrđena tijekom graviditeta i laktacije ili u rasplodnih pasa.
Do not use together with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). 
Ne primjenjivati s drugim nesteroidnim protuupalnim lijekovima (NSAID) ili kortikosteroidima,
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. 
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena u mačaka koje teže manje od 2,5 kg ili u mačaka mlađih od četiri mjeseca.
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) 
EU/2/08/089/016 (7 tableta) EU/2/08/089/017 (14 tableta) EU/2/08/089/018 (28 tableta) EU/2/08/089/019 (70 tableta) EU/2/08/089/028 (30 x 1 tableta) EU/2/08/089/029 (60 x 1 tableta)
Do not use in case of hypersensitivity to robenacoxib or to any ingredients of the solution. 
Ne primjenjivati u životinja koje su preosjetljive na robenakoksib ili bilo koji sastojak otopine.
The safety of this veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age. 
Neškodljivost ovog veterinarsko-medicinskog proizvoda nije utvrđena u pasa koji teže manje od 2,5 kg ili u pasa mlađih od tri mjeseca.
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) 
EU/2/08/089/004 (7 tableta) EU/2/08/089/005 (14 tableta) EU/2/08/089/006 (28 tableta) EU/2/08/089/007 (70 tableta) EU/2/08/089/022 (30 x 1 tableta) EU/2/08/089/023 (60 x 1 tableta)
The safety of this veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age. 
Neškodljivost ovog veterinarsko-medicinskog proizvoda nije utvrđena u mačaka koje teže manje od 2,5 kg ili u mačaka mlađih od četiri mjeseca.
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) 
EU/2/08/089/008 (7 tableta) EU/2/08/089/009 (14 tableta) EU/2/08/089/010 (28 tableta) EU/2/08/089/011 (70 tableta) EU/2/08/089/024 (30 x 1 tableta) EU/2/08/089/025 (60 x 1 tableta)
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. 
Koristite ovaj veterinarsko-medicinski proizvod pod strogim veterinarskim nadzorom u mačaka s rizikom od ulceracija u probavnom sustavu ili ako je mačka prethodno iskazala netoleranciju na druge nesteroidne protuupalne lijekove.
PACKAGE LEAFLET: Onsior 6 mg tablets for cats 
Onsior 6 mg tablete za mačke
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) 
EU/2/08/089/012 (7 tableta) EU/2/08/089/013 (14 tableta) EU/2/08/089/014 (28 tableta) EU/2/08/089/015 (70 tableta) EU/2/08/089/026 (30 x 1 tableta) EU/2/08/089/027 (60 x 1 tableta)
In clinical trials at the recommended dose (2 mg/kg), robenacoxib reduced pain and inflammation in dogs undergoing orthopaedic or soft tissue surgery. 
(2 mg/kg) robenakoksib je ublažio bol i upalu u pasa koji su bili podvrgnuti ortopedskim kirurškim zahvatima ili zahvatima na mekom tkivu.
Give orally. 
Dajte kroz usta.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: Wash hands and exposed skin immediately after use of the veterinary medicinal product. 
Operite ruke i izloženu kožu odmah nakon primjene veterinarsko-medicinskog proizvoda.
Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats used for breeding. 
Ne primjenjivati na gravidnim i mačkama u laktaciji jer neškodljivost robenakoksiba nije utvrđena tijekom graviditeta i laktacije ili u rasplodnih mačaka.
Use this veterinary medicinal product under strict veterinary monitoring in dogs at risk of stomach ulcer or if the animal previously displayed intolerance to other NSAIDs. 
Primjenjujte ovaj veterinarsko-medicinski proizvod pod strogim veterinarskim nadzorom na psima s rizikom od ulceracija u probavnom sustavu ili ako je životinja prethodno iskazala netoleranciju na druge nesteroidne protuupalne lijekove.
QUANTITY OF THE ACTIVE SUBSTANCE(S) 20 mg/ml 
20 mg/ml
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. 
Primjenjujte ovaj veterinarsko-medicinski proizvod pod strogim veterinarskim nadzorom na životinjama s rizikom od ulceracija u probavnom sustavu ili ako je životinja prethodno iskazala netoleranciju na nesteroidne protuupalne lijekove.
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. 
Primjenjujte ovaj veterinarsko-medicinski proizvod pod strogim veterinarskim nadzorom na psima s rizikom od ulceracija u probavnom sustavu ili ako je pas prethodno iskazao netoleranciju na druge nesteroidne protuupalne lijekove.
After oral administration of the tablets, the terminal half-life in blood was 1.2 h. Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood. 
Robenakoksib se zadržava dulje i pri višim koncentracijama na mjestima upale nego u krvi.
Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation 
Znanstveni zaključci, razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet i detaljno pojašnjenje znanstvenih razloga za razlike u
Ask your doctor for effective contraception method suitable for you and your partner. 
Upitajte liječnika koja je učinkovita metoda kontracepcije pogodna za Vas i Vašeg partnera.
Date of first authorisation: 06 July 2016 
Datum prvog odobrenja: 06. srpanj 2016
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. 
Stoga je vrlo važno da Vi (ili Vaša partnerica) ne zatrudnite tijekom ovog liječenja ili u određenom razdoblju nakon završetka liječenja.
• If you are currently taking any of the following medicines: 
• Ako trenutno uzimate neki od sljedećih lijekova:
These medicines include: 
Ti lijekovi uključuju:
The mechanism is not established. 
Mehanizam nije ustanovljen.
Do not give this medicine to children and adolescents under 18 years of age. 
Nemojte davati ovaj lijek djeci i adolescentima u dobi ispod 18 godina.
Ribavirin can harm your unborn baby. 
Ribavirin može izazvati oštećenja kod nerođenog djeteta.
• Your doctor can decide if you should take Epclusa and for how long; 
• Vaš liječnik može odlučiti trebate li uzimati lijek Epclusa i koliko dugo;
Medicinal product by therapeutic areas/Possible Mechanism of Interaction 
Lijek prema terapijskim područjima/mogući mehanizam interakcije
NA = Not available 
ND = nije dostupno
The tablet is 20 mm long and 10 mm wide. 
Tableta je dugačka 20 mm i široka 10 mm.
Increased score (Worsening) 
Povećani rezultat (pogoršanje)
Increased score (Worsening) No assessment 
Povećani rezultat (pogoršanje) Bez procjene
e These are medicinal products within class where similar interactions could be predicted. 
Ovo su lijekovi iz skupine u kojoj se mogu predvidjeti slične interakcije.
Swallow the tablet whole with or without food. 
Tabletu progutajte cijelu sa ili bez hrane.
Recommended dose The recommended dose is one tablet once a day for 12 weeks. 
Preporučena doza Preporučena doza je jedna tableta jedanput na dan tijekom 12 tjedana.
Talk to your doctor or pharmacist before taking Epclusa if: 
Obratite se svom liječniku ili ljekarniku prije nego uzmete Epclusa ako:
The human relevance of this finding is not known. 
Značajnost tog otkrića za ljude nije poznato.
The following dosing is recommended where ribavirin is divided in two daily doses and given with food: 
Sljedeća doza preporučuje se kada je ribavirin podijeljen u dvije dnevne doze i kada se daje uz obrok:
What Epclusa is and what it is used for 
Što je Epclusa i za što se koristi
Mean ratio (90% confidence interval)a,b 
Srednji omjer (90 % interval pouzdanosti)a,b