FrancophonIA/ELRC3.0 huggingface dataset:
English: Gamithromycin administered subcutaneously into the neck of cattle at a single dose of 6 mg/kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 30 to 60 min with a long plasma half-life (> 2 days).
Croatian: Subkutana primjena gamitromicina u područje vrata goveda u jednokratnoj dozi od 6 mg/kg tjelesne mase, rezultira brzom apsorpcijom s vršnom koncentracijom u plazmi nakon 30 do 60 min uz dugi poluvijek u plazmi (> 2 dana).
English: Do not use in pregnant animals which are intended to produce milk for human consumption within 2 months (cows, heifers) or 1 month (ewes) of expected parturition.
Croatian: Ne primjenjivati na gravidnim životinjama koje su namijenjene za proizvodnju mlijeka za ljudsku uporabu u roku od 2 mjeseca (krave, junice) ili 1 mjesec (ovce), od očekivanog teljenja.
English: Treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida,Haemophilus parasuis and Bordetella bronchiseptica.
Croatian: Liječenje respiratorne bolesti svinja (SRD) povezane s Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis i Bordetella bronchiseptica.
English: Treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica.
Croatian: Liječenje respiratorne bolesti svinja (SRD) povezane s Actinobacillus pleuropneumoniae, Pasteurella multocida,Haemophilus parasuis i Bordetella bronchiseptica.
English: Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment.
Croatian: Liječenje zarazne šepavosti ovaca stoga treba poduzeti zajedno s drugim mjerama upravljanja stadom, npr. provođenje suhog držanja.
English: Not authorised for use in lactating animals producing milk for human consumption.
Croatian: Nije odobren za upotrebu kod životinja koje proizvode mlijeko za ljudski upotrebu.
English: SPECIAL WARNING(S)
Croatian: 12. POSEBNO (A) UPOZORENJE
English: 100 μg/kg
Croatian: 100 µg/kg 100 µg/kg
English: • Rare (more than 1 but less than 10 animals in 10,000 animals treated)
Croatian: • Manje često (više od 1 ali manje od 10 životinja u 1000 tretiranih životinja)
English: Gamithromycin skin concentrations were much higher than the plasma concentrations resulting in skin/plasma concentration ratios of approximately 21, 58, and 138 at two, five and ten days post-dosing, respectively, demonstrating extensive distribution and accumulation in skin tissue.
Croatian: Subkutana primjena gamitromicina u područje vrata ovce u jednokratnoj dozi od 6 mg/kg tjelesne težine, rezultira brzom apsorpcijom s vršnom koncentracijom u plazmi zabilježenom u vremenu između 15 minuta i 6 sati nakon aplikacije (2,3 sati u prosjeku) s visokom apsolutnom biodostupnosti od 89%, Koncentracija gamitromicina u koži je bila mnogo veća od koncentracije u plazmi što rezultira omjerom koncentracije koža/plazma od oko 21, 58, i 138 u dva, pet i deset dana nakon primjene, pokazujući opsežnu distribuciju i nakupljanje u tkivu kože.
English: Specific pharmacovigilance requirements:
Croatian: Posebni zahtjevi u famakoviliganciji:
English: Do not use in case of hypersensitivity to a certain type of antibiotics called macrolides or to any of the excipients.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na makrolidne antibiotike ili na bilo koju od pomoćnih tvari.
English: Shelf life after first opening the container: 28 days Once opened, use by __/__/__
Croatian: Rok valjanosti nakon prvog otvaranja spremnika: 28 dana.
English: 50 μg/kg 300 μg/kg 200 μg/kg
Croatian: 50 µg/kg 50 µg/kg
English: Do not use this veterinary medicinal product after the expiry date which is stated on the vial after EXP. Shelf-life after first opening the container: 28 days.
Croatian: Ne primjenjivati veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na bočici poslije EXP.
English: Solution for injection.
Croatian: Suspenzija za injekci ju.
English: ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs
Croatian: ZACTRAN 150 mg/ml otopina za injekciju za govedo,ovcu i svinje
English: ZACTRAN 150 mg/ml solution for injection for cattle and pigs gamithromycin
Croatian: ZACTRAN 150 mg/ml otopina za injekciju za goveda i svinje gamitromcin
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs Gamithromycin
Croatian: ZACTRAN 150 mg/ml otopina za injekciju za govedo, ovcu i svinje gamitromicin
English: ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs gamithromycin
Croatian: ZACTRAN 150 mg/ml otopina za injekciju za govedo, ovcu i svinje Gamitromicin
English: Cattle and sheep: Subcutaneous use Pigs: Intramuscular use Read the package leaflet before use.
Croatian: Govedo i ovca: subkutana injekcija.
English: Fat
Croatian: NUSPOJAVE
English: 14 capsules
Croatian: 14 kapsula
English: 123 mg Capsule, hard
Croatian: 123 mg Kapsula, tvrda
English: Oral use blister (PVC/PCTFE/PVC/Al)
Croatian: Peroralna primjena blister (PVC/PCTFE/PVC/Al)
English: EMA/CHMP/55623/2016
Croatian: EU/1/15/1082/001 Galafold
English: Annex A
Croatian: Broj EU odobrenja
English: MA (EU) number Invented name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1082/001 Galafold
Croatian: Jačina Farmaceutski oblik Put primjene
English: Do not give this medicine to children under 12 years of age.
Croatian: Nemojte davati ovaj lijek djeci mlađoj od 12 godina.
English: Blood tests may also show:
Croatian: Krvne pretrage također mogu pokazati:
English: It is therefore very important that you (or your partner) do not become pregnant during this therapy.
Croatian: Stoga je vrlo važno da Vi (ili Vaša partnerica) ne zatrudnite tijekom ove terapije.
English: This is so your doctor can:
Croatian: Razlog tome je taj da Vaš liječnik može:
English: - This medicine has been prescribed for you only.
Croatian: ­ Ovaj je lijek propisan samo Vama.
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Croatian: Ponesite bočicu s tabletama sa sobom tako da možete lako opisati što ste uzeli.
English: The optimal regimen and treatment duration have not been established.
Croatian: Optimalni režim i trajanje liječenja nisu ustanovljeni.
English: The effects of higher doses are unknown.
Croatian: Učinci viših doza su nepoznati.
English: <12 g/dL despite 4 weeks at reduced dose
Croatian: < 12 g/dl unatoč 4 tjedna na sniženoj dozi
English: The majority of patients (69%) had been infected through vertical transmission.
Croatian: Većina bolesnika (69%) zaražena je putem vertikalne transmisije.
English: b. These are exploratory or Phase 2 studies.
Croatian: b. Ovo su eksplorativna ispitivanja ili ispitivanja faze 2.
English: • Decide what other medicines you should take with Sovaldi and for how long;
Croatian: ● odlučiti koje još lijekove trebate uzimati sa Sovaldijem i koliko dugo;
English: Vomiting and missed doses
Croatian: Povraćanje i propuštene doze
English: In clinical studies - Adults
Croatian: U kliničkim ispitivanjima - odrasli
English: • loss of appetite
Croatian: ● gubitak apetita
English: (Induction of P-gp)
Croatian: (Indukcija P­gp)
English: • trouble sleeping (insomnia)
Croatian: ● poteškoće sa spavanjem (nesanica)
English: If you take more Sovaldi than you should
Croatian: Ako uzmete više Sovaldija nego što ste trebali
English: Patient population (Study number/name)
Croatian: Populacija bolesnika (broj/naziv ispitivanja)
English: Most patients had no prior HCV treatment (81.3%).
Croatian: Većina bolesnika prethodno nije primala liječenje za HCV (81,3%).
English: Eight patients (20%) received epoetin and/or a blood product.
Croatian: Osam bolesnika (20%) primilo je epoetin i/ili krvni pripravak.
English: The response rates observed for patients over 65 years of age were similar to that of younger patients across treatment groups.
Croatian: Stope odgovora opažene za bolesnika u dobi iznad 65 godina bile su slične onima u mlađih bolesnika u svim terapijskim skupinama.
English: c. Summary data from both studies.
Croatian: c. Sažeti podaci iz oba ispitivanja.
English: If you have any of these side effects, do not drive or use any tools or machines.
Croatian: Ako imate neku od ovih nuspojava, nemojte upravljati vozilima niti rukovati ikakvim alatima ili strojevima.
English: In 5 patients (12.5%), study drugs were discontinued, modified or interrupted due to adverse events.
Croatian: U 5 bolesnika (12,5%) primjena ispitivanih lijekova bila je prekinuta, prilagođena ili privremeno obustavljena zbog štetnih događaja.
English: • If you are currently taking any of the following medicines:
Croatian: Ako trenutno uzimate neke od sljedećih lijekova:
English: This medicine works by lowering the amount of hepatitis C virus in your body and removing the virus from your blood over a period of time.
Croatian: Ovaj lijek djeluje tako što smanjuje količinu virusa hepatitisa C u tijelu i nakon određenog razdoblja uklanja virus iz Vaše krvi.
English: If this applies to you, tell your doctor immediately.
Croatian: Ako se ovo odnosi na Vas, odmah obavijestite svog liječnika.
English: The active metabolite is formed in hepatocytes and not observed in plasma.
Croatian: Aktivni metabolit stvara se u hepatocitima i nije opažen u plazmi.
English: • The other ingredients are
Croatian: Drugi sastojci su
English: • Currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine);
Croatian: ● trenutno uzimate ili ste u posljednjih nekoliko mjeseci uzimali lijek amiodaron za liječenje nepravilnih otkucaja srca (Vaš liječnik može razmotriti zamjensko liječenje ako ste uzimali ovaj lijek)
English: • If you are allergic to sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Croatian: ● ako ste alergični na sofosbuvir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6. ove upute).
English: Response rates for selected subgroups are presented in Table 8.
Croatian: Stope odgovora za odabrane podskupine prikazane su u tablici 8.
English: EU/1/13/894/001 EU/1/13/894/002
Croatian: EU/1/13/894/002
English: What Sovaldi is and what it is used for
Croatian: Što je Sovaldi i za što se koristi
English: Your doctor will tell you for how long you should take Sovaldi.
Croatian: Liječnik će Vam reći koliko dugo trebate uzimati Sovaldi.
English: Preliminary SVR12 data are available for 210 patients.
Croatian: Preliminarni podaci o SVR12 dostupni su za 210 bolesnika.
English: • Have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Croatian: ● imate ili ste prethodno imali infekciju virusom hepatitisa B, jer će Vas liječnik možda htjeti pobliže pratiti
English: It is commonly taken with either:
Croatian: Obično se uzima s:
English: Talk to your doctor or pharmacist before taking this medicine if you:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek ako:
English: It is very important that you complete the full course of treatment to give the medicines the best chance to treat your hepatitis C virus infection.
Croatian: Vrlo je važno da dovršite cijelu kuru liječenja kako bi lijekovi imali najveću mogućnost izliječiti infekciju virusom hepatitisa C.
English: The tablet should be taken with food (see section 5.2).
Croatian: Tabletu treba uzeti s hranom (vidjeti dio 5.2).
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.
Croatian: U tom ograničenom skupu sigurnosnih podataka, stopa štetnih događaja i smrti nije bila očito viša od one kakva se očekuje u bolesnika s ESRD­om.
English: • changes in your liver (as shown by increased amounts of a substance called bilirubin in the blood)
Croatian: ● promjene u jetri (koje pokazuju povišene količine tvari koja se zove bilirubin u krvi)
English: On-treatment virologic failure < 1% (1/256) Relapseb
Croatian: Virološki neuspjeh uz liječenje < 1% (1/256) Relapsb
English: • Have liver problems other than hepatitis C, e.g. if you are awaiting a liver transplantation;
Croatian: ● imate i druge tegobe s jetrom osim hepatitisa C, npr. ako čekate na transplantaciju jetre
English: Date of first authorisation: 16 January 2014 Date of latest renewal: 17 September 2018
Croatian: Datum posljednje obnove odobrenja: 17 rujan 2018
English: • severe headaches (migraine), memory loss, loss of concentration
Croatian: ● jake glavobolje (migrena), gubitak pamćenja, gubitak koncentracije
English: a. These data are preliminary.
Croatian: Ovi su preliminarni podaci.
English: Clinical studies of sofosbuvir included 65 patients aged 65 and over.
Croatian: Klinička ispitivanja sofosbuvira uključila su 65 bolesnika u dobi od 65 i više godina.
English: 12 weeksa,b
Croatian: 12 tjedanaa, b
English: Other medicines and Sovaldi
Croatian: Drugi lijekovi i Sovaldi
English: Treatment of overdose with Sovaldi consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Croatian: Liječenje predoziranja Sovaldijem sastoji se od općih potpornih mjera uključujući praćenje vitalnih znakova kao i promatranje kliničkog stanja bolesnika.
English: It is formed through sequential and parallel pathways to the formation of active metabolite.
Croatian: Stvara se slijednim i usporednim putevima nastanka aktivnog metabolita.
English: • hair loss and thinning hair
Croatian: ● ispadanje kose i prorijeđena kosa
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Croatian: Bolesnike kojima je utvrđen visok rizik od bradiaritmije potrebno je kontinuirano nadzirati tijekom 48 sati u odgovarajućem kliničkom okruženju.
English: Animal studies do not indicate harmful effects on fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke na plodnost.
English: Effects on drug levels.
Croatian: Učinci na razinu lijekova.
English: • shortness of breath or worsening of any shortness of breath you already have Tell your doctor or your pharmacist if you notice any of the above side effects during therapy.
Croatian: ● nedostatak zraka ili pogoršanje već prisutnog nedostatka zraka Obavijestite svog liječnika ili ljekarnika ako opazite neku od gore navedenih nuspojava tijekom liječenja.
English: Regimen/Duration
Croatian: Režim/trajanje
English: The use of Sovaldi in children under 12 years of age has not yet been studied.
Croatian: Primjena lijeka Sovaldi u djece mlađe od 12 godina nije još ispitana.
English: Among these, one patient was found to have a NS5B RAV substitution (F289L).
Croatian: Među njima je jedan bolesnik imao NS5B RAV supstituciju (F289L).
English: Skin disorders Frequency not known: Stevens-Johnson syndrome
Croatian: Poremećaji kože Nepoznata učestalost: Stevens­Johnsonov sindrom
English: Thus, the optimal treatment duration in this population has not been established (see also sections 4.2 and 5.1).
Croatian: Stoga, optimalno trajanje liječenja ove populacije nije ustanovljeno (vidjeti također dijelove 4.2 i 5.1).
English: Assessment of adverse reactions is based on pooled data from five Phase 3 clinical studies (both controlled and uncontrolled).
Croatian: Procjena nuspojava temelji se na objedinjenim podacima iz pet kliničkih ispitivanja faze 3 (i kontroliranih i nekontroliranih).
English: Overall SVR12
Croatian: Ukupni SVR12
English: c. See Special patient populations - Patients awaiting liver transplantation below.
Croatian: Vidjeti niže: Posebne populacije bolesnika - Bolesnici koji čekaju transplantaciju jetre.
English: Your doctor will test your blood before, during and after your treatment with Sovaldi.
Croatian: Liječnik će Vam napraviti krvne pretrage prije, tijekom i nakon liječenja Sovaldijem.
English: Available pharmacokinetic data in animals have shown excretion of metabolites in milk (for details see section 5.3).
Croatian: Dostupni farmakokinetički podaci u životinja pokazuju da se metaboliti izlučuju u mlijeku (za detalje vidjeti dio 5.3).
English: Adult patients awaiting liver transplantation - Study 2025
Croatian: Odrasli bolesnici koji čekaju transplantaciju jetre - ispitivanje 2025
English: The extent of absorption of sofosbuvir was increased approximately 1.8-fold, with little effect on peak concentration.
Croatian: Opseg apsorpcije sofosbuvira bio je približno povećan 1,8 puta, uz malo učinka na vršnu koncentraciju.
English: What Sovaldi is and what it is used for What you need to know before you take Sovaldi How to take Sovaldi
Croatian: Što je Sovaldi i za što se koristi Što morate znati prije nego počnete uzimati Sovaldi Kako uzimati Sovaldi
English: However, neither of these entities has been evidenced to be a general surrogate marker for efficacy (SVR12) at the therapeutic 400 mg dose.
Croatian: Međutim, nijedan od njih nije se općenito pokazao kao zamjenski biljeg za djelotvornost (SVR12) kod terapijske doze od 400 mg.
English: What Sovaldi looks like and contents of the pack
Croatian: Kako Sovaldi izgleda i sadržaj pakiranja
English: Treatment-experienced (LONESTAR-2b)
Croatian: Prethodno liječeni bolesnici (LONESTAR­2b)
English: Patients in these studies had compensated liver disease including cirrhosis.
Croatian: Bolesnici u tim ispitivanjima imali su kompenziranu bolest jetre uključujući cirozu.
English: Women of childbearing potential / contraception in males and females
Croatian: Žene reproduktivne dobi/kontracepcija u muškaraca i žena
English: The recommended dose is one tablet (400 mg) once a day with food.
Croatian: Preporučena doza je jedna tableta (400 mg) jedanput na dan s hranom.
English: Adolescents (12 to 18 years of age) The recommended dose of Sovaldi is one tablet once daily with food (see section 5.2).
Croatian: Adolescenti (u dobi od 12 do 18 godina) Preporučena doza Sovaldija je jedna tableta jedanput na dan s hranom (vidjeti dio 5.2).
English: However, it is not recommended that ribavirin be increased to the original assigned dose (1,000 mg to 1,200 mg daily).
Croatian: Međutim, ne preporučuje se povisiti ribavirin do prvobitno primjenjivane doze (1000 mg do 1200 mg na dan).
English: c. All patients were non-cirrhotic in these two studies.
Croatian: c. Svi bolesnici u ova dva ispitivanja bili su bez ciroze.
English: • Confirm that your treatment has worked and you are free of the hepatitis C virus.
Croatian: ● potvrditi da Vam liječenje djeluje i da više nemate virus hepatitisa C.
English: If overdose occurs the patient must be monitored for evidence of toxicity.
Croatian: U slučaju predoziranja, bolesnik se mora nadzirati na znakove toksičnosti.
English: Sovaldi has moderate influence on the ability to drive and use machines.
Croatian: Sovaldi umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The film-coated tablet should not be chewed or crushed, due to the bitter taste of the active substance.
Croatian: Filmom obložena tableta ne smije se žvakati niti drobiti, zbog gorkog okusa djelatne tvari.
English: • slow or irregular heartbeat or heart rhythm problems
Croatian: ● usporene ili nepravilne otkucaje srca ili tegobe sa srčanim ritmom
English: In repeat dose toxicology studies in rat and dog, high doses of the 1:1 diastereomeric mixture caused adverse liver (dog) and heart (rat) effects and gastrointestinal reactions (dog).
Croatian: U ispitivanjima toksičnosti ponovljene doze u štakora i psa, visoke doze diastereomerne mješavine u omjeru 1:1 uzrokovale su štetne učinke na jetru (pas) i srce (štakor) i gastrointestinalne reakcije (pas).
English: The proportions of patients who were interferon intolerant, ineligible, or unwilling were 9%, 44%, and 47%, respectively.
Croatian: Udio bolesnika koji nisu podnosili, nisu bili pogodni ili nisu pristali na interferon iznosio je 9%, 44% odnosno 47%.
English: Sofosbuvir is approximately 85% bound to human plasma proteins (ex vivo data) and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
Croatian: Sofosbuvir je približno 85% vezan za proteine ljudske plazme (podaci ex vivo) i vezanje ne ovisi o koncentraciji lijeka u rasponu 1 μg/ml do 20 μg/ml.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin (see section 4.4).
Croatian: Značajni teratogeni i/ili embriocidni učinci pokazani su u svih životinjskih vrsta izloženih ribavirinu (vidjeti dio 4.4).
English: The predominant (>90%) metabolite, GS-331007, is inactive.
Croatian: Glavni (> 90%) metabolit, GS­331007, nije aktivan.
English: The S282T substitution reverted to wild-type over the next 8 weeks and was no longer detectable by deep sequencing at 12 weeks post-treatment.
Croatian: Supstitucija S282T vratila se na divlji tip tijekom sljedećih 8 tjedana i više se nije mogla otkriti detaljnim sekvenciranjem 12 tjedana nakon liječenja.
English: Talk to your doctor about taking Sovaldi if you are taking any of the following medicines:
Croatian: Obratite se liječniku o uzimanju lijeka Sovaldi ako uzimate neke od sljedećih lijekova:
English: Patients should be instructed to swallow the tablet whole.
Croatian: Bolesnicima treba savjetovati da tabletu progutaju cijelu.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Sovaldi, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Croatian: Kako bi se procijenilo ponovno pojavljivanje hepatocelularnog karcinoma povezanog s primjenom Sovaldi, nositelj odobrenja mora provesti i dostaviti rezultate prospektivnog ispitivanja sigurnosti, koristeći podtake koji proizlaze iz kohorte dobro definirane skupine bolesnika, na temelju dogovorenog protokola.
English: Such regimens should only be used for patients that are intolerant to or ineligible for interferon therapy, and are in urgent need of treatment.
Croatian: Takvi režimi smiju se primjenjivati samo u bolesnika koji ne podnose ili nisu pogodni za terapiju interferonom, a hitno im je potrebno liječenje.
English: Effect of baseline HCV polymorphisms on treatment outcome
Croatian: Utjecaj početnih HCV polimorfizama na ishod liječenja
English: Ribavirin can damage your unborn baby.
Croatian: Ribavirin može izazvati oštećenja kod nerođenog djeteta.
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir.
Croatian: Prisutnost 40% ljudskog seruma nije imala učinka na djelovanje sofosbuvira protiv HCV­a.
English: • Have diabetes.
Croatian: ● imate šećernu bolest.
English: 84 (3 bottles of 28) film-coated tablets.
Croatian: 84 (3 bočice s 28) filmom obloženih tableta.
English: No effects on foetal development have been observed in rats and rabbits at the highest doses tested.
Croatian: Nisu opaženi učinci na fetalni razvoj u štakora i kunića pri najvišim ispitivanim dozama.
English: The safety and efficacy of Sovaldi have not been established in patients with decompensated cirrhosis.
Croatian: Sigurnost i djelotvornost Sovaldija nisu ustanovljene u bolesnika s dekompenziranom cirozom.
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Sovaldi.
Croatian: Vaš će liječnik možda morati pažljivo pratiti druge lijekove koje uzimate i prilagoditi njihovu dozu nakon što počnete uzimati Sovaldi.
English: When taking Sovaldi together with other medicines for the treatment of hepatitis C infection, patients have reported tiredness, dizziness, blurred vision and reduced attention.
Croatian: Kad su uzimali Sovaldi zajedno s drugim lijekovima za liječenje infekcije hepatitisom C, bolesnici su prijavili umor, omaglicu, zamagljen vid i smanjenu pozornost.
English: This patient achieved SVR12.
Croatian: Taj je bolesnik postigao SVR12.