FrancophonIA/ELRC3.0 huggingface dataset:
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Croatian: Ako se primjenjuje na ostale domaće ili divlje vrste preživača za koje se smatra da su izložene riziku od infekcije, cjepivo je potrebno pažljivo primijeniti te se preporučuje ispitivanje cjepiva na malom broju životinja prije masovnog cijepljenja.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna je tvar biološkog podrijetla namijenjena izazivanju aktivne imunosti te se na nju ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: Shelf life after first opening the immediate packaging: 10 hours.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakiranja: 10 sati.
English: The expiry date refers to the last date of that month.
Croatian: Rok valjanosti odnosi se na zadnji dan tekućeg mjeseca.
English: CEVA ΕΛΛΑΣ ΕΠΕ Αγίου Νικολάου 15 EL-17455 - ΑΛΙΜΟΣ Tel: +302109851200
Croatian: EL-17455 - ΑΛΙΜΟΣ Tel: +302109851200
English: After administration of a double dose, no other adverse reactions different to those mentioned in section 4.6 were observed.
Croatian: Nakon primjene dvostruke doze nisu opažene nuspojave drugačije od onih navedenih u dijelu 4.6.
English: Semi-purified saponin from Quillaja saponaria
Croatian: Polupročišćeni saponin iz biljke Quillaja saponaria
English: Most local reactions disappear or become residual (≤ 1 cm) before 70 days in sheep and 30 days in cattle, although residual nodules can persist after that time.
Croatian: Većina lokalnih nuspojava nestaje ili postaju rezidualne (≤ 1 cm) prije 70. dana u ovaca i 30. dana u goveda, iako rezidualni čvorići mogu potrajati i nakon tog razdoblja.
English: * Relative potency compared to a reference vaccine.
Croatian: * Relativna potencija u usporedbi s referentnim cjepivom.
English: Administer subcutaneously to sheep from 3 months of age, according to the following scheme:
Croatian: Primijeniti supkutano u ovaca starijih od tri mjeseca, prema shemi navedenoj u nastavku:
English: Cattle: Intramuscular use.
Croatian: Goveda: intramuskularna primjena.
English: Store and transport refrigerated (2 ºC - 8 ºC).
Croatian: Čuvati i prevoziti na hladnom (2ºC - 8ºC).
English: A painless nodule that may reach up to 3.8 cm diameter in sheep and 7 cm diameter in cattle develops very commonly after 2 to 6 days and diminishes progressively over time.
Croatian: Bolni čvorić, koji može doseći promjer do 3,8 cm u ovaca i do 7 cm u goveda, javlja se vrlo često nakon dva do šest dana i s vremenom postupno nestaje.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: Interakcija s drugim medicinskim proizvodima i drugi oblici interakcija
English: The number and type(s) of strains included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.
Croatian: Broj i vrste sojeva koji su uključeni u gotov VMP bit će prilagođeni trenutačnoj epidemiološkoj situaciji u vrijeme formulacije gotovog VMP-a te prikazani na naljepnici.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State´s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Svaka osoba koja namjerava proizvoditi, uvoziti, posjedovati, prodavati, opskrbljivati i koristiti ovaj veterinarsko-medicinski proizvod mora prethodno konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju jer te aktivnosti mogu biti zabranjene u državi članici, u cijelosti ili samo na djelu njezina područja, u skladu s nacionalnim zakonodavstvom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI I DRUGIH
English: Syvazul BTV suspension for injection for sheep and cattle
Croatian: UPUTA O VMP: Syvazul BTV suspenzija za injekciju za ovce i goveda
English: - Reproductive system disorders: abortion, perinatal mortality or premature parturition - Systemic disorders: apathy, recumbency, fever, anorexia or lethargy.
Croatian: - poremećaji reproduktivnog sustava: pobačaj, perinatalna smrtnost ili prijevremena parturicija, - sustavni poremećaji: apatija, dugotrajno ležanje, vrućica, anoreksija ili letargija.
English: Pinkish-white suspension easily homogenised by shaking.
Croatian: Ružičasto-bijela suspenzija, koja se jednostavno homogenizira protresanjem.
English: Duration of immunity: one year after completion of the primary vaccination scheme.
Croatian: Trajanje imunosti: jedna godina nakon dovršetka sheme primarnog cijepljenja.
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Croatian: Proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena ovog veterinarsko-medicinskog proizvoda može biti zabranjena u određenim državama članicama na cijelom ili na dijelu njihova područja, za daljnje informacije vidi uputu o VMP-u.
English: An abscess may appear on rare occasions.
Croatian: Rijetko se može pojaviti apsces.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Croatian: 14. DATUM KADA JE UPUTA O VMP-U ZADNJI PUTA ODOBRENA
English: Pharmacotherapeutic group: Inactivated bluetongue virus vaccines for sheep.
Croatian: Farmakoterapijska skupina: cjepiva inaktiviranog virusa bolesti plavog jezika za ovce.
English: No information is available on the use of the vaccine containing BTV4 serotype in cattle with maternally-derived antibodies.
Croatian: Nisu dostupne informacije o primjeni cjepiva koje sadržava BTV, serotip 4, na govedima u kojih su antitijela prenesena s majke.
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Croatian: Neškodljivost i djelotvornost cjepiva nisu utvrđene u muških rasplodnih jedinki.
English: * Maximum of two different inactivated bluetongue virus serotypes:
Croatian: RP** ≥ 1 * Najviše dvije različite vrste serotipa inaktiviranog virusa bolesti plavog jezika:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja), - manje česte (više od 1 ali manje od 10 životinja na 1 000 tretiranih životinja),
English: Erythema associated with mild to moderate oedema is very common from 1 to 6 days after the administration.
Croatian: Eritem povezan s blagim do umjerenim edemom vrlo je česta nuspojava te se javlja od jednog do šest dana nakon primjene.
English: Sheep: Subcutaneous use.
Croatian: Ovce: supkutana primjena.
English: ** Relative potency measured by ELISA in relation to a reference vaccine whose efficacy has been demonstrated by challenge in the target species.
Croatian: ** Relativna potencija izmjerena testom ELISA u odnosu na referentno cjepivo, čija je djelotvornost utvrđena ispitivanjem ciljnih vrsta životinja.
English: * Relative potency measured by ELISA in relation to a reference vaccine whose efficacy has been demonstrated by challenge in the target species.
Croatian: * Relativna potencija izmjerena testom ELISA u odnosu na referentno cjepivo, čija je djelotvornost utvrđena ispitivanjem ciljnih vrsta životinja.
English: 4.7 Use during pregnancy, lactation or lay
Croatian: Primjena tijekom graviditeta, laktacije ili nesenja Graviditet:
English: Polypropylene colourless vial containing 80 ml or 200 ml, with a type I bromobutyl rubber stopper, sealed with an aluminium closure.
Croatian: Prozirne bočice od polipropilena od 80 ml ili 200 ml, s čepom od brombutilne gume i aluminijskim zatvaračem.
English: 4.9 Amounts to be administered and administration route
Croatian: Količine koje se primjenjuju i put primjene
English: Active substances*:
Croatian: Djelatne tvari*:
English: Onset of immunity: 39 days after completion of the primary vaccination scheme.
Croatian: Početak imunosti: 39 dana nakon dovršetka sheme primarnog cijepljenja.
English: After administration of a double dose, no other adverse reactions different to those mentioned in ‘ADVERSE REACTIONS' were observed.
Croatian: Nakon primjene dvostruke doze nisu opažene nuspojave drugačije od onih navedenih u dijelu
English: No information is available on the use of the vaccine in sheep with maternally-derived antibodies.
Croatian: Nisu dostupne informacije o primjeni cjepiva na ovcama u kojih su antitijela prenesena s majke.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EK i Europskog parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz,
English: België/Belgique/Belgien laboratorios syva, s.a.u.
Croatian: B e lgië/Belgique/Belgien laboratorios syva, s.a.u.
English: To stimulate active immunity of sheep and cattle against bluetongue virus serotypes 1, 4 and/ or 8 related to those contained in the vaccine (combination of maximum 2 serotypes).
Croatian: Kako bi se stimulirala aktivna imunost ovaca i goveda protiv virusa plavog jezika, serotipa 1, 4 i/ili 8, povezanog s onim sadržanim u cjepivu (kombinacija najviše dva serotipa).
English: - Primary vaccination: administer a single 2 ml dose
Croatian: - Primarno cijepljenje: primijeniti jednu dozu od 2 ml
English: a) the administration of the product to animals will interfere with the implementation of national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: posjedovanje, prodaju, isporuku i/ili uporabu imunoloških veterinarsko-medicinskih proizvoda na cijelom području ili dijelu svojeg područja ako se utvrdi da: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: - Reduction in milk production - Neurological disorders: paralysis, ataxia, blindness or incoordination - Respiratory tract disorders: pulmonary congestion, dyspnoea - Digestive tract disorders: rumen atony or bloating - Hypersensitivity reactions: with hypersalivation - Death.
Croatian: - neurološki poremećaji: paraliza, ataksija, sljepoća ili nekoordiniranost, - poremećaji dišnog sustava: plućna kongestija, dispneja, - poremećaji probavnog sustava: atonija rumena ili nadimanje,
English: Suspension for injection
Croatian: OBLIK Suspenzija za injekciju
English: The following might be observed on very rare occasions in sheep and cattle:
Croatian: Nuspojave navedene u nastavku vrlo rijetko mogu se opaziti u ovaca i goveda:
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate anhydrous Sodium chloride
Croatian: Popis pomoćnih tvari aluminijev hidroksid polupročišćeni saponin iz biljke Quillaja saponaria tiomersal kalijev klorid monokalijev fosfat bezvodni dinatrijev fosfat natrijev klorid silikonsko sredstvo protiv pjenjenja voda za injekcije
English: Pinkish-white suspension for injection easily homogenised by shaking.
Croatian: 0,1 mg Ružičasto-bijela suspenzija za injekciju koja se jednostavno homogenizira protresanjem.
English: 4.4 Special warnings for each target species
Croatian: Posebna upozorenja za svaku od ciljnih vrsta životinja
English: Luxembourg/Luxemburg laboratorios syva, s.a.u.
Croatian: Luxe mbourg/Luxemburg laboratorios syva, s.a.u.
English: - Revaccination: administer one dose of 4 ml after 12 months.
Croatian: - Docjepljivanje: primijeniti jednu dozu od 4 ml nakon 12 mjeseci.
English: Zero days.
Croatian: KARENCIJA Nula dana.
English: Administer intramuscularly to cattle from 2 months of age in naïve animals or from 3 months of age in calves born to immune cattle, according to the following scheme:
Croatian: Primijeniti intramuskularno u goveda starijih od dva mjeseca u životinja koje prethodno nisu cijepljene ili starijih od tri mjeseca u teladi rođenoj za imunizaciju goveda, prema shemi navedenoj u nastavku: - Primarno cijepljenje: primijeniti dvije doze od 4 ml u razmaku od tri tjedna.
English: - Revaccination: administer one dose of 2 ml after 12 months.
Croatian: - Docjepljivanje: primijeniti jednu dozu od 2 ml nakon 12 mjeseci.
English: 6.5 Nature and composition of immediate packaging
Croatian: Osobine i sastav unutarnjeg pakiranja
English: 4.5 Special precautions for use
Croatian: 4.5. Posebne mjere opreza prilikom primjene
English: For active immunisation of sheep to prevent viraemia* and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and clinical signs and lesions caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
Croatian: Za aktivnu imunizaciju ovaca u cilju sprječavanja viremije* i smanjenja kliničkih znakova i lezija izazvanih virusom bolesti plavog jezika, serotipovi 1 i/ili 8 i/ili smanjenja viremije* i kliničkih znakova i lezija izazvanih virusom bolesti plavog jezika, serotip 4 (kombinacija najviše dva serotipa).
English: Potassium chloride
Croatian: De uts chland
English: The following might be observed on rare occasions in sheep and on very rare occasions in cattle:
Croatian: Nuspojave navedene u nastavku rijetko se mogu opaziti u ovaca i vrlo rijeko u goveda:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 14. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET
English: EU/2/18/231/001-012
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/18/231/001-012
English: WITHDRAWAL PERIOD
Croatian: Rok valjanosti
English: Aluminium hydroxide
Croatian: Aluminijev hidroksid (Al
English: Withdrawal period: zero days.
Croatian: KARENCIJA Karencija: nula dana.
English: Република България laboratorios syva, s.a.u.
Croatian: Ре публика България laboratorios syva, s.a.u.
English: Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1
Croatian: Djelatnu(e) tvar(i): inaktivirani virus bolesti plavog jezika, serotip 1 (BTV-1), soj ALG2006/01 E1
English: Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 RP* ≥ 1 Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01
Croatian: inaktivirani virus bolesti plavog jezika, serotip 4 (BTV-4), soj BTV-4/SPA-1/2004 RP* ≥ 1 inaktivirani virus bolesti plavog jezika, serotip 8 (BTV-8), soj BEL2006/01
English: Box of 1 vial of 80 ml Box of 1 vial of 200 ml
Croatian: Kartonska kutija s 1 bočicom od 80 ml Kartonska kutija s 1 bočicom od 200 ml
English: Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1 RP* ≥ 1 Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 RP* ≥ 1 Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01
Croatian: Djelatnu(e) tvar(i): inaktivirani virus bolesti plavog jezika, serotip 1 (BTV-1), soj ALG2006/01 E1 RP* ≥ 1 inaktivirani virus bolesti plavog jezika, serotip 4 (BTV-4), soj BTV-4/SPA-1/2004 RP* ≥ 1 inaktivirani virus bolesti plavog jezika, serotip 8 (BTV-8), soj BEL2006/01 RP* ≥ 1
English: Cardboard box with 1 vial containing 80 ml.
Croatian: kartonska kutija s 1 bočicom koja sadržava 80 ml. kartonska kutija s 1 bočicom koja sadržava 200 ml.
English: Vial of 80 ml Vial of 200 ml
Croatian: Bočica od 80 ml Bočica od 200 ml
English: Sheep and cattle
Croatian: CILJNE VRSTE ŽIVOTINJA Ovce i goveda
English: United Kingdom laboratorios syva, s.a.u.
Croatian: Unite d Kingdom laboratorios syva, s.a.u.
English: Pack sizes:
Croatian: Gove da:
English: LABELLING AND PACKAGE LEAFLET
Croatian: OZNAČIVANJE I UPUTA O VMP
English: EXPIRY DATE
Croatian: ROK VALJANOSTI EXP {mjesec/godina}
English: For active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
Croatian: serotipovi 1 i/ili 8 i/ili smanjenja viremije* izazvane virusom bolesti plavog jezika, serotip 4 (kombinacija najviše dva serotipa).
English: This leaflet was last revised in <{MM/YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}>
English: Loc. Fontana del Ceraso
Croatian: Fontana del Ceraso
English: Read all of this leaflet carefully before you start taking this medicine because it contains
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne
English: Tell your doctor immediately if you are taking any medicines for heart problems and during treatment
Croatian: Odmah obavijestite svojeg liječnika ako uzimate bilo kakve lijekove za srčane probleme i tijekom
English: * Includes patients co-infected with human immunodeficiency virus (HIV).
Croatian: * Uključuje bolesnike s istodobnom infekcijom virusom humane imunodeficijencije (HIV).
English: What Daklinza looks like and contents of the pack
Croatian: Kako Daklinza izgleda i sadržaj pakiranja
English: Yellow iron oxide (E172) 6.2 Incompatibilities Not applicable.
Croatian: željezov oksid, žuti (E172) 6.2 Inkompatibilnosti
English: Warnings and precautions Talk to your doctor or pharmacist before taking Daklinza.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Daklinza.
English: HCV genotype: 1a
Croatian: Genotip HCV-a: 1a
English: What Daklinza is and what it is used for 2.
Croatian: Što je Daklinza i za što se koristi 2.
English: You may have to take your other medicines for different lengths of time.
Croatian: Možda ćete morati uzimati druge lijekove u različitim vremenskim periodima.
English: Do not stop taking Daklinza unless your
Croatian: Nemojte prestati uzimati lijek Daklinza osim ako
English: If you forget to take Daklinza It is important not to miss a dose of this medicine.
Croatian: Ako ste zaboravili uzeti lijek Daklinza Važno je da ne propustite uzeti dozu ovog lijeka.
English: Age (years): median (range) Race: White
Croatian: Dob (godine): medijan (raspon)
English: Q2 2023
Croatian: Drugom tromjesječju 2023. godine
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP07
Croatian: Farmakoterapijska skupina: antivirusni lijek s izravnim djelovanjem, ATK oznaka: J05AP07
English: In phase 1 clinical studies, healthy subjects who received up to 100 mg once daily for up to 14 days or single doses up to 200 mg had no unexpected adverse reactions.
Croatian: U kliničkim ispitivanjima faze I, zdravi ispitanici koji su primali do 100 mg jedanput na dan tijekom najdulje 14 dana ili jednokratne doze do najviše 200 mg, nisu imali neočekivanih nuspojava.
English: Adverse reactions are listed in Table 5 by regimen, system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Croatian: Nuspojave su u Tablici 5 popisane prema režimu, organskim sustavima i učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
English: Data are available from a completed follow-up study to assess durability of response for approximately 3 years after treatment with daclatasvir.
Croatian: Dostupni su podaci iz ispitivanja praćenja koje je završeno, a u kojem se ocjenjuje postojanost odgovora otprilike 3 godine nakon liječenja daklatazvirom.
English: Patients should be instructed that, if they miss a dose of Daklinza, the dose should be taken as soon as possible if remembered within 20 hours of the scheduled dose time.
Croatian: Bolesnike treba uputiti da, zaborave li uzeti dozu lijeka Daklinza, propuštenu dozu trebaju uzeti što je prije moguće, pod uvjetom da je to unutar 20 sati od predviđenog vremena uzimanja.
English: No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective
Croatian: Nije primijećena klinički značajna antivirusna aktivnost protiv niza različitih RNK i DNK virusa, uključujući HIV, što potvrđuje da je daklatazvir, koji inhibira ciljno mjesto specifično za HCV, visoko
English: Seventy-seven (77 [98.7%]) of treated patients in this study were infected with HCV GT-3a, and 1 patient (1.3%) was infected with HCV GT-3b.
Croatian: Sedamdeset i sedam (77 [98,7%]) od liječenih bolesnika u tom ispitivanju bilo je zaraženo virusom HCV GT-3a i 1 bolesnik (1,3%) bio je zaražen virusom HCV GT-3b.
English: As liver function may change during treatment with Daklinza, a close monitoring of International Normalized Ratio (INR) values is recommended.
Croatian: Budući da tijekom liječenja lijekom Daklinza može doći do promjene u funkciji jetre, preporučuje se pomno praćenje vrijednosti međunarodnog normaliziranog omjera (INR).
English: * 2 patients had detectable HCV RNA at end of treatment; 1 of these patients achieved SVR.
Croatian: *2 bolesnika imala su nemjerljivu razinu HCV RNK na kraju liječenja; 1 od tih bolesnika postigao je SVR.
English: ** The patient with virologic breakthrough met the original protocol definition of confirmed HCV RNA <LLOQ, detectable at treatment Week 8.
Croatian: ** Bolesnik s virološkim probojem zadovoljio je izvornu protokolarnu definiciju potvrđene razine HCV RNK < LLOQ, koja je bila mjerljiva u 8. tjednu liječenja.
English: Table 5: Adverse reactions in clinical studies System Organ Class
Croatian: Tablica 5: Nuspojave u kliničkim ispitivanjima Organski sustav
English: *results are dose-normalised to 60 mg
Croatian: *rezultati su normalizirani za dozu od 60 mg.
English: Daklinza has not yet been studied in
Croatian: Daklinza još nije ispitana u djece i
English: Treatment week 24: ≥25 IU/ml
Croatian: 24. tjedan liječenja: ≥25 IU/ml
English: If the starting dose is not well-tolerated, the dose should be reduced as clinically indicated, based on haemoglobin and creatinine clearance measurements (see Table 2).
Croatian: Ako bolesnik ne podnosi dobro početnu dozu, treba je smanjiti sukladno kliničkoj potrebi, na temelju izmjerenih vrijednosti hemoglobina i klirensa kreatinina (vidjeti Tablicu 2).
English: * One treatment-experienced patient achieved SVR12 per local HCV RNA results.
Croatian: * Jedan prethodno liječeni bolesnik postigao je SVR12 prema lokalnim rezultatima HCV RNK.
English: If you can become pregnant, use effective contraception during and for 5 weeks after your treatment
Croatian: Ako biste mogli zatrudnjeti, morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom Daklinza i još 5 tjedana nakon završetka liječenja.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji se nalazi u Modulu 1.8.2