FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju da se nehotice samoinjicira, odmah potražiti savjet liječnika i pokažite mu uputu o VMP-u ili etiketu.
English: EU/2/17/205/009 10 mg/ml 1 vial EU/2/17/205/001 10 mg/ml 2 vials EU/2/17/205/002 10 mg/ml 6 vials EU/2/17/205/010 20 mg/ml 1 vial EU/2/17/205/003 20 mg/ml 2 vials EU/2/17/205/004 20 mg/ml 6 vials EU/2/17/205/011 30 mg/ml 1 vial EU/2/17/205/005 30 mg/ml 2 vials EU/2/17/205/006 30 mg/ml 6 vials
Croatian: EU/2/17/205/009 10 mg/ml 1 bočica EU/2/17/205/001 10 mg/ml 2 bočice EU/2/17/205/002 10 mg/ml 6 bočica EU/2/17/205/010 20 mg/ml 1 bočica EU/2/17/205/003 20 mg/ml 2 bočice EU/2/17/205/004 20 mg/ml 6 bočica EU/2/17/205/011 30 mg/ml 1 bočica EU/2/17/205/005 30 mg/ml 2 bočice EU/2/17/205/006 30 mg/ml 6 bočica
English: 1348 Louvain-la-Neuve BELGIUM
Croatian: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIJA
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: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10000 tretiranih životinja)
English: In a laboratory model study lokivetmab demonstrated an onset of efficacy for pruritus by the first time point at 8 hours post administration.
Croatian: U laboratorijskom modelu ispitivanja lokivetmab je iskazao početak djelotvornosti protiv pruritusa do prve vremenske točke koja je bila 8 sati nakon primjene.
English: The recommended minimum dose is 1 mg/kg bodyweight, once a month.
Croatian: Plan doziranja i liječenja: Preporučena minimalna doza je 1 mg/kg tjelesne težine jednom mjesečno.
English: Each vial of 1 ml contains:
Croatian: Jedna bočica od 1 ml sadrži:
English: Shelf life after first opening the immediate packaging: use immediately
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: odmah upotrijebiti.
English: It is recommended to monitor dogs for bacterial infections associated with atopic dermatitis, especially during the first weeks of treatment.
Croatian: Preporučuje se nadzirati pse u pogledu bakterijskih infekcija povezanih s atopijskim dermatitisom, osobito tijekom prvih tjedana liječenja.
English: INDICATION(S) Treatment of clinical manifestations of atopic dermatitis in dogs.
Croatian: INDIKACIJA(E) Liječenje kliničkih manifestacija atopijskog dermatitisa pasa.
English: Vomiting and/or diarrhoea have been reported to occur in rare cases from spontaneous reports and may occur in connection with hypersensitivity reactions.
Croatian: Povraćanje i/ili proljev prijavljeni su u rijetkim slučajevima, izvješteno je u spontanim prijavama i mogu se pojaviti u vezi s reakcijama preosjetljivosti.
English: Avoid excessive shaking or foaming of the solution.
Croatian: Izbjegavati pretjerano potresanje ili pjenjenje otopine.
English: In field studies up to 9 months, treatment of dogs with atopic dermatitis was demonstrated to have a favourable effect on the reduction of pruritus and on the reduction of disease severity as evaluated by Canine Atopic Dermatitis Extent and Severity Index (CADESI) 03 scores.
Croatian: U terenskim ispitivanjima u trajanju od 9 mjeseci, dokazano je da liječenje pasa s atopijskim dermatitisom ima povoljan učinak na smanjenje pruritusa te na smanjenje ozbiljnosti bolesti, prema rezultatima evaluacije indeksom stupnja i ozbiljnosti psećeg atopijskog dermatitisa (engl.
English: EU/2/17/205/012 40 mg/ml 1 vial EU/2/17/205/007 40 mg/ml 2 vials EU/2/17/205/008 40 mg/ml 6 vials
Croatian: EU/2/17/205/012 40 mg/ml 1 bočica EU/2/17/205/007 40 mg/ml 2 bočice EU/2/17/205/008 40 mg/ml 6 bočica
English: 4.8 Interaction with other medicinal products and other forms of interaction No drug interactions were observed in field studies where lokivetmab was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials, anti-inflammatories and vaccines.
Croatian: 4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija Nisu zabilježene interakcije u terenskim ispitivanjima u kojima je lokivetmab primjenjivan istodobno s veterinarsko-medicinskim proizvodima poput endoparaziticida, ektoparaziticida, antimikrobnih i protuupalnih proizvoda te cjepiva.
English: Lokivetmab is a caninised monoclonal antibody (mAb) specifically targeting canine interleukin-31.
Croatian: Lokivetmab je monoklonsko protutijelo (mAb) modificirano posebno za pse, koje specifično cilja pseći interleukin-31.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/205/001-012
Croatian: EU/2/17/205/001-012
English: No drug interactions were observed in field studies where lokivetmab was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials antiinflammatories and vaccines.
Croatian: Nisu zabilježene interakcije u terenskim ispitivanjima u kojima je lokivetmab primjenjivan istodobno s veterinarsko-medicinskim proizvodima poput endoparaziticida, ektoparaziticida, antimikrobnih i protuupalnih proizvoda te cjepiva.
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Veterinarsko - medicinski proizvodi se ne smiju odlagati u otvorene vode ili kućni otpad.
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Croatian: Ne smije se primjenjivati u slučaju preosjetljivosti na djelatnu tvar ili neku od pomoćnih tvari.
English: Hypersensitivity reactions (anaphylaxis, facial oedema, urticaria) have been reported to occur in rare cases from spontaneous reports.
Croatian: U rijetkim slučajevima prijavljene su reakcije preosjetljivosti (anafilaksija, facijalni edem, urtikarija), izvješteno u spontanim prijavama.
English: Lokivetmab may induce transient or persistent anti-drug antibodies.
Croatian: Lokivetmab može izazvati stvaranje prolaznih ili trajnih protutijela na lijek.
English: For dogs above 40 kg, the contents of more than one vial are required to administer a single dose.
Croatian: Primjena jedne doze kod pasa težih od 40 kg zahtijeva sadržaj veći od jedne bočice
English: Do not use this veterinary medicinal product after the expiry date which stated on the label after EXP Shelf life after first opening the container: use immediately.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije oznake EXP.
English: Special warnings for each target species
Croatian: Posebne mjere opreza za svaku ciljnu vrstu:
English: 4.9 Amounts to be administered and administration route Subcutaneous use.
Croatian: 4.9 Količine koje se primjenjuju i put primjene Potkožna primjena.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Potkožna primjena.
English: If no or limited response is obtained within one month after initial dosing, a second dose one month later may increase effectiveness.
Croatian: Ukoliko se ne vidi učinak u roku od mjesec dana nakon početnog doziranja, postoji mogućnost da će se učinak vidjeti mjesec dana nakon primjene druge doze.
English: 6.2 Major incompatibilities
Croatian: Voda za injekcije 6.2 Glavne inkompatibilnosti
English: *Lokivetmab is a caninised monoclonal antibody expressed through recombinant techniques in Chinese hamster ovary (CHO) cells
Croatian: *Lokivetmab je monoklonsko protutijelo modificirano posebno za pse, koje se proizvodi rekombinantnim tehnikama u jajnim stanicama kineskog hrčka.
English: No adverse reactions other than those mentioned in section 6 were observed in laboratory overdose studies.
Croatian: U laboratorijskim ispitivanjima predoziranja nisu zabilježene nuspojave izuzev onih navedenih u odjeljku 6.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Subcutaneous use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Croatian: NAVOĐENJE DJELATNE TVARI I DRUGIH SASTOJAKA Djelatne tvari:
English: Marketing authorisation holder and Manufacturer responsible for batch release:
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet:
English: 6 x 1 ml
Croatian: 1 x 1 ml 2 x 1 ml 6 x 1 ml
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološki djelate tvari Zoetis Inc.
English: C. STATEMENT OF THE MRLs Not applicable.
Croatian: C. IZVJEŠĆE O MRL
English: If a vaccine(s) is to be administered at the same time as treatment with lokivetmab, the vaccine(s) should be administered at a different site to that of lokivetmab administration.
Croatian: Ako se neko cjepivo (ili više cjepiva) primjenjuje istodobno s lokivetmabom, takvo(a) cjepivo(a)
English: Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection.
Croatian: U slučaju da se nehotice samoinjicira, moguće su reakcije preosjetljivosti, uključujući anafilaksiju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
English: Dog.
Croatian: Pas.
English: Name and address of the manufacturer responsible for batch release
Croatian: SJEDINJENE AMERIČKE DRŽAVE Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs lokivetmab
Croatian: CYTOPOINT 10 mg otopina za injekciju za pse CYTOPOINT 20 mg otopina za injekciju za pse CYTOPOINT 30 mg otopina za injekciju za pse CYTOPOINT 40 mg otopina za injekciju za pse lokivetmab
English: Methionine
Croatian: Canine
English: PACKAGE LEAFLET:
Croatian: Veličine pakiranja:
English: CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs
Croatian: CYTOPOINT 10 mg otopina za injekciju za pse CYTOPOINT 20 mg otopina za injekciju za pse CYTOPOINT 30 mg otopina za injekciju za pse CYTOPOINT 40 mg otopina za injekciju za pse
English: Primary packaging: Single dose clear glass Type I vials with chlorobutyl rubber stopper.
Croatian: Primarno pakovanje: prozirne staklene bočice tipa
English: Dose according to the dosing chart below.
Croatian: Dozirajte prema donjoj tablici doziranja:
English: Each vial of 1 ml contains 20 mg lokivetmab.
Croatian: Jedna bočica od 1 ml sadrži 20 mg lokivetmaba.
English: Each vial of 1 ml contains 40 mg lokivetmab.
Croatian: Jedna bočica od 1 ml sadrži 40 mg lokivetmaba.
English: A small number of dogs showed a low or an absence of clinical response to lokivetmab.
Croatian: Atopic Dermatitis Extent and Severity Index), CADESI rezultat: 03. Malen broj pasa iskazao je nizak ili nikakav klinički odgovor na lokivetmab.
English: Dogs
Croatian: NUSPOJAVE
English: Each vial of 1 ml contains 30 mg lokivetmab.
Croatian: Jedna bočica od 1 ml sadrži 30 mg lokivetmaba.
English: Each vial of 1 ml contains 10 mg lokivetmab.
Croatian: Jedna bočica od 1 ml sadrži 10 mg lokivetmaba.
English: WITHDRAWAL PERIOD(S)
Croatian: KARENCIJA(E)
English: 4.11 Withdrawal period(s) Not applicable.
Croatian: 4.11 Karencija(e)
English: CARDBOARD BOX
Croatian: UPUTA O VMP
English: 4.5 Special precautions for use
Croatian: 4.5 Posebne mjere opreza prilikom primjene Posebne mjere opreza prilikom primjene na životinjama
English: CYTOPOINT 10 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Croatian: Kartonska kutija s 1 bočicom od 1 ml Kartonska kutija s 2 bočice od 1 ml Kartonska kutija sa 6 bočica od 1 ml
English: Dose according to the dosing chart below:
Croatian: Učestalost nuspojava određena je prema sljedećim pravilima:
English: 2 vials 1 vial
Croatian: 1 bočica 1 bočica
English: Symptoms you should be aware of
Croatian: Simptomi na koje morate pripaziti
English: Body weight <60 kg
Croatian: Tjelesna težina <60 kg
English: Daxas will not help you in this situation.
Croatian: Daxas Vam u takvim situacijama neće pomoći.
English: The relevance of these findings to humans is unknown.
Croatian: Značaj tih opažanja za ljude nije poznat.
English: Some side effects could be serious.
Croatian: Neke nuspojave mogu biti ozbiljne.
English: • multiple sclerosis or SLE
Croatian: • multiplu sklerozu ili SLE
English: Swallow the tablet with some water.
Croatian: Progutajte tabletu s malo vode.
English: Continue taking your medicine at the usual times.
Croatian: Nastavite uzimati lijek u uobičajeno vrijeme.
English: Children and adolescents Daxas should not be used by children and adolescents under 18 years of age.
Croatian: Djeca i adolescenti Daxas nije namijenjen djeci i adolescentima mlađim od 18 godina.
English: The specific indication approved.
Croatian: Specifičnu odobrenu indikaciju.
English: None of these changes were considered to be clinically meaningful.
Croatian: Nijedno od tih odstupanja ne smatra se klinički značajnim.
English: Moderate or severe
Croatian: Umjerena ili teška
English: Ask your doctor for advice.
Croatian: Obratite se liječniku za savjet.
English: The major reasons for trial discontinuation were withdrawal of consent and reported adverse events.
Croatian: Glavni razlozi za prijevremeno istupanje iz ispitivanja bili su povlačenje pristanka i prijavljeni štetni događaji.
English: Do not stop taking these medicines or reduce their dose unless advised by your doctor.
Croatian: Ne prekidajte terapiju tim lijekovima niti smanjujte njihovu dozu, osim ako Vam tako ne savjetuje liječnik.
English: Other medicines and Daxas
Croatian: Drugi lijekovi i Daxas
English: - The starting dose is a low dose used to help your body get used to the medicine before you start taking the full dose.
Croatian: - početna doza je niska doza koja se korisiti kako bi pomogla da se Vaše tijelo privikne na lijek prije nego počnete uzimati punu dozu.
English: Ratio Roflumilast/Placebo
Croatian: Omjer roflumilast/placebo
English: What Daxas is and what it is used for
Croatian: Što je Daxas i za što se koristi
English: Analysis model
Croatian: Model analize
English: (N=969) Rate (n)
Croatian: (N=969) Stopa (n)
English: The tablet can be taken with or without food.
Croatian: Tablete se mogu uzimati s hranom ili bez nje.
English: • severe infection
Croatian: • teške infekcije
English: 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); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti na temelju dostupnih podataka).
English: In uncommon cases allergic reactions may occur.
Croatian: U manje čestim slučajevima mogu se pojaviti alergijske reakcije.
English: If you forget to take a tablet at the usual time, take the tablet as soon as you remember on the same day.
Croatian: Ako zaboravite uzeti tabletu u uobičajeno vrijeme, uzmite ju čim se sjetite isti dan.
English: A risk to the breastfed infant cannot be excluded.
Croatian: Rizik za dojenče se ne može isključiti.
English: In case of an allergic reaction, stop taking Daxas and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital.
Croatian: U slučaju alergijske reakcije, prestanite uzimati Daxas i odmah se obratite svom liječniku ili se odmah javite na hitni prijem najbliže bolnice.
English: Take the tablet at the same time every day.
Croatian: Tablete uzimajte svaki dan u isto vrijeme.
English: Each pack contains 28 tablets.
Croatian: Jedno pakiranje sadrži 28 tableta.
English: The Marketing Authorisation Holder shall agree the content and format of the updated educational material with the national competent authority.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će dogovoriti sadržaj i oblik obnovljenih edukacijskih materijala s nadležnim nacionalnim tijelom.
English: EU/1/10/636/001 10 film-coated tablets EU/1/10/636/002 30 film-coated tablets EU/1/10/636/003 90 film-coated tablets EU/1/10/636/004 14 film-coated tablets EU/1/10/636/005 28 film-coated tablets EU/1/10/636/006 84 film-coated tablets EU/1/10/636/007 98 film-coated tablets
Croatian: EU/1/10/636/001 10 filmom obloženih tableta EU/1/10/636/002 30 filmom obloženih tableta EU/1/10/636/003 90 filmom obloženih tableta EU/1/10/636/004 14 filmom obloženih tableta EU/1/10/636/005 28 filmom obloženih tableta EU/1/10/636/006 84 filmom obloženih tableta EU/1/10/636/007 98 filmom obloženih tableta
English: Date of first authorisation: 05 July 2010 Date of latest renewal: 24 April 2015
Croatian: Datum posljednje obnove odobrenja: 24. travnja 2015.
English: Persistent intolerability
Croatian: Trajna nepodnošljivost
English: PVC/PVDC aluminium blisters in packs of 28 tablets.
Croatian: PVC/PVDC aluminijski blisteri u pakiranjima s 28 tableta.
English: Other diseases
Croatian: Druge bolesti
English: You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Daxas may be harmful for the unborn baby.
Croatian: Tijekom liječenja ovim lijekom ne smijete zatrudnjeti, te morate koristiti učinkovitu metodu kontracepcije za vrijeme liječenja, jer Daxas može naškoditi nerođenom djetetu.
English: Placebo (N=966) Rate (n)
Croatian: Placebo (N=966) Stopa (n)
English: Warnings and precautions Talk to your doctor or pharmacist before taking Daxas.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Daxas.
English: What Daxas looks like and contents of the pack
Croatian: Kako Daxas izgleda i sadržaj pakiranja
English: • infection with tuberculosis, herpes, hepatitis, HIV
Croatian: • tuberkuloznu infekciju, herpes, hepatitis, HIV
English: Daxas 500 micrograms has been studied in clinical trials for up to one year, and is intended for maintenance treatment.
Croatian: Daxas 500 mikrograma ispitan je u kliničkim ispitivanjima u trajanju do godine dana i namijenjen je za terapiju održavanja.
English: The patient card should contain the following key elements:
Croatian: Kartica za bolesnike mora sadržavati sljedeće ključne elemente:
English: Women of childbearing age should be advised to use an effective method of contraception during treatment.
Croatian: Ženama u reproduktivnoj dobi treba savjetovati da tijekom liječenja koriste učinkovitu metodu kontracepcije.
English: The tablet should be swallowed with water and taken at the same time every day.
Croatian: Tablete treba progutati s vodom svaki dan u isto vrijeme.
English: Roflumilast improved lung function after 4 weeks (sustained over 52 weeks).
Croatian: Roflumilast je poboljšao plućnu funkciju nakon 4 tjedna (održana tijekom 52 tjedna).
English: You may need to take Daxas for several weeks to achieve its beneficial effect.
Croatian: Ponekad je Daxas potrebno uzimati nekoliko tjedana da biste osjetili povoljan učinak.
English: Before starting treatment with Daxas, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects.
Croatian: Prije početka primjene lijeka Daxas obavijestite liječnika ako patite od takvih simptoma, kao i o svim dodatnim lijekovima koje uzimate, jer neki mogu povećati vjerojatnost pojave takvih nuspojava.
English: Poisson regression
Croatian: Poissonova regresija
English: If possible take your medicine and this leaflet with you.
Croatian: Ako je moguće, ponesite sa sobom lijek i ovu uputu.
English: Thus Daxas eases breathing problems.
Croatian: Daxas stoga ublažava teškoće s disanjem.
English: After discontinuation of roflumilast, the majority of patients had regained body weight after 3 months.
Croatian: Nakon prekida terapije roflumilastom većina bolesnika se vratila na početnu tjelesnu težinu nakon 3 mjeseca.
English: Take all your medicines and this leaflet with you and provide full information of your current medications.
Croatian: Sa sobom ponesite sve svoje lijekove i ovu uputu, kako biste pružili potpunu informaciju o svim lijekovima koje trenutno uzimate.
English: What Daxas is and what it is used for What you need to know before you take Daxas How to take Daxas
Croatian: Što je Daxas i za što se koristi Što morate znati prije nego počnete uzimati Daxas Kako uzimati Daxas
English: You should check your body weight on a regular basis.
Croatian: Redovito provjeravajte tjelesnu težinu.
English: The improvement in lung function was apparent at the first visit after 4 weeks and was maintained up to one year (end of treatment period).
Croatian: Poboljšanje plućne funkcije bilo je očito pri prvoj kontrolnoj posjeti nakon 4 tjedna i održalo se tijekom godine dana (kraj razdoblja liječenja).
English: In case of overdose, it is recommended that the appropriate supportive medical care is provided.
Croatian: U slučaju predoziranja preporučuje se primjereno potporno liječenje.
English: The educational material for the prescriber should include information on the following key elements:
Croatian: Edukacijski materijal za propisivače treba uključivati informacije o sljedećim ključnim elementima:
English: Please talk to your doctor if you have one of these diseases.
Croatian: Molimo obratite se svom liječniku ako imate koju od ovih bolesti.
English: The design of the studies was parallel-group, double-blind and placebo-controlled.
Croatian: Ispitivanja su bila s paralelnim skupinama, dvostruko slijepa, kontrolirana placebom.
English: The limited or missing information in patients with liver impairment.
Croatian: Ograničene ili nepostojeće podatke o bolesnicima sa zatajenjem jetre.
English: Linearity/Non-linearity
Croatian: Linearnost/nelinearnost
English: At this low dose you will not get the full effect from the medicinetherefore it is important that you move on to the full dose (called a ‘maintenance dose') after 28 days.
Croatian: Pri toj niskoj dozi lijek neće imati puni učinak - stoga je važno da započenete uzimati punu dozu (zvanu „doza održavanja”) nakon 28 dana.
English: There is no evidence for a specific accumulation or retention of roflumilast or its metabolites in organs and fatty tissue.
Croatian: Nema dokaza specifične akumulacije ili retencije roflumilasta ili njegovih metabolita u organima ili masnom tkivu.
English: Roflumilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, nervousness and depression.
Croatian: Roflumilast je povezan s povećanim rizikom psihijatrijskih poremećaja poput nesanice, tjeskobe, nervoze i depresije.
English: The affinity to the PDE4C splicing variants is 5 to 10-fold lower.
Croatian: Afinitet za PDE4C je 5 do 10 puta niži.
English: 28 tablets - 28-day starter pack.
Croatian: 28 tableta - pakiranje za 28-dnevno početno liječenje.
English: Tell your doctor or pharmacist straight away.
Croatian: Odmah se obratite liječniku ili ljekarniku.
English: Negative binomial regression
Croatian: Teška negativna binomna regresija