FrancophonIA/ELRC3.0 huggingface dataset:
English: Lucane Pharma Tél/Tel: + 33 153 868 750 info@lucanepharma.com
Croatian: Luxembourg/Luxemburg Lucane Pharma Tél/Tel: + 33 153 868 750 info@lucanepharma.com
English: The sachet should not be used if it is swollen or if the granules have lost their light brown colour, and are turning dark brown or purple.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Vrećica se ne smije upotrebljavati ako je nabubrila ili ako su granule promijenile boju iz svjetlo smeđe u tamno smeđu ili ljubičastu.
English: Package leaflet: Information for the patient GRANUPAS 4 g gastro-resistant granules para-aminosalicylic acid
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GRANUPAS 4g želučanootporne granule paraaminosalicilatna kiselina Primjena kroz usta
English: • diarrhoea,
Croatian: • vrtoglavica,
English: GRANUPAS 4 g gastro-resistant granules
Croatian: NAZIV LIJEKA GRANUPAS 4 g želučanootporne granule
English: EU/1/17/1255/001
Croatian: EU/1/17/1255/001 Intrarosa
English: Vaginal use blister (PVC/PE)
Croatian: Blister (PVC/PE)
English: 28 pessaries + 6 applicators
Croatian: 28 vagitorija i 6 aplikatora
English: Intrarosa
Croatian: Jačina
English: Pessary
Croatian: Vagitoriji
English: (Invented) name
Croatian: EMA broj postupka (Novoizumljeno) ime
English: Pack size
Croatian: U rodnicu
English: The reference Member State was France and 12 concerned Member States were involved: Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and United Kingdom.
Croatian: Referentna država članica bila je Francuska, a uključeno je i 12 zahvaćenih država članica: Austrija, Belgija, Danska, Njemačka, Grčka, Irska, Italija, Luksemburg, Portugal, Slovenija, Španjolska i Ujedinjeno Kraljevstvo.
English: 25 September 2013
Croatian: 25. rujna 2013.
English: Veterinary Medicines and Product Data Management
Croatian: Upravljanje veterinarsko-medicinskim lijekovima i podacima o proizvodima
English: The final opinion was converted into a Decision by the European Commission on 25 September 2013.
Croatian: Zaključno mišljenje promijenjeno je u Odluku Europske komisije 25. rujna 2013.
English: The type II variation procedure (FR/V/0201/002/II/006) started on 16 May 2012.
Croatian: Postupak izmjene tipa II (FR/V/0201/002/II/006) započet je 16. svibnja 2012.
English: The Committee appointed Dr B. Urbain as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur.
Croatian: Odbor je imenovao Dr. B. Urbaina kao izvjestitelja i Dr. M. Holzhauser-Albertia kao suizvjestitelja.
English: During the variation procedure a potential serious risk to animal health was identified by Belgium and in particular that the efficacy against the lice species had been insufficiently substantiated.
Croatian: Tijekom postupka izmjene, Belgija je identificirala potencijalni ozbiljni rizik za zdravlje životinja, a posebice da djelotvornost protiv vrsta ušiju nije dovoljno dokazana.
English: Day 60 of the CMD(v) procedure was on 14 March 2013, and since there was no agreement the procedure was referred to the CVMP.
Croatian: Dan 60. postupka CMD(v)-a bio je 14. ožujka 2013., te s obzirom da nije postignut dogovor, postupak je proslijeđen CVMP-u.
English: The referral procedure started on 10 April 2013.
Croatian: Postupak upućivanja započet je 10. travnja 2013.
English: The product is administered topically on the back of the animal and is indicated for the treatment of mixed nematode and fluke infections in cattle.
Croatian: Proizvod se primjenjuje topikalno na leđa životinje i indiciran je za liječenje mješovitih infekcija nematodama i metiljem u stoke.
English: International non-proprietary names (INN): moxidectin and triclabendazole
Croatian: Međunarodni nezaštićeni nazivi (INN): moksidektin i triklabendazol
English: Written explanations were provided by the marketing authorisation holder on 20 May 2013.
Croatian: Nositelj odobrenja dostavio je pisana pojašnjenja 20. svibnja 2013.
English: The CVMP concluded that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field.
Croatian: CVMP je zaključio da se na terenu može očekivati zadovoljavajuća djelotvornost s obzirom na Linognatus vituli, Bovicola bovis i Solenopotes capillatus.
English: The CMD(v) 60-day referral procedure was initiated on 14 January 2013.
Croatian: Šezdesetodnevni postupak upućivanja CMD(v)-a započet je 14. siječnja 2013.
English: On 3 April 2013, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No 1234/2008.
Croatian: Francuska je uputila predmet CVMP-u u skladu sa člankom 13. stavkom 2. Uredbe Komisije (EZ) br. 1234/2008.
English: On Day 90, major issues raised by the CMS, Belgium, remained unsolved.
Croatian: Značajnija pitanja koja je postavila zahvaćena država članica, Belgija, ostala su neriješena do 90. dana.
English: The CVMP was requested to give its opinion on whether or not the data for the type II variation application support the new indication against lice infestations.
Croatian: Od CVMP-a je zatraženo da dostavi svoje mišljenje o tome potkrjepljuju li podaci dostavljeni uz zahtjev za izmjenu tipa II nove indikacije protiv infestacije ušima ili ne.
English: The procedure was thus referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Veterinary (CMD(v)) under Article 13(1) of Commission Regulation (EC) No 1234/2008 on 11 December 2012 by the RMS (France).
Croatian: Stoga je 11. prosinca 2012. referenta država članica Francuska uputila postupak Koordinacijskoj skupini za postupak međusobnog priznavanja i decentralizirani postupak za veterinarske lijekove (CMD(v)) u skladu sa člankom 13. stavkom 1. Uredbe Komisije (EZ) br. 1234/2008.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments of the relevant sections of the Summary of Product Characteristics, labelling and package leaflet in Annex III.
Croatian: Znanstveni zaključci navedeni su u Prilogu II. zajedno s dopunama relevantnih dijelova Sažetka opisa svojstava VMP-a, naljepnice i upute o VMP-u u Prilogu III.
English: Based on the evaluation of the available data, the CVMP adopted, on 16 July 2013, an opinion recommending the granting of the variation to the marketing authorisations for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle.
Croatian: Na temelju procjene dostupnih podataka, 16. srpnja 2013. CVMP usvojio je mišljenje kojim se preporuča odobravanje izmjene odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda za poliv otopinu za stoku Cydectin TriclaMox (5 mg/ml i 200 mg/ml).
English: Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle is a veterinary medicinal product containing 5 mg moxidectin per ml and 200 mg triclabendazole per ml.
Croatian: Otopina za polijevanje po koži za stoku Cydectin TriclaMox (5 mg/ml i 200 mg/ml) je veterinarskomedicinski proizvod koji sadrži 5 mg moksidektina po ml i 200 mg triklabendazola po ml.
English: The marketing authorisation holder, Pfizer Animal Health, submitted an application for a type II variation, according to Article 16 of Commission Regulation (EC) 1234/2008, to add a new indication against lice species (Linognatus vituli, Bovicola bovis and Solenopotes capillatus) for Cydectin TriclaMox 5 mg/ml and 200 mg/ml pour-on solution for cattle.
Croatian: Uredbe Komisije (EZ) br. 1234/2008 kako bi se dodala nova indikacija protiv vrsta ušiju (Linognatus vituli, Bovicola bovis i Solenopotes capillatus) za otopinu za polijevanje po koži za stoku Cydectin TriclaMox od 5 mg/ml i 200 mg/ml.
English: Opinion following an Article 131 referral for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle
Croatian: 13.1 za otopinu za polijevanje po koži za stoku Cydectin TriclaMox (5 mg/ml i 200 mg/ml)
English: Opinion following an Article 130F referral for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle
Croatian: Mišljenje nakon postupka upućivanja u skladu s člankom 13.0F za otopinu za polijevanje po koži za stoku Cydectin TriclaMox (5 mg/ml i 200 mg/ml) EMA/549503/2013
English: The differences were not statistically significant.
Croatian: Razlike nisu bile statistički značajne.
English: Choose a time of the day that works best for you.
Croatian: Odaberite vrijeme u danu koje Vam najbolje odgovara.
English: You may then hear or feel a click.
Croatian: Tada ćete možda čuti ili osjetiti ‘klik'.
English: Do not cover it with your fingers.
Croatian: Ne pokrivajte ga prstima.
English: How much solution is left?
Croatian: Koliko je otopine preostalo?
English: Then carry on with your medicine as usual.
Croatian: Zatim nastavite liječenje lijekom kao obično.
English: The recommended starting dose should not be exceeded.
Croatian: Preporučena početna doza ne smije se prekoračiti.
English: • drink alcohol
Croatian: • pijete alkohol
English: The duration of observation was minimum 3.5 years and up to a maximum of 5 years.
Croatian: Praćenje je trajalo najmanje 3,5 godina, a najviše 5 godina.
English: Avoidance of medication errors
Croatian: Izbjegavanje medikacijskih pogrešaka
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Croatian: To može predstavljati rizik u situacijama u kojima su takve sposobnosti vrlo važne (primjerice, vožnja automobila ili rukovanje strojevima).
English: You have diabetes because your body:
Croatian: Imate šećernu bolest jer Vaše tijelo:
English: • how to adjust the dose.
Croatian: • kako prilagoditi dozu.
English: During use
Croatian: Tijekom uporabe
English: This is especially important if you take more than one type of injectable medicine.
Croatian: To je posebno važno ako primjenjujete više od jedne vrste lijeka koji se injicira.
English: Do not give this medicine to children or adolescents.
Croatian: Nemojte davati ovaj lijek djeci ili adolescentima.
English: Change the needle as described in section 5 and repeat all steps starting with section 1: Prepare your pen with a new needle.
Croatian: Promijenite iglu kako je opisano u dijelu 5. i ponovite sve korake počevši od dijela 1: Pripremite brizgalicu s novom iglom.
English: This is normal, but you must still check the flow.
Croatian: To je normalno, ali ipak morate provjeriti protok.
English: Component of a multipack, can't be sold separately
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: • how much Xultophy you will need each day
Croatian: • koliko će Vam lijeka Xultophy biti potrebno svaki dan
English: • Do not store your pen at temperatures above 30°C.
Croatian: • Ne čuvajte brizgalicu na temperaturi iznad 30ºC.
English: Tell everyone you spend time with that you have diabetes.
Croatian: Recite svim ljudima s kojima provodite vrijeme da imate šećernu bolest.
English: Do not inject it into a vein or muscle.
Croatian: Nemojte ga injicirati u venu ili mišić.
English: • eat more than usual
Croatian: • jedete više nego obično
English: Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby.
Croatian: Obavijestite svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: • is not able to use the insulin properly.
Croatian: • ne može ispravno koristiti inzulin.
English: The proportion of patients reporting nausea per week at any point during treatment was below 4%.
Croatian: Udio bolesnika koji je prijavio mučninu tjedno u bilo kojem trenutku tijekom liječenja bio je ispod 4%.
English: GLP-1 is a physiological regulator of appetite and food intake, but the exact mechanism of action is not entirely clear.
Croatian: GLP-1 je fiziološki regulator apetita i unosa hrane, no točan mehanizam njegovog djelovanja nije potpuno jasan.
English: Xultophy which has been frozen must not be used.
Croatian: Xultophy koji je bio zamrznut se ne smije primijeniti.
English: One study was further extended to 52 weeks.
Croatian: Jedno ispitivanje je dodatno produljeno na 52 tjedna.
English: Look through the pen window.
Croatian: Pogledajte kroz prozorčić na brizgalici.
English: • beta-blockers - for high blood pressure.
Croatian: • beta-blokatore - za visoki krvni tlak.
English: The MAH shall agree the final content and modality of distribution for the educational materials together with a communication plan, with the National Competent Authority in each Member State prior to distribution of the educational materials in the Member State.
Croatian: Nositelj odobrenja će konačan sadržaj i način distribucije edukacijskih materijala, zajedno s komunikacijskim planom, dogovoriti s nacionalnim nadležnim tijelom u pojedinoj državi članici prije distribucije edukacijskih materijala u toj državi članici.
English: • get an infection or a fever
Croatian: • dobijete infekciju ili vrućicu
English: What others need to do if you pass out:
Croatian: Što drugi moraju napraviti ako izgubite svijest:
English: ATC code: A10AE56
Croatian: ATK oznaka: A10AE56.
English: • Always follow your doctor's advice for dose and dose adjustment.
Croatian: • Uvijek se pridržavajte savjeta svog liječnika o dozi i podešavanju doze.
English: After first opening: Use within 21 days
Croatian: Nakon prvog otvaranja: upotrijebiti unutar 21 dana.
English: Date of first authorisation: 18 September 2014 Date of latest renewal: 08 July 2019
Croatian: Datum posljednje obnove odobrenja: 8. srpnja 2019.
English: The efficacy and safety of Xultophy were sustained up to 52 weeks of treatment.
Croatian: Djelotvornost i sigurnost lijeka Xultophy održale su se do 52 tjedna liječenja.
English: It might lead to crossinfection.
Croatian: To bi moglo dovesti do križnih infekcija.
English: • a reminder of the need to report all medication errors irrespective of whether or not they resulted in an adverse event.
Croatian: • podsjetnik o tome da je potrebno prijaviti svaku medikacijsku pogrešku, bez obzira na to je li za posljedicu imala nuspojavu.
English: • exercise less than usual
Croatian: • vježbate manje nego obično
English: This also applies when administration at the same time of the day is not possible.
Croatian: To se također odnosi na slučajeve kada primjena u isto doba dana nije moguća.
English: Nausea was reported in 7.8% of patients and was transient in nature for most patients.
Croatian: Mučnina je prijavljena u 7,8% bolesnika i bila je prolazne prirode kod većine bolesnika.
English: Further important information • Always keep an extra pen and new needles, in case of loss or damage.
Croatian: Dodatne važne informacije • Uvijek trebate imati dodatnu brizgalicu i nove igle, za slučaj da izgubite ili oštetite one koje koristite.
English: • other medicines for diabetes (tablets or injections)
Croatian: • druge lijekove za šećernu bolest (tablete ili injekcije)
English: These reactions were usually mild and transitory and they normally disappear during continued treatment.
Croatian: Te reakcije su obično bile blage i prolazne te su normalno nestale tijekom daljnjeg liječenja.
English: • If the pen is damaged or has not been stored correctly (see section 5).
Croatian: • ako je brizgalica oštećena ili nije ispravno čuvana (vidjeti dio 5).
English: Local tolerance was assessed in rabbits and pigs.
Croatian: Lokalna podnošljivost ispitivana je u kunića i svinja.
English: Do not stop using Xultophy without talking to your doctor.
Croatian: Nemojte prestati primjenjivati Xultophy bez razgovora sa svojim liječnikom.
English: • To see precisely how much solution is left, use the dose counter:
Croatian: • Da biste točno vidjeli koliko je otopine preostalo, koristite brojčanik doze:
English: • If the liquid you can see through the pen window does not look clear and colourless.
Croatian: • ako tekućina koju možete vidjeti kroz prozorčić na brizgalici nije bistra i bezbojna.
English: • not give you any food or drink - because you may choke.
Croatian: • odmah zatražiti medicinsku pomoć • ne davati Vam nikakvu hranu ili piće - jer biste se mogli ugušiti.
English: • sulfonamides - for infections
Croatian: • sulfonamide - za infekcije
English: It is therefore recommended that the patient always carries sugar-containing products
Croatian: Stoga se bolesniku preporučuje da sa sobom uvijek nosi proizvode koji sadrže šećer.
English: • If you need more medicine than what is left in your pen, you can split your dose between two pens.
Croatian: • Ako trebate više lijeka od preostalog u Vašoj brizgalici, svoju dozu možete podijeliti između dvije brizgalice.
English: Time since randomisation (week)
Croatian: Vrijeme od randomizacije (tjedni)
English: Your medicine might be harmful to their health.
Croatian: Vaš lijek može naštetiti njihovu zdravlju.
English: Pay special attention to these notes as they are important for safe use of the pen.
Croatian: Važne informacije Posvetite posebnu pozornost ovim napomenama jer su važne za sigurnu uporabu brizgalice.
English: Important things to know while you are using this medicine:
Croatian: Važne stvari koje morate znati dok primjenjujete ovaj lijek:
English: • Cardiovascular Safety
Croatian: • Kardiovaskularna sigurnost
English: If you discover that you missed your previous dose when it is time to take your next regular scheduled dose, do not take a double dose.
Croatian: Ako primijetite da ste izostavili prethodnu dozu u vrijeme kada trebate primijeniti sljedeću redovnu dozu, nemojte primijeniti dvostruku dozu.
English: If there is still no drop, change the needle and repeat steps 2A to 2C once more.
Croatian: Ako se kapljica i dalje ne pojavi, promijenite iglu i ponovite korake 2A do 2C još jednom.
English: • Never share your needles with other people.
Croatian: • Nikada ne dijelite svoje igle s drugim osobama.
English: Detailed instructions for use are on the other side of this leaflet.
Croatian: Detaljne upute za uporabu nalaze se na poleđini ove upute.
English: If no drop appears, repeat steps 2A to 2C up to 6 times.
Croatian: Ako se kapljica ne pojavi, ponovite korake 2A do 2C do 6 puta.
English: Do not attach a new needle to your pen until you are ready to take your injection.
Croatian: Ne pričvršćujte novu iglu na brizgalicu dok niste spremni za primjenu injekcije.
English: In both groups 66%-67% achieved HbA1c < 7%.
Croatian: U obje je skupine 66% do 67% bolesnika postiglo HbA1c < 7%.
English: • Serious allergic reaction (anaphylactic reaction) (not known: frequency cannot be estimated from the available data).
Croatian: • ozbiljna alergijska reakcija (anafilaktička reakcija) (nepoznato: učestalost se ne može procijeniti iz dostupnih podataka)
English: • If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
Croatian: • Ako se na brojčaniku doze ne pojavi 0 nakon neprestanog pritiskanja gumba za doziranje, možda ste koristili začepljenu ili oštećenu iglu.
English: After first opening, the medicinal product can be stored for 21 days at a maximum temperature of 30°C.
Croatian: Nakon prvog otvaranja, lijek se može čuvati 21 dan na maksimalnoj temperaturi od 30ºC.
English: • danazol - medicine affecting ovulation
Croatian: • danazol - lijek koji utječe na ovulaciju
English: Liraglutide (Victoza)
Croatian: Liraglutid (Victoza)
English: This is because improvement in your blood sugar may not happen straight away.
Croatian: To je zato jer se regulacija šećera u krvi možda neće odmah poboljšati.
English: • you have had low blood sugar a few times recently.
Croatian: • ste u zadnje vrijeme nekoliko puta imali nisku razinu šećera u krvi.
English: The educational materials should contain: - Summary of product characteristics and package leaflet; - Healthcare professional brochure that should contain the following key elements:
Croatian: Edukacijski materijali moraju sadržavati: - Sažetak opisa svojstava lijeka i uputu o lijeku; - Brošuru za zdravstvene radnike koja mora sadržavati sljedeće ključne elemente:
English: Before you use Xultophy for the first time, your doctor or nurse will show you how to inject.
Croatian: Prije prve primjene lijeka Xultophy, Vaš liječnik ili medicinska sestra pokazat će Vam kako injicirati.
English: • a clear explanation of the posology of the product and the meaning of ‘dose steps' - with reference to dose of each component for each dose step
Croatian: • jasno objašnjeno doziranje lijeka i značenje pojma „odmjerni koraci” - uz navođenje doze svake komponente u svakom odmjernom koraku
English: Xultophy contains two active substances that help your body control your blood sugar:
Croatian: Xultophy sadrži dvije djelatne tvari koje pomažu Vašem tijelu regulirati razinu šećera u krvi:
English: • Change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting (see section 4).
Croatian: • Svaki dan promijenite mjesto injiciranja unutar područja u koje injicirate kako biste smanjili rizik od stvaranja kvržica i ulegnuća na koži (vidjeti dio 4).
English: If you drink alcohol, your need for Xultophy may change.
Croatian: Ako pijete alkohol, Vaša potreba za lijekom Xultophy može se promijeniti.
English: • if you are allergic to insulin degludec or liraglutide or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na degludek inzulin ili liraglutid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Never try to put the inner needle cap back on the needle.
Croatian: Nikada ne pokušavajte vratiti unutarnji zatvarač igle natrag na iglu.
English: If the dose counter does not return to 0, the full dose has not been delivered, which may lead to high blood sugar level.
Croatian: Ako se brojčanik doze ne vrati na 0, nije isporučena cijela doza, što može dovesti do visoke razine šećera u krvi.
English: The medicinal product should be discarded 21 days after first opening.
Croatian: Lijek treba baciti 21 dan nakon prvog otvaranja.
English: Insulins and analogues for injection, long-acting.
Croatian: Inzulini i analozi za injiciranje dugog djelovanja.
English: Octreotide and lanreotide - used for treatment of acromegaly (a rare illness with too much growth hormone).
Croatian: Oktreotid i lanreotid - koji se koriste za liječenje akromegalije (rijetka bolest koju karakterizira višak hormona rasta).
English: • if you have a severe stomach ache which does not go away, tell your doctor - this could be a sign of inflamed pancreas (acute pancreatitis).
Croatian: • ako imate jaku bol u trbuhu koja ne prolazi, obavijestite svog liječnika - to bi mogao biti znak upale gušterače (akutni pankreatitis).
English: Taking the wrong medicine could be harmful to your health.
Croatian: Primjena pogrešnog lijeka može naštetiti Vašem zdravlju.
English: • have eye problems.
Croatian: • ako imate problema s očima.
English: • does not make enough insulin to control the level of sugar in your blood or
Croatian: • ne stvara dovoljno inzulina za regulaciju razine šećera u krvi ili
English: If blood appears at the injection site, press lightly.
Croatian: Ako se na mjestu injiciranja pojavi krv, lagano pritisnite.
English: If you select a wrong dose, you can turn the dose selector forward or backward to the correct dose.
Croatian: Ako ste odabrali pogrešnu dozu, možete okretati izbornik doze unaprijed ili unazad do ispravne doze.
English: Warfarin or other blood thinners - medicines used to prevent clotting of the blood.
Croatian: Varfarin ili drugi lijekovi za razrjeđivanje krvi - lijekovi koji se koriste za sprječavanje zgrušavanja krvi.
English: Hallas Alle, Kalundborg, 4400, Denmark Novo Nordisk A/S
Croatian: Hallas Alle, Kalundborg, 4400, Danska
English: Inform your doctor straight away if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Croatian: Odmah obavijestite svog liječnika ako osjetite znakove zatajivanja srca kao što je neuobičajen nedostatak zraka ili naglo povećanje tjelesne težine ili lokalizirano oticanje (edem).