FrancophonIA/ELRC3.0 huggingface dataset:
English: Outcome of a procedure under Article 78 of Directive 2001/82/EC
Croatian: Ishod postupka u skladu s člankom 78. Direktive 2001/82/EZ
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 March 2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22. ožujka 2016.
English: Which data has the CVMP reviewed?
Croatian: Koje je podatke CVMP ponovno pregledao?
English: Accordingly, the CVMP was requested to give its opinion on the matter concerning animal safety.
Croatian: U skladu s time od CVMP-a je zatraženo mišljenje o pitanju koje se odnosi na sigurnost životinja.
English: It was also recommended that the suspension of the marketing authorisation for CLOSAMECTIN POURON SOLUTION POUR BOVINS in France be lifted.
Croatian: Također je preporučeno ukidanje suspenzije odobrenja za stavljanje u promet za CLOSAMECTIN POURON SOLUTION POUR BOVINS u Francuskoj.
English: Questions and answers on Closamectin Pour-On Solution and associated names EMA/672999/2015
Croatian: Pitanja i odgovori o otopini za polijevanje po koži Closamectin i srodnim lijekovima EMA/672999/2015
English: Between 25 May 2011 and 31 May 2015 the French medicines regulatory agency (Agence Nationale du Médicament Vétérinaire (ANMV)) received a total of 123 adverse event reports involving CLOSAMECTIN POUR-ON POUR BOVINS in which 401 animals were affected and 121 died.
Croatian: Između 25. svibnja 2011. i 31. svibnja 2015. francuska regulatorna agencija za lijekove (Agence Nationale du Médicament Vétérinaire (ANMV)) zaprimila je ukupno 123 izvješća o nuspojavama povezanima s lijekom CLOSAMECTIN POUR-ON POUR BOVINS pri čemu je 401 životinja zahvaćena, a 121 je preminula.
English: Although the overall incidence of adverse events was considered to be within acceptable limits (0.006% in the last annual periodic safety update report ) the continued occurrence of serious adverse events and the severity of subsequent losses on farms in France were considered significant, which led to the suspension of the marketing authorisation in France on 6 July 2015.
Croatian: Iako je zaključeno kako je ukupna incidencija nuspojava unutar prihvatljivih granica (0,006 % u posljednjem godišnjem izvješću o neškodljivosti), zaključeno je kako su nastavak pojave ozbiljnih nuspojava i ozbiljnost naknadnog gubitka na farmama u Francuskoj značajni, što je rezultiralo suspenzijom odobrenja za stavljanje u
English: The adverse events principally related to neurological signs (ataxia, recumbency, paresis/paralysis and blindness) and/or gastrointestinal disorders (diarrhoea, anorexia etc.) some of which had a fatal outcome.
Croatian: Nuspojave su u prvom redu obuhvaćale neurološke znakove (ataksija, ležanje, parezija/paraliza i sljepoća) i/ili gastrointestinalne poremećaje (proljev, anoreksija itd.) od kojih su pojedini imali smrtonosni ishod.
English: • conditions of the marketing authorisations concerning risk mitigation and surveillance measures.
Croatian: • uvjeti odobrenja za stavljanje u promet s obzirom na mjere ublažavanja rizika i nadzora.
English: On 19 June 2015, France triggered a procedure under Article 78 of Directive 2001/82/EC for Closamectin Pour-On Solution and associated names following evaluation of pharmacovigilance data indicating serious concerns for animal safety and subsequent suspension of the marketing authorisation for the product.
Croatian: Francuska je 19. lipnja 2015. pokrenula postupak u skladu s člankom 78. Direktive 2001/82/EZ za otopinu za polijevanje po koži Closamectin i srodne lijekove nakon procjene farmakovigilancijskih podataka koji su ukazivali na ozbiljne zabrinutosti za sigurnost životinja te nakon suspenzije odobrenja za stavljanje tog proizvoda u promet.
English: Closamectin Pour-On Solution and associated names contain closantel and ivermectin and are authorised in several European Union (EU) Member States1 via decentralised and national procedures.
Croatian: Otopina za polijevanje po koži Closamectin i srodni lijekovi sadržavaju klozantel i ivermektin te su odobreni u nekoliko država članica Europske unije (EU)1 putem decentraliziranih i nacionalnih postupaka.
English: This included a review of scientific literature regarding the pharmacology and toxicology of ivermectin and closantel, cumulative pharmacovigilance experience following use of the products in the EU since 2009, a comparison with ivermectin-based products and with ivermectin/closantel injectable formulations held by the MAH, investigations carried out by the MAH to identify possible factors involved in reported adverse events and proposals for risk mitigation measures and actions.
Croatian: Ti podaci uključuju pregled znanstvene literature u vezi s farmakologijom i toksikologijom ivermektina i klozantela, kumulativnim farmakovigilancijskim iskustvom nakon primjene proizvoda u Europskoj uniji (EU) od 2009. godine, usporedbom s lijekovima koji se temelje na ivermektinu i injektivnim formulacijama ivermektina/klozantela koje u promet stavlja nositelj odobrenja, istraživanjima koje je proveo nositelj odobrenja kako bi identificirao moguće faktore uključene u prijavljivanje nuspojava i prijedloge za mjere za smanjivanje rizika i radnje.
English: To investigate the potential relation between the adverse events observed and Closamectin Pour-On Solution and associated names, the CVMP considered the data provided by the marketing authorisation holder (MAH).
Croatian: Kako bi istražio potencijalnu povezanost između primijećenih nuspojava i otopine za polijevanje po koži Closamectin, CVMP je razmotrio podatke koje je dostavio nositelj odobrenja za stavljanje u promet (MAH).
English: The products are effective for use in beef cattle for the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice.
Croatian: Proizvodi su djelotvorni za primjenu u stoke za liječenje miješanih infestacija trematodima (metilji) i nematodima ili artropodima uzrokovanih oblićima, plućnim crvima, očnim crvima, šugarcima, krpeljima i ušima.
English: On 8 October 2015, the European Medicines Agency (the Agency) completed a review of the animal safety of Closamectin Pour-On Solution and associated names.
Croatian: Europska agencija za lijekove (Agencija) dovršila je 8. listopada 2015. pregled sigurne primjene u životinja otopine za polijevanje po koži Closamectin i srodnih lijekova.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of Closamectin Pour-On Solution and associated names continue to outweigh their risks subject to:
Croatian: Na temelju procjene trenutačno dostupnih podataka i znanstvenih rasprava u Odboru, CVMP je zaključio da koristi otopine za polijevanje po koži Closamectin i srodnih lijekova i dalje nadmašuju s njima povezane, uz sljedeće uvjete:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Closamectin Pour-On Solution and associated names continue to outweigh their risks subject to variation of the marketing authorisations to include new adverse reactions and precautionary measures and conditions concerning risk mitigation and surveillance measures.
Croatian: Odbor za veterinarskomedicinske proizvode (CVMP) pri Agenciji zaključio je da koristi otopine za polijevanje po koži Closamectin i srodnih lijekova i dalje nadmašuju s njima povezane rizike, uz uvjet izmjene odobrenja za stavljanje u promet kako bi se uključile nove nuspojave i mjere opreza te uvjeti s obzirom na mjere ublažavanja rizika i nadzora.
English: The nature of the reported clinical signs was considered by ANMV to be indicative of the clinical signs associated with overdose toxicity of closantel.
Croatian: ANMV je zaključio kako priroda prijavljenih kliničkih znakova ukazuje na kliničke znakove povezane s trovanjem uslijed predoziranja klozantelom.
English: Questions and answers on Closamectin Pour-On Solution and associated names
Croatian: Pitanja i odgovori o otopini za polijevanje po koži Closamectin i srodnim lijekovima
English: Why were Closamectin Pour-On Solution and associated names reviewed?
Croatian: Zašto su otopina za polijevanje po koži Closamectin i srodni lijekovi ponovno pregledani?
English: What is Closamectin Pour-On Solution and associated names?
Croatian: Što su otopina za polijevanje po koži Closamectin i srodni lijekovi?
English: • variation of the marketing authorisations for Closamectin Pour-On Solution and associated names to amend the summary of product characteristics and package leaflet to include new precautionary measures and adverse reactions; and
Croatian: • izmjena odobrenje za stavljanje u promet otopine za polijevanje po koži Closamectin i srodnih lijekova kako bi se izmijenili sažetak opisa svojstava lijeka i uputa o lijeku te uključile nove mjere opreza i nuspojave te
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Gdje je to potrebno, informacije o lijeku mogu naknadno biti ažurirane od strane nadležnih tijela zemlje članice, u suradnji s referentnom zemljom članicom, i u skladu s postupcima opisanim u Poglavlju 4, Glave III, Direktive 2001/83/EZ.
English: The valid product information is the final version achieved during the Coordination group procedure.
Croatian: Valjane informacije o lijeku konačna su verzija proizvedena tijekom postupka Koordinacijske skupine.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ove informacije o lijeku rezultat su ishoda postupka upućivanja na koji se odnosi ova odluka Komisije.
English: • if you gave birth less than a few weeks ago.
Croatian: • ako ste rodili prije manje od nekoliko tjedana.
English: Changes generally remain within the normal laboratory range.
Croatian: Promjene uglavnom ostaju unutar normalnih laboratorijskih nalaza.
English: There was no significant effect of cool water on these parameters.
Croatian: Nije bilo značajnog utjecaja hladne vode na ove parametre.
English: The following interactions have been reported in the literature.
Croatian: Sljedeće interakcije bile su prijavljene u literaturi.
English: • This usually stops after the first few cycles.
Croatian: • Ono uobičajeno prestaje nakon nekoliko prvih ciklusa.
English: VTE may be fatal in 1-2% of cases.
Croatian: VTE može imati smrtni ishod u 1-2% slučajeva.
English: Current Cycle Next Cycle
Croatian: Trenutni ciklus Sljedeći ciklus
English: • Wait until you get your menstrual period.
Croatian: • Pričekajte dok ne dobijete menstruaciju.
English: • Sensitivity to sunlight.
Croatian: • osjetljivost na sunčevu svjetlost.
English: Change day adjustment
Croatian: Prilagodba dana izmjene
English: Symptoms most commonly occur in one eye:
Croatian: Simptomi koji najčešće nastaju u jednom oku:
English: Particularly important to consider if other risk factors also present.
Croatian: Osobito je važno razmotriti jesu li prisutni i drugi čimbenici rizika.
English: What EVRA is and what is it used for
Croatian: Što je EVRA i za što se koristi
English: The net effect of these changes may be clinically relevant in some cases.
Croatian: U nekim slučajevima neto učinak ovih promjena može biti klinički značajan.
English: • Talk to your doctor.
Croatian: • Razgovarajte sa svojim liječnikom.
English: These include medicines used for the treatment of:
Croatian: Oni uključuju lijekove koji se koriste za liječenje:
English: If this happens to you, talk to your doctor immediately.
Croatian: Ako Vam se to dogodi, odmah razgovarajte s liječnikom.
English: arm and stomach;
Croatian: ruku ili želudac;
English: Date of first authorisation: 22 August 2002.
Croatian: Datum prvog odobrenja: 22. kolovoza 2002.
English: • You have depression;
Croatian: • imate depresiju;
English: • Problems sleeping (insomnia)
Croatian: • problem sa spavanjem (nesanica)
English: In both cases, the number of VTEs per year is fewer than the number expected in women during pregnancy or in the postpartum period.
Croatian: U oba slučaja, broj slučajeva VTE u godinu dana manji je od broja koji se očekuje u žena tijekom trudnoće ili postpartalnog razdoblja.
English: • Take it off as soon as you remember.
Croatian: • Uklonite ga čim se sjetite.
English: How many patches to use
Croatian: Koliko flastera treba primijeniti
English: This may help prevent you from getting these spots or help prevent them from getting worse.
Croatian: To Vam može pomoći spriječiti nastanak tih mrlja ili može spriječiti njihovo pogoršanje.
English: Number of VTE events per 10,000 women in one year
Croatian: Broj VTE događaja na 10 000 žena u godinu dana
English: Chloasma is often not fully reversible.
Croatian: Kloazma često nije u potpunosti reverzibilna.
English: Clinical efficacy and safety Pearl Indices (see table):
Croatian: Klinička djelotvornost i sigurnost Pearlovi indeksi (vidjeti tablicu):
English: The safety and efficacy has been established in women aged 18 to 45 years.
Croatian: Sigurnost i djelotvornost utvrđene su u žena između 18 i 45 godina.
English: • Do not try to put a patch back on if:
Croatian: • Nemojte pokušavati ponovno zalijepiti flaster ako:
English: Particularly important in women with additional risk factors.
Croatian: Osobito važno kod žena s dodatnim čimbenicima rizika.
English: For more than 2 days (48 hours or more):
Croatian: Više od 2 dana (48 sati ili više):
English: • You may start this medicine right away.
Croatian: • Možete odmah početi primjenjivati ovaj lijek.
English: Date of latest renewal: 22 August 2012.
Croatian: Datum posljednje obnove odobrenja: 22. kolovoza 2012.
English: Before you start using EVRA you should read the information on blood clots in section 2.
Croatian: Prije nego što počnete primjenjivati EVRU trebate pročitati informacije o krvnim ugrušcima u dijelu 2.
English: Talk with your doctor before deciding to delay your period.
Croatian: Razgovarajte sa svojim liječnikom prije odluke o odgađanju menstruacije.
English: Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products.
Croatian: Liječnik će Vam propisati drugu vrstu kontraceptiva prije početka liječenja s ovim lijekovima.
English: • Keep using the patches even if you do not have sex very often.
Croatian: • Nastavite koristiti flastere čak i ako nemate vrlo česte spolne odnose.
English: Frequency MedDRA convention: 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: Učestalost javljanja nuspojava po MedDRA-i je sljedeća: vrlo često (≥ 1/10); često (≥ 1/100 to < 1/10); manje često (≥ 1/1000 to < 1/100); rijetko (≥ 1/10 000 to < 1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • During this week you are protected from getting pregnant only if you start your next patch on time.
Croatian: • Tijekom tog tjedna zaštićeni ste od trudnoće jedino ako stavite svoj sljedeći flaster na vrijeme.
English: Your doctor may need to adjust the dose of the other medicine.
Croatian: Liječnik će Vam možda morati prilagoditi dozu drugog lijeka.
English: Combined hormonal contraceptives and cancer
Croatian: Kombinirani hormonski kontraceptivi i rak
English: • Problems when wearing contact lenses
Croatian: • problemi s nošenjem kontaktnih leća
English: What are you possibly suffering from?
Croatian: Koji je mogući uzrok?
English: If this is the first time you are using EVRA, wait until the day you get your menstrual period.
Croatian: Ako je ovo prvi put da se koristite EVROM, pričekajte do dana dobivanja menstruacije.
English: See section “When you should not use EVRA”.
Croatian: Pogledajte dio “ Kad ne smijete primjenjivati EVRU”.
English: Safety was evaluated in 3,322 sexually active women who participated in three Phase III clinical trials, which were designed to evaluate contraceptive efficacy.
Croatian: Sigurnost primjene ispitana je u 3322 spolno aktivnih žena koje su sudjelovale u tri klinička ispitivanja faze III, u kojima se procjenjivala kontracepcijska djelotvornost.
English: This may include curettage.
Croatian: To može uključitivati i kiretažu.
English: • Swelling due to water retention in the body
Croatian: • oticanje zbog zadržavanja vode u tijelu
English: If EVRA has been taken according to the directions described in section 4.2, it is unlikely that the woman is pregnant.
Croatian: Ako je EVRA korištena prema uputama iz dijela 4.2, malo je vjerojatno da je žena trudna.
English: • You have a blood problem called porphyria;
Croatian: • imate poremećaj krvi koji se zove porfirija;
English: Sachets are packaged in a cardboard carton.
Croatian: Vrećice su pakirane u kartonsku kutiju.
English: • Never put the patch on your breasts.
Croatian: • Nikada ne stavljajte flaster na grudi.
English: • If you have been using this medicine correctly and you do not have a period, this does not necessarily mean that you are pregnant.
Croatian: • Ako ste ispravno koristili ovaj lijek i nemate menstruaciju, to ne znači nužno da ste trudni.
English: Do not use this medicine if any of the above applies to you.
Croatian: Nemojte koristiti ovaj lijek ako se bilo što od navedenog odnosi na Vas.
English: Vaginal bleeding may occur in some females.
Croatian: Vaginalno krvarenje može se pojaviti u nekih žena.
English: EVRA is intended for women of fertile age.
Croatian: EVRA je namijenjena ženama generativne dobi.
English: Enzyme induction may be observed after a few days of treatment.
Croatian: Indukcija enzima može biti zabilježena nakon nekoliko dana liječenja.
English: Do not put on a patch this week.
Croatian: Ovaj tjedan nemojte primijeniti flaster.
English: Recovery from blood clots is not always complete.
Croatian: Oporavak od krvnih ugrušaka ponekad nije potpun.
English: • You do not need to use extra contraception if you have an upset stomach.
Croatian: • ne morate koristiti dodatnu kontracepciju ako imate problema sa želucem.
English: Try not to touch the sticky surface.
Croatian: Izbjegavajte dodirivanje ljepljive površine.
English: All combined birth control pills have risks, which may lead to disability or death.
Croatian: Sve kombinirane kontracepcijske tablete sa sobom nose rizike, koji mogu dovesti do invalidnosti ili smrti.
English: Choose a place on your body to put the patch.
Croatian: Izaberite mjesto na tijelu na koje ćete staviti flaster.
English: • Do this no matter when your period begins or ends.
Croatian: • Učinite prema uputi bez obzira na to kada Vam menstruacija započne ili završi.
English: • Continue using this medicine and if the bleeding lasts more than the first three cycles, talk to your doctor or pharmacist.
Croatian: • Nastavite s upotrebom ovog lijeka, ali ako krvarenje traje više od prva tri ciklusa, razgovarajte o tome sa svojim liječnikom ili ljekarnikom.
English: Protect your skin from sunlight or ultraviolet radiation.
Croatian: Zaštitite svoju kožu od sunca i ultraljubičastog zračenja.
English: • If you forget to change your patch for more than 2 days, you may become pregnant.
Croatian: • Ako zaboravite promijeniti flaster više od 2 dana, možete ostati trudni.
English: Number of VTE events
Croatian: Broj VTE događaja
English: If you forget to change your patch for one or two days (up to 48 hours):
Croatian: Ako zaboravite promijeniti flaster jedan ili dva dana (do 48 sati):
English: Note: temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors
Croatian: Napomena: privremena imobilizacija uključujući putovanje avionom >4 sata također može biti čimbenik rizika za VTE, osobito u žena s drugim čimbenicima rizika.
English: • Week 4:
Croatian: • 4. tjedan:
English: • The patch is designed to stay in place during these types of activities.
Croatian: • Flaster je napravljen tako da ostane na mjestu za vrijeme tih aktivnosti.
English: Maximal enzyme induction is generally seen in about 10 days but may then be sustained for at least 4 weeks after the cessation of medicinal product therapy.
Croatian: Maksimalna indukcija enzima općenito je viđena nakon otprilike 10 dana, no može biti održana tijekom najmanje 4 tjedna nakon prestanka terapije lijekom.
English: Below 90 kg there was no association between body weight and pregnancy.
Croatian: Kod tjelesne težine manje od 90 kg nije bilo povezanosti između tjelesne težine i trudnoće.
English: The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
Croatian: Taj rizik ovisi o Vašem prirodnom riziku za VTE i vrsti kombiniranog hormonskog kontraceptiva koju uzimate.
English: Medical examination/consultation
Croatian: Medicinski pregled/savjetovanje
English: It is used to prevent pregnancy.
Croatian: Koristi se za sprječavanje trudnoće.
English: In case of minor skin irritation
Croatian: U slučaju manje nadraženosti kože
English: For example, it can cause a heart attack or a stroke.
Croatian: Na primjer, može uzrokovati srčani ili moždani udar.
English: However, this may be due to other causes including sexually-transmitted disease.
Croatian: Međutim, ova vrsta raka može biti posljedica i drugih uzroka, uključujući spolno prenosive bolesti.
English: Warnings and precautions Before using this medicine, you will need to see your doctor for a medical check-up.
Croatian: Upozorenja i mjere opreza Prije primjene ovog lijeka, morate posjetiti liječnika radi liječničkog pregleda.
English: This can cause bleeding inside the body with very bad pain in the stomach area.
Croatian: Oni mogu izazvati unutarnje krvarenje s vrlo jakim bolovima u području trbuha.
English: For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use EVRA”.
Croatian: Za dodatne informacije o različitim rizicima zbog uzimanja kombinirane hormonske kontracepcije, molimo pročitajte dio 2 “Što morate znati prije nego počnete primjenjivati EVRU”.
English: Use these stickers on your calendar to help you remember when to change your patch
Croatian: Zalijepite ove naljepnice na svoj kalendar kako biste lakše zapamtili kada je potrebno zamijeniti flaster
English: The relevance of these data for human exposure is unknown as these effects have been seen as related to well-known pharmacodynamic or species-specific actions.
Croatian: Nije poznata važnost ovih podataka za izloženost u ljudi, jer se smatra da su ovi učinci povezani s dobro poznatim farmakodinamičkim djelovanjem ili djelovanjem specifičnim za vrstu.
English: Prior to the initiation or reinstitution of EVRA a complete medical history (including family history) should be taken and pregnancy should be ruled out.
Croatian: Prije uvođenja ili ponovnog uvođenja EVRE, mora se uzeti cjelokupna povijest bolesti (uključujući obiteljsku anamnezu) i isključiti trudnoću.
English: • Check each day to make sure the patch has not fallen off.
Croatian: • Svaki dan provjerite da flaster nije otpao.
English: The most commonly reported adverse reactions in clinical trials were headache, nausea, and breast tenderness, occurring in approximately 21.0%, 16.6%, and 15.9% of patients, respectively.
Croatian: Najčešće prijavljene nuspojave u kliničkim ispitivanjima bile su glavobolja, mučnina i osjetljivost dojki, što se pojavilo u otprilike 21,0%; 16,6%, odnosno u 15,9% žena.
English: • if you are allergic to norelgestromin, ethinyl estradiol or any of the other ingredients of this medicine (listed in section 6);
Croatian: • ako ste alergični na norelgestromin, etinilestradiol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6);
English: Everyday activities while using the patches
Croatian: Svakodnevne aktivnosti za vrijeme korištenja flastera
English: Because it contains two hormones, EVRA is called a ‘combined hormonal contraceptive'.
Croatian: Obzirom da sadrži dva hormona, EVRA se naziva “kombinirani hormonski kontraceptiv”.