FrancophonIA/ELRC3.0 huggingface dataset:
English: Published data from a field study using a pour-on deltamethrin product indicated that the effects of deltamethrin can persist for a number of weeks and have the potential to affect dung insect populations in some circumstances.
Croatian: Objavljeni podaci iz terenskih ispitivanja upotrebom proizvoda deltametrina za polijevanje ukazali su na to da učinak deltametrina može potrajati tjednima te da u određenim okolnostima ima potencijal utjecaja na populacije insekata koji se hrane otpadom.
English: Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands who considered no acceptable data in the environmental risk assessment has been provided on: n-octanol:water partition coefficient (KOW); soil adsorption coefficient (KOC); soil degradation; bioaccumulation (BCF); toxicity to dung insects, and therefore the environmental risk assessment cannot be finalised.
Croatian: Njemačka je identificirala moguće ozbiljan rizike tijekom decentraliziranog postupka kao i Nizozemska koja je smatrala da nisu predani prihvatljivi podaci o procjeni rizika za okoliš za: noktanol:koeficijent particije vode (KOW); koeficijent adsorpcije u tlu (KOC); degradacija u tlu; bioakumulacija (BCF); toksičnost za insekte koji se hrane otpadom i stoga nije moguće dovršiti procjenu rizika za okoliš.
English: The benefit of the products is that treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs can be carried out using the products.
Croatian: Dobrobit proizvoda je liječenje i prevencija infestacije ušima i buhama kod stoke; proizvodima je moguće je provesti udar na krpelje, uši i leteće muhe na ovcama te na uši i krpelje na janjadi.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the products.
Croatian: Ova procjena u skladu s člankom 33(4) Direktive 2001/82/EK načinjena je zbog zabrinutosti da podnositelj zahtjeva nije na zadovoljavajući način dokazao da je sigurnost proizvoda Deltanil 10 mg/ml otopine za polijevanje za stoku i ovce i Deltanil 100 mg otopine za nakapavanje za stoku zbog nedostatka ključnih podataka bez kojih nije moguće zaključiti o sigurnosti proizvoda za okoliš.
English: As the active substance is an ectoparasiticide a Phase II ERA was presented.
Croatian: S obzirom da je djelatna tvar ektoparaziticid, prikazane je faza II ERA-e.
English: Deltamethrin is used topically (dip, spray or pouron) for the control of ectoparasites in cattle and sheep.
Croatian: Deltametrin se koristi topikalno (umakanje, sprejanje ili polijevanje) za kontrolu ektoparazita u stoke i ovaca.
English: Overall deltamethrin was not considered to be a PBT compound.
Croatian: Ne smatra se da je ukupni PBT komponenta PBT-a.
English: An ERA was provided for the Deltanil products, which was in accordance with VICH and CVMP guidelines.
Croatian: Osigurana je ERA za Deltanil proizvode što je bilo u skladu sa VICH i CHMP smjernicama.
English: Based on acceptable published data for sediment species the RQ for sediment was <1.
Croatian: Na temelju prihvatljivih objavljenih podataka za vrste sedimenta, RQ za sediment bio je manje od 1.
English: Consequently in order to mitigate the risk for dung insects RMMs were included in the SPC in sections 4.5.iii and 5 (Environmental properties).
Croatian: Posljedično, kako bi se smanjio rizik za insektekoji se hrane otpadom, mjere za smanjenje rizika uključene su u Sažetak opisa svojstava u dijelove 4.5 iii 5 (Svojstva okoliša).
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Croatian: Konačni oblici Sažetka opisa svojstava, Označavanja i Upute o VMP postignuti su tijekom procedure sa Koordinacijskom grupom
English: The applications in question, submitted via the decentralised procedure, are generic applications according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose authorised in the United Kingdom.
Croatian: Dotični zahtjevi predani putem decentraliziranog postupka su generički zahtjevi u skladu s Čl. 13(3) Direktive 2001/82/EK i njenoj nadopuni odnose se na referentne kutanu otopinu za polijevanje tvrtke Pfizer Insecticide 1% w/v (masenog omjera) i njeni višedozni oblik koji su odobrene u Ujedinjenom Kraljevstvu.
English: The amended Summaries of Product Characteristics and package leaflets of the reference Member State are set out in Annex III.
Croatian: Promijenjeni Sažetak opisa svojstava veterinarsko-medicinskog proizvoda i uputa o VMP za referentnu državu članicu nalaze se u Prilogu III.
English: Comparison of the predicted environmental concentration (PEC) value for soil with the PNEC showed that the RQ for the soil compartment was <1 and no further assessment was required.
Croatian: Usporedba vrijednosti predviđene koncentracije u okolišu (PEC) za tlo s PNEC pokazala je da je RQ za odjeljak tla manji od 1 i da nisu potrebne daljnje procjene.
English: GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf
Croatian: GL6 i GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf
English: Deltamethrin residues will be introduced into the environment following direct excretion onto pasture.
Croatian: Rezidue deltametrina uvode se u okoliš nakon izravnog izlučivanja na pašnjak.
English: VICH GL38: Guideline on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines
Croatian: VICH GL38: Smjernica o procjeni utjecaja na okoliš za veterinarsko-medicinski proizvod faza II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 CVMP smjernice o procjeni utjecaja na okoliš za veterinarsko-medicinske proizvode kao potpora VICH smjernicama
English: Evaluation of secondary poisoning showed the risk quotient (RQ) values for terrestrial and aquatic predators were <1 and further assessment was not required.
Croatian: Procjena sekundarnog trovanja pokazala je da su vrijednosti kvocijenta rizika (RQ) za kopnene i morske grabežljivce manje od 1 i da nije potrebna daljnja procjena.
English: No further assessment of risks to surface water and sediment was necessary and no RMMs were needed.
Croatian: Nije bila potrebna daljnja procjena rizika za površinske vode i sediment te nisu bile potrebne mjere za smanjenje rizika.
English: 5 Environmental properties
Croatian: 5 Svojstva koja se tiču zaštite okoliša
English: The RMMs and warnings in the Summary of Product Characteristics (SPC) and package leaflet address the risk to dung insects by advising on the frequency of re-treatments and the duration of deltamethrin excretion.
Croatian: Mjere smanjenja rizika i upozorenja u Sažetku opisa svojstava veterinarsko-medicinskog proizvoda i Uputa o VMP obraćaju pozornost na rizik za insekte koji se hrane otpadom putem savjetovanja o učestalosti i ponovljenom liječenju te trajanju ekskrecije deltametrina.
English: These PNECs were compared with the PEC values (calculated using agreed methods) for surface water exposed via drainage through soil, via direct excretion by cattle and via loss from the fleece of sheep.
Croatian: Te vrijednosti PNEC bile su uspoređene s PEC vrijednostima (izračunate upotrebom dogovorene metode) za površinske vode izložene deltametrinu putem drenaže kroz
English: Add, where applicable, “Deltamethrin is toxic to aquatic organisms and honey bees and may accumulate in sediment.”
Croatian: Dodati u dio koji se navodi: “Deltametrin je otrovan za vodene životinje i pčele, te se nakuplja u tlu.“
English: Package leaflet:
Croatian: I sadržavaju ove dodatke:
English: A risk for dung insects was identified by the ERA and RMMs were proposed to address the risk.
Croatian: ERA je identificirala rizik za insekte koji se hrane otpadom te su predložene mjere za smanjenje rizika.
English: Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin, a synthetic pyrethroid.
Croatian: Deltanil 10 mg/ml otopina za polijevanje za stoku i ovce i Deltanil 100 mg otopina za nakapavanje za stoku sadrži deltametrin, sintetski piretroid.
English: Additionally, RMMs have been considered and proposed for the risk identified for dung insects.
Croatian: Osim toga, razmatrane su mjere za smanjenje rizika te su predložene mjere za identifikaciju rizika u insekata koji se hrane otpadom.
English: Therefore, the CVMP recommended the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle with amendment to the Summaries of Product Characteristics and package leaflets of the reference Member State.
Croatian: Stoga je CVMP preporučio davanje odobrenja za stavljanje u promet lijeka Deltanil 10 mg/ml otopina za polijevanje za stoku i ovce i Deltanil 100 mg otopina za nakapavanje za stoku uz promjenu Sažetka opisa svojstava veterinarsko-medicinskog proizvoda i Upute o VMP u referentnoj državi članici.
English: Spot-on solution Cattle
Croatian: Spot-on otopina Goveda
English: Add the following text in the relevant sections of the product information:
Croatian: Dodati slijedeći tekst: Sažetak opisa svojstava
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Croatian: Znanstveni zaključci i razlozi da davanje odobrenja za stavljanje u promet za Deltanil 10 mg/ml otopinu za polijevanje za stoku i ovce i Deltanil 100 mg otopina za nakapavanje za stoku
English: Evaluation of the benefit-risk balance
Croatian: Procjena odnosa dobrobiti i rizika
English: Route of administration
Croatian: Način i putevi primjene
English: Grounds for the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Croatian: Razlozi za davanje odobrenja za stavljanje u promet za Deltanil 10 mg/ml otopina za polijevanje za stoku i ovce i Deltanil 100 mg otopina za nakapavanje za stoku
English: On the basis of the ERA no other RMMs were proposed by the applicant.
Croatian: Podnositelj zahtjeva nije predložio nikakve druge mjere smanjenja rizika na temelju ERA-e.
English: Amendments in the relevant sections of the Summaries of Product Characteristics and package leaflets
Croatian: Dodatci u dijelovima Sažetka opisa svojstava i u Uputi o VMP
English: Overall summary of the scientific evaluation of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Croatian: Ukupni sažetak znanstvene procjene za Deltanil 10 mg/ml otopine za polijevanje za stoku i ovce te Deltanil 100 mg otopine za nakapavanje za stoku
English: The benefit-risk balance is considered positive for both Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Croatian: Omjer dobrobiti i rizika smatrao se pozitivnim i za Deltanil 10 mg/ml otopinu za polijevanje za stoku i ovce i za Deltanil otopinu za nakapavanje za stoku.
English: Applicant
Croatian: Topical use
English: Summary of Product Characteristics
Croatian: Naziv veterinarsko medicinskog proizvoda
English: Name
Croatian: Djelatna tvar
English: The full EPAR for Halaven can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Halaven nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as a solution for injection.
Croatian: Dostupan je kao otopina za injekciju.
English: Safety in this patient population was considered acceptable and similar to that in patients with breast cancer.
Croatian: Smatralo se da je sigurnost u ovoj populaciji bolesnika bila prihvatljiva i slična onoj u bolesnika s rakom dojke.
English: The calculated dose is given into a vein over two to five minutes on days 1 and 8 of each cycle.
Croatian: Preporučena doza daje se u venu tijekom dvije do pet minuta na 1. i 8. dana svakog ciklusa.
English: What measures are being taken to ensure the safe and effective use of Halaven?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Halaven?
English: The main measure of effectiveness was overall survival (how long the patients lived).
Croatian: Glavna mjera djelotvornosti bilo je ukupno preživljenje (koliko su dugo bolesnici živjeli).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Halaven on 17 March 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Halaven na snazi u Europskoj uniji od 17. ožujka 2011.
English: The most common side effects with Halaven (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), reduced appetite, peripheral neuropathy (damage to the nerves in the extremities causing numbness, tingling and prickling sensations), headache, dyspnoea (difficulty breathing), cough, nausea (feeling sick), constipation, diarrhoea, vomiting, alopecia (hair loss), muscle and joint pain or pain in the back or limbs, fatigue (tiredness), pyrexia (fever) and weight loss.
Croatian: Najčešće nuspojave povezane s lijekom Halaven (mogu se javiti u više od 1 na 10 bolesnika) su neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica koje se bore protiv infekcije), leukopenija (nizak broj leukocita), anemija (nizak broj eritrocita), smanjen apetit, periferna neuropatija (oštećenje živaca u ekstremitetima što uzrokuje obamrlost, žarenje i osjećaj bockanja), glavobolja, dispneja (otežano disanje), kašalj, mučnina (osjećaj muke), zatvor, proljev, povraćanje, alopecija (gubitak kose), bol u mišićima i zglobovima ili bol u leđima ili udovima, umor, pireksija (vrućica) i gubitak težine.
English: This is a summary of the European public assessment report (EPAR) for Halaven.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Halaven.
English: It is used in patients who have already been treated with anthracyclines (unless this treatment was not suitable).
Croatian: Koristi se u bolesnika koji su već liječeni antraciklinima (osim ako terapija nije bila prikladna).
English: Women in the Halaven group lived for an average of 13.1 months, compared with 10.6 months in the group that received other treatments.
Croatian: Žene u skupini koja je primala Halaven živjele su prosjeku 13,1 mjesec u usporedbi s 10,6 mjeseci u skupini koja je primala druge terapije.
English: Why has Halaven been approved?
Croatian: Zašto je Halaven odobren?
English: What is the risk associated with Halaven?
Croatian: Koji su rizici povezani s lijekom Halaven?
English: Halaven is given as intravenous (into a vein) injections over 21-day cycles.
Croatian: Halaven se daje intravenski (u venu) injekcijama tijekom ciklusa od 21 dan.
English: Doses may be delayed or reduced if patients have very low levels of neutrophils (a type of white blood cell) and platelets (components that help the blood to clot) in their blood or if liver or kidney function is impaired.
Croatian: Doze mogu biti odgođene ili smanjene ako bolesnici imaju vrlo niske razine neutrofila (vrste bijelih krvnih stanica) i trombocita (komponenti koje pomažu u zgrušavanju krvi) u njihovoj krvi ili ako je oštećena funkcija jetre ili bubrega.
English: Halaven was compared with dacarbazine (another cancer medicine), and the main measure of effectiveness was overall survival.
Croatian: Halaven je uspoređen s dakarbazinom (drugim lijekom protiv karcinoma) i glavna mjera djelotvornosti bilo je ukupno preživljenje.
English: The main measures of effectiveness were overall survival and progression-free survival (how long the patients lived without their disease getting worse).
Croatian: Glavne mjere djelotvornosti bile su ukupno preživljenje i preživljenje bez napredovanja bolesti (koliko su dugo bolesnici živjeli bez pogoršavanja bolesti).
English: It attaches to a protein in cells called tubulin, which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Croatian: Veže se za protein u stanicama zvani tubulin koji je važan u formiranju unutarnjeg „kostura” koji stanice trebaju kako bi se udružile prilikom diobe.
English: The active substance in Halaven, eribulin, is similar to an anticancer substance called halichondrin B, which is found in the marine sponge Halichondria okadai.
Croatian: Djelatna tvar u lijeku Halaven, eribulin, slična je tvari protiv karcinoma zvanoj halikodrin B koji se nalazi u morskoj spužvi Halichondria okadai.
English: A risk management plan has been developed to ensure that Halaven is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Halaven.
English: In breast cancer, Halaven was studied in two main studies involving a total of 1,864 patients.
Croatian: U vezi s rakom dojke, Halaven je proučavan u dvama glavnim ispitivanjima koja su obuhvatila ukupno 1 864 bolesnika.
English: Other information about Halaven
Croatian: Ostale informacije o lijeku Halaven
English: In the second study, there was no significant difference in the average progression-free survival with Halaven (4.1 months) compared with capecitabine (4.2 months) or in the average overall survival with Halaven (15.9 months) compared with capecitabine (14.5 months).
Croatian: U drugom ispitivanju nije bilo značajne razlike u prosječnom preživljenju bez napredovanja bolesti s lijekom Halaven (4,1 mjesec) u usporedbi s kapecitabinom (4,2 mjeseca) ili u prosječnom ukupnom preživljavanju s lijekom Halaven (15,9 mjeseci) u usporedbi s kapecitabinom (14,5 mjeseci).
English: In the first study, when comparing Halaven with all the other treatments grouped together, Halaven was shown to be more effective at prolonging life.
Croatian: U prvom ispitivanju, prilikom usporedbe lijeka Halaven sa svim drugim terapijama zajedno, Halaven se pokazao djelotvornijim u produljenju života.
English: The dose to be given is calculated using the patient's height and weight.
Croatian: Doza koje će se dati računa se uporabom površine bolesnikova tijela (izračunata uporabom bolesnikove težine i visine).
English: The third study showed that Halaven was effective at prolonging life in patients with liposarcoma: patients treated with Halaven lived for an average of 15.6 months, compared with 8.4 months for patients treated with dacarbazine.
Croatian: Treće ispitivanje pokazalo je da je Halaven djelotvoran u produljenju života u bolesnika s liposarkomom: bolesnici koji su primali Halaven živjeli su u prosjeku 15,6 mjeseci u usporedbi s 8,4 mjeseci za bolesnike koji su primali dakarbazin.
English: Doctors should consider giving patients an antiemetic (a medicine that prevents nausea and vomiting) as Halaven may cause nausea or vomiting.
Croatian: Liječnici trebaju razmotriti davanje antiemetičkog lijeka bolesniku (lijeka koji sprječava mučninu i povraćanje) jer Halaven može uzrokovati mučninu ili povraćanje.
English: Additionally, Halaven prolonged the length of time that liposarcoma patients lived, and this was considered important as these patients have limited treatment options.
Croatian: Osim toga, Halaven je produljio duljinu života bolesnika s liposarkomom, a to se smatra važnim jer su mogućnosti liječenja kod tih bolesnika ograničene.
English: For more information about treatment with Halaven, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Halaven pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: By attaching to tubulin in cancer cells, eribulin disrupts the formation of the skeleton, preventing the division and spread of the cancer cells.
Croatian: Vezivanjem za tubulin u stanicama karcinoma, eribulin prekida formiranje kostura i tako sprječava diobu i širenje stanica karcinoma.
English: For more details on the use of Halaven including recommendations on dose reduction, see the summary of product characteristics (also part of the EPAR).
Croatian: Za više pojedinosti o uporabi lijeka Halaven uključujući preporuke o smanjenju doze, vidjeti sažetak opisa svojstava lijeka (također dio EPAR-a).
English: Halaven treatment should be given under the supervision of a doctor experienced in the use of cancer medicines.
Croatian: Terapiju lijekom Halaven treba davati u specijaliziranim odjelima za liječenje karcinoma pod nadzorom liječnika iskusnog u uporabi lijekova protiv karcinoma.
English: The women were given either Halaven or another approved cancer medicine chosen by their doctor.
Croatian: Žene su primale ili Halaven ili drugi odobreni lijek protiv karcinoma koji je odabrao njihov liječnik.
English: Halaven is also used to treat adults with advanced or metastatic liposarcoma (a type of cancer of the soft tissues that develops from fat cells) that cannot be surgically removed.
Croatian: Halaven se koristi i za liječenje odraslih osoba s uznapredovalim ili metastatskim liposarkomom (vrstom karcinoma mekih tkiva koji se razvije iz masnih stanica) koji se ne može kirurški ukloniti.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Halaven.
Croatian: Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenio lijek Halaven da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje na tržište te preporuke o uvjetima za primjenu lijeka Halaven.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Halaven, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka, kao i u uputu o lijeku Halaven, nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The second study involved 1,102 patients with advanced or metastatic breast cancer, with one or two previous treatments for advanced/metastatic cancer including an anthracycline and a taxane.
Croatian: Drugo ispitivanje uključivalo je 1 102 bolesnika s uznapredovalim ili metastatskim karcinomom dojke, s jednom ili dvije prethodne terapije za uznapredovali/metastatski karcinom, uključujući antraciklin i taksan.
English: Halaven must not be used in women who are breastfeeding.
Croatian: Halaven ne smiju uzimati dojilje.
English: The study compared Halaven with capecitabine (another cancer medicine).
Croatian: U ispitivanju je Halaven uspoređen s kapecitabinom (drugim lijekom protiv karcinoma).
English: What is Halaven?
Croatian: Što je Halaven?
English: Halaven is a cancer medicine that contains the active substance eribulin.
Croatian: Halaven je lijek protiv karcinoma koji sadrži djelatnu tvar eribulin.