FrancophonIA/ELRC3.0 huggingface dataset:
English: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Copalia HCT 10 mg/320 mg/25 mg filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: EU/1/09/575/026 28 film-coated tablets
Croatian: EU/1/09/575/026 28 filmom obloženih tableta
English: EU/1/09/575/019 280 film-coated tablets
Croatian: EU/1/09/575/019 280 filmom obloženih tableta
English: EU/1/09/575/049 14 film-coated tablets
Croatian: EU/1/09/575/049 14 filmom obloženih tableta
English: EU/1/09/575/055 280 film-coated tablets
Croatian: EU/1/09/575/055 280 filmom obloženih tableta
English: EU/1/09/575/030 98 film-coated tablets
Croatian: EU/1/09/575/030 98 filmom obloženih tableta
English: EU/1/09/575/027 30 film-coated tablets
Croatian: EU/1/09/575/027 30 filmom obloženih tableta
English: EU/1/09/575/001 14 film-coated tablets
Croatian: EU/1/09/575/001 14 filmom obloženih tableta
English: Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.
Croatian: Zbog ograničenog broja dostupnih podataka u ovoj populaciji bolesnika, u starijih bolesnika se preporučuje oprez, uključujući češće praćenje krvnog tlaka, posebno pri najvišoj dozi Copalia HCT-a, 10 mg/320 mg/25 mg.
English: EU/1/09/575/052 56 film-coated tablets
Croatian: EU/1/09/575/052 56 filmom obloženih tableta
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan, and 25 mg hydrochlorothiazide.
Croatian: Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 320 mg valsartana i 25 mg hidroklorotiazida.
English: EU/1/09/575/029 90 film-coated tablets
Croatian: EU/1/09/575/029 90 filmom obloženih tableta
English: EU/1/09/575/005 90 film-coated tablets
Croatian: EU/1/09/575/005 90 filmom obloženih tableta
English: EU/1/09/575/038 28 film-coated tablets
Croatian: EU/1/09/575/038 28 filmom obloženih tableta
English: EU/1/09/575/025 14 film-coated tablets
Croatian: EU/1/09/575/025 14 filmom obloženih tableta
English: EU/1/09/575/003 30 film-coated tablets
Croatian: EU/1/09/575/003 30 filmom obloženih tableta
English: EU/1/09/575/053 90 film-coated tablets
Croatian: EU/1/09/575/053 90 filmom obloženih tableta
English: EU/1/09/575/037 14 film-coated tablets
Croatian: EU/1/09/575/037 14 filmom obloženih tableta
English: EU/1/09/575/014 28 film-coated tablets
Croatian: EU/1/09/575/014 28 filmom obloženih tableta
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Croatian: Copalia HCT 10 mg/160 mg/25 mg filmom obložene tablete su žuto-smeđe, ovalne tablete s oznakom „NVR“ na jednoj strani i „VHL“ na drugoj strani.
English: EU/1/09/575/017 90 film-coated tablets
Croatian: EU/1/09/575/017 90 filmom obloženih tableta
English: Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Croatian: Hipromeloza zamjenski tip 2910 (3 mPas) makrogol 4000 talk titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: EU/1/09/575/039 30 film-coated tablets
Croatian: EU/1/09/575/039 30 filmom obloženih tableta
English: EU/1/09/575/015 30 film-coated tablets
Croatian: EU/1/09/575/015 30 filmom obloženih tableta
English: EU/1/09/575/051 30 film-coated tablets
Croatian: EU/1/09/575/051 30 filmom obloženih tableta
English: EU/1/09/575/044 56 x 1 film-coated tablet (unit dose) EU/1/09/575/045 98 x 1 film-coated tablet (unit dose) EU/1/09/575/046 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/575/044 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/045 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/046 280 x 1 filmom obloženih tableta (jedinična doza)
English: EU/1/09/575/002 28 film-coated tablets
Croatian: EU/1/09/575/002 28 filmom obloženih tableta
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Copalia HCT 5 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: EU/1/09/575/013 14 film-coated tablets
Croatian: EU/1/09/575/013 14 filmom obloženih tableta
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Copalia HCT 5 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: EU/1/09/575/032 56 x 1 film-coated tablet (unit dose) EU/1/09/575/033 98 x 1 film-coated tablet (unit dose) EU/1/09/575/034 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/575/032 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/033 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/034 280 x 1 filmom obloženih tableta (jedinična doza)
English: EU/1/09/575/008 56 x 1 film-coated tablet (unit dose) EU/1/09/575/009 98 x 1 film-coated tablet (unit dose) EU/1/09/575/010 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/575/008 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/009 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/010 280 x 1 filmom obloženih tableta (jedinična doza)
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Copalia HCT 10 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: EU/1/09/575/028 56 film-coated tablets
Croatian: EU/1/09/575/028 56 filmom obloženih tableta
English: EU/1/09/575/056 56 x 1 film-coated tablet (unit dose) EU/1/09/575/057 98 x 1 film-coated tablet (unit dose) EU/1/09/575/058 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/575/056 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/057 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/058 280 x 1 filmom obloženih tableta (jedinična doza)
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Copalia HCT 10 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Copalia HCT 5 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Copalia HCT 5 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Croatian: Copalia HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Copalia HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
English: EU/1/09/575/050 28 film-coated tablets
Croatian: EU/1/09/575/050 28 filmom obloženih tableta
English: EU/1/09/575/020 56 x 1 film-coated tablet (unit dose) EU/1/09/575/021 98 x 1 film-coated tablet (unit dose) EU/1/09/575/022 280 x 1 film-coated tablet (unit dose)
Croatian: EU/1/09/575/020 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/021 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/575/022 280 x 1 filmom obloženih tableta (jedinična doza)
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Croatian: Copalia HCT 10 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide.
Croatian: Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
English: No dose adjustment of Copalia HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Croatian: U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR >30 ml/min/1,73 m 2) dozu Copalia
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
Croatian: Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
English: EU/1/09/575/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/575/048 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/047 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: EU/1/09/575/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/575/060 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/059 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: EU/1/09/575/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/575/012 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/011 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: EU/1/09/575/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/575/036 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/035 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: EU/1/09/575/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Croatian: EU/1/09/575/024 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/575/023 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
English: Hypromellose, substitution type 2910 (3 mPa.s) Macrogol 4000
Croatian: Hipromeloza zamjenski tip 2910 (3 mPas) makrogol 4000 talk željezov oksid, žuti (E172)
English: It is available as capsules (150 mg).
Croatian: Dostupan je u obliku kapsula (150 mg).
English: The recommended dose is one capsule once a day.
Croatian: Preporučena je doza jedna kapsula na dan.
English: The full EPAR for Erivedge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Erivedge nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Around 33% (11 out of 33) of patients with metastatic disease and 48% (30 out of 63) of patients with locally advanced disease responded to treatment.
Croatian: Približno 33 % (11 od 33) bolesnika s metastatskom bolesti i 48 % (30 od 63) bolesnika s lokalno uznapredovalom bolesti reagiralo je na terapiju.
English: Erivedge was not compared with another treatment.
Croatian: Erivedge nije uspoređivan ni s jednom drugom terapijom.
English: What is Erivedge and what is it used for?
Croatian: Što je Erivedge i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Erivedge?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Erivedge?
English: The main measure of effectiveness was the response to treatment, based on reduction by at least 30% in tumour size or disappearance of all signs of cancer (the objective response rate).
Croatian: Glavna mjera djelotvornosti bio je odgovor na terapiju na temelju smanjenja veličine tumora od barem 30 % ili nestanka svih znakova karcinoma (objektivna stopa odgovora).
English: Erivedge was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Croatian: Lijeku Erivedge je prvotno izdano „uvjetno odobrenje” jer su se očekivali dodatni dokazi o lijeku.
English: The patients were given Erivedge until their disease got worse or they could no longer tolerate treatment or withdrew from the study.
Croatian: Bolesnici su dobivali Erivedge sve dok im se bolest nije pogoršala ili dok nisu mogli podnositi terapiju ili dok se nisu povukli iz ispitivanja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Erivedge on 12 July 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Erivedge u promet koje vrijedi na prostoru Europske unije od 12. srpnja 2013.
English: It also considered that the side effects were manageable.
Croatian: Smatra također da je nuspojave moguće kontrolirati.
English: This is a summary of the European public assessment report (EPAR) for Erivedge.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Erivedge.
English: The most common side effects with Erivedge (seen in more than 3 in 10 people) are muscle spasms, hair loss, taste disturbances, weight loss, tiredness, nausea (feeling sick) and diarrhoea.
Croatian: Najčešće nuspojave lijeka Erivedge (uočene u više od 3 na 10 osoba) su grčevi u mišićima, gubitak kose, poremećaj okusa, gubitak težine, umor, mučnina i proljev.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Croatian: Budući da je farmaceutska tvrtka dostavila dodatne potrebne podatke o lijeku, odobrenje je pretvoreno iz uvjetnog u potpuno.
English: Why is Erivedge approved?
Croatian: Zašto je lijek Erivedge odobren?
English: It is not intended to provide practical advice on how to use Erivedge.
Croatian: Svrha sažetka nije davati praktične savjete o načinu primjene lijeka Erivedge.
English: It is used to treat adults with basal cell carcinoma (a slow-growing form of skin cancer) in advanced stages: when the cancer is metastatic (has spread to other parts of the body) and is causing symptoms, or when it is locally advanced (has started to spread to nearby areas) and is not suitable for surgery or radiotherapy (treatment with radiation).
Croatian: Koristi se za liječenje odraslih osoba s karcinomom bazalnih stanica (sporo rastućim oblikom karcinoma kože) u uznapredovalim stadijima: kad je karcinom metastazirao (proširio se u druge dijelove tijela) te uzrokuje simptome ili kad je lokalno uznapredovao (počeo se širiti na obližnja područja) te nije prikladan za kirurško ili radioterapijsko liječenje (liječenje zračenjem).
English: Erivedge must not be used in women who are pregnant or breast-feeding, or who could potentially have children and do not comply with the special pregnancy prevention programme for Erivedge.
Croatian: Erivedge se ne smije koristiti u žena koje su trudne ili koje doje ili koje bi mogle zatrudnjeti, a koje ne primjenjuju poseban program prevencije trudnoće za Erivedge.
English: Erivedge was studied in one main study involving 104 patients with either metastatic or locally advanced basal cell carcinoma.
Croatian: Erivedge je proučavan u jednom glavnom ispitivanju koje je uključivalo 104 bolesnika s metastatskim ili lokalno uznapredovalim karcinomom bazalnih stanica.
English: The benefits of continuing treatment should be regularly assessed and the best duration of treatment will vary based on the benefit and side effects experienced by each patient.
Croatian: Potrebno je redovito procjenjivati dobrobiti od nastavka terapije, a optimalno trajanje liječenja varirat će ovisno o koristima i nuspojavama kod svakog bolesnika.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Erivedge's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Erivedge nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: What are the risks associated with Erivedge?
Croatian: Koji su rizici povezani s lijekom Erivedge?
English: The company will report any pregnancies that occur during treatment with Erivedge and will monitor their outcome.
Croatian: Tvrtka će prijaviti sve trudnoće koje nastupe tijekom liječenja lijekom Erivedge te će pratiti njihove ishode.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Erivedge have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Erivedge nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Since Erivedge disrupts the mechanism involved in the early development stages of unborn babies, the CHMP concluded that appropriate measures were needed for both men and women treated with Erivedge to prevent pregnancy during and after stopping treatment.
Croatian: S obzirom na to da Erivedge prekida mehanizam koji je uključen u rane razvojne stadije nerođene djece, CHMP je zaključio da su potrebne odgovarajuće mjere i za muškarce i za žene koji se liječe lijekom Erivedge za sprječavanje trudnoće tijekom i nakon prekida terapije.
English: Other information about Erivedge
Croatian: Ostale informacije o lijeku Erivedge:
English: The company will implement a pregnancy prevention programme, by providing educational materials on the risks to the unborn baby, including a reminder card, to patients and healthcare professionals who prescribe and dispense Erivedge.
Croatian: Tvrtka će uspostaviti program prevencije trudnoće osiguravanjem edukativnih materijala o rizicima za nerođeno dijete koji uključuju kartice s podsjetnikom za bolesnike i zdravstvene radnike koji će propisivati i izdavati lijek Erivedge.
English: It must not be used together with St John's wort (a herbal medicine used to treat depression).
Croatian: Ne smije se koristiti zajedno s gospinom travom (biljnim lijekom za liječenje depresije).
English: Erivedge is a cancer medicine that contains the active substance vismodegib.
Croatian: Erivedge je lijek protiv karcinoma koji sadrži djelatnu tvar vismodegib.
English: For more information about treatment with Erivedge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Erivedge pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Erivedge can only be obtained with a prescription.
Croatian: Lijek se izdaje samo na recept.
English: The Committee considered that the benefits of Erivedge had been shown for patients with locally advanced and metastatic disease.
Croatian: Odbor smatra da su koristi lijeka Erivedge dokazane za bolesnike s lokalno uznapredovalom metastatskom bolesti.
English: In basal cell carcinoma, the Hedgehog signalling pathway becomes abnormally active and leads to the growth and spread of the cancerous cells.
Croatian: Kod karcinoma bazalnih stanica, signalni put Hedgehog postaje nenormalno aktivan i uzrokuje rast i širenje kanceroznih stanica.
English: Vismodegib attaches to a protein called ‘SMO', which is involved in activating the Hedgehog signalling pathway.
Croatian: Vismodegib se veže za protein naziva „SMO” koji je uključen u aktivaciju signalnog puta Hedgehog.
English: By attaching to SMO, vismodegib blocks this pathway, thereby slowing down the growth and spread of the cancer cells in basal cell carcinoma.
Croatian: Vezivanjem na SMO vismodegib blokira taj put i tako usporava rast i širenje stanica karcinoma kod karcinoma bazalnih stanica.
English: How is Erivedge used?
Croatian: Kako se Erivedge koristi?
English: What benefits of Erivedge have been shown in studies?
Croatian: Koje su koristi lijeka Erivedge dokazane u ispitivanjima?
English: The active substance in Erivedge, vismodegib, disrupts the so-called ‘Hedgehog signalling pathway', which is normally involved in regulating the early stages of cell development in unborn babies and certain cell processes in adults.
Croatian: Djelatna tvar u lijeku Erivedge, vismodegib, prekida takozvani „signalni put Hedgehog”, koji je inače uključen u regulaciju ranih stadija razvoja stanice kod nerođene djece te u određene stanične procese u odraslih.
English: For practical information about using Erivedge, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Erivedge bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: It should only be prescribed by or under the supervision of a specialist doctor experienced in managing basal cell carcinoma.
Croatian: Smije ga propisati samo liječnik specijalist iskusan u liječenju karcinoma bazalnih stanica ili se lijek smije propisivati pod njegovim nadzorom.
English: For the full list of all side effects reported with Erivedge, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Erivedge potražite u uputi o lijeku.
English: How does Erivedge work?
Croatian: Kako djeluje Erivedge?
English: Milk: 7 days.
Croatian: Mlijeko: Sedam dana.
English: The mean half-life calculated is 20.41 days.
Croatian: Izračun srednjeg poluvijeka iznosi 20,41 dana.
English: It is normally used as the sulfate salt.
Croatian: Normalno se koristi kao sulfatna sol.
English: Repeated injections should be made at different injection sites.
Croatian: Ponovljene injekcije trebaju biti na različitim mjestima injiciranja.
English: This is not a standard approach and is not referred to in CVMP guidance.
Croatian: To nije standardan pristup i ne navodi se u smjernicama CVMP-a.
English: This withdrawal period includes a wide safety margin with regard to the available data.
Croatian: Ovo razdoblje karencije uključuje široku marginu sigurnosti s obzirom na dostupne podatke.
English: 1, it was not possible for Belgium to confirm that the withdrawal periods of 95 days for cattle and 60 days for pigs are safe.
Croatian: 1, Belgija nije mogla potvrditi da su razdoblja karencije od 95 dana za goveda i 60 dana za svinje sigurna.
English: Meat and offal: as recommended in the relevant sections of Annex III above.
Croatian: Meso i iznutrice: prema preporukama iz odgovarajućih odjeljaka prethodnog Priloga III.
English: Milk samples were collected up to 90 hours after the last administration.
Croatian: Uzorci mlijeka prikupljeni su do 90 sati nakon posljednje primjene.
English: No stability data were presented.
Croatian: Nisu dostavljeni podaci o stabilnosti.
English: DISTRIBUIDORA DE PROD. AGRO-PECUÁRIOS, SA Centro Empresarial da Rainha, Lote 27
Croatian: AGRO-PECUÁRIOS, SA Centro Empresarial da Rainha, Lote 27
English: It should be emphasised that the extrapolation method used is a pragmatic approach aimed at preserving product availability while in the same time ensuring consumer safety.
Croatian: Treba naglasiti da je primijenjena metoda ekstrapolacije praktičan pristup kojem je cilj održati dostupnost proizvoda i istodobno zajamčiti sigurnost potrošača.
English: Only two animals per slaughter point were involved.
Croatian: Bile su uključene samo dvije životinje po klanju.
English: The study design is in accordance with current standards.
Croatian: Izvedba ispitivanja u skladu je s postojećim standardima.
English: Poligono Industrial Vallecas 28031 Madrid Spain
Croatian: Poligono Industrial Vallecas 28031 Madrid