FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 4.4 - Special warnings and precautions
Croatian: Dio 4.4 - Posebna upozorenja i mjere opreza pri uporabi
English: The risk of muscle toxicity is increased when nicotinic acid is administered concomitantly with a statin (i.e. a 3-hydroxy-3- methylglutaryl coenzyme A [HMGCoA] reductase inhibitor).
Croatian: Rizik od mišićne toksičnosti povećan je kada se nikotinska kiselina primjenjuje istodobno sa statinom (tj. inhibitorom 3-hidroksi-3-metilglutarilkoenzim A [HMG-CoA] reduktaze).
English: This medicine contains acipimox, which is used to treat lipid disorders by reducing high blood levels of certain types of fats called triglycerides.
Croatian: Ovaj lijek sadrži acipimoks, koji se koristi za liječenje poremećaja lipida tako što smanjuje visoke razine određenih vrsta masnoća u krvi koje se nazivaju trigliceridima.
English: [Product name] capsules should be used in addition to other medicines, such as medicines called ‘statins' or ‘fibrates' or instead of these medicines where they may not be appropriate or of expected benefit.
Croatian: [Ime lijeka] kapsule treba primijeniti kao dodatak uz druge lijekove, kao što su lijekovi koji se nazivaju ‘statini' ili ‘fibrati', ili umjesto tih lijekova kada oni možda nisu prikladni ili kada se od njih ne očekuje korist.
English: In one study, Chinese patients taking nicotinic acid plus laropiprant concomitantly with simvastatin were reported to have a higher incidence of myopathy and rhabdomyolysis compared to Caucasians.
Croatian: U jednom je ispitivanju prijavljeno da su kineski bolesnici koji su uzimali nikotinsku kiselinu plus laropiprant istodobno uz simvastatin imali višu incidenciju miopatije i rabdomiolize u usporedbi s bolesnicima bijele rase.
English: [Product name] is indicated as alternative or adjunct treatment to reduce triglyceride levels in patients who have not responded adequately to other treatments such as statin or fibrate treatment for:
Croatian: [Ime lijeka] je indiciran kao zamjena ili dodatak u liječenju za smanjivanje razina triglicerida u bolesnika koji nisu adekvatno odgovorili na druga liječenja kao što su liječenje statinima ili fibratima kod:
English: It has not been shown that treatment of hyperlipoproteinaemia with acipimox leads to a reduction of cardiac morbidity or mortality.
Croatian: Nije se pokazalo da liječenje hiperlipoproteinemije acipimoksom dovodi do smanjenja srčanog morbiditeta i mortaliteta.
English: [Product name] should be used after other measures have been taken such as dietary changes and other non-pharmacological treatment (e.g. exercise, weight reduction).
Croatian: [Ime lijeka] treba primijeniti nakon što su poduzete druge mjere poput promjena u prehrani i drugog nefarmakološkog liječenja (npr. vježbanje, smanjenje težine).
English: • hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia);
Croatian: • hipertrigliceridemije (hiperlipoproteinemije tipa IV po Fredricksonu);
English: [Product name] capsules prevent the release of fatty acids from fatty tissue and decrease the blood level of triglycerides and cholesterol.
Croatian: [Ime lijeka] kapsule sprječavaju oslobađanje masnih kiselina iz masnog tkiva i smanjuju razinu triglicerida i kolesterola u krvi.
English: [Product name] capsules should only be used in patients where diet alone or other non-drug measures (weight loss or exercises) failed to correct the levels of these fats.
Croatian: [Ime lijeka] kapsule smiju se primjenjivati samo u bolesnika kada sama promjena prehrane ili druge mjere bez lijekova (gubitak težine ili vježbanje) nisu bile učinkovite u ispravljanju razina tih masnoća.
English: • hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia).
Croatian: • hiperkolesterolemije i hipertrigliceridemije (hiperlipoproteinemije tipa
English: Acipimox is structurally related to nicotinic acid.
Croatian: U ovom dijelu potrebno je umetnuti tekst u nastavku Acipimoks je strukturno povezan s nikotinskom kiselinom.
English: Summary of Product Characteristics
Croatian: Sažetak opisa svojstava lijeka
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Croatian: Izmjene i nadopune značajnih dijelova sažetka opisa svojstava lijeka i uputa o lijeku
English: Package leaflet
Croatian: Dodatak III
English: Member State EU/EEA
Croatian: Zemlja članica EU/EEA
English: Add, to all products:
Croatian: Dodati, svim proizvodima:
English: Postępu 17 B 02-676 Warszawa POLAND
Croatian: Postępu 17 B 02-676 Warszawa POLJSKA
English: 00330 Helsinki FINLAND
Croatian: 00330 Helsinki FINSKA
English: 2909 LD Capelle a/d IJssel THE NETHERLANDS
Croatian: 2909 LD Capelle a/d IJssel NIZOZEMSKA
English: Therefore, this scenario was not considered for sheep.
Croatian: Stoga, ovaj scenarij nije uzet u obzir u slučaju ovaca.
English: Kennedy L-1855 Luxembourg LUXEMBOURG
Croatian: Kennedy L-1855 Luksemburg LUKSEMBURG
English: The figure of 66 days was rounded up to 70 days, to bring it into line with the figure recommended for cattle.
Croatian: Brojka od 66 dana zaokružena je na 70 dana kako bi se uskladila s brojkom preporučenom za goveda.
English: Consumer safety
Croatian: Sigurnost potrošača
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Croatian: Oba spoja dijele zajednički široki spektar antiparazitnog djelovanja, te proizvode slične paralize u nematoda i parazitskih artropoda.
English: 35396 Gießen GERMANY
Croatian: 35396 Gießen NJEMAČKA
English: Name
Croatian: Ime
English: This is a likely source of the variation in the observed residue levels.
Croatian: Ovo je izgledan izvor varijacija u uočenim razinama rezidua.
English: Discussion
Croatian: Rasprava
English: Applicant/marketing authorisation holder
Croatian: Podnositelji/nositelji odobrenja za stavljanje u promet
English: Amend where applicable:
Croatian: Dodati gdje je primjenjivo:
English: Several studies in cattle were provided.
Croatian: Dostavljeno je nekoliko ispitivanja provedenih u goveda.
English: According to the VICH Guideline 38 Phase II, a Tier B assessment is required.
Croatian: Sukladno smjernici VICH 38 za fazu II, potrebna je procjena u stupnju B.
English: This period was also considered sufficiently conservative for use in reindeer.
Croatian: Ovo se razdoblje smatra dovoljno konzervativnim za primjenu u jelena.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Croatian: Lista imena, farmaceutskih oblika, jačina veterinarsko medicinskog proizvoda, vrste životinja, putevi primjene, podnositelji/nositelji odobrenja za stavljanje u promet u zemljama članicama
English: Pfizer Corporation Austria Gesellschaft m.b.H.
Croatian: Pfizer Corporation Austrija Gesellschaft m.b.H.
English: PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GREECE
Croatian: PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GRČKA
English: Whereas:
Croatian: Budući da:
English: Like other macrocyclic lactones, doramectin has the potential to adversely affect non-target organisms.
Croatian: Poput drugih makrocikličkih laktona, doramektin ima mogućnost negativnog učinka na ne-ciljne životinje.
English: For cattle it was considered that the standard 2 month period between treatment and calving could be accepted.
Croatian: U slučaju goveda zaključeno je da je standardno razdoblje od 2 mjeseca između liječenja i teljenje prihvatljivo.
English: Czech republic Pfizer Limited Veterinary Medical Research & Development
Croatian: Rumunjska Pfizer Limited Veterinary Medical Research & Development
English: By applying this ratio to milk and using 6 µg as the total amount of doramectin residues that can be considered safe in 1.5 litres of milk (i.e. the amount of milk considered to be consumed on a daily basis), one can calculate the concentration of doramectin in milk that can be considered safe to be 3.44 µg/l (6 µg x 0.86/1.5 l).
Croatian: Primjenom ovog omjera na mlijeko i uporabom 6 µg kao ukupne količine rezidua doramektina, koja se može smatrati sigurnom u 1,5 litre mlijeka (odnosno količini mlijeka koja se smatra sigurnom za konzumaciju na dnevnoj bazi), može se izračunati koncentracija doramektina u mlijeku, koja se može smatrati sigurnom, te ta koncentracija iznosi 3.44 µg/l (6 µg x 0.86/1.5 l).
English: Other precautions
Croatian: Ostale mjere opreza
English: The supplementary data provided did not allow ruling out a medium to long-term risk to dung insects.
Croatian: Dostavljeni dopunski podaci nisu dozvolili isključivanje srednjoročnog i dugoročnog rizika za insekte prisutne u gnoju.
English: The current data package does not allow the assessment of bioaccumulation and therefore, bioaccumulation of doramectin cannot be ruled out.
Croatian: Trenutni paket podataka ne omogućuje procjenu bioakumulacije, zato nije moguće isključiti bioakumulaciju doramektina.
English: Following treatment, excretion of potentially toxic levels of doramectin may take place over a period of several weeks.
Croatian: Nakon liječenja može doći do ekskrecije potencijalno toksičnih razina doramektina tijekom razdoblja od nekoliko tjedana.
English: 13 Rue Pages 92158 Suresnes Cedex FRANCE
Croatian: Lilly Francuska 13 Rue Pages 92158 Suresnes Cedex FRANCUSKA
English: Meat and offal: 70 days
Croatian: Meso i jestive iznutrice: 70 dana
English: Meat and offal: 77 days
Croatian: Meso i jestive iznutrice: 77 dana
English: Pour-on solution topical - on the back of the animal
Croatian: Poliv, otopina na kožu - na leđa životinje
English: The MRLs currently established for doramectin in tissues use 90% (60 μg/person per day) of the ADI, leaving 10% (6 μg) available to cover exposure to residues resulting from other sources, such as via milk.
Croatian: MRL trenutačno utvrđeni za doramektin u tkivu koriste 90% (60 μg/osobi po danu) ADI, čime preostaje samo 10% (6 μg) za pokrivanje izlaganja reziduima, koji potječu iz drugih izvora, poput primjerice mlijeka.
English: Labelling:
Croatian: Označavanje:
English: Pfizer Trading Polska s.p. z o.o.
Croatian: Pfizer Trading Polska s.p. z o.o. ul.
English: Pfizer Luxembourg SARL 51, Avenue J.F.
Croatian: Pfizer Luksemburg SARL 51, Avenue J.F.
English: Residue data
Croatian: Podaci o reziduima
English: It should be noted that due to the absence of a maximum residue limit (MRL) in milk the veterinary medicinal products containing doramectin are not authorised for use in lactating animals.
Croatian: Potrebno je navesti da zbog izostanka maksimalne razine rezidua (MRL) u mlijeku, VMP koji sadrže doramektin nisu odobreni za uporabu u životinja u laktaciji.
English: However, study results were highly variable (the studies predate the current CVMP and VICH guidelines recommending injection site sampling procedures and consequently did not incorporate quality control measures to ensure that the injection site was appropriately sampled).
Croatian: No, rezultati ispitivanja bili su vrlo varijabilni (ispitivanja prethode aktualnim smjernicama CVMP i VICH kojima se preporučaju postupci uzrokovanja u mjestu injekcije VMP, te slijedom toga nisu uključivala mjere kontrole kvalitete kako bi se osiguralo da je mjesto injekcije uzorkovano na primjeren način).
English: In respect to the environmental impact for the use of the solution for injection in sheep the CVMP considered that according to the CVMP guidance, only cattle are concerned with the scenario “direct excretion into surface water”.
Croatian: S obzirom na utjecaj na okoliš u slučaju primjene otopine za injekciju u ovaca, CVMP je zaključio da su, u skladu sa smjernicama CVMP, samo goveda pogođena scenarijem „izravne ekskrecije u površinske vode“.
English: 4.5 Special precaution for use
Croatian: 4.5 Posebne mjere opreza prilikom primjene
English: The value of 3.44 µg/l was rounded down to 3 µg/l, which was considered to represent a safe doramectin level in milk.
Croatian: Vrijednost od 3.44 µg/l zaokružena je na 3 µg/l, što predstavlja sigurnu razinu doramektina u mlijeku.
English: While no data were available that would allow the establishment of the ratio of marker to total residues for milk, it was considered that the ratio established by CVMP for fat (0.86) could be applied to milk.
Croatian: Iako nema dostupnih podataka koji bi omogućili utvrđivanje omjera markera u odnosu na ukupne rezidue za mlijeko, smatra se da se omjer, kojeg je CVMP utvrdio za masti (0.86), može primijeniti i na mlijeko.
English: Meat and offal:
Croatian: Meso i iznutrice:
English: For the run-off scenario, as the highest PECcattle (0.84 µg/kg) is higher than the highest PECsheep (0.48 µg/kg), the conclusion from the cattle can be extrapolated to sheep.
Croatian: S obzirom da je najviši PKOgoveda (0.84 µg/kg) veći od najvišeg PKOovce (0.48 µg/kg), u slučaju scenarija istjecanja zaključci donijeti za goveda mogu se ekstrapolirati na ovce.
English: However, in view of the variability seen across the studies, in view of the fact that none of the studies were performed in line with standards in place today and considering that in a number of studies residue levels remained above the MRL at the last timepoint, it was considered appropriate to add a safety margin of 30% to compensate for the uncertainties associated with the overall data package.
Croatian: No, s obzirom na varijabilnost koja je uočena u svim ispitivanjima te činjenicu da niti jedno ispitivanje nije provedeno u skladu sa standardima primjenjivima danas, te uzimajući u obzir da su u nizu ispitivanja razine rezidua ostale veće od MRL u posljednjoj vremenskoj točki, zaključeno je da je primjereno dodati sigurnosnu marginu od 30% kako bi se kompenzirale nesigurnosti povezane s cjelokupnim paketom podataka.
English: Not permitted for use in lactating animals producing milk for human consumption.
Croatian: Nije odobrena primjena na životinjama koje proizvode mlijeko za ljudsku upotrebu.
English: The following text should be included in SPC section 4.5 Special precautions for use:
Croatian: Sljedeći tekst treba se uključiti u dio 4.5 Posebne mjere opreza za uporabu Sažetka opisa svojstava VMP:
English: Aquatic organisms were considered not at risk from doramectin entering surface water bodies via run-off from use in sheep.
Croatian: Zaključeno je da vodeni organizmi nisu izloženi riziku da će dorametktin ući u tijela površinskih voda putem otjecanja od uporabe u ovaca.
English: This withdrawal period (70 days) is recommended for both doses in sheep (i.e. 200 µg/kg bw and 300 µg/kg bw) approved for intramuscular administration.
Croatian: Ova karencija (70 dana) preporuča se za obje doze (odnosno za 200 µg/kg tm i 300 µg/kg tm) odobrene za intramišićnu primjenu.
English: As no harmonised guidance on how to conduct Tier B assessment studies for dung insects is currently available, risk mitigation measures to reduce exposure are considered to overcome the identified risk.
Croatian: S obzirom da trenutno nisu dostupne nikakve usklađene smjernice za način provođenja ispitivanja za procjenu u stupnja B u insekata u gnoju, smatra se da se mjerama za smanjenje rizika sa ciljem smanjivanja izlaganja može prevladati identificirani rizik.
English: As part of the CVMP evaluation the Committee considered whether further recommendations are necessary in order to ensure that use during the non-lactating period would not lead to residues in milk that, combined with residues from other foodstuffs, would result in consumer exposure exceeding the acceptable daily intake (ADI) (60 μg/person per day).
Croatian: U sklopu ocjene CVMP, Odbor je razmotrio potrebu za daljnjim preporukama kako bi se osiguralo da uporaba tijekom razdoblja suhostaja ne rezultira reziduima u mlijeku koji bi, zajedno s reziduima iz ostalih prehrambenih proizvoda, rezultirali izlaganjem u potrošača koje premašuje prihvatljivi dnevni unos (ADI) (60 μg/osobi po danu).
English: One GLP residue study (1998) in reindeer was available for evaluation by the CVMP but could not be used to determine the withdrawal period as there were only two slaughter time points, the number of animals/group was relatively small and at the last time point one of the injection site samples contained residues above the MRL for muscle (40 μg/kg).
Croatian: CVMP dostavljeno je na ocjenu jedno DLP ispitivanje rezidua (iz 1998. godine) provedeno u jelena, no ovo ispitivanje nije moglo biti upotrijebljeno za utvrđivanje karencije jer je obuhvatilo samo dva klanja, broj životinja/grupa bio/bila je relativno mali/mala te su u posljednjoj vremenskoj točki uzorci jednog od mjesta injekcije sadržali rezidue veće od razine MRL za mišiće (40 μg/kg).
English: As some data in reindeer were available it was considered appropriate to refine this estimate.
Croatian: S obzirom da su bili dostupni određeni podaci za jelene, zaključeno je da se ova procjena mora prilagoditi.
English: However, these products have been used during the dry period with different precautionary measures in place to limit residues in milk, in particular instructions are given on the time that must be allowed to elapse between treatment and calving or lambing.
Croatian: No, ovi proizvodi su korišteni tijekom razdoblja suhostaja uz primjenu različitih mjera opreza kako bi se ograničili rezidui u mlijeku, upute su posebice dane vezano uz vremenska razmake koji moraju biti dovoljno dugi između liječenja i teljenje ili janjenje.
English: Two studies in sheep were provided.
Croatian: Dostavljena su dva ispitivanja provedena u ovaca.
English: As a result these studies did not include quality control measures and the accuracy of the injection site sampling is therefore questionable.
Croatian: Stoga, ova ispitivanja nisu uključivala mjere kvalitete kontrole, te je točnost uzorkovanja mjesta injekcije upitna.
English: Therefore, risk mitigation measures are considered necessary to be included in the product information as specified above.
Croatian: Stoga je ocijenjeno da je nužno uključivanje mjera za smanjenje rizika u informacije o VMP, kako je prethodno navedeno.
English: In addition to the fact that the available data do not allow to rule out bioaccumulation of doramectin, a risk to aquatic organisms has been identified based on available toxicity data (acute toxicity for Daphnia magna) as well as a risk to dung fauna exposed to residue-containing dung when the products are used in accordance with the recommended posology.
Croatian: Uz činjenicu da dostupni podaci ne dozvoljavaju isključivanje bioakumulacije doramektina, utvrđen je rizik za vodene organizme na temelju dostupnih podataka toksičnosti (akutna toksičnost za daphnia magna), kao i rizik za faunu prisutnu u gnoju izloženu reziduima sadržanima u gnoju, ako se ovi lijekovi koriste u skladu s preporučenim doziranjem.
English: The marketing authorisation holders provided a Phase II environmental risk assessment.
Croatian: Nositelji odobrenja za stavljanje VMP u promet dostavili su procjenu rizika za okoliš faze II.
English: With regard to pour-on products the information received from Member States indicates that the withdrawal period for cattle meat and offal is 35 days in all Member States (EU/EEA), where the products are authorised or pending authorisations.
Croatian: S obzirom na VMP za polijevanje po koži, informacije koje su dostavile države članice ukazuju da karencija za goveđe meso i iznutrice iznosi 35 dana u svim državama članicama (EU/EEA), u kojima je odobrena uporaba VMP ili je postupak odobrenja za stavljanje VMP u promet u tijeku.
English: However, as reindeer is considered to be a minor species (with cattle being the corresponding major species) the possibility of extrapolating a withdrawal period from cattle was considered appropriate.
Croatian: No, s obzirom da se jeleni smatraju manjom vrstom (pri čemu su goveda odgovarajuća velika vrsta) mogućnost ekstrapolacije karencije na temelju podataka za goveda primjerenom se smatra.
English: Considering the highest residue levels seen at 10 days and taking account of the estimated half it was calculated that by 66 days after product administration doramectin levels at the injection site would be present at levels below half the MRL.
Croatian: Uzimajući u obzir najviše razine rezidua primijećene 10. dana i procijenjeni poluvijek izračunato je da su do 66 dana nakon primjene lijeka razine doramektina u mjestu injekcije prisutne ispod polovice MRL.
English: Using the data from the most appropriate study a calculated withdrawal period of 54 days could be derived.
Croatian: Uporabom podataka iz najprimjerenijeg ispitivanja, izvedena je izračunata karencija u trajanju od 54 dana.
English: It is a macrocyclic lactone closely related to ivermectin.
Croatian: Doramektin je antiparazitik, koji je makrociklički lakton blisko povezan s ivermektinom.
English: CZECH REPUBLIC
Croatian: Češka Republika
English: Based on the data available it was considered that the existing warning sentence in the product information (Do not use in dry dairy ewes including pregnant dairy ewes within 70 days prior to lambing) is conservative and gives sufficient assurance in terms of consumer safety following administration at the highest recommended dose of 300 μg/kg bw.
Croatian: Na temelju dostupnih podataka smatra se da je postojeće upozorenje u informaciji o lijeku (Ne koristite u mliječnih ovaca u suhostaju, uključujući i gravidnih mliječnih ovaca, tijekom 70 dana prije janjenja) konzervativno i osigurava dovoljno sigurnosti u smislu sigurnosti potrošača nakon primjene VMP u najvećoj preporučenoj dozi od 300 μg/kg tm.
English: A Daphnia magna reproduction study for conducting a Tier B assessment was not submitted in the ERA.
Croatian: Ispitivanje reprodukcije organizma daphnia magna za provođenje procjene u stupnju B nije dostavljeno u procijeni rizika za okoliš.
English: Benefit-Risk Assessment
Croatian: Procjena koristi i rizika
English: The Netherlands noted that identical or similar injectable veterinary medicinal products containing doramectin intended for food producing species have different withdrawal periods established by the Member States (EU/EEA).
Croatian: Nizozemska je upozorila da identični ili slični injekcijski VMP, koji sadrže doramektin i predviđeni su za uporabu u vrsta koje se koriste za proizvodnju hrane, imaju različita razdoblja karencije utvrđena od strane država članica (EU/EEA).
English: The outcome of the ERA indicates that RQ are higher than 1 in the Tier A assessment in two cases, namely aquatic invertebrates (following direct excretion scenario) and dung fauna.
Croatian: Ishod procjene rizika za okoliš pokazao je da je količina rizika (RQ) veća od 1 pri procijeni u stupnju A u dva slučaja, i to u vodenih beskralježnjaka (scenarij nakon izravne ekskrecije) i u fauni u gnoju.
English: In terms of bioaccumulation the log Pow value is not considered to be robust given the method employed (shake flask), but nevertheless indicates doramectin being potentially bioaccumulative.
Croatian: Što se tiče bioakumulacije, vrijednost koeficijenta raspodjele oktanol/voda (log Pow) zbog primijenjene metode (tresena boca) nije bila ocijenjena pouzdanom, no ipak ukazuje na činjenicu da je doramektin potencijalno bioakumulativan.
English: The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Croatian: Rizik za vodene ekosustave smanjit će se držanjem liječenih goveda dalje od vodenih tijela u razdoblju od dva do pet tjedana nakon liječenja.
English: The Committee therefore calculated a minimum time spans of 2 months for cattle and reindeer and 70 days for sheep that should elapse between administration of these doramectin containing products and calving or lambing.
Croatian: Odbor je stoga izračunao minimalne vremenske razmake od 2 mjeseca za goveda i jelene te 70 dana za ovce, koji moraju proći od primjene ovih VMP koji sadrže doramektin, i teljenja ili janjenja.
English: intramuscular Pigs
Croatian: intramuskularno Svinje