FrancophonIA/ELRC3.0 huggingface dataset:
English: Maximum solubility of the product in water of at least 10 °C is approximately 6 g/l within 10 minutes.
Croatian: Maksimalna topljivost proizvoda u vodi pri najmanje 10 °C je približno 6 g/l unutar 10 minuta.
English: In order to obtain the correct dosage the concentration of amoxicillin has to be adjusted taking into account water intake.
Croatian: Kako bi dobile točnu dozu, koncentraciju amoksicilina treba prilagoditi uzimajući u obzir unos vode.
English: At lower temperatures (4 °C), the maximum solubility is approximately 5 g/l within 10 minutes.
Croatian: Pri nižim temperaturama (4 °C) maksimalna topljivost je približno 5 g/l unutar 5 minuta.
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: Važeći sažetak opisa svojstava, označavanje i uputa o VMP su završna verzija postignuta tijekom postupka pod nadzorom Koordinacijske grupe uz sljedeće izmjene:
English: It is also active against a limited range of Gram negative bacteria on which the outer layer of the bacterial cell wall is composed of lipopolysaccharide and proteins.
Croatian: Djelotvoran je i protiv ograničenog broja Gram negativnih bakterija čiji se vanjski sloj bakterijskog staničnog zida sastoji od lipopolisaharida i proteina.
English: Cross-resistance is observed between amoxicillin and other penicillins, particularly with aminopenicillins.
Croatian: Uočena je ukrižena rezistencija između amoksicilina i drugih penicilina, posebice aminopenicilina.
English: These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Croatian: Ta su pitanja ostala neriješena i stoga je pokrenuto upućivanje u skladu s člankom 33. stavkom 1. Direktive 2001/82/EZ Koordinacijskoj grupi za uzajamno priznavanje i decentralizirani postupak (za veterinarsko-medicinske proizvode) (CMDv).
English: They have demonstrated that the highest therapeutic concentration is fully soluble within 10 minutes in hard/high pH water and soft/low pH water and have determined the maximum solubility (within 10 minutes) in water of different qualities and different temperatures, including very cold (4 °C) water.
Croatian: Dokazao je da se najviša terapeutska koncentracija u potpunosti otapa u roku od 10 minuta u tvrdoj vodi/vodi s visokom pH vrijednošću te mekanoj vodi/vodi s niskom pH vrijednošću te je utvrdio najveću topivost (u roku od 10 minuta) u vodi različite kvalitete i temperature, uključujući vrlo hladnu vodu
English: In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated.
Croatian: Kako bi se osiguralo uzimanje vodene otopine lijeka, životinje ne smiju imati pristup vodi za vrijeme liječenja.
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Croatian: Pri uporabi proizvoda treba uzeti u obzir službene nacionalne i lokalne smjernice o primjeni antimikrobnih lijekova.
English: The use of extended spectrum beta-lactam drugs (e.g. aminopenicillins) might lead to the selection of multi-resistant bacterial phenotypes (e.g. those producing extended spectrum beta-lactamases (ESBLs)).
Croatian: Primjena beta-laktamskih lijekova proširenog spektra (npr. aminopenicilina) može dovesti do selekcije multirezistentnih bakterijskih fenotipa (npr. onih koji proizvode beta-laktamaze proširenog spektra (engl. extended spectrum beta-lactamase (ESBL))).
English: It inhibits the formation of bridges between the chains of linear polymers constituting the peptidoglycan cell wall of Gram positive bacteria.
Croatian: On inhibira stvaranje veza između lanaca linearnih polimera koji sačinjavaju peptidoglikanski stanični zid Gram pozitivnih bakterija.
English: There are three main mechanisms of resistance to beta-lactams: beta-lactamase production, altered expression and/or modification of penicillin binding proteins (PBP), and decreased penetration of the outer membrane.
Croatian: Postoje tri glavna mehanizma rezistencije na beta-laktame: stvaranje beta-laktamaze, promjena ekspresije i/ili modifikacija receptora koji vežu penicilin (engl. penicillin binding protein (PBP)) te smanjenje propusnosti vanjske membrane.
English: Since the issues raised by Denmark remained unresolved, the Member States concerned failed to reach agreement regarding the marketing authorisation for the product Solamocta and consequently the matter was referred to the CVMP on 28 May 2015 under Article 33(4) of Directive 2001/82/EC.
Croatian: Budući da su pitanja koja je istaknula Danska ostala neriješena, države članice sudionice u postupku nisu mogle postići sporazum u vezi s odobrenjem za stavljanje u promet VMP Solamocta, zbog čega je predmet upućen CVMP-u 28. svibnja 2015. u skladu s člankom 33. stavkom 4.
English: The CVMP was asked to consider the issues raised by Denmark and conclude whether marketing authorisations for Solamocta should be granted.
Croatian: Od CVMP-a je zatraženo da razmotri pitanja koja je postavila Danska i donese zaključak o izdavanju odobrenjâ za stavljanje u promet VMP Solamocta.
English: The beta-lactamase could be encoded in chromosomal or plasmidic genes.
Croatian: Beta laktamaza može biti kodirana kromosomskim ili plazmidskim genima.
English: Advice on prudent use has been proposed to address responsible use in relation to development of antimicrobial resistance.
Croatian: Predloženi su savjeti o razumnoj uporabi u smislu odgovorne uporabe s obzirom na razvoj antimikrobne rezistencije.
English: These enzymes are capable of cleaving the beta-lactam ring of penicillins, making them inactive.
Croatian: Ti enzimi mogu razoriti beta-laktamski prsten penicilina i tako ih inaktivirati.
English: Sodium citrate binds calcium and magnesium ions (present in hard water) and prevents the formation of insoluble carbonate salts.
Croatian: Natrijev citrat veže ione kalcija i magnezija (prisutne u tvrdoj vodi) i sprječava stvaranje netopivih karbonatnih soli.
English: Use of the product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacterial resistance to amoxicillin and may decrease its effectiveness.
Croatian: Primjena proizvoda na način koji odstupa od uputa navedenih u sažetku opisa svojstava može povećati učestalost rezistencije bakterija na amoksicilin i smanjiti njegovu djelotvornost.
English: In addition, Denmark raised a concern that the advice for prudent use in the product information is insufficient, particularly in the context of increasing concerns regarding development of antimicrobial resistance and the widespread use of in-feed and in-water antimicrobial products.
Croatian: Nadalje, Danska je istaknula da su savjeti o razumnoj primjeni navedeni u informacijama o VMP-u nedostatni, posebice u kontekstu sve ozbiljnijih pitanja o razvoju antimikrobne rezistencije i sve raširenijoj uporabi antimikrobnih proizvoda za uporabu u hrani i vodi.
English: Overall summary of the scientific evaluation of Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene praška Solamocta 697 mg/g za uporabu u pitkoj vodi za piliće, patke i pure (vidjeti Prilog I.)
English: guideline on the conduct of bioequivalence studies for veterinary medicinal products
Croatian: smjernica CVMP-a o provođenju ispitivanja bioekvivalencije za veterinarsko-medicinske proizvode
English: One of the most important is the inactivation of penicillin by beta-lactamase enzymes produced by certain bacteria.
Croatian: Jedan od najvažnijih mehanizama je inaktivacija penicilina enzimima beta-laktamazama koje proizvode neke bakterije.
English: No reference can be found to any evidence that they can affect the gastrointestinal transit, absorption or in vivo stability of amoxicillin.
Croatian: Nije moguće pronaći reference ni na kakve dokaze o tome da one mogu utjecati na prolazak amoksicilina kroz probavni sustav, njegovu apsorpciju ili in vivo stabilnost.
English: Grounds for the granting of the marketing authorisations for Solamocta
Croatian: Razlozi za izdavanje odobrenja za stavljanje u promet VMP Solamocta
English: Overall, the CVMP considered that the concerns expressed by Denmark should not prevent the granting of marketing authorisations and the benefit-risk evaluation is deemed to be positive for Solamocta provided that the product information is amended to include revised instructions on product administration and prudent use warnings.
Croatian: Općenito govoreći, CVMP smatra da zabrinutost koju je izrazila Danska ne bi trebala spriječiti izdavanje odobrenja za stavljanje u promet te da je procjena koristi i rizika za VMP Solamocta pozitivna, uz uvjet da se izmijene informacije o VMP-u na način da uključuju revidirane upute o primjeni VMP-a i upozorenja o razumnoj uporabi.
English: The following formula may be used to calculate the required concentration of product (in milligrams of product per litre drinking water): ___ mg product per kg body weight per day
Croatian: Za izračunavanje potrebne koncentracije proizvoda (u miligramima proizvoda po litri vode za piće) može se koristiti sljedeća formula: ___ mg proizvoda po kg tjelesne težine po danu
English: In particular, Denmark considered that Solamocta is essentially different from the reference product Amoxinsol and that these differences could be sufficient to require a formal bioequivalence study.
Croatian: Danska je smatrala da se Solamocta u bitnome razlikuje od referentnog VMP Amoxinsola i da su te razlike dostatne za zahtjev za provođenje formalnog ispitivanja bioekvivalencije.
English: The SPC section 4.5 Special precautions for use in animals, now includes the standard wording regarding use based on susceptibility testing where possible and advising to follow the instructions given in the product information, and the SPC section 5.1 Pharmacodynamic properties, now includes up-to-date information regarding the mode of action of amoxicillin and the three main mechanisms of resistance to beta-lactams.
Croatian: Odjeljak 4.5 Sažetka opisa svojstava VMP-a pod naslovom Posebne mjere za primjenu u životinja sada uključuje standardnu formulaciju u smislu primjene na temelju ispitivanja osjetljivosti, gdje je to moguće, te se savjetuje poštovanje uputa navedenih u informacijama o VMP-u, dok dio 5.1 Sažetka opisa svojstava VMP-a, Farmakodinamička svojstva, sada sadrži ažurirane podatke o načinu djelovanja amoksicilina i o trima glavnim mehanizmima otpornosti na beta-laktame.
English: The formulation of Solamocta does not alter the pH of the medicated drinking water beyond the naturally occurring range of drinking water.
Croatian: Formulacija VMP Solamocta ne mijenja pH vrijednost pitke vode koja sadrži VMP izvan vrijednosti koje se prirodno pojavljuju u pitkoj vodi.
English: Amoxicillin is a broad-spectrum penicillin.
Croatian: Amoksicilin je penicilin širokog spektra.
English: Sodium carbonate increases the pH of the solution allowing more concentrated solutions to be used and therefore facilitating administration via automatic water supply systems.
Croatian: Natrijev karbonat podiže pH vrijednost otopine, što omogućuje korištenje koncentriranijih otopina, a stoga i lakšu primjenu putem automatskih sustava vodoopskrbe.
English: The warnings are in line with CVMP guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)3.
Croatian: Upozorenja su u skladu sa smjernicama CVMP-a o sažetku opisa svojstava za antimikrobne VMP(EMEA/CVMP/SAGAM/383441/2005)3.
English: The rationale for the inclusion of the excipients was provided.
Croatian: Dostavljeno je objašnjenje za uključivanje pomoćnih tvari.
English: Extrapolation of the safety and efficacy of the reference product to Solamocta
Croatian: Ekstrapolacija sigurnosti i učinkovitosti referentnog VMP-a na VMP Solamocta
English: The amended sections of the summary of product characteristics and package leaflet of the reference Member State are set out in Annex III.
Croatian: Izmijenjeni dijelovi sažetka opisa svojstava VMP-a i uputa o VMP-u države članice sudionice u postupku navedeni su u Prilogu III.
English: Amendments to the SPC text have been proposed to address responsible use in relation to development of antimicrobial resistance in order to minimise the risk to both animal and public health.
Croatian: Predložene su izmjene Sažetka opisa svojstava VMP-a kako bi se riješilo pitanje odgovorne uporabe s obzirom na razvoj antimikrobne rezistencije u svrhu smanjenja opasnosti za zdravlje životinja i ljudi.
English: The composition of Solamocta differs to that of the reference product (Amoxinsol 100% w/w Powder for Oral Solution) in that it contains only 80% w/w amoxicillin trihydrate and in addition three excipients (sodium carbonate monohydrate, sodium citrate and colloidal anhydrous silica) that are not present in the reference product.
Croatian: Sastav VMP Solamocta razlikuje se od sastava referentnog VMP-a (praška za oralnu otopinu Amoxinsol 100 % masenog udjela) jer sadrži samo 80 % masenog udjela amoksicilin trihidrata i tri pomoćne tvari (natrijev karbonat monohidrat, natrijev citrat i bezvodni koloidni silicijev dioksid) koje nisu prisutne u referentnom VMP-u.
English: Amoxicillin is a time-dependent bactericidal antibiotic which acts by inhibiting the synthesis of bacterial cell walls during bacterial replication.
Croatian: Amoksicilin je baktericidni antibiotik s učinkom ovisnim o vremenu koji inhibira sintezu bakterijskog staničnog zida tijekom umnožavanja bakterija.
English: Therefore, the CVMP recommended granting of the marketing authorisation for the veterinary medicinal products referred to in Annex I with amendments to the summary of product characteristics and package leaflet of the reference Member State.
Croatian: Stoga je CVMP preporučio izdavanje odobrenja za stavljanje veterinarsko-medicinskih proizvoda navedenih u Prilogu I. u promet s izmjenama sažetka opisa svojstava VMP-a i uputa o VMP-u države članice sudionice u postupku.
English: Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (thereafter called ‘Solamocta') contains 800 mg amoxicillin trihydrate (equivalent to 697 mg amoxicillin) as an active substance per gram product.
Croatian: Prašak Solamocta 697 mg/g za uporabu u pitkoj vodi za piliće, patke i pure (u daljnjem tekstu: Solamocta) sadrži 800 mg djelatne tvari amoksicilin trihidrata (istovjetno 697 mg amoksicilina) po gramu VMP-a.
English: Scientific conclusions and grounds for the granting of the marketing authorisations and amendment of the summary of product characteristics and package leaflet
Croatian: Znanstveni zaključci i razlozi za izdavanje odobrenja za stavljanje u promet te izmjenu sažetka opisa svojstava VMPa i upute o VMP-u
English: Solamocta contains sodium carbonate monohydrate as a solubility improvement agent, sodium citrate as a complexing agent and silica colloidal anhydrous as a flow conditioning agent.
Croatian: Solamocta sadrži natrijev karbonat monohidrat kao sredstvo za poboljšanje topivosti, natrijev citrat kao kompleksirajući agens te bezvodni koloidni silicijev dioksid kao sredstvo za regulaciju toka.
English: These excipients have well-established use in other similar EU-authorised veterinary medicinal products and are of negligible toxicological concern at the proposed administration rate.
Croatian: Te pomoćne tvari imaju provjerenu uporabu u sličnim veterinarsko-medicinskim proizvodima za koje je izdano odobrenje za stavljanje u promet u EU-u te pri predloženoj stopi primjene imaju zanemariv toksikološki učinak.
English: Sufficient guidance is provided in the product information to ensure that the product can be properly prepared and is fully in solution at the time of administration in accordance with the requirements for the therapeutic dose.
Croatian: U informacijama o VMP.u dostavljeni su zadovoljavajući dokazi o tome da se VMP može ispravno pripremiti i biti potpuno otopljen u trenutku primjene, u skladu sa zahtjevima o terapeutskoj dozi.
English: • Revised information on solubility and advice on prudent use should be included in the product information.
Croatian: • U informacije o VMP-u valja uključiti revidirane podatke o topivosti i savjete o razumnoj uporabi.
English: However, both products are aqueous oral solutions at the time of administration, containing an identical concentration of amoxicillin.
Croatian: Međutim, u trenutku primjene oba su VMP-a vodene oralne otopine koje sadrže identičnu koncentraciju amoksicilina.
English: Given the legal basis of this application (under Article 13(3) of Directive 2001/82/EC - a hybrid or mixed application) and the satisfactory justification for a waiver from the requirement to demonstrate in vivo bioequivalence with the reference product in accordance with section 7.1.c) of the abovementioned CVMP guideline (EMA/CVMP/016/00-Rev.2), it is considered that the safety and efficacy of amoxicillin can be extrapolated from that of the reference product.
Croatian: S obzirom na pravnu osnovu ovog zahtjeva (čl. 13. st. 3. Direktive 2001/82/EZ - hibridna ili miješana primjena) te zadovoljavajuće opravdanje zahtjeva za izuzeće od dokazivanja in vivo bioekvivalencije s referentnim VMP-om u skladu s odjeljkom 7.1. točkom (c) prethodno navedenih smjernica CVMP-a (EMA/CVMP/016/00-Rev.2), smatra se da se sigurnost i učinkovitost amoksicilina mogu ekstrapolirati iz sigurnosti i učinkovitosti referentnog VMP-a.
English: The applicant has provided all solubility data as required by the CVMP guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water (EMEA/CVMP/540/03Rev.1)2.
Croatian: Podnositelj zahtjeva dostavio je sve podatke o topivosti utvrđene smjernicama CVMP-a o kvaliteti farmaceutskih veterinarskih proizvoda koji se daju putem pitke vode (EMEA/CVMP/540/03-Rev.1)2.
English: Exemption from the requirement for bioequivalence studies
Croatian: Izuzeće od obveze provođenja ispitivanja bioekvivalencije
English: Ducks
Croatian: Patke
English: Solamocta is indicated for treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin.
Croatian: Veterinarskomedicinski proizvod (VMP) Solamocta indiciran je za liječenje infekcija uzrokovanih bakterijama osjetljivima na amoksicilin u pilića, pura i pataka.
English: 2 CVMP guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water EMEA/CVMP/540/03-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004462.pdf
Croatian: CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105372.pdf 2 CVMP guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water EMEA/CVMP/540/03-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004462.pdf
English: It is therefore considered that the applicant has demonstrated compliance with the requirements of section 7.1.c) of the abovementioned CVMP guideline (EMA/CVMP/016/00-Rev.2), allowing bridging to the safety and efficacy data associated with the reference product.
Croatian: Stoga se smatra da je podnositelj zahtjeva dokazao sukladnost sa zahtjevima iz odjeljka 7.1. točke (c) prethodno spomenutih smjernica CVMP-a (EMA/CVMP/016/00-Rev.2), čime je omogućeno premošćivanje razlika u smislu podataka o sigurnosti i učinkovitosti referentnog VMP-a.
English: (EMA/CVMP/016/00-Rev.2), and exemption from the requirement for bioequivalence studies.
Croatian: (EMA/CVMP/016/00-Rev.2)1.
English: The applicant has claimed exemption from the requirement for bioequivalence studies in accordance with section 7.1.c) of the aforementioned CVMP guideline (EMA/CVMP/016/00-Rev.2).
Croatian: Podnositelj zahtjeva zatražio je izuzeće od obveze provođenja ispitivanja bioekvivalencije u skladu s odjeljkom 7.1. točkom (c) prethodno navedenih smjernica CVMP-a (EMA/CVMP/016/00-Rev.2).
English: Amendments in the relevant sections of the summary of product characteristics and package leaflet
Croatian: Izmjene odgovarajućih dijelova sažetka opisa svojstava i upute o VMP
English: These data have been used to specify appropriate product administration instructions in the Summary of Product Characteristics (SPC) section 4.9 Amounts to be administered and administration route, which will ensure that Solamocta will be fully in solution at the time of administration at the appropriate therapeutic concentration.
Croatian: Sažetka opisa svojstava VMP-a pod naslovom Količine koje se primjenjuju i put primjene, čime se jamči da će VMP Solamocta biti u potpunosti otopljen u trenutku primjene u prikladnoj terapeutskoj koncentraciji.
English: = ___ mg product per litre drinking water mean daily water consumption (litre) per animal per day To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Croatian: = ___ mg proizvoda po litri vode za piće srednja vrijednost potrošnje vode (litra) po životinji po danu
English: The applicant Eurovet Animal Health B.V. submitted a marketing authorisation application, via the decentralised procedure, for Solamocta according to Article 13(3) of Directive 2001/82/EC, referring to the reference product Amoxinsol 100% w/w Powder for Oral Solution authorised in the United Kingdom.
Croatian: Podnositelj zahtjeva, Eurovet Animal Health B.V., podnio je zahtjev za izdavanje odobrenja za stavljanje VMP-a Solamocta u promet putem decentraliziranog postupka, u skladu s člankom 13. stavkom
English: INN Strength Pharmaceutical form
Croatian: Podnositelj zahtjeva Izmišljeno ime INN Jačina Farmaceutski oblik
English: A satisfactory justification has been provided that the product, Solamocta, is eligible for a waiver from the requirement to demonstrate in vivo bioequivalence with the reference product in accordance with section 7.1.c) of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) and that the excipients will not impact the bioavailability or safety of this product compared to the reference product.
Croatian: Podnositelj zahtjeva dostavio je zadovoljavajuće opravdanje o tome da se na VMP Solamocta može primijeniti izuzeće od obveze dokazivanja in vivo bioekvivalencije u odnosu na referentni VMP, sukladno odjeljku 7.1. točki (c) smjernica CVMP-a o provođenju ispitivanja bioekvivalencije za veterinarsko-medicinske proizvode (EMA/CVMP/016/00-Rev.2) te je dokazao da pomoćne tvari neće utjecati na bioraspoloživost ili sigurnost ovog VMP-a u usporedbi s referentnim VMP-om.
English: Colloidal anhydrous silica is a flow aid.
Croatian: Bezvodni koloidni silicijev dioksid pomaže pri protoku.
English: Turkeys
Croatian: Topivost
English: Luxembourg Eurovet Animal Health BV Handelsweg 25
Croatian: Luksemburg Eurovet Animal Health BV Handelsweg 25
English: Czech Republic Eurovet Animal Health BV Handelsweg 25
Croatian: Češka Republika Eurovet Animal Health BV Handelsweg 25
English: In this procedure, the CVMP was asked to consider whether the available data related to Solamocta is sufficient to support exemption from the requirement for bioequivalence studies in accordance with section 7.1.c) of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2)1.
Croatian: U ovom je postupku od CVMP-a zatraženo da ocijeni jesu li dostupni podaci o VMP Solamocta dostatni za izuzeće od obveze provođenja ispitivanja bioekvivalencije u skladu s odjeljkom 7.1. točkom (c)
English: United Kingdom Eurovet Animal Health BV Handelsweg 25
Croatian: Velika Britanija Eurovet Animal Health BV Handelsweg 25
English: Recommended dosage is 17.4 mg amoxicillin (equivalent to 25 mg veterinary medicinal product) per kg body weight for 3 consecutive days.
Croatian: Preporučena doza je 17,4 mg amoksicilina (ekvivalentno 25 mg veterinarsko-medicinskog proizvoda) po kg tjelesne težine tijekom 3 uzastopna dana.