natgillin/translations-raw huggingface dataset:
Add the following text in the relevant sections of the product information:
Dodajte naslednje besedilo v ustrezne oddelke informacije o izdelku:
Having considered all the data submitted the CVMP concluded that:
Ob upoštevanju vseh predloženih podatkov je odbor CVMP zaključil naslednje:
Advice for prudent use
Nasvet za preudarno rabo
During the decentralised procedure Denmark, as a concerned Member State, considered that Solamocta may present a potential serious risk to human and animal health.
Med decentraliziranim postopkom je Danska, zadevna država članica, menila, da lahko zdravilo Solamocta predstavlja morebitno resno tveganje za zdravje ljudi in živali.
Exemption from the requirement for bioequivalence studies
Opustitev zahteve za bioekvivalenčne študije
Any unused medicated water should be discarded after 12 hours.
Neuporabljeno raztopino z zdravilom je po 12 urah treba zavreči.
Prepare the solution with fresh tap water immediately before use.
Raztopino pripraviti s svežo vodo iz vodovoda tik pred uporabo.
Each of these excipients is well-established and widely used in medicinal products and foodstuffs.
Vsaka od teh pomožnih snovi je dobro uveljavljena in se pogosto uporablja v zdravilih in živilih.
Extrapolation of the safety and efficacy of the reference product to Solamocta
Ekstrapolacija varnosti in učinkovitosti referenčnega zdravila na zdravilo Solamocta
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.
Ti so pokazali, da je najvišja terapevtska koncentracija popolnoma topna v 10 minutah v trdi vodi (visoka vrednost pH) in mehki vodi (nizka vrednost pH), in so določili največjo topnost (v 10 minutah) v vodi različnih kakovosti in različnih temperatur, tudi v zelo mrzli (4 °C) vodi.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Pri uporabi izdelka upoštevati uradne, nacionalne in regionalne proti-mikrobne smernice.
After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Po končanem zdravljenju je treba napajalni sistem ustrezno očistiti, da se prepreči vnos pod-terapevtske količine aktivne snovi.
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.
Poleg tega je Danska izpostavila zaskrbljenost, da je nasvet za preudarno rabo v informacijah o zdravilu nezadosten, zlasti v smislu večje zaskrbljenosti glede razvoja protimikrobne odpornosti in široke uporabe protimikrobnih izdelkov v krmi in vodi.
• Revised information on solubility and advice on prudent use should be included in the product information.
• Revidirane podatke o topnosti in nasvete o preudarni uporabi je treba vključiti v informacije o zdravilu.
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti veterinarskega zdravila, živalskih vrst, načinov uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
The CVMP was asked to consider the issues raised by Denmark and conclude whether marketing authorisations for Solamocta should be granted.
Odbor CVMP je bil naprošen, da preuči vprašanja, ki jih je izpostavila Danska, in ugotovi, ali je treba odobriti dovoljenje za promet z zdravilom Solamocta.
The uptake of medicated water depends on the clinical condition of the birds.
Vnos vode, v kateri je zdravilo, je odvisen od kliničnega stanja ptic.
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.
Ker pa so vprašanja, ki jih je izpostavila Danska, ostala nerazrešena, zadevne države članice niso uspele doseči soglasja v zvezi z dovoljenjem za promet z zdravilom Solamocta, zato je bila zadeva dne 28. maja 2015 predložena odboru CVMP v skladu s členom 33(4) Direktive 2001/82/ES.
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
Naslednja formula se lahko uporabi za izračun potrebne koncentracije izdelka (v miligramih izdelka na liter pitne vode): ___ mg zdravila na kg telesne teže na dan
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.
Te pomožne snovi imajo dobro uveljavljeno uporabo v drugih podobnih zdravilih za uporabo v veterinarski medicini, odobrenih v EU, in predstavljajo zanemarljivo toksikološko zaskrbljenost ob predlagani stopnji dajanja.
Maximum solubility of the product in water of at least 10 °C is approximately 6 g/l within 10 minutes.
Največja topnost produkta v vodi pri najmanj 10 °C je približno 6 g/L v 10 minutah.
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.
Danska je med drugim menila, da se zdravilo Solamocta bistveno razlikuje od referenčnega zdravila Amoxinsol in da lahko te razlike zadostujejo za zahtevo formalne bioekvivalenčne študije.
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.
Obstajajo trije glavni mehanizmi odpornosti na beta-laktame: proizvodnja beta-laktamaze, spremenjeno izražanje in / ali modifikacija beljakovin, ki vežejo penicilin (PBP), in zmanjšanje predirnosti zunanje membrane.
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine z naslednjimi dopolnitvami:
Advice on prudent use has been proposed to address responsible use in relation to development of antimicrobial resistance.
Predlagan je bil nasvet o preudarni uporabi za obravnavanje odgovorne uporabe v zvezi z razvojem protimikrobne odpornosti.
At lower temperatures (4 °C), the maximum solubility is approximately 5 g/l within 10 minutes.
Pri nižjih temperaturah (4 °C), je največja topnost približno 5 g/L v 10 minutah.
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.
V informacijah o zdravilu so podane zadostne smernice za zagotovitev, da se izdelek lahko ustrezno pripravi in je v celoti raztopljen v času dajanja v skladu z zahtevami za terapevtski odmerek.
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.
Na splošno je odbor CVMP menil, da skrbi, ki jih je izrazila Danska, ne bi smele preprečiti podelitve dovoljenja za promet z zdravilom in da ocena razmerja med tveganji in koristmi velja za pozitivno za zdravilo Solamocta pod pogojem, da se informacije o zdravilu spremenijo tako, da vključujejo popravljena navodila o dajanju izdelka in opozorila o preudarni uporabi.
In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated.
Da se zagotovi pitne vode z zdravilom, je treba med zdravljenjem živalim preprečiti dostop do drugih virov vode.
The beta-lactamase could be encoded in chromosomal or plasmidic genes.
Beta-laktamaza se lahko kodira v kromosomskih ali plazmidnih genih.
Cross-resistance is observed between amoxicillin and other penicillins, particularly with aminopenicillins.
Opaziti je navzkrižno odpornost med amoksicilinom in drugimi penicilini, zlasti aminopenicilini.
Sodium carbonate increases the pH of the solution allowing more concentrated solutions to be used and therefore facilitating administration via automatic water supply systems.
Natrijev karbonat poveča vrednost pH raztopine, kar omogoča uporabo bolj koncentriranih raztopin in s tem olajša dajanje prek samodejnih sistemov za oskrbo z vodo.
It inhibits the formation of bridges between the chains of linear polymers constituting the peptidoglycan cell wall of Gram positive bacteria.
Zavira tvorbo mostov med verigami linearnih polimerov, ki tvorijo peptidoglikansko celično steno gram-pozitivnih bakterij.
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)).
Uporaba beta-laktamskih zdravil z razširjenim spektrom (npr. aminopenicilinov) lahko vodi do selekcije večkratno odpornih bakterijskih fenotipov (npr. fenotipov, ki tvorijo beta-laktamaze z razširjenim spektrom (ESBL)).
Solamocta is indicated for treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin.
Zdravilo Solamocta je indicirano za zdravljenje okužb pri piščancih, puranih in racah, ki jih povzročajo bakterije, občutljive na amoksicilin.
The amended sections of the summary of product characteristics and package leaflet of the reference Member State are set out in Annex III.
Spremenjeni poglavji povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice sta navedeni v Prilogi III.
No reference can be found to any evidence that they can affect the gastrointestinal transit, absorption or in vivo stability of amoxicillin.
Ni nobenih dokazov, da lahko vplivajo na prehod skozi prebavni trakt, absorpcijo ali in vivo stabilnost amoksicilina.
Sodium citrate binds calcium and magnesium ions (present in hard water) and prevents the formation of insoluble carbonate salts.
Natrijev citrat veže kalcijeve in magnezijeve ione (prisotne v trdi vodi) ter preprečuje nastanek netopnih karbonatnih soli.
The formulation of Solamocta does not alter the pH of the medicated drinking water beyond the naturally occurring range of drinking water.
Formulacija zdravila Solamocta ne spremeni vrednosti pH medicirane pitne vode, kot je njena vrednost v običajni pitni vodi.
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.
Odbor CVMP je zato priporočil izdajo dovoljenja za promet z zdravili za uporabo v veterinarski medicini, navedenimi v Prilogi I, skupaj s spremembami povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice.
Grounds for the granting of the marketing authorisations for Solamocta
Podlaga za izdajo dovoljenj za promet z zdravilom Solamocta
In order to obtain the correct dosage the concentration of amoxicillin has to be adjusted taking into account water intake.
Da zagotovimo pravilen odmerek, moramo prilagoditi koncentracijo amoksicilina količini popite vode.
The rationale for the inclusion of the excipients was provided.
Podan je bil razlog za vključitev pomožnih snovi.
Amoxicillin is a time-dependent bactericidal antibiotic which acts by inhibiting the synthesis of bacterial cell walls during bacterial replication.
Amoksicilin je časovno odvisen baktericidni antibiotik, ki deluje z zaviranjem sinteze bakterijske celične stene med replikacijo bakterij.
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)
Splošni povzetek znanstvenega vrednotenja zdravila Solamocta 697 mg/g prašek za uporabo v pitni vodi za piščance, race in purane (glejte Prilogo I)
These enzymes are capable of cleaving the beta-lactam ring of penicillins, making them inactive.
Ti encimi so sposobni cepiti beta-laktamski obroč v penicilinih, tako da niso več aktivni.
INN Strength Pharmaceutical form
Farmacevtska oblika
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.
Poglavje povzetka glavnih značilnosti zdravila 4.5 Posebni previdnostni ukrepi za uporabo pri živalih sedaj vključuje standardno besedilo v zvezi z uporabo, ki temelji na preskušanju odpornosti, kjer je to mogoče, in svetuje, da je treba slediti navodilom v informacijah o zdravilu, in poglavje povzetka glavnih značilnosti zdravila 5.1 Farmakodinamične lastnosti zdaj vključuje najnovejše informacije o načinu delovanja amoksicilina in treh glavnih mehanizmih odpornosti na betalaktame.
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.
Predlagane so bile spremembe besedila povzetka glavnih značilnosti zdravila za obravnavanje odgovorne uporabe v zvezi z razvojem protimikrobne odpornosti, da bi zmanjšali tveganje za zdravje živali in javno zdravje.
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.
Zdravilo je tudi aktivno proti manjši skupini gram-negativnih bakterij, katerih zunanja plast celične stene je sestavljena iz lipo-polisaharidov in beljakovin.
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.
Predlagatelj Eurovet Animal Health BV je prek decentraliziranega postopka predložil vlogo za pridobitev dovoljenja za promet z zdravilom Solamocta v skladu s členom 13(3) Direktive 2001/82/ES, ki se nanaša na referenčno zdravilo Amoxinsol 100 % m/m prašek za peroralno raztopino, odobreno v Združenem kraljestvu.
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.
Uporaba zdravila za uporabo v veterinarski medicini, ki odstopa od navodil, ki jih vsebuje povzetek glavnih značilnosti zdravila, lahko poveča prevalenco bakterij, odpornih na amoksicilin, in zmanjša učinkovitost zdravila.
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.
Sestava zdravila Solamocta se razlikuje od sestave referenčnega zdravila (Amoxinsol 100 % m/m prašek za peroralno raztopino) v tem, da vsebuje samo 80 % m/m amoksicilin trihidrata in poleg tega tri pomožne snovi (natrijev karbonat monohidrat, natrijev citrat in koloidni brezvodni silicijev dioksid), ki niso prisotne v referenčnem zdravilu.
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.
Zdravilo Solamocta 697 mg/g prašek za uporabo v pitni vodi za piščance, race in purane (v nadaljevanju ‘Solamocta') vsebuje 800 mg amoksicilin trihidrata (kar ustreza 697 mg amoksicilina) kot zdravilno učinkovino na gram zdravila.
However, both products are aqueous oral solutions at the time of administration, containing an identical concentration of amoxicillin.
Vendar sta obe zdravili v času dajanja peroralni vodni raztopini in vsebujeta enako koncentracijo amoksicilina.
mean body weight (kg) of animals to be treated
povprečna telesna masa (kg) živali, ki se jih zdravi
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.
Podatki so bili uporabljeni za določitev ustreznih navodil za dajanje zdravila v povzetku glavnih značilnosti zdravila v poglavju 4.9 Odmerjanje in pot uporabe, ki bodo zagotovili, da bo zdravilo Solamocta v času dajanja popolnoma raztopljeno pri ustrezni terapevtski koncentraciji.
Amendments in the relevant sections of the summary of product characteristics and package leaflet
Spremembe v ustreznih poglavjih povzetka glavnih značilnosti zdravila in navodil za uporabo
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.
Glede na pravno podlago tega zahtevka (v skladu s členom 13(3) Direktive 2001/82/ES - hibridna ali mešana uporaba) in zadovoljivo utemeljitev za odstop od zahteve za dokazovanje in vivo bioekvivalence z referenčnim zdravilom v skladu s točko 7.1.c) zgoraj omenjenih smernic CVMP (EMA/CVMP/016/00-Rev.2) se šteje, da je varnost in učinkovitost amoksicilina mogoče ekstrapolirati iz referenčnega zdravila.
The warnings are in line with CVMP guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)3.
Opozorila so v skladu s smernicami CVMP o povzetku glavnih značilnosti protimikrobnih zdravil (EMEA/CVMP/SAGAM/383441/2005)3.
Scientific conclusions and grounds for the granting of the marketing authorisations and amendment of the summary of product characteristics and package leaflet
Znanstveni zaključki in podlaga za izdajo dovoljenja za promet z zdravilom ter dopolnilo povzetka glavnih značilnosti zdravila in navodila za uporabo
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.
Predlagatelj je predložil vse podatke o topnosti, kot to zahtevajo smernice CVMP o vidikih kakovosti farmacevtskih zdravil, uporabljenih v veterinarski medicini za dajanje s pitno vodo (EMEA/CVMP/540/03-Rev.1)2.
One of the most important is the inactivation of penicillin by beta-lactamase enzymes produced by certain bacteria.
Eden od najbolj pomembnih je inaktivacija penicilina z betalaktamazami, to je encimi nekaterih bakterij.
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.
Zdravilo Solamocta vsebuje natrijev karbonat monohidrat kot sredstvo za izboljšanje topnosti, natrijev citrat kot tvorca kompleksa in brezvodni koloidni silicijev dioksid kot sredstvo za drsenje.
Amoxicillin is a broad-spectrum penicillin.
Amoksicilin je penicilin s širokim spektrom delovanja.
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.
Zato se šteje, da je predlagatelj dokazal skladnost z zgoraj omenjenimi zahtevami iz točke 7.1.c) zgoraj omenjenih smernic CVMP (EMA/CVMP/016/00-Rev.2), ki omogoča povezavo s podatki o varnosti in učinkovitosti, povezanimi z referenčnim zdravilom.
If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Za uporabo tega zdravila se odločamo na osnovi testa občutljivosti pri živali izoliranih bakterij Če to ni mogoče, naj zdravljenje temelji na lokalnih epidemioloških podatkih (na ravni okolice, kmetije) o občutljivosti ciljnih bakterij.
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.
Podana je bila zadovoljiva utemeljitev, da je zdravilo Solamocta upravičeno do odstopa od zahteve za dokaz in vivo bioekvivalence z referenčnim zdravilom v skladu s točko 7.1.c) smernic CVMP o izvajanju bioekvivalenčnih študij za zdravila za uporabo v veterinarski medicini (EMA/CVMP/016/00-Rev. 2) in da pomožne snovi ne bodo vplivale na biološko razpoložljivost ali varnost tega zdravila v primerjavi z referenčnim zdravilom.
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.
V tem postopku je bil odbor CVMP naprošen, da preuči, ali razpoložljivi podatki, povezani z zdravilom Solamocta, zadostujejo za podporo opustitve zahteve za bioekvivalenčne študije v skladu s točko 7.1.c) smernic CVMP o izvajanju bioekvivalenčnih študij za zdravila za uporabo v veterinarski medicini
Colloidal anhydrous silica is a flow aid.
Brezvodni koloidni silicijev dioksid je drsilo.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA Za uporabo v vodi za pitje.
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).
Predlagatelj je zahteval opustitev zahteve za bioekvivalenčne študije v skladu s točko 7.1.c) zgoraj navedenih smernic CVMP o izvajanju bioekvivalenčnih študij za zdravila za uporabo v veterinarski medicini (EMA/CVMP/016/00-Rev.2).
Recommended dosage is 17.4 mg amoxicillin (equivalent to 25 mg veterinary medicinal product) per kg body weight for 3 consecutive days.
Priporočeni odmerek je 17,4 mg amoksicilina (kar ustreza 25 mg zdravila za uporabo v veterinarski medicini) na kg telesne teže tri zaporedne dni.
= ___ 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.
= ___ mg izdelka na liter pitne vode povprečna dnevna poraba vode (l) na žival na dan
Recommended dosage is 13.1-17.4 mg amoxicillin (equivalent to 18.8 to 25 mg veterinary medicinal product) per kg body weight for 3 days or in severe cases for 5 days.
Priporočeni odmerek je 13,1-17,4 mg amoksicilina (kar ustreza 18,8 do 25 mg zdravila za uporabo v veterinarski medicini) na kg telesne teže za 3 dni ali v hujših primerih za 5 dni.