FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicated drinking water should be refreshed or replaced every 24 hours.
Slovenian: Pitno vodo z zdravilom je treba obnoviti ali zamenjati vsakih 24 ur.
English: • Indications;
Slovenian: • indikacije;
English: Mean daily water consumption (l) per animal
Slovenian: Povprečna dnevna poraba (l) vode na žival
English: Tetracyclines may - in very rare cases - induce photosensitivity and allergic reactions.
Slovenian: Tetraciklini lahko - v zelo redkih primerih - inducirajo občutljivost na svetlobo in alergične reakcije.
English: The daily amount is to be added to the drinking water such that all medication will be consumed in 24 hours.
Slovenian: V pitno vodo je treba dodati tolikšno dnevno količino, da se zdravilo v celoti porabi v 24 urah.
English: It is clear that there are very limited scientific data available to support many of the proposed indications for use of the product, however it could be considered to have “well established use”.
Slovenian: Jasno je, da so razpoložljivi znanstveni podatki v podporo več predlaganim indikacijam za uporabo tega zdravila zelo omejeni, vendar pa se lahko šteje, da ima zdravilo „dobro uveljavljeno uporabo“.
English: The recommended dose in pigs is:
Slovenian: Priporočeni odmerek za prašiče je:
English: For animal treatment only.
Slovenian: Samo za zdravljenje živali.
English: Although resistance in the latter pathogens may be of less significance to public health, provision of an appropriate dosing regimen to limit the development of resistance is necessary to protect animal health.
Slovenian: Čeprav je odpornost pri slednjih patogenih morda manj pomembna za javno zdravje, je kljub temu treba določiti ustrezen režim odmerjanja, ki bo omejeval razvoj odpornosti, potrebne za zaščito zdravja živali.
English: There was no clear discrepancy between Member States in the dose regimen for use of the product in pigs.
Slovenian: Med državami članicami ni bilo očitnih razlik med režimi odmerjanja pri uporabi zdravila pri prašičih.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je primerno
English: Alternatively, the concentrated solution can be used in a proportional water medicator.
Slovenian: Druga možnost je, da se koncentrirano raztopino uporabi v proporcionalnem medikatorju za vodo.
English: The Marketing Authorisation Holder was requested to submit data to support the target species and indications in pigs.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj predloži podatke v podporo ciljnim živalskim vrstam in indikacijam pri prašičih.
English: EXPIRY DATE EXP {month/year}; Do not use after the expiry date stated on the label after EXP.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}; Ne uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini po EXP.
English: If no improvement in clinical signs is seen within this time, the diagnosis should be reviewed and treatment changed.
Slovenian: Če v tem času ni opaziti izboljšanja kliničnih znakov, je treba pregledati diagnozo in spremeniti zdravljenje.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Doxyfar 50 % and associated names, the issue was referred to CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics (SPC) across the European Union.
Slovenian: Zaradi različnih nacionalnih odločitev držav članic glede odobritve zdravila Doxyfar 50 % in povezanih imen je bila zadeva napotena na CVMP v skladu s členom 34(1) Direktive 2001/82/ES, da bi se razrešile razlike med nacionalno odobrenimi povzetki glavnih značilnosti zdravila v Evropski uniji.
English: Doxycyline hyclate can be considered to have “well established use”.
Slovenian: Za doksiciklinijev hiklat lahko velja, da ima „dobro uveljavljeno uporabo“.
English: Inform your veterinary surgeon if adverse reactions occur that are not stated.
Slovenian: Obvestite svojega veterinarja, če se pojavijo neželeni učinki, ki niso navedeni.
English: • Target species;
Slovenian: • ciljne živalske vrste;
English: In the absence of compatibility studies, this product must not be mixed with other veterinary medicinal products.
Slovenian: Ker študije kompatibilnosti niso na razpolago, tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
English: For Ornithobacterium rhinotracheale results demonstrate a great variation from high to low susceptibility, depending on the geographical region where isolates came from.
Slovenian: Rezultati za Ornithobacterium rhinotracheale kažejo velik razpon od visoke do nizke občutljivosti, odvisno od geografskega področja, od koder izolati izvirajo.
English: Use at minimum concentrations of 200 mg powder per litre drinking water in areas with hard alkaline drinking water (hardness above 10.2 °d and pH more than 8.1).
Slovenian: Uporabite v koncentracijah najmanj 200 mg praška na liter pitne vode na območjih s trdo alkalno pitno vodo (trdota nad 10,2 °d in pH več kot 8,1).
English: It was noted that there have been no “real” divergent decisions taken by the Member States regarding the target species (chickens and pigs) because the Marketing Authorisation Holder‘s decisions for inclusion/exclusion of chickens and/or pigs as target species were based on commercial grounds and the data in support of the applications was the same.
Slovenian: Ugotovljeno je bilo, da med državami članicami ni bilo „resnično“ različnih odločitev glede ciljnih živalskih vrst (piščanci in prašiči), saj je bila odločitev imetnika dovoljenja za promet z zdravilom glede vključitve/izključitve piščancev in/ali prašičev kot ciljnih živalskih vrst utemeljena na komercialni podlagi, podatki v podporo vlogam pa so bili enaki.
English: In addressing the dosing regimen the Marketing Authorisation Holder has not discussed Pharmacokinetic/Pharmacodynamic in terms of a parameter that will limit the development of resistance.
Slovenian: Imetnik dovoljenja za promet z zdravilom v zvezi z režimom odmerjanja ni obravnaval farmakokinetike/farmakodinamike v zvezi s parametrom, ki bi omejil razvoj odpornosti.
English: High levels of resistance to tetracyclines in swine respiratory pathogens have been documented (ARBAO-II study, 2008)6.
Slovenian: Dokumentirane so bile visoke stopnje odpornosti na tetracikline pri prašičjih respiratornih patogenih (študija ARBAO-II, 2008)6.
English: During the treatment period animals should not have access to other water sources than the medicated water.
Slovenian: Med zdravljenjem živali ne smejo imeti dostopa do drugih vodnih virov, razen do vode z zdravilom.
English: If the same feed is provided ad libitum throughout the day the lung concentration rises to 2.9 +/- 0.6 µg/ml.
Slovenian: Če se enaka krma daje ad libitum skozi cel dan, se koncentracija v pljučih poveča na 2,9 +/-0,6 µg/ml.
English: The recommended dose in chickens is:
Slovenian: Priporočeni odmerek za piščance je:
English: The use of suitably calibrated weighing equipment is recommended if part packs are used.
Slovenian: Priporočljivo je uporabljati ustrezno kalibrirano opremo za tehtanje, če uporabite samo del vsebine pakiranja.
English: If you notice any serious effects or other effects not mentioned in this product information, please inform your veterinary surgeon or pharmacist.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja ali apotekarja.
English: The uptake of medicated drinking water depends on the clinical condition of the pigs/chickens.
Slovenian: Vnos pitne vode z zdravilom je odvisen od kliničnega stanja prašičev / piščancev.
English: Mean body weight (kg) of animals to be treated
Slovenian: Povprečna teža (kg) živali, ki jih je treba zdraviti
English: The main sections of disharmony of the existing SPCs were:
Slovenian: Največja neskladja med obstoječimi povzetki glavnih značilnosti zdravila so bila:
English: Inhibition of bacterial protein synthesis results in disturbance of all functions necessary for the life of bacteria.
Slovenian: Zaviranje sinteze beljakovin v bakteriji ima za posledice motnje v vseh funkcijah, ki so za življenje bakterije potrebne.
English: Cross resistance between tetracyclines has also been described.
Slovenian: Navzkrižno odpornost med tetraciklini so tudi že opisali.
English: Overall summary of the scientific evaluation of Doxyfar 50% and associated names (see annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Doxyfar 50 % in povezanih imen (glejte Dodatek I)
English: Do not store the drinking water in metallic containers.
Slovenian: Ne hranite pitne vode v kovinskih vsebnikih.
English: It is advised that the interval between the administration of other products containing polyvalent cations should be 1-2 hours because they limit the absorption of tetracyclines.
Slovenian: Pred dajanjem drugih izdelkov, ki vsebujejo polivalentne katione, se priporoča presledek 1-2 uri, ker omejujejo absorpcijo tetraciklinov.
English: Take measures to avoid producing dust when incorporating the product into water.
Slovenian: SPoskrbite, da preprečite dviganje prahu, ko izdelek dodajate v vodo.
English: Data were inconclusive with regards to the indication for O. rhinotracheale, but it was concluded that on the basis of well established use and as there have been no reports of adverse events, including suspected lack of expected efficacy, the current dosage could be considered to be safe and effective.
Slovenian: Podatki glede indikacije za O. rhinotracheale niso omogočali dokončnih zaključkov, vendar je bilo sklenjeno, da se lahko na podlagi dobro uveljavljene uporabe, in ker ni nobenih poročil o neželenih učinkih, vključno z domnevno manjšo učinkovitostjo od pričakovane, sedanji odmerki štejejo za varne in učinkovite.
English: Formed from a polyester/polyethylene/aluminium/polyethylene or a polyester/ polyethylene/aluminium/ionomer laminate.
Slovenian: Vrečka iz poliestra/polietilena/aluminija/polietilena ali iz poliester/ polietilen/aluminij/ionomer laminata.
English: In case of severe infections the medication period may be prolonged for a maximum of 8 consecutive days as determined by the attending veterinary surgeon.
Slovenian: Pri hudih okužbah se lahko obdobje zdravljenja podaljša na največ 8 zaporednih dni, kot to odloči lečeči veterinar.
English: During preparation and administration of the medicated drinking water, skin contact with the product and inhalation of dust particles should be avoided.
Slovenian: Med pripravljanjem in dajanjem pitne vode z zdravilom se je treba izogibati stiku kože z zdravilom in vdihavanju prašnih delcev.
English: Especially cell-division and the formation of the cell wall are impaired.
Slovenian: Posebno oslabljeni sta pri tem celična delitev in nastajanje celične stene.
English: It is recommended to prepare a concentrated pre-solution - approximately 100 grams product per litre drinking water - and to dilute this further to therapeutic concentrations if required.
Slovenian: Priporočljivo je pripraviti koncentrirano predraztopino - približno 100 gramov zdravila na liter pitne vode -, ki se jo po potrebi redči na terapevtske koncentracije.
English: Tetracycline resistance is usually acquired by means of plasmids or other mobile elements (e.g. conjugative transposones).
Slovenian: Odpornost na tetraciklin se običajno pridobi s pomočjo plazmidov ali drugih mobilnih elementov (npr. konjugativnih transpozonov).
English: However, it is accepted that levels of resistance to tetracyclines reported in literature cannot be directly extrapolated to doxycycline, and that the greater liposolubility of doxycycline may explain why in vitro susceptibility of organisms has been maintained despite the emerging resistance to tetracycline.
Slovenian: Vendar pa velja, da ravni odpornosti na tetracikline, o katerih so poročali v literaturi, ni mogoče neposredno ekstrapolirati na doksiciklin ter da lahko večja topnost doksiciklina v maščobi pojasni, zakaj se je občutljivost organizmov in vitro ohranila kljub pojavljajoči se odpornosti na tetraciklin.
English: In order to obtain the correct dosage the concentration of doxycycline has to be adjusted accordingly.
Slovenian: Za pravilen odmerek je treba prilagajati koncentracijo doksiciklina.
English: There have been no data to indicate increasing levels of resistance and the relevance of cross resistance between doxycycline and older tetracyclines was also discussed but again data were insufficient to enable firm conclusions to be reached.
Slovenian: Nobeni podatki niso kazali na povečane ravni odpornosti, razpravljali pa so tudi o pomenu navzkrižne odpornosti med doksiciklinom in starejšimi tetraciklini, vendar tudi tukaj podatki niso zadostovali za sklepanje zanesljivih zaključkov.
English: Published data related to existing levels of resistance to doxycycline in target pathogens was also submitted.
Slovenian: Predloženi so bili tudi objavljeni podatki v zvezi z obstoječimi ravnmi odpornosti na doksiciklin pri ciljnih patogenih.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Izpolni država članica
English: From these data it may be predicted that doxycycline concentrations would exceed the MIC in the target tissue for the majority of the named pathogens in pigs.
Slovenian: Na podlagi teh podatkov je mogoče sklepati, da bi koncentracije doksiciklina presegle vrednost MIC v ciljnem tkivu za večino imenovanih patogenov pri prašičih.
English: In the event of eye or skin contact, rinse the affected area with large amounts of clean water and if irritation occurs, seek medical attention.
Slovenian: Ob stiku z očmi ali kožo mesto sperite z veliko količino čiste vode in, če pride do razdraženosti, poiščite zdravniško pomoč.
English: The Marketing Authorisation Holder provided persuasive argument that in the field differentiation between Pasteurellosis and O. rhinotracheale in poultry could be readily achieved.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil prepričljiv argument, da bi bilo mogoče na terenu pri piščancih hitro doseči diferenciacijo med Pasteurellosis in O. rhinotracheale.
English: As eradication of the target pathogens may not be achieved, medication should therefore be combined with good management practices, e.g. good hygiene, proper ventilation, no overstocking.
Slovenian: Ker izkoreninjenja ciljnih patogenov ni vedno mogoče doseči, je treba zdravljenje zato združiti z dobro prakso upravljanja, npr. z dobro higieno, pravilnim prezračevanjem in preprečevanjem prenapolnjenosti vzrejnega objekta.
English: There are no changes to the dosing regimen being proposed for either chickens or pigs therefore there will be no increased exposure of the environment to doxycycline.
Slovenian: Ker niti pri piščancih niti pri prašičih niso predlagane nobene spremembe pri režimu odmerjanja, tudi okolje doksiciklinu ne bo izpostavljeno v večji meri.
English: These antibiotics have a broad spectrum of antimicrobial activity, sharing the same basic structure of polycyclic naphthacenecarboxamide.
Slovenian: Ti antibiotiki imajo širok spekter protimikrobnega delovanja, z isto osnovno strukturo, kot jo imajo policiklični naftacenkarboksamidi.
English: DATE OF REVISION OF THE TEXT To be completed nationally
Slovenian: DATUM REVIZIJE BESEDILA Izpolni država članica
English: If suspected adverse reactions occur, treatment should be discontinued.
Slovenian: Ob sumu na neželene reakcije je treba zdravljenje prekiniti.
English: Avoid direct contact with skin and eyes when handling the product to prevent sensitisation and contact dermatitis.
Slovenian: Pri delu z izdelkom se izogibajte neposrednemu stiku s kožo in očmi, da ne pride do preobčutljivosti in kontaktnega dermatitisa.
English: Doxycycline increases the action of anticoagulants.
Slovenian: Doksiciklin povečuje delovanje antikoagulantov.
English: These warnings have been broadened to take account of resistance to tetracyclines recognised in isolates from pigs.
Slovenian: Ta opozorila so nekoliko razširili, tako da vključujejo tudi odpornost na tetracikline, ki so jo odkrili v izolatih iz prašičev.
English: Belgium Eurovet N.V. Poorthoevestraat 4, 3 550 Heusen-Zolder Belgium
Slovenian: Poorthoevestraat 4, 3 550 Heusen-Zolder Belgium
English: Keep the bag tightly closed after first opening in order to protect from moisture.
Slovenian: Po prvem odprtju vrečko hranite tesno zaprto, da zagotovite zaščito pred vlago.
English: LABELLING 10 x 100 g
Slovenian: OZNAČEVANJE 10 x 100 g
English: Do not use within 4 weeks of onset of the laying period.
Slovenian: Ne uporabljati 4 tedne pred začetkom obdobja nesnosti.
English: MANUFACTURER'S BATCH NUMBER Lot{number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE Lot {številka}
English: Doxycycline has a low affinity for forming complexes with calcium and studies have demonstrated that doxycycline scarcely affects skeleton formation.
Slovenian: Doksiciklin ima nizko afiniteto za tvorjenje kompleksov s kalcijem in študije so pokazale, da doksiciklin redko vpliva na oblikovanje okostja.
English: - Eggs: Not authorised for use in laying birds producing eggs for human consumption.
Slovenian: - Jajca: Ni dovoljeno za uporabo pri pticah nesnicah jajc za prehrano ljudi.
English: Due to the greater liposolubility and greater facility to pass through cell membranes (in comparison to tetracycline), doxycycline retains a certain degree of efficacy against microorganisms with acquired resistance to tetracyclines.
Slovenian: Zaradi večje topnosti v lipidih in večje zmožnosti za prehod skozi celične membrane (v primerjavi s tetraciklini), doksiciklin proti mikroorganizmom, ki so pridobili odpornost proti tetraciklinom, ohranja določeno stopnjo učinkovitosti.
English: List of the names, pharmaceutical form(s), strength of the veterinary medicinal products, animal species, route of administration, applicant/marketing authorisation holder in the member states
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Doxycycline is listed as a “highly important antimicrobial” for human use, and “critically important” for veterinary use according to the WHO criteria, 2007.
Slovenian: Doksiciklin je po merilih SZO iz leta 2007 naveden kot „zelo pomembno protimikrobno sredstvo“ za uporabo pri ljudeh in „kritično pomemben“ za veterinarsko uporabo.
English: Risk Assessment
Slovenian: Ocena tveganja
English: In addition, in the absence of any adverse pharmacovigilance data indicating suspected lack of expected efficacy, it is considered that revision of the dose rate and regimen is not justified.
Slovenian: Poleg tega se v odsotnosti kakršnih koli farmakovigilančnih podatkov o neželenih učinkih, ki bi kazali na domnevno manjšo učinkovitost od pričakovane, pregled odmerka in režima odmerjanja šteje kot neutemeljen.
English: At the time of the Article 35 referral, there was no documented evidence in relation to suspected lack of expected efficacy of doxycycline products in chickens.
Slovenian: V času napotitve v skladu s členom 35 niso bili dokumentirani nobeni dokazi glede domnevno manjše učinkovitosti zdravil z doksiciklinom od pričakovane pri piščancih.
English: Food-borne, direct as well as environmental transmission of resistant microorganisms (resistant determinants) has to be considered a risk related to the use of the product despite the fact that quantification of transmission of zoonotic agents and horizontal transfer of resistance genes between animal and human bacteria is extremely difficult in vivo (F. J. Angulo et al., 2004)4.
Slovenian: Prenos s hrano ter neposredni in okoljski prenos odpornih mikroorganizmov (odporne determinante) je treba upoštevati kot tveganje, povezano z uporabo zdravila, ne glede na dejstvo, da je kvantifikacija in vivo prenosa povzročiteljev zoonoze ter horizontalnega prenosa genov odpornosti med živalskimi in človeškimi bakterijami zelo težavna (F. J. Angulo et al., 2004)4.
English: Pharmacotherapeutic group: Antibacterial - Tetracycline.
Slovenian: Farmakoterapevtska skupina: Protibakterijsko zdravilo - tetraciklin.
English: If you develop symptoms following exposure such as skin rash, you should seek medical advice and show this warning to the physician.
Slovenian: Če se po izpostavljenosti pojavijo simptomi, kot so izpuščaji na koži, morate poiskati zdravniško pomoč in toopozorilo pokazati zdravniku.
English: Pigs: - Meat and offal: 4 days
Slovenian: Prašiči: - meso in organi: 4 dni
English: Wear impermeable gloves (e.g. rubber or latex) and an appropriate dust mask (e.g. disposable half-mask respirator conforming to European Standard EN149) when applying the product.
Slovenian: Nosite pri uporabi zdravila nepremočljive rokavice (npr. iz gume ali lateksa) in ustrezno masko (npr. respirator za enkratno uporabo s pol-obrazno masko v skladu z evropskim standardom EN149).
English: Precipitation will occur in an alkaline solution.
Slovenian: V alkalnih raztopinah pride do precipitacije.
English: From 24 h up to 96 h after start of treatment the doxycycline plasma concentrations exceeded 2 µg/ml.
Slovenian: Od 24 h do 96 ur po začetku zdravljenja so koncentracije doksiciklina presegale 2 µg/ml.
English: Shelf-life after first opening the packaging: 9 months.
Slovenian: Rok uporabnosti po prvem odpiranju ovojnine: 9 mescev.
English: In addition, no evidence from pharmacovigilance of serious risk has been demonstrated to be associated with the current dosing regimens for chickens or pigs and as such they can be maintained.
Slovenian: Prav tako ni nobenih farmakovigilančnih dokazov, ki bi kazali na resno tveganje, povezano s trenutnim režimom odmerjanja za piščance ali prašiče, kar pomeni, da se tak režim odmerjanja lahko ohrani.
English: In the absence of specific studies the use of the product is not recommended during pregnancy or lactation.
Slovenian: Ker ni na razpolago ustreznih študij, se uporaba zdravila med nosečnostjo ali dojenjem ne priporoča.
English: The following formula can be used to calculate the concentration of the product in drinking water:
Slovenian: Za izračun koncentracije zdravila v pitni vodi se lahko uporabi naslednjo formulo:
English: Bousquet et al. 19973 provides evidence of minimum inhibitory concentrations (MICs) of doxycycline against: P. multocida of 0.13 - 2.0 µg/ml (55 strains), A. pleuropneumoniae 0.25 - 2.0 µg/ml (59 strains), M. hyponeumoniae 0.016 - 2 µg/ml (26 strains).
Slovenian: Avtor Bousquet et al. 19973 predstavlja dokaze o minimalnih inhibitornih koncentracijah (MIC) doksiciklina proti: P. multocida 0,13-2,0 µg/ml (55 sevov), A. pleuropneumoniae 0,25-2,0 µg/ml (59 sevov), M. hyopneumoniae 0,016-2 µg/ml (26 sevov).
English: 6.4 Storage precautions
Slovenian: 6.4 Previdnostni ukrepi pri shranjevanju
English: The majority of the data quoted related to tetracycline resistance generally, and it was noted that resistance to doxycycline specifically was less commonly documented.
Slovenian: Večina navedenih podatkov se je nanašala predvsem na odpornost na tetraciklin in ugotovljeno je bilo, da je odpornost na doksiciklin redkeje dokumentirana.
English: Do not use in case of hypersensitivity to the active substance or to any of excipients.
Slovenian: Ne uporabljajte v primeru preobčutljivosti na zdravilno učinkovino ali na katero koli pomožno snov.
English: Poultry tolerate double overdoses of doxycycline (40 mg/kg body weight) without any clinical effect.
Slovenian: Perutnina prenaša dvakraten odmerek doksiciklina (40 mg/kg) brez kakršnega koli kliničnega učinka.