FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant conducted a pivotal controlled, randomized two-centred field trial using their final formulation to demonstrate efficacy for respiratory disease caused by P.multocida and B.bronchiseptica.
Slovenian: Vlagatelj je opravil ključno, kontrolirano, randomizirano, dvocentrično, terensko preskušanje končne formulacije za dokaz učinkovitosti zdravila pri zdravljenju okužb zaradi P. multocida in B. bronchiseptica.
English: Amendments to the pharmacokinetic section of the SPC and the origin of the MIC values included in this section should be inserted, too.
Slovenian: V povzetku glavnih značilnosti zdravila je treba spremeniti tudi poglavje o farmakokinetiki in dodati vire k vrednostim MIK, ki so navedene v tem poglavju.
English: PHARMACEUTICAL FORM Premix for medicated feeding stuff
Slovenian: FARMACEVTSKA OBLIKA Predmešanica za zdravilno krmno mešanico.
English: In conclusion the applicant has justified their application as well-established use of the active substance, doxycycline.
Slovenian: Končna ugotovitev je, da je vlagatelj utemeljil svojo vlogo na osnovi dobro uveljavljene rabe zdravilne učinkovine - doksiciklina.
English: In Spain the product has been authorised for the indication the treatment of swine respiratory disease caused by Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Slovenian: V Španiji je bil izdelek odobren za zdravljenje bolezni dihal pri prašičih, ki jo povzročajo Pasteurella multocida, Bordetella bronchiseptica in Mycoplasma hyopneumoniae.
English: No dose confirmation studies appear to have been presented in this study and therefore it was important that the references provided should present robust evidence for the field efficacy of the product.
Slovenian: V tej raziskavi ni bilo predstavljenih študij potrjevanja odmerka, zato je pomembno, da priloženi viri posredujejo trdne dokaze o učinkovitosti zdravila na terenu.
English: Do not administer to animals with hepatic damage.
Slovenian: Ne uporabljajte pri živalih s poškodbami jeter.
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: The use is not recommended during pregnancy and lactation.
Slovenian: Uporaba ni priporočljiva v celotnem obdobju brejosti in laktacije.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Doxyprex 100 mg/g Premix
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Doxyprex 100 mg/g predmešanica
English: For pigs with a daily consumption of 40 g of feed/kg b.w./day this dose corresponds to 250 mg of doxycycline per kg of feed which gives a rate of incorporation of 2.5 kg/Ton.
Slovenian: Pri prašičih z dnevnim vnosom 40 g krmne mešanice/kg telesne teže/dan ta odmerek ustreza 250 mg doksiciklina na kg krmne mešanice, kar pomeni, da je razmerje za mešanje 2,5 kg/tono.
English: The closure is by thermosealing.
Slovenian: Vsebniki so zaprti s toplotnim varjenjem.
English: Allergic reactions and photosensitivity may appear, as for all tetracyclines.
Slovenian: Kot pri vseh zdravilnih učinkovinah iz skupine tetraciklinov se lahko pojavijo alergične reakcije in občutljivost za svetlobo.
English: Relapses were assessed.
Slovenian: Ovrednotili so tudi ponovitve bolezni.
English: LABELLING AND PACKAGE INSERT
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Due to variability in susceptibility of bacteria for doxycycline, use of the product should be based on bacteriological sampling and susceptibility testing or recent experience on the farm.
Slovenian: Ker občutljivost bakterij za doksiciklin variira, mora uporaba zdravila temeljiti na bakterioloških vzorcih in preverjanju občutljivosti ali nedavnih izkušnjah na kmetiji.
English: Shelf-life after first opening the immediate packaging: 3 months.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 3 meseci.
English: In the pivotal clinical trial, the presence of P.multocida and B.bronchiseptica was clearly demonstrated in sick pigs, however no post treatment sampling was done to show bacteriological cure.
Slovenian: V ključnem kliničnem preskušanju so pri obolelih prašičih nedvoumno dokazali prisotnost P. multocida in B. bronchiseptica, vendar niso odvzeli vzorcev po zdravljenju za dokaz bakteriološke ozdravitve.
English: The CVMP concluded that according to “current” GCP requirements this pivotal study design has many deficiencies.
Slovenian: CVMP je sklenil, da ima ključna raziskava številne pomanjkljivosti po „trenutno veljavnih“ zahtevah iz smernic za dobro klinično prakso.
English: CONTRAINDICATIONS
Slovenian: Kontraindikacije
English: The Marketing Authorisation Holder (MAH) was requested to substantiate the indication and posology as discussed during the recent MRP.
Slovenian: Odbor je zaprosil imetnika dovoljenja za promet z zdravilom (MAH), da utemelji indikacijo in odmerjanje na osnovi razprave med zadnjim postopkom medsebojnega priznavanja.
English: Withdrawal period
Slovenian: Rok uporabnosti
English: Digestive alterations by intestinal dysbiosis may appear in very long-term treatments.
Slovenian: Pri zelo dolgotrajnem zdravljenju se lahko zaradi črevesne disbioze pojavijo spremembe na prebavilih.
English: It is not recommended its use in pregnant animals and during lactation periods.
Slovenian: Uporaba ni priporočljiva v obdobju brejosti in med laktacijo.
English: Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg thermosealed bags containing 100 mg/g doxycycline base as hyclate.
Slovenian: Zdravilo Doxyprex 100 mg premiks je na voljo v 5 kg, 20 kg ali 25 kg toplotno varjenih vrečah, ki vsebujejo doksiciklin v obliki hiklata.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION In feed use
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
English: {NATURE/TYPE}
Slovenian: VRSTA/TIP
English: Nature and composition of immediate packaging Containers of 1 kg, 5 kg, 20 kg and 25 kg.
Slovenian: Vsebniki po 1, 5, 20 in 25 kg.
English: Do not administer in animals with hypersensitivity to tetracyclines.
Slovenian: Ne uporabljajte, če so živali preobčutljive za zdravilne učinkovine iz skupine tetraciklinov.
English: Applicant or Marketing Authorisation Holder
Slovenian: Vlagatelj ali imetnik dovoljenja za promet z zdravilom
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Slovenian: BESEDILO »ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM« Shranjujte nedosegljivo otrokom.
English: The recommended dose is 10 mg of doxycycline/kg of body weight/day (equivalent to 1 g of Doxyprex/10 kg of b.w.)
Slovenian: Priporočeni odmerek je 10 mg doksiciklina/kg telesne teže/dan (kar je enako 1 g zdravila Doxyprex/10 kg telesne teže) 7 zaporednih dni.
English: Following discussions in the CMD(v), the proposed indication was changed during the course of the MRP to: “For treatment of swine respiratory disease caused by susceptible Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae to doxycycline.”
Slovenian: Po razpravi v usklajevalni skupini za postopke medsebojnega priznavanja in decentralizirane postopke, CMD(v), je bila tekom postopka medsebojnega priznavanja predlagana indikacija spremenjena v: „Za zdravljenje bolezni dihal pri prašičih, ki jo povzročajo za doksiciklin občutljive bakterije Pasteurella multocida, Bordetella bronchiseptica in Mycoplasma hyopneumoniae.“
English: PACKAGE LEAFLET Doxyprex 100 mg/g Premix
Slovenian: NAVODILO ZA UPORABO Doxyprex 100 mg/g predmešanica
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Doxyprex is presented as yellow granules containing 100 mg of doxycycline base as hyclate per gram of product.
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Zdravilo Doxyprex je na voljo v obliki rumenih granul, ki vsebujejo po 100 mg doksiciklinskega hiklata na gram izdelka.
English: 100 mg of Doxycycline base as hyclate
Slovenian: 100 mg doksiciklinijevega hiklata Pomožne snovi:
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {<DD/MM/YYYY>}
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO {<DD/MM/LLLL>}
English: PHARMACEUTICAL FORM Premix for medicated feeding stuff Doxyprex is presented as yellow granules.
Slovenian: Zdravilo Doxyprex je na voljo v obliki rumenih granul.
English: SPECIAL STORAGE CONDITIONS Keep out of the reach and sight of children.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte nedosegljivo otrokom.
English: In feed use.
Slovenian: V krmi.
English: Overdose (symptoms, emergency procedures, antidotes), if necessary No symptoms of intolerance to the speciality have been detected in the studies conducted in which a medicated feed with 600 ppm (2.4 times the recommended dose) was administered to the 20-30 kg animals during twice the recommended period.
Slovenian: V raziskavah, pri katerih so 600 ppm (2,4-kratna količina priporočenega odmerka) dajali 20-30kilogramskim živalim v obdobju, ki je bilo dvakrat daljše od priporočenega trajanja zdravljenja, niso opazili slabega prenašanja tega zdravila.
English: 10 mg/kg .bw
Slovenian: uporaba v krmi 10 mg/kg TM
English: Semoline is employed as carrier.
Slovenian: Kot nosilec je uporabljen pšenični zdrob.
English: Indications for use, specifying the target species For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.
Slovenian: Indikacije za uporabo pri ciljnih živalskih vrstah Za zdravljenje in preprečevanje prašičje respiratorne bolezni, ki jo povzročata bakteriji Pasteurella multocida in Bordetella bronchiseptica, dovzetni za doksiciklin, kadar je bila ta bolezen diagnosticirana v čredi.
English: 1 mg Doxyprex/kg feed = 10 mg doxycycline/kg b.w.
Slovenian: 1 mg Doxyprex/kg krmne mešanice = 10 mg doksiciklina/kg telesne teže x 10 x telesna teža (kg)/dnevni vnos krmne mešanice (kg)
English: For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.
Slovenian: Za zdravljenje in preprečevanje prašičje respiratorne bolezni, ki jo povzročata bakteriji Pasteurella multocida in Bordetella bronchiseptica, dovzetni za doksiciklin, kadar je bila ta bolezen diagnosticirana v čredi.
English: Absorption of doxycycline may be diminished in the presence of high quantities of Ca, Fe, Mg or Al in the diet. Do not administer together with antacids, kaolin and iron preparations.
Slovenian: Če je v krmi velika količina Ca, Fe, Mg ali Al, se lahko zniža absorpcija doksiciklina.
English: The applicant has a justifiable rational behind the choice of products used as positive controls.
Slovenian: Vlagateljeva izbira pozitivnih kontrolnih zdravil je utemeljena.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Izogibajte se uporabi zdravila, če obstaja preobčutljivost za tetracikline.
English: Pharmacokinetic particulars
Slovenian: 5.2 Farmakokinetični podatki
English: Frequency and route of administration
Slovenian: Živalska vrsta Pogostost in pot uporabe zdravila
English: “For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.
Slovenian: „Za zdravljenje in preprečevanje bolezni dihal pri prašičih, ki jo povzročajo za doksiciklin občutljivi bakteriji Pasteurella multocida in Bordetella bronchiseptica, ko je bolezen v čredi dokazana.“
English: Liquid paraffin
Slovenian: Karenca
English: Excipients:
Slovenian: Jakost
English: Very small losses occur in the faeces, sweat and urine.
Slovenian: Zelo majhne izgube se tako pojavijo v blatu, znoju in urinu.
English: Iron is an essential micronutrient.
Slovenian: Železo je pomembno mikrohranilo.
English: If more injections than that are needed, the use of a multiple-dose syringe is recommended.
Slovenian: Če je potrebnih več injekcij kot to, je priporočena uporaba brizge z več odmerki.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Slovenian: PREPOVED PRODAJE, DOBAVE IN/ALI UPORABE Ni smiselno.
English: This product may be harmful for the unborn child.
Slovenian: To zdravilo lahko škoduje nerojenemu otroku.
English: Hypersensitivity reactions can occur.
Slovenian: Pojavijo se lahko preobčutljivostne reakcije.
English: Hygienic measures may reduce the risk of porcine coccidiosis.
Slovenian: Higienski ukrepi lahko zmanjšajo tveganje za kokcidiozo pri prašičih.
English: As with any antiparasiticide, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.
Slovenian: Tako kot pri vsakem antiparazitiku lahko tudi tu pogosta in ponavljajoča se uporaba antiprotozoikov iz istega razreda povzroči razvoj odpornosti.
English: Dark brown suspension.
Slovenian: Temno rjava suspenzija.
English: 6.4 mg For the full list of excipients, see section 6.1.
Slovenian: 6,4 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Interactions with other medicinal products and other forms of interaction: None known.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Niso znane.
English: Excess iron is stored principally in the liver.
Slovenian: Presežek železa se shranjuje predvsem v jetrih.
English: Shake well (for 20 seconds) before use.
Slovenian: Pred uporabo zdravilo dobro pretresite (za 20 sekund).
English: It is therefore recommended to concomitantly improve the hygiene conditions in the farm concerned, particularly by increasing dryness and cleanliness.
Slovenian: Zato je priporočljivo istočasno izboljšati higienske pogoje na farmi, zlasti s povečanjem suhosti in čistoče.
English: The product must not be administered more than once.
Slovenian: Zdravila se ne sme dati več kot enkrat.
English: Since iron is recycled in the body little of the absorbed iron is excreted.
Slovenian: Ker se železo v telesu reciklira, se izloči le malo absorbiranega železa.
English: The recommended dose should not be exceeded, given the relatively low margin of safety for the veterinary medicinal product.
Slovenian: Priporočenega odmerka ne smete prekoračiti zaradi relativno nizke meje varnosti zdravila.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml vsebuje:
English: Toltrazuril sulfone
Slovenian: Toltrazuril sulfon
English: Pharmacotherapeutic group: Toltrazuril, combinations ATCvet code: QP51AJ51
Slovenian: Farmakoterapevtska skupina: Toltrazuril, kombinacije Oznaka ATCvet: QP51AJ51
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Pomožne snovi, navedene v poglavju 6.1 SPC so bodisi dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: For porcine species the fat MRL relates to ‘skin and fat in natural proportions'.
Slovenian: Pri prašičjih vrstah se MRL maščobe nanaša na »kožo in maščobo v naravnih razmerjih«.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/04/2019
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 23/04/2019
English: Meat and offal: 70 days.
Slovenian: Meso in organi: 70 dni.
English: The tolerance of the product after repeated administrations has not been assessed.
Slovenian: Toleranca zdravila po večkratni uporabi ni bila ocenjena.
English: Therefore, the product should be administered to all animals before the expected onset of clinical signs, that is, in the prepatent period.
Slovenian: Zato je treba zdravilo dati vsem živalim pred pričakovanim pojavom kliničnih znakov, tj. v prepatentni dobi.
English: Piglet deaths have been reported which have been attributed to an increased susceptibility to infection due to temporary blocking of the reticuloendothelial system.
Slovenian: Poročali so o smrtnih primerih pujskov, ki jih gre pripisati povečani dovzetnosti za okužbe zaradi začasne blokade retikuloendotelijskega sistema.
English: It plays a major role in the transport of oxygen via haemoglobin and myoglobin, as well as having a key role in enzymes, such as cytochromes, catalases, and peroxidases.
Slovenian: Ima pomembno vlogo pri transportu kisika prek hemoglobina in mioglobina ter ključno vlogo pri tvorbi encimov, kot so citokromi, katalaze in peroksidaze.
English: In case of accidental exposure to the skin or eyes, wash the affected area with water.
Slovenian: V primeru nenamerne izpostavljenosti kože ali oči, prizadeto področje sperite z vodo.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after "EXP".
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli takoj za »EXP«.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ .
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agencyhttp://www.ema.europa.eu/).
English: 4.7 Use during pregnancy or lactation
Slovenian: 4.7 Uporaba v obdobju brejosti ali laktacije
English: The principal route of excretion is via the faeces.
Slovenian: Glavna pot izločanja je potekala prek blata.
English: Toltrazuril and toltrazuril sulfone were eliminated slowly with a half-life of 3 days each.
Slovenian: Toltrazuril in toltrazuril sulfon sta se izločila počasi, z razpolovnim časom 3 dni.
English: Following intramuscular injection, gleptoferron is absorbed and metabolised to release the iron for use and/or storage in accordance with the nutritional status of the animal.
Slovenian: Po intramuskularnem injiciranju se gleptoferon absorbira in presnavlja z namenom, da sprosti železo za uporabo in/ali shranjevanje v skladu s prehranskim stanjem živali.
English: Translucent multi-layered plastic (polypropylene/ethylene vinyl alcohol/polypropylene) vials with bromobutyl rubber stoppers coated with a fluor film and aluminium and plastic flip capsules, containing 100 ml, 250 ml or 500 ml.
Slovenian: Prosojne večplastne plastične (polipropilen/etilen vinil alkohol/polipropilen) viale z zamaškom iz bromobutilne gume, prevlečene s fluor filmom in aluminijastimi in plastičnimi kapsulami z vsebnostjo 100 ml, 250 ml ali 500 ml.
English: Accidental self-injection may cause local reactions such as irritation, granulomas, or severe anaphylactic reactions in sensitive people.
Slovenian: Nenamerno samo-injiciranje lahko pri občutljivih osebah povzroči lokalne reakcije, kot so draženje, granulomi ali hude anafilaktične reakcije.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Slovenian: NAČIN IN POT(I) UPORABE Intramuskularna uporaba.
English: Once clinical signs of coccidiosis are evident, damage to the small intestine will have already occurred.
Slovenian: Ko enkrat opazite klinične znake kokcidioze, je tanko črevesje že poškodovano.
English: The responsible veterinarian should take into account the results of clinical examinations and/or analysis of faecal samples and/or histological findings which confirmed the presence of C. suis in a previous infection episode on the farm.
Slovenian: Odgovorni veterinar mora upoštevati rezultate kliničnih preiskav in/ali analiz vzorcev blata in/ali histoloških preiskav, s katerimi je bila v prejšnji infekcijski epizodi na farmi potrjena prisotnost parazita Cystoisospora suis.
English: Exposure to the veterinary medicinal product may cause eye irritation or adverse effects to the skin.
Slovenian: Izpostavljenost zdravilu lahko povzroči draženje oči ali ima škodljiv vpliv na kožo.
English: Doses higher than 150 mg/kg/day and 667 mg/kg/day for toltrazuril and iron respectively, i.e. 3 times the highest recommended dose, have not been evaluated in the target animal safety studies.
Slovenian: Odmerki, višji od 150 mg/kg/dan in 667 mg/kg/dan za toltrazuril in železo, tj. trikratni najvišji priporočeni odmerki, v študijah varnosti za ciljne živali niso bili ovrednoteni.
English: Toltrazuril is primarily metabolised into toltrazuril sulfone.
Slovenian: Toltrazuril se primarno presnavlja v toltrazuril sulfon.
English: It is not recommended to use the veterinary medicinal product in piglets weighing less than 0.9 kg.
Slovenian: Zdravila ni priporočljivo uporabljati pri pujskih, ki tehtajo manj kot 0,9 kg.
English: It has coccidiocidal activity against all intracellular development stages of the genera Cystoisospora, that is, merogony (asexual multiplication) and gamogony (sexual phase).
Slovenian: Deluje kokcidiocidno proti vsem intracelularnim razvojnim stopnjam rodov parazita Cystoisospora, tj. pri merogoniji (nespolno razmnoževanje) in gamogoniji (spolna faza).
English: These deaths have been associated with genetic factors or deficiencies of vitamin E and/or selenium.
Slovenian: Te smrti so bile povezane z genetskimi dejavniki ali pomanjkanjem vitamina E in/ali selena.
English: In safety studies, after any overdosage, an increased susceptibility for (systemic) bacterial disease, arthritis, and abscess formation was observed and a dose-dependent increase in mortality could not be excluded.
Slovenian: V študijah varnosti so po vsakem prevelikem odmerjanju opazili povečano dovzetnost za (sistemske) bakterijske bolezni, artritis in nastanek abscesa, od odmerka odvisnega povečanja smrtnosti pa ni bilo mogoče izključiti.
English: Pregnant women and women intending to conceive should avoid contact with the veterinary medicinal product, especially accidental self-injection.
Slovenian: Nosečnice in ženske, ki nameravajo zanositi, naj se izogibajo stiku z zdravilom, zlasti nenamernemu samo-injiciranju.
English: PHARMACEUTICAL FORM Suspension for injection
Slovenian: FARMACEVTSKA OBLIKA Suspenzija za injiciranje
English: Injectable iron-carbohydrate complexes, such as gleptoferron, are established haematinic agents in veterinary medicine and are effective in significantly increasing the haemoglobin levels in piglets raised under intensive farming conditions in which an all milk diet for several weeks does not provide an adequate source of iron.
Slovenian: Injekcijski kompleksi železa in ogljikovih hidratov, kot je gleptoferon, so v veterinarski medicini uveljavljena hematinska sredstva, ki so učinkovita pri bistvenem zvišanju ravni hemoglobina pri pujskih, vzrejenih v pogojih intenzivnega kmetovanja, pri katerih več tedenska mlečna prehrana ne zagotavlja ustreznega vira železa.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Slovenian: POSEBNA OPOZORILA, ČE SO POTREBNA Pred uporabo preberite navodilo za uporabo.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains:
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN En ml vsebuje:
English: Pigs (piglets 24 to 96 hours after birth)
Slovenian: Prašiči (pujski, 24 do 96 ur po kotitvi)
English: People with known hypersensitivity to iron (as gleptoferron complex) or toltrazuril or any of the excipients should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo na železo (v obliki kompleksa gleptoferona) ali toltrazuril ali katero koli pomožno snov naj se izogibajo stiku z zdravilom.
English: Toltrazuril is a triazinon derivative and an antiprotozoal agent.
Slovenian: Toltrazuril je derivat triazinona in antiprotozoik.