FrancophonIA/ELRC3.0 huggingface dataset:
English: Capecitabine Accord is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Slovenian: Zdravilo Capecitabine Accord se uporablja z docetakselom (drugim zdravilom proti raku), potem ko zdravljenje z antraciklini (drugo vrsto zdravila proti raku) ni bilo uspešno.
English: Capecitabine Accord is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Slovenian: Zdravilo Capecitabine Accord se uporablja z drugimi zdravili proti raku ali samostojno pri bolnikih po operaciji raka kolona stadija III ali stadija Dukes C;
English: The active substance in Capecitabine Accord, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Slovenian: Zdravilna učinkovina zdravila Capecitabine Accord, kapecitabin, je citotoksik (zdravilo, ki uniči celice, ki se delijo, kot na primer rakave celice) iz skupine antimetabolitov.
English: Capecitabine Accord is an anticancer medicine.
Slovenian: Zdravilo Capecitabine Accord je zdravilo proti raku.
English: Capecitabine Accord is a medicine that contains the active substance capecitabine.
Slovenian: Capecitabine Accord je zdravilo, ki vsebuje zdravilno učinkovino kapecitabin.
English: Capecitabine Accord is used with or without other anticancer medicines;
Slovenian: Zdravilo Capecitabine Accord se uporablja z drugimi zdravili proti raku ali samostojno;
English: Why has Capecitabine Accord been approved?
Slovenian: Zakaj je bilo zdravilo Capecitabine Accord odobreno?
English: How has Capecitabine Accord been studied?
Slovenian: Kako je bilo zdravilo Capecitabine Accord raziskano?
English: How is Capecitabine Accord used?
Slovenian: Kako se zdravilo Capecitabine Accord uporablja?
English: What is Capecitabine Accord used for?
Slovenian: Za kaj se zdravilo Capecitabine Accord uporablja?
English: What is Capecitabine Accord?
Slovenian: Kaj je zdravilo Capecitabine Accord?
English: How does Capecitabine Accord work?
Slovenian: Kako zdravilo Capecitabine Accord deluje?
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV V DRŽAVAH ČLANICAH
English: Norway
Slovenian: NO - Norveška
English: Iceland
Slovenian: IS - Islandija
English: Portugal
Slovenian: PT - Portugalska
English: United Kingdom
Slovenian: UK - Velika Britanija
English: Netherlands
Slovenian: NL - Nizozemska
English: Sweden
Slovenian: SE - Švedska
English: Romania
Slovenian: RO - Romunija
English: Poland
Slovenian: PL - Poljska
English: France
Slovenian: FR - Francija
English: Belgium
Slovenian: BE - Belgija
English: Luxembourg
Slovenian: LU - Luksemburg
English: Czech Republic
Slovenian: CZ - Češka
English: Slovak Republic
Slovenian: SK - Slovaška
English: Bulgaria
Slovenian: BG - Bolgarija
English: Finland
Slovenian: FI - Finska
English: Italy
Slovenian: IT - Italija
English: Denmark
Slovenian: DK - Danska
English: Ireland
Slovenian: IE - Irska
English: Germany
Slovenian: DE - Nemčija
English: Mikrogramm/10 Mikrogramm pro Sprühstoß Druckgasinhalation
Slovenian: Flutiform 250 Mikrogramm/10 Mikrogramm pro Sprühstoß Druckgasinhalation
English: Austria
Slovenian: AT - Avstrija
English: Flutiform® 250/10 µg 250mcg/10mcg
Slovenian: Flutiform® 250/10 µg
English: 140 (2 x 70) tablets (multipack)
Slovenian: 140 (2 x 70) tablet (skupno pakiranje)
English: Strength
Slovenian: Jakost
English: MA (EU) number (Invented) name
Slovenian: (Izmišljeno ime)
English: Pharmaceutical Form
Slovenian: Farmacevtska oblika Pot uporabe
English: Immediate Packaging
Slovenian: Velikost pakiranja
English: Pack size
Slovenian: Stična ovojnina
English: Protect from direct sunlight.
Slovenian: Zaščitite pred neposredno sončno svetlobo.
English: Wash hands after use.
Slovenian: Po uporabi si operite roke.
English: In particular, its activity has been demonstrated against the following microorganism:
Slovenian: Dokazana je aktivnost proti naslednjim mikroorganizmom:
English: Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.
Slovenian: Alergijske reakcije na te snovi so lahko občasno resne, zato je treba neposredni stik preprečiti.
English: 4.8 Interaction with other medicinal products and other forms of interaction None known.
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Niso znane.
English: Do not inject
Slovenian: Ne injicirajte.
English: In very rare cases, a decrease in water intake has been observed.
Slovenian: V zelo redkih primerih so opazili zmanjšan vnos vode.
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 smiselno
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: 4.6 Neželeni učinki (pogostost in resnost)
English: Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Slovenian: Otekanje obraza, ustnic in oči ter oteženo dihanje so resnejši simptomi in zahtevajo nujno zdravniško pomoč.
English: Based on the data presented, the following self-life periods are considered acceptable:
Slovenian: Na podlagi predloženih podatkov se kot sprejemljivi štejejo naslednji roki uporabnosti:
English: ATC vet code: QJ01FA91
Slovenian: Oznaka ATC vet: QJ01FA91
English: 35396 Gießen Germany
Slovenian: 35396 Gießen Nemčija
English: Pigs, chickens and turkeys: Water consumption should be monitored in order to guarantee adequate dosing.
Slovenian: Prašiči, kokoši in purani: za zagotovitev ustreznega odmerjanja je treba spremljati porabo vode.
English: LABELLING
Slovenian: OZNAČEVANJE
English: Do not eat, drink or smoke when handling this product.
Slovenian: Med ravnanjem z zdravilom ne jejte, pijte ali kadite.
English: 4600 Wels Austria
Slovenian: 4600 Wels Avstrija
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
English: SPECIAL WARNING(S), IF NECESSARY
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
English: Manure from treated animals should not be deposited on the same field in successive years.
Slovenian: Gnoj zdravljenih živali se ne sme odlagati na isto polje več let zapored.
English: INDICATION(S)
Slovenian: INDIKACIJA(E)
English: Eight marketing Authorisations were approved via the Mutual Recognition Procedure using Italy as the Reference Member State.
Slovenian: Osem dovoljenj za promet z zdravilom je bilo odobrenih po postopku z medsebojnim priznavanjem, v katerem je bila Italija referenčna država članica.
English: The other marketing authorisations were approved via national procedures.
Slovenian: Druga dovoljenja za promet z zdravilom so bila odobrena po nacionalnih postopkih.
English: Scientific evidence suggests that macrolides act synergistically with the host immune system.
Slovenian: Znanstveni dokazi kažejo, da makrolidi delujejo v sinergiji z imunskim sistemom gostitelja.
English: 13 Rue Pagès 92158 Suresnes Cedex France
Slovenian: 13 Rue Pagès 92158 Suresnes Cedex Francija
English: The referral relates to the divergent national decisions taken by Member States, raised by Germany.
Slovenian: Ta napotitveni postopek, ki ga je sprožila Nemčija, se nanaša na različne odločitve držav članic.
English: It has bacteriostatic action but at high concentrations it may be bactericidal.
Slovenian: Ima bakteriostatično delovanje, vendar je v visokih koncentracijah lahko baktericiden.
English: Therapeutically effective concentrations of tilmicosin were measured up to 60 hours after treatment.
Slovenian: Terapevtsko učinkovite koncentracije so izmerili še 60 ur po zdravljenju.
English: Special precautions for storage
Slovenian: Posebna navodila za shranjevanje
English: 3991 RA Houten
Slovenian: 3991 RA Houten Nizozemska
English: A graduated polypropylene cup is also supplied.
Slovenian: Priložena je graduirana čaša iz polipropilena.
English: Pigs - 14 days
Slovenian: Prašiči - 14 dni
English: PACKAGE SIZE 240 ml
Slovenian: VELIKOST PAKIRANJA 240 ml
English: Introduction
Slovenian: Uvod
English: 4.1 Target species/ 4.2 Indications for Use, Specifying the Target Species: In some Member States the product is indicated for turkeys and in others not.
Slovenian: 4.1 Ciljne živalske vrste/ 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah: V nekaterih državah članicah je zdravilo indicirano za purane, v nekaterih pa ne.
English: 10 DATE OF REVISION OF THE TEXT {For national implementation}
Slovenian: 10 DATUM REVIZIJE BESEDILA {Izpolni država članica}
English: Do not allow horses and other equines access to drinking water containing tilmicosin.
Slovenian: Konji in drugi kopitarji ne smejo imeti dostopa do pitne vode, ki vsebuje tilmikozin.
English: Macrolides appear to enhance phagocyte killing of bacteria.
Slovenian: Zdi se, da makrolidi pospešijo fagocitno uničevanje bakterij.
English: Pharmacotherapeutic Group: antibacterials for systemic use, macrolides.
Slovenian: Farmakoterapevtska skupina: protibakterijska zdravila za sistemsko uporabo, makrolidi.
English: The use of the product should be based on susceptibility tests.
Slovenian: Uporaba zdravila mora temeljiti na določitvi občutljivosti.
English: Although this has a self-limiting effect on tilmicosin intake, it could, in extreme circumstances, result in dehydration.
Slovenian: Čeprav ima to samoomejitveni učinek na vnos tilmikozina, lahko v izjemnih okoliščinah privede do dehidracije.
English: Efficacy in pigs
Slovenian: Učinkovitost pri prašičih
English: In case water consumption does not match quantities for which recommended concentrations were calculated, the concentration of Pulmotil AC has to be adapted in a way that the recommended dosage will be taken up by the animals or different medication should be considered.
Slovenian: Če poraba vode ne ustreza količinam, za katere ste izračunali priporočene koncentracije, morate koncentracijo zdravila Pulmotil AC prilagoditi tako, da živali zaužijejo priporočeni odmerek, ali pa razmisliti o uporabi drugega zdravila.
English: Discussion
Slovenian: Razprava
English: Personal protective equipment should be worn.
Slovenian: Nosite osebno zaščitno opremo.
English: Pulmotil AC 250 mg/ml concentrate for oral solution is currently registered in 18 European Member States.
Slovenian: Zdravilo Pulmotil AC 250 mg/ml, koncentrat za peroralno raztopino, je trenutno registrirano v 18 evropskih državah članicah.
English: Lilly Portugal - Produtos Farmacêuticos, Lda Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, Miraflores 1495-016 Algés Portugal
Slovenian: Lilly Portugal - Produtos Farmacêuticos, Lda Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, Miraflores 1495-016 Algés Portugalska
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Slovenian: Pri uporabi zdravila morate upoštevati uradna, nacionalna in regionalna pravila uporabe protimikrobnih zdravil.
English: People with known hypersensitivity to tilmicosin should avoid contact with the product.
Slovenian: Osebe z znano preobčutljivostjo za tilmikozin naj se izogibajo stiku z zdravilom.
English: The CVMP can accept the indication and posology in all species as these are in accordance with those used in the experimental and field studies.
Slovenian: CVMP lahko sprejme indikacijo in odmerjanje za vse živalske vrste, saj sta skladni z indikacijo in odmerjanjem v eksperimentalnih in terenskih študijah.
English: The uptake of medicated drinking water/milk replacer depends on the clinical condition of the animals.
Slovenian: Vnos pitne vode/nadomestka mleka s primešanim zdravilom je odvisna od kliničnega stanja živali.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I 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: - If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning.
Slovenian: - Če se pri vas po izpostavitvi pojavijo simptomi, kot je kožni izpuščaj, se posvetujte z zdravnikom in mu pokažite to opozorilo.
English: The main section of disharmony of the existing SPCs (non exhaustive) are:
Slovenian: Poglavitna poglavja neskladnosti v obstoječih povzetkih glavnih značilnosti zdravila so (med drugim):
English: Cross-resistance between tilmicosin and other macrolides and lincomycin has been observed.
Slovenian: Opazili so navzkrižno odpornost proti tilmikozinu in drugim makrolidom ter linkomicinu.
English: Veterinary medicinal product must not be disposed of via waste water or the drainage systems.
Slovenian: Zdravilo za uporabo v veterinarski medicini se ne sme odstranjevati v odpadne vode ali drenažne sisteme.
English: For oral use only.
Slovenian: Samo za peroralno uporabo.
English: Inappropriate use of the product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin-related substances.
Slovenian: Neustrezna uporaba zdravila lahko zviša pogostnost bakterij, odpornih proti tilmikozinu, ter lahko zmanjša učinkovitost zdravljenja z zdravili, ki so sorodna tilmikozinu.
English: - Do not handle the product if you are allergic to ingredients in the product.
Slovenian: - Na ravnajte z zdravilom, če ste alergični na sestavine zdravila.
English: 4.1 Target species
Slovenian: 4.1 Ciljne živalske vrste
English: In case of accidental eye contact, flush the eyes with plenty of clean, running water.
Slovenian: V primeru nenamernega stika z očmi izperite z veliko količino čiste, tekoče vode.
English: Efficacy in calves (non-ruminant)
Slovenian: Učinkovitost pri teletih (neprežvekovalcih)
English: Important: Must be diluted before administration to animals.
Slovenian: Pomembno: pred dajanjem živali je treba zdravilo razredčiti.
English: This can be corrected by the removal of the medicated drinking water and replacement with fresh unmedicated water.
Slovenian: To odpravimo z odstranitvijo pitne vode s primešanim zdravilom, ki se nadomesti s svežo vodo brez zdravila.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Slovenian: Vsako neuporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
English: United Kingdom
Slovenian: Združeno kraljestvo
English: Member State Marketing Authorisation Holder
Slovenian: Država članica Imetnik dovoljenja za promet
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {For national implementation}
Slovenian: DATUM PRVE PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET {Izpolni država članica}
English: Not all pack sizes may be marketed.
Slovenian: Ni nujno, da so v prometu vsa navedena pakiranja.
English: The CVMP has assessed two early dose determination studies, two definitive dose determination studies and eleven clinical study reports in pigs.
Slovenian: CVMP je ovrednotil dve začetni študiji določitve odmerka, dve dokončni študiji določitve odmerka in enajst poročil o klinični študiji pri prašičih.
English: This antibacterial activity is predominantly against Gram-positive microorganism with activity against certain gram-negative ones and Mycoplasma of a bovine, porcine, ovine and avian origin.
Slovenian: Ta protibakterijska aktivnost je predvsem usmerjena proti grampozitivnim mikroorganizmom, pa tudi proti določenim gramnegativnim mikroorganizmom ter mikoplazmam goveda, prašičev, ovac in ptic.
English: Calves (non ruminant)
Slovenian: Teleta (neprežvekovalci)
English: Animal species
Slovenian: Živalska vrsta
English: NAME OF THE VETERINARY MEDICINAL PRODUCT To be completed nationally
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Izpolni država članica
English: The CVMP accepts the Marketing Authorisation Holders' proposal to harmonise the withdrawal period for all species on the basis of the pivotal residue studies presented.
Slovenian: CVMP je sprejel predlog imetnikov dovoljenj za promet z zdravilom, da se karenca za vse živalske vrste uskladi na podlagi predloženih ključnih študij ostankov.
English: 4.11 Withdrawal period(s): Withdrawal periods granted for the product vary among the Member States for all target species
Slovenian: 4.11 Karenca(e): Odobrene karence za zdravilo se razlikujejo med državami članicami za vse ciljne živalske vrste.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND LABELLING
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN OZNAČEVANJA
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PULMOTIL AC AND ASSOCIATED NAMES
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA PULMOTIL AC
English: Pigs
Slovenian: Prašiči
English: 6.2 Incompatibilities None known.
Slovenian: 6.2 Inkompatibilnosti
English: The Marketing Authorisation Holders submitted at the request of CVMP: - an exhaustive list of differences between the SPCs of the product authorized in the member states; - a proposal for a harmonised product information (SPC, labelling and package leaflet), taking into account the latest guidance; - the available relevant data substantiating such proposed harmonised product information.
Slovenian: Imetniki dovoljenj za promet z zdravilom so na zahtevo odbora CVMP predložili: - popoln seznam razlik med povzetkom glavnih značilnosti zdravila, ki je odobreno v državah članicah; - osnutek usklajenih informacij o zdravilu (povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo) ob upoštevanju najnovejših priporočil; - razpoložljive zadevne podatke, ki utemeljujejo tako predlagane usklajene informacije o zdravilu.
English: - In the case of accidental ingestion, wash out mouth immediately with water and seek medical advice.
Slovenian: - V primeru nenamernega zaužitja takoj sperite usta z vodo in se posvetujte z zdravnikom.
English: ; - The pharmacodynamic properties need rewording; - The shelf life of the veterinary medicinal product as packaged for sale is 2 years,
Slovenian: ; - opis farmakodinamičnih lastnosti je treba preoblikovati; - rok uporabnosti zdravila v pakiranju za prodajo je 2 leti;
English: When mixing the veterinary medicinal product direct contact with eyes, skin and mucous membranes should be avoided.
Slovenian: Pri mešanju zdravila za uporabo v veterinarski medicini preprečite stik zdravila z očmi, kožo in sluznicami.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance: Tilmicosin (as phosphate) 250 mg/ml.
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Zdravilna učinkovina: tilmikozin (v obliki fosfata) 250 mg/ml.
English: Having considered the grounds for referral and the response provided by the Marketing Authorisation Holders, the CVMP concludes that the benefit/risk balance of the product is positive for use in pigs, chicken (except hens producing eggs for human consumption), calves (non-ruminant) and turkeys subject to the recommended changes of Summary of the Product Characteristics and product information.
Slovenian: Ob upoštevanju podlage za napotitveni postopek ter odgovora imetnika dovoljenja za promet z zdravilom CVMP meni, da je razmerje med koristmi in tveganji za zdravilo pozitivno za uporabo pri prašičih, piščancih (razen za kokoši v obdobju nesnosti, katerih jajca so namenjena prehrani ljudi), teletih (neprežvekovalcih) in puranih ob upoštevanju priporočenih sprememb povzetka glavnih značilnosti zdravila in informacij o zdravilu.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Do not use in case of hypersensitivity to tilmicosin or to any of the excipients
Slovenian: Ne uporabljajte v primeru preobčutljivosti za tilmikozin ali katero koli pomožno snov.
English: As no Maximum Residue Limit has been set for tilmicosin in eggs, the following statement should be included in the SPC: Not authorised for use in laying birds producing eggs for human consumption.
Slovenian: Ker mejna vrednost ostankov tilmikozina v jajcih ni določena, je treba v povzetek glavnih značilnosti zdravila vključiti naslednjo izjavo: Ni dovoljena uporaba pri pticah v obdobju nesnosti, katerih jajca so namenjena prehrani ljudi.
English: 4.9 Amounts to be administered and administration route
Slovenian: 4.9 Odmerjanje in pot uporabe
English: Medicated drinking water or milk replacer should be prepared fresh every 24 hours.
Slovenian: Vsakih 24 ur morate pripraviti svežo pitno vodo ali nadomestek mleka z zdravilom.
English: When pigs are offered drinking water containing 300 or 400 mg/litre (equivalent to 22.5-40 mg/kg bodyweight or 1.5-2 times the recommended concentration) commonly animals exhibit a reduced water intake.
Slovenian: Če prašičem ponudimo pitno vodo s 300 ali 400 mg/liter (enakovredno 22,5-40 mg/kg telesne mase ali 1,5-2-kratniku priporočene koncentracije), živali običajno zmanjšajo pitje vode.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 2 years Shelf-life after first opening the immediate packaging: 3 months Shelf-life after dilution or reconstitution according to directions: 24 hours
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesece Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili: 24 ur.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neuporabljenega zdravila ali iz njih nastalih odpadnih snovi
English: MANUFACTURER'S BATCH NUMBER Lot
Slovenian: ŠTEVILKA SERIJE Lot
English: 5.2 Pharmacokinetic particulars
Slovenian: 5.2 Farmakokinetični podatki
English: Whilst blood concentrations of tilmicosin are low, there is pH-dependent macrophage accumulation of tilmicosin in inflamed tissues.
Slovenian: Čeprav so koncentracije tilmikozina v krvi nizke, se v vnetih tkivih pojavi kopičenje tilmikozina v makrofagih, ki je odvisno od vrednosti pH.
English: ¾ Pigs: Mycoplasma hyopneumoniae, Pasteurella multocida and Actinobacillus pleuropneumoniae ¾ Chickens and turkeys: Mycoplasma gallisepticum and Mycoplasma synoviae ¾ Calves: Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis and M. dispar.
Slovenian: ¾ Prašiči: Mycoplasma hyopneumoniae, Pasteurella multocida in Actinobacillus pleuropneumoniae ¾ Kokoši in purani: Mycoplasma gallisepticum in Mycoplasma synoviae ¾ Teleta: Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis in M. dispar.
English: 78 hours after the start of treatment, the tilmicosin concentration in lung tissue was 42.7 µg/g.
Slovenian: Po 78 urah od začetka zdravljenja je bila koncentracija tilmikozina v pljučnem tkivu 42,7 µg/g.
English: One 960 ml bottle is sufficient to medicate 1200 litres of drinking water for pigs or 3200 litres of drinking water for chickens or turkeys.
Slovenian: Ena plastenka z 960 ml zdravila zadostuje za pripravo 1 200 litrov pitne vode, ki se ji primeša zdravilo, za prašiče ali 3200 litrov pitne vode, ki se ji primeša zdravilo, za kokoši ali purane.
English: 4.5 Special precautions for use
Slovenian: 4.5 Posebni previdnostni ukrepi
English: MARKETING AUTHORISATION NUMBER(S) {For national implementation}
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET {Izpolni država članica}