FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder submitted a body of literature references which supported a prediction that when administered at the proposed dose rate, doxycycline concentration in the relevant tissues would exceed the MIC for most target pathogens.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil sklop literature, ki potrjuje pričakovanje, da bi pri uporabi predlaganega odmerka koncentracija doksiciklina v zadevnih tkivih presegla vrednost MIC za večino ciljnih patogenov.
English: Interactions with other medicinal products and other forms of interaction Do not combine with antibiotics that are bactericidal like penicillins or cephalosporins.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ne kombinirajte z antibiotiki, ki so baktericidni, kot so penicilini ali cefalosporini.
English: LABEL TEXT SINGLE SACHETS/BAGS
Slovenian: BESEDILO ZA OZNAKE ENOJNIH VREČK
English: In pig pathogens resistance against doxycycline may also vary; especially susceptibility figures of A. pleuropneumoniae may differ from country to country and even farm to farm.
Slovenian: Tudi pri prašičih lahko odpornost patogenov na doksiciklin niha; predvsem vrednosti za občutljivost A. pleuropneumoniae se lahko od države do države in celo od kmetije do kmetije razlikujejo.
English: Prescription only medicine - To be completed nationally.
Slovenian: Zdravilo samo na veterinarski recept - Izpolni država članica .
English: Four resistance mechanisms acquired by microorganisms against tetracyclines in general have been reported: Decreased accumulation of tetracyclines (decreased permeability of the bacterial cell wall and active efflux), protein protection of the bacterial ribosome, enzymatic inactivation of the antibiotic and rRNA mutations (preventing the tetracycline binding to ribosome).
Slovenian: Kar se pridobljene odpornosti mikroorganizmov proti tetraciklinu tiče, so poročali o štirih splošnih mehanizmih: Zmanjšano kopičenje tetraciklinov (zmanjšana prepustnost bakterijske celične stene in aktivni iztok), proteinska zaščita bakterijskega ribosoma, encimska inaktivacija antibiotika in rRNA mutacije (ki preprečujejo, da se tetraciklini vežejo na ribosom).
English: Composition per gram product: Active Substance:
Slovenian: Sestava na gram izdelka: Aktivna snov:
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 9 months Shelf-life after dilution or reconstitution according to directions: After reconstitution with water, any product remaining after 24 hours should be discarded.
Slovenian: Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 3 leta Rok uporabnosti po prvem odpiranju stične ovojnine: 9 mescev Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili: Po rekonstituciji z vodo je treba po 24 urah preostanek izdelka zavreči.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Aluminium Foil Sachet 100g (packed per 10)
Slovenian: PODATKI NA ZUNANJI OVOJNINI torbica iz aluminijeve folije 100g (pakirano po 10)
English: For O. rhinotracheale, no therapeutic dose could be confirmed.
Slovenian: Za okužbo z O. rhinotracheale ni bilo mogoče potrditi terapevtskega odmerka.
English: Do not combine with antibiotics that are bacteriocidal e.g. penicillins or cephalosporins.
Slovenian: Ne kombinirajte z antibiotiki, ki so baktericidni, kot so penicilini ali cefalosporini.
English: If you know you are allergic to the tetracycline class of antibiotics, special care should be taken when handling this product or the medicated solution.
Slovenian: Če veste, da ste alergični na tetraciklinske antibiotike, je pri rokovanju z zdravilom ali s pripravljeno raztopino potrebna posebna previdnost .
English: The precautions to limit the development of resistance, which were recommended by CVMP during the Article 35 referral, have been included in section 4.5 of the SPC.
Slovenian: Obvladovanje tveganja ali ukrepi za zmanjševanje tveganja Previdnostni ukrepi za zmanjševanje razvoja odpornosti, ki jih je priporočil CVMP med postopkom napotitve v skladu s členom 35, so bili vključeni v poglavje 4.5 povzetka glavnih značilnosti zdravila.
English: 2 Bousquet et al. 1998, Pharmacokinetics of doxycycline in pigs following oral administration in feed Vet.Res.
Slovenian: 2 Bousquet et al. (1998): Pharmacokinetics of doxycycline in pigs following oral administration in feed.
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Slovenian: Vse neporabljeno veterinarsko zdravilo ali odpadke, ki nastanejo iz tega veterinarskega zdravila, je treba odstraniti v skladu z lokalnimi predpisi.
English: PACKAGE SIZE 100 g (250 g, 500 g, 1 kg)
Slovenian: VELIKOST PAKIRANJA 100 g (250 g, 500 g, 1 kg)
English: Doxycycline is primarily a bacteriostatic drug.
Slovenian: Doksiciklin je predvsem bakteriostatično zdravilo.
English: To be completed nationally
Slovenian: Izpolni država članica
English: Doxycycline is absorbed in the stomach and the first part of the duodenum.
Slovenian: Doksiciklin se absorbira v želodcu in začetnem delu dvanajstnika.
English: Compared to the older tetracyclines the absorption of doxycycline is less affected by the presence of bivalent cations in food.
Slovenian: V primerjavi s starejšimi tetraciklini ima prisotnost dvovalentnih kationov v hrani manj vpliva na absorpcijo doksiciklina.
English: Administration orally with the drinking water.
Slovenian: Daje se oralno s pitno vodo.
English: Wash hands and contaminated skin immediately after handling the product.
Slovenian: Po delu s proizvodom si takoj umijte roke in kontaminirano kožo.
English: TARGET SPECIES Pigs and chickens (broiler, pullet, breeder).
Slovenian: CILJNE ŽIVALSKE VRSTE Prašiči in piščanci (brojler, kokoška, rejnica).
English: Significantly no cross resistance was observed between oxytetracycline and doxycycline.
Slovenian: Pomembno je tudi, da ni bila opažena nobena navzkrižna odpornost med oksitetraciklinom in doksiciklinom.
English: = .... mg product per l drinking water
Slovenian: = .... mg izdelka na l pitne vode
English: 6 The ARBAO-II study, Occurrence of antimicrobial resistance among bacterial pathogens and indicator bacteria in pigs in different European countries form year 2002-2004, Acta Veterinaria Scandinavica 50(19) (2008)
Slovenian: 6 The ARBAO-II study, Occurrence of antimicrobial resistance among bacterial pathogens and indicator bacteria in pigs in different European countries form year 2002-2004.
English: Respiratory tract tissue: plasma ratios of 1.3 (healthy lungs), 1.9 (pneumonic lungs) and 2.3 (nasal mucosa) have been reported for doxycycline.
Slovenian: Tkivo v dihalnem traktu: za doksiciklin navajajo razmerja v plazmi 1,3 (zdrava pljuča), 1,9 (pneumonična pljuča) in 2.3 (sluznica v nosu).
English: Carton box for the 10x100 grams Alufoil sachets with label for 100 gram sachets and leaflet
Slovenian: Škatla za 10x100 gramske vrečke iz aluminijeve folije z oznako za 100 gramske vrečke in navodilo za uporabo
English: METHOD AND ROUTE(S) OF ADMINISTRATION To be administered orally in the drinking water.
Slovenian: NAČIN IN POT(I) UPORABE Daje se peroralno v pitni vodi.
English: Composition per gram product Active Substance:
Slovenian: Sestava na gram izdelka Aktivna snov:
English: In human medicine, doxycycline is the treatment of choice for the treatment of acute tracheobronchitis, acute bronchitis and acute bronchiolitis caused by primary bacterial infections (Mycoplasma pneumoniae, Chlamydia pneumoniae) and bacterial superinfections (Pneumococci, Haemophilus spp.).
Slovenian: V humani medicini je doksiciklin zdravilo izbire za zdravljenje akutnega traheobronhitisa, akutnega bronhitisa in akutnega bronhiolitisa, ki ga povzročajo primarne bakterijske okužbe (Mycoplasma pneumoniae, Chlamydia pneumoniae) in sekundarne bakterijske okužbe (pnevmokoki, Haemophilus spp).
English: The chicken residue depletion data submitted allowed the setting of meat withdrawal periods in chickens.
Slovenian: Predloženi podatki o izločanju ostankov pri piščancih so omogočili določitev karence za meso pri piščancih.
English: Do not use in animals with an impaired liver function.
Slovenian: Ne uporabljajte pri živalih z okvaro jeter.
English: In response to this the Marketing Authorisation Holder submitted PSUR data covering the past 5 years.
Slovenian: V odgovor je imetnik dovoljenja za promet z zdravilom predložil dopolnjeno redno poročilo o varnosti zdravila (PSUR), ki je zajemalo zadnjih pet let.
English: For the treatment of P. multocida, a dosage regimen of 10 mg/kg body weight for 4 or 5 days was agreed.
Slovenian: Za zdravljenje okužb zaradi P. multocida je bil dogovorjen režim odmerjanja 10 mg/kg telesne mase 4 ali 5 dni.
English: Doxycycline is a broad-spectrum antibiotic, active against a large number of Gram-positive and Gramnegative, aerobe and anaerobe micro-organisms, Mycoplasmata, Chlamydiae and Rickettsia.
Slovenian: Doksiciklin je antibiotik širokega spektra, učinkovit za obsežno skupino Gram-pozitivnih in Gramnegativnih, aerobnih in anaerobnih mikroorganizmov, kot so Mycoplasmata, Chlamydiae in Rickettsia.
English: In addition the Marketing Authorisation Holder submitted Periodic Safety Update Report (PSUR) data which indicated that no adverse events in chickens, including suspected lack of expected efficacy, has been reported for the past 5 years in the European Union.
Slovenian: Poleg tega je imetnik dovoljenja za promet z zdravilom predložil dopolnjeno redno poročilo o varnosti zdravila (PSUR), ki je kazalo, da v zadnjih petih letih v Evropski uniji niso poročali o nobenih neželenih učinkih pri piščancih, vključno z domnevno manjšo učinkovitostjo od pričakovane.
English: Doxycycline is scarcely metabolised.
Slovenian: Doksiciklin se komajda metabolizira.
English: Sachets of 100g, 250g, 500g and 1 kg and 10x 100g in a carton box.
Slovenian: Vrečke s 100g, 250g, 500g in 1 kg in 10x 100g v kartonski škatli.
English: There have been no reports of adverse events in pigs, including suspected lack of expected efficacy, during the last 5 years.
Slovenian: V zadnjih petih letih ni bilo nobenih poročil o neželenih učinkih pri prašičih, vključno z domnevno manjšo učinkovitostjo od pričakovane.
English: Chickens: Where clinical disease is present in the flock, to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale (ORT).
Slovenian: Piščanci: kjer je v jati prisotno klinično obolenje, da se zmanjša smrtnost, obolevnost in klinične znake in da se zmanjša poškodbe zaradi pasteureloze, ki jo povzroča Pasteurella multocida, ali pa da se zmanjša morbidnost in poškodbe zaradi okužb dihal, ki jih povzroča Ornithobacterium rhinotracheale (ORT).
English: It was identified at the time of the Article 35 referral for water soluble powders and oral solutions containing doxycycline hyclate that a high resistance rate to tetracyclines existed in E. coli isolated from chickens (De Jong et al, 2009)5.
Slovenian: V času napotitve v skladu s členom 35 je bilo za v vodi topne praške in peroralne raztopine, ki vsebujejo doksiciklinijev hiklat, ugotovljeno, da je obstajala visoka stopnja odpornosti na tetracikline pri bakteriji E.coli, izolirani iz piščancev (De Jong et al., 2009)5.
English: Shelf-life after dilution or reconstitution according to directions: After reconstitution with water any product remaining after 24 hours should be discarded.
Slovenian: Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili: Po rekonstituciji z vodo je treba po 24 urah preostanek izdelka zavreči.
English: It exerts its action by inhibiting the protein synthesis of the bacterial cell.
Slovenian: Deluje tako, da zavira sintezo beljakovin v bakterijski celici.
English: Data were provided in support of the indication for P. multocida at a dose of 10 mg doxycycline hyclate per kg body weight per day.
Slovenian: Predloženi so bili podatki v podporo indikaciji za P. multocida z odmerkom 10 mg doksiciklinijevega hiklata na kg telesne mase na dan.
English: Because doxycycline is highly lipid soluble, it has a good tissue penetration.
Slovenian: Glede na to, da je doksiciklin zelo topen v lipidih, ima zelo dobro sposobnost.
English: Doxycycline is bacteriostatic and acts by inhibiting protein synthesis intracellularly by binding to the 30-S subunit of the bacterial ribosome.
Slovenian: Doksiciklin je bakteriostatičen in deluje tako, da znotraj celic z vezavo na podenote 30-S bakterijskega ribosoma zavira sintezo beljakovin.
English: Special precautions for use in animals Read the package leaflet before use.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Pred uporabo preberite navodilo za uporabo.
English: Doxycycline belongs to the group of the tetracycline antibiotics.
Slovenian: Doksiciklina spada v skupino tetraciklinskih antibiotikov.
English: Benefit Assessment
Slovenian: Ocena koristi
English: Solubility of doxycycline is pH dependent.
Slovenian: Topnost doksiciklina je odvisna od pH.
English: Doxyfar 50 % and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g.
Slovenian: Zdravilo Doxyfar 50 % in z njim povezana imena je prašek za uporabo v pitni vodi, ki vsebuje zdravilno učinkovino doksiciklinijev hiklat 500 mg/g.
English: mg product / kg body weight / day x
Slovenian: ..... mg produkta / kg telesne teže /dan x
English: Soludox 500 mg/g κόνις για χρήση στο πόσιμο νερό για όρνιθες
Slovenian: Soludox 500 mg/g κόνις για χρήση στο πόσιμο νερό για όρνιθες doksiciklinijev hiklat
English: (ii) User warnings:
Slovenian: Opozorila za uporabnika
English: Further the Marketing Authorisation Holder has also provided evidence (Bousquet et al. 1998)2 that doxycycline will concentrate in nasal secretions and if fed at dose regimens between 11.8 -13.3 mg/kg body weight for 1 hour per day concentrations of between 0.7 and 1 µg/ml are achieved in the lung and nasal concentrations of 1.7 +/- 0.4 µg/ml are reached.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil tudi dokaze (Bousquet et al. 1998)2, da se doksiciklin koncentrira v nosnih izločkih; če se daje s hrano z odmerki med 11,8 in 13,3 mg/kg telesne mase za eno uro na dan, pa se dosežeta koncentracija med 0,7 in 1 µg/ml v pljučih in koncentracija 1,7 +/-0,4 µg/ml v nosu.
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Slovenian: na ravni področja, na ravni kmetije) epidemiološke podatke o dovzetnosti ciljne bakterije.
English: The Marketing Authorisation Holder has provided evidence that the baseline PK of doxycycline, when delivered orally to pigs at a dose of 12.5 mg/kg body weight will provide plasma levels of 0.71 - 1.14 µg/ml (Pijpers et al (1991) 1.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil dokaze, da osnovna farmakokinetika doksiciklina pri peroralni uporabi pri prašičih z odmerkom 12,5 mg/kg telesne mase zagotavlja plazemsko raven od 0,71 do 1,14 µg/ml (Pijpers et al. (1991)1.
English: Based on the dose to be used, and the number and weight of the animals to be treated, the exact daily amount of product can be calculated.
Slovenian: Točno dnevno količino proizvoda se lahko izračuna na podlagi odmerka, ki ga je treba uporabiti, ter števila in teže živali, ki jih je treba zdraviti.
English: • the CVMP considered that the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet;
Slovenian: • CVMP je upošteval, da je bil namen napotitve uskladiti povzetek glavnih značilnosti zdravila,
English: The solubility of the product is pH dependent and will precipitate if mixed in alkaline solution.
Slovenian: Topnost izdelka je odvisna od pH in v alkalni mešanici bo prišlo bo do obarjanja.
English: Pigs and chickens (broiler, pullet, breeder).
Slovenian: Prašiči in piščanci (brojler, kokoš nesnica, jarkica).
English: On the basis of well established use and absence of data for suspected lack of expected efficacy the dose regimen for infections caused by P. multocida of 10 mg doxycycline hyclate per kg body weight for 3 to 4 consecutive days and for infections caused by O. rhinotracheale of 20 mg doxycycline hyclate per kg body weight for 3 to 4 consecutive days were considered acceptable.
Slovenian: Na podlagi dobro uveljavljene uporabe in pomanjkanja podatkov o domnevno manjši učinkovitosti od pričakovane sta se režim odmerjanja 10 mg doksiciklinijevega hiklata na kg telesne mase 3 do 4 zaporedne dni za okužbe, ki jih povzroča P. multocida, in režim odmerjanja 20 mg doksiciklinijevega hiklata na kg telesne mase 3 do 4 zaporedne dni za okužbe, ki jih povzroča O. rhinotracheale, štela kot sprejemljiva.
English: Following oral administration at a dose of 12.8 mg/kg body weight, steady state concentrations during medication range between a Cmin of 0.40 µg/ml in the early morning to a Cmax of 0.87 µg/ml in the late afternoon in pigs.
Slovenian: Po peroralnem odmerku 12,8 mg/kg znašajo pri prašičih ustaljene koncentracije zdravila med Cmin 0,40 µg/ml v zgodnjih jutranjih urah in Cmax 0,87 µg/ml v poznih popoldanskih urah.
English: It was agreed that the target species should be harmonised across all Member States where the product is authorised or pending authorisation and in consistency with the recent Article 35 harmonisation as “chickens (broiler, pullet, breeder)”, and the following indications for Doxyfar 50% and associate names were agreed:
Slovenian: Dogovorjeno je bilo, da je v vseh državah članicah, v katerih je zdravilo odobreno ali čaka na odobritev, treba uskladiti ciljne živalske vrste in zagotoviti skladnost z nedavnim postopkom usklajevanja po členu 35 za „piščance (brojlerji, za vzrejo nesnic, vzrejni)“.
English: Absorption of doxycycline can be decreased in the presence of high quantities of calcium, iron, magnesium or aluminium in the diet. Do not administered together with antacids, kaolin and iron preparations.
Slovenian: Absorpcija doksiciklina se v prisotnosti velike količine kalcija, železa, magnezija ali aluminija v prehrani lahko zmanjša.
English: PACKAGE SIZE 100 gram
Slovenian: VELIKOST PAKIRANJA 100 gramov
English: No data have been provided for chickens, however the Marketing Authorisation Holder submitted in support of the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047).
Slovenian: Za piščance niso bili predloženi nobeni podatki, vendar je imetnik dovoljenja za promet z zdravilom v nedavnem napotitvenem postopku v skladu s členom 35 predložil podatke za vse jakosti v vodi topnih praškov in peroralnih raztopin, ki vsebujejo doksiciklinijev hiklat ter so indicirani za dajanje pri perutnini in namenjeni za uporabo s pitno vodo (EMEA/V/A/047).
English: Evaluation of the Benefit-risk balance
Slovenian: Ocena razmerja med tveganji in koristmi
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POTI IN NAČIN UPORABE ZDRAVILA
English: • Pigs: 12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4
Slovenian: • Prašiči: 12,5 mg doksiciklinijevega hiklata (25 mg zdravila) na kg telesne mase na dan 4
English: Solubility of the product is pH dependent and it may precipitate if it is mixed in hard alkaline drinking water.
Slovenian: Topnost zdravila je odvisna od pH in, če se ga vmešava v trdo alkalno vodo za pitje, lahko pride do precipitacije.
English: Data had previously been submitted as part of the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047).
Slovenian: Podatki so bili predloženi že predhodno v napotitvenem postopku v skladu s členom 35 za vse jakosti v vodi topnih praškov in peroralnih raztopin, ki vsebujejo doksiciklinijev hiklat ter so indicirani za uporabo pri perutnini in namenjeni za dajanje s pitno vodo (EMEA/V/A/047).
English: 500 mg corresponding to 433 mg doxycycline 433 mg corresponding to 500 mg doxycycline hyclate
Slovenian: 500 mg ustreza 433 mg doksiciklina 433 mg ustreza 500 mg Doksiciklinijev hiklata
English: PHARMACEUTICAL FORM Yellow crystalline powder for use in drinking water.
Slovenian: FARMACEVTSKA OBLIKA Rumen kristalni prašek za uporabo v pitni vodi.
English: 4 CLINICAL PARTICULARS
Slovenian: KLINIČNE PODROBNOSTI
English: 3 PHARMACEUTICAL FORM Powder for use in drinking water Yellow crystalline powder
Slovenian: FARMACEVTSKA OBLIKA Prašek za uporabo v pitni vodi Rumen kristalen prašek
English: Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline France: Doxycycline 433 mg, corresponding to 500 mg doxycycline hyclate
Slovenian: Doksiciklinijev hiklat 500 mg, ustreza 433 mg doksiciklina FR: Doksiciklin 433 mg, ustreza 500 mg doksiciklinijevega hiklata
English: Due to likely variability (time, geographical) in susceptibility of bacteria for doxycycline, especially susceptibility of A. pleuropneumoniae and O. rhinotracheale may differ from country to country and even farm to farm, bacteriological sampling and susceptibility testing are recommended.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Ker je pričakovati spremenljivost (časovno, geografsko), kar se dovzetnosti bakterij za doksiciklin tiče, zlasti vrednosti za občutljivost A. pleuropneumoniae in O. rhinotracheale, razlikujejo od države do države in celo od kmetije do kmetije, se priporoča bakteriološko vzorčenje in testiranje občutljivosti.
English: Following administration of doxycycline hyclate at an actual dose of 21 mg/kg body weight to chickens mean plasma concentrations above 1 µg/ml were reached within 6 hours and lasted for 6 hours after cessation of medication.
Slovenian: Po odmerku Doksiciklinijev hiklata v odmerku 21 mg/kg telesne teže so bile pri piščancih povprečne koncentracije v plazmi nad 1 µg/ml dosežene po 6 urah.
English: PACKAGE SIZE 10x100 gram
Slovenian: VELIKOST PAKIRANJA 10x100 gramov
English: When pigs are administered 12.5 mg doxycycline hyclate/kg bw/day for 8 days; meat withdrawal periods of 4 days will ensure consumer safety.
Slovenian: Kadar prašiči 8 dni prejemajo 12,5 mg doksiciklinijevega hiklata na kg telesne mase na dan, karenca za meso 4 dni zagotavlja varnost potrošnikov.
English: Additional information has been added to the SPC regarding mechanisms of resistance to tetracyclines in general.
Slovenian: V povzetek glavnih značilnosti zdravila so bile dodane informacije glede splošnih mehanizmov odpornosti na tetracikline.
English: PHARMACEUTICAL FORM Yellow powder for use in drinking water.
Slovenian: FARMACEVTSKA OBLIKA Rumen Prašek za uporabo v pitni vodi.
English: SPECIAL STORAGE CONDITIONS This veterinary medicinal product does not require any special storage conditions.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Za shranjevanje tega zdravila ni posebnih navodil.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Izpolni država članica
English: Soludox 50%; 500 mg/g proszek do podawania w wodzie do picia dla swiń i kur
Slovenian: Soludox 50%; 500 mg/g proszek do podawania w wodzie do picia dla swiń i kur doksiciklinijev hiklat
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Izpolni država članica
English: MARKETING AUTHORISATION NUMBER To be completed nationally
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Izpolni država članica
English: No negative effects were observed in poultry after the administration of therapeutic doses of doxycycline.
Slovenian: Po uporabi terapevtskih odmerkov doksiciklina pri perutnini negativnih učinkov ni bilo opaziti.