natgillin/translations-raw huggingface dataset:
Shelf-life after dilution or reconstitution according to directions: After reconstitution with water any product remaining after 24 hours should be discarded. 
Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili: Po rekonstituciji z vodo je treba po 24 urah preostanek izdelka zavreči.
It exerts its action by inhibiting the protein synthesis of the bacterial cell. 
Deluje tako, da zavira sintezo beljakovin v bakterijski celici.
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. 
Predloženi so bili podatki v podporo indikaciji za P. multocida z odmerkom 10 mg doksiciklinijevega hiklata na kg telesne mase na dan.
Because doxycycline is highly lipid soluble, it has a good tissue penetration. 
Glede na to, da je doksiciklin zelo topen v lipidih, ima zelo dobro sposobnost.
Doxycycline is bacteriostatic and acts by inhibiting protein synthesis intracellularly by binding to the 30-S subunit of the bacterial ribosome. 
Doksiciklin je bakteriostatičen in deluje tako, da znotraj celic z vezavo na podenote 30-S bakterijskega ribosoma zavira sintezo beljakovin.
Special precautions for use in animals Read the package leaflet before use. 
Posebni previdnostni ukrepi za uporabo pri živalih Pred uporabo preberite navodilo za uporabo.
Doxycycline belongs to the group of the tetracycline antibiotics. 
Doksiciklina spada v skupino tetraciklinskih antibiotikov.
Benefit Assessment 
Ocena koristi
Solubility of doxycycline is pH dependent. 
Topnost doksiciklina je odvisna od pH.
Doxyfar 50 % and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g. 
Zdravilo Doxyfar 50 % in z njim povezana imena je prašek za uporabo v pitni vodi, ki vsebuje zdravilno učinkovino doksiciklinijev hiklat 500 mg/g.
mg product / kg body weight / day x 
..... mg produkta / kg telesne teže /dan x
Soludox 500 mg/g κόνις για χρήση στο πόσιμο νερό για όρνιθες 
Soludox 500 mg/g κόνις για χρήση στο πόσιμο νερό για όρνιθες doksiciklinijev hiklat
(ii) User warnings: 
Opozorila za uporabnika
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. 
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.
If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. 
na ravni področja, na ravni kmetije) epidemiološke podatke o dovzetnosti ciljne bakterije.
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. 
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.
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. 
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.
• the CVMP considered that the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet; 
• CVMP je upošteval, da je bil namen napotitve uskladiti povzetek glavnih značilnosti zdravila,
The solubility of the product is pH dependent and will precipitate if mixed in alkaline solution. 
Topnost izdelka je odvisna od pH in v alkalni mešanici bo prišlo bo do obarjanja.
Pigs and chickens (broiler, pullet, breeder). 
Prašiči in piščanci (brojler, kokoš nesnica, jarkica).
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. 
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.
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. 
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.
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: 
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)“.
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. 
Absorpcija doksiciklina se v prisotnosti velike količine kalcija, železa, magnezija ali aluminija v prehrani lahko zmanjša.
PACKAGE SIZE 100 gram 
VELIKOST PAKIRANJA 100 gramov
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). 
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).
Evaluation of the Benefit-risk balance 
Ocena razmerja med tveganji in koristmi
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POTI IN NAČIN UPORABE ZDRAVILA
• Pigs: 12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4 
• Prašiči: 12,5 mg doksiciklinijevega hiklata (25 mg zdravila) na kg telesne mase na dan 4
Solubility of the product is pH dependent and it may precipitate if it is mixed in hard alkaline drinking water. 
Topnost zdravila je odvisna od pH in, če se ga vmešava v trdo alkalno vodo za pitje, lahko pride do precipitacije.
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). 
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).
500 mg corresponding to 433 mg doxycycline 433 mg corresponding to 500 mg doxycycline hyclate 
500 mg ustreza 433 mg doksiciklina 433 mg ustreza 500 mg Doksiciklinijev hiklata
PHARMACEUTICAL FORM Yellow crystalline powder for use in drinking water. 
FARMACEVTSKA OBLIKA Rumen kristalni prašek za uporabo v pitni vodi.
4 CLINICAL PARTICULARS 
KLINIČNE PODROBNOSTI
3 PHARMACEUTICAL FORM Powder for use in drinking water Yellow crystalline powder 
FARMACEVTSKA OBLIKA Prašek za uporabo v pitni vodi Rumen kristalen prašek
Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline France: Doxycycline 433 mg, corresponding to 500 mg doxycycline hyclate 
Doksiciklinijev hiklat 500 mg, ustreza 433 mg doksiciklina FR: Doksiciklin 433 mg, ustreza 500 mg doksiciklinijevega hiklata
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. 
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.
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. 
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.
PACKAGE SIZE 10x100 gram 
VELIKOST PAKIRANJA 10x100 gramov
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. 
Kadar prašiči 8 dni prejemajo 12,5 mg doksiciklinijevega hiklata na kg telesne mase na dan, karenca za meso 4 dni zagotavlja varnost potrošnikov.
Additional information has been added to the SPC regarding mechanisms of resistance to tetracyclines in general. 
V povzetek glavnih značilnosti zdravila so bile dodane informacije glede splošnih mehanizmov odpornosti na tetracikline.
PHARMACEUTICAL FORM Yellow powder for use in drinking water. 
FARMACEVTSKA OBLIKA Rumen Prašek za uporabo v pitni vodi.
SPECIAL STORAGE CONDITIONS This veterinary medicinal product does not require any special storage conditions. 
POSEBNA NAVODILA ZA SHRANJEVANJE Za shranjevanje tega zdravila ni posebnih navodil.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Izpolni država članica
Soludox 50%; 500 mg/g proszek do podawania w wodzie do picia dla swiń i kur 
Soludox 50%; 500 mg/g proszek do podawania w wodzie do picia dla swiń i kur doksiciklinijev hiklat
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Izpolni država članica
MARKETING AUTHORISATION NUMBER To be completed nationally 
ŠTEVILKA DOVOLJENJA ZA PROMET Izpolni država članica
No negative effects were observed in poultry after the administration of therapeutic doses of doxycycline. 
Po uporabi terapevtskih odmerkov doksiciklina pri perutnini negativnih učinkov ni bilo opaziti.
Hungary Eurovet Animal Health B.V., P.O. 179, 
Madžarska Eurovet Animal Health B.V., P.O. 179,
• Chickens (broiler, pullet, breeder): 10 mg doxycycline hyclate per kg body weight per day for 3-4 days for the treatment of infections caused by P. multocida and 20 mg doxycycline hyclate per kg body weight per day for 3-4 days for the treatment of infections caused by 
• Piščanci (brojlerji, za vzrejo nesnic, vzrejni): 10 mg doksiciklinijevega hiklata na kg telesne mase na dan 3-4 dni za zdravljenje okužb, ki jih povzroča P. multocida, in 20 mg doksiciklinijevega hiklata na kg telesne mase na dan 3-4 dni za zdravljenje okužb, ki jih povzroča O. rhinotracheale.
NAME OF THE VETERINARY MEDICINAL PRODUCT Soludox 500 mg/g powder for use in drinking water for pigs and chickens Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France only) 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Soludox 500 mg/g Prašek za uporabo v pitni vodi za prašiče in piščanci Soludox 433 mg/g Prašek za uporabo v pitni vodi za prašiče in piščanci (FR)
Doxycycline is primarily excreted with the faeces. 
Doksiciklin se v glavnem izloča z blatom.
Pigs and chicken 
Prašiči piščanci
The chicken meat residue depletion data for both dosing regimens (10 mg doxycycline hyclate per kg body weight per day for 4 days and 20 mg doxycycline hyclate per kg body weight per day for 4 days) were submitted. 
Za oba režima odmerjanja so bili predloženi podatki o izločanju ostankov v piščančjem mesu (10 mg doksiciklinijevega hiklata na kg telesne mase na dan 4 dni in 20 mg doksiciklinijevega hiklata na kg telesne mase na dan 4 dni).
MARKETING AUTHORISATION NUMBER(S) To be completed nationally 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET) Izpolni država članica
Pigs: For the treatment of the clinical signs associated with porcine respiratory disease caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae susceptible to doxycycline. 
Prašiči: Za zdravljenje kliničnih znakov, povezanih z obolenjem dihal pri prašičih, ki ga povzročajo Actinobacillus pleuropneumoniae, Pasteurella multocida, in Mycoplasma hyopneumoniae, občutljivi na doksiciklin.
Use during pregnancy or lactation 
Uporaba v obdobju brejosti in laktacije
10 mg doxycycline hyclate (20 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by P. multocida and 
10 mg Doksiciklinijev hiklata (20 mg izdelka) na kg teže na dan 3-4 zaporedne dni, če gre za infekcije, ki jih je povzročila P. multocida, in
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON 10 X 100 GRAM only 
PODATKI NA ZUNANJI OVOJNINI samo ŠKATLA 10 X 100 GRAMOV
12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4 consecutive days. 
12,5 mg Doksiciklinijev hiklata (25 mg izdelka) na kg teže na dan, 4 zaporedne dnei.
- Meat and offal: 12 days, following a dose rate of 20 mg/kg body weight for 4 days. 
- Meso in organi: 12 dni, po odmerku 20 mg / kg telesne teže za 4 dni.
500 mg/g, suukaudse lahuse pulber sigadele 
500 mg/g, suukaudse lahuse pulber sigadele doksiciklinijev hiklat
• the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; the CVMP recommends the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxyfar 50 % and associated names (see Annex I). 
CVMP priporoča spremembo dovoljenj za promet z zdravilom Doxyfar 50 % in z njim povezanimi imeni (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
OTHER INFORMATION Pack sizes: 100g, 10x100g, 250g, 500g and 1 kg Not all pack sizes may be marketed. 
DRUGE INFORMACIJE Velikosti ovojnine: 100g, 10x100g, 250g, 500g in 1 kg Ni nujno, da so v prometu vsa navedena pakiranja
20 mg doxycycline hyclate (40 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by O. rhinotracheale 
20 mg Doksiciklinijev hiklata (40 mg izdelka) na kg teže na dan 3-4 zaporedne dneve dolgo, če gre za infekcije, ki jih je povzročila O. rhinotracheale
Chickens: - Meat and offal: 3 days, following a dose rate of 10 mg/kg body weight for 4 days. 
Piščanci: - Meso in organi: 3 dni, po odmerku 10 mg/kg telesne teže za 4 dni.
• Pigs: For the treatment of the clinical signs associated with porcine respiratory disease caused by Actinobacillus pleuropeumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae susceptible to doxycycline. 
• Prašiči: za zdravljenje kliničnih znakov, povezanih s prašičjo boleznijo dihal, kadar jo povzročajo bakterije Actinobacillus pleuropneumoniae, Pasteurella multocida in Mycoplasma hyopneumoniae, ki so občutljive na doksiciklin.
OTHER INFORMATION Pack sizes: 100g, 10x 100g, 250g, 500g and 1 kg Not all pack sizes may be marketed. 
DRUGE INFORMACIJE Velikosti ovojnine: 100g, 10x 100g, 250g, 500g in 1 kg Ni nujno, da so v prometu vsa navedena pakiranja
Special precautions for use 
NAVODILO ZA UPORABO
• Chickens (broiler, pullet, breeder): Where clinical disease is present in the flock, to reduce mortality, morbidity and clinical signs and to reduce lesions due to Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by O. rhinotracheale. 
• Piščanci (brojlerji, za vzrejo nesnic, vzrejni): Kadar je v jati prisotna klinična bolezen, za zniževanje umrljivosti, obolevnosti in kliničnih znakov ter za zmanjševanje lezij zaradi
Chickens 
KARENCE
Special precautions to be taken by the person administering the veterinary medicinal product to animals 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Pred uporabo preberite navodilo za uporabo.
The following indications for Doxyfar 50% and associate names were agreed: 
Potrjene so bile naslednje indikacije za zdravilo Doxyfar 50 % in povezana imena:
The following recommended dose for Doxyfar 50% and associate names was agreed: 
Dogovorjeni so bili naslednji priporočeni odmerki zdravila Doxyfar 50 % in povezanih imen:
DOXY ORT 50% Poeder voor toediening aan het drinkwater van varkens en kippen 
DOXY ORT 50% Poeder voor toediening aan het drinkwater van varkens en kippen doksiciklinijev hiklat
(1997), Comparative in vitro activity of doxycycline and oxytetracycline against porcine respiratory pathogens, Veterinary Record, July 12, 141(2), p. 37-40 
(1997): Comparative in vitro activity of doxycycline and oxytetracycline against porcine respiratory pathogens.
A chicken meat withdrawal period of 3 days when chickens are treated with 10 mg doxycycline hyclate/kg bw/day for 4 days; and a meat withdrawal period of 12 days when the chicken are treated with 20 mg doxycycline hyclate/kg bw/day for 4 days can be accepted. 
Potrjena je lahko karenca za meso piščancev 3 dni, kadar piščance 4 dni zdravijo z 10 mg doksiciklinijevega hiklata na kg telesne mase na dan; in karenca 12 dni, kadar piščance 4 dni zdravijo z 20 mg doksiciklinijevega hiklata na kg telesne mase na dan.
Finland Eurovet Animal Health B.V., Handelsweg 25, 
Nizozemska Eurovet Animal Health B.V., Handelsweg 25,
Summary of product characteristics, labelling and package leaflet 
Povzetek glavnih značilnosti zdravila, besedilo za oznake, navodilo za uporabo
SOLUDOX 50%, poeder voor toediening via het drinkwater aan varkens en kippen 
SOLUDOX 50%, poeder voor toediening via het drinkwater aan varkens en kippen doksiciklinijev hiklat
This veterinary medicinal product does not require any special storage conditions. 
Za shranjevanje tega zdravila ni posebnih navodil.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children. 
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
Residue depletion data in pigs support a meat withdrawal period of 4 days when pigs are administered at 12.5 mg doxycycline hyclate/kg body weight/day for up to 8 days. 
Podatki o izločanju ostankov pri prašičih podpirajo karenco za meso 4 dni, kadar prašiči do 8 dni prejemajo 12,5 mg doksiciklinijevega hiklata na kg telesne mase na dan.
DOXYFAR 50% Poeder voor toediening aan het drinkwater van varkens en kippen 
DOXYFAR 50% Poeder voor toediening aan het drinkwater van varkens en kippen doksiciklinijev hiklat
LEAFLET 
Jakost
Tartaric acid 
doksiciklinijev hiklat
Residue depletion data in chickens support a meat withdrawal period of 3 days when chickens are administered at 10 mg doxycycline hyclate/kg body weight/day for 4 days. 
Podatki o izločanju ostankov pri piščancih podpirajo karenco za meso 3 dni, kadar piščanci 4 dni prejemajo 10 mg doksiciklinijevega hiklata na kg telesne mase na dan.
500 mg/g, suukaudse lahuse pulber kanadele 
500 mg/g, suukaudse lahuse pulber kanadele doksiciklinijev hiklat
Doxycycline hyclate France: Doxycycline Excipients 
Doksiciklinijev hiklat FR: Doksiciklin Pomožne snovi Vinska kislina
Lithuania Eurovet Animal Health B.V. Handelsveg 25 - PO Box 179, 5530 AD Bladel 
Handelsveg 25 - PO Box 179, 5530 AD Bladel
F. J. Angulo et al., Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Antimicrobial Resistance Among Bacteria Isolated from Humans and the Human Health Consequences of Such Resistance, J. Vet. Med.. 51: 374 - 379 
4 F. J. Angulo et al.: Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Anti-microbial
Residue depletion data in chickens support a meat withdrawal period of 12 days when chickens are administered at 20 mg doxycycline hyclate/kg body weight/day for 4 days. 
Podatki o izločanju ostankov pri piščancih podpirajo karenco za meso 12 dni, kadar piščanci 4 dni prejemajo 20 mg doksiciklinijevega hiklata na kg telesne mase na dan.
A chicken meat withdrawal period of 3 days following a dose rate of 10 mg doxycycline hyclate per kg body weight per day for 4 days was considered acceptable. 
Za piščančje meso je bila za odmerek 10 mg doksiciklinijevega hiklata na kg telesne mase na dan 4 dni sprejemljiva tridnevna karenca.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT 
NAVEDBA ZDRAVILNE UCINKOVINE IN DRUGIH SNOVI
Soludox 50% Doxycycline hyclate 500 mg/g 
Soludox 50% doksiciklinijev hiklat
MARKETING AUTHORISATION HOLDER To be completed nationally 
IMETNIK DOVOLJENJA ZA PROMET Izpolni država članica
The pig meat residue depletion data was made available and supported a meat withdrawal period of 4 days when pigs are administered 12.5 mg doxycycline hyclate/kg body weight/day for up to 8 days. 
Predloženi so bili podatki o izločanju ostankov v prašičjem mesu, ki so potrdili karenco za meso 4 dni, kadar prašiči 8 dni prejemajo 12,5 mg doksiciklinijevega hiklata na kg telesne mase na dan.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally 
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Treba izpolniti
Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille 
Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille doksiciklinijev hiklat
Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi kanoille 
Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi kanoille doksiciklinijev hiklat
Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata 
Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata doksiciklinijev hiklat
Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni vistām 
Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni vistām doksiciklinijev hiklat
INN & Strength 
Vet.Res.
Special precautions for use in animals 
4.2 Indikacije za uporabo pri tarčnih živalskih vrstah
Soludox 500 mg/g powder for use in drinking water for pigs and chickens Doxycycline hyclate. 
Soludox 500 mg/g Prašek za uporabo v pitni vodi za prašiče in piščanci Doksiciklinijev hiklat.
Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Hühner 
Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Hühner doksiciklinijev hiklat
France only: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline. 
FR: Soludox 433 mg/g Prašek za uporabo v pitni vodi za prašiče in piščanci Doksiciklin.
Soludox 500 mg/g prášok pre užívanie s pitnou vodou pre ošípané 
Soludox 500 mg/g prášok pre užívanie s pitnou vodou pre ošípané doksiciklinijev hiklat