natgillin/translations-raw huggingface dataset:
CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf 
Chemotherapy 63, 733-744, 2009 Popravljena smernica CVMP o povzetku glavnih značilnosti protimikrobnih zdravil (EMEA/CVMP/SAGAM/383441/2005) - http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf
In the submitted Periodic Safety Update Reports for the concerned products no lack of efficacy has been reported for any of the claimed indications in any of the target species. 
V predloženih rednih posodobljenih poročilih o varnosti zadevnih zdravil niso poročali o neučinkovitost za predlagane indikacije pri ciljnih živalskih vrstah.
As regards Ornithobacterium rhinotracheale infections, one GCP compliant controlled confirmatory efficacy study in chickens experimentally infected with O. rhinotracheale was presented. 
V zvezi z okužbami z Ornithobacterium rhinotracheale je bila predložena ena kontrolirana potrditvena študija učinkovitosti (skladna z dobro klinično prakso) na piščancih, ki so bili eksperimentalno okuženi z O. rhinotracheale.
Huvepharma, Uitbreidingstraat 
Nizozemska Huvepharma, Uitbreidingstraat
Both studies indicate that doxycycline at a daily dose of 10 mg/kg bw for 4 (5) consecutive days was effective in the treatment of induced acute fowl cholera as evidenced by the significant reduction of the mortality rate and pathological lesions characteristic for the disease as well as the recovery rate of the challenge strain, compared to infected unmedicated controls. 
Obe študiji kažeta, da je bil doksiciklin v dnevnem odmerku 10 mg/kg TM za 4 (5) zaporednih dni učinkovit za zdravljenje inducirane akutne kolere perutnine, kar dokazuje pomembno zmanjšanje stopnje smrtnosti, patoloških lezij, ki so značilne za bolezen, ter stopnje izolacije izzivnega seva v primerjavi z okuženimi kontrolnimi živalmi, ki niso prejele zdravila.
Barcelona SPAIN 
Barcelona ŠPANIJA
As evident from pharmacodynamic data, E. coli strains showed a very variable susceptibility against doxycycline with MIC90 values of 2 - 32µg/ ml. 
Kot je razvidno iz farmakodinamičnih podatkov, so imeli sevi E. coli zelo različno občutljivost za doksiciklin, saj so bile vrednosti MIK 90 v razponu 2-32 µg/ml.
INDUSTRIAL VETERINARIA S.A. Esmeralda, 19 - 4º 08950 ESPLUGUES DE LLOBREGAT SPAIN 
INDUSTRIAL VETERINARIA S.A. Esmeralda, 19 - 4º 08950 ESPLUGUES DE LLOBREGAT ŠPANIJA
As no need for revision of the dose was identified consequently the withdrawal periods of the products concerned do not need revision. 
Ker ni bila ugotovljena potreba po spremembi odmerka, karenc za zadevna zdravila ni treba spreminjati.
Due to variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and susceptibility testing of micro-organisms from diseased birds on farm are highly recommended. 
Zaradi razlik (časovnih, geografskih) med občutljivostjo bakterij za doksiciklin je zelo priporočljiv odvzem vzorca za bakteriologijo in določanje občutljivosti mikroorganizmov iz bolnih ptic na kmetiji.
In conclusion, no therapeutic dose can be confirmed for the treatment of respiratory disease caused by O. rhinotracheale on basis of the data submitted. 
Na podlagi predloženih podatkov torej ni možno potrditi terapevtskega odmerka za zdravljenje bolezni dihal zaradi O. rhinotracheale.
Given at a daily dose of 250 mg/l drinking water for 5 consecutive days, doxycycline was shown to be efficacious in preventing mortality, reducing the occurrence of E. coli lesions and growth depression. 
Dokazali so, da je doksiciklin pri dnevnem odmerku 250 mg/l pitne vode 5 zaporednih dni učinkovit pri preprečevanju smrtnosti, zmanjšanju pojavnosti lezij E. coli in upočasnitvi rasti.
Overall summary of the scientific evaluation of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in pultry (see Annex I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA VODOTOPNIH PRAŠKOV IN PERORALNIH RAZTOPIN, KI VSEBUJEJO DOKSICIKLINIJEV HIKLAT IN SO INDICIRANI ZA UPORABO PRI PERUTNINI (glejte Dodatek I)
FRANVET ZI d'Etriche-Route d'Avire 
Francija FRANVET ZI d'Etriche-Route d'Avire
Meat - 7 days 
meso - 7 dni
Oral (drinking water) 
peroralno (pitna voda)
Doxycycline tends to be more active against some of these species that other tetracyclines. 
Doksiciklin je proti določenim vrstam bakterij učinkovitejši od drugih tetraciklinov.
Compared to infected unmedicated controls, doxycycline was shown to be effective in reducing the mortality rate and pathological lesions characteristic for Colibacillosis (pericarditis, aerosacculitis and perihepatitis) as well as the clinical performance of the chickens at dose levels from 400 ppm (corresponding to 96 mg/kg bw) onwards. 
V primerjavi z okuženimi kontrolnimi živalmi, ki niso prejele zdravila, so dokazali, da je doksiciklin učinkovit pri zmanjšanju stopnje smrtnosti in patoloških lezij, značilnih za kolibacilozo (perikarditis, aerosakulitis in perihepatitis), ter klinično zmogljivost piščancev pri odmerkih vsaj 400 ppm (kar ustreza 96 mg/kg TM).
In summary, the Committee considered that the efficacy of doxycycline in the treatment of chronic respiratory disease caused by M. gallisepticum was sufficiently supported by a clinical dose determination study and clinical trials under commercial use conditions for use in chicken at a dose of 20 mg/kg for 5 consecutive days. 
Odbor je zato menil, da je učinkovitost doksiciklina pri zdravljenju kronične bolezni dihal zaradi M. gallisepticum zadostno podprta s klinično študijo določevanja odmerka in kliničnimi preskušanji v okoliščinah komercialne uporabe pri piščancih v odmerku 20 mg/kg 5 zaporednih dni.
Concerning resistance, the results of a recent pan European survey of antimicrobial susceptibility towards antimicrobials among zoonotic and commensal enteric bacteria resistance, published in 20097, revealed a high resistance rate for E. coli, isolated from chickens, against tetracyclines. 
V zvezi z odpornostjo so rezultati nedavne vseevropske raziskave občutljivosti zoonotskih in komenzalnih enteričnih bakterij za protimikrobne snovi, objavljeni leta 20097, pokazali visoko stopnjo odpornosti proti tetraciklinom pri E. coli, izolirani iz piščancev.
Amendments to be included in the relevant sections of the summary of product characteristics 
DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
S.A. Pol. Ind. La Borda c/Mas 
S.A. Pol. Ind.
Also, the results of the submitted clinical field study in broilers suffering from Colibacillosis, treated with doxycycline at a dose of 25 mg/kg for 3 days were not convincing. 
Poleg tega rezultati predložene klinične terenske študije pri pitovnih piščancih s kolibacilozo, ki se zdravijo z doksiciklinom v odmerku 25 mg/kg 3 dni, niso bili prepričljivi.
• the CVMP considered that a recent pan European survey of antimicrobial susceptibility towards antimicrobials among zoonotic and commensal enteric bacteria resistance, published in 2009, revealed a high resistance rate for E. coli, isolated from chickens, against tetracyclines. 
• CVMP je menil, da je nedavna vseevropska raziskava občutljivosti zoonotskih in komenzalnih enteričnih bakterij za protimikrobne snovi, objavljena leta 2009, pokazala visoko stopnjo odpornosti proti tetraciklinom pri E. coli, izolirani iz piščancev.
Doxycycline hyclate was administered in all but two studies at a target dose of 20 mg/kg body weight per day for 5 consecutive days. 
Doksiciklinijev hiklat se je v vseh študijah razen dveh dajal s ciljnim odmerkom 20 mg/kg telesne mase na dan 5 zaporednih dni.
Having considered all the data submitted by the Applicants/Marketing Authorisation Holders, there was sufficient documented evidence in support of acceptable efficacy of doxycycline hyclate when used in broiler chickens for the treatment of respiratory infection associated with Mycoplasma gallisepticum, susceptible to doxycycline, at a daily dose of 20 mg/kg bw for 5 consecutive days. 
Ob upoštevanju vseh podatkov, ki so jih predložili predlagatelji/imetniki dovoljenja za promet z zdravili, je bilo dovolj dokumentiranih dokazov v podporo sprejemljivi učinkovitosti doksiciklinijevega hiklata pri pitovnih piščancih za zdravljenje okužb dihal z Mycoplasma gallisepticum, občutljivo za doksiciklin, z dnevnim odmerkom 20 mg/kg TM 5 zaporednih dni.
The water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water, are used for treatment of respiratory and gastrointestinal infections caused by different bacterial pathogens susceptible to doxycycline. 
Vodotopni praški in peroralne raztopine, ki vsebujejo doksiciklinijev hiklat in so indicirani za uporabo pri perutnini ter za dajanje s pitno vodo, se uporabljajo za zdravljenje okužb dihal in prebavil, ki jih povzročajo različni bakterijski bolezenski povzročitelji, občutljivi za doksiciklin.
The use of suitably calibrated weighing equipment is recommended if part packs are used. 
Če se uporabijo delna pakiranja, je treba uporabiti primerno umerjeno tehtnico.
Romania FRANVET ZI d'Etriche-Route d'Avire 
Romunija FRANVET ZI d'Etriche-Route d'Avire
response relationship could be shown. 
Dokazali so jasno povezavo med odmerkom in odzivom.
2 g product/ 100 kg bw/ day in case of Pasteurellosis or 4 g product / 100 kg bw/ day in case of 
2 g zdravila/100 kg TM/dan v primeru pasteureloze ali 4 g zdravila/100 kg TM/dan v primeru okužbe z
(M.gallisepticum, Escherichia coli, Septicamia caused by Pasteurella multocida 
(M.gallisepticum, Escherichia coli, septikemija zaradi Pasteurella multocida
In contrast, in the study of George et al. (1977)2 doxycycline proved to be effective in reducing mortality rate and typical pathological lesions at a dose level of 50 ppm in drinking water for 3 consecutive days, when compared to infected un-medicated controls, and proved to be superior to chlortetracycline and lincomycin-spectinomycin used as positive controls. 
Za razliko od tega so George et al. (1977)2 v študiji dokazali, da je doksiciklin učinkovit pri zmanjšanju stopnje smrtnosti in tipičnih patoloških lezij pri odmerku 50 ppm v pitni vodi za 3 zaporedne dni v primerjavi z okuženimi kontrolnimi živalmi, ki niso prejele zdravila.
3 43206 Reus SPAIN 
3 43206 Reus ŠPANIJA
300 mg/4 g Oral powder pigeon, parrot pigeon: 4g prodyct/ 2 liters of drinking water, parrot: 4 g product/ 0,5 liter 
300 mg/4 g peroralni prašek golobi, papige golobi: 4 g zdravila/2 litra pitne vode, papige: 4 g zdravila/0,5 litra
In the submitted Periodic Safety Update Reports neither lack of efficacy nor any resistance problem has been reported for any of the approved indications in any of the approved species. 
V predloženih rednih posodobljenih poročilih o varnosti zdravil niso poročali o neučinkovitosti ali odpornosti za odobrene indikacije in ciljne živalske vrste.
- 75 ml of product/100 litres drinking water/day for 3-5 consecutive days in young poultry up to 4 weeks 
- 75 ml zdravila/100 litrov pitne vode/dan 35 zaporednih dni za mlado perutnino do 4 tedne
In turkeys, doxycycline was administered for the treatment of respiratory disease and airosacculitis and respiratory disease together with joint syndrome (Mycoplasma, Staphylococcus). 
Puranom so dajali doksiciklin za zdravljenje bolezni dihal in aerosakulitisa ter bolezni dihal s pridruženim sindromom sklepov (Mycoplasma, Staphylococcus).
Three studies were presented concerning the efficacy of doxycycline in turkeys and geese. 
V zvezi z učinkovitostjo doksiciklina pri puranih in goseh so bile predložene tri študije.
Chicken older than 2 weeks: 2 g powder/1 litre of drinking water. 
piščanci, starejši od 2 tednov: 2 g praška/1 liter pitne vode
5 days. 
45 dni
Withdrawal period(s) / Indications necrotic enteritis (Clostridium perfringens), chlamydiosis (Chlamydia psittaci), prevention in stress conditions (vaccination, changes in housing, transportation) 
Karenca/ indikacije coli), nekrotični enteritidis (Clostridium perfringens), klamidioza (Chlamydia psittaci), preprečevanje v stresnih okoliščinah (cepljenje, sprememba bivališča, prevažanje)
A daily dose of approximately 20 mg doxycycline/kg body weight was administered in eight studies. 
V osmih študijah je bil uporabljen dnevni odmerek približno 20 mg doksiciklina/kg telesne mase.
Recommen ded dose 
Priporočeni odmerek
Romania LABORATORIOS SYVA S.A. 
Romunija LABORATORIOS SYVA S.A.
Hungary VIRBAC S.A. 1ère avenue2065 m - L.I.D. 
Madžarska VIRBAC S.A. 1ère avenue2065 m - L.I.D.
1 ml/20 kg bw/day dissolved in the drinking water. 
1 ml/20 kg TM/dan, raztopljeno v pitni vodi
43205 Reus SPAIN 
43205 Reus ŠPANIJA
<approved dose> mg doxycycline hyclate /kg body weight / day, corresponding to mg <product name>per kg body weight, for …<approved treatment duration> consecutive days. 
<odobreni odmerek> mg doksiciklinijevega hiklata/kg telesne mase/dan, ustreza mg zdravila <ime zdravila> na kg telesne mase, … <odobreno trajanje zdravljenja> zaporednih dni.
Meat and offal: Broilers: 5 days Turkeys: 7 days Pigs: 4 days 
meso in drobovina: pitovni piščanci: 5 dni purani: 7 dni prašiči: 4 dni
Indication: Prevention and treatment of CRD 
indikacije: preprečevanje in zdravljenje kronične
Germany LABORATORIOS CALIER, S.A. 
Nemčija LABORATORIOS CALIER, S.A.
The following dosage advice should be followed: <approved dose> mg doxycycline hyclate /kg body weight / day, corresponding to mg <product name>per kg body weight, for …<approved treatment duration> consecutive days. 
Upoštevati morate naslednje nasvete o odmerjanju: <odobreni odmerek> mg doksiciklinijevega hiklata/kg telesne mase/dan, ustreza mg zdravila <ime zdravila> na kg telesne mase, … <odobreno trajanje zdravljenja> zaporednih dni.
The geese were treated with doxycycline because of respiratory distress (mycoplasmosis). 
Gosi so zdravili z doksiciklinom zaradi dihalne stiske (mikoplazmoze).
Hungary Laboratorios Hipra S.A. 
Madžarska Laboratorios Hipra S.A.
Grounds for amendment of the summary of product characteristics, labelling and package leaflet 
PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
CVMP Note for guidance: Approach towards harmonisation of withdrawal periods http://www.ema.europa.eu/pdfs/vet/swp/003695en.pdf 
Smernica CVMP: pristop k usklajevanju karenc http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf vnos zdravila pri živalih v smislu mg na kg telesne mase.
Esmeralda, 19 - 4º 08950 ESPLUGUES DE LLOBREGAT SPAIN 
Esmeralda, 19 - 4º 08950 ESPLUGUES
Mild clinical symptoms and some deaths were observed in treated animals in the post-observation period. 
Pri zdravljenih živalih so s spremljanjem po koncu zdravljenju ugotovili blage klinične simptome in nekaj primerov smrti.
COOPHAVET Saint Herblon 44150 Ancenis FRANCE 
COOPHAVET Saint Herblon 44150 Ancenis FRANCIJA
Belgium VIRBAC S.A. 1ère avenue2065 m - L.I.D. 
Francija VIRBAC S.A. 1ère avenue2065 m - L.I.D.
One GCP compliant open clinical field study was provided on broiler chickens suffering from Colibacillosis. 
Predložena je bila ena odprta klinična terenska študija, skladna z dobro klinično prakso, na pitovnih piščancih s kolibacilozo.
Hungary CHEMIFARMA S.p.A 
Madžarska CHEMIFARMA S.p.A
Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum 
Haemophilus paragalinarum, Bordetella avium in ileitisa zaradi Clostridium perfringens in Cl. colinum
Indications: prevention and treatment of colibacillosis, respiratory diseases, mycoplasmosis. 
indikacije: preprečevanje in zdravljenje kolibaciloze, okužb dihal, mikoplazmoze
- 20-40 mg of product/kg body weight/day for 5 consecutive days , per os; 
- 20-40 mg zdravila/kg telesne mase/dan 5 zaporednih dni, peroralno;
No or very limited clinical data was presented to support other indications (e.g. infections caused by M. meleagridis, M. synoviae, Haemophilus paragallinarum, Clostridium perfringens, Clostridium colinum, Bordetella avium, etc.) in chickens or in any other target species that are currently approved for the products within the scope of this procedure. 
V podporo drugim indikacijam (npr. okužbam zaradi M. meleagridis, M. synoviae, Haemophilus paragallinarum, Clostridium perfringens, Clostridium colinum, Bordetella avium itn.) pri piščancih in drugih ciljnih živalskih vrstah, ki so trenutno odobrene za zdravila, zajeta v obseg te napotitve, je bilo predloženih kliničnih podatkov zelo malo ali pa sploh nič.
Hungary COOPHAVET Saint Herblon 44150 Ancenis FRANCE 
Madžarska COOPHAVET Saint Herblon 44150 Ancenis FRANCIJA
5 g produkt/ 100 kg bw/ day or 0,5 g / 1 liter of drinking water 
5 g zdravila/100 kg TM/dan ali 0,5 g/1 liter pitne vode
40 g product/100 kg bw/100 litre of drinking water. 
40 g zdravila/100 kg TM/100 litrov pitne vode
Kepro B.V. 
Nizozemska Kepro B.V.
Romania CHEMIFARMA S.p.A 
Romunija CHEMIFARMA S.p.A
5 g product/100 kg bw/day, dissolved in the drinking water. 
5 g zdravila/100 kg TM/dan, raztopljeno v pitni vodi
Based on the recommended dose, and the number and weight of the birds to be treated, the exact daily amount of <product name>should be calculated according to the following formula: .....mg [product name] /kg body weight/ day x 
Na podlagi priporočenega odmerka ter števila in telesne mase ptic, ki se bodo zdravile, se natančna dnevna količina zdravila <ime zdravila> izračuna po naslednji enačbi: … mg zdravila <ime zdravila>/kg telesne mase/ dan x povprečna telesna masa (kg) ptic, ki se bodo zdravile povprečni dnevni vnos vode (l) na ptico
Doxycycline was administered at a daily target dose of 25 mg/kg body weight for 3 days. 
Doksiciklin so dajali z dnevnih ciljnim odmerkom 25 mg/kg telesne mase 3 dni.
Chicken (Broilers) meat and offal: 5 days; Tukeys meat and offal:6 days; 
(pitovni) piščancimeso in drobovina: 5 dni; purani - meso in drobovina:6 dni;
Romania Laboratorios Karizoo S.A 
Romunija Laboratorios Karizoo S.A
w./day correspondin g to 0,5 g product/10 kg b.w. 
M/dan, kar ustreza 0,5 g zdravila/10 kg TM
250-500 ml product/ 1000 liter of drinking water 
250-500 ml zdravila/1 000 litrov pitne vode
Hungary Laboratorios Karizoo S.A 
Madžarska Laboratorios Karizoo S.A
Seven clinical field studies in broiler chickens with respiratory disease and confirmed 
Predstavljenih je bilo sedem kliničnih terenskih študij pri pitovnih piščancih z boleznijo dihal ter potrjeno okužbo z M. gallisepticum.
Respiratory infections caused by Mycoplasma gallisepticum,E.coli Pasteurella multocida,Chlamydia psittaci 
indikacije: okužbe dihal zaradi Mycoplasma gallisepticum, E.coli, Pasteurella multocida, Chlamydia multocida, Chlamydia psittaci
Indications: Infections caused by Mycoplasma spp (Micoplasmosis, CRD) or Pasteurella multocida (Pasteurellosis). 
indikacije: okužbe zaradi Mycoplasma spp (mikoplazmoza, kronična bolezen dihal) ali Pasteurella multocida (pasteureloza);
BULGARIA 
BOLGARIJA
Broilers: 3-5 days, Pigs: 5 days, in drinking water 
3-5 dni, prašiči: 5 dni, s pitno vodo pitovni piščanci:
Based on a GLP compliant dose determination study on broiler chickens artificially infected with Mycoplasma gallisepticum a therapeutic dose of 20 mg/kg body weight administered for 5 consecutive days can be derived. 
Na podlagi študije določevanja odmerka, ki je bila skladna z načeli dobre laboratorijske prakse in izvedena na pitovnih piščancih, umetno okuženih z Mycoplasma gallisepticum, je bil izpeljan terapevtski odmerek 20 mg/kg telesne mase, ki se daje 5 zaporednih dni.
10 mg doxycycliny hyclate/ kg bw/ day in case of Pasteurellosi s or 20 mg doxycyclini hyclate/ kg bw/ day in case of Ornithrobact erium rhinotracheal e infection for 3-4 days 
10 mg doksiciklinije vega hiklata/kg TM/dan v primeru pasteureloze ali 20 mg doksiciklinije vega hiklata/kg TM/dan v primeru okužbe z Ornithrobact erium rhinotracheal e 3-4 dni meso in drobovina: 5 dni v primeru pasteureloze;
Chickens: 6 days Do not use in laying birds producing eggs for human consumption 
(pitovni) piščancimeso: 6 dni ne uporabljajte pri piščancih, katerih jajca so namenjena prehrani ljudi
Withdrawal period(s) / Indications sensitive to doxycycline. 
Karenca/ indikacije občutljivih za doksiciklin.
(M. gallisepticum, M. synoviae and M. melagridis), E. coli, Haemophylus paragallinarium and Ornithobacterium rhinotracheale. 
(M. gallisepticum, M. synoviae in M. melagridis), E. coli, Haemophylus paragallinarium in Ornithobacterium rhinotracheale; enteritis zaradi Clostridium
(M.gallisepticum, M.synoviae and M.meleagridis), Escherichia coli, Haemophilus paragallinarum and Ornithobacterium rhinotracheale, enteritis caused by Clostridium perfringens and Clostridium colinum, septicemia caused by Pasteurella multocida 
(M gallisepticum, M, synoviae in M, melagridis), Escherichia coli, Haemophilus paragallinarum in Ornithobacterium rhinotracheale; enteritis zaradi Clostridium perfringens in Clostridium colinum; septikemija zaradi Pasteurella multocida
Withdrawal period(s) / Indications lowest dosage maybe used for (highly) susceptible strains (MIC up to 0.51.0 µg/ml) 
Karenca/ indikacije dnevno 4 dni * večji odmerek se priporoča v primeru okužb, ki jih povzročijo sevi, ki so zmerno občutljivi (MIK do 2 µg/ml), manjši odmerek se lahko uporabi za (zelo) občutljive seve (MIK do 0,5-1,0 µg/ml)
100g/1000 litres of water;broiler 29 -35 days: 120g/1000 litres of water; 
50 g/1 000 litrov vode; pitovni piščanci 1528 dni: 100 g/1 000 litrov vode;pitovni piščanci 2935 dni: 120 g/1 000 litrov vode;
ACTI DOXY 5 Doxycycline hyclate 
ACTI DOXY 5 doksiciklinijev hiklat
Respiratory infections caused by Ornithobacte rium rhinotracheal e (ORT): 20 mg doxycycline hyclate per kg bodyweight per day for 3-4 days 
Karenca/ indikacije rium rhinotracheal e (ORT): 20 mg doksiciklinije vega hiklata na kg telesne mase na dan 3-4 dni
Indications: infection of respiratory tract caused by Mycoplasma spp. 
indikacije: okužba dihal zaradi Mycoplasma spp.
Amendment to the summary of product characteristics, labelling and package leaflet 
DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
Dutch Farm Veterinary Pharmaceuticals B.V. 
Nizozemska Dutch Farm International B.V.
All studies but one has been performed in broiler chickens. 
Študije so bile opravljene na pitovnih piščancih, razen ene, ki je bila opravljena na puranih.
Enteritis caused by Clostridium perfringens and colinum 
Clostridium perfringens in colinum
In two studies the concentration of the final product in drinking water was reported, but the animals' actual drug intake in terms of mg per kg body weight was not specified. 
V dveh študijah je bila objavljena koncentracija gotovega zdravila v pitni vodi, vendar ni bil naveden dejanski
Indications: Chronic respiratory disease and associated complications. 
indikacije: kolibaciloza, kronična bolezen dihal in povezane okužbe.
Chickens for slaughter: 7 days Eggs: May not be administered to egg laying poultry if the eggs are intended for human use. 
piščanci za zakol: 7 dni; jajca: ni primerna za uporabo pri perutnini v obdobju nesnosti, če so jajca so namenjena prehrani ljudi;
15 mg/ kg bw./ day for 5 days, in case of parrot desease or clinical ornitosis for 3-4 weeks 
15 mg/kg TM/ dan 5 dni, v primeru bolezni papig ali klinične ornitoze 3-4 tedne se ne uporablja za golobe, ki so namenjeni prehrani ljudi
Chicken (Broilers) meat and offal: 7 days. 
(pitovni) piščanci: meso in drobovina: 7 dni;
HIPRADOXI-P Doxycycline hyclate 
HIPRADOXI-P doksiciklinijev hiklat
20% in 100l drinking water /3-5 days/ 
Doxycycline 20 % v 100 l pitne vode/3-5 dni/
25-50 g powder/ 1 liter of drinking water 
25-50 g praška/1 liter pitne vode
200 mg/g Oral powder chicken 
200 mg/g peroralni prašek piščanci
DOXY 5 FRANVET Doxycycline hyclate 
DOXY 5 FRANVET doksiciklinijev hiklat
Indication: Respiratory tract Infections caused by Mycoplasma spp. 
indikacije: okužbe dihal zaradi Mycoplasma spp.
Enteritis (Clostridium perfringens and Clostridium colinum; Septicemia (Pasteurella multocida) 
Karenca/ indikacije perfringens in Clostridium colinum septikemija zaradi Pasteurella multocida
Chicken (broilers): 
(pitovni) piščanci:
5 days, in drinking water 
uporaba peroralno, 5 dni s pitno vodo
25 mg doxycyclini hyclate / kg bw/ day 
25 mg doksiciklinijevega hiklata/kg TM/dan