natgillin/translations-raw huggingface dataset:
Other medicines and Oslif Breezhaler 
Druga zdravila in zdravilo Oslif Breezhaler
The Oslif Breezhaler inhaler enables you to inhale the medicine contained in an Oslif Breezhaler capsule. 
S pomočjo inhalatorja Oslif Breezhaler lahko inhalirate zdravilo, ki je v kapsuli Oslif Breezhaler.
Carton containing 30 capsules and one Oslif Breezhaler inhaler. 
Škatla vsebuje 30 kapsul in en inhalator Oslif Breezhaler.
At the recommended doses, the adverse reaction profile of Oslif Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation. 
Pri uporabi priporočenih odmerkov so bili med neželenimi učinki zdravila Oslif Breezhaler pri bolnikih s KOPB klinično nepomembni sistemski učinki beta-2-adrenergične stimulacije.
INSTRUCTIONS FOR USE OF OSLIF BREEZHALER INHALER 
NAVODILA ZA UPORABO INHALATORJA OSLIF BREEZHALER
Oslif Breezhaler capsules must not be swallowed. 
Kapsul Oslif Breezhaler se ne sme pogoltniti.
54 c a 
54 c a b
• Only use the Oslif Breezhaler inhaler contained in this pack. 
• Uporabljajte samo inhalator Oslif Breezhaler, ki je priložen temu pakiranju.
Percentage of days with no rescue medication use a 
0,4 b odstotek dni brez uporabe nadomestnega zdravila a b b b a n/o a b
Carton containing 10 capsules and one Oslif Breezhaler inhaler. 
Škatla vsebuje 10 kapsul in en inhalator Oslif Breezhaler.
• Do not swallow the capsules. 
• Kapsul ne smete pogoltniti.
Effects on the cardiovascular system attributable to the beta2-agonistic properties of indacaterol included tachycardia, arrhythmias and myocardial lesions in dogs. 
Pri psih so med učinki na kardiovaskularni sistem, ki jih ima inadakaterol zaradi svojega agonističnega delovanja na receptorje beta-2, opažali aritmije in poškodbe miokarda.
When you start a new pack, use the new Oslif Breezhaler inhaler that is supplied in the pack. 
Ko odprete novo škatlo z zdravilom, začnite uporabljati tudi nov inhalator Oslif Breezhaler, ki je priložen pakiranju.
Never wash the Oslif Breezhaler inhaler with water. 
Inhalatorja Oslif Breezhaler nikoli ne umivajte z vodo.
• When you start a new pack, only use the new Oslif Breezhaler inhaler that is supplied in the pack. 
• Ko odprete novo škatlo z zdravilom, začnite uporabljati tudi nov inhalator Oslif Breezhaler, ki je priložen pakiranju.
Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol. 
Ena kapsula vsebuje indakaterolijev maleat, kar ustreza 150 mikrogramom indakaterola.
300 capsules + 30 inhalers 
300 kapsul + 30 inhalatorjev
• Open the mouthpiece again, and remove the empty capsule by tipping it out of the capsule chamber. 
• Spet odprite ustnik in odstranite kapsulo.
Show the pack of Oslif Breezhaler. 
Tam pokažite škatlo z zdravilom Oslif Breezhaler.
Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Oslif Breezhaler. 
Poročila o preobčutljivosti izhajajo iz izkušenj z uporabo zdravila Oslif Breezhaler po njegovem prihodu na trg.
Carton containing 30 capsules and 1 inhaler. 
Škatla, ki vsebuje 30 kapsul in 1 inhalator.
Renal impairment No dose adjustment is required for patients with renal impairment. 
Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerjanja ni potrebno.
Infections and infestations Upper respiratory tract infection 
Infekcijske in parazitske bolezni okužbe zgornjih dihal pogosti nazofaringitis pogosti sinusitis pogosti
Each capsule contains 24.6 mg lactose. 
Pomožna(e) snov(i) z znanim učinkom: Ena kapsula vsebuje 24,6 mg laktoze.
Lung function 
Pljučna funkcija
Do not store the capsules in the Oslif Breezhaler inhaler. 
Kapsul ne shranjujte v inhalatorju Oslif Breezhaler.
90 capsules + 3 inhalers 
90 kapsul + 3 inhalatorji
Pull off the cap. 
Snemite pokrovček.
Each capsule contains 24.8 mg lactose. 
Pomožna(e) snov(i) z znanim učinkom: Ena kapsula vsebuje 24,8 mg laktoze.
Musculoskeletal and connective tissue disorders Muscle spasm 
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični krči pogosti bolečine v mišicah občasni mišičnoskeletna bolečina občasni
Carton containing 10 capsules and 1 inhaler. 
Škatla, ki vsebuje 10 kapsul in 1 inhalator.
The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 240 microgram indacaterol. 
Odmerek indakaterolijevega maleata, ki pride skozi ustnik inhalatorja, ustreza 240 mikrogramom indakaterola.
• sore throat 
• vnetje žrela in grla
Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol. 
Ena kapsula vsebuje indakaterolijev maleat, kar ustreza 300 mikrogramom indakaterola.
How to clean your inhaler 
Čiščenje inhalatorja
medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol). 
S tem lahko povečate možnost za neželene učinke; jemljete zdravila, ki jih imenujemo zaviralci adrenergičnih receptorjev beta in jih uporabljamo pri zdravljenju visokega krvnega tlaka ali drugih težav s srcem (na primer propranolol) ali pa pri bolezni oči, ki jo imenujemo glavkom (na primer timolol); jemljete zdravila, ki znižujejo raven kalija v krvi.
• if you get crushing chest pain, (common). 
• če začutite stiskajočo bolečino v prsih (pogost neželeni učinek),
60 capsules + 2 inhalers 
60 kapsul + 2 inhalatorja
Only use the Oslif Breezhaler inhaler contained in this pack. 
Uporabljajte samo inhalator Oslif Breezhaler, ki je priložen temu pakiranju.
The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 120 microgram indacaterol. 
Odmerek indakaterolijevega maleata, ki pride skozi ustnik inhalatorja, ustreza 120 mikrogramom indakaterola.
The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h dosing interval on Day 14 compared to Day 1, was in the range of 2.9 to 3.5 for once-daily inhaled doses between 150 microgram and 600 microgram. 
Pri enkrat dnevnem inhaliranju odmerkov od 150 mikrogramov do 600 mikrogramov je bilo povprečno razmerje kopičenja indakaterola, kar pomeni AUC v 24-urnem odmernem intervalu na 14. dan v primerjavi s 1. dnem, v obsegu od 2,9 do 3,5.
How to use Oslif Breezhaler 
Kako uporabljati zdravilo Oslif Breezhaler
No dose adjustment is required for patients with mild and moderate hepatic impairment. 
Pri bolnikih z blago in zmerno okvaro jeter prilagajanje odmerjanja ni potrebno.
The Oslif Breezhaler inhaler enables you to inhale the medicine contained in a capsule. 
S pomočjo inhalatorja Oslif Breezhaler boste lahko vdihnili (inhalirali) zdravilo, ki je v kapsuli.
Never blow into the mouthpiece of the Oslif Breezhaler inhaler. 
Nikoli ne pihajte v ustnik inhalatorja Oslif Breezhaler.
It is not harmful if these pieces are swallowed or inhaled. 
Če te delce pogoltnete ali vdihnete, vam to ne bo škodovalo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 30. november 2009
Therefore, this shows no concern for a pro-arrhythmic potential related to QT-interval prolongations at recommended therapeutic doses or at twice the maximum recommended dose. 
Na podlagi teh rezultatov ni nobenega razloga za zaskrbljenost, da bi uporaba priporočenih terapevtskih odmerkov ali odmerkov, ki bi bili dvakrat višji od najvišjega priporočenega odmerka, lahko spodbujala razvoj aritmij v povezavi s podaljšanjem intervala QT.
Store in the original blister in order to protect from moisture and do not remove until immediately before use. 
Shranjujte v originalnem pretisnem omotu za zagotovitev zaščite pred vlago in vzemite iz ovojnine šele tik pred uporabo.
10 capsules + 1 inhaler 
10 kapsul + 1 inhalatorr
Skin and subcutaneous tissue disorders Pruritus/rash 
Bolezni kože in podkožja srbenje/izpuščaj pogosti
Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. 
Med zdravljenjem z zdravilom Oslif Breezhaler Takoj prenehajte uporabljati zdravilo in obvestite zdravnika, če vas začne takoj po uporabi zdravila stiskati v prsih, če začnete kašljati, če vam v pljučih piska ali vam zmanjkuje sape.
SIA „Novartis Baltics” Lietuvos filialas Tel: +370 5 269 16 50 
Lietuva SIA „Novartis Baltics” Lietuvos filialasTel: +370 5
10 capsules and 1 inhaler. 
10 kapsul in 1 inhalator.
Never place a Oslif Breezhaler capsule directly into the mouthpiece of the Oslif Breezhaler inhaler. 
Kapsule Oslif Breezhaler nikoli ne nameščajte neposredno na ustnik inhalatorja Oslif Breezhaler.
Never take the Oslif Breezhaler inhaler apart. 
Inhalatorja Oslif Breezhaler nikoli ne razstavljajte.
Beta-adrenergic blockers 
Zaviralci adrenergičnih receptorjev beta
In COPD the muscles around the airways tighten. 
Pri KOPB se mišice okrog dihalnih poti skrčijo, kar otežuje dihanje.
30 capsules and 1 inhaler. 
30 kapsul in 1 inhalator.
The Oslif Breezhaler inhaler provided with each new prescription should be used. 
Vedno je treba uporabiti inhalator Oslif Breezhaler, ki je priložen novemu pakiranju zdravila.
The side buttons should be facing left and right. 
• Držite inhalator, kot kaže slika: stranska gumba naj bosta obrnjena levo in desno.
Always use the new Oslif Breezhaler inhaler that comes with your new pack. 
Vedno uporabljajte samo inhalator Oslif Breezhaler, ki je priložen novemu pakiranju.
Oslif Breezhaler 150 microgram inhalation powder, hard capsules Oslif Breezhaler 300 microgram inhalation powder, hard capsules indacaterol 
Oslif Breezhaler 150 mikrogramov prašek za inhaliranje, trde kapsule Oslif Breezhaler 300 mikrogramov prašek za inhaliranje, trde kapsule indakaterol
Multipack: 90 (3 packs of 30 capsules and 1 inhaler). 
Skupno pakiranje: 90 kapsul (3 pakiranja po 30 kapsul in 1 inhalator).
You will experience a sweet flavour as the medicine goes into your lungs. 
Pri vstopu zdravila v pljuča začutite sladek okus.
Mark daily dose tracker: 
Označite odmerjanje na koledarčku za beleženje odmerjanja:
Multipack: 300 (30 packs of 10 capsules and 1 inhaler). 
Skupno pakiranje: 300 kapsul (30 pakiranj po 10 kapsul in 1 inhalator).
In a human ADME study where indacaterol was given orally, the faecal route of excretion was dominant over the urinary route. 
V študiji absorpcije, porazdelitve, presnove in izločanja pri ljudeh je bilo po peroralni uporabi indakaterola izločanje z blatom bolj pomembno od izločanja z urinom.
Always keep the Oslif Breezhaler inhaler and capsules in a dry place. 
Pazite, da bodo inhalator in kapsule Oslif Breezhaler vedno na suhem.
Indacaterol serum concentrations increased with repeated once-daily administration. 
S ponavljanjem enkrat dnevnega odmerjanja se je koncentracija indakaterola v serumu zviševala.
Multipack: 60 (2 packs of 30 capsules and 1 inhaler). 
Skupno pakiranje: 60 kapsul (2 pakiranji po 30 kapsul in 1 inhalator).
• Close the inhaler and replace the cap. 
• Zaprite inhalator in ga pokrijte s pokrovčkom.
Oslif Breezhaler 150 microgram capsules have a black product code “IDL 150” printed above a black bar and a black company logo ( ) printed below the black bar. 
Kapsule Oslif Breezhaler 150 mikrogramov imajo nad črno črto s črno natisnjeno oznako
Oslif Breezhaler 300 microgram capsules have a blue product code “IDL 300” printed above a blue bar and a blue company logo ( ) printed below the blue bar. 
Kapsule Oslif Breezhaler 300 mikrogramov imajo nad modro črto z modro natisnjeno oznako
Oslif Breezhaler 300 microgram inhalation powder, hard capsules indacaterol 
Oslif Breezhaler 300 mikrogramov prašek za inhaliranje, trde kapsule indakaterol
Oslif Breezhaler 150 microgram inhalation powder, hard capsules 
Oslif Breezhaler 150 mikrogramov prašek za inhaliranje, trde kapsule
What Oslif Breezhaler is 
Kaj je zdravilo Oslif Breezhaler
Oslif Breezhaler 300 microgram inhalation powder, hard capsules 
Oslif Breezhaler 300 mikrogramov prašek za inhaliranje, trde kapsule
Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler). 
Skupno pakiranje, ki obsega 30 pakiranj (vsako vsebuje 10 kapsul in 1 inhalator).
Beta-adrenergic blockers and beta2-adrenergic agonists may weaken or antagonise the effect of each other when administered concurrently. 
Zaviralci adrenergičnih receptorjev beta in agonisti adrenergičnih receptorjev beta-2 lahko pri sočasni uporabi oslabijo ali zavrejo učinke drug drugega, zato se indakaterola ne sme jemati skupaj z zaviralci adrenergičnih receptorjev beta (kar pomeni tudi s kapljicami za oči), razen če za sočasno uporabo obstajajo nujni razlogi.
Oslif Breezhaler 150 microgram inhalation powder, hard capsules indacaterol 
Oslif Breezhaler 150 mikrogramov prašek za inhaliranje, trde kapsule indakaterol
Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler). 
Skupno pakiranje, ki obsega 2 pakiranji (vsako vsebuje 30 kapsul in 1 inhalator).
Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler). 
Skupno pakiranje, ki obsega 3 pakiranja (vsako vsebuje 30 kapsul in 1 inhalator).
57 b a 
59 c b a
What Oslif Breezhaler is used for 
Za kaj uporabljamo zdravilo Oslif Breezhaler
Store in the blister in order to protect from moisture and only remove immediately before use. 
Za zagotovitev zaščite pred vlago shranjujte kapsule v pretisnem omotu in jih vzemite iz njega šele tik pred uporabo.
Lactose monohydrate 
6.1 Seznam pomožnih snovi Vsebina kapsule laktoza monohidrat
General disorders and administration site conditions Chest pain 
Splošne težave in spremembe na mestu aplikacije bolečina v prsnem košu pogosti periferni edemi pogosti
A hydroxylated derivative was the most prominent metabolite in serum. 
Najbolj izrazit metabolit v serumu je bil hidroksiliran derivat, sledila pa sta mu fenol-O-glukuronid indakaterol in hidroksiliran indakater.
Oslif Breezhaler inhaler 
inhalator Oslif Breezhaler pretisni omot spodnji del inhalatorja
Hepatic impairment 
Okvara jeter
10 capsules + 1 inhaler 30 capsules + 1 inhaler 
prašek za inhaliranje, trde kapsule 10 kapsul + 1 inhalator
Nervous system disorders Headache 
Bolezni živčevja glavobol pogosti omotičnost pogosti parestezije občasni
Condition 
Pogoj
In order to remove any traces of cow's milk proteins from their finished product, the MAHs should replace the current formulations in their marketing authorisations with formulations free from cow's milk proteins and submit for assessment the corresponding documentation to the relevant National Competent Authorities: 
Da bi imetniki dovoljenj za promet odstranili vse sledi beljakovin iz kravjega mleka iz končnega proizvoda, morajo nadomestiti veljavne formulacije v dovoljenjih za promet z zdravilom s formulacijami, ki ne vsebujejo beljakovin iz kravjega mleka, in predložiti v presojo ustrezno dokumentacijo zadevnim nacionalnim pristojnim organom: do 30. junija 2019
Annex IV Condition to the marketing authorisations 
Priloga IV Pogoji dovoljenj za promet z zdravilom
Condition to the marketing authorisations 
Pogoji dovoljenj za promet z zdravilom
Therefore no clear conclusion can be drawn from these studies. 
Zato te študije ne dajo jasnih zaključkov.
The experimental conditions were similar in both studies. 
Eksperimentalni pogoji so bili v obeh študijah podobni.
Several shortcomings of the study were noted (e.g. lack of a control group). 
Ugotovljeno je bilo več pomanjkljivosti študije (npr. odsotnost kontrolne skupine).
LAB. DR ESTEVE Avda Mare de Deu de Montserrat 
DR ESTEVE Avda Mare de Deu de Montserrat
In these cases the alternative approach6 was applied or the study was considered to be of confirmatory nature. 
V teh primerih so uporabili alternativni pristop6 ali pa so študijo šteli za potrditveno.
Clinical symptoms following infection were almost absent even at the highest infectious dose. 
Klinični simptomi po okužbi so bili skoraj odsotni tudi pri največjem infektivnem odmerku.
24010 TROBAJO DEL CAMINO SPAIN 
24010 TROBAJO DEL CAMINO ŠPANIJA
4550 Peshtera BULGARIA 
4550 Peshtera BOLGARIJA
The efficacy evaluation was based on mortality, clinical observations and microbiology. 
Ocena učinkovitosti je temeljila na smrtnosti, kliničnih opažanjih in mikrobiologiji.
The documentation of the original proprietary studies was very heterogeneous and in many cases did not comply with current standards. 
Dokumentacija izvirnih lastniških študij je bila zelo raznolika in večinoma neskladna s trenutnimi standardi.
46 (1), pp.85-93, 1998 
46 (1), str. 85-93, 1998
B 1400-119 Lisboa PORTUGAL 
B 1400-119 Lisboa PORTUGALSKA
Romania DELOS IMPEX' 96 SRL 
Romunija DELOS IMPEX' 96 SRL
Bulgaria Interchemie Werken 
Bolgarija Interchemie Werken
4.5 Special precautions for use in animals 
4.5 Posebni previdnostni ukrepi za uporabo pri živalih
Bulgaria Vetpartners OOD Ivan Asen Str. 
Bolgarija Vetpartners OOD Ivan Asen Str.
For four responses the written information provided did not contain data pertinent to the questions raised by the CVMP. 
V štirih odgovorih predložene pisne informacije niso vsebovale podatkov v zvezi z vprašanji, ki jih je postavil CVMP.
No adverse effects related to treatment were recorded. 
Neželeni učinki, povezani z zdravljenjem, niso bili zabeleženi.
Romania CEVA SANTE ANIMALE 
Romunija CEVA SANTE ANIMALE
Bulgaria Ceva Sante Animale France La Balastiere 
Bolgarija Ceva Sante Animale France La Balastiere
As all three studies were poorly documented (e.g. relevant information of diagnostic procedures, microbiology, clinical observations etc were missing) therefore the results can not be interpreted properly. 
Ker so bile vse tri študije slabo dokumentirane (npr. manjkali so ustrezni podatki o diagnostičnih postopkih, mikrobiologiji, kliničnih ugotovitvah itn.), rezultatov ni možno pravilno razlagati.
2320 Hoogstraten BELGIUM 
2320 Hoogstraten BELGIJA
25250 Bellpuig (Lerida) SPAIN 
25250 Bellpuig (Lerida) ŠPANIJA
The uptake of medicated water is dependant on the clinical conditions of the birds. 
Vnos medicirane vode je odvisen od kliničnega stanja ptic.
9140 Temse BELGIUM 
9140 Temse BELGIJA
Romania INDUSTRIA ITAILIANA 
Romunija INDUSTRIA ITAILIANA
One response was received after the given deadline for submission and therefore was not accepted and the CVMP performed its assessment without considering the product specific data. 
En odgovor je bil prejet po postavljenem roku za predložitev, zato ni bil sprejet, CVMP pa je opravil oceno brez upoštevanja podatkov v zvezi s tem zdravilom.
Romania VMD Berendonk 74 
Romunija VMD Berendonk 74
Bulgaria Biovet AD 39 Petar Rakov Str. 
Bolgarija Biovet AD 39 Petar Rakov Str.
03-176 Warszawa POLAND 
03-176 Warszawa POLJSKA
Medicated drinking water should be freshly prepared every 24 hours. 
Vsakih 24 ur je treba pripraviti svežo medicirano pitno vodo.
This was the only study submitted in support of the O. rhinotracheale claim. 
To je bila edina študija, predložena v podporo trditvi glede O. rhinotracheale.
The study was run in 2 phases, a pilot phase determining the optimal infectious dose followed by a confirmatory phase. 
Študija je bila izvedena v dveh fazah, v pilotski fazi so določili optimalni infektivni odmerek, sledila pa je potrditvena faza.
s.r.o., Višňová 2/484, 140 00 Praha 4, Czech Republic 
s.r.o., Višňová 2/484, 140 00 Praha 4, Češka republika
V.M.D.n.v./ s.a. Hoge Muew 900 2370 Arendonk BELGIUM 
V.M.D.n.v./ s.a. Hoge Muew 900 2370 Arendonk BELGIJA
The procedure involved 179 veterinary medicinal products authorised or pending authorisation in different Member States of the European Union (see Annex I). 
Postopek je zajel 179 zdravil za uporabo v veterinarski medicini, ki so že odobrena ali v postopku odobritve v državah članicah Evropske unije (glejte Dodatek I).
2600 Antwerpen BELGIUM 
2600 Antwerpen BELGIJA
To ensure a correct dosage body weight should be determined as accurately as possible. 
Za zagotovitev pravilnega odmerka je treba čim natančneje določiti telesno maso.
• the CVMP considered that the use of doxycycline hyclate was well established. 
• CVMP je menil, da je uporaba doksiciklinijevega hiklata dobro uveljavljena.
It is recommended to prepare a concentrated pre-solution - approximately 100 grams product per litre drinking water - and to dilute this further to therapeutic concentrations if required. 
Priporočljivo je, da se pripravi koncentrirana vnaprej pripravljena raztopina - približno 100 gramov zdravila na liter pitne vode - in se po potrebi dodatno redči do terapevtskih koncentracij.
The latest resistance rates of E. coli isolated from chickens is reported for Germany in a range of 19.3-37% (Wallmann et al, 2007)5. 
Zadnji podatki o stopnjah odpornosti E. coli, izolirane iz piščancev, so iz Nemčije in so v razponu 19,3-37 % (Wallmann et al, 2007)5.
30625 Hannover GERMANY 
30625 Hannover NEMČIJA
Univete SA Rua D. Jerónimo Osório, 5 
Portugalska Univete SA Rua D. Jerónimo Osório, 5
Romania S.C. VIM SPECTRUM SRL 409 Sighisoarei Targu Mures ROMANIA 
Romunija S.C. VIM SPECTRUM SRL 409 Sighisoarei Targu Mures ROMUNIJA
06516 CARROS FRANCE 
06516 CARROS FRANCIJA
Székesfehérvár HUNGARY 
Székesfehérvár MADŽARSKA
The other studies provide with indicative support for the target dose, since a subjective primary endpoint - clinical improvement - was used, and since these studies were poorly documented. 
Druge študije kažejo podporo ciljnemu odmerku, ker so uporabili subjektivno primarno merilo izida - klinično izboljšanje - in ker so bile te študije slabo dokumentirane.
Budapest Ottó u. 14, Hungary 
Budapest Ottó u. 14, Madžarska
Maxx Pharma OÜ Kaluri tee 5 
Estonija Maxx Pharma OÜ Kaluri tee 5
ZA Le Patis 78120 Rambouillet FRANCE 
ZA Le Patis 78120 Rambouillet FRANCIJA
Residue studies were mainly conducted in chickens. 
Študije ostankov so bile predvsem izvedene pri piščancih.
831 02 Bratislava SLOVENIA 
831 02 Bratislava SLOVAŠKA
Hungary Animal-Med Kft. 1029 Budapest 
Madžarska Animal-Med Kft. 1029 Budapest
Bulgaria Farmavet OOD 40 Otec Paisij Str. 
Bolgarija Farmavet OOD 40 Otec Paisij Str.
Romania CEVA PHYLAXIA VETERINARY 
Romunija CEVA PHYLAXIA VETERINARY
Only the above mentioned nineteen responses that contained full dossiers developed in accordance with the Article 12(3) of Directive 2001/82/EC were considered of adequate quality for the purpose of answering to the specific issues raised. 
Samo zgoraj omenjeni devetnajsti odgovori, ki so vsebovali popolno dokumentacijo, pripravljeno v skladu s členom 12(3) Direktive 2001/82/ES, so se šteli za zadostne kakovosti, da so odgovorili na posamezna postavljena vprašanja.
The daily amount is to be added to the drinking water such that all medication will be consumed in 24 hours. 
Dnevna količina se doda v pitno vodo tako, da živali zaužijejo celotno zdravilo v 24 urah.
Viale Corassori 62 41100 Modena ITALY 
Viale Corassori 62 41100 Modena ITALIJA
Verovskava 57 1000 Ljubljana SLOVENIA 
Verovškova 57 1000 Ljubljana SLOVENIJA
The data made available indicated that the concerned veterinary medicinal products are authorised or pending authorisations via different marketing authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases (full, generic and informed consent). 
Predloženi podatki so kazali, da so zadevna zdravila za uporabo v veterinarski medicini odobrena ali v postopku odobritve po različnih postopkih pridobitve dovoljenja za promet z zdravilom (postopki z medsebojnim priznavanjem ali nacionalni postopki) in na različnih pravnih podlagah (popolnih, generičnih in s prostovoljnim soglasjem).
Skierniewice POLAND 
Skierniewice POLJSKA
It was noted that some parts of the data submitted were identical but were submitted by different MAHs. 
Ugotovljeno je bilo, da so nekateri deli predloženih podatkov enaki, vendar so jih predložili različni imetniki dovoljenj za promet z zdravilom.
The results indicated that doxycycline effectively improved the clinical performance of the chickens and reduced gradually mortality. 
Rezultati so pokazali, da je doksiciklin učinkovito izboljšali klinično zmogljivost piščancev in postopoma zmanjšal smrtnost.
Obviously no attempts were made to determine the actual dose in chickens. 
Jasno je, da poskusov določitve dejanskega odmerka pri piščancih ni bilo.
De Adelaar BV Hosterweg 26a 5811 Ccastenray THE 
De Adelaar BV Hosterweg 26a 5811 Ccastenray NIZOZEMSKA