natgillin/translations-raw huggingface dataset:
In patients with uncorrected hypokalaemia (serum potassium of less than 3.5 mmol/l), potassium levels should be corrected prior to use of vernakalant. 
Bolnikom z nekorigirano hipokaliemijo (koncentracija kalija v serumu manj kot
Common: Infusion site pain; feeling hot; infusion site paraesthesia Uncommon: Fatigue; infusion site irritation; infusion site hypersensitivity; infusion site pruritus; malaise 
Občasni: utrujenost, draženje na mestu infundiranja, preobčutljivost na mestu infundiranja, srbenje na mestu infundiranja, splošno slabo počutje
There are no clinical data on repeat doses after the initial and second infusions. 
Kliničnih podatkov o ponovni uporabi po začetni in drugi infuziji ni. Kot kaže, je koncentracija vernakalanta po 24 urah zanemarljiva.
Each vial contains 200 mg vernakalant hydrochloride equivalent to 181 mg vernakalant. 
Ena viala vsebuje 200 mg vernakalantijevega klorida, kar ustreza 181 mg vernakalanta.
Each 10 ml vial contains 200 mg of vernakalant hydrochloride equivalent to 181 mg of vernakalant. 
Ena 10 ml viala vsebuje 200 mg vernakalantijevega klorida, kar ustreza 181 mg vernakalanta.
Clinically significant adverse reactions observed in clinical trials included hypotension and ventricular arrhythmia. 
Med klinično pomembnimi neželenimi učinki v kliničnih preskušanjih so bile hipotenzija in prekatne motnje srčnega ritma (glejte poglavji 4.4 Hipotenzija, Kongestivno srčno popuščanje).
The patient is required to be monitored for signs and symptoms of a sudden decrease in blood pressure or heart rate for the duration of the infusion and for at least 15 minutes after the completion of the infusion. 
Bolnika je treba med infundiranjem ter še vsaj 15 minut po zaključku infundiranja nadzorovati glede znakov in simptomov nenadnega znižanja krvnega tlaka ali srčne frekvence.
These effects, seen within 24 hours of being given BRINAVESS, should pass quickly, however, if they do not you should consult your doctor. 
• kihanje Ta neželena učinka, ki se opazita v 24 urah po dajanju zdravila BRINAVESS, naj bi minila hitro.
Please refer to the Summary of Product Characteristics and the educational material for additional information prior to the use of BRINAVESS 
Pred uporabo zdravila BRINAVESS za dodatne informacije preberite Povzetek glavnih značilnosti tega zdravila in izobraževalno gradivo.
Do NOT give other IV antiarrhythmic medicines (class I and/or class III) for at least 4 hours after infusion of BRINAVESS. 
Vsaj 4 ure po infuziji zdravila BRINAVESS NE smete dati drugih intravenskih antiaritmikov (skupine I in/ali III).
A pre-infusion checklist is provided with the medicinal product. 
K zdravilu je priložen kontrolni seznam, s katerim mora predpisovalec pred uporabo zdravila preveriti,
Each vial of 200 mg vernakalant hydrochloride is equivalent to 181 mg vernakalant. 
Ena viala z 200 mg vernakalantijevega klorida ustreza 181 mg vernakalanta.
Resumption or initiation of oral maintenance antiarrhythmic therapy can be considered starting 2 hours after vernakalant administration. 
Ponoven začetek ali uvedba peroralnega vzdrževalnega antiaritmičnega zdravljenja pride v poštev
BRINAVESS is a concentrate for solution for infusion (sterile concentrate) which is clear and colourless to pale yellow. 
Zdravilo BRINAVESS je bister, brezbarven do bledorumen koncentrat za raztopino za infundiranje (sterilen koncentrat).
Vernakalant given by infusion is not expected to perpetrate meaningful drug drug interactions due to the rapid distribution and transient exposure, low protein binding, lack of inhibition of other CYP P450 enzymes tested (CYP3A4, 1A2, 2C9, 2C19 or 2E1) and lack of P-glycoprotein inhibition in a digoxin transport assay. 
Ni pričakovati, da bi infundirani vernakalant povzročil pomembna medsebojna delovanja zdravil, ker se hitro porazdeli in je izpostavljenost prehodna, vezava na beljakovine majhna, ne zavira drugih testiranih encimov CYP
Each vial of 500 mg of vernakalant hydrochloride is equivalent to 452.5 mg of vernakalant. 
Ena viala s 500 mg vernakalantijevega klorida ustreza 452,5 mg vernakalanta.
No dose adjustment of vernakalant is required on the basis of CYP2D6 metaboliser status, or when vernakalant is administered concurrently with 2D6 inhibitors. 
CYP2D6, ali če je vernakalant uporabljen sočasno z zaviralci 2D6.
STATEMENT OF ACTIVE SUBSTANCE 
NAVEDBA ZDRAVILNE UČINKOVINE
Package leaflet: Information for the user BRINAVESS 20 mg/ml concentrate for solution for infusion vernakalant hydrochloride 
Navodilo za uporabo BRINAVESS 20 mg/ml koncentrat za raztopino za infundiranje vernakalantijev klorid
• generalised itching 
• splošno srbenje • utrujenost
• fatigue 
Correvop
• Use of intravenous rhythm control antiarrhythmics (class I and class III) within 4 hours prior to, 
• Intravenskih antiaritmikov za kontrolo srčnega ritma se v prvih 4 urah po uporabi zdravila
The safety of vernakalant has been evaluated in clinical studies involving 1,148 subjects (patients and healthy volunteers) who received treatment with it. Based on data from 1,018 patients in eight phase 2 and phase 3 trials, the most commonly reported adverse reactions (> 5 %) seen in the first 24 hours after receiving vernakalant were dysgeusia (taste disturbance) (17.9 %), sneezing (12.5 %), and paraesthesia (6.9 %). 
3. faze so bili najpogosteje poročani neželeni učinki (> 5 %), ki so se pojavili v prvih 24 urah po uporabi vernakalanta, disgevzija (motnja okušanja) (7,9 %), kihanje (12,5 %) in parestezije (6,9 %).
If conversion to sinus rhythm did not occur with the initial infusion or within the 15 minute observation period, administer a 2 mg/kg second infusion over 10 minutes. 
Če bolnik po začetni infuziji ali v 15 minutnem obdobju spremljanja ne preide v sinusni ritem,
Efficacy in patients who developed atrial fibrillation post cardiac surgery (ACT II) Efficacy was studied in patients with atrial fibrillation after cardiac surgery in ACT II, a phase 3, double-blind, placebo-controlled, parallel group study (ACT II) in 150 patients with sustained atrial fibrillation (3 hours to 72 hours duration) that occurred between 24 hours and 7 days post coronary artery bypass graft and/or valvular surgery. 
Učinkovitost pri bolnikih, ki se jim je atrijska fibrilacija pojavila po kardiokirurškem posegu (ACT II) Učinkovitost pri bolnikih z atrijsko fibrilacijo po kardiokirurškem posegu so raziskali v študiji ACT II.
• coughing, sore nose 
• kašelj, vnet nos • prekomerno znojenje, srbenje
Common: Cough; nasal discomfort 
Zelo pogosti: kihanje Pogosti: kašelj, nelagodje v nosu
• the electrical activity of your heart (uncommon) 
(občasni), kratki premori med normalnim delovanjem srca (občasni))
This summary was last updated in January 2012. 
Ta povzetek je bil nazadnje posodobljen januarja 2012.
In rare cases, particularly in older or in sensitive dogs, these effects may become very serious. 
V redkih primerih, zlasti pri starejših ali občutljivih psih, lahko postanejo ti učinki zelo resni.
Zubrin should not be used in people. 
Zdravilo Zubrin se ne sme uporabljati za ljudi.
If the lyophilisate disintegrates prematurely in your hands, wash your hands thoroughly. 
Če se liofilizat prezgodaj raztopi v vaših rokah, si roke temeljito umijte.
The European Commission granted a marketing authorisation valid throughout the European Union, for Zubrin on 13 March 2001. 
Evropska Komisija je dovoljenje za promet z zdravilom Zubrin, veljavno po vsej Evropski uniji, odobrila dne 13. marca 2001.
Occasionally, loss of hair or red patches on the skin might occurr. 
Občasno lahko pride do izpadanja dlake ali pojava rdečih lis na koži.
In these clinical studies, the animal owners gave Zubrin to their dogs, once daily at a dose of 10 mg per kg dog's bodyweight with or without food. 
V teh kliničnih raziskavah so lastniki živali dajali Zubrin psom enkrat dnevno v odmerku 10 mg na kg telesne mase psa z ali brez hrane.
Vomiting or diarrhoea has been observed in one out of 10 dogs. 
Bruhanje ali drisko so opazili pri enem izmed 10 psov.
Zubrin has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices/clinics in the USA and in a number of countries in Europe (“clinical studies”). 
Zdravilo Zubrin je bilo preučeno na laboratorijskih živalih in na psih, ki so bili zdravljeni v različnih veterinarskih ambulantah/klinikah v ZDA in številnih državah v Evropi („klinične raziskave“).
Also, before you start using Zubrin, inform the veterinarian if your dog receives any other medication since some medicines might influence each other's effectiveness. 
Ravno tako je treba pred začetkom uporabe zdravila Zubrin veterinarja obvestiti, če pes prejema katerakoli druga zdravila, saj lahko nekatera zdravila vplivajo na učinkovitost drugih zdravil.
Information on the prescription status of this product may be found on the label of the carton. 
Podatki o statusu predpisovanja tega zdravila so navedeni na škatli zdravila.
The best results were achieved when Zubrin was adminstered 1-2 hours after feeding. 
Najboljše rezultate so dosegli z dajanjem zdravila Zubrin 1-2 uri po hranjenju.
Its purpose is to explain how the assessment done by the CVMP on the basis of the documentation provided led to the recommendations on the conditions of use. 
Njegov namen je pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) na podlagi ocene predložene dokumentacije oblikoval priporočila glede uporabe zdravila.
However, since side effects might occur, any treatment exceeding 1 - 2 weeks should be under regular veterinary supervision. 
Ker pa se lahko pojavijo neželeni učinki, mora biti vsako zdravljenje, ki je daljše od 1 do 2 tednov, pod rednim veterinarskim nadzorom.
Zubrin acts by blocking enzymes, cyclooxygenase-1 and cyclooxygenase-2. 
Zdravilo Zubrin deluje z zaviranjem encimov ciklooksigenaza-1 in ciklooksigenaza-2.
Zubrin should be placed directly into the dog's mouth and you should try to keep the mouth of the dog closed for a short while. 
Zdravilo Zubrin morate položiti neposredno v gobec psa, nato pa poskusite gobec psa za kratek čas zadržati zaprtega.
When such undesirable effects are seen in the dog, you should discontinue giving Zubrin to your dog. 
Če se pri psu pojavijo takšni neželeni učinki, je treba dajanje zdravila Zubrin prekiniti.
Zubrin is given to the dog once a day within 1-2 hours after feeding until the dog gets better. 
Zdravilo Zubrin se daje psom enkrat dnevno 1-2 uri po hranjenju, dokler se stanje ne izboljša.
Zubrin contains tepoxalin, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs). 
Zdravilo Zubrin vsebuje tepoksalin, ki spada v skupino zdravil z imenom nesteroidna protivnetna zdravila (NSPVZ).
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Zubrin are greater than any risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Zubrin should be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristni učinki zdravila Zubrin pri zdravljenju vnetja ali bolečin v mišicah ali sklepih pri psih večji od vseh tveganj, in priporoča odobritev dovoljenja za promet z zdravilom Zubrin.
Why has Zubrin been approved? 
Zakaj je bilo zdravilo Zubrin odobreno?
Therefore, you should make sure to administer the medicine with dry hands. 
Zato zdravilo vedno dajajte s suhimi rokami.
Zubrin was as effective as other medicines of the same class and showed significant improvement in dogs with muscle or joint disease. 
Zdravilo Zubrin je bilo učinkovito enako kot druga zdravila iz iste skupine in je pokazalo statistično značilno izboljšanje stanja pri psih z boleznimi mišic ali sklepov.
When these enzymes are blocked, less prostaglandin is produced. 
Ko sta ta dva encima zavrta, pride do zmanjšane tvorbe prostaglandinov.
Zubrin is used in dogs to reduce inflammation and relief of pain caused by acute and chronic musculoskeletal disorders. 
Zdravilo Zubrin se uporablja za zmanjšanje vnetja in bolečine, ki jih povzročajo akutna in kronična mišičnoskeletna obolenja.
Zubrin is an oral lyophilisate, i.e. a kind of tablet that will quickly disintegrate upon contact with moisture e.g. when placed on your dog's tongue. 
Zdravilo Zubrin je oralni liofilizat, t. j. vrsta tablet, ki se hitro razgradijo ob stiku z vlago, npr. ko tableto položite na jezik psa.
Zubrin has a special pharmaceutical form (lyophilisate) that will quickly dissolve upon contact with moisture and might get very slippery or sticky when kept in your fingers. 
Zdravilo Zubrin je v posebni farmacevtski obliki (liofilizat), ki se hitro raztopi pri stiku z vlago in lahko postane zelo spolzko ali lepljivo, če ga držite med prsti.
The side effects of Zubrin are those seen with other NSAIDs, such as vomiting, soft faeces or diarrhoea, blood in faeces, reduced appetite and tiredness. 
Neželeni učinki zdravila Zubrin so enaki kot pri drugih nesteroidnih protivnetnih zdravilih, in sicer vključujejo bruhanje, mehko blato ali drisko, kri v blatu, zmanjšan apetit in utrujenost.
However, if a number of tablets are accidentially consumed by a person, the advice of a doctor should be sought immediately. 
Če pride do nenamernega zaužitja več tablet pri človeku, se nemudoma posvetujte z zdravnikom.
What is Zubrin used for? 
Za kaj se zdravilo Zubrin uporablja?
What are the side effects of Zubrin? 
Kakšni so neželeni učinki zdravila Zubrin?
As the prostaglandins are substances that trigger inflammation, tepoxalin reduces the inflammation and the swelling of muscles or joints and the pain associated with this. 
Ker prostaglandini sprožajo vnetje, tepoksalin zmanjša vnetje in otekanje mišic ali sklepov ter bolečine,
What is Zubrin? 
Kaj je zdravilo Zubrin?
How has the effectiveness of Zubrin been studied? 
Kako je bilo zdravilo Zubrin raziskano?
Zubrin contains the active substance tepoxalin. 
Zdravilo Zubrin vsebuje zdravilno učinkovino tepoksalin.
How does Zubrin work? 
Kako zdravilo Zubrin deluje?
15 to 21 days 
15 do 21 dni
The CVMP can accept: 
CVMP lahko sprejme:
This effect is transient. 
Ta učinek je prehoden.
The elimination half-life was 22 hours. 
Razpolovni čas je bil 22 ur.
See the environmental properties section. 
Glejte poglavje o okoljskih lastnostih.
In particular its activity has been demonstrated against the following micro-organism: 
Dokazana je aktivnost proti naslednjim mikroorganizmom:
The majority of the marketing authorisations have been approved via national procedures. 
Večina dovoljenj za promet z zdravilom je bila odobrena po nacionalnih postopkih.
Applicable to both species: 
Velja za obe živalski vrsti:
Soya-bean oil (as stated in the Ph.Eur) 
Sojino olje (kakor je navedeno v Ph. Eur)
However, marketing authorisations were also granted via two separate Mutual Recognition Procedures with Italy and Ireland as the Reference Member States. 
Vendar so bila dovoljenja za promet z zdravilom odobrena tudi po dveh ločenih postopkih z medsebojnim priznavanjem, v katerih sta bili Italija in Irska referenčni državi članici.
ATCvet code: QJ01FA91. 
Oznaka ATC vet: QJ01FA91.
It would give warning that there could be other components (such as other cereals) that could produce the same effect, since the reason for this loss of activity has not been explained in the submission and remained unknown. 
To opozarja na možnost, da lahko druge sestavine (kot so druge žitarice) povzročijo enak učinek, ker razlog za to zmanjšanje aktivnosti ni razložen v prijavi in ostaja neznan.
The primary route of environmental exposure is from manure applied to agricultural land as fertilizer. 
Primarna pot okoljske izpostavljenosti je prek gnoja, ki se nanese na kmetijske površine kot gnojilo.
2800 Lyngby Denmark 
2800 Lyngby Danska
CVMP can also accept the proposed dose in both pigs and rabbits as these are in accordance with those used in the experimental and field studies. 
CVMP lahko sprejme tudi predlagani odmerek za prašiče in kunce, saj je skladen z odmerki, uporabljenimi v eksperimentalnih in terenskih študijah.
The uptake of medicated feed depends on the clinical condition of the animals. 
Vnos zdravilne krmne mešanice je odvisen od kliničnega stanja živali.
4.2 Indications for Use, Specifying the Target Species: in some Member States the product is indicated for rabbits and in others not. 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah: v nekaterih državah članicah je zdravilo indicirano za kunce, v nekaterih pa ne.
However the bulk of tilmicosin is excreted unchanged. 
Vendar pa se večina tilmikozina izloči v nespremenjeni obliki.
• Two sentences should be added in point 4.9: in accordance with the information provided, it has been observed that before incorporation into the finished feed, it was performed a previous mix with a suitable amount of feed. 
• dva stavka se dodata v poglavje 4.9: V skladu s predloženimi podatki je bilo ugotovljeno, da se pred dodajanjem v končano krmo opravi predhodno mešanje s primerno količino krme.
Rabbits were approved as target species only in Austria, Belgium, Italy and Luxembourg for Pulmotil 200 Vet premix. 
Kunci so bili kot ciljna živalska vrsta odobreni le v Avstriji, Belgiji, Italiji in Luksemburgu za zdravilo Pulmotil 200 Vet premix.
Besides, temperature in the pelleting conditions have not exceeded 75 ºC; 
Poleg tega temperature pri peletiranju niso presegle 75 °C;
Where the indications in rabbits are restricted to respiratory infections, the CVMP can accept this claim. 
Kadar so indikacije pri kuncih omejene na okužbe dihal, lahko CVMP sprejme to zahtevo.
SPECIAL STORAGE CONDITIONS Store in a dry place. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte na suhem mestu.
4.9 Amount to be administered and administered route: the recommended amount to be administered and the treatment duration vary amount the Member States. 
4.9 Odmerjanje in pot uporabe: priporočena količina za uporabo in trajanje zdravljenja se razlikujeta med državami članicami.
Macrolides appear to enhance phagocyte killing of bacteria. 
Izgleda, da makrolidi pospešijo fagocitno uničevanje bakterij.
Tilmicosin plasma concentrations decreased to 0.1 µg/ml within 2 hours and to 0.02 µg/ml after 8 hours. 
Koncentracije tilmikozina v plazmi so se znižale na 0,1 µg/ml v 2 urah ter na 0,02 µg/ml po 8 urah.
Biotransformation: Several metabolites are formed, the predominant one being identified as T1. 
Biološka transformacija: Nastane več presnovkov, prevladujočega pa imenujemo T1.
• Indication for pigs: delete the microorganism Haemophilus parasuis; 
• indikacija za prašiče: brisanje mikroorganizma Haemophilus parasuis;
In relation to ‘shelf life after incorporation into meal or pelleted feed', CVMP cannot accept the Marketing Authorisation Holders' proposal “ 3 months, except for medicated feed containing 30% wheat in which case the validity is reduced to 1 month”. 
V zvezi z „rokom uporabnosti po dodajanju v obrok ali peletirano hrano“ CVMP ne more sprejeti predloga imetnikov dovoljenja za promet z zdravilom, tj. „3 mesece, razen za medicinirano krmo, ki vsebuje 30 % pšenice, kjer se rok skrajša na 1 mesec“.
The CVMP has assessed for the preventive use a pilot study, four dose determination studies and 12 field trial reports. 
CVMP je s področja preventivne uporabe ocenil pilotno študijo, štiri študije določitve odmerka in 12 poročil o terenskih preskušanjih.
In relation to the pathogens involved the microorganism Haemophilus parasuis should be removed. 
V zvezi z vpletenimi patogenimi mikroorganizmi je treba izbrisati mikroorganizem Haemophilus parasuis.
Lung concentrations increased rapidly between days 2 and 4 but no significant changes were obtained following four days of dosing. 
Koncentracije v pljučih se hitro povečujejo od 2. do 4. dne, po 4 dneh odmerjanja pa ni več pomembnih razlik.
Pigs: 21 days Rabbits: 4 days 
Prašiči: 21 dni Kunci: 4 dni
Pulmotil VET Premix for medicated feeding stuff is currently registered in 19 EU Member States with three different strengths (40g, 100g and 200g per kg) available. 
Zdravilo Pulmotil VET Premix za medicirano krmo je trenutno registrirano v 19 državah članicah EU, pri čemer so na voljo tri jakosti (40 g, 100 g in 200 g na kg).
Read the package leaflet on reverse of the bag before use. 
Pred uporabo preberite navodilo na zadnji strani vreče.
• The inclusion rate in feed established at the tables (4.9) would differ on each product strength; 
• stopnja dodajanja v krmo na podlagi preglednic (4.9) se razlikuje pri vsaki posamezni jakosti zdravila;
• Modify the special precautions to be taken by the person administering the veterinary medicinal product to animals; 
• popravek poglavja Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo;
PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: antibacterials for systemic use, macrolides. 
Farmakoterapevtska skupina: protibakterijska zdravila za sistemsko uporabo, makrolidi.
Although tilmicosin appears to have an acceptable stability through 3 months at 25 ºC in meal type feeds, in pelleted feeds the behaviour is not the same. 
Čeprav se zdi, da ima tilmikozin sprejemljivo stabilnost 3 mesece pri 25 °C v krmi, oblikovani v obrok, pa v peletirani hrani njegovo obnašanje ni enako.
- Do not handle the product if you are allergic to ingredients in the product. 
- Na ravnajte z zdravilom, če ste alergični na njegove sestavine.
This product can be incorporated into pelleted feed, preconditioned for the minimum time-period at a temperature not exceeding 75°C. 
To zdravilo lahko vmešate v peletirano krmo, predoblikovano za najkrajše časovno obdobje pri temperaturi, ki ne presega 75 °C.
Maximum concentrations were reached in 30 minutes, being the Cmax obtained of 0.35 µg/ml. 
Najvišje koncentracije so bile po 30 minutah, pri čemer je bil Cmax 0,35 µg/ml.
Shelf life after first opening the immediate packaging: 3 months is not included in the Marketing Authorisation Holders' proposal, but it is part of the marketing authorisation in 3 Member States. 
Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesece; ni vključen v predlogu imetnikov dovoljenja za promet z zdravilom, vendar je vključen v dovoljenju za promet z zdravilom v 3 državah članicah.
The main sections of disharmony of the existing SPCs (non exhaustive) are: 
Poglavitna poglavja neskladnosti v obstoječih povzetkih glavnih značilnosti zdravila so (med drugim):
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements. 
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
In very rare cases, feed intake may decrease (including feed refusal) in animals receiving medicated feed. 
V zelo redkih primerih so pri živalih, ki so prejemale zdravilno krmno mešanico, opazili zmanjšan vnos krme (vključno z odklanjanjem).
To ensure thorough dispersion of the product, it should first be mixed with a suitable quantity of feed before incorporation into the finished feed. 
Da zagotovite temeljito porazdelitev zdravila, ga morate najprej vmešati v primerno količino krmne mešanice in šele nato v končno krmno mešanico.
For the treatment use, the field trial reports included in the two European Clinical Field Trials Programme (9 field trial in the first phase and 10 field trial in the second phase) and two additional field trial reports were assessed. 
S področja terapevtske uporabe je CVMP ocenil poročila o terenskih preskušanjih, vključenih v dve seriji preskušanj v okviru evropskega programa kliničnih terenskih preskušanj (9 terenskih preskušanj v prvi fazi in 10 terenskih preskušanj v drugi fazi), in dve dodatni poročili o terenskih preskušanjih.
• Contraindications: include a new statement in relation to the hypersensitivity to tilmicosin; 
• kontraindikacije: vključitev nove izjave v zvezi s preobčutljivostjo za tilmikozin;