natgillin/translations-raw huggingface dataset:
In view of the benefits afforded by the product as set out above and on the basis of the evidence provided by the representative of the MAHs the CVMP is of the opinion that this approach is however not proportionate. 
Ob upoštevanju koristnih učinkov zdravila, ki so opredeljeni zgoraj, in na podlagi dokazov, ki jih je predložil predstavnik imetnikov dovoljenj za promet, je CVMP mnenja, da ta pristop ni sorazmeren.
Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim Germany 
Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim Nemčija
Administration of dobutamine should also be considered due to its positive inotropic effects although it does not influence tachycardia. 
Upoštevati je treba tudi možnost dajanja dobutamina zaradi njegovih pozitivnih inotropnih učinkov, čeprav ne vpliva na tahikardijo.
DO NOT GIVE ADRENALIN OR BETA-ADRENERGIC ANTAGONISTS SUCH AS PROPRANOLOL. 
NE DAJAJTE ADRENALINA ALI ZAVIRALCEV BETA-ADRENERGIČNIH RECEPTORJEV, KOT JE PROPRANOLOL.
As the dosage of the product in adult sheep is typically 1-5 ml and in adult cattle is typically 15-20 ml, it is difficult to accurately estimate the incidence of human reactions or fatalities. 
Ker je odmerek zdravila pri odraslih ovcah ponavadi 1-5 ml, pri odraslem govedu pa ponavadi 15-20 ml, je težko natančno oceniti pojavnost reakcij in smrtnih primerov pri ljudeh.
These results suggest that intravenous epinephrine may be contraindicated. 
Ti rezultati kažejo, da je intravensko dajanje epinefrina morda kontraindicirano.
RG21 6XA United Kingdom 
RG21 6XA Združeno kraljestvo
Overall, the CVMP considers the risks inherent to this option would be the lowest. 
Na podlagi vsega naštetega CVMP smatra, da bodo tveganja pri tej možnosti najmanjša.
Additional recommendation to any of the options 3. to 5. regarding limitation of the volume of Micotil to be held per syringe or of maximum pack size or re-formulation of the product 
Dodatna priporočila k možnostim 3 do 5 glede omejitev volumna zdravila Micotil na brizgo, največjega pakiranja ali reformulacije zdravila
Such cardiotoxic effects have also been observed in human beings (mainly after intentional injection but in 2 known cases outside the EU after accidental injection of Micotil). 
Te kardiotoksične učinke so opazili tudi pri ljudeh (predvsem po namernem injiciranju, vendar tudi v 2 znanih primerih nenamernega injiciranja zdravila Micotil izven EU).
The benefits of treatment with Micotil include that the animal is treated with an effective antibacterial. 
Korist zdravljenja z zdravilom Micotil je med drugim tudi, da se žival zdravi z učinkovitim protibakterijskim sredstvom.
Evidence from investigations of 13 occurrences of intentional intramuscular injection suggests that 60% of people who received 10 to 12 ml of Micotil died. 
Raziskava 13 primerov namernega intramuskularnega injiciranja kaže, da umre 60 % oseb, ki prejmejo 10 do 12 ml zdravila Micotil.
Apply a cold pack (not ice directly) to the injection site. 
Na mesto vbrizganja položite hladen obkladek (ledu ne polagajte neposredno).
While reducing the maximum amount available for accidental injection of the user, this measure would increase the chances for accidental exposure of human beings. 
Kljub zmanjšanju največje količine, ki bi bila uporabniku na voljo za nenamerno injiciranje, bi ta ukrep povečal verjetnosti nenamerne izpostavitve ljudi.
Tilmicosin is an antimicrobial substance that is not used in human medicine and resistance in human bacteria to tilmicosin is very low (source: DANMAP). 
Tilmikozin je protimikrobno sredstvo, ki se v humani medicini ne uporablja in je odpornost pri bakterijah človeka zelo redka (vir: DANMAP).
Do not inject more than 20 ml per injection site. 
Ne vbrizgajte več kot 20 ml pripravka na enem mestu vbrizganja.
For the EU the average bovine weight was put on 150 kg (90% of the sales) whereas the average ovine weight was kept at 30 kg. 
Za EU je bila upoštevana povprečna telesna masa govedi 150 kg (90 % prodaje), povprečna masa ovac pa je ostala 30 kg.
This option bears the following inherent risk: 
Ta možnost predstavlja naslednje tveganje:
Thirdly, re-formulation to a lower strength product might not lead to a tangible risk reduction as the dose causing adverse effects in human beings is not known and is expected to vary depending on the physical condition of the individual. 
Tretjič, reformulacija v šibkejšo obliko morda ne bo realno zmanjšala tveganja, saj odmerek, ki povzroča neželene učinke pri ljudeh ni znan, pričakuje pa se, da je odvisen od telesne kondicije posameznika.
Interdigital necrobacillosis in cattle: 
Interdigitalna nekrobaciloza pri govedu:
The risk of serious signs of toxicity and death in human beings appear to be linked to plasma concentrations around 5 µg/ml, whereas plasma concentrations of 1-2 µg/ml did not lead to fatalities. 
Izgleda, da je tveganje hudih znakov toksičnosti in smrti pri ljudeh povezano s plazemskimi koncentracijami približno 5 µg/ml, plazemske koncentracije 1-2 µg/ml pa niso povzročile smrti.
- the Committee considered the referral made under Article 35 of Directive 2001/82/EC in the interest of the Community regarding user safety for national marketing authorisations for Micotil or variations of that name as listed in Annex I of the opinion; 
- Odbor je preučil postopek napotitve po členu 35 Direktive 2001/82/ES v interesu Skupnosti glede varnosti uporabnika v nacionalnih dovoljenjih za promet zdravila Micotil ali variacij tega imena iz Dodatka 1 mnenja;
This option bears the following inherent risks: 
Ta možnost predstavlja naslednja tveganja:
Recognising that farming practices in the USA, where the accidental fatalities were reported, differ significantly from farming practices in the EU different risk management approaches between the USA and the EU may be required. 
Ob upoštevanju, da se kmetovanje v ZDA, kjer sta bila zabeležena nezgodna smrtna primera, znatno razlikuje od kmetovanja v EU, se bo morda moral pristop k upravljanju tveganja v EU razlikovati od tistega v ZDA.
Animal species 
Vrsta živali
Bearing the aforesaid in mind, based on the data provided by the representative of the MAHs on world-wide sales of Micotil since 1999 and the 2 cases of accidental fatal injections in human beings reported to date in the USA, the risk of an accidental human fatality may be estimated as less than 1 per 60 million administrations1. 
Upoštevajoč navedeno in na podlagi podatkov, ki jih je predložil predstavnik imetnikov dovoljenj za promet, o svetovni prodaji zdravila Micotil od leta 1999 in 2 doslej ugotovljenih primerih nenamernega smrtnega injiciranja v ZDA, je tveganje nezgodne smrti pri ljudeh ocenjeno na manj kot 1 na 60 milijonov odmerjanj1.
Withdraw the required dose from the vial and remove the syringe from the needle. 
Odmerite zahtevan odmerek iz viale in snemite brizgo iz igle.
In the two accidental fatalities recorded to date the victims were farmers and in both treatment of the adverse reactions involved use of adrenaline (epinephrine), which is considered as contra-indicated in cases of human exposure to tilmicosin. 
V dveh nezgodnih smrtnih primerih ugotovljenih do sedaj, sta bila žrtvi kmeta in v obeh primerih je bil pri zdravljenju neželenih reakcij uporabljen adrenalin (epinefrin), ki je kontraindiciran v primerih človeške izpostavitve tilmikozinu.
Micotil is a single-injection, low volume treatment and therefore has benefits of ease of use, animal welfare and compliance with dosage regimen. 
Zdravilo Micotil je za enkratno injiciranje z majhnim volumnom in zato ima koristi enostavne uporabe, blagostanja živali in doslednega upoštevanja sheme uporabe.
A related risk is that certain substances, in particular adrenaline (epinephrine), used in standard emergency treatment in human medicine may exacerbate the effects of tilmicosin. 
Povezano tveganje predstavljajo določene snovi, zlasti adrenalin (epinefrin), ki se uporabljajo v standardnem nujnem zdravljenju v humani medicini, ker lahko poslabšajo učinke tilmikozina.
The likelihood of resistance development in these pathogens through exposure to tilmicosin when used for treatment of animals is expected to be negligible. 
Pričakuje se, da je verjetnost razvoja odpornosti pri teh patogenih organizmih zaradi izpostavitve tilmikozinu pri zdravljenju živali, zanemarljiva.
• May cause sensitisation by skin contact. 
• V stiku s kožo lahko povzroči senzibilizacijo.
• Do not work alone when using Micotil. 
• Zdravila Micotil ne uporabljajte sami.
Eli Lilly Italia S.p.A Elanco Animal Health Via Gramsci, 733 Sesto Fiorentino, 50019 Firenze Italy 
Eli Lilly Italia S.p.A Elanco Animal Health Via Gramsci, 733 Sesto Fiorentino, 50019 Firenze Italija
On the basis of a standard human body weight of 60 kg this would equate to 50-60 mg/kg bw. 
Pri predpostavki standardne telesne mase človeka 60 kg, je to enakovredno 50-60 mg/kg TM.
Certain others (e.g. dobutamine) have partially countered cardiac effects of tilmicosin in animal experiments (pigs and dogs). 
Določene druge snovi (npr. dobutamin) so delno zmanjšale kardiološke učinke tilmikozina v poskusih na živalih (prašičih in psih).
It noted that a lower strength product would firstly lead to an increase in the number of administrations necessary to achieve a therapeutic dose. 
Upošteval je, da bi šibkejša oblika zdravila povzročila povečanje števila odmerjanj, ki bi bila potrebna za doseganje terapevtskega odmerka.
the CVMP recommends by a majority of 18 out of 27 votes that the warnings relative to user safety of the nationally granted Marketing Authorisations be harmonised and that the conditions of use be harmonised to ‘For use by veterinary surgeons only'; the revised aspects of the Summary of Product Characteristics are set out in Annex III and the conditions considered essential for the safe use of the product, as referred to in Article 36(4) of Directive 2001/82/EC as amended, are set out in Annex IV. 
CVMP z večino 18 od 27 glasov priporoča, da se uskladijo opozorila v zvezi z varnostjo uporabnikov v nacionalnih dovoljenjih za promet in da se uskladijo pogoji uporabe z besedilom ‘Zdravilo lahko uporablja samo veterinar'; v Dodatku III so opredeljeni popravljeni vidiki Povzetka glavnih značilnosti zdravila in pogoji, v Dodatku IV pa so opredeljeni spremenjeni pogoji, ki so ključni za varno uporabo zdravila, iz člena 36(4) Direktive 2001/82/ES.
Young cattle (bovine) Not for use in cows producing milk for human consumption 
Mlado govedo Ni za uporabo pri kravah za mleko za prehrano ljudi
A theoretical risk management option would be to maintain the status quo with respect to the divergence in the different EU Member States of user safety warnings, and additional safety measures, such as limitations of volume to be held per syringe, or restriction to use by veterinarians. 
Teoretična možnost upravljanja s tveganjem bi bila vzdrževanje statusa quo glede razlik med posameznimi državami članicami EU v varnostnih opozorilih za uporabnike in dodatnih varnostnih ukrepih, kot so omejitve volumna na brizgo in omejitev uporabe na samo veterinarje.
This measure would additionally increase the stress to the treated animals by longer duration of restraint and multiple injections and reduce the benefits of the product in respect to a higher number of injection sites. 
Ta ukrep bi dodatno povečal stres pri zdravljenih živalih zaradi časovno dolgotrajnejšega zadržanja, večkratnega injiciranja in zmanjšanja koristnih učinkov zdravila glede na večje število mest injiciranja.
Young cattle 
Mlado govedo
The CVMP did not consider it necessary to recommend a limitation of the amount of Micotil to be held per syringe. 
Po mnenju CVMP ni potrebe po priporočilu omejitve količine zdravila Micotil na brizgo.
When administered by injection, tilmicosin has been fatal in various species, including primates (in monkeys 30 mg/kg bw were shown to be fatal), mainly due to its cardio-toxic effects. 
Pri injiciranju je bil tilmikozin usoden za različne živalske vrste, vključno s primati (pri opicah je bil smrtni odmerek 30 mg/kg TM), predvsem zaradi svojih kardiotoksičnih učinkov.
Concerns were raised concerning the adequacy of the existing safety warnings and conditions for use of the product in protecting users from self-injection and its potential serious consequences as well as the need to provide adequate information for medical action in case of such an occurrence or abuse of the product (suicide). 
Predstavljeni so bili zadržki o ustreznosti sedanjih varnostnih opozoril in pogojev uporabe zdravila v smislu varovanja uporabnika pred samoinjiciranjem in potencialno hudimi posledicami; predstavljena je bila tudi potreba po zagotovitvi zadostnih podatkov za zdravniško oskrbo v primeru takšnih dogodkov ali zlorabe zdravila (samomor).
The blockade of this cardiac current is a possible mechanism for the negative inotropic effects that have been observed following the administration of the compound to conscious dogs. 
Blokada tega srčnega električnega toka je možen mehanizem negativnih inotropnih učinkov, ki so jih opazili po dajanju te spojine psom pri zavesti.
Appropriate educational measures targeted at users (mainly the agricultural community) would be undertaken by the MAHs. 
Ustrezne izobraževalne ukrepe za uporabnike (predvsem kmetijsko skupnost) bi izvedli imetniki dovoljenj za promet.
The CVMP is aware that educational measures are not likely to be 100% effective in reaching the intended target audience, the users, and will require repetition at regular intervals in order to achieve a high level of awareness. 
CVMP se zaveda, da izobraževalni ukrepi verjetno ne bodo 100-odstotno učinkovito dosegli ciljnega občinstva, uporabnikov, in bodo za doseganje visoke stopnje zavesti potrebne ponovitve v rednih časovnih presledkih.
Furthermore the revised aspects of the Summary of Product Characteristics should be implemented in the labelling and product leaflet as set out below. 
Poleg tega je treba spremembe Povzetka glavnih značilnosti zdravila uvesti tudi v označevanje zdravila in njegovo navodilo za uporabo, kakor je prikazano spodaj.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE CONCERNED MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINA UPORABE, ŽIVALSKIH VRST IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V ZADEVNIH DRŽAVAH ČLANICAH
Keep the syringe and needle separate at all other times. 
Brizga in igla morata biti vedno ločeni.
The fact that the product is administered subcutaneously may also be considered as a benefit from the point of view of the quality of foodstuffs (muscle) when compared to certain so-called long acting formulations such as tetracyclines. 
Dejstvo, da se zdravilo daje subkutano, se lahko z vidika kakovosti živil (mišic) v primerjavi s pripravki s podaljšanim delovanjem (npr. tetraciklini) smatra kot korist.
On the inside of the peel-back label 
Notranja stran odlepljive nalepke
The representative of the MAHs further identified a report of accidental injection in humans where CaCl2 had been used as part of the emergency treatment of the patient. 
Predstavnik imetnikov dovoljenj za promet z zdravili je nadalje predložil poročilo o nenamernem injiciranju pri ljudeh, kjer so uporabili CaCl2 kot del nujnega zdravljenja bolnika.
- The CVMP is aware that educational measures are not likely to be 100% effective in reaching all intended targets and will require repetition at regular intervals in order to achieve a high level of awareness. 
- CVMP se zaveda, da izobraževalni ukrepi verjetno ne bodo 100-odstotno učinkovito dosegli celotnega ciljnega občinstva in bodo za doseganje visoke stopnje zavesti potrebne ponovitve v rednih časovnih presledkih.
- A residual risk remains that the veterinary surgeon may not fully comply with the recommended measures intended to ensure their personal safety (e.g. the user may fail to detach the needle from the syringe containing the product). 
- Ostaja tveganje, da veterinarji morda ne bodo popolnoma upoštevali priporočenih ukrepov, ki so namenjeni njihovi osebni varnosti (tj. uporabniki morda ne bodo sneli igle iz brizge z zdravilom).
Some form of documentation would be required to note the dispensing veterinary surgeon's decision to consider a person suitably qualified, where the suitably qualified person also acknowledges understanding of the risks afforded by the product, the implications with respect to personal safety and regarding safe storage. 
Potrebna je dokumentacija, kjer bo zabeležena odločitev veterinarja, ki je izdaja zdravilo, o primerni usposobljenosti posamezne osebe in kjer bo primerno usposobljena oseba potrdila, da razume tveganja, povezana z zdravilom, posledice v zvezi z osebno varnostjo in varnim shranjevanjem.
The primary cardiac effects are increased heart rate (tachycardia) and decreased contractility (negative inotrophy). 
Primarni kardiološki učinki so zvišana srčna frekvenca (tahikardija) in zmanjšana krčljivost (negativna inotropija).
The risk of failure of the proposed measure is considered as very real; - The users of the products, though a number may be highly qualified and experienced in handling farm animals, are likely to be very divergent in respect to experience in handling and administration of medicines of high toxic potential. 
Pričakuje se realno tveganje neuspeha predlaganega ukrepa; - Čeprav so lahko nekateri uporabniki zdravila visoko usposobljeni in izkušeni pri ravnanju z domačimi živalmi, se ostali verjetno zelo razlikujejo med seboj v izkušenosti pri ravnanju z zdravili in dajanjem zdravil z visokim potencialom toksičnosti.
The use of the product would be restricted to veterinary surgeons only. 
Uporaba zdravila bi bila omejena samo na veterinarje.
The results of an additional study with administration of epinephrine as a treatment for combating intravenous tilmicosin toxicity in swine strongly suggest that intravenous administration of epinephrine may be contraindicated due to the rate of deaths in the treated group. 
Rezultati dodatne raziskave z dajanjem epinefrina za zdravljenje intravenske toksičnosti tilmikozina pri prašičih močno nakazuje, da je morda intravensko dajanje epinefrina kontraindicirano zaradi visoke smrtnosti v skupini, ki je prejemala zdravljenje.
Qualitative risk assessment 
Kvalitativno vrednotenje tveganja
Before attempting a quantitative risk assessment for human adverse reactions to Micotil, it must be pointed out that any calculations of incidences of reactions in veterinary pharmacovigilance can only be regarded as rough estimates that are influenced by many variables, not the least uncertainties regarding actual doses used in order to estimate the number of animal treatments, and under reporting of actual occurrences of adverse reactions. 
Pred poskusom kvantitativnega vrednotenja tveganja neželenih reakcij na Micotil pri človeku, je treba izpostaviti, da se lahko vse izračune pojavnosti reakcij v veterinarski farmakovigilanci jemlje kot grobe ocene, na katere vplivajo številne spremenljivke, med drugim tudi negotovost dejansko uporabljenih odmerkov, na podlagi katerih bi ocenili število epizod zdravljenj živali, in podcenjeno dejansko poročanje o neželenih učinkih.
Considering the recommendation of the Committee to restrict use to veterinary surgeons only, restriction of maximum pack size is not relevant, as the product will remain in the care of the veterinary surgeon. 
V okviru priporočila Odbora o omejitvi uporabe na samo veterinarje omejitev največjega pakiranja ni smiselna, ker bo zdravilo v presoji veterinarja.
In particular, therapeutic levels of the antibacterial tilmicosin are reported to occur in the lung within one hour of administration of Micotil in animals. 
Zlasti zato, ker protibakterijska učinkovina tilmikozin v pljučih doseže terapevtske ravniže v eni uri po dajanju zdravila Micotil pri živalih.
Appropriate educational measures for veterinary surgeons in practice would be required of the MAH to ensure awareness of veterinary surgeons to the changed evaluation of the product. 
Z ustreznimi izobraževalnimi ukrepi za veterinarje v praksi bi moral imetnik dovoljenja za promet (MAH) zagotoviti zavedanje veterinarjev o spremenjeni oceni zdravila.
• Never carry a syringe loaded with Micotil 300 with the needle attached. 
• Nikoli ne prenašajte brizge napolnjene z zdravilom Micotil 300 in nameščeno iglo.
However, serious adverse reactions after accidental injection have been reported. 
Vendar so bila poročila o hudih neželenih reakcijah po nenamernem injiciranju.
Following oral or parenteral administration of tilmicosin the main target organ for toxicity is the heart. 
Pri peroralni ali parenteralni uporabi je srce poglavitni ciljni organ toksičnih učinkov tilmikozina.
No accidental fatalities due to accidental injection of Micotil have been reported in the EU. 
V EU ni zabeleženih nezgodnih smrti zaradi nenamernega injiciranja zdravila Micotil.
NOTE TO THE PHYSICIAN 
OPOMBA ZA ZDRAVNIKA
If a group of animals is to be treated, leave the needle in the vial as a draw-off needle for subsequent doses. 
Če zdravite skupino živali, pustite iglo v viali za odmerjanje naslednjih odmerkov.
Subsequent studies were conducted to determine if intravenous calcium chloride administration reduces or diminishes this toxic cardiovascular effect of tilmicosin. 
S kasnejšimi raziskavami so ugotavljali, ali intravensko dajanje CaCl2 zmanjša ali odpravi ta toksični kardiovaskularni učinek tilmikozina.
Product trade name 
Lastniško ime izdelka
NOTE TO THE PHYSICIAN: Please see inside part of label or package leaflet for details. 
OPOMBA ZA ZDRAVNIKA: Za podrobnosti glejte notranji del nalepke ali navodilo za uporabo.
Exposure assessment 
Vrednotenje izpostavitve
Calculation of number of administrations (doses) based on a 10 mg/kg BW dose, 90% in cattle (250 kg BW) and 10% in sheep (30 kg BW) for the USA. 
Izračun števila odmerjanj (odmerkov) je za ZDA temeljilo na odmerku 10 mg/kg TM, 90 % pri govedu (250 kg TM) in 10 % pri ovcah (30 kg TM).
However, it is possible that if the lay use of the product were to continue, any improvements in medical advice and hospital care might be of academic use as the appropriate medical intervention could be too late. 
Če pa bi bila uporaba zdravila s strani laikov še naprej možna, bi bila vsa izboljšanja nasvetov in bolnišnične oskrbe nepraktična, saj bi bila ustrezna zdravniška oskrba prepozna.
Cattle (not to be used in lactating cows) 
Govedo (ni za uporabo pri kravah v obdobju laktacije)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON -ALL AUTHORISED PACK SIZES 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLICA - VSA ODOBRENA PAKIRANJA
Although the actual role of CaCl2 infusion following tilmicosin exposure in humans is inconclusive because of the limited data available, it is suggested that CaCl2 infusion may help to reverse the induced changes in blood pressure and heart rate in humans. 
Čeprav dejanska vloga infundiranja CaCl2 po izpostavitvi tilmikozinu pri ljudeh ni dokončna zaradi omejene količine podatkov, ki so na voljo, izgleda, da infundiranje CaCl2 pri ljudeh lahko pripomore k spremembi induciranih sprememb krvnega tlaka in srčne frekvence.
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use. 
NAČIN UPORABE IN DAJANJA Pred uporabo preberite navodila za uporabo.
Two fatalities following accidental injection of Micotil were reported in the United States but no accidental human fatality has ever been reported in Europe since the introduction of Micotil. 
Iz Združenih držav Amerike poročajo o dveh smrtnih primerih po nenamernem injiciranju zdravila Micotil, vendar v Evropi od uvedbe zdravila Micotil nikoli ni bilo poročil o nezgodnih smrtnih primerih pri ljudeh.
Cardiovascular toxicity may be due to calcium channel blockade. 
Kardiovaskularna toksičnost je lahko posledica blokiranja kalcijevih kanalčkov.