FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicine is also used as an add-on treatment in patients from 2 years of age with seizures (fits) related to tuberous sclerosis that have not responded to other treatments.
Slovenian: Zdravilo se uporablja tudi kot dodatek k zdravljenju pri bolnikih od drugega leta starosti z napadi, povezanimi s tuberozno sklerozo, ki se niso odzvali na druga zdravljenja.
English: The active substance in Votubia, everolimus, is an anti-tumour medicine that acts by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR), which has increased activity in tumour cells of patients with SEGA or renal angiomyolipoma.
Slovenian: Zdravilna učinkovina zdravila Votubia, everolimus, je protitumorsko zdravilo, ki deluje tako, da zavira delovanje encima, imenovanega „tarča rapamicina pri sesalcih“(mTOR), ki v tumorskih celicah pri bolnikih s subependimskim gigantoceličnim astrocitomom ali ledvičnim angiomiolipomom deluje s povečanim delovanjem.
English: For the full list of all side effects reported with Votubia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Votubia, glejte navodilo za uporabo.
English: How is Votubia used?
Slovenian: Kako se zdravilo Votubia uporablja?
English: How does Votubia work?
Slovenian: Kako zdravilo Votubia deluje?
English: Overall, the patients given Votubia had a 29 and 40% reduction respectively in the number of seizures during treatment, compared with a 15% reduction in those given placebo.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Votubia, je med zdravljenjem prišlo do 29 % oziroma 40 % zmanjšanja števila napadov, v primerjavi s 15 % zmanjšanjem števila napadov pri tistih, ki so jemali placebo.
English: • renal angiomyolipoma, a benign tumour of the kidneys, where it is used in adults who are at risk of complications but who do not require immediate surgery.
Slovenian: • ledvičnega angiomiolipoma, tj. benignega tumorja ledvic, pri odraslih, ki so izpostavljeni tveganju za pojav zapletov, vendar takojšnji kirurški poseg pri njih ni potreben.
English: Votubia has been shown to be effective at treating patients with SEGA and renal angiomyolipoma by shrinking the volume of the tumours.
Slovenian: Zdravilo Votubia se je izkazalo kot učinkovito pri zdravljenju bolnikov s subependimskim gigantoceličnim astrocitomom in ledvičnim angiomiolipomom, saj je vplivalo na zmanjšanje velikosti tumorjev.
English: Although surgery remains the standard treatment for this condition, Votubia is expected to benefit patients whose tumour cannot be operated on. Votubia has also been shown to reduce the size of kidney tumours in patients with renal angiomyolipoma and has been shown to be beneficial as an add-on treatment in the management of partial-onset seizures related to tuberous sclerosis that have not sufficiently responded to other therapy.
Slovenian: Čeprav se ta bolezen običajno zdravi s kirurškim posegom, se pričakuje, da bo zdravilo Votubia koristilo bolnikom, pri katerih tumorja ni mogoče operirati.
English: This estimate has not been independently verified.
Slovenian: Ta ocena ni bila neodvisno preverjena.
English: Some of these cases required hospitalisation.
Slovenian: V nekaterih primerih je bila potrebna hospitalizacija.
English: Also the situation is dynamic and may change as new cases arise.
Slovenian: Prav tako je situacija dinamična in se lahko spremeni z odkritjem novih primerov.
English: • Avoid contact with eyes.
Slovenian: • Preprečite stik z očmi.
English: Maintaining the status quo
Slovenian: Ohranjanje statusa quo
English: Secondly, re-formulation would necessitate new quality, safety and efficacy studies, which might not be feasible.
Slovenian: Drugič, reformulacija bi zahtevala nove raziskave kakovosti, varnosti in učinkovitosti, ki morda niso izvedljive.
English: - the Committee assessed the information provided by the Marketing Authorisation Holders in response to the list of questions agreed by the Committee on 16 June 2004 and the additional information provided on 12 July 2005;
Slovenian: - Odbor je ovrednotil podatke, ki so jih predložili imetniki dovoljenja za promet kot odgovor na seznam vprašanj, o katerih se je Odbor sporazumel 16. junija 2004, in dodatne podatke, ki so bili predloženi 12. julija 2005;
English: Other combinations of measures would theoretically be possible, but would not present significant additional benefits to risk management, and they are therefore not discussed.
Slovenian: Druge kombinacije ukrepov bi teoretično bile možne, vendar ne predstavljajo znatnih dodatnih koristi k upravljanju tveganja, zato o njih ni bilo razprave.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MICOTIL (see Annex I)
Slovenian: ZAKLJUČNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA MICOTIL (glejte Dodatek I)
English: • Ensure that animals are properly restrained, including those in the vicinity.
Slovenian: • Zagotovite, da je žival ustrezno zadržana, prav tako morajo biti zadržane živali v bližini.
English: They tend to be physically active and involved in handling animals every day.
Slovenian: So telesno dejavni in ravnajo z živalmi vsak dan.
English: 90027 Bernolakova, Slovak Republic
Slovenian: 90027 Bernolakova, Slovaška
English: D-35396 Gießen
Slovenian: D-35396 Gießen Nemčija
English: Cattle and calves up to 2 years of age;
Slovenian: Govedo in teleta do 2 let starosti;
English: Harmonised, stringent user safety warnings would include:
Slovenian: Usklajena obvezna varnostna opozorila za uporabnike bi vključevala:
English: Survival rates are greatly improved by the correct medical intervention.
Slovenian: Stopnjo preživetja zelo izboljša pravilna zdravniška pomoč.
English: In addition this measure would bear a high risk of being ignored.
Slovenian: Poleg tega bi ta ukrep povečal tveganje ignoriranja ukrepa.
English: A statement in a frame with yellow background colour, saying:
Slovenian: Izjava v okvirju z rumeno podlago in naslednjim besedilom:
English: Accurate weighing of lambs is important to avoid overdosage.
Slovenian: Natančno tehtanje jagenj je pomembno, da preprečite prekomerno odmerjanje.
English: It is evident that accidental injections may occur, but normally the volume injected is low.
Slovenian: Razvidno je, da do nenamernega injiciranja lahko pride, vendar je običajno injicirani volumen majhen.
English: Stawki no. 2, 21 pietro 00-193 Warsaw Poland
Slovenian: Stawki no. 2, 21 pietro 00-193 Warsaw Poljska
English: The product has a relatively long history of use with few questions over its effectiveness in the field.
Slovenian: Zdravilo ima v praksi relativno dolgo zgodovino uporabe z le nekaj dvomi o njegovi učinkovitosti.
English: Under paragraph 5.1 “Pharmacodynamic properties”
Slovenian: Pod točko 5.1 „Farmakodinamične lastnosti“
English: As tilmicosin persists in tissues for several days, the cardiovascular system should be closely monitored and supportive treatment provided.
Slovenian: Ker tilmikozin vztraja v tkivih več dni, je potrebno srčno-žilni sistem skrbno nadzorovati in nuditi podporno zdravljenje.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: DODATEK IV POGOJI DOVOLJENJA ZA PROMET
English: - The educational measures for the user are a prerequisite to ensure appropriate adherence to the safety warnings.
Slovenian: - Izobraževalni ukrepi za uporabnike so predpogoj za zagotovitev primerne doslednosti pri upoštevanju varnostnih opozoril.
English: Under paragraph 4.4 “Special warnings for each target species”
Slovenian: Pod točko 4,4 „Posebna opozorila za vsako ciljno živalsko vrsto“
English: Cattle Sheep (over 15kg)
Slovenian: Govedo Ovce (težje od 15 kg)
English: In total 520 human exposures were reported since 1999, of which 509 were accidental.
Slovenian: Skupno so od leta 1999 poročali o 520 izpostavitvah človeka, od tega je bilo 509 izpostavitev nenamernih.
English: Do not inject lambs weighing less than 15 kg, since there is a real risk of overdose toxicity.
Slovenian: Ne injicirajte jagnjem lažjim od 15 kg, saj obstaja resnično tveganje toksičnosti čezmernega odmerka.
English: Arquiparque - Miraflores 1495-131 Algés Portugal
Slovenian: Arquiparque - Miraflores 1495-131 Algés
English: In the opinion of the CVMP, this is not a solution in view of the potential risk of accidental fatalities in human beings.
Slovenian: Po mnenju CVMP to ni rešitev zaradi potencialnega tveganja nezgodnih smrtnih primerov pri ljudeh.
English: “Special precautions to be taken by the person administering the medicinal product to animals”
Slovenian: „Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo živalim“
English: Of these 509 reports, 214 cases related to non-injection exposures, and 295 to injection exposures, with minor needle scratches being the most common.
Slovenian: Od teh 509 poročil je bilo 214 primerov povezanih z izpostavitvijo brez injiciranja in 295 primerov povezanih z izpostavitvijo z injiciranjem, pri čemer so bile najpogostejše manjše praske z iglo.
English: Discussion of risk management options
Slovenian: Razpravljanje o možnostih upravljanja tveganja
English: INJECTION OF THIS DRUG IN HUMANS HAS BEEN ASSOCIATED WITH FATALITIES.
Slovenian: INJICIRANJE TEGA ZDRAVILA V ČLOVEKA JE POVEZANO S SMRTNIMI PRIMERI.
English: Nevertheless, it is necessary to put in practice some measures to reduce the risks of accidental self-injection.
Slovenian: Kljub temu je treba v praksi začeti uresničevati nekatere ukrepe za zmanjšanje tveganja nenamernega samoinjiciranja.
English: Additional data were provided in relation to 4 studies on the likely action mechanism of tilmicosin on the heart function and on possible remedial measures.
Slovenian: Predloženi so bili podatki v zvezi s 4 raziskavami o verjetnem mehanizmu delovanja tilmikozina na srce in o možnih ukrepih za zdravljenje.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGE ZA DOPOLNITEV POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, KI JIH ZASTOPA EMEA
English: Withdrawal of the product from the market in the EU
Slovenian: Umik zdravila iz prometa v EU
English: However, evidence based data to demonstrate the benefits of Micotil relative to other authorised antibacterials has not been provided.
Slovenian: Vendar podatki na osnovi dokazov, s katerimi bi bile prikazane koristi zdravila Micotil relativno na ostala odobrena protibakterijska sredstva, niso bili predloženi.
English: However, it is not possible on the basis of available evidence, to estimate a dose without adverse effects in human beings.
Slovenian: Vendar na podlagi dostopnih dokazov ni možno oceniti odmerka brez neželenih učinkov pri človeku.
English: Given the diversity of farming conditions throughout the different EU Member States concerned by the referral, the various capabilities of farmers in the EU Member States concerned, as well as the recent trends in farming of more suckler animals and scarcity of labour in some EU Member States, the CVMP does not concur with the view of the representative of the MAHs that all ‘professional' farmers may be regarded as experienced and competent.
Slovenian: Glede na raznolikost pogojev kmetovanja po državah članicah EU, ki jih zadeva postopek napotitve, različne zmogljivosti kmetov v zadevnih članicah EU ter nedavne trende v pretežnejši reji dojilj in pomanjkanje dela v nekaterih državah članicah EU, CVMP ne soglaša s pogledom predstavnika imetnikov dovoljenj za promet, da imamo lahko vse „profesionalne“ kmete za izkušene in usposobljene.
English: Tilmicosin was found to dosedependently reduce ICa amplitude with an IC50 value of 26.75 µM.
Slovenian: Ugotovili so, da tilmikozin v odvisnosti od odmerka zmanjša amplitudo ICa z vrednostjo IC50 26,75 uM.
English: Very rarely the volume is higher than 1-2 ml and it is improbable that a fatality will occur.
Slovenian: Zelo redko je volumen večji od 1-2 ml in smrtni primeri niso verjetni.
English: The risk : benefit analysis for Micotil is rather complex and various risk management proposals must be carefully considered.
Slovenian: Analiza tveganja in koristi zdravila Micotil je precej zapletena, zato je treba natančno upoštevati različne predloge upravljanja s tveganjem.
English: Veterinary surgeons have specific training in drug safety, clinical medicine, animal husbandry, restraining and handling of animals.
Slovenian: Veterinarji so specifično usposobljeni na področjih varnosti zdravil, klinične medicine, živinoreje, zadržanja in ravnanja z živalmi.
English: Single dose All sheep indications and pneumonia in cattle:
Slovenian: En odmerek Vse indikacije pri ovcah in pljučnica pri govedu:
English: It is appreciated that this action would reduce the therapeutic armoury available for the effective treatment of diseases in animals.
Slovenian: Ocenjeno je bilo, da bi ta ukrep zmanjšal terapevtske možnosti za učinkovito zdravljenje bolezni pri živalih.
English: ELANCO ELLAS Messogion 335 Av, 15231 Athens Greece
Slovenian: ELANCO ELLAS Messogion 335 Av, 15231 Athens Grčija
English: 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.
Slovenian: 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.
English: Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim Germany
Slovenian: Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim Nemčija
English: Administration of dobutamine should also be considered due to its positive inotropic effects although it does not influence tachycardia.
Slovenian: Upoštevati je treba tudi možnost dajanja dobutamina zaradi njegovih pozitivnih inotropnih učinkov, čeprav ne vpliva na tahikardijo.
English: DO NOT GIVE ADRENALIN OR BETA-ADRENERGIC ANTAGONISTS SUCH AS PROPRANOLOL.
Slovenian: NE DAJAJTE ADRENALINA ALI ZAVIRALCEV BETA-ADRENERGIČNIH RECEPTORJEV, KOT JE PROPRANOLOL.
English: 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.
Slovenian: 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.
English: These results suggest that intravenous epinephrine may be contraindicated.
Slovenian: Ti rezultati kažejo, da je intravensko dajanje epinefrina morda kontraindicirano.
English: RG21 6XA United Kingdom
Slovenian: RG21 6XA Združeno kraljestvo
English: Overall, the CVMP considers the risks inherent to this option would be the lowest.
Slovenian: Na podlagi vsega naštetega CVMP smatra, da bodo tveganja pri tej možnosti najmanjša.
English: 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
Slovenian: Dodatna priporočila k možnostim 3 do 5 glede omejitev volumna zdravila Micotil na brizgo, največjega pakiranja ali reformulacije zdravila
English: 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).
Slovenian: Te kardiotoksične učinke so opazili tudi pri ljudeh (predvsem po namernem injiciranju, vendar tudi v 2 znanih primerih nenamernega injiciranja zdravila Micotil izven EU).
English: The benefits of treatment with Micotil include that the animal is treated with an effective antibacterial.
Slovenian: Korist zdravljenja z zdravilom Micotil je med drugim tudi, da se žival zdravi z učinkovitim protibakterijskim sredstvom.
English: Evidence from investigations of 13 occurrences of intentional intramuscular injection suggests that 60% of people who received 10 to 12 ml of Micotil died.
Slovenian: Raziskava 13 primerov namernega intramuskularnega injiciranja kaže, da umre 60 % oseb, ki prejmejo 10 do 12 ml zdravila Micotil.
English: Apply a cold pack (not ice directly) to the injection site.
Slovenian: Na mesto vbrizganja položite hladen obkladek (ledu ne polagajte neposredno).
English: While reducing the maximum amount available for accidental injection of the user, this measure would increase the chances for accidental exposure of human beings.
Slovenian: Kljub zmanjšanju največje količine, ki bi bila uporabniku na voljo za nenamerno injiciranje, bi ta ukrep povečal verjetnosti nenamerne izpostavitve ljudi.
English: Tilmicosin is an antimicrobial substance that is not used in human medicine and resistance in human bacteria to tilmicosin is very low (source: DANMAP).
Slovenian: Tilmikozin je protimikrobno sredstvo, ki se v humani medicini ne uporablja in je odpornost pri bakterijah človeka zelo redka (vir: DANMAP).
English: Do not inject more than 20 ml per injection site.
Slovenian: Ne vbrizgajte več kot 20 ml pripravka na enem mestu vbrizganja.
English: 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.
Slovenian: Za EU je bila upoštevana povprečna telesna masa govedi 150 kg (90 % prodaje), povprečna masa ovac pa je ostala 30 kg.
English: This option bears the following inherent risk:
Slovenian: Ta možnost predstavlja naslednje tveganje:
English: 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.
Slovenian: 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.
English: Interdigital necrobacillosis in cattle:
Slovenian: Interdigitalna nekrobaciloza pri govedu:
English: 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.
Slovenian: 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.
English: - 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;
Slovenian: - 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;
English: This option bears the following inherent risks:
Slovenian: Ta možnost predstavlja naslednja tveganja:
English: 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.
Slovenian: 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.
English: Animal species
Slovenian: Vrsta živali
English: 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.
Slovenian: 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.
English: Withdraw the required dose from the vial and remove the syringe from the needle.
Slovenian: Odmerite zahtevan odmerek iz viale in snemite brizgo iz igle.
English: 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.
Slovenian: 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.
English: Micotil is a single-injection, low volume treatment and therefore has benefits of ease of use, animal welfare and compliance with dosage regimen.
Slovenian: Zdravilo Micotil je za enkratno injiciranje z majhnim volumnom in zato ima koristi enostavne uporabe, blagostanja živali in doslednega upoštevanja sheme uporabe.
English: 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.
Slovenian: Povezano tveganje predstavljajo določene snovi, zlasti adrenalin (epinefrin), ki se uporabljajo v standardnem nujnem zdravljenju v humani medicini, ker lahko poslabšajo učinke tilmikozina.
English: The likelihood of resistance development in these pathogens through exposure to tilmicosin when used for treatment of animals is expected to be negligible.
Slovenian: Pričakuje se, da je verjetnost razvoja odpornosti pri teh patogenih organizmih zaradi izpostavitve tilmikozinu pri zdravljenju živali, zanemarljiva.
English: • May cause sensitisation by skin contact.
Slovenian: • V stiku s kožo lahko povzroči senzibilizacijo.
English: • Do not work alone when using Micotil.
Slovenian: • Zdravila Micotil ne uporabljajte sami.
English: Eli Lilly Italia S.p.A Elanco Animal Health Via Gramsci, 733 Sesto Fiorentino, 50019 Firenze Italy
Slovenian: Eli Lilly Italia S.p.A Elanco Animal Health Via Gramsci, 733 Sesto Fiorentino, 50019 Firenze Italija
English: On the basis of a standard human body weight of 60 kg this would equate to 50-60 mg/kg bw.
Slovenian: Pri predpostavki standardne telesne mase človeka 60 kg, je to enakovredno 50-60 mg/kg TM.
English: Certain others (e.g. dobutamine) have partially countered cardiac effects of tilmicosin in animal experiments (pigs and dogs).
Slovenian: Določene druge snovi (npr. dobutamin) so delno zmanjšale kardiološke učinke tilmikozina v poskusih na živalih (prašičih in psih).
English: It noted that a lower strength product would firstly lead to an increase in the number of administrations necessary to achieve a therapeutic dose.
Slovenian: Upošteval je, da bi šibkejša oblika zdravila povzročila povečanje števila odmerjanj, ki bi bila potrebna za doseganje terapevtskega odmerka.
English: 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.
Slovenian: 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.
English: Young cattle (bovine) Not for use in cows producing milk for human consumption
Slovenian: Mlado govedo Ni za uporabo pri kravah za mleko za prehrano ljudi