natgillin/translations-raw huggingface dataset:
The pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g of tilmicosin per kg premix, are veterinary medicinal products which are indicated in pigs for the prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin. 
Predmešanice za medicirano krmo, ki vsebujejo 40 g, 100 g ali 200 g tilmikozina na kg predmešanice, so zdravila za uporabo v veterinarski medicini in so indicirana za preprečevanje in zdravljenje bolezni dihal pri prašičih, ki jih povzročajo Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida in drugi organizmi, občutljivi na tilmikozin.
Amendments in the relevant sections of the labelling 
Dopolnila v ustreznih poglavjih označevanja
Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4 
Nemčija Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
The results of a mixing uniformity study (with tilmicosin 100 g and 200 g pre-mixes) the homogeneity results obtained from ten analysed samples per batch, showed no samples out of the 85-115% range of the mean content. 
Rezultati o homogenosti v študiji o enotnem mešanju (s 100-gramskimi in 200-gramskimi predmešanicami), ki so pridobljeni iz desetih analiziranih vzorcev na serijo, niso pokazali nobenih primerov izven 85-115-odstotnega razpona povprečne vsebnosti.
Dose of tilmicosin Duration of treatment Inclusion rate in feed 
Odmerek tilmikozina Trajanje zdravljenja Stopnja dodajanja v krmo
The marketing authorisation holders should conduct conditioning/pelleting stability studies with three batches of medicated rabbit feeds (manufactured using tilmicosin 200 g per kg pre-mix) in order to confirm that if meal rabbit feed was correctly formulated with a concentration of 200 ppm, tilmicosin content in the pelleted feed would still be within the specification range of ±15 % of nominal value over a period of 3 months. 
Imetniki dovoljenja za promet z zdravilom morajo opraviti študije o stabilnosti kondicioniranja/peletiranja s tremi serijami medicirane krme za kunce (izdelane z uporabo 200 g tilmikozina na kg predmešanice) in potrditi, da bi bila v primeru, da bi bil krmni obrok za kunce pravilno sestavljen s koncentracijo 200 ppm, vsebnost tilmikozina v peletirani krmi v obdobju 3 mesecev še vedno v območju specifikacije v višini ± 15 % nominalne vrednosti.
Taking into account the characteristics of a rabbit feed used to prepare pelleted medicated feedingstuffs, it was concluded that the maximum limit of cereal meals that can be used in commercial feedingstuffs for fattening rabbits should be less than 30% (the inclusion of 30% of wheat meal is not appropriate due to the risk of triggering severe enteric problems). 
Glede na značilnosti krme za kunce, ki se je uporabljala za pripravo mediciranih krmil, je bilo zaključeno, da se v komercialnih krmilih za pitanje kuncev lahko uporablja največ do 30 % žitne moke (dodajanje 30 % pšenične moke ni primerno zaradi nevarnosti sprožitve hudih črevesnih težav).
Scientific conclusions and grounds for amendment of the Summary of Product Characteristics and labelling 
Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila in označevanja
Consequently, since the inclusion of 30% of wheat meal in medicated pelleted feed in rabbits would not be appropriate, it was considered that there would be no problem with the restriction on the shelf life after incorporation into meal adopted through a worksharing procedure because that case was not expected to be presented in rabbit. 
Ker dodajanje 30 odstotkov pšenične moke v medicirane brikete za kunce ne bi bilo primerno, ni bilo nobene težave glede omejitve roka uporabnosti po dodajanju v moko, ki je bil sprejet skozi postopek za delitev dela, saj ni bilo pričakovano, da se bo to pokazalo pri kuncih.
Regarding meal feeds, concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg. 
Glede krmnih obrokov so koncentracije za 10-13 % višje od pričakovane nominalne koncentracije 200 mg/kg.
Decrease on tilmicosin content for swine medicated pelleted feeds containing more than 30% wheat was noted. 
Opazili so zmanjšano vsebnost tilmikozina v mediciranih briketih za prašiče, ki vsebujejo več kot 30 % pšenice.
Note: The text in grey shading below is not applicable for MICLOZAN 200 premix (see Annex I of the opinion) 
Opomba: Sivo osenčeno besedilo spodaj ne velja za predmešanico MICLOZAN 200 (glejte Prilogo I mnenja)
Regardless of the unexplained high meal assay results, it has been considered that if rabbit feed meal was correctly formulated with a concentration of 200 ppm (instead of the high values reported) it would be expected that the tilmicosin content in the pelleted feed would still be within the specification range of ±15 % of nominal value. 
Ne glede na nepojasnjeno visoke rezultate testnega obroka, je bil Odbor CVMP mnenja, da bi v primeru, da bi bil krmni obrok za kunce pravilno sestavljen s koncentracijo 200 ppm (namesto prijavljenih visokih vrednosti), pričakovali, da bo vsebnost tilmikozina v peletirani krmi še vedno v območju specifikacije v višini ± 15 % nominalne vrednosti.
Additionally, these veterinary medicinal products are indicated in rabbits for the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin. 
Poleg tega so ta zdravila za uporabo v veterinarski medicini indicirana za preprečevanje in zdravljenje bolezni dihal pri kuncih, ki jih povzročata Pasteurella multocida in Bordetella bronchiseptica, ki sta občutljivi na tilmikozin.
The pharmakokinetic/pharmacodynamic study and MIC data to support use in respiratory disease in rabbits at dose of 12.5 mg/kg bw/day for 7 days (submitted previously) were referenced in the answers to the CVMP list of questions and were found to be acceptable. 
Podatki farmakokinetične/farmakodinamične študije in MIK za uporabo pri bolezni dihal pri kuncih v odmerku 12,5 mg/kg telesne mase/dan v obdobju 7 dni (ki so bili predloženi predhodno) so bili navedeni v odgovorih na seznam vprašanj Odbora CVMP, ki je ugotovil, da so sprejemljivi.
When comparing tilmicosin content in the meal feeds during the mixing uniformity test (i.e. prior to pelleting) versus tilmicosin content of the pelleted feeds, a significant decrease in tilmicosin content was observed, although that decrease was within the ± 15% preset acceptance range. 
Primerjava vsebnosti tilmikozina v krmnih obrokih v testih za enotno mešanje (tj. pred peletiranjem) in vsebnosti tilmikozina v peletiranih krmilih je pokazala pomembno zmanjšanje vsebnosti tilmikozina, čeprav je bilo to zmanjšanje v okviru ± 15 % vnaprej določenega razpona sprejemljivosti.
Conditions of the marketing authorisation 
Pogoji za pridobitev dovoljenja za promet z zdravilom
Taking into account that stability results on medicated pelleted rabbit feeds were similar to those obtained for medicated pelleted pig feeds, a shelf life period of 3 months after incorporation into feeding stuffs was considered acceptable. 
Ob upoštevanju rezultatov o stabilnosti mediciranih briketov za kunce, ki so bili podobni rezultatom za medicirane brikete za prašiče, se je zdelo sprejemljivo, da se določi 3-mesečni rok uporabnosti po dodajanju v krmila.
Netherlands Eli Lilly Nederland B.V.Elanco Animal Health 
Nizozemska Eli Lilly Nederland B.V.Elanco Animal Health
The use of tilmicosin in rabbits orally at 12.5 mg/kg bw/day for 7 days showed that from the second day of treatment, tilmicosin concentrations attained in lung tissue and pulmonary alveolar macrophages exceeded those in plasma by 7 and 400 fold, respectively, and high levels were maintained in lung tissues during the entire treatment duration. 
Peroralna uporaba tilmikozina pri kuncih v odmerkih 12,5 mg/kg telesne mase/dan v obdobju 7 dni je pokazala, da je od drugega dne zdravljenja koncentracija tilmikozina v pljučnem tkivu in pljučnih alveolarnih makrofagih za 7- oziroma 400-krat presegla koncentracije tilmikozina v plazmi, visoke ravni v pljučnih tkivih pa so se ohranile ves čas zdravljenja.
Only medicated rabbit feed prepared with tilmicosin 100 g pre-mix was used. 
Uporabljena je bila le medicirana krma za kunce, pripravljena s 100-gramsko predmešanico tilmikozina.
The CVMP has recommended variations of the Marketing Authorisation for all the pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits (see Annex I) in order to amend the Summary of Product Characteristics and labelling in line with recommended changes in the product information as set out in Annex III. 
Odbor CVMP je zato priporočil spremembo dovoljenja za promet z zdravilom za vse predmešanice za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem (glejte Prilogo I), da se povzetek glavnih značilnosti zdravila in označevanje dopolnita v skladu s priporočenimi spremembami v informacijah o zdravilu, kot je določeno v Prilogi III.
12.5 mg/kg bodyweight/day 
12,5 mg/kg telesne mase/dan
A risk has been identified on the assessment due to the high values of tilmicosin content in the meal feed prior to the conditioning/pelleting process and no explanation has been provided 
Pri oceni je bilo ugotovljeno tveganje zaradi visokih vrednosti vsebnosti tilmikozina na krmni obrok pred postopkom kondicioniranja/peletiranja, za kar ni bila podana nobena obrazložitev.
As the product information is common for pigs and rabbits, the one month shelf life after incorporation into pelleted feed containing more than 30% wheat was considered acceptable. 
Ker so informacije o izdelku skupne za prašiče in kunce, se je zdelo sprejemljivo, da se določi enomesečni rok uporabnosti po dodajanju v peletirano krmo, ki vsebuje več kot 30 % pšenice.
The approved dose is 12.5 mg/kg bw/day for 7 days, which is achieved by incorporating tilmicosin at a rate of 200 g per ton of finished feed (equivalent to 200 ppm). 
Odobreni odmerek je 12,5 mg/kg telesne mase/dan v obdobju 7 dni, kar se doseže z dodajanjem 200 g tilmikozina na tono končne krme (enakovredno 200 ppm (delov na milijon)).
In a study provided on the homogeneity of a 200 g pre-mix two different batches of 200 g premix were used to prepare 4 pilot batches of medicated feedingstuff (2 batches of crumble feed and 2 batches of pelleted feed). 
V študiji o homogenosti 200-gramske predmešanice so z dvema različnima serijama 200-gramske predmešanice pripravili 4 pilotne serije medicirane krme (2 seriji drobljenca in 2 seriji peletirane krme).
Overall summary of the scientific evaluation of all pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits (see Annex I) 
Splošni povzetek znanstvenega vrednotenja vseh predmešanic za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem (glejte Prilogo I)
CVMP assessed the efficacy of tilmicosin in rabbits and considered that, notwithstanding the fact that the clinical field study using dosage of the product had some shortcomings, the pre-clinical studies and the minimal inhibitory concentration (MICs) data suggested the effective dosage in feed is 12.5 mg/kg bw/day for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in rabbits. 
Odbor CVMP ocenil učinkovitost tilmikozina pri kuncih in menil, da so ne glede na to, da je imela klinična terenska študija z uporabo odmerka zdravila nekaj pomanjkljivosti, podatki predkliničnih študij in minimalna inhibitorna koncentracija (MIK) pokazali, da je za preprečevanje in zdravljenje bolezni dihal pri kuncih, ki jih povzročata Pasteurella multocida in Bordetella bronchiseptica, učinkovito odmerjanje v krmi 12,5 mg/kg telesne mase/dan v obdobju 7 dni.
Inclusion rates 
Stopnje dodajanja
Administer in the feed at 12.5 mg/kg bodyweight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days. 
V krmo dajajte 12,5 mg tilmikozina/kg telesne mase/dan (enakovredno 200 ppm v krmi) v obdobju 7 dni.
• the CVMP considered that high values of tilmicosin content in the meal rabbit feed have been observed prior to the conditioning/pelleting process. 
• menil, da so bile visoke vrednosti vsebnosti tilmikozina v krmnih obrokih za kunce opažene pred postopkom kondicioniranja/peletiranja.
Grounds for amendment of the Summary of Product Characteristics and labelling 
Podlaga za dopolnilo povzetka glavnih značilnosti zdravila in označevanja
Taking into account the information provided, it is considered that the target of 200 g of tilmicosin per ton of rabbit pelleted feed (200 ppm) could be achieved with the appropriate inclusion rate of the tilmicosin 40 g pre-mix, tilmicosin 100 g pre-mix and tilmicosin 200 g pre-mix, and with all of the pack sizes mentioned. 
Glede na navedene informacije, se lahko ciljnih 200 g tilmikozina na tono peletirane krme za kunce (200 ppm) doseže z ustrezno stopnjo dodajanja 40-gramske predmešanice tilmikozina, 100-gramske predmešanice tilmikozina in 200-gramske predmešanice tilmikozina, in sicer za vse omenjene velikosti pakiranja.
34 Rue Jean Monnet Zi D'Etriche 49500 Serge FRANCE 
Francija QALIAN 34 Rue Jean Monnet Zi D'Etriche
No data on incorporation were provided for Tilmicosin 40 g pre-mix. 
Za 40-gramsko predmešanico tilmikozina ni bilo podatkov o dodajanju.
Tilmicosin content was around 105% of the theoretical value of 200 ppm for crumble 
Vsebnost tilmikozina v drobljencu je bila okoli 105 % teoretične vrednosti 200 ppm, v peletirani krmi pa 100-103 %.
Elli Lilly and Company Limited.Speke OperationsFleming RoadSpeke Liverpool 
Slovaška Elli Lilly and Company Limited.Speke
Conclusion on the benefit-risk balance 
Zaključek o oceni razmerja med koristmi in tveganji
High values of tilmicosin content in the rabbit feed meal have been observed prior to the conditioning/pelleting process. 
Opazili so visoke vrednosti vsebnosti tilmikozina v krmnih obrokih za kunce pred postopkom kondicioniranja/peletiranja.
Supporting data for the recommended dose 
Podatki o priporočenem odmerku
5 kg tilmicosin 40 g premix /ton 
5 kg predmešanice, ki vsebuje 40 g tilmikozina/tono
The CVMP was requested to give its opinion on the recommended dose and inclusion rates in feed for pre-mixes for medicated feedingstuffs containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits. 
Odbor CVMP je zaprosila, naj poda svoje mnenje o priporočenem odmerku in stopnjah dodajanja v krmo za predmešanice za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem.
Hungary Eli Lilly Regional Operations GmbH 
Madžarska Eli Lilly Regional Operations GmbH
Romania Eli Lilly Regional Operations GmbH 
Romunija Eli Lilly Regional Operations GmbH
• the CVMP considered the data provided regarding the inclusion rates and agreed that the requirement for the dose being in at least half the daily ration was fulfilled, and that the target of 200 ppm of tilmicosin per ton of feed could be achieved with all the pack sizes of the different strengths (40 g, 100 g and 200 g). 
• preučil podatke glede stopenj dodajanja in soglašal, da je bila zahteva za odmerjanje v vsaj polovici dnevnih obrokov izpolnjena ter da se ciljnih 200 ppm tilmikozina na tono krme lahko doseže pri vseh velikostih pakiranj različnih jakosti (40 g, 100 g in 200 g);
Justification and relevant supporting data for the recommended dose and inclusion rates in feed for pre-mixes for medicated feedingstuffs containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits. 
1. utemeljitev in ustrezne informacije glede priporočenega odmerka in stopenj dodajanja v krmo za predmešanice za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem.
With regard to the inclusion rates it is considered that the requirement for the dose being in at least half the daily ration was fulfilled, and that the target of 200 ppm of tilmicosin per ton of feed could be achieved with all the pack sizes of the different strengths (40 g, 100 g and 200 g). 
Glede na stopnje dodajanja velja, da je bila zahteva za odmerjanje v vsaj polovici dnevnih obrokov izpolnjena ter da se ciljnih 200 ppm tilmikozina na tono krme lahko doseže pri vseh velikostih pakiranj različnih jakosti (40 g, 100 g in 200 g).
• the CVMP considered the recommended dose and inclusion rates in feed for pre-mixes for medicated feedingstuffs containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits. 
• preučil priporočeni odmerek in stopnje dodajanja v krmo za predmešanice za medicirano krmo, ki vsebujejo 40, 100 ali 200 g tilmikozina na kg predmešanice in se dajejo kuncem;
Amendments in the relevant sections of the Summary of Product Characteristics and labelling 
Dopolnila v ustreznih poglavjih povzetka glavnih značilnosti zdravila in označevanja
Taking into account the information provided, the CVMP considered that the requirement for the dose being in at least half the daily ration was fulfilled, and that the target of 200 ppm of tilmicosin per ton of feed could be achieved with all the pack sizes of the different strengths (40 g, 100 g and 200 g). 
Odbor CVMP je upošteval predložene podatke in menil, da je bila zahteva za odmerek v vsaj polovici dnevnih obrokov izpolnjena ter da se ciljnih 200 ppm tilmikozina na tono krme lahko doseže pri vseh velikostih pakiranj različnih jakosti (40 g, 100 g in 200 g).
Evaluation of the benefit-risk balance 
Ocena razmerja med koristmi in tveganji
INN 
je
With regard to the recommended dose it is agreed that the effective dosage in feed is 12.5 mg per kg BW per day for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in the minor species rabbits. 
Glede na priporočeni odmerek je dogovorjeno, da je za preprečevanje in zdravljenje bolezni dihal pri kuncih manjše vrste, ki jih povzročata Pasteurella multocida in Bordetella bronchiseptica, učinkovit odmerek v krmi 12,5 mg telesne mase na dan v obdobju 7 dni.
1 kg tilmicosin 200 g pre-mix /ton 
1 kg predmešanice, ki vsebuje 200 g tilmikozina/tono
2 kg tilmicosin 100 g pre-mix/ton 
2 kg predmešanice, ki vsebuje 100 g tilmikozina/tono
It is agreed that the effective dosage in feed is 12.5 mg/kg bw/day for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in the minor species rabbits. 
Dogovorjeno je, da je za preprečevanje in zdravljenje bolezni dihal pri kuncih manjše vrste, ki jih povzročata Pasteurella multocida in Bordetella bronchiseptica, učinkovit odmerek v krmi 12,5 mg/kg telesne mase/dan 7 dni.
Amendments in the relevant sections of the Summary of Product Characteristics 
Dopolnila v ustreznih poglavjih povzetka glavnih značilnosti zdravila
QALIAN 
Ciper
• the CVMP considered that the recommended dose in feed is 12.5 mg/kg bw/day for 7 days for rabbits in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica. 
• menil, da je za preprečevanje in zdravljenje bolezni dihal pri kuncih, ki jih povzročata Pasteurella multocida in Bordetella bronchiseptica, priporočeni odmerek v krmi 12,5 mg/kg telesne mase/dan v obdobju 7 dni;
The effective dosage in feed is 12.5 mg/kg bw/day for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in the minor species rabbits. 
Za preprečevanje in zdravljenje bolezni dihal pri kuncih manjše vrste, ki jih povzročata Pasteurella multocida in Bordetella bronchiseptica, je učinkovit odmerek v krmi 12,5 mg/kg telesne mase/dan 7 dni.
Butylated hydroxytoluene 0.08%. 
Butilhidroksitoluen 0,08%.
Stronghold should not enter water courses as this may be dangerous for fish and other aquatic organisms. 
Stronghold ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.
Do not store above 30 °C. 
Shranjujte pri temperaturi pod 30°C.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo,, obvestite svojega veterinarja.
Used applicators should be disposed of immediately and not left within the sight or reach of children. 
Uporabljene aplikatorje je treba takoj odstraniti in ne pustiti na dosegu otrok.
Do not use in animals under 6 weeks of age. 
Zdravila ne uporabljamo pri živalih, mlajših od 6 tednov.
Stronghold was administered at 10 times the recommended dose, and no undesirable effects were observed. 
Stronghold so dajali v desetkratnem priporočenem odmerku in niso opazili nobenih neželenih učinkov.
Date of last renewal: 01/10/2009. 
Datum podaljšanja dovoljenja za promet: 01/10/2009.
A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. 
Priporočamo, da veterinar ponovno pregleda žival 30 dni po prvem zdravljenju, ker je pri nekaterih živalih potreben še drugi odmerek.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimizahtevami.
Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age). 
Zdravila ne uporabljamo pri močno obolelih mačkah, pri mačkah, ki so močno oslabljene ali podhranjene (glede na velikost in starost).
Selamectin paralyses and/or kills a wide range of invertebrate parasites through interference with their chloride channel conductance causing disruption of normal neurotransmission. 
Selamektin povzroča paralizo in/ali pogin širokega spektra parazitov (nevretenčarjev) z oviranjem prevodnosti kloridnih kanalov, kar povzroči motnje v normalni nevrotransmisiji.
Do not administer orally or parenterally. 
Zdravila ne dajemo peroralno ali parenteralno.
People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution. 
Osebe z občutljivo kožo ali znano alergijo na tovrstna zdravila za uporabo v veterinarski medicini naj zdravilo dajejo previdno.
Administer Stronghold in accordance with the following table: 
Odmerke zdravila Stronghold določimo po naslednji tabeli:
This product is highly flammable; keep away from heat, sparks, open flames or other sources of ignition. 
Izdelek je lahko vnetljiv, zato ga hranite zaščitenega pred vročino, iskrami, odprtim plamenom ali drugimi vnetljivimi viri.
Avoid direct contact with treated animals until the application site is dry. 
Izogibamo se neposrednemu stiku z zdravljenimi živalmi, dokler območje nanosa ni suho.
On very rare occasions transient focal irritation may also be observed. 
V zelo redkih primerih so opazili tudi prehodno lokalno vzdraženje kože.
Squeeze the pipette firmly to empty the contents in one spot. 
Merilno kapalko dodobra stisnemo, da se vsebina izprazni na enem mestu.
This veterinary medicinal product is not effective against adult D. immitis. 
Zdravilo za uporabo v veterinarski medicini ne učinkuje na odrasle oblike D. immitis.
If accidental eye exposure occurs, flush the eyes immediately with water and seek medical advice immediately and show the package leaflet or the label to the physician. 
Če pride zdravilo pomotoma v oči, jih je treba takoj izpirati z obilo vode in se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Store in the unopened foil package in a dry place. 
Shranjujte v neodprti foliji, v suhem prostoru.
Date of first authorisation: 25/11/1999. 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 25/11/1999.