natgillin/translations-raw huggingface dataset:
PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OPTISON 0.19 mg/ml dispersion for injection Perflutren-containing microspheres Intravenous use METHOD OF ADMINISTRATION 
OVOJNINAH NALEPKA NA VIALI IME ZDRAVILA IN POT(I ) UPORABE OPTISON 0,19 mg/ml disperzija za injiciranje mikrosfere s perflutrenom intravenska uporaba POSTOPEK UPORABE
• Dizziness 
• zardevanje,
• Dysgeusia (altered taste) 
• disgevzija (motnje okušanja),
See the package leaflet for further information. 
Dodatne informacije so navedene v navodilu za uporabo.
The contents of the OPTISON vial should be used within 30 minutes after the rubber stopper has been penetrated. 
Po predrtju gumijastega zamaška morate vsebino viale kontrastnega sredstva OPTISON uporabiti v 30 minutah.
Discard any unused portion. 
Neuporabljeno kontrastno sredstvo je treba zavreči.
• Visual disturbances 
• motnje vida.
Common Rare 
Zardevanje pogosti
The product is supplied as 1 vial of 3 ml and 5 vials of 3 ml. 
Kontrastno sredstvo je na voljo v naslednjih velikostih pakiranja: 1 viala po 3 ml in 5 vial po 3 ml. Na trgu ni vseh navedenih pakiranj.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg - The other ingredients are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections. 
- Pomožne snovi so humani albumin, natrijev klorid, N-acetiltriptofan, kaprilna kislina, natrijev hidroksid in voda za injekcije.
Your heart activity and rhythm will be monitored when you get OPTISON. 
Ko boste prejeli kontrastno sredstvo OPTISON, vam bodo spremljali delovanje srca in srčni ritem.
Eosinophilia 
Eozinofilija občasni
• Feeling sick (nausea) 
• občutek toplote, • občutek slabosti (navzea).
Anaphylactic reactions have been associated with the administration of human albumin products. 
Z uporabo pripravkov s humanim albuminom so povezovali anafilaktične reakcije.
As OPTISON consists of microspheres that are stable and small enough for transpulmonary passage, it will also give enhanced echo signals in the left heart cavities. 
Kontrastno sredstvo OPTISON povzroča tudi ojačitve ultrazvočnega signala v votlini levega srca, ker je sestavljeno iz mikrosfer, ki so dovolj obstojne in majhne za transpulmonalni prehod.
• Chest pain 
• bolečine v prsih.
EXPIRY DATE 
Dispnea občasni
MARKETING AUTHORISATION HOLDER GE Healthcare AS 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM GE Healthcare AS
• Paraesthesia (tingling sensations) 
• parestezija (mravljinčenje),
Driving and using machines No effects are known. 
Ni znanih učinkov.
6.1 List of excipients 
6.1 Seznam pomožnih snovi humani albumin natrijev klorid
Visual disturbances 
Bolezni prebavil
• Eosinophilia (increased number of a type of white blood cells in the blood) 
Občasni neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov): • eozinofilija (zvečano število ene od vrst belih krvničk v krvi),
Nervous system disorders 
Ultrazvočno kontrastno sredstvo.
This is considered to represent a pragmatic approach, appropriate in the case of this referral. 
To se šteje za pragmatičen pristop, ustrezen v primeru te napotitve.
The European reference product is Zanil which has been authorised for decades in several Member States of the European Union. 
Evropsko referenčno zdravilo je Zanil, ki je že desetletja odobreno v več državah članicah Evropske unije.
When the products are administered at the recommended doses, the available data supported: 
Če se zdravila dajejo v priporočenih odmerkih, so razpoložljivi podatki podprli:
These withdrawal periods are considered adequate to ensure consumer safety. 
Te karence se štejejo kot ustrezne za zagotovitev varnosti potrošnikov.
Milk: 108 hours (4.5 days). 
Mleko: 108 ur (4,5 dni).
Tissue samples were analysed using a HPLC-MS/MS analytical method. 
Vzorci tkiva so bili analizirani z analitsko metodo HPLC-MS/MS.
Therefore, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC, for the veterinary medicinal products Zanil and associated names, and generic products thereof. 
Tako je Francija 1. septembra 2016 začela postopek v skladu s členom 35 Direktive 2001/82/ES za zdravilo Zanil in povezana imena za uporabo v veterinarski medicini ter njegova generična zdravila.
Fasciola hepatica (common name: liver fluke), is the causative agent of fasciolosis, one of the most economically important helminth diseases of livestock worldwide. 
Fasciola hepatica (splošno ime: veliki metljaj) je povzročitelj fascioloze, ene od gospodarsko najpomembnejših helmintskih bolezni živine na svetu.
Residues on day 21 were considered to be outliers and were excluded from the analysis. 
Ostanki na 21. dan se štejejo za osamelce in so bili izključeni iz analize.
In the first study, a group of cows with very low milk yield was used (11 to 14 L/day) whereas in the second study, the lowest milk yield was 16.8 L/day/animal. 
V prvi študiji je bila uporabljena skupina krav z zelo majhno mlečnostjo (od 11 do 14 l/dan), v drugi študiji pa je bila najmanjša mlečnost 16,8 l/dan/žival.
The 25 cows included in the study were at different stages of lactation with low to high milk yield. 
V študijo je bilo vključenih 25 krav v različnih fazah laktacije z majhno do veliko mlečnostjo.
Recalculated fat data (at 2, 4 and 7 days after administration) were analysed using the EMA statistical software (WT 1.4). 
Preračunane podatke za maščobe (2, 4 in 7 dni po uporabi zdravila) so analizirali z uporabo statističnega programa EMA (WT 1.4).
Where cattle, sheep and/or goats have already been approved as target species the wording below relating to the relevant species should be used: 
Kadar je bila uporaba pri govedu, ovcah in/ali kozah že odobrena, je treba v zvezi z zadevnimi živalskimi vrstami uporabiti spodnje besedilo:
The CVMP considered this figure to represent a worst case scenario as it was derived from a group of animals that included low yielding cows, and that consequently the addition of a safety span was not necessary. 
Odbor CVMP je menil, da ta številka predstavlja najslabši možni scenarij, saj izhaja iz skupine živali, v kateri so bile krave z majhno mlečnostjo, zato dodajanje varnostnega območja ni bilo potrebno.
The first time point at which all milk residues were below the MRL was 108 hours. 
Prva časovna točka, pri kateri so bili vsi ostanki v mleku pod mejno vrednostjo ostankov, je bila 108 ur.
It was acknowledged that extrapolation from one major species to another is not discussed in current CVMP guidelines, that no species-specific half-life for sheep fat is available and that the half-life in cattle fat was calculated on the basis of a limited number of data points. 
Ugotovljeno je bilo, da ekstrapolacija iz ene glavne živalske vrste na drugo v trenutnih smernicah CVMP ni omenjena, da ni razpoložljive vrstno specifične razpolovne dobe za ovčjo maščobo in da je bila razpolovna doba za govedo izračunana na podlagi omejenega števila podatkovnih točk.
This was also the case when the raw data were corrected to take account of single batch accuracy data (which was seen to deviate considerably from the inter-day accuracy). 
To se ni spremenilo tudi, ko so bili neobdelani podatki popravljeni, da bi se upoštevali podatki o natančnosti ene serije (za katero je bilo ugotovljeno, da precej odstopa od natančnosti med dnevi).
Quality, target animal safety, user safety, environmental risk and parasitic resistance for Zanil and associated names, and generic products thereof have not been assessed in this referral procedure. 
Kakovost, varnost za ciljno živalsko vrsto, varnost uporabnikov, tveganje za okolje in odpornost parazitov proti zdravilu Zanil in povezanimi imeni ter generičnim zdravilom niso bili ocenjeni v tem napotitvenem postopku.
Assumptions of log-linearity, homogeneity of variances and normality of residuals were confirmed and a withdrawal period of 12.78 days, was calculated. 
Potrjene so bile domneve o logaritemski linearnosti, homogenosti varianc in normalnosti ostankov ter izračunana je bila karenca 12,78 dni.
For example for cattle meat and offal the approved withdrawal periods ranged from 10 days to 28 days; for cattle milk from zero hours to 108 hours; for sheep meat and offal from 14 days to 28 days; for sheep milk from ‘do not use in sheep producing milk for human consumption' to 7 days. 
Na primer, za meso in organe goveda so odobrene karence znašale od 10 dni do 28 dni; za kravje mleko od 0 do 108 ur; za ovčje meso in organe od 14 dni do 28 dni; za ovčje mleko od „prepovedana uporaba pri ovcah za pridelavo mleka za prehrano ljudi“ do 7 dni.
None of the cows in the medium or high milk yield groups had any samples with residue levels above the MRL (10 μg/kg). 
Nobena od krav v skupini s srednjo ali veliko mlečnostjo ni imela vzorcev z ostanki nad mejno vrednostjo ostankov (10 μg/kg).
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, applicants/marketing authorisation holders in the Member States 
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in predlagateljev/imetnikov dovoljenj za promet z zdravilom v državah članicah
Using the alternative method, a withdrawal period of zero hours could be derived based on the results of this study, as milk samples were sampled every 12 hours, and even at the first time point, residues were seen to be below the MRL. 
Z uporabo alternativne metode je bilo na podlagi rezultatov te študije možno izpeljati karenco 0 ur, saj so vzorce mleka jemali vsakih 12 ur, in celo v prvi časovni točki so bili ostanki pod mejno vrednostjo ostankov.
However all the fat samples from the four treated animals and one of the control animals sacrificed on day 21 had detectable levels of oxyclozanide, with higher values than in the fat samples from days 5, 10 and 15. 
Vendar pa so bile v vseh vzorcih maščob iz štirih zdravljenih živali in eni kontrolni živali, žrtvovani na 21. dan, zaznavne ravni oksiklozanida, pri čemer so bile vrednosti višje v vzorcih maščobe iz 5., 10. in 15. dne.
Overall summary of the scientific evaluation of Zanil and associated names, and generic products thereof (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Zanil in povezanih imen ter njegovih generičnih zdravil (glejte Prilogo I)
While the efficacy of the products in cattle, sheep and goats has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and control of fasciolosis caused by adult flukes (Fasciola spp.). 
Čeprav učinkovitost zdravil pri govedu, ovcah in kozah v okviru te napotitve ni bila natančno ovrednotena, se šteje, da so ocenjevana zdravila učinkovita pri zdravljenju in obvladovanju fascioloze, ki jo povzročajo odrasli metljaji (Fasciola spp.).
Before performing the statistical analysis, the CVMP corrected the raw oxyclozanide residue concentrations reported in the study with the single-batch accuracy instead of inter-day accuracy evaluated in the validation study, because these single-batch accuracies deviate considerably from the inter-day accuracy. 
Pred izvedbo statistične analize je odbor CVMP popravil neobdelane koncentracije ostankov oksiklozanida, navedene v študiji, z natančnostjo ene serije namesto natančnosti med dnevi, ki je bila ocenjena v validacijski študiji, ker natančnosti ene serije precej odstopajo od natančnosti med dnevi.
The highest residues levels (2 µg/kg i.e. 1/5 of the MRL) were observed in one cow at the second milking. 
Najvišje mejne vrednosti ostankov (2 μg/kg tj. 1/5 mejne vrednosti ostankov) so bile ugotovljene pri eni kravi pri drugi molži.
Therefore, the Committee considered that based on the results of this study, a safe withdrawal period of 13 days for cattle meat and offal can be recommended. 
Zato je Odbor menil, da je na podlagi rezultatov te študije mogoče priporočiti varno karenco 13 dni za meso in organe goveda.
Whilst these veterinary medicinal products (the reference product Zanil and its generics Chanil/Rumenil) are oral suspensions, bioequivalent and should have similar withdrawal periods the two residue depletion studies led to substantially different withdrawal periods. 
Čeprav so zdravila za uporabo v veterinarski medicini (referenčno zdravilo Zanil in njegovi generični zdravili Chanil/Rumenil) peroralne suspenzije, biološko enakovredna in bi morala imeti podobne karence, sta študiji o izločanju ostankov privedli do bistveno različnih karenc.
Based on this, considering that in the study with the combination product ‘Nilzan Drench Plus', residues were also measured in the untreated control, the results seen in the ‘Nilzan Drench Plus' study at day 21 were considered to be outliers and excluded from the analysis. 
Na podlagi tega in ob upoštevanju, da so bili v študiji s kombiniranim zdravilom „Nilzan Drench Plus“ ostanki izmerjeni tudi pri nezdravljenih kontrolah, se rezultati na 21. dan v študiji „Nilzan Drench Plus“ štejejo za osamelce in so izključeni iz analize.
Based on the available residue depletion data, the CVMP considered that oxyclozanide residue levels are higher in cows with a low milk yield and that the daily milk yield has more influence on milk residue levels than the animals' body weights. 
Na podlagi razpoložljivih podatkov o izločanju ostankov je odbor CVMP menil, da so ravni ostankov oksiklozanida višje pri kravah z majhno mlečnostjo in da ima mlečnost večji vpliv na ravni ostankov v mleku kot telesna masa živali.
The second study was conducted in 2013 with a generic product containing oxyclozanide 34 mg/ml (marketed under the names Chanil 34 mg/ml oral suspension for cattle and Rumenil 34 mg/ml oral suspension for cattle). 
Druga študija je bila izvedena leta 2013 z generičnim zdravilom, ki vsebuje oksiklozanid 34 mg/ml (ki se trži pod imeni Chanil 34 mg/ml peroralna suspenzija za govedo in Rumenil 34 mg/ml peroralna suspenzija za govedo).
Because the dose increase between cattle and sheep/goat is less than double, one half-life (i.e. approximately 1 day) should be added to the withdrawal period for cattle meat and offal (13 days) to compensate for the difference in dose. 
Ker je povečanje odmerka med govedom in ovcami/kozami manj kot dvojno, je treba karenci za goveje meso in organe (13 dni) dodati eno razpolovno dobo (tj. približno 1 dan), da se nadomesti razlika v odmerku.
Both the immature and mature flukes are harmful to the target species. 
Za ciljne živalske vrste so škodljivi nezreli in zreli metljaji.
Taking into account that Zanil is administered orally and assuming that bioequivalence between Zanil and its generic products is accepted, France considered that it is in the interest of consumer safety to review the adequacy of the withdrawal periods for cattle, sheep and goats and referred the matter to the Committee for Medicinal Products for Veterinary Use (CVMP). 
Ob upoštevanju dejstva, da se zdravilo Zanil daje peroralno in ob predpostavki, da je bila sprejeta biološka enakovrednost med zdravilom Zanil in njegovimi generičnimi zdravili, je Francija menila, da je v interesu varnosti potrošnikov, da se preveri ustreznost karenc za govedo, ovce in koze, zato je zadevo napotila na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
A withdrawal period of 14 days is also supported by the fact that the same figure can be reached by extrapolating from the withdrawal period recommended for cattle, taking the half-life of oxyclozanide in fat into consideration. 
Karenco 14 dni podpira tudi dejstvo, da lahko enako številko dobimo z ekstrapoliranjem karence, priporočene za govedo, z upoštevanjem razpolovne dobe oksiklozanida v maščobi.
The control of liver fluke is achieved primarily by treatment with veterinary medicinal products containing flukicidal substances and is also assisted by appropriate husbandry measures (e.g. not grazing low-lying pastures or wet pastures near ponds and streams). 
Obvladovanje velikega metljaja se doseže predvsem z zdravljenjem z zdravili za uporabo v veterinarski medicini, ki vsebujejo učinkovine proti metljajem, ob uvedbi ustreznih ukrepov pri vzreji (npr. brez paše na nizko ležečih pašnikih ali mokrih pašnikih v bližini ribnikov in potokov).
In the low milk yield group, 3 of 9 cows had residue levels above the MRL. 
V skupini z majhno mlečnostjo so imele tri krave od devetih ostanke nad mejno vrednostjo ostankov.
In order to mitigate for the uncertainty due to the difference in dosage between the species and the different milk yield and fat concentrations in milk from sheep and goats compared to cattle, the CVMP recommends use of a safety factor of 1.5 compared to the recommended cattle milk withdrawal period (108 hours or 4.5 days), resulting in a withdrawal period of 7 days for milk from sheep and goats. 
Da bi ublažili negotovost zaradi razlike v odmerjanju med živalskimi vrstami in različno mlečnostjo ter koncentracijami maščobe v mleku ovac in koz v primerjavi s kravami, odbor CVMP priporoča uporabo varnostnega faktorja 1,5 v primerjavi s priporočeno karenco za kravje mleko (108 ur ali 4,5 dni), kar privede do karence 7 dni za mleko ovac in koz.
According to the CVMP EPMAR for oxyclozanide (EMEA/MRL/889/03-FINAL) the pharmacokinetics and residue depletion data are not significantly different between cattle, sheep and goats. 
V skladu z dokumentom EPMAR odbora CVMP za oksiklozanid (EMEA/MRL/889/03FINAL) se farmakokinetika in podatki o izločanju ostanka ne razlikujejo bistveno med govedom, ovcami in kozami.
None of the statistical methods mentioned in the CVMP note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98)3 could be applied as the requirements described in the guideline were not met. 
Nobene od statističnih metod, navedenih v sporočilu odbora CVMP glede priporočil za določanje karence za mleko (EMEA/CVMP/473/98)3, ni možno uporabiti, saj niso bile izpolnjene zahteve, opisane v smernici.
After treatment the oxyclozanide residues in milk were below the MRL at all milkings. 
Po zdravljenju so bili ostanki oksiklozanida v mleku pod vsemi mejnimi vrednostmi ostankov pri vseh molžah.
Milk residues were assayed using a HPLC-MS/MS analytical method before treatment and at 12 hour intervals up to 72 hours after administration. 
Ostanke v mleku so analizirali z analitsko metodo HPLC-MS/MS pred zdravljenjem in v 12-urnih intervalih do 72 ur po uporabi zdravila.
Milk residues were assayed using a HPLC-MS/MS analytical method before the treatment and at 12 hours intervals up to 168 hours after administration. 
Ostanke v mleku so analizirali z analitsko metodo HPLC-MS/MS pred zdravljenjem in v 12-urnih intervalih do 168 ur po uporabi zdravila.
• the CVMP considered that the overall benefit-risk balance for the products under this procedure remains positive subject to amendments in the product information; the CVMP has recommended variations of the marketing authorisations for veterinary medicinal products Zanil and associated names, and generic products thereof remains positive (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III. 
• odbor CVMP je menil, da splošno razmerje med koristmi in tveganjem za zdravila iz te napotitve ostaja pozitivno, pod pogojem, da se upoštevajo spremembe informacij o zdravilu; odbor CVMP je priporočil spremembe dovoljenj za promet z zdravili za uporabo v veterinarski medicini za zdravilo Zanil in povezana imena ter njegova generična zdravila (glejte Prilogo I), da se spremenijo povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.
The CVMP concluded that for the determination of the withdrawal period, the worst-case scenario must be taken into account, i.e. consideration should be given to residues in low yielding animals. 
Odbor CVMP je sklenil, da je treba za določitev karence upoštevati najslabši scenarij, zato je treba upoštevati ostanke pri živalih z majhno mlečnostjo.
The first study was conducted in 2000 with the veterinary medicinal product ‘Zanil Fluke Drench' at the single maximum recommended dose volume of 105 ml of product per animal and in accordance with the VICH Guideline 482. 
Prva študija je bila izvedena leta 2000 z zdravilom za uporabo v veterinarski medicini „Zanil Fluke Drench“ z največjim priporočenim odmerkom 105 ml zdravila na žival in v skladu s smernico VICH 482.
In these 3 cows the maximum levels were 11.4, 20.26 and 23.2 µg/kg at 24 and 48 hours after administration and residue levels decreased to below the MRL by the 6th, 7th or 8th milking after administration, although the last 
Pri teh treh kravah so bile največje vrednosti 11,4, 20,26, 23,2 µg/kg po 24 oz. 48 urah po dajanju,
The study was conducted in 2000 with sixteen treated animals (8 males and 8 females) and a control group consisting of four untreated animals (two males and two females). 
Študija je bila izvedena leta 2000 na šestnajstih zdravljenih živalih (8 samcih in 8 samicah) in kontrolni skupini, sestavljeni iz štirih nezdravljenih živali (2 samca in 2 samici).
2 VICH topic GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) - link sample presented a level of 10.09 µg/kg, close to the MRL (of 10 µg/kg) at the 8th milking after administration. 
2 VICH topic GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) - link nato so se ravni ostankov znižale pod mejno vrednost ostankov po 6., 7. ali 8. molži po dajanju zdravila, čeprav je imel zadnji vzorec raven 10,09 µg/kg, blizu mejne vrednosti ostankov (10 µg/kg) pri 8. molži po dajanju zdravila.
Oral suspension Cattle, sheep, goats 
govedo, ovce, koze
Therefore, based on the pharmacokinetic similarities between sheep and other ruminants the withdrawal period of 14 days recommended for sheep meat and offal can also be applied for goat meat and offal. 
Zato se na podlagi farmakokinetičnih podobnosti med ovcami in drugimi prežvekovalci lahko tudi za kozje meso in organe uporablja 14-dnevna karenca, priporočena za ovčje meso in organe.
A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Nilzan Drench Plus', a combination product containing oxyclozanide (3.1% w/v) and levamisole (1.5% w/v). 
Predložena je bila študija o izločanju ostankov pri ovcah za veterinarsko zdravilo „Nilzan Drench Plus“, kombinirano zdravilo, ki vsebuje oksiklozanid (3,1 % m/v) in levamisol (1,5 % m/v).
A risk of residue levels exceeding the MRLs after some of the approved withdrawal periods was identified based on the milk, meat and offal residue depletion data provided. 
Tveganje, da ravni ostankov presežejo mejne vrednosti ostankov po odobrenih karencah, je bilo ugotovljeno na podlagi podatkov o izločanju ostankov iz mleka, mesa in organov.
The product was administered to 22 cows at the single maximum recommended dose volume of 105 ml of product per animal and in accordance with the VICH Guideline 48. 
Zdravilo so dajali 22 kravam z enkratnim največjim priporočenim volumnom odmerjanja 105 ml zdravila na žival in v skladu s smernico VICH 48.
Therefore, the Committee considered that based on the available data, a safe withdrawal period of 108 hours (4.5 days) for cattle milk could be derived. 
Zato je odbor menil, da bi na podlagi razpoložljivih podatkov lahko izpeljali varno karenco za kravje mleko 108 ur (4,5 dni).