natgillin/translations-raw huggingface dataset:
Frequency System Organ Class
Zmanjšanje telesne mase
Roflumilast
Roflumilast in roflumilast
Immune system disorders
Organski sistemi
This means that it was intended to be similar to a biological medicine (the ‘reference medicine') already authorised in the European Union (EU).
To pomeni, da je podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
It can request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
V roku 15 dni od prejema uradnega obvestila o negativnem mnenju lahko zahteva ponovno presojo mnenja.
The company that applied for authorisation is Marvel Lifesciences Ltd.
Družba, ki je zaprosila za dovoljenje, je Marvel Lifesciences Ltd.
Two additional studies in patients with type 1 and type 2 diabetes compared the safety and effectiveness of Solumarv and Humulin S.
Dve dodatni študiji pri bolnikih s sladkorno boleznijo tipa 1 in tipa 2 sta primerjali varnost in učinkovitost zdravil Solumarv in Humulin S.
On 19 November 2015, the Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorisation for the medicinal product Solumarv, intended for the treatment of diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je 19. novembra 2015 priporočil zavrnitev dovoljenja za promet z zdravilom Solumarv, namenjenim zdravljenju sladkorne bolezni.
The company informed the CHMP that there are no clinical trials or compassionate use programmes affected by the Committee's opinion.
Družba je CHMP obvestila, da ni nobenih kliničnih preizkušanj ali programov sočutne uporabe, na katere bi lahko vplivalo mnenje odbora.
Diabetes is a condition in which the body does not produce enough insulin to control the level of blood sugar or in which the body is unable to use insulin effectively.
Sladkorna bolezen je bolezen, pri kateri telo ne tvori dovolj insulina za uravnavanje ravni sladkorja v krvi ali pri katerem telo insulina ne more učinkovito izrabiti.
The CHMP's main concern was that the company did not define the manufacturing process for Solumarv in sufficient detail.
Glavni zadržek CHMP je bil, da družba ni dovolj podrobno opredelila proizvodnega postopka za zdravilo Solumarv.
The company presented results of studies in healthy people designed to show that Solumarv is similar to its reference medicine Humulin S in terms of biological activity and how the body handles the medicine.
Družba je predstavila rezultate študij pri zdravih ljudeh, ki naj bi pokazale, da je zdravilo Solumarv podobno referenčnemu zdravilu Humulin S v smislu biološke aktivnosti in načina, na katerega telo presnavlja zdravilo.
It was to be available as a solution for injection.
Na voljo je v obliki raztopine za injiciranje.
Solumarv was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels.
Zdravilo Solumarv naj bi se uporabljalo za zdravljenje bolnikov s sladkorno boleznijo, ki za nadzor ravni sladkorja v krvi potrebujejo insulin.
As such, it was not possible to show that Solumarv used in clinical studies was representative of batches intended for the market and that its quality was comparable to Humulin S's.
Tako ni bilo mogoče dokazati, da je bilo zdravilo Solumarv, ki je bilo uporabljeno v kliničnih študijah, reprezentativno za serije, namenjene za promet, in da je bila njegova kvaliteta primerljiva z zdravilom Humulin S.
The reference medicine for Solumarv in this application was Humulin S.
Referenčno zdravilo za Solumarv v tej vlogi je bilo zdravilo Humulin S.
Refusal of the marketing authorisation for Solumarv (insulin human) EMA/765377/2015
Zavrnitev vloge za dovoljenje za promet z zdravilom Solumarv (humani insulin) EMA/861021/2015
The CHMP concluded that Solumarv could not be approved as a biosimilar of Humulin S and recommended that it be refused marketing authorisation.
CHMP je zaključil, da zdravila Solumarv ni mogoče odobriti kot biološko podobnega zdravilu Humulin S, in priporočil, da se dovoljenje za promet zavrne.
Refusal of the marketing authorisation for Solumarv (insulin human)
Zavrnitev vloge za dovoljenje za promet z zdravilom Solumarv (humani insulin)
Solumarv is a medicine that contains the active substance human insulin.
Zdravilo Solumarv je zdravilo, ki vsebuje zdravilno učinkovino humani insulin.
Solumarv was intended as a replacement for the insulin made by the body.
Zdravilo Solumarv je bilo predvideno kot nadomestilo za insulin, ki nastaja v telesu.
Solumarv was developed as a biosimilar medicine.
Zdravilo Solumarv je biološko podobno zdravilo.
These differences are also expected to occur in practice;
Te razlike se pričakujejo tudi v praksi;
In this way, 13 formulation groups were established.
Na ta način so sestavili 13 formulacijskih skupin.
The numbering of the formulation groups is arbitrary.
Številčenje formulacijskih skupin je samovoljno.
Formulation Group
Formulacija skupina
Not for use in animals producing milk for human consumption.
Ni za uporabo pri živalih za proizvodnjo mleka za prehrano ljudi.
22,23-Dihydroavermectin B1a
22,23-dihidroavermektin B1a
No suitable data
Ni primernih podatkov
CEVA SANTE ANIMALE Str. Chindiei, nr. 5
Romunija CEVA SANTE ANIMALE Str. Chindiei, nr. 5
The individual withdrawal periods calculated by the CVMP ranged from 21 days to 78 days.
Posamezne karence, ki jih je izračunal CVMP, so znašale od 21 dni do 78 dni.
Ceva-Phylaxia Oltóanyagtermelő Zrt.
Madžarska Ceva-Phylaxia Oltóanyagtermelő Zrt.
Such an effect has been shown in experimental studies performed by a number of different groups (Lo et al., 19853; Wicks et al., 19934; Lifschitz et al. 19995, Lifschitz et al., 20046).
Takšen učinek je v izkustvenih študijah dokazalo več različnih skupin (Lo et al., 19853; Wicks et al., 19934; Lifschitz et al. 19995, Lifschitz et al., 20046).
In fact, a small and pharmacologically insignificant difference in absorbed fraction (e.g. 99.5% versus 99.9%) at a certain time point may imply a significant difference in the amount remaining in the injection site (a factor of 5 in this example).
Dejansko lahko manjša in farmakološko nepomembna razlika v absorbirani frakciji (npr. 99,5 % namesto 99,9 %) na določeni časovni točki povzroči pomembno razliko v količini, ki je preostala na mestu injiciranja (v tem primeru faktor 5).
However, the Committee considered that the use of the alternative approach (first time point below the ADI plus safety span) would insufficiently take account of the substantial amount of data (280 data points) available in this particular case.
Vendar je Odbor ugotovil, da z uporabo alternativnega pristopa (prva časovna točka pod ADI z dodatkom varnostnega razpona) ne bi zadostno upoštevali velike količine podatkov (280 podatkovnih točk), razpoložljivih v tem primeru.
The United Kingdom expressed concerns that the difference in withdrawal periods established across the European Union for the relevant products may present a potential serious risk to human health, and requested the Committee for Medicinal Products for Veterinary Use (CVMP) to give its opinion on the matter.
Združeno kraljestvo je izrazilo zadržek, da lahko razlike v karencah, ki veljajo v Evropski uniji za zadevna zdravila, predstavljajo potencialno resno tveganje za človeško zdravje, zato je zaprosilo Odbor za zdravila za uporabo v veterinarski medicini (CVMP), naj poda svoje mnenje glede omenjene zadeve.
From table 1 above, it is clear that for group 1, for which a number of studies was available, the range of calculated withdrawal periods varied considerably (from 21 to >49 days).
Iz preglednice 1 zgoraj je razvidno, da je za skupino 1, za katero je bilo na voljo več študij, razpon izračunanih karenc precej variiral (od 21 do >49 dni).
The studies were well-conducted and comprised a considerable number of slaughter time points.
Študije so bile dobro izvedene in so zajele precej časovnih točk.
PASTEUR - Filiala Filipeşti Str. Principală, nr. 944, Filipeştii de Pădure,
Romunija PASTEUR - Filiala Filipeşti Str. Principală, nr. 944, Filipeştii de Pădure, Jud.
Ivermectin is currently included in Annex I of Council Regulation (EEC) No 2377/90 with MRLs for all food producing species as follows:
Ivermektin je trenutno vključen v Dodatku I Uredbe Sveta (EGS) št. 2377/90, v katerem so določene MRL za vse živalske vrste za proizvodnjo živil, in sicer:
Ivermectin is a broad spectrum endectocide of the avermectin family.
Ivermektin je endektocid širokega spektra iz družine avermektinov.
Number of acceptable residue depletion studies
Število zdravil Število sprejemljivih študij o izločanju ostankov
No suitable data No suitable data No suitable data
Ni primernih podatkov Ni primernih podatkov Ni primernih podatkov
Formulation groups allocated for the 293 products that are the subject of this referral.
Formulacijske skupine za 293 zdravil, ki so vključena v ta napotitveni postopek.
Each group contained products considered to be essentially the same, in formulation terms.
Vsaka skupina je vsebovala zdravila, ki v okviru formulacije veljajo za bistveno enaka.
Based on these MRLs, the daily intake of total residues will represent about 15% of the ADI.
Na podlagi teh MRL bo dnevni vnos skupnih ostankov obsegal približno 15 % ADI.
1 CVMP Note for guidance:
1 Navodila CVMP:
These observations support the view that in the studies provided to the CVMP, sources of variation were present that were more important than formulation effects.
Takšna opažanja podpirajo mnenje, da so bili v študijah, predloženih CVMP, prisotni viri variacije, ki so pomembnejši od učinkov formulacije.
To address this question quality experts examined the qualitative and quantitative composition of all the 293 ivermectin containing products that are the subject of this referral, grouping products that can be considered to be the same or essentially the same.
Da bi odgovorili na to vprašanje, so strokovnjaki za kakovost pregledali kakovostno in količinsko sestavo vseh 293 zdravil, ki vsebujejo ivermektin in so vključena v ta napotitveni postopek, ter združili zdravila, ki jih lahko štejemo za enaka ali bistveno enaka.
It was noted that some of the studies were identical but were submitted by different MAHs.
Ugotovili so, da so nekatere študije identične, vendar so jih predložili različni imetniki dovoljenj za promet z zdravilom.
It was not possible to use the statistical method for the analysis of these pooled data because a number of relevant statistical assumptions were not met.
Statistične metode za analizo teh združenih podatkov ni bilo mogoče uporabiti, ker ni bilo izpolnjenih več pomembnih statističnih predpostavk.
Ivermectin was previously evaluated by the CVMP in order to establish maximum residue limits (MRLs).
CVMP je ivermektin že ovrednotil, da bi določil najvišje mejne vrednosti zaostankov zdravila (MRL).
EMEA website publication,
Objavljeno na spletišču EMEA,
Veterina Polska Sp. Zo.o.
Madžarska Veterina Polska Sp. Zo.o.
Individual withdrawal periods (days) derived from the ivermectin residue studies
Posamezne karence (v dneh), izpeljane iz študij ostankov ivermektina
Marketing Authorisations for injectable veterinary medicinal products containing ivermectin for use in cattle have been granted in all Member States of the European Union via different authorisation procedures (mutual recognition procedures and national procedures) and under various legal bases (full, generic, bibliographic, informed consent).
Dovoljenja za promet z zdravili za injiciranje, ki vsebujejo ivermektin, za uporabo pri govedu so bila odobrena v vseh državah članicah Evropske unije po različnih postopkih odobritve (postopki medsebojnega priznavanja in nacionalni postopki) ter na različnih pravnih podlagah (popolna, generična, bibliografska, privoljenje po pojasnilu).
VETERINA Plus d.o.o.,Dunajska 1000 Ljubljana,
Slovenija VETERINA Plus d.o.o.,Dunajska 51, 1000 Ljubljana,
Overall, from the data examined, the presence of a formulation effect can neither be confirmed nor refuted.
Na splošno na podlagi pregledanih podatkov ni možno potrditi ali zavreči prisotnosti učinka formulacije.
INTERVET ROMANIA S.R.L.
Romunija INTERVET ROMANIA S.R.L.
The table below lists the 13 formulation groups along with the number of products in each group, the number of available studies for each group, and the individual withdrawal periods calculated for the various products for which adequate data were made available.
V spodnji preglednici je navedeno teh 13 formulacijskih skupin s številom zdravil v vsaki skupini, številom razpoložljivih študij za vsako skupino in posameznimi karencami, izračunanimi za različna zdravila, za katera so bili dostopni primerno kakovostni podatki.
On the other hand, there is no scientific rationale to explain why withdrawal periods for formulations that are the same or essentially the same, should be different.
Po drugi strani pa ni znanstvene razlage za razlike med karencami za formulacije, ki so enake ali bistveno enake.
All products containing ivermectin and clorsulon had similar formulations and a number of residue depletion studies were submitted for the clorsulon component of products in this group.
Vsa zdravila, ki vsebujejo ivermektin in klorsulon, so imela podobne formulacije in v tej skupini je bilo predloženih več študij izločanja ostankov za klorsulonsko komponento.
3., 1093 Budapest Hungary
3., 1093 Budapest
Av. Párroco Pablo Diez, 49 - 57 24010 - Leon
Romunija SYVA Av. Párroco Pablo Diez, 49 - 57 24010 - Leon
LIST OF THE NAMES, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, JAKOSTI ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, NAČINOV UPORABE ZDRAVILA, PRIPOROČENIH ODMERKOV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The high level of variation in residue concentrations and depletion profiles seen both within and between formulation groups could easily have masked a formulation effect.
Visoka raven variacije koncentracij ostankov ter profilov izločanja, ki je opazna znotraj formulacijskih skupin in med njimi, lahko enostavno zakrije učinek formulacije.
The procedure involved 293 authorised injectable veterinary medicinal products containing ivermectin (see Annex I).
Postopek je vključeval 293 odobrenih veterinarskih zdravil za injiciranje, ki vsebujejo ivermektin (glejte Dodatek I)
While the precise sources of variation remain unidentified, it is quite likely that the sampling procedure is one important factor; it is difficult to be sure that the area with the highest residue concentration is accurately sampled, in particular for subcutaneous injections.
Čeprav ostajajo točni viri variacije neznani, je verjetno pomemben faktor postopek vzorčenja; težko je zagotoviti, da se natančno odvzame vzorec iz področja z najvišjo koncentracijo zaostankov, zlasti pri podkožnem injiciranju.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF INJECTABLE VETERINARY MEDICINAL PRODUCTS CONTAINING IVERMECTIN
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA VETERINARSKIH ZDRAVIL ZA INJICIRANJE, KI VSEBUJEJO IVERMEKTIN
However, literature data indicate that the formulation can have an impact on the absorption rate of avermectins from the injection sites.
Vendar podatki iz literature kažejo, da lahko formulacija vpliva na hitrost absorpcije avermektinov z mest injiciranja.
BIOWET GORZOW PHARMACEUTICALS COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK
Romunija BIOWET GORZOW PHARMACEUTICALS COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK
The Committee considered that based on the totality of the data, and based on the fact that at and beyond day 49 the intake calculation remains above the ADI for only two animals, a withdrawal period of 49 days would provide a degree of safety comparable to that provided using the statistical approach (and a withdrawal period based on the 95% tolerance limit).
Odbor je menil, da bi na podlagi celotnega nabora podatkov in dejstva, da na 49. dan in po njem izračun vnosa ostane nad ADI le pri dveh živalih, 49-dnevna karenca zagotovila raven varnosti, ki je primerljiva z ravnjo varnosti, izpeljano s statističnim pristopom (in karenco na podlagi 95-odstotne meje tolerance).
All mammalian food producing species
Vse vrste sesalcev za proizvodnjo živil
Since there is no muscle MRL for ivermectin, the ADI-based approach was used for evaluating the total daily intake of residues that may arise from the consumption of tissues of each animal (EMEA/CVMP/542/03-Final)2.
Ker za ivermektin ni MRL v mišičnem tkivu, so pristop na podlagi ADI uporabili za vrednotenje skupnega dnevnega vnosa zaostankov, ki lahko nastane zaradi uporabe tkiv posamezne živali (EMEA/CVMP/542/03-Final)2.
all intake data for ivermectin time (days)
vsi podatki o vnosu za ivermektin čas (v dneh)
Wherever possible the CVMP used the statistical method for calculating the individual withdrawal periods based on single studies, but in line with the CVMP Note for Guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1, where the necessary parameters were not shown to be valid for the statistical analysis, the alternative approach was used for calculating withdrawal periods.
Kjer je bilo mogoče, je CVMP uporabil statistično metodo za izračun posameznih karenc na podlagi posameznih študij, vendar v skladu z Navodili CVMP: pristop k usklajevanju karenc (EMEA/CVMP/036/95)1; kjer se za potrebne parametre ni dokazala veljavnost za statistično analizo, so za izračun karenc uporabili alternativni pristop.
Marketing Authorisation Holder and address
Imetnik dovoljenja za promet z zdravilom in naslov
On a log-scale, the total ivermectin residue intake (µg) for a consumer, calculated from data of each animal (data points), compared with the ADI (µg/person, horizontal line).
Logaritemska vrednost skupnega vnosa zaostankov ivermektina (µg) za potrošnika, izračunana iz podatkov za vsako žival (podatkovne točke), v primerjavi z ADI (µg/osebo, vodoravna črta).
In these studies, different formulations showed different absorption patterns of avermectins (including ivermectin), while all other parameters were the same (such as species, breed, weight, and place of injection).
V teh študijah so različne formulacije pokazale različne vzorce absorpcije avermektinov (vključno z ivermektinom), medtem ko so bili drugi parametri enaki (kot so živalska vrsta, pasma, telesna masa in mesto injiciranja).
From the data available no correlations were found that could explain the difference in depletion profiles or estimated withdrawal periods, and none of the parameters recorded could be identified as a large single source of variation.
V razpoložljivih podatkih niso našli korelacij, ki bi lahko pojasnile razlike v profilih izločanja ali ocenjenih karencah, hkrati pa se noben ugotovljen parameter ni pokazal kot velik in edini vir variacije.
From the overall data submitted by the MAHs and the National Competent Authorities of the Member States only 11 ivermectin residue depletion studies were considered of adequate quality for the purpose of calculating withdrawal periods, as only in these studies the relevant tissues including the injection sites were sampled and analysed.
Od vseh podatkov, ki so jih imetniki dovoljenj za promet z zdravilom predložili nacionalnim pristojnim organom držav članic, je le 11 študij o izločanju ostankov ivermektina bilo primerno kakovostnih za izračun karenc, ker so v teh študijah vzeli vzorce primernih tkiv, vključno z mesti injiciranja, ter jih analizirali.
Considering the totality of the data on clorsulon residue depletion, the statistical method could not be used for calculating the withdrawal periods as the relevant statistical assumptions were not met.
Če upoštevamo celoten nabor podatkov o izločanju zaostankov klorsulona, ni možno uporabiti statistične metode za izračun karenc, saj niso izpolnjene ustrezne statistične predpostavke.
Czech Republic Bioveta a.s., Komenského 212
Romunija Bioveta a.s., Komenského 212
Using the alternative approach and applying safety span of 10% a withdrawal period of 66 days was derived.
Z alternativnim pristopom in uporabo varnostnega faktorja 10 % so izpeljali karenco 66 dni.
Divasa Farmavic Hungaria Ltd. H-6070 Izsák, Kossuth L. u. 60.
Madžarska Divasa Farmavic Hungaria Ltd. H-6070 Izsák, Kossuth L. u. 60.
As a matter of principle with regards to products that have been shown to be bioequivalent, it should be noted that the definition of bioequivalence does not guarantee equal levels of residues at the injection site far beyond the time points where plasma samples were taken.
Upoštevati je treba, da načelno pri zdravilih z dokazano bioekvivalenco definicija bioekvivalence ne zagotavlja enakih ravni zaostankov na mestu injiciranja na časovnih točkah dolgo po odvzemu vzorcev plazme.
• the CVMP assessed the original data provided during this referral and concluded that, based on these data, an impact of formulation on residue depletion could not be demonstrated and that the variability in the data was such that an effect of formulation on residue depletion could have been masked;
• CVMP je ovrednotil izvirne podatke, ki so bili predloženi v tem napotitvenem postopku, ter zaključil, da na podlagi teh podatkov ni možno dokazati vpliva formulacije na izločanje ostankov, ter da je variabilnost podatkov lahko zakrila učinek formulacije na izločanje ostankov;
Bremer Pharma GmbH.
Madžarska Bremer Pharma GmbH.
While the data examined by the CVMP did lead to the calculation of different withdrawal periods for products that are essentially the same, this variability is not considered to reflect product specific effects but is rather a feature of the way the products were used (i.e. the variation results from differences such as animal bodyweight, breed, sex, age, injection volume and sampling procedure).
Čeprav so podatki, ki jih je pregledal CVMP, dali izračune različnih karenc za zdravila, ki so bistveno enaka, velja, da ta variabilnost ne odraža za zdravilo specifičnih učinkov, ampak je posledica načina uporabe zdravil (tj. variacija je posledica razlik v telesni masi živali, pasmi, spolu, starosti, injiciranem volumnu in postopku vzorčenja).
Residue depletion data submitted for the formulation group containing ivermectin and closantel led to a withdrawal period of 36 days for closantel, calculated using the alternative approach and applying a safety span of 30%.
Iz podatkov o izločanju ostankov, predloženih za formulacijsko skupino z ivermektinom in klosantelom, so za klosantel z alternativnim pristopom in uporabo varnostnega faktorja 30 % izračunali karenco 36 dni.
The variability in calculated withdrawal periods reflects the variability in the depletion profiles and particularly the variability in depletion of residues from the injection site.
Variabilnost izračunanih karenc odraža variabilnost profilov izločanja in zlasti variabilnost izločanja zaostankov z mesta injiciranja.
• the CVMP considered that sources of variation linked to the subcutaneous use of ivermectin in cattle are present that lead to different depletion profiles in residue studies, and this variation is of much more importance than any variation that may be caused by formulation differences.
• CVMP je upošteval, da so prisotni viri variacij, povezani s podkožno uporabo ivermektina pri govedu, ki povzročajo različne profile izločanja v študijah ostankov, ter da je ta variacija veliko pomembnejša od vseh variacij, ki so morda posledica razlik v formulacijah.
In cattle injectable veterinary medicinal products containing ivermectin, either as a single active ingredient or in combination with a second active substance, are used against infestations with endoparasites and ectoparasites by administering 200 μg ivermectin/kg bw subcutaneously.
Pri govedu se zdravila za injiciranje, ki vsebujejo ivermektin kot edino zdravilno učinkovino ali v kombinaciji z drugo, uporabljajo za infestacije z endoparaziti in ektoparaziti z dajanjem subkutano 200 μg ivermektina/kg TM.
A key question raised by this referral asks whether there is a formulation effect on residue depletion from tissues and particularly from the injection site.
Ključno vprašanje, zastavljeno v tem napotitvenem postopku, je, ali obstaja učinek formulacije na izločanje ostankov iz tkiv, zlasti iz mesta injiciranja.