natgillin/translations-raw huggingface dataset:
What Daliresp is and what it is used for What you need to know before you take Daliresp How to take Daliresp 
Kaj je zdravilo Daliresp in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Daliresp Kako jemati zdravilo Daliresp Možni neželeni učinki
Daliresp is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C). 
Zdravilo Daliresp je kontraindicirano pri bolnikih z zmerno ali hudo okvaro jeter (Child-Pugh B ali C).
Daliresp may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators. 
Zdravilo Daliresp lahko jemljete skupaj z drugimi zdravili za zdravljenje KOPB, kot so inhalacijski ali peroralni bronhodilatatorji.
Rescue medicinal products Daliresp is not indicated as rescue medicinal product for the relief of acute bronchospasms. 
Zdravila za prvo pomoč Zdravilo Daliresp ni indicirano kot zdravilo za prvo pomoč pri zdravljenju akutnih bronhospazmov.
If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended todiscontinue treatment with Daliresp. 
Če bolniki trpijo zaradi novih ali zaradi poslabšanja psihiatričnih simptomov ali če se ugotovi pojav samomorilnih misli ali poskus samomora, je priporočljivo prekiniti zdravljenje z zdravilom Daliresp.
Daliresp will not help you in this situation. 
Zdravilo Daliresp v takšnih primerih ne pomaga.
That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card. 
Da zdravilo Daliresp lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na opozorilno kartico za bolnika.
What Daliresp contains - The active substance is roflumilast. 
Kaj vsebuje zdravilo Daliresp - Zdravilna učinkovina je roflumilast.
Daliresp contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor. 
Zdravilo Daliresp vsebuje zdravilno učinkovino roflumilast, ki je protivnetno zdravilo, imenovano zaviralec fosfodiesteraze 4.
The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g.multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Dalirespshould not be initiated or should be stopped in these patients. 
Pomanjkanje izkušenj pri bolnikih z okužbo HIV ali aktivnim hepatitisom, z resnimi imunološkimi boleznimi (npr. multiplo sklerozo, eritematoznim lupusom, multifokalno leukoencefalopatijo) ali na zdravljenju z imunosupresivnimi zdravili (razen kratkotrajnega zdravljenja s sistemskimi kortikosteroidi) in zdravila Dalirespse pri teh bolnikih ne sme uvajati oz. ga je treba ukiniti.
Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase 4 (PDE4) inhibitory activity. 
Za obe spojini, roflumilast in roflumilast N-oksid, je značilno intrinzično inhibitorno delovanje na fosfodiesterazo 4 (PDE4).
In a pooled analysis of the one-year studies M2-124 and M2-125, roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 48 ml (pre-bronchodilator FEV1, primary endpoint, p<0.0001), and by 55 ml (post-bronchodilator FEV1, p<0.0001). 
V analizi združenih podatkov iz enoletnih študij M28124 in M28125 je roflumilast 500 mikrogramov enkrat na dan pomembno izboljšal pljučno funkcijo v primerjavi s placebom, v povprečju za 48 ml (FEV1 pred bronhodilatatorjem, primarni klinični izid, p < 0,0001) in za 55 ml (FEV1 po bronhodilatatorju, p < 0,0001).
Daliresp is not recommended in patients with a history of depression associated with suicidal thinking or behaviour. 
Zdravilo Daliresp ni priporočljivo za bolnike z anamnezo depresije, ki je bila povezana s samomorilnimi mislimi ali vedenjem.
Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daliresp (see section 4.3). 
Bolniki z zmerno ali hudo okvaro jeter stopnje Child-Pugh B ali C zdravila Daliresp ne smejo jemati (glejte poglavje 4.3).
Warnings and precautions Talk to your doctor or pharmacist before taking Daliresp 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Daliresp se posvetujte z zdravnikom ali s farmacevtom.
Roflumilast is not recommended in women of childbearing potential not using contraception. 
Pri bolnicah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, uporaba zdravila roflumilasta ni priporočljiva.
Analysis 
Analizni model
It is important to continue taking Daliresp for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function. 
Zaradi vzdrževanja normalnega delovanja pljuč je pomembno, da nadaljujete z jemanjem zdravila Daliresp tako dolgo, kot vam je predpisal zdravnik, tudi če nimate simptomov.
3 How to take Daliresp 
Kako jemati zdravilo Daliresp
Thus, roflumilast treatment is not recommended in patients receiving strong cytochrome P450 enzyme inducers. 
Pri bolnikih, ki se zdravijo z močnimi zaviralci encima citokroma P450, uporaba zdravila roflumilasta tako ni priporočljiva.
How to store Daliresp 
Shranjevanje zdravila Daliresp
Daliresp 500 micrograms tablets roflumilast 
Daliresp 500 mikrogramov tablete roflumilast
What Daliresp looks like and contents of the pack Daliresp 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side. 
Daliresp 500 mikrogramov filmsko obložene tablete so rumene barve, v obliki črke D in imajo na eni strani izbočeno črko “D”.
(LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function 
Zdravljenje z zdravilom Daliresp ni priporočljivo, če imate eno ali več naslednjih bolezni: - resne bolezni imunskega sistema, kot so okužba s HIV, multipla skleroza (MS), eritematozni lupus (EL) ali progresivna multifokalna levkoencefalopatija (PML), - resne akutne infekcijske bolezni, kot sta tuberkuloza ali akutni hepatitis, - raka (razen bazalnoceličnega karcinom- počasi napredujoča oblika kožnega raka), - resno okvaro srčne funkcije.
Daliresp contains Lactose 
Zdravilo Daliresp vsebuje laktozo
Daliresp 500 micrograms film-coated tablets Roflumilast 
Daliresp 500 mikrogramov filmsko obložene tablete roflumilast
You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Daliresp. 
V prvih tednih zdravljenja z zdravilom Daliresp boste morda imeli drisko, slabost, bolečine v trebuhu ali glavobol.
Daliresp 500 micrograms film-coated tablets 
Daliresp 500 mikrogramov filmsko obložene tablete
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)