natgillin/translations-raw huggingface dataset:
Do not drive, use any tools or machines or carry out any hazardous tasks if you experience side effects, such as confusion, hallucinations, dizziness, tiredness, sleepiness, fainting or blurred vision. 
Če se pri vas pojavijo neželeni učinki, kot so zmedenost, halucinacije, omotica, utrujenost, zaspanost, omedlevica ali zamegljen vid, ne smete upravljati vozil in uporabljati nobenih orodij ali strojev ter opravljati nevarnih opravil.
Potassium supplementation should be given particularly if there is a risk of cardiac arrhythmia or concurrent hypokalaemic medicinal products. 
Dodajanje kalija je potrebno predvsem pri bolnikih s tveganjem za srčno aritmijo in tistih, ki sočasno uporabljajo zdravila, ki znižujejo ravni kalija.
You must tell your doctor immediately if you experience shortness of breath, chest pain or swelling in the arms or legs. 
Če opazite kratko sapo, bolečino v prsnem košu ali otekanje rok ali nog, se takoj posvetujte z zdravnikom.
Neofordex is used to treat adult patients with multiple myeloma, a cancer of the blood affecting the white blood cells that produce antibodies. 
krvnim rakom, ki prizadene bele krvne celice, ki proizvajajo protitelesa.
− Ulcers, perforations and/or bleeding in the oesophagus (gullet), stomach or intestine, inflamed pancreas 
− razjede, predrtje in/ali krvavitve, ki se pojavijo v požiralniku, želodcu ali črevesju, vnetje trebušne slinavke (ki se lahko kaže z bolečino v hrbtu in trebuhu);
Not known: Adrenal atrophy, steroid withdrawal syndrome, adrenal insufficiency, hirsutism, menstrual irregularity. 
Bolezni endokrinega sistema pogosti: Cushingov sindrom; občasni: hipotiroidizem; neznana pogostnost: atrofija nadledvične žleze, odtegnitveni sindrom po prenehanju jemanja steroidov, insuficienca nadledvične žleze, hirzutizem, neredne menstruacije.
Common: Rash, erythema, hyperhidrosis, pruritus, dry skin, alopecia; 
Bolezni kože in podkožja pogosti: izpuščaj, eritem, hiperhidroza, pruritus, suha koža, alopecija; občasni: urtikarija; neznana pogostnost: atrofija kože, akne.
Common: Hypokalaemia, diabetes mellitus, anorexia, increased or decreased appetite, hypoalbuminaemia, fluid retention, hyperuricaemia; 
Presnovne in prehranske motnje zelo pogosti: hiperglikemija; pogosti: hipokaliemija, sladkorna bolezen, neješčnost, povečan ali zmanjšan tek, hipoalbuminemija, zastajanje tekočin, hiperurikemija; občasni: dehidracija, hipokalciemija, hipomagneziemija; neznana pogostnost: zmanjšana toleranca za glukozo, zastajanje natrija, presnovna alkaloza.
Uncommon: Conjunctivitis, increased lacrimation; Not known: Chorioretinopathy, glaucoma. 
Očesne bolezni pogosti: zamegljen vid, katarakta; občasni: konjunktivitis, povečano solzenje; neznana pogostnost: horioretinopatija, glavkom.
Pharmaceutical Form Route of administration 
Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Following the absence of agreement between the Reference Member State (the United Kingdom) and one of the Concerned Member States (Spain) at day 90 of the CMDv procedure, the matter was referred to the CVMP on 2 October 2009. 
Ker ni bilo strinjanja med referenčno državo članico (Združenim kraljestvom) in eno od zadevnih držav članic (Španijo) na 90. dan postopka, je bila zadeva dne 2. oktobra 2009 napotena na CVMP.
Thus, the overall the benefit/risk balance is considered to be positive. 
Tako šteje celokupno razmerje med koristmi in tveganji za pozitivno.
For breeding pigs…” 
Pri prašičih za razplod…“
ADVICE ON CORRECT ADMINISTRATION 
NASVET O PRAVILNI UPORABI
There are both practical reasons as well as clinical advantages to administering these 2 products together which leads to an overall improvement in animal welfare. 
Obstajajo praktični razlogi in klinične prednosti dajanja teh dveh zdravil skupaj, kar vodi do celokupnega izboljšanja stanja živali.
2.3 Potential impact on the efficacy parameter of duration of immunity due to an interference caused by mixing of the two products. 
2.3 Potencialni vpliv na parameter učinkovitosti trajanje imunosti zaradi interference, ki jo povzroči mešanje obeh zdravil.
3) The minimum efficacious titre is 4.0 TCID50 
3) najmanjši učinkovit titer je 4,0 TCID50;
Benefit/Risk assessment 
Ocena koristi in tveganj
Intramuscular injection: 2 ml in the neck. 
Intramuskularno dajanje: 2 ml na vratu.
Given that a lack of interference has been demonstrated at a specific time point the duration of immunity remains the same as originally proven. 
Ker je bilo dokazano pomanjkanje medsebojnih vplivov, ostaja specifična časovna točka trajanja imunosti enaka, kot je bila dokazana na začetku.
Intervet GmbH Siemensstrasse 107 1210 Wien Austria 
Intervet GmbH Siemensstrasse 107 1210 Wien Avstrija
2) The apparent drop over 1 hour from the titre at release (6.4/6.2 TCID50) is 0.12/ 
2) očitno zmanjšanje po 1 uri iz titra ob sprostitvi (6,4/6,2 TCID50) je 0,12/-0,02
Finishing pigs: a single vaccination is sufficient for protection until slaughter. 
Prašiči pitanci: Eno cepljenje zadošča za zaščito do zakola.
To maintain a high and homologous level of immunity, revaccination at regular intervals is recommended, either before each next gestation or at random at 4 month intervals. 
Za ohranitev visoke in homologne ravni imunosti, priporočajo redno revakcinacijo pred vsako naslednjo brejostjo ali v 4-mesečnih razmikih.
It is advised to vaccinate all target pigs within a herd from the earliest recommended age onwards. 
Priporočeno je cepiti vse ciljne prašiče v čredi od najzgodnejše priporočene starosti.
1) The claimed in-use shelf life for the “mixed” product is one hour; 
1) predlagani rok uporabnosti „mešanega“ zdravila je ena ura;
In addition, it was not known whether the studies were performed with batches of vaccines approaching the end of their shelf life. 
Poleg tega ni bilo znano, ali so bile študije izvedene s serijami cepiv, ki so se bližala izteku roka uporabnosti.
Use sterile syringes and needles or clean intradermal equipment. 
Uporabite sterilne brizge in igle ali čisto opremo za intradermalno uporabo.
The solvent includes dl--tocopherol acetate as adjuvant. 
Vehikel vsebuje dl--tokoferol acetat kot adjuvans.
The marketing authorisation holder considers that the reduction of clinical signs is the direct effect of reduction of viraemia. 
Imetnik dovoljenja za promet z zdravilom meni, da je zmanjšanje kliničnih znakov neposreden učinek zmanjšanja viremije.
It should be noted that local and systemic reactions were unremarkable (mild and seen in a small proportion of animals) and consistent with those seen when vaccines were used alone. 
Poudariti je treba, da so bile lokalne in sistemske reakcije nepomembne (blage in opažene le pri majhnem številu živali) in enake kot pri samostojni uporabi cepiv.
The in-use stability of the mixed vaccines has been adequately demonstrated over an in-use period of an hour which is sufficient to vaccinate the number of animals representative of a realistic scenario. 
Stabilnost mešanih cepiv med uporabo je bila ustrezno dokazana v obdobju uporabe ene ure, kar zadošča za cepljenje tolikšnega števila živali, ki je reprezentativno za realistični scenarij.
It should be noted that the general claim to reduce viraemia has only been demonstrated in laboratory studies. 
Treba je poudariti, da je bila splošna zahteva (zmanjšanje viremije) dokazana le v laboratorijskih študijah.
4) this means that in the worst case scenario of a batch at the end of shelf being mixed there will be no statistically significant drop below the minimum titre over the claimed in-use shelf life of 1 hour. 
4) to pomeni, da v najslabšem primeru pri mešanju serije ob izteku roka uporabnosti ni statistično značilnega zmanjšanja pod minimalni titer po predlaganem roku uporabnosti 1 ure.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis. 
Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila odločamo od primera od primera.
It should be borne in mind that PRRS is a multifactorial disease and therefore all clinical signs may not always be seen in laboratory studies (animals kept free from other agents) as in field studies. 
Zavedati se je treba, da je prašičji reprodukcijski in respiratorni sindrom (PRRS) multifaktorska bolezen, zato v laboratorijskih študijah niso vedno vidni vsi klinični znaki (na živali ne vplivajo drugi dejavniki) tako kot v terenskih študijah.
Volume (ml) of diluent needed for 
Potreben volumen (ml) vehilka za
The marketing authorisation holder Intervet International BV submitted a Type II variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the veterinary medicinal product Porcilis PRRS in the framework of Article 6 of Commission Regulation (EC) No 1084/2003. 
Imetnik dovoljenja za promet družba Intervet International BV je predložil vlogo za spremembo tipa II, ki je predmet postopka medsebojnega priznavanja dovoljenj za promet z zdravilom za uporabo v veterinarski medicini Porcilis PRRS v okviru člena 6 Uredbe Komisije (ES) št. 1084/2003.
0.02 (mean 0.05) which is within assay variability; 
(povprečje 0,05), kar je v okviru variabilnosti testa;
Porcilis PRRS is an immunological veterinary medicinal product containing the Porcine Reproductive and Respiratory Syndrome (PRRS) virus. 
Porcilis PRRS je imunološko veterinarsko zdravilo, ki vsebuje virus prašičjega reprodukcijskega in respiratornega sindroma (PRRS).
Pharmaceutical form 
Farmacevtsk a oblika
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PORCILIS PRRS (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA PORCILIS PRRS (GLEJTE DODATEK I)
Intradermal application: 0.2 ml on top or to the left or right side of the neck, or along the muscles of the back, using an intradermal device. 
Intradermalno dajanje: 0,2 ml v zgornji ali stranska predela vratu ali vzdolž hrbtnih mišic z napravo za intradermalno dajanje.
A small, transient, intradermal lump observed after the intradermal application is indicative of the appropriate vaccination technique. 
Majhna in prehodna intradermalna zatrdlina, ki se pojavi po intradermalnem dajanju, je znak pravilne tehnike dajanja cepiva.
Specific claims For finishing pigs, the effect of the virus on the respiratory system is most relevant. 
Posebne navedbe Pri zakolu prašičev je najbolj pomemben učinek virusa na dihalni sistem.
The specific claims for finishing pigs to improve the rearing results have not been demonstrated. 
Specifične navedbe za prašiče, ki se redijo za zakol, glede izboljšanja rezultata pri vzreji niso bile dokazane.
Reduction of viraemia was shown in two laboratory efficacy studies and this was considered sufficient by the marketing authorisation holder for the assessment of the clinical efficacy. 
Zmanjšanje viremije je bilo dokazano v dveh laboratorijskih študijah učinkovitosti, kar je bilo za imetnika dovoljenja za promet dovolj za oceno klinične učinkovitosti.
The CVMP therefore considers that the efficacy of the mixed vaccine regarding the PRRS component has been sufficiently supported. 
CVMP zato meni, da je bila učinkovitost mešanega zdravila glede komponente PRRS zadostno dokazana.
Number of doses per vial intramuscular injection intradermal application 
Število odmerkov v viali intramuskularno dajanje intradermalno dajanje
The guideline on data requirements to support in-use stability claims for veterinary vaccines1, states that “For inactivated vaccines, if the proposed in-use shelf-life is within one working day (maximum 10 hours) it is acceptable to omit the potency testing from the in-use shelf-life stability study.” 
Smernica o zahtevah glede podatkov v podporo zahtevkov po stabilnosti cepiv za uporabo v veterinarski medicini1 med njihovo uporabo , navaja, da je „pri inaktiviranih cepivih v primeru, da je predlagan rok uporabnosti krajši od enega delovnega dne (največ 10 ur), sprejemljivo, da se v študiji stabilnosti roka uporabnosti test jakosti izpusti“.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 
O varnosti in učinkovitosti sočasne uporabe tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicine, razen z zgoraj navedenim, ni podatkov.
However the argumentation provided by the marketing authorisation holder to date raised some concerns that by mixing the products some of the efficacy claims for the monovalent products would not be achieved. 
Vendar pa utemeljitev, ki jo je doslej predložil imetnik dovoljenja za promet z zdravilom, zbuja določene pomisleke, da z mešanjem zdravil nekatere zahteve učinkovitosti monovalentnih zdravil ne bi bile izpolnjene.
After mixing with Porcilis M Hyo: 1 hour (at room temperature) 
Po mešanju s Porcilisom M Hyo: 1 ura (pri sobni temperaturi)
There is no reason to believe that other efficacy parameters would be influenced any differently in the field. 
Iz tega razloga tudi za druge parametre učinkovitosti ni pričakovati, da bi bil v terenskih študijah vpliv nanje drugačen.
The safety of the regimen for the both individual and mixed vaccines has been supported. 
Varnost režima za samostojno dajana in mešana cepiva je podprta.
The National Competent Authority of Spain was concerned that some aspects regarding the quality and the efficacy after mixing the two products (Porcilis PRRS and Porcilis M Hyo) were not adequately justified. 
Nacionalni pristojni organ Španije je izrazil zaskrbljenost, da nekateri vidiki kakovosti, varnosti in učinkovitosti po mešanju obeh zdravil (Porcilis PRRS in Porcilis M Hyo) niso bili ustrezno utemeljeni.
Do not mix with any other veterinary medicinal product, except the diluent supplied with the product or with Porcilis M Hyo. 
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen s priloženim vehihlom ali Porcilisom M Hyo.
In both of them, there was no gain in the average daily weight of the vaccinated animals, even when there were indications that PRRS infection had occurred. 
V nobeni od njiju ni bilo opaziti pridobivanja telesne mase pri cepljenih živalih, tudi če ni bilo znakov o okužbi z PRRS.
This would support an in-use shelf life of one hour, except for the lack of information necessary to properly evaluate the results: the batch release protocols of the batches used and the protocols with the conditions of the assay were not provided. 
To podpira rok uporabnosti po mešanju (ena ura), vendar ni dovolj informacij, ki so potrebne za pravilno ocenitev rezultatov: protokoli za sproščanje serije pri uporabljenih serijah in protokoli s pogoji testa niso bili predloženi.
The amendments of the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III. 
Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so navedene v Dodatku III.
Intervet PortugalSaúde Animal, Lda Rua Agualva dos Açores, n.º 16, 
Portugalska Intervet PortugalSaúde Animal, Lda Rua Agualva dos
In order to ascertain that there is no significant decrease in the titre right after mixing (i.e., at t=0), it was considered important to know the titre at release (or after reconstitution in the diluent fraction of Porcilis PRRS). 
Za zagotovitev, da ni bistvenega zmanjšanja titra neposredno po mešanju (tj. pri času t=0), je bilo bistvenega pomena poznavanje titra ob sprostitvi (ali po rekonstituciji v raztopljeni frakciji zdravila Porcilis PRRS).
Product name 
Lastniško ime
Since the protective immunity against viraemia is not altered by the mixed administration, the marketing authorisation holder considered that all the other efficacy parameters will also not be altered, and therefore, no more data are required in support of the duration of immunity for the mixed administration. 
Ker dajanje mešanega cepiva ne spremeni zaščitne imunosti proti viremiji, je imetnik dovoljenja za promet z zdravilom menil, da tudi noben drug parameter učinkovitosti ne bo spremenjen, zato niso potrebni nadaljnji podatki za podporo trajanja imunosti ob dajanju mešanega cepiva.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 
Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
4.9 Amounts to be administered and administration route Reconstitute the vaccine with the corresponding adjuvating diluent (use only Diluvac Forte). 
4.9 Odmerjanje in pot uporabe Cepivo rekonstituirajte z ustreznim vehiklom (uporabljajte samo Diluvac Forte).
In addition to the above mentioned laboratory studies, the marketing authorisation holder has provided efficacy data for the mixed products of two field studies. 
Poleg omenjenih laboratorijskih študij je imetnik dovoljenja za promet predložil tudi podatke o učinkovitosti iz dveh terenskih študij za mešano zdravilo.
12 months (after storage by the manufacturer at ≤-20°C during maximum 12 months) Diluent: in glass vials 4 years, in PET vials 24 months After reconstitution: 3 hours at room temperature. 
12 mesecev (po shranjevanju pri izdelovalcu pri ≤-20 °C največ 12 mesecev) Vehikel: v steklenih vialah: 4 leta, v vialah iz PET: 24 mesecev Po rekonstituciji: 3 ure pri sobni temperaturi Po mešanju s Porcilisom M Hyo: 1 uro pri sobni temperaturi
As regards why the stability studies were not performed with batches approaching the end of their shelf-life, the marketing authorisation holder has commented that there is no impact on the existing minimum titre proven to be efficacious: 
Na vprašanje, zakaj študije stabilnosti s serijami, ki so se bližale izteku roka uporabnosti, niso bile izvedene, je imetnik dovoljenja za promet z zdravilom odgovoril, da se noben učinek na obstoječi minimalni titer ni izkazal za učinkovitega:
Breeding pigs: For gilts a (re)vaccination 2-4 weeks before mating is recommended. 
Vzrejni prašiči: Pri mladicah priporočajo (re)vakcinacijo 2 do 4 tedne pred parjenjem.
Nevertheless, absence of immunological interference has not been inferred but has been clearly demonstrated by providing laboratory challenge data which showed that there is no significant difference in protection between animals vaccinated with the mixed products and those vaccinated with single products. 
Odsotnost imunološkega medsebojnega vpliva ni bila rezultat sklepanja, temveč je bila jasno dokazana s predloženimi podatki iz dodatne laboratorijske študije, ki so pokazali, da ni bistvene razlike med zaščito živali, ki so bile cepljene z mešanim zdravilom, in živali, ki so prejele samo eno cepivo.
RUE OLIVIER DE SERRES ANGERS TECHNOPOLE 49071 BEAUCOUZE France 
ANGERS TECHNOPOLE 49071 BEAUCOUZE Francija
The efficacy studies using appropriate challenges for Porcilis PRRS and Porcilis M Hyo have shown that there is no affect of simultaneous administration on the efficacy parameters of reduced viraemia and a reduction in lung lesions. 
Študije učinkovitosti, ki so vključevale ustrezne izzive za zdravili Porcilis M Hyo in Porcilis PRRS, so pokazale, da sočasna uporaba ne vpliva na parametra učinkovitosti zmanjšanje viremije in zmanjšanje lezij pljuč.
These can be regarded as demonstrating equivalence of immune response and it would not be expected that if the immune response is not altered at one point in time that the duration of that response will be any different. 
Te študije dokazujejo ekvivalenco imunskega odziva, poleg tega ni pričakovati spremembe trajanje odziva, če se v določeni časovni točki imunski odziv ne spremeni.
In addition, it was considered that potency of the Porcilis M Hyo component after mixing should have been analysed in order to the exclude a quality interference right after mixing (at t=0) and after the proposed in-use shelf life. 
Poleg tega velja, da bi bilo treba analizirati jakost komponente Porcilis M Hyo po mešanju, da bi bilo mogoče izključiti vpliv na kakovost neposredno po mešanju (pri času t=0) in po izteku predlaganega roka uporabnosti mešanice.
The results indicated that there was a limited drop in the PRRS virus titre after mixing with Porcilis M Hyo (average drop after the claimed 1 hour in-use shelf life of 0.05 log). 
Rezultati so pokazali omejeno zmanjšanje titra virusa PRRS po mešanju z zdravilom Porcilis M Hyo (povprečno zmanjšanje po predlaganem roku uporabnosti 1 ure za 0,05 log).
Therefore, the specific claim for finishing pigs of “a significant improvement of rearing results (reduced morbidity due to PRRS infection and a better daily growth and feed conversion) until the end of the fattening period” has not been demonstrated and the efficacy of the mixed product has not been proved. 
Zato posebne navedbe za prašiče za zakol, tj. „ znatno izboljšanje rezultatov pri vzreji (zmanjšana morbidnost, ki jo povzroča okužba z virusom PRRS in boljša dnevna rast in sprememba krme) do konca dobe vzreje“, niso bila prikazane, učinkovitost mešanega zdravila pa ni bila dokazana.
The lyophilised fraction of Porcilis PRRS (containing the live virus antigen) would be reconstituted in the inactivated vaccine Porcilis M Hyo. 
Liofilizirana frakcija zdravila Porcilis PRRS (ki vsebuje antigen živega virusa) bi bila rekonstituirana v inaktiviranem cepivu Porcilis M Hyo.
The live vaccine is composed of a lyophilised fraction, which includes the antigen, and a solvent for suspension for injection. 
Živo cepivo je sestavljeno iz liofilizirane frakcije, ki vsebuje antigen in vehikel za supenzijo za injiciranje.
Pregnant sows should only be vaccinated after previous exposure to European PRRS virus. 
Breje svinje smemo cepiti samo, če so že bile izpostavljene evropskemu virusu PRRS.
Data on two laboratory efficacy studies were provided showing that reduction of PRRS viraemia of pigs vaccinated with the mixed product is similar to the reduction of PRRS viraemia of pigs vaccinated with Porcilis PRRS alone. 
Predloženi so bili podatki iz dveh študij laboratorijske učinkovitostI, ki so pokazali, da je zmanjšanje viremije zaradi PRRS pri prašičih, ki so prejeli mešano cepivo, podobno zmanjšanju viremije zaradi PRRS pri prašičih, ki so prejeli samo cepivo Porcilis PRRS.
The claims of Porcilis PRRS, indications section of SPC (section 4.2) are: “For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus. 
Navedbe za zdravilo Porcilis PRRS, razdelek z navedbami v povzetku glavnih značilnosti zdravila (razdelek 4.2) so: „za aktivno imunizacijo klinično zdravih prašičev v okolju, kjer je prisoten virus PRRS, za zmanjšanje viremije, ki jo povzročajo okužbe z evropskimi sevi virusa PRRS.
The serological response to PRRS vaccination was also found similar in both groups of pigs. 
V obeh skupinah prašičev je bil podoben tudi serološki odziv na cepljenje s PRRS.
The marketing authorisation holder has justified the absence of data demonstrating all efficacy claims for the mixed product. 
Imetnik dovoljenja za promet z zdravilom je utemeljil pomanjkanje podatkov, ki bi dokazovali vse navedbe za mešano zdravilo.
For finishing pigs a single dose is given, which may be administered intradermally or intramuscularly. 
Pri prašičih, ki se redijo za zakol, se daje en odmerek, in sicer intradermalno ali intramuskularno.
The marketing authorisation holder was requested to provide additional data and justification that the efficacy claims and duration of immunity of Porcilis PRRS are not altered when the vaccine is administered mixed with Porcilis M Hyo. 
Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj predloži dodatne podatke in utemeljitev, da se zahteve učinkovitosti in trajanje imunosti za zdravilo Porcilis PRRS ne spremenijo, če se cepivo daje mešano s cepivom Porcilis M Hyo.
Freeze-dried vaccine: 
Cepivo v obliki liofilizata:
2.1 In-use shelf-life proposed after mixing the two products (Porcilis PRRS and Porcilis M Hyo) 
2.1 Predlagani rok uporabnosti po mešanju obeh zdravil (Porcilis PRRS in Porcilis M Hyo)