natgillin/translations-raw huggingface dataset:
Stomatitis ulcerative, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools Pancreatitis, ischaemic colitis, ulcerative colitis, gingival bleeding
navzea oz. bruhanje, trebušne bolečine, driska, stomatitis, dispepsija ulcerozni stomatitis, bolečine v zgornjem desnem kvadrantu trebuha, glositis, gingivitis, zaprtje, vodeno blato pankreatitis, ishemični kolitis, ulcerozni kolitis, krvavitve iz dlesni periodontalna bolezen NOS, zobna bolezen NOS pigmentacija jezika
Patients with pre-existing cardiac abnormalities
Bolniki z že obstoječimi srčnimi motnjami
EU/1/99/127/024 1 multiple dose vial 6 injection syringes of 1 mL, 6 injection needles and 12 cleansing swabs
EU/1/99/127/024 1 viala z večkratnimi odmerki, 6 (1-mililitrskih) injekcijskih brizg, 6 injekcijskih igel in 12 čistilnih tamponov
1 multiple dose vial, 6 injection syringes with attached needle of 1 mL and 12 cleansing swabs 2 multiple dose vials
1 viala z večkratnimi odmerki, 6 (1-mililitrskih) injekcijskih brizg s pritrjeno iglo in 12 čistilnih tamponov
Cardiomyopathy
Karcinoidni tumor
IntronA 25 million IU/2.5 mL solution for injection or infusion interferon alfa-2b
IntronA 25 milijonov i.e./2,5 ml raztopina za injiciranje ali infundiranje interferon alfa-2b s.c./i.v.
Solution for injection or infusion.
(podkožno) injekcijo.
Relapse patients
Bolniki s ponovitvijo oz. relapsom bolezni
Determine TSH levels if, during the course of IntronA therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Če se pri bolniku med zdravljenjem z zdravilom IntronA pojavijo simptomi, ki kažejo na morebitne motnje delovanja žleze ščitnice, določite koncentracijo TSH.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION OF THE MARKETING AUTHORISATION OF PROCOMVAX PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO DOVOLJENJA ZA PROMET Z ZDRAVILOM PROCOMVAX, KI JIH JE PREDSTAVILA EMEA
As there are currently no reports on increased numbers of Hepatitis B breakthrough cases after PROCOMVAX vaccination, considering that the EU is a low endemic region, no immediate safety signal could be identified by the CHMP.
Ker trenutno ne poročajo o povečanem številu primerov izbruha hepatitisa B po cepljenju s cepivom PROCOMVAX in ob upoštevanju, da je EU nizko endemično območje, CHMP ne vidi nikakršnega
The CHMP also considered the commitments given by the MAH in response to CHMP's requests to meticulously control the performance of PROCOMVAX from now on in a broad array of appropriate clinical trials including all age and risk categories.
Prav tako je CHMP upošteval obljubo imetnika dovoljenja za promet, kot odgovor na prošnjo odbora CHMP, naj od sedaj dalje temeljito preverja delovanje cepiva PROCOMVAX v širokem spektru primernih kliničnih preizkušanj, vključno z vsemi starostnimi kategorijami in kategorijami tveganja.
The CHMP reviewed all the technical and clinical data available for PROCOMVAX extensively.
CHMP je temeljito pregledal vse tehnične in klinične podatke o cepivu PROCOMVAX.
Considering all points raised, including time lines required to fully explore all issues related to low HepB immunogenicity following vaccination with PROCOMVAX and, further to the assessment of the data provided by the MAH, the CHMP concluded that the MA of PROCOMVAX should be varied in accordance with Article 5(2) of Regulation (EC) No 726/2004.
Ob upoštevanju vseh različnih točk, vključno s časovno razporeditvijo, potrebno za pregled vseh vprašanj glede nizke imunogenosti HepB po cepljenju s PROCOMVAX, do ocene podatkov, ki jih je podal imetnik dovoljenja za promet, je CHMP zaključil, da mora biti dovoljenje za promet s cepivom PROCOMVAX spremenjeno v skladu s členom 5(1) Uredbe (ES) št. 726/2004.
• The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component and that following extensive review of the manufacturing process the MAH has identified the current adjuvantation process as a potential root cause for decreased immunogenicity of the HepB vaccine
• CHMP je ugotovil, da je vzrok za zmanjšano imunogenost sestavine HepB, ki jo je izdal imetnik dovoljenja za promet, v spremenljivosti proizvodnega postopka za to sestavino in da je po temeljitem pregledu proizvodnega postopka imetnik dovoljenja za promet ugotovil, da je možni temeljni vzrok za zmanjšano imunogenost sestavine HepB cepiva sedanji pomožni postopek.
The clinical issues were discussed with the MAH at the Vaccine Working Party (VWP) during its February 2006 meeting, while the quality issues were discussed at the February BWP meeting.
Na zasedanju delovne skupine za cepiva (VWP) februarja 2006 je z imetnikom dovoljenja za promet obravnaval klinična vprašanja, medtem ko so vprašanja o kakovosti obravnavali na zasedanju delovne skupine za
In view of the lack of analytical tools to predict immunogenicity in man, the need for regular testing of recombinant HepB batches in clinical trials was considered, in order to ensure consistent high immunogenicity of PROCOMVAX produced in particular according to the new updated/improved process.
Zaradi pomanjkanja analitičnih orodij za napoved imunogenosti pri človeku se je pojavila potreba po rednem testiranju serij rekombinantnega HepB v kliničnih preizkušanjih, z namenom zagotoviti nepretrgano visoko imunogenost cepiva PROCOMVAX, posebej izdelanega v skladu z novim/izboljšanim postopkom.
In addition to the immunogenicity data generated in the past 5 years from clinical trials with the PROCOMVAX data, the acceptable performance of these vaccines are supported from findings of surveillance for hepatitis B cases in the United States and New Zealand and from an analysis of the trend in vaccine failures reported to the MAH safety database.
Poleg podatkov o imunogenosti, zbranih v zadnjih petih letih iz kliničnih preizkušanj s podatki cepiv HBVAXPRO in PROCOMVAX, je sprejemljivo delovanje teh cepiv podprto z ugotovitvami nadzora nad primeri hepatitisa B v ZDA in Novi Zelandiji ter iz analize trenda neuspešnega cepljenja, podanega varnostni podatkovni bazi imetnika dovoljenja za promet.
The CHMP is of the Opinion that the Product Information of PROCOMVAX, should be varied in order to maintain the safe and effective clinical use for the following reasons:
CHMP je mnenja, da morajo biti za ohranjanje varne in učinkovite klinične uporabe podatki o cepivu PROCOMVAX spremenjeni zaradi naslednjih razlogov:
• Considering the data on low immunogenicity available today, the CHMP identified the need for further studies to ensure long-term protection against Hepatitis B with the current vaccine in
• Ob upoštevanju danes dostopnih podatkov o nizki imunogenosti je CHMP, za zagotavljanje dolgoročne zaščite pred hepatitisom B s trenutnim cepivom tudi v prihodnosti, ugotovil potrebo po
The CHMP was requested to give an opinion as to whether the marketing authorisation for Procomvax should be maintained, varied, suspended or withdrawn in the context of an Article 20 of Regulation (EC) No726/2004 procedure.
Evropska komisija je prosila CHMP za mnenje o tem, ali naj dovoljenje za promet za cepivo PROCOMVAX ohrani, spremeni, ukine ali umakne v skladu s postopkom člena 20
Potential remaining risks will be minimised to an acceptable level by the
Bistveno spremenjen SPC bo ostala možna tveganja zmanjšal na
• The CHMP considered that the benefit/risk balance of PROCOMVAX concerning protection against hepatitis B virus infection caused by all known subtypes in all age categories considered at risk of exposure to hepatitis B virus remains favourable.
• CHMP je mnenja, da je razmerje med koristmi in tveganji cepiva PROCOMVAX, glede zaščite pred okužbo z virusom hepatitisa B z vsemi znanimi podtipi virusa pri vseh starostnih skupinah, ki jih ogroža okužba s tem virusom, ugodno.
Following the suspension of Hexavac due to reduced immunogenicity of the Hep B component in the vaccine, the MAH (Sanofi Pasteur MSD) was requested in September 2005 to provide further data and clarification on long-term immunological memory and protection against Hep B viral infection afforded by HBVAXPRO and PROCOMVAX, and the timelines of availability of further data.
Septembra 2005 je bil imetnik dovoljenja za promet (Sanofi Pasteur MSD) po začasnem umiku cepiva Hexavac zaradi zmanjšane imunogenosti sestavine HepB v cepivu, zaprošen za nadaljnje podatke in obrazložitev o dolgoročnem imunološkem spominu ter zaščiti pred virusno okužbo s hepatitisom B, ki jo dajeta HBVAXPRO in PROCOMVAX, ter za časovno razporeditev dostopnosti nadaljnjih
The CHMP requested the MAH to conduct studies regarding neonates, infants, older adults, renal dialysis patients, dose ranging and a booster study with the current formulation and the process upgraded product to further ensure that the vaccine provides a sufficient level of long-term protection against Hepatitis B.
CHMP je prosil imetnika dovoljenja za promet, naj izvede raziskave o novorojenčkih, dojenčkih, starejših odraslih, bolnikih na ledvični dializi, raziskavo z razponom odmerkov in poživitveno raziskavo s trenutnim pripravkom ter s posodobljenim izdelkom, da bi dodatno zagotovila, da cepivo
The CHMP agreed with the MAH on revised product information for all presentations of PROCOMVAX, reflecting advice and suggestions made during the procedure.
CHMP se z imetnikom dovoljenja za promet strinja o spremembah podatkov za vse oblike cepiva HBVAXPRO, v skladu z nasveti in predlogi, ki so se pojavili med postopkom.
The interim outcome of a clinical trial with the ‘process upgraded' recombinant Hepatitis B batches confirms that the immunogenicity of the current PROCOMVAX vaccine is at the historic standard, and provides evidence for a consistent trend to higher GMTs with PROCOMVAX manufactured with the process modification.
Vmesni izid kliničnega preizkušanja serij rekombinantnega hepatitisa, pridobljenih s posodobljenim postopkom B, potrjuje, da je imunogenost trenutnega cepiva PROCOMVAX na standardu izpred nekaj let in kaže nepretrgan trend višanja vrednosti GMT (geometric mean titre) pri cepivu PROCOMVAX, izdelanim s spremenjenim postopkom.
Pending the outcome of the studies, the MAH committed to amend the SPC section 5.1 in order to update this section with the latest results from clinical studies regarding anti-HBs responses in individuals previously vaccinated and not vaccinated with Hepatitis B Vaccine as well as anti-PRP responses.
Imetnik dovoljenja za promet z zdravilom (MAH) se je zavezal, da bo dokler ne bodo znani rezultati študij, dopolnil poglavje 5.1 Povzetka glavnih značilnosti zdravila z najnovejšimi rezultati kliničnih raziskav v zvezi z odzivi anti-HBs pri posameznikih, ki so ali niso bili predhodno cepljeni s cepivom proti hepatitisu B, kakor tudi z odzivi anti-PRP.
As there is no in vitro or in vivo system suitable to predict acceptable immunogenicity in man, it is important to note at this stage that the C3H mouse model suggested by the MAH appears to be able to discriminate between Hepatitis B lots which are acceptable and those who are not.
Ker za napoved imunogenosti pri človeku primeren sistem in vitro ali in vivo ne obstaja, je pomemben podatek to, da model C3H pri miših, ki ga je predlagal imetnik dovoljenja za promet, lahko razloči med sprejemljivimi in nesprejemljivimi pošiljkami hepatitisa B. Ne glede na to bo imel nov predlagan model, ko bo popolnoma odobren in ko bo med kliničnim preizkušanjem zmožen razlikovati serije PROCOMVAX z visokim od tistih z nizkim imunskim odgovorom, le napovedno vrednost.
GROUNDS FOR THE VARIATION OF THE MARKETING AUTHORISATION OF PROCOMVAX
PODLAGA ZA SPREMEMBO DOVOLJENJA ZA PROMET S CEPIVOM PROCOMVAX OB UPOŠTEVANJU NASLEDNJEGA
On 13 February 2006, the European Commission (EC) triggered the procedure under Article 20 of Regulation (EC) No 726/2004, after the CHMP expressed concerns on the low immunogenicity of the HepB component of Procomvax.
Po tem, ko je CHMP izrazil zadržke glede nizke imunogenosti sestavine HepB v cepivu PROCOMVAX, je Evropska Komisija 13. februarja 2006 sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004.
The CHMP has recommended the variation of the Marketing Authorisations for PROCOMVAX in accordance with Article 5(2) of Regulation (EC) No 726/2004.
CHMP je priporočil spremembo dovoljenja za promet s cepivom PROCOMVAX v skladu s členom
The Commission Decision C(2014)5053 was issued on 11 July 2014.
Sklep Komisije C(2014)5053 je bil izdan 11. julija 2014.
Some of the strains might be naturally resistant.
Nekateri sevi so lahko naravno odporni.
This CVMP decision should also be taken into account in the present referral procedure.
Ta sklep odbora CVMP je treba upoštevati tudi v trenutnem napotitvenem postopku.
Add, to all products: 12.
Vsem zdravilom dodajte: 12.
The treatment durations were unclear but were probably of several weeks.
Ni jasno, kako dolgo so zdravljenja trajala, vendar je šlo verjetno za več tednov.
The results are favourable but the treatment was metaphylactic.
Rezultati so ugodni, vendar je bilo zdravljenje metafilaktično.
Following a referral procedure (EMEA/V/A/088)
Z napotitvenim postopkom (EMEA/V/A/088)
This is however difficult to interpret in terms of field efficacy since this study was based on an experimental infection model.
Vendar je to težko razložiti v smislu terenske učinkovitosti, saj je ta študija temeljila na poskusnem modelu okužbe.
Delete, where applicable, any references to systematic/prophylactic use.
Kadar je ustrezno, izbrišite vse sklice na sistematično/profilaktično uporabo.
Bacteria were frequently re-isolated in the treated animals and in the case of E. coli, the reduction in the percentage of positive animals is not statistically significant.
Bakterije so bile v zdravljenih živalih pogosto ponovno izolirane, v primeru E. coli pa zmanjšanje odstotka pozitivnih živali ni bilo statistično pomembno.
Zoetis Portugal Lda.
Portugalska Zoetis Portugal Lda.
Most importantly, these studies are very old (they were conducted in the context of the development and marketing of the combination more than 40 years ago) and the in vitro susceptibility of the B. hyodysenteriae strains is unknown.
Najpomembneje pa je, da so te študije zelo stare (izvedene so bile v okviru razvoja in trženja kombinacije pred več kot 40 leti), in občutljivost sevov B. hyodysenteriae in vitro ni znana.
In those trials, it seems that the treatment is used for prevention in a non-specific manner, maybe even as a growth promoter.
Zdi se, da je zdravljenje v teh preskušanjih uporabljeno za preprečevanje na nespecifičen način, morda celo kot pospeševalec rasti.
Parque Empresarial La Moraleja Alcobendas 28108 Spain
de Europa, 20B Parque Empresarial La Moraleja Alcobendas 28108 Spain
Add, to all products: 4.4 Special warnings for each target species
Vsem zdravilom dodajte: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto
In those bacterial species there is no evidence of an important resistant population or of an evolving resistance status.
Pri teh vrstah bakterij ni dokazov o pomembni odporni populaciji ali o stanju razvijajoče se odpornosti.
Moreover, product use in such conditions is associated with a risk of further resistance selection or co-selection.
Poleg tega je uporaba zdravila v takih pogojih povezana s tveganjem za dodatno selekcijo ali koselekcijo odpornosti.
3, although the two situations are not directly comparable since the MIC values for tylosin are, overall, higher, and the doses used and pharmacokinetics may also differ.
3, čeprav položaja nista neposredno primerljiva, saj so vrednosti MIK za tilozin v splošnem višje, zato se lahko razlikujejo tudi uporabljeni odmerki in farmakokinetika.
In E. coli and Salmonella, based on in vitro data, spectinomycin resistance rates of about 30-50% can be expected.
Pri E. coli in Salmonella je glede na podatke in vitro mogoče pričakovati stopnje odpornosti spektinomicina, ki znašajo od 30 do 50 %.
Thus the overall benefit-risk balance for such product formulations is considered negative.
Zato splošno razmerje med tveganji in koristmi za take formulacije zdravil velja za negativno;
No firm clinical breakpoint could be proposed which would allow the prediction of clinical efficacy in the presence of poorly susceptible isolates, which currently represent the majority of isolates.
Ni bilo mogoče predlagati trdnih kliničnih mejnih vrednosti, ki bi omogočale napovedovanje klinične učinkovitosti v prisotnosti slabo občutljivih izolatov, ki trenutno predstavljajo večino izolatov.
Those data indicate that strains with some level of MIC increase might nevertheless be effectively treated, leading to a favourable clinical outcome.
Ti podatki kažejo, da so sevi, pri katerih je MIK nekoliko povečana, vseeno lahko učinkovito zdravljeni, kar privede do ugodnega kliničnega izida.
In addition, in the study the induced clinical signs can only be considered only as moderate, since no mortality occurred and clinical scores were rather low.
Poleg tega je mogoče sprožene klinične znake v študiji šteti le za zmerne, saj ni prišlo do umrljivosti, klinični rezultati pa so bili precej nizki.
Deletion of target species chickens from the concerned products could increase the use of antimicrobial substances currently considered as even more critical in terms of the consequences of selection of resistance and relevance for public health, such as fluoroquinolones.
Izbris piščancev ciljnih vrst iz zadevnih zdravil lahko poveča uporabo protimikrobnih snovi, ki trenutno veljajo za še bolj kritične v smislu posledic selekcije odpornosti in pomena za javno zdravje, kot so fluorokinoloni.
In addition, some mutations in that area can confer increased MICs to both pleuromutilins and lincosamides.
Poleg tega lahko nekatere mutacije na tem področju povzročijo povečane MIK pri plevromutilinih in linkozamidih.
The associated aetiology of B. hyodysenteriae and its role in pathogenesis is however not fully clear and no bacteriological follow-up has been performed in those studies.
Vendar sorodna etiologija B. hyodysenteriae in njena vloga pri patogenezi ni popolnoma jasna, v teh študijah pa ni bila opravljena nobena bakteriološka kontrola.
From the available information it appears that the resistance rates in the target bacteria are relatively low, and there is no indication of an evolving status.
Iz informacij, ki so na voljo, se zdi, da so stopnje odpornosti pri ciljnih bakterijah sorazmerno nizke, in ni znakov razvijajočega se stanja.
Animals must not be slaughtered for human consumption during treatment.
Živali se med zdravljenjem ne smejo zaklati za prehrano ljudi.
This major uncertainty cannot be addressed until new clinical studies are conducted, under well controlled conditions including proper diagnoses and follow-up of the bacterial pathogens involved and determination of their in vitro susceptibility.
Te glavne negotovosti ni mogoče obravnavati, dokler se ne izvedejo nove klinične študije v dobro nadzorovanih pogojih, vključno s pravilnimi diagnozami, kontrolo vpletenih bakterijskih patogenov in določanjem njihove občutljivosti in vitro.
It is possible that the substances are synergistic, act at different locations (intra- and extracellularly), or act by influencing the concurrent gut flora conditions.
Možno je, da sta snovi sinergijski, da delujeta na različnih lokacijah (znotraj in zunaj celice) ali pa tako, da vplivata na sočasne pogoje v črevesni flori.
Therefore, most available clinical data do not take into account the current status of in vitro susceptibility/resistance of the concerned bacterial species.
Zato večina razpoložljivih kliničnih podatkov ne upošteva trenutnega stanja občutljivosti/odpornosti zadevnih bakterijskih vrst in vitro.
Its added value above the single substances in that context has been demonstrated in old clinical studies, although with limitations at the level of bacteriological inclusion criteria and bacteriological follow-up.
Njena dodana vrednost v primerjavi s posameznimi snovmi v tem okviru je dokazana v starejših kliničnih študijah, čeprav z omejitvami glede meril za stopnjo bakteriološke vključenosti in bakteriološke kontrole.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, and marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in imetnikov dovoljenj za promet z zdravilom v državah članicah
A series of old field studies, which investigated the impact of a systematic treatment on the zootechnical performances of flocks in comparison to a positive control, are also presented.
Predstavljen je bil tudi niz starejših študij, v katerih so preučevali vpliv sistematskega zdravljenja na zootehnične rezultate jat v primerjavi s pozitivno kontrolno skupino.
The indication against swine dysentery caused by B. hyodysenteriae, can no longer be maintained and should be removed.
Indikacije pri prašičji dizenteriji, ki jo povzroča B. hyodysenteriae, ni več mogoče navajati in mora biti odstranjena.
In Campylobacter, variable but possibly high resistance rates were shown against lincomycin; however the situation could be more complex because those bacteria are also considered susceptible to spectinomycin, for which few data are available.
Pri Campylobacter so bile dokazane spremenljive, a potencialno visoke stopnje odpornosti proti linkomicinu; položaj pa je morda bolj zapleten, saj te bakterije veljajo tudi za občutljive na spektinomicin, za katerega obstaja malo podatkov.
For similar reasons, i.e. because of high in vitro resistance rates, in 2014, in the context of a referral procedure (EMEA/V/A/100)
Zaradi podobnih razlogov, tj. zaradi visokih stopenj odpornosti in vitro, je odbor CVMP leta 2014 v okviru napotitvenega postopka (EMEA/V/A/100)
Nevertheless, the available in vitro susceptibility data suggest that the expected benefit is now considerably reduced due to a rapid and widespread MIC increase in B. hyodysenteriae.
Kljub temu razpoložljivi podatki o občutljivosti in vitro kažejo, da je pričakovana korist zdaj zelo zmanjšana zaradi hitrega in zelo razširjenega povečanja MIK pri B. hyodysenteriae.
Although doses are only expressed as levels in water, it can be estimated that the optimal doses range from 75 to 300 mg combined actives/kg bw.
Čeprav so odmerki izraženi le kot vrednosti v vodi, je mogoče oceniti, da optimalni odmerki znašajo od 75 mg do 300 mg kombiniranih zdravilnih učinkovin na kilogram telesne mase.
Data from a pilot challenge study suggest efficacy in case of proliferative enteropathy associated with a colibacillosis outbreak, although the study was not formally designed to investigate efficacy against E. coli.
Podatki iz pilotne provokacijske študije kažejo učinkovitost v primeru proliferativne enteropatije, povezane z izbruhom kolibaciloze, čeprav študija uradno ni bila zasnovana za preučevanje učinkovitosti proti E. coli.
All indications and dosing instructions corresponding to systematic prevention in healthy animals or to fixed antimicrobial levels in the drinking water relate to variable and uncontrolled antimicrobial exposures, should be deleted from the product literature.
Vse indikacije in navodila za odmerjanje, ki ustrezajo sistematičnemu preprečevanju pri zdravih živalih ali nespremenljivim vrednostim protimikrobnih učinkovin v vodi za pitje, povezanimi z spremenljivimi in nenadzorovanimi izpostavljenostmi protimikrobnim učinkovinam, morajo biti izbrisani iz literature o zdravilu.
Delete, where applicable, any references to swine dysentery caused by Brachyspira hyodysenteriae, or to other bacterial species than those specified in the indications.
Kadar je ustrezno, izbrišite vse sklice na prašičjo dizenterijo, ki jo povzroča Brachyspira hyodysenteriae, ali na druge bakterijske vrste, ki niso navedene v indikacijah.
However this has not been validated and it has not been shown that spectinomycin undergoes any metabolism in any species and it appears from PK data that most of the therapeutic dose can be recovered from faeces and urine.
Vendar to ni bilo potrjeno in ni bilo dokazano, da je spektinomicin pri kateri koli vrsti na kakršen koli način presnovljen, iz farmakokinetičnih podatkov pa se zdi, da je mogoče večino terapevtskega odmerka najti v iztrebkih in urinu.