natgillin/translations-raw huggingface dataset:
and 24 cleansing swabs - Pack of 12 vials - Pack of 12 vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs - Pack of 12 vials, 72 injection syringes with attached needle and needle protection device of 
24 čistilnih tamponov - 12 vial - 12 vial, 72 (1-mililitrskih) injekcijskih brizg, 72 injekcijskih igel in 144 čistilnih tamponov - 12 vial, 72 (1-mililitrskih) injekcijskih brizg s pritrjeno iglo ter pripomočkom za zaščito igle in
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
IntronA contains less than 1 mmol sodium (23 mg) per 1 mL, i.e., essentially "sodium-free". 
Zdravilo IntronA vsebuje manj kot 1 mmol (23 mg) natrija na 1 ml, kar v bistvu pomeni "brez natrija".
EU/1/99/127/042 12 multiple dose vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs 
EU/1/99/127/042 12 vial z večkratnimi odmerki, 72 (1-mililitrskih) injekcijskih brizg, 72 injekcijskih igel in 144 čistilnih tamponov
12 multiple dose vial, 72 injection syringes with attached needle of 1 mL and 144 cleansing swabs 
12 vial z večkratnimi odmerki, 72 (1-mililitrskih) injekcijskih brizg s pritrjeno iglo in 144 čistilnih tamponov
and 12 cleansing swabs - Pack of 2 vials - Pack of 2 vials, 12 injection syringes of 1 mL, 12 injection needles and 24 cleansing swabs - Pack of 2 vials, 12 injection syringes with attached needle and needle protection device of 1 mL 
12 čistilnih tamponov - 2 viali - 2 viali, 12 (1-mililitrskih) injekcijskih brizg, 12 injekcijskih igel in 24 čistilnih tamponov - 2 viali, 12 (1-mililitrskih) injekcijskih brizg s pritrjeno iglo ter pripomočkom za zaščito igle in
EU/1/99/127/027 1 multiple dose vial 
EU/1/99/127/027 1 viala z večkratnimi odmerki
Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 1 mL, i.e., essentially "sodiumfree". 
Pomembne informacije o nekaterih sestavinah zdravila IntronA To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 1 ml, kar v bistvu pomeni "brez natrija".
EU/1/99/127/044 12 multiple dose vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs 
EU/1/99/127/044 12 vial z večkratnimi odmerki, 72 (1-mililitrskih) injekcijskih brizg, 72 injekcijskih igel in 144 čistilnih tamponov
irritability, chest pain, malaise Injection site pain Injection site necrosis, face oedema 
§, astenija, razdražljivost, bolečine v prsnem košu, splošno slabo počutje bolečina na mestu injiciranja nekroza na mestu injiciranja, obrazni edem
See ribavirin SPC for ribavirin-related undesirable effects if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C. 
Če boste zdravilo IntronA pri bolnikih s kroničnim hepatitisom C uporabljali v kombinaciji z ribavirinom, si preberite podatke o z ribavirinom povezanih neželenih učinkih v SPC-ju za ribavirin.
Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhea, sneezing 
dispneja, tahipneja, epistaksa, kašelj, zamašen nos, draženje nosne sluznice, izcedek iz nosu, kihanje
Kidney and liver graft rejection 
Zavrnitev ledvičnega in jetrnega presadka
IntronA contains less than 1 mmol sodium (23 mg) per 3 mL, i.e., essentially "sodium-free". 
Zdravilo IntronA vsebuje manj kot 1 mmol (23 mg) natrija na 3 ml, kar v bistvu pomeni "brez natrija".
EU/1/99/127/043 2 multiple dose vials, 12 injection syringes of 1 mL, 12 injection needles and 24 cleansing swabs 
EU/1/99/127/043 2 viali z večkratnimi odmerki, 12 (1-mililitrskih) injekcijskih brizg, 12 injekcijskih igel in 24 čistilnih tamponov
8 IU. 
8 i.e.
Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 mL, i.e., essentially "sodium-free". 
Pomembne informacije o nekaterih sestavinah zdravila IntronA To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 0,5 ml, kar v bistvu pomeni "brez natrija".
EU/1/99/127/016 1 single dose vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab 
EU/1/99/127/016 1 viala z enkratnim odmerkom, 1 (1-mililitrska) injekcijska brizga, 1 injekcijska igla in 1 čistilni tampon
EU/1/99/127/020 1 single dose vial, 1 injection syringe of 2 mL, 1 injection needle and 1 cleansing swab 
EU/1/99/127/020 1 viala z enkratnim odmerkom, 1 (2-mililitrska) injekcijska brizga, 1 injekcijska igla in 1 čistilni tampon
Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 2.5 mL, i.e., essentially "sodium-free". 
Pomembne informacije o nekaterih sestavinah zdravila IntronA To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 2,5 ml, kar v bistvu pomeni "brez natrija".
Pack of 1 vial, 1 injection syringe of 2 mL, 1 injection needle and 1 cleansing swab Pack of 6 vials, 6 injection syringes of 2 mL, 6 injection needles and 6 cleansing swabs Pack of 12 vials, 12 injection syringes of 2 mL, 12 injection needles and 12 cleansing swabs Not all pack sizes may be marketed. 
Zdravilo IntronA je na voljo v štirih različnih pakiranjih: - 1 viala - 1 viala, 1 (2-mililitrska) injekcijska brizga, 1 injekcijska igla in 1 čistilni tampon - 6 vial, 6 (2-mililitrskih) injekcijskih brizg, 6 injekcijskih igel in 6 čistilnih tamponov - 12 vial, 12 (2-mililitrskih) injekcijskih brizg, 12 injekcijskih igel in 12 čistilnih tamponov Na trgu morda ni vseh navedenih pakiranj.
Important information about some of the ingredients of IntronA This medicinal product contains less than 1 mmol sodium (23 mg) per 3 mL, i.e., essentially "sodiumfree". 
Pomembne informacije o nekaterih sestavinah zdravila IntronA To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 3 ml, kar v bistvu pomeni "brez natrija".
EU/1/99/127/028 1 multiple dose vial, 6 injection syringes of 1 mL, 6 injection needles and 12 cleansing swabs 
EU/1/99/127/028 1 viala z večkratnimi odmerki, 6 (1-mililitrskih) injekcijskih brizg, 6 injekcijskih igel in 12 čistilnih tamponov
2 multiple dose vials, 12 injection syringes of 1 mL, 12 injection needles and 24 cleansing swabs 2 multiple dose vials, 12 injection syringes with attached needle and needle protection device of 1 mL and 24 cleansing swabs 
2 viali, 12 (1-mililitrskih) injekcijskih brizg, 12 injekcijskih igel in 24 čistilnih tamponov 2 viali, 12 (1-mililitrskih) injekcijskih brizg s pritrjeno iglo ter pripomočkom za zaščito igle in 24 čistilnih tamponov
Discontinuation of IntronA should be considered in patients who develop new or worsening ophthalmological disorders. 
Pri bolnikih, pri katerih se pojavijo nove oftalmološke motnje ali se obstoječe poslabšajo, premislite o prekinitvi zdravljenja z zdravilom IntronA.
Retinal haemorrhages 
bipolarna motnja
Serous retinal detachment 
Injiciranje raztopine
EU/1/99/127/022 12 single dose vials, 12 injection syringes of 2 mL, 12 injection needles and 12 cleansing swabs 
EU/1/99/127/022 12 vial z enkratnim odmerkom, 12 (2-mililitrskih) injekcijskih brizg, 12 injekcijskih igel in 12 čistilnih tamponov
EU/1/99/127/041 2 multiple dose vials, 12 injection syringes of 1 mL, 12 injection needles and 24 cleansing swabs 
EU/1/99/127/041 2 viali z večkratnimi odmerki, 12 (1-mililitrskih) injekcijskih brizg, 12 injekcijskih igel in 24 čistilnih tamponov
EU/1/99/127/017 6 single dose vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs 
EU/1/99/127/017 6 vial z enkratnim odmerkom, 6 (1-mililitrskih) injekcijskih brizg, 6 injekcijskih igel in 6 čistilnih tamponov
Dizziness, headache, concentration impaired, mouth dry Tremor, paresthesia, hypoesthesia, migraine, flushing, somnolence, taste perversion 
omotica, glavobol, motnje koncentracije, suha usta tremor, parestezije, hipoestezija, migrena, zardevanje, zaspanost, motnje okusa periferna nevropatija možganskožilne krvavitve, možganskožilna ishemija, epileptični napad, motnje zavesti, encefalopatija mononevropatije, koma
EU/1/99/127/014 12 single dose vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs 
EU/1/99/127/014 12 vial z enkratnim odmerkom, 12 (1-mililitrskih) injekcijskih brizg, 12 injekcijskih igel in 12 čistilnih tamponov
EU/1/99/127/013 6 single dose vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs 
EU/1/99/127/013 6 vial z enkratnim odmerkom, 6 (1-mililitrskih) injekcijskih brizg, 6 injekcijskih igel in 6 čistilnih tamponov
EU/1/99/127/018 12 single dose vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs 
EU/1/99/127/018 12 vial z enkratnim odmerkom, 12 (1-mililitrskih) injekcijskih brizg, 12 injekcijskih igel in 12 čistilnih tamponov
EU/1/99/127/021 6 single dose vials, 6 injection syringes of 2 mL, 6 injection needles and 6 cleansing swabs 
EU/1/99/127/021 6 vial z enkratnim odmerkom, 6 (2-mililitrskih) injekcijskih brizg, 6 injekcijskih igel in 6 čistilnih tamponov
IntronA 5 million IU/0.5 mL solution for injection or infusion Interferon alfa-2b 
IntronA 5 milijonov i.e./0,5 ml raztopina za injiciranje ali infundiranje interferon alfa-2b
EU/1/99/127/012 1 single dose vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab 
EU/1/99/127/012 1 viala z enkratnim odmerkom, 1 (1-mililitrska) injekcijska brizga, 1 injekcijska igla in 1 čistilni tampon
Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C. 
Če zdravilo IntronA pri bolnikih s kroničnim hepatitisom C uporabljate v kombinaciji z ribavirinom, glejte tudi SPC za ribavirin.
Leukopaenia 
Dojenje
IntronA 3 million IU/0.5 mL solution for injection or infusion interferon alfa-2b 
IntronA 3 milijoni i.e./0,5 ml raztopina za injiciranje ali infundiranje interferon alfa-2b
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.