FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptomatic hypotension, especially after the first dose of Telmisartan Teva Pharma, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Slovenian: Pri bolnikih z zmanjšanim volumnom krvi in/ali zmanjšano količino natrija zaradi intenzivnega diuretičnega zdravljenja, omejitve količine soli v hrani, driske ali bruhanja, se zlasti po prvem odmerku zdravila
English: Telmisartan
Slovenian: tahikardija
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Slovenian: Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno hipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
English: Telmisartan Teva Pharma contains sodium
Slovenian: Zdravilo Telmisartan Teva Pharma vsebuje natrij
English: Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis
Slovenian: okužba sečil, tudi cistitis, okužba zgornjih dihal,
English: Telmisartan Teva Pharma 40 mg tablets telmisartan
Slovenian: Telmisartan Teva Pharma 40 mg tablete telmisartan
English: Telmisartan Teva Pharma 80 mg tablets
Slovenian: Telmisartan Teva Pharma 80 mg tablete
English: Telmisartan Teva Pharma 20 mg tablets
Slovenian: Telmisartan Teva Pharma 20 mg tablete
English: Telmisartan Teva Pharma 20 mg tablets telmisartan
Slovenian: Telmisartan Teva Pharma 20 mg tablete telmisartan
English: Telmisartan Teva Pharma 80 mg tablets telmisartan
Slovenian: Telmisartan Teva Pharma 80 mg tablete telmisartan
English: (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Slovenian: bolečina v kitah, simptomi oslabelosti, gripi podobna bolezen, znižan hemoglobin (krvna beljakovina), zvišana raven sečne kisline, zvišana raven jetrnih encimov ali kreatin fosfokinaze v krvi.
English: Pharma.
Slovenian: Тел.
English: There is no experience regarding the administration of Telmisartan Teva Pharma in patients with recent kidney transplantation.
Slovenian: Pri bolnikih z nedavno presajeno ledvico ni izkušenj z uporabo zdravila Telmisartan Teva Pharma.
English: Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan.
Slovenian: Ena tableta zdravila Telmisartan Teva Pharma vsebuje 40 mg telmisartana.
English: Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.
Slovenian: Ena tableta zdravila Telmisartan Teva Pharma vsebuje 20 mg telmisartana.
English: Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan.
Slovenian: Ena tableta zdravila Telmisartan Teva Pharma vsebuje 80 mg telmisartana.
English: Renal impairment and kidney transplantation
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: Pallagi út 13,
Slovenian: - Navodilo shranite.
English: Arthralgia, pain in extremetis, tendon pain (tendinitis like symptoms)
Slovenian: mialgija artralgija,bolečine v okončini, bolečina v kitah
English: EU/1/11/719/041 14x1 tablets EU/1/11/719/042 28x1 tablets EU/1/11/719/043 30x1 tablets EU/1/11/719/044 40x1 tablets EU/1/11/719/045 56x1 tablets EU/1/11/719/046 60x1 tablets EU/1/11/719/047 84x1 tablets EU/1/11/719/048 90x1 tablets EU/1/11/719/049 98x1 tablets EU/1/11/719/050 100x1 tablets
Slovenian: EU/1/11/719/041 14x1 tableta EU/1/11/719/042 28x1 tableta EU/1/11/719/043 30x1 tableta EU/1/11/719/044 40x1 tableta EU/1/11/719/045 56x1 tableta EU/1/11/719/046 60x1 tableta EU/1/11/719/047 84x1 tableta EU/1/11/719/048 90x1 tableta EU/1/11/719/049 98x1 tableta EU/1/11/719/050 100x1 tableta
English: Talk to your doctor before taking Telmisartan Teva Pharma: - if you are taking digoxin.
Slovenian: - sladkorna bolezen Pred začetkom jemanja zdravila Telmisartan Teva Pharma se posvetujte z zdravnikom:
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Slovenian: izpuščaj, srbež, oteženo dihanje, piskanje, otekanje obraza ali nizek krvni tlak), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), občutek tesnobe, zaspanost, motnje vida, hitro bitje srca (tahikardija), suha usta, želodčne težave, motnje okusa (disgevzija), motnje v delovanju jeter (pri japonskih bolnikih obstaja večja verjetnost pojavljanja teh neželenih učinkov), hitro otekanje kože in sluznice kar lahko privede tudi do smrti (angioedem tudi s smrtnim izidom), ekcem (kožno obolenje), kožna rdečica,
English: EU/1/11/719/001 14x1 tablets EU/1/11/719/002 28x1 tablets EU/1/11/719/003 30x1 tablets EU/1/11/719/004 40x1 tablets EU/1/11/719/005 56x1 tablets EU/1/11/719/006 60x1 tablets EU/1/11/719/007 84x1 tablets EU/1/11/719/008 90x1 tablets EU/1/11/719/009 98x1 tablets EU/1/11/719/010 100x1 tablets
Slovenian: EU/1/11/719/001 14x1 tableta EU/1/11/719/002 28x1 tableta EU/1/11/719/003 30x1 tableta EU/1/11/719/004 40x1 tableta EU/1/11/719/005 56x1 tableta EU/1/11/719/006 60x1 tableta EU/1/11/719/007 84x1 tableta EU/1/11/719/008 90x1 tableta EU/1/11/719/009 98x1 tableta EU/1/11/719/010 100x1 tableta
English: • Risk Management Plan (RMP)
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
English: EU/1/11/719/021 14x1 tablets EU/1/11/719/022 28x1 tablets EU/1/11/719/023 30x1 tablets EU/1/11/719/024 40x1 tablets EU/1/11/719/025 56x1 tablets EU/1/11/719/026 60x1 tablets EU/1/11/719/027 84x1 tablets EU/1/11/719/028 90x1 tablets EU/1/11/719/029 98x1 tablets EU/1/11/719/030 100x1 tablets
Slovenian: EU/1/11/719/021 14x1 tableta EU/1/11/719/022 28x1 tableta EU/1/11/719/023 30x1 tableta EU/1/11/719/024 40x1 tableta EU/1/11/719/025 56x1 tableta EU/1/11/719/026 60x1 tableta EU/1/11/719/027 84x1 tableta EU/1/11/719/028 90x1 tableta EU/1/11/719/029 98x1 tableta EU/1/11/719/030 100x1 tableta
English: EU/1/11/719/031 14x1 tablets EU/1/11/719/032 28x1 tablets EU/1/11/719/033 30x1 tablets EU/1/11/719/034 40x1 tablets EU/1/11/719/035 56x1 tablets EU/1/11/719/036 60x1 tablets EU/1/11/719/037 84x1 tablets EU/1/11/719/038 90x1 tablets EU/1/11/719/039 98x1 tablets EU/1/11/719/040 100x1 tablets EU/1/11/719/061 30 tablets EU/1/11/719/064 28 tablets
Slovenian: EU/1/11/719/031 14x1 tableta EU/1/11/719/032 28x1 tableta EU/1/11/719/033 30x1 tableta EU/1/11/719/034 40x1 tableta EU/1/11/719/035 56x1 tableta EU/1/11/719/036 60x1 tableta EU/1/11/719/037 84x1 tableta EU/1/11/719/038 90x1 tableta EU/1/11/719/039 98x1 tableta EU/1/11/719/040 100x1 tableta EU/1/11/719/061 30 tablet EU/1/11/719/064 28 tablet
English: EU/1/11/719/051 14x1 tablets EU/1/11/719/052 28x1 tablets EU/1/11/719/053 30x1 tablets EU/1/11/719/054 40x1 tablets EU/1/11/719/055 56x1 tablets EU/1/11/719/056 60x1 tablets EU/1/11/719/057 84x1 tablets EU/1/11/719/058 90x1 tablets EU/1/11/719/059 98x1 tablets EU/1/11/719/060 100x1 tablets EU/1/11/719/062 30 tablets EU/1/11/719/065 28 tablets
Slovenian: EU/1/11/719/051 14x1 tableta EU/1/11/719/052 28x1 tableta EU/1/11/719/053 30x1 tableta EU/1/11/719/054 40x1 tableta EU/1/11/719/055 56x1 tableta EU/1/11/719/056 60x1 tableta EU/1/11/719/057 84x1 tableta EU/1/11/719/058 90x1 tableta EU/1/11/719/059 98x1 tableta EU/1/11/719/060 100x1 tableta EU/1/11/719/062 30 tablet EU/1/11/719/065 28 tablet
English: EU/1/11/719/011 14x1 tablets EU/1/11/719/012 28x1 tablets EU/1/11/719/013 30x1 tablets EU/1/11/719/014 40x1 tablets EU/1/11/719/015 56x1 tablets EU/1/11/719/016 60x1 tablets EU/1/11/719/017 84x1 tablets EU/1/11/719/018 90x1 tablets EU/1/11/719/019 98x1 tablets EU/1/11/719/020 100x1 tablets EU/1/11/719/063 28 tablets
Slovenian: EU/1/11/719/011 14x1 tableta EU/1/11/719/012 28x1 tableta EU/1/11/719/013 30x1 tableta EU/1/11/719/014 40x1 tableta EU/1/11/719/015 56x1 tableta EU/1/11/719/016 60x1 tableta EU/1/11/719/017 84x1 tableta EU/1/11/719/018 90x1 tableta EU/1/11/719/019 98x1 tableta EU/1/11/719/020 100x1 tableta EU/1/11/719/063 28 tablet
English: The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassiumsparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Slovenian: zaviralci ACE, antagonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (tudi selektivni zaviralci ciklooksigenaze 2), heparin, imunosupresivi (ciklosporin ali takrolimus) in trimetoprim).
English: • Severe hepatic impairment
Slovenian: • huda jetrna okvara
English: Package leaflet: Information for the user Telmisartan Teva Pharma 20 mg Tablets
Slovenian: Navodilo za uporabo Telmisartan Teva Pharma 20 mg tablete telmisartan
English: Package leaflet: Information for the user Telmisartan Teva Pharma 80 mg Tablets
Slovenian: Navodilo za uporabo Telmisartan Teva Pharma 80 mg tablete telmisartan
English: Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: Številka EU ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja k s
English: Member State (EU/EEA)
Slovenian: Država članica (EU/EEA)
English: For the mutual recognition procedure (MRP), Hungary acted as a reference Member State and Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom were concerned Member States.
Slovenian: Pri postopku z medsebojnim priznavanjem je bila Madžarska referenčna država članica, Avstrija, Belgija, Bolgarija, Hrvaška, Ciper, Češka republika, Estonija, Finska, Nemčija, Grčija, Islandija, Irska, Italija, Latvija, Litva, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Švedska in Združeno kraljestvo pa zadevne države članice.
English: Add the following text in the relevant sections of the product information:
Slovenian: Dodajte naslednje besedilo v ustrezne dele informacij o produktu:
English: Efficacy of the vaccine under practical conditions of use
Slovenian: Učinkovitost cepiva pri praktičnih pogojih uporabe
English: Furthermore, it was confirmed that standardisation of variables was applied.
Slovenian: Poleg tega je potrdil, da je uporabil standardizacijo spremenljivk.
English: Duration of immunity
Slovenian: Trajanje imunosti
English: Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%.
Slovenian: Vrednost p je bila manjša od 0,0001, kar pomeni, da je možnost lažno pozitivne povezave manjša od 0,01 %.
English: Quality and safety were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Slovenian: V tem napotitvenem postopku niso ocenjevali kakovosti in varnosti, saj referenčna država članica ni priglasila nobenega pomisleka.
English: The total quantity is 20 x 109 inactivated germs per dose.
Slovenian: Totalna količina je 20 x 109 inaktiviranih bakterij na odmerek.
English: Having considered all data submitted the CVMP concluded that:
Slovenian: Ob upoštevanju vseh predloženih podatkov je odbor CVMP zaključil naslednje:
English: 17455 ALIMOS Greece
Slovenian: 17455 ALIMOS Grčija
English: 1107 Budapest Hungary
Slovenian: 1107 Budapest Madžarska
English: Furthermore, the formulation of the finished product, either in terms of antigen content or of additional components, was questioned.
Slovenian: Poleg tega je bila vprašljiva formulacija končnega zdravila glede na vsebnost antigena ali dodatnih sestavin.
English: 831 53 Bratislava Slovakia
Slovenian: 831 53 Bratislava Slovaška
English: 40472 Düsseldorf Germany
Slovenian: 40472 Düsseldorf Nemčija
English: ATCvet code: QI09AB07
Slovenian: oznaka ATC vet: QI09AB07
English: Farmacéuticos e Imunológicos, Lda.
Slovenian: Imunológicos, Lda.
English: All the strains express also ApxII.
Slovenian: Vsi sevi izražajo tudi ApxII.
English: Healthier vaccinated pigs are expected to give better growth rates, although this was not demonstrated under field conditions.
Slovenian: Pri bolj zdravih cepljenih prašičih je pričakovati hitrejšo rast, čeprav tega niso dokazali pri pogojih na terenu.
English: Furthermore, the information gathered from Periodic Safety Update Reports was similarly considered to be only supportive and did not substantiate the claims.
Slovenian: Tudi podatki, zbrani med redno posodobljenimi poročili o varnosti zdravila, so bili samo podporni in niso podkrepili trditev.
English: Since the issues raised by Italy remained unresolved, the Member States concerned failed to reach agreement regarding the efficacy of Coglapix and consequently the matter was referred to the CVMP on 24 October 2014 under Article 33(4) of Directive 2001/82/EC.
Slovenian: Ker pa so vprašanja, ki jih je izpostavila Italija, ostala nerazrešena, zadevne države članice niso uspele doseči soglasja v zvezi z učinkovitostjo zdravila Coglapix, zato je bila zadeva dne 24. oktobra 2014 predložena odboru CVMP v skladu s členom 33(4) Direktive 2001/82/ES.
English: 040185 Bucharest Romania
Slovenian: 040185 Bucharest Romunija
English: Special attention was given to the use of a combined analysis using a limited number of animals for sample size and the use of global clinical scores as measure of the primary efficacy parameter.
Slovenian: Posebno pozornost so namenili uporabi kombinirane analize z omejenim številom živali za velikost vzorca in uporabi globalnih kliničnih rezultatov kot merilu za primarni parameter učinkovitosti.
English: The market sales over the past 15 years provided by the MAH were not considered sufficient to support the claims.
Slovenian: Podatki o prodaji na trgu v zadnjih 15 letih, ki jih je predložil imetnik dovoljenja za promet z zdravilom, niso bili zadostni, da bi podprli te trditve.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti veterinarskih medicinskih produktov, vrst živali, poti uporabe, imetnikov dovoljenj za promet z zdravili v državah članicah
English: Six additional laboratory studies were also provided, but these studies were carried out for the marketing authorisation of Coglapix in a country outside the EU and in some elements did not meet the criteria of Ph. Eur.
Slovenian: Predloženih je bilo tudi šest dodatnih laboratorijskih študij, vendar so bile te opravljene za izdajo dovoljenja za promet z zdravilom Coglapix v državi zunaj EU in nekateri njihovi elementi niso izpolnjevali meril monografije Ph.
English: Details of statistics were provided for each serotype in order to support the magnitude of the positive relationship between the two concerned measures.
Slovenian: Podrobnosti statistike je predložil za posamezne serotipe, da bi podprl obsežnost pozitivne povezave med zadevnima meriloma.
English: The reduction of the indication to two clinical parameters required a further demonstration of significance for these two remaining efficacy parameters between vaccinates and controls.
Slovenian: Zmanjšanje indikacije na dva klinična parametra je zahtevalo dodatne dokaze o pomembnosti teh dveh preostalih parametrov učinkovitosti med cepljenimi in kontrolnimi skupinami.
English: Hungary CEVA-Phylaxia Veterinary Biologicals Co. Ltd
Slovenian: Madžarska CEVA-Phylaxia Veterinary Biologicals Co. Ltd
English: These batches had been tested according to the requirements when the product was first authorised in Hungary.
Slovenian: Ti seriji je testiral skladno z zahtevami, ki so veljale ob prvi odobritvi zdravila na Madžarskem.
English: Correlation between the reduction of lung lesions and the reduction of clinical signs
Slovenian: Povezava med zmanjšanjem pljučnih lezij in zmanjšanjem kliničnih znakov
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Slovenian: Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, dogovorjene med postopkom koordinacijske skupine, z naslednjimi spremembami:
English: Romania Ceva Santé Animale Romania
Slovenian: Romunija Ceva Santé Animale Romania
English: Strain NT3 belongs to the serotype 1, expressing ApxI whereas strains SzII, PO, U3 and B4 belong to the serotype 2, expressing ApxIII.
Slovenian: Sev NT3 pripada serotipu 1 in izraža ApxI, medtem ko sevi SzII, PO, U3 in B4 pripadajo serotipu 2 in izražajo ApxIII.
English: Monograph 04/2013:1360, Porcine Actinobacillosis Vaccines (inactivated)).
Slovenian: Monografija 04/2013:1360, Cepiva proti prašičji aktinobacilozi (inaktivirana)).
English: Bulgaria Ceva Animal Health Bulgaria ul.
Slovenian: Bolgarija Ceva Animal Health Bulgaria ul.
English: Based on the data presented in relation to the concerns notified for this referral procedure, the benefitrisk balance is considered to be favourable.
Slovenian: Na podlagi podatkov, predstavljenih v povezavi s pomisleki pri tem napotitvenem postopku, je razmerje med tveganji in koristmi ugodno.
English: Although a positive correlation between the reduction of lung lesions and the reduction of clinical signs as a consequence of the vaccination is predictable, it was not possible to evaluate the magnitude of such a correlation.
Slovenian: Čeprav je pozitivna povezava med zmanjšanjem pljučnih lezij in zmanjšanjem kliničnih znakov, ki je posledica cepljenja, pričakovana, ni bilo mogoče oceniti obsežnosti te povezave.
English: Major issues concerning the complex nature of A. pleuropneumaniae infections, and compliance with the requirements of European Pharmacopoeia was also addressed.
Slovenian: Prav tako je obravnaval velike pomisleke glede kompleksnega značaja okužb z A. pleuropneumaniae in skladnost z zahtevami Evropske farmakopeje.
English: The marketing authorisation holder (MAH), Ceva-Phylaxia Veterinary Biologicals Co. Ltd., submitted an application for mutual recognition of the marketing authorisation granted by Hungary in accordance with Article 32 of Directive 2001/82/EC.
Slovenian: Imetnik dovoljenja za promet z zdravilom, Ceva-Phylaxia Veterinary Biologicals Co. Ltd., je predložil vlogo za medsebojno priznavanje dovoljenja za promet z zdravilom, ki je bilo izdano na Madžarskem, skladno s členom 32 Direktive 2001/82/ES.
English: Field trials have not corroborated the results obtained under laboratory conditions and there were concerns regarding the benefit of the vaccine under practical conditions of use.
Slovenian: Terenska preskušanja niso podprla rezultatov, ki so jih pridobili pri laboratorijskih pogojih, zato so se pojavili pomisleki glede koristi cepiva pri praktičnih pogojih uporabe.
English: The vaccination schedule is 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.
Slovenian: Razpored cepljenja je 2 odmerka, ki se dajeta živalim, starim 7 tednov in več, v presledku 3 tednov med odmerkoma.
English: Product name Strength
Slovenian: Ime produkta Jakost
English: Germany Ceva Tiergesundheit GmbH
Slovenian: Nemčija Ceva Tiergesundheit GmbH
English: The main difference was that the vaccine batch used in these studies had a higher antigen content than the minimum one proposed for the EU market.
Slovenian: Glavna razlika v teh študijah je bila uporaba serije cepiva, ki je imela večjo vsebnost antigena, kot je najmanjša vsebnost, predlagana za trg v EU.
English: However, the MAH clarified that the efficacy in the field has only been partially demonstrated and that lack of relevant information could be reflected in the Summary of Product Characteristics.
Slovenian: Vendar je imetnik dovoljenja za promet z zdravilom pojasnil, da so učinkovitost na terenu dokazali samo delno in da je mogoče pomanjkanje zadevnih podatkov navesti v povzetku glavnih značilnosti zdravila.
English: Efficacy was demonstrated under laboratory but not under field conditions.
Slovenian: Učinkovitost je bila dokazana z laboratorijskimi študijami, a ne na terenu.
English: Pharmacotherapeutic group: Actinobacillus/Haemophilus vaccine.
Slovenian: Farmakoterapevtska skupina: Actinobacillus/Haemophilus cepivo.
English: The vaccine is supplied in multidose containers as a suspension for injection containing an aluminium hydroxide-based adjuvant.
Slovenian: Cepivo je na voljo v vsebnikih z več odmerki suspenzije za injiciranje, ki vsebuje adjuvans na podlagi aluminijevega hidroksida.
English: Regarding the three field studies no significant differences in mortality rate and lung lesion scores were observed between vaccinated and control groups but the level of field challenge from A. pleuropneumoniae in the one significant field study was low.
Slovenian: Pri treh terenskih študijah niso opazili nobenih pomembnih razlik v deležu umrljivosti in rezultatu pljučnih lezij med cepljenimi in kontrolnimi skupinami, vendar pa je bila stopnja terenske provokacije z A. pleuropneumoniae v eni pomembni terenski študiji majhna.
English: During the MRP Italy, as a concerned Member State, considered that Coglapix may present a potential serious risk to animal health.
Slovenian: Med postopkom z medsebojnim priznavanjem je Italija, zadevna država članica, menila, da lahko zdravilo Coglapix predstavlja morebitno resno tveganje za zdravje živali.
English: Furthermore, the MAH was requested to comment on whether the significance (for both serotypes 1 and 2) of the results (concerning the impact on weight gain) shown in two laboratory studies is sufficient to erase the nonsignificance of the results in three ‘non-significant' laboratory studies.
Slovenian: Poleg tega so imetnika dovoljenja za promet z zdravilom zaprosili, naj razloži, ali je pomembnost (za serotipa 1 in 2) rezultatov (glede vpliva na pridobivanje telesne mase), ki so jo pokazali v dveh laboratorijskih študijah, zadostna za izbris nepomembnosti rezultatov iz treh „nepomembnih“ laboratorijskih študij.
English: • This referral was raised due to concerns regarding the overall efficacy of the vaccine.
Slovenian: • Ta napotitveni postopek je bil sprožen zaradi zadržkov v zvezi s splošno učinkovitostjo cepiva.