FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, rosiglitazone was not genotoxic in a battery of in vivo and in vitro genotoxicity studies and there was no evidence of colon tumours in lifetime studies of rosiglitazone in two rodent species.
Slovenian: Poleg tega rosiglitazon v vrsti raziskav genotoksičnosti in vivo ter in vitro ni pokazal genotoksičnosti pri dveh vrstah glodalcev, ki so jih v sklopu raziskav z rosiglitazonom spremljali vse življenje; prav tako niso odkrili nobenih znakov črevesnega raka.
English: No intact drug is excreted in urine or faeces.
Slovenian: Zdravilo se z urinom in blatom ne izloča v nespremenjeni obliki.
English: Rosiglitazone did not stimulate pancreatic insulin secretion or induce hypoglycaemia in rats and mice.
Slovenian: Rosiglitazon pri miših in podganah ni spodbujal izločanja insulina iz trebušne slinavke ali pri njih sprožal hipoglikemije.
English: The tablets are provided in blister packs containing 7, 28, 84, 90 or 112 film-coated tablets.
Slovenian: Tablete so na voljo v pretisnih omotih po 7, 28, 84, 90 ali 112 filmsko obloženih tablet.
English: Rosiglitazone failed to demonstrate non-inferiority to metformin.
Slovenian: Enakovrednosti rosiglitazona metforminu niso dokazali.
English: General disorders and administration site conditions oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije edem
English: Hepatobiliary disorders hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5 Rare
Slovenian: Bolezni jeter, žolčnika in žolčevodov disfunkcija jeter, ki se prvenstveno kaže s povišanjem vrednosti jetrnih encimov5
English: Heart failure was also reported more frequently in patients with a history of heart failure; oedema and heart failure was also reported more frequently in elderly patients and in patients with mild or moderate renal failure.
Slovenian: O pojavu edemov in srčnega popuščanja so pogosteje poročali tudi pri starostnikih in pri bolnikih z blagimi do zmernimi motnjami delovanja ledvic.
English: Since NSAIDs and rosiglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema.
Slovenian: Ker nesteroidna protivnetna zdravila in rosiglitazon povezujejo z zastajanjem tekočine v telesu, lahko sočasno jemanje poveča tveganje nastanka edemov.
English: INFORMATION IN BRAILLE avandia 8 mg
Slovenian: avandia 8 mg
English: Moreover in patients with congestive heart failure NYHA class I-II, a placebo-controlled one-year trial demonstrated worsening or possible worsening of heart failure in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
Slovenian: razred po NYHA) so poslabšanje ali možno poslabšanje srčnega popuščanja ugotovili pri 6,4 % bolnikov, ki so prejemali rosiglitazon in pri 3,5 % bolnikov, ki so prejemali placebo.
English: Avandia contains lactose
Slovenian: Zdravilo Avandia vsebuje laktozo
English: Therefore, liver enzymes should be checked prior to the initiation of therapy with rosiglitazone in all patients and periodically thereafter based on clinical judgement.
Slovenian: Pri bolnikih z zvišanimi vrednostmi jetrnih encimov (ALT > 2,5-krat od zgornje meje normalne vrednosti) so izkušnje z rosiglitazonom omejene, zato je pred pričetkom zdravljenja z rosiglitazonom pri vseh bolnikih potrebno preveriti jetrne encime in jih nato na osnovi klinične presoje preverjati periodično.
English: Uncommon hypoglycaemia
Slovenian: Občasni hipoglikemija
English: 3 In a retrospective analysis of data from 42 pooled short-term clinical studies, the overall incidence of events typically associated with cardiac ischaemia was higher for rosiglitazone containing regimens, 2.00% versus combined active and placebo comparators, 1.53% [hazard ratio (HR) 1.30 (95% confidence interval (CI) 1.004 - 1.69)].
Slovenian: 3 Pri retrospektivni analizi podatkov iz 42 združenih kratkotrajnih kliničnih študij je bila celotna pojavnost dogodkov, tipično povezanih s srčno ishemijo, višja pri režimih zdravljenja z rosiglitazonom (2,00%) kot pri primerjalni kombinaciji učinkovine in placeba (1,53%) [razmerje ogroženosti () 1,30(95 % interval zaupanja (IZ) 1,004-1,69)].
English: • shortness of breath, waking up short of breath at night
Slovenian: Simptomi srčnega popuščanja vključujejo: težko dihanje, prebujanje ponoči zaradi težkega dihanja.
English: Renal insufficiency: There are no clinically significant differences in the pharmacokinetics of rosiglitazone in patients with renal impairment or end stage renal disease on chronic dialysis.
Slovenian: Bolniki z ledvično okvaro: Pri bolnikih z ledvično okvaro ali v zadnjem stadiju ledvične bolezni, ki so kronično na dializi, niso zasledili klinično pomembnih razlik v farmakokinetiki rosiglitazona.
English: INFORMATION IN BRAILLE avandia 4 mg
Slovenian: avandia 4 mg
English: INFORMATION IN BRAILLE avandia 2 mg
Slovenian: avandia 2 mg
English: Rosiglitazone should be used with caution during concomitant administration of CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Slovenian: V primeru sočasnega dajanja zaviralcev CYP2C8 (npr. gemfibrozil) ali induktorjev CYP2C8 (npr. rifampicin) je potrebno rosiglitazon uporabljati previdno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/005-009, EU/1/00/137/014, EU/1/00/137/017
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/137/005-009, EU/1/00/137/014, EU/1/00/137/017
English: The tablets are provided in blister packs containing 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets in a unit dose pack.
Slovenian: Tablete so na voljo v pretisnih omotih po 56, 112, 168 ali 180 filmsko obloženih tablet ali 65 filmsko obloženih tablet v enem vsebniku.
English: EU/1/00/137/016 180 tablets
Slovenian: EU/1/00/137/016 180 tablet
English: Therapy with rosiglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT >2.5X upper limit of normal) or with any other evidence of liver disease.
Slovenian: Pri bolnikih, z zvišanimi osnovnimi vrednostmi jetrnih encimov (ALT > 2,5-krat večji od zgornje meje normalne vrednosti) ali s katerimikoli drugimi znaki jetrnega obolenja, zdravljenja z rosiglitazonom ne smemo uvesti.
English: Symptoms of heart failure include:
Slovenian: Zgodnji simptomi nizkega krvnega sladkorja so:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016
English: Increased monitoring of the patient is recommended if rosiglitazone is used in combination with metformin and insulin.
Slovenian: Bolnike, ki rosiglitazon uporabljajo v kombinaciji z metforminom in insulinom, je treba skrbno nadzirati.
English: If jaundice is observed, drug therapy should be discontinued.
Slovenian: Če dobi bolnik zlatenico, moramo z dajanjem zdravila prenehati.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018
English: EU/1/00/137/013 168 tablets
Slovenian: EU/1/00/137/013 168 tablet
English: Read the package leaflet before use Use only as directed by your doctor
Slovenian: Pred uporabo preberite priloženo navodilo.
English: The incidence of heart failure on triple oral therapy was 1.4% in the main double blind study, compared to 0.4% for metformin plus sulphonylurea dual therapy.
Slovenian: V obsežni dvojno slepi študiji je bila incidenca srčnega popuščanja pri peroralnem zdravljenju s tremi zdravili 1,4 %, pri režimu zdravljenja z dvema zdraviloma (metformin in sulfonilsečnina) pa 0,4 %.
English: Stop taking Avandia.
Slovenian: Ne jemljite zdravila Avandia.
English: Increased monitoring of the patient is recommended and adjustment of the dose of sulphonylurea may be necessary.
Slovenian: Morda bo potrebno prilagoditi odmerek sulfonilsečnine.
English: Always take Avandia tablets exactly as your doctor has told you.
Slovenian: Pri jemanju Avandia tablet natančno upoštevajte zdravnikova navodila.
English: EU/1/00/137/003 112 tablets
Slovenian: EU/1/00/137/003 112 tablet
English: What Avandia contains
Slovenian: Kaj vsebuje zdravilo Avandia
English: Rosiglitazone should therefore not be used in women who are breast-feeding.
Slovenian: Ženske, ki dojijo, naj zato rosiglitazona ne jemljejo.
English: The tablets are provided in blister packs containing 7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets in a unit dose pack.
Slovenian: Tablete so na voljo v pretisnih omotih po 7, 28, 56, 84, 90 ali 112 filmsko obloženih tablet ali 65 filmsko obloženih tablet v enem vsebniku.
English: 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets, unit dose pack.
Slovenian: 56, 112, 168 ali 180 filmsko obloženih tablet v neprozornih pretisnih omotih (PVC/aluminij) ali 56 filmsko obloženih tablet v pakiranju po enoti odmerka.
English: Orange film-coated tablets debossed with “GSK” on one side and "4" on the other side.
Slovenian: Filmsko obložena tableta Oranžne filmsko obložene tablete, označene z “GSK” na eni in “4” na drugi strani.
English: − hepatic impairment
Slovenian: Očesne bolezni
English: Metabolism and nutrition disorders hypercholesterolaemia1 Common Common Common
Slovenian: Presnovne in prehranske motnje hiperholesterolemija1 Pogosti hipertrigliceridemija Pogosti hiperlipemija povečanje telesne mase povečanje apetita
English: EU/1/00/137/002 56 tablets
Slovenian: EU/1/00/137/002 56 tablet
English: Pink film-coated tablets debossed with “GSK” on one side and "2" on the other side.
Slovenian: Filmsko obložena tableta Rožnate filmsko obložene tablete, označene z “GSK” na eni in “2” na drugi strani.
English: In an update to this retrospective analysis that included 10 further studies that met the criteria for inclusion, but were not available at the time of the original analysis, the overall incidence of events typically associated with cardiac ischaemia was not statistically different for rosiglitazone containing regimens, 2.21% versus combined active and placebo comparators, 2.08% [HR 1.098 (95% CI 0.809 - 1.354)].
Slovenian: Ta posodobitev je pokazala, da se celotna incidenca dogodkov, tipično povezanih s srčno ishemijo pri bolnikih, ki so prejemali rosiglitazon (2,21 %) ni statistično značilno razlikovala od incidence pri bolnikih, ki so prejemali primerjalno učinkovino ali placebo (2,08 %) [razmerje ogroženosti 1,098 (95 % IZ 0,809-1,354)].
English: HOW TO STORE AVANDIA
Slovenian: SHRANJEVANJE ZDRAVILA AVANDIA
English: 7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets, unit dose pack.
Slovenian: 7, 28, 56, 84, 90 ali 112 filmsko obloženih tablet v neprozornih pretisnih omotih (PVC/aluminij) ali 56 filmsko obloženih tablet v pakiranju po enoti odmerka.
English: Any unused product should be disposed of in accordance with local requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg film-coated tablets.
Slovenian: IME ZDRAVILA AVANDIA 8 mg filmsko obložene tablete
English: Red-brown film-coated tablets debossed with “GSK” on one side and "8" on the other side.
Slovenian: Filmsko obložena tableta Rdeče-rjave filmsko obložene tablete, označene z “GSK” na eni in “8” na drugi strani.
English: United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Slovenian: Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Slovenian: Po pridobitvi dovoljenja za uporabo rosiglitazona so poleg neželenih učinkov, odkritih med kliničnimi preskušanji poročali še o neželenih učinkih, ki so navedeni v preglednici2.
English: EU/1/00/137/004 56 tablet unit dose pack
Slovenian: EU/1/00/137/004 56 tablet, pakiranje po enoti odmerka
English: GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
Slovenian: Tel: + 371 67312687 lv-epasts@gsk.com
English: Preclinical data
Slovenian: Predklinični podatki
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg film-coated tablets.
Slovenian: IME ZDRAVILA AVANDIA 4 mg filmsko obložene tablete
English: • liver doesn't function as well as it should (increase in liver enzymes).
Slovenian: • oteklina mrežnice na očesnem ozadju (makularni edem) • okvara delovanja jeter (zvišana vrednost jetrnih encimov).
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg film-coated tablets.
Slovenian: IME ZDRAVILA AVANDIA 2 mg filmsko obložene tablete
English: Triple oral therapy
Slovenian: Peroralno zdravljenje s tremi zdravili
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje rosiglitazonijev maleat, ki ustreza 8 mg rosiglitazona.
English: SmithKline Beecham Ltd 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom
Slovenian: SmithKline Beecham Ltd, 980 Great West Road Brentford, Middlesex, TW8 9GS Velika Britanija
English: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Slovenian: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Velika Britanija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje rosiglitazonijev maleat, ki ustreza 4 mg rosiglitazona.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje rosiglitazonijev maleat, ki ustreza 2 mg rosiglitazona.
English: Common Common Common myalgia*
Slovenian: mialgija*
English: New or worse cases of macular oedema have occurred on rare occasions in people taking Avandia and similar medicines.
Slovenian: V redkih primerih so pri bolnikih, ki so se zdravili z zdravilom Avandia in podobnimi zdravili poročali o novem pojavu ali poslabšanju že obstoječega makularnega edema.
English: EU/1/00/137/005 7 tablets EU/1/00/137/006 28 tablets EU/1/00/137/007 56 tablets EU/1/00/137/014 84 tablets EU/1/00/137/017 90 tablets EU/1/00/137/008 112 tablets EU/1/00/137/009 56 tablet unit dose pack
Slovenian: EU/1/00/137/008 112 tablet EU/1/00/137/009 56 tablet, pakiranje po enoti odmerka
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg tablets rosiglitazone
Slovenian: IME ZDRAVILA AVANDIA 2 mg tablete rosiglitazon
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg tablets rosiglitazone
Slovenian: IME ZDRAVILA AVANDIA 8 mg tablete rosiglitazon
English: Film coating (Opadry pink OY-L-24803): Hypromellose 6cP
Slovenian: Filmska obloga (Opadry pink OY-L-24802): hipromeloza 6cP titanov dioksid E171 makrogol 3000 laktoza monohidrat triacetin rdeči železov oksid E172
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg tablets rosiglitazone
Slovenian: IME ZDRAVILA AVANDIA 4 mg tablete rosiglitazon
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu
Slovenian: (EMEA) http://www.ema.europa.eu
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: Izgled zdravila Avandia in vsebina pakiranja
English: In patients administered rosiglitazone in combination with a sulphonylurea, an increase in rosiglitazone to 8 mg/day should be undertaken cautiously following appropriate clinical evaluation to assess the patient's risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8).
Slovenian: Pred tem je treba opraviti ustrezen klinični pregled in oceniti bolnikovo ogroženost za pojav neželenih učinkov, povezanih z zastajanjem tekočine (glejte poglavji 4.4 in 4.8).
English: MARKETING AUTHORISATION HOLDER SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Velika Britanija
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 8 mg film-coated tablets rosiglitazone
Slovenian: AVANDIA 8 mg filmsko obložene tablete rosiglitazon
English: • rapid increase in your weight
Slovenian: hitro povečanje telesne mase.
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 4 mg film-coated tablets rosiglitazone
Slovenian: AVANDIA 4 mg filmsko obložene tablete rosiglitazon
English: NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg film-coated tablets rosiglitazone
Slovenian: AVANDIA 2 mg filmsko obložene tablete rosiglitazon
English: Insulin and rosiglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema and could increase the risk of ischaemic heart disease.
Slovenian: Pri njuni sočasni uporabi se lahko poveča tveganje za pojav edemov in ishemične bolezni srca.
English: • raised and itchy rash (hives)
Slovenian: • privzdignjen in srbeč kožni izpuščaj (koprivnica)
English: Avandia 8 mg tablets are red-brown, marked "GSK" on one side and "8" on the other.
Slovenian: Na eni strani imajo oznako "gsk", na drugi pa "8".
English: 7, 28, 84, 90 or 112 film-coated tablets.
Slovenian: 7, 28, 84, 90 ali 112 filmsko obloženih tablet v neprozornih pretisnih omotih (PVC/aluminij).
English: BEFORE YOU TAKE AVANDIA
Slovenian: Če ste pozabili vzeti zdravilo Avandia
English: Excipient
Slovenian: Presnova
English: Film coating (Opadry orange OY-L-23028): Hypromellose 6cP
Slovenian: Filmska obloga (Opadry orange OY-L-23028): hipromeloza 6cP titanov dioksid E171 makrogol 3000 smukec laktoza monohidrat triacetin rdeči železov oksid E172 rumeni železov oksid E172
English: POSSIBLE SIDE EFFECTS
Slovenian: Neželeni učinki
English: 30 HU**.
Slovenian: 30 HE**.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Slovenian: Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo (ES) št. 470/2009.
English: **Haemolytic units For the full list of excipients, see section 6.1.
Slovenian: **Hemolizne enote Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Slovenian: a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
English: Revaccination Annual.
Slovenian: Ponovno cepljenje Letno.
English: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ UNITED KINGDOM
Slovenian: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Velika Britanija
English: Any person intending to manufacture, import, possess, sell, supply and use BTVPUR AlSap 2-4 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati BTVPUR AlSap 2-4, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Slovenian: Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena pod posebnimi pogoji, ki jih predpisuje zakonodaja Evropske Skupnosti za nadzor nad boleznijo modrega jezika.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member States may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
English: One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).
Slovenian: Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2,5 meseca starosti pri mladičih imunih ovc).
English: The manufacture, import, possession, sale, supply and/or use of BTVPUR AlSap 2-4 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Izdelava uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba BTVPUR AlSap 2-4 je lahko prepovedana v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: The duration of immunity is 1 year after primary vaccination course.
Slovenian: Trajanje imunosti je 1 leto po osnovnem cepljenju.
English: The marketing authorization holder should provide a suitable system for quantifying active ingredient at blending stage as soon as feasible.
Slovenian: Imetnik dovoljenja za promet mora takoj ko bo to mogoče, predložiti zadovoljiv sistem za kvantitativno določanje vsebnosti zdravilne učinkovine na stopnji mešanja v proizvodnem postopku.
English: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest FRANCE
Slovenian: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest Francija
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini, po EXP.
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double-dose of the vaccine.
Slovenian: Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6, niso bili opaženi po dajanju dvakratnega odmerka cepiva.
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National Competent Authorities on the current vaccination policies against bluetongue virus (BTV).
Slovenian: Pri tej kategoriji živali je treba cepivo uporabljati glede na presojo odgovornega veterinarja glede razmerja korist/tveganje oziroma v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrega jezika (BTV).
English: *Cell culture infectious dose 50% equivalent to titre prior to inactivation (log10).
Slovenian: *Infektivni odmerek za celično kulturo 50%, ekvivalent titru pred inaktivacijo (log10) **Hemolizne enote.
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Slovenian: Varnost in učinkovitost cepiva nista bili ugotovljena pri plemenjakih.
English: Vaccination may be followed by a small local swelling at the injection site (at most 24 cm2) for a short period (at most 14 days).
Slovenian: Po cepljenju se lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 24 cm ki hitro izgine (v največ 14 dneh).
English: *(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission)
Slovenian: *(pod stopnjo detekcije z validirano metodo RT-PCR pri 3,68 log10 RNA kopijah/ml ni prenosa virusa)