FrancophonIA/ELRC3.0 huggingface dataset:
English: - If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor - A small number of people being treated with anti-epileptics such as Levetiracetam Accord have had thoughts of harming or killing themselves.
Slovenian: • če ste pri otroku opazili počasnejšo rast ali nepričakovan razvoj v puberteti, se posvetujte z zdravnikom.
English: 0.20 ml/kg) once daily (3) (5) (1) Levetiracetam oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Slovenian: (1) Pri odmerkih, manjših od 250 mg, pri odmerkih, ki niso večkratniki 250 mg in priporočenega odmerjanja zato ni mogoče doseči z več tabletami, in pri bolnikih, ki ne morejo požirati tablet, je treba uporabiti levetiracetam v obliki peroralne raztopine.
English: 3.5 to 10.5 mg /kg (0.035 to 0.105 ml/kg) twice daily
Slovenian: 3,5 do 10,5 mg/kg (0,035 do 0,105 ml/kg)
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia,disturbance in attention
Slovenian: glavobol konvulzije, motnje ravnotežja, omotica, letargija, tremor amnezija, oslabljen spomin, poslabšana koordinacija/ataksija, parestezija, motnje pozornosti horeoatetoza, diskinezija, hiperkinezija, motnje hoje, encefalopatija
English: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Levetiracetam overdoses.
Slovenian: Pri prevelikem odmerjanju zdravila Levetiracetam Accord so opažali somnolenco, agitiranost, agresivnost, zmanjšano stopnjo zavesti, depresijo dihanja in komo.
English: PVC-Alu blister
Slovenian: makrogol smukec
English: Levetiracetam Accord 1000 mg film-coated tablets Each film-coated tablet contains 1000 mg levetiracetam
Slovenian: Levetiracetam Accord 1.000 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1.000 mg levetiracetama.
English: This medicine has been prescribed for you only.
Slovenian: − Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: What Levetiracetam Accord contains:
Slovenian: Zdravilo Levetiracetam Accord se uporablja:
English: An oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don't allow accurate dosage.
Slovenian: Za dojenčke in otroke, mlajše od 6 let, za otroke in mladostnike (od 6 do 17 let), lažjih od 50 kg in kadar s tabletami ne moremo zagotoviti natančnega odmerjanja je zdravilo Levetiracetam Accord 100 mg/ml peroralna raztopina primernejša farmacevtska oblika.
English: 1000 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
Slovenian: polivinilalkohol, titanov dioksid (E171), makrogol, smukec
English: Levetiracetam oral solution is the preferred formulation for use in this population.
Slovenian: Pri tej populaciji je najprimernejša farmacevtska oblika za uporabo zdravila levetiracetam peroralna raztopina.
English: Yellow coloured, oval, biconvex, film coated tablet, debossed ‘L 65' and break line on one side and plain on the other side.
Slovenian: Rumene, podolgovate, bikonveksne, filmsko obložene tablete z vtisnjeno oznako ‘L 65' in zarezo na eni strani ter brez oznak na drugi strani.
English: Nervous system disorders
Slovenian: Bolezni živčevja somnolenca,
English: Blood and lymphatic system disorders
Slovenian: Aluminijast/PVC pretisni omot
English: Levetiracetam Accord 1000 mg film-coated tablets White to off white, oval, biconvex, debossed ‘L 67' and break line on one side and plain on the other side.
Slovenian: Levetiracetam Accord 1.000 mg filmsko obložene tablete Bele ali umazano bele, podolgovate, bikonveksne tablete, z vtisnjeno oznako ‘L 67' in zarezo na eni strani ter brez oznak na drugi strani.
English: NAME OF THE MEDICINAL PRODUCT Levetiracetam Accord 500 mg film-coated tablets Levetiracetam
Slovenian: Levetiracetam Accord 500 mg filmsko obložene tablete levetiracetam
English: Levetiracetam Accord 250 mg film-coated tablets Levetiracetam
Slovenian: Levetiracetam Accord 250 mg filmsko obložene tablete levetiracetam
English: Pink coloured, oval, biconvex, film coated tablet, debossed ‘L 66' and break line on one side and plain on the other side.
Slovenian: Rožnate, podolgovate, bikonveksne, filmsko obložene tablete z vtisnjeno oznako ‘L 66' in zarezo na eni strani ter brez oznak na drugi strani.
English: Mild
Slovenian: MedDRA
English: 7 to 14 mg /kg (0.07 to 0.14 ml/kg)once daily (2)
Slovenian: 0,14 ml/kg) enkrat na dan (2) (4)
English: 7 to 21 mg /kg (0.07 to 0.21 ml/kg) twice daily
Slovenian: 7 do 21 mg/kg (0,07 do
English: STATEMENT OF ACTIVE SUBSTANCE (S) Each film-coated tablet contains 500 mg levetiracetam.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 500 mg levetiracetama.
English: Levetiracetam Accord 1000 mg film-coated tablet Levetiracetam
Slovenian: Levetiracetam Accord 1.000 mg filmsko obložene tablete levetiracetam
English: EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/035-037 (30/60/100tablets in Unit dose Blister)
Slovenian: EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/035-037 (30/60/100 tablet v enoodmernih pretisnih omotih)
English: Levetiracetam Accord 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Levetiracetam Accord 250 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
English: How to store Levetiracetam Accord
Slovenian: Shranjevanje zdravila Levetiracetam Accord
English: White to off white, oval, biconvex, film coated tablet, debossed ‘L 67' and break line on one side and plain on the other side.
Slovenian: Bele ali umazano bele, podolgovate, bikonveksnefilmsko obložene tablete z vtisnjeno oznako ‘L 67' in zarezo na eni strani ter brez oznak na drugi strani.
English: EU/1/11/712/001-007 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/029-031(30/60/100 tablets in Unit dose Blister)
Slovenian: EU/1/11/712/001-007 (10/20/30/50/60/100/200 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/029-031(30/60/100 tablet v enoodmernih pretisnih omotih)
English: 5 to 15 mg /kg (0.05 to 0.15 ml/kg) twice daily
Slovenian: 5 do 15 mg/kg (0,05 do
English: White to off white, oval, biconvex, film coated tablet, debossed ‘L 64' and break line on one side and plain on the other side.
Slovenian: Bele ali pastel bele barve, podolgovate, bikonveksne, filmsko obložene tablete, z vtisnjeno oznako ‘L 64' in zarezo na eni strani ter brez oznak na drugi strani.
English: EU/1/11/712/008-014 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/032-034 (30/60/100tablets in Unit dose Blister)
Slovenian: EU/1/11/712/008-014 (10/20/30/50/60/100/200 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/032-034 (30/60/100 tablet v enoodmernih pretisnih omotih)
English: Each film-coated tablet contains 250 mg levetiracetam.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
English: EU/1/11/712/022-028 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/038-040(30/60/100tablets in Unit dose Blister)
Slovenian: EU/1/11/712/022-028 (10/20/30/50/60/100/200 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/038-040 (30/60/100 tablet v enoodmernih pretisnih omotih)
English: 7 to 14 mg /kg (0.07 to 0.14 ml/kg) twice daily
Slovenian: 7 do 14 mg/kg (0,07 do
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/035-037 (30/60/100tablets in Unit dose Blister)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/035-037 (30/60/100 tablet v enoodmernih pretisnih omotih)
English: PVC/Alu blister pack:
Slovenian: Zdravilo je na voljo v pretisnih omotih iz PVC-ja/aluminija:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/712/001-007 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/029-031(30/60/100tablets in Unit dose Blister)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/712/001-007 (10/20/30/50/60/100/200 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/029-031(30/60/100 tablet v enoodmernih pretisnih omotih)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/712/022-028 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/038-040 (30/60/100tablets in Unit dose Blister)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/712/022-028 (10/20/30/50/60/100/200 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/038-040 (30/60/100 tablet v enoodmernih pretisnih omotih)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/712/008-014 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/032-034 (30/60/100tablets in Unit dose Blister)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/712/008-014 (10/20/30/50/60/100/200 tablet v pretisnih omotih iz PVC-ja/aluminija) EU/1/11/712/032-034 (30/60/100 tablet v enoodmernih pretisnih omotih)
English: NAME OF THE MEDICINAL PRODUCT Levetiracetam Accord 1000 mg film-coated tablets Levetiracetam STATEMENT OF ACTIVE SUBSTANCE (S) Each film-coated tablet contains 1000 mg levetiracetam.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 1.000 mg levetiracetama.
English: Each film-coated tablet contains 750 mg levetiracetam.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 750 mg levetiracetama
English: 5 to 10 mg /kg (0.05 to 0.10 ml/kg) twice daily
Slovenian: 5 do 10 mg/kg (0,05 do
English: --1 Live attenuated avian infectious bronchitis virus (IBV), variant strain 4-91: ≥3.6 log10 EID50* per dose * EID50: 50% embryo infective dose - the virus titre required to produce infection in 50% of the embryos inoculated.
Slovenian: --1 Živi, oslabljeni variantni sev virusa kužnega bronhitisa perutnine (IBV) 4-91: ≥ 3,6 log 10 EID50* na odmerek * EID50: 50-odstotni infektivni odmerek za zarodke - titer virusa, ki povzroči okužbo pri 50 % inokuliranih zarodkov
English: 3 Bottles
Slovenian: 3 kapalni vsebniki
English: 1 Bottle
Slovenian: 1 kapalni vsebnik
English: If so, treatment should be stopped immediately.
Slovenian: Če se to zgodi, je treba takoj prekiniti zdravljenje.
English: After 3 weeks a break of at least 2 weeks is required.
Slovenian: Po treh tednih je potreben premor vsaj dveh tednov.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Slovenian: To pomeni, da obstajajo podatki v literaturi z znanstvenimi dokazi o njihovi učinkovitosti in varnosti pri uporabi na navedene načine, ki zajemajo obdobje vsaj 10 let v EU.
English: In rare cases allergic skin reactions can occur.
Slovenian: V redkih primerih lahko pride do alergijskih kožnih reakcij.
English: Capsicum should only be used in adults over the age of 18 years and should not be used continuously for more than 3 weeks.
Slovenian: Plodovi paprike se smejo uporabljati samo pri odraslih, starejših od 18 let, in se ne smejo uporabljati neprekinjeno več kot tri tedne.
English: Overstimulating the receptors makes them become ‘desensitised' and no longer able to respond to the stimuli that normally cause pain.
Slovenian: Receptorji s čezmernim spodbujanjem postanejo „desenzibilizirani“ in se ne morejo več odzivati na dražljaje, ki navadno povzročajo bolečino.
English: This means that it stimulates the TRPV1 receptor, which is found in the nociceptors (pain receptors) in the skin.
Slovenian: To pomeni, da spodbuja receptor TRPV1, ki ga najdemo v nociceptorjih (receptorjih za bolečino) v koži.
English: Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus
Slovenian: Capsicum annuum L. var. minimum (Miller) Heiser in različice z majhnimi plodovi Capsicum frutescens L. , fructus
English: This summary is not intended to provide practical advice on how to use medicines containing capsicum.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo plod paprike.
English: Capsicum contains a substance known as capsaicin.
Slovenian: Plod paprike vsebuje snov, imenovano kapsaicin.
English: The capsaicin is used to overstimulate the TRPV1 receptors.
Slovenian: Kapsaicin se uporablja za čezmerno spodbujanje receptorjev TRPV1.
English: Capsaicin is a selective agonist of the ‘transientreceptor-potential-vanilloid-1' (TRPV1) receptor.
Slovenian: Kapsaicin je selektivni agonist „vaniloidnega receptorja TRP podtipa 1“ (TRPV1).
English: The HMPC conclusions on the use of capsicum medicines relief of muscle pain are based on their ‘wellestablished use' in this condition.
Slovenian: Zaključki odbora HMPC o uporabi zdravil za lajšanje mišične bolečine, ki vsebujejo plod paprike, temeljijo na njihovi „dobro uveljavljeni medicinski uporabi“ pri tem stanju.
English: Further information on the risks associated with capsicum medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo plod paprike, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Capsicum preparations are obtained by ethanol or propanol extraction (a technique used to extract compounds from plant parts by dissolving them in alcohol).
Slovenian: Pripravki plodov paprike se pridobijo z ekstrakcijo s pomočjo etanola ali propanola (tehniko, ki se uporablja za ekstrakcijo snovi iz rastlinskih delov z raztapljanjem v alkoholu).
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of capsicum.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo plodov paprike.
English: The HMPC concluded that, on the basis of its well-established use, capsicum can be used for the relief of muscle pain, such as low back pain.
Slovenian: Odbor HMPC je zaključil, da se lahko plod paprike na podlagi dobro uveljavljene medicinske uporabe uporablja za lajšanje mišičnih bolečin, kot so bolečine v spodnjem delu hrbta.
English: In its assessment, the HMPC considered a number of clinical studies which showed improvements in pain relief following treatment with capsicum medicated plaster and skin preparations compared with placebo (a dummy treatment).
Slovenian: Pri svoji oceni je odbor HMPC upošteval številne klinične študije, ki so pokazale pomembno lajšanje bolečine pri zdravljenju z zdravilnimi obliži in pripravki za kožo, ki vsebujejo plod paprike, v primerjavi s placebom (zdravilom brez zdravilne učinkovine).
English: Capsicum is the common name for the fruits of the plant Capsicum annuum L. var. minimum (Miller) Heiser and Capsicum frutescens L. These are types of peppers that are cultivated or gathered to obtain the plant parts for medicinal use.
Slovenian: Plod paprike je splošno ime za sadeže rastlin Capsicum annuum L. var. minimum (Miller) Heiser in Capsicum frutescens L. To so vrste paprike, ki se gojijo ali nabirajo za pridobivanje delov rastline za medicinsko uporabo.
English: How does capsicum work as a medicine?
Slovenian: Kako plod paprike deluje kot zdravilo?
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing capsicum.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo plod paprike.
English: Any applications for the licensing of medicines containing capsicum have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo plod paprike, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: Further information on the HMPC assessment of capsicum medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo plod paprike, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom »Vsi dokumenti«: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Information on the use and licensing of capsicum medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo plod paprike, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Herbal medicines containing capsicum are usually available in a medicated plaster or in semi-solid forms to be applied to the skin (such as creams).
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo plod paprike, so navadno na voljo kot zdravilni obliži ali poltrdne oblike, ki se nanašajo na kožo (kot so kreme).
English: How are capsicum medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo plod paprike, odobrena v EU?
English: Detailed instructions on how to use capsicum medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o tem, kako uporabljati zdravila, ki vsebujejo plod paprike in kdo jih sme uporabljati, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: Capsicum
Slovenian: Plod paprike
English: What evidence supports the use of capsicum medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo plod paprike?
English: Other information about capsicum medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo plod paprike
English: Capsicum medicines can cause reddening and a burning sensation on the areas of the skin where they are applied.
Slovenian: Zdravila, ki vsebujejo plod paprike, lahko povzročajo pordelost in pekoč občutek na delih kože, kamor se nanesejo.
English: For more information about treatment with capsicum medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo plod paprike, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: Capsicum medicines must not be used in patients allergic to other sources of capsaicin and capsaicinlike compounds (e.g. paprika or chilli) and must not be applied onto broken skin, wounds and eczema.
Slovenian: Zdravila, ki vsebujejo plod paprike, se ne smejo uporabljati pri bolnikih, alergičnih na druge vire kapsaicina in kapsaicinu podobne snovi (npr. papriko ali čili).
English: What are the risks associated with capsicum medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo plod paprike?
English: For practical information about using capsicum medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: What is capsicum?
Slovenian: Kaj je plod paprike?
English: Interactions with other medical products and other forms of interaction:
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
English: Rectal temperatures should then return to normal values.
Slovenian: Nato se rektalna temperatura vrne na normalno vrednost.
English: EU/2/11/130/002
Slovenian: EU/2/11/130/001 EU/2/11/130/002 EU/2/11/130/003
English: Adjuvants: Aluminium hydroxide (Al3+)
Slovenian: aluminijev hidroksid (Al3+)
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Slovenian: *(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT-PCR, kar kaže, da virusni genom ni prisoten)
English: Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus.
Slovenian: Farmakoterapevtska skupina: Inaktivirana virusna cepiva - virus bolezni modrikastega jezika.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 2.5 months of age.
Slovenian: Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja: 1. injekcija: od 2,5 meseca starosti.
English: No information is available on the use of the vaccine in animals with maternally derived antibodies.
Slovenian: Na voljo ni nobenih informacij o uporabi cepiva pri živalih z maternalnimi protitelesi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05/08/2011
Slovenian: Datum pridobitve dovoljenja za promet: 05/08/2011 Datum zadnjega podaljšanja dovoljenja za promet: 18/04/2016
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Once broached use immediately.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po {EXP}.Načeto uporabite takoj.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of the 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, z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove izdelavo, uvoz/vnos,
English: A slight to moderate increase of local reactions may commonly be observed after a 2-fold overdose lasting for a maximum of 56 days.
Slovenian: Pri 2-krat prevelikem odmerku se lahko pogosto opazi blago do zmerno povečanje lokalnih reakcij, ki trajajo največ 56 dni.
English: Duration of immunity: 12 months after completion of the primary vaccination course.
Slovenian: Trajanje imunosti: 12 mesecev po končanem osnovnem cepljenju.
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate dodecahydrate Sodium chloride
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aluminijev hidroksid saponin tiomersal kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat natrijev klorid
English: PACKAGE LEAFLET: Zulvac1 Bovis suspension for injection for cattle
Slovenian: NAVODILO ZA UPORABO Zulvac 1 Bovis suspenzija za injiciranje za govedo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20ml, 1 x 100ml and 1 x 240ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml
English: Onset of immunity: 15 days after completion of the primary vaccination scheme.
Slovenian: Nastop imunosti: 15 dni po osnovnem programu cepljenja.
English: For active immunisation of cattle from 2 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotypes 1.
Slovenian: Za aktivno imunizacijo goveda, starejšega od 2 in pol meseca starosti, za preprečitev* viremije, ki jo povzroča virus bolezni modrikastega jezika, serotip 1.
English: EXPIRY DATE EXP {month/year} Once broached use immediately.
Slovenian: EXP {mesec/leto} Načeto uporabite takoj.