FrancophonIA/ELRC3.0 huggingface dataset:
English: Epivir 300 mg tablet lamivudine
Slovenian: Epivir 300 mg tablete lamivudin
English: 3.3 mg/kg once daily
Slovenian: 3,3 mg/kg enkrat na dan
English: Co-administration of lamivudine with food results in a delay of tmax and a lower C max (decreased by 47%).
Slovenian: Dajanje lamivudina sočasno s hrano podaljša tmax in zniža Cmax (za 47 %), vendar na obseg (na osnovi AUC) absorbiranega lamivudina ne vpliva.
English: This may be administered as either 75 mg (one-half of a 150 mg tablet) taken in the morning and 150 mg (one whole 150 mg tablet) taken in the evening, or 225 mg (one and a half 150 mg tablets) taken once daily.
Slovenian: Odmerek se lahko daje v obliki 75 mg odmerka (polovica 150 mg tablete) zjutraj in v obliki 150 mg odmerka (ena cela 150 mg tableta) zvečer ali v obliki 225 mg odmerka (ena in pol 150 mg tableta) enkrat na dan.
English: Dosing according to weight bands is recommended for Epivir tablets.
Slovenian: Pri uporabi Epivir tablet priporočamo odmerjanje na osnovi telesne mase.
English: Grey, diamond shaped and engraved with “GX EJ7” on one face
Slovenian: Siva tableta v obliki diamanta, ki ima na eni strani odtisnjeno oznako“GX EJ7”.
English: BOTTLE LABEL X 30 FILM-COATED TABLETS (300 mg )
Slovenian: ŠKATLA S PRETISNIMI OMOTI S 30 FILMSKO OBLOŽENIMI TABLETAMI (300 mg)
English: This may be administered as 75 mg (one-half of a 150 mg tablet) taken twice daily, or 150 mg (one whole 150 mg tablet) taken once daily.
Slovenian: Odmerek se lahko daje v obliki 75 mg odmerka (polovica 150 mg tablete) dvakrat na dan ali v obliki 150 mg odmerka (ena cela 150 mg tableta) enkrat na dan.
English: This difference in suppression rates between tablets and solutions remained through Week 96 with once daily dosing.
Slovenian: Tekom 96. tedna, je pri režimu odmerjanja enkrat na dan, razlika v stopnjah supresije med tabletami in raztopinami ostala nespremenjena.
English: How to store Epivir
Slovenian: Shranjevanje zdravila Epivir
English: HDPE bottles:
Slovenian: Peroralna raztopina:
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Slovenian: Imetnik dovoljenja za promet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila Epivir in vsebina pakiranja
English: Placental transfer of lamivudine has been shown to occur in humans.
Slovenian: Ugotovljeno je bilo, da lamivudin pri človeku prehaja skozi placento.
English: In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen.
Slovenian: V farmakokinetični študiji (PENTA 15) so štirje virološko obvladani preiskovanci, mlajši od 12 mesecev, prešli s peroralne raztopine abakavirja in lamivudina dvakrat na dan na režim odmerjanja enkrat na dan. Trije preiskovanci so imeli 48. teden nezaznavno virusno obremenitev, eden pa je imel HIV-RNA v plazmi 900 kopij/ml.
English: A very rare side effect that may show up in blood tests is: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Slovenian: • nesposobnost kostnega mozga proizvajati nove rdeče krvne celice (čista aplazija rdečih krvnih celic).
English: This can be taken as either one 150 mg tablet twice a day (leaving approximately 12 hours between each dose), or two 150 mg tablets once a day as advised by your doctor.
Slovenian: Običajni odmerek zdravila Epivir je 300 mg na dan. Odmerek se lahko jemlje v obliki ene 150 mg tablete dvakrat na dan (z razmikom približno 12 ur med obema odmerkoma) ali po posvetu z zdravnikom v obliki dveh 150 mg tablet enkrat na dan.
English: Co-administration of zidovudine results in a 13% increase in zidovudine exposure and a 28% increase in peak plasma levels.
Slovenian: Sočasno dajanje zidovudina za 13% poveča izpostavljenost zidovudinu in za 28% poveča njegove največje plazemske vrednosti, kar pa naj ne bi vplivalo na varnost bolnika in tako prilagajanje odmerkov ni potrebno.
English: • if you have a kidney problem, your dose may be altered.
Slovenian: • če imate težave z ledvicami, vam bo zdravnik morda spremenil odmerek.
English: This may be administered as either 150 mg twice daily or 300 mg once daily (see section 4.4).
Slovenian: Priporočen dnevni odmerek zdravila Epivir je 300 mg. Priporočen dnevni odmerek se lahko daje bodisi v obliki 150 mg odmerka dvakrat na dan, bodisi v obliki 300 mg odmerka enkrat na dan (glejte poglavje 4.4).
English: Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate Film-coat: hypromellose, titanium dioxide, black iron oxide (E172), macrogol, polysorbate 80 This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Slovenian: Filmska obloga: hipromeloza, titanov dioksid, črni železov oksid (E172), makrogol in polisorbat 80.
English: Epivir 150 mg Film-coated tablets
Slovenian: Epivir 150 mg filmsko obložene tablete
English: A 150 mg strength Epivir tablet is also available for the treatment of children from 3 months of age who weigh less than 25 kg:
Slovenian: Za zdravljenje otrok, od treh mesecev starosti, ki tehtajo manj kot 25 kg, je na voljo tudi jakost 150 mg zdravila Epivir tablete.
English: EU/1/96/015/001 (Bottle) EU/1/96/015/004 (Blister pack)
Slovenian: EU/1/96/015/004 (Pretisni omot)
English: BOTTLE LABEL X 60 FILM-COATED TABLETS (150 mg)
Slovenian: ŠKATLA S PRETISNIMI OMOTI S 60 FILMSKO OBLOŽENIMI TABLETAMI (150 mg)
English: If you get any of the side effects talk to your doctor or pharmacist.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Epivir 150 mg film-coated tablets lamivudine
Slovenian: Epivir 150 mg filmsko obložene tablete lamivudin
English: This can be given as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one whole 150 mg tablet) in the evening, or 225 mg (one and a half 150 mg tablets) once a day as advised by your doctor.
Slovenian: Običajni odmerek zdravila Epivir je 225 mg na dan. Odmerek se lahko daje v obliki 75 mg odmerka (polovica 150 mg tablete) zjutraj in v obliki 150 mg odmerka (ena cela 150 mg tableta) zvečer ali po posvetu z zdravnikom v obliki 225 mg odmerka (ena in pol 150 mg tableta) enkrat na dan.
English: Epivir 300 mg Film-coated tablets
Slovenian: Epivir 300 mg filmsko obložene tablete
English: This can be given as 75 mg (half a 150 mg tablet) twice a day (leaving approximately 12 hours between each dose), or 150 mg (one 150 mg tablet) once a day as advised by your doctor.
Slovenian: Običajni odmerek zdravila Epivir je 150 mg na dan. Odmerek se lahko daje v obliki 75 mg odmerka (polovica 150 mg tablete) dvakrat na dan (z razmikom približno 12 ur med obema odmerkoma) ali po posvetu z zdravnikom v obliki 150 mg odmerka (ena cela 150 mg tableta) enkrat na dan.
English: Administration of co-trimoxazole with lamivudine in patients with renal impairment should be carefully assessed.
Slovenian: Pri bolnikih z oslabljenim delovanjem ledvic pa sočasno dajanje kotrimoksazola in lamivudina terja previdnost.
English: Epivir 300 mg film-coated tablets Lamivudine
Slovenian: Epivir 300 mg filmsko obložene tablete lamivudin
English: BLISTER CARTON X 60 FILM-COATED TABLETS (150 mg)
Slovenian: NALEPKA ZA PLASTENKO S 60 FILMSKO OBLOŽENIMI TABLETAMI (150 mg)
English: Children from 3 months of age weighing less than 25 kg The dose depends on the child's body weight.
Slovenian: Otroci, od treh mesecev starosti, ki tehtajo manj kot 25 kg
English: Epivir 150 mg film-coated tablets
Slovenian: Epivir 150 mg filmsko obložene tablete filmsko obložena tableta
English: • stomach pains
Slovenian: • bolečine v želodcu,
English: Macrogol, Polysorbate 80
Slovenian: Filmska obloga: hipromeloza, titanov dioksid, makrogol in polisorbat 80.
English: Epivir 300 mg film-coated tablets
Slovenian: Epivir 300 mg filmsko obložene tablete filmsko obložena tableta
English: 300 mg or
Slovenian: 300 mg ali 150 mg
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Slovenian: Občasni: utrujenost, splošno slabo počutje, povišana telesna temperatura Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi (glejte poglavje 4.4).
English: Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate Film-coat: hypromellose, titanium dioxide, macrogol, polysorbate 80 This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Slovenian: Jedro tablete: mikrokristalna celuloza, natrijev karboksimetilškrob (brez glutena) in magnezijev stearat.
English: Children Corlentor is not intended for use in children and adolescents younger than 18 years.
Slovenian: Corlentor ni namenjen za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: In this way Corlentor helps to control and reduce the number of angina attacks.
Slovenian: Corlentor pripomore k nadzoru in zmanjševanju anginoznih napadov.
English: Symptomatic treatment of chronic stable angina pectoris
Slovenian: Simptomatsko zdravljenje kronične stabilne angine pektoris
English: Corlentor 5 mg film-coated tablets EU/1/05/317/001-007
Slovenian: Corlentor 5 mg filmsko obložene tablete EU/1/05/317/001-007
English: Pregnancy There are no or limited amount of data from the use of ivabradine in pregnant women.
Slovenian: Podatkov o uporabi ivabradina pri nosečnicah ni oziroma so omejeni.
English: Corlentor 7.5 mg film-coated tablets EU/1/05/317/008-014
Slovenian: Corlentor 7,5 mg filmsko obložene tablete EU/1/05/317/008-014
English: nd degree Ivabradine is not recommended in patients with AV-block of 2nd degree.
Slovenian: Ivabradin ni priporočljiv pri bolnikih z atrioventrikularnim blokom 2. stopnje.
English: If any of the above applies to you, talk straight away to your doctor before or while taking Corlentor.
Slovenian: Če karkoli od naštetega velja za vas, se takoj pogovorite z zdravnikom pred jemanjem zdravila
English: A randomised, double blind, placebo controlled study was performed in 116 paediatric patients (17 aged [6-12[months, 36 aged [1-3[ years and 63 aged [3-18[ years) with CHF and dilated cardiomyopathy (DCM) on top of optimal background treatment.
Slovenian: Randomizirana, dvojno slepa, s placebom nadzorovana študija je vključevala 116 pediatričnih bolnikov (17 bolnikov, starih [6-12[ mesecev, 36 bolnikov, starih [1-3[ leta in 63 bolnikov, starih [3-18[ let) s kroničnim srčnim popuščanjem in dilatirano kardiomiopatijo (DKM), ki so prejemali ivabradin poleg optimalnega osnovnega zdravljenja.
English: Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle spasms, changes in laboratory parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.
Slovenian: Palpitacije in dodatni srčni utripi, občutek slabosti (navzea), zaprtje, driska, bolečina v trebuhu, občutek vrtoglavosti (vertigo), oteženo dihanje (dispneja), mišični spazmi (krči), spremembe laboratorijskih parametrov: visoke vrednosti sečne kisline v krvi, preveliko število eozinofilcev (vrsta belih krvnih celic) in povečanje kreatinina v krvi (razgradni produkt mišic), kožni izpuščaj, angioedem (kot je otečen obraz, jezik ali grlo, težave pri dihanju ali požiranju), nizek krvni tlak, omedlevica, občutek utrujenosti, občutek šibkosti, nepravilnosti v zapisu EKG srca, dvojni vid,
English: 75 years) and titration up to 10 mg b.i.d).
Slovenian: starih ≥ 75 let) in povečanje odmerka do 10 mg dvakrat na dan).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Corlentor in all subsets of the paediatric population for the treatment of angina pectoris.
Slovenian: Corlentor za vse podskupine pediatrične populacije za zdravljenje angine pektoris.
English: Corlentor (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Slovenian: Kaj je zdravilo Corlentor in za kaj ga uporabljamo Corlentor (ivabradin) je zdravilo za srce, namenjeno za zdravljenje: - simptomatske stabilne angine pektoris (bolezen, ki povzroča bolečine v prsih) pri odraslih bolnikih, ki imajo srčno frekvenco višjo ali enako 70 utripom na minuto.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Corlentor in children aged 0 to less than 6 months for the treatment of chronic heart failure.
Slovenian: Corlentor za otroke od 0 do manj kot 6 mesecev starosti za zdravljenje kroničnega srčnega popuščanja.
English: The usual recommended starting dose is one tablet of Corlentor 5 mg twice daily increasing if necessary to one tablet of Corlentor 7.5 mg twice daily.
Slovenian: Če se zdravite zaradi kroničnega srčnega popuščanja Običajen priporočljiv začetni odmerek je ena tableta zdravila Corlentor 5 mg dvakrat na dan, kar lahko povečate na eno tableto zdravila Corlentor 7,5 mg dvakrat na dan, če je potrebno.
English: ECG prolonged QT interval * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Slovenian: *Pogostnost neželenih učinkov iz spontanega poročanja je izračunana na podlagi podatkov iz kliničnih študij
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breast-feeding should be discontinued if you take Corlentor.
Slovenian: Če dojite ali nameravate dojiti se posvetujte z zdravnikom, ker morate z dojenjem prekiniti, če jemljete zdravilo Corlentor.
English: The dose was adapted depending on the therapeutic response with maximum doses of 0.2 mg/kg bid, 0.3 mg/kg bid and 15 mg bid respectively.
Slovenian: pri čemer so bili najvišji odmerki 0,2 mg/kg dvakrat na dan oz. 0,3 mg/kg dvakrat na dan oz. 15 mg dvakrat na dan.
English: Corlentor 7.5 mg film-coated tablets
Slovenian: Corlentor 7,5 mg filmsko obložene tablete
English: Talk to your doctor or pharmacist before taking Corlentor - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Slovenian: Pred začetkom jemanja zdravila Corlentor se posvetujte z zdravnikom ali farmacevtom: - če imate motnje srčnega ritma (kot so nepravilen srčni utrip, palpitacije, povečana bolečina v prsih), vztrajno atrijsko fibrilacijo (vrsto nerednega srčnega utripa) ali nepravilnost v elektrokardiogramu (EKG), ki se imenuje 'podaljšan interval QT'; - če opažate simptome, kot so utrujenost, vrtoglavost ali zasoplost (to bi lahko pomenilo, da se vaše srce preveč upočasnjuje); - če imate simptome atrijske fibrilacije (nenavadno visok srčni utrip v mirovanju (nad 110 utripov na minuto) ali brez posebnega vzroka nereden srčni utrip, ki ga je težko izmeriti);
English: Corlentor 5 mg film-coated tablets
Slovenian: Corlentor 5 mg filmsko obložene tablete
English: What Corlentor contains - The active substance is ivabradine (as hydrochloride).
Slovenian: - Učinkovina je ivabradin (v obliki klorida).
English: In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74;1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]).
Slovenian: 95 % interval zaupanja [0,74; 1,28]) in drugih sekundarnih končnih izidov, vključno s hospitalizacijo zaradi poslabšanja srčnega popuščanja (razmerje tveganja: 0,79, 95 % interval zaupanja [0,56; 1,10]) ali umrljivosti zaradi srčnega popuščanja (razmerje tveganja: 0,69, 95 % [0,31; 1,53]).
English: Package leaflet: information for the patient Corlentor 5 mg film-coated tablets Corlentor 7.5 mg film-coated tablets ivabradine
Slovenian: Navodilo za uporabo Corlentor 5 mg filmsko obložene tablete Corlentor 7,5 mg filmsko obložene tablete ivabradin
English: Excipient with known effect: 63.91 mg lactose monohydrate Corlentor 7.5 mg film-coated tablets
Slovenian: Pomožna snov z znanim učinkom: 63,91 mg laktoze monohidrata.
English: AV 1st degree block (ECG prolonged PQ interval)
Slovenian: Preiskave občasni povečanje kreatinina v krvi podaljšanje intervala QT na EKG
English: Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Slovenian: do IV. razreda po funkcijski razvrstitvi Newyorškega društva za srce (NYHA) s sistolično disfunkcijo pri bolnikih v sinusnem ritmu, pri katerih je srčna frekvenca ≥ 75 utripov na minuto, v kombinaciji s standardno terapijo,
English: Treatment effect on the primary composite endpoint, its components and secondary endpoints
Slovenian: Učinek zdravljenja na primarni sestavljeni končni izid, njegove komponente in sekundarne končne izide ivabradin (N=3241) n (%)
English: NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets ivabradine
Slovenian: Corlentor 7,5 mg filmsko obložene tablete ivabradin
English: itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris); - if you are a woman able to have children and not using reliable contraception; - if you are pregnant or trying to become pregnant; - if you are breast-feeding.
Slovenian: - če vam srčni utrip narekuje izključno vaš srčni spodbujevalnik; - če imate hude težave z jetri; - če že jemljete zdravila proti glivičnim okužbam (na primer ketokonazol, itrakonazol), makrolidne antibiotike (na primer josamicin, klaritromicin, telitromicin ali eritromicin peroralno), zdravila proti okužbam z virusom HIV (na primer nelfinavir, ritonavir) ali nefazodon (zdravilo proti depresiji) ali diltiazem, verapamil (uporabljata se za zniževanje krvnega tlaka oz. zdravljenje angine pektoris);
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Slovenian: - kinidin, dizopiramid, ibutilid, sotalol, amjodaron (proti motnjam srčnega ritma) - bepridil (proti angini pektoris)
English: The starting dose was 0.02 mg/kg bid in age-subset [6-12[months, 0.05 mg/kg bid in [1-3[ years and
Slovenian: Začetni odmerek ivabradina pri podskupini bolnikov, starih [6-12[ mesecev, je bil 0,02 mg/kg dvakrat na dan, pri podskupini bolnikov, starih [1-3[ leta, in bolnikih, starih [3-18[ let, ki so tehtali manj kot 40 kg, je bil odmerek 0,05 mg/kg dvakrat na dan, pri bolnikih, starih [3-18[ let, ki so tehtali 40 kg ali več, pa je bil odmerek 2,5 mg dvakrat na dan. Odmerek je bil prilagojen glede na terapevtski odziv,
English: Cattle (calves and adult cows).
Slovenian: Govedo (teleta in odrasle krave).
English: Recommended vaccination programme:
Slovenian: Priporočeni program cepljenja:
English: This slight swelling lasts for less than 24 hours in most cases.
Slovenian: Ta rahla oteklina traja v večini primerov manj kot 24 ur.
English: ATCvet code QI02AD01.
Slovenian: oznaka ATC vet QI02AD01.
English: This transient rise in temperature is spontaneously resolved within 48 hours without treatment and it is not related to a febrile process.
Slovenian: Ta prehoden porast temperature samodejno izzveni v 48 urah brez zdravljenja in ni povezan s febrilnim procesom.
English: In such cases, an appropriate symptomatic treatment should be administered.
Slovenian: V takem primeru je potrebno ustrezno zdravljenje simptomov.
English: Vaccination might very rarely cause hypersensitivity reactions.
Slovenian: Cepljenje lahko zelo redko povzroči preobčutljivostne reakcije.
English: Date of first authorisation: 27/01/2011 Date of last renewal: 06/11/2015
Slovenian: Datum pridobitve dovoljenja za promet: 27/01/2011 Datum podaljšanja dovoljenja za promet: 06/11/2015
English: Diagnostic tools designed to detect gE antibodies should be suitable for this purpose.
Slovenian: Diagnostične metode za zaznavo protiteles gE naj bi bile primerne za ta namen.
English: A slight increase in body temperature up to 1 °C is common within 4 days following vaccination.
Slovenian: Rahel porast telesne temperature do 1°C je v obdobju 4 dni po cepljenju običajen.
English: The animal should be revaccinated 3 weeks later with the same dose.
Slovenian: Žival je treba ponovno cepiti z enakim odmerkom čez 3 tedne.
English: Commonly, an increase in rectal temperature up to 1.63 ºC in adult cows and up to 2.18 ºC in calves may be observed.
Slovenian: Pogosto je mogoče opaziti zvišanje rektalne temperature do 1,63 ºC pri odraslih kravah in do 2,18 ºC pri teletih.
English: A transient inflammation at the inoculation site is common in cattle within 72 hours post-vaccination.
Slovenian: Prehodno vnetje na mestu inokulacije je običajno pri govedu v roku 72 ur po cepljenju.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Slovenian: Za pomožne snovi, navedene v poglavju 6.1 SPC , tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009..
English: The tk deletion is related to reduced viral neurotropism and reduced establishment of latency.
Slovenian: Izbris tk je povezan z zmanjšanjem virusnega nevrotropizma in zmanjšanim nastopom latence.
English: Cattle from the age of 3 months onwards.
Slovenian: Govedo od 3 mesecev starosti naprej.
English: Cattle: from the age of 3 months onwards.
Slovenian: Govedo: od 3 mesecev starosti naprej.
English: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) SPAIN
Slovenian: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) ŠPANIJA
English: Each dose of 2 ml contains: Lyophilisate:
Slovenian: Vsak odmerek po 2 ml vsebuje: Liofilizat:
English: The recommended initial dose is 1 injection of 2 ml of the reconstituted vaccine per animal.
Slovenian: Priporočeni začetni odmerek je 1 injiciranje 2 ml rekonstituiranega cepiva na žival.