FrancophonIA/ELRC3.0 huggingface dataset:
English: Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy.
Slovenian: Pri bolnikih, ki so prejemali zdravljenje s perampanelom, so poročali o agresiji in sovražnem vedenju.
English: Clonazepam No influence
Slovenian: Lamotrigin ni vpliva
English: A similar result was seen in a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials.
Slovenian: Podoben je bil rezultat populacijske farmakokinetične analize pri bolnikih z napadi parcialnega izvora, ki so prejemali perampanel do 12 mg/dan, in bolnikih s primarnimi generaliziranimi napadi s tonično-kloničnimi krči, ki so prejemali perampanel do 8 mg/dan v kliničnih preskušanjih, kontroliranih s placebom.
English: Do not stop treatment without first discussing it with your doctor.
Slovenian: Preden prenehate z zdravljenjem, se posvetujte z zdravnikom.
English: In a population pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in a placebo-controlled clinical study, perampanel clearance was not influenced by baseline creatinine clearance.
Slovenian: V populacijski farmakokinetični analizi bolnikov s primarnimi generaliziranimi napadi s tonično-kloničnimi krči, ki so prejemali perampanel do 8 mg/dan v klinični študiji, kontrolirani s placebom, izhodiščni očistek kreatinina ni vplival na očistek perampanela.
English: perampanel oral suspension achieves equivalent AUC0-inf and approximately 23 % lower Cmax and 2 hours delay in time to peak exposure (tmax) compared to the tablet formulation.
Slovenian: Ko so dali enkraten 12-miligramski odmerek obeh oblik zdravila z zelo mastnim obrokom, je peroralna suspenzija perampanela dosegla enakovredno AUC0-inf in približno 23 % nižjo Cmax in dveurno podaljšanje časa do največje izpostavljenosti (tmax) v primerjavi z zdravilom v obliki tablet.
English: Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg film-coated tablets Perampanel
Slovenian: Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg in 12 mg filmsko obložene tablete perampanel
English: There were no effects on male fertility.
Slovenian: Na sposobnost razmnoževanja pri samcih ni bilo vpliva.
English: In all three trials, following a 6-week Baseline Phase to establish baseline seizure frequency prior to randomisation, subjects were randomised and titrated to the randomised dose.
Slovenian: V vseh treh preskušanjih so bile osebe randomizirane in titrirane do randomiziranega odmerka po 6-tedenski izhodiščni fazi, v kateri se je ugotavljala pogostnost napadov pred randomizacijo.
English: A clinically meaningful reduction in seizure frequency relative to placebo was achieved as early as the second week of dosing when patients reached a daily dose of 4 mg.
Slovenian: Že v drugem tednu uporabe, ko so bolniki dosegli dnevni odmerek 4 mg, je bilo doseženo klinično pomembno zmanjšanje pogostnosti napadov v primerjavi s placebom.
English: Dose adjustment is not required in patients with mild renal impairment.
Slovenian: Pri bolnikih z blago okvaro ledvic ni treba prilagajati odmerka.
English: Lactose monohydrate Low-substituted hydroxypropyl cellulose Povidone K-29/32
Slovenian: Jedro laktoza monohidrat nizko substituirana hidroksipropilceluloza povidon K-29/32 magnezijev stearat (E470b)
English: Fycompa 0.5 mg/ml oral suspension Perampanel
Slovenian: Fycompa 0,5 mg/ml peroralna suspenzija perampanel
English: Patients should be up-titrated using 2 mg (4 ml) doses no faster than every 2 weeks based on tolerability and effectiveness.
Slovenian: Odmerek za bolnika je treba vsaka 2 tedna povečati za 2 mg (4 ml) glede na prenašanje in učinkovitost.
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased up to 12 mg/day (24 ml/day), which may be effective in some patients (see section 4.4).
Slovenian: Glede na individualni klinični odziv in prenašanje pri odmerku 8 mg/dan (16 ml/dan) se lahko odmerek zvečuje do 12 mg/dan (24 ml/dan), ki je pri nekaterih bolnikih lahko učinkovit (glejte poglavje 4.4).
English: In a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials, a linear relationship was found between dose and perampanel plasma concentrations.
Slovenian: V farmakokinetični analizi populacije pri bolnikih z napadi parcialnega izvora, ki so prejemali perampanel do 12 mg/dan, in bolnikih s primarnimi generaliziranimi napadi s tonično-kloničnimi krči, ki so prejemali perampanel do 8 mg/dan v kliničnih preskušanjih, kontroliranih s placebom, so ugotovili linearno razmerje med odmerkom in koncentracijami perampanela v plazmi.
English: Do not start or stop other medicines without talking to your doctor or pharmacist.
Slovenian: Pred začetkom ali prenehanjem uporabe drugih zdravil se posvetujte z zdravnikom ali farmacevtom.
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased by increments of 2 mg/day (4 ml/day) to 12 mg/day (24 ml/day).
Slovenian: Glede na individualni klinični odziv in prenašanje pri odmerku 8 mg/dan (16 ml/dan) se lahko odmerek zvečuje postopoma po 2 mg/dan (4 ml/dan) do 12 mg/dan (24 ml/dan).
English: - It is also used to treat certain fits that affect all of your brain from the start (called “generalised seizures”) and cause convulsions or staring spells.
Slovenian: - Uporablja se tudi za zdravljenje nekaterih napadov, ki že od začetka prizadenejo cele možgane
English: Clobazam No influence
Slovenian: Klobazam ni vpliva
English: Each ml contains 0.5 mg perampanel.
Slovenian: En ml vsebuje 0,5 mg perampanela.
English: In the table below, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency.
Slovenian: Ugotovljeni so bili po pregledu celotne zbirke podatkov o varnosti kliničnih študij z zdravilom Fycompa.
English: 4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets - packs of 7, 28, 84 and 98
Slovenian: 2 mg tableta - pakiranje s 7, 28 in 98 tabletami 4 mg, 6 mg, 8 mg, 10 mg in 12 mg tableta - pakiranje s 7, 28, 84 in 98 tabletami
English: - Fycompa is not recommended in pregnancy.
Slovenian: Zdravila Fycompa ne uporabljajte pri nosečnicah.
English: If you have taken more Fycompa than you should contact your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Fycompa, kot bi smeli Če ste vzeli večji odmerek zdravila Fycompa, kot bi smeli, se takoj posvetujte z zdravnikom.
English: Fycompa 2 mg, 4 mg film-coated tablets
Slovenian: Fycompa 2 mg, 4 mg filmsko obložene tablete
English: The effects of perampanel on tasks involving alertness and vigilance such as driving ability were additive or supra-additive to the effects of alcohol itself, as found in a pharmacodynamic interaction study in healthy subjects.
Slovenian: V študiji farmakodinamičnih interakcij pri zdravih prostovoljcih so ugotovili, da so učinki perampanela na aktivnosti, za katere sta potrebni zbranost in budnost, denimo sposobnost vožnje bili aditivni ali supra-aditivni učinkom samega alkohola.
English: 8 mg tablet: Ferric Oxide, Red (E172), Ferric Oxide, Black (E172) 10 mg tablet: Ferric Oxide, Yellow (E172), FD&C Blue #2 Indigo carmine aluminium lake (E132) 12 mg tablet: FD&C Blue #2 Indigo carmine aluminium lake (E132)
Slovenian: 2 mg tableta: železov oksid, rumeni (E172), železov oksid, rdeči (E172) 4 mg tableta: železov oksid, rdeči (E172) 6 mg tableta: železov oksid, rdeči (E172) 8 mg tableta: železov oksid, rdeči (E172), železov oksid, črni (E172) 10 mg tableta: železov oksid, rumeni (E172), indigotin (E132) 12 mg tableta: indigotin (E132)
English: Perampanel dosing for patients with mild and moderate impairment should not exceed 8 mg. Use in patients with severe hepatic impairment is not recommended.
Slovenian: Odmerek perampanela naj pri bolnikih z blago do zmerno okvaro ne preseže 8 mg.
English: Valproic Acid No influence
Slovenian: 19-odstotno zmanjšanje ni vpliva valprojska kislina ni vpliva
English: 1.7 fold decrease
Slovenian: 1,7-kratno zmanjšanje ni vpliva topiramat
English: Fycompa 0.5 mg/ml oral suspension
Slovenian: Fycompa 0,5 mg/ml peroralna suspenzija
English: 7 Turn upright and remove the oral syringe.
Slovenian: Plastenko spet zasukajte navzgor in izvlecite brizgo za peroralno dajanje.
English: Each tablet contains 8 mg perampanel.
Slovenian: Ena tableta vsebuje 8 mg perampanela.
English: Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: ena 2 mg tableta vsebuje 78,5 mg laktoze (v obliki monohidrata).
English: How to take Fycompa
Slovenian: Kako jemati zdravilo Fycompa
English: Insert adaptor into the neck of the bottle until a tight seal is made.
Slovenian: V vrat plastenke vstavite nastavek, ki plastenko neprepustno zatesni.
English: Each film-coated tablet contains 8 mg perampanel.
Slovenian: Ena filmsko obložena tableta vsebuje 8 mg perampanela.
English: Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of perampanel.
Slovenian: Pri uporabi perampanela so poročali o hudih kožnih reakcijah, vključno z reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - drug reaction with eosinophilia and systemic symptoms).
English: Excipient with known effect: Each 8 mg tablet contains 149.0 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: ena 8 mg tableta vsebuje 149,0 mg laktoze (v obliki monohidrata).
English: Fycompa 8 mg tablets Perampanel
Slovenian: Fycompa 8 mg tablete perampanel
English: Each millilitre contains 0.5 mg of perampanel.
Slovenian: En mililiter vsebuje 0,5 mg perampanela.
English: Partial-Onset Seizures
Slovenian: Napadi parcialnega izvora
English: Red, round, biconvex tablet, engraved with E277 on one side and ‘4' on other side
Slovenian: Fycompa 4 mg filmsko obložene tablete rdeča, okrogla, bikonveksna tableta z vtisom E277 na eni strani površini in "4" na drugi strani
English: Orange, round, biconvex tablet, engraved with E275 on one side and ‘2' on other side
Slovenian: Fycompa 2 mg filmsko obložene tablete oranžna, okrogla, bikonveksna tableta z vtisom E275 na eni strani in "2" na drugi strani
English: Each ml of oral suspension contains 0.5 mg perampanel
Slovenian: En mililiter peroralne suspenzije vsebuje 0,5 mg perampanela.
English: Treatment with Fycompa should be initiated at a dose of 2 mg/day (4 ml/day).
Slovenian: Zdravljenje z zdravilom Fycompa je treba začeti pri odmerku 2 mg/dan (4 ml/dan).
English: Systemic Symptoms (DRESS)*
Slovenian: Bolezni kože in podkožja reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)*
English: Levetiracetam No influence
Slovenian: Zonisamid ni vpliva ni vpliva
English: Blue, round, biconvex tablet, engraved with E297 on one side and ‘12' on other side
Slovenian: Fycompa 12 mg filmsko obložene tablete modra, okrogla, bikonveksna tableta z vtisom E297 na eni strani in "12" na drugi strani
English: Treatment with Fycompa should be initiated at a dose of 2 mg/day.
Slovenian: Zdravljenje z zdravilom Fycompa je treba začeti pri odmerku 2 mg/dan.
English: Treatment with Fycompa should be initiated with a dose of 2 mg/day (4 ml/day).
Slovenian: Zdravljenje z zdravilom Fycompa je treba začeti z odmerkom 2 mg/dan (4 ml/dan).
English: Green, round, biconvex tablet, engraved with E296 on one side and ‘10' on other side
Slovenian: Fycompa 10 mg filmsko obložene tablete zelena, okrogla, bikonveksna tableta z vtisom E296 na eni strani in "10" na drugi strani
English: The oral syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
Slovenian: Brizgo za peroralno dajanje vstavite v PIBA, zasukajte plastenko na glavo in izvlecite odmerek v brizgo.
English: 1 press-in-bottle adapter (PIBA)
Slovenian: 2 brizgi za peroralno dajanje 1 vtisljiv nastavek (PIBA)
English: Each tablet contains 12 mg perampanel.
Slovenian: Ena tableta vsebuje 12 mg perampanela.
English: Fycompa 8 mg film-coated tablets
Slovenian: Fycompa 8 mg filmsko obložene tablete
English: Pink, round, biconvex tablet, engraved with E294 on one side and ‘6' on other side
Slovenian: Fycompa 6 mg filmsko obložene tablete rožnata, okrogla, bikonveksna tableta z vtisom E294 na eni strani in "6" na drugi strani
English: Excipient with known effect: Each 6 mg tablet contains 151.0 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: ena 6 mg tableta vsebuje 151,0 mg laktoze (v obliki monohidrata).
English: Each tablet contains 10 mg perampanel.
Slovenian: Ena tableta vsebuje 10 mg perampanela.
English: Each tablet contains 4 mg perampanel.
Slovenian: Ena tableta vsebuje 4 mg perampanela.
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with perampanel treatment (see section 4.4).
Slovenian: V povezavi z zdravljenjem z perampanelom so poročali o hudih kožnih neželenih reakcijah (SCAR), vključno z reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) (glejte poglavje 4.4).
English: Treatment with Fycompa should be initiated with a dose of 2 mg/day.
Slovenian: Zdravljenje z zdravilom Fycompa je treba začeti z odmerkom 2 mg/dan.
English: Fycompa 8 mg film-coated tablets 8 mg - packs of 7, 28, 84 and 98
Slovenian: Fycompa 8 mg filmsko obložene tablete 8 mg - pakiranje po 7, 28, 84 in 98
English: - These partial seizures may or may not then be followed by a fit affecting all of your brain
Slovenian: - Tem delnim napadom lahko sledi napad, ki prizadene cele možgane (imenovan „sekundarna generalizacija“).
English: Each tablet contains 6 mg perampanel.
Slovenian: Ena tableta vsebuje 6 mg perampanela.
English: Each tablet contains 2 mg perampanel.
Slovenian: Ena tableta vsebuje 2 mg perampanela.
English: Each film-coated tablet contains 10 mg perampanel.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg perampanela.
English: Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: ena 10 mg tableta vsebuje 147,0 mg laktoze (v obliki monohidrata).
English: Lamotrigine
Slovenian: Levodopa
English: Each film-coated tablet contains 12 mg perampanel.
Slovenian: Ena filmsko obložena tableta vsebuje 12 mg perampanela.
English: Each film-coated tablet contains 4 mg perampanel.
Slovenian: Ena filmsko obložena tableta vsebuje 4 mg perampanela.
English: What Fycompa contains
Slovenian: Kaj vsebuje zdravilo Fycompa
English: Purple, round, biconvex tablet, engraved with E295 on one side and ‘8' on other side
Slovenian: Fycompa 8 mg filmsko obložene tablete vijolična, okrogla, bikonveksna tableta z vtisom E295 na eni strani in "8" na drugi strani
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (4 ml) (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day (8 ml/day) to 8 mg/day (16 ml/day).
Slovenian: Odmerek se lahko zvečuje na podlagi kliničnega odziva in prenašanja postopoma po 2 mg (4 ml) (bodisi vsak teden bodisi vsaka 2 tedna ob upoštevanju razpolovnega časa, kot je opisano spodaj) do vzdrževalnega odmerka 4 mg/dan (8 ml/dan) do 8 mg/dan (16 ml/dan).
English: Fycompa 10 mg tablets Perampanel
Slovenian: Fycompa 10 mg tablete perampanel
English: Fycompa 8 mg film-coated tablets Perampanel
Slovenian: Fycompa 8 mg filmsko obložene tablete perampanel
English: Excipient with known effect: Each 12 mg tablet contains 145.0 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: ena 12 mg tableta vsebuje 145,0 mg laktoze (v obliki monohidrata).
English: Sorbitol (E420) liquid (crystallising)
Slovenian: 6.1 Seznam pomožnih snovi sorbitol (E420) tekoči (kristalizirajoči) mikrokristalna celuloza (E460) natrijev karmelozat (E466) poloksamer 188
English: 8 Leave the adaptor in place and replace cap on bottle.
Slovenian: Nastavek pustite v plastenki in jo zaprite z zaporko.
English: Each film-coated tablet contains 2 mg perampanel.
Slovenian: Ena filmsko obložena tableta vsebuje 2 mg perampanela.
English: Each film-coated tablet contains 6 mg perampanel.
Slovenian: Ena filmsko obložena tableta vsebuje 6 mg perampanela.
English: Excipient with known effect: Each 4 mg tablet contains 157.0 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: ena 4 mg tableta vsebuje 157,0 mg laktoze (v obliki monohidrata).
English: Fycompa 12 mg tablets Perampanel
Slovenian: Fycompa 12 mg tablete perampanel
English: AED coadministered
Slovenian: Sočasna uporaba AEZ
English: Fycompa 2 mg tablets Perampanel
Slovenian: Fycompa 2 mg tablete perampanel
English: Fycompa 10 mg film-coated tablets
Slovenian: Fycompa 10 mg filmsko obložene tablete
English: Fycompa 4 mg tablets Perampanel
Slovenian: Fycompa 4 mg tablete perampanel
English: Fycompa 6 mg tablets Perampanel
Slovenian: Fycompa 6 mg tablete perampanel
English: Fycompa 4 mg film-coated tablets 4 mg - packs of 7, 28, 84 and 98
Slovenian: Fycompa 4 mg filmsko obložene tablete 4 mg - pakiranje po 7, 28, 84 in 98
English: Fycompa 12 mg film-coated tablets 12 mg - packs of 7, 28, 84 and 98
Slovenian: Fycompa 12 mg filmsko obložene tablete 12 mg - pakiranje po 7, 28, 84 in 98
English: Fycompa 10 mg film-coated tablets 10 mg - packs of 7, 28, 84 and 98
Slovenian: Fycompa 10 mg filmsko obložene tablete 10 mg - pakiranje po 7, 28, 84 in 98
English: Fycompa 12 mg film-coated tablets
Slovenian: Fycompa 12 mg filmsko obložene tablete
English: Fycompa 10 mg film-coated tablets Perampanel
Slovenian: Fycompa 10 mg filmsko obložene tablete perampanel
English: Patients should be up-titrated using 2 mg doses no faster than every 2 weeks based on tolerability and effectiveness.
Slovenian: Za bolnike z blago ali zmerno okvaro jeter se lahko odmerjanje začne pri 2 mg. Odmerek za bolnika je treba vsaka 2 tedna povečati za 2 mg glede na prenašanje in učinkovitost.
English: Fycompa 2 mg film-coated tablets
Slovenian: Fycompa 2 mg filmsko obložene tablete
English: Fycompa 4 mg film-coated tablets
Slovenian: Fycompa 4 mg filmsko obložene tablete
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks, as per half-life considerations described below) to a maintenance dose of up to 8 mg/day.
Slovenian: Odmerek se lahko zvečuje na podlagi kliničnega odziva in prenašanja postopoma po 2 mg (bodisi vsak teden bodisi vsaka 2 tedna ob upoštevanju razpolovnega časa, kot je opisano spodaj) do vzdrževalnega odmerka, ki je do 8 mg/dan.
English: How to store Fycompa
Slovenian: Shranjevanje zdravila Fycompa
English: Fycompa 12 mg film-coated tablets Perampanel
Slovenian: Fycompa 12 mg filmsko obložene tablete perampanel
English: Fycompa 6 mg film-coated tablets
Slovenian: Fycompa 6 mg filmsko obložene tablete
English: The 50% responder rate was 22.2% in combination with enzyme-inducing anti-epileptic medicinal products and was 69.4% when perampanel was given in combination with non-enzyme-inducing anti-epileptic medicinal products.
Slovenian: 50 % stopnja odziva pri primarnih generaliziranih napadih s tonično-kloničnimi krči v obdobju vzdrževanja je bila značilno višja v skupini s perampanelom (58,0 %) kot v skupini s placebom (35,8 %), P = 0,0059. 50 % stopnja odziva je bila 22,2 % v kombinaciji z antiepileptičnimi zdravili, ki spodbujajo encime, ter 69,4 % pri dajanju perampanela v kombinaciji z antiepileptičnimi zdravili, ki ne spodbujajo encimov.
English: Fycompa 6 mg film-coated tablets 6 mg - packs of 7, 28, 84 and 98
Slovenian: Fycompa 6 mg filmsko obložene tablete 6 mg - pakiranje po 7, 28, 84 in 98
English: Titanium dioxide (E171) Ferric oxide, yellow (E172) Ferric oxide, red (E172)
Slovenian: Filmska obloga hipromeloza 2910 smukec makrogol 8000 titanov dioksid (E171) železov oksid, rumeni (E172) železov oksid, rdeči (E172)
English: Fycompa 6 mg film-coated tablets Perampanel
Slovenian: Fycompa 6 mg filmsko obložene tablete perampanel
English: Fycompa 2 mg film-coated tablets Perampanel
Slovenian: Fycompa 2 mg filmsko obložene tablete perampanel
English: Fycompa 4 mg film-coated tablets Perampanel
Slovenian: Fycompa 4 mg filmsko obložene tablete perampanel
English: Do not drive or use machines until you know how Fycompa affects you.
Slovenian: Dokler ne veste, kako zdravilo Fycompa vpliva na vas, ne upravljajte vozil in strojev.
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (4 ml/day) (either weekly or every 2 weeks, as per half-life considerations described below) to a maintenance dose of up to 8 mg/day (16 ml/day).
Slovenian: Odmerek se lahko zvečuje na podlagi kliničnega odziva in prenašanja postopoma po 2 mg (4 ml) (bodisi vsak teden bodisi vsaka 2 tedna ob upoštevanju razpolovnega časa, kot je opisano spodaj) do vzdrževalnega odmerka, ki je do 8 mg/dan (16 ml/dan).
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day.
Slovenian: Odmerek se lahko zvečuje na podlagi kliničnega odziva in prenašanja postopoma po 2 mg (bodisi vsak teden bodisi vsaka 2 tedna ob upoštevanju razpolovnega časa, kot je opisano spodaj) do vzdrževalnega odmerka 4 mg/dan do 8 mg/dan.
English: Diplopia Vision blurred
Slovenian: Očesne bolezni dvojni vid zamegljen vid
English: System Organ Class
Slovenian: Preiskave povečanje telesne mase
English: Hepatic impairment
Slovenian: Bolezni prebavil navzea
English: EXP {month/year}
Slovenian: EXP {mesec/ leto}
English: One dose (30 µl) contains:
Slovenian: En odmerek (30 µl) vsebuje:
English: See also section 4.7
Slovenian: Glejte tudi poglavje 4. 7.
English: This may occur during the whole life of the vaccinated bird.
Slovenian: Do tega lahko pride v celotnem obdobju življenja cepljene ptice.
English: du Plessis Beuscher 35220 Chateaubourg France
Slovenian: du Plessis Beuscher 35220 Chateaubourg
English: 1000 doses
Slovenian: 1000 odmerkov
English: Date of first authorisation: 14/06/2011 Date of last renewal: 17/05/2016
Slovenian: Datum pridobitve dovoljenja za promet: 14/06/2011 Datum podaljšanja dovoljenja za promet: 17/05/2016
English: The MS-H vaccine should always be protected from direct sunlight.
Slovenian: Cepivo MS-H mora biti vedno zaščiteno pred neposredno sončno svetlobo.
English: Do not thaw at higher temperatures or for longer time periods.
Slovenian: Ne odtajajte pri višji temperaturi ali daljše časovno obdobje.
English: Allow the bird to blink before releasing it.
Slovenian: Pustite, da ptica mežikne, preden jo spustite.
English: Chickens from 5 weeks of age
Slovenian: Piščanci od starosti 5 tednov
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne neželene učinke ali druge učinke, ki niso omenjeni v tem navodilu za uporabo, obvestite svojega veterinarja.
English: Laboratoire LCV Z.I.
Slovenian: Laboratoire LCV
English: They should not be given within 2 weeks after vaccination.
Slovenian: Ti se ne smejo dati v obdobju dveh tednov po cepljenju.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Učinkovina(e):
English: Use at room temperature (22-27°C) within 2 hours after thawing.
Slovenian: Po odtajanju uporabite pri sobni temperaturi (22-27 °C) v roku dveh ur po odtajanju.
English: DO7 PF53
Slovenian: Dublin DO7 PF53 Irska
English: Chickens should be vaccinated once by applying one eye drop (30 µl) from 5 weeks of age and at least 5 weeks before the onset of the laying period.
Slovenian: Piščance je treba cepiti enkrat z uporabo ene kapljice v oko (30 µl), in sicer od starosti 5 tednov naprej in vsaj 5 tednov pred obdobjem nesnosti.