FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Priloga I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Other studies have been conducted in rats under different experimental conditions leading to increased ammonia availability (starvation, protein-free or high-protein diet).
Slovenian: V drugih raziskavah na podganah, ki so jih izvajali pod različnimi eksperimentalnimi pogoji, so dobili povečano raven amoniaka (stradanje, dieta brez beljakovin ali visokobeljakovinska dieta).
English: What you need to know before you take Ucedane Do not take Ucedane:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ucedane Ne jemljite zdravilaUcedane:
English: The pharmacokinetics of carglumic acid has been studied in healthy male volunteers using both radiolabelled and unlabelled product.
Slovenian: Farmakokinetiko kargluminske kisline so proučevali pri zdravih prostovoljcih moškega spola z radioaktivno označenim in neoznačenim zdravilom.
English: Your doctor may prescribe supplemental arginine or restrict your protein intake.
Slovenian: Zdravnik vam lahko predpiše dodatek arginina ali omeji vnos beljakovin.
English: The initial daily dose should be 100 mg/kg, up to 250 mg/kg if necessary.
Slovenian: Začetni dnevni odmerek mora znašati 100 mg/kg, po potrebi pa do 250 mg/kg.
English: In one patient treated with carglumic acid, where the dose was increased up to 750 mg/kg/day, symptoms of intoxication occurred which can be characterised as a sympathomimetic reaction: tachycardia, profuse sweating, increased bronchial secretion, increased body temperature and restlessness.
Slovenian: Pri enem bolniku, zdravljenem s kargluminsko kislino, pri katerem se je odmerek povečal do 750 mg/kg/dan, so se pojavili znaki zastrupitve, ki so značilni za simpatomimetično reakcijo: tahikardija, močno znojenje, povečano izločanje bronhialne sluzi, povišana telesna temperatura in nemir.
English: Lucane Pharma 172 rue de Charonne
Slovenian: Izdelovalec Lucane Pharma 172 rue de Charonne
English: In rats and rabbits no evidence has been seen of embryotoxicity, foetotoxicity or teratogenicity up to maternotoxic doses leading to fifty times exposure as compared to humans in rats and seven times in rabbits.
Slovenian: Pri podganah in kuncih niso našli znakov embriotoksičnosti, fetotoksičnosti ali teratogenosti vse do odmerkov, toksičnih za mater, kar je pomenilo pri podganah petdesetkrat, pri kuncih pa sedemkrat večjo izpostavljenost kot pri ljudeh.
English: The initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight (for example, if you weight 10 kg, you should take 1 g per day, or 5 tablets of 200 mg).
Slovenian: Začetni dnevni odmerek je običajno 100 mg na kilogram telesne mase, do največ 250 mg na kilogram telesne mase (če na primer tehtate 10 kg, morate dobiti 1 g na dan, kar je pet tablet po 200 mg).
English: Single doses of carglumic acid up to 2800 mg/kg orally and 239 mg/kg intravenously did not induce any mortality or abnormal clinical signs in adult rats.
Slovenian: Kargluminska kislina v enkratnih odmerkih do 2 800 mg/kg peroralno in 239 mg/kg intravensko pri odraslih podganah ni povzročila smrtnosti ali nenormalnih kliničnih znakov.
English: The plasma elimination curve of carglumic acid is biphasic with a rapid phase over the first 12 hours after administration followed by a slow phase (terminal half-life up to 28 hours).
Slovenian: Krivulja eliminacije kargluminske kisline iz plazme je dvofazna s hitro fazo v prvih 12 urah po uporabi, sledi pa ji počasna faza (terminalni razpolovni čas do 28 ur).
English: Pack size of 12 or 60 tablets.
Slovenian: Velikost pakiranja 12 ali 60 tablet.
English: Safety pharmacology studies have shown that carglumic acid administered orally at doses of 250, 500, 1000 mg/kg had no statistically significant effect on respiration, central nervous system and cardiovascular system.
Slovenian: V študijah farmakološke varnosti niso ugotovili, da bi kargluminska kislina v peroralnih odmerkih po 250, 500 in 1 000 mg/kg imela statistično pomembne učinke na dihala, osrednji živčni sistem in srčnožilni sistem.
English: After a single oral dose of 100 mg/kg body weight, 9% of the dose is excreted unchanged in the urine and up to 60% in the faeces.
Slovenian: Po enkratnem peroralnem odmerku 100 mg/kg telesne mase se 9 % odmerka izloči v nespremenjeni obliki v urinu, do 60 % pa v blatu.
English: Other medicines and Ucedane
Slovenian: Druga zdravila in zdravilo Ucedane
English: Breast-feeding Although it is not known whether carglumic acid is secreted into human milk, it has been shown to be present in the milk of lactating rats (see section 5.3).
Slovenian: Čeprav ni znano, ali se kargluminska kislina izloča v materino mleko, so dokazali njeno prisotnost v mleku doječih podgan (glejte poglavje 5.3).
English: At that dose-level, in 12 volunteers given carglumic acid tablets, plasma concentration peaked at 2.6 μg/mL (median; range 1.8-4.8) after 3 hours (median; range 2-4).
Slovenian: Pri tej velikosti odmerka je koncentracija v plazmi pri 12 prostovoljcih, ki so prejeli kargluminsko kislino, dosegla vrh pri 2,6 µg/ml (mediana; območje 1,8-4,8) po 3 urah (mediana; območje 2-4).
English: This could be explained by the following observations: i) The mitochondrial membrane is more readily permeable for carglumic acid than for Nacetylglutamate ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in the cytosol.
Slovenian: To se da razložiti z naslednjimi ugotovitvami: i) mitohondrijska membrana je bolj propustna za kargluminsko kislino kot za N-acetilglutamat; ii) kargluminska kislina je v primerjavi z N-acetilglutamatom odpornejša za hidrolizo z aminoacilazo v citosolu.
English: Nutritional management
Slovenian: Uravnavanje s prehrano
English: The tablets must be dispersed in a minimum of 5-10 mL of water and ingested immediately or administered by fast push through a syringe via a nasogastric tube.
Slovenian: Tablete je treba dispergirati v najmanj 5-10 ml vode in takoj zaužiti ali aplicirati s hitrim vbrizganjem skozi nazogastrično sondo.
English: In newborn rats receiving daily carglumic acid by oral gavage for 18 days as well as in young rats receiving daily carglumic acid for 26 weeks, the No Observed Effect Level (NOEL) was established at 500 mg/kg/day and the No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/kg/day.
Slovenian: Pri novorojenih podganah, ki so prejemale kargluminsko kislino 18 dni po oralni sondi, kot tudi pri mladih podganah, ki so prejemale kargluminsko kislino dnevno 26 tednov, je bila meja ravni brez opaznih učinkov (NOEL - No Observed Effect Level) pri 500 mg/kg/dan, meja brez opaznih neželenih učinkov (NOAEL - No Adverse Effect Level) pa pri 1 000 mg/kg/dan.
English: Do not take a double dose to make up for forgotten individual doses.
Slovenian: Če ste pozabili vzeti zdravilo Ucedane Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Uncommon increased transaminases
Slovenian: Preiskave občasni zvišane transaminaze
English: When the patient is in hyperammonaemic coma, Ucedane is administered by fast push through a syringe via the tube set up and used to feed you.
Slovenian: Kadar je bolnik v hiperamonemični komi, se zdravilo Ucedane daje z naglim izbrizgom iz brizge skozi vstavljeno cevko, po kateri vas hranijo.
English: Ucedane should ONLY be administered by mouth or via a feeding tube into the stomach (using a syringe, if necessary).
Slovenian: Zdravilo Ucedane se sme dajati SAMO peroralno ali prek cevke za hranjenje v želodec (po potrebi z brizgo).
English: sodium stearyl fumarate, mannitol, copovidone K28, crospovidone type B.
Slovenian: manitol, kopovidon K28, krospovidon tipa B.
English: The tablets are presented in Aluminium/aluminium blister packed in cartons.
Slovenian: Tablete so na voljo v aluminijastem pretisnem omotu, zapakiranem v škatlo.
English: In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid normalisation of plasma ammonia levels, usually within 24 hours.
Slovenian: Ugotovili so, da pri bolnikih s pomanjkanjem N-acetilglutamat-sintaze kargluminska kislina hitro normalizira ravni amoniaka v plazmi, običajno že v 24 urah.
English: What you need to know before you take Ucedane 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ucedane
English: Absorption After a single oral dose of 100 mg/kg body weight, approximately 30% of carglumic acid is estimated to be absorbed.
Slovenian: Ocenjujejo, da se po enkratnem peroralnem odmerku 100 mg/kg telesne mase absorbira približno 30 % kargluminske kisline.
English: Ucedane dispersible tablets are rod-shaped, white, and biconvex with three score lines on both sides and engraving “L/L/L/L” on one side.
Slovenian: Izgled zdravila Ucedane in vsebina pakiranja Disperzibilne tablete Ucedane so palične, bele in bikonveksne s tremi zarezami na obeh straneh in vtisnjeno oznako “L/L/L/L” na eni.
English: - In a patient with moderate hyperammonaemia, administer a test dose of 100 to 200 mg/kg/day for 3 days with a constant protein intake and perform repeated determinations of ammonia plasma concentration (before and 1 hour after a meal); adjust the dose in order to maintain normal ammonia plasma levels.
Slovenian: - bolnik z zmerno hiperamoniemijo naj tri dni prejema poskusni odmerek od 100 do 200 mg/kg/dan ob stalnem vnosu beljakovin; preverjanje koncentracij amoniaka v plazmi se ponavlja (pred jedjo in eno uro po jedi); za vzdrževanje normalnih ravni amoniaka v plazmi se odmerek ustrezno prilagodi.
English: Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring activator of carbamoyl phosphate synthetase, the first enzyme of the urea cycle.
Slovenian: Kargluminska kislina je strukturni analog N-acetilglutamata, ki je naravni vzpodbujevalec karbamoilfosfat-sintetaze, prvega encima ciklusa sečnine.
English: Hyperammonaemia may be due to the lack of a specific liver enzyme N- acetylglutamate synthase.
Slovenian: Hiperamoniemija lahko nastane zaradi pomanjkanja določenega jetrnega encima, N-acetilglutamatsintaze.
English: In the long term, it may not be necessary to increase the dose according to body weight as long as adequate metabolic control is achieved; daily doses range from 10 mg/kg to 100 mg/kg.
Slovenian: Če je doseženo ustrezno obvladovanje presnove, dolgoročno ni nujno povečevati odmerka glede na telesno maso; dnevni odmerki znašajo od 10 mg/kg do 100 mg/kg.
English: For carglumic acid no clinical data on exposed pregnancies are available.
Slovenian: Kliničnih podatkov o nosečnicah, ki so bile izpostavljene zdravilu, za kargluminsko kislino ni na voljo.
English: How to take Ucedane
Slovenian: Kako jemati zdravilo Ucedane
English: Each tablet contains 200 mg of carglumic acid.
Slovenian: Ena tableta vsebuje 200 mg kargluminske kisline.
English: No carcinogenicity study has been conducted with carglumic acid.
Slovenian: Študij kancerogenosti v zvezi s kargluminsko kislino niso izvajali.
English: In order to follow-up your condition and your treatment, your doctor may examine your liver, your kidneys, your heart and your blood on a regular basis.
Slovenian: Zdravnik vam bo mogoče redno pregledoval jetra, ledvici, srce in kri, da bo spremljal vaše zdravstveno stanje in zdravljenje.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients microcrystalline cellulose, mannitol, colloidal anhydrous silica, sodium stearyl fumarate, crospovidone type B, copovidone K 28.
Slovenian: 6.1 Seznam pomožnih snovi mikrokristalna celuloza, manitol, brezvodni koloidni silicijev dioksid, natrijev stearilfumarat, krospovidon tipa B, kopovidon K 28
English: • diarrhoea,
Slovenian: • driska,
English: In the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.
Slovenian: Ob dolgotrajnem zdravljenju se dnevni odmerek običajno giblje med 10 mg in 100 mg na kilogram telesne mase.
English: Diffusion into erythrocytes is non-existent.
Slovenian: Zdravilo ne difundira v eritrocite.
English: If you have any further questions on the use of this medicine, ask your doctor, or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Lucane Pharma
English: Pack size of 12 or 60 dispersible tablets.
Slovenian: Velikost pakiranja 12 ali 60 disperzibilnih tablet.
English: Despite a lower affinity of carbamoyl phosphate synthetase for carglumic acid than for Nacetylglutamate, carglumic acid has been shown in vivo to stimulate carbamoyl phosphate synthetase and to be much more effective than N-acetylglutamate in protecting against ammonia intoxication in rats.
Slovenian: Čeprav ima karbamoilfosfat-sintetaza nižjo afiniteto za kargluminsko kislino kot za N-acetilglutamat, so raziskave in vivo na podganah pokazale, da kargluminska kislina stimulira karbamoilfosfatsintetazo in v primerjavi z N-acetilglutamatom veliko učinkoviteje ščiti pred zastrupitvijo z amoniakom.
English: Effects on the ability to drive and use machines are not known.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Vpliv na sposobnost vožnje in upravljanja strojev ni znan.
English: Uncommon diarrhea, vomiting
Slovenian: Bolezni prebavil občasni diareja, bruhanje
English: Carglumic acid is secreted in the milk of lactating rats and although developmental parameters were unaffected, there were some effects on body weight / body weight gain of pups breast-fed by dams treated with 500 mg/kg/day and a higher mortality of pups from dams treated with
Slovenian: Kargluminska kislina se izloča v mleku doječih podgan, in čeprav razvojni parametri niso bili prizadeti, sta se pokazala manjši vpliv na telesno maso/naraščanje telesne mase mladičev, ki so jih dojile samice, ki so prejemale 500 mg/kg/dan, in večja smrtnost mladičev samic, ki so prejeli odmerek 2000 mg/kg/dan, kar je odmerek, ki je povzročil toksičnost za mater.
English: This medicine is for oral use ONLY (ingestion or via nasogastric tube using a syringe, if necessary).
Slovenian: Način uporabe To zdravilo je SAMO za peroralno uporabo (zaužitje ali prek nazogastrične sonde, po potrebi z brizgo).
English: Blister (ALU/ALU) packed in cartons.
Slovenian: Škatla s (ALU/ALU) pretisnim omotom.
English: - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica,
Slovenian: - Pomožne snovi so mikrokristalna celuloza, , brezvodni koloidni silikagel, natrijev stearilfumarat,
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Vpliva na sposobnost vožnje in upravljanja strojev niso raziskovali.
English: As examples: - In a comatose child, start with a dose of 100 to 250 mg/kg/day and measure ammonia plasma concentration at least before each administration; it should normalise within a few hours after starting Ucedane.
Slovenian: - pri komatoznih otrocih je treba začeti z odmerkom 100 do 250 mg/kg/dan in preverjati koncentracijo amoniaka v plazmi vsaj pred vsako aplikacijo; vrednosti bi se morale normalizirati nekaj ur po uvedbi zdravljenja z zdravilom Ucedane;
English: Ucedane must be taken orally before meals or feedings.
Slovenian: Zdravilo Ucedane skupaj s hrano in pijačo Zdravilo Ucedane morate jemati peroralno pred obrokom hrane ali hranjenjem.
English: Ucedane 200 mg dispersible tablets
Slovenian: Ucedane 200 mg disperzibilne tablete
English: Ucedane is indicated in treatment of hyperammonaemia due to N-acetylglutamate synthase primary deficiency.
Slovenian: Zdravilo Ucedane je indicirano za zdravljenje hiperamoniemije, ki je posledica primarnega pomanjkanja N-acetilglutamat-sintaze.
English: Do not stop Ucedane without informing your doctor.
Slovenian: Če ste prenehali jemati zdravilo Ucedane Ne prenehajte jemati zdravilaUcedane, če niste obvestili zdravnika.
English: The breaking of the tablets in halves allows most of the required posology adjustments.
Slovenian: Z razpolavljanjem tablet je običajno mogoče doseči zahtevano prilagoditev odmerka.
English: Ucedane can help eliminating excessive ammonia plasma levels (elevated ammonia level in the blood).
Slovenian: Kaj je zdravilo Ucedane in za kaj ga uporabljamo Zdravilo Ucedane lahko pomaga zniževati prvisoke ravni amonijaka v plazmi (povišana raven amoniaka v krvi).
English: Dispersible tablet.
Slovenian: disperzibilne tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON X 60 TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA X 60 TABLET
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON X 12 TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA X 12 TABLET
English: Protein restriction and arginine supplementation may be indicated in case of low protein tolerance.
Slovenian: Pri slabem prenašanju beljakovin je lahko umestno omejevanje vnosa beljakovin in dodajanje arginina.
English: Carglumic acid
Slovenian: Test odgovora na kargluminsko kislino
English: Eurocept International BV Trapgans 5
Slovenian: Eurocept International BV
English: Nevertheless, as carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects for their fed pups, you must not breast-feed your baby if you are taking Ucedane.
Slovenian: Vendar ne smete dojiti svojega otroka, če jemljete zdravilo Ucedane, ker so v mleku doječih podgan dokazali kargluminsko kislino, ki ima lahko toksične učinke za njihove dojene mladiče.
English: FrostPharma AB Puh/Tel: +35 875 32 51 209 info@frostpharma.com
Slovenian: Suomi/Finland FrostPharma AB Puh/Tel: +35 875 32 51 209 info@frostpharma.com
English: Uncommon bradycardia
Slovenian: Srčne bolezni občasni bradikardija
English: The dose should be individually adjusted in order to maintain normal ammonia plasma levels.
Slovenian: Za vzdrževanje normalne ravni amoniaka v plazmi je treba odmerek individualno prilagoditi.
English: Consult your doctor for advice if you are pregnant or planning to become pregnant.
Slovenian: Če ste noseči ali če načrtujete zanositev, se posvetujte z zdravnikom.
English: Ucedane 200 mg dispersible tablets carglumic acid
Slovenian: Ucedane 200 mg disperzibilne tablete kargluminska kislina
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), , ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Talk to your doctor or pharmacist before taking Ucedane.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Ucedane se posvetujte z zdravnikom ali farmacevtom.
English: - The active substance is carglumic acid.
Slovenian: Kaj vsebuje zdravilo Ucedane - Učinkovina je kargluminska kislina.
English: Carglumic acid showed no significant mutagenic activity in a battery of genotoxicity tests performed in vitro (Ames test, human lymphocyte metaphase analysis) and in vivo (micronucleus test in rat).
Slovenian: S serijo genotoksičnih testov in vitro (Amesov test, analiza metafaze humanih limfocitov) kot tudi in vivo (mikrojedrni test pri podganah) niso ugotovili, da bi kargluminska kislina imela pomembne mutagene učinke.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja pogosti povečano znojenje neznana izpuščaj
English: Metabolism
Slovenian: Absorpcija
English: 12 dispersible tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 12 disperzibilnih tablet
English: Lucane Pharma Tél/Tel: + 33 153 868 750 info@lucanepharma.com
Slovenian: Česká republika Lucane Pharma Tél/Tel: + 33 153 868 750 info@lucanepharma.com
English: It should then be adjusted individually in order to maintain normal ammonia plasma levels (see section 4.4).
Slovenian: Za vzdrževanje normalne ravni amoniaka v plazmi je treba nato odmerek individualno prilagajati
English: 60 dispersible tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 60 disperzibilnih tablet
English: PC:
Slovenian: Odmerjanje:
English: 19 June 2015
Slovenian: 19. junij 2015
English: March 2015 CMDh
Slovenian: marec 2015, CMDh
English: Implementation of the agreement by the Member States (submission of the Type IB variation by the Marketing Authorisation Holder):
Slovenian: Izvajanje sporazuma v državah članicah (imetnik dovoljenja za promet z zdravilom predložil vlogo za spremembo tipa IB dne):
English: Annex IV
Slovenian: Priloga IV Časovni razpored za izvajanje sporazuma
English: This summary was last updated in May 2013.
Slovenian: Povzetek je bil nazadnje posodobljen maja 2013.
English: The safety of the vaccine was studied in two main laboratory safety studies carried out in sheep (overdose and single and repeated administration) and two studies carried out in pregnant ewes.
Slovenian: Varnost zdravila je bila raziskana v dveh glavnih laboratorijskih študijah varnosti, ki sta bili opravljeni pri ovcah (prekomerno odmerjanje ter enkratna in ponavljajoča se uporaba), in dveh študijah, opravljenih pri brejih ovcah.
English: The vaccine was generally well tolerated as demonstrated by the absence of major systemic reactions.
Slovenian: Cepivo so ovce na splošno dobro prenašale, saj se niso pojavile večje sistemske reakcije.
English: Protection starts three weeks after the last injection and lasts for one year.
Slovenian: Zaščita je učinkovita od tretjega tedna po zadnji injekciji in traja eno leto.
English: The first injection is given from one and a half months age and the second injection is given three weeks later.
Slovenian: Prva injekcija se daje od starosti enega meseca in pol, druga pa tri tedne pozneje.
English: There may be a local reaction at the injection site, such as swelling (lasting no more than one week) or ‘nodules' (hardening under the skin) possibly lasting more than six or seven weeks.
Slovenian: Po cepljenju se lahko pojavi lokalna reakcija na mestu injiciranja, kot je oteklina (ki ne traja več kot teden dni) ali „noduli“ (zatrdline pod kožo), ki lahko trajajo več kot šest ali sedem tednov.
English: When it is given to sheep and cattle, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Slovenian: Ko ovce in govedo prejmejo cepivo, njihov imunski sistem viruse prepozna kot „tujke“ in proti njim razvije protitelesa.
English: Sheep may show a temporary increase in rectal temperature, not more than 1.2 °C in the 24 hours following vaccination.
Slovenian: V 24 urah po cepljenju se lahko pri ovcah pojavi prehodno povišanje rektalno merjene temperature, ki pa ne presega 1,2℃.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 1+8 Ovis to convert to a normal status.
Slovenian: Leta 2013 je CVMP menil, da predloženi podatki zadostujejo, da dovoljenje za promet s cepivom ZULVAC 1+8 Ovis dobi običajen status.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for ZULVAC 1+8 Ovis on 14 March 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom ZULVAC 1+8 Ovis, veljavno po vsej Evropski uniji, odobrila dne 14. marca 2011.
English: ZULVAC 1+8 Ovis was initially authorised under ‘exceptional circumstances'.
Slovenian: Cepivo ZULVAC 1+8 Ovis je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: Inactivated adjuvanted vaccine against bluetongue disease virus, serotypes 1 and 8
Slovenian: Inaktivirano cepivo z adjuvansom proti virusu bolezni modrikastega jezika, serotipa 1 in 8
English: The efficacy of the vaccine was studied in four main laboratory trials in sheep of young age where animals were challenged with both BTV-1 and BTV-8 serotypes using ZULVAC 1-8 Ovis vaccines containing low antigen quantities.
Slovenian: Učinkovitost cepiva so proučevali v štirih glavnih laboratorijskih študijah pri mladih ovcah, pri čemer so bile ob uporabi cepiva ZULVAC 1+8 Ovis, ki je vseboval majhne količine antigena, izpostavljene serotipoma BTV-1 in BTV-8.