FrancophonIA/ELRC3.0 huggingface dataset:
English: Potential serious risks were identified during the decentralised procedure by Denmark regarding the cumulative failure rate observed in the pivotal clinical field trial and potential for development of antimicrobial resistance to florfenicol.
Slovenian: Med decentraliziranim postopkom je Danska ugotovila morebitna resna tveganja, povezana s kumulativno stopnjo neuspešnosti zdravljenja, ki so jo zabeležili med ključno klinično terensko študijo, ter nevarnostjo za razvoj odpornosti mikrobov proti florfenikolu.
English: The reconsideration procedure started on 10 October 2012.
Slovenian: Postopek ponovne preučitve mnenja se je začel 10. oktobra 2012.
English: The referral procedure started on 10 January 2012.
Slovenian: Napotitveni postopek se je začel 10. januarja 2012.
English: Oral explanations were given by the applicant on 10 January 2013.
Slovenian: Predlagatelj je 10. januarja 2013 podal ustna pojasnila.
English: The Committee re-appointed Prof Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur for the reconsideration procedure.
Slovenian: Odbor je za poročevalca in soporočevalko v postopku ponovno imenoval prof. Christiana Friisa in dr. Cornelio Ibrahim.
English: Day 60 of the CMD(v) procedure was on 15 December 2011, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Slovenian: Ker na 60. dan postopka CMD(v), 15. decembra 2011, zadevne države članice še vedno niso dosegle soglasja v zvezi z zdravilom, je bil postopek napoten na CVMP.
English: Nuflor Swine Once 450 mg per ml solution for injection contains florfenicol as active ingredient and is intended for use in pigs for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae, Haemophilus parasuis and Pasteurella multocida susceptible to florfenicol.
Slovenian: Zdravilo Nuflor Swine Once 450 mg/ml raztopina za injiciranje vsebuje zdravilno učinkovino florfenikol in je namenjeno zdravljenju prašičev z okužbami dihal, ki jih povzročajo sevi za florfenikol občutljivih bakterij Actinobacillus pleuropneumoniae, Haemophilus parasuis in Pasteurella multocida.
English: On 19 December 2011, the reference Member State, Germany, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Slovenian: Referenčna država članica, Nemčija, je 19. decembra 2011 obvestila Evropsko agencijo za zdravila, da Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)) ni dosegla soglasja v zvezi z zdravilom, in zadevo napotila na CVMP skladno s členom 33(4) Direktive 2001/82/ES.
English: The proposed dose is 30 mg florfenicol per kg bodyweight given by intramuscular administration as a single injection.
Slovenian: Predlagani odmerek je 30 mg florfenikola na kg telesne mase, ki se daje intramuskularno z enkratnim injiciranjem.
English: This was a ‘hybrid application' according to Article 13(3) Directive 2001/82/EC, as amended, referring to the reference product, Nuflor Swine 300 mg/ml solution for injection (FR/V/0118/001).
Slovenian: V skladu s členom 13(3) dopolnjene Direktive 2001/82/ES je šlo za „hibridno vlogo‟, ki se nanaša na referenčno zdravilo Nuflor Swine Once 300 mg/ml raztopina za injiciranje (FR/V/0118/001).
English: On 31 August 2012, the Netherlands submitted an objection to the opinion adopted by CVMP on 13 June 2012 during the written phase of the Standing Committee procedure.
Slovenian: Nizozemska je med pisnim delom postopka stalnega odbora, 31. avgusta 2012 vložila ugovor zoper mnenje, ki ga je 13. junija 2012 sprejel CVMP.
English: Based on the evaluation of the available data, the CVMP adopted, on 13 June 2012, an opinion recommending the granting of marketing authorisations for Nuflor Swine Once 450 mg/ml solution for injection, subject to certain conditions.
Slovenian: Na podlagi ocene razpoložljivih podatkov je CVMP dne 13. junija 2012 sprejel mnenje, v katerem je priporočil odobritev dovoljenja za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje pod določenimi pogoji.
English: Nuflor Swine Once 450 mg/ml solution for injection differs from the reference veterinary medicinal product by a higher concentration of active substance, single administration, a change in therapeutic indication but also by a different co-solvent.
Slovenian: Zdravilo Nuflor Swine Once 450 mg/ml raztopina za injiciranje se od referenčnega zdravila za uporabo v veterinarski medicini razlikuje po večji koncentraciji zdravilne učinkovine, enkratni aplikaciji, spremenjeni terapevtski indikaciji in po drugačnem pomožnem topilu.
English: Written explanations were provided by the applicant on 20 March 2012.
Slovenian: Predlagatelj je 20. marca 2012 predložil pisna pojasnila ter 15. maja 2012 še ustna pojasnila.
English: The applicant, Intervet International BV, submitted an application for a decentralised procedure for Nuflor Swine Once 450 mg/ml solution for injection.
Slovenian: Predlagatelj, Intervet International BV, je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje po decentraliziranem postopku.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures
Slovenian: Ker ta vprašanja na 210. dan še vedno niso bila rešena, je bila zadeva 17. oktobra 2011 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
English: Article 33(4) of Directive 2001/82/EC, as amended
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)
English: Opinion following an Article 33(4)1 referral for Nuflor Swine Once 450 mg/ml solution for injection
Slovenian: za zdravilo Nuflor Swine Once 450 mg/ml raztopina za injiciranje
English: Opinion following an Article 33(4)0F referral for Nuflor Swine Once 450 mg/ml solution for injection
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)0F za zdravilo Nuflor Swine Once
English: 12-16 hours
Slovenian: 12-16 ur
English: Date of first authorisation: 23 November 2007 Date of latest renewal: 20 July 2012
Slovenian: Datum prve odobritve: 23. november 2007 Datum zadnjega podaljšanja: 20. julij 2012
English: It depends on how serious the poisoning is.
Slovenian: To je odvisno od tega, kako resna je zastrupitev.
English: The survival rate of 41% depended very much on the clinical situation.
Slovenian: Stopnja preživetja, 41 %, je bila v veliki meri odvisna od klinične situacije.
English: Documentation on efficacy is available for 54 paediatric patients.
Slovenian: Dokumentacija učinkovitosti je na voljo za 54 pediatričnih bolnikov.
English: Repeat this procedure if necessary with the second vial.
Slovenian: Po potrebi postopek ponovite z drugo vialo.
English: 24 hours with the exception of bilirubin (up to 4 days)
Slovenian: 24 ur, razen pri bilirubinu (do 4 dni)
English: You may need one or two infusions.
Slovenian: Morda boste infundiranje potrebovali enkrat ali dvakrat.
English: Survival at Hour 4, N (%) 7 (41) Survival at Day 14, N (%) 3 (18)
Slovenian: Preživetje po 4 urah, N (%) 7 (41) Preživetje po 14 dneh, N (%) 3 (18)
English: This red colouration has no other consequences on your body.
Slovenian: Rdeča barva nima nikakršnega vpliva na vaše telo.
English: The following side effects may be expected (frequency cannot be estimated from the available data):
Slovenian: Pričakujete lahko naslednje neželene učinke (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: Results may vary considerably from one analyser to another, therefore, caution is required when reporting and interpreting laboratory results.
Slovenian: Rezultati se pri različnih analizatorjih lahko precej razlikujejo, zato je pri poročanju in interpretaciji laboratorijskih rezultatov potrebna previdnost.
English: Due to ethical considerations, no controlled human efficacy studies have been performed.
Slovenian: Zaradi etičnih razlogov nadzorovane študije učinkovitosti pri človeku niso bile opravljene.
English: From a microbiological point of view, the medicinal product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba zdravilo uporabiti takoj.
English: Tell your doctor as soon as possible if you were pregnant or think you may have been pregnant during treatment with Cyanokit.
Slovenian: Svojemu zdravniku čim prej povejte, da ste noseči ali mislite, da ste morda bili noseči med zdravljenjem z zdravilom Cyanokit.
English: It can be administered during pregnancy and breast-feeding.
Slovenian: Lahko se uporablja med nosečnostjo in dojenjem.
English: Initial dose in g in mL
Slovenian: Začetni odmerek v g v ml
English: If overdose occurs, treatment is directed to the management of symptoms.
Slovenian: Če pride do prevelikega odmerjanja, je zdravljenje usmerjeno k obravnavanju simptomov.
English: Read all of this leaflet carefully before using this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Cyanide is a highly poisonous chemical.
Slovenian: Cianid je zelo strupena kemikalija.
English: • altered mental status
Slovenian: • spremenjeno duševno stanje.
English: No dose adjustment is required in these patients.
Slovenian: Prilagoditev odmerka pri teh bolnikih ni potrebna.
English: Cyanokit may modify the results of these tests.
Slovenian: Zdravilo Cyanokit lahko spremeni rezultate teh preiskav.
English: Tell your doctor immediately if you have the following symptoms during or after this treatment:
Slovenian: Zdravniku takoj povejte, če imate med zdravljenjem ali po njem naslednje simptome:
English: Tell your doctor or other health care professional if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali drugo zdravstveno osebje, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Avenue Louise 480 1050 Brussels Belgium
Slovenian: Avenue Louise 480 1050 Brussels Belgija
English: However, because of the limitations of the available data, it is not possible to apply frequency estimations:
Slovenian: Vendar pa zaradi omejenih podatkov, ki so na voljo, ni mogoče dati ocene pogostnosti.
English: The effects on these tests typically last 48 hours after a 5 g dose, but may persist for longer periods.
Slovenian: Učinki na te teste navadno trajajo 48 ur po 5-gramskem odmerku, vendar lahko vztrajajo daljše obdobje.
English: • swelling around the eyes, lips, tongue, throat or hands
Slovenian: • otekanje okrog oči, ustnic, jezika, grla ali rok
English: There are no adequate data from the use of hydroxocobalamin in pregnant women and the potential risk for humans is unknown.
Slovenian: Ni zadostnih podatkov o uporabi hidroksokobalamina pri nosečnicah in možno tveganje za ljudi ni znano.
English: Activated partial thromboplastin time (aPTT)
Slovenian: Aktivirani parcialni tromboplastinski čas (aPTT)
English: • that you have been treated with Cyanokit if you need to have the following: - any blood or urine tests.
Slovenian: • da so vas zdravili z zdravilom Cyanokit, če vam morajo opraviti naslednje: preiskave krvi ali urina.
English: Of the 213 patients in whom the outcome was known the survival was 58%.
Slovenian: Pri 213 bolnikih, pri katerih je izid bil znan, je bilo preživetje 58-odstotno.
English: Ventricular extrasystoles.
Slovenian: Ventrikularne ekstrasistole.
English: Dark red crystalline powder.
Slovenian: Temno rdeč kristaliničen prašek.
English: • if you are allergic to hydroxocobalamin or vitamin B12.
Slovenian: • če ste alergični na hidroksokobalamin ali vitamin B12.
English: Cyanokit may lead to shut down of haemodialysis machines until it is eliminated from the blood (at least 5.5 to 6.5 days).
Slovenian: Zdravilo Cyanokit lahko povzroči ustavitev aparatov za hemodializo, dokler se ne izloči iz krvi (vsaj 5,5 do 6,5 dni).
English: However findings were only seen at exposure levels considered being higher than the maximum human exposure, indicating limited relevance to clinical use.
Slovenian: Vendar so te učinke opazili samo pri izpostavljenosti, ki je večja od največje izpostavljenosti pri človeku, kar kaže na omejen pomen za klinično uporabo.
English: The rate of intravenous infusion for the second dose ranges from 15 minutes (for patients extremely unstable) to 2 hours based on patient condition.
Slovenian: Razpon hitrosti intravenske infuzije za drugi odmerek je od 15 minut (za izjemno nestabilne bolnike) do 2 uri, kar je odvisno od bolnikovega stanja.
English: Animal studies have shown teratogenic effects following daily exposure throughout organogenesis (see section 5.3).
Slovenian: Študije na živalih so pokazale teratogene učinke po dnevni izpostavljenosti ves čas trajanja organogeneze (glejte poglavje 5.3).
English: Caution is required in the interpretation of urinary colorimetric tests for as long as chromaturia is present.
Slovenian: Pri interpretaciji urinskih kolorimetričnih testov je potrebna previdnost, dokler je prisotna kromaturija.
English: • exposure to fire smoke in an enclosed area
Slovenian: • izpostavljenost dimu zaradi požara v zaprtem prostoru;
English: The dose of 150 mg/kg approximately corresponds to the maximum recommended human dose.
Slovenian: Odmerek 150 mg/kg približno ustreza največjemu priporočenemu odmerku za ljudi.
English: • problems with memory
Slovenian: • težave s spominom
English: Limited data on children (0 to 18 years old) treated with hydroxocobalamin did not show any difference in the safety profile of hydroxocobalamin between adults and children.
Slovenian: Omejeni podatki pri otrocih (0 do 18 let starosti), zdravljenih s hidroksokobalaminom, niso pokazali razlike v varnostnem profilu hidroksokobalamina med odraslimi in otroci.
English: Increase in blood pressure
Slovenian: Zvišanje krvnega tlaka
English: • inflammation in the part of the body where the medicine was infused.
Slovenian: • vnetje mesta na telesu, kjer so zdravilo infundirali
English: Of the 89 patients who died, 63 were initially found in cardiac arrest, suggesting that many of these patients had almost certainly suffered irreparable brain injury prior to administration of hydroxocobalamin.
Slovenian: Od 89 bolnikov, ki so umrli, so jih 63 našli v stanju srčnega zastoja, kar kaže na to, da je veliko teh bolnikov skoraj zagotovo že imelo nepopravljive možganske poškodbe pred uporabo hidroksokobalamina.
English: Body weight in kg
Slovenian: Telesna masa v kg
English: The majority of the urinary excretion occurred during the first 24 hours, but red coloured urine was observed for up to 35 days following the intravenous infusion.
Slovenian: Večina izločanja z urinom se pojavi v prvih 24 urah, vendar so rdeče obarvani urin opažali do 35 dni po intravenskem infundiranju.
English: In some situations, hemodialysis was required to achieve recovery (see section 4.8).
Slovenian: V nekaterih primerih je bila za okrevanje potrebna hemodializa (glejte poglavje 4.8).
English: Lactate dehydrogenase (LDH)
Slovenian: Laktat-dehidrogenaza (LDH)
English: No studies on fertility have been performed (see section 5.3).
Slovenian: Študij plodnosti niso izvedli (glejte poglavje 5.3).
English: Alanine aminotransferase (ALT)
Slovenian: Alaninaminotransferaza (ALT)
English: • soot present around mouth, nose and/or oropharynx
Slovenian: • prisotnost saj okrog ust, nosa in/ali orofarinksa;
English: In case of known pregnancy at the time of treatment with Cyanokit or in case that pregnancy becomes known after treatment with Cyanokit, health care professionals are requested to promptly report the exposure during pregnancy to the Marketing Authorisation Holder and/or Health Authorities and to carefully follow-up on the pregnancy and its outcome.
Slovenian: V primeru znane nosečnosti v času zdravljenja z zdravilom Cyanokit ali v primeru, da postane nosečnost znana po zdravljenju z zdravilom Cyanokit, mora zdravstveno osebje o izpostavljenosti med nosečnostjo takoj poročati imetniku dovoljenja za promet in/ali zdravstveni agenciji in skrbno spremljati nosečnost in njen izid.
English: Tell your doctor or other health care professional
Slovenian: Povejte zdravniku ali drugemu zdravstvenemu osebju,
English: Consequently, these and other medicinal products must not be administered simultaneously through the same intravenous line as hydroxocobalamin.
Slovenian: Zato se ta in druga zdravila ne smejo dajati sočasno po isti intravenski liniji kot hidroksokobalamin.
English: The maximal increase in blood pressure has been observed toward the end of infusion (see section 4.8).
Slovenian: Največje zvišanje krvnega tlaka so opazili proti koncu infundiranja (glejte poglavje 4.8).
English: Hydroxocobalamin may interfere with all urine colorimetric parameters.
Slovenian: Hidroksokobalamin lahko moti vse urinske kolorimetrične parametre.
English: Interference following a 10 g dose can be expected to last up to an additional 24 hours.
Slovenian: Pričakovati je, da bo motenje po 10-gramskem odmerku trajalo do dodatnih 24 ur.
English: “To be attached to the patient's medical record:
Slovenian: “V bolnikovo zdravstveno kartoteko je treba priložiti naslednje:
English: However, taken into account: - that no more than two injections of hydroxocobalamin are to be administered, - the potentially life threatening condition, - the lack of alternative treatment, hydroxocobalamin may be given to a pregnant woman.
Slovenian: Vendar pa se ob upoštevanju naslednjega: - uporabljeni ne bosta več kot dve injekciji hidroksokobalamina, - morebitnega smrtno nevarnega stanja, - pomanjkanja alternativnih zdravljenj, hidroksokobalamin lahko da nosečnici.
English: One short catheter for administration to children.
Slovenian: En kratek kateter za uporabo pri otrocih.
English: The remaining 102 subjects were healthy volunteers who had not been exposed to cyanide at the time of hydroxocobalamin administration.
Slovenian: Preostalih 102 oseb je bilo zdravih prostovoljcev, ki v času uporabe hidroksokobalamina niso bili izpostavljeni cianidu.
English: Do not use this medicine after the expiry date which is stated on the vial, the cardboard box and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali, kartonski škatli in ovojnini poleg oznake »EXP«.
English: Heart and blood pressure problems
Slovenian: Težave s srcem in krvnim tlakom
English: • breathing difficulties, hoarseness, difficulty in speaking
Slovenian: • težave pri dihanju, hripavost, težave pri govoru
English: Pustular rashes, which may last for several weeks, affecting mainly the face and the neck.
Slovenian: Pustulozni izpuščaji, ki lahko trajajo več tednov, predvsem na obrazu in vratu.
English: Treatment decisions must be made on the basis of clinical history and/or signs and symptoms of cyanide intoxication.
Slovenian: Odločitve o zdravljenju morajo temeljiti na klinični anamnezi in/ali znakih in simptomih intoksikacije s cianidom.
English: • coloured plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters.
Slovenian: • obarvana plazma, ki lahko povzroči umetno zvišanje ali znižanje ravni nekaterih laboratorijskih vrednosti
English: Overall, the total urinary excretion was calculated to be at least 60 to 70% of the administered dose.
Slovenian: Izračunali so, da se z urinom skupno izloči vsaj 60 do 70% uporabljenega odmerka.
English: Clinical chemistry
Slovenian: Klinična kemija
English: Two transfer devices.
Slovenian: Dve napravi za prenos.
English: Based on in vitro studies and pharmacokinetic data obtained in healthy volunteers the following table describes interference with laboratory tests that may be observed following a 5 g dose of hydroxocobalamin.
Slovenian: Na podlagi študij in vitro in farmakokinetičnih podatkov, pridobljenih pri zdravih prostovoljcih, naslednja preglednica opisuje interference laboratorijskih testov, ki jih lahko opazimo po 5-gramskem odmerku hidroksokobalamina.
English: The presence of altered mental status (confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning.
Slovenian: Spremenjeno duševno stanje (zmedenost in dezorientiranost) in/ali midriaza kažeta na resnično zastrupitev s cianidom.
English: Haemodialysis may be effective in such a circumstance, but is only indicated in the event of significant hydroxocobalamin-related toxicity.
Slovenian: V takšnih okoliščinah je hemodializa lahko učinkovita, vendar je indicirana le pri pomembni toksičnosti, povezani s hidroksokobalaminom.
English: In general, the effectiveness of hydroxocobalamin in these patients was similar to that of younger patients.
Slovenian: Na splošno je bila učinkovitost hidroksokobalamina pri teh bolnikih podobna učinkovitosti pri mlajših bolnikih.
English: • changes in the results of blood tests for certain white blood cells (lymphocytes)
Slovenian: • spremembe rezultatov krvnih preiskav določenih levkocitov (limfocitov)
English: The extent and duration of interference in cyanide-poisoned patients may differ according to the severity of intoxication.
Slovenian: Stopnja in trajanje motenja pri bolnikih, zastrupljenih s cianidom, se lahko razlikujeta glede na stopnjo intoksikacije.
English: Before Cyanokit is administered, it is recommended to check affected persons for the presence of the following:
Slovenian: Pred uporabo zdravila Cyanokit je priporočeno pri prizadetih osebah preveriti naslednje:
English: Centre de Production de Semoy 2, rue du Pressoir Vert F-45400 Semoy France
Slovenian: Centre de Production de Semoy 2, rue du Pressoir Vert F-54400 Semoy Francija
English: In this setting hypotension and/or a plasma lactate concentration ≥ 10 mmol/L (higher than the one mentioned under signs and symptoms due to the fact that carbon monoxide contributes to lactic acidaemia) are highly suggestive of cyanide poisoning.
Slovenian: V teh okoliščinah hipotenzija in/ali koncentracija laktata v plazmi ≥ 10 mmol/l (ta vrednost je večja od tiste, ki je navedena med znaki in simptomi, ker ogljikov monoksid prispeva k laktacidemiji) močno kažeta na zastrupitev s cianidom.
English: This medicine is an emergency treatment.
Slovenian: To zdravilo se uporablja v nujnih primerih.
English: The relevance of this finding to humans is unlikely since it was not reported in short-term studies conducted with hydroxocobalamin.
Slovenian: Ta ugotovitev najverjetneje ni pomembna za človeka, saj v kratkotrajnih študijah, opravljenih s hidroksokobalaminom, o njej niso poročali.
English: This should be considered before haemodialysis is initiated in patients treated with hydroxocobalamin.
Slovenian: To je treba upoštevati preden začnemo z hemodializo pri bolnikih, ki se zdravijo s hidroksokobalaminom.
English: Depending upon the severity of the poisoning and the clinical response (see section 4.4), a second dose may be administered.
Slovenian: Glede na stopnjo zastrupitve in klinični odziv (glejte poglavje 4.4) lahko dajete naslednji odmerek.
English: For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of usual transport (15 days submitted to temperatures ranging from 5°C to 40°C), transport in the desert (4 days submitted to temperatures ranging from 5°C to 60°C) and freezing/defrosting cycles (15 days submitted to temperatures ranging from -20°C to 40°C).
Slovenian: Pri ambulantni uporabi se lahko zdravilo Cyanokit krajši čas izpostavlja temperaturnim razlikam, ki nastanejo med običajnim transportom (15 dni temperaturam od 5 °C do 40 °C), med transportom v puščavi (4 dni temperaturam od 5 °C do 60 °C) in ciklom zamrzovanja/odmrzovanja (15 dni temperaturam od -20 °C do 40 °C).
English: Allergy (hypersensitivity)
Slovenian: Alergija (preobčutljivost)
English: • discomfort in your stomach
Slovenian: • občutek neugodja v želodcu