FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Octegra solution for infusion.
Slovenian: Evropska agencija za zdravila je po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Octegra raztopina za infundiranje zaključila postopek arbitraže.
English: However, the prescribing information for Octegra solution for infusion should be amended in all the Member States where it is authorised.
Slovenian: Vendar je treba dopolniti podatke o predpisovanju zdravila Octegra raztopina za infundiranje v vseh državah članicah, kjer je odobreno.
English: What is Octegra solution for infusion?
Slovenian: Kaj je zdravilo Octegra raztopina za infundiranje?
English: The Committee recommended that:
Slovenian: Odbor je priporočil, da:
English: 20 February 2013
Slovenian: 20. februarja 2013
English: It was authorised in October 2008 and is available in 11 EU member states1.
Slovenian: Odobreno je bilo oktobra 2008 in je na voljo v 11 državah članicah EU1.
English: Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 31 of Directive 2001/83/EC
Slovenian: Izid postopkov v skladu s členom 20 Uredbe (ES) št. 726/2004 in členom 31 Direktive 2001/83/ES.
English: 1 Austria, Denmark, Estonia, France, Finland, Germany, Ireland, Netherlands, Spain, Sweden and United Kingdom, as well as Norway.
Slovenian: Ukrepi so vključevali spremembe informacij o zdravilu, v katerih je 1 Avstrija, Danska, Estonija, Francija, Finska, Nemčija, Irska, Nizozemska, Španija, Švedska in Združeno kraljestvo ter Norveška.
English: This indicates that the risk minimisation measures have not been sufficient.
Slovenian: Iz tega je razvidno, da ukrepi za zmanjšanje tveganja niso zadostni.
English: The solution is currently sprayed using either pressurised air or carbon dioxide (CO2).
Slovenian: Trenutno se raztopina naprši z zrakom pod tlakom ali ogljikovim dioksidom (CO2).
English: The European Commission issued a decision for Evicel on 13 February 2013 and for Quixil on 20 February 2013.
Slovenian: Evropska komisija je sklep o zdravilu Evicel izdala 13. februarja 2013, sklep o zdravilu Quixil pa 20. februarja 2013.
English: At the same time, the UK's medicines regulatory agency requested the CHMP to carry out the same assessment for Quixil and the other fibrin sealants available in the EU.
Slovenian: Istočasno je agencija Združenega kraljestva za zdravila zaprosila CHPM, naj opravi podobno presojo za zdravilo Quixil in druga fibrinska lepila, ki so na voljo v EU.
English: • the wording for the product information should be strengthened and educational materials updated to provide clear and consistent information to surgeons on the recommended pressure and distance during spray application;
Slovenian: • je treba okrepiti besedilo informacij o zdravilu in posodobiti izobraževalno gradivo, da se kirurgom zagotovijo jasne in dosledne informacije o priporočenem tlaku in razdalji med pršenjem;
English: The Committee also agreed that the company marketing these medicines should provide a letter to relevant healthcare professionals in the EU explaining these risk minimisation measures.
Slovenian: Odbor se je prav tako strinjal, da morajo podjetja, ki imajo dovoljenje za promet s temi zdravili, zadevnim zdravnikom v EU poslati dopis z obrazložitvijo teh ukrepov za zmanjšanje tveganja.
English: In addition, care should be taken during laparoscopy (another type of less invasive surgical procedure) to ensure that the minimum safe distance from the tissues is observed;
Slovenian: Poleg tega je treba posebej paziti med laparoskopijo (drugo vrsto manj invazivnega kirurškega posega), da se zagotovi upoštevanje najmanjše varne razdalje od tkiva;
English: Consequently, in May 2012, the European Commission asked the CHMP to issue an opinion on whether further measures are necessary to ensure the safe use of Evicel and on whether its marketing authorisation should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: Evropska komisija je zato maja 2012 CHMP pozvala, naj predloži svoje mnenje o tem, ali je treba za zagotovitev varne uporabe zdravila Evicel uvesti nadaljnje ukrepe, in o tem, ali se lahko dovoljenje za promet za to zdravilo v EU ohrani ali pa ga je treba spremeniti, začasno umakniti oziroma preklicati.
English: • these medicines should not be sprayed in endoscopic surgery (a type of less invasive surgical procedure).
Slovenian: • teh zdravil ni dovoljeno napršiti pri endoskopskem posegu (vrsti manj invazivnega kirurškega posega).
English: The full changes made to the product information for Evicel are detailed here, and for Quixil here.
Slovenian: Celotne spremembe informacij o zdravilu Evicel so na voljo tukaj in o zdravilu Quixil tukaj.
English: The CHMP noted that fibrin sealants have the potential to be life-saving in certain circumstances, and that applying these medicines by spray is considered to be of benefit when there is a large surface area of bleeding during certain surgical procedures.
Slovenian: CHMP je opozoril, da lahko fibrinska lepila v določenih okoliščinah rešijo življenje in da je nanos teh zdravil s pršenjem koristen, kadar gre za krvavenje iz večje površine med določenimi kirurškimi posegi.
English: The CHMP reviewed available safety data on fibrin sealants from clinical studies, post-marketing use and the published literature, focusing on reported cases of confirmed or suspected gas embolism.
Slovenian: CHMP je pregledal razpoložljive varnostne podatke o fibrinskih lepilih iz kliničnih študij, podatke o uporabi zdravila po izdaji dovoljenja za promet in podatke iz objavljene literature, pri čemer se je osredotočil na opisane primere potrjene ali domnevne plinske embolije.
English: In August 2010, measures were taken to minimise the risk of gas embolism (presence of a gas bubble in the blood that affects the blood flow) following five reported cases involving Evicel or Quixil applied
Slovenian: Avgusta 2010 so bili sprejeti ukrepi za zmanjšanje tveganja za plinsko embolijo (prisotnost plinskih mehurčkov v krvi, ki vplivajo na krvi obtok), potem ko so o njej poročali v petih primerih po nanosu zdravila Evicel ali Quixil s pršenjem.
English: The CHMP is still reviewing four other fibrin sealants: Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Slovenian: CHMP še zmeraj presoja štiri druga fibrinska lepila: Tisseel, Tissucol, Artiss in Beriplast P (in povezana imena).
English: However, since then, three further cases of gas embolism have been reported with Evicel, which were due to insufficient distance between the applicator and tissue or too high spray pressure.
Slovenian: Vendar so po tem poročali še o treh primerih plinske embolije po uporabi zdravila Evicel, do katerih je prišlo zaradi nezadostne razdalje med pršilnikom in tkivom ali previsokega pršilnega tlaka.
English: On 15 November 2012, the European Medicines Agency completed a review of the safety and effectiveness of the fibrin sealants Evicel and Quixil given by spray application, following cases of gas embolisms reported with these medicines.
Slovenian: Evropska agencija za zdravila je 15. novembra 2012 zaključila pregled varnosti in učinkovitosti fibrinskih lepil Evicel in Quixil za pršenje, ki je bil sprožen zaradi primerov plinske embolije pri uporabi teh zdravil.
English: The CHMP also noted that, although cases of gas embolism are rare, there is a need to take further measures to prevent this life-threatening risk.
Slovenian: CHMP je prav tako poudaril, da je treba kljub redkim primerom plinske embolije sprejeti nadaljnje ukrepe za preprečitev smrtno nevarnega tveganja.
English: • the company for Evicel and Quixil should ensure that these products are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that contain labels stating the recommended pressure and distance.
Slovenian: • mora podjetje za zdravila Evicel in Quixil zagotoviti, da se zdravila uporabljajo z regulatorji tlaka, ki ne presegajo največjega tlaka, dovoljenega za nanos fibrinskih lepil, in da sta na nalepkah izdelkov navedena priporočeni tlak in priporočena razdalja.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Evicel and Quixil continue to outweigh their risks, but that further risk minimisation measures should be implemented when these medicines are given by spray application to ensure that they are used correctly.
Slovenian: Na osnovi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi zdravil Evicel in Quixil še zmeraj odtehtajo z njima povezana tveganja, vendar je treba uvesti nadaljnje ukrepe za zmanjšanje tveganja pri nanosu zdravil s pršenjem, da bi zagotovili njihovo pravilno uporabo.
English: • Surgeons should note the potential risk of gas embolism with improper spray application of Evicel and Quixil and take the necessary precautions detailed in the updated prescribing advice for these medicines.
Slovenian: • Kirurgi naj upoštevajo morebitno tveganje za plinsko embolijo pri neustreznem pršenju zdravil Evicel in Quixil in izvajajo potrebne varnostne ukrepe, opredeljene v posodobljenih navodilih o predpisovanju teh zdravil.
English: Evicel is the only centrally authorised fibrin sealant.
Slovenian: Zdravilo Evicel je edino fibrinsko lepilo, odobreno po centraliziranem postopku.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines given by spray application continue to outweigh their risks, but that appropriate measures have to be put in place to minimise the risk of gas embolism.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je sklenil, da koristi zadevnih zdravil za pršenje še zmeraj odtehtajo z njimi povezana tveganja, vendar je treba sprejeti ustrezne ukrepe za zmanjšanje tveganja za plinsko embolijo.
English: They are composed of two solutions, one containing fibrinogen and the other containing thrombin, which are both proteins involved in the blood clotting process.
Slovenian: Sestavljena so iz dveh raztopin, od katerih ena vsebuje fibrinogen, druga pa trombin.
English: The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, stopping the bleeding.
Slovenian: Fibrini se nato združijo (medsebojno zlepijo) in ustvarijo fibrinski strdek, ki pomaga ozdraviti rano, saj ustavi krvavenje.
English: • Evicel or Quixil application by spray should only be considered if it is possible to accurately judge the spraying distance.
Slovenian: • Zdravilo Evicel ali Quixil naj se naprši samo v primeru, ko je mogoče ustrezno presoditi razdaljo pršenja.
English: • Evicel and Quixil should be sprayed using CO2 only.
Slovenian: • Zdravili Evicel in Quixil naj se napršita samo s CO2.
English: • Spraying Evicel or Quixil in endoscopic surgery is contraindicated.
Slovenian: • Nanos zdravila Evicel ali Quixil s pršenjem pri endoskopskem posegu je kontraindicirana.
English: Fibrin sealants can be applied by dripping or spraying the solution onto bleeding tissue.
Slovenian: Fibrinska lepila se lahko nanesejo s kapljanjem ali pršenjem raztopine na krvaveče področje.
English: Other fibrin sealants in the EU are authorised nationally and these include Quixil, Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Slovenian: Mednje spadajo zdravila Quixil, Tisseel, Tissucol, Artiss in Beriplast P (in povezana imena).
English: • Evicel and Quixil should be sprayed using CO2 only, instead of pressurised air, because the greater solubility of CO2 in blood reduces the risk of embolism;
Slovenian: • se zdravili Evicel in Quixil namesto z zrakom pod tlakom napršita samo s CO2, saj večja topnost
English: These included changes to the product information to specify the maximum spray pressure to use during application and the recommended distance from the tissue surface.
Slovenian: določen največji pršilni tlak med nanosom zdravila ter priporočena razdalja od površine tkiva.
English: It has been authorised in 24 EU Member States.
Slovenian: Odobreno je v 24 državah članicah EU.
English: These measures should help to protect the environment.
Slovenian: Takšni ukrepi bodo pomagali varovati okolje.
English: Hungary Zoetis Hungary Kft. Alkotás u. 53.
Slovenian: Madžarska Zoetis Hungary Kft. Alkotás u. 53.
English: The symptoms disappeared within 5 to 8 days without interruption of the treatment.
Slovenian: Spremembe izginejo v 5 do 8 dneh, brez prekinitve zdravljenja.
English: Contact with skin and eyes should be avoided.
Slovenian: Treba se je izogibati stiku s kožo in očmi.
English: There is no evidence that this situation is evolving.
Slovenian: Dokazov o nadaljnjem razvoju tega stanja ni.
English: Postępu 17B 02-676 Warszawa Poland
Slovenian: Postępu 17B 02-676 Warszawa Poljska
English: FI 00330 Helsinki Finland
Slovenian: FI 00330 Helsinki Finska
English: A fresh solution should be prepared each day.
Slovenian: Svežo raztopino je treba pripraviti vsak dan.
English: The first marketing authorisation was granted in 1972.
Slovenian: Prvo dovoljenje za promet z zdravilom je bilo odobreno leta 1972.
English: H-1123 Budapest Hungary
Slovenian: H-1123 Budapest
English: This might be due partly to natural resistance.
Slovenian: To je lahko delno posledica naravne odpornosti.
English: Via Andrea Doria, 41 M 00192 Roma Italy
Slovenian: Via Andrea Doria, 41 M 00192 Roma Italija
English: Human and animal bacteria share the same resistance determinants.
Slovenian: Človeške in živalske bakterije imajo enake determinante odpornosti.
English: Care should be taken not to raise and inhale any dust.
Slovenian: Paziti je treba, da se ne dviguje in vdihuje prahu.
English: EC4A 3AE London United Kingdom
Slovenian: EC4A 3AE London Združeno Kraljestvo
English: This evaluation focuses on issues in regards to the harmonisation that may change the benefit-risk balance.
Slovenian: Ta ocena se osredotoča na težave, povezane z uskladitvijo, ki bi lahko spremenile razmerje med tveganji in koristmi.
English: Denmark Zoetis Finland Oy Tietokuja 4
Slovenian: Zoetis Finland Oy Tietokuja 4
English: B-2870 Puurs Belgium
Slovenian: B-2870 Puurs Belgija
English: Discussion of data available
Slovenian: Razprava o razpoložljivih podatkih
English: Moreover the harmonised dosing regimen is the one recommended in a vast majority of the Member States.
Slovenian: Poleg tega je usklajeni režim odmerjanja eden od priporočenih v večini držav članic.
English: Treatment should be initiated as soon as first clinical signs occur.
Slovenian: Z zdravljenjem je treba začeti takoj, ko se pojavijo prvi klinični znaki.
English: * The restriction of the indications to those that are adequately substantiated by efficacy data;
Slovenian: • omejitvijo indikacij na zadostno utemeljene s podatki o učinkovitosti;
English: Medicated water should be removed every day and replaced by a new solution.
Slovenian: Medicirano vodo je treba vsak dan odstraniti in zamenjati z novo raztopino.
English: * The deletion of all recommendations for prophylactic use;
Slovenian: • izbrisom vseh priporočil, povezanih s profilaktično uporabo;
English: 150 g of powder = 100 g antibiotic activity should be diluted in…
Slovenian: 150 g praška = 100 g aktivnosti antibiotika je treba raztopiti v…
English: The oral absorption of lincomycin was found to be 53% ± 19%.
Slovenian: Ugotovljena peroralna absorpcija linkomicina je bila med 53 % ± 19 %.
English: Excipients: For the full list of excipients, see section 6.1.
Slovenian: Pomožne snovi: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Also, as the dosing regimens and indications have not been extended, there is no change in the assessment of user safety.
Slovenian: Ker se režimi odmerjanja in indikacije niso razširili, prav tako ni spremembe pri oceni varnosti za uporabnika.
English: Regarding B. hyodysenteriae, including the points already mentioned, several issues were identified:
Slovenian: Glede B. hyodysenteriae so bile ugotovljene mnoge težave (vključno z že omenjenimi):
English: Overall summary of the scientific evaluation of LincoSpectin 100 and its associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila LincoSpectin 100 in povezanih imen (glejte Prilogo I)
English: Ireland Pfizer Healthcare Ireland Trading as Pfizer Animal Health,
Slovenian: Pfizer Healthcare Ireland Trading as Pfizer Animal Health,
English: Moreover L. intracellularis, like Brachyspira spp.
Slovenian: Poleg tega je L. intracellularis tako kot Brachyspira spp.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally.
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Podatke je treba dopolniti v posameznih državah.
English: Sick animals have a reduced appetite and an altered drinking pattern, and severely affected animals may therefore require parenteral treatment.
Slovenian: Bolne živali imajo zmanjšan apetit in spremenjen vzorec pitja in hudo prizadete živali bodo zaradi tega morda potrebovale parenteralno zdravljenje.
English: In the challenge study the bacterial infection seemed to be eradicated.
Slovenian: V provokacijski študiji je bilo videti, da je bila bakterijska okužba izkoreninjena.
English: The average of the half-lives of elimination of all routes of administration is 2.82 hours in pigs.
Slovenian: Povprečna razplovna doba izločanja po vseh poteh dajanja pri prašičih je 2,82 ure.
English: Cmax occurred at 4 hours after introduction of the medicated water.
Slovenian: Cmax je bila dosežena 4 ure po tem, ko so jim dali na razpolago medicirano vodo.
English: Allergic/hypersensitive reactions are rare but can occur and require stopping treatment with the veterinary medicinal product.
Slovenian: Alergijske/preobčutljive reakcije so redke, vendar se lahko pojavijo in zahtevajo prenehanje zdravljenja z zdravilom za uporabo v veterinarski medicini.
English: The combination of lincosamides and macrolides is antagonistic, due to competitive binding to their target sites.
Slovenian: Kombinacija linkozamidov in makrolidov deluje antagonistično zaradi kompetitivne vezave na njihova ciljna mesta.
English: Lincomycin is excreted in milk.
Slovenian: Linkomicin se izloča v mleko.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilne učinkovine:
English: The recommended harmonised dosing regimens do not lead to increased exposure of the environment to the active substances.
Slovenian: Priporočeni usklajeni režimi odmerjanja ne povzročajo povečane izpostavljenosti okolja zdravilnima učinkovinama.
English: Do not leave access to the medicated water for other animals.
Slovenian: Drugim živalim ne omogočite dostopa do medicirane vode.
English: Old tolerance studies are available for pigs, chickens and turkeys.
Slovenian: Stare študije tolerance so na voljo za prašiče, piščance in purane.
English: Shelf life after dilution according to directions: 24 hours.
Slovenian: Rok uporabnosti po razredčenju v skladu z navodili: 24 ur.
English: Overall and considering also the older literature data, a rate of clinical resistance of at least 10% was suggested.
Slovenian: Upoštevajoč tudi podatke iz starejše literature je bil predlagan skupni delež klinične odpornosti vsaj 10 %.
English: The combination might have a synergistic effect in Mycoplasma, but the clinical significance of this was not investigated.
Slovenian: Kombinacija ima morda sinergistični učinek na organizem Mycoplasma, vendar klinična pomembnost ni bila raziskana.
English: The medicated drinking water should be the sole source of drinking water for the treatment duration.
Slovenian: Medicirana pitna voda naj bo edini vir pitne vode za čas trajanja zdravljenja.
English: On 28 September 2012, Belgium sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Linco-Spectin 100 and its associated names.
Slovenian: 28. septembra 2012 je Belgija poslala obvestilo o napotitvi v skladu s členom 34(1) Direktive 2001/82/ES, kakor je bila nazadnje spremenjena, odboru CVMP/Evropski agenciji za zdravila za zdravilo Linco-Spectin 100 in z njim povezana imena.
English: This could be partly related to natural resistance in those bacterial species.
Slovenian: To je lahko delno povezano z naravno odpornostjo pri teh vrstah bakterij.
English: Further to the assessment of the available data, the CVMP considered that the benefit-risk balance for the target species pigs remains positive.
Slovenian: Po oceni razpoložljivih podatkov je odbor CVMP menil, da razmerje med tveganji in koristmi pri ciljni živalski vrsti, prašičih, ostaja pozitivno.
English: and/or E. coli in chickens.
Slovenian: in/ali E. coli pri piščancih.
English: Consumer safety remains ensured by the recommended harmonised withdrawal periods of 0 days in pig and 5 days in chickens.
Slovenian: Varnost uporabnika še vedno zagotavljajo priporočene usklajene karence, ki so 0 dni pri prašičih in 5 dni pri piščancih.
English: However, again no firm breakpoint has been established.
Slovenian: Vendar spet ni bila določena nobena zanesljiva mejna vrednost.
English: A symptomatic treatment must be implemented.
Slovenian: Uvesti je treba simptomatsko zdravljenje.
English: However, the CVMP considered the indication for B. hyodysenteriae should be maintained, taking into account the scope of this Article 34 referral procedure.
Slovenian: Kljub temu je odbor CVMP menil, da je treba indikacijo za B. hyodysenteriae ohraniti, pri čemer je upošteval obseg tega napotitvenega postopka v skladu s členom 34.
English: Taking into account the scope of this Article 34 referral procedure, the proposed indication for L. intracellularis in pigs was deemed acceptable.
Slovenian: Upoštevajoč obseg tega napotitvenega postopka v skladu s členom 34 je odbor menil, da je predlagana indikacija za L. intracellularis pri prašičih sprejemljiva.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the bottle or bag.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti navedenega na plastenki ali vreči.
English: In the proposed harmonised SPC all references to prophylactic treatment were deleted, which was confirmed by the CVMP.
Slovenian: V predlaganem usklajenem povzetku glavnih značilnosti zdravila so bile izbrisane vse navedbe, povezane s profilaktičnim zdravljenjem, kar je potrdil odbor CVMP.
English: 2 Goren E, de Jong WA, Doornenbal P. Therapeutic efficacy of medicating drinking water with spectinomycin and lincomycin-spectinomycin in experimental Escherichia coli infection in poultry.
Slovenian: 2 Goren E, de Jong WA, Doornenbal P. Therapeutic efficacy of medicating drinking water with spectinomycin and lincomycinspectinomycin in experimental Escherichia coli infection in poultry.
English: In case of accidental overdose, the treatment should be interrupted and restarted at the recommended dose.
Slovenian: V primeru, da do prevelikega odmerjanja pride po nesreči, je treba zdravljenje prekiniti in ponovno začeti zdravljenje s priporočenim odmerkom.
English: Use only accordingly to benefit-risk assessment by the responsible veterinarian.
Slovenian: Uporabite le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
English: If co-administration is mandatory, respect a delay of two hours between intakes.
Slovenian: Če je sočasno dajanje obvezno, upoštevajte med dajanji razmak dveh ur.
English: Combination with anaesthetics may lead to possible neuromuscular blocking.
Slovenian: Kombinacija z anestetiki lahko privede do nevromuskularne blokade.