FrancophonIA/ELRC3.0 huggingface dataset:
English: For effectiveness in treating foot rot in sheep, Draxxin was compared to tilmicosin in a study involving 477 sheep with typical signs of foot rot (foul smell, damaged tissue between the claws of at least one foot and lameness).
Slovenian: Za ugotavljanje učinkovitosti zdravila Draxxin pri nalezljivi šepavosti ovac so ga s tilmikozinom primerjali v eni študiji, v katero je bilo vključenih 477 ovac z značilnimi znaki šepavosti (smrad, poškodovano tkivo med parklji na vsaj eni nogi ter šepanje).
English: Other types of reaction to the injection persist for about 30 days after injection in cattle and pigs.
Slovenian: Druge vrste reakcij na injiciranje so pri govedu in prašičih prisotne približno 30 dni po injiciranju zdravila.
English: • bovine respiratory disease (BRD) in cattle caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis;
Slovenian: • dihalnih obolenj goveda (BRD), ki jih povzročajo bakterije Mannheimia haemolytica, Pasteurella multocida, Histophilus somni in Mycoplasma bovis;
English: How does Draxxin work?
Slovenian: Kako zdravilo Draxxin deluje?
English: The main measure of effectiveness was clinical cure rate (no SRD or mild SRD) on day 14.
Slovenian: Glavno merilo učinkovitosti je bila stopnja klinične ozdravitve (brez dihalnega obolenja prašičev ali z milejšo obliko tega obolenja) na 14. dan.
English: Draxxin was compared with tilmicosin or florfenicol (other antibiotics), and, in the prevention studies also with placebo (a dummy treatment).
Slovenian: Zdravilo Draxxin so primerjali s tilmikozinom ali florfenikolom (drugima antibiotikoma), v študijah preprečevanja bolezni pa tudi s placebom (zdravilom brez zdravilne učinkovine).
English: For practical information about using Draxxin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Draxxin naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For more information about treatment with Draxxin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Draxxin naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: In cattle, it is injected under the skin, and the dose is divided in cattle weighing over 300 kg so that no more than 7.5 ml are injected at one site.
Slovenian: Pri govedu se injicira pod kožo, če žival tehta več kot 300 kg, pa je treba odmerek razdeliti tako, da se na enem mestu ne injicira več kot 7,5 ml zdravila.
English: Draxxin can cause eye irritation.
Slovenian: Zdravilo Draxxin lahko povzroči draženje oči.
English: If accidental skin exposure occurs, the skin should be washed immediately with soap and water.
Slovenian: Pri nenamernem stiku kože z zdravilom je treba kožo nemudoma sprati z milom in vodo.
English: The active substance in Draxxin, tulathromycin, is an antibiotic that belongs to the class ‘macrolides'.
Slovenian: Zdravilna učinkovina v zdravilu Draxxin, tulatromicin, je antibiotik, ki spada v skupino „makrolidov“.
English: In two studies, it was compared with placebo, and the third study also compared it with oxytetracycline (another antibiotic).
Slovenian: V dveh študijah so ga primerjali z učinkovitostjo placeba, v tretji pa tudi z oksitetraciklinom (drugim antibiotikom).
English: Draxxin was as effective as tilmicosin in treating the early stages of severe foot rot.
Slovenian: Zdravilo Draxxin je bilo pri zdravljenju zgodnjih stadijev hude šepavosti enako učinkovito kot tilmikozin.
English: The effectiveness of Draxxin in treating SRD has been studied in pigs in two main studies, where it was compared with the antibiotics tiamulin or florfenicol.
Slovenian: Učinkovitost zdravila Draxxin pri zdravljenju dihalnih obolenj prašičev so raziskovali v dveh glavnih študijah, v katerih so ga primerjali z antibiotikoma tiamulinom ali florfenikolom.
English: In pigs it is injected into a muscle, and the dose is divided in pigs weighing over 80 kg so that no more than 2 ml are injected at one site.
Slovenian: Pri prašičih se injicira v mišico, če žival tehta več kot 80 kg, pa je treba odmerek razdeliti tako, da se na enem mestu ne injicira več kot 2 ml zdravila.
English: In case of accidental selfinjection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Slovenian: V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali ovojnino.
English: In two of the three studies of IBK, Draxxin was more effective than placebo in curing the disease.
Slovenian: V dveh od treh študij infekcioznega govejega keratokonjuktivitisa je bilo zdravilo Draxxin pri ozdravljenju bolezni učinkovitejše od placeba.
English: Draxxin is an antibiotic medicine that contains the active substance tulathromycin.
Slovenian: Zdravilo Draxxin je zdravilo z antibiotičnim delovanjem, ki vsebuje zdravilno učinkovino tulatromicin.
English: The effectiveness of Draxxin in treating or preventing BRD was studied in nine main studies involving calves, carried out during an outbreak of the disease.
Slovenian: Učinkovitost zdravila Draxxin pri zdravljenju ali preprečevanju dihalnih obolenj goveda so raziskovali v devetih glavnih študijah, v katere so bila vključena teleta, izvedene pa so bile med izbruhom bolezni.
English: Treatment with Draxxin was compared to another antibiotic, tildipirosin.
Slovenian: Zdravljenje z zdravilom Draxxin so primerjali s tildipirozinom (drugim antibiotikom).
English: For the metaphylaxis of SRD, the effectiveness of Draxxin was studied in six main studies, in which it was compared with placebo.
Slovenian: Pri metafilaksi dihalnih obolenj prašičev so učinkovitost zdravila Draxxin raziskovali v šestih glavnih študijah, v katerih so ga primerjali s placebom.
English: If Draxxin accidentally gets into the eyes, they should be flushed immediately with clean water.
Slovenian: V primeru nenamernega stika zdravila z očmi jih je treba nemudoma sprati s čisto vodo.
English: Temporary pain and swelling at the injection site in cattle can last up to 30 days after subcutaneous injection.
Slovenian: Podkožno injiciranje zdravila lahko pri govedu povzroči trenutno bolečino in lokalno oteklino na mestu injiciranja, ki lahko traja do 30 dni.
English: Draxxin is effective against the bacteria that most commonly cause BRD, SRD, IBK and foot rot.
Slovenian: Zdravilo Draxxin je učinkovito proti bakterijam, ki najpogosteje povzročajo dihalna obolenja goveda, dihalna obolenja prašičev, infekciozni goveji keratokonjuktivitis in šepavost ovac.
English: Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica.
Slovenian: • dihalnih obolenj prašičev (SRD), ki jih povzročajo bakterije Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae Haemophilus parasuis ali Bordetella bronchiseptica;
English: Draxxin can also be used for metaphylaxis of BRD and SRD.
Slovenian: Zdravilo Draxxin se lahko uporablja tudi za metafilakso dihalnih obolenj goveda in dihalnih obolenj prašičev.
English: For the treatment of IBK, the effectiveness of Draxxin has been studied in three main studies involving calves.
Slovenian: Pri zdravljenju infekcioznega govejega keratokonjuktivitisa so učinkovitost zdravila Draxxin raziskovali v treh glavnih študijah, v katere so bila vključena teleta.
English: SRD with Bordetella bronchiseptica present.
Slovenian: V tretjo študijo so bili vključeni prašiči z dihalnim obolenjem in prisotnostjo bakterije Bordetella bronchiseptica.
English: These include the following:
Slovenian: Ukrepi vključujejo naslednje:
English: 15 March 2013
Slovenian: 15. marec 2013
English: The European Commission issued a decision on 15 March 2013.
Slovenian: Evropska komisija je sklep izdala dne 15. marca 2013.
English: 1 For information on the outcome of this review, see: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Fibrinogencontaining_solutions_for_sealant_authorised_for_administration_by_spray_application/human_referral_000329.jsp&mid=W C0b01ac05805c516f
Slovenian: 1 Za informacije o izsledkih tega pregleda glejte spletno stran: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Fibrinogencontaining_solutions_for_sealant_authorised_for_administration_by_spray_application/human_referral_000329.jsp&mid=W C0b01ac05805c516f
English: What are the recommendations for surgeons?
Slovenian: Kakšna so priporočila za kirurge?
English: varied, suspended or withdrawn across the EU.
Slovenian: ohrani ali pa ga je treba spremeniti, začasno umakniti oziroma preklicati.
English: Why were fibrin sealants reviewed?
Slovenian: Zakaj so bila fibrinska lepila ponovno preučena?
English: Several fibrin sealants have been authorised in European Union (EU) Member States through national procedures.
Slovenian: V državah članicah EU je bilo z nacionalnimi postopki odobrenih več fibrinskih lepil.
English: At the same time, the United Kingdom medicines agency requested a similar assessment for Quixil and for the other fibrin sealants authorised in EU countries, given that the risk of air embolism could not be excluded for these products.
Slovenian: Istočasno je agencija Združenega kraljestva za zdravila zaprosila za podobno oceno zdravila Quixil in drugih fibrinskih lepil, odobrenih v državah EU, glede na to, da tveganja za zračno embolijo pri teh izdelkih ni mogoče izvzeti.
English: A group of experts in blood products, haemostasis (the stopping of bleeding) and surgery was also consulted.
Slovenian: Posvetoval se je tudi s skupino strokovnjakov za krvne proizvode, hemostazo (ustavljanje krvavenja) in kirurgijo.
English: What are fibrin sealants?
Slovenian: Kaj so fibrinska lepila?
English: • the wording of 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: • okrepiti je treba besedilo informacij o zdravilu in posodobiti izobraževalno gradivo, da se kirurgom zagotovijo jasne in dosledne informacije o priporočenem tlaku in razdalji med pršenjem;
English: When the two solutions are mixed together, thrombin breaks fibrinogen up into smaller units called fibrin.
Slovenian: Če raztopini pomešamo, trombin povzroči razpad fibrinogena v manjše enote, ki jih imenujemo fibrini.
English: Due to the close similarity of Evicel and Quixil, the CHMP concluded its review of Evicel and Quixil in November 20121.
Slovenian: Zaradi velike podobnosti zdravil Evicel in Quixil je odbor CHMP pregled teh zdravil zaključil novembra 20121.
English: In particular, when spraying these products: the recommended pressures should not be exceeded, and the sealant should not be sprayed at a closer distance than recommended; patients should be closely monitored for signs of possible gas embolism (by measuring blood pressure, pulse rate, and oxygen and CO2 levels in the blood).
Slovenian: Pri pršenju teh zdravil je treba upoštevati zlasti naslednje: ne presezite priporočenega tlaka in lepila ne pršite na manjši razdalji od priporočene; bolnike je treba natančno spremljati za znake morebitne plinske embolije (z merjenjem krvnega tlaka, srčnega utripa ter koncentracij kisika in CO2 v krvi).
English: The Committee also agreed that the company marketing Tisseel, Tissucol and Artiss should provide a letter to relevant healthcare professionals in the EU including important information on the safe use of these medicines.
Slovenian: Odbor se je prav tako strinjal, da morajo podjetja, ki imajo dovoljenje za promet z zdravili Tisseel, Tissucol in Artiss, zadevnim zdravnikom v EU poslati dopis s pomembnimi informacijami o varni uporabi teh zdravil.
English: Beriplast P does not require a gas-assisted spray device.
Slovenian: Zdravilo Beriplast P ne zahteva uporabe pripomočka za plinsko pršenje.
English: For Evicel, Quixil, Tisseel, Tissucol and Artiss, the solution is currently sprayed using either pressurised air or carbon dioxide (CO2).
Slovenian: Trenutno se zdravila Evicel, Quixil, Tisseel, Tissucol in Artiss pršijo z uporabo zraka pod tlakom ali ogljikovega dioksida (CO2).
English: Following cases of gas embolism (presence of a gas bubble in the blood that affects the blood flow) reported in association with the use of Evicel and Quixil, in May 2012 the European Commission asked the CHMP to issue an opinion on whether the marketing authorisation for Evicel should be maintained,
Slovenian: Evropska komisija je po primerih plinske embolije (prisotnost zračnega mehurčka v krvi, ki vpliva na krvni obtok), o katerih so poročali v povezavi z uporabo zdravil Evicel in Quixil, maja 2012 pozvala CHMP, naj predloži svoje mnenje o tem, ali se lahko dovoljenje za promet za zdravilo Evicel v EU
English: • the product information should include a warning that the risk of gas embolism appears to be higher when fibrin sealants are sprayed using air, as compared to CO2, and patients should be closely monitored for signs of possible gas embolism.
Slovenian: • informacije o zdravilu morajo vključevati opozorilo, da je tveganje za plinsko embolijo večje pri pršenju fibrinskih lepil z zrakom kot pri pršenju s CO2, in da je treba bolnike natančno spremljati za znake morebitne plinske embolije.
English: • the company for Tisseel, Tissucol and Artiss should ensure that these products are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and which have labels stating the recommended pressure and distance;
Slovenian: • podjetje za zdravila Tisseel, Tissucol in Artiss mora 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: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines continue to outweigh their risks, but that appropriate measures have to be put in place to optimise the safe use of these medicines when they are applied as a spray during surgery.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je sklenil, da koristi teh zdravil še zmeraj odtehtajo z njimi povezana tveganja, vendar je treba sprejeti ustrezne ukrepe za optimizacijo njihove varne uporabe pri nanosu s pršenjem med kirurškim posegom.
English: Fibrin sealants are medicines that are used as a sealant (glue) during surgery to help reduce local bleeding.
Slovenian: Fibrinska lepila so zdravila, ki se med kirurškimi posegi uporabljajo kot tesnila (lepila) v pomoč pri zmanjšanju lokaliziranega krvavenja.
English: The CHMP reviewed the 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: • Surgeons should note the potential risk of gas embolism with incorrect spray application of Tisseel, Tissucol and Artiss 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 Tisseel, Tissucol in Artiss ter izvajajo potrebne varnostne ukrepe, opredeljene v posodobljenih navodilih o predpisovanju teh zdravil.
English: On 13 December 2012, the European Medicines Agency completed a review of the safety and effectiveness of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names), following concerns over the risk of gas embolism when these medicines are given by spray application.
Slovenian: Evropska agencija za zdravila je 13. decembra 2012 zaključila pregled varnosti in učinkovitosti fibrinskih lepil Tisseel, Tissucol, Artiss in Beriplast P (in povezanih imen), ki je bil sprožen zaradi zadržkov glede tveganja za plinsko embolijo pri nanosu teh zdravil s pršenjem.
English: They are composed of two solutions, one containing fibrinogen and another containing thrombin, both of which are proteins involved in the blood clotting process.
Slovenian: Sestavljena so iz dveh raztopin, od katerih ena vsebuje fibrinogen, druga pa trombin.
English: Regarding Tisseel, Tissucol and Artiss (and associated names), the CHMP concluded that, although the risk of gas embolism was considered very low, risk minimisation measures should be implemented when these medicines are given by spray application to help ensure they are used safely.
Slovenian: Glede zdravil Tisseel, Tissucol in Artiss (in povezanih imen) je CHMP zaključil, da je treba kljub majhnemu tveganju za plinsko embolijo sprejeti ukrepe za zmanjšanje tveganj pri nanosu teh zdravil s pršenjem, da se zagotovi njihova varna uporaba.
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 zaceliti rano, saj ustavi krvavenje.
English: The CHMP noted that all of the cases of gas embolism seen with Evicel and Quixil were related to the use of the spray device at higher-than-recommended pressures or in closer proximity to the tissue surface than recommended.
Slovenian: CHMP je opozoril, da so bili vsi primeri plinske embolije, o katerih so poročali pri uporabi zdravil Evicel in Quixil, posledica uporabe večjega tlaka od priporočenega ali manjše razdalje od tkiva od priporočene.
English: As Beriplast P (and associated names) does not require a gas-assisted spray device, the CHMP concluded that there is no risk of gas embolism with this product when used in accordance with the prescribing advice and with the recommended device.
Slovenian: Ker zdravilo Beriplast P (in povezana imena) ne zahteva uporabe pripomočka za plinsko pršenje, je CHMP zaključil, da pri uporabi tega zdravila v skladu z navodili o predpisovanju skupaj s priporočeno napravo tveganje za plinsko embolijo ne obstaja.
English: Fibrin sealants can be applied by dripping or spraying the solution onto bleeding tissue.
Slovenian: Fibrinska lepila se lahko nanesejo s kapanjem ali pršenjem raztopine na krvaveče področje.
English: The Committee also considered the spray devices used together with these medicines, and the benefit of giving fibrin sealants by spray application.
Slovenian: Prav tako je preučil pršilnike, ki se uporabljajo z zadevnimi zdravili, ter koristi nanosa fibrinskih lepil s pršenjem.
English: 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: The current conclusions concern Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Slovenian: Trenutni zaključki veljajo za zdravila Tisseel, Tissucol, Artiss in Beriplast P (in povezana imena).
English: Questions and answers on the review of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) given by spray application
Slovenian: Vprašanja in odgovori v zvezi s pregledom fibrinskih lepil Tisseel, Tissucol, Artiss in Beriplast P (in povezanih imen) za pršenje
English: Evicel is the only centrally authorised fibrin sealant for use by spray application.
Slovenian: Edino fibrinsko lepilo za uporabo s pršenjem, odobreno po centraliziranem postopku, je zdravilo Evicel.
English: • There is no risk of gas embolism with Beriplast P when used in accordance with the prescribing advice and with the recommended device.
Slovenian: • Pri uporabi zdravila Beriplast P v skladu z navodili o predpisovanju skupaj s priporočeno napravo tveganje za plinsko embolijo ne obstaja.
English: 30 x 1 tablets (unit dose)
Slovenian: 30 × 1 tableta (posamezni odmerek)
English: Tell your doctor:
Slovenian: Povejte zdravniku:
English: Some patients have actually committed suicide.
Slovenian: Nekaj bolnikov je naredilo samomor.
English: Date of latest renewal: 23 April 2014
Slovenian: Datum zadnjega podaljšanja: 23. april 2014
English: Risk to the infant can not be excluded.
Slovenian: Tveganja za dojenčka ne moremo izključiti.
English: Do not add more food.
Slovenian: Hrane ne dodajte več.
English: ---, not performed.
Slovenian: --, ni izvedeno.
English: Control regimen (n=635)
Slovenian: kontrolna skupina (n = 635)
English: any signs of inflammation or infection.
Slovenian: katere koli znake vnetja ali okužbe.
English: Long-term use of efavirenz in this study was not associated with any new safety concerns.
Slovenian: Dolgotrajna uporaba efavirenza v tej študiji ni bila povezana s kakršnimi koli novimi pomisleki glede varnosti.
English: These metabolites are essentially inactive against HIV-1.
Slovenian: Ti metaboliti so v glavnem neaktivni proti HIV-1.
English: Effect of food
Slovenian: Vpliv hrane
English: if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
Slovenian: če je kateri koli član vaše družine (starši, stari starši, bratje ali sestre) nenadoma umrl zaradi težav s srcem ali je bil rojen z okvaro na srcu.
English: Undesirable effects in children were generally similar to those of adult patients.
Slovenian: Neželeni učinki pri otrocih so bili na splošno podobni kakor pri odraslih bolnikih.
English: Your doctor will test for these changes.
Slovenian: Zdravnik bo opravil preiskave glede teh sprememb
English: Interaction studies have only been performed in adults.
Slovenian: Študije medsebojnega delovanja so bile izvedene samo pri odraslih.
English: Children and adolescents (3 months to 17 years)
Slovenian: Otroci in mladostniki (stari od 3 mesecev do 17 let)
English: Studies were conducted in healthy subjects unless otherwise noted.
Slovenian: Študije so izvajali na zdravih osebah, razen če ni drugače navedeno.
English: Tell your doctor immediately if you are pregnant or intend to become pregnant.
Slovenian: Zdravniku takoj povejte, če ste noseči ali če nameravate zanositi.
English: Gender, race, elderly
Slovenian: Spol, rasa, starejši bolniki
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Slovenian: Take reakcije so značilno opazili v prvih nekaj tednih ali mesecih po uvedbi CART.
English: Contrada Fontana del Ceraso 03012 Anagni (FR) Italy
Slovenian: Contrada Fontana del Ceraso 03012 Anagni (FR) Italija
English: SUSTIVA must be taken every day.
Slovenian: Zdravilo SUSTIVA je treba jemati vsak dan.
English: If you are affected, do not drive and do not use any tools or machines.
Slovenian: Če se to pojavi pri vas, ne vozite in ne upravljajte z orodji ali s stroji.
English: Some patients have more serious symptoms that may affect mood or the ability to think clearly.
Slovenian: Nekateri bolniki imajo hujše simptome, ki lahko vplivajo na njihovo razpoloženje ali zmožnost jasnega mišljenja.
English: Study ACTG 364 48 weeks
Slovenian: Študija ACTG 364 48 tednov
English: Dose reduction or splitting the daily dose has not been shown to provide benefit.
Slovenian: Zmanjšanje odmerka ali razdelitev dnevnega odmerka nista pokazala nobene koristi.
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Slovenian: Posvetujte se s svojim zdravnikom o potrebnih previdnostnih ukrepih, da se izognete okužbi drugih ljudi.
English: This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection.
Slovenian: To bo okrepilo vaš imunski sistem in zmanjšalo tveganje za razvoj bolezni, povezanih z okužbo z virusom HIV.
English: You must check with your doctor first.
Slovenian: Najprej se morate posvetovati z zdravnikom.
English: 48 weeks
Slovenian: 48 tednov