FrancophonIA/ELRC3.0 huggingface dataset:
English: What is the risk associated with Kexxtone?
Slovenian: Kakšna tveganja so povezana z zdravilom Kexxtone?
English: Treated cattle should be held in a confined area for one hour after administration to observe for failure to swallow or regurgitation.
Slovenian: Zdravljeno govedo je treba eno uro po uporabi zdravila zadržati v zaprtem prostoru in opazovati, ali lahko požira oziroma ali pride do regurgitacije.
English: Kexxtone is used to reduce the incidence of ketosis in dairy cows and heifers which are expected to develop ketosis in the period around calving.
Slovenian: Zdravilo Kexxtone se uporablja za zmanjšanje pojavnosti ketoze pri kravah molznicah in telicah, pri katerih se pričakuje razvoj ketoze v obdobju pred in po telitvi.
English: Kexxtone is a veterinary medicine that contains the active substance monensin.
Slovenian: Kexxtone je zdravilo, ki vsebuje zdravilno učinkovino monenzin.
English: Why has Kexxtone been approved?
Slovenian: Zakaj je bilo zdravilo Kexxtone odobreno?
English: Cattle should be re-checked for up to four days after dosing in case the intraruminal device has not been fully swallowed and has lodged in the oesophagus (the gullet or tube leading from the mouth to the rumen).
Slovenian: Govedo je treba do štiri dni po odmerjanju pregledovati, saj se lahko zgodi, da žival intraruminalnega sistema ne požre v celoti in se ta zagozdi v požiralniku (oziroma cevi, ki povezuje usta in vamp).
English: If this occurs, the product should be re-administered if undamaged.
Slovenian: Če ne požira ali če regurgitira, je treba ponovno dati zdravilo, če sistem ni poškodovan.
English: How does Kexxtone work?
Slovenian: Kako zdravilo Kexxtone deluje?
English: What is Kexxtone used for?
Slovenian: Za kaj se zdravilo Kexxtone uporablja?
English: How has Kexxtone been studied?
Slovenian: Kako je bilo zdravilo Kexxtone raziskano?
English: What is Kexxtone?
Slovenian: Kaj je zdravilo Kexxtone?
English: The withdrawal period for Kexxtone for cattle is zero days for meat and milk.
Slovenian: Karenca za meso in mleko po uporabi zdravila Kexxtone je nič dni.
English: References: 1.
Slovenian: Referenčna literatura: 1.
English: More about the procedures
Slovenian: Več o postopkih
English: While the re-examination was ongoing, some Member States decided to suspend or limit the marketing or use of these medicines in their territories.
Slovenian: V času, ko je potekal ponoven pregled, so se nekatere države članice odločile, da bodo začasno ustavile ali omejile trženje oziroma uporabo teh zdravil na svojih ozemljih.
English: * The CMDh is a medicines regulatory body representing the European Union (EU) Member States
Slovenian: * CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU).
English: HES will be available in restricted patient populations
Slovenian: HES bo na voljo za omejene populacije bolnikov
English: For the re-examination procedure the PRAC confirmed its previous position.
Slovenian: Pri ponovnem pregledu mnenja je odbor PRAC potrdil svoje prvotno stališče.
English: These recommendations are based on a review of all available safety and efficacy data, including recent data4,5,6, from clinical studies, meta-analyses and post-marketing experience.
Slovenian: Ta priporočila temeljijo na pregledu vseh razpoložljivih podatkov o varnosti in učinkovitosti, vključno z najnovejšimi podatki4,5,6 iz kliničnih študij, metaanaliz in izkušenj v obdobju trženja.
English: • Patients who have any questions or concerns should speak to the treating doctor, pharmacist or nurse.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z lečečim zdravnikom, farmacevtom ali medicinsko sestro.
English: A review of HES solutions for infusion was initiated on 29 November 2012 at the request of the German medicines agency, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled raztopin za infundiranje, ki vsebujejo HES, se je začel dne 29. novembra 2012 na zahtevo nemške agencije za zdravila v skladu s členom 31 Direktive 2001/83/ES.
English: In accordance with EU legislation, this type of action required that an EU review procedure be carried out.
Slovenian: V skladu z zakonodajo EU je treba v takem primeru opraviti revizijski postopek na ravni EU.
English: This review procedure ran in parallel with the re-examination of the PRAC's June 2013 recommendation and both procedures were finalised on 10 October 2013.
Slovenian: Ta je potekal vzporedno s ponovnim pregledom mnenja, ki ga je odbor PRAC podal junija 2013, tako da sta se oba postopka zaključila 10. oktobra 2013.
English: This review, which had been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), concluded on 13 June 2013, but some of the marketing authorisation holders requested a re-examination.
Slovenian: Pregled, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), se je zaključil 13. junija 2013, vendar so nekateri imetniki dovoljenja za promet z zdravilom zahtevali ponoven pregled.
English: Consequently, on 27 June 2013, the UK triggered an EU review of HES solutions under Article 107i of Directive 2001/83/EC.
Slovenian: Posledično je Združeno kraljestvo dne 27. junija 2013 sprožilo pregled raztopin, ki vsebujejo HES, na ravni EU v skladu s členom 107i Direktive 2001/83/ES.
English: The expected benefit of treatment should be carefully weighed against the uncertainties with regard to long-term safety, and other available treatment options should be considered.
Slovenian: Zato je treba skrbno pretehtati pričakovane koristi zdravljenja in negotovosti v zvezi z dolgoročno varnostjo ter razmisliti o drugih možnostih zdravljenja, ki so na voljo.
English: In the EU, HES-containing solutions for infusion have been approved via national procedures and are available in all Member States under various trade names.
Slovenian: Raztopine za infundiranje, ki vsebujejo HES, so bile v EU odobrene po nacionalnih postopkih in so pod različnimi trgovskimi imeni na voljo v vseh državah članicah.
English: Colloids contain large molecules such as starch, whereas crystalloids, such as saline (salt) solutions or Ringer's acetate, contain smaller molecules.
Slovenian: Koloidi vsebujejo velike molekule, kot je na primer škrob, medtem ko kristaloidi, kot so na primer raztopine soli ali Ringerjev acetat, vsebujejo manjše molekule.
English: • HES solutions should be used at the lowest effective dose for the shortest period of time.
Slovenian: • Raztopine, ki vsebujejo HES, je treba uporabljati pri najmanjšem učinkovitem odmerku za najkrajši možni čas.
English: As HES-containing solutions for infusion are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Slovenian: Ker so vse raztopine za infundiranje, ki vsebujejo HES, odobrene na nacionalni ravni, so bila priporočila odbora PRAC posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
English: Healthcare professionals have been informed in writing of the outcome of the review and the changes to the use of HES solutions.
Slovenian: Zdravstveni delavci so bili pisno obveščeni o izidu tega pregleda in o spremembah v zvezi z uporabo raztopin, ki vsebujejo HES.
English: The use of HES must be discontinued at the first sign of renal injury.
Slovenian: Uporabo HES je treba prekiniti ob prvem znaku okvare ledvic.
English: There are two main types of medicines used for volume replacement: crystalloids and colloids.
Slovenian: Za nadomeščanje volumna se v glavnem uporabljata dve vrsti zdravil: kristaloidi in koloidi.
English: In addition to updating the product information, further studies should be carried out on the use of these medicines in elective surgery and trauma patients.
Slovenian: Poleg posodobitve informacij o zdravilu je treba opraviti tudi dodatne študije o uporabi teh zdravil pri načrtovanih kirurških posegih in bolnikih s poškodbami.
English: However, new evidence was considered in the parallel Article 107i procedure and this was the basis for the PRAC's final recommendation on the use of HES solutions.
Slovenian: V vzporednem postopku po členu 107i pa so bili upoštevani novi dokazi, na podlagi katerih je odbor PRAC podal končno priporočilo glede uporabe raztopin, ki vsebujejo HES.
English: In order to minimise potential risks in these patients, HES solutions should not be used for more than 24 hours and patients' kidney function should be monitored after HES administration.
Slovenian: Da bi zmanjšali možna tveganja pri teh bolnikih, se raztopine, ki vsebujejo HES, ne smejo uporabljati dlje kot 24 ur, po njihovem dajanju pa je treba pri bolnikih spremljati delovanje ledvic.
English: On 23 October 2013, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)*, endorsed by majority the recommendations of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients because of an increased risk of kidney injury and mortality.
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh)* je 23. oktobra 2013 z večino potrdila priporočila Odbora za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila, ki je zaključil, da se raztopine, ki vsebujejo HES, ne smejo več uporabljati za zdravljenje bolnikov s sepso (bakterijsko okužbo krvi) ali opeklinami in kritično bolnih, saj obstaja povečano tveganje za okvaro ledvic in smrt.
English: Available on: http://clinicaltrials.gov/ct2/show/NCT00318942 5.
Slovenian: Dostopno na: http://clinicaltrials.gov/ct2/show/NCT00318942
English: Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients:BaSES (130;0.4) Trial, listed at http://clinicaltrials.gov/show/NCT00273728
Slovenian: Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients:BaSES (130;0.4) Trial, navedeno na http://clinicaltrials.gov/show/NCT00273728
English: Available on ClinicalTrials.gov (NCT01122277) last updated on 07 July 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
Slovenian: Dostopno na ClinicalTrials.gov (NCT01122277), nazadnje posodobljeno 7. julija 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
English: Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved.
Slovenian: Pri zdravljenju je treba upoštevati rezultate stalnega hemodinamskega spremljanja, tako da se infundiranje prekine takoj, ko so dosežene ustrezne ciljne vrednosti hemodinamskih spremenljivk.
English: The review of HES solutions was carried out by the PRAC following the publication of studies showing an increased risk of mortality in patients with sepsis1,2 and an increased risk of kidney injury requiring dialysis in critically ill patients1,2,3 following treatment with HES solutions.
Slovenian: Odbor PRAC je pregled raztopin, ki vsebujejo HES, opravil po objavi študij, ki so pokazale, da se je po zdravljenju z raztopinami, ki vsebujejo HES, pri bolnikih s sepso1,2 povečalo tveganje za smrt, pri kritično bolnih1,2,3 pa tveganje za okvaro ledvic, ki zahteva zdravljenje z dializo.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and, on 19 December 2013, adopted a final legally binding decision valid throughout the European Union (EU).
Slovenian: Ker je skupina CMDh omenjeno stališče sprejela z večino, je bilo posredovano Evropski komisiji, ki ga je potrdila in dne 19. decembra 2013 sprejela končno pravno zavezujočo odločbo, ki velja za celotno Evropsko unijo (EU).
English: As the CMDh position was adopted by majority vote, it was sent sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 19 December 2013.
Slovenian: Ker je skupina CMDh stališče sprejela z večino glasov, je bilo posredovano Evropski komisiji, ki ga je potrdila in dne 19. decembra 2013 sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
English: • HES solutions are contraindicated in severe coagulopathy.
Slovenian: • Raztopine, ki vsebujejo HES, so kontraindicirane pri hudi koagulopatiji.
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Slovenian: V obdobju do 90 dni po dajanju HES so poročali o povečani potrebi po nadomestnem zdravljenju ledvične odpovedi.
English: Infusion solutions containing HES are frequently used for volume replacement and belong to the class known as colloids.
Slovenian: Raztopine za infundiranje, ki vsebujejo HES, se pogosto uporabljajo za nadomeščanje volumna in spadajo v skupino zdravil, imenovanih koloidi.
English: • There is a lack of robust long-term safety data in patients undergoing surgical procedures and in patients with trauma.
Slovenian: • Zanesljivih podatkov o dolgoročni varnosti pri bolnikih z načrtovanim kirurškim posegom in bolnikih s poškodbami je zelo malo.
English: HES solutions may continue to be used in patients to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss, where treatment with alternative infusions solutions known as ‘crystalloids' alone are not considered to be sufficient.
Slovenian: Raztopine, ki vsebujejo HES, se lahko še naprej uporabljajo za zdravljenje bolnikov s hipovolemijo (zmanjšanim volumnom krvi) zaradi akutne (nenadne) izgube krvi, kadar samo zdravljenje z drugimi raztopinami za infundiranje, ki jim pravimo kristaloidi, ne zadošča.
English: • HES solutions may continue to be used to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss.
Slovenian: • Raztopine, ki vsebujejo HES, se lahko še naprej uporabljajo za zdravljenje hipovolemije (zmanjšanega volumna krvi) zaradi akutne (nenadne) izgube krvi.
English: Blood coagulation parameters should be monitored carefully in case of repeated administration.
Slovenian: Pri večkratnem dajanju HES je treba skrbno spremljati parametre strjevanja krvi.
English: However, the doctor should monitor the patient's kidney function after HES administration.
Slovenian: Vendar pa mora zdravnik po dajanju HES spremljati delovanje ledvic bolnika.
English: • HES solutions should only be used for the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Slovenian: • Raztopine, ki vsebujejo HES, se lahko uporabljajo samo za zdravljenje hipovolemije zaradi akutne izgube krvi, kadar sami kristaloidi ne zadoščajo.
English: Additional studies will be performed with HES solutions in patients with trauma and in elective surgery.
Slovenian: Raztopine, ki vsebujejo HES, bodo pri bolnikih s poškodbami in pri načrtovanih kirurških posegih raziskali v dodatnih študijah.
English: • HES solutions are now contraindicated in patients with renal impairment or renal replacement therapy.
Slovenian: • Raztopine, ki vsebujejo HES, so po novem kontraindicirane pri bolnikih z okvaro ledvic in bolnikih, ki potrebujejo nadomestno zdravljenje ledvične odpovedi.
English: • Because of the risk of kidney injury and mortality, HES solutions must no longer be used in patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients.
Slovenian: • Raztopine, ki vsebujejo HES, se zaradi tveganja za okvaro ledvic in smrt ne smejo več uporabljati pri bolnikih s sepso (bakterijsko okužbo krvi) ali opeklinami in pri kritično bolnih.
English: • Because of the risk of kidney injury and mortality, HES solutions must no longer be used in patients with sepsis, burn injuries or critically ill patients.
Slovenian: • Raztopine, ki vsebujejo HES, se zaradi tveganja za okvaro ledvic in smrt ne smejo več uporabljati pri bolnikih s sepso ali opeklinami in pri kritično bolnih.
English: Brunkhorst FM, Engel C, Bloos F et al.
Slovenian: Brunkhorst FM, Engel C, Bloos F et al. Intensive Insulin Therapy and Pentastarch Resuscitation in Severe Sepsis.
English: HES solutions should be discontinued at the first sign of coagulopathy.
Slovenian: Ob prvem znaku koagulopatije je treba uporabo raztopin, ki vsebujejo HES, prekiniti.
English: Patients' kidney function should be monitored after HES administration.
Slovenian: Po dajanju HES je treba spremljati delovanje ledvic bolnikov.
English: EU/1/13/896/001 GRANUPAS 4 g
Slovenian: EU/1/13/896/001 GRANUPAS
English: Oral use sachet , , , , , , , , , , (Paper/LDPE/alu/ n n n LDPE)
Slovenian: Peroralna uporaba vrečka (papir/LDPE/alu/LDPE)
English: Gastro-resistant v granules
Slovenian: Gastrorezistentna zrnca
English: Pack size
Slovenian: 30 vrečk
English: Name
Slovenian: Jakost
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evicel on 6 October 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Evicel, veljavno po vsej Evropski uniji, odobrila dne 6. oktobra 2008.
English: The full EPAR for Evicel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Evicel je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Evicel has been studied in two main studies involving a total of 282 patients.
Slovenian: Zdravilo Evicel so raziskali v dveh glavnih študijah, v kateri je bilo vključenih skupaj 282 bolnikov.
English: What measures are being taken to ensure the safe use of Evicel?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Evicel?
English: Other information about Evicel
Slovenian: Druge informacije o zdravilu Evicel
English: When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin.
Slovenian: Kadar se ti dve zdravilni učinkovini zmešata, trombin razreže fibrinogen v manjše enote, imenovane fibrin.
English: This is a summary of the European public assessment report (EPAR) for Evicel.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Evicel.
English: Evicel human clottable protein / human thrombin
Slovenian: Evicel humana koagulacijska beljakovina/humani trombin
English: For more information about treatment with Evicel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Evicel preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is available as two solutions, one containing the active substance human clottable protein (50 to 90 mg/ml), and the other containing the active substance human thrombin (800 to 1200 international units per millilitre).
Slovenian: Na voljo je v obliki dveh raztopin, od katerih ena vsebuje zdravilno učinkovino humano koagulacijsko beljakovino (od 50 do 90 mg/ml), druga pa zdravilno učinkovino humani trombin (od 800 do 1200 mednarodnih enot na mililiter).
English: The volume of Evicel to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.
Slovenian: Količina uporabljenega zdravila Evicel je odvisna od več dejavnikov, med drugim vrste kirurškega posega, velikosti rane in števila nanosov.
English: Because the thrombin solution of Evicel is also used in another medicine, Quixil, the company used some data from Quixil to support the use of Evicel.
Slovenian: Ker se trombinska raztopina zdravila Evicel uporablja tudi v drugem zdravilu, imenovanem Quixil, je družba v podporo uporabi zdravila Evicel uporabila nekatere podatke o zdravilu Quixil.
English: In order to reduce the risk of gas embolism with spray application, the company will provide educational material and training to all surgeons who will use Evicel as a spray.
Slovenian: Za zmanjševanje tveganja plinske embolije pri uporabi pršila, bo družba priskrbela izobraževalno gradivo in organizirala usposabljanja za vse kirurge, ki bodo zdravilo Evicel uporabljali v obliki pršila.
English: What benefit has Evicel shown during the studies?
Slovenian: Kakšne koristi je zdravilo Evicel izkazalo med študijami?
English: In addition, the company will ensure that Evicel is used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that the regulators contain labels stating the recommended pressure and distance for the spray application.
Slovenian: Poleg tega bo podjetje zagotovilo, da se zdravilo Evicel uporablja z regulatorjem tlaka, ki ne presega največjega tlaka, potrebnega za odmerjanje fibrinskega sredstva za zapiranje ran, ter da so regulatorji opremljeni z nalepko z navedbo priporočenega tlaka in razdalje za uporabo zdravila v pršilu.
English: Evicel is used by surgeons to help reduce local bleeding during operations when standard techniques are not sufficient.
Slovenian: Zdravilo Evicel uporabljajo kirurgi med operacijami, saj pomaga zmanjšati lokalne krvavitve, kadar običajne tehnike ne zadoščajo.
English: Evicel must not be used in people who are hypersensitive (allergic) to human clottable protein, thrombin or any of the other ingredients.
Slovenian: Zdravila Evicel ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humano koagulacijsko beljakovino, trombin ali katero koli drugo sestavino zdravila.
English: The CHMP decided that Evicel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Evicel večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Evicel.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Evicel, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Evicel has also been studied in one further main study involving 139 patients undergoing brain surgery and whose dura mater was leaking fluid following suturing of the dural incision.
Slovenian: Zdravilo Evicel so proučevali še v dodatni glavni študiji s 139 bolniki, ki so bili operirani na možganih in pri katerih je dura mater po šivanju kirurškega reza v duro prepuščala tekočino.
English: In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting.
Slovenian: V redkih primerih se lahko pri bolnikih razvijejo protitelesa na beljakovine v zdravilu Evicel, kar lahko moti strjevanje krvi.
English: As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly.
Slovenian: Kot druga tesnila lahko tudi zdravilo Evicel povzroči resno alergijsko reakcijo, zlasti pri večkratni uporabi.
English: What is the risk associated with Evicel?
Slovenian: Kakšna tveganja so povezana z zdravilom Evicel?
English: The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.
Slovenian: Fibrin se nato združi (medsebojno zlepi) in ustvari fibrinski strdek, ki pomaga ozdraviti rano, saj preprečuje krvavenje.
English: Evicel is a medicine that is used as a sealant (glue).
Slovenian: Evicel je zdravilo, ki se uporablja kot tesnilno sredstvo (lepilo).
English: The active substances in Evicel, human clottable protein and thrombin, are natural substances obtained from human plasma (the liquid part of the blood).
Slovenian: Zdravilni učinkovini zdravila Evicel, humana koagulacijska beljakovina in trombin, sta naravni snovi, pridobljeni iz človeške plazme (tekočega dela krvi).