natgillin/translations-raw huggingface dataset:
• Patients who have any questions or concerns should speak to the treating doctor, pharmacist or nurse. 
• Bolniki, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z lečečim zdravnikom, farmacevtom ali medicinsko sestro.
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. 
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.
In accordance with EU legislation, this type of action required that an EU review procedure be carried out. 
V skladu z zakonodajo EU je treba v takem primeru opraviti revizijski postopek na ravni EU.
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. 
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.
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. 
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.
Consequently, on 27 June 2013, the UK triggered an EU review of HES solutions under Article 107i of Directive 2001/83/EC. 
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.
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. 
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.
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. 
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.
Colloids contain large molecules such as starch, whereas crystalloids, such as saline (salt) solutions or Ringer's acetate, contain smaller molecules. 
Koloidi vsebujejo velike molekule, kot je na primer škrob, medtem ko kristaloidi, kot so na primer raztopine soli ali Ringerjev acetat, vsebujejo manjše molekule.
• HES solutions should be used at the lowest effective dose for the shortest period of time. 
• Raztopine, ki vsebujejo HES, je treba uporabljati pri najmanjšem učinkovitem odmerku za najkrajši možni čas.
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. 
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.
Healthcare professionals have been informed in writing of the outcome of the review and the changes to the use of HES solutions. 
Zdravstveni delavci so bili pisno obveščeni o izidu tega pregleda in o spremembah v zvezi z uporabo raztopin, ki vsebujejo HES.
The use of HES must be discontinued at the first sign of renal injury. 
Uporabo HES je treba prekiniti ob prvem znaku okvare ledvic.
There are two main types of medicines used for volume replacement: crystalloids and colloids. 
Za nadomeščanje volumna se v glavnem uporabljata dve vrsti zdravil: kristaloidi in koloidi.
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. 
Poleg posodobitve informacij o zdravilu je treba opraviti tudi dodatne študije o uporabi teh zdravil pri načrtovanih kirurških posegih in bolnikih s poškodbami.
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. 
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.
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. 
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.
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. 
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.
Available on: http://clinicaltrials.gov/ct2/show/NCT00318942 5. 
Dostopno na: http://clinicaltrials.gov/ct2/show/NCT00318942
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 
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
Available on ClinicalTrials.gov (NCT01122277) last updated on 07 July 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1 
Dostopno na ClinicalTrials.gov (NCT01122277), nazadnje posodobljeno 7. julija 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved. 
Pri zdravljenju je treba upoštevati rezultate stalnega hemodinamskega spremljanja, tako da se infundiranje prekine takoj, ko so dosežene ustrezne ciljne vrednosti hemodinamskih spremenljivk.
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. 
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.
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). 
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).
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. 
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.
• HES solutions are contraindicated in severe coagulopathy. 
• Raztopine, ki vsebujejo HES, so kontraindicirane pri hudi koagulopatiji.
An increased need for renal replacement therapy has been reported up to 90 days after HES administration. 
V obdobju do 90 dni po dajanju HES so poročali o povečani potrebi po nadomestnem zdravljenju ledvične odpovedi.
Infusion solutions containing HES are frequently used for volume replacement and belong to the class known as colloids. 
Raztopine za infundiranje, ki vsebujejo HES, se pogosto uporabljajo za nadomeščanje volumna in spadajo v skupino zdravil, imenovanih koloidi.
• There is a lack of robust long-term safety data in patients undergoing surgical procedures and in patients with trauma. 
• Zanesljivih podatkov o dolgoročni varnosti pri bolnikih z načrtovanim kirurškim posegom in bolnikih s poškodbami je zelo malo.
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. 
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.
• HES solutions may continue to be used to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss. 
• Raztopine, ki vsebujejo HES, se lahko še naprej uporabljajo za zdravljenje hipovolemije (zmanjšanega volumna krvi) zaradi akutne (nenadne) izgube krvi.
Blood coagulation parameters should be monitored carefully in case of repeated administration. 
Pri večkratnem dajanju HES je treba skrbno spremljati parametre strjevanja krvi.
However, the doctor should monitor the patient's kidney function after HES administration. 
Vendar pa mora zdravnik po dajanju HES spremljati delovanje ledvic bolnika.
• HES solutions should only be used for the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. 
• Raztopine, ki vsebujejo HES, se lahko uporabljajo samo za zdravljenje hipovolemije zaradi akutne izgube krvi, kadar sami kristaloidi ne zadoščajo.
Additional studies will be performed with HES solutions in patients with trauma and in elective surgery. 
Raztopine, ki vsebujejo HES, bodo pri bolnikih s poškodbami in pri načrtovanih kirurških posegih raziskali v dodatnih študijah.
• HES solutions are now contraindicated in patients with renal impairment or renal replacement therapy. 
• Raztopine, ki vsebujejo HES, so po novem kontraindicirane pri bolnikih z okvaro ledvic in bolnikih, ki potrebujejo nadomestno zdravljenje ledvične odpovedi.
• 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. 
• 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.
• 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. 
• 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.
HES solutions should be discontinued at the first sign of coagulopathy. 
Ob prvem znaku koagulopatije je treba uporabo raztopin, ki vsebujejo HES, prekiniti.
Patients' kidney function should be monitored after HES administration. 
Po dajanju HES je treba spremljati delovanje ledvic bolnikov.
Oral use sachet , , , , , , , , , , (Paper/LDPE/alu/ n n n LDPE) 
Peroralna uporaba vrečka (papir/LDPE/alu/LDPE)
Gastro-resistant v granules 
Gastrorezistentna zrnca
Pack size 
30 vrečk
Name 
Jakost
The European Commission granted a marketing authorisation valid throughout the European Union for Evicel on 6 October 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Evicel, veljavno po vsej Evropski uniji, odobrila dne 6. oktobra 2008.
The full EPAR for Evicel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
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.
Evicel has been studied in two main studies involving a total of 282 patients. 
Zdravilo Evicel so raziskali v dveh glavnih študijah, v kateri je bilo vključenih skupaj 282 bolnikov.
What measures are being taken to ensure the safe use of Evicel? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Evicel?
Other information about Evicel 
Druge informacije o zdravilu Evicel
When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin. 
Kadar se ti dve zdravilni učinkovini zmešata, trombin razreže fibrinogen v manjše enote, imenovane fibrin.
This is a summary of the European public assessment report (EPAR) for Evicel. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Evicel.
Evicel human clottable protein / human thrombin 
Evicel humana koagulacijska beljakovina/humani trombin
For more information about treatment with Evicel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
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.
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). 
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).
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. 
Količina uporabljenega zdravila Evicel je odvisna od več dejavnikov, med drugim vrste kirurškega posega, velikosti rane in števila nanosov.
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. 
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.
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. 
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.
What benefit has Evicel shown during the studies? 
Kakšne koristi je zdravilo Evicel izkazalo med študijami?
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. 
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.
Evicel is used by surgeons to help reduce local bleeding during operations when standard techniques are not sufficient. 
Zdravilo Evicel uporabljajo kirurgi med operacijami, saj pomaga zmanjšati lokalne krvavitve, kadar običajne tehnike ne zadoščajo.
Evicel must not be used in people who are hypersensitive (allergic) to human clottable protein, thrombin or any of the other ingredients. 
Zdravila Evicel ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humano koagulacijsko beljakovino, trombin ali katero koli drugo sestavino zdravila.
The CHMP decided that Evicel's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Evicel večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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. 
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.
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. 
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.
In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting. 
V redkih primerih se lahko pri bolnikih razvijejo protitelesa na beljakovine v zdravilu Evicel, kar lahko moti strjevanje krvi.
As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly. 
Kot druga tesnila lahko tudi zdravilo Evicel povzroči resno alergijsko reakcijo, zlasti pri večkratni uporabi.
What is the risk associated with Evicel? 
Kakšna tveganja so povezana z zdravilom Evicel?
The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding. 
Fibrin se nato združi (medsebojno zlepi) in ustvari fibrinski strdek, ki pomaga ozdraviti rano, saj preprečuje krvavenje.
Evicel is a medicine that is used as a sealant (glue). 
Evicel je zdravilo, ki se uporablja kot tesnilno sredstvo (lepilo).
The active substances in Evicel, human clottable protein and thrombin, are natural substances obtained from human plasma (the liquid part of the blood). 
Zdravilni učinkovini zdravila Evicel, humana koagulacijska beljakovina in trombin, sta naravni snovi, pridobljeni iz človeške plazme (tekočega dela krvi).
The human clottable protein contains as its main component, fibrinogen, a protein involved in the natural clotting process. 
Glavna sestavina humane koagulacijske beljakovine je fibrinogen, beljakovina, ki sodeluje pri naravnem procesu strjevanja krvi.
Why has Evicel been approved? 
Zakaj je bilo zdravilo Evicel odobreno?
When used in endoscopic procedures (procedures that use an endoscope for viewing internal organs), 
Kadar se zdravilo Evicel uporablja pri endoskopskih posegih (postopkih, pri katerih se endoskop uporabi za ogled notranjih organov), se ne sme uporabiti v obliki pršila.
Cases of gas embolism (gas bubbles in the blood that affect the blood flow) have occurred when Evicel was applied as spray. 
Primeri plinske embolije (plinski mehurčki v krvi, ki motijo njen pretok) so bili opaženi pri uporabi zdravila Evicel v obliki pršila.
For the full list of all side effects reported with Evicel, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Evicel, glejte navodilo za uporabo.
The main measure of effectiveness was the number of patients whose dura mater closure was watertight with no leakage. 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila dura mater vodotesna in ni prepuščala tekočine.
Evicel should only be used by an experienced surgeon who has been trained in the use of Evicel. 
Zdravilo Evicel lahko uporablja samo izkušen kirurg, ki je bil usposobljen za dajanje tega zdravila.
It must not be given as an injection into a blood vessel. 
Zdravilo se ne sme dati v obliki injekcije v žilo.
Evicel was more effective than the comparator treatments in reducing the bleeding at the site of application. 
Zdravilo Evicel je bilo pri zmanjšanju krvavitve na mestu uporabe učinkovitejše od zdravljenja s primerjalnimi zdravili.
The main measure of effectiveness was the number of patients with no bleeding (haemostasis) at the site of application, four minutes after having received Evicel or manual compression. 
Glavno merilo učinkovitosti je bilo število bolnikov brez krvavitve (hemostaza) na mestu uporabe štiri minute po prejetju zdravila Evicel ali ročni kompresiji.
The main measure of effectiveness was the number of patients with no bleeding at the site of application, 10 minutes after having received Evicel or Surgicel. 
Glavno merilo učinkovitosti je bilo število bolnikov brez krvavitve na mestu uporabe deset minut po prejetju zdravila Evicel ali snovi Surgicel.
In dura mater closure, 92% of patients treated with Evicel (82 out of 89) had a watertight closure compared with 38% of the patients who did not receive Evicel (19 out of 50). 
Celjenje dure mater je bilo pri 92 % (82 od 89) bolnikov, ki so prejemali zdravilo Evicel, vodotesno v primerjavi z 38 % (19 od 50) bolnikov, ki tega zdravila niso prejeli.
Evicel can also be used in addition to sutures to obtain a watertight closure of the dura mater (a thin fluid-filled membrane surrounding the brain and the spinal cord) during brain surgery. 
Zdravilo Evicel se lahko uporabi poleg šivov za vodotesno zaporo dure mater (tanke, s tekočino napolnjene ovojnice, ki obkroža možgane in hrbtenjačo) med možgansko operacijo.
Before use, the two solutions of Evicel are mixed together using a special device that is supplied with the medicine. 
Pred uporabo se raztopini zdravila Evicel zmešata s posebnim pripomočkom, ki je priložen zdravilu.
The second study compared Evicel with Surgicel (a material used to help control bleeding) in reducing bleeding during abdominal surgery (surgery of organs in the tummy). 
V drugi študiji so zdravilo Evicel primerjali s snovjo Surgicel (snovjo, ki se uporablja za nadzorovanje krvavitev) pri zmanjšanju krvavenja med abdominalnim kirurškim posegom (operacijo trebušnih organov).
For further details see the package leaflet. 
Za več informacij glejte navodilo za uporabo.
In vascular surgery, 85% of the patients had no bleeding four minutes after treatment with Evicel (64 out of 75), compared with 39% of the patients treated with manual compression (28 out of 72). 
Pri vaskularnem kirurškem posegu je pri 85 % (64 od 75) bolnikov krvavitev prenehala v štirih minutah po zdravljenju z zdravilom Evicel , v primeru zdravljenja z ročno kompresijo pa je krvavitev prenehala pri 39 % (28 od 72) bolnikov.
The first study compared Evicel with manual compression (applying direct pressure) in reducing bleeding during vascular surgery. 
V prvi študiji so zdravilo Evicel primerjali z metodo ročne kompresije (neposrednim pritiskanjem) pri zmanjševanju krvavitve med vaskularnim kirurškim posegom.
What is Evicel used for? 
Za kaj se zdravilo Evicel uporablja?
The study compared the effectiveness of Evicel in addition to sutures with sutures alone in sealing the dura mater. 
V študiji so primerjali učinkovitost zdravila Evicel kot podporo šivom s samimi šivi pri celjenju dure mater.