FrancophonIA/ELRC3.0 huggingface dataset:
English: HES will be available in restricted patient populations
Estonian: HESi tohib kasutada ainult piiratud patsiendipopulatsioonides
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.
Estonian: Need soovitused põhinevad kõigi olemasolevate ohutus- ja efektiivsusandmete, sealhulgas kliiniliste uuringute, metaanalüüside ning turustamisjärgsete uute andmete4, 5, 6 ülevaatamisel.
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.
Estonian: Paralleelses artikli 107i menetluses kaaluti uusi andmeid ja see oli riskihindamiskomitee lõpliku soovituse alus HESi lahuste kasutamise kohta.
English: • HES solutions should be used at the lowest effective dose for the shortest period of time.
Estonian: • HESi lahuseid tuleb kasutada väikseimas efektiivses annuses lühima võimaliku aja jooksul.
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.
Estonian: Mainitud patsientide võimalike riskide minimeerimiseks ei tohi HESi lahuseid kasutada kauem kui 24 tundi ja pärast HESi manustamist tuleb jälgida patsientide neerutalitlust.
English: Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved.
Estonian: Ravi peab toimuma hemodünaamika pideva jälgimise järgi nii, et infusioon peatatakse kohe pärast sobivate hemodünaamiliste eesmärkide saavutamist.
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.
Estonian: Peale ravimiteabe uuendamise tuleb korraldada edasised uuringud nende ravimite kasutamise kohta elektiivse kirurgia ja traumapatsientidel.
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.
Estonian: Hüdroksüetüültärklist sisaldavad infusioonilahused on Euroopa Liidus saanud müügiloa riiklike menetluste kaudu ja neid turustatakse kõigis liikmesriikides mitmesuguste kaubanduslike nimetuste all.
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.
Estonian: Riskihindamiskomitee vaatas HESi lahuste andmed üle pärast uuringute avaldamist, mis näitasid suremuse suurenenud riski sepsisega patsientidel1, 2 ja dialüüsi vajava neerukahjustuse suurenenud riski kriitilises seisundis patsientidel1, 2, 3 pärast ravi HESi lahustega.
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.
Estonian: 23. oktoobril 2013 kinnitas inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm (CMDh)* häälteenamusega Euroopa Ravimiameti (EMA) ravimiohutuse järelevalve riskihindamiskomitee soovituse, kus järeldati, et hüdroksüetüültärklise lahuseid (HES) ei tohi enam kasutada sepsise (veremürgistuse) või põletusvigastustega või kriitilises seisundis patsientide raviks, neerukahjustuse ja suremuse suurenenud riski tõttu.
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.
Estonian: Kuivõrd kõik hüdroksüetüültärklist sisaldavad infusioonilahused on saanud müügiloa riiklike menetlustega, edastati riskihindamiskomitee soovitused inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühmale, kes võttis vastu lõpliku seisukoha.
English: There are two main types of medicines used for volume replacement: crystalloids and colloids.
Estonian: Vedelikumahu asendamiseks kasutatakse kaht peamist tüüpi ravimeid - kristalloide ja kolloide.
English: Available on: http://clinicaltrials.gov/ct2/show/NCT00318942 5.
Estonian: Avaldatud veebiaadressil http://clinicaltrials.gov/ct2/show/NCT00318942 5.
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
Estonian: Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients:BaSES (130;0.4) Trial, registreeritud veebiaadressil http://clinicaltrials.gov/show/NCT00273728 6.
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).
Estonian: Et koordineerimisrühma arvamus võeti vastu häälteenamusega, saadeti see Euroopa Komisjonile, kes kiitis selle heaks ja võttis 19 detsembril 2013 vastu lõpliku õiguslikult siduva otsuse, mis kehtib kogu Euroopa Liidus.
English: Available on ClinicalTrials.gov (NCT01122277) last updated on 07 July 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
Estonian: Avaldatud veebiaadressil ClinicalTrials.gov (NCT01122277), viimane uuendus 7.7.2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
English: • Patients who have any questions or concerns should speak to the treating doctor, pharmacist or nurse.
Estonian: • Küsimuste korral peavad patsiendid pöörduma oma raviarsti, apteekri või meditsiiniõe poole.
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.
Estonian: Menetlus lõppes 13. juunil 2013, kuid mõni müügiloa hoidja soovis taasläbivaatamist.
English: • HES solutions are contraindicated in severe coagulopathy.
Estonian: • HESi lahused on vastunäidustatud raske koagulopaatia korral.
English: • HES solutions are now contraindicated in patients with renal impairment or renal replacement therapy.
Estonian: • HESi lahused on nüüd vastunäidustatud neerupuudulikkusega või renaalset asendusravi saavatel patsientidel.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Estonian: Euroopa Liidu liikmesriike esindav kooskõlastusrühm vastutab ühtlustatud ohutusstandardite tagamise eest ravimitele, mis on saanud Euroopa Liidus müügiloa riiklike menetluste kaudu.
English: Infusion solutions containing HES are frequently used for volume replacement and belong to the class known as colloids.
Estonian: Hüdroksüetüültärklist (HES) sisaldavaid lahuseid kasutatakse sageli vedelikumahu asendamiseks ja need kuuluvad kolloidide klassi.
English: Healthcare professionals have been informed in writing of the outcome of the review and the changes to the use of HES solutions.
Estonian: Tervishoiutöötajatele on läbivaatamise tulemused ja HESi lahuste kasutamisviisi muutused teatatud kirjalikult.
English: The use of HES must be discontinued at the first sign of renal injury.
Estonian: HESi kasutamine tuleb katkestada neerukahjustuse esimeste nähtude ilmnemisel.
English: * The CMDh is a medicines regulatory body representing the European Union (EU) Member States
Estonian: * Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm on Euroopa Liidu liikmesriike esindav ravimite reguleerimise organ.
English: • HES solutions should only be used for the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Estonian: • HESi lahuseid tohib kasutada ainult akuutse verekaotuse tõttu tekkinud hüpovoleemia raviks, kui kristalloide üksi ei peeta piisavaks.
English: Colloids contain large molecules such as starch, whereas crystalloids, such as saline (salt) solutions or Ringer's acetate, contain smaller molecules.
Estonian: Kolloidid sisaldavad suuri molekule (nt tärklis) ja kristalloidid väiksemaid (nt NaCl lahus või Ringeri atsetaat).
English: However, the doctor should monitor the patient's kidney function after HES administration.
Estonian: Arst peab siiski pärast HESi manustamist jälgima patsiendi neerutalitlust.
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.
Estonian: Nende andmete puudumise tõttu tuleb hoolikalt kaaluda ravi eeldatavat kasulikkust ja teiste olemasolevate ravivõimaluste kasutamist.
English: Blood coagulation parameters should be monitored carefully in case of repeated administration.
Estonian: Korduval manustamisel tuleb hoolikalt jälgida vere hüübimisparameetreid.
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.
Estonian: • Neerukahjustuse ja suremuse riski tõttu ei tohi HESi lahuseid enam kasutada sepsise, põletusvigastustega ega kriitilises seisundis patsientidel.
English: • There is a lack of robust long-term safety data in patients undergoing surgical procedures and in patients with trauma.
Estonian: • Patsientide kohta, kellele tehakse kirurgilisi protseduure, ja traumaga patsientide kohta puuduvad põhjalikud pikaajalised ohutusandmed.
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.
Estonian: HESi lahuste kasutamist tohib jätkata akuutsest (ägedast) verekaotusest põhjustatud hüpovoleemia (vere ebanormaalselt väikese mahu) raviks, kui alternatiivseid infusioonilahuseid (nn kristalloide) üksi ei peeta piisavaks.
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.
Estonian: • Neerukahjustuse ja suremuse riski tõttu ei tohi HESi lahuseid enam kasutada sepsise (veremürgistuse), põletusvigastustega ega kriitilises seisundis patsientidel.
English: • HES solutions may continue to be used to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss.
Estonian: • HESi lahuste kasutamist tohib jätkata akuutsest (ägedast) verekaotusest põhjustatud hüpovoleemia (vere ebanormaalselt väikese mahu) raviks.
English: Brunkhorst FM, Engel C, Bloos F et al.
Estonian: 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.
Estonian: Koagulopaatia esimeste nähtude ilmnemisel tuleb HESi lahuste manustamine katkestada.
English: Additional studies will be performed with HES solutions in patients with trauma and in elective surgery.
Estonian: HESi lahuste kasutamise kohta trauma- ja elektiivse kirurgia patsientidel korraldatakse lisauuringud.
English: Patients' kidney function should be monitored after HES administration.
Estonian: Pärast HESi manustamist tuleb jälgida patsiendi neerutalitlust.
English: EU/1/13/896/001 GRANUPAS 4 g
Estonian: EU/1/13/896/001 GRANUPAS
English: Oral use sachet , , , , , , , , , , (Paper/LDPE/alu/ n n n LDPE)
Estonian: Suukaudne kotike (paber/LDPE/alu/LD PE)
English: Gastro-resistant v granules
Estonian: Gastroresistentsed graanulid
English: Immediate Packaging
Estonian: 30 kotikest
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.
Estonian: Euroopa avaliku hindamisaruande täistekst Eviceli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Evicel
Estonian: Muu teave Eviceli kohta
English: Evicel has been studied in two main studies involving a total of 282 patients.
Estonian: Eviceli uuriti kahes põhiuuringus, milles osales kokku 282 patsienti.
English: What measures are being taken to ensure the safe use of Evicel?
Estonian: Mis meetmeid võetakse, et tagada Eviceli kasutamise ohutus?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evicel on 6 October 2008.
Estonian: Euroopa Komisjon andis Eviceli müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 6. oktoobril
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.
Estonian: Eviceli kasutatav kogus sõltub mitmest tegurist, näiteks operatsiooni liigist, haava suurusest ja haavale kandmise kordade arvust.
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.
Estonian: Et Eviceli koostisse kuuluvat trombiinilahust kasutatakse ka ravimis Quixil, kasutas ettevõte Eviceli kasutuse toetamiseks mõnesid Quixili andmeid.
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).
Estonian: Ravimit turustatakse kahe lahusena: ühe toimeaine on hüübiv inimvalk (50-90 mg/ml) ja teise toimeaine on inimtrombiin (800-1200 IU/ml).
English: For more information about treatment with Evicel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Eviceliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The CHMP decided that Evicel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Eviceli kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.
Estonian: Seejärel fibriin agregeerub (kleepub kokku) ja moodustab fibriinhüübe, mis soodustab haava paranemist ja takistab verejooksu.
English: When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin.
Estonian: Toimeainete segunemisel lõigustab trombiin fibrinogeeni väiksemateks osadeks fibriinideks.
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.
Estonian: Eviceli uuriti veel ühes põhiuuringus, milles osales 139 ajuoperatsiooni patsienti, kellel kõvakesta sisselõike õmblemise järel eritus kõvakestast vedelikku.
English: Evicel human clottable protein / human thrombin
Estonian: Evicel hüübiv inimvalk / inimtrombiin
English: Evicel must also not be used in dura mater closure if the dura mater cannot be sutured, or if there are gaps greater than 2 mm after suturing.
Estonian: Eviceli ei tohi kasutada ka kõvakesta sulgemisel, kui kõvakesta ei saa õmmelda või kui õmbluse järel on haaval üle 2 mm avad.
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.
Estonian: Eviceli pihustamisel esineva gaasembooliariski vähendamiseks annab ettevõte kõigile Eviceli pihust manustavatele kirurgidele teabematerjali ja väljaõppe.
English: In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting.
Estonian: Harvadel juhtudel võivad patsiendil tekkida Evicelis sisalduvate valkude vastu antikehad, mis võivad takistada vere hüübimist.
English: As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly.
Estonian: Nagu teised koeliimid, võib Evicel tekitada allergilise reaktsiooni, mis eelkõige korduvkasutamisel võib olla raske.
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.
Estonian: Lisaks tagab ettevõte, et Eviceli kasutatakse rõhuregulaatoritega, millega ei saa ületada fibriinliimi pihustamiseks vajalikku maksimumrõhku ning millele on märgitud soovitatav rõhk ja pihustamiskaugus.
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.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Evicel should only be used by an experienced surgeon who has been trained in the use of Evicel.
Estonian: Eviceli tohivad kasutada üksnes kogenud kirurgid, kes on saanud Eviceli kasutamise väljaõppe.
English: This is a summary of the European public assessment report (EPAR) for Evicel.
Estonian: See on ravimi Evicel Euroopa avaliku hindamisaruande kokkuvõte.
English: Evicel is used by surgeons to help reduce local bleeding during operations when standard techniques are not sufficient.
Estonian: Eviceli kasutavad kirurgid operatsiooni ajal paikse veritsuse vähendamiseks, kui tavapärased meetodid on ebapiisavad.
English: The active substances in Evicel, human clottable protein and thrombin, are natural substances obtained from human plasma (the liquid part of the blood).
Estonian: Eviceli toimeained hüübiv inimvalk ja trombiin on inimplasmast (vedel verekomponent) saadud looduslikud ained.
English: The main measure of effectiveness was the number of patients whose dura mater closure was watertight with no leakage.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kelle kõvakesta sulgemine oli kindel ega lekkinud.
English: Evicel must not be used in people who are hypersensitive (allergic) to human clottable protein, thrombin or any of the other ingredients.
Estonian: Eviceli ei tohi kasutada patsiendid, kes on hüübiva inimvalgu, trombiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: When used in endoscopic procedures (procedures that use an endoscope for viewing internal organs),
Estonian: Endoskoopiaprotseduuridel (protseduuridel, kus siseelundeid vaadeldakse endoskoobiga) ei tohi Eviceli pihustada.
English: What is the risk associated with Evicel?
Estonian: Mis riskid Eviceliga kaasnevad?
English: The human clottable protein contains as its main component, fibrinogen, a protein involved in the natural clotting process.
Estonian: Hüübiv inimvalk sisaldab põhikomponendina fibrinogeeni, mis on vere looduslikus hüübimisprotsessis osalev valk.
English: Why has Evicel been approved?
Estonian: Miks Evicel heaks kiideti?
English: For the full list of all side effects reported with Evicel, see the package leaflet.
Estonian: Eviceli kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What is Evicel?
Estonian: Mis on Evicel?
English: Before use, the two solutions of Evicel are mixed together using a special device that is supplied with the medicine.
Estonian: Enne kasutamist segatakse pakendis oleva spetsiaalse vahendi abil Eviceli mõlemad lahused.
English: It must not be given as an injection into a blood vessel.
Estonian: Ravimit ei tohi süstida veresoonde.
English: 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).
Estonian: Kõvakest oli suletud lekkekindlalt 92%-l Eviceli saanud patsientidest (82 patsienti 89st) ja 38%-l, kui Eviceli ei kasutatud (19 patsienti 50st).
English: During abdominal surgery, 95% of the patients had no bleeding 10 minutes after treatment with Evicel (63 out of 66), compared with 81% of the patients treated with Surgicel (56 out of 69).
Estonian: Kõhuõõnekirurgias puudus 10 minutit pärast Eviceli manustamist verejooks 95%-l (63 patsienti 66st) ja Surgiceli korral 81%-l patsientidest (56 patsienti 69st).
English: The first study compared Evicel with manual compression (applying direct pressure) in reducing bleeding during vascular surgery.
Estonian: Esimeses uuringus võrreldi, kuidas Evicel ja manuaalne kompressioon (veresoonele surumine) vähendavad veresoontekirurgias verejooksu.
English: 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).
Estonian: Veresoontekirurgias puudus 4 minutit pärast Eviceli manustamist verejooks 85%-l (64 patsienti 75st) ja manuaalse kompressiooni korral 39%-l patsientidest (28 patsienti 72st).
English: For further details see the package leaflet.
Estonian: Üksikasjalik teave on pakendi infolehel.
English: Evicel was more effective than the comparator treatments in reducing the bleeding at the site of application.
Estonian: Evicel oli kasutuskohas verejooksu vähendamisel efektiivsem kui võrdlusravimid.
English: 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.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel kasutuskoht ei veritsenud, kui Eviceli manustamisest või manuaalsest kompressioonist oli möödunud 4 minutit.
English: What benefit has Evicel shown during the studies?
Estonian: Milles seisneb uuringute põhjal Eviceli kasulikkus?
English: What is Evicel used for?
Estonian: Milleks Eviceli kasutatakse?
English: How is Evicel used?
Estonian: Kuidas Eviceli kasutatakse?
English: Evicel is a medicine that is used as a sealant (glue).
Estonian: Evicel on koeliimina kasutatav ravim.
English: 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.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel 10 minutit pärast Eviceli või Surgiceli manustamist ei esinenud kasutuskohas verejooksu.
English: Evicel must also not be used as a glue for the fixation of dural patches (material which is sewn over an opening in the dura mater).
Estonian: Eviceli ei tohi kasutada koeliimina kõvakesta tükkide (kõvakesta avausele õmmeldav koematerjal) kinnitamiseks.
English: 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).
Estonian: Teises uuringus võrreldi Eviceli ja Surgiceli (verejooksu vähendav materjal) verejooksu vähendavat toimet kõhuõõnekirurgias.
English: The study compared the effectiveness of Evicel in addition to sutures with sutures alone in sealing the dura mater.
Estonian: Uuringus võrreldi, kui efektiivne on kõvakesta sulgemisel lisaks õmblemisele kasutatud Evicel või üksnes õmblemine.
English: How has Evicel been studied?
Estonian: Kuidas Eviceli uuriti?
English: Cases of gas embolism (gas bubbles in the blood that affect the blood flow) have occurred when Evicel was applied as spray.
Estonian: Eviceli pihustamisel on olnud gaasemboolia juhte (verevoolu takistavad gaasimullid veres).