FrancophonIA/ELRC3.0 huggingface dataset:
English: Linco-Spectin 100 is a powder for oral solution containing 33.3 g lincomycin (as lincomycin hydrochloride) and 66.7 g spectinomycin (as spectinomycin sulphate) per 150 g pack.
Estonian: Linco-Spectin 100 on suukaudse lahuse pulber, mis sisaldab 33,3 g linkomütsiini (linkomütsiinvesinikkloriidina) ja 66,7 g spektinomütsiini (spektinomütsiinsulfaadina) 150 g paki kohta.
English: Due to divergent national decisions taken by Member States with respect to target species, indications, posology and withdrawal periods concerning the authorisations of Linco-Spectin 100 and its associated names, on 28 September 2012 Belgium referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences in the nationally authorised product information across the European Union.
Estonian: Et liikmesriigid on Linco-Spectin 100 ja sarnaste nimetuste müügilubadega seoses võtnud loomaliikide, näidustuste, annustamise ja keeluaegade kohta vastu erinevaid riiklikke otsuseid, saatis Belgia 28. septembril 2012 veterinaarravimite komiteele direktiivi 2001/82/EÜ artikli 34 lõike 1 kohase esildise, et kaotada riiklikult heakskiidetud ravimiteabe lahknevused Euroopa Liidus.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of of Linco-Spectin 100 and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information.
Estonian: Praegu olemasolevate andmete hindamise põhjal leidis veterinaarravimite komitee, et LincoSpectin 100 ja sarnaste nimetuste kasulikkuse ja riski profiil on endiselt positiivne, tingimusel et müügilube muudetakse soovitatud ravimiteabe kohaselt.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics, labelling and package leaflet in Annex III.
Estonian: Asjaomased raviminimetused on esitatud I lisas, teaduslikud järeldused II lisas ning muudetud ravimi omaduste kokkuvõte, märgistus ja pakendi infoleht III lisas.
English: Spectinomycin is classified as an aminocyclitol antibiotic, close to aminoglycosides.
Estonian: Spektinomütsiin on klassifitseeritud aminotsüklitool-antibiootikumina ning on lähedane aminoglükosiididele.
English: International non-proprietary name (INN): lincomycin and spectinomycin
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): linkomütsiin ja spektinomütsiin
English: Opinion following an Article 341 referral for Linco-Spectin 100 and associated names
Estonian: Arvamus pärast artikli 340F kohast esildist Linco-Spectin 100 ja sarnaste nimetuste kohta
English: Lincomycin is a lincosamide antibiotic, closely related to macrolide and streptogramin B antimicrobials.
Estonian: Linkomütsiin on linkosamiidantibiootikum, mis on lähedalt seotud makroliid- ja streptogramiin Bantimikroobikumidega.
English: Strength Pharmaceutical Form Route of Administration
Estonian: Tugevus Ravimvorm Manustamistee Sisepakendi iseloomustus
English: Immediate Packaging
Estonian: Pakendi sisu (kontsentratsioon)
English: TachoSil is used when standard techniques are not sufficient.
Estonian: TachoSili kasutatakse juhul, kui standardtehnikast ei piisa.
English: This summary was last updated in 03-2016.
Estonian: Kokkuvõtte viimane uuendus: 03-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for TachoSil on 8 June 2004.
Estonian: Euroopa Komisjon andis TachoSili müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 8. juunil
English: What measures are being taken to ensure the safe and effective use of TachoSil?
Estonian: Mis meetmed võetakse, et tagada TachoSili ohutu ja efektiivne kasutamine?
English: The full EPAR for TachoSil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst TachoSili kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: TachoSil is used in adults:
Estonian: TachoSili kasutatakse täiskasvanutel:
English: A risk management plan has been developed to ensure that TachoSil is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada TachoSili võimalikult ohutu kasutamine.
English: TachoSil fibrinogen / thrombin
Estonian: TachoSil fibrinogeen/trombiin
English: TachoSil should only be used by an experienced surgeon.
Estonian: TachoSili tohib kasutada üksnes kogenud kirurg.
English: The main measure of effectiveness was the number of patients whose bleeding had stopped after three minutes.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kelle veritsus peatus kolme minuti pärast.
English: The TachoSil patch is left in the body, where it dissolves and disappears completely.
Estonian: TachoSili plaaster jäetakse organismi sisemusse, kus see lahustub ja kaob täielikult.
English: The amount of TachoSil to be used depends on the size of the wound and the material can be cut to size if needed.
Estonian: Kasutatavate plaastrite kogus sõltub haava suurusest ning plaastrit võib vajaduse korral lõigata väiksemaks.
English: • during an operation, to stop bleeding and to seal the surfaces of internal organs;
Estonian: • operatsiooni ajal verejooksu peatamiseks ja siseelundite pindade liimimiseks;
English: Like other sealants, TachoSil may cause an allergic reaction.
Estonian: Nagu teisedki koeliimid, võib TachoSil põhjustada allergilise reaktsiooni.
English: TachoSil should only be applied directly onto the treatment site so that it covers 1 to 2 cm beyond the edge of the wound.
Estonian: TachoSili tohib asetada üksnes vahetult ravitavale kohale nii, et see ulatub 1-2 cm üle haavaservade.
English: Other information about TachoSil
Estonian: Muu teave TachoSili kohta
English: The CHMP decided that TachoSil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et TachoSili kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: In the first study, the average time until bleeding stopped was 3.9 minutes with TachoSil compared with 6.3 minutes with the argon beamer, and in the second study, these values were 3.6 and 5.0 minutes, respectively.
Estonian: Esimeses uuringus oli keskmine aeg veritsuse peatumiseni TachoSili kasutamisel 3,9 minutit ja argoonlaseri kasutamisel 6,3 minutit; teises uuringus olid need väärtused vastavalt 3,6 ja 5,0 minutit.
English: Patients may also develop antibodies to the proteins in TachoSil, which could interfere with blood clotting.
Estonian: Patsiendil võivad tekkida ka antikehad TachoSilis olevate valkude vastu, mis võivad takistada verehüübimist.
English: For more information about treatment with TachoSil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate TachoSiliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: • A sixth study looked at the effectiveness of TachoSil in surgery on the heart or major blood vessels.
Estonian: • Kuuendas uuringus vaadeldi TachoSili efektiivsust südame- või suurte veresoonte operatsioonidel.
English: After three minutes, bleeding had stopped in 75% of the patients treated with TachoSil (44 out of 59), compared with 33% of those treated with standard techniques (20 out of 60).
Estonian: Kolme minuti pärast peatus veritsus 75%-l patsientidest, kellel kasutati TachoSili (44 patsienti 59st), võrreldes 33%-ga standardtehnikaga ravitutest (20 patsienti 60st).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for TachoSil, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati TachoSili omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: However, in the second study, which involved 301 patients, it took an average of 15.3 hours for leakage to stop with TachoSil compared with 20.5 hours with current techniques.
Estonian: Teises uuringus, milles osales 301 patsienti, kulus TachoSili kasutamisel õhulekke peatumiseni keskmiselt 15,3 tundi, võrreldes 20,5 tunniga praeguste tehnikate kasutamisel.
English: When TachoSil is applied to a bleeding area during surgery, the moisture causes the active substances to react together, leading to the rapid formation of a clot.
Estonian: Kui TachoSili kasutatakse operatsiooni ajal veritsuskohal, põhjustab niiskus toimeainete reaktsiooni, mille tulemusel tekib kiiresti hüüve.
English: The clot enables the patch to stick more firmly to the tissue, helping to stop the bleeding and sealing the wound.
Estonian: Hüüve hoiab plaastrit tihedamalt koe vastas, aidates peatada veritsemist ja sulgedes haava.
English: TachoSil is a sealant patch coated with the active substances human fibrinogen and human thrombin.
Estonian: TachoSil on koeliimiplaaster, mis on kaetud toimeainete inimfibrinogeeni ja inimtrombiiniga.
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 TachoSil.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The active substances in TachoSil, fibrinogen and thrombin, are proteins extracted from blood, which are involved in the natural clotting process.
Estonian: TachoSili toimeained fibrinogeen ja trombiin on verest eraldatud valgud, mis osalevad looduslikus hüübimises.
English: • Two studies were carried out to see if TachoSil could be used as a tissue sealant.
Estonian: • Kahe uuringu eesmärk oli välja selgitada, kas TachoSili tohib kasutada koeliimina.
English: The first study looking at lung surgery patients was not sufficient to support the use of TachoSil in sealing tissue since very few patients in the study had any air leakage.
Estonian: Kopsuoperatsiooni patsientide esimesest uuringust ei saadud TachoSili kasutamise kohta kudede liimimisel piisavalt tõendeid, sest operatsiooni järel lekkis õhku vaid väga vähestel patsientidel.
English: TachoSil must not be applied inside a blood vessel.
Estonian: TachoSili ei tohi kasutada veresoone sees.
English: For the full list of all side effects and restrictions with TachoSil, see the package leaflet.
Estonian: TachoSili kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: This is a summary of the European public assessment report (EPAR) for TachoSil.
Estonian: See on ravimi TachoSil Euroopa avaliku hindamisaruande kokkuvõte.
English: Thrombin works by converting fibrinogen into smaller units called fibrin, which then stick together to form a local clot.
Estonian: Trombiin muundab fibrinogeeni väiksemateks osakesteks (fibriinideks), mis seejärel liimuvad ja tekitavad toimimiskohal hüübe.
English: TachoSil has been studied in seven studies:
Estonian: TachoSili uuriti seitsmes uuringus.
English: The main measure of effectiveness was the time until the bleeding stopped.
Estonian: Efektiivsuse põhinäitaja oli aeg veritsuse peatumiseni.
English: What is the risk associated with TachoSil?
Estonian: Mis riskid TachoSiliga kaasnevad?
English: • Another study in 726 patients compared TachoSil with current techniques used in daily practice in preventing CSF leakage during neurological surgery.
Estonian: • Ühes uuringus (726 patsienti) võrreldi TachoSili praeguste tavatehnikatega, mida kasutatakse liikvori lekkimise tõkestamiseks neuroloogilistel operatsioonidel.
English: Why has TachoSil been approved?
Estonian: Miks TachoSil heaks kiideti?
English: The studies compared the effects of TachoSil and an argon beamer (a device that sears the cut surface and reduces bleeding) in a total of 240 adults having liver surgery.
Estonian: Uuringutes võrreldi TachoSili ja argoonlaseri (seade, mis kõrvetab lõikepinda ja vähendab veritsemist) toimet kokku 240 täiskasvanud patsiendil, kellele tehti maksaoperatsioon.
English: In the study in neurological surgery, TachoSil was comparable to current techniques: around 7% (25 out of 361) of patients treated with TachoSil had a leak of CSF, compared with around 8% (30 out of 365) of patients on current techniques.
Estonian: Neuroloogiliste operatsioonide uuringus oli TachoSil võrreldav praeguste tehnikatega: liikvori leke esines ligikaudu 7% TachoSiliga ravitud patsientidest (25 patsiendil 361st), praeguste tehnikate kasutamisel esines leke 8%-l (30 patsiendil 365st).
English: • Two of the studies looked at the effects of TachoSil in stopping bleeding.
Estonian: • Kahes uuringus vaadeldi TachoSili toimet veritsuse peatamisel.
English: A third study compared TachoSil with standard stitching in 185 patients having kidney surgery.
Estonian: Kolmandas uuringus võrreldi TachoSili tavalise õmblemisega 185 patsiendil, kellele tehti neeruoperatsioon.
English: The study compared TachoSil with standard materials in 120 patients, of whom around three-quarters also had surgery on vessels with stitches and one-quarter had surgery on the heart.
Estonian: Uuringus võrreldi TachoSili tavavahenditega 120 patsiendil, kellest ligikaudu kolmveerandil opereeriti ja õmmeldi veresooni ja veerandile tehti südameoperatsioon.
English: TachoSil was more effective than stitching in the kidney surgery patients.
Estonian: TachoSil oli neeruoperatsiooni patsientidel efektiivsem kui õmblemine.
English: What is TachoSil?
Estonian: Mis on TachoSil?
English: • as support to stitching during surgery on the blood vessels;
Estonian: • veresoonte operatsioonidel õmblemist toetava vahendina;
English: Effectiveness was measured by looking at whether air leaked from the lungs after surgery.
Estonian: Efektiivsuse põhinäitaja oli operatsioonijärgne õhulekkimine kopsudest.
English: Thromboembolic complications (blood clots in vessels) may occur if TachoSil is applied inside a blood vessel.
Estonian: TachoSili juhuslikul asetamisel veresoonde võivad tekkida trombemboolilised tüsistused (verehüübed veresoontes).
English: TachoSil was more effective than the argon beamer at stopping bleeding during liver surgery.
Estonian: TachoSil oli maksaoperatsiooni ajal veritsuse peatamisel efektiivsem kui argoonlaser.
English: How does TachoSil work?
Estonian: Kuidas TachoSil toimib?
English: TachoSil was also more effective than standard materials at stopping bleeding during surgery on the heart or blood vessels.
Estonian: TachoSil oli südame- või veresoonte operatsioonidel veritsuse peatamisel tavalistest vahenditest efektiivsem.
English: How has TachoSil been studied?
Estonian: Kuidas TachoSili uuriti?
English: What benefit has TachoSil shown during the studies?
Estonian: Milles seisneb uuringute põhjal TachoSili kasulikkus?
English: What is TachoSil used for?
Estonian: Milleks TachoSili kasutatakse?
English: How is TachoSil used?
Estonian: Kuidas TachoSili kasutatakse?
English: In neurological surgery, it works by sealing together the cut areas of the outermost layer (dura mater) of the membranes around the brain.
Estonian: Neuroloogilisel operatsioonil toimib TachoSil kõvakesta tehtud lõigete pinnaliimina, tõkestades sel viisil liikvori lekkimist.
English: • during neurological surgery to prevent leakage of the fluid surrounding the brain (called cerebrospinal fluid or CSF).
Estonian: • neuroloogilisel operatsioonil liikvori lekke ennetamiseks.
English: The studies compared TachoSil and standard surgical techniques, such as stitching and stapling, in a total of 490 patients having lung surgery.
Estonian: Neis võrreldi 490-l kopsuoperatsiooni patsiendil TachoSili operatsiooni tavatehnikaga, nagu õmblemine ja klambriga kinnitamine.
English: This summary was last updated in 04-2008.
Estonian: Kokkuvõtte viimane uuendus: 04-2008.
English: It should be used according to official recommendations.
Estonian: Vaktsiini tuleb kasutada ametlike soovituste kohaselt.
English: This helps to protect against the diseases that these bacteria and viruses cause.
Estonian: See aitab kaitsta organismi haiguste eest, mida need bakterid ja viirused põhjustavad.
English: The Hib component has also been available in other vaccines.
Estonian: Ka Hib-bakteri komponenti on kasutatud teistes vaktsiinides.
English: This means that the active substances are fixed on aluminium compounds, to stimulate a better immune response.
Estonian: See tähendab, et toimeained on kinnitunud alumiiniumühendite külge, mis stimuleerib tugevamat immuunvastust.
English: Their breathing should be monitored for up to three days after vaccination.
Estonian: Selliste laste hingamistegevust tuleb jälgida vähemalt kolme päeva vältel pärast vaktsineerimist.
English: In all of the studies, the main measure of effectiveness was the production of protective levels of antibodies after the final vaccination.
Estonian: Kõigis uuringutes oli peamine tulemusnäitaja antikehade kaitsval tasemel tekkimine organismis pärast viimast vaktsineerimist.
English: The European Commission granted a marketing authorisation valid throughout the EU for Quintanrix to GlaxoSmithKline Biologicals s.a. on 21 October 2004.
Estonian: Euroopa Komisjon väljastas Quintanrixi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele GlaxoSmithKline Biologicals s.a. 21. oktoobril 2004.
English: It is also used as a booster immunisation of young children during the second year of life.
Estonian: Samuti kasutatakse seda väikelaste revaktsineerimiseks teisel eluaastal.
English: There was no impact of prior hepatitis B vaccination on the effectiveness of Quintanrix.
Estonian: Varasem B-hepatiidi vastane vaktsineerimine ei mõjutanud Quintanrixi tõhusust.
English: The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Estonian: Seejärel suudab immuunsüsteem kiiremini antikehi toota, kui ta puutub kokku looduslike bakterite või viirustega.
English: The Committee recommended that Quintanrix be given marketing authorisation.
Estonian: Komitee soovitas anda Quintanrixile müügiloa.
English: Quintanrix should not be used in people who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Estonian: Quintanrixi ei tohi kasutada patsiendid, kes võivad olla ravimi mis tahes toimeaine või koostisaine suhtes ülitundlikud (allergilised).
English: The effects of Quintanrix have been studied in five main studies involving over 2,000 infants.
Estonian: Quintanrixi toimet hinnati viies põhiuuringus, milles osales enam kui 2000 last.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Estonian: Kui soovite lisateavet inimravimite komitee soovituste aluse kohta, lugege palun teadusliku arutelu kokkuvõtet (samuti Euroopa avaliku hindamisaruande osa)
English: When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Estonian: Kui väikelapsele manustatakse vaktsiini, siis identifitseerib immuunsüsteem bakterite ja viiruste osad kui võõrkehad ja tekitab nende vastu antikehi.
English: Quintanrix contains small amounts of:
Estonian: Quintanrix sisaldab väheses koguses järgmisi koostisosi:
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Estonian: Vaktsiin õpetab immuunsüsteemi (organismi kehaomane kaitsemehhanism) end haiguste vastu kaitsma.
English: The vaccine is given by deep injection into a muscle, preferably the thigh.
Estonian: Vaktsiin manustatakse sügava lihasesisese süstena, eelistatult reide.
English: It should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis.
Estonian: Vaktsiini ei tohi manustada lapsele, kellel seitsme päeva jooksul pärast eelnevat läkaköha sisaldava vaktsiiniga vaktsineerimist esines teadmata põhjustel entsefalopaatia (ajuhaigus).
English: The recommended vaccination schedule for Quintanrix is three doses, given at intervals of at least four weeks within the first six months of life.
Estonian: Soovitatav Quintanrixi vaktsineerimisskeem näeb ette kolme annuse manustamist vähemalt neljanädalaste ajavahemike järel esimese kuue elukuu vältel.
English: These active substances were also available in other vaccines before that date.
Estonian: Enne seda on ravimi toimeained olnud kasutusel ka muudes vaktsiinides.
English: In three studies, the effects of Quintarix were compared with those of the combination of Tritanrix HepB and a vaccine containing Hib: two of these studies involved a total of 1,208 infants who were vaccinated at two, four and six months of age and one involved 294 infants vaccinated at three, four and five months of age.
Estonian: Kolmes uuringus võrreldi Quintanrixi toimet vaktsiini Tritanrix HepB ja Hib-bakterit sisaldava vaktsiini kombineeritud toimega: kahes uuringus osales 1208 väikelast, keda vaktsineeriti kahe, nelja ja kuue kuu vanuselt; ühes uuringus osales 294 väikelast, keda vaktsineeriti kolme, nelja ja viie kuu vanuselt.
English: The fifth study looked at the effects of a fourth, booster dose of Quintanrix in the second year of life in 357 infants.
Estonian: Viiendas uuringus hinnati teisel eluaastal manustatud Quintanrixi neljanda revaktsineerimisannuse tõhusust 357 väikelapsel.
English: Quintarix was as effective as the two separate vaccines at producing protective levels of antibodies.
Estonian: Quintarix oli antikehade kaitsval tasemel tekkimise poolest sama tõhus kui kaks eraldi manustatud vaktsiini.
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Estonian: B-hepatiidi pinnaantigeene toodetakse rekombinantDNA-tehnika meetodil: neid toodab pärm, millesse on viidud valkude teket võimaldav geen (DNA).
English: The most common side effects with Quintanrix (seen in more than 1 in 10 doses of the vaccine) are irritability, drowsiness, loss of appetite, pain, redness and swelling, and fever.
Estonian: Quintanrixi kõige sagedamad kõrvalnähud (esinenud enam kui ühe annuse korral kümnest) olid kergesti ärrituvus, uimasus, isutus, valu, punetus, turse ja palavik.
English: The first dose can be administered at six weeks of age.
Estonian: Esimese annuse võib manustada kuuenädalasele imikule.
English: The fourth study compared the effects of Quintarix given at six, 10 and 14 weeks of age in 318 infants who either had or had not received a hepatitis B vaccine at birth.
Estonian: Neljandas uuringus võrreldi 6., 10. ja 14. elunädalal manustatud Quintanrixi toimet 318 väikelapsele, keda pärast sündimist oli või ei olnud vaktsineeritud B-hepatiidi vastu.
English: Quintanrix is a vaccine.
Estonian: Quintanrix on vaktsiin.
English: The study of booster vaccination also showed Quintanrix was as effective as the two separate vaccines, with between 92 and 100% of the infants having protective levels of antibodies 42 days after the booster vaccination.
Estonian: Ka revaktsineerimise uuring näitas, et Quintanrix oli niisama tõhus kui kaks eraldi manustatud vaktsiini: 42 päeva pärast vaktsiini manustamist oli 92-100% väikelastel kaitsval tasemel antikehi.