FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used on its own to treat patients with small cell lung cancer, when the cancer has relapsed (come back).
Estonian: Seda kasutatakse relapseerunud (taastunud) väikerakk-kopsuvähiga patsientide raviks.
English: Topotecan Eagle is a ‘hybrid generic medicine'.
Estonian: Topotecan Eagle on hübriid-geneeriline ravim.
English: What are the benefits and risks of Topotecan Eagle?
Estonian: Milles seisneb Topotecan Eagle kasulikkus ja mis riskid Topotecan Eaglega kaasnevad?
English: What is Topotecan Eagle?
Estonian: Mis on Topotecan Eagle?
English: Why has Topotecan Eagle been approved?
Estonian: Miks Topotecan Eagle heaks kiideti?
English: The doses may need to be adjusted or other medicines given to the patients, when the level of white blood cells remains particularly low.
Estonian: leukotsüütide sisaldus püsib eriti väike, võib olla vaja annuseid kohandada või anda patsientidele muid ravimeid.
English: The active substance in Topotecan Eagle, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Estonian: Topotecan Eagle toimeaine topotekaan on topoisomeraasiinhibiitorite rühma kuuluv vähiravim.
English: Topotecan Eagle is an anticancer medicine.
Estonian: Topotecan Eagle on vähiravim.
English: How has Topotecan Eagle been studied?
Estonian: Kuidas Topotecan Eaglet uuriti?
English: How is Topotecan Eagle used?
Estonian: Kuidas Topotecan Eaglet kasutatakse?
English: How does Topotecan Eagle work?
Estonian: Kuidas Topotecan Eagle toimib?
English: What is Topotecan Eagle used for?
Estonian: Milleks Topotecan Eaglet kasutatakse?
English: • Bacteraemia/ Septicaemia / Sepsis
Estonian: • Baktereemia/septitseemia/sepsis
English: A harmonised Module 3 was also adopted.
Estonian: Samuti kiideti heaks ühtlustatud 3. moodul.
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC
Estonian: • inimravimite komitee arutas direktiivi 2001/83/EÜ artikli 30 kohast esildist;
English: The study protocol of this non-interventional PASS shall be submitted within 2 months as of the Commission Decision.
Estonian: Selle mitteinterventsioonilise uuringu plaan tuleb esitada kahe kuu jooksul pärast komisjoni otsust.
English: It can be concluded that batch results prove good consistency of the manufacturing process.
Estonian: Võib järeldada, et partii tulemused näitavad tootmisprotsessi head järjepidevust.
English: Some of the subcomponents are in fact groups of smaller peaks, namely A2-1, A2-3, A2-5 and A3.
Estonian: Mõned komponendid on tegelikult väiksematest ühenditest koosnevad rühmad, nimelt A2-1, A2-3, A2-5 ja A3.
English: The protocols, abstracts and final study reports shall be submitted in the format set out in Annex III of the Commission Implementing Regulation (EC) No 520/2012.
Estonian: Uuringuplaanid, kokkuvõtted ja lõplikud uuringuaruanded tuleb esitada vormingus, mis on sätestatud komisjoni rakendusmääruse (EL) nr 520/2012 III lisas.
English: Targocid is not administered by the intraventricular route and is mentioned as a special warning in section 4.4.
Estonian: Targocidi ei manustata intraventrikulaarselt ja seda mainitakse erihoiatuses lõigus 4.4.
English: Measurement of trough serum concentrations is also recommended at least once a week during the maintenance treatment.
Estonian: Minimaalsete seerumikontsentratsioonide mõõtmist soovitatakse ka vähemalt kord nädalas säilitusravi ajal.
English: In keeping with the adult studies, the clinical cure was > 80%.
Estonian: Sarnaselt täiskasvanute uuringule oli kliiniline tervistumine > 80%.
English: In all (pooled data), 72 episodes of infection were treated in 71 adult patients.
Estonian: Kokku (ühendatud andmed) raviti 72 infektsiooniepisoodi 71 täiskasvanud patsiendil.
English: • Infective endocarditis
Estonian: • Infektsioosne endokardiit
English: As ‘Sepsis' is generally a secondary condition to a primary site infection, it was not considered to be acceptable as a stand-alone indication, and was therefore deleted from the list of indications.
Estonian: Kuna „sepsis” on tavaliselt esmase infektsioonikoha sekundaarne seisund, ei peetud seda eraldi näidustusena vastuvõetavaks ja see kustutati seetõttu näidustuste hulgast.
English: Chemother 1997 ; 39: 789-96.
Estonian: J Antimicrob Chemother 1997; 39: 789-96.
English: The study protocol shall be entered in the EU electronic register of postauthorisation studies (EU PAS Register) before the start of data collection.
Estonian: Uuringuplaan tuleb sisestada ELi müügiloa väljastamise järgsete uuringute elektroonilisse registrisse (ELi PASS-register) enne andmete kogumise alustamist.
English: Detailed information on the starting materials, fermentation and purification process was provided and found acceptable.
Estonian: Esitati üksikasjalik teave algmaterjalide, fermentatsiooni ja puhastusprotsessi kohta ja see leiti olevat vastuvõetav.
English: Limits for all individual subcomponents were established based on batch data at release and during stability testing.
Estonian: Kõigi individuaalsete komponentide piirmäärad määrati kindlaks partii vabastamise andmete alusel ja stabiilsuskatsete ajal.
English: Information on development, manufacture and control of the finished product has been presented in a satisfactory manner.
Estonian: Valmisravimi väljatöötamise, tootmise ja kontrolli teave on esitatud rahuldaval moel.
English: • Clinical issues
Estonian: • Kliinilised probleemid
English: The clinical cure and improvement rate was about 90% and bacteriological success rate was 76%.
Estonian: Kliinilise tervistumise ja paranemise sagedus oli umbes 90% ja bakterioloogiline tõhusus 76%.
English: The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that these products should have a satisfactory and uniform performance.
Estonian: Testide tulemused näitavad ravimi oluliste kvaliteeditunnuste järjepidevust ja samalaadsust, millest omakorda järeldub, et neil ravimitel on ühesugune ja rahuldav toime.
English: monograph.
Estonian: teikoplaniini monograafias.
English: A valid TSE certificate was provided for the active substance.
Estonian: Toimeaine jaoks esitati kehtiv TSE sertifikaat.
English: It is a complex antibiotic, consisting of six closely related glycopeptide subcomponents (A2-1, A2-2, A2-3, A2-4 and A2-5 forming A2 group, and A3) as defined in the current European Pharmacopoeia (Ph.
Estonian: See on kompleksne antibiootikum, mis koosneb kuuest tihedalt seotud glükopeptiidkomponendist (A2-1, A2-2, A2-3, A2-4 ja A2-5, mis moodustavad A2 rühma, ning A3), nagu on määratletud Euroopa Farmakopöa (Ph.
English: There were also a few cases of endocarditis, respiratory tract infections and urinary tract infections.
Estonian: Samuti esinesid mõned endokardiidi, hingamisteede infektsioonide ja kuseteede infektsioonide juhud.
English: Recent time-kill studies confirm that in vitro bactericidal activity of teicoplanin is optimally tested according to CLSI guidelines, with tolerance defined at 24 hours.
Estonian: Äsjased hävimisaja uuringud kinnitavad, et teikoplaniini in vitro bakteritsiidset toimet on optimaalselt testitud CLSi suuniste järgi, mille puhul tolerantsus määratakse 24 tunni järel.
English: The spectrum of teicoplanin subcomponents has been better characterised.
Estonian: Teikoplaniini komponentide spektrit iseloomustati üksikasjalikumalt.
English: The preclinical safety data reported support these proposed amendments and are provided within the expert report on the toxicological and pharmacological documentation.
Estonian: Teatatud prekliinilised ohutusandmed toetavad väljapakutud muudatusi ning need on esitatud toksikoloogilise ja farmakoloogilise dokumentatsiooni ekspertaruandes.
English: The clinical and bacteriological efficacy of teicoplanin was shown in both the European Multicentre Study and in the US open multicentre study.
Estonian: Teikoplaniini kliinilist ja bakterioloogilist efektiivsust näidati nii Euroopa mitmekeskuselises uuringus kui ka USA avatud mitmekeskuselises uuringus.
English: Four clinical studies provided data in children treated with specific paediatric protocols, and one study that included 7 neonates.
Estonian: Neli kliinilist uuringut pakkus andmeid laste kohta, keda raviti erinevate pediaatriliste raviskeemidega, ja ühes uuringus osales seitse vastsündinut.
English: The clinical development focussed on the susceptibility of gram-positive bacteria to teicoplanin and not on specific indications.
Estonian: Kliiniline arendustegevus keskendus gram-positiivsete bakterite tundlikkusele teikoplaniini suhtes, mitte spetsiifilistele näidustustele.
English: Linearity of the pharmacokinetics as well as a statement addressing special populations has also been included, in line with the above mentioned EU guideline.
Estonian: Samuti on lisatud farmakokineetika lineaarsus ja eripopulatsioone puudutav avaldus ülalmainitud ELi suuniste järgi.
English: Since teicoplanin is already used in children in most member states and clinical guidelines recommend its use in children, the indication for the use of teicoplanin in children, as well as in neonates and infants was supported by the CHMP.
Estonian: Kuna teikoplaniini juba kasutatakse lastel enamikus liikmesriikides ja kliinilised suunised soovitavad seda lastel kasutada, toetas inimravimite komitee kasutusnäidustust lastel ning vastsündinutel ja imikutel.
English: These studies were small and clinical experience with teicoplanin in neonates, infants and children is limited.
Estonian: Need uuringud olid väikesed ning kliiniline kogemus teikoplaniiniga vastsündinutel, imikutel ja lastel on piiratud.
English: The results from these three studies showed that teicoplanin achieves an overall clinical and bacteriological response rate of nearly 90% in culture and toxin positive patients.
Estonian: Nende kolme uuringu tulemused näitasid, et teikoplaniin andis üldise kliinilise ja bakterioloogilise vastuse peaaegu 90%-l positiivse kultuuri ja
English: Nevertheless a warning has been added in this section that “Teicoplanin should not be administered by intraventricular route”.
Estonian: Siiski lisati sellesse lõiku hoiatus, et „Teikoplaniini ei tohi manustada intraventrikulaarselt”.
English: The pharmacokinetics of teicoplanin for the treatment of Clostridium difficile was investigated in study DRC342-DLI073.
Estonian: Teikoplaniini farmakokineetikat Clostridium difficile ravis uuriti uuringus DRC342-DLI073.
English: The data was not considered to be sufficiently robust as they were open labelled comparative studies that did not demonstrate that teicoplanin was better than the comparators.
Estonian: Andmeid ei peetud piisavalt veenvaks, sest avatud võrdlusuuringud ei näidanud, et teikoplaniin oleks parem kui võrdlusravimid.
English: Section 4.1 of the SmPC does not include the paediatric population in all Member States.
Estonian: Ravimi omaduste kokkuvõtte lõik 4.1 ei sisalda kõigis liikmesriikides lapsi.
English: For infective endocarditis, the CHMP considered that 21 days would be the minimum period of use, and that treatment beyond 4 months should be avoided.
Estonian: Inimravimite komitee leidis, et infektsioosse endokardiidi korral on 21 päeva minimaalne kasutusperiood ja üle nelja kuu kestvat ravi tuleb vältida.
English: The overall duration of treatment with teicoplanin has not been given precisely since it should be adjusted individually, according to the underlying type and severity of infection, the clinical response of the patient and patient factors such as age and renal function.
Estonian: Ravi üldine kestus teikoplaniiniga ei ole täpselt esitatud, sest seda tuleb individuaalselt kohandada olenevalt infektsiooni tüübist ja raskusest, patsiendi kliinilisest ravivastusest ja sellistest teguritest nagu patsiendi vanus ja neerutalitlus.
English: Due to the divergent national decisions taken by Member States concerning the authorization of the Targocid and associated names, the European Commission notified the EMA of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised SmPCs for the above-mentioned products and thus to harmonise the SmPCs across the EU.
Estonian: Et liikmesriigid olid Targocidi ja sarnaste nimetuste müügiloa kohta vastu võtnud erinevaid otsuseid, tegi Euroopa Komisjon Euroopa Ravimiametile direktiivi 2001/83/EÜ artikli 30 kohase ametliku esildise eesmärgiga tuvastada lahknevused liikmesriikides heakskiidetud ravimite omaduste kokkuvõtetes ja ühtlustada need kogu Euroopa Liidus.
English: Harmonisation of the active substance specification was needed as tighter limits for the individual subcomponents were approved in some Member States, compared to the current Ph. Eur.
Estonian: Vaja oli ühtlustada ka toimeaine täpne kirjeldus, kuna mõnes liikmesriigis olid individuaalsete komponentide jaoks heaks kiidetud rangemad piirmäärad kui praeguses Euroopa Farmakopöa monograafias.
English: Although no PK-PD modelling has been done, the proposed posology for children is based on Monte Carlo simulations conducted by Lucas et al in 2004 3and Reed in 19974, which was considered to be acceptable by the CHMP.
Estonian: Kuigi farmakokineetika-farmakodünaamika modelleerimist ei ole tehtud, põhineb annustamine lastel Monte Carlo simulatsioonidel, mille tegid Lucas jt 2004. aastal 3ja Reed 1997. aastal4 ning mida inimravimite komitee pidas vastuvõetavaks.
English: Risk minimisation activities
Estonian: Riskivähendusmeetmed
English: The indication for the prophylactic use of teicoplanin in orthopaedic surgery was not adequately justified.
Estonian: Teikoplaniini profülaktilise kasutamise näidustus ortopeedilises kirurgias ei olnud piisavalt põhjendatud.
English: This PASS is imposed as a condition to the Marketing Authorisation.
Estonian: Ohutusuuring on määratud müügiloa tingimuseks.
English: The loading dose of 12mg/kg bid is in line with what is currently recommended in the SmPCs in France and Finland.
Estonian: Küllastussannus 12 mg/kg kaks korda ööpäevas vastab praegu Prantsusmaa ja Soome ravimi omaduste kokkuvõttes soovitatule.
English: Prophylaxis of infections caused by Gram-positive microorganisms Four prophylaxis comparative studies were conducted.
Estonian: Gram-positiivsete mikroorganismide põhjustatud infektsioonide profülaktika Korraldati neli profülaktika võrdlusuuringut.
English: Considering all the available information, the CHMP agreed that this indication should remain in the harmonised SmPC.
Estonian: Arvestades kogu olemasolevat teavet, nõustus inimravimite komitee, et see näidustus peab jääma ühtlustatud ravimi omaduste kokkuvõttesse.
English: The clinical studies included two open-label non-comparative therapeutic studies; the European Multicentre Study (EG-87-42) and the US Open Multicentre Study (N-86-04) and a review of the comparative studies conducted with teicoplanin (EG-87-35).
Estonian: Kliiniliste uuringute hulka kuulusid kaks avatud mittevõrdlevat raviuuringut, Euroopa mitmekeskuseline uuring (EG-87-42) ja USA avatud mitmekeskuseline uuring (N-86-04) ning teikoplaniiniga tehtud võrdlusuuringute ülevaade (EG-87-35).
English: Most of the patients included in study EG-87-42 (which was the larger of the two non-comparative studies) had suspected gram-positive infections from different sites, with the majority of them having skin and soft tissues infections (SSTIs), septicaemia and bone and joint infections.
Estonian: Enamikul patsientidest, kes osalesid uuringus EG-87-42 (mis oli kahest mittevõrdlevast uuringust suurem), esines erinevatel kohtadel gram-positiivsete infektsioonide kahtlus, enamikul esinesid naha ja pehmete kudede infektsioonid, septitseemia ning luu- ja liigeseinfektsioonid.
English: In accordance with the CHMP guideline and the SmPC Guideline, the applicant has also inserted information with regard to fertility.
Estonian: Inimravimite komitee ja ravimi omaduste kokkuvõtte suunise kohaselt lisas taotleja ka fertiilsuse teabe.
English: Peptidoglycan synthesis is blocked by specific binding to D-alanyl-D-alanine residues.
Estonian: Peptidoglükaani süntees blokeeritakse spetsiifilise seondumise tõttu Dalanüül-D-alaniinjääkidega.
English: In study EG-87-42, the clinical outcome for endocarditis was 83% (excluding patients considered as non-evaluable).
Estonian: Uuringus EG-87-42 oli endokardiidi kliiniline lõpptulemus 83% (v.a patsiendid, keda ei saanud hinnata).
English: In most of them the posology for children, neonates and new-borns is mentioned in section 4.2.
Estonian: Enamikus neist on annustamine lastel, imikutel ja vastsündinutel mainitud lõigus 4.2.
English: Treatment of infections caused by Gram-positive microorganisms The following infections caused by Gram-positive microorganisms were discussed by the CHMP:
Estonian: Gram-positiivsete mikroorganismide põhjustatud infektsioonide ravi Inimravimite komitee arutas järgmisi gram-positiivsete mikroorganismide põhjustatud infektsioone:
English: In addition, the CHMP has recommended conditions to the Marketing Authorisation which are set out in Annex IV.
Estonian: Lisaks soovitab inimravimite komitee kehtestada müügiloale IV lisas esitatud tingimused.
English: The finished product dossier was updated to include compatibility studies with various types of diluents, PVC bags and syringes, together with in-use stability data.
Estonian: Valmisravimi toimikut uuendati ning sellesse lisati sobivusuuringud mitmesugust tüüpi lahustite, PVC-kottide ja süstaldega koos kasutamisaegsete stabiilsusandmetega.
English: However due to its limited spectrum of antibacterial activity, a crossreference to section 4.4 commenting on the limited spectrum of antibacterial use and its rational use has been included.
Estonian: Siiski lisati ravimi piiratud antibakteriaalse toimespektri tõttu ristviide lõigule 4.4, milles selgitatakse ravimi piiratud antibakteriaalset toimespektrit ja arukat kasutamist.
English: • Pneumonia and respiratory tract infections
Estonian: • Pneumoonia ja hingamisteede infektsioonid
English: Teicoplanin antimicrobial activity is thought to depend on trough concentrations being higher than MIC of particular pathogens, and also dependent on the duration of time during which trough concentrations remain higher than MIC.
Estonian: Arvatakse, et teikoplaniini antimikroobne toime sõltub sellest, et minimaalsed kontsentratsioonid ületavad konkreetsete patogeenide vähimaid inhibeerivaid kontsentratsioone (MIC-väärtusi), ja samuti aja kestusest, millal minimaalsed kontsentratsioonid jäävad MIC-ist kõrgemaks.
English: In Study EG-87-42, the European multi-centre study, approximately 9% of the subjects enrolled had lower respiratory tract infections.
Estonian: Euroopa mitmekeskuselises uuringus EG-87-42 esines umbes 9% osalejatest alumiste hingamisteede infektsioone.
English: The applicant has not provided data to demonstrate a lack of effect on breast-fed newborns or infants; hence the sentence “No effects on the breastfed newborns/infants are anticipated since teicoplanin is not orally absorbed” has been deleted.
Estonian: Et taotleja ei esitanud andmeid, et näidata toime puudumist rinnaga toidetavatele vastsündinutele või imikutele, kustutati lause „Toimet rinnaga toidetavatele vastsündinutele/imikutele ei oodata, kuna teikoplaniin ei imendu suu kaudu”.
English: No specific study has been conducted by the MAH in support of this indication.
Estonian: Müügiloa hoidja ei ole selle näidustuse toetamiseks teinud eriuuringuid.
English: The efficacy of teicoplanin in the treatment of Gram-positive infections has been investigated in a number of clinical studies that were submitted in the initial authorisation along with literature references.
Estonian: Teikoplaniini efektiivsust gram-positiivsete infektsioonide ravis on uuritud mitmes kliinilises uuringus, mis esitati esmasel müügiloa taotlemisel koos kirjandusviidetega.
English: The microbiological spectrum of teicoplanin covers staphylococci including Staphylococcus aureus susceptible or resistant to methicillin, Streptococcus pneumoniae and other streptococci mainly including Streptococcus pyogenes, streptococci in the Viridans group and Enterococcus faecalis.
Estonian: Teikoplaniini mikrobioloogiline spekter katab stafülokokke, sh metitsilliinile tundlikku või resistentset Staphylococcus aureus't, Streprococcus pneumoniae'd ja muid streptokokke, peamiselt Streptococcus pyogenes't, Viridans'i rühma kuuluvaid streptokokke ja Enterococcus faecalis't.
English: Regarding dental surgery prophylaxis, the results suggested that teicoplanin could be useful.
Estonian: Seoses hambakirurgia profülaktikaga viitavad tulemused, et teikoplaniin võib olla kasulik.
English: Adults and elderly patients with impaired renal function The requirement for the adjustment of the dosage in patients with renal impairment, from the fourth day of treatment with teicoplanin has been included.
Estonian: Neerutalitluse kahjustusega täiskasvanud ja eakad patsiendid Lisati vajadus kohaldada annust neerukahjustusega patsientidel alates neljandast ravipäevast teikoplaniiniga.
English: Although no pharmacokinetic evidence has been provided, the rationale for having a bolus alternative to the 30-minute infusion to facilitate use in out-patients settings was considered to be acceptable by the CHMP.
Estonian: Kuigi farmakokineetilisi tõendeid ei ole esitatud, pidas inimravimite komitee vastuvõetavaks boolussüsti alternatiivi 30-minutilisele infusioonile, et soodustada ambulatoorset kasutamist.
English: The MAH has amended section 4.3 only including hypersensitivity to teicoplanin (or to any of the excipients).
Estonian: Müügiloa hoidja muutis lõiku 4.3, lisades ainult ülitundlikkuse teikoplaniini (või ravimi mis tahes abiaine) suhtes.
English: Regarding interactions with teicoplanin, it is known that due to the potential for increased adverse effects, teicoplanin should be administered with caution in patients receiving concurrent nephrotoxic or ototoxic drugs, such as aminoglycosides, amphotericin B, ciclosporin, and furosemide.
Estonian: Seoses teikoplaniini koostoimetega on teada, et suurenenud kõrvaltoimete potentsiaali tõttu tuleb teikoplaniini manustada ettevaatlikult patsientidele, kes saavad samal ajal nefrotoksilisi või ototoksilisi ravimeid, nagu aminoglükosiidid, amfoteritsiin B, tsüklosporiin ja furosemiid.
English: No new specific reactions due to teicoplanin overdose in the adult population have been identified.
Estonian: Teikoplaniini üleannustamise tõttu tekkinud spetsiifilisi reaktsioone ei ole täiskasvanud populatsioonis tuvastatud.
English: The CHMP agreed that teicoplanin can be indicated for the treatment of pneumonia (hospital acquired and community acquired pneumonia) without restricting its use according to the pathogen.
Estonian: Inimravimite komitee nõustus, et teikoplaniin võib olla näidustatud pneumoonia (haigla- ja keskkonnatekkese pneumoonia) raviks, piiramata selle kasutamist patogeeni alusel.
English: The harmonization of the pharmacokinetic section in the teicoplanin SmPC is based on the data first provided in the initial marketing authorisation application, and more recent data retrieved from a literature research.
Estonian: Teikoplaniini ravimi omaduste kokkuvõtte farmakokineetika lõigu ühtlustamine põhineb andmetel, mis esitati algses müügiloa taotluses, ja uuematel andmetel, mis saadi kirjanduse otsingust.
English: A Readability Testing was performed and submitted during the referral procedure.
Estonian: Esildismenetluse käigus testiti loetavust ja esitati selle tulemused.
English: The MAH has provided evidence from publications in support of the use of teicoplanin in combination with other anti-microbial agents such as aminoglycosides.
Estonian: Müügiloa hoidja on esitanud publikatsioonidest pärinevad tõendid, mis toetavad teikoplaniini kasutamist koos teiste antimikroobsete ainetega, nagu aminoglükosiidid.
English: The studies provided in support of prophylactic use in cardiac surgery suggest that teicoplanin was not effective in preventing post-operative infections.
Estonian: Uuringud, mis korraldati profülaktilise kasutamise toetamiseks südamekirurgias, viitavad, et teikoplaniin ei ole operatsioonijärgsete infektsioonide ennetamisel efektiivne.