FrancophonIA/ELRC3.0 huggingface dataset:
English: • Around 73% of patients given Vectibix plus FOLFIRI and 78% of those given Vectibix with FOLFOX had some reduction in signs of cancer in a study of 80 previously untreated patients.
Estonian: • Uuringus, milles osales 80 varem ravimata patsienti, oli Vectibixi koos FOLFIRI-raviga kasutanud patsientidest neid, kellel vähisümptomid vähenesid teatud määral, ligikaudu 73% ning Vectibixi koos FOLFIRI-raviga saanute seas 78%.
English: Vectibix can only be obtained with a prescription.
Estonian: Vectibix on retseptiravim.
English: • Patients receiving Vectibix in combination with FOLFOX lived for an average of 10.1 months without the disease getting worse in a study of 1,183 previously untreated patients compared with 7.9 months for those receiving FOLFOX alone.
Estonian: • Uuringus, milles osales 1183 varem ravimata patsienti, oli keskmine progresseerumiseta elumus Vectibixi koos FOLFOX-raviga kasutanud patsientidel 10,1 kuud ning üksnes FOLFOX-ravi saanud patsientidel 7,9 kuud.
English: Vectibix is used alone or with other cancer medicines in patients with a type of tumour that has normal (‘wild-type') copies of a gene known as RAS.
Estonian: Seda kasutatakse ainuravimina või koos teiste vähiravimitega patsientidel, kellel kasvajarakud sisaldavad tavalist (muteerumata) RAS-geeni.
English: • Around 59% of patients who received Vectibix plus FOLFIRI in a study of 154 previously untreated had some reduction in signs of cancer.
Estonian: • Uuringus, milles osales 154 varem ravimata patsienti, oli Vectibixi koos FOLFIRI-raviga kasutanud patsientidest neid, kellel vähisümptomid vähenesid teatud määral, 59%.
English: Vectibix is available for infusion (drip) into a vein.
Estonian: Vectibixi manustatakse veeniinfusioonina.
English: Whereas,
Estonian: Võttes arvesse et,
English: Benefit/risk balance
Estonian: Kasulikkuse ja riski suhe
English: These are appropriately reflected in the product information.
Estonian: Kõik need riskid on tooteinfos adekvaatselt kajastatud.
English: Major vascular events were increased by about one third by a coxib (rate ratio [RR] 1.37, 95% confidence interval [CI] 1.14-1.66; p=0.0009) or diclofenac (1.41, 1.12-1.78; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, 1.31-2.37; p=0.0001; diclofenac: 1.70, 1.19-2.41; p=0.0032).
Estonian: Oluliste vaskulaarsete juhtude esinemine oli nii koksiibide (riskisuhe 1,37, 95% usaldusvahemik 1,141,66; p=0,0009) kui ka diklofenaki (1,41, 1,12-1,78; p=0,0036) korral umbes kolmandiku võrra suurem, seda eelkõige oluliste koronaarsete juhtude suurema esinemissageduse tõttu (koksiibid: 1,76, 1,31-2,37; p=0,0001; diklofenak: 1,70, 1,19-2,41; p=0,0032).
English: This review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Estonian: Selle hindamise teostas ravimiohutuse riskihindamise nõuandekomitee.
English: The available information on the dose effect of diclofenac is limited.
Estonian: Kättesaadavad andmed diklofenaki annuse mõju kohta on piiratud.
English: • The PRAC also concluded that there was need for further risk minimisation measures such as information to healthcare professionals.
Estonian: • ravimiohutuse riskihindamise nõuandekomitee järeldas samuti, et tuleb võtta riskivähendamise lisameetmeid, nagu tervishoiutöötajate teatis.
English: 1 For more details on the MEDAL programme, including its components, please refer to the assessment report for the review conducted in 2006 at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/01/WC500054344.pdf.
Estonian: 1 Täpsem teave programmi MEDAL, sh selle koostisosade kohta, on 2006. aastal läbiviidud hindamise aruandes: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/01/WC500054344.pdf.
English: With regards to cardiovascular risks, the PRAC noted that the initial signal from the MEDAL programme was confirmed by the meta-analyses of randomised clinical trials conducted by Trelle et al (2011) and Chen and Ashcroft (2007).
Estonian: Kardiovaskulaarsete riskide kohta märkis ravimiohutuse riskihindamise nõuandekomitee, et programmist MEDAL saadud esialgne ohumärk leidis kinnitust Trelle et al. (2011) ning Cheni ja Ashcrofti (2007) läbiviidud randomiseeritud kliiniliste uuringute meta-analüüsides.
English: Data provided by the MAHs in writing and at an oral explanation and relevant data made available by independent researchers were also considered.
Estonian: Samuti võeti arvesse müügiloa hoidjate kirjalikke ja suulisi selgitusi ja sõltumatute uurijate esitatud asjakohaseid andmeid.
English: The PRAC concluded that diclofenac is effective in reducing inflammation and pain.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee järeldas, et diklofenak on põletiku ja valu vähendamisel tõhus.
English: Schjerning Olsen et al (2011) provided data on risks in relation to duration of exposure and found that the risks associated with diclofenac were very similar to those of coxibs at all time points.
Estonian: Schjerning Olsen et al. (2011) esitasid andmed kasutamise kestusest sõltuvate riskide kohta ja leidsid, et diklofenakiga seotud riskid olid kõigil ajahetkedel väga sarnased koksiibide riskidele.
English: Diclofenac is a non-steroidal anti-inflammatory drug (NSAID).
Estonian: Diklofenak on mittesteroidne põletikuvastane ravim (NSAID).
English: An increased risk with diclofenac was also observed in the SOS nested-cases control studies across all databases and for both myocardial infarction and ischaemic stroke.
Estonian: Diklofenaki suuremat riski täheldati ka SOS projekti juhtumipõhistes uuringutes kõigis andmebaasides ning ka müokardi infarkti ja isheemilise insuldi osas.
English: Another evaluation conducted by the CHMP in 20122 considered all available published evidence to date from meta-analysis of clinical trials and observational studies, and also epidemiological studies.
Estonian: Teises hindamises, mille inimravimite komitee teostas 2012. aastal2, võeti arvesse kõiki kuni selle ajani avaldatud andmeid kliiniliste uuringute ning vaatluslike ja epidemioloogiliste uuringute metaanalüüsidest.
English: The data available (in particular data from the MEDAL1 programme) suggested that the risk of arterial thrombotic events with diclofenac was similar to that for coxibs, but firm conclusions could not be drawn and further epidemiological studies were needed to obtain additional data.
Estonian: Ehkki olemasolevad andmed (eelkõige programmi MEDAL1 andmed) näitasid, et arteriaalsete trombootiliste juhtude risk võib diklofenaki korral olla sarnane koksiibidele, ei saanud nende alusel teha kindlaid järeldusi ning täiendavate andmete saamiseks tulnuks teha uued epidemioloogilised uuringud.
English: A new review was considered necessary and was initiated to address the cardiovascular safety concerns for diclofenac and their impact on the benefit-risk balance of diclofenac containing medicinal products (systemic formulations).
Estonian: Seetõttu peeti vajalikuks algatada uus hindamine, et uurida diklofenaki kardiovaskulaarset ohutust ja selle mõju diklofenakki sisaldavate ravimite (süsteemsed ravimvormid) kasulikkuse ja riski suhtele.
English: Recognised risks associated with NSAID treatment in general, and with diclofenac treatment in particular, include serious gastrointestinal effects including PUB (perforation, ulcer, bleeding), cardio-renal effects, hepatic effects and skin reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis).
Estonian: NSAID-ravi hästituntud riskid üldiselt - eriti diklofenaki kasutamisel - on rasked seedetrakti kahjustused, sh perforatsioon, haavandid ja verejooks, toime südamele ja neerudele, toime maksale ning nahareaktsioonid (sh Stevens-Johnsoni sündroom ja epidermise toksiline nekrolüüs).
English: The data available today do not allow conclusion on the specific mechanisms underlying the cardiovascular thrombotic risks of diclofenac, although several studies have explored different options and it can be noted that is unlikely that one single mechanism would explain the risk.
Estonian: Praegu kättesaadavate andmete alusel ei ole võimalik otsustada spetsiifiliste mehhanismide üle, millest tuleneb diklofenaki kardiovaskulaarne trombootiline risk, ehkki selle erinevaid võimalikke põhjuseid on uuritud mitmetes uuringutes, mistõttu võib väita, et suure tõenäosusega ei saa seda riski selgitada ühe kindla mehhanismi abil.
English: The PRAC considered that the recommendation for update of the product information should be applicable to all medicinal products containing diclofenac (systemic formulations), regardless of dose.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee otsustas, et tooteinfo ajakohastamise soovitus kehtib kõigi diklofenakki sisaldavate ravimite kohta (süsteemsed ravimvormid), sõltumata nende annusest.
English: • The PRAC considered that diclofenac containing medicinal products are effective in their approved indications.
Estonian: • ravimiohutuse riskihindamise nõuandekomitee leidis, et diklofenakki sisaldavad ravimid on heakskiidetud näidustustel efektiivsed;
English: Therefore in accordance with Articles 31 and 32 of Directive 2001/83/EC, the PRAC recommends the variation of the marketing authorisations for all medicinal products referred to in Annex I and for which the amendments to the product information are set out in annex III of the recommendation.
Estonian: Seetõttu soovitab ravimiohutuse riskihindamise nõuandekomitee direktiivi 2001/83/EÜ artiklite 31 ja 32 alusel muuta kõigi I lisas nimetatud ravimite müügilubasid vastavalt soovituse III lisas esitatud tooteinfo muudatustele.
English: Overall summary of the scientific evaluation of diclofenac containing medicinal products (systemic formulations) (see Annex I)
Estonian: Diklofenakki sisaldavate ravimite (süsteemsed ravimvormid) (vt I lisa) teadusliku hindamise üldkokkuvõte
English: • The PRAC considered that with regards to the arterial thrombotic risks of diclofenac, the data available to date from randomised clinical trials, observational studies and individual epidemiological studies, including meta-analysis thereof, allow the conclusion that diclofenac is associated with increased cardiovascular risks.
Estonian: • ravimiohutuse riskihindamise nõuandekomitee leidis diklofenaki arteriaalse tromboosi riskidega seoses, et randomiseeritud kliinilistest uuringutest, vaatluslikest ja üksikutest epidemioloogilistest uuringutest, sh nende kõigi meta-analüüsidest pärinevad andmed võimaldavad järeldada, et diklofenak on seotud suurema kardiovaskulaarse riskiga.
English: Considering that an increased cardiovascular risk with diclofenac is observed, and this appears similar to that of selective Cox-2 inhibitors, it therefore follows that any risk minimisation in place for Cox-2 inhibitors with respect to cardiovascular risk should also apply to diclofenac.
Estonian: Võttes arvesse asjaolu, et diklofenakil on tuvastatud suurem kardiovaskulaarne risk, mis näib olevat sarnane selektiivsete Cox-2 inhibiitorite vastava riskiga, on selge, et riskivähendusmeetmeid, mis on võetud Cox-2 inhibiitorite kardiovaskulaarse riski vähendamiseks, tuleb rakendada ka diklofenaki puhul.
English: Evidence available from a new meta-analysis of randomised clinical trials conducted by an independent research group was included in the review.
Estonian: Hindamisse kaasati sõltumatu uurimisgrupi läbiviidud randomiseeritud kliiniliste uuringute metaanalüüsi andmed.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for diclofenac containing medicinal products (systemic formulations).
Estonian: • ravimiohutuse riskihindamise nõuandekomitee arutas direktiivi 2001/83/EÜ artikli 31 kohast esildist, mis käsitles diklofenakki sisaldavate ravimite (süsteemsed ravimvormid) ravimiohutuse andmeid;
English: NSAIDs, such as diclofenac, are indicated in the relief of all grades of pain and inflammation associated with a wide range of conditions, including arthritic conditions, acute musculo-skeletal disorders and other painful conditions resulting from trauma.
Estonian: NSAIDid, sealhulgas diklofenak, on näidustatud igasuguse tugevusega valu ja põletiku raviks, mis on seotud väga erinevate haigustega, nagu liigesehaigused, ägedad luu-lihaskonna kahjustused ja muud valusündroomiga haigusseisundid, mis on tingitud traumadest.
English: • The PRAC considered the totality of the data available in relation to the cardiovascular safety of diclofenac containing medicinal products, acknowledging the conclusions from previous reviews by the CHMP, the submissions by marketing authorisation holders in writing and at an oral explanation, and emerging data from independent researchers.
Estonian: • ravimiohutuse riskihindamise nõuandekomitee vaatas läbi kõik kättesaadavad andmed diklofenakki sisaldavate ravimite kardiovaskulaarse ohutuse kohta ning tutvus inimravimite komitee varasemate hindamiste järelduste, müügiloa hoidjate kirjalike ja suuliste selgituste ja sõltumatute uurijate esitatud uute andmetega;
English: The study, which looked at more than 600 randomised clinical trials, concluded that the vascular risks of high dose diclofenac are comparable to Cox-2 inhibitors.
Estonian: Uuringus, mis hõlmas enam kui 600 randomiseeritud kliinilist uuringut, järeldati, et vaskulaarsed riskid diklofenaki suurte annuste korral on võrreldavad Cox-2 inhibiitorite riskidega.
English: Results of the ‘safety of non-steroidal anti-inflammatory drugs' (SOS) research project funded by the European Commission under the Seventh Framework Programme were considered in the review that concluded that available evidence regarding diclofenac seemed to consistently point towards a less favourable cardiovascular risk profile compared to other NSAIDs, and similar risks as those of Cox-2 inhibitors.
Estonian: Kõnealuses hindamises käsitleti ka Euroopa Komisjoni seitsmenda raamprogrammi kaudu rahastatud „mittesteroidsete põletikuvastaste ravimite ohutuse” (safety of non-steroidal antiinflammatory drugs, SOS) uurimisprojekti tulemusi ning järeldati, et kättesaadavad andmed diklofenaki kohta näitavad ühetaoliselt selle vähem soodsat kardiovaskulaarse riski profiili võrreldes teiste NSAIDidega ning sarnast riski Cox-2 inhibiitoritega.
English: The study by Krum et al 2012, a post hoc analysis of the MEDAL trial, showed that there was no significant differential effect between etoricoxib and diclofenac in relation to cardiovascular events, except for confirmed congestive heart failure.
Estonian: Krumi et al. poolt 2012. aastal avaldatud uuringu MEDAL post hoc analüüs näitas, et kardiovaskulaarsete juhtude osas ei täheldatud etorikoksiibi ja diklofenaki vahel olulist erinevust, v.a kinnitust leidnud südame paispuudulikkuse juhud.
English: • The PRAC concluded that in view of the currently available safety data in order to maintain a favourable benefit/risk, diclofenac containing medicinal products should be contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Estonian: • ravimiohutuse riskihindamise nõuandekomitee järeldas praegu kättesaadavate ohutusandmete põhjal, et diklofenakki sisaldavate ravimite soodsa kasulikkuse ja riski suhte säilitamiseks peavad need ravimid olema vastunäidustatud patsientidel, kellel on väljendunud südame paispuudulikkus (NYHA II-IV klass), südame isheemiatõbi, perifeersete arterite haigus ja/või ajuveresoonte haigus.
English: Meta-analyses of observational data and individual observational studies also consistently indicated that diclofenac is associated with a similar level of risk as Cox-2 inhibitors.
Estonian: Vaatluslike andmete meta-analüüsid ja individuaalsed vaatluslikud uuringud näitasid samuti ühetaoliselt, et risk diklofenaki kasutamisel on samal tasemel Cox-2 inhibiitoritega.
English: The PRAC acknowledged the conclusions of previous reviews with regards to the cardiovascular safety of diclofenac.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee tutvus varasemate hindamiste järeldustega diklofenaki kardiovaskulaarse ohutuse kohta.
English: In addition, patients with certain cardiovascular risk factors (such as hypertension, hyperlipidaemia, diabetes mellitus or smoking) should only use diclofenac after careful consideration and therefore the warnings should also be updated to reflect this.
Estonian: Lisaks sellele võivad teatud kardiovaskulaarsete riskiteguritega patsiendid (nt hüpertensioon, hüperlipideemia, diabeet või suitsetamine) diklofenakki kasutada üksnes pärast põhjalikku kaalumist, mistõttu tooteinfo hoiatuste lõiku tuleb vastava teabega ajakohastada.
English: It was observed that these are similar to those of selective Cox-2 inhibitors.
Estonian: Nimetatud risk on sarnane selektiivsete Cox-2 inhibiitorite vastava riskiga;
English: Furthermore, a proactive communication of these new measures through a direct healthcare professional communication (DHPC) was recommended.
Estonian: Samuti on soovitatav teavitada arste proaktiivselt tervishoiutöötajate teatisega neist uutest võetud meetmetest.
English: The PRAC therefore recommended an amendment to the product information for diclofenac to include an updated contraindication in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Estonian: Seetõttu soovitas ravimiohutuse riskihindamise nõuandekomitee muuta diklofenaki tooteinfot ning lisada sellesse diklofenaki kasutamise vastunäidustuse patsientidel, kellel on väljendunud südame paispuudulikkus (NYHA II-IV klass), südame isheemiatõbi, perifeersete arterite haigus ja/või ajuveresoonte haigus.
English: Although the data point towards a dose dependent effect on thrombotic risk associated with the use of diclofenac, particularly at high dose, it is difficult to establish a clear cut-off dose above which the risks become significantly increased.
Estonian: Ehkki olemasolevad andmed näitavad, et tromboosi risk diklofenaki kasutamisel näib sõltuvat annusest, eriti suurte annuste korral, ei ole võimalik kindlaks teha selget annuse piirväärtust, millest alates risk oluliselt suureneb.
English: Epidemiological and clinical trial data on the cardiovascular risks of NSAIDs, including diclofenac, were previously reviewed by the Committee for Medicinal Products for Human Use (CHMP).
Estonian: Inimravimite komitee on juba varem läbi vaadanud epidemioloogilised ja kliiniliste uuringute andmed NSAIDide, sh diklofenaki kardiovaskulaarsete riskide kohta.
English: Some studies also report an association with lower doses.
Estonian: Mõnes uuringus on leitud seos kardiovaskulaarse riskiga ka väiksemate annuste korral.
English: Diclofenac containing medicinal products (systemic formulations) are available as tablets, capsules for oral administration, suppositories for rectal administration and solutions for intravenous or intramuscular injection.
Estonian: Diklofenakki sisaldavaid ravimeid (süsteemsed ravimvormid) turustatakse suukaudseks manustamiseks ettenähtud tablettide ja kapslitena, rektaalseks manustamiseks ettenähtud ravimküünaldena ning veenisiseseks või lihasesiseseks manustamiseks ettenähtud süstelahustena.
English: The CMDh, having considered the PRAC recommendation dated 13 June 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of diclofenac containing medicinal products for which the amendments to the product information are set out in annex III.
Estonian: Olles tutvunud ravimiohutuse riskihindamise nõuandekomitee 13. juuni 2013. aasta soovitusega, võttis inimravimite komitee vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm direktiivi 2001/83/EÜ artikli 107k lõigete 1 ja 2 alusel vastu otsuse muuta kõigi I lisas nimetatud ravimite müügilubasid vastavalt III lisas esitatud tooteinfo muudatustele.
English: Based on the available data to date, the PRAC therefore concluded that the cardiovascular thrombotic risk cannot be excluded across all doses of diclofenac, especially in patients with pre-existing co-morbidities.
Estonian: Praegu kättesaadavaid andmeid arvesse võttes otsustas ravimiohutuse riskihindamise nõuandekomitee, et kardiovaskulaarse tromboosi riski ei saa välistada diklofenaki mis tahes annuse korral, eriti kaasuvate haigustega patsientidel.
English: The PRAC concluded that the benefit-risk balance for diclofenac containing medicinal products (systemic formulations) remains favourable subject to the agreed restrictions, warnings, other changes to the product information and additional risk minimisation measures, in the form of a communication letter.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee järeldas, et diklofenakki sisaldavate ravimite (süsteemsed ravimvormid) kasulikkuse ja riski suhe on jätkuvalt positiivne, kui tooteinfosse viiakse sisse kokkulepitud piirangud ja hoiatused ning muud muudatused ja kui võetakse riskivähendamise lisameetmed arstidele suunatud teatise näol.
English: Having noted all of the above, the PRAC concluded that the benefit-risk balance for diclofenac containing medicinal products (systemic formulations) remains favourable subject to the agreed restrictions, warnings, other changes to the product information and additional risk minimisation measures, in the form of a DHPC letter.
Estonian: Kõike eespool nimetatut arvesse võttes otsustas ravimiohutuse riskihindamise nõuandekomitee, et diklofenakki sisaldavate ravimite (süsteemsed ravimvormid) kasulikkuse ja riski suhe on jätkuvalt positiivne, kui tooteinfosse viiakse sisse kokkulepitud piirangud ja hoiatused ning muud muudatused ja kui võetakse riskivähendamise lisameetmed arstidele suunatud tervishoiutöötajate teatise näol.
English: Key elements for a direct healthcare professional communication were agreed, together with the timelines for distribution.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee leppis kokku selle teatise põhipunktid ja levitamise ajakava.
English: For more information on the review conducted in 2012, please refer to the assessment report for the procedure at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/11/WC500134717.pdf compared to other NSAIDs and that the risk with diclofenac is similar to that of coxibs.
Estonian: Täpsem teave 2012. aastal läbiviidud hindamise kohta on vastavas aruandes: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/11/WC500134717.pdf.
English: The new evidence provided by marketing authorisation holders including evidence from new casecontrol studies and retrospective studies add to the evidence of an increased risk with diclofenac
Estonian: Uued müügiloa hoidjate esitatud tõendid, sh uute juhtumipõhiste uuringute ja retrospektiivsete uuringute andmed kinnitavad olemasolevaid tõendeid diklofenaki suurema riski kohta võrreldes teiste NSAIDidega ja diklofenakiga kaasneva riski sarnasust koksiibide riskile.
English: In 2006 it was concluded that a small increase in the absolute risk of thrombotic events could not be excluded for NSAIDs as a class, especially when used at high-doses and long-term therapy, although the risk was considered to be higher for the selective cyclooxygenase-2 (Cox-2) inhibitors (also known as coxibs) compared to NSAIDs.
Estonian: 2006. aastal järeldati, et NSAIDide kui ravimirühmaga seoses ei saa välistada trombootiliste juhtude absoluutse riski väikest suurenemist, eriti kui neid ravimeid kasutatakse suurtes annustes ja pika aja vältel.
English: The CMDh, having considered the PRAC recommendation dated 13 June 2013 with regards to diclofenac containing medicinal products (systemic formulations), agrees with the recommendation therein as stated below:
Estonian: Võttes arvesse ravimiohutuse riskihindamise nõuandekomitee 13. juuni 2013. aasta soovitust diklofenakki sisaldavate ravimite (süsteemsed ravimvormid) kohta, nõustub inimravimite komitee vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm kõnealuse soovitusega, mis on kokku võetud allpool.