FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding the treatment of severe hypertension in pregnancy, the CHMP took into account the limited study data, the lack of long-term study data on morbidity and mortality and the recommendations of current guidelines.
Estonian: Kasutamise kohta raske hüpertensiooni ravis raseduse ajal arvestas komitee uuringuandmete piiratust, haigestumise ja suremuse pikaajaliste uuringuandmete puudumist ning praeguste ravijuhendite soovitusi.
English: The RMS therefore decided to suspend the DCP procedure at day 210 and triggered a procedure under Article 31 of Directive 2001/83/EC, requesting the Committee for Medicinal Products for Human Use (CHMP) to review the benefit-risk of all intravenous nicardipine-containing products for intravenous use and to clarify the data supporting the licensing of these products.
Estonian: Viiteliikmesriik otsustas seepärast peatada detsentraliseeritud menetluse 210. päeval ja tegi direktiivi 2001/83/EÜ artikli 31 kohase esildise, paludes inimravimite komiteel üle vaadata kõigi nikardipiini sisaldavate intravenoossete ravimite kasulikkus ja risk ning selgitada andmeid, mis toetavad nende ravimite müügilube.
English: • The Committee reviewed all available data, including the responses submitted by the marketing authorisation holders, published studies and post-marketing data;
Estonian: • inimravimite komitee vaatas läbi kõik kättesaadavad andmed, sealhulgas müügiloa hoidjate vastused, avaldatud uuringud ja müügiloa andmise järgsed andmed;
English: In view of the identified divergences in the nationally approved product information, the CHMP also considered it to be of community interest to harmonise the product information across the EU.
Estonian: Arvestades tuvastatud erinevusi riikides heakskiidetud ravimiteabes, leidis inimravimite komitee ka, et ühenduse huvides tuleb ühtlustada ravimiteave kogu Euroopa Liidus
English: With regards to hypotension, the CHMP considered that the use of intravenous nicardipine for this indication is no longer relevant in the context of current surgical and anaesthetic practice.
Estonian: Hüpotensiooni suhtes järeldas inimravimite komitee, et intravenoosse nikardipiini kasutamine sellel näidustusel ei ole praeguse kirurgia- ja anesteesiapraktika kontekstis enam asjakohane.
English: Grounds for the variation to the terms of the marketing authorisation Whereas
Estonian: Müügiloa tingimuste muutmise alused Arvestades, et
English: Intravenous nicardipine can also continue to be used in malignant arterial hypertension/hypertensive encephalopathy; however, due to the risk of intracranial pressure elevation, the CHMP recommended the addition of a warning on this risk.
Estonian: Intravenoosse nikardipiini kasutamist võib samuti jätkata pahaloomulise arteriaalse hüpertensiooni / hüpertensiivse entsefalopaatia korral; koljusisese rõhu tõusu riski tõttu soovitas komitee lisada selle riski hoiatuse.
English: The CHMP considered all data available in its assessment, including published studies, article and guideline reviews, expert statements, user surveys, national guidelines as well as safety data from post-marketing and marketing authorisation holder databases.
Estonian: Inimravimite komitee hindas kõiki kättesaadavaid andmeid, sealhulgas avaldatud uuringuid, artiklite ja suuniste ülevaateid, eksperdiarvamusi, kasutajauuringuid, riiklikke suuniseid ning müügiloa andmise järgseid ja müügiloa hoidja andmebaaside ohutusandmeid.
English: Additionally, significant concerns were raised regarding the administration of IV nicardipine by bolus dose injection or direct intravenous administration due to a higher potential risk of iatrogenic hypotension, in particular in pre-eclampsia.
Estonian: Lisaks tõstatati olulisi probleeme seoses intravenoosse nikardipiini manustamisega boolussüstina või otsese intravenoosse manustamisega iatrogeense hüpotensiooni suurema potentsiaalse riski tõttu eriti pre-eklampsia korral.
English: Considering the limited efficacy data and overall safety profile, the CHMP therefore considered that the indications in hypotension should be removed from the product information.
Estonian: Arvestades piiratud efektiivsusandmeid ja üldist ohutusprofiili, järeldas komitee, et hüpotensiooni näidustused tuleb ravimiteabest eemaldada.
English: The CHMP also made significant revisions to the posology section of the product information, including bringing the recommendations in special populations in line with current knowledge of the use of intravenous nicardipine.
Estonian: Inimravimite komitee tegi samuti olulisi muudatusi ravimiteabe annustamise lõigus, sealhulgas kooskõlastas eripopulatsioonidele annustamise soovitused intravenoosse nikardipiini kasutamise praeguste teadmistega.
English: • The Committee considered that in view of the identified serious limitations of the efficacy data and the overall safety profile of nicardipine, the benefits were no longer considered to outweigh the risks for some indications, which should therefore be removed;
Estonian: • komitee leidis, et nikardipiini efektiivsusandmeid ja üldist ohutusprofiili arvestades ei ületa kasulikkus enam riske mõne näidustuse korral, mis tuleb eemaldada;
English: These adverse effects are consistent with other dihydropyridine calcium channel blockers and were not considered to impact negatively on the benefit-risk balance of IV nicardipine.
Estonian: Need kõrvaltoimed sarnanevad teiste dihüdropüridiinsete kaltsiumikanaliblokaatorite omadega ning leiti, et need ei kahjusta intravenoosse nikardipiini kasulikkuse ja riski tasakaalu.
English: Having reviewed the available safety data, the CHMP noted that most common adverse effects and those that most frequently result in drug discontinuance are cardiovascular and nervous system effects related to the expected vasodilator effects of the drug, in particular headache, hypotension, flushing, oedema and tachycardia.
Estonian: Kättesadavate ohutusandmete põhjal märkis komitee, et kõige sagedamad kõrvaltoimed ning need, mille tõttu patsiendid kõige sagedamini lõpetavad ravimi võtmise, on kardiovaskulaarsed ja närvisüsteemi toimed, mis on seotud ravimi eeldatava vasodilatatsiooniga, eriti peavalu, hüpotensiooni, punetuse, tursete ja tahhükardiaga.
English: The CHMP concluded that data is only available to support the use of nicardipine in the post-operative hypertension indication setting.
Estonian: Komitee järeldas, et olemas on ainult andmed, mis toetavad nikardipiini kasutamist operatsioonijärgse hüpertensiooni näidustusel.
English: Following the submission of a marketing authorisation application under the decentralised procedure (DCP) for a generic nicardipine-containing product for intravenous (IV) use (10 mg/10ml solution for injection) and the assessment of the application dossier, the reference member state (RMS) UK considered the clinical data submitted to be insufficient to determine the efficacy, safety and overall benefit-risk of IV nicardipine in the proposed indications.
Estonian: Pärast geneerilise nikardipiini sisaldava intravenoosse ravimi (10 mg / 10 ml süstelahus) detsentraliseeritud müügiloa taotluse esitamist ja taotlustoimiku hindamist leidis viiteliikmesriik Ühendkuningriik, et esitatud kliinilised andmed ei ole piisavad intravenoosse nikardipiini efektiivsuse, ohutuse ning üldise kasulikkuse ja riski tuvastamiseks kavandatud näidustustel.
English: The Committee, as a consequence, concluded that the benefit-risk balance of intravenous nicardipinecontaining medicinal products remains positive, taking into account the restrictions, warnings and other changes to the product information.
Estonian: Eeltoodut arvestades järeldas inimravimite komitee, et nikardipiini sisaldavate intravenoossete ravimite kasulikkuse ja riski tasakaal on endiselt positiivne, arvestades piiranguid, hoiatusi ja muid ravimiteabe muudatusi.
English: Despite being used as a first line treatment in some member states, the CHMP considered a second-line indication to be appropriate for IV nicardipine for pre-eclampsia and agreed on an indication in severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated.
Estonian: Kuigi ravimit kasutatakse mõnes liikmesriigis esimese valiku ravimina, pidas komitee intravenoosse nikardipiini jaoks sobivaks kasutamist teise valiku ravimina preeklampsia korral ja nõustus kasutamisega raske pre-eklampsia näidustusel, kui teisi intravenoosseid antihüpertensiivseid ravimeid ei soovitata või need on vastunäidustatud.
English: • The Committee considered that the available efficacy data is supportive of the use of nicardipine for intravenous use in the treatment of acute life-threatening hypertension and post-operative hypertension;
Estonian: • komitee leidis, et kättesaadavad efektiivsusandmed toetavad intravenoosse nikardipiini kasutamist ägeda eluohtliku hüpertensiooni ja postoperatiivse hüpertensiooni ravis;
English: The CHMP reviewed the broad indication for hypertension in the peri-operative period, which includes the pre-operative phase, the time of surgery itself and the post-operative period.
Estonian: Inimravimite komitee vaatas läbi ulatusliku näidustuse kasutamiseks hüpertensiooni raviks perioperatiivsel perioodil, mis koosneb preoperatiivsest faasist, operatsiooni enda ajast ja postoperatiivsest perioodist.
English: There are safety concerns associated with the use of nicardipine in patients with left ventricular heart failure as well as in patients with suspected coronary artery disease and therefore nicardipine should no longer be used for acute severe hypertension with accompanying left ventricular decompensation and pulmonary oedema.
Estonian: Nikardipiini kasutamisega on seotud ohutusprobleemid südame vasaku vatsakese puudulikkusega patsientidel ja kahtlustatava koronaararterite haigusega patsientidel, mille tõttu ei tohi nikardipiini enam kasutada ägeda raske hüpertensiooni korral koos kaasuva vasaku vatsakese dekompensatsiooni ja kopsutursega.
English: The CHMP considered that overall, sufficient evidence is available on the safety and efficacy of nicardipine containing medical products for IV use in the treatment of post-operative hypertension and treatment of acute life-threatening hypertension in specific settings, with appropriate specialist intervention and monitoring and when used by specialists.
Estonian: Inimravimite komitee järeldas, et üldiselt on olemas piisavalt andmeid nikardipiini sisaldavate intravenoossete ravimite ohutuse ja efektiivsuse kohta postoperatiivse hüpertensiooni ravis ja ägeda eluohtliku hüpertensiooni ravis spetsiifilises keskkonnas meditsiinitöötaja sobiva sekkumise ja jälgimise korral ning kui neid kasutavad meditsiinitöötajad.
English: In view of the available evidence and current medical knowledge on the use of intravenous nicardipine, and considering the potentially serious adverse reactions associated with the use of nicardipine, the CHMP considered that the benefit-risk balance of IV nicardipine is negative in some indications due to serious limitations of the efficacy data.
Estonian: Arvestades kättesaadavaid andmeid ja praegusi meditsiinilisi teadmisi intravenoosse nikardipiini kasutamise kohta ning nikardipiini kasutamisega seostatavaid potentsiaalselt raskeid kõrvaltoimeid, järeldas inimravimite komitee, et intravenoosse nikardipiini kasulikkuse ja riski tasakaal on mõnel näidustusel negatiivne efektiivsusandmete olulise piiratuse tõttu.
English: The CHMP therefore concluded that nicardipine for intravenous use should only be administered by continuous infusion and not by bolus dose administration, due to the abovementioned safety concerns.
Estonian: Inimravimite komitee järeldas seega, et intravenoosset nikardipiini tohib eelnimetatud ohutusprobleemide tõttu manustada ainult pidevinfusioonina, mitte boolusannusena.
English: In addition, significant discrepancies between the information submitted and the posology and safety information in the proposed Summary of product characteristics (SmPC) were also identified by the RMS.
Estonian: Samuti leidis viiteliikmesriik ka olulisi erinevusi esitatud teabe ja kavandatud ravimi omaduste kokkuvõttes oleva annustamis- ja ohutusteabe vahel.
English: • The Committee considered that the product information should be updated, including with regard to the therapeutic indications and advised that nicardipine should only be administered by continuous infusion and not by bolus dose administration, due to safety concerns.
Estonian: • komitee leidis, et ravimiteavet tuleb uuendada, sealhulgas seoses terapeutiliste näidustustega, ja soovitas, et nikardipiini tohib ohutusprobleemide tõttu manustada ainult pidevinfusioonina, mitte boolusannusena, järeldas komitee, et normaalsetel kasutustingimustel on nikardipiini sisaldavate intravenoossete ravimite kasulikkuse ja riski tasakaal endiselt positiivne, arvestades ravimiteabesse tehtavaid kokkulepitud muudatusi.
English: No suitable risk minimisation measures were identified to reduce the associated risks, given the nature of the patient population and the possible emergency setting in which IV nicardipine is used.
Estonian: Arvestades patsiendipopulatsiooni iseloomu ja võimalikke erakorralisi tingimusi, milles intravenoosset nikardipiini kasutatakse, ei tuvastatud kaasuvate riskide vähendamiseks sobivaid riskivähendamismeetmeid.
English: The CHMP considered that there is a role for intravenous nicardipine in aortic dissection based on the information submitted, the evidence of widespread use, the expert statements and the absence of new safety signals in this patient population; however, in line with the available evidence, the CHMP recommended the clinical use as second line treatment, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective.
Estonian: Esitatud teabele, laialdase kasutamise andmetele, eksperdihinnangutele ja uute ohutussignaalide puudumisele selles patsiendipopulatsioonis, järeldas komitee, et intravenoossel nikardipiinil on teatud roll aordidissektsiooni korral.
English: The usual dose is 40 mg once a day, taken preferably in the morning.
Estonian: Tavaline annus on 40 mg üks kord ööpäevas, mis manustatakse eelistatavalt hommikul.
English: The full EPAR and risk management plan summary for Neofordex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Neofordexi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Neofordex is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Neofordexi võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Neofordex?
Estonian: Mis meetmed võetakse, et tagada Neofordexi ohutu ja efektiivne kasutamine?
English: Other information about Neofordex
Estonian: Muu teave Neofordexi kohta
English: The CHMP therefore decided that Neofordex's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas seetõttu, et Neofordexi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Neofordex is available as 40 mg tablets.
Estonian: Neofordexit turustatakse 40 mg tablettidena.
English: Less common but serious side effects include pneumonia (infection of the lungs) and other infections and psychiatric disorders such as depression.
Estonian: Harvem esinevad, kuid rasked kõrvalnähud on muu hulgas pneumoonia (kopsupõletik) ja muud infektsioonid ning psühhiaatrilised häired, näiteks depressioon.
English: This means that it is similar to a reference medicine containing the same active substance, but Neofordex is available at a higher strength.
Estonian: See tähendab, et Neofordex on sarnane võrdlusravimiga, mis sisaldab sama toimeainet, kuid Neofordexi turustatakse suurema tugevusega.
English: In addition, a bioequivalence study was carried out in 24 healthy volunteers which showed that Neofordex has comparable quality to the reference medicine, Dectancyl.
Estonian: Peale selle toimus bioekvivalentsuse uuring 24 tervel vabatahtlikul, mis tõendas, et Neofordexil oli võrreldav kvaliteet võrdlusravimi Dectancyliga.
English: Neofordex must not be used in patients with active viral disease (especially hepatitis, cold sores, shingles or chicken pox) or with uncontrolled psychoses (altered sense of reality).
Estonian: Neofordexit ei tohi kasutada patsiendid, kellel on aktiivne viirushaigus (eriti hepatiit, huule lihtohatis, vöötohatis või tuulerõuged) või ohjamata psühhoosid (reaalsustaju muutused).
English: Neofordex dexamethasone
Estonian: Neofordex deksametasoon
English: The most common side effects with Neofordex (which may affect more than 1 in 10 people) include hyperglycaemia (high blood sugar levels), insomnia (difficulty sleeping), muscle pain and weakness, asthenia (weakness), tiredness, oedema (swelling) and weight increase.
Estonian: Neofordexi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on hüperglükeemia (vere suur glükoosisisaldus), unetus, lihasvalu ja -nõrkus, asteenia (nõrkus), väsimus, tursed ja kehakaalu tõus.
English: Neofordex is a medicine used together with cancer medicines to treat adults with multiple myeloma who have developed symptoms.
Estonian: Neofordex on ravim, mida kasutatakse koos vähiravimitega hulgimüeloomiga täiskasvanute raviks, kellel on tekkinud sümptomid.
English: What is Neofordex and what is it used for?
Estonian: Mis on Neofordex ja milleks seda kasutatakse?
English: It is not intended to provide practical advice on how to use Neofordex.
Estonian: Hindamisaruandes ei anta Neofordexi kasutamise praktilisi nõuandeid.
English: Neofordex may also reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.
Estonian: Neofordex võib ka leevendada vähiravi teatud kõrvalnähte, näiteks iiveldust ja oksendamist.
English: This is a summary of the European public assessment report (EPAR) for Neofordex.
Estonian: See on ravimi Neofordex Euroopa avaliku hindamisaruande kokkuvõte.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neofordex, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Neofordexi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Why is Neofordex approved?
Estonian: Miks Neofordex heaks kiideti?
English: It does this by interacting with different proteins (nuclear factor kB and caspase 9) that regulate cell death.
Estonian: rakusurma reguleerivat valku (tuumafaktor κB ja kaspaas-9).
English: What are the risks associated with Neofordex?
Estonian: Mis riskid Neofordexiga kaasnevad?
English: The reference medicine for Neofordex is Dectancyl.
Estonian: Neofordexi võrdlusravim on Dectancyl.
English: In multiple myeloma, Neofordex is used together with cancer medicines to kill cancerous plasma cells.
Estonian: Hulgimüeloomi korral kasutatakse Neofordexit koos vähiravimitega vähiga plasmarakkude hävitamiseks.
English: For practical information about using Neofordex, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Neofordexi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Multiple myeloma is a cancer of a type of white blood cell called plasma cells, which are part of the immune system (the body's natural defences).
Estonian: Need rakud on osa immuunsüsteemist (organismi looduslikust kaitsesüsteemist).
English: For more information about treatment with Neofordex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Neofordexiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Neofordex has been shown to have comparable quality to Dectancyl and the use of high-dose dexamethasone in multiple meyloma is well established.
Estonian: Inimravimite komitee järeldas, et on tõendatud Neofordexi võrreldav kvaliteet ravimiga Dectancyl ja deksametasooni suurte annuste kasutamine hulgimüeloomi korral on hästi teada.
English: Because the effects of high-dose dexamethasone in multiple myeloma are well established, the company for Neofordex presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.
Estonian: Et deksametasooni suurte annuste toime on hulgimüeloomi korral hästi teada, esitas Neofordexi tootja kirjandusest pärinevad uuringud deksametasooni kasutamise kohta hulgimüeloomi ravis.
English: For the full list of all side effects reported with Neofordex, see the package leaflet.
Estonian: Neofordexi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: However, the dose and how frequently Neofordex is given varies depending on the medicines it is given with and the patient's condition.
Estonian: Neofordexi annus ja manustamissagedus sõltub patsiendi seisundist ning teistest samaaegsetest ravimitest.
English: How is Neofordex used?
Estonian: Kuidas Neofordexit kasutatakse?
English: How does Neofordex work?
Estonian: Kuidas Neofordex toimib?
English: Neofordex can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.
Estonian: Ravi peab alustama ja jälgima hulgimüeloomi ravis kogenud arst.
English: What benefits of Neofordex have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Neofordexi kasulikkus?
English: The active substance in Neofordex, dexamethasone, belongs to a group of medicines known as corticosteroids.
Estonian: Neofordexi toimeaine deksametasoon kuulub kortikosteroidide rühma.
English: It is a ‘hybrid medicine'.
Estonian: Neofordex on hübriidravim.
English: It is available as capsules (250 mg) and tablets (500 mg).
Estonian: Seda turustatakse kapslitena (250 mg) ja tablettidena (500 mg).
English: The full EPAR for Mycophenolate mofetil Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Mycophenolate mofetil Teva kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Estonian: Selle tulemusena ei saa need siiratud elundit nii efektiivselt ära tunda ega rünnata, mis vähendab elundi äratõukereaktsiooni tekkimise tõenäosust.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mycophenolate mofetil Teva on 21 February 2008.
Estonian: Euroopa Komisjon andis Mycophenolate mofetil Teva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 21. veebruaril 2008.
English: It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Estonian: Ravimit kasutatakse koos tsüklosporiini ja kortikosteroididega (samuti äratõukereaktsiooni ennetamise ravimid).
English: In children aged between two and 18 years, the dose of Mycophenolate mofetil Teva is calculated depending on height and weight.
Estonian: 2-18-aastastel lastel arvutatakse Mycophenolate mofetil Teva annus olenevalt nende pikkusest ja kehakaalust.
English: For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant.
Estonian: Neeru siirdamise korral on soovituslik annus täiskasvanutele 1,0 g kaks korda ööpäevas, manustamist tuleb alustada 72 tunni jooksul pärast siirdamist.