FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits continue to outweigh the risks in patients with angina pectoris but that treatment should be restricted to add-on to existing treatments in patients who are not adequately controlled by or who are intolerant to other medicines for angina pectoris.
Estonian: Euroopa Ravimiameti inimravimite komitee järeldas, et stenokardiaga patsientidel ületab kasulikkus endiselt riskid, kuid ravi tuleb kasutada vaid olemasoleva ravi lisaravina patsientidel, kelle sümptomeid ei ole muude stenokardiaravimitega piisavalt kontrolli alla saadud või kes ei talu neid ravimeid.
English: It also recommended contraindicating trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
Estonian: Samuti soovitas inimravimite komitee trimetasidiini mitte kasutada Parkinsoni tõve või parkinsonismi sümptomitega patsientidel ja raske neerupuudulikkusega patsientidel.
English: This summary was last updated in 06-2014.
Estonian: Kokkuvõtte viimane uuendus: 06-2014.
English: As a result, levodopa remains active for longer.
Estonian: Selle tulemusena püsib levodopa toime kauem.
English: It is available as tablets (100 mg and 200 mg).
Estonian: Seda turustatakse tablettidena (100 mg ja 200 mg).
English: The recommended dose is 100 mg three times a day.
Estonian: Soovitatav annus on 100 mg kolm korda ööpäevas.
English: Tasmar tolcapone
Estonian: Tasmar tolkapoon
English: The tablets should be swallowed whole.
Estonian: Tabletid tuleb alla neelata tervelt.
English: What measures are being taken to ensure the safe and effective use of Tasmar?
Estonian: Mis meetmed võetakse, et tagada Tasmari ohutu ja efektiivne kasutamine?
English: The initial studies showed that Tasmar was more effective than placebo.
Estonian: Esialgsed uuringud näitasid, et Tasmar oli efektiivsem kui platseebo.
English: A risk management plan has been developed to ensure that Tasmar is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Tasmari võimalikult ohutu kasutamine.
English: The full EPAR for Tasmar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Tasmari kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If after three weeks, no substantial benefit has been seen, treatment with Tasmar should be stopped.
Estonian: Kui kolme nädala pärast ei ilmne olulist kasulikkust, tuleb Tasmari ravi lõpetada.
English: Tasmar can cause liver injury, which can be fatal in rare cases.
Estonian: Tasmar võib põhjustada maksakahjustusi, mis harvadel juhtudel võivad olla surmavad.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tasmar on 27 August 1997.
Estonian: Euroopa Komisjon andis Tasmari müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 27. augustil
English: The dose of Tasmar may be increased to 200 mg three times a day but only when the benefit expected outweighs the risk of liver injury.
Estonian: Tasmari annust võib suurendada 200 mg-ni kolm korda ööpäevas, kuid üksnes juhul, kui oodatav kasulikkus on suurem kui maksakahjustuse risk.
English: Doctors should monitor patients very carefully during treatment.
Estonian: Arst peab ravi ajal patsienti väga hoolikalt jälgima.
English: The first dose of the day of Tasmar should be taken together with the first daily dose of the levodopa preparation, and subsequent doses of Tasmar should be given approximately 6 and 12 hours later.
Estonian: Tasmari esimene ööpäevaannus tuleb võta koos levodopapreparaadi esimese ööpäevaannusega ning Tasmari järgnevad annused tuleb võtta ligikaudu 6 ja 12 tundi hiljem.
English: The patients then lose their ability to control their movements reliably.
Estonian: Selle tagajärjel ei suuda patsiendid liigutusi enam usaldusväärselt juhtida.
English: Treatment should be stopped in patients who develop liver problems.
Estonian: Ravi tuleb lõpetada patsientidel, kellel tekivad maksaprobleemid.
English: Tasmar was originally studied in a total of 594 patients, in two 13-week studies and one six-week study.
Estonian: Tasmarit uuriti esialgu kahes 13-nädalases ja ühes 6-nädalases uuringus kokku 594 patsiendil.
English: This is a summary of the European public assessment report (EPAR) for Tasmar.
Estonian: See on ravimi Tasmar Euroopa avaliku hindamisaruande kokkuvõte.
English: Tasmar is only used when patients do not respond, or cannot take other medicines of the same type.
Estonian: Tasmarit kasutatakse üksnes juhul, kui patsiendil ei teki teistele sama liiki ravimitele ravivastust või nad ei saa neid kasutada.
English: The Committee recommended that Tasmar be given marketing authorisation.
Estonian: Komitee soovitas anda Tasmari müügiloa.
English: For the full list of restrictions see the package leaflet.
Estonian: Piirangute täielik loetelu on pakendi infolehel.
English: Other information about Tasmar
Estonian: Muu teave Tasmari kohta
English: In the switch study, more patients responded to Tasmar (53%; 40 out of 75) than to entacapone (43%; 32 out of 75).
Estonian: Ravimi muutmise uuringus oli Tasmarit kasutanud rühmas ravivastusega patsiente rohkem kui entakapooni kasutanud patsientide rühmas (vastavalt 53% ehk 40 patsienti 75-st ja 43% ehk 32 patsienti 75-st).
English: • signs of liver disease or increased liver enzymes;
Estonian: • maksahaiguse nähud või maksaensüümide suurem sisaldus;
English: The most common side effects with Tasmar (seen in more than 1 patient in 10) are nausea (feeling sick), loss of appetite, diarrhoea, dyskinesia (uncontrollable movements), dystonia (muscle spasms), headache, dizziness, sleep disorders, excessive dreaming, somnolence (sleepiness), confusion, hallucination (seeing things that are not there) and orthostatic complaints (dizziness on standing).
Estonian: Tasmari kõige sagedamad kõrvalnähud (esinenud enam kui ühel patsiendil kümnest) on iiveldus, isukaotus, kõhulahtisus, düskineesia (kontrollimatud liigutused), düstoonia (lihasespasmid), peavalu, peapööritus, unehäired, ülemäärased unenäod, unisus, segasus, hallutsinatsioonid (olematute asjade nägemine) ja ortostaatika kaebused (peapööritus seismisel).
English: • severe dyskinesia.
Estonian: • raskekujuline düskineesia.
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 Tasmar.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Doctors should check the patient's liver before starting treatment with Tasmar and then regularly during treatment.
Estonian: Arst jälgima patsiendi maksatalitlust nii enne ravi alustamist kui ka regulaarselt ravi kestel.
English: Tasmar must also not be used in patients who are being treated with medicines known as nonselective monoamine oxidase (MAO) inhibitors.
Estonian: Tasmarit ei tohi kasutada patsientidel, kes saavad mitteselektiivseid monoamiinioksüdaasi (MAO) inhibiitoreid.
English: This helps to improve the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Estonian: See aitab leevendada Parkinsoni tõve tunnuseid ja sümptomeid, näiteks jäikust ja liigutuste aeglust.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tasmar, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Tasmari ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Tasmar is always given with levodopa and benserazide or with levodopa and carbidopa.
Estonian: Tasmarit kasutatakse alati koos levodopa ja benserasiidi või levodopa ja karbidopaga.
English: What is Tasmar?
Estonian: Mis on Tasmar?
English: For more information about treatment with Tasmar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Tasmariga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Estonian: See toimib ainult kasutamisel koos levodopaga, mis on neurotransmitter dopamiini analoog, mida võib manustada suukaudselt.
English: Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Estonian: Parkinsoni tõbi on progresseeruv ajuhäire, mis põhjustab värinaid, liigutuste aeglust ja lihasjäikust.
English: Tasmar is a medicine that contains the active substance tolcapone.
Estonian: Tasmar on ravim, mis sisaldab toimeainena tolkapooni.
English: • a history of neuroleptic malignant syndrome (a dangerous nervous disorder usually caused by antipsychotic medicines), rhabdomyolysis (breakdown of muscle fibres) or hyperthermia (heat stroke);
Estonian: • varem esinenud neuroleptosündroom (ohtlik närvisüsteemi häire, mida põhjustavad tavaliselt antipsühhootikumid) või rabdomüolüüs (lihaskiudude lagunemine) või hüpertermia (kuumarabandus);
English: The active substance in Tasmar, tolcapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination.
Estonian: Tasmari toimeaine tolkapooni toimel taastub dopamiini sisaldus aju osades, mis juhivad liigutusi ja koordinatsiooni.
English: • phaeochromocytoma (a tumour of the adrenal gland);
Estonian: • feokromotsütoom (neerupealise kasvaja);
English: Tasmar is used together with other standard treatments for Parkinson's disease (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patients have ‘fluctuations' towards the end of the period between two doses of their standard combination.
Estonian: Tasmarit kasutatakse koos teiste Parkinsoni tõve standardravimitega (kas levodopa ja benserasiidi või levodopa ja karbidopa kombinatsiooniga), kui patsientidel esineb standardravimikombinatsiooni kahe annuse vahelise aja lõpus haigustunnuste kõikumisi.
English: Why has Tasmar been approved?
Estonian: Miks Tasmar heaks kiideti?
English: When patients add Tasmar to their existing anti Parkinson's disease medication, they need to be made aware that they may experience some of the side effects of levodopa, although these can often be reduced by lowering the dose of levodopa.
Estonian: Tasmari lisamisel patsiendi olemasolevale Parkinsoni tõve ravile on vaja teda teavitada levodopa võimalikest kõrvalnähtudest, kuigi neid võib levodopa annuse vähendamisega leevendada.
English: The main measure of effectiveness was the number of patients with an increase in ‘on' time of one hour or more, during the three weeks following the switch.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel Tasmari ravile üleminekule järgnenud kolme nädala kestel on-seisund pikenes vähemalt ühe tunni võrra.
English: The study compared continuing to take entacapone with switching to Tasmar.
Estonian: Uuringus võrreldi entakapooni ravi jätkamist ja Tasmari ravile üleminekut.
English: For the full list of all side effects reported with Tasmar, see the package leaflet.
Estonian: Tasmari kohta teatatud kõrvalnähtude täieliku loetelu on pakendi infolehel.
English: Tasmar is used to treat patients with Parkinson's disease.
Estonian: Tasmarit kasutatakse Parkinsoni tõvega patsientide raviks.
English: What is the risk associated with Tasmar?
Estonian: Mis riskid Tasmariga kaasnevad?
English: Tasmar has also been studied in a ‘switch' study in 150 patients.
Estonian: Tasmarit uuriti ka 150 patsiendil, kelle ravi muudeti.
English: These patients were already receiving a combination of levodopa and entacapone (another medicine that blocks COMT).
Estonian: Need patsiendid juba said levodopa ja entakapooni (teine katehhool-O-metüültransferaasi blokeeriv ravim) kombinatsioonravi.
English: Tolcapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catecholO-methyl transferase (COMT).
Estonian: Tolkapoon blokeerib ensüümi katehhool-O-metüültransferaasi, mis osaleb levodopa lagundamisel kehas.
English: In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Estonian: Parkinsoni tõvega patsientidel hakkavad neurotransmitterit (närvide virgatsainet) dopamiini tootvad rakud hävima ja dopamiini sisaldus ajus väheneb.
English: Tasmar treatment should only be prescribed and supervised by a doctor who has experience in the management of advanced Parkinson's disease.
Estonian: Tasmari ravi võib välja kirjutada ja jälgida üksnes kaugelearenenud Parkinsoni tõvega patsientide ravi kogemusega arst.
English: Fluctuations are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and immobile.
Estonian: Kõikumised on seotud levodopa toime vähenemisega, mille korral patsiendil hakkavad vahelduma seisundid, mil nad on võimelised liikuma (on-seisund), seisunditega, mil neil on liikumisega raskusi (off-seisund).
English: Tasmar must not be used in patients with:
Estonian: Tasmarit ei tohi kasutada patsiendid, kellel on järgmised haigused:
English: All of the studies compared Tasmar with placebo (a dummy treatment) when they were added to the patient's existing medication (levodopa and either carbidopa or benserazide).
Estonian: Kõikides uuringutes võrreldi Tasmarit platseeboga (näiv ravim) nende lisamisel patsiendi ravile (levodopa ja karbidopa või levodopa ja benserasiid).
English: The CHMP decided that Tasmar's benefits are greater than its risks in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors.
Estonian: Inimravimite komitee otsustas, et Tasmari kasulikkus selle kasutamisel koos levodopa/benserasiidi või levodopa/karbidopaga patsientidel, kelle idiopaatiline Parkinsoni tõbi ja seisundite vaheldumine allub levodopa ravile, kuid kellel ei teki teistele katehhool-O-metüültransferaasi inhibiitoritele ravivastust või kellele need ravimid ei sobi, on suurem kui Tasmariga kaasnevad riskid.
English: How does Tasmar work?
Estonian: Kuidas Tasmar toimib?
English: The main measure of effectiveness was how long the patients spent in the ‘off' or in the ‘on' state.
Estonian: Ravi efektiivsuse põhinäitaja oli patsiendi off- või on-seisundi kestus.
English: There was a reduction of about 20 to 30% in ‘off' time in patients taking Tasmar.
Estonian: Tasmarit saanud patsientidel vähenes off-seisund 20-30% võrra.
English: What is Tasmar used for?
Estonian: Milleks Tasmarit kasutatakse?
English: How is Tasmar used?
Estonian: Kuidas Tasmarit kasutatakse?
English: What benefit has Tasmar shown during the studies?
Estonian: Milles seisneb uuringute põhjal Tasmari kasulikkus?
English: How has Tasmar been studied?
Estonian: Kuidas Tasmarit uuriti?
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) will provide physicians who are expected to prescribe/use Leflunomide medac with a physician educational pack containing the following:
Estonian: Liikmesriigid peavad tagama, et müügiloa hoidja (MLH) varustab kõik arstid, kes oodatavalt kirjutavad välja/kasutavad Leflunomide medac'it, hariva materjali paketiga arstide jaoks, mis sisaldab järgnevat:
English: The Physician Leaflet should contain the following key messages:
Estonian: Infoleht arstile peab sisaldama järgnevaid olulise tähtusega sõnumeid:
English: • That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
Estonian: On oht tõsise maksakahjustuse tekkeks, mistõttu on oluline regulaarselt mõõta ALAT (SGPT) taset, et jälgida maksafunktsiooni.
English: • That there is a risk of teratogenicity and so pregnancy must be avoided until leflunomide plasma levels are at an appropriate level.
Estonian: Eksisteerib teratogeensuse oht ja seetõttu tuleb rasedust vältida kuni leflunomiidi sisaldus vereplasmas langeb kohase tasemeni.
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
Estonian: Teadaolev sünergistliku hepato- või hematotoksilisuse oht seoses kombinatsioonraviga teise haigust modifitseeriva antireumaatilise ravimiga (nt metotreksaat).
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing
Estonian: Arste ja patsiente tuleb teavitada erakorralise nõustamisteenuse olemasolust, et anda teavet leflunomiidi taseme laboratoorse määramise kohta vereplasmas.
English: • The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Estonian: Vajadus nõustada patsiente leflunomiidraviga seotud oluliste ohtude ning asjakohaste ettevaatusabinõude kohta ravimi kasutamisel.
English: • The risk of infections, including opportunistic infections, and the contraindication for use in immuno-compromised patients.
Estonian: Infektsioonide oht, sealhulgas oportunistlikud infektsioonid ja kasutamise vastunäidustus immuunpuudulikkusega patsientidel.
English: • The Summary of Product Characteristics • Physician Leaflet
Estonian: ravimi omaduste kokkuvõte infoleht arstile
English: To avoid adverse reactions:
Estonian: Nende reaktsioonide vältimiseks:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Estonian: Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt http://www.ema.europa.eu/.
English: Date of latest renewal: 14/12/2016.
Estonian: Viimase uuendamise kuupäev: 14.12.2016.
English: Used pipettes should be disposed of immediately.
Estonian: Kasutatud pipetid tuleb koheselt hävitada.
English: Do not eat, drink or smoke while handling the veterinary medicinal product.
Estonian: Mitte süüa, juua ega suitsetada veterinaarravimiga töötamise ajal.
English: • as the veterinary medicinal product may cause moderate eye irritation, avoid contact with eyes.
Estonian: • kuna veterinaarravim võib põhjustada mõõdukat silmade ärritust, siis vältida kontakti silmadega.
English: 1 pipette 4 pipettes 6 pipettes
Estonian: 1 pipett 4 pipetti 6 pipetti
English: A proper treatment of the pet´s environment by additional chemical or physical measures is recommended.
Estonian: Soovitatav on lemmiklooma keskkonna korralik töötlemine täiendavate keemiliste või füüsikaliste meetmetega.
English: This product is highly flammable.
Estonian: See preparaat on väga tuleohtlik.
English: Date of first authorisation: 09/01/2012.
Estonian: Esmase müügiloa väljastamise kuupäev: 09.01.2012.
English: If this occurs, rinse slowly and gently with water.
Estonian: Kontakti korral loputada aeglaselt ja õrnalt veega.
English: 0.5 Minimum of 15 Minimum of 48
Estonian: 0,5 Minimaalselt 15 Minimaalselt 48
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Toimeained:
English: A dry white residue may also be observed.
Estonian: Täheldada võib ka kuiva valget sadet.
English: See section 6.6
Estonian: Vaadake lõik 6.6.
English: Open one sachet and remove the pipette.
Estonian: Avada üks kotike ja eemaldada pipett.
English: The appropriate combination of pipettes should be used
Estonian: Kasutada tuleb sobivat pipettide kombinatsiooni
English: Recovery occurs normally within 24-36 hours after treatment.
Estonian: Taastumine toimub tavaliselt 24-36 tunni jooksul pärast ravi.
English: 10 DATE OF REVISION OF THE TEXT
Estonian: TEKSTI LÄBIVAATAMISE KUUPÄEV
English: In case of frequent shampooing, the duration of activity may be reduced.
Estonian: Sagedase šampooniga pesemise korral võib toime kestvus lüheneda.
English: However, dogs should not be allowed to swim or be shampooed within 48 hours after treatment.
Estonian: Siiski ei tohiks koeri lubada ujuma või pesta neid šampooniga 48 tunni jooksul pärast ravi.
English: These changes do not affect the safety or efficacy of the veterinary medicinal product.
Estonian: Need muutused ei avalda mõju veterinaarravimi ohutusele ega toimele.
English: ATCvet code: QP53AC54.
Estonian: ATCvet kood: QP53AC54
English: Ticks already attached on the dog may not be killed within two days after treatment and may remain attached and visible.
Estonian: Koera külge juba kinnitunud puugid ei pruugi surra kahe päeva jooksul pärast ravi ja võivad püsida kinnitunud ja nähtavad.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Estonian: MÜÜGI, TARNIMISE JA/VÕI KASUTAMISE KEELD
English: This is normal and will generally resolve within a couple of days after administration.
Estonian: See on normaalne ja tavaliselt kaob mõne päeva jooksul pärast manustamist.
English: Activyl Tick Plus should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Estonian: Activyl Tick Plus ei tohi sattuda veekogudesse, sest on ohtlik kaladele ja teistele veeorganismidele.
English: These signs are usually transient and generally resolve within 24 - 48 hours.
Estonian: Need nähud on tavaliselt pöörduvad ja kaovad enamasti 24-48 tunni jooksul.
English: • on the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children;
Estonian: • ravimise päeval ei tohi lapsed ravitud loomi katsuda ning loomadel ei tohi lubada magada omanikega, eriti lastega, samas voodis;
English: For this reason the transmission of infectious diseases by ticks cannot be excluded.
Estonian: Sellepärast ei saa välistada nakkushaiguste edasikandumist puukidega.
English: In case of exposure of this type seek veterinary advice immediately.
Estonian: Sellist laadi kokkupuute korral pöörduda viivitamatult loomaarsti poole.
English: Keep away from heat, sparks, open flame or other sources of ignition.
Estonian: Hoida eemal kuumusest, sädemetest, lahtisest leegist ja teistest tuleallikatest.
English: Pentobarbital, phenobarbital or propofol might be indicated if repeated occasions of cramp/tremors occur.
Estonian: Pentobarbitaal, fenobarbitaal või propofool võivad olla näidustatud korduvate krampide/värinate korral.
English: It is important to ensure that the product is applied to an area where the dog cannot lick it off, and to ensure that other animals do not lick the treatment sites following application.
Estonian: Tähtis on tagada ravimi manustamine piirkonda, kust koer ei saa seda ära lakkuda, ja tagada, et teised loomad ei lakuks manustamiskohti pärast manustamist.
English: Do not administer orally or via any other route.
Estonian: Mitte manustada suukaudselt või ühelgi teisel viisil.
English: Intervet Productions SA Rue de Lyons 27460 Igoville France
Estonian: Intervet Productions SA Rue de Lyons 27460 Igoville Prantsusmaa
English: The veterinary product should not enter water courses.
Estonian: Veterinaarravimit ei tohi lasta sattuda veekogudesse.
English: However, potential transmission of infectious disease by sand flies cannot be excluded if conditions are unfavourable.
Estonian: Siiski ei saa välistada nakkushaiguste võimalikku moskiitodega edasikandumist, kui tingimused on ebasoodsad.