FrancophonIA/ELRC3.0 huggingface dataset:
English: Gently mix and re-suspend the contents of the bag, inspecting for particles, clumps or clots.
Estonian: Koti sisu tuleb õrnalt segada ja uuesti suspendeerida, seda osakeste, tükkide ja trombide osas kontrollides.
English: To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Estonian: Sellega tuleb arvestada nõrgenenud neerufunktsiooni või kontrollitud kaaliumisisaldusega dieedil olevate patsientide puhul.
English: In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the Provenge group.
Estonian: Kontrollitud kliinilistes uuringutes kujunes 3,5% Provenge ravirühma patsientidest välja tõsine (3. aste) infusioonireaktsioon.
English: You will receive a total of 3 infusions of Provenge at approximately 2 week intervals.
Estonian: Provenge-ravi koosneb 3 infusioonist, mida manustatakse umbes 2-nädalaste intervallidega.
English: Hyperhidrosis Pruritus Urticaria
Estonian: Naha ja nahaaluskoe kahjustused lööve hüperhidroos sügelus nõgestõbi
English: • The disposition form verifying the product has been APPROVED has been provided
Estonian: • Ravimi HEAKSKIIDETUD vastuvõtu ja lugemise kinnitus on kätte saadud.
English: Eosinophilia
Estonian: Aeg-ajalt eosinofiilia
English: In controlled clinical trials, 23.8% of patients treated with Provenge required opioids (a single dose of pethidine) on the day of infusion for infusion reactions (see sections 4.4 and 4.8).
Estonian: Kontrollitud kliinilistes uuringutes vajas 23,8% Provengega ravitud patsientidest infusioonipäeval infusioonireaktsioonide leevendamiseks opioide (ühekordne annus petidiini) (vt lõigud 4.4 ja 4.8).
English: IgG) responses against both PAP-GM-CSF and the PAP antigens were observed in the Provenge group through the follow up period.
Estonian: Provenge ravirühmas täheldati kogu järelkontrolli jooksul antikeha (IgM ja IgG) vastuseid nii PAP-GM-CSF-ile, kui PAP-antigeenidele.
English: Patients with renal impairment and/or hyperkalaemia and/or on a controlled potassium diet Provenge has not been investigated in patients with renal impairment.
Estonian: Neerufunktsiooni kahjustuse ja/või hüperkaleemia ja/või kontrollitud kaaliumi sisaldusega dieedil olevad patsiendid
English: In controlled clinical trials, 23.8% of patients treated with Provenge required opioids (a single dose of pethidine) on the day of infusion for infusion reactions (see sections 4.2 and 4.8).
Estonian: Kontrollitud kliinilistes uuringutes vajas 23,8% Provengega ravitud patsientidest infusioonipäeval infusioonireaktsioonide leevendamiseks opioide (ühekordne annus petidiini) (vt lõigud 4.2 ja 4.8).
English: The effects of Provenge on male fertility are not known at this time.
Estonian: Provenge toimest meeste viljakusele hetkel andmeid ei ole.
English: It is important that you read the entire content of this procedure prior to administering Provenge.
Estonian: Enne Provenge manustamist tuleb kogu protseduuri kirjeldus kindlasti läbi lugeda.
English: Tel: (0)20 7554 2222
Estonian: 0,775a (0,614; 0,979)
English: Before infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the Provenge bag and on the Final Product Disposition Notification form.
Estonian: Enne infundeerimist tuleb veenduda, et patsiendi isik vastab Provenge infusioonikotil ja lõplikul ravimi vastuvõtu ja lugemise kinnitusel olevale unikaalsele patsienditeabele.
English: Driving and using machines You may feel tired, faint, or dizzy or have a headache or chills after receiving your Provenge infusion.
Estonian: Te võite end pärast Provenge infundeerimist tunda väsinuna ja nõrgana ning teil võib esineda peapööritust, peavalu või külmavärinaid.
English: To mitigate such reactions, premedication, consisting of paracetamol and an antihistamine was administered in clinical studies prior to infusion.
Estonian: Kliinilistes uuringutes manustati patsientidele nende reaktsioonide leevendamiseks infundeerimiseelselt paratsetamooli ja antihistamiinikumi.
English: • Upon completion of the infusion, the patient specific label on the infusion bag should be removed and adhered to the patient file.
Estonian: Pärast infundeerimist • Infundeerimise lõpetamisel tuleb patsiendispetsiifiline etikett infusioonikotilt eemaldada ja
English: Patients with hepatic impairment
Estonian: Neerufunktsiooni kahjustusega patsiendid
English: NAME OF THE MEDICINAL PRODUCT PROVENGE 50 x 106 CD54+ cells/250 mL dispersion for infusion.
Estonian: RAVIMPREPARAADI NIMETUS PROVENGE 50 x 106 CD54+ rakku/250 ml infusioonidispersioon
English: Serious infections including sepsis have been observed in patients treated with Provenge.
Estonian: Provengega ravitud patsientidel on täheldatud tõsiste infektsioonide, sh sepsise esinemist.
English: The active substance is autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 x 106 autologous CD54+ cells.
Estonian: Toimeaine on autoloogsed, PAP-GM-CSF-ga (eesnäärme happeline fosfataas-granulotsüütide makrofaagide kolooniat stimuleeriv faktor) aktiveeritud perifeersed mononukleaarsed vererakud, sh vähemalt 50 x 106 autoloogset CD54+ rakku.
English: To be taken into consideration by patients with heart conditions or those on a controlled sodium diet.
Estonian: Sellega tuleb arvestada südamehaigustega või kontrollitud naatriumisisaldusega dieedil olevate patsientide puhul;
English: Potassium chloride Calcium chloride.
Estonian: Naatriumkloriid, naatriumlaktaat, kaaliumkloriid, kaltsiumkloriid.
English: Due dates
Estonian: Kuupäev
English: • It must be ensured that the patient's identity matches the essential unique patient information on the Provenge bag and the Final Product Disposition Notification form.
Estonian: • Enne infundeerimist tuleb veenduda, et patsiendi isik vastab Provenge infusioonikotil ja lõplikul ravimi vastuvõtu ja lugemise kinnitusel olevale unikaalsele patsienditeabele.
English: Interim data submitted in each PSUR Final study report by 31 December 2018
Estonian: Uuringuplaan tuleb esitada koos esimese perioodilise ohutusaruandega Vaheandmed tuleb esitada koos iga järgmise perioodilise ohutusaruandega Lõplik uuringuraport tuleb esitada 31. detsembriks 2018
English: Dizziness
Estonian: Insult
English: The entire volume of the infusion bag should be used.
Estonian: Infundeerida tuleb kogu infusioonikoti sisu.
English: Stroke
Estonian: Annustamine
English: One bag contains autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 x 106 autologous CD54+ cells
Estonian: Üks kott sisaldab autoloogseid, PAP-GM-CSF-ga (eesnäärme happeline fosfataas-granulotsüütide makrofaagide kolooniat stimuleeriv faktor) aktiveeritud perifeerseid mononukleaarseid vererakke, sh vähemalt 50 x 106 autoloogset CD54+ rakku.
English: Respiratory, thoracic, and mediastinal disorders
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired hüpoksia vilistav hingamine düspnea bronhospasm
English: Vomiting Nausea
Estonian: Seedetrakti häired oksendamine iiveldus kõhuvalu
English: Patients should be advised not to drive or use machines if they experience these symptoms following their infusion.
Estonian: Nimetatud sümptomite infundeerimisjärgsel ilmnemisel tuleb patsientidel soovitada autojuhtimist ja masinate käsitsemist vältida.
English: Very common
Estonian: Üldine elulemus
English: Musculoskeletal and connective tissue disorders
Estonian: Lihas-skeleti ja sidekoe kahjustused artralgia müalgia lihaskrambid*
English: One bag containins autologous peripheral blood mononuclear cells activated with PAP-GM-CSF, including a minimum of 50 x 106 autologous CD54+ cells.
Estonian: Üks kott sisaldab autoloogseid, PAP-GM-CSF-ga aktiveeritud perifeerseid mononukleaarseid vererakke, sh vähemalt 50 x 106 autoloogset CD54+ rakku..
English: To be taken into consideration by patients on a controlled sodium diet.
Estonian: Sellega tuleb arvestada kontrollitud naatriumi sisaldusega dieedil olevate patsientide puhul.
English: Provenge has not been investigated in patients with hepatic impairment.
Estonian: Neerufunktsiooni kahjustusega patsientidel ei ole Provenget uuritud.
English: Haematuria
Estonian: Vastunäidustused
English: - reduced sense of touch or sensation (hypoaesthesia) - collapse of one of the bones in the spine (spinal cord compression)
Estonian: - bakterid veres (baktereemia); - vähenenud puutetundlikkus (hüpoesteesia); - selgroolüli kollaps (spinaalkompressioon); - ebaregulaarne või kiire pulss;
English: Do not use Provenge
Estonian: Provenget ei tohi kasutada, kui
English: Blood and lymphatic system disorders
Estonian: Vere ja lümfisüsteemi häired Väga sage aneemia*
English: Healthcare professionals are asked to report any suspected adverse reactions.
Estonian: ▼ Käesoleva ravimi suhtes kohaldatakse täiendavat järelevalvet, mis võimaldab kiiresti tuvastada uut ohutusteavet.Tervishoiutöötajatel palutakse teavitada kõigist võimalikest kõrvaltoimetest.
English: The identity of the patient must be matched with the essential unique patient information on the infusion bag and the Final Product Disposition Notification form prior to infusion.
Estonian: Enne infundeerimist tuleb veenduda, et patsiendi isik vastab infusioonikotil ja lõplikul ravimi vastuvõtu ja lugemise kinnitusel olevale unikaalsele patsienditeabele.
English: Arthralgia Myalgia Muscle spasms*
Estonian: Väga sage tsitraadimürgistus*
English: Shelf life and special precautions for storage
Estonian: Kõlblikkusaeg ja säilitamise eritingimused
English: • Only one of the 2 spike ports should be used and should not be opened prior to administration in order to avoid contamination.
Estonian: Saastumise vältimiseks ei tohi seda enne manustamist avada.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Estonian: See aitab säilitada sidet patsiendi ja ravimipartii vahel.
English: EXPIRY DATE
Estonian: Ravi annus ja kulg
English: Cerebrovascular accident Transient ischaemic attack Tremor
Estonian: Sage gripisarnane haigus ebamugavustunne rindkeres
English: The study should provide a summary of baseline patient characteristics including PSA and
Estonian: Uuringus peavad olema välja toodud patsientide ravieelsed näitajad, sh PSA ja PSA kahekordistumise aeg; patsientide arv, kellel kujunevad välja metastaasid; metastaasi
English: The entire volume of the bag should be infused.
Estonian: Lisateave vt pakendi infoleht.
English: Sodium lactate
Estonian: Naatriumi- ja kaaliumisisaldus
English: Keep this leaflet.
Estonian: Mitte kiiritada.
English: Pharmaceutical Form Route of Administration
Estonian: TugevusRavimvorm Manustamistee Pakendi iseloomustus
English: It is available as tablets (375 mg).
Estonian: Seda turustatakse tablettidena (375 mg).
English: The full EPAR for Incivo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Incivo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe use of Incivo?
Estonian: Mis meetmed võetakse, et tagada Incivo kasutamise ohutus?
English: Alternatively, two Incivo tablets can be taken every eight hours with food.
Estonian: Teine võimalus on võtta iga 8 tunni järel koos toiduga kaks Incivo tabletti.
English: In addition, treatment could be shortened for many patients and the benefits could be seen across different patient types with different degrees of liver damage.
Estonian: Peale selle saab paljudel patsientidel ravi lühendada ja selle kasulikkust on näidatud maksakahjustuse mitmesuguse astmega patsiendirühmades.
English: The European Commission granted a marketing authorisation valid throughout the European Union
Estonian: Euroopa Komisjon andis Incivo müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. septembril
English: The CHMP considered that adding Incivo to standard treatment represents a major advance in treating the most common type of hepatitis C virus.
Estonian: Inimravimite komitee leidis, et Incivo lisamine standardravile on oluline edasiminek C-hepatiidi viiruse kõige sagedama tüübi ravis.
English: What is the risk associated with Incivo?
Estonian: Mis riskid Incivoga kaasnevad?
English: The company that markets Incivo will provide all doctors who are expected to prescribe it with an educational pack containing important safety information on the main risks with Incivo, in particular the risk of rash and severe skin reactions.
Estonian: Incivo turustaja annab kõigile ravimit määravatele arstidele teabepakme, milles on Incivo riskide, eriti lööbe ja raskete nahareaktsioonide tekkimise tähtis ohutusteave.
English: Three Incivo tablets should be swallowed whole twice a day with food for a period of 12 weeks.
Estonian: 12 nädala jooksul tuleb kaks korda ööpäevas neelata tervelt koos toiduga kolm Incivo tabletti.
English: Incivo must not be given in combination with several other medicines, including those which are affected by or affect the CYP3A gene and Class Ia or III antiarrhythmics.
Estonian: Incivot ei tohi kasutada koos mitme muu ravimiga, sealhulgas sellistega, mida mõjutab CYP3A-geen või mis mõjutavad CYP3A-geeni, ja koos Ia või III klassi arütmiaravimitega.
English: The Committee noted that in both previously untreated patients and patients who had already been treated, adding Incivo to standard treatment considerably increased the number showing no sign of infection after six months.
Estonian: Komitee märkis, et Incivo lisamine standardravile nii varem ravimata kui ka ravitud patsientidel suurendas oluliselt nende arvu, kellel pärast 6 kuud ei esinenud infektsiooni nähte.
English: Incivo is a medicine that contains the active substance telaprevir.
Estonian: Incivo on ravim, mis sisaldab toimeainena telapreviiri.
English: Incivo must not be used in patients who are hypersensitive (allergic) to telaprevir or any of the other ingredients.
Estonian: Incivot ei tohi kasutada patsiendid, kes on telapreviiri või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: The Committee noted that the main risks identified were severe rash and the possibility of the virus developing drug resistance, but considered that these risks were manageable.
Estonian: Komitee märkis, et peamised tuvastatud riskid olid raske lööve ja viiruse ravimresistentsuse tekke võimalus, kuid pidas neid riske talutavateks.
English: For more information about treatment with Incivo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Incivoga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: How does Incivo work?
Estonian: Kuidas Incivo toimib?
English: This is a summary of the European public assessment report (EPAR) for Incivo.
Estonian: See on ravimi Incivo Euroopa avaliku hindamisaruande kokkuvõte.
English: In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus six months after the end of
Estonian: Kõigis kolmes uuringus oli efektiivsuse põhinäitaja nende patsientide arv, kelle vereanalüüsiga ei leitud 6 kuud pärast ravi lõppu C-hepatiidi viirust.
English: When Incivo is added to peginterferon alfa and ribavirin (the current standard treatment for hepatitis C) this increases the likelihood of the virus being killed.
Estonian: Incivo lisamine alfapeginterferoonile ja ribaviriinile (praegune C-hepatiidi standardravi) suurendab viiruse hävitamise tõenäosust.
English: Treatment with ribavirin and peginterferon alfa will continue for a longer period, based on whether the patient has been treated before and test results during their Incivo treatment.
Estonian: Ravi ribaviriini ja alfapeginterferooniga jätkub pikema aja jooksul sõltuvalt analüüside tulemustest Incivoga toimuva ravi ajal ja sellest, kas patsienti on varem ravitud.
English: The CHMP therefore concluded that the benefits of Incivo were greater than its risks, and recommended it be granted marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Incivo kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: It is used in adults who have compensated liver disease (when the liver is damaged but is still functioning normally) including cirrhosis (scarring of the liver) either in previously untreated patients or in those who have already been treated with interferon alfa.
Estonian: Incivot kasutatakse kompenseeritud maksahaigusega (kui maks on kahjustatud, kuid talitleb normaalselt), sealhulgas tsirroosiga (maksa sidekoestumine) täiskasvanutel, kes ei ole varem ravi saanud või keda on juba ravitud alfainterferooniga.
English: The most common side effects with Incivo (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), nausea (feeling sick), diarrhoea, vomiting, haemorrhoids (piles), proctalgia (anal pain), pruritus (itching) and rash.
Estonian: Incivo kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on aneemia (erütrotsüütide vähesus), iiveldus, kõhulahtisus, oksendamine, hemorroidid, pärakuvalu, kihelus ja lööve.
English: How has Incivo been studied?
Estonian: Kuidas Incivot uuriti?
English: Incivo is used to treat chronic (long term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in combination with two other medicines, peginterferon alfa and ribavirin.
Estonian: Incivot kasutatakse kroonilise (pikaajalise) C-hepatiidi (C-hepatiidi viiruse infektsioonist tulenev maksahaigus) raviks kombinatsioonis kahe teise ravimi, alfapeginterferooni ja ribaviriiniga.
English: This stops the hepatitis C virus from replicating in the infected host cells of the body.
Estonian: See peatab C-hepatiidi viiruse paljunemise viirusega nakatunud organismi rakkudes.
English: Both studies compared Incivo with placebo (a dummy treatment) added to a course of peginterferon alfa and ribavirin.
Estonian: Mõlemas uuringus võrreldi Incivot platseeboga (näiv ravim), lisatuna alfapeginterferooni ja ribaviriini ravikuurile.
English: What benefit has Incivo shown during the studies?
Estonian: Milles seisneb uuringute põhjal Incivo kasulikkus?
English: The third study showed that in patients treated with Incivo, giving peginterferon alfa and ribavirin for six months was as effective as giving these medicines for one year, since 92% of patients receiving them for six months tested negative for hepatitis C compared with 88% of patients
Estonian: Kolmas uuring näitas, et Incivoga ravitud patsientidel oli alfapeginterferooni ja ribaviriini manustamine 6 kuu jooksul sama efektiivne kui nende ravimite manustamine 1 aasta vältel, sest patsiente, kelle Chepatiidi testi tulemus oli negatiivne, oli 6 kuud ravimeid saanute seas 92% ja 1 aasta ravimeid
English: A third study in previously untreated patients compared the effects of giving peginterferon alfa and ribavirin for different lengths of time (either six months or one year) together with three months of Incivo treatment.
Estonian: Kolmandas, varem ravimata patsientide uuringus võrreldi alfapeginterferooni ja ribaviriini eri manustamiskestuse (6 kuud või 1 aasta) toimet, kui neid manustati koos Incovoga, mida võeti 3 kuud.
English: Incivo was investigated in three main studies in patients infected with hepatitis C. The first study involved 1,095 previously untreated patients, and the second study involved 663 patients who had already been treated with peginterferon alfa and ribavirin but were still infected.
Estonian: Esimeses osales 1095 varem ravimata patsienti ja teises 663 patsienti, kes olid juba saanud ravi alfapeginterferooni ja ribaviriiniga, kuid kelle nakkus püsis.
English: It blocks the action of an enzyme called NS3-4A protease in the hepatitis C virus, which is essential for its life cycle.
Estonian: Incivo toimeaine telapreviir on proteaasiinhibiitor, mis blokeerib C-hepatiidi viiruse paljunemisel osaleva ensüümi NS3-4A proteaasi.
English: Treatment with Incivo should be started and monitored by a doctor experienced in managing chronic
Estonian: Ravi Incivoga peab alustama kroonilise C-hepatiidi ravis kogenud arst ja ravi peab toimuma tema
English: In the first study, when Incivo was given for three months, 75% of patients tested negative for hepatitis C compared with 44% of patients receiving placebo.
Estonian: Esimeses uuringus oli patsiente, kelle C-hepatiidi testi tulemus oli pärast 3 kuud kestnud ravi negatiivne, Incivo-rühmas 75% ja platseeborühmas 44%, teises uuringus vastavalt 88% ja 24%.
English: For the full list of all side effects reported with Incivo, see the
Estonian: Incivo kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The first European approval was in Sweden on 12 April 1996.
Estonian: Euroopas kiideti toimeaine esimest korda heaks Rootsis, 12. aprillil 1996.
English: The pregnancy section has been revised in line with the relevant guideline[7].
Estonian: Raseduse jaotis toimetati vastavalt kehtivatele suunistele[7].
English: Cancer Patients 2014, Chapter 15, pp.251-269.
Estonian: Renal Disease in Cancer Patients 2014, Chapter 15, pp.251-269.
English: Etopophos is currently approved in DE, FR, SE and UK.
Estonian: Etopophos on praegu heaks kiidetud järgmistes riikides: DE, FR, SE, UK.
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: As breastfeeding women could replace breastfeeding by dairy products to feed their child the text has been amended accordingly.
Estonian: Et imetavad naised saavad asendada lapse toitmisel rinnapiima piimatoodetega, on teksti ka vastavalt parandatud.
English: Paediatric indications were agreed in the following indications:
Estonian: Lepiti kokku järgmised pediaatrilised näidustused:
English: Etoposide is used for the treatment of various neoplastic diseases.
Estonian: Etoposiidi kasutatakse mitmesuguste neoplastiliste haiguste raviks.
English: The CHMP also noted that etoposide may decrease male fertility.
Estonian: Inimravimite komitee märkis ka, et etoposiid võib vähendada meeste viljakust.
English: - Small-cell lung cancer
Estonian: - Väikerakk-kopsuvähk
English: • The product information proposed by the Marketing Authorisation Holder has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Estonian: • müügiloa hoidja esitatud ravimiteabe hindamisel tugineti esitatud dokumentidele ja komitees toimunud teaduslikule arutelule,
English: • The scope of the referral was the harmonisation of the product information,
Estonian: • esildise kohaldamisala oli ravimiteabe ühtlustamine,
English: The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
Estonian: Järgmised erihoiatused ja ettevaatusabinõud on ühtlustatud lõigus 4.4, kus need sisaldusid juba enne mõnes riiklikus ravimi omaduste kokkuvõttes või enamikus neist: müelosuppressioon, sekundaarne leukeemia, ülitundlikkus, süstekoha reaktsioon, seerumi väike albumiinisisaldus, neeru- ja maksafunktsiooni puudulikkus, tuumorilüüsi sündroom ja mutageensuse potentsiaal.
English: - Gestational trophoblastic neoplasia
Estonian: - Rasedusaegne trofoblastiline neoplaasia