FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Refacto AF have been included in the summary of product characteristics and the package leaflet.
Estonian: ReFacto AFi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Patients may also develop antibodies against factor VIII medicines such as Refacto AF.
Estonian: Patsientidel võivad tekkida ka VIII faktorit sisaldavate ravimite vastased antikehad.
English: ReFacto AF was first authorised as ReFacto in April 1999, for use in previously treated and untreated patients with haemophilia A, based on the results of three main studies.
Estonian: ReFacto AF sai esmalt müügiloa aprillis 1999 ravimina ReFacto, mis oli ette nähtud varem ravitud või ravimata A-hemofiiliaga patsientide raviks, tuginedes kolme põhiuuringu tulemustele.
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems, such as bleeding in the joints, muscles and internal organs.
Estonian: A-hemofiiliaga patsientidel ei ole piisavalt VIII hüübimisfaktorit, mis on vere normaalseks hüübimiseks vajalik valk, ning seetõttu tekivad neil kergesti verejooksud ja neil võivad esineda sellised probleemid nagu liigeste, lihaste ja siseelundite verejooks.
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 ReFacto AF.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: It is available as vials or pre-filled syringes.
Estonian: Seda turustatakse kas viaalides või eeltäidetud süstaldes.
English: The human coagulation factor VIII in ReFacto AF is not extracted from human blood but is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.
Estonian: Inimese VIII hüübimisfaktorit ReFacto AFis ei eraldata inimverest, vaid valmistatakse rekombinantDNA-tehnika abil: seda tekitab rakk, millele on lisatud VIII inimhüübimisfaktori teket võimaldav geen (DNA).
English: The active substance in ReFacto AF, moroctocog alfa, works in the body in the same way as human factor VIII.
Estonian: ReFacto AFi toimeaine alfamoroktokog toimib organismis samamoodi nagu inimese VIII hüübimisfaktor.
English: These are known as inhibitors as they can prevent the medicine from working effectively, which may result in a loss of bleeding control.
Estonian: Neid nimetatakse inhibiitoriteks, sest nad pärsivad ravimi toimet, nii et see ei peata enam verejookse.
English: Other information about ReFacto AF
Estonian: Muu teave ReFacto AFi kohta
English: This is a summary of the European public assessment report (EPAR) for ReFacto AF.
Estonian: See on ravimi ReFacto AF Euroopa avaliku hindamisaruande kokkuvõte.
English: Why has ReFacto AF been approved?
Estonian: Miks ReFacto AF heaks kiideti?
English: The name of the medicine was also changed from ReFacto to ReFacto AF.
Estonian: Lisaks muudeti ravimi nimetus ReFactost ReFacto AFiks.
English: What is the risk associated with ReFacto AF?
Estonian: Mis riskid ReFacto AFiga kaasnevad?
English: The CHMP noted that ReFacto AF was comparable to ReFacto, the original form of the medicine.
Estonian: Inimravimite komitee märkis, et ReFacto AF on võrreldav esialgse ravimiga ReFacto.
English: ReFacto AF contains the active substance moroctocog alfa.
Estonian: ReFacto AF sisaldab toimeainena alfamoroktokogi.
English: ReFacto AF must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to any of the other ingredients or to hamster proteins.
Estonian: ReFacto AFi ei tohi kasutada patsiendid, kes on inimese VIII hüübimisfaktori, mis tahes muu koostisaine või hamstriproteiinide suhtes ülitundlikud (allergilised).
English: The studies showed that ReFacto AF was as safe and effective as ReFacto in preventing and treating bleeding episodes in patients with haemophilia A.
Estonian: Uuringud tõendasid, et ReFacto AF on A-hemofiiliaga patsientidel verejooksude ennetamisel ja ravimisel sama ohutu ja efektiivne kui ReFacto.
English: Full details on how to calculate the dose are included in the summary of product characteristics (also part of the EPAR).
Estonian: Annuste arvutamise üksikasjad on ravimi omaduste kokkuvõttes (mis on samuti Euroopa avaliku hindamisaruande osa).
English: ReFacto AF is given by injection into a vein over several minutes.
Estonian: ReFacto AFi manustatakse mitu minutit kestva veenisüstega.
English: What is ReFacto AF?
Estonian: Mis on ReFacto AF?
English: What benefit has ReFacto AF shown during the studies?
Estonian: Milles seisneb uuringute põhjal ReFacto kasulikkus?
English: For the full list of all side effects reported with ReFacto AF, see the package leaflet.
Estonian: ReFacto AFi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder).
Estonian: ReFacto AFi kasutatakse A-hemofiiliaga (teatud pärilik hüübimishäire) patsientidel verejooksude ravimiseks ja ennetamiseks.
English: ReFacto AF should be started under the supervision of a doctor who has experience in the treatment of haemophilia A.
Estonian: Ravi ReFacto AFiga peab alustama üksnes A-hemofiilia ravis kogenud arst.
English: ReFacto AF is a powder and solvent used to make up a solution for injection.
Estonian: ReFacto AF on pulber ja lahusti, millest segatakse kokku süstelahus.
English: In February 2009, a number of changes to the way ReFacto is made were introduced.
Estonian: Veebruaris 2009 muudeti ReFacto tootmisviisi, näiteks jäeti tootmisprotsessist välja inimverest valmistatud valk albumiin.
English: The medicine can only be obtained with a prescription.
Estonian: ReFacto AF on retseptiravim.
English: Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
Estonian: Kui patsient või hooldaja on saanud asjakohase väljaõppe, tohib ta ReFacto AFi süstida ka ise.
English: How has ReFacto AF been studied?
Estonian: Kuidas ReFacto AFi uuriti?
English: How is ReFacto AF used?
Estonian: Kuidas ReFacto AFi kasutatakse?
English: What is ReFacto AF used for?
Estonian: Milleks ReFacto AFi kasutatakse?
English: How does ReFacto AF work?
Estonian: Kuidas ReFacto AF toimib?
English: (Invented) name Strength Pharmaceutical Form
Estonian: Tugevus Ravimvorm Manustamisviis Sisepakendi iseloomustus
English: This authorisation was based on the authorisation granted to Procoralan in 2005 (‘informed consent').
Estonian: Müügiluba põhineb 2005. aastal antud Procoralani müügiloal (teabel põhinev nõusolek).
English: Further information on Ivabradine Anpharm can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
Estonian: Lisateave Ivabradine Anpharmi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
English: Ivabradine Anpharm received a marketing authorisation valid throughout the EU on 8 September 2015.
Estonian: Ivabradine Anpharm on saanud müügiloa, mis kehtib kogu ELis, 8. septembril 2015.
English: Ivabradine Anpharm must not be taken with a number of other medicines.
Estonian: Ivabradine Anpharmi ei tohi kasutada koos teatavate teiste ravimitega.
English: Ivabradine Anpharm is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Estonian: Ivabradine Anpharmi turustatakse tablettidena (5 ja 7,5 mg) ja see on retseptiravim.
English: What measures are being taken to ensure the safe and effective use of Ivabradine Anpharm?
Estonian: Mis meetmed võetakse, et tagada Ivabradine Anpharmi ohutu ja efektiivne kasutamine?
English: The medicine is used in patients who have a normal heart rhythm and whose heart rate is at least 70 beats per minute.
Estonian: Ravimit kasutatakse patsientidel, kellel on normaalne südamerütm ja südame löögisagedus on vähemalt 70 lööki minutis.
English: The Agency decided that Ivabradine Anpharm's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Ivabradine Anpharmi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Anpharm have been included in the summary of product characteristics and the package leaflet.
Estonian: Ivabradine Anpharmi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: For more information about using Ivabradine Anpharm, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Ivabradine Anpharmi kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Ivabradine Anpharm (ivabradine)
Estonian: Ivabradine Anpharm (ivabradiin)
English: However, a fifth study in 728 patients showed that adding Ivabradine Anpharm to amlodipine did not provide an additional benefit.
Estonian: Seevastu viiendas uuringus, milles osales 728 patsienti, ei suurendanud Ivabradine Anpharmi lisamine amlodipiinile ravi kasulikkust.
English: Ivabradine Anpharm must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Estonian: Ivabradine Anpharmi ei tohi kasutada patsiendid, kelle südame löögisagedus on puhkeolekus alla 70 löögi minutis, kellel on väga madal vererõhk, mitmesugused südamehäired (sh kardiogeenne šokk, rütmihäired, südameinfarkt, ebastabiilne või äge (äkiline) südamepuudulikkus ja ebastabiilne stenokardia) või rasked maksaprobleemid.
English: As for all medicines, data on the use of Ivabradine Anpharm are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Ivabradine Anpharmi kasutamise kohta pidevat järelevalvet.
English: Ivabradine Anpharm is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Estonian: Ivabradine Anpharmi kasutatakse ka pikaajalise südamepuudulikkusega (süda ei suuda pumbata organismi piisaval hulgal verd) patsientidel, kellel on normaalne südamerütm ja südame löögisagedus on vähemalt 75 lööki minutis.
English: The European Medicines Agency concluded that Ivabradine Anpharm was shown to be effective in longterm angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them.
Estonian: Euroopa Ravimiamet järeldas, et Ivabradine Anpharm on pikaajalise stenokardia ravis efektiivne ning selle ohutusprofiil on vastuvõetav kasutamiseks alternatiivse ravimina patsientidel, kelle haigus ei allu ravile beetablokaatoritega või kes ei saa neid kasutada.
English: What is Ivabradine Anpharm and what is it used for?
Estonian: Mis on Ivabradine Anpharm ja milleks seda kasutatakse?
English: It also concluded that Ivabradine Anpharm was effective in long-term heart failure with an acceptable safety profile.
Estonian: Amet järeldas ka, et Ivabradine Anpharm on efektiivne pikaajalise südamepuudulikkuse ravis ja selle ohutusprofiil on vastuvõetav.
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Ivabradine Anpharm compared with placebo (3.4% vs 2.9% yearly incidence rates).
Estonian: Selles uuringus täheldati teatavas sümptomaatilise stenokardiaga patsientide alagrupis Ivabradine Anpharmi puhul väikest, aga olulist kardiovaskulaarse surma või mittefataalse südameinfarkti riski suurenemist võrreldes platseeboga (aastane esinemuse määr 3,4% vs 2,9%).
English: By lowering the heart rate, Ivabradine Anpharm reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Estonian: Südame löögisagedust aeglustades vähendab Ivabradine Anpharm südame koormust, pidurdades südamepuudulikkuse kulgu ja leevendades sümptomeid.
English: Results showed that it was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Ivabradine Anpharm died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Estonian: Ivabradine Anpharm ennetas kardiovaskulaarset surma või haiglaravi progresseerunud südamepuudulikkuse tõttu efektiivsemalt kui platseebo: patsiente, kes surid või said haiglaravi progresseerunud südamepuudulikkuse tõttu, oli Ivabradine Anpharmiga ravitud patsientidest 24,5% (793 patsienti 3241st) ja platseebot kasutanud patsientidest 28,7% (937 patsienti 3264st).
English: The most common side effect with Ivabradine Anpharm (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Estonian: Ivabradine Anpharmi kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on helendav nägemisfenomen (fosfeenid, nägemisvälja mööduv helendus).
English: Ivabradine Anpharm is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).
Estonian: Ivabradine Anpharm on südameravim, mida kasutatakse pikaajalise stabiilse stenokardia (füüsilise pingutuse tagajärjel tekkiv rindkere-, lõua- ja seljavalu) sümptomaatiliseks raviks südame isheemiatõvega (südamelihast verega varustavate veresoonte ummistusest põhjustatud haigus) täiskasvanutel.
English: Ivabradine Anpharm was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Estonian: Ivabradine Anpharmi võrreldi platseeboga ühes põhiuuringus, milles osales enam kui 6500 mõõduka või raske pikaajalise südamepuudulikkusega patsienti.
English: In a fourth study in 889 patients, Ivabradine Anpharm was more effective than placebo when both were added to atenolol.
Estonian: Neljandas uuringus, milles osales 889 patsienti, oli atenoloolile lisatud Ivabradine Anpharm efektiivsem kui atenoloolile lisatud platseebo.
English: A sixth study compared Ivabradine Anpharm with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Estonian: Kuuendas uuringus võrreldi Ivabradine Anpharmi platseeboga 19 102 patsiendil, kellel oli südame isheemiatõbi, aga ei olnud kliinilist südamepuudulikkust.
English: Side effects reported with this medicine are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ivabradine Anpharmi kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Other information about Ivabradine Anpharm
Estonian: Muu teave Ivabradine Anpharmi kohta
English: Ivabradine Anpharm contains the active substance ivabradine.
Estonian: Ivabradine Anpharm sisaldab toimeainena ivabradiini.
English: Ivabradine Anpharm was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Estonian: Ivabradine Anpharmi võrreldi platseeboga (näiv ravim) ja teiste ravimitega viies põhiuuringus, milles osales enam kui 4000 pikaajalise stabiilse stenokardiaga täiskasvanut.
English: Ivabradine Anpharm therefore reduces or prevents the symptoms of angina.
Estonian: Sellega vähendab Ivabradine Anpharm stenokardiasümptomeid või ennetab neid.
English: What are the risks associated with Ivabradine Anpharm?
Estonian: Mis riskid Ivabradine Anpharmiga kaasnevad?
English: An overview of Ivabradine Anpharm and why it is authorised in the EU
Estonian: Ülevaade ravimist Ivabradine Anpharm ja ELis müügiloa väljastamise põhjendus
English: How is Ivabradine Anpharm used?
Estonian: Kuidas Ivabradine Anpharmi kasutatakse?
English: It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
Estonian: Uuringus, milles osales 939 patsienti, oli Ivabradine Anpharm sama efektiivne kui atenolool (beetablokaator), ning teises uuringus (1195 patsienti) oli see sama efektiivne kui amlodipiin (samuti stenokardiaravim).
English: The active substance in Ivabradine Anpharm, ivabradine, works by blocking the ‘If currents' in the sinus node, the natural ‘pacemaker' that controls the heart's contractions and regulates the heart rate.
Estonian: Ivabradine Anpharmi toimeaine ivabradiin blokeerib siinussõlmes (südame kokkutõmbeid juhtiv ja löögisagedust reguleeriv südamepiirkond ehk loomulik rütmur) tekkiva nn If-voolu.
English: It must not be used in women who are pregnant, breastfeeding or by women who could become pregnant and who are not using appropriate contraceptives.
Estonian: Ivabradine Anpharmi ei tohi kasutada raseduse ega imetamise ajal; samuti ei tohi ravimit kasutada fertiilses eas naised, kes ei kasuta efektiivseid rasestumisvastaseid vahendeid.
English: For the full list of restrictions with Ivabradine Anpharm, see the package leaflet.
Estonian: Ivabradine Anpharmi kohta teatatud piirangute täielik loetelu on pakendi infolehel.
English: For the full list of all side effects reported with Ivabradine Anpharm, see the package leaflet.
Estonian: Ivabradine Anpharmi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What benefits of Ivabradine Anpharm have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Ivabradine Anpharmi kasulikkus?
English: Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
Estonian: Sage kõrvalnäht (võib esineda kuni 1 patsiendil 10st) on bradükardia (aeglane südame löögisagedus).
English: ATCvet code: QI01AD07.
Estonian: ATCvet kood: QI07AD07
English: After reconstitution the suspension looks clear.
Estonian: Pärast manustamiskõlblikuks muutmist on suspensioon selge.
English: Each container should be used immediately and completely after opening.
Estonian: Iga pakendi sisu tuleb pärast avamist kasutada kohe ja täielikult.
English: Simultaneous use of both vaccines increases the risk of recombination of viruses and potential emergence of new variants.
Estonian: Mõlema vaktsiini samaaegne kasutamine suurendab viiruste rekombinatsiooni ja uute variantide võimaliku tekkimise riski.
English: Date of first authorisation: 09/06/1998.
Estonian: Esmase müügiloa väljastamise kuupäev: 09/06/1998.
English: Live IBV, 4-91
Estonian: Elus IBV, 4-91.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Estonian: Vastavalt Euroopa Parlamendi ja nõukogu direktiivi nr 2001/82/EÜ artiklile 71 võivad liikmesriigid kooskõlas siseriiklike õigusaktidega keelustada immunoloogilise veterinaarravimi tootmise, impordi, omamise, müügi, tarnimise ja/või kasutamise oma territooriumil või osal oma territooriumist, kui on tuvastatud, et:
English: The length of time of water deprivation is strongly dependent on the climatological circumstances.
Estonian: Veevõtu piiramise pikkus sõltub kliimatingimustest.
English: Date of last renewal: 21/05/2008.
Estonian: Müügiloa viimase uuendamise kuupäev: 21/05/2008.
English: Sorbitol
Estonian: Sorbitool,
English: Feed should be available when vaccinating.
Estonian: Sööt peaks vaktsineerimise ajal olema kättesaadav.
English: The safety parameters of the mixed vaccines are not different from those described for the vaccines administered separately.
Estonian: Segatud vaktsiinide ohutuse näitajad ei erine nendest, mida on kirjeldatud vaktsiinide eraldi manustamisel.
English: Water withholding should be kept as short as possible with a minimum of half an hour.
Estonian: Joogivee piiramine olgu nii lühike kui võimalik, kuid minimaalselt 30 minutit.
English: In laboratory studies and field trials:
Estonian: Laboratoorsetel ja väliuuringutel:
English: Chickens should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local IB vaccination programme.
Estonian: Kanad tuleb vaktsineerida teiste levinud IBV serotüüpide (näiteks Massachusetts) vastu kohaliku IB vaktsineerimisprogrammi järgi.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of spray administration, personal protective equipment consisting of masks with eye protection should be worn when handling the veterinary medicinal product.
Estonian: Ettevaatusabinõud veterinaarravimit loomale manustavale isikule Pihustamismeetodil manustamise korral tuleb veterinaarravimi käsitsemisel kanda isiklikke kaitsevahendeid, mis koosnevad silmi kaitsvast maskist.
English: For prolonged immunity, chickens should be revaccinated every 6 weeks after the initial administration.
Estonian: Pikema immuunsuse saavutamiseks tuleb tibud revaktsineerida iga 6 nädala järel pärast esmakordset vaktsineerimist.
English: Do not mix with any other veterinary medicinal product, except Nobilis IB Ma5 recommended for use with the veterinary medicinal product.
Estonian: Mitte segada teiste veterinaarravimitega, välja arvatud Nobilis IB Ma5-ga, mis on soovitatud kasutamiseks koos selle veterinaarravimiga.
English: In case of the latter presentation the cups may contain 3 up to 100 spheres depending on the required dosages and production yields.
Estonian: Viimasel juhul võivad topsid sisaldada 3…10 kera sõltuvalt vajalikust annusest ja toodangu tulemusest.
English: The same volumes as for the single product should be used.
Estonian: Kasutama peab samu koguseid nagu üksikute preparaatide korral.
English: However, the chance of a hazard occurring has been estimated very low and is minimized by routinely vaccinating all chickens on the premise at the same time and cleaning and disinfection after each production round.
Estonian: Siiski hinnatakse ohu esinemise tõenäosust väga väikeseks ja selle muudab minimaalseks kõikide kanalas olevate kanade samaaegne vaktsineerimine ning kanala puhastamine ja desinfitseerimine pärast igat tootmisrotatsiooni.
English: Each dose of reconstituted vaccine contains:
Estonian: Üks annus manustamiskõlblikuks muudetud vaktsiini sisaldab:
English: In case of the product presented in cups, do not use the product if the contents are brownish and stick to the container as this indicates that the integrity of the container has been breached.
Estonian: Mõõtetopside korral mitte kasutada ravimit, kui topsi sisu on pruunikas ja kleepub pakendi külge, sest see näitab, et pakendi terviklikkust on rikutud.
English: One drop should be applied onto one nostril or one eye.
Estonian: Manustada üks tilk ninaavasse või silma.