FrancophonIA/ELRC3.0 huggingface dataset:
English: For the suspension to be lifted, the MAH shall register a manufacturing site for the active substance, finished product and batch release (see Annex II).
Estonian: Peatamise lõpetamiseks registreerib müügiloa hoidja toimeaine ja lõpptoote tootmise ning ravimipartii kasutamiseks vabastamisega seotud tootmiskoha (vt II lisa).
English: ATC vet code: QI07AB01.
Estonian: ATCvet kood: QI07AB01.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/171/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/14/171/001
English: The mixed vaccines should be injected immediately via the subcutaneous route.
Estonian: Segatud vaktsiinid tuleb kohe subkutaanselt süstida.
English: * Antibody micro agglutination-lytic reaction.
Estonian: * antikeha mikroaglutinatsiooni-lüütiline reaktsioon.
English: Type I glass vial containing 1 ml closed with a chlorobutyl rubber stopper and aluminium cap.
Estonian: I tüüpi klaasviaal, mis sisaldab 1 ml ja on suletud klorobutüülkummist korgi ja alumiiniumkattega.
English: Pharmacotherapeutic group: Immunologicals for canidae, inactivated bacterial vaccines.
Estonian: Farmakoterapeutiline rühm: immunoloogilised ained koerlastele, inaktiveeritud baktervaktsiinid.
English: 10 DATE OF REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Estonian: 10 TEKSTI LÄBIVAATAMISE KUUPÄEV Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt http://www.ema.europa.eu/.
English: ADVICE ON CORRECT ADMINISTRATION Shake well and administer immediately the entire contents (1 ml) of the product.
Estonian: SOOVITUSED ÕIGE MANUSTAMISE OSAS Loksutage korralikult ja manustage kohe kogu viaali sisu (1 ml).
English: Plastic box containing 50 vials (1 ml).
Estonian: Plastkarp, milles on 50 viaali (1 ml).
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products except those mentioned in section 4.8.
Estonian: Sobivusuuringute puudumise tõttu ei tohi seda veterinaarravimit segada teiste veterinaarravimitega, välja arvatud need, mida on mainitud lõigus 4.8.
English: L. interrogans serovar Bratislava
Estonian: L. interrogans'i serotüüp Bratislava,
English: Plastic box containing 25 vials (1 ml).
Estonian: Plastkarp, milles on 25 viaali (1 ml).
English: Primary vaccination scheme: Two doses of Versican Plus L4 3-4 weeks apart from 6 weeks of age.
Estonian: Esmane vaktsineerimisskeem Kaks annust Versican Plus L4 3-4-nädalase vahega alates 6. elunädalast.
English: No data are available on the safety of an overdose.
Estonian: Liigannuse ohutuse kohta andmeid saadaval ei ole.
English: Onset of immunity: 4 weeks after completion of the primary course.
Estonian: Immuunsuse teke 4 nädalat pärast esmase vaktsineerimiskuuri lõpetamist.
English: Overdose (symptoms, emergency procedures, antidotes): No data are available on the safety of an overdose.
Estonian: Üleannustamine (sümptomid, esmaabi, antidoodid) Liigannuse ohutuse kohta andmeid saadaval ei ole.
English: Dose and route of administration: Shake well and administer immediately the entire contents (1 ml) of the product.
Estonian: Annustamine ja manustamistee Loksutage korralikult ja manustage kohe kogu viaali sisu (1 ml).
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products other than those mentioned in section 8.
Estonian: Sobivusuuringute puudumise tõttu ei tohi seda veterinaarravimit segada teiste veterinaarravimitega, välja arvatud need, mida on mainitud lõigus 8.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Estonian: Vaktsiin on ette nähtud tervete kutsikate ja koerte aktiivseks immuniseerimiseks haiguste vastu, mida põhjustavad Leptospira interrogens'i serogrupi Australis serotüüp Bratislava, Leptospira interrogens'i serogrupi Canicola sertüüp Canicola, Leptospira kirschneri serogrupi Grippotyphosa serotüüp Grippotyphosa ja Leptospira interrogens'i serogrupi Icterohaemorrhagiae serotüüp Icterohaemorrhagiae.
English: Special precautions for use in animals: Not applicable.
Estonian: Ettevaatusabinõud kasutamisel loomadel Ei kohaldata.
English: Once mixed, the contents of the vial should appear a whitish to yellowish colour with a slight opalescence.
Estonian: Pärast lahustamist peab viaali sisu olema valkja kuni kollaka värvusega ja veidi opalestseeruv.
English: The visual appearance is as follows: Whitish liquid with fine sediment.
Estonian: Visuaalne välimus on järgmine: valkjas vedelik peene settega.
English: If protection against DHPPi or Pi is required, dogs can be vaccinated with two doses of Versican Plus DHPPi or Versican Plus Pi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus DHPPi or Versican Plus Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Estonian: Vaktsineerimine katku-, adeno-, parvo- ja paragripiviiruse vastu (DHPPi) Kui vajatakse kaitset DHPPi või Pi vastu, võib koeri vaktsineerida alates 6. elunädalast 3-4-nädalase vahega kahe annuse Versican Plus DHPPi või Versican Plus Pi-ga, mis on segatud Versican Plus L4-ga.
English: Re-vaccination scheme: A single dose of Versican Plus L4 to be given annually.
Estonian: Kordusvaktsineerimise skeem Üks annus Versican Plus L4 manustatakse üks kord aastas.
English: L. kirschneri serovar Grippotyphosa
Estonian: L. kirschneri serotüüp Grippotyphosa,
English: Appearance: whitish liquid with fine sediment.
Estonian: Välimus: valkjas vedelik peene settega.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Estonian: Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - Väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast) - Sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus L4 for dogs
Estonian: VETERINAARRAVIMI NIMETUS Versican Plus L4 süstesuspensioon koertele
English: PACKAGE LEAFLET: Versican Plus L4 suspension for injection for dogs
Estonian: PAKENDI INFOLEHT Versican Plus L4 süstesuspensioon koertele
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Estonian: - Aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast) - Harv (rohkem kui 1-l, kuid vähem kui 10-l loomal 10 000-st ravitud loomast) - Väga harv (vähem kui 1-l loomal 10 000-st ravitud loomast, kaasaarvatudüksikjuhud).
English: Once broached, use immediately.
Estonian: Pärast korgi esmast läbistamist kasutada kohe.
English: Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus L4.
Estonian: Kõigil Versican Plus L4 koostisosadel vähemalt üks aasta pärast esmase vaktsineerimiskuuri lõpetamist.
English: − to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and
Estonian: − L. interrogans'i serogrupi Canicola serotüübist Canicola ja L. interrogans'i serogrupi Icterohaemorrhagiae serotüübist Icterohaemorrhagiae põhjustatud kliiniliste nähtude ja uriiniga eritamise ärahoidmiseks ning infektsiooni vähendamiseks; ja
English: − to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Estonian: − L. kirschneri serogrupi Grippotyphosa serotüübist Grippotyphosa põhjustatud kliiniliste nähtude ärahoidmiseks ja infektsiooni ning uriiniga eritamise vähendamiseks.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versican Plus DHPPi and Versican Plus Pi. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Estonian: Andmed antud vaktsiini ohutuse ja efektiivsuse kohta selle kasutamise koos teiste veterinaarravimitega puuduvad, välja arvatud koos Versican Plus DHPPi ja Versican Plus Pi-ga.
English: Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versican Plus DHPPi and Versican Plus Pi. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Estonian: Andmed antud vaktsiini ohutuse ja efektiivsuse kohta selle kasutamisel koos teiste veterinaarravimitega puuduvad, välja arvatud koos Versican Plus DHPPi ja Versican Plus Pi-ga.
English: L. interrogans serovar Icterohaemorrhagiae
Estonian: L. interrogans'i serotüüp Icterohaemorrhagiae ALR tiiter ≥ 1 : 51 L. interrogans'i serotüüp Canicola
English: ALR* titre ≥ 1:40
Estonian: ALR* tiiter ≥ 1 : 40
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injections
Estonian: Suspensioon: naatriumkloriid kaaliumkloriid kaaliumdivesinikfosfaat dinaatriumfosfaatdodekahüdraat süstevesi.
English: ALR* titre ≥ 1:51
Estonian: ALR* tiiter ≥ 1:51
English: 10 July 2015
Estonian: 10. juuli 2015
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Estonian: See tähendab, et kuigi puuduvad kliinilistest uuringutest saadud piisavad tõendid, on usutav, et need taimsed ravimid on tõhusad, ja on tõendeid, et neid on sel viisil ohutult kasutatud vähemalt 30 aastat (sh vähemalt 15 aastat Euroopa Liidus).
English: If symptoms last longer than two weeks during treatment, a doctor or a qualified healthcare practitioner should be consulted.
Estonian: Kui sümptomid kestavad ravi ajal üle kahe nädala, tuleb pöörduda arsti või pädeva tervishoiutöötaja poole.
English: Mouse-ear hawkweed EMA/HMPC/331455/2015
Estonian: Karutubakaürt koos juurtega EMA/HMPC/331455/2015
English: Mouse-ear hawkweed medicines must not be used in patients with conditions in which a reduced fluid intake is recommended (such as severe heart or kidney disease).
Estonian: Karutubakaürti koos juurtega sisaldavaid ravimeid ei tohi kasutada patsiendid, kellel on haigus, mille korral soovitatakse vähendada vedeliku tarbimist (nt raske südame- või neeruhaigus).
English: Mouse-ear hawkweed should only be used in adults.
Estonian: Koos juurtega karutubakaürti tohivad kasutada üksnes täiskasvanud.
English: Moreover, the intended use does not require medical supervision.
Estonian: Samuti ei ole nende näidustusekohasel kasutamisel vaja meditsiinilist järelevalvet.
English: The HMPC noted the lack of clinical studies with mouse-ear hawkweed, but took into account the well documented use of this herbal medicine for the above uses.
Estonian: Taimsete ravimite komitee märkis, et puuduvad karutubakaürti koos juurtega käsitlevad kliinilised uuringud, kuid arvestas selle taimse ravimi hästi dokumenteeritud kasutust eespool nimetatud näidustuste korral.
English: Further information on the risks associated with mouse-ear hawkweed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave karutubakaürti koos juurtega sisaldava ravimiga kaasnevate riskide, sh selle ohutu kasutamise ettevaatusabinõude kohta, on ravimtaime monograafias Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Estonian: Taimsete ravimite komitee hindamise ajaks ei olnud teatatud nende ravimite kõrvaltoimetest.
English: Further information on the HMPC assessment of mouse-ear hawkweed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave karutubakaürti koos juurtega sisaldava ravimi hinnangu kohta, sh komitee kokkuvõtte detailne kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Mouse-ear hawkweed medicines are generally well tolerated.
Estonian: Karutubakaürti koos juurtega sisaldavaid ravimeid talutakse üldiselt hästi.
English: Any applications for the licensing of medicines containing mouse-ear hawkweed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Estonian: Karutubakaürti koos juurtega sisaldava ravimi müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimse ravimi müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslike järelduste kokkuvõtet.
English: For further information, see the HMPC assessment report.
Estonian: Üksikasjalik teave on taimsete ravimite komitee hindamisaruandes.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of mouse-ear hawkweed.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb koos juurtega karutubakaürdi meditsiinilisi kasutusviise.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing mouse-ear hawkweed.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad karutubakaürti koos juurtega sisaldavate taimsete ravimite müügilubade taotlusi.
English: The HMPC conclusions on the use of mouse-ear hawkweed medicines for the relief of minor urinary problems are based on their ‘traditional use'.
Estonian: Taimsete ravimite komitee järeldused karutubakaürti koos juurtega sisaldavate ravimite kasutamise kohta kergete kuseteeprobleemide leevendamiseks põhinevad nende traditsioonilisel kasutamisel.
English: The HMPC concluded that, on the basis of its long-standing use, mouse-ear hawkweed can be used as a mild diuretic (a medicine to increase production of urine) for the relief of minor problems of the urinary tract (the structures that carry urine).
Estonian: Taimsete ravimite komitee järeldas, et juurtega karutubakaürdi pikaaegse kasutamise alusel tohib seda kasutada nõrgatoimelise diureetikumina (uriini eritumist soodustav ravim) kergete kuseteeprobleemide leevendamiseks.
English: What evidence supports the use of mouse-ear hawkweed medicines?
Estonian: Millised tõendid toetavad karutubakaürti koos juurtega sisaldava ravimi kasutamist?
English: Herbal medicines containing mouse-ear hawkweed are usually available as a herbal tea to be drunk and in solid forms to be taken by mouth.
Estonian: Karutubakaürti koos juurtega sisaldavaid taimseid ravimeid turustatakse tavaliselt joodava taimeteena ja suukaudsete tahkete ravimvormidena.
English: What is mouse-ear hawkweed?
Estonian: Mis on karutubakaürt koos juurtega?
English: How are mouse-ear hawkweed medicines approved in the EU?
Estonian: Kuidas antakse Euroopa Liidus karutubakaürti koos juurtega sisaldavale ravimile müügiluba?
English: For more information about treatment with mouse-ear hawkweed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Estonian: Kui vajate lisateavet karutubakaürti koos juurtega sisaldava ravimi kasutamise kohta, lugege palun pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For practical information about using mouse-ear hawkweed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Estonian: Kui vajate karutubakaürti koos juurtega sisaldava ravimi kasutamise kohta praktilisi nõuandeid, lugege ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Detailed instructions on how to take mouse-ear hawkweed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Estonian: Karutubakaürti koos juurtega sisaldavate ravimite kasutamise üksikasjalikud juhised ja näidustused on ravimi pakendi infolehel.
English: What are the risks associated with mouse-ear hawkweed medicines?
Estonian: Mis riskid kaasnevad karutubakaürti koos juurtega sisaldava ravimiga?
English: This summary is not intended to provide practical advice on how to use medicines containing mouseear hawkweed.
Estonian: Kokkuvõttes ei anta karutubakaürti koos juurtega sisaldava ravimi kasutamise kohta praktilisi nõuandeid.
English: Other information about mouse-ear hawkweed medicines
Estonian: Muu teave karutubakaürti koos juurtega sisaldava ravimi kohta
English: Mouse-ear hawkweed is the common name for the above-ground parts (which may include flowers) and parts of the root of the plant Hieracium pilosella L. The plant is cultivated or gathered to obtain the plant parts for medicinal use.
Estonian: Karutubakaürt koos juurtega on taime Hieracium pilosella L. (harilik karutubakas) maapealsete osade (ka koos õitega) ja juureosade üldnimetus.
English: Information on the use and licensing of mouse-ear hawkweed medicines in EU Member States should be obtained from the relevant national authorities.
Estonian: ELi liikmesriikides saab teavet karutubakaürti koos juurtega sisaldava ravimi kasutamise ja müügiloa kohta riiklikult ravimiametilt.
English: Mouse-ear hawkweed preparations are obtained by comminuting (reducing into tiny pieces) or powdering the dried plant parts.
Estonian: Koos juurtega karutubakaürdi preparaate saadakse kuivatatud taimeosi peenestades või jahvatades.
English: Further information on Posaconazole Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/posaconazole-accord.
Estonian: Lisateave Posaconazole Accordi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/posaconazole-accord.
English: Posaconazole Accord (posaconazole) EMA/320670/2019
Estonian: Posaconazole Accord (posakonasool) EMA/320670/2019
English: The recommended dose is 300 mg twice a day on the first day followed by 300 mg once a day thereafter; the duration of treatment depends on the severity of the disease and the patient's response.
Estonian: Soovitatav annus on esimesel päeval 300 mg 2 korda ööpäevas ja seejärel 300 mg 1 kord ööpäevas.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Estonian: Ettevõte tegi ka uuringuid, mis tõendasid, et see on bioekvivalentne võrdlusravimiga.
English: Side effects reported with Posaconazole Accord are carefully evaluated and any necessary action taken to protect patients.
Estonian: Posaconazole Accordi kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: What measures are being taken to ensure the safe and effective use of Posaconazole Accord?
Estonian: Mis meetmed võetakse, et tagada Posaconazole Accordi ohutu ja efektiivne kasutamine?
English: Posaconazole Accord is also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow).
Estonian: Posaconazole Accord ennetab teadaolevalt ka invasiivsete seeninfektsioonide teket patsientidel, kelle immuunsüsteemi on nõrgestanud vere- või luuüdivähi ravi või ravimid, mida kasutatakse vereloome tüviraku siirdamisel (protseduur, kus patsiendi luuüdi asendatakse doonori tüvirakkudega, mis moodustavad uue luuüdi).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Posaconazole Accord has been shown to have comparable quality and to be bioequivalent to Noxafil.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud ravimi Posaconazole Accord võrreldav kvaliteet ja bioekvivalentsus ravimiga Noxafil.
English: For more information about using Posaconazole Accord, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Posaconazole Accordi kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: This means that Posaconazole Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Noxafil.
Estonian: See tähendab, et Posaconazole Accord sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Noxafil, millel juba on ELis müügiluba.
English: Posaconazole Accord is available as gastro-resistant tablets (100 mg).
Estonian: Posaconazole Accordi turustatakse gastroresistentsete tablettidena (100 mg).
English: • chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
Estonian: • kromoblastomükoos ja mütsetoom (naha või nahaaluskoe pikaajalised seeninfektsioonid, mida tavaliselt põhjustab okka- või pinnuhaava nakatumine seenespooridega);
English: Posaconazole Accord (posaconazole)
Estonian: Posaconazole Accord (posakonasool)
English: Because Posaconazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Posaconazole Accord on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Gastro-resistant means that the tablets pass through the stomach without being broken down until they reach the intestine.
Estonian: Gastroresistentne tähendab, et tabletid lagunevad mitte maos, vaid alles sooles.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Posaconazole Accord have been included in the summary of product characteristics and the package leaflet.
Estonian: Posaconazole Accordi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Posaconazole Accord is an antifungal medicine used to treat adults with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Estonian: Posaconazole Accordi kasutatakse järgmiste seenhaiguste raviks vähemalt 18-aastastel täiskasvanutel, kui patsient ei talu muid seenevastaseid ravimeid (amfoteritsiin-B, itrakonasool või flukonasool) või ravi nendega on olnud ebaefektiivne:
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Noxafil, and do not need to be repeated for Posaconazole Accord.
Estonian: Võrdlusravimiga Noxafil on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja Posaconazole Accordiga korrata.