FrancophonIA/ELRC3.0 huggingface dataset:
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Estonian: Kui inimesele manustatakse vaktsiini, peab immuunsüsteem viirust võõraks ja tekitab selle vastu antikehi.
English: The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') in line with the CHMP criteria for prepandemic vaccines.
Estonian: Uuringutes hinnati vaktsiini toimet stimuleerida antikehade teket (immunogeensust), järgides inimravimite komitee poolt prepandeemilistele vaktsiinidele esitatud kriteeriume.
English: The vaccine contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Estonian: Vaktsiin sisaldab parema immuunvastuse saamiseks ka adjuvanti (teatud õlisegu).
English: The full EPAR for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low levels) such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Estonian: Vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ei tohi manustada patsientidele, kellel on tekkinud anafülaktiline reaktsioon (raske allergiline reaktsioon) vaktsiini mis tahes komponentide suhtes, sh nende suhtes, mida vaktsiin sisaldab mikrokogustes, nt muna- või kanavalgud, ovalbumiin (munavalge teatud valk), kanamütsiin või neomütsiinsulfaat (antibiootikumid), formaldehüüd ja tsetüültrimetüülammooniumbromiid.
English: In the event of an officially declared pandemic caused by the H5N1 strain of the influenza A, people who have already been vaccinated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (with one or two doses) may be given only one more dose, instead of the two doses recommended for unvaccinated people.
Estonian: Kui ametlikult on välja kuulutatud A-gripi tüve H5N1 põhjustatud pandeemia, piisab varem vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ühe või kahe annusega vaktsineeritutele ainult ühest selle vaktsiini lisaannusest kahe annuse asemel, mida soovitatakse vaktsineerimata inimestele.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains a flu strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14).
Estonian: Vaktsiin Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics sisaldab gripiviiruse A/Vietnam/1194/2004 (H5N1)-laadset tüve NIBRG-14.
English: The most common side effects with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
Estonian: Vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kõige sagedamad kõrvalnähud (esinenud enam kui 1 vaktsineeritul 10st) on peavalu, lihasevalu, süstekoha reaktsioonid (paistetus, valu, kõvenemine ja punetus) ning väsimus.
English: The second study established that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should be given as two doses at least three weeks apart.
Estonian: Teise uuringuga tehti kindlaks, et vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics tuleb manustada kahe annusena, mille vahele peab jääma vähemalt kolm nädalat.
English: The CHMP decided that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
English: EPAR summary for the public prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Estonian: Kokkuvõte üldsusele prepandeemiline gripiviiruse vaktsiin (H5N1) (pinnaantigeen, inaktiveeritud, adjuveeritud)
English: For more information about treatment with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kasutamise kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults to protect against flu caused by the H5N1 (“bird flu”) strain of the influenza A virus.
Estonian: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics on vaktsiin, mida kasutatakse täiskasvanutel, et kaitsta neid A-tüüpi H5N1 gripiviiruse (nn linnugripiviiruse) põhjustatud gripi eest.. Vaktsiini määratakse vastavalt ametlikele soovitustele.
English: In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics three weeks apart, or a placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart.
Estonian: Ühes uuringus (3372 osalejat) manustati osalejatele hooajalise gripi vaktsiini, mille järel manustati kolmenädalase vahega kaks annust vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics või platseebot (näiv vaktsiin).
English: The studies showed that overall Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics produced an antibody response that met these criteria.
Estonian: Uuring näitas, et vaktsiin Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kokkuvõttes tekitas nendele kriteeriumidele vastava antikehade sisalduse.
English: In the second study involving 240 people, subjects were given Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics using different vaccination schedules.
Estonian: Teises uuringus (240 osalejat) manustati osalejatele vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics mitmesuguste vaktsineerimisskeemide alusel.
English: This is a summary of the European public assessment report (EPAR) for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Estonian: Käesolev dokument on vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics Euroopa avaliku hindamisaruande kokkuvõte.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics to Novartis Vaccines and Diagnostics S.r.l.
Estonian: Euroopa Komisjon andis vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Novartis Vaccines and Diagnostics S.r.l.
English: Other information about Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Estonian: Muu teave vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticskohta
English: For the full list of all side effects reported with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, see the package leaflet.
Estonian: Vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Two main studies provided data on vaccination with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in healthy adults aged below and above 60 years.
Estonian: Vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics toimet tervetele täiskasvanutele (alla ja üle 60-aastased) uuriti kahes põhiuuringus.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine.
Estonian: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics on vaktsiin.
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a ‘prepandemic' vaccine.
Estonian: Vaktsiin Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics on prepandeemiline vaktsiin.
English: What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Estonian: Mis on vaktsiin Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: The applicant presented data on experimental models with vaccines similar to Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Estonian: Müügiloa taotleja esitas vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics laadsete vaktsiinide katsemudelite andmed.
English: Why has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been approved?
Estonian: Miks vaktsiin Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticsheaks kiideti?
English: How has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been studied?
Estonian: Kuidas vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics uuriti?
English: How does Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics work?
Estonian: Kuidas vaktsiin Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics toimib?
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 Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas vaktsiini Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas vaktsiini kasutada.
English: The studies varied between 28 days and 13 months.
Estonian: Uuringud kestsid 28 päevast 13 kuuni.
English: Durogesic (fentanyl) transdermal patches are registered nationally in the following 24 European Economic Area (EEA) countries: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden and United Kingdom.
Estonian: Transdermaalne plaaster Durogesic (fentanüül) on riiklikult registreeritud Euroopa Majanduspiirkonna (EMP) järgmises 24 riigis: Austria, Belgia, Hispaania, Horvaatia, Iirimaa, Island, Itaalia, Kreeka, Küpros, Luksemburg, Madalmaad, Malta, Norra, Poola, Portugal, Prantsusmaa, Rootsi, Saksamaa, Sloveenia, Soome, Taani, Tšehhi Vabariik, Ungari ja Ühendkuningriik.
English: There are 5 different strengths of patch available: 12, 25, 50, 75 and 100 μg/h.
Estonian: Turustatakse viie erineva tugevusega plaastreid: 12, 25, 50, 75 ja 100 μg/h.
English: In these cases the benefits of such treatment should outweigh the risks (central nervous system depression and respiratory depression).
Estonian: Neil juhtudel peab ravist saadav kasu olema suurem kui riskid (kesknärvisüsteemi pidurdus ja hingamise pärssimine).
English: The wording in this section has been amended according to the PSUR worksharing (2010), that Durogesic may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving or operating machinery.
Estonian: Selle lõigu sõnastuses on tööjaotusega perioodilise ohutusaruande (2010) alusel tehtud muudatus, et Durogesic võib kahjustada vaimseid ja/või füüsilisi võimeid, mis on vajalikud potentsiaalselt ohtlike ülesannete täitmiseks, nagu autojuhtimine või masinatega töötamine.
English: Since the term “intractable pain” is not properly defined, it has been replaced by ‘severe', which captures the term ‘intractable'.
Estonian: Kuna terminil „ravile allumatu valu” puudub kohane määratlus, asendati see terminiga „tugev”, mis hõlmab ka terminit „ravile allumatu”.
English: In such cases, the potential for life-threatening hypoventilation has been added as a warning.
Estonian: Sellisteks juhtudeks on hoiatusena lisatud võimalik eluohtlik hüpoventilatsioon.
English: The information provided in section 4.2 is partly presented in up to three tables and are only be used to convert from other opioids to Durogesic and not vice versa:
Estonian: Lõigus 4.2 olev teave on osaliselt esitatud kuni kolmes tabelis ning need on mõeldud ümberarvutamiseks ainult teistelt opioididelt Durogesicule üleminekul ja mitte vastupidi.
English: In such a case it is recommended that the patient should be monitored closely for increased serum concentrations.
Estonian: Sel juhul on soovitatav patsienti hoolikalt jälgida ravimisisalduse suurenemise suhtes seerumis.
English: According to the EMA Guideline on the Clinical Development of Medicinal Products Intended for the Treatment of Pain (EMA/CHMP/970057/2011, Corr. 11) and the WHO Guideline on Cancer Pain Relief, pain severity can be classified as mild, moderate and severe.
Estonian: Valu raviks ettenähtud ravimpreparaatide kliinilise arenduse Euroopa Ravimiameti juhiste (EMA/CHMP/970057/2011, Corr. 11) ja vähivalu leevendamise Maailma Terviseorganisatsiooni juhiste järgi saab valu liigitada tugevuse alusel nõrgaks, mõõdukaks ja tugevaks.
English: anaesthetic since the 1960s.
Estonian: Fentanüüli on intravenoosse anesteetikumina turustatud 1960. aastatest saadik.
English: The scope of this procedure is limited to Durogesic transdermal patches.
Estonian: Menetlus hõlmab ainult Durogesicu transdermaalseid plaastreid.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC concerning the medicinal product Durogesic transdermal patches;
Estonian: • komitee arutas direktiivi 2001/83/EÜ artikli 30 kohast ametlikku esildist ravimpreparaadi Durogesic transdermaalsete plaastrite kohta;
English: Elderly or patients with renal or hepatic impairment should be closely observed and dose reductions made if necessary.
Estonian: Eakaid või neeru- või maksakahjustusega patsiente tuleb hoolikalt jälgida ja vajaduse korral annust vähendada.
English: Replacing the patch before 72 hours may result in increased serum concentrations of fentanyl, which could increase the risk for adverse events.
Estonian: Kui vahetada plaastrit enne 72 tunni möödumist, võib fentanüüli kontsentratsioon seerumis suureneda ja see võib suurendada kõrvalnähtude riski.
English: The efficacy of Durogesic has been shown in six studies in adults with non-malignant pain, of which five were open-label and 3 did not have a comparator arm.
Estonian: Durogesicu efektiivsust on tõestatud kuues mittemaliigse valuga täiskasvanutel tehtud uuringus, neist viis olid avatud uuringud ja kolm võrdlusrühmata.
English: The lowest available patch strength is 12.5 μg/h, which is designated as 12μg/h to distinguish it from a 125μg/h dosage that could be prescribed by using multiple patches.
Estonian: Turustatava plaastri väikseim tugevus on 12,5 μg/h, millele on märgitud 12 μg/h, et eristada seda annusest 125 μg/h,
English: The transdermal patches were developed as a non-invasive parenteral treatment option to avoid the first pass mechanism and to achieve a constant release and plasma levels.
Estonian: Transdermaalsed plaastrid on välja töötatud mitteinvasiivseks parenteraalseks raviks, et vältida esmast maksapassaaži ning saavutada ravimi pidev ühtlane vabanemine ja püsiv sisaldus plasmas.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Durogesic and associated names, the European Commission (EC) notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the authorised summary of product characteristics (SmPCs) for the above-mentioned product, and thus to harmonise the SmPCs across the EU.
Estonian: Et liikmesriigid olid Durogesicu ja sarnaste nimetuste müügiloa kohta vastu võtnud erinevaid otsuseid, tegi Euroopa Komisjon Euroopa Ravimiametile direktiivi 2001/83/EÜ artikli 30 alusel ametliku esildise eesmärgiga tuvastada lahknevused liikmesriikides heakskiidetud ravimi omaduste kokkuvõtetes ja ühtlustada need kogu Euroopa Liidus.
English: The subjects (N=1667) included had chronic low back pain, osteoarthritis or rheumatoid arthritis or pain of unspecified origin.
Estonian: Uuringus osalenutel (n = 1667) oli krooniline alaseljavalu, osteoartriit või reumatoidartriit või täpsustamata valu.
English: The new sub heading on linearity/non linearity is justified by adequate data and also considered to be acceptable.
Estonian: Uus alapealkiri lineaarsuse/mittelineaarsuse kohta on õigustatud, sest on olemas piisavalt andmeid, ka see kiideti heaks.
English: Information related to studies in the post-operative pain indication in opioid naïve subjects has not been retained since this is not in the indication of Durogesic.
Estonian: Operatsioonijärgse valu näidustusel opioidravi varem mittesaanud patsientide uuringute teavet ei ole säilitatud, sest see ei ole Durogesicu näidustus.
English: Major differences between SmPCs regarding the assigned frequencies for individual adverse reactions were discussed and resolved.
Estonian: Ravimi omaduste kokkuvõtetes esinenud suuremad erinevused individuaalsete kõrvalnähtude esinemissageduses arutati läbi ja likvideeriti.
English: As there were no striking differences in the safety profile between adult and paediatric subjects, the MAH's decision not to include a separate table was considered to be acceptable.
Estonian: Kuna laste ja täiskasvanute ohutusprofiilides ei olnud suuri erinevusi, kiideti heaks müügiloa hoidja otsus eraldi tabelit mitte lisada.
English: The MAH has clarified that only at first application could a patch be replaced after 48 hours when analgesia is insufficient.
Estonian: Müügiloa hoidja on selgitanud, et plaastrit võib 48 tunni pärast vahetada ainult esmakordsel paigaldamisel, kui analgeetiline toime ei ole piisav.
English: With regard to the interactions with CYP3A4 inhibitors, although the concomitant use with Durogesic is not recommended, in cases where the benefits outweigh the increased risk of adverse effects, a washout period of 2 days before the first Durogesic patch is applied was considered to be sufficient in most cases.
Estonian: Mis puutub koostoimetesse CYP3A4 inhibiitoritega, kuigi nende samaaegne kasutamine Durogesicuga ei ole soovitatav, siis juhtudel, kui kasu ületab kõrvalnähtude suurenenud riski, on enamikul juhtudel peetud piisavaks kahepäevast väljauhtmisperioodi enne esimese Durogesicu plaastri asetamist.
English: With respect to ‘Special Populations' the text based on the data are justified and were considered to be acceptable with some amendments.
Estonian: Andmetel põhinev tekst lõigus „Erirühmad” on õigustatud ja kiideti mõnede parandustega heaks.
English: These are: pharmacodynamic-related interactions with centrally-acting medicinal products and alcohol, monoamine oxidase inhibitors, serotonergic drugs and concomitant use of mixed opioid agonists/antagonists, and pharmacokinetic-related interactions with CYP3A4 Inhibitors and CYP3A4 inducers.
Estonian: Need on farmakodünaamikaga seotud koostoimed tsentraalselt toimivate ravimite ja alkoholi, monoamiini oksüdaasi inhibiitorite ja serotonergiliste ravimitega ning segatud opioidi agonistide/antagonistide samaaegne kasutamine ja farmakokineetikaga seotud koostoimed CYP3A4 inhibiitorite ning CYP3A4 indutseerijate farmakokineetikaga seotud koostoimed.
English: Other warnings included in section 4.4 are: chronic pulmonary disease, drug dependence and potential for abuse, central nervous system including increased intracranial pressure, cardiac disease, hypotension, hepatic impairment, renal impairment, respiratory depression, serotonin syndrome, accidental exposure by patch transfer, use in elderly patients, gastrointestinal tract, paediatric population, lactation, and patients with myasthenia gravis.
Estonian: Muud lõiku 4.4 lisatud hoiatused on kroonilised kopsuhaigused, ravimisõltuvus ja võimalik kuritarvitamine, kesknärvisüsteemi häired, sealhulgas koljusisese rõhu tõus, südamehaigused, hüpotensioon, maksakahjustus, neerukahjustus, hingamise pärssumine, serotoniinisündroom, juhuslik kokkupuude ravimiga plaastri kleepumise tõttu, kasutamine eakatel patsientidel, seedetrakt, lapsed, imetamine ja myasthenia gravis'ega patsiendid.
English: Table 2: Designed for adult patients who have a need for rotation of, or conversion from, another opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 150:1).
Estonian: Tabel 2.Koostatud täiskasvanud patsientidele, kes vajavad opioidide vahelduvat kasutamist või teiselt opioidi raviskeemilt üleminekut (üleminekul suukaudselt morfiinilt transdermaalsele fentanüülile on konverteerimise määr ligikaudu võrdne suhtega 150 : 1).
English: As placental passage of fentanyl is known to occur in human pregnancies and the potential risk for humans is unknown, a cautionary statement that Durogesic should not be used during pregnancy unless clearly necessary has been included.
Estonian: Kuna on teada, et fentanüül läbib inimese platsenta ja võimalik risk inimesele ei ole teada, on lisatud hoiatus, et Durogesicut ei tohi raseduse ajal kasutada, välja arvatud selge vajaduse korral.