FrancophonIA/ELRC3.0 huggingface dataset:
English: Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial.
Danish: Suspender vaccinen i enkeltdosis hætteglasset med 1 ml Nobivac Myxo-RHD solvens og injicèr hele hætteglassets indhold.
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) -.
English: Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD solvent vial is properly mixed.
Danish: Det skal sikres at Nobivac Myxo-RHD vaccinen og solvens blandes omhyggeligt.
English: Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
Danish: Overfør det nu opblandede vaccinekoncentrat fra vaccinehætteglasset til hætteglasset med Nobivac Myxo-RHD solvens.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/001-004
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/132/001-004
English: The swelling will resolve completely by 3 weeks after vaccination.
Danish: I løbet af den tredje uge efter vaccinationen vil hævelsen helt forsvinde.
English: PACKAGE SIZE 1 x 50 ml
Danish: PAKNINGSSTØRRELSE 1 x 50 ml DYREARTER Kaniner
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/132/003
English: The scabs usually disappear within 2 weeks after the small swellings have been observed.
Danish: På disse steder vil der hurtigt dannes sårskorper, som almindeligvis forsvinder inden for to uger.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/004
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/132/004
English: PACKAGE SIZE 10 x 10 ml
Danish: PAKNINGSSTØRRELSE 10 x 10 ml DYREARTER Kaniner
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER - SOLVENS ETIKET TIL SOLVENS
English: ml vial of solvent.
Danish: Myxo-RHD solvens.
English: - Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50 ml vial of solvent.
Danish: - Karton med 10 x 50 doser vaccine i hætteglas + 2 x kartonner hver indeholdende 1 x 50 ml solvens i hætteglas.
English: - Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.
Danish: - Karton med 10 x 50 doser vaccine i hætteglas + karton med 10 x 10 ml solvens i hætteglas.
English: - Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
Danish: - Plastikæske med 25 x 1 dosis vaccine i hætteglas og 25 x 1 ml solvens i hætteglas.
English: Lyophilisate:
Danish: Drægtighed:
English: 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Kaniner
English: Packaging: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Danish: Pakningsstørrelser: - Plastikæske med 5 x 1 dosis vaccine i hætteglas og 5 x 1 ml solvens i hætteglas.
English: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Danish: - Plastikæske med 5 x 1 dosis vaccine i hætteglas og 5 x 1 ml solvens i hætteglas.
English: 50 ml vial
Danish: 50 ml hætteglas
English: - if you have diarrhoea for more than one day.
Danish: - hvis du har diarré i mere end én dag.
English: These effects are more frequent if you also drink alcohol.
Danish: Disse virkninger ses oftere, hvis du også drikker alkohol.
English: Approximately 2% of the radioactivity was eliminated in the urine.
Danish: Ca. 2 % af radioaktiviteten blev elimineret i urinen.
English: Most patients completely recover after appropriate measures are taken.
Danish: De fleste patienter kommer sig fuldstændigt, efter at der er truffet passende foranstaltninger.
English: Date of first authorisation: 18 July 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse:18. juli 2014 Dato for seneste fornyelse:
English: This medicine should be taken once a day.
Danish: Denne medicin skal tages én gang om dagen.
English: To date, no other relevant epidemiological data are available.
Danish: Til dato foreligger der ikke andre relevante epidemiologiske data.
English: However, cases of spontaneous abortion have been reported.
Danish: Der er dog rapporteret tilfælde af spontan abort.
English: The educational pack should contain the following:
Danish: Pakken med uddannelsesmaterialet skal indeholde følgende:
English: Prevention and management should be in accordance with appropriate clinical guidance.
Danish: Forebyggelse og håndtering bør være i overensstemmelse med passende klinisk vejledning.
English: Take the tablet as soon as possible on the same day.
Danish: Tag tabletten så hurtigt som muligt samme dag.
English: The course of pre-existing infections may be aggravated.
Danish: Sygdomsforløbet af eksisterende infektioner kan forværres.
English: The tablets should be swallowed whole with a glass of water.
Danish: Tabletterne skal sluges hele med et glas vand.
English: A double dose should not be taken on the next day.
Danish: Der må ikke tages dobbelt dosis den næste dag.
English: When treating rejection, the same doses may be used.
Danish: Ved behandling af afstødning kan samme doser anvendes.
English: Envarsus with food and drink
Danish: Brug af Envarsus sammen med mad og drikke
English: - if you have an alteration of the electrical activity of your heart called “QT prolongation”.
Danish: - hvis du har en ændret elektrisk aktivitet i hjertet, der kaldes ”QT-forlængelse”.
English: A forgotten dose should be taken as soon as possible on the same day.
Danish: En glemt dosis bør tages så hurtigt som muligt den samme dag.
English: The other metabolites have only weak or no immunosuppressive activity.
Danish: De øvrige metabolitter har kun svag eller ingen immunsuppressiv aktivitet.
English: Envarsus is used in adults.
Danish: Envarsus anvendes til voksne.
English: The recommended initial doses presented below are intended to act solely as a guideline.
Danish: De nedenfor anførte anbefalede begyndelsesdoser er kun vejledende.
English: Administration should commence within 24 hours after the completion of surgery.
Danish: Administrationen bør påbegyndes inden for 24 timer efter afslutningen af det kirurgiske indgreb.
English: Gonzagagasse 16/16 1010 Wien Austria
Danish: Gonzagagasse 16/16 1010 Wien Østrig
English: Hypersensitivity to other macrolides.
Danish: Overfølsomhed over for andre makrolider.
English: • Educational material for Healthcare Professionals
Danish: • Uddannelsesmateriale til læger og sundhedspersonale
English: This effect may be enhanced if Envarsus is administered in association with alcohol.
Danish: Denne virkning kan forstærkes, hvis Envarsus administreres sammen med alkohol.
English: Do not stop your treatment unless your doctor tells you to do so.
Danish: Du må ikke ophøre med behandlingen, medmindre din læge siger, at du skal.
English: Both generalised and localised infections can occur.
Danish: Der kan både opstå generaliserede og lokale infektioner.
English: Other interactions leading to clinically detrimental effects
Danish: Andre interaktioner, der har medført klinisk skadelige virkninger
English: Elderly patients (> 65 years) There is no evidence currently available to indicate that dose should be adjusted in elderly patients.
Danish: Ældre patienter (> 65 år) På nuværende tidspunkt er der intet, der tyder på, at doseringen justeres hos ældre patienter.
English: Your doctor will usually reduce your Envarsus dose once your condition has stabilised.
Danish: Din læge vil som regel reducere din Envarsus-dosis, når din tilstand har stabiliseret sig.
English: Your dose depends on your general condition and on which other immunosuppressive medicines you are taking.
Danish: Din dosis afhænger af din almene tilstand og hvilke andre immunhæmmende lægemidler du tager.
English: You should keep in regular contact with your doctor.
Danish: Du skal være i regelmæssig kontakt med din læge.
English: Stevens Johnson syndrome
Danish: StevensJohnsons syndrom
English: Infection including opportunistic infections
Danish: Infektioner, herunder opportuniske infektioner
English: Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Danish: Anvend passende beskyttende beklædning, og brug en solcreme med høj solfaktor.
English: This medicine should only be prescribed for you by a doctor with experience in the treatment of transplant patients.
Danish: Dette lægemiddel må kun ordineres til dig af en læge med erfaring i behandling af transplanterede patienter.
English: In addition, synergistic/additive nephrotoxic effects can occur.
Danish: Endvidere kan der opstå synergistiske/additive nefrotoksiske bivirkninger.
English: The use of live attenuated vaccines should be avoided.
Danish: Anvendelse af levende, afsvækkede vacciner bør undgås.
English: If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Danish: I tilfælde af overdosering skal der benyttes generelle, understøttende foranstaltninger og symptomatisk behandling.
English: Do not use this medicine after the expiry date which is stated on the carton, blister and wrapper after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken, blisteren og pakningen efter “EXP”.
English: Dose adjustments should be made to ensure that similar systemic exposure is maintained after the switch.
Danish: Der bør foretages dosisjusteringer for at sikre, at samme systemiske eksponering opretholdes efter skiftet.
English: The use of Envarsus is not recommended in children and adolescents under 18 years.
Danish: Envarsus anbefales ikke til børn og unge under 18 år.
English: Posterior reversible encephalopathy syndrome (PRES)
Danish: Posterior reversibel encefalopati-syndrom (PRES)
English: A number of associated cases of transplant rejection have been reported.
Danish: Der er rapporteret et antal tilknyttede tilfælde af transplantatafstødning.
English: It should be noted however, that there has been no direct experience with Envarsus in overdose.
Danish: Det bør dog bemærkes, at der ikke har været nogen direkte erfaring med Envarsus i forbindelse med overdosering.
English: In the de novo liver transplant study, 29 subjects were treated with Envarsus.
Danish: I det de novo levertransplantatstudie blev 29 forsøgspersoner behandlet med Envarsus.
English: Tacrolimus may cause visual and neurological disturbances.
Danish: Tacrolimus kan forårsage visuelle og neurologiske forstyrrelser.
English: • Patient cards to be given to patients with the product
Danish: • Huskekort, som udleveres til patienter samtidig med produktet
English: It is recommended that the oral daily dose of Envarsus is administered once daily in the morning.
Danish: Det anbefales, at den daglige orale dosis af Envarsus administreres én gang dagligt om morgenen.
English: Available tacrolimus is generally rapidly absorbed.
Danish: Tilgængeligt tacrolimus absorberes som regel hurtigt.
English: If the appearance of this medicine is not the same as usual, or if doe instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Danish: Hvis dette lægemiddel ikke ser ud som normalt, eller hvis dosisvejledningen er ændret, skal du tale med din læge eller apotekspersonalet hurtigst muligt for at sikre, at du har fået den korrekte medicin.
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Envarsus.
Danish: I denne patientgruppe skal EBV-VCA-serologien derfor kendes, før behandlingen med Envarsus påbegyndes.
English: Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
Danish: Efter intravenøs og oral administration af 14C-mærket tacrolimus blev størstedelen af radioaktiviteten elimineret i fæces.
English: - The clinical risks associated with over- and under-dosing.
Danish: - De kliniske risici ved over- og underdosering.
English: Talk to your doctor before taking Envarsus: - if you have, or have had, liver problems.
Danish: Kontakt lægen, før du tager Envarsus: - hvis du har eller har haft leverproblemer.
English: Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Envarsus.
Danish: Du må ikke føre motorkøretøj, arbejde med værktøj eller betjene maskiner, hvis du føler dig svimmel eller søvnig eller har problemer med at se klart, efter du har taget Envarsus.
English: Absorption is variable and the mean oral bioavailability of tacrolimus is in the range of 20%-25% (individual range in adult patients 6%-43%).
Danish: Absorptionen er variabel og den orale gennemsnitlige biotilgængelighed af tacrolimus ligger mellem 20 %-25 % (individuelt hos voksne patienter 6 %-43 %).
English: Limited knowledge of interactions between tacrolimus and statins is available.
Danish: Der er begrænset viden om interaktionen mellem tacrolimus og statiner.
English: Severe effects may occur, including allergic and anaphylactic reactions.
Danish: Der kan forekomme alvorlige bivirkninger, herunder allergiske og anafylaktiske reaktioner.
English: Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Danish: Før lancering af lægemidlet i de enkelte medlemslande skal indehaveren af markedsføringstilladelsen aftale indholdet og formen af uddannelsesprogrammet med den relevante nationale myndighed.
English: - The need for specialist supervision and monitoring if there is a clinical decision to switch a patient to another tacrolimus containing products.
Danish: - Behovet for professionel overvågning og monitorering, hvis der træffes en klinisk beslutning om at skifte en patient til et andet tacrolimus-indeholdende produkt.
English: During treatment, careful monitoring with EBV-PCR (Polymerase-Chain-Reaction) is recommended.
Danish: Under behandlingen anbefales omhyggelig monitorering med EBV-PCR (polymerasekædereaktion).
English: Tacrolimus is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Danish: Tacrolimus administreres rutinemæssigt sammen med andre immunsuppressive lægemidler i den første postoperative periode.
English: Patients should be advised not to swallow the desiccant.
Danish: Patienter bør informeres om ikke at indtage tørremidlet.
English: Therefore, you may be more prone to infections while you are taking Envarsus.
Danish: Derfor kan du være mere tilbøjelig til at få infektioner, mens du tager Envarsus.
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Danish: Som med andre potente immunsuppressive lægemidler er risikoen for sekundær cancer ukendt (se pkt.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to
Danish: Tabel over bivirkninger Hyppigheden af bivirkninger defineres som følger: meget almindelig (≥1/10); almindelig (≥1/100 til
English: Envarsus doses are usually reduced in the post-transplant period.
Danish: Doseringen af Envarsus reduceres sædvanligvis i perioden efter transplantationen.
English: The tablets should be swallowed whole with fluid (preferably water) immediately following removal from the blister.
Danish: Tabletterne skal indtages hele med væske (helst vand) umiddelbart efter fjernelse fra blisteren.
English: Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel.
Danish: Behandling med tacrolimus kræver omhyggelig overvågning af velkvalificeret og specielt uddannet personale.
English: There is a risk for premature delivery (<37 week) (incidence of 66 of 123 births, i.e. 53.7%; however, data showed that the majority of the newborns had normal birth weight for their gestational age) as well as for hyperkalaemia in the newborn (incidence 8 of 111 neonates, i.e. 7.2 %) which, however normalises spontaneously.
Danish: Der er risiko for præmatur fødsel (<37 uger) (forekomst hos 66 ud af 123 fødsler, dvs. 53,7 %; data har dog vist, at størstedelen af de nyfødte havde normal fødselsvægt for deres gestationelle alder) samt for hyperkaliæmi hos den nyfødte (forekomst hos 8 ud af 111 nyfødte, dvs. 7,2 %), hvilket dog normaliseres spontant).
English: The frequency of blood level monitoring should be based on clinical needs.
Danish: Hyppigheden af blodkoncentrationsmålinger skal baseres på det kliniske behov.
English: The oral bioavailability of Envarsus was decreased when the medicinal product was administered after a meal; the extent of absorption was decreased by 55% and the maximum plasma concentration was decreased by 22% when taken directly after a high-fat meal.
Danish: Den orale biotilgængelighed af Envarsus faldt, når lægemidlet blev administreret efter et måltid; omfanget af absorption faldt med 55 % og den maksimale plasmakoncentration faldt med 22 %, når præparatet blev taget direkte efter et måltid med højt fedtindhold.
English: As gastrointestinal perforation is a medically important event that may lead to a life-threatening or serious condition, adequate treatments should be considered immediately after suspected symptoms or signs occur.
Danish: Da gastrointestinal perforation er en vigtig bivirkning, som kan føre til en livstruende eller alvorlig tilstand, bør passende behandling overvejes umiddelbart efter forekomsten af formodede symptomer eller tegn.
English: Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine.
Danish: Sørg for, at du får samme tacrolimus-medicin hver gang du henter din recept, medmindre speciallægen i transplantation har aftalt at skifte over til en anden type tacrolimus-medicin.
English: The combined administration of ciclosporin and tacrolimus is not recommended.
Danish: Den kombinerede administration af ciclosporin og tacrolimus kan ikke anbefales.
English: These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating hepatic or renal function or neurological symptoms.
Danish: Disse infektioner er ofte relateret til en høj total immunsuppressiv belastning og kan føre til alvorlige eller fatale tilstande, som læger bør overveje i differentialdiagnosticeringen af immunsupprimerede patienter med forringet lever- eller nyrefunktion eller neurologiske symptomer.
English: Envarsus may have a minor influence on the ability to drive and use machines.
Danish: Envarsus påvirker kun i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: It is not recommended that Envarsus is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Danish: Det frarådes at tage Envarsus sammen med ciclosporin (et andet lægemiddel, der anvendes til forebyggelse af afstødning af transplanterede organer).
English: After opening the aluminium foil wrapper: 45 days.
Danish: Efter åbning af alufolieemballage: 45 dage.
English: Tacrolimus treatment can be considered in pregnant women when there is no safer alternative, and when the perceived benefit justifies the potential risk to the foetus.
Danish: Behandling med tacrolimus kan overvejes til gravide kvinder, når der ikke findes andre sikre alternativer, og når de forventede fordele opvejer den potentielle risiko for fosteret.
English: In vitro test results indicate that there is no risk of in vivo dose dumping related to alcohol intake.
Danish: In vitro-testresultater indikerer, at der ikke er nogen risiko for in vivo-dosisdumpning i forbindelse med indtagelse af alkohol.
English: Clinically significant interactions have also been observed with phenobarbital.
Danish: Der er også observeret klinisk signifikante interaktioner med fenobarbital.
English: Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Danish: Positiv EBV-PCR kan vedvare i flere måneder, men er ikke som sådan indikation på lymfoproliferativ sygdom eller lymfom.
English: - The importance of avoiding inadvertent switching between tacrolimus containing products and the risk of under and overdosing if monitoring is inadequate.
Danish: - Vigtigheden af at undgå utilsigtet skift mellem tacrolimus-indeholdende produkter og risikoen for under- og overdosering, hvis monitorering er utilstrækkelig.
English: Accordingly, high-risk patients receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9-12 months).
Danish: Derfor skal højrisikopatienter, der behandles med betydelig immunsuppression, monitoreres med sådanne procedurer som ekkokardiografi eller ekg før og efter transplantationen (f.eks. initialt efter 3 måneder og derefter efter 9-12 måneder).
English: These may worsen kidney or nervous system problems when taken together with Envarsus.
Danish: Disse midler kan forværre problemer med nyrerne eller nervesystemet, hvis de tages sammen med Envarsus.
English: As with other immunosuppressive agents, owing to the potential risk of malignant skin changes, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Danish: Som med andre immunsuppressive lægemidler, på grund af den potentielle risiko for maligne hudændringer, bør eksponering for sollys eller UV-lys begrænses ved at benytte passende beskyttende beklædning og ved brug af solcreme med høj solfaktor.
English: Lactose monohydrate Macrogol 6000
Danish: Hypromellose Lactosemonohydrat Macrogol 6000
English: The safety and efficacy of Envarsus in children below 18 years of age have not yet been established.
Danish: Envarsus' sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly.
Danish: Halveringstiden for ciclosporin forlænges, når tacrolimus gives samtidig.
English: Following the initiation of your treatment with this medicine, frequent blood tests will be taken by your doctor to define the correct dose.
Danish: Efter begyndelsen af din behandling med dette lægemiddel vil din læge hyppigt tage blodprøver for at bestemme den korrekte dosis.
English: Caution should be exercised in patients with diagnosed or suspected Congenital Long QT Syndrome.
Danish: Der skal udvises forsigtighed hos patienter med diagnosticeret eller mistanke om medfødt langt QT-syndrom.
English: Some cases have reported resolution on switching to alternative immunosuppression.
Danish: I nogle tilfælde er der rapporteret, at det gik over ved skift til alternativ immunsuppression.
English: Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments.
Danish: Tacrolimus er et meget potent immunosuppressivt middel med påvist aktivitet i både in vitro- og in vivo- eksperimenter.
English: Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Danish: Monitorering af dalkoncentrationerne i fuldblod giver derfor et godt estimat af den systemiske eksponering.
English: Tell your doctor immediately if during treatment you suffer from: - problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Danish: Fortæl straks din læge, hvis du under behandlingen lider af: - problemer med syn, såsom sløret syn, ændring i farvesynet, problemer med at se detaljer eller hvis dit synsfelt bliver begrænsest.