FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should therefore remain continuously informed by responsible representatives for their local laboratory on the performance of the locally used method for concentration determination of sirolimus.
Danish: Lægerne skal derfor fortsætte med løbende at blive informeret af repræsentanter for deres lokale laboratorium om udførelsen af de lokalt anvendte metoder til bestemmelse af sirolimuskoncentrationen.
English: Patients with symptomatic ovarian cysts should be referred for further evaluation.
Danish: Patienter med symptomatiske ovariecyster bør henvises til yderligere udredning.
English: At 12, 24 and 36 months, graft and patient survival were similar for both groups.
Danish: I måned 12, 24 og 36 var transplantat- og patientoverlevelsen den samme for begge grupper.
English: If you miss a dose of Rapamune completely, you should inform your doctor.
Danish: Hvis De glemmer en dosis Rapamune fuldstændigt, skal De fortælle det til Deres læge.
English: The following list of adverse reactions is based on experience from clinical studies and on postmarketing experience.
Danish: Nedenstående liste over bivirkninger er baseret på erfaringer fra kliniske forsøg og erfaringer efter markedsføringen.
English: However, the development of such special dosing recommendations for children requires more data to be definitely confirmed.
Danish: Sådanne særlige anbefalinger om dosering til børn kræver imidlertid flere data for at blive udviklet og endeligt bekræftet.
English: Sirolimus in combination with other immunosuppressive agents has not been extensively investigated.
Danish: Sirolimus i kombination med andre immunsuppressiva er ikke blevet grundigt undersøgt.
English: Maintenance doses of 4 mg or less contain small amounts of ethanol (100 mg or less) that are likely to be too low to be harmful.
Danish: Vedligeholdelsesdoser på 4 mg eller derunder indeholder små mængder ethanol (100 mg eller mindre), som sandsynligvis er for lave til at være skadelige.
English: Non-melanoma skin cancer*
Danish: Non-melanom hudkræft*
English: Pfizer Service Company bvba Hoge Wei 10, B-1930 Zaventem Belgium
Danish: Pfizer Service Company bvba Hoge Wei 10, B-1930 Zaventem Belgien
English: Always take the labelled medicine bottle with you, even if it is empty.
Danish: Tag altid den mærkede medicinflaske med, også selv om den er tom.
English: Clear polyvinyl chloride (PVC)/polyethylene (PE)/polychlorotrifluoroethylene (Aclar) aluminium blister packages of 30 and 100 tablets.
Danish: Klar polyvinylchlorid (PVC)/polyethylen (PE)/polychlorotrifluoethylen (Aclar) aluminium blisterpakninger med 30 og 100 tabletter.
English: An abbreviated dosing schedule of daclizumab was used in one of the studies.
Danish: Der blev anvendt en kortere doseringsplan for daclizumab i et af forsøgene.
English: Use within 30 days after opening bottle.
Danish: Anvendes inden 30 dage efter åbning af flasken.
English: For skin carcinoma, the median time to first occurrence was significantly delayed.
Danish: I forbindelse med hudkarcinom er den gennemsnitlige tid til første forekomst signifikant forlænget.
English: Optimal therapy requires therapeutic concentration monitoring of the medicinal product in all patients.
Danish: Optimal behandling kræver monitorering af terapeutisk lægemiddelkoncentration hos alle patienter.
English: The incidence of ovarian cysts may be higher in premenopausal females compared to postmenopausal females.
Danish: Incidensen af ovariecyster kan være højere hos præmenopausale end hos postmenopausale kvinder.
English: The efficacy and safety data are too limited to allow specific recommendations for use of sirolimus in Black recipients.
Danish: Effekt- og sikkerhedsdata er begrænset til at give specifikke anbefalinger for brugen af sirolimus til negroide patienter.
English: Stir vigorously and drink at once.
Danish: Omrøres kraftigt og drikkes med det samme.
English: Careful attention should be made to clinical signs/symptoms, tissue biopsies, and laboratory parameters.
Danish: Der bør være en nøje overvågning af kliniske tegn/symptomer, vævsbiopsier og laboratorieparametre.
English: The presence of this haze does not affect the quality of Rapamune.
Danish: Dette tågede udseende påvirker ikke kvaliteten af Rapamune.
English: The systemic availability of sirolimus in combination with simultaneously administered ciclosporin (Sandimune) is approximately 14%.
Danish: Den systemiske tilgængelighed af sirolimus i kombination med samtidig administration af ciclosporin (Sandimmun) er ca. 14%.
English: If you are also taking ciclosporin, then you must take the two medicines approximately 4 hours apart.
Danish: Hvis De også tager ciclosporin, skal der gå ca. 4 timer mellem, at De tager de to lægemidler.
English: Rapamune contains the active substance sirolimus, which belongs to a group of medicines called immunosuppressants.
Danish: Rapamune indeholder det aktive stof sirolimus, som hører til en gruppe lægemidler, der kaldes immunhæmmere.
English: Always take the labelled blister with you, even if it is empty.
Danish: Tag altid den mærkede blisterpakning med, også selv om den er tom.
English: If an estimated daily dose exceeds 40 mg due to the addition of a loading dose, the loading dose should be administered over 2 days.
Danish: Hvis en forventet daglig dosis overstiger 40 mg på grund af tilføjelse af en støddosis, så bør støddosis gives over 2 dage.
English: Your doctor will give you an initial dose of 6 mg as soon as possible after the kidney transplant operation.
Danish: Deres læge vil normalt give en indledende dosis på 6 mg så hurtigt som muligt efter nyretransplantationen.
English: Use within 24 hours after filling the dosing syringe.
Danish: Anvendes inden 24 timer efter fyldning af doseringssprøjten.
English: Cytomegalovirus (CMV) prophylaxis is recommended for 3 months after renal transplantation, particularly for patients at increased risk for CMV disease.
Danish: Profylakse mod cytomegalovirus (CMV) anbefales i 3 måneder efter nyretransplantation, specielt til patienter med forhøjet risiko for CMV-sygdom.
English: The most common symptom of S-LAM is shortness of breath.
Danish: Det mest almindelige symptom i forbindelse med S-LAM er åndenød.
English: There is insufficient experience to recommend the use of Rapamune in children and adolescents (see section 4.2).
Danish: Der er ikke tilstrækkelig erfaring til at anbefale brugen af Rapamune til børn og unge (se afsnit 4.2).
English: Partly reversible reductions in sperm counts were reported in a 13-week rat study.
Danish: Delvist reversible reduktioner i sædtal er rapporteret i et 13 uger langt rotteforsøg.
English: Food can affect the amount of medicine that gets into your bloodstream, and taking your medicine in a consistent way means that the blood levels of Rapamune remain more stable.
Danish: Mad kan påvirke mængden af medicin, der når ud i blodbanen, og ved at tage Deres medicin på en konsekvent måde bliver niveauet af Rapamune i blodet mere stabilt.
English: The active substance is sirolimus.
Danish: Aktivt stof: sirolimus.
English: The dosing syringe should be used to withdraw the prescribed amount of Rapamune from the bottle.
Danish: Doseringssprøjten skal anvendes til udtagelse af den foreskrevne mængde Rapamune fra flasken.
English: Magnesium stearate Talc
Danish: Magnesiumstearat Talcum
English: Neuroendoc rine carcinoma of the skin*
Danish: Neuroendokri nt karcinom i huden*
English: Since results are assay and laboratory dependent, and the results may change over time, adjustment to the targeted therapeutic range must be made with a detailed knowledge of the site-specific assay used.
Danish: Eftersom resultaterne er analyse- og laboratorieafhængige, og da resultaterne kan ændre sig over tid, skal tilpasningen til det tilstræbte terapeutiske niveau ske med detaljeret viden om, hvilken specifik analyse der er anvendt.
English: Patients allergic to peanut or soya must not take this medicine.
Danish: Patienter, som er allergiske over for jordnødder eller soja må ikke tage dette lægemiddel.
English: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee 1
Danish: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mosswaldallee 1
English: if you are allergic to sirolimus or any of the other ingredients of this medicine (listed in section 6).
Danish: hvis De er allergisk over for sirolimus eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Rapamune is for oral use only.
Danish: Rapamune er udelukkende til oral indtagelse.
English: Although the results of a single-dose interaction study with an oral contraceptive suggest the lack of a pharmacokinetic interaction, the results cannot exclude the possibility of changes in the pharmacokinetics that might affect the efficacy of the oral contraceptive during long-term treatment with Rapamune.
Danish: Skønt resultaterne af interaktionsforsøg med en enkelt dosis af et oralt antikonceptiva ikke tyder på farmakokinetisk interaktion, kan resultaterne ikke udelukke ændringer i farmakokinetikken, som kan påvirke effekten af orale antikonceptiva ved langtidsbehandling med Rapamune.
English: Do not crush, chew, or split the tablets.
Danish: De må ikke knuse, tygge eller dele tabletterne.
English: Seven major metabolites, including hydroxyl, demethyl, and hydroxydemethyl, are identifiable in whole blood.
Danish: 7 hovedmetabolitter, herunder hydroxyl, demethyl og hydroxydemethyl kan identificeres i fuldblod.
English: Insert the syringe adapter into the bottle until it is flush with the top of the bottle.
Danish: Sæt sprøjteadapteren i flasken, indtil den er på linie med flaskens top.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markdsføringstilladelsen:
English: Sirolimus is extensively metabolised by O-demethylation and/or hydroxylation.
Danish: Sirolimus metaboliseres i vid udstrækning af O-demetylering og/eller hydroxylering.
English: Therefore, antimicrobial prophylaxis for Pneumocystis carinii pneumonia should be administered for the first 12 months following transplantation.
Danish: Antimikrobiel profylakse mod Pneumocystis jiroveci pneumoni bør derfor gives i de første 12 måneder efter transplantationen.
English: Instructions for use and handling:
Danish: Eventuelle instruktioner vedrørende anvendelse og håndtering:
English: Rapamune contains ethanol (alcohol)
Danish: Rapamune indeholder ethanol (alkohol)
English: Impairments of sperm parameters have been observed among some patients treated with Rapamune.
Danish: Der har været observeret forringede spermparametre hos nogle patienter behandlet med Rapamune.
English: If you forget to take Rapamune, take it as soon as you remember, but not within 4 hours of the next dose of ciclosporin.
Danish: Hvis De glemmer at tage Rapamune, skal De tage medicinen, så snart De kommer i tanke om det, men ikke hvis De skal have Deres næste dosis ciclosporin inden for 4 timer.
English: The effect of CsA was also reflected by increases in sirolimus Cmax and tmax.
Danish: Effekten af CsA afspejles også i øget sirolimus-Cmax og -tmax.
English: Rapamune oral solution contains soya oil.
Danish: Rapamune oral opløsning indeholder sojaolie.
English: Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist.
Danish: Behandling bør påbegyndes og fortsættes under ledelse af en passende kvalificeret specialist.
English: Patients can be switched from Rapamune oral solution to the tablet formulation on a mg per mg basis.
Danish: Patienterne kan skiftes fra Rapamune oral opløsning til tabletformuleringen på mg til mg basis.
English: If necessary, the patient may store the bottles at room temperatures up to 25C for a short period of time (24 hours).
Danish: Hvis nødvendigt kan patienten opbevare flasken ved stuetemperatur på op til 25°C i en kort periode (24 timer).
English: Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives en dosisanbefaling.
English: Do not attempt to remove the syringe adapter from the bottle once inserted.
Danish: Forsøg ikke at fjerne sprøjteadapteren fra flasken, efter at den er sat i.
English: The difference in bioavailability was less marked upon steady-state administration to renal transplant recipients, and therapeutic equivalence has been demonstrated in a randomised study of 477 patients.
Danish: Forskellen i biotilgængeligheden er mindre tydelig ved steady-stateindgivelse til nyretransplanterede patienter, og terapeutisk ækvivalens er påvist i et randomiseret forsøg af 477 patienter.
English: Pfizer Ireland Pharmaceuticals Little Connell, Newbridge, Co. Kildare Ireland
Danish: Pfizer Ireland Pharmaceuticals Little Connell, Newbridge, Co. Kildare Irland
English: It is recommended that Rapamune be administered 4 hours after ciclosporin (microemulsion).
Danish: Det anbefales, at Rapamune indgives 4 timer efter ciclosporin (mikroemulsion).
English: Undesirable effects observed with patients with S-LAM
Danish: Bivirkninger observeret hos patienter med S-LAM
English: As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Danish: Som normalt for patienter med øget risiko for hudkræft bør udsættelse for sollys og ultraviolet (UV-) lys begrænses ved at bære beskyttende tøj og bruge solcreme med høj beskyttelsesfaktor.
English: In addition, re-transplant recipients whose previous grafts survived for at least 6 months after transplantation were included.
Danish: Yderligere blev gen-transplanterede patienter, hvis tidligere donororgan havde overlevet mindst 6 måneder efter transplantation, inkluderet.
English: The recommended 24-hour trough concentration ranges for sirolimus are based on chromatographic methods.
Danish: De anbefalede 24-timers dalkoncentrationsintervaller af sirolimus er baseret på kromatografiske metoder.
English: Treatment emergent adverse events occurred more frequently during the first 6 months after Rapamune conversion.
Danish: Bivirkninger opstået under behandling opstår hyppigere i de første 6 måneder efter skift til Rapamune.
English: Among 89 patients known to be Epstein-Barr virus (EBV) seronegative prior to transplantation, 13 (15.6%) were reported to have developed PTLD.
Danish: Af de 89 patienter, der var konstateret Epstein-Barr virus (EBV-) seronegative inden transplantationen, udviklede 13 (15,6%) PTLD.
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 renal function or neurological symptoms.
Danish: Disse infektioner er ofte relateret til en høj, total immunsuppressiv belastning og kan føre til alvorlige eller livstruende tilstande, som læger bør overveje ved en differentialdiagnose hos immunsuppressive patienter med forringet nyrefunktion eller neurologiske symptomer.
English: Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist in transplantation.
Danish: Behandling bør påbegyndes og fortsættes under ledelse af en passende kvalificeret specialist inden for transplantation.
English: Talk to your doctor or pharmacist before taking Rapamune
Danish: Kontakt lægen eller apoteket, før De tager Rapamune
English: Rapamune should be given with corticosteroids.
Danish: Rapamune bør gives sammen med kortikosteroider.
English: If you prefer to take Rapamune without food, then you should always take it without food.
Danish: Hvis De foretrækker at tage Rapamune uden mad, skal De altid tage det uden mad.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter “EXP”.
English: S-LAM is a rare progressive lung disease that affects predominantly women of childbearing age.
Danish: S-LAM er en sjælden progressiv lungesygdom, der hovedsageligt rammer kvinder i den fødedygtige alder.
English: It helps to control your body's immune system after you have received a kidney transplant.
Danish: Lægemidlet hjælper med at kontrollere kroppens immunsystem efter en nyretransplantation.
English: Patients initiated on ramipril 10 mg had a higher rate of BCAR (15%) compared to patients initiated on ramipril 5 mg (5%).
Danish: Patienter, som initialt fik ramipril 10 mg, havde en højere hyppighed af BCAR (15%) sammenlignet med patienter, som initialt fik Ramipril 5 mg (5%).
English: The key inclusion criteria was post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤70% of predicted during the baseline visit.
Danish: Det centrale inklusionskriterie var forceret eksspiratorisk volumen (FEV1) efter bronkiedilatation i 1 sekund på ≤70 % af det forventede ved baseline-besøget.
English: Exposure to sunlight and UV light should be limited by covering your skin with clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer.
Danish: Udsættelse for sollys og UV-stråler bør begrænses ved at dække huden med tøj og bruge solcreme med høj beskyttelsesfaktor på grund af den øgede risiko for hudkræft.
English: 30 dosing syringes 1 syringe adapter 1 carrying case
Danish: 30 doseringssprøjter 1 sprøjteadapter 1 transportæske
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opført efter systemorganklasse og hyppighed (antal patienter, som forventes at opleve en bivirkning) ved brug af følgende kategorier: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In particular, you should inform your doctor or pharmacist if you are taking any of the following:
Danish: De bedes især informere lægen eller apotekspersonalet, hvis De tager noget af følgende:
English: It is known that malignancies (lymphoma) secondary to the chronic use of immunosuppressive agents can occur and have been reported in patients in rare instances.
Danish: Det er kendt, at maligne sygdomme (lymfom) sekundært til kronisk anvendelse af immunsuppressiva, kan forekomme og er rapporteret hos patienter i sjældne tilfælde.
English: There is limited information indicating that Black renal transplant recipients (predominantly African-American) require higher doses and trough levels of sirolimus to achieve the same efficacy as observed in non-Black patients.
Danish: Der er begrænsede oplysninger, som tyder på, at negroide nyretransplanterede patienter (hovedsageligt afro-amerikanere) har brug for højere doser og højere dalkoncentrationer af sirolimus for at opnå samme effekt som observeret hos ikke-negroide patienter.
English: In patients for whom ciclosporin withdrawal is either unsuccessful or cannot be attempted, the combination of ciclosporin and Rapamune should not be maintained for more than 3 months post-transplantation.
Danish: Hos patienter, hvor ophør med ciclosporin enten er mislykkedes eller ikke kan forsøges, bør kombinationen af ciclosporin og Rapamune ikke fortsætte mere end 3 måneder efter transplantationen.
English: Rapamune, like other immunosuppressive medicines, may decrease your body's ability to fight infection, and may increase the risk of developing cancer of the lymphoid tissues and skin.
Danish: - Rapamune kan, som al anden immunhæmmende medicin, nedsætte kroppens evne til at bekæmpe infektioner og kan øge risikoen for kræft i lymfevæv og hud.
English: If you prefer to take Rapamune with food, then you should always take it with food.
Danish: Hvis De foretrækker at tage Rapamune sammen med mad, skal De altid tage det med mad.
English: Once the contents of the dosing syringe have been diluted with water or orange juice, the preparation should be drunk immediately.
Danish: Når indholdet af doseringssprøjten er blevet fortyndet med vand eller appelsinjuice, skal opløsningen drikkes straks.
English: Pancreatitis; Stomatitis; Ascites
Danish: Pankreatitis, stomatitis, ascites
English: Instructions on how to dilute Rapamune
Danish: Vejledning i hvordan man fortynder Rapamune
English: Sirolimus levels should be monitored, and appropriate dose reductions of both medicinal products should be considered.
Danish: Sirolimusniveauet skal monitoreres, og passende dosisreduktion af begge lægemidler bør overvejes.
English: Pharmacokinetic/pharmacodynamic relationship
Danish: Farkakokinetiske/farmakodynamiske forhold
English: No clinically significant pharmacokinetic interaction was observed between Rapamune oral solution and 0.3 mg norgestrel/0.03 mg ethinyl estradiol.
Danish: Der ses ingen klinisk signifikant, farmakokinetisk interaktion mellem Rapamune oral opløsning og 0,3 mg norgestrel/0,03 mg ethinylestradiol.
English: Most patients were on immunosuppressive regimens, which included Rapamune in combination with other immunosuppressive agents.
Danish: De fleste patienter var i immunsuppressiv behandling, der inkluderede Rapamune i kombination med andre immunsuppressive lægemidler.
English: There is limited experience on the use of Rapamune in children and adolescents less than 18 years of age.
Danish: Der er begrænset erfaring med brug af Rapamune til børn og unge under 18 år.
English: The target for trough concentrations was 10-20 ng/mL.
Danish: Målet for dalkoncentrationerne var 10-20 ng/ml.
English: Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.
Danish: Selv om behandling med Rapamune ikke forventes at påvirke evnen til at køre bil, skal De tale med lægen, hvis De er bekymret for dette.
English: Caution should be exercised when co-administering other agents that are known to have a deleterious effect on renal function.
Danish: Der bør udvises forsigtighed ved samtidig indgivelse af andre lægemidler, som er kendt for at have en skadelig virkning på nyrefunktionen.
English: In an open-label, randomised, comparative, multi-centre study where renal transplant patients were either converted from tacrolimus to sirolimus 3 to 5 months post-transplant or remained on tacrolimus, there was no significant difference in renal function at 2 years.
Danish: I et åbent, randomiseret, komparativt multicenterforsøg, hvor nyretransplanterede patienter enten blev skiftet fra tacrolimus til sirolimus 3 til 5 måneder efter transplantation eller forblev på tacrolimus, var der ingen signifikant forskel i nyrefunktion efter 2 år.
English: The primary endpoint was the difference between the groups in the rate of change (slope) in FEV1.
Danish: Det primære endepunkt var forskellen i ændringsraten (hældning) i FEV1 mellem grupperne.
English: In 24 healthy volunteers receiving Rapamune tablets with a high-fat meal, Cmax, tmax and AUC showed increases of 65%, 32%, and 23%, respectively.
Danish: Hos 24 raske frivillige personer, som fik Rapamune tabletter og et måltid med højt fedtindhold, viste Cmax, tmax og AUC stigninger på henholdsvis 65%, 32% og 23%.
English: If it is necessary to carry your medication with you, fill the dosing syringe to the appropriate mark and place a cap securely on it - the cap should snap into place.
Danish: Hvis De er nødt til at tage Deres medicin med Dem, fyldes doseringssprøjten til det rette sted, og hætten sættes forsvarligt på - hætten skal klikke på plads.