FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births (0.05-0.1%).
Danish: Forekomsten af neuralrørsdefekter i befolkningen generelt er 0,5-1 tilfælde pr. 1.000 levendefødte børn (0,05-0,1 %).
English: Dolutegravir was shown to cross the placenta in animals.
Danish: Det er påvist, at dolutegravir passerer placenta hos dyr.
English: If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
Danish: Hvis du oplever humørsvingninger og depressive symptomer, skal du kontakte din læge for yderligere rådgivning så hurtigt som muligt.
English: Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide.
Danish: Depression kan være alvorligt og er en velkendt risikofaktor for selvmordsadfærd og selvmord.
English: Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
Danish: Kvinder bør rådes til at kontakte deres læge, hvis de oplever humørsvingninger og depressive symptomer, herunder kort tid efter behandlingsstart.
English: • abnormal levels of fats (lipids) in the blood
Danish: Unormalt indhold af fedt (lipider) i blodet
English: Some women using hormonal contraceptives including {product name} have reported depression or depressed mood.
Danish: Nogle kvinder, der anvender hormonelle præventionsmidler, herunder {produktnavn}, har rapporteret om depression eller nedtrykthed.
English: New product information wording - Extracts from PRAC recommendations on signals
Danish: Ny ordlyd til produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler
English: Due to the potential risk of neural tube defects, dolutegravir should not be used during the first trimester unless there is no alternative.
Danish: På grund af den potentielle risiko for neuralrørsdefekter bør dolutegravir ikke anvendes i det første trimester, medmindre der ikke findes andre muligheder.
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir at the time of conception compared with mothers exposed to non-dolutegravir containing regimens (0.1%).
Danish: Foreløbige data fra et overvågningsstudie peger på øget forekomst af neuralrørsdefekter (0,9 %) hos mødre, der eksponeres for dolutegravir på undfangelsestidspunktet, sammenholdt med mødre, der eksponeres for regimer, som ikke indeholder dolutegravir (0,1 %).
English: If you could get pregnant while receiving {product name}, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Danish: Hvis du kan blive gravid, mens du får {produktnavn}, skal du bruge sikker prævention i form af en barrieremetode (f.eks. kondom) sammen med en anden præventionsmetode, herunder p-piller eller andre hormonelle præventionsmidler (fx implantat, injektion) for at undgå graviditet.
English: Direct acting antivirals (DAAV) indicated for the treatment of hepatitis C2 - Dysglycaemia (EPITT no 19234)
Danish: Direkte virkende antivirale lægemidler (DAA'er) til behandling af hepatitis C2 - dysglykæmi (EPITT-nr. 19234)
English: Dolutegravir should only be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus.
Danish: Dolutegravir bør derfor kun bruges i andet og tredje trimester af en graviditet, hvis de forventede fordele opvejer de potentielle risici for fosteret.
English: However, as the mechanism by which dolutegravir may interfere in human pregnancy is unknown, the safety in use during the second and third trimester cannot be confirmed.
Danish: Men da mekanismen bag dolutegravirs eventuelle indvirkning på graviditetsforløbet hos mennesker ikke kendes, kan sikkerheden ved brug af lægemidlet i andet og tredje trimester ikke bekræftes.
English: Teriflunomide - Dyslipidaemia (EPITT no 19227)
Danish: Teriflunomid - dyslipidæmi (EPITT-nr. 19227)
English: As neural tube defects occur within the first 4 weeks of foetal development (at which time the neural tubes are sealed) this potential risk would concern women exposed to dolutegravir at the time of conception and in early pregnancy.
Danish: Da neuralrørsdefekter opstår inden for de første 4 uger af fosterets udvikling (hvor neuralrørene forsegles), vedrører denne potentielle risiko kvinder, der eksponeres for dolutegravir på undfangelsestidspunktet og i den tidlige graviditet.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like {product name}.
Danish: Nogle patienter med diabetes har oplevet lavt blodsukker (hypoglykæmi) efter påbegyndelse af behandling med lægemidler som {produktnavn}.
English: What you need to know before you take {product name} Warnings and precautions
Danish: Det skal du vide, før du begynder at tage {produktnavn} Advarsler og forsigtighedsregler
English: More than 1000 outcomes from second and third trimester exposure in pregnant women indicate no evidence of increased risk of malformative and foeto/neonatal negative effects.
Danish: Mere end 1.000 graviditetsudfald efter eksponering af de pågældende kvinder i andet og tredje trimester peger ikke på nogen øget risiko for misdannelser og negative virkninger hos fosteret/den nyfødte.
English: Glucose levels of diabetic patients initiating {direct acting antiviral / DAA} therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Danish: Blodsukkeret hos patienter med diabetes, der påbegynder behandling med {direkte virkende antivirale lægemidler/DAA'er}, bør overvåges nøje, navnlig inden for de første 3 måneder, og patienternes diabetesmedicinering bør om nødvendigt ændres.
English: In animal reproductive toxicology studies, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Danish: I studier af reproduktionstoksicitet hos dyr er der ikke set negative indvirkninger, herunder neuralrørsdefekter, på afkommets udvikling (se pkt.
English: Dolutegravir - Evaluation of preliminary data from an observational study on birth outcomes in human immunodeficiency virus (HIV)-infected women (EPITT no
Danish: Dolutegravir - evaluering af foreløbige data fra et observationsstudie af udfaldet af graviditet hos kvinder med humant immundefektvirus (hiv) (EPITT-nr. 19244)
English: Undesirable effects Tabulated list of adverse reactions Metabolism and nutrition disorders Frequency ‘Not known'': Dyslipidaemia
Danish: Oversigt over bivirkninger Metabolisme og ernæring Hyppighed ikke kendt: Dyslipidæmi
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting {product name}.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med {produktnavn}.
English: The physician in charge of the diabetic care of the patient should be informed when {direct acting antiviral / DAA} therapy is initiated.
Danish: Den læge, der er ansvarlig for patientens diabetesbehandling, bør informeres, når behandling med {direkte virkende antivirale lægemidler/DAA'er} påbegyndes.
English: Warnings and precautions Talk to your doctor or pharmacist before taking this medicine if you: - Have diabetes.
Danish: Det skal du vide, før du begynder at tage {produktnavn} Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager dette lægemiddel: - hvis du har diabetes.
English: Hormonal contraceptives3 - Suicidality with hormonal contraceptives following a recent publication (EPITT no
Danish: Hormonelle præventionsmidler3 - suicidalitet ved brug af hormonelle præventionsmidler ifølge en nylig publikation (EPITT-nr. 19144)
English: WOCBP who are taking dolutegravir should use effective contraception throughout treatment.
Danish: Fertile kvinder, der tager dolutegravir, bør anvende sikker prævention under hele behandlingen.
English: What you need to know before you take {product name} Pregnancy
Danish: Det skal du vide, før du begynder at tage {produktnavn} Graviditet
English: Taking {product name} at the time of becoming pregnant or during the first twelve weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
Danish: Hvis du tager {produktnavn} på tidspunktet for undfangelse eller i de første tolv uger af graviditeten, kan det øge risikoen for en fødselsdefekt, der kaldes neuralrørsdefekt, hvor der f.eks. ses manglende sammenvoksning af rydraden.
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV {direct acting antiviral / DAA} treatment.
Danish: Patienter med diabetes kan opleve forbedret blodsukkerkontrol efter påbegyndelse af HCV-behandling med {direkte virkende antivirale lægemidler/DAA'er}, hvilket potentielt kan resultere i symptomatisk hypoglykæmi.
English: Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of dolutegravir.
Danish: Fertile kvinder bør have taget en graviditetstest inden påbegyndelse af behandling med dolutegravir.
English: Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see section 4.8).
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Nedtrykthed og depression er velkendte bivirkninger ved hormonelle præventionsmidler (se pkt.
English: -> Talk to your doctor about the risks and benefits of taking {product name}.
Danish: Hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid: -> Tal med lægen om risici og fordele ved at tage {produktnavn}.
English: Women of childbearing potential
Danish: Fertile kvinder
English: Please open here.
Danish: Åbnes her.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra en mikrobiologisk synsvinkel bør produktet anvendes med det samme.
English: Follow your doctor's instructions carefully.
Danish: Følg nøje din læges anvisninger.
English: Date of first authorisation: 09/10/1998 Date of latest renewal: 09/10/2008
Danish: Dato for første markedsføringstilladelse: 09/10/1998 Dato for sidste fornyelse: 09/10/2008
English: Powder: 3 years
Danish: Pulver: 3 år
English: The terminal half-life was 7.23.2 days.
Danish: Den terminale halveringstid var 7,23,2 dage.
English: Simulect can be given to children and adolescents.
Danish: Simulect kan gives til børn og unge.
English: The overall safety profiles were similar in both groups.
Danish: Den samlede sikkerhedsprofil var den samme i begge grupper.
English: In this situation, you may have received Simulect.
Danish: I denne situation har du muligvis fået Simulect.
English: Simulect may harm your baby.
Danish: Simulect, kan skade dit barn.
English: You must not be given Simulect if you are pregnant.
Danish: Du må ikke få Simulect, hvis du er gravid.
English: No mutagenic potential was observed in vitro.
Danish: In vitro blev der ikke observeret noget mutagent potentiale.
English: Elimination half-life was not influenced by age, gender, or race.
Danish: Elimineringshalveringstiden blev ikke påvirket af alder, køn eller race.
English: You will only be given two doses of Simulect.
Danish: Du vil kun få to doser af Simulect.
English: Compatibility with a number of infusion sets has been verified.
Danish: Kompatibilitet med et antal infusionssæt er blevet verificeret.
English: These will be given in hospital, around the time of your transplant operation.
Danish: Disse vil blive givet på hospitalet i tiden omkring selve transplantationen.
English: Do not use if foreign particles are present.
Danish: Må ikke anvendes hvis der er fremmede partikler tilstede.
English: INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION
Danish: INSTRUKTIONER TIL REKONSTITUERING OG ADMINISTRATION
English: Reconstituted products should be inspected visually for particulate matter prior to administration.
Danish: Rekonstituerede produkter skal tjekkes visuelt for partikler før administration.
English: Total body clearance was 4119 ml/h.
Danish: Den totale clearance var 4119 ml/t.
English: If you become pregnant during this time, despite the use of contraceptive measures, you should tell your doctor immediately.
Danish: Hvis du bliver gravid i denne tidsperiode, selvom du har brugt prævention, skal du straks fortælle det til din læge.
English: This solvent is used to dissolve the powder before it is given to you.
Danish: Denne solvens bruges til at opløse pulveret, før det gives til dig.
English: Centre de Biotechnologie 8 rue de l'Industrie 68330 Huningue France
Danish: Centre de Biotechnologie 8 rue de l'Industrie 68330 Huningue Frankrig
English: Breastfeeding must therefore be avoided.
Danish: Amning skal derfor undgås.
English: Neoplasms and infections
Danish: Neoplasmer og infektioner
English: - if you are pregnant or breast-feeding.
Danish: - hvis du er gravid eller ammer.
English: It is very important to tell your doctor before your transplant if you are pregnant or you think that you may be pregnant.
Danish: Det er meget vigtigt, at du fortæller din læge forud for transplantationen, hvis du er gravid eller overvejer, om du kan være gravid.
English: The volume of distribution at steady state was 8.64.1 l. The extent and degree of distribution to various body compartments have not been fully studied.
Danish: Fordelingsvolumen ved steady state var 8,64,1 l. Udbredelsen og graden af fordeling til forskellige compartments i kroppen er ikke blevet fuldstændigt undersøgt.
English: The dose for children who weigh less than 35 kg will be smaller than the dose usually given to adults.
Danish: Dosis til børn, der vejer mindre end 35 kg vil være mindre end den dosis, der sædvanligvis gives til voksne.
English: The reconstituted solution is isotonic.
Danish: Den opblandede opløsning er isotonisk.
English: Extension studies also showed that patients who experienced an acute rejection episode during the first year after transplantation experienced more graft losses and deaths over the five-year follow-up period than patients who had no rejection.
Danish: Forlængelsesstudier viste også, at patienter, der oplever en akut afstødningsperiode i løbet af det første år efter transplantionen, oplevede flere graft-tab og dødsfald i løbet af den 5 års opfølgningsperiode end patienter, der ikke havde afstødning.
English: Nevertheless, live vaccines are not recommended for immunosuppressed patients.
Danish: Ikke desto mindre anbefales levende vacciner ikke til immunsupprimerede patienter.
English: An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer.
Danish: En overdosering af Simulect giver sandsynligvis ingen øjeblikkelige bivirkninger, men det kan svække dit immunsystem i en længere periode.
English: Immunosuppressants reduce the body's response to anything that it sees as “foreign” - which includes transplanted organs.
Danish: Immunsuppressiva reducerer kroppens respons på alt som synes ”fremmed” - inklusive transplanterede organer.
English: These events were not influenced by basiliximab.
Danish: Disse tilfælde blev ikke påvirket af basiliximab.
English: There is accumulating evidence that a subgroup of patients is at an increased risk of developing hypersensitivity reactions.
Danish: Der er akkumulerende beviser for, at en undergruppe af patienter har en øget risiko for at udvikle overfølsomhedsreaktioner.
English: Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are being given Simulect, or during the 8 weeks afterwards, even if you do not think that they are related to the medicine.
Danish: Fortæl din læge eller sundhedspersonalet så tidligt som muligt, hvis du oplever nogle uventede symptomer, mens du får Simulect eller i løbet af de efterfølgende 8 uger, også selvom du ikke tror, at de er relateret til medicinen.
English: Your doctor will watch out for any effects on your immune system and treat them if necessary.
Danish: Din læge vil holde øje med dit immunforsvar og behandle det om nødvendigt.
English: Your doctor will check this for you and discuss with you the possibility of repeated treatment with Simulect.
Danish: Din læge vil undersøge dette for dig og diskutere muligheden for gentagen behandling med Simulect med dig.
English: If you are given too much Simulect
Danish: Hvis du får for meget Simulect
English: Compatibility with the following infusion sets has been verified:
Danish: Overensstemmelse med følgende infusionssæt er kontrolleret:
English: The following adverse reactions have been identified based on post-marketing spontaneous reports and are organised by system organ class.
Danish: Følgende bivirkninger er identificeret på baggrund af spontane post-marketingrapporter og er opdelt efter systemorganklasser.
English: Women of childbearing potential must use effective contraception during and up to 16 weeks after treatment.
Danish: Kvinder i den fertile alder skal anvende effektiv antikonception under og indtil 16 uger efter behandlingen.
English: There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Danish: Der er begrænsede data tilgængelige vedrørende anvendelsen af Simulect til ældre, men der er intet, der tyder på, at ældre patienter kræver en anden dosering end yngre voksne patienter.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på karton og etiket efter Udløbsdato/EXP.
English: Peak serum concentration following intravenous infusion of 20 mg over 30 minutes is 7.15.1 mg/l.
Danish: Peak serum koncentrationen efter intravenøs infusion af 20 mg over 30 minutter var 7,15,1 mg/l.
English: Infusion bag - Baxter minibag NaCl 0.9%
Danish: Infusionstaske - Baxter minitaske NaCl 0,9%
English: Your doctor may discuss this with you before you are given Simulect.
Danish: Din læge kan diskutere dette med dig, før du får Simulect.
English: Simulect should be administered under qualified medical supervision.
Danish: Simulect skal administreres under opsyn af kvalificeret medicinsk personale.
English: Inactivated vaccines may be administered to immunosuppressed patients; however, response to the vaccine may depend on the degree of the immunosuppression, therefore vaccination during treatment with Simulect may be less effective.
Danish: Inaktiverede vacciner kan gives til immunsupprimerede patienter, men responset på vaccinen kan afhænge af graden af immunsuppression, hvorfor vaccination under behandling med Simulect kan være mindre effektiv.
English: The adverse event profile remained comparable between treatment groups.
Danish: Bivirkningsprofilen forblev sammenlignelig mellem behandlingsgrupperne.
English: Of the 202 patients, 104 were randomised to basiliximab and 98 to placebo.
Danish: Ud af de 202 patienter blev 104 randomiseret til basiliximab og 98 til placebo.
English: Patients receiving Simulect must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity reactions.
Danish: Patienter i behandling med Simulect bør behandles i faciliteter udstyret og bemandet med egnet laboratorie og medicinsk support ressourcer, herunder medicin til behandling af alvorlige overfølsomhedsreaktioner.
English: It is given in hospital to adults, adolescents and children who are having a kidney transplant.
Danish: Det gives på hospitalet til voksne, unge og børn, der skal nyretransplanteres.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Danish: Da disse rapporter er indrapporteret frivilligt fra en population af ukendt størrelse, er det ikke altid muligt at give et pålideligt estimat for bivirkningernes hyppighed.
English: Children and adolescents (1-17 years)
Danish: Børn og unge (1-17 år)
English: As concentrations fall below this level, expression of the CD25 antigen returns to pretherapy values within 1-2 weeks.
Danish: Når koncentrationen falder til under denne værdi, vender udtrykkelsen af CD25 antigenet tilbage til før-behandling-niveauet indenfor 1-2 uger.
English: Elderly ( 65 years)
Danish: Ældre (65 år)
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Simulect, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Tell your doctor if you suspect you may have had an allergic reaction to any of these ingredients in the past.
Danish: Fortæl din læge, hvis du tror, du tidligere har haft en allergisk reaktion over for et af disse hjælpestoffer.
English: Discard the reconstituted solution if not used within 24 hours.
Danish: Kassér den opblandede opløsning, hvis den ikke er brugt inden for 24 timer.
English: Mannitol (E421) Glycine
Danish: Mannitol (E421) Glycin
English: Basiliximab does not cause myelosuppression.
Danish: Basiliximab forårsager ikke myelosuppression.
English: You will be given other medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids and after you leave hospital.
Danish: Du vil samtidig få anden medicin, som skal hjælpe til med at beskytte din nye nyre, såsom ciclosporin og kortikosteroider, og efter du forlader hospitalet.
English: The body's immune system thinks a transplanted organ is a foreign body and will try to reject it. Simulect works by stopping the immune cells that attack transplanted organs.
Danish: Kroppens immunforsvar ser et transplanteret organ som et fremmedlegeme og vil forsøge at afstøde det. Simulect virker ved, at hindre immunforsvarets celler, der angriber transplanterede organer.
English: Acute rejection occurred in 14.6% of patients by 6 months post-transplantation, and in 24.3% by 12 months.
Danish: Akut afstødning forekom hos 14,6 % af patienterne 6 måneder efter transplantationen og hos 24,3 % efter 12 måneder.
English: If you need to have a vaccination, seek your doctor's advice first.
Danish: Hvis du skal vaccineres, skal du først rådføre dig med din læge.
English: There is no animal or human data available concerning excretion of basiliximab into breast milk.
Danish: Der foreligger ingen data på dyr eller mennesker vedrørende udskillelse af basiliximab i mælk.
English: The use of live attenuated vaccines should therefore be avoided in patients treated with Simulect.
Danish: Anvendelse af levende svækkede vacciner skal derfor undgås til patienter i behandling med Simulect.
English: Talk to your doctor, nurse or pharmacist before you are given Simulect: - if you have previously received a transplant that failed after only a short time or, - if you have previously been in the operating theatre for a transplantation that in the end was not performed.
Danish: Kontakt lægen, sundhedspersonalet eller apotekspersonalet, før du får Simulect: - hvis du tidligere har fået transplanteret et organ, som svigtede efter kun kort tid eller, - hvis du tidligere har været på operationsbordet med henblik på en transplantation, der alligevel ikke blev gennemført.
English: No data are available on either the effects of live and inactive vaccination or the transmission of infection by live vaccines in patients receiving Simulect.
Danish: Der foreligger ingen data hverken for effekten af vaccination med levende eller inaktiveret vaccine eller for infektionsoverførsel fra levende vacciner hos patienter, som får Simulect.
English: Distribution volume and clearance are reduced by about 50% compared to adult renal transplantation patients.
Danish: Fordelingsvolumen og clearance er reduceret med omkring 50 % i forhold til voksne nyretransplanterede patienter.