FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to withdrawal periods for cattle, sheep and goats to provide assurance for consumer safety.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CVMP) konkluderede, at det overordnede forhold mellem fordele og risici (benefit/riskforhold) for de pågældende produkter er positivt, og anbefalede ændringer af tilbageholdelsestiderne for kvæg, får og geder af hensyn til forbrugernes sikkerhed.
English: The EU Member States shall ensure that:
Danish: EU-medlemslandene skal sikre at:
English: • Product information
Danish: • Produktinformation
English: Details of such a surveillance programme should be agreed with the National Competent Authorities in each member state and put in place prior to marketing of the product.
Danish: Enkelthederne i et sådant overvågningsprogram bør aftales med de kompetente nationale myndigheder i hver enkelt medlemsstat og være på plads før markedsføring af produktet.
English: • The need to tell their doctor that they are taking Thelin
Danish: • Nødvendigheden af at fortælle deres læge, at de tager Thelin.
English: • Physician information about Thelin
Danish: • Lægens information om Thelin
English: The physician information about Thelin should contain the following key elements:
Danish: Lægens information om Thelin bør indeholde følgende hovedelementer:
English: • The need to tell their doctor about any adverse events
Danish: • Nødvendigheden af at fortælle deres læge om alle uønskede hændelser.
English: • That Thelin is teratogenic
Danish: • At Thelin er teratogent.
English: Continue to monitor aminotransferases at least every 2 weeks.
Danish: Monitorering af aminotransferaser fortsættes mindst hver fjortende dag.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF
English: The Patient information card should include the following information
Danish: Informationskortet til patienten bør omfatte følgende information:
English: > 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
Danish: • > 8 x ULN: Behandlingen skal afbrydes, og behandling med Thelin bør ikke genoptages.
English: • The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant.
Danish: • Nødvendigheden af at kvindelige patienter kontakter deres behandlingslæge, straks efter at de får mistanke om, at de er gravide.
English: Partner of patient information card should include the following information: • That Thelin is teratogenic and that women of child bearing age must use effective contraception
Danish: Informationskortet til patientens partner bør omfatte følgende information: • At Thelin er teratogent, og at kvinder i den fødedygtige alder skal bruge sikker prævention.
English: • That the safety database of Thelin is limited and physicians are encouraged to enrol patients in a surveillance programme to increase knowledge about the incidence of important adverse drug reactions (ADRs).
Danish: • At sikkerhedsdatabasen for Thelin er begrænset, og at læger opfordres til at indskrive patienter i et overvågningsprogram med henblik på at øge kendskabet til forekomsten af væsentlige bivirkninger (ADR'er).
English: The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all doctors who intend to prescribe Thelin are provided with a physician information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal aftale enkelthederne i et kontrolleret distributionssystem med de kompetente nationale myndigheder og skal implementere et sådan program nationalt for at sikre, at alle læger, der har til hensigt at ordinere Thelin før ordinering får tilsendt en lægeinformationspakke, som indeholder følgende:
English: The surveillance programme should prompt doctors to report serious ADRs and certain selected ADRs as below immediately and other non-serious ADRs at three monthly intervals.
Danish: Overvågningsprogrammet bør tilskynde læger til at indberette alvorlige bivirkninger og visse bestemte bivirkninger, som er nævnt nedenfor, øjeblikkeligt samt andre ikke-alvorlige bivirkninger med tre måneders intervaller.
English: • That there is an interaction with ciclosporin A which may lead to higher blood concentration of Thelin and hence an increased risk of adverse reactions.
Danish: • At der er interaktion med ciclosporin, som kan medføre højere blodkoncentrationer af Thelin og således en øget risiko for bivirkninger.
English: o Contraindication in patients with elevated direct bilirubin > 2 x ULN prior to initiation of treatment.
Danish: o Kontraindikation hos patienter med forhøjet direkte bilirubin inden påbegyndelse af behandling (> 2 x ULN).
English: The information collected should include: o Anonymised patient details - age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Elevated direct bilirubin > 2 × ULN o Anaemia o Haemorrhage o Pregnancy and outcome o Pulmonary oedema (associated with veno-occlusive disease) o Suspected interactions o Unexpected ADRs according to the SPC.
Danish: Den indhentede information bør omfatte: o Anonymiserede patientoplysninger - alder, køn og ætiologi for PAH o Anden medicin o Årsager til ophør o Bivirkninger ○ Alle alvorlige bivirkninger ○ Stigning i leverenzymer til > 3 x ULN ○ Forhøjet direkte bilirubin > 2 x ULN ○ Anæmi ○ Hæmoragi ○ Graviditet og udfald ○ Lungeødem (forbundet med veneokklusiv sygdom) ○ Forventede interaktioner ○ Uventede bivirkninger i henhold til produktresumé.
English: The MAH shall set up a surveillance programme to collect information on: the demographics of patients prescribed Thelin, any adverse reactions and reasons for discontinuation of Thelin.
Danish: Indehaveren af markedsføringstilladelsen skal etablere et overvågningsprogram, der indsamler information om: demografien for de patienter, der ordineres Thelin, alle uønskede hændelser samt årsager til ophør med Thelin.
English: • That treatment with Thelin often causes a decrease in haemoglobin and related red cell parameters o Need for full blood count prior to use and monitoring at clinically appropriate intervals
Danish: • At behandling med Thelin ofte forårsager et fald i hæmoglobin og tilknyttede røde blodlegemers parametre o Nødvendigheden af undersøgelse af det samlede blodbillede før brug og kontrol med klinisk hensigtsmæssige intervaller.
English: • That Thelin is hepatotoxic and they will need to attend for regular blood tests
Danish: • At Thelin er levertoksisk, og at de er nødt til at møde op til regelmæssig blodprøvetagning.
English: If the aminotransferase levels return to pre-treatment values, reintroducing Thelin may be considered.
Danish: Hvis aminotransferasenivauerne returnerer til værdierne inden behandling, kan genoptagelse af Thelinbehandling overvejes.
English: • The need to ensure that women of child bearing age are using effective contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued
Danish: • At kvinder i den fødedygtige alder skal bruge sikker prævention, og at de skal informere deres læge om mulig graviditet, før udskrivning af en ny recept.
English: • Partner of patient information card
Danish: • Informationskort til patientens partner
English: If the aminotransferase levels return to pre-treatment values consider resuming the initial treatment schedule.
Danish: Hvis aminotransferaseniveauerne vender tilbage til niveauerne, inden indledning af behandlingen, bør genoptagelse af den initiale dosering overvejes.
English: • Patient information card
Danish: • Informationskort til patienten
English: • That Thelin is hepatotoxic o Need for liver function tests prior to and during treatment o Contraindication in patients with pre-existing hepatic impairment (Child-Pugh Class AC).
Danish: • At Thelin er hepatotoksisk o Nødvendigheden af leverfunktionstests før og i løbet af behandlingen.
English: > 5 and ≤ 8 × ULN: Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Danish: Ved bekræftelse skal behandlingen afbrydes, og aminotransferaseniveauer monitoreres mindst hver fjortende dag, indtil niveauerne normaliseres.
English: • That Thelin is teratogenic o Use of effective contraception in women of child bearing age o Possible interaction with oral contraceptives and increased risk of thromboembolism o Need to advise female patients about teratogenicity, contraception, if necessary the need for pregnancy testing and what to do if they become pregnant o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
Danish: o Nødvendigheden af at informere kvindelige patienter om risikoen for teratogenicitet, kontraception og om nødvendigt nødvendigheden af graviditetstests, samt om hvad de skal gøre, hvis de bliver gravide.
English: o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN): > 3 and ≤ 5 × ULN: Confirm by another liver test; if confirmed, a decision should be made on an individual basis to continue or to stop Thelin administration.
Danish: • > 3 ≤ 5 x ULN: Bekræft med ny levertest.
English: • Effect of Thelin on bleeding o Interaction with warfarin and vitamin K antagonists leading to an increased INR o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium oNeed for regular monitoring of INR oBe aware of the potential for haemorrhage and investigate as appropriate o Increased risk of epistaxis and gingival bleeding
Danish: • Thelins effekt på blødning o Interaktion med warfarin- og vitamin K-antagonister, der fører til en øget INR.
English: Blister (OPA/Alu/PVC) 60 tablets
Danish: EU/1/10/663/001 Lamivudin/Zidovudin Teva 150 mg/300 mg Filmovertrukket tablet Oral anvendelse blister (OPA/Alu/PVC) 60 tabletter EU/1/10/663/002 Lamivudin/Zidovudin Teva 150 mg/300 mg Filmovertrukket tablet Oral anvendelse flaske (HDPE)
English: EU number
Danish: EU-Nummer
English: Tablet container (HDPE) 60 tablets
Danish: 60 tabletter
English: This is especially important for infants and young children.
Danish: Dette er særligt vigtigt for spædbørn og små børn.
English: Date of first authorisation: 20 March 2001 Date of latest renewal: 20 March 2011
Danish: Dato for første tilladelse: 20. marts 2001 Dato for seneste fornyelse: 20. marts 2011
English: Black ‘O' ring
Danish: Sort ‘O' ring
English: This list is not intended to be inclusive or comprehensive.
Danish: Formålet med denne liste er ikke at være fyldestgørende eller altomfattende.
English: Instead, contact your doctor.
Danish: Kontakt din læge.
English: How much Kaletra should be taken and when?
Danish: Hvor meget Kaletra skal der tages og hvornår?
English: Gender, Race and Age
Danish: Køn, race og alder
English: The appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Danish: Passende doser for denne kombination, med hensyn til effekt og sikkerhed, er ikke fastlagt.
English: The following side effects have been reported by patients who took this medicine.
Danish: Følgende bivirkninger er rapporteret af patienter, som tog denne medicin.
English: How do I measure the correct dose?
Danish: Hvordan udmåles den korrekte dosis?
English: Your doctor will discuss with you and determine which medicines are best for you.
Danish: Din læge vil diskutere med dig og afgøre, hvilke lægemidler der er mest velegnede til dig.
English: Due to the possibility of undetected fructose intolerance, this medicinal product should only be given to babies and infants after consultation with a doctor.
Danish: På grund af uopdaget fruktose intolerans, bør dette lægemiddel kun gives til babyer og børn efter konsultation med en læge.
English: NC= Failure
Danish: NC= Fejl
English: It is not known whether this medicinal product is excreted in human milk.
Danish: Det vides ikke, om dette lægemiddel udskilles i human mælk.
English: It is recommended that INR (international normalised ratio) be monitored.
Danish: Det anbefales, at INR (internationalt normaliseringsforhold) overvåges.
English: Other medicines may also contain alcohol and alcohol may be consumed in food and drinks.
Danish: Andre lægemidler kan også indeholde alkohol og alkohol kan indtages med mad og drikke.
English: These medicinal products include:
Danish: Disse lægemidler indbefatter:
English: • Do not take Kaletra if you are currently taking avanafil or vardenafil.
Danish: • Tag ikke Kaletra, hvis du i øjeblikket tager avanafil eller vardenafil.
English: When you travel or need to stay in the hospital make sure you will have enough Kaletra to last until you can get a new supply.
Danish: Når du er på rejse eller skal indlægges på hospital, skal du sørge for at have tilstrækkeligt med Kaletra, indtil du kan få en ny forsyning.
English: Polyvinyl alcohol
Danish: Polyvinyl alkohol
English: Further stratification within each group was 1:1 (tablet versus soft capsule).
Danish: Yderligere stratificering inden for hver gruppe var 1:1 (tablet mod blød kapsel).
English: This may be unsuitable in hereditary fructose intolerance.
Danish: Dette kan være uhensigtsmæssigt ved arvelig fruktose intolerans.
English: 4.8 Undesirable effects a. Summary of the safety profile
Danish: 4.8 Bivirkninger a. Sammendrag af sikkerhedsprofilen
English: These changes may be seen on an ECG (electrocardiogram).
Danish: Disse forandringer kan ses på et EKG (elektrokardiogram).
English: • loss or changed sense of taste;
Danish: • tab eller ændring af smag;
English: The amount of alcohol in this medicine may affect your ability to drive or use machines and may affect your judgement and reaction times.
Danish: Mængden af alkohol i dette lægemiddel kan have en virkning på din evne til at køre eller betjene maskiner og kan have en virkning på din vurderingsevne og reaktionstid.
English: • damage to nerves of the peripheral nervous system;
Danish: • skade på nerver i det perifere nervesystem;
English: You should tell your doctor promptly about these or any other symptoms.
Danish: Du skal straks underrette din læge om disse eller andre symptomer.
English: They will tell you how to use the syringe correctly.
Danish: De kan fortælle dig, hvordan du skal bruge den korrekt.
English: • low number of red blood cells, low number of white blood cells which are usually used to fight infection;
Danish: • lavt antal røde blodlegemer, lavt antal hvide blodlegemer, der normalt bruges til at bekæmpe infektioner;
English: Uncommon Weight increased, increased appetite
Danish: Ikke almindelig Vægtstigning, øget appetit
English: Your doctor can explain these symptoms to you.
Danish: Din læge kan forklare disse symptomer nærmere.
English: If you are currently taking any of these medicines, ask your doctor about making necessary changes either in the treatment for your other condition(s) or in your antiretroviral treatment.
Danish: Hvis du i øjeblikket tager et af disse lægemidler, skal du bede din læge om foretage de nødvendige ændringer enten i behandlingen af dine andre sygdom(me) eller i din antiretrovirale behandling.
English: Do not shake the bottle - this is because air bubbles can form which will affect how well you can measure the dose.
Danish: Ryst ikke flasken - det kan danne luftbobler, som vil have en virkning på, hvor godt du kan afmåle dosen.
English: A causal relationship had been evoked, although the mechanism of action had not been elucidated.
Danish: En årsagssammenhæng er blevet foreslået, selvom virkemekanismen ikke er blevet afdækket.
English: The median follow-up was 48 weeks in Cohort I and 72 weeks in Cohort II.
Danish: Den mediane opfølgning var 48 uger i kohorte I og 72 uger i kohorte II.
English: Concomitant administration of these medicinal products is not recommended.
Danish: Samtidig administration af disse lægemidler anbefales ikke.
English: Take the next dose as usual.
Danish: Tag den næste dosis på det sædvanlige tidspunkt.
English: However, only the increase in voxilaprevir exposure is considered clinically relevant.
Danish: Det er dog kun øgningen i voxilaprevir eksponering som vurderes at være klinisk relevant.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Around 85% of patients had a viral load of < 100,000 copies/ml.
Danish: Omkring 85% af patienterne havde en virusmængde på <100.000 kopier/ml.
English: The frequency of this is unknown (see section 4.4).
Danish: Hyppigheden af dette er ukendt (se punkt 4.4).
English: Paediatric population (2 years of age and above)
Danish: Pædiatrisk population (2 år og ældre)
English: • Continue to take this medicine until your doctor tells you otherwise.
Danish: • Fortsæt med at tage denne medicin, indtil lægen anbefaler noget andet.
English: DM-6705 (delamanid active metabolite):
Danish: DM-6705 (delamanids aktive metabolit):
English: Autoimmune disorders may occur many months after the start of treatment.
Danish: Autoimmune sygdomme kan forekomme flere måneder efter påbegyndelsen af behandlingen.
English: Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Danish: Konklusioner vedrørende betydningen af særlige mutationer eller mutationsmønstre, kan blive ændret ved fremkomst af yderligere data, og det anbefales altid at rådføre sig med gældende fortolkningssystemer til analyse af resistenstestresultater.
English: Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the table below.
Danish: Kendte og teoretiske interaktioner med udvalgte antiretrovirale og ikke-antiretrovirale lægemidler er opført i tabellen nedenfor.
English: Children less than 2 years of age
Danish: Børn under 2 år
English: {MM/YYYY}
Danish: {MM/ÅÅÅÅ}
English: • increased appetite;
Danish: • øget appetit;
English: • It is important to keep Kaletra in the bottle it came in and replace the bottle cap after each dose.
Danish: • Det er vigtigt at opbevare Kaletra i den beholder, den kom i og skift flaskens låg efter hver dosis.
English: Amprenavir concentrations are significantly reduced.
Danish: Amprenavir-koncentrationerne nedsættes betydeligt.
English: QD BID Difference [95% CI]
Danish: QD BID Forskel [95% CI]
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Det antages, at disse symptomer skyldes en forbedring i kroppens immunforsvar, så kroppen bliver i stand til at bekæmpe infektioner, der kan have været til stede uden tydelige symptomer.
English: Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.
Danish: Ligeledes kan administration af aktivt kul anvendes for at lette fjernelsen af ikkeabsorberet aktivt stof.
English: Kaletra is an antiretroviral medicine.
Danish: Kaletra er et antiretroviralt lægemiddel.
English: Therefore, this co-administration should be avoided unless judged strictly necessary.
Danish: Denne samtidige administration bør derfor undgås, medmindre den vurderes at være strengt nødvendig.
English: • Taking Kaletra as recommended should give you the best chance of delaying the development of resistance to the product.
Danish: • Hvis du tager Kaletra som anbefalet, burde du få de bedste muligheder for at forsinke udvikling af resistens over for medicinen.
English: Dosage adjustment for midazolam should be considered especially if more than a single dose of midazolam is administered.
Danish: Dosisjustering af midazolam bør især overvejes, hvis der administreres mere end en enkeltdosis af midazolam.
English: Take care when dosing children.
Danish: Vær forsigtig med dosering af børn.
English: Cohort II
Danish: Kohorte II
English: • Kaletra is prescribed for use in combination with other antiviral medicines.
Danish: • Kaletra ordineres til brug i kombination med andre antivirale lægemidler.
English: See further the detailed description of the clinical studies.
Danish: Se yderligere detaljer i beskrivelsen af de kliniske studier.
English: 67061 Ludwigshafen Germany
Danish: 67061 Ludwigshafen Tyskland
English: • Do not stop or change the daily dose of Kaletra without first consulting with your doctor.
Danish: • Du må ikke ændre eller holde op med at tage den daglige dosis Kaletra uden først at konsultere din læge.
English: Dosing should be less than 5 ml twice daily for children weighing less than 40 kg.
Danish: Dosis skal være mindre end 5 ml to gange dagligt til børn som vejer mindre end 40 kg.
English: If the condition persists or worsens, seek medical attention.
Danish: Hvis tilstanden varer ved eller forværres, skal du søge lægehjælp.
English: • Always keep enough Kaletra on hand so you don't run out.
Danish: • Sørg altid for at have tilstrækkeligt med Kaletra på lager, så du ikke løber tør.
English: It is advised to write the date of removal from the refrigerator on the package.
Danish: Det anbefales at skrive dato på pakningen, når den tages ud af køleskabet.
English: Special Populations
Danish: Specielle populationer
English: • bone death caused by poor blood supply to the area;
Danish: • knogledød forårsaget af dårlig blodtilførsel til området;
English: • weight gain.
Danish: • vægtforøgelse.
English: The mechanism of this interaction may result from inhibition of transport proteins.
Danish: Mekanismen bag denne interaktion kan skyldes hæmning af transportproteiner.
English: Lopinavir: ↔ (relative to historical comparison)
Danish: Lopinavir: ↔ (I forhold til historisk sammenligning)
English: 96 week arm (N=13)
Danish: 96 uger arm (N=13)
English: • uncontrolled shaking of the body;
Danish: • ukontrollerede rystelser af kroppen;
English: Mean (%CV) Steady-State Pharmacokinetic Parameters of Lopinavir in HIV-Infected Pregnant Women
Danish: Gennemsnitlig (% CV) steady-state farmakokinetiske parametre for lopinavir i hiv-inficerede gravide kvinder
English: At steady state, lopinavir is approximately 98 − 99% bound to serum proteins.
Danish: Ved steady-state er lopinavir cirka 98-99 % bundet til serumproteiner.
English: Wash the plunger and the syringe with washing up liquid and warm water as soon as you can; you may soak both in soapy water for up to 15 minutes.
Danish: Vask pumpestemplet og sprøjten med opvaskesæbe og varmt vand, så snart du kan komme til det; du kan lægge begge dele i blød i sæbevand i op til 15 minutter.
English: • You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: • Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: Effects of food on oral absorption
Danish: Fødeindtagelse og virkning på oral absorption
English: After multiple dosing, less than 3% of the lopinavir dose is excreted unchanged in the urine.
Danish: Efter flergangsdosering bliver mindre end 3 % af lopinavir dosis udskilt uændret i urinen.