FrancophonIA/ELRC3.0 huggingface dataset:
English: Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
Danish: I overensstemmelse med resultaterne ovenfor, blev det vist i en metaanalyse af 6 studier med 335 clopidogrelbehandlede ved steady state, at eksponeringen for den aktive metabolit nedsattes med 28 % for personer med intermediate metabolisme, og 72 % for personer med poor metabolisme.
English: • You should tell your doctor if a surgery (including dental) is planned.
Danish: • Bør De fortælle Deres læge, at De er i behandling med Clopidogrel Acino Pharma GmbH hvis De skal have foretaget en planlagt operation (også hos tandlægen)
English: Do not take Clopidogrel Acino Pharma GmbH:
Danish: Tag ikke Clopidogrel Acino Pharma GmbH:
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino Pharma GmbH 75 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Clopidogrel Acino Pharma GmbH 75 mg filmovertrukne tabletter
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased
Danish: Forlænget blødningstid, fald i neutrofiltal, fald i trombocyttal.
English: You have a condition of hardening of arteries (also known as atherosclerosis), and You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease (disturbed blood flow in arms or legs caused by vascular occlusions)
Danish: De har fået recept på Clopidogrel Acino Pharma GmbH til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi: - De lider af åreforkalkning (også kaldet aterosklerose) - og - De tidligere har haft et hjerteanfald, apopleksi eller en tilstand kaldet perifer arteriel sygdom (kredsløbsforstyrrelser i arme eller ben, forårsaget af vaskulær okklusion)
English: While you are taking Clopidogrel Acino Pharma GmbH:
Danish: Mens De er i behandling med Clopidogrel Acino Pharma GmbH:
English: What Clopidogrel Acino Pharma GmbH is and what it is used for Before you take Clopidogrel Acino Pharma GmbH How to take Clopidogrel Acino Pharma GmbH Possible side effects
Danish: Det skal De vide, før De begynder at tage Clopidogrel Acino Pharma GmbH Sådan skal De tage Clopidogrel Acino Pharma GmbH Bivirkninger
English: HOW TO TAKE CLOPIDOGREL ACINO PHARMA GMBH Always take Clopidogrel Acino Pharma GmbH exactly as your doctor has told you.
Danish: Tag/brug altid Clopidogrel Acino Pharma GmbH nøjagtigt efter lægens anvisninger.
English: Take special care with Clopidogrel Acino Pharma GmbH:
Danish: Vær ekstra forsigtig med at bruge Clopidogrel Acino Pharma GmbH:
English: BEFORE YOU TAKE CLOPIDOGREL ACINO PHARMA GMBH
Danish: SÅDAN SKAL DE TAGE CLOPIDOGREL ACINO PHARMA GMBH
English: - For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Danish: - MVed mere end 12 timer efter planlagt administration: patienten børskal tage næste dosis
English: MARKETING AUTHORISATION HOLDER
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSE
English: You may need to read it again.
Danish: Du får muligvis brug for at læse den igen.
English: 95% confidence intervals.
Danish: 95% konfidensintervaller.
English: The recommended dose regimens are as follows:
Danish: De anbefalede dosisregimer er som følger:
English: Date of first authorisation: 4th January 2017
Danish: Dato for første markedsføringstilladelse: 4. januar 2017
English: - if you have severe liver problems.
Danish: - hvis du har alvorlige leverproblemer.
English: Examples are: increase in some white blood cells.
Danish: Eksempler er: forøgelse af visse hvide blodceller.
English: You must keep in regular contact with your doctor.
Danish: Du skal være i regelmæssig kontakt med din læge.
English: Other corticosteroids: interaction not studied.
Danish: Andre kortikosteroider: Interaktion ikke undersøgt.
English: 117 Allee des Parcs 69 800 Saint Priest France
Danish: 117 Allee des Parcs 69 800 Saint Priest Frankrig
English: - This medicine has been prescribed for you only.
Danish: - Denne medicin er ordineret til dig personligt.
English: This is not a complete list of medicines.
Danish: Dette er ikke en fuldstændig liste over lægemidler.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Som med al anden medicin kan denne medicin forårsage bivirkninger, selvom ikke alle får dem.
English: On rare occasions, these muscle disorders have been serious.
Danish: I sjældne tilfælde har disse muskellidelser været alvorlige.
English: These can be seen in the results of blood and/or urine tests.
Danish: Det kan påvises i resultaterne fra blod- og/eller urintests.
English: Due to a decrease in the exposure (AUC) of darunavir by 40%, appropriate doses of the combination have not been established.
Danish: På grund af et fald i eksponering (AUC) af darunavir med 40% er de rette doser af kombinationen ikke blevet fastlagt.
English: Cobicistat is not indicated for use in twice daily regimens or for use in the paediatric population.
Danish: Cobicistat er ikke indiceret til brug to gange dagligt eller til brug hos den pædiatriske population.
English: Voriconazole should only be taken after medical evaluation.
Danish: Voriconazol bør kun tages efter lægelig vurdering.
English: Based on a normal approximation of the difference in % response c
Danish: Baseret på en normal approksimation af forskellen i% respons c
English: These effects may be secondary to pup exposure to the active substance via the milk and/or maternal toxicity.
Danish: Disse virkninger kan være sekundære til hvalpenes eksponering for det aktive stof via mælken og/eller maternel toksicitet.
English: Hence, the use of creatinine clearance as an estimate of renal elimination capacity may be misleading.
Danish: Brugen af kreatinin-clearance til vurdering af renal elimineringsevne kan således være misvisende.
English: Your doctor will test for these changes.
Danish: Din læge vil foretage tests af disse ændringer.
English: to treat gout or familial Mediterranean fever
Danish: til behandling af urinsyregigt eller familiær middelhavsfeber
English: [On carton only:] Open date: __________
Danish: [Kun på pap:] Dato for åbning:
English: Treatment difference (95% CI of difference)
Danish: Behandlingsforskel (95% CI for forskel)
English: If you notice any of these symptoms please inform your doctor.
Danish: Hvis du bemærker nogle af disse symptomer, bedes du informere din læge.
English: Interaction Geometric mean change (%)
Danish: Interaktioner Geometrisk middelændring (%)
English: These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to > 100 µM.
Danish: Disse EC50-værdier ligger et godt stykke under 50% af koncentrationsområdet for cellulær toksicitet på 87 µM til > 100 µM.
English: - Ethinylestradiol/drospirenone.
Danish: - Ethinylestradiol/drospirenon.
English: If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Danish: Hvis der ikke kan anvendes alternativer, bør de kun anvendes efter medicinsk evaluering, og din læge bør overvåge dig tæt for bivirkninger fra kortikosteroider.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Undgå at tage dobbeltdosis for at kompensere for en glemt dosis.
English: Difference in means e
Danish: Forskelle i gennemsnit e
English: A lower dose of the βblocker should be considered.
Danish: En lavere dosis af betablokkeren bør overvejes.
English: GS-US-216-130 Week 48
Danish: GS-US-216-130 Uge 48
English: This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Danish: Dette vil forbedre dit immunforsvar og reducerer risikoen for at udvikle sygdomme, der er forbundet med en hiv-infektion.
English: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 15% R(-) methadone Cmax ↓ 24%
Danish: R(-) methadon AUC ↓ 16% R(-) methadon Cmin ↓ 15% R(-) methadon Cmax ↓ 24%
English: Treatment of overdose with darunavir consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling ved overdosering af darunavir består i generelle supportive foranstaltninger, herunder monitorering af vitaltegn og observation af patientens kliniske tilstand.
English: Out of the 59 patients who responded with complete viral suppression (< 50 copies/ml) at week 48, 47 patients (80% of the responders at week 48) remained responders at week 96.
Danish: Af de 59 patienter, der responderede med komplet virologisk suppression (< 50 kopier/ml) ved uge 48, var 47 patienter (80% af de responderende i uge 48) fortsat responderende i uge 96.
English: Talk to your doctor about the signs and symptoms of liver problems.
Danish: Tal med din læge om tegn og symptomer på leverproblemer.
English: Number of baseline mutations a
Danish: Antal af baseline-mutationer a
English: CARTON (BLISTERS AND BOTTLES)
Danish: ÆSKE (BLISTER OG FLASKER)
English: Tell your doctor immediately if you are pregnant, planning to become pregnant or if you are breastfeeding.
Danish: Giv omgående din læge besked, hvis du planlægger at blive gravid, eller hvis du ammer.
English: The following patient populations were evaluated (see section 5.1):
Danish: Følgende patientpopulationer blev evalueret (se pkt.
English: - in certain patients who have used antiretroviral medicines before (your doctor will determine this).
Danish: - til visse patienter, som har anvendt antiretrovirale lægemidler før (din læge vil afgøre dette).
English: The most frequent adverse reactions reported were diarrhoea (28%), nausea (23%), and rash (16%).
Danish: De hyppigst rapporterede bivirkninger var diarré (28%), kvalme (23%) og udslæt (16%).
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Danish: Patienterne skal rådes til at søge lægelig rådgivning, hvis de oplever ømhed og smerter i led, stivhed i led eller bevægelsesbesvær.
English: Tell your healthcare provider about all medicines that you are taking.
Danish: Giv dit sundhedspersonale besked om alle de lægemidler, du tager.
English: A skin rash might also be a symptom of a rare severe situation.
Danish: Et hududslæt kan også være et symptom på en sjælden, alvorlig situation.
English: Liver problems that may occasionally be severe have been reported.
Danish: Der har været rapporteret leverproblemer, som af og til er alvorlige.
English: It belongs to a group of medicines called protease inhibitors.
Danish: Det tilhører en medicingruppe, der kaldes proteasehæmmere.
English: The safety assessment in paediatric patients is based on the 48-week analysis of safety data from three Phase II trials.
Danish: Pædiatrisk population Sikkerhedsvurderingen for pædiatriske patienter er baseret på analysen af sikkerhedsdata efter 48 uger fra tre fase II-studier.
English: Carbamazepine concentrations should be monitored and its dose should be titrated for adequate response.
Danish: Carbamazepin koncentrationer skal monitoreres og der dosistitreres til et passende respons.
English: Primary (major) PI
Danish: Primære (major) PImutationer
English: For blisters with plastic on one side and aluminium on the other: Do not store above 25°C.
Danish: For blisterpakker med plastik på den ene side og aluminium på den anden side: Må ikke opbevares over 25 °C.
English: According to the TLOVR non-virologic failure censored algorithm 24 (30.0%) patients experienced virological failure, of which 17 (21.3%) patients were rebounders and 7 (8.8%) patients were nonresponders.
Danish: Ifølge den TLOVR non-virologisk svigt censorerede algoritme oplevede 24 (30,0%) patienter virologisk svigt, af hvilke 17 (21,3%) patienter fik tilbagefald, og 7 (8,8%) patienter ikke responderede på behandlingen.
English: MedDRA system organ class Frequency category
Danish: MedDRA-systemorganklasse Hyppighedskategori
English: ≥ 1.0 log10 decrease from baseline in plasma viral load a
Danish: ≥ 1.0 log10 fald fra baseline i viral load i plasma a
English: Lidocaine (systemic)
Danish: Lidocain (systemisk)
English: However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (ChildPugh Class B) higher, respectively.
Danish: Dog var koncentrationer af ubundet darunavir henholdsvis ca. 55% (ChildPugh klasse A) og 100% (Child-Pugh klasse B) højere.
English: The requirements for submission of PSURs 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: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene om fremsendelse af PSUR'er for dette lægemiddel er anført i kravene på listen over EUreferencedatoer (EURD-listen) i henhold til artikel 107c, stk. 7, i direktiv 2001/83/EF og alle andre efterfølgende opdateringer, som er offentliggjort på den europæiske webportal for lægemidler.
English: Your doctor might want to do some additional tests.
Danish: Din læge vil måske foretage yderligere tests.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende opdatering af RMP.
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: Man mener, at disse symptomer skyldes en forbedring i kroppens immunforsvar, som gør kroppen i stand til at bekæmpe infektioner, som kan have været til stede uden nogen tydelige symptomer.
English: - Oestrogen-based hormonal contraceptives and hormonal replacement therapy.
Danish: - Østrogenbaserede hormonelle kontraceptive midler og hormonel substitutionsterapi.
English: Dexamethasone (systemic)
Danish: Dexamethason (systemisk)
English: Clades A1, D, F1, G, K, CRF02_AG, CRF12_BF, and CRF06_CPX
Danish: Subtype A1, D, F1, G, K, CRF02_AG, CRF12_BF og CRF06_CPX
English: If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems.
Danish: Hvis du har en kronisk hepatitis B- eller C-infektion, bør din læge kontrollere dine blodprøver oftere, da du vil have en forøget risiko for at udvikle leverproblemer.
English: Isolates with baseline FC ≤ 10 are susceptible; isolates with FC > 10 to 40 have decreased susceptibility; isolates with FC > 40 are resistant (see Clinical results).
Danish: Isolater med baseline FC ≤ 10 (mindre end 10-fold øgning i EC50) er følsomme; isolater med FC > 10 til 40 har nedsat følsomhed; isolater med FC > 40 er resistente (se ”Kliniske resultater”).
English: In case of safety issues, a further increase of the dosing interval for rifabutin and/or monitoring of rifabutin levels should be considered.
Danish: I tilfælde af sikkerhedsmæssige risici skal det overvejes at forlænge doseringsintervallet yderligere og/eller monitorere rifabutin-niveauerne.
English: It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles.
Danish: Det er en selektiv hæmmer af spaltningen af hiv-kodede Gag-Pol polyproteiner i virusinficerede celler, hvorved dannelsen af modne, infektiøse viruspartikler forhindres.
English: Total number of virologic failures a,
Danish: Samlet antal virologiske svigt a, n
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig videregive hiv, når du tager dette lægemiddel, selvom risikoen er lavere med effektiv antiretroviral behandling.
English: Autoimmune disorders may occur many months after the start of treatment.
Danish: Autoimmune sygdomme kan også opstå mange måneder, efter at behandlingen er påbegyndt.
English: Contents of the pack and other information
Danish: Pakningens indhold og øvrige oplysninger
English: Increased concentrations of quetiapine may lead to coma (see section 4.3).
Danish: En øget koncentration af quetiapin kan føre til koma (se punkt 4.3).
English: - Apixaban, edoxaban, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.
Danish: - Apixaban, edoxaban, rivaroxaban, warfarin (til reduktion af blodkoagulering), da deres behandlingsmæssige effekt eller bivirkninger kan ændres; din læge kan være nødt til at undersøge dit blod.
English: People taking darunavir may still develop infections or other illnesses associated with HIV infection.
Danish: Personer, der tager darunavir, kan stadig udvikle infektioner eller andre sygdomme forbundet med hivinfektion.
English: For blisters with aluminium on both sides: This medicine does not require any special storage conditions.
Danish: For blisterpakker med aluminium på begge sider: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Darunavir has only been used in limited numbers of patients 65 years or older.
Danish: Darunavir er kun blevet anvendt til et begrænset antal patienter, der er 65 år eller ældre.
English: ● In ART-experienced patients with no darunavir resistance associated mutations (DRV-RAMs)*
Danish: ● Hos ART-erfarne patienter uden mutationer associeret med darunavirresistens (DRV-RAMs)*,
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Et hvilket som helst inflammatorisk symptom skal vurderes, og behandling påbegyndes ved behov.
English: Darunavir AUC24h ↑ 33% (based on population pharmacokinetic model)
Danish: Darunavir AUC24h ↑ 33 % (baseret på en populationsfarmakokinetisk model)
English: Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitors, ATC code: J05AE10.
Danish: Farmakoterapeutisk klassifikation: Antivirale stoffer til systemisk brug, proteasehæmmere, ATC-kode: J05AE10.
English: Other c
Danish: Andet c
English: If you belong to this age group, please discuss with your doctor if you can use Darunavir Mylan.
Danish: Hvis du tilhører denne aldersgruppe, skal du spørge din læge, om du kan anvende Darunavir Mylan.
English: Frequency categories are defined as follows: 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) and not known (frequency cannot be estimated from the available data).
Danish: Hyppighedskategorierne defineres som 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Darunavir/ritonavir may be considered as an alternative.
Danish: darunavir /ritonavir kan overvejes som et alternativ.
English: The substantial reduction in darunavir exposure may result in virological failure and an increased risk of mother to child transmission of HIV infection.
Danish: Den betydelige reduktion i eksponeringen for darunavir kan medføre virologisk svigt og en øget risiko for overførsel af hiv-infektion fra mor til barn.
English: Patients with naïve use of ENF
Danish: Patienter, som er naive over for brug af ENF
English: A lower and upper clinical cut-off of 10 and 40 were identified.
Danish: Der blev identificeret en nedre og øvre klinisk grænse (cut-off) på 10 og 40.
English: - Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection.
Danish: - Giv din læge besked, hvis du tidligere har haft problemer med din lever, herunder hepatitis Beller C-infektion.
English: Therapy should be initiated by a health care provider experienced in the management of HIV infection.
Danish: Behandlingen skal påbegyndes af en læge, der har erfaring med håndtering af hiv-infektion.
English: When used for birth control, alternative methods of non-hormonal contraception are recommended.
Danish: Når det anvendes som svangerskabsforebyggelse, anbefales andre ikke-hormonelle kontraceptive midler.
English: Infections and infestations Uncommon herpes simplex
Danish: Infektioner og parasitære sygdomme Ikke almindelig herpes simplex
English: Due to uncertainties regarding the rate of development of the human blood brain barrier and liver enzymes, darunavir with low dose ritonavir should not be used in paediatric patients below 3 years of age.
Danish: På grund af usikkerheden omkring udviklingshastigheden af den humane blod-hjerne-barriere og leverenzymer bør darunavir plus lavdosis ritonavir ikke bruges til pædiatriske patienter under 3 år.
English: Infrequently a rash may become severe or potentially life-threatening.
Danish: Et udslæt kan i sjældne tilfælde blive alvorligt og potentielt livstruende.
English: The doctor will inform you on how many Darunavir Mylan tablets and how much ritonavir (capsules, tablets or solution) the child must take.
Danish: Lægen fortæller dig, hvor mange Darunavir Mylan-tabletter og hvor meget ritonavir (kapsler, tabletter eller opløsning) barnet skal tage.
English: Darunavir works by reducing the amount of HIV in your body.
Danish: Darunavir virker ved at reducere mængden af hiv i din krop.
English: ● For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
Danish: ● til behandling af hiv-1-infektion hos voksne patienter, som tidligere har været i antiretroviral behandling (ART-erfarne), inklusive patienter, der tidligere har fået omfattende præmedicinering
English: Very common side effects (may affect more than 1 in 10 people) - diarrhoea.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - diarré
English: During attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with low dose ritonavir, a high frequency of liver reactions was seen with rifampicin.
Danish: Under forsøg på at imødegå den nedsatte eksponering, ved at øge dosis af andre proteasehæmmere med lavdosis ritonavir, blev der set en høj frekvens af leverreaktioner med rifampicin.
English: - Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever).
Danish: - Fortæl straks din læge, hvis du bemærker nogen symptomer på infektion (f.eks. forstørrede lymfeknuder og feber).
English: Darunavir in combination with ritonavir caused a reduction in the number of pups that exhibited the startle response on day 15 of lactation and a reduced pup survival during lactation.
Danish: Darunavir i kombination med ritonavir medførte et fald i antallet af hvalpe, der udviste forskrækkelsesrespons på dag 15 af diegivningen og en reduceret overlevelse for hvalpene under diegivningsperioden.
English: Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed under any circumstances if they are receiving darunavir.
Danish: Både på grund af risiko for overførsel af hiv og risiko for bivirkninger hos de ammede spædbørn, skal mødre instrueres i, at de under ingen omstændigheder må amme, hvis de behandles med darunavir.
English: The steady-state pharmacokinetic parameters of darunavir were comparable when boosted with cobicistat versus ritonavir.
Danish: De farmakokinetiske steady-state-parametre for darunavir var sammenlignelige, når der blev boostet med cobicistat versus ritonavir.