FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no food restrictions in the adult studies (using tablet formulations) or in the paediatric study (using both tablet and oral solution formulations).
Danish: Der var ingen restriktioner med hensyn til fødeindtagelse i studierne med voksne (ved anvendelse af tabletformuleringen) eller i det pædiatriske studie (både ved anvendelse af tabletformuleringen og oral opløsning).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: Medicinal product by therapeutic areas (dose of CELSENTRI used in study)
Danish: Lægemiddel efter terapeutisk område (dosis af Celsentri anvendt i studier)
English: The date should be written as soon as the bottle has been opened for first use.
Danish: Datoen skal anføres så snart flasken er åbnet første gang.
English: CELSENTRI could potentially increase your risk of developing infections.
Danish: Celsentri kan muligvis øge din risiko for at udvikle infektioner.
English: Clinical status and relevant blood chemistry should be monitored and appropriate symptomatic therapy initiated.
Danish: Den kliniske status og relevant blodkemi skal monitoreres og relevant symptomatisk behandling initieres.
English: Get medical help immediately if you get these symptoms.
Danish: Søg straks lægehjælp, hvis du får disse symptomer.
English: Some medicines may change the amount of CELSENTRI in the body when they are taken at the same time as CELSENTRI.
Danish: Noget medicin kan ændre mængden af Celsentri i kroppen, når det tages samtidig med Celsentri.
English: Your doctor must take blood samples to test whether CELSENTRI is an appropriate treatment for you (or your child, if they are the patient).
Danish: Lægen skal tage blodprøver for at kontrollere, om Celsentri er en egnet behandling til dig (eller dit barn, hvis barnet er patienten).
English: Residual activity in vivo for viruses with MPI-values <95% has not been determined.
Danish: Residualaktiviteten for virus med MPI-værdier < 95 % er ikke bestemt in vivo.
English: This dose adjustment has not been studied in HIV patients.
Danish: Denne dosisjustering er ikke undersøgt i hivpatienter.
English: Patients with very low CD4+ count at baseline (i.e. <50 cells/µL) had a less favourable outcome.
Danish: Patienter med et meget lavt CD4+-tal ved baseline (dvs. < 50 celler/µl) havde et mindre favorabelt resultat.
English: Tell your doctor if you notice anything unusual about your own health or your child's health.
Danish: Tal med lægen, hvis du bemærker noget usædvanligt i din egen eller dit barns helbredstilstand.
English: Caution should be exercised when treating these patients.
Danish: Der skal udvises forsigtighed ved behandling af disse patienter.
English: Maraviroc should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
Danish: Maraviroc bør kun anvendes under graviditet, hvis den forventede potentielle fordel opvejer den potentielle risiko for fostret.
English: There may be a risk of suboptimal levels with risk of loss of virologic response and resistance development.
Danish: Der kan være en risiko for suboptimale niveauer med risiko for tab af virologisk respons og resistensudvikling.
English: Oral solution Pfizer Service Company Hoge Wei 10
Danish: Oral opløsning Pfizer Service Company Hoge Wei 10
English: There is no specific antidote for overdose with maraviroc.
Danish: Der er ingen specifik antidot for overdosering med maraviroc.
English: Do not push too hard and squirt the liquid into the back of the throat, as that could cause choking.
Danish: Du må ikke trykke for hårdt og sprøjte væsken ned i halsen, da det kan medføre, at det kommer galt i halsen.
English: If you notice any of these symptoms: Tell your doctor.
Danish: Hvis du bemærker nogen af disse symptomer: Fortæl det til lægen.
English: Table 2: Interactions and adulta dose recommendations with other medicinal products
Danish: Tabel 2: Interaktioner og dosisanbefalinger til voksnea med andre lægemidler
English: Wait for the next dose at its regular time.
Danish: Vent til næste dosis på det planlagte tidspunkt.
English: Therefore, CELSENTRI should be used with caution in this population.
Danish: Celsentri skal derfor anvendes med forsigtighed til denne population.
English: Data to support these doses are lacking.
Danish: Der findes ingen data til understøttelse af disse doser
English: The results did not indicate any relevant efficacy or safety concern related to either fed or fasted dosing conditions.
Danish: Resultaterne indikerede ingen relevante virknings- eller sikkerhedsproblemer i forbindelse med doseringsbetingelser hverken ved indtagelse af føde eller ved faste.
English: OBT: Optimised Background Therapy * Percentages based on total patients evaluated for each laboratory parameter
Danish: OB: Optimal baggrundsbehandling * Procent baseret på det totale antal patienter evalueret for hver laboratorieparameter
English: The frequency of this is unknown (see section 4.4).
Danish: Frekvensen af dette er ukendt (se pkt.
English: The adverse reactions and laboratory abnormalities presented below are not exposure adjusted.
Danish: Bivirkningerne og laboratorieanormaliteterne, der er anført nedenfor, er ikke justeret med hensyn til eksponering.
English: Changes in viral tropism occur over time in HIV-1 infected patients.
Danish: Ændringer i viral tropisme sker over tid hos hiv 1-smittede patienter.
English: Only a limited number of people with serious heart or circulatory problems have taken CELSENTRI.
Danish: Det er kun et begrænset antal personer med alvorlige hjerte- eller kredsløbsproblemer, som har fået Celsentri.
English: Do not use CELSENTRI after the expiry date which is stated on the bottle and carton label.
Danish: Brug ikke Celsentri efter den udløbsdato, der står på flasken og kartonens etiket.
English: Your doctor will advise you whether it is better to take CELSENTRI oral solution, if you (or your child) are unable to swallow tablets.
Danish: Lægen vil rådgive dig om, hvorvidt det er bedre at tage Celsentri oral opløsning, hvis du (eller dit barn) ikke er i stand til at synke tabletter.
English: • fever (high temperature).
Danish: • feber (forhøjet temperatur).
English: Read the information ‘Other possible side effects of combination therapy for HIV' in Section 4 of this leaflet.
Danish: Læs informationen "Andre bivirkninger ved kombinationsbehandling af hiv" i punkt 4 af denne indlægsseddel.
English: Close the bottle tightly with the cap, leaving the adaptor in place.
Danish: Luk flasken tæt til med låget, og lad adapteren blive siddende.
English: Refer to section 4.5 for corresponding adult dosage.
Danish: 4.5 for den tilsvarende dosis til voksne.
English: When getting up, do so as slowly as possible.
Danish: Når du (eller dit barn) rejser dig op, så gør det så langtsomt som muligt.
English: People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Danish: Personer med fremskreden hiv-infektion (aids) har et svagt immunsystem og har større sandsynlighed for at udvikle alvorlige infektioner (opportunistiske infektioner).
English: Always take the dose recommended by your doctor.
Danish: Du skal altid tage den dosis, lægen har anbefalet.
English: CELSENTRI has only been taken by limited numbers of people 65 years or older.
Danish: Celsentri er kun blevet anvenddt af et begrænset antal personer på 65 år og derover.
English: This is particularly important if you are also taking some other medicines (see ‘Other medicines and CELSENTRI' later in section 2).
Danish: Dette er specielt vigtigt, hvis du også tager visse andre lægemidler (se "Brug af anden medicin sammen med Celsentri" senere i punkt 2).
English: One subject in each treatment arm met the primary endpoint by Week 48 (at Week 8 for placebo and Week 36 for the maraviroc arm).
Danish: En forsøgsperson i hver behandlingsarm opfyldte det primære endepunkt ved uge 48 (ved uge 8 for placebo-armen og uge 36 for maraviroc-armen).
English: Clear, colourless, oral solution.
Danish: Klar, farveløs oral opløsning.
English: If you forget to take or give CELSENTRI
Danish: Hvis du har glemt at tage eller give Celsentri
English: Treatment of overdose should consist of general supportive measures including keeping the patient in a supine position, careful assessment of patient vital signs, blood pressure and ECG.
Danish: Behandling af overdosering er generelt understøttende foranstaltninger, herunder at holde patienten i rygleje samt omhyggelig vurdering af patientens vitale tegn, blodtryk og EKG.
English: No relevant difference between Caucasian, Asian and Black subjects has been observed.
Danish: Der er ikke observeret relevante forskelle mellem hvide, asiater og sorte forsøgspersoner.
English: Push the plastic adapter (B) into the neck of the bottle so it is fully inserted.
Danish: Tryk plastikadapteren (B) ned i flaskens hals, så den er sat helt i. 3.
English: Maraviroc is a substrate for the transporters P-glycoprotein and OATP1B1, but the effect of these transporters on the exposure to maraviroc is not known.
Danish: Maraviroc er et substrat for transportørerne P-glycoprotein og OAT1B1, men virkningen af disse transportører på eksponeringen for maraviroc er ikke kendt.
English: Pfizer Service Company, Hoge Wei 10, B 1930 Zaventem, Belgium
Danish: Pfizer Service Company, Hoge Wei 10, B 1930 Zaventem, Belgien.
English: Maraviroc may have a minor influence on the ability to drive and use machines.
Danish: Maraviroc kan have en mindre indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: These adverse reactions were common (≥ 1/100 to < 1/10).
Danish: Disse bivirkninger var almindelige (≥ 1/100 til < 1/10).
English: Subjects were required to have HIV-1 RNA greater than 1,000 copies per mL at Screening.
Danish: Det var et krav, at forsøgspersonerne havde hiv 1 RNA over 1.000 kopier pr. ml ved screening.
English: This subgroup had a high degree of bad prognostic markers, i.e. extensive resistance and high baseline viral loads.
Danish: Denne undergruppe havde en høj grad af dårlige prognosemarkører, dvs. udpræget resistens og høj viralbelastning ved baseline.
English: Symptoms of infection and inflammation may develop, caused by either:
Danish: Der kan udvikles symptomer på infektion og betændelse, som skyldes enten:
English: The effects of moderate hepatic impairment may be underestimated due to limited data in patients with decreased metabolic capacity and higher renal clearance in these subjects.
Danish: Virkningen af moderat nedsat leverfunktion kan være undervurderet på grund af de begrænsede data fra patienter med nedsat metabolisk kapacitet og højere renal clearance hos disse forsøgspersoner.
English: The most significant circulating metabolite in humans is a secondary amine (approximately 22% radioactivity) formed by N-dealkylation.
Danish: Den mest betydende cirkulerende metabolit hos mennesker er en sekundær amin (ca. 22 % radioaktivitet), der er dannet ved N-dealkylering.
English: Studies with the tablets demonstrated a reduced foodeffect at higher doses.
Danish: Studier med tabletterne påviste en reduceret effekt af fødeindtagelse ved højere doser.
English: In mice and human beings that lack CCR5 receptors through genetic deletion, no significant adverse consequences have been reported.
Danish: Hos mus og mennesker, der mangler CCR5-receptorer gennem genetisk udeladelse, blev der ikke rapporteret om signifikante, betydende bivirkninger.
English: Don't take other medicines for the infection without your doctor's advice.
Danish: Du må ikke tage anden medicin mod infektionen, uden aftale med lægen.
English: Further management should be as recommended by the national poisons centre, where available.
Danish: Yderligere behandling bør være som anbefalet af forgiftningscentre.
English: Overall, the safety profile in paediatric patients was similar to that observed in adult clinical studies.
Danish: Samlet set var sikkerhedsprofilen hos pædiatriske patienter den samme som observeret i kliniske studier med voksne.
English: boceprevir, telaprevir)
Danish: saquinavir, boceprevir, telaprevir)
English:  problems with your heart or circulatory system.
Danish:  problemer med hjertet eller kredsløbet.
English: ANTIBIOTICS
Danish: ANTIBIOTIKA
English: Maraviroc is the major circulating component (approximately 42% radioactivity) following a single oral dose of 300 mg.
Danish: Maraviroc er den væsentlige cirkulerende komponent (ca. 42 % radioaktivitet) efter en enkelt oral dosis på 300 mg.
English: In the remaining 36 patients, there was no evidence of virus with reduced sensitivity as identified by exploratory virology analyses on a representative group.
Danish: Hos de resterende 36 patienter, var der ikke bevis på virus med reduceret følsomhed, som blev identificeret ved virologiske analyser med en repræsentativ patientgruppe.
English: Available toxicological data in animals has shown extensive excretion of maraviroc in milk.
Danish: De tilgængelige toksikologiske data hos dyr har vist omfattende udskillelse af maraviroc i mælk.
English: If it is almost time for the next dose, do not take or give the missed dose.
Danish: Hvis det næsten er tid til den næste dosis, må du ikke tage eller give den glemte dosis.
English: The latter group had markers correlating to low compliance (low and variable drug levels and often a calculated high residual sensitivity score of the OBT).
Danish: Den sidste gruppe havde markører svarende til lav compliance (lave og variable lægemiddelkoncentrationer og ofte en beregnet høj OB-score for residualfølsomhed).
English: Pull out applicator plunger (D) until the applicator contains the first part of the full dose.
Danish: Træk doseringssprøjtens stempel (D) ud, indtil doseringssprøjten indeholder den første del af den fulde dosis.
English: Maraviroc is primarily metabolized and eliminated by the liver.
Danish: Maraviroc metaboliseres og elimineres primært i leveren.
English: CELSENTRI works by blocking a receptor called CCR5 which HIV uses to enter and infect your blood cells.
Danish: Celsentri virker ved at blokere en receptor, der kaldes CCR5, som hiv bruger til at trænge ind i dine blodlegemer og inficere dem.
English: Genotypic resistance
Danish: Genotypisk resistens
English: ULN: Upper Limit of Normal
Danish: ULN: Den øvre grænseværdi
English: BSA (m2)-based bands have been modified to weight (kg)-based bands to simplify dosing and reduce dosing errors (see section 4.2).
Danish: BSA (m2)-baserede grupper blev modificeret til vægt-(kg)-baserede grupper for at simplificere dosering og reducere doseringsfejl (se pkt.
English: Contains soya lecithin: see leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder sojalecithin: se indlægssedlen for yderligere information.
English: If you (or your child) miss a dose of CELSENTRI, take or give the missed dose as soon as possible and then continue with the next dose at its regular time.
Danish: Hvis du (eller dit barn) har glemt en dosis Celsentri, skal du tage eller give den glemte dosis hurtigst muligt og derefter fortsætte med den næste dosis på det sædvanlige tidspunkt.
English: CELSENTRI oral solution (20 mg per mL) formulation should be prescribed if a child is unable to reliably swallow CELSENTRI tablets.
Danish: Celsentri oral opløsning (20 mg pr. ml) skal ordineres, hvis et barn ikke er i stand til på pålidelig vis at synke Celsentri-tabletterne.
English: Some people taking CELSENTRI have developed serious allergic reactions or skin reactions (see also ‘Serious side effects' in section 4).
Danish: Nogle personer, der tager Celsentri, udvikler alvorlige allergiske reaktioner eller hudreaktioner (se også "Alvorlige bivirkninger" i punkt 4).
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hiv-infektion overføres ved seksuel kontakt med en, der har infektionen, eller via overførsel af inficeret blod (f.eks. ved at dele injektionsnåle med andre).
English: Neoplasm benign, malignant and unspecified (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inklusive cyster og polypper)
English: You (or your child) can still pass on HIV when taking this medicine, although the risk is lowered by effective treatment.
Danish: Du (eller dit barn) kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv behandling.
English: Taking your medicines at the right time every day is important as it makes sure the HIV infection does not increase in your body.
Danish: Det er vigtigt at tage din medicin på det rette tidspunkt hver dag, da den sikrer, at hiv-infektionen ikke øges i din krop.
English: Subjects with virologic failure generally appeared to have low compliance to both maraviroc and the background antiretroviral elements of their regimens.
Danish: Forsøgspersoner med virologisk svigt synes generelt at have lav komplians over for både maraviroc og de antiretrovirale baggrundselementer i deres regimer.
English: There are no data regarding the switch from a medicinal product of a different antiretroviral class to CELSENTRI in virologically suppressed patients.
Danish: Der er ikke dokumentation vedrørende skift fra et antiretroviralt lægemiddel i en anden klasse til Celsentri hos virologisk supprimerede patienter.
English: Special patient populations:
Danish: Særlige patientpopulationer:
English: Breast-feeding Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.
Danish: Kvinder, som er hiv-positive, må ikke amme deres børn, fordi hiv-infektionen kan overføres til barnet med mælken.
English: Hypersensitivity reactions including severe and potentially life threatening events have been reported in patients taking maraviroc, in most cases concomitantly with other medicinal products associated with these reactions.
Danish: Overfølsomhedsreaktioner, inklusive alvorlige og potentielt livstruende hændelser, er rapporteret hos patienter, der tager maraviroc, i det fleste tilfælde samtidig med andre lægemidler, der er forbundet med disse reaktioner.
English: Maraviroc is bound (approximately 76%) to human plasma proteins, and shows moderate affinity for albumin and alpha-1 acid glycoprotein.
Danish: Maraviroc bindes til humane plasmaproteiner (ca. 76 %), og udviser moderat affinitet til albumin og alfa-1 glycoproteinsyre.
English: Many medicines have profound effects on maraviroc exposure due to drug-drug interactions.
Danish: Mange lægemidler har markant indvirkning på eksponering for maraviroc på grund af lægemiddelinteraktioner.
English: You should not take them while you're taking CELSENTRI.
Danish: Du bør ikke tage denne medicin, mens du tager Celsentri.
English: 30 to less than 40 kg at least 40 kg
Danish: 30 til mindre end 40 kg mindst 40 kg
English: The recommended dose of CELSENTRI differs depending on interactions with concomitant antiretroviral therapy and other medicinal products.
Danish: Den anbefalede dosis af Celsentri varierer afhængig af interaktioner med samtidig antiretroviral behandling og anden medicin.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumoni forårsaget af pneumocystis jiroveci (tidligere kendt som pneumocystis carinii).
English: No relevant differences in pharmacokinetics have been observed.
Danish: Der er ikke observeret relevant forskel i farmakokinetikken.
English: Data to support these doses are lacking and CELSENTRI is not recommended in children taking concomitant interacting medicinal products that in adults would require a 600 mg twice daily dose.
Danish: Der findes ingen data til understøttelse af disse doser, og Celsentri frarådes til børn, der tager samtidig interagerende lægemidler, som hos voksne ville kræve en dosis på 600 mg to gange dagligt.
English: Contact a doctor immediately if you get these symptoms.
Danish: Kontakt omgående lægen, hvis du oplever disse symptomer.
English: Table 3: Adverse reactions observed in clinical trials or post-marketing
Danish: Tabel 3: Bivirkninger observeret i kliniske studier eller efter markedsføring
English: At higher exposure of maraviroc a potential inhibition of CYP2D6 cannot be excluded.
Danish: Ved højere eksponering for maraviroc kan en potentiel hæmning af CYP2D6 ikke udelukkes.
English: A slight increase in motor activity in high-dose male rats at both weaning and as adults was noted, while no effects were seen in females.
Danish: Der ses en lille stigning i den motoriske aktivitet i høj-dosis hanrotter ved både fravænning og som voksne, mens der ikke ses påvirkninger hos hunnerne.
English: CCR5 antagonists could potentially impair the immune response to certain infections.
Danish: CCR5-antagonister kan muligvis nedsætte immunresponset ved visse infektioner.
English: The gp120 amino acid substitutions identified so far are context dependent and inherently unpredictable with regards to maraviroc susceptibility.
Danish: De gp120-aminosyresubstitutioner, der er identificeret hidtil, er kontekstafhængige og i sagens natur uforudsigelige med hensyn til maraviroc-følsomhed.
English: Doses were given with food on intensive pharmacokinetic evaluation days and optimised to achieve an average concentration over the dosing interval (Cavg) of greater than 100 ng/mL; otherwise, maraviroc was given with or without food.
Danish: Der blev givet doser med føde på intensive farmakokinetiske evalueringsdage, og de blev optimeret til at opnå en gennemsnitlig koncentration over doseringsintervallet (Cavg) større end 100 ng/ml; ellers blev maraviroc givet med eller uden føde.
English: • tuberculosis (TB) or serious fungal infections.
Danish: • tuberkulose (TB) eller alvorlige svampeinfektioner.
English: The antiviral activity of maraviroc against HIV-2 has not been evaluated.
Danish: Den antivirale aktivitet af maraviroc mod hiv 2 er ikke vurderet.
English: • ritonavir-boosted protease inhibitors (with the exception of tipranavir/ritonavir),
Danish: • ritonavir-boostede proteasehæmmere (undtagen tipranavir/ritonavir),
English: The absorption of maraviroc is variable with multiple peaks.
Danish: Maravirocs absorption er variabel med multiple toppe.
English: It is not known whether the ingredients in CELSENTRI can also pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Celsentri også kan udskilles i mælk.
English: In case of concomitant antiviral therapy for hepatitis B and/or C, please refer to the relevant product information for these medicinal products.
Danish: Ved samtidig antiviralbehandling for hepatitis B og/eller C henvises til produktresuméerne for de relevante lægemidler.
English: Other developmental parameters of these offspring, including fertility and reproductive performance, were not affected by the maternal administration of maraviroc.
Danish: Andre udviklingsparametre i disse afkom, herunder fertilitet og reproduktionsevne, blev ikke påvirket af administration af maraviroc til moderdyret.
English: Slowly push the plunger in, allowing time to swallow.
Danish: Tryk langsomt stemplet ind, og giv dig tid til a synke.
English: These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI.
Danish: Dette er sjældent og kan forekomme hos op til 1 ud af 1.000 personer, som tager Celsentri.
English: Angina pectoris rare
Danish: Angina pectoris
English: • liver problems, including chronic hepatitis B or C. Only a limited number of people with liver problems have taken CELSENTRI.
Danish: • leverproblemer, herunder kronisk hepatitis B eller C. Der er kun et begrænset antal personer med leverproblemer, som har fået Celsentri.
English: Hold the bottle firmly.
Danish: Hold godt fat på flasken.