FrancophonIA/ELRC3.0 huggingface dataset:
English: Maraviroc Cmax: ↑ compared to historical controls Nevirapine concentrations not measured, no effect is expected.
Danish: Maraviroc AUC12: ↔ Sammenlignet med historiske kontroller Maraviroc Cmax: ↑ Sammenlignet med historiske kontroller Nevirapin koncentrationer er ikke undersøgt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - maraviroc 20 mg/ml oral solution
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Etiket til flaske - maraviroc 20 mg/ml oral opløsning
English: However, no clinically significant QT prolongation compared to placebo + OBT was seen in the Phase 3 clinical studies using the recommended dose of maraviroc or in a specific pharmacokinetic study to evaluate the potential of maraviroc to prolong the QT interval.
Danish: Der er ikke set klinisk signifikant QT-forlængelse sammenlignet med placebo + OB i fase 3-studier, når den anbefalede dosis af maraviroc anvendes.
English: The most frequently reported adverse reactions occurring in the Phase 2b/3 studies were nausea,
Danish: De hyppigst rapporterede bivirkninger, der blev set i fase 2b/3-studierne var kvalme, diarré, træthed og hovedpine.
English: In addition, dosing was based on whether subjects were receiving potent CYP3A inhibitors (38/50), potent CYP3A inducers (2/50) or other concomitant medicinal products that are not potent CYP3A inhibitors or potent CYP3A inducers (10/50) as part of OBT.
Danish: Derudover blev dosering baseret på, om forsøgspersonerne fik potente CYP3A-hæmmere (38/50), potente CYP3A-induktorer (2/50) eller andre samtidige lægemidler, som ikke er potente CYP3A-hæmmere eller potente CYP3A-induktorer (10/50) som del af OB. Der blev evalueret sparsom farmakokinetik for alle forsøgspersoner, herunder de yderligere 47 forsøgspersoner, der fik potente CYP3Ahæmmere, som ikke deltog i dosisbestemmelsesfasen.
English: Joint pain, stiffness and bone problems
Danish: Ledsmerter, stivhed og knogleproblemer
English: The incidence of AIDS-defining infections was similar between maraviroc and placebo arms in the pivotal studies.
Danish: I de pivotale studier var hyppigheden af aids-definerede infektioner den samme for maraviroc og placebo.
English: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 180 film-coated tablets.
Danish: High density polyethylenbeholder (HDPE) med børnesikret polypropylenlåg og med en aluminiumsfolie/polyethylen varmeinduceret forsegling, der indeholder 180 filmovertrukne tabletter.
English: Screening Viral Load >100,000 copies/mL Baseline CD4+ Cell Count ≤200 cells/mm3 Number (Percentage) of patients with GSS score1:
Danish: Baseline CD4+-celletal ≤ 200 celler/mm Antal patienter (i procent) med GSS-score1:
English: Recommended dosing regimen in children aged 2 years and above and weighing at least 10 kg
Danish: Anbefalet doseringsregime til børn på 2 år og derover, som vejer mindst 10 kg
English:  old, hidden infections flaring up again as the body fights them  the immune system attacking healthy body tissue (autoimmune disorders).
Danish: • gamle, skjulte infektioner, der blusser op igen, når kroppen bekæmper dem.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz 600 mg QD (maraviroc 100 mg BID)
Danish: Non-nukleosid revers transkriptasehæmmere (NNRTI) Efavirenz 600 mg 1 gang daglig (maraviroc 100 mg 2 gange daglig)
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX09
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; andre virale midler.
English: Pfizer Manufacturing Deutschland GmbH
Danish: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee 1
English: CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets
Danish: Celsentri 25 mg filmovertrukne tabletter Celsentri 75 mg filmovertrukne tabletter Celsentri 150 mg filmovertrukne tabletter Celsentri 300 mg filmovertrukne tabletter
English: celsentri 20 mg/ml
Danish: INFORMATION I BRAILLE-SKRIFT celsentri 20 mg/ml
English: Concomitant Medications
Danish: Voksendosis* Samtidig medicin
English: Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Danish: • Øvrige indholdsstoffer: Tabletkerne: cellulose, mikrokrystallinsk; calciumhydrogenphosphat, vandfrit; natriumstivelsesglycolat; magnesiumstearat.
English: At the time of failure with CXCR4-using virus, the resistance pattern to other antiretrovirals appears similar to that of the CCR5-tropic population at baseline, based on available data.
Danish: Baseret på tilgængelige data for tidspunkt for behandlingssvigt med CXCR4-using virus viser resistensmønsteret for andre antiretrovirale lægemidler at være det samme som for CCR5-tropisme populationen ved baseline.
English: Uncommon side effects These may affect up to 1 in 100 people:
Danish: Almindelige bivirkninger Kan forekomme hos 1 til 10 ud af 100 personer:
English: Therefore, CELSENTRI should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
Danish: Derfor bør Celsentri anvendes med forsigtighed til patienter med nedsat leverfunktion (se pkt.
English: Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label.
Danish: Brug ikke Celsentri efter den udløbsdato, der står på kartonen, blisterkortet eller etiketten på beholderen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The Monogram Trofile assay was used in the clinical studies of CELSENTRI (see sections 4.4 and 5.1).
Danish: Monogram Trofile-assay blev benyttet i de kliniske studier med Celsentri (se pkt.
English: CELSENTRI with products that are potent CYP3A inhibitors (with or without a CYP3A inducer)
Danish: Celsentri sammen med produkter, der er potente CYP3A-hæmmere (med eller uden en CYP3A-induktor)
English: CELSENTRI 300 mg twice daily and sulphamethoxazole/ trimethoprim can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og sulphamethoxazol/trimethoprim kan anvendes samtidigt uden dosisjustering.
English: There is limited experience in patients >65 years of age (see section 5.2), therefore CELSENTRI should be used with caution in this population.
Danish: Der er begrænset erfaring med behandling af patienter > 65 år (se pkt.
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with clarithromycin and telithromycin.
Danish: Celsentri-dosis bør nedsættes til 150 mg 2 gange daglig, når det anvendes samtidigt med clarithromycin og telithromycin.
English: • The other ingredients are: citric acid (anhydrous), sodium citrate dihydrate, sucralose, sodium benzoate, strawberry flavouring (501440T), purified water
Danish: • Øvrige indholdsstoffer: citronsyre (vandfri), natriumcitratdihydrat, sucralose, natriumbenzoat,
English: Multipack: 180 (2 packs of 90) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Multipakning: 180 (2 pakninger med 90) filmovertrukne tabletter
English: CD4+ cell count Mean change from baseline (cells/µL) 1 p-values < 0.0001 2 For all efficacy endpoints the confidence intervals were 95%, except for HIV-1 RNA Change from baseline, which was 97.5%
Danish: 2 For alle effekt endepunkter var konfidensintervallet 95 %, undtagen for hiv 1-RNA, hvor ændring fra baseline var 97,5 %.
English: CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets maraviroc
Danish: Celsentri 25 mg filmovertrukne tabletter Celsentri 75 mg filmovertrukne tabletter Celsentri 150 mg filmovertrukne tabletter Celsentri 300 mg filmovertrukne tabletter maraviroc
English: Darunavir Cmax: ↔ 0.96 Darunavir C12: ↓ 0.77
Danish: Darunavir AUC12: ↓ 0,86 Darunavir Cmax: ↔ 0,96 Darunavir C12: ↓ 0,77
English: Co-administration of maraviroc with St. John's Wort is expected to substantially decrease maraviroc concentrations and may result in suboptimal levels and lead to loss of virologic response and possible resistance to maraviroc.
Danish: Dette kan resultere i suboptimale niveauer af maraviroc og dermed tab i det virologiske respons og mulig resistens over for maraviroc.
English:  kidney problems.
Danish:  nyreproblemer.
English: EXP {MM-YYYY }
Danish: UDLØBSDATO Exp {MM-ÅÅÅÅ}
English: Race (White/Black/Other) Mean Baseline HIV-1 RNA (log10 copies/mL) Median Baseline CD4+ Cell Count (cells/mm3) (range, cells/mm3)
Danish: Race (hvide / sorte / andre) Gennemsnit baseline hiv 1-RNA (log10 kopier/ml)
English: Each ml of oral solution contains 20 mg maraviroc.
Danish: Hver ml opløsning indeholder 20 mg maraviroc.
English: 2x carton for blister pack containing 300 mg maraviroc film-coated tablets - without Blue Box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 2x karton for blisterpakning der indeholder 300 mg maraviroc filmovertrukne tabletter - uden blue box tekst
English: Hepatobiliary disorders Aspartate aminotransferase
Danish: Lever og galdeveje Aspartataminotransferase
English: Concomitant use of maraviroc and St. John's Wort or products containing St. John's Wort is not recommended.
Danish: Samtidig anvendelse af maraviroc og perikon eller præparater, der indeholder perikon kan ikke tilrådes.
English: Male Sex
Danish: Køn, mænd
English: Signs include:
Danish: Dette inkluderer:
English: Zidovudine AUC12: ↔ 0.98
Danish: Levonorgestrel AUC12: ↔ 0,98
English: • stomach pain or tenderness
Danish: • ondt i maven eller ømhed i maven
English: 2x carton for blister pack containing 150 mg maraviroc film-coated tablets - without Blue Box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 2x karton for blisterpakning der indeholder 150 mg maraviroc filmovertrukne tabletter - uden blue box tekst
English: Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 300 mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre etiket til multipakning med 180 (2 pakninger med 90 filmovertrukne tabletter) pakket med gennemsigtig folie - med blue box tekst - 300 mg filmovertrukne tabletter
English: CELSENTRI dose should be increased to 600 mg twice daily when co-administered with carbamazepine, phenobarbital or phenytoin in the absence of a potent CYP3A4 inhibitor.
Danish: Dosis af Celsentri bør øges til 600 mg to gange dagligt ved samtidig administration med carbamazepin, phenobarbital eller phenytoin i fravær af en potent CYP3A4hæmmer.
English: Not studied, no interaction expected.
Danish: Der forventes ingen interaktion.
English: 1Based on GeneSeq resistance assay
Danish: Baseret på GeneSeq resistensanalyse
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with rifabutin and a PI (except tipranavir/ritonavir where the dose should be 300 mg twice daily).
Danish: Celsentri-dosis bør nedsættes til 150 mg 2 gange daglig, når det anvendes samtidigt med rifabutin og en proteasehæmmer (undtaget tipranavir/ritonavir, hvor dosis bør være 300 mg 2 gange daglig).
English: Etravirine C12: ↔ 1.08
Danish: Etravirin C12: ↔ 1,08
English: Maraviroc 300 mg twice daily + OBT N =421*
Danish: Maraviroc 300 mg 2 gange daglig + OB N=421*
English: Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 150 mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre etiket til multipakning med 180 (2 pakninger med 90 filmovertrukne tabletter) pakket med gennemsigtig folie - med blue box tekst - 150 mg filmovertrukne tabletter
English: ANTIBIOTICS Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (maraviroc 300 mg BID)
Danish: ANTIBIOTIKA Sulphamethoxazol/trimethoprim 800 mg/160 mg 2 gange daglig (maraviroc 300 mg 2 gange daglig)
English: CELSENTRI 75 mg film-coated tablets
Danish: Celsentri 75 mg filmovertrukne tabletter
English: Discard 60 days after first opening Discard by:
Danish: Bortskaffes 60 dage efter anbrud Bortskaffes senest:
English: CELSENTRI 300 mg film-coated tablets
Danish: Celsentri 300 mg filmovertrukne tabletter
English: Nelfinavir is a potent CYP3A4 inhibitor and would be expected to increase maraviroc concentrations.
Danish: Nelfinavir er en potent CYP3A4-hæmmer der kan forventes at øge maravirocs koncentration.
English: Poly (vinyl alcohol) Titanium dioxide (E171) Macrogol 3350
Danish: Titandioxid (E171)
English: Rifabutin + PI
Danish: Rifabutin + proteasehæmmer
English: Itraconazole, is a potent CYP3A4 inhibitor and would be expected to increase the exposure of maraviroc.
Danish: Itraconazol er en potent CYP3A4-hæmmer, og den forventes at øge maraviroceksponeringen.
English: Efavirenz, saquinavir/ritonavir concentrations not measured, no effect expected.
Danish: Efavirenz, saquinavir/ritonavir koncentrationer er ikke målt.
English: CELSENTRI with products that are CYP3A inducers (without a potent CYP3A inhibitor)
Danish: Celsentri sammen med produkter, der er CYP3Ainduktorer (uden en potent CYP3Ahæmmer)
English: Efavirenz 600 mg QD + saquinavir/ritonavir 1000 mg/100 mg BID (maraviroc 100 mg BID)
Danish: Efavirenz 600 mg 1 gang daglig + saquinavir/ritonavir 1.000 mg/100 mg 2 gange daglig (maraviroc 100 mg 2 gange daglig)
English: HIV-1 RNA <50 copies/mL Maraviroc 300 mg twice daily + OBT N=426
Danish: Hiv 1-RNA < 50 kopier/ml Maraviroc 300 mg 2 gange daglig + OB N=426
English: Sodium starch glycolate Magnesium stearate
Danish: Natriumstivelsesglycolat
English: Maraviroc 300 mg twice daily + OBT N=426
Danish: Maraviroc 300 mg 2 gange daglig + OB N=426
English: celsentri 300 mg
Danish: INFORMATION I BRAILLE-SKRIFT celsentri 300 mg
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with efavirenz and a PI (except tipranavir/ritonavir where the dose should be 600 mg twice daily).
Danish: Celsentri-dosis bør nedsættes til 150 mg 2 gange daglig, når det anvendes samtidigt med efavirenz og en proteasehæmmer (undtaget tipranavir/ritonavir, hvor dosis bør være 600 mg 2 gange daglig).
English: Nevirapine 200 mg BID (maraviroc 300 mg Single Dose)
Danish: Nevirapin 200 mg 2 gange daglig (maraviroc 300 mg enkeltdosis)
English: Gastrointestinal disorders Amylase
Danish: Mave-tarmkanalen Amylase
English: EXP {MM/YYYY}
Danish: UDLØBSDATO EXP {MM ÅÅÅÅ}
English: Maraviroc is not recommended to be used in treatment-naïve patients based on the results of a clinical study in this population (see section 5.1).
Danish: På baggrund af resultater fra et klinisk studie med behandlingsnaive patienter kan det ikke anbefales at anvende maraviroc til denne patientgruppe (se pkt.
English: Atazanavir/ritonavir concentrations not measured, no effect is expected.
Danish: Atazanavir/ritonavir koncentrationer er ikke undersøgt.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Danish: Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression og højere Body Mass Index).
English: Efavirenz concentrations not measured, no effect is expected.
Danish: Efavirenz koncentrationer er ikke undersøgt.
English: 90 film-coated tablets.
Danish: 90 filmovertrukne tabletter
English: CELSENTRI 150 mg film-coated tablets
Danish: Celsentri 150 mg filmovertrukne tabletter
English: Metabolism and nutrition disorders Anorexia common
Danish: Metabolisme og ernæring
English: In addition, cholangiocarcinomas (2/60 males at 900 mg/kg) and cholangioma (1/60 females at 500 mg/kg) were reported in the rat study at a systemic exposure at least 15-times the expected free human exposure.
Danish: I et studie med rotter ved en systemisk eksponering, der er mindst 15 gange den forventede humane dosis, blev der rapporteret kolangiokarcinom (2/60 hanner ved 900 mg/kg) og kolangiom (1/60 hunner ved 500 mg/kg).
English: ANTIARRHYTHMICS Digoxin 0.25 mg Single Dose (maraviroc 300 mg BID)
Danish: ANTIARYTMIKA Digoxin 0,25 mg Enkeltdosis (maraviroc 300 mg 2 gange daglig)
English: Limited data exist with the use of maraviroc in patients with severe cardiovascular disease, therefore special caution should be exercised when treating these patients with maraviroc.
Danish: Der er begrænsede data vedrørende brug af maraviroc hos patienter med alvorlig kardiovaskulær sygdom.
English: Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous
Danish: Calciumhydrogenphosphat, vandfrit
English: Therefore, no dose adjustment is necessary in patients with renal impairment receiving maraviroc without a potent CYP3A4 inhibitor (see sections 4.2, 4.4 and 4.5).
Danish: Dosisjustering er derfor ikke nødvendig hos patienter med nedsat nyrefunktion, der behandles med maraviroc uden samtidig behandling med en potent CYP3A4-hæmmer (se pkt.
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with ketoconazole.
Danish: Celsentri-dosis bør nedsættes til 150 mg 2 gange daglig, når det anvendes samtidigt med ketoconazol.
English: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) Lamivudine 150 mg BID (maraviroc 300 mg BID)
Danish: Nukleosid/Nukleotid revers transkriptasehæmmere (NRTI) Lamivudin 150 mg 2 gange daglig (maraviroc 300 mg 2 gange daglig)
English: CELSENTRI 25 mg film-coated tablets
Danish: Celsentri 25 mg filmovertrukne tabletter
English: Blue, biconvex, oval film-coated tablets, approximate dimensions 8.56 mm x 15.5 mm and debossed with “MVC 150”.
Danish: Blå, bikonvekse, ovale filmovertrukne tabletter, der måler ca. 8,56 mm x 15,5 mm og er præget med ”MVC 150”.
English: Other medicines and CELSENTRI Tell your doctor or pharmacist if you (or your child) are taking any other medicines,have recently taken, or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du (eller dit barn) tager anden medicin eller har gjort det for nylig.
English: The hepatic safety of maraviroc in combination with other antiretroviral agents in CCR5-tropic HIV-1-infected subjects with HIV RNA <50 copies/mL, co-infected with Hepatitis C and/or Hepatitis B Virus was evaluated in a multicentre, randomized, double blinded, placebo-controlled study.
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie undersøgte den hepatiske sikkerhed af maraviroc i kombination med andre antiretrovirale lægemidler hos CCR5-tropisme HIV1-smittede forsøgspersoner med HIV-RNA <50 kopier/ml og samtidig hepatitis C- og/eller hepatitis B-virusinfektion.
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with itraconazole.
Danish: Celsentri-dosis bør nedsættes til 150 mg 2 gange daglig, når det anvendes samtidigt med itraconazol.
English: ANTIFUNGALS
Danish: ANTIARYTMIKA
English: CXCR4-using virus was detected at failure in approximately 60% of subjects who failed treatment on maraviroc, as compared to 6% of subjects who experienced treatment failure in the placebo + OBT arm. To investigate the likely origin of the on-treatment CXCR4-using virus, a detailed clonal analysis was conducted on virus from 20 representative subjects (16 subjects from the maraviroc arms and 4 subjects from the placebo + OBT arm) in whom CXCR4-using virus was detected at treatment failure.
Danish: For at undersøge den sandsynlige oprindelse af på behandling CXCR4-using virus blev en detaljeret klonal-analyse udført på virus hos 20 repræsentativeforsøgspersoner (16 forsøgspersoner fra maraviroc-gruppen og 4 forsøgspersoner fra placebo+OBgruppen).
English: CELSENTRI dose should be increased to 600 mg twice daily when co-administered with rifampicin in the absence of a potent CYP3A4 inhibitor.
Danish: Celsentri-dosis bør øges til 600 mg 2 gange daglig, når det anvendes samtidigt med rifampicin i fravær af en potent CYP3A4hæmmer.
English: Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (maraviroc 300 mg BID)
Danish: Sulphamethoxazol/trimethoprim 800 mg/160 mg 2 gange daglig (maraviroc 300 mg 2 gange daglig)
English: Blue, biconvex, oval film-coated tablets, approximate dimensions 6.74 mm x 12.2 mm and debossed with “MVC 75”.
Danish: Blå, bikonvekse, ovale filmovertrukne tabletter, der måler ca. 6,74 mm x 12,2 mm og er præget med “MVC 75”.
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with cobicistat containing regimen.
Danish: Celsentri-dosis skal nedsættes til 150 mg to gange daglig, når det administreres samtidig med et cobicistatindeholdende regime.
English: If you get any of the following symptoms while you're taking CELSENTRI :  swelling of the face, lips or tongue  difficulty breathing  widespread skin rash  fever (high temperature)  blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.
Danish: • blærer og afskallende hud, især omkring munden, næsen, øjnene og kønsorganerne.
English: Maraviroc concentrations not measured, no effect is expected.
Danish: Maraviroc koncentrationer er ikke målt.
English: Excipient with known effect: each 300 mg film-coated tablet contains 1.68 mg of soya lecithin.
Danish: Hver 300 mg filmovertrukken tablet indeholder 1,68 mg sojalecithin.
English: celsentri 150 mg
Danish: Levonorgestrel 150 mikg.
English: If you take or give more CELSENTRI than you should
Danish: Hvis du har taget eller givet for meget Celsentri
English: Tipranavir/ritonavir 500 mg/200 mg BID (maraviroc 150 mg BID)
Danish: Tipranavir/ritonavir 500 mg/200 mg 2 gange daglig (maraviroc 150 mg 2 gange daglig)
English: 120 film-coated tablets
Danish: 60 filmovertrukne tabletter
English: Excipient with known effect: each 75 mg film-coated tablet contains 0.42 mg of soya lecithin.
Danish: Hver 75 mg filmovertrukken tablet indeholder 0,42 mg sojalecithin.
English: Cmax: ↔ 1.21
Danish: Midazolam Cmax: ↔ 1,21
English: Atazanavir concentrations not measured, no effect is expected.
Danish: Atazanavir-koncentrationer er ikke undersøgt.
English: celsentri 75 mg
Danish: INFORMATION I BRAILLE-SKRIFT celsentri 75 mg
English: Blue, biconvex, oval film-coated tablets, approximate dimensions 10.5 mm x 19.0 mm and debossed with “MVC 300”.
Danish: Blå, bikonvekse, ovale filmovertrukne tabletter, der måler ca. 10,5 mm x 19,0 mm og er præget med “MVC 300”.
English: Rifampicin 600 mg QD (maraviroc 100 mg BID)
Danish: Rifampicin 600 mg 1 gang daglig (maraviroc 100 mg 2 gange daglig)
English: Atazanavir/ritonavir 300 mg/100 mg QD (maraviroc 300 mg BID)
Danish: Atazanavir/ritonavir 300 mg/100 mg 1 gang daglig (maraviroc 300 mg 2 gange daglig)
English: Studies in Treatment-Experienced Adult Patients Infected with Non-CCR5-tropic Virus
Danish: Studier med Behandlingserfarne Voksne Patienter inficeret med Non-CCR5-tropismevirus
English: Benzodiazepines
Danish: Natriumbenzoat
English: Tenofovir 300 mg QD (maraviroc 300 mg BID)
Danish: Tenofovir 300 mg 1 gang daglig (maraviroc 300 mg 2 gange daglig)
English: Midazolam 7.5 mg Single Dose (maraviroc 300 mg BID)
Danish: Benzodiazepiner Midazolam 7,5 mg enkeltdosis (maraviroc 300 mg 2 gange daglig)
English: Therefore, unless your doctor tells you (or your child) to stop treatment, it is important to keep taking CELSENTRI correctly, as described above.
Danish: Derfor er det vigtigt, at fortsætte med at tage Celsentri korrekt, som beskrevet ovenfor, medmindre lægen beder dig (eller dit barn) om at stoppe behandlingen.
English: Efavirenz, lopinavir/ritonavir concentrations not measured, no effect expected.
Danish: Efavirenz, lopinavir/ritonavir koncentrationer er ikke målt.
English: AUC: ↔ 1.18 Midazolam.
Danish: Midazolam AUC: ↔ 1,18
English: INSTRUCTIONS ON USE 16.
Danish: Virkning og anvendelse 2.