natgillin/translations-raw huggingface dataset:
Maraviroc-resistente virus, der opstår in vitro forbliver følsomme over for fusionshæmmeren enfuvirtid og PIen, saquinavir.
Maraviroc-resistant viruses that emerged in vitro remained sensitive to the fusion inhibitor enfuvirtide and the PI, saquinavir.
Intensiv farmakokinetik for maraviroc blev evalueret hos 50 behandlingserfarne, hiv 1-inficerede pædiatriske patienter i alderen 2 til 18 år (vægt fra 10,0 til 57,6 kg) med CCR5-tropisme i dosisbestemmelsesfasen af det kliniske studie A4001031.
Intensive pharmacokinetics of maraviroc were evaluated in 50 treatment-experienced, CCR5tropic, HIV-1 infected paediatric patients aged 2 to 18 years (weight 10.0 to 57.6 kg) in the dosefinding stage of clinical trial A4001031.
Der er begrænsede data fra patienter med samtidig hepatitis B- og/eller C-virusinfektion (se pkt.
There are limited data in patients with hepatitis B and/or C virus co-infection (see section 5.1).
Maravirocs sikkerhed og virkning hos patienter med alvorlig underliggende leversygdom er ikke undersøgt specifikt.
The safety and efficacy of maraviroc have not been specifically studied in patients with significant underlying liver disorders.
Den anbefalede dosis er 150 mg (med potent CYP3A-hæmmer med eller uden en potent CYP3Ainduktor), 300 mg (uden potente CYP3A-hæmmere eller -induktorer) eller 600 mg Celsentri 2 gange daglig (med potent CYP3A-induktor uden en potent CYP3A-hæmmer) afhængig af interaktion med samtidig antiretroviralbehandling og anden medicin (se pkt.
The recommended dose of CELSENTRI is 150 mg (with potent CYP3A inhibitor with or without a potent CYP3A inducer), 300 mg (without potent CYP3A inhibitors or inducers) or 600 mg twice daily (with potent CYP3A inducer without a potent CYP3A inhibitor) depending on interactions with concomitant antiretroviral therapy and other medicinal products (see section 4.5).
Fortæl lægen eller apotekspersonalet, hvis du (eller dit barn) begynder at tage ny medicin under behandling med Celsentri.
Tell your doctor or pharmacist if you (or your child) begin taking a new medicine while taking CELSENTRI.
High density polyethylenflaske (HDPE) med børnesikret lukning indeholdende 230 ml maraviroc 20 mg/ml opløsning.
High density polyethylene (HDPE) bottle, with a child resistant closure, containing 230 mL maraviroc 20 mg/mL solution.
Studiet A4001031 er et åbent multicenterstudie med pædiatriske patienter (i alderen 2 år til under 18 år), der er inficeret med CCR5-tropisme hiv 1, bestemt ved Trofile-assay for øget følsomhed.
Study A4001031 is an open-label, multicenter trial in paediatric patients (aged 2 years to less than 18 years) infected with CCR5-tropic HIV-1, determined by the enhanced-sensitivity Trofile assay.
OB var valgt ud fra patienternes tidligere behandlingsanamnese og genotypisk og fænotypisk viral resistensbestemmelse ved baseline.
The OBT was selected on the basis of the subject's prior treatment history and baseline genotypic and phenotypic viral resistance measurements.
Depression, søvnløshed
Depression, insomnia common
Sådan skal du tage Celsentri
How to take CELSENTRI
Pancytopeni, granulocytopeni
Pancytopenia, granulocytopenia rare
Maraviroc tilhører en terapeutisk gruppe, som kaldes CCR5-antagonister.
Maraviroc is a member of a therapeutic class called CCR5 antagonists.
• gulfarvning af huden eller det hvide i øjnene
• yellowing of skin or eyes
Hvis du har taget eller givet for meget Celsentri Hvis du ved et uheld har taget eller givet for meget Celsentri:
If you accidentally take or give too much CELSENTRI:
Fluconazol anses for at være en moderat CYP3A4-hæmmer.
Fluconazole is considered to be a moderate CYP3A4 inhibitor.
På baggrund af hæmningsgraden af lopinavir/ritonavir, saquinavir/ritonavir eller atazanavir/ritonavir i fravær af efavirenz, forventes en øget eksponering.
Based on the extent of inhibition by lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir in the absence of etravirine, an increased exposure is expected.
Ved initiering af antiretroviral kombinationsbehandling (CART) hos hiv-inficerede patienter med svær immuninsufficiens kan der opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Patienterne blev randomiseret i forholdet 2:2:1, således at de enten fik maraviroc 300 mg (dosisækvivalens) 1 gang daglig, Celsentri 300 mg 2 gange daglig eller placebo i kombination med en optimal baggrundsbehandling (OB), der omfattede 3 til 6 antiretrovirale lægemidler (undtagen lavdosis ritonavir).
Patients were randomised in a 2:2:1 ratio to maraviroc 300 mg (dose equivalence) once daily, twice daily or placebo in combination with an optimized background consisting of 3 to 6 antiretroviral medicinal products (excluding low-dose ritonavir).
Celsentri er, i kombination med andre antiretrovirale lægemidler, indiceret til behandlingserfarne, voksne, unge og børn på 2 år og derover, som vejer mindst 10 kg og er smittet kun med hiv 1-virus med verificeret CCR5-tropisme (se pkt.
CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adults, adolescents and children of 2 years of age, and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable (see sections 4.2 and 5.1).
• nyreproblemer.
• kidney problems.
Forskellen i eksponering for maraviroc mellem ekstensive og dårlige metabolisatorer af CYP3A5 blev reduceret, når maraviroc blev anvendt sammen med en stærk CYP3A-hæmmer: ekstensive CYP3A5-metabolisatorer (n = 12) havde en 17 % lavere AUC for maraviroc sammenlignet med dårlige CYP3A5-metabolisatorer (n = 11), når maraviroc 150 mg blev givet én gang dagligt sammen med darunavir/cobicistat (800/150 mg).
The difference in maraviroc exposure between CYP3A5 extensive and poor metabolisers was reduced when maraviroc was administered together with a strong CYP3A inhibitor: extensive CYP3A5 metabolisers (n=12) had a 17% lower maraviroc AUC compared with poor CYP3A5 metabolisers (n=11) when dosed with maraviroc 150 mg once daily in the presence of darunavir/cobicistat (800/150 mg).
Inden behandling med dette lægemiddel skal du fortælle det til lægen, hvis du (eller dit barn) har eller tidligere har haft nogle af følgende lidelser:
Before taking this medicine, make sure that your doctor knows if you (or your child) have or in the past had any of the following:
Den kliniske effekt af maraviroc (i kombination med andre antiretrovirale lægemidler) på plasma-hivRNA-koncentrationer og CD4+-celletal er undersøgt i to pivotale, randomiserede, dobbeltblindede, multicenterstudier (MOTIVATE 1 og MOTIVATE 2, n=1.076) hos patienter inficeret med CCR5tropisme hiv 1-virus, bestemt ved Monogram Trofile-assay.
The clinical efficacy of maraviroc (in combination with other antiretroviral medicinal products) on plasma HIV RNA levels and CD4+ cell counts have been investigated in two pivotal randomized, double blind, multicentre studies (MOTIVATE 1 and MOTIVATE 2, n=1076) in patients infected with CCR5 tropic HIV-1 as determined by the Monogram Trofile Assay.
Unge og børn fra 2 år, som vejer mindst 10 kg
Adolescents and children from 2 years of age and weighing at least 10 kg
Celsentri 25 mg filmovertrukne tabletter EU/1/07/418/011
CELSENTRI 25 mg film-coated tablets EU/1/07/418/011
Lot:
Lot: {number}
• øget indhold i blodet af et stof, der kaldes CPK (som kan ses i blodprøver), hvilket er et tegn på,
• an increase in a substance known as CPK (seen in blood test results) which is a sign that muscles are inflamed or damaged.
Der er øget risiko for ortostatisk hypotension hos patienter med alvorligt nedsat nyrefunktion, der behandles med potente CYP3A-hæmmere eller boostede proteasehæmmere og maraviroc.
An increased risk of postural hypotension may occur in patients with severe renal insufficiency who are treated with potent CYP3A inhibitors or boosted protease inhibitors (PIs) and maraviroc.
I en retrospektiv analyse af MOTIVATE-studierne med en mere følsom analyse til screening for tropisme (Trofile ES) var responsraten (< 50 kopier/ml ved uge 48) 48,2 % hos patienter med kun CCR5-tropisk virus påvist ved baseline og behandlet med maraviroc + OB (n=328) og 16,3 % hos patienter behandlet med placebo+OB (n=178).
In a retrospective analysis of the MOTIVATE studies with a more sensitive assay for screening of tropism (Trofile ES), the response rates (<50 copies/mL at week 48) in patients with only CCR5tropic virus detected at baseline was 48.2% in those treated with maraviroc + OBT (n=328), and 16.3% in those treated with placebo + OBT (n=178).
Tabel 1 Anbefalet doseringsregime til børn på 2 år og derover, som vejer mindst 10 kg
Table 1 Recommended dosing regimen in children aged 2 years and above and weighing at least 10 kg
Farmakokinetiske populationsanalyser fra fase 3-studier tyder på dosisreduktion af maraviroc, da det giver passende maraviroceksponering, hvis det gives samtidig med indinavir.
Population PK analysis in phase 3 studies suggests dose reduction of maraviroc when co-administered with indinavir gives appropriate maraviroc exposure.
Hos behandlingsnaive patienter var hepatobiliære lidelser ikke almindelige og ligeligt fordelt mellem de forskellige behandlingsgrupper (se pkt.
Hepatobiliary disorders reported in treatment-naïve patients were uncommon and balanced between treatment groups (see section 4.8).
Den orale opløsning skal opbevares ved temperaturer under 30 °C.
Store the oral solution below 30°C.
Placebo+OB
Placebo + OBT
Celsentri indeholder et aktivt stof, der kaldes maraviroc.
CELSENTRI contains a medicine called maraviroc.
• Aktivt stof: maraviroc.
• The active ingredient in CELSENTRI is maraviroc.
Behandlingssvigt med CCR5-tropismevirus
Failure with CCR5-tropic virus
Tabel 4: Hyppigheden ≥ 1 % af grad 3-4 anormaliteter (ACTG-kriterier) baseret på den maksimale grænse i laboratorieværdier uden hensyn til baseline studier MOTIVATE 1 og MOTIVATE 2 (puljede analyser op til 48 uger)
Table 4: Incidence ≥1% of grade 3-4 abnormalities (ACTG criteria) based on maximum shift in laboratory test values without regard to baseline studies MOTIVATE 1 and MOTIVATE 2 (pooled analysis, up to 48 weeks)
I observationsfasen var forekomsten af disse valgte endepunkter for patienter behandlet med maraviroc i overensstemmelse med den forekomst, der er set på tidligere tidspunkter i studierne.
The incidence of these selected endpoints for subjects on maraviroc in this observational phase was consistent with the incidence seen at earlier timepoints in the studies.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN ViiV Healthcare (logo)
ViiV Healthcare (logo)
Der er ikke set nogen signifikant interaktion.
No clinically significant interaction seen.
Etravirin og lopinavir/ritonavir, saquinavir/ritonavir eller atazanavir/ritonavir
Etravirine and lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir
Tabel 6: Effektresultater ved 48 uger (puljede data fra studierne MOTIVATE 1 og MOTIVATE 2)
Table 6: Efficacy Outcomes at week 48 (pooled studies MOTIVATE 1 and MOTIVATE 2) Outcomes
Ved administration af maraviroc hos rotter ses thyroideaadenom, der er forbundet med adaptive leverændringer ved en systemisk eksponering, der er 21 gange den forventede humane dosis.
In rats, administration of maraviroc at a systemic exposure 21-times the expected human exposure produced thyroid adenomas associated with adaptive liver changes.
Inden for hver gruppe af bivirkninger med samme frekvens, er bivirkningerne opstillet efter, hvor alvorlige bivirkningerne er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
België/Belgique/Belgien ViiV Healthcare sprl/bvba.
ViiV Healthcare sprl/bvba .
Efavirenz og atazanavir/ritonavir eller darunavir/ritonavir
Efavirenz and atazanavir/ritonavir or darunavir/ritonavir
Derudover er der i studier med behandlingserfarne forsøgspersoner med hiv-infektion set et øget antal leverpåvirkninger med maraviroc, men der var ikke en samlet stigning i ACTG-grad 3-4 anormalitet i leverfunktionsprøverne (se pkt.
In addition, an increase in hepatic adverse reactions with maraviroc was observed during studies of treatment-experienced subjects with HIV infection, although there was no overall increase in ACTG Grade 3/4 liver function test abnormalities (see section 4.8).
Maraviroc metaboliseres af CYP3A4 og CYP3A5.
Maraviroc is metabolised by cytochrome P450 CYP3A4 and CYP3A5.
Vend flasken med bunden opad.
Turn the bottle upside down.
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Holland.
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands.
Ved baseline var middel plasma hiv 1 RNA 4,3 log10 kopier/ml (interval 2,4 til 6,2 log10 kopier pr. ml), middel CD4+-celletal var 551 celler/mm3 (interval 1 til 1654 celler/mm3) og middel CD4+ % var 21 % (interval 0 % til 42 %).
At baseline, mean plasma HIV-1 RNA was 4.3 log10 copies/mL (range 2.4 to 6.2 log10 copies per mL), mean CD4+ cell count was 551 cells/mm3 (range 1 to 1654 cells/mm3) and mean CD4+ % was 21% (range 0% to 42%).
Når rifabutin kombineres med en proteasehæmmer, som er en potent hæmmer af CYP3A4, forventes en netto hæmmende virkning på maraviroc.
When combining rifabutin with protease inhibitors that are potent inhibitors of CYP3A4 a net inhibitory effect on maraviroc is expected.
Hos patienter med moderat nedsat nyrefunktion var Cavg for maraviroc lav fra 24-48 timer (Cavg: 32,8 ng/ml).
The Cavg of maraviroc from 24-48 hours for subjects with moderate renal impairment was low (Cavg: 32.8 ng/mL).
Cancer i galdegange, diffust storcellet B-celle lymfom, Hodgkins sygdom, knoglemetastaser, levermetastaser, metastaser i peritoneum, kræft i næsesvælget, øsofagal karcinom
Bile duct cancer, diffuse large B-cell lymphoma, Hodgkin's disease, metastases to bone, metastases to liver, metastases to peritoneum, nasopharyngeal cancer, oesophageal carcinoma rare
In vitro har maraviroc ingen aktivitet mod virus, der bruger CXCR4 som deres indtrædende coreceptor (dual-tropisme eller CXCR4-tropisme, der tilsammen benævnes CXCR4-using virus, se nedenfor).
Maraviroc has no antiviral activity in vitro against viruses which can use CXCR4 as their entry coreceptor (dual-tropic or CXCR4-tropic viruses, collectively termed ‘CXCR4-using' virus below).
Der er udført præ- og postnatale udviklingsstudier i rotter i doser op til 27 gange det estimerede frie kliniske AUC ved en dosis på 300 mg 2 gange daglig.
Pre- and post-natal developmental studies were performed in rats at doses up to 27-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Toksisk hepatitis, leversvigt, levercirrose, forhøjet blod-phosphatase
Hepatitis toxic, hepatic failure, hepatic cirrhosis, blood alkaline phosphatase increased rare
Celsentri bør anvendes med forsigtighed hos voksne patienter med alvorligt nedsat nyrefunktion (kreatininclearance < 30 ml/min), som får potente CYP3A4-hæmmere (se pkt.
CELSENTRI should be used with caution in adult patients with severe renal impairment (CLcr <30 mL/min) who are receiving potent CYP3A4 inhibitors (see sections 4.4 and 5.2).
• krampestillende medicin (carbamazepin, phenytoin, phenobarbital).
• anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).
Maravirocs farmakokinetik er ikke undersøgt hos børn under 2 år (se pkt.
The pharmacokinetics of maraviroc in paediatric patients below 2 years of age have not been established (see section 4.2).
 symptomer på infektioner og betændelse  ledsmerter, stivhed og knogleproblemer.
These include:  symptoms of infections and inflammation  joint pain, stiffness and bone problems.
Cobicistat er en potent CYP3Ahæmmer.
Cobicistat is a potent CYP3A inhibitor.
Celsentri 150 mg filmovertrukne tabletter EU/1/07/418/001 (180 tabletter) EU/1/07/418/002 (30 tabletter) EU/1/07/418/003 (60 tabletter) EU/1/07/418/004 (90 tabletter) EU/1/07/418/005 (2 x 90 tabletter - multipakning)
CELSENTRI 150 mg film-coated tablets EU/1/07/418/001 (180 tablets) EU/1/07/418/002 (30 tablets) EU/1/07/418/003 (60 tablets) EU/1/07/418/004 (90 tablets) EU/1/07/418/005 (2 x 90 tablets - multipack)
Maraviroc havde ingen klinisk relevant effekt på midazolams farmakokinetik, de orale antikonceptiva ethinylestradiol og levonorgestrel, eller på urin 6-hydroxycortisol/cortisol-forholdet.
Maraviroc had no clinically relevant effect on the pharmacokinetics of midazolam, the oral contraceptives ethinylestradiol and levonorgestrel, or urinary 6β-hydroxycortisol/cortisol ratio, suggesting no inhibition or induction of CYP3A4 in vivo.
Celsentri 75 mg filmovertrukne tabletter EU/1/07/418/012
CELSENTRI 75 mg film-coated tablets EU/1/07/418/012
• forhøjede leverenzymer (kan ses i blodprøver), som kan være tegn på leverproblemer (se også
• increase in liver enzymes (seen in blood test results), which can be a sign of liver problems (see also ‘Liver problems' earlier in section 4).
Denne dosiseksponering svarer til 39 gange det estimerede frie kliniske AUC med en dosis på 300 mg 2 gange daglig.
The exposure at this dose level corresponded to 39-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Cmax (CV%) var 335,6 ng/ml (87 %) hos raske frivillige forsøgspersoner (normal nyrefunktion); 801,2 ng/ml (56 %) ved alvorligt nedsat nyrefunktion; 576,7 ng/ml (51 %) ved ESRD (dosering efter dialyse) og 478,5 ng/ml (38 %) ved ESRD (dosering før dialyse).
The C max (CV%) was 335.6 ng/mL (87%) in healthy volunteers (normal renal function); 801.2 ng/mL (56%) in severe renal impairment; 576.7 ng/mL (51%) in ESRD (dosing after dialysis) and 478.5 ng/mL (38%) in ESRD (dosing before dialysis).
Celsentri 25 mg og 75 mg filmovertrukne tabletter findes i en beholder med 120 tabletter.
CELSENTRI 25 mg and 75 mg film-coated tablets are supplied in bottles of 120 tablets.
Hvis dette sker, skal du ligge ned, indtil du (eller dit barn) føler dig bedre tilpas.
If this happens, lie down until you (or your child) feel better.
Ved uge 48, hvor manglende data på follow-up, et skift eller seponering betragtes som svigt, opnåede 48 % af forsøgspersonerne, der blev behandlet med maraviroc og OB plasma hiv 1-RNA mindre end 48 kopier/ml og 65 % af forsøgspersonerne opnåede plasma hiv 1 RNA mindre end 400 kopier pr. ml.
At 48 weeks, using a missing, switch or discontinuation equals failure analysis, 48% of subjects treated with maraviroc and OBT achieved plasma HIV-1 RNA less than 48 copies/mL and 65% of subjects achieved plasma HIV-1 RNA less than 400 copies per mL.
Opbevares ved temperaturer under 30 ºC.
Store below 30 °C.
Celsentri 300 mg filmovertrukne tabletter EU/1/07/418/006 (180 tabletter) EU/1/07/418/007 (30 tabletter) EU/1/07/418/008 (60 tabletter) EU/1/07/418/009 (90 tabletter) EU/1/07/418/010 (2 x 90 tabletter - multipakning)
CELSENTRI 300 mg film-coated tablets EU/1/07/418/006 (180 tablets) EU/1/07/418/007 (30 tablets) EU/1/07/418/008 (60 tablets) EU/1/07/418/009 (90 tablets) EU/1/07/418/010 (2 x 90 tablets - multipack)
Celsentri 20 mg/ml oral opløsning maraviroc
CELSENTRI 20 mg/ml oral solution maraviroc
Koncentrationerne, der blev set hos patienter med alvorligt nedsat nyrefunktion og ESRD, lå inden for intervallet set ved en enkelt 300 mg dosis maraviroc til raske frivillige forsøgspersoner med normal nyrefunktion.
Exposures observed in subjects with severe renal impairment and ESRD were within the range observed in single maraviroc 300 mg dose studies in healthy volunteers with normal renal function.
Ketoconazol koncentrationer er ikke målt.
Ketoconazole concentrations not measured, no effect is expected.
Anvendelse af vægt-(kg)-baserede doser hos behandlingserfarne hiv 1-inficerede børn og unge resulterer i eksponering for maraviroc, der er magen til den, der observeres hos behandlingserfarne voksne, der får anbefalede doser sammen med anden medicin.
Use of weight (kg)-based doses in treatment-experienced HIV-1-infected children and adolescents results in maraviroc exposures similar to those observed in treatment-experienced adults receiving recommended doses with concomitant medications.
Lægen skal sikre den nødvendige dosisjustering af maraviroc, når det anvendes sammen med potente CYP3A4-hæmmere og/eller -induktorer, da maravirockoncentrationer og den terapeutiske effekt kan påvirkes (se pkt.
Physicians should ensure that appropriate dose adjustment of maraviroc is made when maraviroc is co-administered with potent CYP3A4 inhibitors and/or inducers since maraviroc concentrations and its therapeutic effects may be affected (see sections 4.2 and 4.5).
4.5 inden fastlæggelse af dosis af Celsentri efter vægt, så den tilsvarende voksendosis kan fastlægges præcist.
Prior to deciding the dose of CELSENTRI by weight, please refer to Table 2 in section 4.5 to carefully determine the corresponding adult dose.
* Baseret på lægemiddelinteraktioner (se pkt.
* Based on drug-drug Interactions (refer to section 4.5)
FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
I et fase 1-studie med raske forsøgspersoner havde sorte med en CYP3A5-genotype, der medfører ekstensiv metabolisme af maraviroc (2 CYP3A5*1-alleler; n = 12), hhv. 37 % og 26 % lavere AUC, når de fik maraviroc 300 mg to gange dagligt, sammenlignet med sorte (n = 11) og kaukasiske (n = 12) forsøgspersoner med en CYP3A5-genotype, der bibringer dårlig metabolisering af maraviroc (ingen CYP3A5*1-allel).
In a Phase 1 study conducted in healthy subjects, Blacks with a CYP3A5 genotype conferring extensive maraviroc metabolism (2 CYP3A5*1 alleles; n=12) had a 37% and 26% lower AUC when dosed with maraviroc 300 mg twice daily compared with Black (n=11) and Caucasian (n=12) subjects with CYP3A5 genotype conferring poor maraviroc metabolism (no CYP3A5*1 allele), respectively.
Ribavirin er ikke undersøgt.
Ribavirin has not been studied, no interaction is expected.
• anden medicin til at behandle hiv- eller hepatitis C-infektion (f.eks. atazanavir, cobicistat,
• other medicines to treat HIV or hepatitis C infection (such as atazanavir, cobicistat, darunavir,
Hyperbilirubinæmi, stigning i gammaglutamyltransferase
Hyperbilirubinaemia, gammaglutamyltransferase increased uncommon
Overfølsomhed over for det aktive stof, jordnødder (peanuts), soja eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1.
Symptomer, som du skal holde øje med, omfatter:
Signs to look out for include:
Et studie sammenlignede farmakokinetikken af en enkeltdosis på 300 mg maraviroc hos patienter med mild (Child-Pugh klasse A, n=8) og moderat (Child-Pugh klasse B, n=8) nedsat leverfunktion og hos raske forsøgspersoner (n=8).
A study compared the pharmacokinetics of a single 300 mg dose of maraviroc in patients with mild (Child-Pugh Class A, n=8), and moderate (Child-Pugh Class B, n=8) hepatic impairment compared to healthy subjects (n=8).
NATURLÆGEMIDLER Perikon (Hypericum perforatum)
HERBAL PRODUCTS St. John's Wort (Hypericum Perforatum)
Den anbefalede dosis Celsentri skal baseres på legemsvægt (kg) og må ikke overstige den anbefalede dosis for voksne.
Children from 2 years of age and weighing at least 10kg The recommended dose of CELSENTRI should be based on body weight (kg) and should not exceed the recommended adult dose.
Celsentri 150 mg og 300 mg filmovertrukne tabletter findes i en beholder med 180 tabletter og i blisterpakninger med 30, 60, 90 filmovertrukne tabletter samt i en multipakning med 180 (2 pakninger med 90) filmovertrukne tabletter.
CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 180 tablets or in blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) filmcoated tablets.
Kontakt apotekspersonalet for rådgivning, hvis der stadig er tvivl.
If uncertainty still exists, contact a pharmacist for advice.