natgillin/translations-raw huggingface dataset:
NEL: samme kriterier som for CHR, men ANC ≥ 500/mm3 og &lt; 1.000/mm3 eller trombocytter ≥ 20.000/mm3 og
NEL: same criteria as for CHR but ANC ≥ 500/mm3 and &lt; 1,000/mm3, or platelets ≥ 20,000/mm3 and
3 Ved trombocytter &lt; 25 × 109/l og/eller recidiv af ANC &lt; 0,5 × 109/l i &gt; 7 dage, gentages trin 1 og behandlingen genoptages med reduceret dosis på 80 mg 1 gang dagligt ved anden episode.
3 If platelets &lt; 25 x 109/L and/or recurrence of ANC &lt; 0.5 x 109/L for &gt; 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
Hvis marvcellulariteten er &lt; 10%, skal behandlingen med SPRYCEL afbrydes, indtil ANC &gt; 500/μl (0,5 × 109/l), hvor behandlingen kan genoptages på fuld dosis.
If marrow cellularity is &lt; 10%, treatment with SPRYCEL should be interrupted until ANC &gt; 500/μL (0.5 x 109/L), at which time treatment may be resumed at full dose.
Hver ml oral suspension indeholder omtrent 291 mg saccharose, 2,1 mg natrium, 0,25 mg natriumbenzoat, 0,25 mg benzoesyre, 0,017 mg benzylalkohol og &lt; 10 ppm svovldioxid (E220).
Each mL of oral suspension contains approximately 291 mg of sucrose, 2.1 mg of sodium, 0.25 mg of sodium benzoate, 0.25 mg of benzoic acid, 0.017 mg of benzyl alcohol and &lt; 10 ppm of sulphur dioxide (E220).
Ved år 1 5%, p &lt; 0,2394
By 1 year 5%, p &lt; .2394
Medianbehandlingsvarigheden for alle patienter ved en opfølgningsperiode på 7 år var ca. 29,8 måneder (1-92,9 måneder).
Median duration of treatment for all patients at 7 years of follow-up was 29.8 months (range &lt; 1-92.9 months).
Der er ikke gennemført kliniske studier med SPRYCEL hos patienter med nedsat nyrefunktion (patienter med en serumkreatinin-koncentration &gt; 3 gange den øvre normalgrænse blev ekskluderet fra studiet med patienter med nyligt diagnosticeret CML i kronisk fase, og patienter med en serumkreatinin-koncentration &gt; 1,5 gange den øvre normalgrænse blev ekskluderet i studier med patienter med CML i kronisk fase med resistens eller intolerans over for tidligere behandling med imatinib).
No clinical studies were conducted with SPRYCEL in patients with decreased renal function (the study in patients with newly diagnosed chronic phase CML excluded patients with serum creatinine concentration &gt; 3 times the upper limit of the normal range, and studies in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy excluded patients with serum creatinine concentration &gt; 1.5 times the upper limit of the normal range).
Tabel 10: Dasatinib patienter BCR-ABL ≤ 10% og &gt; 10% efter 3 måneder
Table 10: Dasatinib patients with BCR-ABL ≤ 10% and &gt; 10% at 3 months
Medianbehandlingsvarigheden var 23 måneder for dasatinib (med 44% af patienterne behandlet i &gt; 24 måneder indtil dato) og 3 måneder for imatinib (med 10% af patienterne behandlet i &gt; 24 måneder til dato).
Median duration of treatment was 23 months for dasatinib (with 44% of patients treated for &gt; 24 months to date) and 3 months for imatinib (with 10% of patients treated for &gt; 24 months to date).
Patienter med BCR-ABL &gt; 10% efter 3 måneder
Patients with BCR-ABL &gt; 10% at 3 months
NEL: samme kriterier som for CHR, men absolut neutrofiltal ≥ 500/mm3 og &lt; 1.000/mm3 eller trombocytter ≥ 20.000/mm3 og ≤ 100.000/mm3.
NEL: same criteria as for CHR but ANC ≥ 500/mm3 and &lt; 1,000/mm3, or platelets ≥ 20,000/mm3 and ≤ 100,000/mm3.
Figur 4: Landmark plot for samlet overlevelse for dasatinib ved BCR-ABL-niveau (≤ 10% eller &gt; 10% ved måned 3 i et fase 3-studie med patienter med nyligt diagnosticeret CML i kronisk fase
Figure 4: Landmark plot for overall survival for dasatinib by BCR-ABL level (≤ 10% or &gt; 10%) at 3 months in a phase 3 study of newly diagnosed patients with chronic phase CML
Forhøjet kreatininniveau grad 3 eller 4 blev rapporteret hos &lt; 1% af patienterne med CML i kronisk fase og blev rapporteret med en øget hyppighed på 1-4% hos patienterne med CML i fremskreden fase.
Grade 3 or 4 elevations in creatinine were reported in &lt; 1% of patients with chronic phase CML and were reported with an increased frequency of 1 to 4% of patients with advanced phase CML.
ANC &lt; 0,5 × 109/l og/eller trombocytter &lt; 10 × 109/l
ANC &lt; 0.5 x 109/L and/or platelets &lt; 10 x 109/L
ANC &lt; 0,5 × 109/l og/eller trombocytter &lt; 50 × 109/l
ANC &lt; 0.5 x 109/L and/or platelets &lt; 50 x 109/L
Blandt 258 dasatinib behandlede patienter og 258 imatinib behandlede patienter med mindst 60 måneders opfølgning i fase III-studiet vedrørende nyligt diagnosticeret CML i kronisk fase rapporteredes QTc-forlængelse som en bivirkning hos 1 patient ( &lt; 1%) i hver gruppe.
In 258 dasatinib-treated patients and 258 imatinib-treated patients with a minimum of 60 months follow-up in the Phase III study in newly diagnosed chronic phase CML, 1 patient ( &lt; 1%) in each group had QTc prolongation reported as an adverse reaction.
Efter mindst 60 måneders opfølgning blev der ikke rapporteret om yderligere patienter med QTcF &gt; 500 msek.
No additional patients were reported to have QTcF &gt; 500 msec after a minimum of 60 months follow-up.
En patient ( &lt; 1%) i hver gruppe havde QTcF &gt; 500 msek.
One patient ( &lt; 1%) in each group experienced a QTcF &gt; 500 msec.
Ved år 5 p &lt; 0,0251
By 5 years 42%, p &lt; .0251
c MCyR kombinerer både fuldstændigt (0% Ph+metafaser) og delvist ( &gt; 0%-35%) respons.
c MCyR combines both complete (0% Ph+ metaphases) and partial ( &gt; 0%-35%) responses.
Blandt 865 patienter med leukæmi, der i kliniske fase II-studier blev behandlet med dasatinib, var de gennemsnitlige ændringer fra baseline i QTc-intervallet ved Fridericias' metode (QTcF) 4-6 msek.
In 865 patients with leukaemia treated with dasatinib in Phase II clinical studies, the mean changes from baseline in QTc interval using Fridericia's method (QTcF) were 4 - 6 msec; the upper 95% confidence intervals for all mean changes from baseline were &lt; 7 msec (see section 4.8).
21 af disse patienter (1%) havde QTcF &gt; 500 msek.
Twenty-one of these patients (1%) experienced a QTcF &gt; 500 msec.
I fase III-studiet med patienter med nyligt diagnosticeret CML i kronisk fase havde 1 patient ( &lt; 1%) af de patienter, der blev behandlet med SPRYCEL, QTcF &gt; 500 msek.
In the Phase III study in patients with newly diagnosed chronic phase CML, one patient ( &lt; 1%) of the SPRYCEL-treated patients had a QTcF &gt; 500 msec after a minimum of 12 months follow-up (see section 4.4).
Ved år 5 p &lt; 0,0022
By 5 years 76%, p &lt; .0022
Ved år 2 p &lt; 0,0008
By 2 years 19%, p &lt; .0008
b Hæmatologiske responskriterier (alle responser blev bekræftet efter 4 uger): Komplet hæmatologisk respons (CHR) (kronisk CML): WBC ≤ gældende ULN, trombocytter &lt; 450.000/mm3, ingen blastceller eller promyelocytter i perifert blod, &lt; 5% myelocytter plus metamyelocytter i perifert blod, basofile celler i perifert blod &lt; 20% og ingen ekstramedullær involvering.
b Haematologic response criteria (all responses confirmed after 4 weeks): Complete haematologic response (CHR) (chronic CML): WBC ≤ institutional ULN, platelets &lt; 450,000/mm3, no blasts or promyelocytes in peripheral blood, &lt; 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt; 20%, and no extramedullary involvement.
c Cytogenetiske responskriterier: fuldstændigt (0% Ph+ metafaser) eller delvist ( &gt; 0%-35%).
c Cytogenetic response criteria: complete (0% Ph+ metaphases) or partial ( &gt; 0%-35%).
Ved år 4 p &lt; 0,0055
By 4 years 34%, p &lt; .0055
Medianbehandlingsvarighed med dasatinib var 24 måneder med 51% af patienterne behandlet i &gt; 24 måneder til dato.
Median duration of treatment on dasatinib was 24 months with 51% of patients treated for &gt; 24 months to date.
Medianbehandlingsvarighed med dasatinib var 3 måneder med 2% behandlet i &gt; 24 måneder til dato.
Median duration of treatment on dasatinib was 3 months with 2% treated for &gt; 24 months to date.
Medianbehandlingsvarighed med dasatinib var 14 måneder med 31% af patienterne behandlet i &gt; 24 måneder til dato.
Median duration of treatment on dasatinib was 14 months with 31% of patients treated for &gt; 24 months to date.
Medianbehandlingsvarighed med dasatinib var 3,5 måneder med 12% af patienterne behandlet i &gt; 24 måneder til dato.
Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for &gt; 24 months to date.
Ved år 3 p &lt; 0,0055
By 3 years 67%, p &lt; .0055
Medianbehandlingsvarighed med dasatinib var 3 måneder med 7% af patienterne behandlet i &gt; 24 måneder til dato.
Median duration of treatment on dasatinib was 3 months with 7% of patients treated for &gt; 24 months to date.
CHR (fremskreden CML/Ph+ ALL): WBC ≤ institutionel ULN, ANC ≥ 1.000/mm3, trombocytter ≥ 100.000/mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5%, &lt; 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod &lt; 20% og ingen ekstramedullær involvering.
CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, &lt; 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt; 20%, and no extramedullary involvement.
CHR: WBC ≤ institutionel ULN, ANC ≥ 1.000/mm3, trombocytter ≥ 100.000/mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5%, &lt; 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod &lt; 20% og ingen ekstramedullær involvering.
CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, &lt; 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt; 20%, and no extramedullary involvement.
Ved år 3 p &lt; 0,0013
By 3 years 24%, p &lt; .0013
Ved år 4 p &lt; 0,0021
By 4 years 73%, p &lt; .0021
CHR (kronisk CML): WBC ≤ institutionel ULN, trombocytter &lt; 450.000/mm3, ingen blaster eller promyelocytter i perifert blod, &lt; 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod &lt; 20% og ingen ekstramedullær involvering.
CHR (chronic CML): WBC ≤ institutional ULN, platelets &lt; 450,000/mm3, no blasts or promyelocytes in peripheral blood, &lt; 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt; 20%, and no extramedullary involvement.
21 patienter (1%) havde QTcF &gt; 500 msek.
Twenty-one patients (1%) experienced a QTcF &gt; 500 msec (see section 4.4).
Ved alle post-dosis tidspunkter på dag 8 var medianændringerne fra baseline i QTcF-intervaller 4-6 msek., med tilhørende øvre 95% konfidensintervaller &lt; 7 msek.
At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals &lt; 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
Ved år 1 p &lt; 0,0001
By 1 year 46%, p &lt; .0001
Ved år 2 p &lt; 0,0001
By 2 years 64%, p &lt; .0001
Andelen af patienter, der oplevede uønskede hændelser og alvorlige uønskede hændelser var ens hos patienter &lt; 65 år og patienter ≥65 år.
The proportion of patients experiencing adverse events and serious adverse events were similar in patients aged &lt; 65 years and those aged &gt; 65 years.
ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions are listed below by MedDRA body system organ class and the following frequency convention: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
Blandt de patienter, der blev behandlet med Combo 450 (n=274), var 194 patienter (70,8 %) &lt; 65 år, 65 patienter (23,7 %) var 65-74 år, og 15 patienter (5,5 %) var &gt; 75 år.
In patients treated with Combo 450 (n = 274), 194 patients (70.8 %) were &lt; 65 years old, 65 patients (23.7 %) were 65 -74 years old and 15 patients (5.5 %) were aged &gt; 75.
• Grad 2 aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) &gt; 3x - ≤ 5x øvre normalgrænse (ULN))
• Grade 2 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) &gt; 3x - ≤ 5x upper limit of normal (ULN)
De mest almindelige uønskede hændelser, som er rapporteret med en højere hyppighed hos patienter ≥65 år sammenlignet med patienter &lt; 65 år, omfattede diarré, kløe, GGT og forhøjet alkalisk fosfatase i blodet.
The most common adverse events reported with a higher incidence in patients aged ≥ 65 years compared to patients aged &lt; 65 years included diarrhoea, pruritus, GGT and blood phosphatase alkaline elevation.
• Grad 3 eller grad 4 (CK &gt; 5x ULN) med muskelsymptomer eller nedsat nyrefunktion
• Grade 3 or grade 4 (CK &gt; 5x ULN) with muscle symptoms or renal impairment
• Grad 4 (CK 10x ULN), asymptomatisk
• Grade 4 (CK &gt; 10x ULN) asymptomatic
Ved brug af den anbefalede dosis (n = 274) hos patienter med inoperabelt eller metastatisk melanom var de mest almindelige bivirkninger ( &gt; 25 %) hos patienter, der fik binimetinib i kombination med encorafenib, træthed, kvalme, diarré, opkastning, retinal løsning, mavesmerter, artralgi, øget CK i blodet og myalgi.
At the recommended dose (n = 274) in patients with unresectable or metastatic melanoma, the most common adverse reactions ( &gt; 25 %) occurring in patients treated with binimetinib administered with encorafenib were fatigue, nausea, diarrhoea, vomiting, retinal detachment, abdominal pain, arthralgia, blood CK increased and myalgia.
• Grad 3 (CK &gt; 5 - 10x øvre normalgrænse (ULN)), asymptomatisk
• Grade 3 (CK &gt; 5 - 10x upper limit of normal (ULN)) asymptomatic
Der blev set QTc-forlængelse &gt; 60 ms i forhold til værdien inden behandling hos 4,9 % (13/268) af patienterne i gruppen, der fik encorafenib plus binimetinib, og hos 3,4 % (7/204) i gruppen, der fik encorafenib som monoterapi (se pkt.
QTc prolongation of &gt; 60 ms compared to pre-treatment values was observed in 4.9 % (13/268) patients in the encorafenib plus binimetinib group, and in 3.4 % (7/204) in the encorafenib single agent group (see section 5.1 of encorafenib SmPC).
• Første forekomst af grad 4 (ASAT eller ALAT &gt; 20 ULN)
• First occurrence of Grade 4 (AST or ALT &gt; 20 ULN)
I sikkerhedsanalysen af de samlede studier af encorafenib 450 mg én gang dagligt i kombination med 45 mg binimetinib to gange dagligt (Combo 450) var forekomsten af ny QTc-forlængelse &gt; 500 ms. 0,7 % (2/268) i gruppen, der fik encorafenib 450 mg plus binimetinib, og 2,5 % (5/203) i gruppen, der fik encorafenib som monoterapi.
In the safety analysis of pooled studies of encorafenib 450 mg once daily in combination with 45 mg binimetinib twice daily (Combo 450), the incidence of new QTc prolongation &gt; 500 ms was 0.7 % (2/268) in the encorafenib 450 mg plus binimetinib group, and 2.5 % (5/203) in the encorafenib single agent group.
Patienter, der under behandling med Esmya har transaminaseværdier &gt; 2 gange den øvre normalgrænse, bør have behandlingen seponeret, og de bør overvåges tæt.
Patients who develop transaminase levels &gt; 2 times the upper level of normal during Esmya treatment should stop treatment and be closely monitored.
Kumulativ urinudskillelse er &lt; 1% af dosis.
Cumulative urinary excretion is &lt; 1 % of dose.
Bivirkningerne er opstillet efter hyppighed ved anvendelse af følgende definition: meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Telmisartan er i høj grad bundet til plasmaprotein ( &gt; 99,5%), hovedsagelig albumin og alfa-1-syreglykoprotein.
Telmisartan is largely bound to plasma protein ( &gt; 99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Infektion i de Ã¸vre luftveje, herunder faryngitis og sinuitis, urinvejsinfektion, herunder cystitis Sepsis, herunder med fatal udgang1
Upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis Sepsis including fatal outcome1
Telmisartan har en bieksponentiel faldende farmakokinetik med en terminal eliminationshalveringstid på &gt; 20 timer.
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of &gt; 20 hours.
Infektioner og parasitÃ¦re sygdomme cystitis
Infections and infestations cystitis
Reduktion af det diastoliske blodtryk til &lt; 90 mmHg sås hos henholdsvis 71,6%, 74,8%, 82,1% 85,3% af patienterne.
The reduction in diastolic blood pressure &lt; 90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3 % of patients respectively.
De vigtigste risikofaktorer for hyperkaliæmi, der skal overvejes, er: - Diabetes mellitus, nedsat nyrefunktion, alder ( &gt; 70 år).
The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age ( &gt; 70 years) - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements.
Dobbelt hæmning af renin-angiotensin-aldosteronsystemet (RAAS) Kombination af telmisartan med aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR &lt; 60 ml/min/1,73 m2) og anbefales ikke til andre patienter (se pkt.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) and is not recommended in other patients (see sections
Infektion i urinblÃ¦ren, tristhed (depression), angst, sÃ¸vnlÃ¸shed, besvimelse, nerveskader i hÃ¦nder eller fÃ¸dder, reduceret fÃ¸lsomhed, smagsforstyrrelser, rysten, opkastning, overvÃ¦kst af tandkÃ¸d, ubehag i maven, mundtÃ¸rhed, eksem (hudsygdom), hudrÃ¸dme, udslÃ¦t, rygsmerter, smerter i benene, natlig trang til at lade vandet, utilpashed, forhÃ¸jede urinsyreniveauer i blodet.
Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood.
Dobbelthæmning af renin-angiotensin-aldosteronsystemet Brug af telmisartan i kombination med aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR &lt; 60 ml/min/1,73 m2) (se pkt.
Dual blockade of the renin-angiotensin-aldosterone system The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see section 4.3).
Samtidig brug af telmisartan og aliskiren er kontraindiceret hos patienter med nedsat nyrefunktion (GFR &lt; 60 ml/min/1,73 m2) (se pkt.
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see section 4.3).
Brug af telmisartan sammen med aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR &lt; 60 ml/min/1,73 m2) (se pkt.
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
Residualaktiviteten for virus med MPI-værdier &lt; 95 % er ikke bestemt in vivo.
Residual activity in vivo for viruses with MPI-values &lt; 95% has not been determined.
Patienter med et meget lavt CD4+-tal ved baseline (dvs. &lt; 50 celler/µl) havde et mindre favorabelt resultat.
Patients with very low CD4+ count at baseline (i.e. &lt; 50 cells/µL) had a less favourable outcome.
Disse bivirkninger var almindelige (≥ 1/100 til &lt; 1/10).
These adverse reactions were common (≥ 1/100 to &lt; 1/10).
Frekvenserne er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥1/1000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1000) , or not known (cannot be estimated from the available data).
Et forholdsvis lille antal individer, der fik maraviroc-holdig behandling, har ikke opnået fænotypisk resistens (dvs. evnen til at anvende lægemiddelbundet CCR5 med MPI &lt; 95 %).
A relatively small number of individuals receiving maraviroc-containing therapy have failed with phenotypic resistance (i.e. the ability to use drug-bound CCR5 with MPI &lt; 95%).
Tabel 7: Andel af patienter, som opnåede &lt; 50 kopier/ml ved uge 48 i henhold til undergrupper (puljede studier MOTIVATE 1 og MOTIVATE 2)
Table 7: Proportion of patients achieving &lt; 50 copies/mL at Week 48 by subgroup (pooled Studies MOTIVATE 1 and MOTIVATE 2)
Procentdel af patienter med hiv 1-RNA &lt; 50 kopier/ml
Percentage of patients with HIV-1 RNA &lt; 50 copies/mL
Det primære mål var at evaluere forekomsten af ALAT grad 3- og 4-anormaliteter ( &gt; 5 x den øvre normale grænseværdi, hvis baseline-ALAT ≤ den øvre normale grænseværdi; eller &gt; 3,5 x baseline, hvis baseline-ALAT &gt; den øvre normale grænseværdi) ved uge 48.
The primary objective assessed the incidence of Grade 3 and 4 ALT abnormalities ( &gt; 5x upper limit of normal (ULN) if baseline ALT ≤ ULN; or &gt; 3.5x baseline if baseline ALT &gt; ULN) at Week 48.
Koncentrationsresponskurver for maraviroc-resistent virus er fænotypisk karakteriseret ved kurver, der ikke når 100 % hæmning ved analyser, når der anvendes fortyndingsserier af maraviroc ( &lt; 100 % af den maksimale procent-hæmning (MPI)).
Concentration response curves for the maraviroc-resistant viruses were characterized phenotypically by curves that did not reach 100% inhibition in assays using serial dilutions of maraviroc ( &lt; 100% maximal percentage inhibition (MPI)).
Efter 48 ugers behandling blev der ikke vist noninferioritet til efavirenz for endepunkt hiv 1-RNA &lt; 50 kopier/ml (hhv. 65,3 % mod 69,3 %, nedre konfidensgrænse -11,9 %).
After 48 weeks of treatment, maraviroc did not reach non-inferiority to efavirenz for the endpoint of HIV-1 RNA &lt; 50 copies/mL (65.3 vs. 69.3 % respectively, lower confidence bound -11.9%).
Bivirkningsprofilen hos pædiatriske patienter er baseret på 48 ugers sikkerhedsdata fra studiet A4001031, hvori 103 hiv 1-inficerede, behandlingserfarne patienter i alderen 2 til &lt; 18 år fik maraviroc to gange dagligt med optimeret baggrundsbehandling (OB).
The adverse reaction profile in paediatric patients is based on 48 Week safety data from study A4001031 in which 103 HIV-1 infected, treatment-experienced patients aged 2 to &lt; 18 years received maraviroc twice-daily with optimised background therapy (OBT).
Middel ændring fra baseline (log kopier/ml) Procentdel af patienter med hiv 1-RNA &lt; 400 kopier/ml
Mean change from baseline (log copies/mL) Percentage of patients with HIV-1 RNA &lt; 400 copies/mL
Hos voksne patienter med kreatininclearance &lt; 80 ml/min, som også får potente CYP3A4-hæmmere, skal doseringen af maraviroc justeres til 150 mg 1 gang daglig (se pkt.
In adult patients with a creatinine clearance of &lt; 80 mL/min, who are also receiving potent CYP3A4 inhibitors, the dose interval of maraviroc should be adjusted to 150 mg once daily (see sections 4.4 and 4.5).