natgillin/translations-raw huggingface dataset:
De hyppigste bivirkninger ved Leucogen (der kan forekomme hos op til 1 ud af 10 katte) er en moderat og kortvarig lokal reaktion ( &lt; 2 cm) efter den første injektion, som fortager sig inden for 3-4 uger uden behandling, høj kropstemperatur (der varer 1-4 dage), mathed og fordøjelsesforstyrrelser.
The most common side effects with Leucogen (which may affect up to 1 in 10 cats) are a moderate and short-lived local reaction ( &lt; 2 cm) after the first injection which resolves without treatment within 3 to 4 weeks, raised body temperature (lasting 1 to 4 days), apathy (listlessness) and digestive disturbances.
RO - Rumænien MERCK SHARP &amp; DOHME ROMÂNIA S.R.L.Bucharest Business ParkŞos.
MERCK SHARP &amp; DOHME ROMÂNIA S.R.L.Bucharest Business ParkŞos.
EL - Grækenland EVANGELOS KALOFOLIAS &amp; CO IAPHARM
EVANGELOS KALOFOLIAS &amp; CO IAPHARM
DK - Danmark Procter &amp; Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GBTW20 9 NW Egham, Surrey, England
DK - Denmark Procter &amp; Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GBTW20 9 NW Egham, Surrey, England
NL - Holland All-gen Pharmaceuticals &amp; Generics B.V.
NL - Netherlands All-gen Pharmaceuticals &amp; Generics B.V.
EL - Grækenland FARMEDIA AE ATHINAS 22 &amp; APOLLONOS GERAKAS ATTIKIS 15344
FARMEDIA AE ATHINAS 22 &amp; APOLLONOS GERAKAS ATTIKIS 15344
DE - Tyskland Heumann Pharma GmbH &amp; Co. Generica KG
DE - Germany Heumann Pharma GmbH &amp; Co. Generica KG
Procter &amp; Gamble Pharmaceuticals Nederland B.V.
NL - Netherlands Procter &amp; Gamble Pharmaceuticals Nederland B.V.
MSD Sharp &amp; Dohme GmbH Lindenplatz 1
DE - Germany MSD Sharp &amp; Dohme GmbH Lindenplatz 1
EL - Grækenland MED-ONE AFBEE AGIOU PETROU 30 &amp; EPAMEINONDA
MED-ONE AFBEE AGIOU PETROU 30 &amp; EPAMEINONDA ACHARNES 13675
AWD.pharma GmbH &amp; Co.KG
DE - Germany AWD.pharma GmbH &amp; Co.KG
Merck Sharp &amp; Dohme BV Waarderweg 39
Merck Sharp &amp; Dohme B.V. Waarderweg 39
EL - Grækenland AURORA PHARMACEUTICALS A.E. EVROU 4 &amp; MESSINIAS 2 GERAKAS 15344
PHARMACEUTICALS A.E. EVROU 4 &amp; MESSINIAS 2 GERAKAS 15344
Actonel Plus Ca &amp; D 35mg film-coated tablets + 1000mg/800 IU Effervescent Granules
Actonel Plus Ca &amp; D 35mg film-coated tablet + 1000mg/800 IU Effervescent Granules
EL - Grækenland VIOFAR LTD ETHNIKIS ANTISTASEWS &amp; TRIZINIAS
ETHNIKIS ANTISTASEWS &amp; TRIZINIAS
Merck Sharp &amp; Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)
SE - Sweden Merck Sharp &amp; Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)
Actonel Plus Ca &amp; D 35mg + 1000mg/880IU Filmovertrukket tablet og
Actonel Plus Ca &amp; D 35mg + 1000mg/880IU
meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Svære stigninger i transaminaser ( &lt; 5%) eller bilirubin ( &lt; 1%) blev observeret hos CML-patienterne og blev sædvanligvis behandlet med dosisreduktion eller seponering (den gennemsnitlige varighed af disse episoder var ca. 1 uge).
Severe elevation of transaminases ( &lt; 5%) or bilirubin ( &lt; 1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Populationsfarmakokinetiske analyser hos CML-patienter har vist, at alder har en lille effekt på fordelingsvolumen (12% stigning hos patienter &gt; 65 år).
Based on population pharmacokinetic analysis in CML patients, there was a small effect of age on the volume of distribution (12% increase in patients &gt; 65 years old).
Der sås også en let til moderat reduktion i spermatogenesen hos hunde ved orale doser &gt; 30 mg/kg.
A slight to moderate reduction in spermatogenesis was also observed in the dog at oral doses ≥ 30 mg/kg.
Total bilirubin: = 1,5 ULN AST: &gt; ULN (kan være normal or &lt; ULN hvis total bilirubin er &gt; ULN)
Total bilirubin: = 1.5 ULN AST: &gt; ULN (can be normal or &lt; ULN if total bilirubin is &gt; ULN)
a ANC &lt; 0.5 x 10
ANC &lt; 0.5 x 10
I denne retrospektive analyse af total overlevelse blev imatinibs overlegenhed vist i forhold til IFN+Ara-C (p &lt; 0,001); inden for 42 måneder var 47 (8,5%) imatinib-patienter og 63 (19,4%) IFN+Ara-C-patienter døde.
In this retrospective analysis, the superiority of imatinib over IFN+Ara-C in overall survival was demonstrated (p &lt; 0.001); within 42 months, 47 (8.5%) imatinib patients and 63 (19.4%) IFN+Ara-C patients had died.
Den estimerede progressionsfri overlevelse efter 84 måneder var 81,2% i imatinib-armen og 60,6% i kontrolarmen (p &lt; 0,001).
The estimated rate of progression-free survival at 84 months was 81.2% in the imatinib arm and 60.6% in the control arm (p &lt; 0.001).
Frekvenskategorier er defineret ved brug af følgende konvention: 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),
(≥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),
Ialt 26 pædiatriske patienter i alderen &lt; 18 år med enten CML i kronisk fase (n=11) eller CML i blastkrise eller Ph+ akut leukæmi (n=15) blev inkluderet i en fase I undersøgelse med dosiseskalering.
A total of 26 paediatric patients of age &lt; 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
Hvor estimeret 96% (93%) af patienterne med CCyR (PCyR) ved 12 måneder var fri for progression til accelereret fase/blastkrise ved 84 måneder, var kun 81% af patienterne uden CCyR ved 12 måneder fri for progression til fremskreden CML ved 84 måneder (p &lt; 0,001 samlet, p=0,25 mellem CCyR og PCyR).
Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p &lt; 0.001 overall, p=0.25 between CCyR and PCyR).
Hvis der opstår stigninger i bilirubin &gt; 3 x IULN (institutional upper limit of normal) eller i levertransaminaser &gt; 5 x IULN, skal Imatinib Teva seponeres indtil bilirubinniveauerne er faldet til &lt; 1,5 x IULN og transaminaseniveauer til &lt; 2,5 x IULN.
If elevations in bilirubin &gt; 3 x institutional upper limit of normal (IULN) or in liver transaminases &gt; 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to &lt; 1.5 x IULN and transaminase levels to &lt; 2.5 x IULN.
CLM i kronisk fase defineres ved, at alle følgende kriterier er opfyldt: blaster &lt; 15% i blod og knoglemarv, perifere blodbasofiltal &lt; 20%, trombocyttal &gt; 100 x 109/l.
Chronic phase CML is defined when all of the following criteria are met: blasts &lt; 15% in blood and bone marrow, peripheral blood basophils &lt; 20%, platelets &gt; 100 x 109/l.
Total bilirubin: &gt; 1,5-3,0 ULN AST: alt
Total bilirubin: &gt; 1.5-3.0 ULN AST: any
Den estimerede frekvens af patienter fri for progressions til fremskreden fase eller blastkrise efter 84 måneder var signifikant højere i imatinib-armen end i IFN-armen (92,5% vs. 85,1%, p &lt; 0,001).
The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the imatinib arm compared to the IFN arm (92.5% versus 85.1%, p &lt; 0.001).
Incidensen af cytopeni hang imidlertid også tydeligt sammen med sygdomsstadiet, idet hyppighed af 3. eller 4. grads neutropeni (ANC &lt; 1,0 x 109/l) og trombocytopeni (trombocyttal &lt; 50 x 109/l) var 4-6 gange højere ved blastkrise og accelereret fase (59-64% og 44-63% for henholdsvis neutropeni og trombopeni) end ved sammenligning med nydiagnosticerede patienter med kronisk fase CML (16,7% neutropeni og 8,9% trombocytopeni).
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC &lt; 1.0 x 109/l) and thrombocytopenias (platelet count &lt; 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Total bilirubin: &gt; 3-10 ULN AST: alt
Total bilirubin: &gt; 3-10 ULN
Accelereret fase defineres som tilstedeværelse af én eller flere af følgende: blaster ≥15%, men &lt; 30% i blod eller knoglemarv, blaster plus promyelocytter ≥30% i blod eller knoglemarv (hvilket giver &lt; 30% blaster), perifere blodbasofiltal ≥20%, trombocyttal &lt; 100 x 109/l uafhængigt af behandlingen.
Accelerated phase is defined by the presence of any of the following: blasts ≥ 15% but &lt; 30% in blood or bone marrow, blasts plus promyelocytes ≥ 30% in blood or bone marrow (providing &lt; 30% blasts), peripheral blood basophils ≥ 20%, platelets &lt; 100 x 109/l unrelated to therapy.
9/l og/eller trombocytter &lt; 10 x 109/l
9/l and/or platelets &lt; 10 x 109/l
CHR: Undersøgelse 0110 [leukocytter &lt; 10 x 109/l, trombocytter &lt; 450 x 109/l, myelocyt+metamyelocyt &lt; 5% i blodet, ingen blaster eller promyelocytter i blodet, basophiler &lt; 20%, ingen ekstramedullær involvering] og i undersøgelse 0102 og 0109 [ANC ≥1,5 x 109/l, trombocytter ≥100 x 109/l, ingen blaster i blodet, BM-blaster &lt; 5% og ingen ekstramedullær sygdom]
CHR: Study 0110 [WBC &lt; 10 x 109/l, platelets &lt; 450 x 109/l, myelocyte+metamyelocyte &lt; 5% in blood, no blasts and promyelocytes in blood, basophils &lt; 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts &lt; 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l (0102 and 0109 only) RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
Der sås 4. grads neutropeni (ANC &lt; 0,5 x 109/l) og trombopeni (trombocyttal &lt; 10 x 109/l) hos henholdsvis 3,6% og &lt; 1% af patienterne med nydiagnosticeret CML i kronisk fase.
In newly diagnosed chronic phase CML grade 4 neutropenia (ANC &lt; 0.5 x 109/l) and thrombocytopenia (platelet count &lt; 10 x 109/l) were observed in 3.6% and &lt; 1% of patients, respectively.
9/l, myelocytter+metamyelocytter &lt; 5% i blod, ingen blaster og promyelocytter i blod, basofile &lt; 20%, ingen ekstramedullær påvirkning Cytogenetiske responskriterier: fuldstændig (0% Ph+ metafaser), delvis (1-35%), mindre (3665%) eller minimal (66-95%).
Major response at 84 months (%) * p &lt; 0.001, Fischer's exact test ** molecular response percentages are based on available samples Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): WBC &lt; 10 x 109/l, platelet &lt; 450 x 109/l, myelocyte+metamyelocyte &lt; 5% in blood, no blasts and promyelocytes in blood, basophils &lt; 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (3665%) or minimal (66-95%).
a ANC &lt; 0.5 x 109/l og/eller trombocytter &lt; 10 x 109/l
a ANC &lt; 0.5 x 109/l and/or platelets &lt; 10 x 109/l
ANC &lt; 1,0 x 109/l og/eller trombocytter &lt; 50 x 109/l
ANC &lt; 1.0 x 109/l and/or platelets &lt; 50 x 109/l
I tilfælde af recidiverende ANC &lt; 1,0 x 109/l og/eller trombocytter &lt; 50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Teva i en reduceret dosis på 260 mg/m2.
In the event of recurrence of ANC &lt; 1.0 x109/l and/or platelets &lt; 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
= intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6MP = 6-mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er &lt; 0,1 μM, Gy= Gray
VCR (1.5 mg/m2/day, IV): days 1, 29 DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 1-56 Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG
I tilfælde af tilbagevenden af ANC &lt; 1,0 x 109/l og/eller trombocytter &lt; 50 x 109/l, gentages trin 1 og Imatinib Teva reintroduceres med nedsat dosering på 400 mg.
In the event of recurrence of ANC &lt; 1.0 x109/l and/or platelets &lt; 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
I tilfælde af recidiverende ANC &lt; 1,0 x 109/l og/eller trombocytter &lt; 50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Teva i en reduceret dosis på 300 mg.
In the event of recurrence of ANC &lt; 1.0 x109/l and/or platelets &lt; 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
): dag 1-5 G-CSF (5 μg/kg, s.c.): dag 6-15, eller indtil ANC &gt; 1500 post nadir I.t.
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC &gt; 1500 post nadir
&lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
&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 available data).
Hyppighed: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til
Frequency estimate: Very common (≥ 1/10), Common (≥ 1/100 to &lt; 1/10), Uncommon (≥ 1/1,000 to
Incidensen af bivirkninger blev evalueret for de patienter, som fik ≤ 6 serier af pemetrexed vedligeholdelsesbehandling (N = 519), og sammenlignet med de patienter, som fik &gt; 6 serier pemetrexed (N = 281).
The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N = 519), and compared to patients who received &gt; 6 cycles of pemetrexed (N = 281).
Der blev observeret en signifikant øget forekomst af grad 3/4-neutropeni, som muligvis var relateret til studiemedicinen, ved længere eksponering for pemetrexed (≤ 6 serier: 3,3 %; &gt; 6 serier: 6,4 %; p = 0,046).
A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤ 6 cycles: 3.3 %, &gt; 6 cycles: 6.4 %: p = 0.046).
Nadir for trombocytter &lt; 50.000/mm³ uanset ANC-nadir
Nadir platelets &lt; 50,000/mm³ regardless of nadir ANC
Hos patienter med en normal nyrefunktion (kreatinin-clearance ≥ 80 ml/min) kan høje doser af nonsteroide anti-inflammatoriske lægemidler (NSAID-præparater såsom ibuprofen &gt; 1.600 mg/dag) og acetylsalicylsyre i høje doser (≥ 1,3 g daglig) nedsætte udskillelsen af pemetrexed, og dermed øge forekomsten af bivirkninger relateret til pemetrexed.
In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen &gt; 1,600 mg/day) and acetylsalicylic acid at higher dose (≥ 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Patienterne behøvede ligeledes mindre erythropoietin/darbepoetin (10,4 % mod 18,1 %, p &lt; 0,001), G-CSF/GM-CSF (3,1 % mod 6,1 %; p = 0,004) og midler med jern (4,3 mod 7,0 %; p = 0,021).
Patients also required lower administration of erythropoietin/darbopoietin (10.4 % versus 18.1 %, p &lt; 0.001), G-CSF/GM-CSF (3.1 % versus 6.1 %, p = 0.004), and iron preparations (4.3 % versus 7.0 %, p = 0.021).
Patienter, der blev behandlet med pemetrexed og cisplatin, havde brug for færre transfusioner (16,4 % mod 28,9 %; p &lt; 0,001), transfusioner af røde blodlegemer (16,1 % mod 27,3 %; p &lt; 0,001) og blodpladetransfusioner (1,8 % mod 4,5 %; p = 0,002).
Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4 % versus 28.9 %, p &lt; 0.001), red blood cell transfusions (16.1 % versus 27.3 %, p &lt; 0.001) and platelet transfusions (1.8 % versus 4.5 %, p = 0.002).
Forkortelser: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute.
Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase * Definition of frequency terms: Very common - ≥ 10 %; Common - &gt; 5 % and &lt; 10 %.
*P-værdier &lt; 0,05 sammenligning af pemetrexed/cisplatin med gemcitabin/cisplatin, ved brug af Fisher Exact test. ** Se National Cancer Institute CTC (v2.0; NCI 1998) for hver toksicitetsgrad.
* P-values &lt; 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test ** Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2
a Statistisk signifikans for non-inferioritet med hele konfidensintervallet for HR pænt under 1,17645 for non-inferioritetmargin (p &lt; 0,001).
Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p &lt; 0.001)
De klinisk relevante CTC-toksiciteter, som blev rapporteret hos &lt; 1 % af de patienter, som blev randomiseret til pemetrexed, omfatter: allergisk reaktion/overfølsomhed, erythema multiforme, supraventrikulær arytmi og lungeemboli.
Clinically relevant CTC toxicity that was reported in &lt; 1 % of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring i PFS i pemetrexeddelen i forhold til placebodelen (n = 581, en uafhængig overvåget population, gennemsnit på henholdsvis 4 måneder og 2 måneder) (hazard ratio = 0,60, 95 %-CI = 0,49-0,73; p &lt; 0,00001).
The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60, 95 % CI = 0.49 - 0.73, p &lt; 0.00001).
Bivirkningerne blev rapporteret hos &gt; 5 % af de 800 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed, og de 402 patienter, som var randomiseret til placebo i studiet med pemetrexed vedligeholdelsesbehandling (JMEN: n = 63) og studiet med pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling (PARAMOUNT: n = 539).
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in &gt; 5 % of 800 patients randomly assigned to receive single-agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N = 663) and continuation pemetrexed maintenance (PARAMOUNT: N = 539) studies.
Nadir for trombocytter &lt; 50.000/mm³ med blødninga uanset ANCnadir
Nadir platelets &lt; 50,000/mm³ with bleedinga, regardless of nadir ANC 50 % of previous dose (both pemetrexed and cisplatin)
¥ p &lt; 0,0001 * For patienter med mere end én hændelse, som bidrog til det sammensatte endepunkt, blev kun den første hændelse rapporteret (f.eks. hvis en forsøgsperson oplevede både DVT og herefter LE, blev kun DVT rapporteret) † De enkelte forsøgspersoner kunne opleve mere end én hændelse og være repræsenteret i begge klassifikationer
¥ p-value &lt; 0.0001 * For patients with more than one event contributing to the composite endpoint, only the first event was reported (e.g., if a subject experienced both a DVT and then a PE, only the DVT was reported) † Individual subjects could experience more than one event and be represented in both classifications
Legemsvægt Lav legemsvægt ( &lt; 60 kg) kan medføre øget blødningsrisiko (se pkt.
Body weight Low body weight ( &lt; 60 kg) may increase haemorrhagic risk (see section 5.2).
*Non-inferior sammenlignet med enoxaparin/warfarin (p &lt; 0,0001)
* Noninferior compared to enoxaparin/warfarin (p-value &lt; 0.0001)
In vitro apixaban forsøg viste ingen hæmmende effekt på aktiviteten af CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6 eller CYP3A4 (IC50 &gt; 45 µM) og svag hæmmende effekt på aktiviteten af CYP2C19 (IC50 &gt; 20 µM) ved koncentrationer, der er signifikant højere end maksimal plasmakoncentration observeret hos patienter.
In vitro apixaban studies showed no inhibitory effect on the activity of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6 or CYP3A4 (IC50 &gt; 45 µM) and weak inhibitory effect on the activity of CYP2C19 (IC50 &gt; 20 µM) at concentrations that are significantly greater than peak plasma concentrations observed in patients.
Tabel 2 viser bivirkningerne anført under systemorganklasse og hyppighed under anvendelse af følgende kategorier: 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) for henholdsvis NVAF og VTEt.
Table 2 shows the adverse reactions ranked under headings of system organ class and 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) for NVAF and VTEt respectively.
Tabel 2 viser bivirkningerne anført under systemorganklasse og hyppighed under anvendelse af følgende kategorier: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til &lt; 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) for henholdsvis VTEp, NVAF og VTEt.
Table 2 shows the adverse reactions ranked under headings of system organ class and 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) for VTEp, NVAF, and VTEt respectively.
Sammenlignet med eksponering til apixaban hos personer med legemsvægt på 65‑85 kg, sås en ca. 30 % lavere eksponering hos personer med legemsvægt på &gt; 120 kg, og ved legemsvægt på &lt; 50 kg sås en ca. 30 % højere eksponering.
Compared to apixaban exposure in subjects with body weight of 65 to 85 kg, body weight &gt; 120 kg was associated with approximately 30% lower exposure and body weight &lt; 50 kg was associated with approximately 30% higher exposure.
Skift fra vitamin K-antagonist- (VKA) behandling til Eliquis Når patienter skiftes fra behandling med vitamin K-antagonist (VKA) til Eliquis, skal warfarin eller anden VKA-behandling seponeres og behandling med Eliquis påbegyndes, når INR (international normaliseret ratio) er &lt; 2.
Switching from vitamin K antagonist (VKA) therapy to Eliquis When converting patients from vitamin K antagonist (VKA) therapy to Eliquis, warfarin or other VKA therapy should be discontinued and Eliquis started when the international normalised ratio (INR) is &lt; 2.
I studiet var apixaban statistisk superior til enoxaparin/warfarin i det primære sikkerhedsendepunkt [relativ risiko 0,31; 95% konfidensinterval (0,17-0,55), p &lt; 0,0001] (se tabel 11).
In the study, apixaban was statistically superior to enoxaparin/warfarin in the primary safety endpoint [Relative Risk 0.31, 95% confidence interval (0.17, 0.55), P-value &lt; 0.0001] (see Table 11).