natgillin/translations-raw huggingface dataset:
Signifikant flere af placebo-patienterne fik opblussen af sygdom i periode B (33/62; 53%) i forhold til de patienter, der fortsat fik abatacept (12/60; 20%; chi-square P &lt; 0,001).
Significantly more placebo recipients flared during Period B (33/62; 53%) than those maintained on abatacept (12/60; 20%; chi-square p &lt; 0.001).
InfusionsvÃ¦sken er holdbar i 24 timer i kÃ¸leskab efter rekonstituering og fortynding, men bÃ¸r af bakteriologiske Ã¥rsager anvendes straks.
After reconstitution and dilution, the infusion solution is stable for 24 hours in a refrigerator, but for bacteriological reasons, it is to be used immediately.
Ved 24 måneder nåede 50,6% (127/251) [95% CI: 44,4, 56,8] af patienterne i abatacept-gruppen og 53,3% (130/244) [95% CI: 47,0, 59,5] af patienterne i adalimumab-gruppen DAS 28 &lt; 2,6.
At 24 months, 50.6% (127/251) [95% CI: 44.4, 56.8] of patients in abatacept and 53.3% (130/244) [95% CI: 47.0, 59.5] of patients in adalimumab groups achieved DAS 28 &lt; 2.6.
Tabel 1 angiver bivirkninger observeret i kliniske undersøgelser og efter markedsføring opdelt i organklasse og hyppighed i følgende kategorier: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til &lt; 1/10); Ikke almindelige (≥ 1/1.000 til &lt; 1/100); Sjælden (≥ 1/10.000 til &lt; 1/1.000); Meget sjælden ( &lt; 1/10.000).
Listed in Table 1 are adverse reactions observed in clinical trials and post-marketing experience presented by system organ class and frequency, using the following categories: 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).
Tabel 2 angiver bivirkninger observeret i kliniske undersøgelser og efter markedsføring opdelt i organklasse og hyppighed i følgende kategorier: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til &lt; 1/10); Ikke almindelige (≥ 1/1.000 til &lt; 1/100); Sjælden (≥ 1/10.000 til &lt; 1/1.000); Meget sjælden ( &lt; 1/10.000).
Listed in Table 2 are adverse reactions observed in clinical trials and post-marketing experience presented by system organ class and frequency, using the following categories: 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).
Der sås større forbedring i DAS28 (p &lt; 0,001) med abatacept og med infliximab sammenlignet med placebo ved 6 måneder i den placebokontrollerede del af studiet.
Greater improvement (p &lt; 0.001) in DAS28 was observed with abatacept and with infliximab compared to placebo at six months in the placebo-controlled portion of the trial; the results between the abatacept and infliximab groups were similar.
†† p &lt; 0,05, abatacept plus MTX vs MTX plus placebo a Fast dosis, ca. 10 mg/kg (se pkt 4.2).
† p &lt; 0.05, abatacept plus MTX vs MTX plus placebo a Fixed dose approximating 10 mg/kg (see section 4.2).
*p &lt; 0,05 vs. placebo, p værdier ikke evalueret for ACR 50 og ACR 70.
* p &lt; 0.05 vs placebo, p values not assessed for ACR 50 and ACR 70. a 37% of patients were previously treated with TNF inhibitor.
Den kumulative forekomst af immunogenicitet ved abatacept med mindst en positiv prøve i den kombinerede korttids- og langtidsperiode var ifølge ECL-analysen 15,7% (215/1.369) under behandling med abatacept med en gennemsnitlig eksponeringsvarighed på 48,8 måneder og 17,3% (194/1121) efter seponering ( &gt; 21 dage og op til 168 dage efter sidste dosis).
The cumulative immunogenicity frequency to abatacept by the ECL assay with at least one positive sample in the short-term and long-term periods combined was 15.7% (215/1369) while on abatacept, with a mean duration of exposure of 48.8 months, and 17.3% (194/1121) after discontinuation ( &gt; 21 days up to 168 days after last dose).
Den gennemsnitlige dalkoncentration af abatacept ved dag 113 var 46,2 mikrog/ml (13,4 til 96,2 mikrog/ml), 48,9 mikrog/ml (22,4 til 122,1 mikrog/ml), og 38,5 mikrog/ml (9,3 til 73,2 mikrog/ml) hos pædiatriske pJIA patienter, som vejer henholdsvis 10 til &lt; 25 kg, 25 til &lt; 50 kg og ≥50 kg.
The mean (range) trough concentration of abatacept at day 113 was 46.2 mcg/mL (13.4 to 96.2 mcg/mL), 48.0 mcg/mL (22.4 to 122.1 mcg/mL), and 38.5 mcg/mL (9.3 to 73.2 mcg/mL) in paediatric pJIA patients weighing 10 to &lt; 25 kg, 25 to &lt; 50 kg, and ≥50 kg, respectively.
†† p &lt; 0,05, abatacept plus MTX vs MTX plus placebo § 95% CI: 4,2, 4,8 (baseret på præspecificeret margin for non-inferioritet på -7,5%) §§ITT-data er anført i tabel a Fast dosis, ca. 10 mg/kg (se pkt 4.2).
† p &lt; 0.01, abatacept plus MTX vs. MTX plus placebo ‡ p &lt; 0.001, abatacept plus MTX vs. MTX plus placebo †† p &lt; 0.05, abatacept plus MTX vs. MTX plus placebo § 95% CI: −4.2, 4.8 (based on prespecified margin for non-inferiority of −7.5%) §§ITT data is presented in table a Fixed dose approximating 10 mg/kg (see section 4.2).
Influenzalignende sygdom, vÃ¦gtstigning
Fatigue, asthenia Uncommon Influenza like illness, weight increased
† p &lt; 0,01, abatacept plus MTX vs MTX plus placebo ‡ p &lt; 0,001, abatacept plus MTX vs MTX plus placebo
† p &lt; 0.01, abatacept plus MTX vs. MTX plus placebo ‡ p &lt; 0.001, abatacept plus MTX vs. MTX plus placebo †† p &lt; 0.05, abatacept plus MTX vs. MTX plus placebo a Fixed dose approximating 10 mg/kg (see section 4.2).
Akutte infusionsrelaterede hændelser rapporteret hos &gt; 0,1% og ≤ 1% af de patienter, der fik behandling med abatacept, inkluderede kardiopulmonære symptomer, som fx hypotension, blodtryksfald, takykardi, bronchospasme og dyspnø.
Acute infusion-related events that were reported in &gt; 0.1% and ≤ 1% of patients treated with abatacept included cardiopulmonary symptoms such as hypotension, decreased blood pressure, tachycardia, bronchospasm, and dyspnea; other symptoms included myalgia, nausea, erythema, flushing, urticaria, hypersensitivity, pruritus, throat tightness, chest discomfort, chills, infusion site extravasation, infusion site pain, infusion site swelling, infusion related reaction, and rash.
I SC-I var ACR 20-responsraterne ved dag 169 for subkutant og intravenøst abatacept henholdsvis 78,3% (472/603 s.c.) og 76,0% (456/600 i.v.)
In SC-I, the ACR 20 response rates at day 169 for subcutaneous and intravenous abatacept were respectively 78.3% (472/603 SC) and 76.0% (456/600 IV) in patients &lt; 65 years, versus 61.1% (55/90 SC) and 74.4% (58/78 IV) for patients ≥ 65 years.
infunderet abatacept hvad angÃ¥r ACR 20-respons op til 6 mÃ¥neders behandling.
In study SC-I, abatacept administered subcutaneously (SC) was non-inferior relative to intravenous IV infusions of abatacept with respect to ACR 20 responses up to 6 months of treatment.
Studie SC-I var et randomiseret, dobbeltblindt, dobbeltdummy non-inferioritetsstudie, som blev gennemført med patienter, der blev stratificeret efter kropsvægt ( &lt; 60 kg, 60-100 kg, &gt; 100 kg).
Study SC-I was a randomised, double-blind, double-dummy noninferiority study administered to patients stratified by body weight ( &lt; 60 kg, 60 to 100 kg, &gt; 100 kg) that compared the efficacy and safety of abatacept administered subcutaneously and intravenously in subjects with rheumatoid arthritis (RA), receiving background methotrexate (MTX), and experiencing an inadequate response to MTX (MTX-IR).
Frekvenser defineres som meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1000), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra nuværende data).
Frequency categories are defined as 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).
InfusionsvÃ¦sken mÃ¥ ikke fryses eller rystes under opbevaring.
Do not freeze or shake the infusion during storage.
Infusionsstedet skal overvÃ¥ges omhyggeligt for eventuel subkutan infiltration under administrationen (se pkt.
The infusion site should be closely monitored for possible subcutaneous infiltration during administration (see section 4.8).
Der sås ingen signifikant forskel i trastuzumabemtansins farmakokinetik hos patienter &lt; 65 år (n=577), patienter i aldersgruppen 65-75 år (n=78) eller patienter &gt; 75 år (n=16).
No significant difference was observed in the PK of trastuzumab emtansine among patients &lt; 65 years (n = 577), patients between 65-75 years (n = 78) and patients &gt; 75 years (n = 16).
Infusionsrelaterede reaktioner forsvandt i lÃ¸bet af adskillige timer til en dag, efter infusion var afsluttet.
Infusion-related reactions resolved over the course of several hours to a day after the infusion was terminated.
Der er set venstre ventrikel uddrivningsfraktion (LVEF) &lt; 40% hos patienter behandlet med trastuzumabemtansin, og symptomatisk hjertesvigt er derfor en potentiel risiko (se pkt.
Left ventricular ejection fraction (LVEF) &lt; 40% has been observed in patients treated with trastuzumab emtansine, and therefore symptomatic congestive heart failure (CHF) is a potential risk (see section 4.8).
Generelle risikofaktorer for kardiale bivirkninger, og de, der er identificeret i brystkræftstudier med trastuzumab som adjuverende behandling, inkluderer stigende alder ( &gt; 50 år), lav LVEF ved baseline ( &lt; 55%), lav LVEF inden eller efter adjuverende behandling med paclitaxel, tidligere eller samtidig brug af antihypertensiva, tidligere behandling med et antracyklin og højt BMI ( &gt; 25 kg/m2).
General risk factors for a cardiac event and those identified in adjuvant breast cancer studies with trastuzumab therapy include advancing age ( &gt; 50 years), low baseline LVEF values ( &lt; 55%), low LVEF levels prior to or following the use of paclitaxel in the adjuvant setting, prior or concomitant use of antihypertensive medicinal products, previous therapy with an anthracycline and high BMI ( &gt; 25 kg/m2).
Hvis LVEF fortsat er &lt; 50% og ikke er forbedret til &lt; 10% point fra baseline, skal trastuzumabemtansin seponeres
If the LVEF remains &lt; 50% and has not recovered to &lt; 10% points from baseline, discontinue trastuzumab emtansine.
● de hyppigste NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) grad ≥3 bivirkninger ( &gt; 2%) var trombocytopeni, forhøjede aminotransferaser, anæmi, neutropeni, træthed og hypokaliæmi.
· the most common National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≥ 3 ADRs ( &gt; 2%) were thrombocytopenia, increased transaminases, anaemia, neutropenia, fatigue and hypokalaemia.
Symptomatisk hjertesvigt, Grad 3-4 LVSD eller Grad 3-4 hjertesvigt eller Grad 2 hjertesvigt ledsaget af LVEF &lt; 45%
Symptomatic CHF, Grade 3-4 LVSD or Grade 3-4 heart failure, or
Der sås klinisk betydningsfuldt og statistisk signifikant forbedring i IDFS hos patienter behandlet med trastuzumabemtansin sammenlignet med trastuzumab (HR = 0,50; 95% KI [0,39; 0,64], p &lt; 0,0001).
A clinically meaningful and statistically significant improvement in IDFS was observed in patients who received trastuzumab emtansine compared with trastuzumab (HR = 0.50, 95% CI [0.39, 0.64], p &lt; 0.0001.
InfusionsvÃ¦sken skal administreres straks efter tilberedning.
Once the infusion is prepared it should be administered immediately.
Grad 4 ( &lt; 25.000/mm3)
Grade 4 ( &lt; 25,000/mm3)
Der blev observeret tilfælde af fald i LVEF &gt; 10 % fra baseline og/eller hjertesvigt i et observationsstudie (BO39807) med metastatiske brystkræft (mBC) patienter med LVEF på 40-49 % ved baseline i almindelig klinisk praksis.
Events of LVEF drop of &gt; 10% from baseline and/or CHF were observed in an observational study (BO39807) of MBC patients with baseline LVEF of 40-49% in a real world setting.
Forekomst af grad 3 og 4 bivirkninger ( &lt; 50.000/mm3) var 8,7% hos mBC-patienter behandlet med trastuzumabemtansin og 5,7% hos eBC-patienter, uafhængig af etnicitet.
Independent of race, the incidence of Grade 3 or 4 events ( &lt; 50,000/mm3) was 8.7% in patients with MBC treated with trastuzumab emtansine and 5.7% in patients with EBC.
Trastuzumabemtansin er ikke undersøgt hos patienter med serum-aminotransferaser &gt; 2,5 ´ øvre normalgrænse eller total-bilirubin &gt; 1,5 ´ øvre normalgrænse inden behandlingsstart.
Trastuzumab emtansine has not been studied in patients with serum transaminases &gt; 2.5 ´ ULN or total bilirubin &gt; 1.5 ´ ULN prior to initiation of treatment.
Hos patienter med serum-aminotransferaser &gt; 3 ´ øvre normalgrænse og samtidigt total-bilirubin &gt; 2 ´ øvre normalgrænse skal behandlingen seponeres permanent.
Treatment in patients with serum transaminases &gt; 3 ´ ULN and concomitant total bilirubin &gt; 2 ´ ULN should be permanently discontinued.
Hvis LVEF &lt; 45% bekræftes, skal trastuzumabemtansin seponeres
If LVEF &lt; 45% is confirmed, discontinue trastuzumab emtansine.
Hvis trombocyttallet er faldet svarende til trombocytopeni grad 3 eller derover ( &lt; 50.000/mm3), må trastuzumabemtansin ikke administreres, før trombocyttallet er forbedret til grad 1 (≥75.000/mm3) (se pkt.
In the event of decreased platelet count to Grade 3 or greater ( &lt; 50,000/mm3), do not administer trastuzumab emtansine until platelet counts recover to Grade 1 (≥ 75,000/mm3) (see section 4.2).
Inflammerede eller beskadigede leverceller kan sende bestemte stoffer (leverenzymer) ud i blodet i stÃ¸rre mÃ¦ngde end normalt.
Inflamed or injured liver cells may leak higher than normal amounts of certain substances (liver enzymes) into the bloodstream, resulting in elevated liver enzymes in blood tests.
Hvis LVEF &lt; 40% bekræftes, seponeres trastuzumabemtansin
If LVEF &lt; 40% is confirmed, discontinue trastuzumab emtansine
● de hyppigste alvorlige bivirkninger ( &gt; 0,5% af patienterne) var blødning, feber, trombocytopeni, dyspnø, abdominalsmerter, muskuloskeletale smerter og opkastning.
· the most common serious ADRs ( &gt; 0.5% of patients) were haemorrhage, pyrexia, thrombocytopenia, dyspnoea, abdominal pain, musculoskeletal pain, and vomiting.
I et observationsstudie (BO39807) oplevede ca. 22 % (7 patienter ud af 32) af mBC patienterne i begyndende behandling med trastuzumabentamsin et fald i LVEF på &gt; 10% fra baseline og/eller hjertesvigt.
In an observational study (BO39807), approximately 22% (7 out of 32) of MBC patients initiating trastuzumab emtansine with LVEF of 40-49% at baseline, experienced a LVEF drop of &gt; 10% from baseline and/or CHF; most of these patients had other cardiovascular risk factors.
Grad 4 på hvilket som helst tidspunkt ( &lt; 25.000/mm3)
Grade 4 at any time &lt; 25,000/mm3
Infusionsrelaterede reaktioner karakteriseres ved en eller flere af fÃ¸lgende symptomer: ansigtsrÃ¸dme, kulderystelser, feber, dyspnÃ¸, hypotension, hvÃ¦sende vejrtrÃ¦kning, bronkospasme og takykardi.
Infusion-related reactions are characterised by one or more of the following symptoms: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm and tachycardia.
( &gt; 5 til ≤20 ´ øvre normalgrænse på dag for planlagt behandling)
( &gt; 5 to ≤ 20´ ULN on day of scheduled treatment)
Serumtransaminaser &gt; 3 ´ øvre normalgrænse og samtidigt total-bilirubin &gt; 2 ´ øvre normalgrænse
Serum transaminases &gt; 3 x ULN and concomitant total bilirubin &gt; 2´ ULN
Grad 4 ( &gt; 20 ´ øvre normalgrænse på hvilket som helst tidspunkt)
Grade 4 ( &gt; 20 ´ ULN at any time)
( &gt; 3,0 til ≤5´ øvre normalgrænse på dag for planlagt behandling)
( &gt; 3.0 to ≤ 5´ ULN on day of scheduled treatment)
LVEF 45% til &lt; 50% og fald er &lt; 10% point fra baseline*
LVEF 45% to &lt; 50% and decrease is &lt; 10% points from baseline*
( &gt; 3,0 til ≤20 ´ øvre normalgrænse på dag for planlagt behandling)
( &gt; 3.0 to ≤ 20´ ULN on day of scheduled treatment)
Grad 2 ( &gt; 2,5 til ≤5 ´ øvre normalgrænse)
Grade 2 ( &gt; 2.5 to ≤ 5´ the ULN)
Symptomatisk hjertesvigt Seponér trastuzumabemtansin LVEF &lt; 40%
Symptomatic CHF Discontinue trastuzumab emtansine LVEF &lt; 40%
Grad 3 (25.000 til &lt; 50.000/mm3)
Thrombocytopenia Grade 3 (25,000 to &lt; 50,000/mm3)
Grad 3 ( &gt; 3 til ≤10 ´ øvre normalgrænse)
Grade 3 ( &gt; 3 to ≤ 10´ the ULN)
LVEF 40% til ≤45% og fald er &lt; 10% point fra baseline
LVEF 40% to ≤ 45% and decrease is &lt; 10% points from baseline
Grad 2-3 på dag for planlagt behandling (25.000 til &lt; 75.000/mm3)
Thrombocytopenia Grade 2-3 on day of scheduled treatment (25,000 to &lt;
Grad 3 ( &gt; 5 til ≤20 ´ øvre normalgrænse)
Grade 3 ( &gt; 5 to ≤ 20´ the ULN)
Total bilirubin &gt; 2 ´ øvre normalgrænse på hvilket som helst tidspunkt
TBILI &gt; 2´ ULN at any time
Primært endepunkt Overlevelse uden invasiv sygdom (IDFS)3 Antal (%) patienter med hændelse hazard ratio [95% konfidensinterval] p-værdi (log-ranktest, ustratificeret) Andel der er hændelsesfri efter 3 år2,% [95% konfidensinterval] Sekundære endepunkter Samlet overlevelse (OS)3 Antal (%) patienter med hændelse hazard ratio [95% konfidensinterval] p-værdi (logrank-test, ustratificeret) Andel der er hændelsesfri efter 5 år 2,% [95% konfidensinterval] IDFS inklusive anden primær kræft (ikke bryst) Antal (%) patienter med hændelse hazard ratio [95% konfidensinterval] p-værdi (log-rank-test, ustratificeret) Andel der er hændelsesfri efter 3 år konfidensinterval] Sygdomsfri overlevelse (DFS)3 Antal (%) patienter med hændelse hazard ratio [95% konfidensinterval] p-værdi (logrank-test, ustratificeret) Andel der er hændelsesfri efter 3 år 2,% [95% konfidensinterval] Interval uden fjernrecidiv (DRFI) Antal (%) patienter uden hændelse hazard ratio [95% konfidensinterval] p-værdi (logrank-test, ustratificeret) Andel der er hændelsesfri efter 3 år konfidensinterval] Data fra første interimanalyse 25 juli 2018 1.
Primary endpoints IRC-assessed progression-free survival (PFS) Number (%) of patients with event Median duration of PFS (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test, stratified*) Overall Survival (OS)** Number (%) of patients who died Median duration of survival (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test*) Key secondary endpoints Investigator-assessed PFS Number (%) of patients with event Median duration of PFS (months) Hazard ratio (95% CI) p-value (Log-rank test*) Objective response rate (ORR) Patients with measurable disease Number of patients with OR (%) Difference (95% CI) p-value (Mantel-Haenszel chi-squared test*) Duration of objective response (months) Number of patients with OR Median 95% CI OS: overall survival; PFS: progression-free survival; ORR: objective response rate; OR: objective response; IRC: independent review committee; HR: hazard ratios; CI: confidence interval * Stratified by: world region (United States, Western Europe, other), number of prior chemotherapeutic regimens for locally advanced or metastatic disease (0-1 vs. &gt; 1), and visceral vs. non-visceral disease.
Grad 4 ( &gt; 10 ´ øvre normalgrænse)
Grade 4 ( &gt; 10´ the ULN)
Grad 4 ( &gt; 20 ´ øvre normalgrænse)
Grade 4 ( &gt; 20´ the ULN)
Infektioner og parasitÃ¦re sygdomme
Infections and infestations Urinary tract infection
Total bilirubin &gt; 1,0 til ≤2,0 ´ øvre normalgrænse på dag for planlagt behandling
&gt; 1.0 to ≤ 2.0´ the ULN
Ziconotid var ikke teratogen hos rotter og kaniner ved eksponeringer &lt; 100 gange de humane plasma niveauer.
Ziconotide was not teratogenic in rats and rabbits at exposures &lt; 100 times human plasma levels.
Ikke almindelig (≥ 1/1.000 til &lt; 1/100) Sjælden (≥ 1/10.000 til &lt; 1/1.000) Meget sjælden ( &lt; 1/10.000)
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)
Infektioner og parasitÃ¦re sygdomme sepsis, meningitis
Infections and infestations sepsis, meningitis
Infusionsdosens hastighed varierede fra 0,03 - 912 Î¼g/dag med en median endelig dosishastighed pÃ¥ 7,2 Î¼g/dag.
The infusion dose rate ranged from 0.03 - 912 μg/day, with a median final dose rate of 7.2 μg/day.
Plasma koncentrationerne efter kontinuerlig (≥ 48 t) IT infusion (≤ 21,6 μg/dag) viste sig at være relativt lave og typisk ikke-målbare (dvs. cirka 80 % af plasma prøverne indsamlet fra smertepatienter indeholder intet kvantificerbart lægemiddel; &lt; 0,04 ng/ml).
Plasma concentrations following continuous (≥ 48 h) IT infusion (≤ 21.6 μg/day) appear to be relatively low and typically undetectable (i.e., about 80% of plasma samples collected from pain patients contain no quantifiable medicinal product; &lt; 0.04 ng/ml).
Ziconotid er en peptid med relativ lav molekylærvægt (MW = 2,639) og bliver filtreret af nyrens glomerulus, men kun minimale mængder ziconotid ( &lt; 1 %) genindvindes i human urin efter intravenøs infusion.
The mean plasma elimination half-life (t½) is 1.3 hr. Ziconotide is a relatively small molecular weight peptide (MW = 2,639) and is filtered by the kidney glomerulus, but only minimal amounts of ziconotide ( &lt; 1%) are recovered in human urine following intravenous infusion.
ASAT: &gt; ULN (kan være normal eller &lt; ULN hvis total-bilirubin er &gt; ULN)
AST: &gt; ULN (can be normal or &lt; ULN if total bilirubin is &gt; ULN)
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), meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequency categories are defined 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).
Hvis der opstår stigninger i bilirubin &gt; 3 x IULN (institutional upper limit of normal) eller i levertransaminaser &gt; 5 x IULN, skal Glivec 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, Glivec should be withheld until bilirubin levels have returned to &lt; 1.5 x IULN and transaminase levels to &lt; 2.5 x IULN.
På et år var den samlede RFS signifikant bedre for Glivec (97,7%) i forhold til placebo (82,3%), (p &lt; 0,0001).
At one year the overall RFS was significantly better for Glivec (97.7%) vs. placebo (82.3%), (p &lt; 0.0001).
Total-bilirubin: &gt; 3-10 ULN ASAT: alt ULN = laboratoriets øvre normalgrænse ASAT = aspartataminotransferase
Total bilirubin: &gt; 3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Pædiatriske patienter: 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 dosis-eskalering.
Paediatric patients: 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.
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.
I denne retrospektive analyse af total overlevelse blev Glivecs overlegenhed vist i forhold til IFN+AraC (p &lt; 0,001); inden for 42 måneder var 47 (8,5%) Glivec-patienter og 63 (19,4%) IFN+Ara-Cpatienter døde.
In this retrospective analysis, the superiority of Glivec over IFN+Ara-C in overall survival was demonstrated (p &lt; 0.001); within 42 months, 47 (8.5%) Glivec patients and 63 (19.4%) IFN+Ara-C patients had died.
Den estimerede progressionsfri overlevelse efter 84 måneder var 81,2% i Glivec-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 Glivec arm and 60.6% in the control arm (p &lt; 0.001).