natgillin/translations-raw huggingface dataset:
infektionshÃ¦mmende midler forbundet med en klinisk diagnose af febril neutropeni var lavere i den gruppe, som fik pegfilgrastim, end i placebogruppen (1 % imod 14 %, p &lt; 0,001, og 2 % imod 10 %, p &lt; 0,001).
The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1 % versus 14 %, p &lt; 0.001; and 2 % versus 10 %, p &lt; 0.001).
(≥ 1/10.000 til
[≥ 1/1,000 to &lt; 1/100]).
Overfølsomhedslignende reaktioner, herunder hududslæt, urticaria, angioødem, åndenød, erytem, rødme og hypotension, optrådte initialt og under vedligeholdelsesbehandling med pegfilgrastim (ikke almindelig [≥ 1/1.000 til &lt; 1/100]).
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon
Der er indberettet kapillærlækage-syndrom hos cancerpatienter, der fik kemoterapi efter indgift af granulocytkolonistimulerende faktor, med frekvensen “ikke almindelig“ (≥ 1/1.000 til &lt; 1/100).
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to &lt; 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below.
I et randomiseret, åbent, fase II multicenterstudie (n = 37) med pædiatriske patienter med sarkom, som fik 100 μg pegfilgrastim/kg efter cyklus 1 kemoterapi med vincristin, doxorubicin og cyclophosphamid (VAdriaC/IE), blev der observeret længere varighed af svær neutropeni (neutrofiler &lt; 0,5 x 109) hos mindre børn i alderen 0-5 år (8,9 dage) sammenlignet med større børn i alderen 6-11 år og 12-21 år (henholdsvis 6 dage og 3,7 dage) og voksne.
(VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils &lt; 0.5 × 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
Blå til hunde &gt; 25-40 kg
Blue for dogs &gt; 25-40 kg
Vectra 3D for til hunde &gt; 40 kg
Vectra 3D for dogs &gt; 40 kg
Gul til hunde &gt; 4-10 kg
Yellow for dogs &gt; 4-10 kg
Lilla til hunde &gt; 40 kg
Purple for dogs &gt; 40 kg
Vectra 3D til hunde 1.5-4 kg til hunde &gt; 4-10 kg
Vectra 3D for dogs 1.5-4 kg for dogs &gt; 4-10 kg
Vectra 3D til hunde &gt; 25-40 kg til hunde &gt; 40 kg
Vectra 3D for dogs &gt; 25-40 kg for dogs &gt; 40 kg
Turkis til hunde &gt; 10-25 kg
Teal for dogs &gt; 10-25 kg
Vectra 3D til hunde &gt; 4-10 kg til hunde &gt; 10-25 kg
Vectra 3D for dogs &gt; 4-10 kg for dogs &gt; 10-25 kg
Vectra 3D spot-on-opløsning til hunde 1.5-4 kg Vectra 3D spot-on-opløsning til hunde &gt; 4-10 kg Vectra 3D spot-on-opløsning til hunde &gt; 10-25 kg Vectra 3D spot-on-opløsning til hunde &gt; 25-40 kg Vectra 3D spot-on-opløsning til hunde &gt; 40 kg dinotefuran/pyriproxyfen/permethrin
Vectra 3D spot-on solution for dogs 1.5-4 kg Vectra 3D spot-on solution for dogs &gt; 4-10 kg Vectra 3D spot-on solution for dogs &gt; 10-25 kg Vectra 3D spot-on solution for dogs &gt; 25-40 kg Vectra 3D spot-on solution for dogs &gt; 40 kg dinotefuran / pyriproxyfen / permethrin
Vectra 3D til hunde &gt; 10-25 kg til hunde &gt; 25-40 kg
Vectra 3D for dogs &gt; 10-25 kg for dogs &gt; 25-40 kg Purple
INDLÆGSSEDDEL TIL: Vectra 3D spot-on-opløsning til hunde 1,5-4 kg Vectra 3D spot-on-opløsning til hunde &gt; 4-10 kg Vectra 3D spot-on-opløsning til hunde &gt; 10-25 kg Vectra 3D spot-on-opløsning til hunde &gt; 25-40 kg Vectra 3D spot-on-opløsning til hunde &gt; 40 kg
PACKAGE LEAFLET: Vectra 3D spot-on solution for dogs 1.5-4 kg Vectra 3D spot-on solution for dogs &gt; 4-10 kg Vectra 3D spot-on solution for dogs &gt; 10-25 kg Vectra 3D spot-on solution for dogs &gt; 25-40 kg Vectra 3D spot-on solution for dogs &gt; 40 kg
Vectra 3D spot-on-opløsning til hunde 1.5-4 kg Vectra 3D spot-on-opløsning til hunde &gt; 4-10 kg Vectra 3D spot-on-opløsning til hunde &gt; 10-25 kg Vectra 3D spot-on-opløsning til hunde &gt; 25-40 kg Vectra 3D spot-on-opløsning til hunde &gt; 40 kg
Vectra 3D spot-on solution for dogs 1.5-4 kg Vectra 3D spot-on solution for dogs &gt; 4-10 kg Vectra 3D spot-on solution for dogs &gt; 10-25 kg Vectra 3D spot-on solution for dogs &gt; 25-40 kg Vectra 3D spot-on solution for dogs &gt; 40 kg
59 patienter var randomiseret til rivaroxaban 20 mg (15 mg for patienter med en kreatinin-clearance (CrCl) på &lt; 50 ml/min), og 61 patienter var randomiseret til warfarin (INR 2,0-3,0).
59 patients were randomized to rivaroxaban 20 mg (15 mg for patients with creatinine clearance (CrCl) &lt; 50 mL/min) and 61 to warfarin (INR 2.0- 3.0).
Tumorstørrelse 2 cm &gt; 2 cm
Tumour size 2 cm &gt; 2 cm
Infusionen tager ca. en time, hvor du skal vÃ¦re pÃ¥ hospitalet.
The infusion will last approximately one hour during which you will be in the hospital.
Informer din lÃ¦ge eller hospitalsfarmaceut, hvis du tager eller for nylig har taget nogen anden form for medicin, herunder ogsÃ¥ medicin, som ikke er pÃ¥ recept.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Hyppigheder 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); hyppighed ikke kendt (kan ikke estimeres ud fra tilgængelige data).
Frequencies 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); not known (cannot be estimated from available data).
LVEF-nedsættelse &gt; 20 % (13,1 % versus 6,1 %), total LVEF-nedsættelse &gt; 30 % (6,2 % versus 1,1 %).
decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
De mest almindeligt rapporterede bivirkninger med docetaxel var: Neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni ( 500 celler/mm
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia ( &lt; 500 cells/mm
Hvis der opstår alvorlig neutropeni ( &lt; 500 celler/mm3) i mere end 7 dage i løbet af en docetaxelbehandling, anbefales det at reducere dosis i de efterfølgende cyklusser eller at tage passende symptomatiske forholdsregler (se pkt.
In the case of severe neutropenia ( &lt; 500 cells/mm for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Responseratio variabler: Fisher's Exact test * p-værdi for beskrivende formål **PSA response: Prostata-specifik antigen respons: PSA niveau &lt; 0,2 ng/ml målte to på hinanden følgende målinger med mindst 4 ugers mellemrum.
** PSA response: Prostate-Specific Antigen response: PSA level &lt; 0.2 ng/mL measured for two consecutive measurements at least 4 weeks apart.
Docetaxel øgede responsraten (33 % mod 12 %, p &lt; 0,0001), forlængede tiden til progression (19 uger mod 11 uger, p = 0,0004), samt forlængede overlevelsen (11 måneder mod 9 måneder, p = 0,01).
Docetaxel increased response rate (33% vs. 12%, p &lt; 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
Med en hazard ratio &lt; 1 kan docetaxel + cisplatin+5-FU anvendes med fordel * Ujusteret log-rank test ** Ujusteret log-rank test, ikke justeret efter multipel sammenligning *** Chi-square-test, ikke justeret for multipel sammenligning NA: Not Applicable
A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Patienterne havde operabel, lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse &gt; 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder &lt; 35 år).
FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size &gt; 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age &lt; 35 years).
Forsigtighedsregler for anvendelse ved adjuverende behandling af brystkræft Der er begrænsede tilgængelige data vedrørende anvendelse af docetaxel i kombination med doxorubicin og cyclophosphamid til patienter over 70 år.
Cautions for use in adjuvant treatment of breast cancer There are limited data available in patients &gt; 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Data fra et multicenter åbent randomiseret studium støtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude-positiv brystkræft og KPS &gt; 80 % i alderen mellem 18 og 70 år.
Data from a multi-centre open label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS  80%, between 18 and 70 years of age.
Der var mindre brug af smertestillende morfika (p &lt; 0,01), smertestillende ikke-morfika (p &lt; 0,01), anden ikke-sygdomsrelateret medicin (p = 0,06) og strålebehandling (p &lt; 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m end hos patienterne, der fik bedste palliative behandling.
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
hos patienter med en initialdosis på 75 mg/m docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på &lt; 25000 celler/mm
In combination with cisplatin For patients who are dosed initially at docetaxel 75 mg/m in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is &lt; 25,000 cells/mm
Docetaxel må ikke anvendes hos patienter med en udgangsværdi for neutrofile granulocytter på &lt; 1.500 celler/mm
Docetaxel must not be used in patients with baseline neutrophil count of &lt; 1,500 cells/mm
445 patienter med KPS  70 blev behandlet med enten docetaxel (T) (75 mg/m på dag 1) i kombination med cisplatin (C) (75 mg/m på dag 1) og 5-fluoruracil (F) (750 mg/m pr. dag i 5 dage)
A total of 445 patients with KPS &gt; 70 were treated with either docetaxel (T) (75 mg/m on day 1) in combination with cisplatin (C) (75 mg/m on day 1) and 5-fluorouracil (F)
Patienter med en udgangsværdi for neutrofile værdier på &lt; 1.500 celler/mm
Patients with baseline neutrophil count of &lt; 1,500 cells/mm
Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau  1.500 celler/mm og blodplader gendannes til et niveau
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level &gt; 1,500 cells/mm and platelets recover to a level &gt; 100,000 cells/mm 3.
På den anden side viste AC-armen en hyppigere forekomst af alvorlig anæmi (15,8 % versus 8,5 %) end AT-armen og tillige en hyppigere forekomst af alvorlig hjertetoksicitet: Hjerteinsufficiens (3,8 % versus 2,8 %), total LVEF-nedsættelse &gt; 20 % (13,1 % versus 6,1 %), total LVEF-nedsættelse &gt; 30 % (6,2 % versus 1,1 %).
In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
InfusionsvÃ¦sken skal bruges indenfor 4 timer ved stuetemperatur (under 25ÂºC).
The infusion solution should be used within 4 hours at room temperature (below 25°C).
Dysgeusi (G3/4: &lt; 1 %); Paræsthesi (G3/4: &lt; 1 %)
Dysgeusia (G3/4: &lt; 1%); Pareaesthesia (G3/4: &lt; 1%)
Docetaxel kan gives, når neutrocyttallet er  1.500 celler/mm I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m til 75 mg/m og/eller fra
Docetaxel should be administered when the neutrophil count is  1,500 cells/mm In patients who experienced either febrile neutropenia, neutrophil count &lt; 500 cells/mm for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m to 75 mg/m and/or from 75 to
Docetaxel forlængede median-tiden til progression (24,6 uger vs 15,6 uger; p &lt; 0,01) og medianoverlevelse (15,3 måneder vs 12,7 måneder; p = 0,03) uden at påvirke det primære endepunkt (32 % vs 25 %, p = 0,10), samlet respons rate (32 % vs 25 %, p = 0,10).
Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p &lt; 0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Hos patienter med serumbilirubin &gt; øvre normalværdi og/eller forhøjelse af ASAT/ALAT på &gt; 3,5 gange øvre normalværdi og samtidig forhøjelse af basisk fosfatase på &gt; 6 gange øvre normalværdi kan det ikke anbefales at reducere dosis.
For patients with serum bilirubin levels &gt; ULN and/or ALT and AST &gt; 3.5 times the ULN concurrent with serum alkaline phosphatase levels &gt; 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Forbedret ( &lt; grad 3)
Improved ( &lt; grade 3)
Inflammation af paronykium blev forbundet med hÃ¦velse af tÃ¦ernes og fingrenes laterale neglefold.
Paronychial inflammation was associated with swelling of the lateral nail folds of the toes and fingers.
Infusionsrelaterede reaktioner forekom dog hyppigere med cetuximab (13 % vs. 3 %), mens elektrolytforstyrrelser var hyppigere med panitumumab, herunder isÃ¦r hypomagnesÃ¦mi (29 % vs. 19 %).
However, infusion reactions were more frequent with cetuximab (13% versus 3%) but electrolyte disturbances were more frequent with panitumumab, especially hypomagnesaemia (29% versus 19%).
Disse reaktioner er relateret til Vectibix farmakologiske virkninger, og størstedelen er milde til moderate af beskaffenhed med 23 % alvorlige (grad 3 NCI-CTC) og &lt; 1 % livstruende (grad 4 NCI-CTC).
These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with 23% severe (grade 3 NCI-CTC) and &lt; 1% life-threatening (grade 4 NCI-CTC).
Behandling og håndtering af dermatologiske reaktioner skal baseres på sværhedsgraden og kan omfatte applikation af fugtighedscreme, solbeskyttelsescreme (SPF &gt; 15 UVA og UVB) og steroidcreme (ikke stærkere end 1 % hydrocortison) på de afficerede hudområder og/eller orale antibiotika (f.eks. doxycyclin).
Treatment and management of dermatologic reactions should be based on severity and may include a moisturiser, sun screen (SPF &gt; 15 UVA and UVB), and topical steroid cream (not stronger than 1% hydrocortisone) applied to affected areas, and/or oral antibiotics (e.g. doxycycline).
var cirka 19 %.
was &lt; 1%;
Deres læge vil muligvis råde Dem til at bruge fugtighedscreme, solbeskyttelsescreme (solfaktor &gt; 15), steroidcreme og/eller orale antibiotika, der kan være en hjælp i håndteringen af de hudbivirkninger, som kan være forbundet med anvendelsen af Vectibix.
Your doctor may ask you to use a moisturiser, sun screen (SPF &gt; 15), topical steroid, and/or oral antibiotics which may help in the management of skin toxicities that can be associated with the use of Vectibix.
Infusionsslangen bÃ¸r skylles med en natriumchloridinjektions/infusionsvÃ¦ske fÃ¸r og efter administration af Vectibix for at undgÃ¥ at blande med andre lÃ¦gemidler eller injektions/infusionsvÃ¦sker.
The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or intravenous solutions.
• Hyppigheden af bindende antistoffer (eksklusive patienter, der var positive inden dosering) var 1 % påvist ved syredissociations-ELISA og &lt; 1 % påvist ved Biacore-analysen;
• The incidence of binding antibodies (excluding predose positive patients) was 1% as detected by the acid-dissociation ELISA and &lt; 1% as detected by the Biacore assay;
Alvorlige (NCI-CTC grad 3) hudreaktioner blev indberettet for 23 %, og livstruende (NCI-CTC grad 4) hudreaktioner for &lt; 1 % af patienterne.
Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in &lt; 1% of patients.
• Hyppigheden af neutraliserende antistoffer (eksklusive patienter, der var positive inden dosering) var &lt; 1 %;
• The incidence of neutralising antibodies (excluding predose positive patients) was &lt; 1%;
Alvorlige (NCI-CTC grad 3) hudreaktioner blev indberettet for 23 %, og livstruende (NCI-CTC grad 4) hudreaktioner for &lt; 1 % af patienterne, som fik Vectibix som monoterapi kombineret med kemoterapi (n = 2.224) (se pkt.
Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in &lt; 1% of patients who received Vectibix monotherapy and in combination with chemotherapy (n = 2,224) (see section 4.8).
• Hyppigheden af neutraliserende antistoffer (eksklusive patienter, der var positive inden dosering eller forbigående positive) var &lt; 1 %;
• The incidence of binding antibodies (excluding predose and transient positive patients) was
• Hyppigheden af bindende antistoffer (eksklusive patienter, der var positive inden dosering eller forbigående positive) var &lt; 1 % påvist ved syredissociations-ELISA og 3,8 % påvist ved Biacore-analysen;
&lt; 1% as detected by the acid-dissociation ELISA and 3.8% as detected by the Biacore assay;
Bedaquilins plasmaproteinbinding er &gt; 99,9 % hos alle de undersøgte arter inklusive mennesker.
The plasma protein binding of bedaquiline is &gt; 99.9% in all species tested, including human.
Hyppighedskategorierne defineres således: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10) og ikke almindelig (≥ 1/1.000 til
Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10) and uncommon (≥ 1/1,000 to &lt; 1/100).
SIRTURO's sikkerhed og virkning hos børn i alderen &lt; 18 år er endnu ikke klarlagt.
The safety and efficacy of SIRTURO in children aged &lt; 18 years have not yet been established.
Dette studie inkluderede patienter fra alle tre resistenskategorier (MDRH &amp; R-, præ-XDR- og XDR-TB).
This study included patients of all three resistance categories (MDRH &amp; R-, pre-XDR- and XDR-TB).
Alle de undersøgte patienter havde et CD4+ celletal &gt; 250 x 10
Those patients studied all had CD4+ cell counts greater than 250 x 10
Der ses kun ubetydelig renal udskillelse af uomdannet bedaquilin ( &lt; 0,001 %).
Renal excretion of unchanged bedaquiline is insignificant ( &lt; 0.001%).
• QT-interval korrigeret med Fridericia-metoden (QTcF) &gt; 450 ms (bekræftet af gentaget elektrokardiogram)
• QT interval as corrected by the Fridericia method (QTcF) &gt; 450 ms (confirmed by repeat electrocardiogram);
• QTcF-interval på &gt; 500 ms (bekræftet af nyt elektrokardiogram).
• A QTcF interval of &gt; 500 ms (confirmed by repeat electrocardiogram).
I SIRTURO-gruppen observeredes ingen eller kun mindre forskelle i tid til konvertering af dyrkningsprøver og konverteringsrater for dyrkningsprøver mellem patienter med præ-XDR-TB og patienter med MDRH &amp; R-TB.
In the SIRTURO group, no or only minor differences in time to culture conversion and culture conversion rates were observed between patients with pre-XDR-TB and patients with MDRH &amp; R-TB.
Der foreligger begrænsede kliniske data (n = 2) om anvendelse af SIRTURO til tuberkulosepatienter i alderen &gt; 65 år.
There is limited clinical data (n = 2) on the use of SIRTURO in tuberculosis patients aged 65 years and older.
Udskillelse i urinen af uomdannet bedaquilin udgjorde &lt; 0,001 % af dosis i kliniske studier, hvilket indikerer, at kun en ubetydelig del af det aktive stof udskilles uomdannet gennem nyrerne.
The urinary excretion of unchanged bedaquiline was &lt; 0.001% of the dose in clinical studies, indicating that renal clearance of unchanged active substance is insignificant.
Et placebokontrolleret, dobbeltblindt, randomiseret fase IIb-studie (C208) evaluerede SIRTURO's antibakterielle virkning, sikkerhed og tolerabilitet hos nydiagnosticerede patienter med pulmonal MDRH &amp; R- og præ-XDR-TB med mikroskopi-positive ekspektorater.
A Phase IIb, placebo-controlled, double-blind, randomised trial (C208) evaluated the antibacterial activity, safety, and tolerability of SIRTURO in newly diagnosed patients with sputum smear-positive pulmonary MDRH &amp; R- and pre-XDR-TB.
Det primære resultatparameter var tid til konvertering af ekspektoratprøver (dvs. interval mellem den første indgift af SIRTURO og den første af to på hinanden følgende dyrkningsnegative flydende ekspektoratprøver udtaget med mindst 25 dages mellemrum) under behandling med SIRTURO eller placebo (median tid til konvertering var 83 døgn for SIRTURO-gruppen, 125 døgn for placebogruppen (hazard ratio, 95 % CI: 2,44 [1,57; 3,80]), p &lt; 0,0001).
The primary outcome parameter was the time to sputum culture conversion (i.e. the interval between the first SIRTURO intake and the first of two consecutive negative liquid cultures from sputum collected at least 25 days apart) during treatment with SIRTURO or placebo (median time to conversion was 83 days for the SIRTURO group, 125 days for the placebo group (hazard ratio, 95% CI: 2.44 [1.57; 3.80]), p &lt; 0.0001).
For patienter med fuld resistensundersøgelse var 76 % (84/111) inficeret med en MDRH &amp; R-TB-stamme, og 24 % (27/111) med en præ-XDR-TB-stamme.
For patients with full characterisation of resistance status, 76% (84/111) were infected with an MDRH &amp; R-TB strain and 24% (27/111) with a pre-XDR-TB strain.
Hos patienter med svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min) eller nyresygdom i terminalstadiet og behov for hæmodialyse eller peritonealdialyse kan koncentrationerne af bedaquilin stige på grund af ændringer i absorption af det aktive stof, fordeling og metabolisme som følge af renal dysfunktion.
However, in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) or end-stage renal disease requiring haemodialysis or peritoneal dialysis, bedaquiline concentrations may be increased due to alteration of active substance absorption, distribution, and metabolism secondary to renal dysfunction.
Samlet antal respondere i uge 24 Patienter med MDRH &amp; R-TB Patienter inficeret med præ-XDR-TB Samlet antal nonrespondere* i uge 24
Overall responder at Week 24 Patients with MDRH &amp; R-TB Patients infected with a pre-XDR-TB Overall nonresponder* at Week 24
De hyppigste bivirkninger (hos &gt; 10,0 % af patienterne) under behandling med SIRTURO i de kontrollerede studier var kvalme (35,3 % i SIRTURO-gruppen vs. 25,7 % i placebogruppen), artralgi (29,4 % vs. 20,0 %), hovedpine (23,5 % vs. 11,4 %), opkastning (20,6 % vs. 22,9 %) og svimmelhed (12,7 % vs. 11,4 %).
The most frequent adverse drug reactions ( &gt; 10.0% of patients) during treatment with SIRTURO in the controlled trials were nausea (35.3% in the SIRTURO group vs 25.7% in the placebo group), arthralgia (29.4% vs 20.0%), headache (23.5% vs 11.4%), vomiting (20.6% vs 22.9%) and dizziness (12.7% vs 11.4%).