natgillin/translations-raw huggingface dataset:
For to af FOCUS-scenarierne (sur og sandet jord) er RQ &gt; 1 for begge belastninger på alle tidspunkter.
For two of the FOCUS scenarios (acidic, sandy soils) the RQs are &gt; 1 for both loading rates at all time points.
Der sås en signifikant reduktion i forekomsten af diarré (p &lt; 0,02) hos de dyr, der fik foder med højt zink-indhold; der sås imidlertid ingen signifikant forskel mellem de to behandlingsperioder.
Significant reduction of diarrhoea (p &lt; 0.02) was observed in animals treated with high zinc diets, although significant differences were not observed between both treatment periods.
Hvis den nuværende praksis ikke ændres i nær fremtid, vil der ved kontinuerlig anvendelse af gødning fra behandlede dyr inden 2060 ses en miljørisiko (defineret ved RQ-værdier &gt; 1) i 4 ud af 19 scenarier for jord, 5 ud af 15 scenarier for overfladevand og 15 ud af 15 scenarier for sedimenter.
If current practices remain unchanged in the near future, the continual application of manure from treated animals will result in risks (defined by RQ values &gt; 1) being established in 4 of 19 soil scenarios, 5 of 15 surface water scenarios and each of the 15 sediment scenarios by 2060.
I delmiljøet jord og det akvatiske delmiljø blev der fundet en risiko (RQ &gt; 1) i 4 ud af 19 scenarier og i 5 ud af 15 scenarier fra 2060 og frem for henholdsvis worst-case doseringen og den laveste dosering.
In the terrestrial and aquatic compartments a risk (RQ &gt; 1) was found at 4 out of 19 scenarios and at 5 of out 15 scenarios from 2060 onwards, for the worst case and lower application rate, respectively.
Patienterne skal observeres med hensyn til tegn og symptomer på infektion og neutrofiltallet skal følges (indtil det overstiger &lt; 1,5 x 109/l).
Patients should be observed for signs and symptoms of infection and neutrophil counts followed (until they exceed 1.5 X 109/L).
(19) Hyppigheden af patienter med et QTc skift fra &lt; 450 msek.
(19) Incidence of patients who have a QTc shift from &lt; 450 msec to ≥450 msec with a ≥30 msec increase.
Information fra kliniske forsÃ¸g viser, at der er en Ã¸get risiko for selvmordstanker og/eller selvmordsadfÃ¦rd hos yngre voksne under 25 Ã¥r med depression.
Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.
Baseret på ændringer over klinisk signifikante tærskler (tilpasset fra National Institutes of Healths kriterier) eller stigninger på &gt; 20 mmHg for systolisk eller &gt; 10 mmHg for diastolisk blodtryk ved ethvert tidspunkt i to akutte (3-6 uger) placebo-kontrollerede forsøg med børn og unge.
Based on shifts above clinically significant thresholds (adapted from the National Institutes of Health criteria) or increases &gt; 20mmHg for systolic or &gt; 10 mmHg for diastolic blood pressure at any time in two acute (3-6 weeks) placebo-controlled trials in children and adolescents.
Bivirkningshyppigheden er inddelt som: Meget almindelig (≥1/10), almindelig (≥1/100, &lt; 1/10), ikke almindelig (≥1/1000, &lt; 1/100), sjælden (≥1/10000, &lt; 1/1000) og meget sjælden ( &lt; 1/10000).
The frequencies of adverse events are ranked according to the following: Very common (≥1/10), common (≥1/100, &lt; 1/10), uncommon (≥1/1000, &lt; 1/100, rare (≥1/10,000, &lt; 1/1000) and very rare ( &lt; 1/10,000).
(18) HDL-kolesterol: &lt; 40 mg/dl (1,025 mmol/l) hankøn; &lt; 50 mg/dl (1,282 mmol/l) hunkøn ved ethvert tidspunkt.
(18) HDL cholesterol: &lt; 40 mg/dL (1.025 mmol/L) males; &lt; 50 mg/dL (1.282 mmol/L) females at any time.
I korttids placebo-kontrollerede forsøg med Seroquel med pædiatriske patienter med bipolar mani var forekomsten af selvmordsrelaterede hændelser 1,0 % (2/193) for quetiapin og 0 % (0/90) for placebo hos patienter på &lt; 18 år.
In short-term placebo-controlled trials with Seroquel in paediatric patients with bipolar mania, the incidence of suicide related events was 1.0% (2/193) for quetiapine and 0% (0/90) for placebo in patients &lt; 18 years of age.
I placebo-kontrollerede monoterapiforsøg hos patienter med et baseline neutrofiltal ≥1,5 x 109/l var hyppigheden af mindst ét tilfælde af et neutrofiltal &lt; 1,5 x 109/l hos quetiapin behandlede patienter 1,72 % sammenlignet med 0,73 % hos de patienter, som fik placebo.
In placebo-controlled monotherapy trials in patients with a baseline neutrophil count ≥ 1.5 X 109/L, the incidence of at least one occurrence of neutrophil count &lt; 1.5 X 109/L, was 1.72% in patients treated with quetiapine compared to 0.73% in placebo-treated patients.
4 Theotokopoulou &amp; Astronafton 151 25 Maroussi, Athens Grækenland
EL - Greece AstraZeneca S.A. 4 Theotokopoulou &amp; Astronafton 151 25
I alle kliniske forsøg (placebokontrollerede, open-label, aktiv komparator; patienter med et baseline neutrofiltal ≥1,5 x 109/l), var hyppigheden af mindst ét tilfælde af et neutrofiltal &lt; 1,5 x 109/l hos quetiapin behandlede patienter 0,21 % og 0 % hos de patienter, som fik placebo.
In all clinical trials (placebocontrolled, open-label, active comparator; patients with a baseline neutrophil count ≥1.5 X 109/L), the incidence of at least one occurrence of neutrophil count &lt; 0.5 X 109/L was 0.21% in patients treated with quetiapine and 0% in placebo treated patients and the incidence ≥0.5 - &lt; 1.0 X 109/L was 0.75% in patients treated with quetiapine and 0.11% in placebo-treated patients.
(11) Mindst ét tilfælde af triglycerider ≥200 mg/dl (≥2,258 mmol/l) (patienter ≥18 år) eller ≥150 mg/dl (≥1,694 mmol/l) (patienter &lt; 18 år).
(11) Triglycerides ≥200 mg/dL (≥2.258 mmol/L) (patients ≥18 years of age) or ≥150 mg/dL (≥1.694 mmol/L) (patients &lt; 18 years of age) on at least one occasion (12) Cholesterol ≥240 mg/dL (≥6.2064 mmol/L) (patients ≥18 years of age) or ≥200 mg/dL (≥5.172 mmol/L) (patients &lt; 18 years of age) on at least one occasion.
Selvmord/selvmordstanker eller klinisk forværring I korttids placebo-kontrollerede kliniske forsøg med Seroquel med pædiatriske patienter med skizofreni var forekomsten af selvmordsrelaterede hændelser 1,4 % (2/147) for quetiapin og 1,3 % (1/75) for placebo hos patienter på &lt; 18 år.
In short-term placebo-controlled clinical trials with Seroquel in paediatric patients with schizophrenia, the incidence of suicide related events was 1.4% (2/147) for quetiapine and 1.3% (1/75) for placebo in patients &lt; 18 years of age.
I kliniske forsøg med quetiapin er der set alvorlig neutropeni (neutrofiltal &lt; 0,5 x 109/l) med hyppigheden ikke almindelig.
Severe neutropenia (neutrophil count &lt; 0.5 X 109/L) has been uncommonly reported in quetiapine clinical trials.
(16) Prolaktinniveauer (patienter &gt; 18 år): &gt; 20 μg/l ( &gt; 869,56 pmol/l) hankøn: &gt; 30 μg/l ( &gt; 1304,34 pmol/l) hunkøn ved ethvert tidspunkt.
(13) See text below (14) Platelets ≤100 x 109/L on at least one occasion (15) Based on clinical trial adverse event reports of blood creatine phosphokinase increase not associated with neuroleptic malignant syndrome (16) Prolactin levels (patients &gt; 18 years of age): &gt; 20 μg/L ( &gt; 869.56 pmol/L) males; &gt; 30 μg/L ( &gt; 1304.34 pmol/L) females at any time.
(7) Mindst ét tilfælde af fastende blodglukose ≥126 mg/dl (≥7,0 mmol/l) eller ikke fastende blodglukose ≥200 mg/dl (≥11,1 mmol/l).
(6) Calculation of Frequency for these ADR's have only been taken from postmarketing data with the immediate release formulation of Seroquel (7) Fasting blood glucose ≥126mg/dL(≥7.0 mmol/L) or a non fasting blood glucose ≥200mg/dL (≥11.1 mmol/L) on at least one occasion (8) An increase in the rate of dysphagia with quetiapine vs. placebo was only observed in the clinical trials in bipolar depression (9) Based on &gt; 7% increase in body weight from baseline.
Hund 2-3,5 kg Hund &gt; 3,5-7,5 kg Hund &gt; 7,5-15 kg Hund &gt; 15-30 kg Hund &gt; 30-60 kg
Dogs 2-3.5 kg Dogs &gt; 3.5-7.5 kg Dogs &gt; 7.5-15 kg Dogs &gt; 15-30 kg Dogs &gt; 30-60 kg
Marmoreret rød til rødbrun, rund (tablet til hund 2-3,5 kg) eller rektangulær (tablet til hund &gt; 3,5-7,5 kg, tablet til hund &gt; 7,5-15 kg, tablet til hund &gt; 15-30 kg og tablet til hund &gt; 30-60 kg).
Mottled red to reddish brown, circular shaped (tablets for dogs 2-3.5 kg) or rectangular shaped (tablets for dogs &gt; 3.5-7.5 kg, tablets for dogs &gt; 7.5-15 kg, tablets for dogs &gt; 15-30 kg and tablets for dogs &gt; 30-60 kg).
NEXGARD SPECTRA 9 mg/2 mg hund 2-3,5 kg NEXGARD SPECTRA 19 mg/4 mg hund &gt; 3,5-7,5 kg NEXGARD SPECTRA 38 mg/8 mg hund &gt; 7,5-15 kg NEXGARD SPECTRA 75 mg/15 mg hund &gt; 15-30 kg NEXGARD SPECTRA 150 mg/30 mg hund &gt; 30-60 kg afoxolaner./milbemycin.oxim.
NEXGARD SPECTRA 9 mg/ 2 mg dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg dogs &gt; 3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg dogs &gt; 7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg dogs &gt; 15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg dogs &gt; 30-60 kg afoxolaner / milbemycin oxime Tablets
NEXGARD SPECTRA 9 mg/ 2 mg tyggetabletter til hund 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tyggetabletter til hund &gt; 3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tyggetabletter til hund &gt; 7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tyggetabletter til hund &gt; 15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tyggetabletter til hund &gt; 30-60 kg Afoxolaner, milbemycinoxim
NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs &gt; 3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs &gt; 7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs &gt; 15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs &gt; 30-60 kg Afoxolaner, milbemycin oxime
NEXGARD SPECTRA 9 mg/ 2 mg tyggetabletter til hund 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tyggetabletter til hund &gt; 3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tyggetabletter til hund &gt; 7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tyggetabletter til hund &gt; 15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tyggetabletter til hund &gt; 30-60 kg
NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs &gt; 3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs &gt; 7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs &gt; 15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs &gt; 30-60 kg
INDLÆGSSEDDEL NEXGARD SPECTRA 9 mg/2 mg tyggetabletter til hund 2-3,5 kg NEXGARD SPECTRA 19 mg/4 mg tyggetabletter til hund &gt; 3,5-7,5 kg NEXGARD SPECTRA 38 mg/8 mg tyggetabletter til hund &gt; 7,5-15 kg NEXGARD SPECTRA 75 mg/15 mg tyggetabletter til hund &gt; 15-30 kg NEXGARD SPECTRA 150 mg/30 mg tyggetabletter til hund &gt; 30-60 kg
PACKAGE LEAFLET: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs &gt; 3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs &gt; 7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs &gt; 15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs &gt; 30-60 kg
Indhold (koncentration)
&lt; Content (concentration) &gt;
EU/2/99/011/001 Locatim &gt; 2.8log10 /ml Bovin, koncentreret valle
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Indehaver af markedsføringstilladelse: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Fremstiller: Merck, Sharp &amp; Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Olanda
Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Manufactured by: Merck Sharp &amp; Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Følgende lokale og systemiske reaktioner blev rapporteret hos ≥ 1.0% af børnene indenfor 5 dage efter injektion med PROCOMVAX: Smerte/ømhed, erytem, hævelse/induration på injektionsstedet; feber ( &gt; 38,3 ºC rektalt), anoreksi, opkastning, diaré; irritabilitet, døsighed, gråd inkl.
The following local reactions and systemic complaints were reported in ≥1.0 % of children within five days after any injection of PROCOMVAX: pain/soreness, erythema, swelling/induration at the injection site; fever ( &gt; 38.3 °C, rectal equivalent); anorexia, vomiting, diarrhoea; irritability, somnolence, crying including unusual high-pitched crying, prolonged crying ( &gt; 4hrs), and crying not otherwise specified; otitis media.
Merck &amp; Co. Inc. Sumneytown Pike
Sumneytown Pike West Point
Det er et niveau, der forbindes med kortsigtet beskyttelse imod invasiv Hib-infektion GMT var i området fra 2,5 µg/ml til 4,3 µg/ml.
Post-dose 2, 95 % to 99 % of infants developed &gt; 0.15 µg/ml of anti-PRP, a level associated with short-term protection against invasive Hib disease, and the GMTs ranged from 2.5 µg/ml to 4.3 µg/ml.
(≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 to &lt; 1/100), sjælden (≥1/10.000 to &lt; 1/1.000), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Class, presented by frequency 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) and not known
Infusionsrelaterede reaktioner kan forekomme pÃ¥ ethvert tidspunkt under infusion af Myozyme eller generelt op til 2 timer efter og er mere sandsynlige ved hÃ¸je infusionshastigheder.
IARs may occur at any time during the infusion of Myozyme or generally up to 2 hours after, and are more likely with higher infusion rates.
Et lille antal patienter ( &lt; 1 %) fra kliniske undersøgelser og post markedsføring udviklede anafylaktisk chok og/eller hjertestop under infusion med Myozyme, som krævede genoplivningstiltag.
A small number of patients ( &lt; 1%) in clinical trials and in the commercial setting developed anaphylactic shock and/or cardiac arrest during Myozyme infusion that required life-support measures.
Infusionsrelaterede reaktioner er defineret som enhver bivirkning, der indtrÃ¦ffer under infusionen eller i lÃ¸bet af timerne efter infusionen.
IARs are defined as any related adverse event occurring during the infusion or during the hours following infusion.
Infusionsposen mÃ¥ ikke rystes eller bevÃ¦ges for meget.
Do not shake or excessively agitate the infusion bag.
Ingen signifikant kvalme (maksimal VAS &lt; 25 på skala 0-100)
No Significant Nausea (maximum VAS &lt; 25 on 0-100 scale)
Hyppighederne defineres 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), meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); not known: frequency cannot be estimated from the available data.
Ved rolapitantkoncentrationer i plasma på &gt; 15 nanogram/ml og 348 nanogram/ml var henholdsvis ca. &gt; 50 % og 90 % af NK1-receptorerne i de kortikale områder okkuperet.
At rolapitant plasma concentrations of &gt; 15 ng/mL and 348 ng/mL, the NK1 receptor occupancies in the cortical regions were approximately &gt; 50% and 90% respectively.
Akut fase: 0 til 24 timer efter ACeller ikke-AC-regime, sen fase: &gt; 24 til 120 timer efter AC- eller ikke-AC-regime, samlede fase: 0 til 120 timer efter AC- eller ikke-AC-regime c Ikke-justerede P-værdier opnået vha.Cochran-Mantel-Haenszel-test, stratificeret efter køn.
Acute phase: 0 to 24 hours after AC or non-AC regimen; Delayed phase: &gt; 24 to 120 hours after AC or non-AC regimen; Overall phase: 0 to 120 hours after AC or non-AC regimen b Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test, stratified by sex. N.S.=Not significant (p &gt; 0.05) * N.S. after pre-specified multiplicity adjustment.
Det primære endepunkt var fuldstændigt respons (defineret som ingen emetiske episoder og ingen nødmedicin) i den sene fase ( &gt; 24 til 120 timer) af kemoterapiinduceret kvalme og opkastning.
The primary endpoint was complete response (defined as no emetic episodes and no rescue medicinal product) in the delayed phase ( &gt; 24 to 120 hours) of chemotherapy-induced nausea and vomiting.
Det primære endepunkt i begge studier var fuldstændigt respons (defineret som ingen emetiske episoder og ingen nødmedicin) i den sene fase ( &gt; 24 til 120 timer) af kemoterapiinduceret kvalme og opkastning.
The primary endpoint in both studies was complete response (defined as no emetic episodes and no rescue medicinal product) in the delayed phase ( &gt; 24 to 120 hours) of chemotherapy-induced nausea and vomiting.
Sen fase: &gt; 24 til 120 timer efter cisplatinbehandling, akut fase: 0 til 24 timer efter cisplatinbehandling, samlede fase: 0 til 120 timer efter cisplatinbehandling b Ikke-justerede P-værdier opnået vha. Cochran-Mantel-Haenszel-test, stratificeret for køn.
Delayed phase: &gt; 24 to 120 hours postcisplatin treatment; Acute phase: 0 to 24 hours post-cisplatin treatment; Overall phase: 0 to 120 hours postcisplatin treatment b Unadjusted P-values are obtained from Cochran-Mantel Haenszel test, stratified for sex. c Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test, stratified by study and sex. N.S.=Not significant (p &gt; 0.05) *Not significant after applying pre-specified multiplicity adjustment.
Tid (timer) til første emese eller brug af nødmedicin
Time (Hours) to First Emesis or Use of Rescue Medication p= &lt; 0.001 for the between-group comparison
Den estimerede tid til første emese eller brug af nødmedicin hos patienter, som fik et MEC-regime, er vist med Kaplan-Meier-plottene i figur 2.
Overall a Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test. N.S.=Not significant (p &gt; 0.05) The estimated time to first emesis or use of rescue medicinal product in patients receiving a MEC regimen is depicted by the Kaplan-Meier plot in Figure 2.
≥ 50 og &lt; 200 ≥ 200 og &lt; 350
≥ 50 and &lt; 200 ≥ 200 and &lt; 350
Frekvenserne defineres 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) og meget sjælden
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10) and uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000) and very rare ( &lt; 1/10,000).
Undgå brug af varme drikke ( &gt; 40 °C) eller drikke med kulsyre.
The use of warm ( &gt; 40°C) or carbonated beverages should be avoided.
Resultaterne fra uge 48 af den poolede analyse af DUET-1 og DUET2 viser, at etravirin-gruppen var placebogruppen overlegen, uanset om ENF blev brugt de novo (p = 0,0199) eller ej (p &lt; 0,0001).
The week 48 results from the pooled analysis of DUET-1 and DUET-2 demonstrated that the etravirine arm was superior to the placebo arm irrespective of whether ENF was used de novo (p = 0.0199) or not (p &lt; 0.0001).
C-etravirin viste, at &lt; 1,2 % af den indgivne etravirindosis udskilles med urinen.
C-etravirine showed that &lt; 1.2% of the administered dose of etravirine is excreted in the urine.
Andelen af pædiatriske patienter med &lt; 400 hiv-1 RNA kopies/ml var 63,4 %.
The proportion of paediatric patients with &lt; 400 HIV-1 RNA copies/ml was 63.4%.
Grænseværdierne for nedsat virkning af etravirin ( &gt; 2 etravirin-associerede mutationer ved baseline, se afsnittet om kliniske resultater) er gældende, når etravirin gives i kombination med en boostet proteasehæmmer.
The breakpoints for reduced efficacy with etravirine ( &gt; 2 etravirine-associated mutations at baseline, see clinical results section) applies when etravirine is given in combination with a boosted protease inhibitor.
Typen og incidensen af bivirkninger hos patienter over 55 år svarede til, hvad der blev observeret hos yngre patienter (se pkt.
The type and incidence of adverse reactions in patients &gt; 55 years of age were similar to the ones in younger patients (see sections 4.2 and 5.2).
I uge 48 havde 53,5 % af alle pædiatriske patienter en bekræftet ikke-detekterbar viral load på &lt; 50 hiv-1 RNA kopier/ml i henhold til TLOVR-algoritmen.
At week 48, 53.5% of all paediatric patients had a confirmed undetectable viral load &lt; 50 HIV-1 RNA copies/ml according to the TLOVR algorithm.
I et retrospektivt kohortestudie efter markedsføringen, hvis formål var at dokumentere den langsigtede sikkerhedsprofil for etravirin hos hiv 1-inficerede børn og unge, der fik etravirin sammen med andre hiv 1-antiretrovirale lægemidler (N = 182), blev der rapporteret Stevens-Johnsons syndrom med højere incidens (1 %) end i kliniske forsøg med voksne ( &lt; 0,1 %).
In a postmarketing retrospective cohort study aiming at substantiating the long-term safety profile of etravirine in HIV-1-infected children and adolescents receiving etravirine with other HIV-1 antiretrovirals (N = 182), Stevens-Johnson Syndrome was reported at a higher incidence (1%) than has been reported in adult clinical trials ( &lt; 0.1%).
- Virologisk respons blev defineret som opnåelse af bekræftet udetekterbar virusmængde ( &lt; 50 hiv-1 RNA kopier/ml).
- Virologic response was defined as achieving a confirmed undetectable viral load ( &lt; 50 HIV-1 RNA copies/ml).
I kliniske forsøg er der i sjældne tilfælde ( &lt; 0,1 %) rapporteret Stevens-Johnsons-syndrom og erythema multiforme.
In clinical trials, Stevens-Johnson Syndrome and erythema multiforme have been rarely ( &lt; 0.1%) reported.
Andel af patienter med hiv-1 RNA &lt; 50 kopier/ml i uge 48
Proportion of subjects with HIV-1 RNA &lt; 50 copies/ml at week 48
• hiv-1-virusmængde i plasma &gt; 5.000 hiv-1 RNA kopier/ml ved screening
• HIV-1 plasma viral load &gt; 5,000 HIV-1 RNA copies/ml at screening
P-værdi fra CMH-test, der kontrollerer for stratificeringsfaktorer = 0,0199 for de novo, og &lt; 0,0001 for ikke de novo.
Confidence interval around observed difference of response rates; P-value from CMH test controlling for stratification factors = 0.0199 for de novo, and &lt; 0.0001 for not de novo.
En undergruppeanalyse af det virologiske respons (defineret som en virusmængde på &lt; 50 hiv-1 RNA kopier/ml) i uge 48 efter virusmængde ved baseline og CD4-celletal ved baseline (poolede DUET-data) vises i tabel 4.
A subgroup analysis of the virologic response (defined as a viral load &lt; 50 HIV-1 RNA copies/ml) at week 48 by baseline viral load and baseline CD4 count (pooled DUET data) is presented in table 4.
≥ 16 til &lt; 20 kg
≥ 16 to &lt; 20 kg
Bekræftet udetekterbar virusmængde ( &lt; 50 hiv-1 RNA kopier/ml) n (%)
Confirmed undetectable viral load ( &lt; 50 HIV-1 RNA copies/ml) n (%)
Tabel 5: Andel af patienter med &lt; 50 hiv-1 RNA kopier/ml i uge 48 efter baselineantal af etravirin-resistensassocierede mutationer i den ekskluderede population bestående af patienter uden virologisk svigt i poolede data fra DUET-1 og DUET-2 Antal etravirinresistensassocierede mutationer* ved baseline
Table 5: Proportion of subjects with &lt; 50 HIV-1 RNA copies/ml at week 48 by baseline number of etravirine RAMs in the non-viral failure excluded population of pooled DUET-1 and DUET-2 trials Baseline number of Etravirine RAMs*
Viral load &lt; 400 kopier/ml i uge 24, n (%)
Viral load &lt; 400 copies/ml at week 24, n (%)
hiv-1 RNA ved baseline &lt; 30.000 kopier/ml ≥ 30.000 og &lt; 100.000 kopier/ml ≥ 100.000 kopier/ml
Baseline HIV-1 RNA &lt; 30,000 copies/ml ≥ 30,000 and &lt; 100,000 copies/ml ≥ 100,000 copies/ml Baseline CD4 count (x 10
Viral load &lt; 50 kopier/ml i uge 24, n (%)
Viral load &lt; 50 copies/ml at week 24, n (%)
Der er begrænset information vedrørende brug af INTELENCE til patienter over 65 år (se pkt.
There is limited information regarding the use of INTELENCE in patients &gt; 65 years of age (see section 5.2), therefore caution should be used in this population.
P-værdi &lt; 0,0001 fra logistisk regressionsmodel, som inkluderer stratificeringsfaktorer.
Confidence interval around observed difference of response rates; P-value &lt; 0.0001 from logistic regression model, including stratification factors.
≥ 25 til &lt; 30 kg
≥ 25 to &lt; 30 kg
TMC125-C213 6 til &lt; 12 år ETR N = 41
TMC125-C213 6 to &lt; 12 years ETR N = 41
≥ 20 til &lt; 25 kg
≥ 20 to &lt; 25 kg