natgillin/translations-raw huggingface dataset:
Generelt var behandlingsresponset med tenofovirdisoproxil sammenligneligt for genotype A, B, C og E [75-100 % af forsøgspersonerne opnåede HBV-dna &lt; 400 kopier/ml (69 IE/ml) ved uge 48] med en lavere responsrate hos forsøgspersoner med genotype D-infektion (55 %).
In general, treatment responses to tenofovir disoproxil were similar for genotypes A, B, C and E [75-100% of subjects achieved HBV DNA &lt; 400 copies/ml (69 IU/ml) at Week 48] with a lower response rate in subjects with genotype D infection
Behandlingsresponset med tenofovirdisoproxil var også sammmenligneligt hos forsøgspersoner, som var HBeAg-negative sammenlignet med dem, som var HBeAg-positive ved baseline, hvor 77 % (43/56) HBeAg-positive og 75,0 % (3/4) HBeAg-negative forsøgspersoner opnåede HBV-dna &lt; 400 kopier/ml (69 IE/ml) ved uge 48.
Response to treatment with tenofovir disoproxil was also similar in subjects who were HBeAg-negative compared with those who were HBeAg-positive at baseline with 77% (43/56) HBeAg-positive and 75.0% (3/4) HBeAg-negative subjects achieving HBV DNA &lt; 400 copies/ml (69 IU/ml) at Week 48.
Ydermere havde 55% (29/53) af patienterne behandlet med tenofovirdisoproxil HBV-DNA, som ikke kunne måles ( &lt; 169 kopier/ml [ &lt; 29 IE/ml]; kvantificeringsgrænsen for Roche Cobas TaqMan HBV-analysen) versus 60 % (31/52) af patienterne behandlet med emtricitabin plus tenofovirdisoproxil (p = 0,504).
In addition 55% (29/53) of patients treated with tenofovir disoproxil had undetectable HBV DNA ( &lt; 169 copies/ml [ &lt; 29 IU/ml]; the limit of quantification of the Roche Cobas TaqMan HBV assay) versus 60% (31/52) of patients treated with emtricitabine plus tenofovir disoproxil (p = 0.504).
I studie GS-US-104-0352 blev 97 behandlingserfarne patienter i alderen 2 til &lt; 12 år med stabil, virologisk suppression på stavudin- eller zidovudin-holdige behandlinger randomiseret til enten at erstatte stavudin eller zidovudin med tenofovirdisoproxil (n = 48) eller at fortsætte med den oprindelige behandling (n = 49) i 48 uger.
In study GS-US-104-0352, 97 treatment-experienced patients 2 to &lt; 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
I studie GS-US-174-0144 blev 89 HBeAg-negative og -positive patienter i alderen 2 til &lt; 12 år med kronisk hepatitis B behandlet med 6,5 mg/kg tenofovirdisoproxil op til en maksimal dosis på 245 mg (n = 60) eller placebo (n = 29) en gang dagligt i 48 uger.
In study GS-US-174-0144, 89 HBeAg-negative and -positive patients aged 2 to &lt; 12 years with chronic hepatitis B were treated with tenofovir disoproxil 6.5 mg/kg up to a maximum dose of 245 mg (n = 60) or placebo (n = 29) once daily for 48 weeks.
Genotypeevaluering blev udført for alle patienter i denne gruppe med HBV-DNA &gt; 400 kopier/ml ved uge 96 (n = 17), uge 144 (n = 7) og uge 192 (n = 8).
Genotypic evaluations were performed on all patients within this group with HBV DNA &gt; 400 copies/ml at week 96 (n = 17), week 144 (n = 7), and week 192 (n = 8).
Ved uge 24 var det overordnede resultat, at 66 % (35/53) af patienterne behandlet med tenofovirdisoproxil havde HBV-DNA &lt; 400 kopier/ml ( &lt; 69 IE/ml) versus 69 % (36/52) af patienterne behandlet med emtricitabin plus tenofovirdisoproxil (p = 0,672).
Overall at week 24, treatment with tenofovir disoproxil resulted in 66% (35/53) of patients with HBV DNA &lt; 400 copies/ml ( &lt; 69 IU/ml) versus 69% (36/52) of patients treated with emtricitabine plus tenofovir disoproxil (p = 0.672).
95 % af de nukleos(t)id-naive patienter, 84 % af de nukleos(t)id-erfarne patienter og 83 % af de lamivudin-resistente patienter opnåede HBV-DNA &lt; 400 kopier/ml ved uge 72.
Ninety-five percent of nucleos(t)ide-naïve patients, 84% of nucleos(t)ide- experienced patients, and 83% of lamivudine-resistant patients achieved HBV DNA &lt; 400 copies/ml at week 72.
Tenofovir-eksponeringen hos HBV-inficerede pædiatriske patienter i alderen 2 til &lt; 12 år i behandling med en oral, daglig dosis tenofovirdisoproxil på 6,5 mg/kg af kropsvægten (tablet eller granulat) op til en maksimal dosis på 245 mg var sammenlignelig med de eksponeringer, der blev opnået hos hiv 1inficerede pædiatriske patienter i alderen 2 til &lt; 12 år i behandling med tenofovirdisoproxil 6,5 mg/kg en gang dagligt op til en maksimal dosis tenofovirdisoproxil på 245 mg.
Tenofovir exposure in HBV infected paediatric patients 2 to &lt; 12 years of age receiving an oral daily dose of tenofovir disoproxil 6.5 mg/kg of body weight (tablet or granules) up to a maximum dose of 245 mg was similar to exposures achieved in HIV-1 infected paediatric patients 2 to &lt; 12 years of age receiving a once daily dose of tenofovir disoproxil 6.5 mg/kg up to a maximum dose of tenofovir disoproxil 245 mg.
Efter uge 72 blev virologisk suppression opretholdt hos de patienter, som fik dobbeltblindet tenofovirdisoproxil efterfulgt af open-label tenofovirdisoproxil (tenofovirdisoproxil-tenofovirdisoproxil-gruppen): 86,5 % (45/52) af patienterne i tenofovirdisoproxiltenofovirdisoproxil-gruppen havde HBV-DNA &lt; 400 kopier/ml ved uge 192.
After week 72, virologic suppression was maintained for those receiving double-blind tenofovir disoproxil followed by open-label tenofovir disoproxil ( tenofovir disoproxil-tenofovir disoproxil group): 86.5% (45/52) of subjects in the tenofovir disoproxil-tenofovir disoproxil group had HBV DNA &lt; 400 copies/ml at week 192.
Efter 240 ugers behandling havde 117 ud af 141 forsøgspersoner (83 %), der var randomiseret til tenofovirdisoproxil, HBV-DNA &lt; 400 kopier/ml, og 51 ud af 79 forsøgspersoner (65 %) havde normalisering af ALAT.
After 240 weeks of treatment, 117 of 141 subjects (83%) randomised to tenofovir disoproxil had HBV DNA &lt; 400 copies/ml, and 51 of 79 subjects (65%) had ALT normalisation.
Kronisk hepatitis B: Steady-state tenofovir-eksponering hos HBV-inficerede unge patienter (i alderen 12 til &lt; 18 år), som fik daglige orale doser på 245 mg tenofovirdisoproxil, svarede til de eksponeringer, der blev opnået hos voksne, som fik 245 mg tenofovirdisoproxil en gang dagligt.
Chronic hepatitis B: Steady-state tenofovir exposure in HBV infected adolescent patients (12 to &lt; 18 years of age) receiving an oral daily dose of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg.
Ved uge 24 var den tidsvægtede gennemsnitsændring fra baseline i log10 plasmakoncentrationer af hiv 1RNA-niveauer (DAVG24) -0,03 log10 kopier/ml og -0,61 log10 kopier/ml for placebogruppen og 245 mg tenofovirdisoproxil gruppen (p &lt; 0,0001).
At week 24 the time-weighted average change from baseline in log10 plasma HIV-1 RNA levels (DAVG24) was -0.03 log10 copies/ml and -0.61 log10 copies/ml for the placebo and tenofovir disoproxil 245 mg recipients (p &lt; 0.0001).
Blandt de patienter, som fik placebo i den dobbeltblinde periode, steg andelen af patienter med HBV-DNA &lt; 400 kopier/ml skarpt efter påbegyndelse af behandling med open-label tenofovirdisoproxil (PLB-tenofovirdisoproxilgruppen): 74,1 % (40/54) af patienterne i PLB-tenofovirdisoproxil-gruppen havde HBV-DNA &lt; 400 kopier/ml ved uge 192.
Among the subjects who received placebo during the double-blind period, the proportion of subjects with HBV DNA &lt; 400 copies/ml rose sharply after they began treatment with open-label tenofovir disoproxil (PLB- tenofovir disoproxil group): 74.1% (40/54) of subjects in the PLB-tenofovir disoproxil group had HBV DNA &lt; 400 copies/ml at week 192.
Hvis serumphosphat er &lt; 1,5 mg/dl (0,48 mmol/l) eller kreatininclearance er faldende til &lt; 50 ml/min hos voksne patienter, der får tenofovirdisoproxil, skal vurderingen af nyrefunktionen gentages inden for en uge, herunder måling af glucose- og kaliumkoncentration i blodet samt uringlucose (se pkt.
If serum phosphate is &lt; 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to &lt; 50 ml/min in any adult patient receiving tenofovir disoproxil , renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Hiv 1: I studie GS-US-104-0321 blev 87 hiv 1-inficerede behandlingserfarne patienter i alderen 12 til &lt; 18 år behandlet med tenofovirdisoproxil (n = 45) eller placebo (n = 42) i kombination med et optimeret baggrundsregime (OBR) i 48 uger.
HIV-1: In study GS-US-104-0321, 87 HIV-1 infected treatment-experienced patients 12 to &lt; 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Hos patienter med CPT-score ≤ 9 opnåede 74 % (29/39) i behandlingsgruppen med tenofovirdisoproxil og 94 % (33/35) i behandlingsgruppen med emtricitabin plus tenofovirdisoproxil HBV-DNA &lt; 400 kopier/ml efter 48 ugers behandling.
In patients with CPT scores ≤ 9, 74% (29/39) of tenofovir disoproxil, and 94% (33/35) of emtricitabine plus tenofovir disoproxil treatment groups achieved HBV DNA &lt; 400 copies/ml after 48 weeks of treatment.
Sammenlignet med patienter med normal nyrefunktion steg den gennemsnitlige (% variationskoefficient) eksponering af tenofovir fra 2.185 (12 %) ng t/ml hos forsøgspersoner med CrCl &gt; 80 ml/min til henholdsvis 3.064 (30 %) ng t/ml, 6.009 (42 %) ng t/ml og 15.985 (45 %) ng t/ml hos patienter med let, moderat og svært nedsat nyrefunktion.
Compared with patients with normal renal function, the mean (%CV) tenofovir exposure increased from 2,185 (12%) ng·h/ml in subjects with CrCl &gt; 80 ml/min to respectively 3,064 (30%) ng h/ml, 6,009 (42%) ng·h/ml and 15,985 (45%) ng h/ml in patients with mild, moderate and severe renal impairment.
Ved uge 48 havde 83 % af patienterne i behandlingsgruppen med tenofovirdisoproxil og 92 % af patienterne i behandlingsgruppen med stavudin eller zidovudin hiv-1 RNA-koncentrationer på &lt; 400 kopier/ml.
At week 48, 83% of patients in the tenofovir disoproxil treatment group and 92% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations &lt; 400 copies/ml.
Efter 240 ugers behandling med emtricitabin plus tenofovirdisoproxil havde 115 ud af 139 forsøgspersoner (83 %) HBV-DNA &lt; 400 kopier/ml, og 59 ud af 83 forsøgspersoner (71 %) havde normalisering af ALAT.
After 240 weeks of treatment with emtricitabine plus tenofovir disoproxil, 115 of 139 subjects (83%) had HBV DNA &lt; 400 copies/ml, and 59 of 83 subjects (71%) had ALT normalisation.
På basis af en analyse af personer, der ikke fuldførte/skiftede = svigt, opnåede 50 % (21/42) af forsøgspersonerne, som fik tenofovirdisoproxil, 76 % (28/37) af forsøgspersonerne, som fik emtricitabin plus tenofovirdisoproxil, og 52 % (11/21) af forsøgspersonerne, som fik entecavir, HBV-DNA &lt; 400 kopier/ml ved uge 168.
Using a noncompleter/switch = failure analysis, 50% (21/42) of subjects receiving tenofovir disoproxil, 76% (28/37) of subjects receiving emtricitabine plus tenofovir disoproxil and 52% (11/21) of subjects receiving entecavir achieved HBV DNA &lt; 400 copies/ml at week 168.
Ved uge 72 havde i alt 88 % (46/52) af patienterne i behandlingsgruppen med tenofovirdisoproxil og 0 % (0/54) af patienterne i placebogruppen HBV-DNA &lt; 400 kopier/ml.
At week 72, overall 88% (46/52) of patients in the tenofovir disoproxil treatment group and 0% (0/54) of patients in the placebo group had HBV DNA &lt; 400 copies/ml.
Ved uge 48 havde 77 % (46 ud af 60) af patienterne i behandlingsgruppen med tenofovirdisoproxil og 7 % (2 ud af 29) af patienterne i placebogruppen HBVdna &lt; 400 kopier/ml (69 IE/ml).
At Week 48, 77% (46 of 60) of patients in the tenofovir disoproxil treatment group and 7% (2 of 29) of patients in the placebo group had HBV DNA &lt; 400 copies/ml (69 IU/ml).
Kronisk hepatitis B: I studie GS-US-174-0115 blev 106 HBeAg-negative og HBeAg-positive patienter i alderen 12 til &lt; 18 år med kronisk HBV-infektion [HBV-DNA ≥ 10
Chronic hepatitis B: In study GS-US-174-0115, 106 HBeAg negative and HBeAg positive patients aged 12 to &lt; 18 years with chronic HBV infection [HBV DNA ≥ 105 copies/ml, elevated serum ALT (≥ 2 x ULN)
Genotype-evalueringer, udført på alle patienter med HBV-DNA &gt; 400 kopier/ml ved uge 48 (n = 16), 96 (n = 5), 144 (n = 1), 192 (n = 2), 240 (n = 1), 288 (n = 1) of 384 (n = 2) af tenofovirdisoproxil-monoterapi viste, at der ikke udvikledes mutationer associeret med tenofovirdisoproxil-resistens.
Genotypic evaluations performed on all patients with HBV DNA &gt; 400 copies/ml at week 48 (n = 16), 96 (n = 5), 144 (n = 1), 192 (n = 2), 240 (n = 1), 288 (n = 1) and 384 (n = 2) of tenofovir disoproxil monotherapy showed that no mutations associated with tenofovir disoproxil resistance have developed.
Vurderingen af bivirkninger er baseret på to randomiserede studier (studie GS-US-104-0321 og studie GS-US-104-0352) med 184 hiv 1-inficerede pædiatriske patienter (i alderen 2 til &lt; 18 år), der blev behandlet med tenofovirdisoproxil (n = 93) eller placebo/aktiv komparator (n = 91) i kombination med andre antiretrovirale midler i 48 uger (se pkt.
Assessment of adverse reactions is based on two randomised trials (studies GS-US-104-0321 and GS-US104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to &lt; 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Genotypeevaluering blev udført for alle patienter i denne gruppe med HBV-DNA &gt; 400 kopier/ml ved uge 48 (n = 6), uge 72 (n = 5), uge 96 (n = 4), uge 144 (n = 2) samt uge 192 (n = 3).
Genotypic evaluations were performed on all patients within this group with HBV DNA &gt; 400 copies/ml at week 48 (n = 6), week 72 (n = 5) week 96 (n = 4), week 144 (n = 2), and week 192 (n = 3).
Vurderingen af bivirkninger er baseret på et randomiseret studie (studie GS-US-174-0115) med 106 unge patienter (i alderen 12 til &lt; 18 år) med kronisk hepatitis B, der blev behandlet med tenofovirdisoproxil 245 mg (n = 52) eller placebo (n = 54) i 72 uger, og på et randomiseret studie (studie GS-US-174-0144) med 89 patienter med kronisk hepatitis B (i alderen 2 til &lt; 12 år), der blev behandlet med tenofovirdisoproxil (n = 60) eller placebo (n = 29) i 48 uger.
Assessment of adverse reactions is based on a randomised study (study GS-US-174-0115) in 106 adolescent patients (12 to &lt; 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and a randomised study (Study GS-US-1740144) in 89 patients with chronic hepatitis B (2 to &lt; 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Hvis serumphosphat bekræftes til at være &lt; 3,0 mg/dl (0,96 mmol/l) hos pædiatriske patienter, der får tenofovirdisoproxil, skal vurderingen af nyrefunktionen gentages inden for en uge, herunder måling af glucose- og kaliumkoncentration i blodet samt uringlucose-koncentration (se pkt.
If serum phosphate is confirmed to be &lt; 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Genotype-evalueringer, udført på alle patienter med HBV-DNA &gt; 400 kopier/ml ved uge 48 (n = 39), 96 (n = 24), 144 (n = 6), 192 (n = 5), 240 (n = 4), 288 (n = 6) og 384 (n = 2) af tenofovirdisoproxil-monoterapi viste, at der ikke udvikledes mutationer associeret med tenofovirdisoproxil-resistens.
Genotypic evaluations performed on all patients with HBV DNA &gt; 400 copies/ml at week 48 (n = 39), 96 (n = 24), 144 (n = 6), 192 (n = 5), 240 (n = 4), 288 (n = 6) and 384 (n = 2) of tenofovir disoproxil monotherapy showed that no mutations associated with tenofovir disoproxil resistance have developed.
HBV-DNA (%) &lt; 400 kopier/ml ( &lt; 69 IE/ml) ALAT (%) Normaliseret ALAT
HBV DNA (%) &lt; 400 copies/ml ( &lt; 69 IU/ml)
3, den gennemsnitlige hiv 1-RNA-plasmakoncentration ved baseline var 3,4 log10 kopier/ml (78 % af patienterne havde en virusmængde på &lt; 5.000 kopier/ml) og den gennemsnitlige varighed af forudgående hiv-behandling var 5,4 år.
The mean baseline CD4 cell count was 427 cells/mm3, the mean baseline plasma HIV-1 RNA was 3.4 log10 copies/ml (78% of patients had a viral load of &lt; 5,000 copies/ml) and the mean duration of prior HIV treatment was 5.4 years.
* p-værdi versus adefovirdipivoxil &lt; 0,05. a Komplet respons defineret som HBV-DNA-niveauer &lt; 400 kopier/ml og en forbedring af Knodells nekroinflammatoriske score på mindst 2 point uden forværring af Knodells fibrosescore.
*p-value versus adefovir dipivoxil &lt; 0.05, a Complete response defined as HBV DNA levels &lt; 400 copies/ml and Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis, b Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis, c Median change from baseline HBV DNA merely reflects the difference between baseline HBV DNA and the limit of detection (LOD) of the assay, d The population used for analysis of ALT normalisation included only patients with ALT above ULN at baseline.
Behandlingsresponset med tenofovirdisoproxil var sammenligneligt hos behandlingsnaive og behandlingserfarne forsøgspersoner, hvor 76 % (38/50) behandlingsnaive og 80 % (8/10)
Response to treatment with tenofovir disoproxil was comparable in treatment-naïve and treatmentexperienced subjects with 76% (38/50) of treatment-naïve and 80% (8/10) of treatment-experienced subjects achieving HBV DNA &lt; 400 copies/ml (69 IU/ml) at Week 48.
kopier/ml, serum-ALAT &gt; 1,5 x ULN) i gruppen, der blev behandlet med tenofovirdisoproxil, og 0 % (0/32) af patienterne i placebogruppen HBV-DNA &lt; 400 kopier/ml.
At week 72, 96% (27/28) of immuneactive patients (HBV DNA ≥ 105 copies/ml, serum ALT &gt; 1.5 x ULN) in the tenofovir disoproxil treatment group and 0% (0/32) of patients in the placebo group had HBV DNA &lt; 400 copies/ml.
Det frarådes at bruge tenofovirdisoproxil hos patienter med svært nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min), og hos patienter med behov for hæmodialyse.
In patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) and in patients who require haemodialysis use of tenofovir disoproxil is not recommended.
I behandlingsarmen med tenofovirdisoproxil seponerede 7 % af patienterne behandlingen på grund af en bivirkning, 9 % af patienterne fik bekræftet forhøjelse i serumkreatinin på ≥ 0,5 mg/dl eller bekræftet serumphosphat på &lt; 2 mg/dl til og med uge 48.
In the tenofovir disoproxil treatment arm, 7% of patients discontinued treatment due to an adverse event; 9% of patients experienced a confirmed increase in serum creatinine of ≥ 0.5 mg/dl or confirmed serum phosphate of &lt; 2 mg/dl through week 48; there were no statistically significant differences between the combined tenofovir-containing arms and the entecavir arm. After 168 weeks, 16% (7/45) of the tenofovir disoproxil group, 4% (2/45) of the emtricitabine plus tenofovir disoproxil group, and 14% (3/22) of the entecavir group experienced tolerability failure.
Se sidst i punkt 4, hvordan du indberetter bivirkninger. &gt;
See the end of section 4 for how to report side effects
(≥ 1/100 til &lt;
(≥ 1/100 to &lt; 1/10)
Begrænsede data viser, at pegfilgrastims farmakokinetik er den samme hos ældre personer ( &gt; 65 år) som hos voksne.
Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects ( &gt; 65 years) is similar to that in adults.
Leukocytose (leukocyttal [WBC] &gt; 100 x 109/l) er indberettet med hyppigheden almindelig (se pkt.
Common cases of leukocytosis (White Blood Count [WBC] &gt; 100 x 109/l) have been reported (see section 4.4).
Forekomsten af hospitalsindlæggelser og brug af intravenøse antiinfektiva i forbindelse med klinisk diagnosticeret febril neutropeni var lavere i pegfilgrastimgruppen end i placebogruppen (1 % vs. 14 %, p &lt; 0,001; og 2 % vs. 10 %, p &lt; 0,001).
The incidence of hospitalisations and Intra Venous 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).
Forekomsten af febril neutropeni var lavere hos de patienter, der blev randomiseret til pegfilgrastim, end hos de patienter, der fik placebo (1 % vs. 17 %, p &lt; 0,001).
The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17 %, p &lt; 0.001).
Kapillærlækagesyndrom, som kan være livstruende, hvis behandling iværksættes for sent, er indberettet med hyppigheden ikke almindelig (≥ 1/1.000 til &lt; 1/100) hos cancerpatienter i kemoterapi efter administration af granulocytkolonistimulerende faktorer; se pkt.
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.
Overfølsomhedsreaktioner, herunder hududslæt, urticaria, angioødem, dyspnø, erythem, flushing og hypotension forekom ved den første eller en efterfølgende behandling 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 [≥
((VAdriaC/IE) blev der set en længere varighed af svær neutropeni (neutrofiler &lt; 0,5 x 109) hos små børn i alderen 0-5 år (8,9 dage) end hos større børn i alderen 6-11 år og i alderen 12-21 år (hhv. 6 dage og 3,7 dage) og hos voksne.
(VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils &lt; 0.5 x 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.
4.8 og 5.1).
1/1,000 to &lt; 1/100]).
Følgende bivirkninger er rapporteret fra kliniske studier, sikkerhedsstudier efter godkendelse og spontant rapporterede tilfælde med følgende hyppigheder: 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) samt “ikke kendt”:
The following adverse reactions have been reported from clinical trials, post-authorisation safety studies and from spontaneously-reported cases with the following frequencies: 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).
I tilfælde af overdosering med &lt; lægemidler, der indeholder aminocapronsyre &gt; skal du straks fortælle det til lægen eller på apoteket eller tage på nærmeste hospital.
In case of overdose with &lt; Aminocaproic acid-containing medicinal products &gt; , tell your doctor or pharmacist immediately, go to the nearest hospital.
Hvis du har brugt for meget &lt; lægemiddel, der indeholder aminocapronsyre &gt; Hvis du har brugt for meget &lt; lægemiddel, der indeholder aminocapronsyre &gt; , kan du få pludseligt blodtryksfald (hypotension) med symptomer som svimmelhed, besvimelse, omtågethed, sløret syn, hurtige, uregelmæssige hjerteslag (hjertebanken), forvirring, kvalme eller generel svækkelse.
If you use more &lt; Aminocaproic acid-containing medicinal products &gt; than you should If you take more &lt; Aminocaproic acid-containing medicinal products &gt; than you should, you may experience a sudden decrease in blood pressure (hypotension), with symptoms including dizziness, fainting, lightheadedness, blurred vision, a rapid, or irregular heartbeat (palpitations), confusion, feeling like you are going to be sick (nausea) or general weakness.