natgillin/translations-raw huggingface dataset:
Reverse genetiske studier viste, at det var nødvendigt med tilstedeværelsen af 6 mutationer i proteasen (I13V, V32I, L33F, K45I, V82L, I84V) for at øge resistensen over for tipranavir &gt; 10 gange, mens 10mutationsgenotypen øgede resistensen over for tipranavir 69 gange.
Reverse genetic experiments showed that the presence of 6 mutations in the protease (I13V, V32I, L33F, K45I, V82L, I84V) was required to confer &gt; 10-fold resistance to tipranavir while the full 10-mutation genotype conferred 69-fold resistance to tipranavir.
Baseline karakteristik for patienter 2 - 12 år, som fik oral opløsning
Baseline characteristics for patients 2 - &lt; 12 years treated with Aptivus oral solution
A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Boehringer Ingelheim Pharma GmbH &amp; Co.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Pharma GmbH &amp; Co. KG, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany.
Didanosin 200 mg x 2, ≥ 60 kg (TPV/r 250/200 mg x 2) - 125 mg x 2, &lt; 60 kg (TPV/r 750/100 mg x 2)
Didanosine 200 mg BID, ≥ 60 kg (TPV/r 250/200 mg BID) - 125 mg BID, &lt; 60 kg (TPV/r 750/100 mg BID)
Patienterne, med en påkrævet baseline hiv-1 RNA-koncentration på mindst 1500 kopier/ml, blev opdelt i aldersgrupperne (2 til &lt; 6 år, 6 til &lt; 12 år og 12 til 18 år), og blev randomiseret til en af de to dosisregimer med tipranavir med ritronavir: 375 mg/m2/150 mg/m2 dosis,
Patients were required to have a baseline HIV-1 RNA concentration of at least 1500 copies/ml, were stratified by age (2 to &lt; 6 years, 6 to &lt; 12 years and 12 to 18 years) and randomized to receive one of two tipranavir with ritonavir dose regimens: 375 mg/m2/150 mg/m dose, compared to the 290 mg/m2/115 mg/m2 dose, plus background therapy of at least two nonprotease inhibitor antiretroviral medicinal products, optimized using baseline genotypic resistance testing.
40 mg x 2 &gt; 60 kg 30 mg x 2 &lt; 60 kg (TPV/r 750/100 mg x 2)
40 mg BID &gt; 60 kg 30 mg BID &lt; 60 kg (TPV/r 750/100 mg BID)
Sikkerhedsanalyse pr. alderskategori ( &lt; 65 vs. ≥ 65 år) viste højere toksicitet hos ældre patienter, om end dette sås i samme omfang i de to grupper.
Safety analysis by age category ( &lt; 65 vs &gt; =65 years) showed higher toxicity in older subjects, although this occurred equally in both arms.
Infusionsrelaterede reaktioner, hjertearytmier og hjertedysfunktion anses for at vÃ¦re hÃ¦ndelser af sÃ¦rlig interesse for olaratumab.
Infusion related reactions, cardiac arrhythmia and cardiac dysfunction are considered events of special interest for olaratumab.
Der blev oftere rapporteret om hjertearytmier i den eksperimentelle gruppe (alle grader: 12,8 % vs. 9,6 %; grad ≥ 3: 2,7 % vs. 0,8 %).
Cardiac arrhythmia events were more commonly reported in the investigational arm (any grade 12.8% vs 9.6%; grade &gt; =3 2.7% vs 0.8%).
• onsdag, den 21. marts, og torsdag, den 22. marts
• Wednesday, 21 March &amp; Thursday, 22 March;
Den øgede risiko for total og svær hypoglykæmi blev primært observeret hos forsøgspersoner med A1C &lt; 7 % ved baseline.
The increased risk of overall and major hypoglycaemia was primarily observed in subjects with A1C &lt; 7% at baseline.
Frekvenser defineres som meget almindelig (≥1/10), almindelig (≥1/100, &lt; 1/10, ikke almindelig (≥1/1.000, &lt; 1/100), sjælden
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to 1/100), rare (≥ 1/10,000 to 1/1,000), very rare ( &lt; 1/10,000), or not known (cannot be estimated from the available data).
Infektioner og parasitÃ¦re sygdomme Ãvre luftvejsinfektion
Infections and infestations Upper respiratory infection
GENERATION var et 52 ugers studie af glykæmisk kontrol hos 720 ældre patienter, hvor den gennemsnitlige alder var 72,6 år; 433 forsøgspersoner (60,1 %) var &lt; 75 år, og 287 forsøgspersoner (39,9 %) var ≥ 75 år.
GENERATION was a 52-week glycaemic control study in 720 elderly patients, the mean age was 72.6 years; 433 subjects (60.1%) were &lt; 75 years of age, and 287 subjects (39.9%) were ≥ 75 years of age.
Onglyzas sikkerhed og virkning hos børn i alderen 0 måneder til &lt; 18 år er endnu ikke klarlagt: Der foreligger ingen data.
The safety and efficacy of Onglyza in children aged birth to &lt; 18 years have not yet been established.
Undersøgelsen omfattede patienter med nedsat nyrefunktion, der blev klassificeret på baggrund af kreatinin-clearance som let (ca. GFR ≥ 45 til &lt; 90 ml/min), moderat (ca. GFR ≥ 30 til &lt; 45 ml/min ) eller svært nedsat (ca. GFR &lt; 30 ml/min ) samt patienter med ESRD i hæmodialyse.
The study included patients with renal impairment classified on the basis of creatinine clearance as mild (approximately GFR ≥ 45 to &lt; 90 mL/min), moderate (approximately GFR ≥ 30 to &lt; 45 mL/min), or severe (approximately GFR &lt; 30 mL/min), as well as patients with ESRD on haemodialysis.
Dosis skal reduceres til 2,5 mg én gang dagligt hos patienter med moderat nyrefunktion, som har GFR &lt; 45 ml/min og hos patienter med svært nedsat nyrefunktion.
The dose should be reduced to 2.5 mg once daily in patients with moderate renal impairment that have GFR &lt; 45 mL/min and in patients with severe renal impairment.
‡ p &lt; 0,001 for noninferioritet (baseret på HR &lt; 1,3) sammenlignet med placebo.
p-value &lt; 0.001 for noninferiority (based on HR &lt; 1.3) compared to placebo.
§ p = 0,99 for superioritet (baseret på HR &lt; 1,0) sammenlignet med placebo.
p-value = 0.99 for superiority (based on HR &lt; 1.0) compared to placebo.
Den anbefalede dosis til patienter med GFR &lt; 45 ml/min er 2,5 mg én gang daglig.
In patients with GFR &lt; 45 mL/min, the recommended dose is 2.5 mg once daily.
Personer behandlet med saxagliptin i tillæg til behandling med dapagliflozin og metformin (n = 153) opnåede statistisk signifikant (p-værdi &lt; 0,0001) større reduktioner i HbA1c versus gruppen med placebo i tillæg til dapagliflozin og metformin (n = 162) efter 24 uger (se tabel 2).
Individuals treated with saxagliptin added to dapagliflozin and metformin (n=153) achieved statistically significantly (p-value &lt; 0.0001) greater reductions in HbA1c versus the group with placebo added to dapagliflozin plus metformin (n=162) at 24 weeks (see Table 2).
Andelen af patienter, der opnåede HbA1c &lt; 7 % i uge 24, var højere i gruppen der blev behandlet med saxagliptin 5 mg plus dapagliflozin plus metformin 35,3 % (95 % CI [28,2,42,4]) sammenlignet med placebo plus dapagliflozin plus metformin gruppen 23,1 % (95 % CI [16,9, 29,3]).
The proportion of patients achieving HbA1c &lt; 7% at Week 24 was higher in the saxagliptin 5 mg plus dapagliflozin plus metformin group 35.3% (95% CI [28.2, 42.4]) compared to the placebo plus dapagliflozin plus metformin group 23.1% (95% CI [16.9, 29.3]).
Den gennemsnitlige HbA1c-ændring er forskellen mellem saxagliptin+dapagliflozin+metformin og dapagliflozin+metformin grupperne (p &lt; 0.0001).
Mean HbA1c change is the difference between the saxagliptin+dapagliflozin+metformin and dapagliflozin+metformin groups (p &lt; 0.0001).
SAVOR var et studie af kardiovaskulære resultater hos 16.492 patienter med HbA1c ≥6,5 % og &lt; 12 % (12.959 med diagnosticeret kardiovaskulær sygdom og 3.533 kun med multiple risikofaktorer), som blev randomiseret til saxagliptin (n=8.280) eller placebo (n=8.212) som tillæg til regional standardbehandling af HbA1c og kardiovaskulære risikofaktorer.
Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes MellitusThrombolysis in Myocardial Infarction (SAVOR) Study SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥6.5% and &lt; 12% (12959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
Den gennemsnitlige HbA1c-ændring er forskellen mellem saxagliptin+metformin og metformin grupperne (p &lt; 0,0001).
Mean HbA1c change is the difference between the saxagliptin+metformin and metformin alone groups (p &lt; 0.0001).
Infliximab er kun blevet undersÃ¸gt i kombination med konventionel immunsuppressiv behandling.
Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Infliximab passerer placenta og er blevet pÃ¥vist i serum hos spÃ¦dbÃ¸rn op til 6 mÃ¥neder efter fÃ¸dslen.
Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Intravenøs anvendelse &lt; i.v. &gt;
Intravenous use &lt; IV &gt;
Infliximab er ikke undersÃ¸gt hos denne patientpopulation.
Infliximab has not been studied in these patient populations.
d p = 0,030 og &lt; 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX.
d p = 0.030 and &lt; 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Infliximab krydsreagerer ikke med TNFÎ± fra andre arter end mennesker og chimpanser.
Infliximab does not cross react with TNFÎ± from species other than human and chimpanzees.
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).
Within the organ system classes, adverse reactions are listed under headings of 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), not known (cannot be estimated from the available data).
b Alle infliximab doser er givet i kombination med methotrexat og folat samt eventuelt kortikosteroider og/eller NSAIDs c p &lt; 0,001, for hver infliximab-behandlingsgruppe versus kontrol d Større værdier indikerer mere uarbejdsdygtighed.
b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs c p &lt; 0.001, for each infliximab treatment group vs. control d greater values indicate more joint damage.
Infliximab blev undersÃ¸gt i et klinisk studie med 120 patienter (alder: 4-17 Ã¥r) med aktiv juvenil reumatoid arthritis til trods for behandling med methotrexat.
Infliximab was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate.
Infliximab forebyggede sygdom hos transgene mus, der udvikler polyarthritis som resultat af konstitutiv ekspression af human TNFÎ±, og fik ved indgift efter sygdomsstart eroderede led til at heles.
Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFÎ± and when administered after disease onset, it allowed eroded joints to heal.
Infliximab er et kimerisk human-murin monoklonalt antistof, der binder sig med hÃ¸j affinitet til bÃ¥de oplÃ¸selige og transmembrane former af TNFÎ±, men ikke til lymphotoxin Î± (TNFÎ²).
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFÎ± but not to lymphotoxin Î± (TNFÎ²).
Infliximab forbedrede livskvaliteten i ACT 1 og ACT 2, hvilket bekrÃ¦ftedes ved statistisk signifikant forbedring i bÃ¥de et sygdomsspecifikt mÃ¥l, IBDQ, og ved forbedring i den almindelige 36-punkt korte udgave af spÃ¸rgeskema SF-36.
In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF
Farmakodynamisk virkning Infliximab hæmmer den funktionelle aktivitet af TNFα i en lang række forskellige in vitro bioassays.
Infliximab inhibits the functional activity of TNFÎ± in a wide variety of in vitro bioassays.
Infusionsrelaterede reaktioner efter fornyet indgift af infliximab Der var designet et klinisk studie med patienter med moderat til svÃ¦r psoriasis for at undersÃ¸ge effekt og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet indgift med et induktionsregimen med infliximab (hÃ¸jst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
Infusion reactions following re-administration of infliximab A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
I SPIRIT var andelen af patienter, der opnåede PASI 75 i uge 10 71,7 % i 3 mg/kg infliximab- gruppen, 87,9 % i 5 mg/kg infliximab-gruppen og 5,9 % i placebogruppen (p &lt; 0,001).
In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p &lt; 0.001).
Infunder ikke Flixabi i den samme intravenÃ¸se slange med andre midler.
Do not infuse Flixabi concomitantly in the same intravenous line with other agents.
En større andel patienter i den kombinerede infliximab-behandlingsgruppe var i stand til at afbryde kortikosteroider og stadig blive i klinisk remission sammenlignet med placebobehandlingsgruppen i både uge 30 (22,3 % mod 7,2 %, p &lt; 0,001, samlede ACT 1- &amp; ACT 2-data) og uge 54 (21,0 % mod 8,9 %, p = 0,022, ACT 1-data).
A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p &lt; 0.001, pooled ACT 1 &amp; ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Infliximabs sikkerhed og virkning hos bÃ¸rn under 6 Ã¥r med Crohns sygdom er ikke undersÃ¸gt.
The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
Infliximabvedligeholdelse 5 mg/kg (n = 113) (p-vÃ¦rdi)
Infliximab Maintenance 5 mg/kg (n=113) (p value)
(p &lt; 0,001)* * P-værdier repræsenterer hver infliximab-behandlingsgruppe vs. AZA monoterapi.
* P-values represent each infliximab treatment group vs. AZA monotherapy
Infliximabvedligeholdelse 10 mg/kg (n = 112) (p-vÃ¦rdi)
Infliximab Maintenance 10 mg/kg (n=112) (p value)
Infliximabs sikkerhed og virkning hos bÃ¸rn og unge under 18 Ã¥r for indikationen juvenil reumatoid arthritis er ikke klarlagt.
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established.
Andelen af patienter med slimhindeheling i uge 26 var signifikant større i grupperne, der fik infliximab plus AZA (43,9 %; p &lt; 0,001) eller infliximab-monoterapi (30,1 %; p = 0,023) sammenlignet med AZAmonoterapigruppen (16,5 %).
The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p &lt; 0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Infliximabs sikkerhed og virkning hos bÃ¸rn og unge under 18 Ã¥r for indikationen psoriasis er ikke klarlagt.
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
• Fortæl din læge, før du får Flixabi, hvis du har en infektion, også selvom det er en meget let infektion.
Infections â¢ Tell your doctor before you are given Flixabi if you have an infection even if it is a very minor one.
Debuterende eller forværring af allerede eksisterende psoriasis, inklusive pustuløs psoriasis (primært palmoplantaris), urticaria, udslæt, pruritus, øget svedtendens, tør hud, svampedermatitis, eksem, alopeci.
New onset or worsening psoriasis including pustular psoriasis (primarily palm &amp; soles), urticaria, rash, pruritus, hyperhidrosis,
Klinisk remission og slimhindeheling forekom i en større andel af patienterne i den kombinerede infliximabbehandlingsgruppe sammenlignet med placebobehandlingsgruppen i uge 54 (henholdsvis 34,6 % mod 16,5 %, p &lt; 0,001 og 46,1 % mod 18,2 %, p &lt; 0,001).
Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p &lt; 0.001 and 46.1% vs. 18.2%, p &lt; 0.001, respectively).
Infliximab med eller uden AZA blev vurderet i et randomiseret, dobbeltblind studie med aktiv komparator (SONIC) hos 508 voksne patienter med moderat til svÃ¦r Crohns sygdom (CDAI â¥ 220 â¤
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI â¥ 220 â¤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Infliximabs sikkerhed og virkning hos bÃ¸rn under 6 Ã¥r med colitis ulcerosa er ikke undersÃ¸gt.
The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years.
Infliximabs effekt og sikkerhed blev undersÃ¸gt i to multicenter, dobbeltblinde, placebokontrollerede studier hos patienter med aktiv ankyloserende spondylitis (Bath Ankylosing Spondylitis Disease
Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
De patienter, der fik kortikosteroider ved baseline, fik ikke kortikosteroider i de 3 måneder forud for uge 54.
b CDAI &lt; 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54 among patients who were receiving corticosteroids at baseline.
Infliximabs sikkerhed og virkning blev vurderet i et multicenter, randomiseret, open-label, parallelgruppe klinisk studie (C0168T72) hos 60 pÃ¦diatriske patienter i alderen 6 til 17 Ã¥r (medianalder
The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Slimhindeheling i uge 30a a p &lt; 0,001 for hver infliximab-behandlingsgruppe mod placebo.
a a p &lt; 0.001, for each infliximab treatment group vs. placebo
Gennemsnit ± SDd a p &lt; 0,001, for hver infliximab-behandlingsgruppe mod kontrol.
Mean ± SDd a p &lt; 0.001, for each infliximab treatment group vs control b greater values indicate more joint damage.
** PASI 75 respons for IMPACT ikke inkluderet som følge af lav N; p &lt; 0,001 for infliximab vs. placebo i uge 24 for IMPACT 2.
* ITT-analysis where subjects with missing data were included as non-responders a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension b Based on patients with PASI ≥ 2.5 at baseline for IMPACT, and patients with ≥ 3% BSA psoriasis skin involvement at baseline in IMPACT 2 ** PASI 75 response for IMPACT not included due to low N; p &lt; 0.001 for infliximab vs. placebo at week 24 for IMPACT 2
Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8 % af patienterne).
a p &lt; 0.001, for each infliximab treatment group vs. control b n = 292 c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Emtricitabins binding in vitro til humane plasmaproteiner var &lt; 4% og uafhængig af koncentrationsområdet på 0,02-200 µg/mL.
In vitro binding of emtricitabine to human plasma proteins was &lt; 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
Emtricitabine/Tenofovir disoproxil Krka bør kun anvendes hos personer med kreatininclearance (CrCl) &lt; 80 ml/min, hvis de potentielle fordele anses for at opveje de potentielle risici.
Emtricitabine/Tenofovir disoproxil Krka should only be used in individuals with creatinine clearance (CrCl) &lt; 80 mL/min if the potential benefits are considered to outweigh the potential risks.
De primære virkningsendepunkter i dette studiet var at opnå og vedligeholde bekræftede hiv 1-rna-koncentrationer &lt; 400 kopier/mL i 48 uger.
The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV-1 RNA concentrations &lt; 400 copies/mL over 48 weeks.
Steady state farmakokinetik af tenofovir blev evalueret hos 8 hiv 1-inficerede unge patienter (i alderen 12 til &lt; 18 år) med kropsvægt ≥ 35 kg og hos 23 hiv 1-inficerede børn i alderen 2 til &lt; 12 år.
Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to &lt; 18 years) with body weight ≥ 35 kg and in 23 HIV1 infected children aged 2 to &lt; 12 years.
Sekundære virkningsanalyser i løbet af de 144 uger omfattede andelen af patienter med hiv 1-rnakoncentrationer &lt; 400 eller &lt; 50 kopier/mL og en ændring i CD4-celletallet fra baseline.
Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations &lt; 400 or &lt; 50 copies/mL, and change from baseline in CD4 cell count.
Det er derfor nødvendigt nøje at vurdere fordele og risici, når Emtricitabine/Tenofovir disoproxil Krka anvendes til patienter med kreatininclearance &lt; 60 ml/min, og nyrefunktionen bør monitoreres omhyggeligt.
Therefore, a careful benefitrisk assessment is needed when Emtricitabine/Tenofovir disoproxil Krka is used in patients with creatinine clearance &lt; 60 mL/min, and renal function should be closely monitored.
Graden af nedsat nyrefunktion blev defineret i henhold til kreatininclearance (CrCl) ved baselinie (normal nyrefunktion med CrCl &gt; 80 ml/min; let nedsat nyrefunktion med CrCl = 50−79 ml/min; moderat nedsat nyrefunktion med CrCl = 30−49 ml/min og svært nedsat nyrefunktion medCrCl = 10−29 ml/min).
The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl &gt; 80 mL/min; mild impairment with CrCl = 50-79 mL/min; moderate impairment with CrCl = 30-49 mL/min and severe impairment with CrCl = 10-29 mL/min).
Hvis der findes kliniske symptomer svarende til akut virusinfektion, og der er mistanke om nylige ( &lt; 1 måned) eksponeringer for HIV 1, bør brugen af Emtricitabine/Tenofovir disoproxil Krka udsættes mindst en måned og HIV 1-status bekræftes før påbegyndelse af Emtricitabine/Tenofovir disoproxil Krka som profylakse før eksponering.
If clinical symptoms consistent with acute viral infection are present and recent ( &lt; 1 month) exposures to HIV-1 are suspected, use of Emtricitabine/Tenofovir disoproxil Krka should be delayed for at least one month and HIV-1 status reconfirmed before starting Emtricitabine/Tenofovir disoproxil Krka for pre-exposure prophylaxis.
Emtricitabin/tenofovirdisoproxils renale sikkerhed er kun blevet undersøgt i meget begrænset omfang hos hiv 1-inficerede patienter med nedsat nyrefunktion (kreatininclearance &lt; 80 ml/min).
Renal safety with emtricitabine/tenofovir disoproxil has only been studied to a very limited degree in HIV-1 infected patients with impaired renal function (creatinine clearance &lt; 80 mL/min).
Emtricitabine/tenofovirdisoproxil er ikke blevet undersøgt hos personer uden HIV 1-infektion med kreatininclearance &lt; 60 ml/min og anbefales derfor ikke til denne population.
Emtricitabine/tenofovir disoproxil has not been studied in HIV-1 uninfected individuals with creatinine clearance &lt; 60 mL/min and is therefore not recommended for use in this population.
Renale bivirkninger svarende til proksimal renal tubulopati er blevet rapporteret hos HIV 1-inficerede pædiatriske patienter i alderen 2 til &lt; 12 år i det kliniske studie GS-US-104-0352 (se pkt.
Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV 1 infected paediatric patients aged 2 to &lt; 12 years in clinical study GS-US-104-0352 (see sections 4.8 and 5.1).