natgillin/translations-raw huggingface dataset:
Infliximab-treated patients demonstrated significant improvement in physical function as assessed by HAQ.
Infliksimabiga ravitud patsientidel oli jÃ¤lgitav mÃ¤rkimisvÃ¤Ã¤rne fÃ¼Ã¼silise funktsiooni paranemine HAQskoori jÃ¤rgi.
Infliximab inhibits the functional activity of TNFÎ± in a wide variety of in vitro bioassays.
Infliksimab pÃ¤rsib TNFÎ± funktsionaalset aktiivsust mitmetes in vitro katsetes.
Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
Infusioonireaktsioonide tÃµttu katkestas ravi umbes 3% patsientidest ja kÃµik patsiendid paranesid kas raviga vÃµi ilma.
Significant improvements from baseline were demonstrated in DLQI (p &lt; 0.001) and the physical and mental component scores of the SF 36 (p &lt; 0.001 for each component comparison).
Võrreldes algväärtusega täheldati märkimisväärset paranemist DLQI (Dermatology Life Quality Index) (p &lt; 0,001) osas ning SF-36 füüsilise ja vaimse komponendi skoorides (p &lt; 0,001 iga komponendi võrdluses).
Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1).
Infliksimabi puhul on tÃ¤heldatud fÃ¼Ã¼silise funktsiooni paranemist psoriaatilise artriidiga patsientidel ning rÃ¶ntgenoloogiliselt on nÃ¤idatud perifeersete liigesekahjustuste progresseerumise aeglustumist haiguse polÃ¼artikulaarsete sÃ¼mmeetriliste alatÃ¼Ã¼pidega patsientidel (vt lÃµik 5.1).
During clinical studies of infliximab across all approved indications the incidence of lymphoma in infliximab-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Infliksimabiga kÃµikidel heakskiidetud nÃ¤idustustel lÃ¤biviidud kliiniliste uuringute kÃ¤igus oli lÃ¼mfoomi esinemissagedus infliksimabravi saanud patsientide seas kÃ¼ll kÃµrgem kui Ã¼ldpopulatsioonis, kuid lÃ¼mfoomi esines siiski harva.
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.
Infliksimabi korduva manustamise jÃ¤rgsed infusioonireaktsioonid Kliinilises uuringus mÃµÃµduka kuni raske psoriaasiga patsientidel hinnati pikaajalise sÃ¤ilitusravi efektiivsust ja ohutust vÃµrreldes haiguse Ã¤genemise jÃ¤rgse kordusraviga infliksimabi induktsiooni reÅ¾iimil (maksimaalselt neli infusiooni 0., 2., 6. ja 14. nÃ¤dalal) .
In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6).
Infliksimabiga ravitud patsientide grupis esines ilmne PASI 50 saavutanute osakaal esimesel visiidil (2. nÃ¤dal) ja PASI 75 saavutanute osakaal teisel visiidil (6. nÃ¤dal).
The efficacy of infliximab was assessed in two multicentre, randomised, double-blind studies: SPIRIT and EXPRESS.
Infliksimabi tÃµhusust hinnati kahes mitmekeskuselises randomiseeritud topeltpimedas uuringus: SPIRIT ja EXPRESS.
Infliximab Maintenance 5 mg/kg (n=113) (p value)
Infliksimab sÃ¤ilitusravi 5 mg/kg (n = 113) (p-vÃ¤Ã¤rtus)
Infections â¢ Tell your doctor before you are given Flixabi if you have an infection even if it is a very minor one.
• Rääkige oma arstile enne Flixabi manustamist, kui teil on infektsioon, isegi kui see on väga väike.
Infliximab Maintenance (5 mg/kg) (n=96)
Infliksimab sÃ¤ilitusravi (5 mg/kg) (n = 96)
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).
Infliksimab on kimeerne inimese-hiire monoklonaalne antikeha, mis on kÃµrge afiinsusega nii lahustuvate kui transmembraansete TNFÎ± vormide suhtes, kuid mitte lÃ¼mfotoksiin-Î± (TNFÃ) suhtes.
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).
Infliksimabi efektiivsust ja ohutust hinnati kahes mitmekeskuselises, topeltpimedas, platseebokontrolliga uuringus, mis viidi lÃ¤bi aktiivse ankÃ¼loseeriva spondÃ¼liidiga patsientidel (haiguse aktiivsuse skoor BASDAI [Bath Ankylosing Spondylitis Disease Activity Index] â¥ 4 ja spinaalse valu skoor â¥ 4 skaalal 1...10).
Infliximab Maintenance 10 mg/kg (n=112) (p value)
Infliksimab sÃ¤ilitusravi 10 mg/kg (n = 112) (p-vÃ¤Ã¤rtus)
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).
Suurem hulk patsiente kombineeritud infliksimabi ravirühmast võrreldes platseebo ravirühmaga olid võimelised katkestama kortikosteroidravi säilitades endiselt kliinilise remissiooni nii 30. nädalal (22,3% vs. 7,2%, p &lt; 0,001, ACT 1 ja ACT 2 ühendatud andmed) kui ka 54. nädalal (21,0% vs. 8,9%, p = 0,022, ACT 1 andmed).
In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with infliximab with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Infliksimabravi saanud patsientidel on turuletulekujÃ¤rgselt teatatud ka hepatospleenilise T-rakulise lÃ¼mfoomi juhtudest, millest enamik olid Crohni tÃµve vÃµi haavandilise koliidiga patsientidel, kellest enamik olid noorukid vÃµi noored meessoost tÃ¤iskasvanud (vt lÃµik 4.4).
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.
Infliksimabi efektiivsust ja ohutust hinnati mitmekeskuselises, randomiseeritud, avatud, paralleelgrupiga kliinilises uuringus (C0168T72) 60 lapsel vanuses 6 kuni 17 eluaastat (mediaanvanus 14,5 aastat), kellel oli mÃµÃµdukas kuni raske aktiivne haavandiline koliit (Mayo skoor 6 kuni 12; endoskoopia alamskoor â¥ 2) ja kelle ravivastus konventsionaalsele ravile oli ebapiisav.
The median time to onset of response in the infliximab-treated group was 2 weeks.
Infliksimabi saanud patsientide rÃ¼hmas oli ravivastuse mediaan 2 nÃ¤dalat.
Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI &lt; 150) and clinical response over time.
Teisene tulemusnäitaja oli patsientide hulk, kes olid neljandal nädalal kliinilises remissioonis (CDAI &lt; 150) ja kliinilise vastuse püsimine.
The co-primary endpoints were the proportion of patients in clinical remission (CDAI &lt; 150) at week 30 and time to loss of response through week 54.
Esmaseks tulemusnäitajaks oli ka kindlaks teha kliinilises remissioonis patsientide hulk (CDAI &lt; 150) 30. nädalaks ning aeg ravivastuse kadumiseni 54. nädalaks .
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.
Infliksimabi koos vÃµi ilma AZA-ta hinnati randomiseeritud, topeltpimedas, aktiivse kontrolliga uuringus (SONIC) 508 mÃµÃµduka kuni raske Crohni tÃµve aktiivse vormiga tÃ¤iskasvanul (CDAI â¥ 220 â¤ 450), kes olid varasemalt bioloogiliste ravimite vÃµi immunosupressantidega ravimata ja haiguse kestvuse mediaaniga 2,3 aastat.
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.
Infliksimab vÃ¤ltis transgeensel hiirel inimese TNFÎ± pideva ekspressiooni tulemusena tekitatud polÃ¼artriiti ja vÃµimaldas erosiivsete liigeste paranemist, kui ravimit manustati kohe pÃ¤rast haiguse vallandumist.
The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Infliksimabi ohutust ja efektiivsust hinnati kahes (ACT 1 ja ACT 2) randomiseeritud, topeltpimedas, platseebokontrolliga kliinilises uuringus mÃµÃµduka kuni raske aktiivse haavandilise koliidiga (Mayo skoor 6 kuni 12; endoskoopia alamskoor â¥ 2) tÃ¤iskasvanud patsientidel, kelle ravivastus tavapÃ¤rasele ravile [suukaudsed kortikosteroidid, aminosalitsÃ¼laadid ja/vÃµi immunomodulaatorid (6-MP, AZA)] oli ebapiisav.
Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Infliksimaai turuletulekujÃ¤rgsete kogemuste pÃµhjal hÃµlmasid spontaansed tÃµsised kÃµrvaltoimed lastel pahaloomulisi kasvajaid, sealhulgas hepatospleenilist T-rakulist lÃ¼mfoomi, mÃ¶Ã¶duvaid kÃµrvalekaldeid maksaensÃ¼Ã¼mide aktiivsuses, luupusesarnaseid sÃ¼ndroome ja positiivseid autoantikehasid (vt lÃµigud 4.4 ja 4.8).
At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p &lt; 0.001).
24. nädalaks oli ASAS 20 (ASsessment in Ankylosing Spondylitis) saavutanuid platseebogrupis 15/78 (19%) ja 123/201 (61%) 5 mg/kg infliksimabi saanute grupis (p &lt; 0,001).
Infliximab does not cross react with TNFÎ± from species other than human and chimpanzees.
Infliksimab reageerib ainult inimese ja Å¡impansi, mitte teiste liikide TNFÎ±-ga.
Infliximab treatment of Crohn's disease patients was also associated with a substantial reduction of the commonly elevated serum inflammatory marker, CRP.
Infliksimabravi tulemusel vÃ¤henes Crohni tÃµve patsientidel oluliselt ka tavaliselt tÃµusnud seerumi pÃµletikulise markeri, Creaktiivse valgu, hulk.
Infliximab (week 54)
Infliksimab (54. nÃ¤dal)
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).
Kliiniline remissioon ja limaskesta paranemine ilmnes 54. nädalaks suuremal hulgal patsientidest kombineeritud infliksimabi ravirühmas võrreldes platseebo ravirühmaga (vastavalt 34,6% vs. 16,5%, p &lt; 0,001 ja 46,1% vs. 18,2%, p &lt; 0,001).
Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group.
Infektsioone esines sagedamini isikutel, kes said infusioonravi iga 8 nÃ¤dala jÃ¤rel vÃµrreldes nendega, kes said seda iga 12 nÃ¤dala jÃ¤rel (vastavalt 73,6% ja 38,0%), sÃ¤ilitusravi grupis esines tÃµsiseid infektsioone kolmel iga 8 nÃ¤dala jÃ¤rel infusioonravi saanud isikul ja iga neljal iga 12 nÃ¤dala jÃ¤rel infusioonravi saanud isikul.
The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p &lt; 0.001; and 20.2% vs. 6.6%, p &lt; 0.001, respectively).
Püsiva ravivastusega ning püsiva remissiooniga patsientide hulk 54. nädalaks oli suurem kombineeritud infliksimabi ravirühmas kui platseebo ravirühmas (vastavalt 37,9% vs. 14,0% p &lt; 0,001; ja 20,2% vs. 6,6%, p &lt; 0,001).
The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
Infliksimabi ohutust ja efektiivsust alla 6-aastastel Crohni tÃµvega lastel ei ole uuritud.
At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p &lt; 0.01).
12. nädalaks oli BASDAI 50 saavutanuid platseebogrupis 3/35 (9%) ja 20/35 (57%) 5 mg/kg infliksimabi saanute grupis (p &lt; 0,01).
Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to develop infusion-related reactions.
Infliksimabivastaste antikehadega patsientidel oli infusioonireaktsioonide teke umbes 2-3 korda tÃµenÃ¤olisem.
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%).
26. nädalal oli paranenud limaskestaga patsientide osakaal märgatavalt suurem rühmas, kus saadi infliksimabi ja AZA-t kombineeritud teraapiana (43,9%, p &lt; 0,001) ja rühmas, kus saadi infliksimabi monoteraapiana (30,1%, p = 0,023), võrreldes rühmaga, kus saadi AZA-t monoteraapiana (16,5%).
Infliximab (week 98)
Infliksimab (98. nÃ¤dal)
In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximab-treated patients compared with control patients.
Infliksimabi eksperimentaalses kliinilises uuringus tÃ¤heldati infliksimabi kasutamisel keskmise raskusega vÃµi raske kroonilise obstruktiivse kopsuhaigusega (KOK) patsientidel pahaloomuliste kasvajate sagedasemat esinemist vÃµrreldes kontrollpatsientidega.
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).
b n = 292. c analüüs põhines patsientidel, kellel oli algväärtusena küüne psoriaas (81,8% patsientidest).
In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving infliximab (see section 4.4).
Infliksimabi turustamise kÃ¤igus on patsientidel tÃ¤heldatud kollatÃµbe ning hepatiiti, mÃµnedel juhtudel autoimmuunse hepatiidi tunnustega (vt lÃµik 4.4).
Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of infliximab.
Infliksimabi turuletulekujÃ¤rgselt on tÃ¤heldatud kollatÃµbe ning mitte-infektsioosset hepatiiti, mÃµnedel juhtudel autoimmuunse hepatiidi tunnustega.
Infliximab (week 24)
Infliksimab (24. nÃ¤dal)
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
Infliksimabi ohutus ja efektiivsus psoriaasi nÃ¤idustusel lastel ja noorukitel alla 18 eluaasta ei ole veel tÃµestatud.
Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean Â± SD score was 0.82 Â± 2.62 in the placebo group compared with -0.70 Â± 2.53 in the infliximab group; p &lt; 0.001).
24. nädalaks saavutatud tulemusnäitaja alusel, mida mõõdeti kui kogu modifitseeritud vdH-S skoori muutust võrreldes algväärtusega (keskmine ± SD skoor oli 0,82 ± 2,62 platseebogrupis võrreldes -0,70 ± 2,53 infliksimabi grupis; p &lt; 0,001), vähendas infliksimab ravi võrreldes platseeboga perifeerse liigeskahjustuse progresseerumise määra.
The following side effects have been observed with infliximab:
Infliksimabi kasutamisel on esinenud jÃ¤rgmised kÃµrvaltoimed:
New onset or worsening psoriasis including pustular psoriasis (primarily palm &amp; soles), urticaria, rash, pruritus, hyperhidrosis,
psoriaasi teke või halvenemine, sealhulgas mädavilliline psoriaas (peamiselt pihud ja tallad), urtikaaria, lööve, sügelus, hüperhidroos, nahakuivus, fungaaldermatiit, ekseem, alopeetsia
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.
Infliksimabi ohutus ja efektiivsus juveniilse reumatoidartriidi nÃ¤idustusel lastel ja noorukitel alla 18 eluaasta ei ole veel tÃµestatud.
Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Infliksimabi kasutamisel vÃµib tekkida Ã¤ge infusioonireaktsioon, kaasa arvatud anafÃ¼laktiline Å¡okk, ja hilist tÃ¼Ã¼pi Ã¼litundlikkusreaktsioon (vt lÃµik 4.8).
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.
Infliksimabiga ravitud patsientidel on tÃ¤heldatud tuberkuloosi, bakteriaalseid infektsioone, sh sepsist ning pneumooniat, invasiivseid seen-, viirus- ning teisi oportunistlikke infektsioone.
Infliximab (week 16)
Infliksimab (16. nÃ¤dal
Infliximab was administered at a dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks.
Infliksimabi manustati annusena 5 mg/kg 0., 2., 6. nÃ¤dalal ja seejÃ¤rel iga 8 nÃ¤dala tagant.
Peripheral blood mononuclear cells (PBMC) from infliximab-treated patients showed undiminished proliferative responsiveness to stimuli compared with untreated patients, and no substantial changes in cytokine production by stimulated PBMC were observed following treatment with infliximab.
Infliksimabravi saanud patsientide perifeerse vere mononukleaarsete rakkude (PBMC) proliferatiivne vastus Ã¤rritusele ei vÃ¤henenud vÃµrreldes ravi mittesaavate patsientidega.
* P-values represent each infliximab treatment group vs. AZA monotherapy
(p &lt; 0,001)* * P-väärtus esindab iga infliksimabi ravirühma vs. rühm, kus saadi AZA-t monoteraapiana.
a a p &lt; 0.001, for each infliximab treatment group vs. placebo
Limaskesta paranemine, 30. nädala a p &lt; 0,001, igas infliksimabi ravirühmas vs. platseebo.
* 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
** PASI 75 ravivastus uuringus IMPACT, mitte arvestatud madala N väärtuse tõttu; p &lt; 0,001 infliksimab vs. platseebo 24. nädalal uuringus IMPACT 2.
Respiratory, thoracic and mediastinal disorders Very common:
Infektsioonid ja infestatsioonid VÃ¤ga sage:
Mean ± SDd a p &lt; 0.001, for each infliximab treatment group vs control b greater values indicate more joint damage.
Nädal 50 a p &lt; 0,001, iga infliksimabi ravigrupi kohta võrreldes kontrolliga.
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.
Emtricitabine/Tenofovir disoproxil Krka't võib kasutada ainult isikutel, kelle kreatiniini kliirens (CrCl) on &lt; 80 ml/min, juhul kui leitakse, et võimalik kasu on suurem sellega kaasnevatest võimalikest ohtudest.
HIV-1 RNA &lt; 400 copies/mL (TLOVR)
HIV-1 RNA &lt; 400 koopiat/ml (TLOVR)
Use is not recommended in HIV-1 uninfected individuals with CrCl &lt; 60 mL/min as it has not been studied in this population (see sections 4.4 and 5.2).
Ei soovitata ilma HIV-1 infektsioonita isikutel, kelle CrCl &lt; 60 ml/min, kuna ravimit ei ole selles populatsioonis uuritud (vt lõike 4.4 ja 5.2).
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.
In vitro oli emtritsitabiini seondumine inimese plasmavalkudega &lt; 4% ja ei sõltunud kontsentratsioonist vahemikus 0,02...200 µg/ml.
The use of Emtricitabine/Tenofovir disoproxil Krka is not recommended in patients with severe renal impairment (creatinine clearance &lt; 30 mL/min) and in patients who require haemodialysis since appropriate dose reductions cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
Emtricitabine/Tenofovir disoproxil Krka't ei soovitata kasutada raske neerufunktsiooni kahjustusega patsientidel (kreatiniini kliirens &lt; 30 ml/min) ja hemodialüüsi vajavatel patsientidel, kuna sobiv annuse vähendamine ei ole saavutatav kombineeritud tabletiga (vt lõigud 4.2 ja 5.2).
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.
Kui esineb ägeda viirusinfektsiooniga kooskõlas olevaid kliinilisi sümptomeid ja kahtlustatakse hiljutist ( &lt; 1 kuu) kokkupuudet HIV-1-ga, tuleb Emtricitabine/Tenofovir disoproxil Krka kasutamine edasi lükata vähemalt üheks kuuks ja enne Emtricitabine/Tenofovir disoproxil Krka kasutama hakkamist kokkupuute-eelseks profülaktikaks tuleb HIV-1 staatus uuesti kinnitada.
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.
Tenofoviiri tasakaalukontsentratsiooni farmakokineetikat hinnati 8-l HIV-1-ga nakatunud noorukieas patsiendil (vanuses 12 kuni &lt; 18 aastat) kehakaaluga ≥ 35 kg ja 23-l HIV-1-ga nakatunud lapsel vanuses 2 kuni &lt; 12 aastat.
- The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil /efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value &lt; 0.05, Fisher's Exact test comparing the emtricitabine+tenofovir disoproxil group to the lamivudine/zidovudine group among all patients).
- M184V/I mutatsioon tekkis 2/19 (10,5%) isolaatides, mida analüüsiti emtritsitabiini/tenofoviirdisoproksiili/efavirensigrupi patsientidel ja 10/29 (34,5%) isolaatides, mida analüüsiti lamivudiini/zidovudiini/efavirensigrupis (p-väärtus &lt; 0,05; Fisheri täpsustest, mis võrdleb emtritsitabiini+tenofoviirdisoproksiiligruppi lamivudiini/zidovudiinigrupiga kõikide patsientide hulgas).
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.
Neerufunktsiooni käsitlus kokkupuute-eelse profülaktika ajal Emtritsitabiini/tenofoviirdisoproksiili ei ole uuritud HIV-1 infektsioonita inimestel, kellel kreatiniini kliirens on &lt; 60 ml/min ja seetõttu ei soovitata seda sellel populatsioonil kasutada.
In vivo - treatment of HIV-1: In an open-label randomised clinical study (GS-01-934) in antiretroviralnaïve patients, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA &gt; 400 copies/mL at weeks 48, 96 or 144 or at the time of early study drug discontinuation.
Avatud, randomiseeritud kliinilises uuringus (GS-01-934) retroviirusvastast ravi varem mitte saanud patsientidega teostati plasma HIV-1-isolaatide genotüüpimine kõikidel patsientidel, kellel tehti kindlaks HIV RNA &gt; 400 koopia/ml 48., 96. või 144. nädalal või uuringuravimi manustamise varajase katkestamise hetkel.