natgillin/translations-raw huggingface dataset:
Hypogonadism male, Cushing syndrome, hypothyroidism
moški hipogonadizem, Cushingov sindrom, hipotiroidizem
Metabolic and nutritional disorders
Presnovne in prehranske motnje
Avitaminosis, dehydration, oedema, increased appetite, lactic acidosis, obesity, anorexia, diabetes, mellitus, hyperglycaemia, hypocholesteremia
avitaminoza, dehidracija, edemi, zvečan apetit, laktacidoza, debelost, anoreksija, diabetes mellitus, hiperglikemija, hipoholesteremija
Abnormal dreams, agitation, anxiety, confusion, depression, dyskenesia, emotional liability, decreased libido, nervousness, abnormal thinking
nenormalne sanje, agitiranost, anksioznost, zmedenost, depresija, diskinezija, čustvena labilnost, zmanjšan libido, živčnost, nenormalno mišljenje
Headache, parathesia
glavobol, parastezija
Dizziness, amnesia, ataxia, encephalopathy, facial paralysis, hypertonia, neuropathy, peripheral neuritis, somnolence, tremor, taste perversion, migraine, extrapyramidal syndrome
omotica, amnezija, ataksija, encefalopatija, paraliza obraza, hipertonija, nevropatija, periferni nevritis, zaspanost, tremor, motnje okusa, migrena, ekstrapiramidni sindrom
Eye disorders Ear and labyrinth disorders Cardiac disorders Vascular disorders
Ušesne bolezni, vključno z motnjami labirinta
Uncommon Uncommon Uncommon Uncommon
tinitus palpitacije, pljučni edem, miokardni infarkt1
Abnormal vision, eye disorder Tinnitus Palpitation, lung oedema, myocardial infarct1 Hypertension, thrombophebitis, vasculitis, varicose vein, deep thrombophlebitis, vascular disorder
hipertenzija, tromboflebitis, vaskulitis, varikozne vene, globoka flebotromboza, žilna motnja
Dyspnoea, rhinitis, cough increased
dispneja, rinitis, povečan kašelj
12 Gastrointestinal disorders
13 Bolezni prebavil
Very Common
zelo pogosto
Nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence, gastrointestinal disorder
navzeja, bruhanje, bolečine v trebuhu, nenormalno blato, dispepsija, flatulenca, prebavne motnje
Abdomen enlarged, constipation, dry mouth, dysphagia, enterocolitis, eructation, oesophagitis, faecal incontinence, gastritis, gastroenteritis, haemorrhagic colitis, mouth ulcerations, pancreatitis2, sialadenitis, stomatitis, ulcerative stomatitis, periodontitis
zvečanje trebuha, zaprtje, suha usta, disfagija, enterokolitis, spahovanje, ezofagitis, fekalna inkontinenca, gastritis, gastroenteritis, hemoragični kolitis, razjede v ustih, pankreatitis2, sialadenitis, stomatitis, ulcerativni stomatitis, periodontitis
Cholecystitis, hepatitis, hepatomegaly, liver fatty deposit, liver tenderness
holecistitis, hepatitis, hepatomegalija, maščobni jetrni depoziti, občutljivost jeter
Rash, lipodystrophy, acne
izpuščaj, lipodistrofija, akne
Alopecia, dry skin, eczema, exfoliative dermatitis, maculopapular rash, nail disorder, pruritis, seborrhoea, skin discoloration, skin ulcer, face oedema, sweating, skin striae
alopecija, suha koža, ekcem, eksfoliacijski dermatitis, makulopapularen izpuščaj, nepravilnosti nohtov, srbenje, diseboreja, sprememba barve kože, razjeda na koži, edem obraza, znojenje, kožne strije
Arthralgia, arthrosis, myalgia, back pain, joint disorder
artralgije, artroza, mialgije, bolečine v hrbtu, sklepna bolezen
Kidney calculus, urine abnormality, albuminuria, hypercalcinuria, hyperuricemia
ledvični kamni, nenormalnosti urina, albuminurija, hiperkalciurija, hiperurikemija
Abnormal ejaculation, breast enlargement, gynecomastia, impotence, menorrhagia
nenormalna ejakulacija, zvečanje prsi, ginekomastija, impotenca, menoragija
Asthenia, pain
astenija, bolečine
Chest pain, chest pain substernal, chills, fever, flu syndrome, malaise, peripheral oedema, drug interactions
bolečine v prsih, bolečine v prsih substernalno, mrzlica, zvišana telesna temperatura, gripozni sindrom, splošno slabo počutje, periferni edemi, interakcije z zdravili
Very common (Grade 3 or 4)
zelo pogosto (3. ali 4. stopnje)
Increased triglycerides, increased total cholesterol, increased GGT
zvišani trigliceridi, zvišan celokupni holesterol, zvišana GGT
Common (Grade 3 or 4)
pogosto (3. ali 4. stopnje)
Increased glucose, increased amylase, increased SGOT/ AST, increased SGPT/ ALT, liver function tests abnormal
zvišana glukoza, zvišana amilaza, zvišana SGOT/ AST, zvišana SGPT/ ALT, nenormalni jetrni funkcijski testi
This event had a fatal outcome
Ta dogodek je imel smrten izid.
Decreased glucose tolerance, weigh gain, weight loss, increased bilirubin, hormone level altered, lab test abnormal
zmanjšana toleranca za glukozo, zvečanje telesne mase, hujšanje, zvišan bilirubin, spremenjen hormonski nivo, nenormalen lab. test
See Section 4.4 pancreatitis and lipids
glejte poglavje 4. 4: pankreatitis in
13 Paediatric patients
14 Pediatrični bolniki
In children 2 years of age and older, the nature of the safety profile is similar to that seen in adults.
Pri otrocih, starih 2 leti in več, so varnostne značilnosti podobne kot pri odraslih.
Undesirable effects in clinical studies in paediatric patients Infections and infestations
Infekcijske in parazitske bolezni
Viral infection
virusne okužbe
Taste perversion
motnje okusa
Gastrointestinal disorders Hepatobiliary disorders Skin and subcutaneous tissue disorders
Bolezni prebavil
Common Common Common
pogosto
Constipation, vomiting, pancreatitis Hepatomegaly Rash, Dry skin
zaprtje, bruhanje, pankreatitis *
Fever
pogosto
Investigations
izpuščaj, suha koža
Increased activated partial thromboplastin time, decreased haemoglobin, decreased platelets, increased sodium, increased potassium, increased calcium, increased bilirubin, increased SGPT/ ALT, increased SGOT/ AST, increased total cholesterol, increased amylase, increased uric acid, decreased sodium, decreased potassium, decreased calcium, decreased neutrophils
zvišan aktivirani parcialni tromboplastinski čas, znižan hemoglobin, zmanjšano število trombocitov, zvišan natrij, zvišan kalij, zvišan kalcij, zvišan bilirubin, zvišana SGPT/ ALT, zvišana SGOT/ AST, zvišan celokupni holesterol, zvišana amilaza, zvišana sečna kislina, znižan natrij, znižan kalij, znižan kalcij, zmanjšano število nevtrofilcev
*see section 4.4: pancreatitis and lipids
* Glejte poglavje 4. 4: pankreatitis in lipidi.
Post marketing experience
Pomarketinške izkušnje
Hepatitis, and rarely jaundice, have been reported in patients on Kaletra therapy in the presence or absence of identifiable risk factors for hepatitis.
Pri bolnikih, ki so dobivali zdravilo Kaletra v prisotnosti ali odsotnosti prepoznavnih dejavnikov tveganja za hepatitis, sta bila opisana hepatitis in, redko, zlatenica.
Stevens-Johnson syndrome and erythema multiforme have been reported.
Poročali so o Stevens- Johnsonovemu sindromu in multiformnemu eritemu.
The adverse clinical signs observed in dogs included salivation, emesis and diarrhoea/ abnormal stool.
Med neželenimi kliničnimi znaki pri psih so bili slinjenje, emeza in driska oz. nenormalno blato.
Since Kaletra is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Ker je zdravilo Kaletra v veliki meri vezano na beljakovine, ni verjetno, da bi dializa pomembno odstranila zdravilno učinkovino.
Pharmaco-therapeutic group: protease inhibitor, ATC code:
Farmakoterapevtska skupina: zaviralci proteaz, oznaka ATC:
Lopinavir provides the antiviral activity of Kaletra.
Mehanizem delovanja: protivirusno delovanje zdravila Kaletra zagotavlja lopinavir.
Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases.
Lopinavir je zaviralec proteaz HIV- 1 in HIV- 2.
Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus.
Zavrtje proteaze HIV prepreči razcep poliproteina gag- pol, tako da nastane nezrel, neinfektivni virus.
Effects on the electrocardiogram:
Učinki na elektrokardiogram:
The maximum mean (95% upper confidence bound) differences in QTcF from placebo were 3.6 (6.3) and 13.1(15.8) for 400/ 100 mg twice daily and supratherapeutic 800/ 200 mg twice daily LPV/ r, respectively.
Največja povprečna razlika (95% zgornja meja zaupanja) QTcF v primerjavi s placebom je bila 3, 6 (6, 3) med uporabo lopinavirja/ ritonavirja 400/ 100 mg dvakrat na dan in 13, 1 (15, 8) med uporabo supraterapevtskega odmerka lopinavirja/ ritonavirja 800/ 200 mg dvakrat na dan.
The induced QRS interval prolongation from 6 ms to 9.5 ms with high dose lopinavir/ ritonavir (800/ 200 mg twice daily) contributes to QT prolongation.
K podaljšanju intervala QT pripomore podaljšanje intervala QRS s 6 ms na 9, 5 ms, ki ga povzročijo veliki odmerki lopinavirja/ ritonavirja (800/ 200 mg dvakrat na dan).
The two regimens resulted in exposures on Day 3 which were approximately 1.5 and 3-fold higher than those observed with recommended once daily or twice daily LPV/ r doses at steady state.
3- krat večja, kot je ugotovljena med uporabo priporočenih odmerkov lopinavirja/ ritonavirja enkrat oz. dvakrat na dan v stanju dinamičnega ravnovesja.
Modest prolongation of the PR interval was also noted in subjects receiving lopinavir/ ritonavir in the same study on Day 3.
Med preiskovanci, ki so dobivali lopinavir/ ritonavir, so v isti študiji 3. dan ugotovili zmerno podaljšanje intervala PR.
The mean changes from baseline in PR interval ranged from 11.6 ms to 24.4 ms in the 12 hour interval post dose.
Povprečna sprememba dolžine intervala PR v primerjavi z izhodiščem je bila med 12- urnim obdobjem po odmerku od 11, 6 ms do 24, 4 ms.
Maximum PR interval was 286 msec and no second or third degree heart block was observed (see section 4.4).
Najdaljši interval PR je bil 286 msec, primerov srčnega bloka druge ali tretje stopnje pa ni bilo (glejte poglavje 4. 4).
Antiviral activity in vitro: the in vitro antiviral activity of lopinavir against laboratory and clinical HIV strains was evaluated in acutely infected lymphoblastic cell lines and peripheral blood lymphocytes, respectively.
Protivirusno delovanje in vitro: protivirusno delovanje lopinavirja proti laboratorijskim in kliničnim sevom HIV so in vitro ocenili pri akutno okuženih limfoblastnih celičnih linijah (laboratorijski sevi) in limfocitih periferne krvi (klinični sevi).
In the absence of human serum, the mean IC50 of lopinavir against five different HIV-1 laboratory strains was 19 nM.
V odsotnosti človeškega seruma je bila povprečna IC50 lopinavirja proti petim različnim laboratorijskim sevom HIV- 1 19 nM.
In the absence and presence of 50% human serum, the mean IC50 of lopinavir against HIV-1IIIB in MT4 cells was 17 nM and 102 nM, respectively.
102 nM.
In the absence of human serum, the mean IC50 of lopinavir was 6.5 nM against several HIV-1 clinical isolates.
V odsotnosti človeškega seruma je bila povprečna IC50 lopinavirja proti več kliničnim izolatom HIV- 1 6, 5 nM.
In vitro selection of resistance:
In vitro selekcija odpornosti:
HIV-1 isolates with reduced susceptibility to lopinavir have been selected in vitro.
Izolati HIV- 1 z zmanjšano občutljivostjo za lopinavir so bili izbrani in vitro.
HIV-1 has been passaged in vitro with lopinavir alone and with lopinavir plus ritonavir at concentration ratios representing the range of plasma concentration ratios observed during Kaletra therapy.
HIV- 1 je bil pasiran in vitro s samim lopinavirjem ter z lopinavirjem in ritonavirjem v koncentracijskih razmerjih, ki so predstavljala razpon koncentracijskih razmerij, ugotovljenih med zdravljenjem z zdravilom Kaletra.
Analysis of resistance in ARV-naïve patients:
Analiza odpornosti pri bolnikih, naivnih za protiretrovirusna zdravila:
In a Phase II study (M97-720) through 204 weeks of treatment, genotypic analysis of viral isolates was successfully conducted in 11 of 16 patients with confirmed HIV RNA above 400 copies/ ml revealed no primary or active site mutations in protease (amino acids at positions 8, 30, 32, 46, 47, 48, 50, 82, 84 and 90) or protease inhibitor phenotypic resistance.
Analiza ni pokazala primarnih mutacij oz. mutacij aktivnega mesta na proteazi (aminokisline na položajih 8, 30, 32, 46, 47, 48, 50, 82, 84 in 90) ali fenotipske odpornosti proti zaviralcu proteaze.
In a Phase III study (M98-863) of 653 patients randomised to receive stavudine plus lamivudine with either lopinavir/ ritonavir or nelfinavir, 113 nelfinavir-treated subjects and 74 lopinavir/ ritonavir- treated subjects had an HIV RNA above 400 copies/ ml while on treatment from Week 24 through Week 96.
Med zdravljenjem je imelo od 24. do 96. tedna HIV RNA nad 400 kopij/ ml 113 preiskovancev, zdravljenih z nelfinavirjem, in 74 preiskovancev, zdravljenih z lopinavirjem/ ritonavirjem.
Of these, isolates from 96 nelfinavir-treated subject and 51 lopinavir/ ritonavir-treated
Med temi je bilo mogoče za testiranje odpornosti amplificirati izolate 96 preiskovancev, zdravljenih z nelfinavirjem, in 51 preiskovancev, zdravljenih z lopinavirjem/ ritonavirjem.
Resistance to nelfinavir, defined as the presence of the D30N or L90M mutation in protease, was observed in 41/ 96 (43%) subjects.
Odpornost proti nelfinavirju, opredeljena kot mutacija D30N ali L90M na proteazi, so ugotovili pri 41 od 96 (43%) preiskovancev.
Resistance to lopinavir, defined as the presence of any primary or active site mutations in protease (see above), was observed in 0/ 51 (0%) subjects.
Odpornosti proti lopinavirju, opredeljene kot primarne mutacije oz. mutacije aktivnega mesta na proteazi (glejte zgoraj), niso ugotovili pri nobenem od 51 preiskovancev (0%).
Lack of resistance to lopinavir was confirmed by phenotypic analysis.
Odsotnost odpornosti proti lopinavirju je potrdila fenotipska analiza.
Analysis of resistance in PI-experienced patients:
Analiza odpornosti pri bolnikih, izkušenih z zaviralci proteaz:
The selection of resistance to lopinavir in patients having failed prior protease inhibitor therapy was characterised by analysing the longitudinal isolates from 19 protease inhibitor-experienced subjects in 2 Phase II and one Phase III studies who either experienced incomplete virologic suppression or viral rebound subsequent to initial response to Kaletra and who demonstrated incremental in vitro resistance between baseline and rebound (defined as emergence of new mutations or 2-fold change in phenotypic susceptibility to lopinavir).
Pri teh bolnikih se je po uvodnem odzivu na zdravilo Kaletra pojavila bodisi nepopolna virološka supresija ali virusni preobrat, poleg tega se je pri njih kazala naraščajoča odpornost in vitro med izhodiščem in preobratom (opredeljenim kot pojav novih mutacij ali 2- kratna sprememba fenotipske občutljivosti za lopinavir).
Incremental resistance was most common in subjects whose baseline isolates had several protease inhibitor-associated mutations, but < 40-fold reduced susceptibility to lopinavir at baseline.
Naraščajoča odpornost je bila najpogostejša pri preiskovancih, ki so imeli v izhodiščnih izolatih več mutacij, povezanih z zaviralci proteaz, toda z izhodiščno < 40- kratno zmanjšano občutljivost za lopinavir.
Mutations L33F, I50V and V32I combined with I47V/ A were also observed.
Opažali so tudi mutacije L33F, I50V in V32I v kombinaciji z I47V/ A.
The 19 isolates demonstrated a 4.3-fold increase in IC50 compared to baseline isolates (from 6.2- to 43-fold, compared to wild-type virus).
Pri 19 izolatih so ugotovili 4, 3- kratno povečanje IC50 v primerjavi z izhodiščnimi izolati (od 6, 2 - do 43- kratno v primerjavi z divjim tipom virusa).
Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir:
V tem okviru so bile z manjšo občutljivostjo za lopinavir in vitro povezane naslednje mutacije proteaze HIV:
L10F/ I/ R/ V, K20M/ R, L24I, M46I/ L, F53L, I54L/ T/ V, L63P, A71I/ L/ T/ V, V82A/ F/ T, I84V and L90M.
L10F/ I/ R/ V, K20M/ R, L24I, M46I/ L, F53L, I54L/ T/ V, L63P, A71I/ L/ T/ V, V82A/ F/ T, I84V in L90M.
The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7 13.5 and 44.0-fold higher than the EC50 against wild type HIV, respectively.
44, 0- krat večja kot EC50 proti divjemu tipu HIV.
The 16 viruses that displayed > 20-fold change in susceptibility all contained mutations at positions 10, 54, 63 plus 82 and/ or 84.
Vseh 16 virusov, ki so pokazali > 20- kratno spremembo v občutljivosti, je imelo mutacije na položajih 10, 54, 63 ter dodatno 82 in/ ali 84.
In addition to the mutations described above, mutations V32I and I47A have been observed in rebound isolates with reduced lopinavir susceptibility from protease inhibitor experienced patients receiving Kaletra therapy.
Poleg zgoraj opisanih mutacij so opažali mutaciji V32I in I47A pri izolatih s preobratom, to je z manjšo občutljivostjo za lopinavir pri bolnikih izkušenih z zaviralci proteaz, ki so dobivali zdravilo Kaletra.
Antiviral activity of Kaletra in patients failing protease inhibitor therapy: the clinical relevance of reduced in vitro susceptibility to lopinavir has been examined by assessing the virologic response to Kaletra therapy, with respect to baseline viral genotype and phenotype, in 56 patients previous failing therapy with multiple protease inhibitors.
Protivirusno delovanje zdravila Kaletra pri bolnikih, pri katerih je bilo zdravljenje z zaviralci proteaz neuspešno: klinični pomen zmanjšane občutljivosti za lopinavir in vitro so raziskali z oceno virološkega odziva na zdravljenje z zdravilom Kaletra (upoštevaje izhodiščni virusni genotip in fenotip) pri 56 bolnikih s predhodno neuspešnim zdravljenjem z več zaviralci proteaz.
The EC50 of lopinavir against the 56 baseline viral isolates ranged from 0.6 to 96-fold higher than the EC50 against wild type HIV.
EC50 lopinavirja proti 56 izhodiščnim virusnim izolatom je bila od 0, 6 - do 96- krat večja kot EC50 proti divjemu tipu HIV.
After 48 weeks of treatment with Kaletra, efavirenz and nucleoside reverse transcriptase inhibitors, plasma HIV RNA ≤ 400 copies/ ml was observed in 93% (25/ 27), 73% (11/ 15), and 25% (2/ 8) of patients with< 10-fold, 10 to 40-fold, and > 40-fold reduced susceptibility to lopinavir at baseline, respectively.
Po 48 tednih zdravljenja z zdravilom Kaletra, efavirenzem in nukleozidnimi zaviralci reverzne transkriptaze so HIV RNA v plazmi ≤ 400 izvodov/ ml ugotovili pri 93% (25/ 27), 73% (11/ 15), in 25% (2/ 8) bolnikov z < 10- krat, 10 - do 40- krat oz. > 40- krat zmanjšano izhodiščno občutljivostjo za lopinavir.
In addition, virologic response was observed in 91% (21/ 23), 71% (15/ 21) and 33% (2/ 6) patients with 0 − 5, 6 − 7, and 8 − 10 mutations of the above mutations in HIV protease associated with reduced in vitro susceptibility to lopinavir.
33% (2/ 6) bolnikov z 0– 5, 6– 7 oz.
Since these patients had not previously been exposed to either Kaletra or efavirenz, part of the response may be attributed to the antiviral activity of efavirenz, particularly in patients harbouring highly lopinavir resistant virus.
Ker ti bolniki predhodno niso bili izpostavljeni niti zdravilu Kaletra niti efavirenzu,
Activity of other protease inhibitors against isolates that developed incremental resistance to lopinavir after Kaletra therapy in protease inhibitor experienced patients:
Dejavnost drugih zaviralcev proteaz proti izolatom, ki so razvili naraščajočo odpornost proti lopinavirju po zdravljenju z zdravilom Kaletra pri bolnikih, izkušenih z zaviralci proteaz:
The presence of cross resistance to other protease inhibitors was analysed in 18 rebound isolates that had demonstrated evolution of resistance to lopinavir during 3 Phase II and one Phase III studies of Kaletra in protease inhibitor-experienced patients.
Obstoj navzkrižne odpornosti proti drugim zaviralcem proteaz so analizirali v 18 izolatih s preobratom; razvoj odpornosti proti lopinavirju so ugotovili med tremi študijami z zdravilom Kaletra II. faze in eno študijo III. faze pri bolnikih, izkušenih z zaviralci proteaz.
The median fold IC50 of lopinavir for these 18 isolates at baseline and rebound was 6.9- and 63-fold, respectively, compared to wild type virus.
Srednji (mediana) kratnik IC50 lopinavirja pri teh 18 izolatih v primerjavi z divjim tipom virusa je bil izhodiščno 6, 9- krat in po preobratu 63- krat.
Modest decreases in amprenavir activity were noted with a median increase of IC50 from 3.7- to 8-fold in the baseline and rebound isolates, respectively.
Ugotovili so zmerno zmanjšano aktivnost amprenavirja s srednjim (mediana) povečanjem IC50 od 3, 7 - krat izhodiščno do 8- krat z izolati po preobratu.
Please refer to the Aptivus Summary of Product
Izolati so ohranili občutljivost za tipranavir s srednjim (mediana) povečanjem IC50 v izhodiščnih izolatih za 1, 9- krat in izolatih po preobratu za 1, 8- krat v primerjavi z divjim tipom virusa.
16 Characteristics for additional information on the use of tipranavir, including genotypic predictors of response, in treatment of lopinavir-resistant HIV-1 infection.
Za dodatne informacije o tipranavirju (vključno z genotipsko napovedjo odziva, pri zdravljenju okužbe s HIV- 1, odporne proti lopinavirju) glejte povzetek glavnih značilnosti zdravila Aptivis.
The effects of Kaletra (in combination with other antiretroviral agents) on biological markers (plasma HIV RNA levels and CD4 counts) have been investigated in a controlled study of Kaletra of 48 weeks duration, and in additional studies of Kaletra of 360 weeks duration.
Učinke zdravila Kaletra (v kombinaciji z drugimi protiretrovirusnimi zdravili) na biološke označevalce (koncentracijo HIV RNA in število celic CD4 v plazmi) so raziskali v kontrolirani 48- tedenski študiji zdravila Kaletra ter v dodatnih 360- tedenskih raziskavah zdravila Kaletra.
Study M98-863 is a randomised, double-blind trial of 653 antiretroviral treatment naïve patients investigating Kaletra (400/ 100 mg twice daily) compared to nelfinavir (750 mg three times daily) plus nucleoside reverse transcriptase inhibitors.
Študija M98- 863 je randomizirano, dvojno slepo preskušanje s 653 bolniki, naivnimi za protiretrovirusno zdravljenje, ki proučuje zdravilo Kaletra (400/ 100 mg dvakrat na dan) v primerjavi z nelfinavirjem (750 mg trikrat na dan) v kombinaciji z nukleozidnimi zaviralci reverzne transkriptaze.
By intent to treat analysis where patients with missing values are considered virologic failures, the proportion of patients at 48 weeks with HIV RNA < 400 copies/ ml in the Kaletra arm was 75% and 63% in the nelfinavir arm.
Z analizo z namenom zdravljenja, pri kateri so bili bolniki z manjkajočimi podatki obravnavani kot virološki neuspeh, je bil po 48 tednih delež bolnikov s HIV RNA < 400 izvodov/ ml v kraku z zdravilom Kaletra 75% in v kraku z nelfinavirjem 63%.
2.6 to 6.8 log10 copies/ ml).
Povprečno izhodiščno število celic CD4 je bilo 259 celic/ mm3 (razpon: od 2 do 949 celic/ mm3), povprečna izhodiščna HIV- 1 RNA v plazmi pa je bila 4, 9 log10 izvodov/ ml (razpon: od 2, 6 do 6, 8 log10 izvodov/ ml).
Through 48 weeks of therapy, the proportion of patients in the Kaletra arm with plasma RNA < 50 copies/ ml was 67% and 52% in the nelfinavir arm.
Med 48 tedni zdravljenja je bil delež bolnikov z RNA v plazmi < 50 izvodov/ ml v kraku z zdravilom Kaletra 67% in v kraku z nelfinavirjem 52%.
The mean increase from baseline in CD4 cell count was 207 cells/ mm3 in the Kaletra arm and 195 cells/ mm3 in the nelfinavir arm.
Povprečno zvečanje števila celic CD4 od izhodišča je bilo 207 celic/ mm3 v kraku z zdravilom Kaletra in 195 celic/ mm3 v kraku z nelfinavirjem.
Through 48 weeks of therapy, a statistically significantly higher proportion of patients in the Kaletra arm had HIV RNA < 50 copies/ ml compared to the nelfinavir arm.
Med 48 tedni zdravljenja je bil delež bolnikov, ki so imeli HIV RNA < 50 izvodov/ ml, statistično značilno večji v kraku z zdravilom Kaletra kot v kraku z nelfinavirjem.
Sustained virological response to Kaletra (in combination with nucleoside/ nucleotide reverse transcriptase inhibitors) has been also observed in a small Phase II study (M97-720) through 360 weeks of treatment.
Dolgotrajni virološki odziv na zdravilo Kaletra (v kombinaciji z nukleozidnimi/ nukleotidnimi zaviralci reverzne transkriptaze) so ugotovili tudi v majhni študiji II. faze (M97- 720) med 360 tedni zdravljenja.