natgillin/translations-raw huggingface dataset:
Due to the metabolic pathway of raltegravir no interaction is expected.
predvidoma ne prihaja do interakcije.
Raltegravir and VIRAMUNE can be co-administered without dose adjustments.
odmerkov.
Antibiotics
Klaritromicin
Clarithromycin 500 mg BID
500 mg 2- krat na dan
Clarithromycin AUC ↓ 0.69 (0.62- 0.76) Clarithromycin Cmin ↓ 0.44 (0.30- 0.64) Clarithromycin Cmax ↓ 0.77 (0.69- 0.86)
0, 76)
Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
Cmin klaritromicina ↓ 0, 44 (0, 30- 0, 64) izpostavljenost presnovku 14- OH pa Cmax klaritromicina ↓ 0, 77 (0, 69- 0, 86) povečala.
Because the clarithromycin active metabolite has reduced activity against Mycobacterium avium- intracellulare complex overall activity against the pathogen may be
Ker je klaritromicinov aktivni presnovek zmanjšal delovanje proti AUC klaritromicinovega presnovka kompleksu Mycobacterium avium 14- OH ↑ 1, 42 (1, 16- 1, 73) Cmin klaritromicinovega presnovka 14 - intracellulare, se skupno delovanje proti povzročitelju lahko spremeni.
Metabolite 14-OH clarithromycin AUC ↑ 1.42 (1.16-1.73) Metabolite 14-OH clarithromycin Cmin ↔ 0 (0.68-1.49) Metabolite 14-OH clarithromycin Cmax ↑ 1.47 (1.21-1.80)
OH ↔ 0 (0, 68- 1, 49) Presoditi je treba o uporabo Cmax klaritromicinovega presnovka alternativnih zdravil namesto 14- OH ↑ 1, 47 (1, 21- 1, 80) klaritromicina, na primer
altered.
10 azitromicina.
Alternatives to clarithromycin, such as azithromycin should be considered.
AUC nevirapina ↑ 1, 26 Cmin nevirapina ↑ 1, 28 Cmax nevirapina ↑ 1, 24 v primerjavi s prejšnjimi, kontrolnimi vrednostmi AUC rifabutina ↑ 1, 17 (0, 98- 1, 40)
Close monitoring for hepatic abnormalities is recommended
natančno spremljanje zaradi odkrivanja jetrnih sprememb.
Nevirapine AUC ↑ 1.26 Nevirapine Cmin ↑ 1.28 Nevirapine Cmax ↑ 1.24 compared to historical controls.
Cmin rifabutina ↔ 1, 07 (0, 84- 1, 37)
Rifabutin 150 or 300 mg QD
150 ali 300 mg na dan
Rifabutin AUC ↑ 1.17 (0.98-1.40) Rifabutin Cmin ↔ 1.07 (0.84-1.37) Rifabutin Cmax ↑ 1.28 (1.09-1.51)
Cmax rifabutina ↑ 1, 28 (1, 09- 1, 51)
No significant effect on rifabutin and VIRAMUNE mean PK parameters is seen.
vrednosti farmakokinetičnih parametrov rifabutina in VIRAMUNA.
Rifabutin and VIRAMUNE can be co-administered without dose
Rifabutin in
Metabolite 25-O-desacetylrifabutin AUC ↑ 1.24 (0.84-1.84) Metabolite 25-O-desacetylrifabutin Cmin ↑ 1.22 (0.86-1.74) Metabolite 25-O-desacetylrifabutin Cmax ↑ 1.29 (0.98-1.68) A clinically not relevant increase in the apparent clearance of nevirapine (by 9%) compared to historical data was reported.
AUC presnovka 25- O - dezacetilrifabutina ↑ 1, 24 (0, 84- 1, 84) Cmin presnovka 25- O - dezacetilrifabutina ↑ 1, 22 (0, 86- 1, 74) Cmax presnovka 25- O - dezacetilrifabutina ↑ 1, 29 (0, 98- 1, 68)
adjustments.
VIRAMUNE lahko dajemo sočasno brez prilagajanja odmerkov.
However, due to the high intersubject variability some patients may experience large increases in rifabutin exposure and may be at higher risk for rifabutin toxicity.
Zato je pri sočasnem
Therefore, caution should be used in concomitant administration.
dajanju potrebna previdnost.
11 Rifampicin 600 mg QD
600 mg na dan
Rifampicin AUC ↔ 1.11 (0.96-1.28) Rifampicin Cmin ND Rifampicin Cmax ↔ 1.06 (0.91-1.22)
Cmin rifampicina ND Cmax rifampicina ↔ 1, 06 (0, 91- 1, 22)
It is not recommended to co- administer rifampicin and VIRAMUNE (see section 4.4).
(glejte poglavje 4. 4).
Physicians needing to treat patients
Zdravniki, ki zdravijo bolnike s
Nevirapine AUC ↓ 0.42 Nevirapine Cmin ↓ 0.32 Nevirapine Cmax ↓ 0.50 compared to historical controls.
AUC nevirapina ↓ 0, 42 Cmin nevirapina ↓ 0, 32 Cmax nevirapina ↓ 0, 50 v primerjavi s prejšnjimi, kontrolnimi vrednostmi
co-infected with tuberculosis and using a VIRAMUNE containing regimen may consider co- administration of rifabutin instead.
sočasno tuberkulozo in v sklopu zdravljenja uporabljajo VIRAMUNE, lahko presodijo o sočasnem dajanju z rifabutinom.
Antifungals
Flukonazol
Fluconazole 200 mg QD
20 mg na dan
Fluconazole AUC ↔ 0.94 (0.88- 1.01) Fluconazole Cmin ↔ 0.93 (0.86-1.01) Fluconazole Cmax ↔ 0.92 (0.85-0.99) Nevirapine: exposure: ↑ 100% compared with historical data where nevirapine was administered alone.
AUC itrakonazola ↓ 0, 39
Because of the risk of increased exposure to VIRAMUNE, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely.
moramo biti pri sočasnem dajanju teh zdravil previdni in bolnike skrbno spremljati.
Itraconazole 200 mg QD
200 mg na dan
Itraconazole AUC ↓ 0.39 Itraconazole Cmin ↓ 0.13 Itraconazole Cmax ↓ 0.62 Nevirapine: there was no significant difference in Nevirapine pharmacokinetic parameters.
Nevirapin: farmakokinetični parametri nevirapina se niso pomembno spremenili.
A dose increase for itraconazole should be considered when these two agents are administered concomitantly.
Sočasnega dajanja ketokonazola in VIRAMUNA ne priporočajo.
Ketoconazole 400 mg QD
400 mg na dan
Ketoconazole AUC ↓ 0.28 (0.20- 0.40) Ketoconazole Cmin ND Ketoconazole Cmax ↓ 0.56 (0.42- 0.73)
Cmin ketokonazola ND Cmax ketokonazola ↓ 0, 56 (0, 42- 0, 73)
It is not recommended to co- administer ketoconazole and VIRAMUNE.
ANTACIDI Cimetidin
Nevirapine: plasma levels: ↑ 1.15- 1.28 compared to historical controls.
Cimetidin: ni pomembnejšega vpliva
ANTACIDS Cimetidine
Cimetidin in VIRAMUNE lahko
Cimetidine: no significant effect on cimetidine PK parameters is seen.
na cimetidinove farmakokinetične parametre.
Cimetidine and VIRAMUNE can be co-administered without dose adjustments.
dajemo sočasno brez prilagajanja odmerkov.
Nevirapine Cmin ↑ 1.07 ANTITHROMBOTICS Warfarin
Cmin nevirapina ↑ 1, 07 ANTITROMBOTIKI Varfarin
The interaction between Nevirapine and the antithrombotic agent warfarin is complex, with the potential for both increases and decreases in coagulation time when used concomitantly.
AUC DMPA ↔
Close monitoring of anticoagulation levels is warranted.
antikoagulacijo.
12 CONTRACEPTIVES Depo- medroxyprogesterone acetate (DMPA) 150 mg every 3
Pri sočasnem dajanju Viramuna se
DMPA AUC ↔ DMPA Cmin ↔ DMPA Cmax ↔
Cmax DMPA ↔
Viramune co-administration did not alter the ovulation suppression effects of DMPA.
zaviralni učinki DMPA na ovulacijo
DMPA and VIRAMUNE can be co-administered without dose
acetat (DMPA), 150 mg vsake 3 mesece
Nevirapine AUC ↑ 1.20 Nevirapine Cmax ↑ 1.20
AUC nevirapina ↑ 1, 20 Cmax nevirapina ↑ 1, 20
adjustments.
DMPA in VIRAMUNE lahko dajemo sočasno brez prilaganja odmerkov.
Ethinyl estradiol (EE) 0.035 mg
Etinilestradiol (EE),
EE AUC ↓ 0.80 (0.67 - 0.97) EE Cmin ND EE Cmax ↔ 0.94 (0.79 - 1.12)
AUC EE ↓ 0, 80 (0, 67- 0, 97)
Oral hormonal contraceptives should not be used as the sole method of contraception in women taking VIRAMUNE (see section 4.4).
Ženske, ki jemljejo VIRAMUNE, hormonskih metod kontracepcije ne
Norethindrone (NET) 1.0 mg QD
0, 035 mg Noretindron (NET)
NET AUC ↓ 0.81 (0.70 - 0.93) NET Cmin ND NET Cmax ↓ 0.84 (0.73 - 0.97)
Cmin EE ND Cmax EE ↔ 0, 94 (0, 79- 1, 12) AUC NET ↓ 0, 81 (0, 70- 0, 93)
Appropriate doses for hormonal contraceptives (oral or other forms of application) other than DMPA in combination with VIRAMUNE have not been established with respect to safety and efficacy.
Varnost in učinkovitost ustreznih
DRUG ABUSE Methadone Individual Patient Dosing
Cmin NET ND Cmax NET ↓ 0, 84 (0, 73- 0, 97)
Methadone AUC ↓ 0.40 (0.31 - 0.51) Methadone-maintained patients Methadone Cmin ND beginning VIRAMUNE therapy Methadone Cmax ↓ 0.58 (0.50 - 0.67) should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly.
odmerkov hormonskih kontraceptivov (za peroralno jemanje ali druge načine uporabe) v kombinaciji z VIRAMUNOM, razen DMPA, nista raziskani.
HERBAL PRODUCTS
Bolnike na metadonu, pri katerih
John's Wort
odmerki ZELIŠČNI PRIPRAVKI
John's Wort (Hypericum perforatum).
Cmin metadona ND Cmax metadona ↓ 0, 58 (0, 50- 0, 67)
This is due to induction of drug metabolism enzymes and/ or transport proteins by St.
uvedemo zdravljenje z VIRAMUNOM, je treba spremljati, da bi odkrili znake odtegnitve, in odmerek metadona ustrezno prilagoditi.
John’ s Wort.
Šentjanževka
John‘ s Wort and VIRAMUNE must not be co-administered (see section 4.3).
Zeliščnih pripravkov, ki vsebujejo šentjanževko, in VIRAMUNA ne smemo dajati sočasno (glejte poglavje 4. 3).
John‘ s Wort check nevirapine and if possible viral levels and stop St John‘ s Wort.
Če bolnik že jemlje šentjanževko, je treba preveriti raven nevirapina in po možnosti virusa, bolnik pa naj jo preneha jemati.
Nevirapine levels may increase on stopping St John‘ s Wort.
Raven nevirapina se lahko po ukinitvi šentjanževke poveča.
The dose of VIRAMUNE may need adjusting.
Odmerek VIRAMUNA je včasih treba prilagoditi.
John‘ s Wort.
Indukcija lahko traja najmanj dva tedna po prekinitvi jemanja šentjanževke.
Studies using human liver microsomes indicated that the formation of nevirapine hydroxylated metabolites was not affected by the presence of dapsone, rifabutin, rifampicin, and trimethoprim/ sulfamethoxazole.
Nevirapinovi presnovki: raziskave, v katerih so uporabili človeške jetrne mikrosome, so pokazale, da na nastajanje nevirapinovih hidroksiliranih presnovkov ne vplivajo dapson, rifabutin, rifampicin in kombinacija trimetoprima in sulfametoksazola.
13 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
Currently available data on pregnant women indicate no malformative or foeto/ neonatal toxicity.
12 Razpoložljivi podatki pri nosečnicah ne kažejo na anomalije ali okvare pri zarodku oziroma novorojenčku zaradi toksičnosti.
No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3).
V raziskavah o vplivu na razmnoževanje, ki so jih izvajali pri brejih podganah in kuncih, niso odkrili zaznavne teratogenosti (glejte poglavje 5. 3).
Caution should be exercised when prescribing VIRAMUNE to pregnant women (see section 4.4).
Nosečnicam moramo VIRAMUNE predpisovati previdno (glejte poglavje 4. 4).
As hepatotoxicity is more frequent in women with CD4 cell counts above 250 cells/ mm3, these conditions should be taken in consideration on therapeutic decision (see section 4.4).
Ker je hepatotoksičnost pogostejša pri ženskah s številom celic CD4 nad 250 celic/ mm3, je treba ta stanja pri odločitvi o zdravljenju upoštevati (glejte poglavje 4. 4).
Women of childbearing potential should not use oral contraceptives as the sole method for birth control, since nevirapine might lower the plasma concentrations of these medications (see sections 4.4 & 4.5).
Ženske v rodni dobi ne smejo uporabljati peroralnih kontraceptivov za preprečevanje zanositve kot edino metodo kontracepcije, ker lahko nevirapin zmanjša njihovo koncentracijo v plazmi (glejte poglavji 4. 4 in 4. 5).
Nevirapine readily crosses the placenta and is found in breast milk.
Vsebuje ga materino mleko.
It is recommended that HIV-infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV and that mothers should discontinue breast-feeding if they are receiving VIRAMUNE.
Priporočamo, naj s HIV okužene matere ne dojijo dojenčkov, da bi se izognili tveganju poporodnega prenosa HIV, in naj prenehajo dojiti, če prejemajo VIRAMUNE.
No studies on the effects on the ability to drive and use machines have been performed.
Raziskav o vplivu na sposobnost upravljanja vozil in strojev niso izvajali.
The most frequently reported adverse reactions related to VIRAMUNE therapy, across all clinical trials, were rash, allergic reactions, hepatitis, abnormal liver function tests, nausea, vomiting, diarrhoea, abdominal pain, fatigue, fever, headache and myalgia.
Neželene reakcije o katerih so najpogosteje poročali v povezavi z zdravljenjem z VIRAMUNOM, so bili v vseh kliničnih raziskavah izpuščaj, alergijske reakcije, hepatitis, nenormalni jetrni izvidi, slabost, bruhanje, driska, trebušna bolečina, utrujenost, vročina, glavobol in mialgija.
The postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome and toxic epidermal necrolysis and serious hepatitis/ hepatic failure and hypersensitivity reactions, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Izkušnje po pridobitvi dovoljenja za promet kažejo, da so najresnejši neželeni učinki Stevens- Johnsonov sindrom in toksična epidermalna nekroliza ter hude oblike hepatitisa oz. jetrna odpoved in preobčutljivostne reakcije, za katere sta značilna izpuščaj s splošnimi simptomi, kot so vročina, artralgija, mialgija in limfadenopatija, in prizadetost visceralnih organov, ki se kaže kot hepatitis, eozinofilija, granulocitopenija in motnje ledvične funkcije.
The first 18 weeks of treatment is a critical period which requires close monitoring (see section 4.4).
Prvih 18 tednov je kritično obdobje, v katerem moramo bolnika skrbno spremljati (glejte poglavje 4. 4).
The following adverse reactions which may be causally related to the administration of VIRAMUNE have been reported.
Poročila navajajo naslednje neželene reakcije, ki so lahko vzročno povezani z dajanjem VIRAMUNA.
The frequencies estimated are based on pooled clinical trial data for events considered related to VIRAMUNE treatment.
Ocena pogostnosti temelji na zbirnih podatkih iz kliničnih raziskav o dogodkih, za katere so menili, da so povezani z VIRAMUNOM.
Frequency is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Razdelitev po pogostnosti: zelo pogosti (> 1/ 10); pogosti (> 1/ 100, < 1/ 10); občasni (> 1/ 1. 000, < 1/ 100); redki (> 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Investigations Common
Preiskave pogosti
liver function tests abnormal
nenormalni izvidi jetrnih preiskav
Blood and lymphatic system disorders Common Uncommon
Bolezni krvi in limfatičnega sistema pogosti občasni
granulocytopenia* anaemia
granulocitopenija * anemija
* In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3%) than patients on nevirapine (2.5%).
* V raziskavi 1100. 1090, iz katere so podatki za večino tovrstnih neželenih dogodkov (n = 28), je bila pri bolnikih, ki so prejemali placebo, pogostnost granulocitopenije večja (3, 3%) kot pri bolnikih, ki so prejemali nevirapin (2, 5%).
14 Nervous system disorders Common
Bolezni živčevja pogosti
Gastrointestinal Common
13 Bolezni prebavil pogosti
disorders vomiting, diarrhoea, abdominal pain, nausea
bruhanje, driska, trebušna bolečina, slabost
Skin and subcutaneous tissue disorders Very common Uncommon oedema, urticaria
Bolezni kože in podkožja zelo pogosti občasni
rash (13.6%) Stevens Johnson Syndrome/ toxic epidermal necrolysis (0.1%), angioneurotic
izpuščaj (13, 6%) Stevens- Johnsonov sindrom/ toksična epidermalna nekroliza (0, 1%), angionevrotični edem, urtikarija
Musculoskeletal and connective tissue disorders Common Uncommon
Bolezni kosti, Pogosti občasni
myalgia arthralgia
sklepov, mišic in vezivnega tkiva mialgija artralgija
fever, fatigue
vročina, utrujenost
Immune system disorders Common Not known
Bolezni imunskega sistema pogosti neznana
hypersensitivity drug rash with eosinophilia and systemic symptoms, anaphylaxis
preobčutljivost medikamentni izpuščaj z eozinofilijo in sistemskimi simptomi, anafilaksija
Hepatobiliary disorders Common Uncommon Rare
Bolezni jeter, žolčnika in žolčevodov pogosti občasni redki
hepatitis (1.4%) jaundice hepatitis fulminant
hepatitis (1, 4%) zlatenica fulminantni hepatitis
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients including the loss of peripheral and facial subcutaneous fat, increased intra- abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Kombinirano protivirusno zdravljenje povezujejo pri s HIV okuženih bolnikih s prerazporeditvijo telesnega maščevja (lipodistrofijo), pri kateri se zmanjša količina perifernega in obraznega podkožnega maščevja, poveča količina maščevja v trebušni votlini in visceralnega maščevja ter se pojavita hipertrofija prsi in dorzocervikalno kopičenje maščevja (bivolja grba).
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Kombinirano protivirusno zdravljenje povezujejo s presnovnimi motnjami, kot so hipertrigliceridemija, hiperholesterolemija, odpornost proti insulinu, hiperglikemija in hiperlaktatemija (glejte poglavje 4. 4).
The following events have also been reported when VIRAMUNE has been used in combination with other anti-retroviral agents: pancreatitis, peripheral neuropathy and thrombocytopaenia.
Med dajanjem VIRAMUNA v kombinaciji z drugimi protiretrovirusnimi zdravili so poročali o naslednjih dogodkih: pankreatitisu, periferni nevropatiji in trombocitopeniji.
These events are commonly associated with other antiretroviral agents and may be expected to occur when VIRAMUNE is used in combination with other agents; however it is unlikely that these events are due to VIRAMUNE treatment.
Verjetno pa takšni dogodki niso posledica zdravljenja z VIRANUNOM.
Hepatic-renal failure syndromes have been reported rarely.
Redko so poročali o sindromu jetrno- ledvične odpovedi.
The most common clinical toxicity of VIRAMUNE is rash, with VIRAMUNE attributable rash occurring in 13.6% of patients in combination regimens in controlled studies.
Najpogostnejši klinični toksični učinek VIRAMUNA je izpuščaj.
Rashes are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or
V nadzorovanih raziskavah s kombiniranim načinom zdravljenja se je pojavil pri 13, 6% bolnikov.
15 without pruritus, located on the trunk, face and extremities.
Izpuščaj je običajno blag do zmerno hud, v obliki makulopapularnih eritemskih kožnih erupcij, s srbežem ali brez njega, ki se pojavi na trupu, obrazu in okončinah.
Allergic reactions (anaphylaxis, angioedema and urticaria) have been reported.
Poročajo o alergijskih reakcijah (anafilaksiji, angioedemu in urtikariji).
Rashes occur alone or in the context of hypersensitivity reactions, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lympadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Izpuščaj se pojavi sam ali v sklopu preobčutljivostnih reakcij, kjer ga značilno spremljajo splošni simptomi, kot so vročina, artralgija, mialgija in limfadenopatija, ter
Severe and life-threatening skin reactions have occurred in patients treated with VIRAMUNE, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
14 prizadetost visceralnih organov, npr. hepatitis, eozinofilija, granulocitopenija in motnje ledvične funkcije.
Fatal cases of SJS, TEN and hypersensitivity reactions have been reported.
Pri bolnikih, ki so se zdravili z VIRAMUNOM, so se pojavile hude in življenjsko nevarne kožne reakcije, tudi Stevens- Johnsonov sindrom in toksična epidermalna nekroliza.
The majority of severe rashes occurred within the first 6 weeks of treatment and some required hospitalisation, with one patient requiring surgical intervention (see section 4.4).
Huda oblika izpuščaja se je večinoma pojavila v prvih 6 tednih zdravljenja in jo je bilo včasih treba zdraviti v bolnišnici, en bolnik pa je potreboval kirurški poseg (glejte poglavje 4. 4).
Cases of hepatitis (severe and life-threatening hepatoxicity, including fatal fulminant hepatitis) have been reported in patients treated with VIRAMUNE.
Pri bolnikih, ki so prejemali VIRAMUNE, poročajo o primerih hepatitisa (hude in življenjsko nevarne toksičnosti za jetra, tudi fulminantnega hepatitisa s smrtnim izidom).
The first 18 weeks of treatment is a critical period which requires close monitoring (see section 4.4).
Prvih 18 tednov zdravljenja je kritično obdobje, v katerem moramo bolnika skrbno opazovati (glejte poglavje 4. 4).
Paediatric population
Otroci
Based on clinical trial experience of 361 paediatric patients the majority of which received combination treatment with ZDV or/ and ddI, the most frequently reported adverse events related to VIRAMUNE were similar to those observed in adults.
Na podlagi izkušenj iz kliničnih preskušanj, v katera je bilo vključenih 361 otrok,, od katerih je večina prejemala kombinirano zdravljenje z ZDV ali/ in ddI, so bili najpogostnejši z VIRAMUNOM povezani neželeni dogodki podobni kot pri odraslih.
In an open-label clinical trial (ACTG 180) granulocytopenia assessed as drug- related occurred in 5/ 37 (13.5%) of patients.
V odprtem kliničnem preskušanju (ACTG 180), se je granulocitopenija, ki je bila po oceni raziskovalcev povezana z zdravilom, pojavila pri 5/ 37 (13, 5%) bolnikov.
In ACTG 245, a double-blind placebo controlled study, the frequency of serious drug-related granulocytopenia was 5/ 305 (1.6%).
V dvojno slepi s placebom nadzorovani raziskavi ACTG 245 so resno, z zdravilom povezano, granulocitopenijo zasledili pri 5 od 305 bolnikov (1, 6%).
Isolated cases of Stevens- Johnson syndrome or Stevens-Johnson/ toxic epidermal necrolysis transition syndrome have been reported in this population.
Pri tej populaciji so poročali o posamičnih primerih Stevens- Johnsonovega sindroma ali sindroma prehoda Stevens- Johnsonovega sindroma v toksično epidermalno nekrolizo.
There is no known antidote for VIRAMUNE overdosage.
Za prevelik odmerek VIRAMUNA ni znanega antidota.
Cases of VIRAMUNE overdose at doses ranging from 800 to 6000 mg per day for up to 15 days have been reported.
Poročajo o dajanju prevelikih odmerkov VIRAMUNA v razponu od 800 do 6000 mg na dan do 15 dni.
All of these effects subsided following discontinuation of VIRAMUNE.
Vsi našteti učinki so po ukinitvi VIRAMUNA minili.
Pharmacotherapeutic group:
5. 1 Farmakodinamične lastnosti
NNRTI (non-nucleoside reverse transcriptase inhibitors), ATC code J05AG01.
NNRTI (nenukleozidni zaviralci reverzne transkriptaze), oznaka ATC J05AG01.
Mechanism of Action Nevirapine is a NNRTI of HIV-1.
Mehanizem delovanja Nevirapin je nenukleozidni zaviralec reverzne transkriptaze HIV- 1.
Nevirapine binds directly to reverse transcriptase and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site.
Veže se direktno na reverzno transkriptazo in blokira od RNA in DNA odvisne učinke DNA- polimeraze, tako da razgradi katalitičo mesto encima.
The activity of nevirapine does not compete with template or nucleoside triphosphates.
Aktivnost nevirapina ni kompetitivna z matričnimi ali nukleozidnimi trifosfati.
HIV-2 reverse transcriptase and eukaryotic DNA polymerases (such as human DNA polymerases α, β, γ, or δ) are not inhibited by nevirapine.
Nevirapin ne zavira reverzne trankriptaze HIV- 2 in evkariotskih DNA- polimeraz (kot so človeške DNA- polimeraze α, β, γ in δ).
16 In vitro HIV susceptibility:
Občutljivost HIV in vitro
The in vitro antiviral activity of nevirapine has been measured in a variety of cell lines including peripheral blood mononuclear cells, monocyte derived macrophages, and lymphoblastoid cell lines.
V novejših
In recent studies using human cord blood lymphocytes and human embryonic kidney 293 cells, EC50 values (50% inhibitory concentration) ranged from 14-302 nM against laboratory and clinical isolates of HIV-1.
15 študijah, v katerih so uporabili človeške limfocite iz popkovnične krvi in človeške embrionalne ledvične celice 293, so bile vrednosti EC50 (ob 50% zaviralni koncentraciji) 14 do 302 nM pri laboratorijskih in kliničnih izolatih HIV- 1.