natgillin/translations-raw huggingface dataset:
Prednisone should not be used to treat a rash related to Nevirapine Teva.
Prednizon se ne smije primjenjivati u liječenju osipa povezanog s Nevirapinom Teva.
If a dose is missed and it is more than 8 hours later, the patient should only take the next dose at the usual time.
Ako je doza propuštena, a prošlo više od 8 sati, treba uzeti sljedeću dozu u uobičajeno vrijeme.
Non-clinical data reveal no special hazard for humans other than those observed in clinical studies based on conventional studies of safety, pharmacology, repeated dose toxicity, and genotoxicity.
Neklinički podaci temeljeni na konvencionalnim ispitivanjima sigurnosti, farmakologije, toksičnosti ponovljenih doza i genotoksičnosti nisu ukazali na posebne opasnosti za ljude osim onih opaženih u kliničkim ispitivanjima.
If co-administered with Nevirapine Teva, an adjustment in the telaprevir dose should be considered.
Ako se uzima istodobno s Nevirapinom Teva, potrebno je razmotriti prilagodbu doze telaprevira.
The following adverse reactions which may be causally related to the administration of nevirapine have been reported.
Prijavljeno je da sljedeće nuspojave mogu biti uzročno povezane s primjenom nevirapinom.
No drug-drug interaction study of telaprevir with nevirapine has been conducted, however, interaction studies of telaprevir with an NNRTI with a similar metabolic pathway as nevirapine demonstrated reduced levels of both.
Međutim, ispitivanja interakcija telaprevira s NNRTI-om sa sličnim metaboličkim putem nevirapinu su pokazala smanjene vrijednosti koncentracije oba lijeka.
As serious and life threatening hepatotoxicity has been observed in controlled and uncontrolled studies predominantly in patients with a plasma HIV-1 viral load of 50 copies/ml or higher, nevirapine should not be initiated in adult females with CD4 cell counts greater than 250 cells/mm3 or in adult males with CD4 cell counts greater than 400 cells/mm3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
S obzirom na slučajeve teške i po život opasne hepatotoksičnosti opažene u kontroliranim i nekontroliranim studijama, uglavnom u bolesnika s HIV-1 virusnim opterećenjem u plazmi od 50 kopija/ml ili više, primjena nevirapina ne smije se početi u odraslih žena s brojem CD4 većim od 250 stanica/mm3 ili u odraslih muškaraca s brojem CD4 stanica većim od 400 stanica/mm3 koji imaju detektibilan HIV 1-RNK u plazmi,
Female gender and higher CD4 counts at the initiation of nevirapine therapy in treatment-naïve patients is associated with increased risk of hepatic adverse reactions.
Žene i povišen broj CD4 na početku terapije nevirapinom, prethodno neliječenih, povezan je s povećanim rizikom nastanka jetrenih nuspojava.
Nevirapine Cmin ↑ 1.28
Nevirapin Cmin ↑ 1,28
Data concerning the pharmacokinetics of nevirapine have been derived from two major sources: a 48 week paediatric study in South Africa (BI 1100.1368) involving 123 HIV-1 positive, antiretroviral naïve patients aged 3 months to 16 years; and a consolidated analysis of five Paediatric AIDS Clinical Trials Group (PACTG) protocols comprising 495 patients aged 14 days to 19 years.
Južnoj Africi (BI 1100.1368) u koje je bilo uključeno 123 HIV-1-pozitivna, antiretrovirusno prethodno neliječena bolesnika u dobi od 3 mjeseca do 16 godina; i skupna analiza pet studija iz programa pedijatrijskih kliničkih ispitivanja AIDS-a (PACTG), uključujući protokole 495 bolesnika u dobi od
Blood and lymphatic system disorders Common granulocytopenia Uncommon anaemia
Poremećaji krvi i limfnog sustava Često granulocitopenija
Nevirapine Cmin ↑ 1.07
Nevirapin Cmin ↑ 1,07
The concomitant administration of Nevirapine Teva with NNRTIs is not recommended (see section
Istodobna primjena Nevirapina Teva s NNRTI-ima se ne preporučuje
Nevirapine should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
Nevirapin se ne smije primjenjivati u bolesnika s teškim oštećenjem jetre (Child-Pugh C, vidjeti dio 4.3.).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Nevirapine Teva.
Ako Vam je liječnik rekao da ne podnosite neke šećere, javite se liječniku prije početka primjene
Because of the risk of increased exposure to Nevirapine Teva, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely.
Nevirapinu Teva, nužan je oprez ako se lijekovi primjenjuju istodobno, a bolesnici se moraju pomno pratiti.
Maraviroc Cmin ND Maraviroc Cmax ↔ 1.54 (0.94-2.52) compared to historical controls
Maravirok AUC ↔ 1,01 (0,6 -1,55) Maravirok Cmin NO Maravirok Cmax ↔ 1,54 (0,94-2,52) u usporedbi s povijesnom kontrolom
In the multinational 2NN study, a population pharmacokinetic substudy of 1,077 patients was performed that included 391 females.
Podaci za 1077 bolesnika (391 žena) uključenih u multinacionalnu studiju 2NN iskorišteni su za populacijsku farmakokinetsku analizu.
Dosing of nevirapine at 150 mg/m2 BID (after a two-week lead in at 150 mg/m2 QD) produced geometric mean or mean trough nevirapine concentrations between 4-6 μg/ml (as targeted from adult data).
Doziranje 150 mg/m2 dvaput dnevno (nakon uvodna dva tjedna s dozom od 150 mg/m2 jednom dnevno) omogućilo je prosječne koncentracije na kraju dozirnog intervala u rasponu od 4 do 6 µg/ml
No significant effect on rifabutin and nevirapine mean PK parameters is seen.
Bez značajnog učinka na rifabutin i srednje vrijednosti PK parametara nevirapina.
Nevirapine Teva 200 mg tablets
Nevirapin Teva 200 mg tablete
Furthermore, in the case nevirapine is used as single dose to prevent vertical transmission of HIV-1 infection, the risk of hepatotoxicity in mother and child cannot be excluded.
Nadalje, u slučaju kada se nevirapin primjenjuje kao jednokratna doza radi prevencije vertikalnog prijenosa infekcije HIV-om 1,
Nevirapine Teva 200 mg tablets nevirapine
Nevirapin Teva 200 mg tablete nevirapin
You must take the dose of Nevirapine Teva as prescribed by your doctor.
Nevirapin Teva uzimajte u dozama koje je propisao liječnik.
Clarithromycin 500 mg BID
Klaritromicin 500 mg 2x/dan
Significantly fewer patients in the abacavir group (9 patients, or 6%) than in the nevirapine group (26 patients, or 17%) or the efavirenz group (27 patients, or 17%) discontinued the medicinal product because of adverse events.
(26 bolesnika ili 17%) ili skupini na efavirenzu (27 bolesnika ili 17%) prekinulo je uzimanje lijeka zbog nuspojava (vidjeti donju tablicu).
Nevirapine must not be administered to patients with pretreatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN (see section
Nevirapin se ne smije primjenjivati na bolesnicima koji imaju AST ili ALT >5 x GGN prije početka liječenja sve dok se vrijednosti AST/ALT ne stabiliziraju na razini <
How to store Nevirapine Teva
Kako čuvati Nevirapin Teva
No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3).
Reproduktivna ispitivanja na gravidnim ženkama štakora i kunića nisu ukazala na teratogeni potencijal (vidi dio 5.3.).
It is not recommended to coadminister fosamprenavir and Nevirapine Teva if fosamprenavir is not co-administered with ritonavir (see section 4.4).
Ne preporučuje se istodobna primjena fosamprenavira i Nevirapina Teva, ako se fosamprenavir ne primjenjuje u kombinaciji istodobno s ritonavirom (vidjeti dio 4.4).
However, patients should be advised that they may experience adverse reactions such as fatigue during treatment with Nevirapine Teva.
Međutim, bolesnike treba upozoriti da tijekom liječenja Nevirapinom Teva mogu dobiti nuspojave, kao što je umor.
Nevirapine must be permanently discontinued in any patient experiencing hypersensitivity reaction (characterised by rash with constitutional symptoms, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction), see section 4.4.
Primjena nevirapina se mora trajno prekinuti u svakog bolesnika kod kojeg se pojavi reakcija preosjetljivosti (karakterizirana osipom s općim simptomima, uz visceralne poremećaje, kao što su hepatitis, eozinofilija, granulocitopenija i disfunkcija bubrega),
Recommendations concerning co-administration
Preporuke s obzirom na istodobnu primjenu
Nevirapine exhibited additive to synergistic anti-HIV-1 activity in combination with the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, saquinavir and tipranavir, and the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir and zidovudine.
amprenavirom, atazanavirom, indinavirom, lopinavirom, sakvinavirom i tipranavirom te s NRTI-ima, abakavirom, didanozinom, emtricitabinom, lamivudinom, stavudinom, tenofovirom i zidovudinom rezultiraju aditivnim do sinergističkom antivirusnom aktivnošću.
Didanosine 100-150 mg BID
Didanozin 100-150 mg 2x/dan
For children under 16 years of age who weigh less than 50 kg or whose body surface area is below 1.25 m2 other nevirapine containing oral formulations are available and should be used if appropriate.
Za bolesnike koji ne mogu progutati tabletu ili koji imaju tjelesnu masu manju od 50 kg ili čija je površina tijela ispod 1.25 m2 prema Mosteller formuli, trebali bi uzeti neke druge dostupne oralne oblike koji sadrže djelatnu tvar nevirapin.
Entecavir is not a substrate, inducer or an inhibitor of cytochrome P450 (CYP450) enzymes.
Entekavir nije supstrat, induktor ili inhibitor enzima citokroma P450
The NEFA study is a controlled prospective randomised study which evaluated treatment options for patients who switch from protease inhibitor (PI) based regimen with undetectable load to either nevirapine, efavirenz or abacavir.
NEFA je prospektivno, randomizirano kontrolirano ispitivanje koje je uspoređivalo opcije liječenja za bolesnike koji su s prethodnog liječenja inhibitorima proteaza prebačeni na nevirapin, efavirenz ili abakavir, a pri tome su imali nedetektabilno opterećenje virusa u plazmi.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, povidone K25, sodium starch glycolate (Type A), colloidal silicon dioxide and magnesium stearate.
Pomoćne tvari celuloza, mikrokristalična laktoza (u obliku hidrata) povidon K25 natrijev škroboglikolat (vrste A) silicijev dioksid, koloidni magnezijev stearat
ANTIFUNGALS
ANTIFUNGICI
If it has been more than 8 hours since the dose was due only take the next dose at the usual time.
Ako primijetite nakon više od 8 sati kad ste trebali uzeti dozu, uzmite sljedeću dozu u uobičajeno vrijeme.
Female gender and higher CD4 counts (>250/mm in adult females and >400/mm in adult males) at the initiation of nevirapine therapy are associated with a greater risk of hepatic adverse reactions if the patient has detectable plasma HIV-1 RNA - i.e. a concentration ≥ 50 copies/ml - at the initiation of nevirapine.
250/mm3 u odraslih žena i >400/mm3 u odraslih muškaraca) imaju na početku terapije nevirapinom i povišeni rizik jetrenih reakcija ako pri tome bolesnici imaju HIV-1 RNK u plazmi
ANTITHROMBOTICS
ANTITROMBOTICI
Atazanavir/r Cmin ↓ 0.28 (0.20-0.40) Atazanavir/r Cmax ↓ 0.72 (0.60-0.86)
Atazanavir/r AUC ↓ 0,58 (0,48-0,71) Atazanavir/r Cmin ↓ 0,28 (0,20-0,40) Atazanavir/r Cmax ↓ 0,72 (0,60-0,86)
Clarithromycin Cmin ↓ 0.44 (0.30Clarithromycin Cmax ↓ 0.77 (0.69
Klaritromicin AUC ↓ 0,69 (0,62-0,76) Klaritromicin Cmin ↓ 0,44 (0,30-0,64) Klaritromicin Cmax ↓ 0,77 (0,69-0,86)
Rifabutin Cmin ↔ 1.07 (0.84-1.37) Rifabutin Cmax ↑ 1.28 (1.09-1.51)
Rifabutin AUC ↑ 1,17 (0,98-1,40) Rifabutin Cmin ↔ 1,07 (0,84-1,37) Rifabutin Cmax ↑ 1,28 (1,09-1,51)
Ketoconazole 400 mg QD
Ketokonazol 400 mg 1x/dan
Zidovudine AUC ↓ 0.72 (0.60-0.96)
Zidovudin AUC ↓ 0,72 (0,60-0,96)
Very common (may affect more than 1 in 10 people): - rash
Manje često (mogu se javiti do 1 od 100 osoba):
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Metabolički parametri Tijekom antiretrovirusne terapije mogu se povećati tjelesna težina i razine lipida i glukoze u krvi
If you develop severe liver, skin or hypersensitivity reactions whilst taking Nevirapine Teva, NEVER TAKE Nevirapine Teva again without referring to your doctor.
Ako razvijete teške jetrene, kožne ili reakcije preosjetljivosti dok uzimate Nevirapin Teva,
Darunavir Cmin ↔ 1.02 (0.79-1.32) Darunavir Cmax ↑ 1.40 (1.14-1.73)
Darunavir AUC ↑ 1,24 (0,97-1,57) Darunavir Cmin ↔ 1,02 (0,79-1,32) Darunavir Cmax ↑ 1,40 (1,14-1,73)
Rifampicin 600 mg QD
Rifampicin 600 mg 1x/dan
Ritonavir Cmin ↔ 0.93 (0.76-1.14) Ritonavir Cmax ↔ 0.93 (0.78-1.07)
Ritonavir AUC↔ 0,92 (0,79-1,07) Ritonavir Cmin ↔ 0,93 (0,76-1,14) Ritonavir Cmax ↔ 0,93 (0,78-1,07)
You should continue to take Nevirapine Teva for as long as instructed by your doctor.
Nevirapine Teva potrebno je uzimati onoliko dugo koliko Vam je rekao liječnik.
EE AUC ↓ 0.80 (0.67 - 0.97)
EE AUC ↓ 0,80 (0,67 - 0,97) EE Cmin NO
Methadone-maintained patients beginning Nevirapine Teva therapy should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly.
Nevirapinom Teva treba pratiti radi znakova apstinencije te sukladno tome prilagoditi dozu metadona.
Efavirenz Cmin ↓ 0.68 (0.65-0.81) Efavirenz Cmax ↓ 0.88 (0.77-1.01)
Efavirenz AUC ↓ 0,72 (0,66-0,86) Efavirenz Cmin ↓ 0,68 (0,65-0,81) Efavirenz Cmax ↓ 0,88 (0,77-1,01)
As hepatotoxicity is more frequent in women with CD4 cell counts above 250 cells/mm3 with detectable HIV-1 RNA in plasma (50 or more copies/ml),
S obzirom da je hepatotoksičnost češća u žena s brojem CD4 stanica iznad 250 stanica/mm3 s detektabilnim HIV-1 RNK u plazmi (50 ili više kopija/mL), ova stanja moraju biti uzeta u obzir prilikom odluke o terapiji (vidjeti dio 4.4.).
or anaphylactic shock - decreased numbers of red blood cells (anaemia) - yellow skin (jaundice) - severe and life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis) - hives (urticaria) - fluid under the skin (angioedema) - joint pain (arthralgia) - muscle pain (myalgia) - decreased blood phosphorus - increased blood pressure
- smanjenjenje broja crvenih krvnih stanica (anemija) - žuta koža (žutica) - teški i po život opasni osipi kože (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza)
Amprenavir Cmin ↓ 0.65 (0.49-0.85) Amprenavir Cmax ↓ 0.75 (0.63-0.89)
Amprenavir AUC ↓ 0,67 (0,55-0,80) Amprenavir Cmin ↓ 0,65 (0,49-0,85) Amprenavir Cmax ↓ 0,75 (0,63-0,89)
It is not recommended to coadminister ketoconazole and Nevirapine Teva (see section 4.4).
Ne preporučuje se istodobna primjena ketokonazola i Nevirapina Teva (vidjeti dio 4.4.).
Itraconazole Cmin ↓ 0.13 Itraconazole Cmax ↓ 0.62
Itrakonazol AUC ↓ 0,39 Itrakonazol Cmin ↓ 0,13
Read the package leaflet before use.
NAČIN I PUT(EVI) PRIMJENE Prije uporabe pročitajte Uputu o lijeku.
In ACTG 245, a double-blind placebo controlled study, the frequency of serious medicinal product-related granulocytopenia was 5/305 (1.6 %).
učestalost teške granulocitopenije povezane s lijekom bila je 5/305 (1,6%).
It is not recommended to coadminister boceprevir and Nevirapine Teva (see section 4.4).
Ne preporučuje se istodobna primjena boceprevira i Nevirapina Teva (vidjeti dio 4.4).
TEVA UK Ltd Brampton Road, Hampden Park,
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Velika Britanija
In a retrospective review of predominantly patients with a plasma HIV-1 viral load of 50 copies/ml or higher, women with CD4 counts > 250 cells/mm3 had a 12 fold higher risk of symptomatic hepatic adverse reactions compared to women with CD4 counts < 250 cells/mm3 (11.0 %
U retrospektivnom pregledu uglavnom bolesnika s HIV-1 virusnim opterećenjem od 50 kopija/ml ili više u plazmi, žene s brojem CD4 >250 stanica/mm3
Each tablet contains 200 mg nevirapine (as nevirapine anhydrate).
Svaka tableta sadrži 200 mg nevirapina (u bezvodnom obliku).
NET AUC ↓ 0.81 (0.70 - 0.93)
NET AUC ↓ 0,81 (0,70 - 0,93) NET Cmin NO
NNRTIs Efavirenz 600 mg QD
NNRTI-i Efavirenz 600 mg 1x/dan
Zidovudine Cmin ND Zidovudine Cmax ↓ 0.70 (0.49-1.04)
100-200 mg 3x/dan Zidovudin Cmin NO Zidovudin Cmax ↓ 0,70 (0,49-1,04)
In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
U slučaju istodobne antivirusne terapije za hepatitis B ili C,
Nevirapine AUC ↑ 1.20
Nevirapin AUC ↑ 1,26
In a mass balance/excretion study in eight healthy male volunteers dosed to steady state with nevirapine 200 mg given twice daily followed by a single 50 mg dose of 14C-nevirapine, approximately 91.4 ± 10.5 % of the radiolabelled dose was recovered, with urine (81.3 ± 11.1 %) representing the primary route of excretion compared to faeces (10.1 ± 1.5%).
U studiji na osam zdravih muških dobrovoljaca koji su primali nevirapin 200 mg dvaput dnevno do stanja dinamičke ravnoteže, a zatim su primili jednokratnu dozu od 50 mg 14C-nevirapina, povrat radioaktivnosti iznosio je otprilike
Hepatic impairment
- anafilaktičkog šoka
Adefovir did not influence any of the common CYP isoforms known to be involved in human drug metabolism and is excreted renally.
CYP izoformi za koje se zna da su uključene u metabolizam lijeka u ljudi te se izlučuje renalnim putem.
Amprenavir Cmin ↓ 0.81 (0.69-0.96) Amprenavir Cmax ↔ 0.97 (0.85-1.10)
Amprenavir AUC ↔ 0,89 (0,77-1,03) Amprenavir Cmin ↓ 0,81 (0,69-0,96) Amprenavir Cmax ↔ 0,97 (0,85-1,10)
Uncommon Stevens-Johnson syndrome/toxic epidermal necrolysis (which may be fatal)
Manje često Stevens-Johnsonov sindrom/toksična epidermalna nekroliza (koji mogu biti fatalni) (0,2%), angioedem, urtikarija
Microcrystalline cellulose Lactose (as monohydrate) Povidone K25
- Pomoćne tvari su mikrokristalična celuloza, laktoza ( u obliku hidrata), povidon
There is not enough evidence to substantiate that the absence of an increased risk for toxicity seen in pretreated women initiating nevirapine with an undetectable viral load (less than 50 copies/ml of HIV-1 in plasma) and CD4 cell counts above 250 cells/mm3 also applies to pregnant women.
Nema dovoljno dokaza za zaključak da je odsutnost povećanog rizika toksičnosti viđen u prethodno liječenih žena na početku primjene nevirapina, s nedektabilnim virusnim opterećenjem (manje od 50 kopija
Rashes occur alone or in the context of drug reaction with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lympadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Osip se pojavljuje samostalno ili u sklopu reakcije na lijek uz eozinofiliju i sistemske simptome, poput, vrućice, artralgije, mijalgije i limpadenopatije, te visceralne poremećaje,
It is not recommended to coadminister atazanavir/ritonavir and Nevirapine Teva (see section
Ne preporučuje se istodobna primjena atazanavir/ritonavira i Nevirapina Teva (vidjeti dio 4.4).
Very common rash (12.5 %)
Poremećaji kože i potkožnog tkiva Vrlo često osip (12,5%)
Common (may affect up to 1 in 10 people): - decreased numbers of white blood cells (granulocytopenia) - allergic reactions (hypersensitivity) - headache - feeling sick (nausea) - vomiting - abdominal pain - loose stools (diarrhoea) - inflammation of the liver (hepatitis) - feeling tired (fatigue) - fever - abnormal liver function tests
Često (mogu se javiti do 1 od 10 osoba): - smanjenje broja bijelih krvnih stanica (granulocitopenija) - alergijske reakcije (preosjetljivost) - glavobolja
Fluconazole 200 mg QD
Flukonazol 200 mg 1x/dan
Lopinavir Cmin ↓ 0.45 (0.25-0.82) Lopinavir Cmax ↓ 0.86 (0.64-1.16)
Lopinavir AUC ↓ 0,78 (0,56-1,09) Lopinavir Cmin ↓ 0,45 (0,25-0,82) Lopinavir Cmax ↓ 0,86 (0,64-1,16)
Sodium starch glycolate (Type A) Colloidal silicon dioxide Magnesium stearate
K25, natrijev škroboglikolat (Vrste A), koloidni silicijev dioksid i magnezijev stearat.
Monotherapy with nevirapine has been associated with the development of NNRTI resistance.
Teva je povezana s razvojem rezistencije na NNRTI.
If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash) accompanied by other side effects such as - fever, - blistering, - mouth sores, - inflammation of the eye, - swelling of the face, - general swelling, - shortness of breath, - muscle or joint pain, - general feelings of illness, - or abdominal pain
Ako dobijete teški osip ili preosjetljivost (alergijske reakcije koje se mogu pojaviti u obliku osipa) popraćene drugim nuspojavama kao što su - vrućica, - pojava mjehurića,
Nevirapine Cmax ↑ 1.20
Nevirapin AUC ↑ 1,20 Nevirapin Cmax ↑ 1,20
Nevirapine Cmin ↑ 1.34 (1.21-1.49) Nevirapine Cmax ↑ 1.25 (1.14-1.37)
Nevirapin AUC ↑ 1,29 (1,19-1,40) Nevirapin Cmin ↑ 1,34 (1,21-1,49) Nevirapin Cmax ↑ 1,25 (1,14-1,37)
Rifampicin Cmin ND Rifampicin Cmax ↔ 1.06 (0.91-1.22)
Rifampicin AUC ↔ 1,11 (0,96-1,28) Rifampicin Cmin NO Rifampicin Cmax ↔ 1,06 (0,91-1,22)
Nevirapine Cmin ↑ 1.47 (1.20-1.82) Nevirapine Cmax ↑ 1.18 (1.02-1.37)
Nevirapin AUC ↑ 1,27 (1,12-1,44) Nevirapin Cmin ↑ 1,47 (1,20-1,82) Nevirapin Cmax ↑ 1,18 (1,02-1,37)
Lopinavir Cmin ↓ 0.54 (0.28-0.74) Lopinavir Cmax ↓ 0.81 (0.62-0.95)
Lopinavir AUC ↓ 0,73 (0,53-0,98) Lopinavir Cmin ↓ 0,54 (0,28-0,74) Lopinavir Cmax ↓ 0,81 (0,62-0,95)
NRTIs
NRTI-i
Musculoskeletal and connective tissue disorders Uncommon arthralgia, myalgia
Manje često artralgija, mijalgija
Renal dysfunction: The single-dose pharmacokinetics of nevirapine has been compared in 23 patients with either mild (50 ≤ CLcr < 80 ml/min), moderate (30 ≤ CLcr < 50 ml/min) or severe renal dysfunction (CLcr < 30 ml/min), renal impairment or end-stage renal disease (ESRD) requiring dialysis, and 8 patients with normal renal function (CLcr > 80 ml/min).
CLcr, >80 ml/min) (n=8), bolesnici s blagom (50≤ CLcr <80ml/min), umjerenom (30 ≤ CLcr
Nevirapine had a median EC50 value (50% inhibitory concentration) of 63 nM against a panel of group M HIV-1 isolates from clades A, B, C, D, F, G, and H, and circulating recombinant forms (CRF), CRF01_AE, CRF02_AG and CRF12_BF replicating in human embryonic kidney 293 cells.
HIV-1 niza izolata skupine M podtipova A, B, C, D, F, G, i H te cirkulirajućih rekombinantnih oblika
Didanosine Cmin ND Didanosine Cmax ↔ 0.98 (0.79-1.21)
Didanozin AUC ↔ 1,08 (0,92-1,27) Didanozin Cmin NO Didanozin Cmax ↔ 0,98 (0,79-1,21)
Ketoconazole Cmax ↓ 0.56 (0.42
Itrakonazol Cmax ↓ 0,62
Herbal preparations containing St. John‘s Wort and Nevirapine Teva must not be co-administered (see section 4.3).
Biljni pripravci koji sadrže gospinu travu i Nevirapin Teva ne smiju se primjenjivati istodobno (vidjeti dio
Hypersensitivity (anaphylactic reaction, angioedema and urticaria) have been reported.
Prijavljeni su slučajevi preosjetljivosti (anafilaktička reakcija,
Saquinavir/ritonavir and Nevirapine Teva can be coadministered without dose adjustments.
Fosamprenavir/ritonavir i Nevirapin Teva mogu se primjenjivati istodobno bez prilagodbe doze.
- abdominal pain
- gubitak apetita
For patients who are unable to swallow tablets or who weigh less than 50 kg or whose body surface area is below 1.25 m2
- čija je površina tijela veća od 1,25 kvadratnih metara Kod djece mlađe od 16 godina, tjelesne mase manje od 50 kg ili površine tijela manje od 1,25
(women more than 250 cells/mm³, men more than 400 cells/mm³) - pre-treated patients with detectable HIV-1 plasma viral load and higher CD4 cell counts at the start of nevirapine therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)
- osobe s poremećenim rezultatima testova jetrene funkcije - bolesnici prethodno neliječeni antiretrovirusnim lijekovima, s povišenim brojem CD4 stanica na početku terapije Nevirapinom Teva (žene s više od 250 stanica/mm3, muškarci s više od 400 stanica/mm3)
Rifabutin and Nevirapine Teva can be coadministered without dose adjustments.
Rifabutin i Nevirapin Teva mogu se istodobno primjenjivati bez prilagodbe doze.
Tenofovir and Nevirapine Teva can be co-administered without dose adjustments.
Tenofovir i Nevirapin Teva mogu se istodobno primjenjivati bez prilagodbe doze.
Nevirapine Teva and emtricitabine may be co-administered without dose adjustments.
Nevirapin Teva i emtricitabin se mogu istodobno primjenjivati bez prilagodbe doze.
The opposite side is debossed with a scoreline.
Na drugoj strani tablete nalazi se samo utisnuta razdjelna crta.