FrancophonIA/ELRC3.0 huggingface dataset:
English: Whilst no dose adjustment of abacavir is necessary in patients with renal dysfunction, lamivudine and zidovudine concentrations are increased in patients with renal impairment due to decreased clearance.
Slovenian: Medtem, ko pri bolnikih z motnjami v delovanju ledvic odmerka abakavirja ni potrebno prilagajati, pa so, zaradi manjšega očistka, koncentracije lamivudina in zidovudina pri bolnikih z okvaro ledvic povečane.
English: Logistic regression modelling of the predictive value for genotype (adjusted for baseline plasma HIV-1 RNA [vRNA], CD4+ cell count, number and duration of prior antiretroviral therapies) showed that the presence of 3 or more NRTI resistance-associated mutations was associated with reduced response at Week 4 (p=0.015) or 4 or more mutations at median Week 24 (p≤0.012).
Slovenian: število CD4+ celic, število in trajanje predhodnih protiretrovirusnih zdravljenj) je pokazal, da je bila prisotnost 3 ali več mutacij, povezanih z odpornostjo proti NRTI, povezana z zmanjšanjem odziva v 4. tednu (p = 0,015), prisotnost 4 ali več mutacij pa v povprečju v 24. tednu (p ≤ 0,012).
English: Treatment with zidovudine should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Slovenian: V primeru simptomatske hiperlaktatemije in metabolične acidoze/laktacidoze, progresivne hepatomegalije ali hitrega zviševanja ravni aminotransferaz je treba zdravljenje z zidovudinom prekiniti.
English: • changes in the colour of your nails, your skin, or the skin inside your mouth
Slovenian: • spremenjena barva nohtov, kože ali ustne sluznice,
English: Separate administration of Trizivir and clarithromycin by at least 2 hours
Slovenian: Med uporabo zdravila Trizivir in uporabo klaritromicina morata miniti vsaj 2 uri.
English: To date there are insufficient data on the efficacy and safety of Trizivir given concomitantly with NNRTIs or PIs (see section 5.1).
Slovenian: Do sedaj ni dovolj podatkov o učinkovitosti in varnosti zdravila Trizivir, če se daje sočasno z nenukleozidnimi zaviralci reverzne transkriptaze (NNRTI) ali zaviralci proteaz (PI) (glejte poglavje 5.1).
English: Pharmacokinetic data has been obtained for abacavir, lamivudine and zidovudine separately.
Slovenian: Farmakokinetični podatki za abakavir, lamivudin in zidovudin so bili pridobljeni posamezno.
English: Rechallenge can result in a more rapid and severe reaction, which can be fatal, therefore rechallenge is contraindicated.
Slovenian: Ponovna uporaba ("rechallenge") lahko povzroči hitrejšo in hujšo reakcijo, ki je lahko smrtna.
English: No specific symptoms or signs have been identified following acute overdose with zidovudine or lamivudine apart from those listed as adverse reactions.
Slovenian: Po akutnem zaužitju prevelikega odmerka zidovudina ali lamivudina niso poročali o specifičnih simptomih ali znakih, razen tistih, ki so navedeni kot neželeni učinki.
English: Those reported in at least 10% of patients with a hypersensitivity reaction are in bold text.
Slovenian: % bolnikov s preobčutljivostno reakcijo, so navedeni v krepkem tisku.
English: Treatment with Trizivir often causes a loss of fat from legs, arms and face (lipoatrophy).
Slovenian: Zdravljenje z zdravilom Trizivir pogosto povzroči izginjanje maščevja na nogah, rokah in obrazu
English: The Trizivir pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity.
Slovenian: Pakiranje zdravila Trizivir vsebuje opozorilno kartico kot opozorilo o preobčutljivosti na abakavir za vas in medicinsko osebje.
English: Malignant tumours occurred in the preputial gland of males and the clitoral gland of females of both species, and in rats in the thyroid gland of males and and in the liver, urinary bladder, lymph nodes and the subcutis of females.
Slovenian: Maligni tumorji so se pri samcih obeh vrst pojavljali na prepucialnih žlezah, pri samicah obeh vrst pa na žlezah klitorisa, pri podganah so se pri samcih pojavljali na ščitnici, pri samicah pa na jetrih, sečnem mehurju, bezgavkah in v podkožju.
English: At week 48 the proportion of subjects with HIV RNA <50 copies/ml were 63 %, 80 % and 86 % for the ZDV/3TC/ABC, ZDV/3TC/EFV and ZDV/3TC/ABC/EFV arms, respectively.
Slovenian: V 48. tednu je HIV RNA < 50 kopij/ml imelo 63 % oseb, ki so prejemale ZDV/3TC/ABC, 80 % oseb, ki so prejemale ZDV/3TC/EFV in 86 % oseb, ki so prejemale ZDV/3TC/ABC/EFV.
English: Some people taking Trizivir develop other conditions, which can be serious.
Slovenian: Nekaterim uporabnikom zdravila Trizivir se pojavijo druge motnje, ki so lahko resne.
English: Although a similar antiviral effect was observed between the abacavir and indinavir containing regimens in terms of proportion of patients with undetectable viral load (≤ 400 copies/ml; intention to treat analysis (ITT), 47 % versus 49 %; as treated analysis (AT), 86 % versus 94 % for abacavir and indinavir combinations respectively), results favoured the indinavir combination, particularly in the subset of patients with high viral load (> 100,000 copies/ml at baseline; ITT, 46 % versus 55 %; AT, 84 % versus 93 % for abacavir and indinavir respectively).
Slovenian: 47 % pri kombinaciji z abakavirjem versus 49 % pri kombinaciji z indinavirjem; analiza zdravljenih bolnikov (AT): 86 % pri kombinaciji z abakavirjem versus 94 % pri kombinaciji z indinavirjem), rezultati nagibajo v korist kombinacije z indinavirjem, še zlasti v podskupini bolnikov z visoko virusno obremenitvijo (> 100.000 kopij/ml v izhodišču; ITT: 46 % pri kombinaciji z abakavirjem versus 55 % pri kombinaciji z indinavirjem; AT: 84 % pri kombinaciji z abakavirjem versus 93 % pri kombinaciji z indinavirjem).
English: • Trizivir should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavir-containing regimen.
Slovenian: • Zdravila Trizivir se nikdar ne sme uvesti bolnikom s pozitivnim HLA-B*5701 statusom; prav tako se ga ne sme uvesti bolnikom z negativnim HLA-B*5701 statusom, ki so imeli v preteklosti med uporabo sheme z abakavirjem sum na HSR na abakavir (npr. Kivexa, Ziagen, Triumeq).
English: In addition, the selection of L74V and K65R was reduced when co-administered with ZDV (K65R: without ZDV: 13/127, 10 %; with ZDV: 1/86, 1 %; L74V: without ZDV: 51/127, 40 %; with ZDV: 2/86, 2 %).
Slovenian: 13/127, 10 %; z ZDV: 1/86, 1 %; L74V: brez ZDV: 51/127, 40 %; z ZDV: 2/86, 2 %).
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: (npr. pojav Gravesove bolezni in avtoimunskega hepatitisa), toda opisani čas do začetka je bolj spremenljiv in ti dogodki se lahko pojavijo veliko mesecev po uvedbi zdravljenja (glejte poglavje 4.4).
English: Zidovudine AUC ↓48% (UGT induction)
Slovenian: zidovudin AUC ↓48% (indukcija UGT)
English: The mean (CV) AUCs for abacavir, lamivudine and zidovudine over a dosing interval of 12 hours are 6.39 µg.h/ml (31 %), 5.73 µg.h/ml (31 %) and 1.50 µg.h/ml (47 %), respectively.
Slovenian: Preko 12 urnega odmernega intervala je srednja AUC abakavirja znašala 6,39 µg.h/ml (31 %), lamivudina 5,73 µg.h/ml (31 %) in zidovudina 1,50 µg.h/ml (47 %).
English: Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products (e.g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin) may also increase the risk of adverse reactions to zidovudine (see section 4.8).
Slovenian: Tveganje neželenih učinkov zidovudina lahko poveča tudi sočasno zdravljenje, zlasti akutno zdravljenje, s potencialno nefrotoksičnimi ali mielosupresivnimi zdravili (npr. sistemskim pentamidinom, dapsonom, pirimetaminom, kotrimoksazolom, amfotericinom, flucitozinom, ganciklovirjem, interferonom, vinkristinom, vinblastinom ali doksorubicinom) (glejte poglavje 4.8).
English: Cross-resistance between abacavir, lamivudine or zidovudine and antiretrovirals from other classes e.g. PIs or NNRTIs is unlikely.
Slovenian: Navzkrižna odpornost med abakavirjem, lamivudinom ali zidovudinom in protiretrovirusnimi zdravili iz drugih skupin, npr. zaviralci proteaz (PI) ali nenukleozidni zaviralci reverzne transkriptaze (NNRTI), je malo verjetna.
English: • Trizivir must be stopped without delay, even in the absence of the HLA-B*5701 allele, if an HSR is suspected.
Slovenian: • Zdravljenje z zdravilom Trizivir je potrebno prekiniti brez odlašanja v primeru suma na HSR, tudi ob odsotnosti alela HLA-B*5701.
English: Common: myalgia Uncommon: myopathy
Slovenian: Pogosti: mialgija Občasni: miopatija
English: Most patients experiencing virological failure with a regimen containing abacavir in a pivotal clinical trial with Combivir (fixed dose combination of lamivudine and zidovudine) showed either no NRTI-related changes from baseline (15 %) or only M184V or M184I selection (78 %).
Slovenian: V ključnem kliničnem preskušanju z zdravilom Combivir (kombinacija lamivudina in zidovudina v fiksnem odmerku) pri večini bolnikov z virusnim neodzivom pri režimu, ki je vključeval abakavir, bodisi niso odkrili z NRTI povezanih sprememb od izhodišča (15 %) ali pa so odkrili le selekcijo M184V ali M184I (78 %).
English: In antiretroviral-naive patients treated with a combination of abacavir, lamivudine, zidovudine and efavirenz in a small, ongoing, open label pilot study, the proportion of patients with undetectable viral load (< 400 copies/ml) was approximately 90 % with 80 % having < 50 copies/ml after 24 weeks of treatment.
Slovenian: V manjši odprti pilotski študiji pri bolnikih, ki predhodno še niso bili zdravljeni s protiretrovirusnimi zdravili in so se zdravili s kombinacijo abakavir, lamivudin, zidovudin in efavirenz, je bil po 24 tednih zdravljenja odstotek bolnikov z nedokazljivo virusno obremenitvijo (< 400 kopij/ml) približno 90 %, od tega je 80 % bolnikov imelo < 50 kopij/ml.
English: Interactions involving binding site displacement are not anticipated with Trizivir.
Slovenian: Interakcije, ki bi obsegale izpodrivanje z vezavnih mest pri zdravilu Trizivir niso pričakovane.
English: • Clinical description of abacavir HSR
Slovenian: Klinični opis HSR na abakavir
English: • fluconazole or flucytosine, to treat fungal infections such as candida
Slovenian: • flukonazol ali flucitozin za zdravljenje glivičnih okužb, npr. okužb s kandido,
English: • After stopping treatment with Trizivir for reasons of a suspected HSR, Trizivir or any other medicinal product containing abacavir (e.g. Kivexa, Ziagen, Triumeq) must never be reinitiated.
Slovenian: • Po prenehanju zdravljenja z zdravilom Trizivir iz razloga suma na HSR, se zdravila Trizivir ali katerega koli drugega zdravila, ki vsebuje abakavir ( npr. Kivexa, Ziagen, Triumeq) nikoli ne sme ponovno uvesti.
English: Tablet Core: microcrystalline cellulose, sodium starch glycollate (type A), magnesium stearate.
Slovenian: Mikrokristalna celuloza, natrijev karboksimetilškrob (vrsta A), magnezijev stearat.
English: Some medicines can make it more likely that you will have side effects, or make side effects worse These include:
Slovenian: Nekatera zdravila povečajo verjetnost neželenih učinkov ali lahko neželene učinke poslabšajo.
English: NAME OF THE MEDICINAL PRODUCT TRIZIVIR 300 mg/150 mg/300 mg film-coated tablets
Slovenian: IME ZDRAVILA TRIZIVIR 300 mg/150 mg/300 mg filmsko obložene tablete
English: What Trizivir looks like and contents of the pack Trizivir film-coated tablets are engraved with ‘GX LL1' on one side.
Slovenian: Trizivir filmsko obložene tablete imajo na eni strani odtisnjeno oznako ‘GX LL1'.
English: If you have discontinued Trizivir due to this reaction, YOU MUST NEVER TAKE Trizivir, or any medicine containing abacavir (Kivexa, Ziagen or Triumeq) again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Slovenian: VEČ VZETI zdravila Trizivir ali katerega koli zdravila, ki vsebuje abakavir (Kivexa, Ziagen ali Triumeq), ker lahko v nekaj urah pride do smrtno nevarnega znižanja krvnega tlaka ali smrti.
English: EU/1/00/156/004 - child-resistant foil PVC/PCTFE/PVC-Al/Paper Blister pack (60 Tablets)
Slovenian: EU/1/00/156/004 PVC/PCTFE/PVC-Al/papir
English: • fever (high temperature) and skin rash
Slovenian: • povišana telesna temperatura (vročina) in izpuščaj na koži.
English: • muscle pain and discomfort
Slovenian: • bolečine in nelagodje v mišicah,
English: Trizivir should not be administered to patients with end-stage renal disease (see sections 4.3 and 5.2).
Slovenian: Zdravilo Trizivir se ne sme dajati bolnikom s terminalnim stadijem ledvične bolezni (glejte poglavji 4.3 in 5.2).
English: No antagonistic effects in vitro were seen with zidovudine and other antiretrovirals (tested agents: didanosine and interferon-alpha).
Slovenian: Antagonističnih učinkov z zidovudinom in drugimi protiretrovirusnimi učinkovinami (testirane učinkovine: didanozin in interferon-α) niso zaznali In vitro.
English: - severe tiredness or achiness or generally feeling ill
Slovenian: - izredna utrujenost ali bolečnost ali splošno slabo počutje
English: • sodium valproate, to treat epilepsy
Slovenian: • natrijev valproat za zdravljenje epilepsije,
English: Common: malaise Uncommon: fever, generalised pain and asthenia Rare: chills, chest pain, and influenza-like syndrome
Slovenian: Občasni: povišana telesna temperatura, generalizirana bolečina in astenija Redki: mrazenje, bolečine v prsih in influenci podoben sindrom
English: URICOSURIC Probenecid/Abacavir
Slovenian: URIKOZURIKI probenecid/abakavir
English: Zidovudine was also incorporated into DNA from cord blood leukocytes of infants from zidovudine-treated mothers.
Slovenian: Zidovudin se je vgradil tudi v DNA levkocitov iz popkovnice otrok,
English: Uncommon: rash and pruritus Rare: nail and skin pigmentation, urticaria and sweating
Slovenian: Redki: pigmentacija nohtov in kože, urtikarija ter znojenje
English: No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents: abacavir, didanosine and nevirapine).
Slovenian: Antagonističnih učinkov z lamivudinom in drugimi protiretrovirusnimi učinkovinami (preskušane učinkovine: abakavir, didanozin in nevirapin) niso zaznali In vitro.
English: Methadone and Trizivir
Slovenian: Metadon in zdravilo Trizivir
English: The tablet coating contains hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.
Slovenian: Obloga tablete vsebuje hipromelozo, titanov dioksid, makrogol, indigotin in rumeni železov oksid.
English: Tell your doctor if you are being treated with any of these.
Slovenian: Zdravniku morate povedati, če jemljete katero od teh zdravil.
English: Abacavir is primarily metabolised by the liver with approximately 2 % of the administered dose being renally excreted, as unchanged compound.
Slovenian: Abakavir se v glavnem presnavlja v jetrih, približno 2 % prejetega odmerka pa se v nespremenjeni obliki izloči preko ledvic.
English: • numbness or weakness in the limbs
Slovenian: • omrtvelost ali šibkost udov.
English: Therefore, the concomitant use of lamivudine with cladribine is not recommended (see section 4.4).
Slovenian: Zato sočasna uporaba lamivudina in kladribina ni priporočljiva (glejte poglavje 4.4).
English: Haematological parameters should therefore be carefully monitored (see section 4.3) in patients receiving Trizivir.
Slovenian: Hematološke parametre je torej potrebno pri bolnikih, ki prejemajo zdravilo Trizivir skrbno nadzorovati (glejte poglavje 4.3).
English: In a meta-analysis of six clinical trials, TAMs were not selected by regimens containing abacavir without zidovudine (0/127), but were selected by regimens containing abacavir and the thymidine analogue zidovudine
Slovenian: V metaanalizi šestih kliničnih preskušanj pri režimu, ki je vseboval abakavir brez zidovudina (0/127), selekcije mutacij timidinskih analogov niso ugotovili, ugotovili pa so jo pri režimih, ki so vsebovali abakavir in timidinski analog zidovudin (22/86, 26 %).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/156/002 - opaque white PCTFE/PVC-Al Blister pack (60 Tablets) EU/1/00/156/003 -Bottle pack (60 Tablets)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/156/002 - PCTFE/PVC-Al pretisni omot (60 tablet) EU/1/00/156/003 - Plastenka (60 tablet) EU/1/00/156/004 - PVC/PCTFE/PVC-Al/papir pretisni omot (60 tablet)
English: Peripheral blood lymphocytes from AIDS patients receiving zidovudine treatment have also been observed to contain higher numbers of chromosome breakages.
Slovenian: Pri bolnikih z AIDS-om, ki se zdravijo z zidovudinom, so v limfocitih iz periferne krvi opazili večje število lomov kromosomov.
English: One year postnatally, there was an increase in the incidence of tumours in the lung, liver and female reproductive tract of offspring exposed to the highest dose level (420 mg/kg term body weight).
Slovenian: Eno leto po kotitvi je pri tistem delu podmladka, ki je bil izpostavljen največjim odmerkom (420 mg/kg/končne telesne teže ob skotitvi), prišlo do pogostejšega pojava tumorjev na pljučih, jetrih in ženskih reproduktivnih organih.
English: How to take Trizivir
Slovenian: Kako jemati zdravilo Trizivir
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66 % of the dose excreted in the urine.
Slovenian: Pri človeku se abakavir v glavnem presnavlja z alkoholno dehidrogenazo in glukuronidacijo, pri čemer nastane 5'-karboksilna kislina in 5'-glukuronid, ki predstavljata približno
English: Limited data in patients with cirrhosis suggest that accumulation of zidovudine may occur in patients with hepatic impairment because of decreased glucuronidation.
Slovenian: Skopi podatki pri bolnikih s cirozo kažejo, da lahko manjši obseg glukuronidacije pri bolnikih z jetrno okvaro privede do kopičenja zidovudina.
English: If lamivudine is being used concomitantly for the treatment of HIV and HBV, additional information relating to the use of lamivudine in the treatment of hepatitis B infection is available in the Zeffix SmPC.
Slovenian: ki se nanašajo na uporabo lamivudina pri zdravljenju okužbe z virusom hepatitisa B, na voljo v SmPC Zeffix.
English: ANNEX II A. MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Lamivudine-TP, carbovir-TP (the active triphosphate form of abacavir) and zidovudine-TP are substrates for and competitive inhibitors of HIV reverse transcriptase (RT).
Slovenian: (aktivna trifosfatna oblika abakavirja) in zidovudin-TP so substrati za reverzno transkriptazo (RT)
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
Slovenian: • redna uporaba zdravil (večinoma raztopine), ki vsebujejo sorbitol ali druge sladkorne alkohole (npr. ksilitol, manitol, laktitol, maltitol); Posvetujte se z zdravnikom ali farmacevtom, če jemljete katerokoli od teh zdravil.
English: Rare: rhabdomyolysis
Slovenian: Redki: rabdomioliza
English: For general Trizivir information enquiries, contact (local company name and telephone number inserted here)
Slovenian: Če imate kakršno koli pomembnejše vprašanje o zdravilu Trizivir se lahko obrnete na: (vpisati naziv in tel. št. lokalnega predstavništva podjetja)
English: What Trizivir contains
Slovenian: Kaj vsebuje zdravilo Trizivir
English: Anaemia, neutropenia and leucopenia occurred more frequently at higher doses (1,200-1,500 mg/day) and in patients with advanced HIV disease (especially when there is poor bone marrow reserve prior to treatment) and particularly in patients with CD4 cell counts less than 100/mm3.
Slovenian: 1500 mg/dan) in pri bolnikih v napredovalem obdobju bolezni (zlasti če so imeli že pred začetkom zdravljenja zmanjšano zalogo kostnega mozga), še posebej pa pri bolnikih, pri katerih je bilo število celic CD4 manjše od 100/mm3.
English: Where discontinuation of therapy with one of the active substances of Trizivir is indicated, or where dose reduction is necessary separate preparations of abacavir, lamivudine and zidovudine are available.
Slovenian: Če je indicirano, da se zdravljenje z eno od učinkovin zdravila Trizivir prekine ali pa je odmerek potrebno zmanjšati, so abakavir, lamivudin in zidovudin na voljo tudi kot samostojna zdravila.
English: Caution should be exercised when administering zidovudine to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Slovenian: hepatitisom ali z drugimi znanimi dejavniki tveganja za jetrno bolezen in jetrno steatozo (vključno z določenimi zdravili in alkoholom) je potrebna previdnost.
English: The metabolites and unchanged abacavir account for about 83 % of the administered abacavir dose in the urine the remainder is eliminated in the faeces.
Slovenian: Približno 83 % prejetega odmerka abakavirja se izloči v obliki presnovkov ali v nespremenjeni obliki z urinom, ostanek se izloči z blatom.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, with predominantly renal clearance (> 70 %) via the organic cationic transport system.
Slovenian: Srednja vrednost sistemskega očistka lamivudina je približno 0,32 l/h/kg, pri čemer glavni delež odpade na ledvični očistek
English: ANTIFUNGALS Fluconazole/Abacavir
Slovenian: ANTIMIKOTIKI flukonazol/abakavir
English: Abacavir is primarily metabolised by the liver with approximately 2 % of abacavir excreted unchanged in the urine.
Slovenian: Abakavir se v glavnem presnavlja v jetrih, pri čemer se ga 2 % izloči v nespremenjeni obliki z urinom.
English: Additionally, autoinduction of abacavir metabolism or induction of the metabolism of other medicinal products hepatically metabolised has not been observed in man.
Slovenian: Prav tako pri človeku niso opazili avtoindukcije presnove abakavirja ali indukcije presnove drugih zdravil,
English: To date there are insufficient data on the efficacy and safety of Trizivir given concomitantly with NNRTIs or PIs.
Slovenian: Do sedaj ni dovolj podatkov o učinkovitosti in varnosti zdravila Trizivir, če se daje sočasno z nenukleozidnimi zaviralci reverzne transkriptaze (NNRTI) ali zaviralci proteaz (PI).
English: Methadone dosage adjustment unlikely in majority of patients; occasionally methadone re-titration may be required.
Slovenian: Pri večini bolnikov prilagoditev odmerka metadona ni potrebna;
English: The malformative risk is unlikely in humans based on the mentioned moderate amount of data.
Slovenian: Glede na omenjeno zmerno količino podatkov, maloformacijsko tveganje pri ljudeh ni verjetno
English: D. CONDITIONS OR RESTRICTIONSWITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO
English: ANTIRETROVIRAL MEDICINAL PRODUCTS Didanosine/Abacavir
Slovenian: PROTIRETROVIRUSNA ZDRAVILA didanozin/abakavir
English: These occurred more frequently at higher zidovudine doses (12001500 mg/day) and in patients with poor bone marrow reserve prior to treatment, particularly with advanced HIV disease.
Slovenian: (1200 do 1500 mg/dan) in pri bolnikih, ki so že pred začetkom zdravljenja imeli zmanjšano zalogo kostnega mozga, še posebej pri tistih v napredovalem obdobju HIV bolezni.