natgillin/translations-raw huggingface dataset:
Do not discontinue Tivicay without consulting your doctor, as this may harm you and your unborn child.
Brez posvetovanja z zdravnikom ne prenehajte jemati zdravilo Tivicay, ker to lahko škoduje vam in vašemu nerojenemu otroku.
Creatinine increases were comparable by various background regimens.
Zvišane vrednosti kreatinina so bile pri različnih osnovnih shemah primerljive.
There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2).
Ni dokazov, da bi starejši bolniki potrebovali drugačen odmerek kot mlajši odrasli bolniki (glejte poglavje 5.2).
• etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection
• etravirin, efavirenz, fosamprenavir/ritonavir, nevirapin ali tipranavir/ritonavir, za zdravljenje okužb z virusom HIV
Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Gastrointestinalna intoleranca (GI) velja za posledico lokalne uporabe učinkovine, zato sta enoti mg/kg ali mg/m2 ustrezni determinanti varnostnega kritja za ta toksični učinek.
Dolutegravir is present in cerebrospinal fluid (CSF).
Dolutegravir je prisoten v cerebrospinalni tekočini (CSF - cerebrospinal fluid).
Lamivudine and dolutegravir
Lamivudin in dolutegravir
Over the preweaning treatment period, mean body weight gain was decreased in this group and the decrease persisted throughout the entire study for females during the postweaning period.
Med obdobjem uporabe zdravila pred odstavitvijo se je povprečno povečanje telesne mase v tej skupini zmanjšalo in zmanjšanje se je ohranilo med celotno študijo pri samicah med obdobjem po odstavitvi.
A clinically relevant phenotypic cut-off value (FC vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Klinično pomembna fenotipska izhodiščna vrednost (FC proti virusu divjega tipa) ni bila določena; boljši napovedni dejavnik izida je bila genotipska odpornost.
At week 96, results were consistent with those seen at week 48.
Rezultati po 96 tednih so se skladali z rezultati po 48 tednih.
• if you are taking another medicine called dofetilide (to treat heart conditions).
• če jemljete drugo zdravilo, ki se imenuje dofetilid (za zdravljenje bolezni srca).
Your doctor will decide on the correct dose of Tivicay for you.
Zdravnik bo presodil o pravilnem odmerku zdravila Tivicay za vas.
Tivicay can be taken with or without food (see section 5.2).
Zdravilo Tivicay se lahko jemlje s hrano ali brez nje (glejte poglavje 5.2).
Your doctor may decide to adjust your dose or that you need extra check ups.
da vam prilagodi odmerek ali da potrebujete dodatne kontrolne preglede.
The effect of prolonged daily treatment with high doses of dolutegravir has been evaluated in repeat oral dose toxicity studies in rats (up to 26 weeks) and in monkeys (up to 38 weeks).
Vpliv dolgotrajnega vsakodnevnega zdravljenja z velikimi odmerki dolutegravirja so ocenili v študijah toksičnosti ponavljajočih se peroralnih odmerkov pri podganah (do 26 tednov) in opicah (do 38 tednov).
TIVICAY ~1 mg/kg Once Daily + OBR
TIVICAY ~1 mg/kg enkrat na dan + OBR
**see below under Description of selected adverse reactions.
** glejte Opis izbranih neželenih učinkov spodaj Opis izbranih neželenih učinkov
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Vsak simptom vnetja, ki se pojavi, je treba oceniti in uvesti zdravljenje, kadar je potrebno.
Some people taking medicines for HIV infection develop other conditions, which can be serious.
Pri nekaterih ljudeh, ki jemljejo zdravila za zdravljenje okužbe s HIV, se pojavijo druge zdravstvene težave, ki so lahko resne.
- This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
- To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Tivicay.
Zdravnik se lahko odloči, da pri vas opravi teste za pregled jeter, ledvic ali krvi in vam naroči, da prenehate z jemanjem zdravila Tivicay.
Bioequivalence has not been unequivocally shown for 1x50 mg tablet compared to 5x10 mg tablets.
Bioekvivalenca ni bila nedvoumno dokazana za 1x50 mg tablete v primerjavi z 5x10 mg tabletami.
The most commonly seen treatment emergent adverse reactions were nausea (13%), diarrhoea (18%) and headache (13%).
Najpogosteje opaženi neželeni učinki, povezani z zdravljenjem, so bili: navzea (13%), driska (18%) in glavobol (13%).
• increase in the level of liver enzymes
• zvišane vrednosti jetrnih encimov
The European Medicines Agency has deferred the obligation to submit the results of studies with Tivicay in paediatric patients aged 4 weeks to below 6 years with HIV infection (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Tivicay pri pediatrični populaciji bolnikov, starih od 4 tednov do manj kot 6 let, okuženih z virusom HIV (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
What you need to know before you take Tivicay 3.
Kaj morate vedeti, preden boste vzeli zdravilo Tivicay 3.
Oral contraceptives Ethinyl estradiol (EE) and Norelgestromin (NGMN)
Peroralni kontraceptivi etinilestradiol (EE) in norelgestromin (NGMN)
• abnormal dreams
• omotica • nenormalne sanje
Resistance in vitro
Odpornost in vitro
In addition, no antagonistic effects were seen for dolutegravir and adefovir, and ribavirin had no apparent effect on dolutegravir activity.
Poleg tega ni bilo opaziti antagonističnih učinkov za dolutegravir in adefovir, ribavirin ni imel opaznega vpliva na delovanje dolutegravirja.
Do not give this medicine to children under 6 years of age, weighing less than 15 kg or with HIV infection that is resistant to other medicines similar to Tivicay.
Ne dajajte tega zdravila otrokom, mlajšim od 6 let, ki tehtajo manj kot 15 kg ali so okuženi z virusom HIV, ki je odporen na druga zdravila, podobna zdravilu Tivicay.
Taking Tivicay at the time of becoming pregnant or during the first twelve weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
Jemanje zdravila Tivicay ob zanositvi ali v prvih dvanajstih tednih nosečnosti lahko poveča tveganje za prirojeno napako, imenovano okvara nevralne cevi, kot je spina bifida (nepravilno oblikovana hrbtenjača).
This regimen is only suitable for the treatment of HIV-1 infection where there is no known or suspected resistance to the integrase inhibitor class, or to lamivudine.
Ta shema je primerna le za zdravljenje okužbe s HIV-1, kadar ni znane ali domnevne odpornosti na skupino zaviralcev integraze ali na lamivudin.
The study enrolled 183 patients, 133 with INI-resistance at Screening and 50 with only historical evidence of resistance (and not at Screening).
V študijo je bilo vključenih 183 bolnikov, 133 z odpornostjo na INI ob presejanju in 50 z zgolj anamnestičnimi podatki o odpornosti (brez odpornosti ob presejanju).
Table 9 Virologic (Snapshot algorithm) and Immunologic Activity of Treatment for Subjects 6 Years and Older in P1093
Preglednica 9: Virološka (»snapshot« algoritem) in imunološka aktivnost zdravljenja pri preiskovancih, starih 6 let ali več, v študiji P1093
There are limited data available on the use of dolutegravir in patients aged 65 years and over.
Starostniki Na voljo so omejeni podatki o uporabi dolutegravirja pri bolnikih starih 65 let ali več.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Bolnikom je treba povedati, da naj se posvetujejo s svojim zdravnikom, če se jim pojavijo bolečine v sklepih, okorelost sklepov ali težave pri gibanju.
Table 7 Virologic response (day 8) after 7 days of functional monotherapy, in patients with RAL/EVG as part of current failing regimen, VIKING 3
Preglednica 7: Virološki odziv (8. dan) po 7 dneh funkcionalne monoterapije pri bolnikih z RAL/EVG kot delom trenutne neuspešne sheme, VIKING-3
What Tivicay is and what it is used for 2.
Kaj je zdravilo Tivicay in za kaj ga uporabljamo 2.
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Osebe z napredovalo okužbo s HIV (AIDS) imajo oslabljen imunski sistem in večjo verjetnost, da se pri njih razvije hujša okužba (oportunistične okužbe).
There were no new target organs identified in juveniles compared to adults.
Pri mladih živalih v primerjavi z odraslimi niso ugotovili novih tarčnih organov.
It is not known whether the ingredients of Tivicay can pass into your breast milk.
Ni znano ali sestavine zdravila Tivicay lahko prehajajo v materino mleko.
Week 48 outcomes (including outcomes by key baseline covariates) for SAILING are shown in Table 6.
Rezultati po 48 tednih (vključno z rezultati po ključnih osnovnih spremenljivkah) študije SAILING so prikazani v Preglednici 6.
Cohort I (12 to <18 years) (n=23)
Kohorta I (od 12 do < 18 let) (n = 23)
Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX12
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, druga zdravila za zdravljenje virusnih infekcij, oznaka ATC: J05AX12
Treatment-emergent mutations observed were consistent with those observed in the VIKING-3 study.
Opažene mutacije, ki so se pojavile med zdravljenjem, so bile skladne z mutacijami, opaženimi v študiji VIKING-3.
In further selection experiments using clinical isolates of subtype B, mutation R263K was seen in all five isolates (after 20 weeks and onwards).
Pri nadaljnjih preskušanjih selekcije z uporabo kliničnih izolatov podtipa B, so pri vseh petih izolatih opazili mutacijo R263K (po 20 tednih in naprej).
Once the bottle has been opened keep the desiccant in the bottle, do not remove it.
Potem, ko vsebnik odprete, pustite sušilno sredstvo v njem in ga ne odstranjujte.
→ Talk to your doctor about the risks and benefits of taking Tivicay.
→ Posvetujte se z zdravnikom o tveganjih in koristih jemanja zdravila Tivicay.
These increases may be clinically relevant in the presence of certain integrase class resistance.
Ta povečanja so lahko klinično pomembna pri odpornosti na določena zdravila iz skupine zaviralcev integraze.
Treatment-emergent mutations or mixtures of mutations observed were L74I (n=1), N155H (n=2).
Opažene med zdravljenjem nastale mutacije ali mešanice mutacij so bile L74I (n = 1), N155H (n = 2).
In subtype C (n=2) and A/G (n=2) isolates the integrase substitution R263K was selected in one isolate, and G118R in two isolates.
Pri izolatih podtipa C (n=2) in A/G (n=2) je bila pri enem izolatu izbrana substitucija integraze R263K, pri dveh pa G118R.
There are no data on the effects of dolutegravir on human male or female fertility.
Ni podatkov o vplivu dolutegravirja na moško ali žensko plodnost pri ljudeh.
Serial passage is used to study resistance evolution in vitro.
Za preučevanje razvoja odpornosti in vitro se uporablja zaporedni prehod.
Tivicay should not be used in children and adolescents with HIV infection that is resistant to other medicines similar to Tivicay.
Zdravilo Tivicay se ne sme uporabljati pri otrocih in mladostnikih z okužbo HIV, ki je odporna na druga zdravila, podobna zdravilu Tivicay.
It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen.
Ni znano, ali je vsa ta količina ali pa samo njen del neabsorbirana učinkovina ali pa je posledica biliarnega izločanja glukuronidnega konjugata, ki se v črevesni svetlini razgradi, tako da nastane izhodna spojina.
With 50 mg twice daily, the exposure over 24 hours was approximately doubled compared to 50 mg once daily.
Pri 50 mg dvakrat na dan se je izpostavljenost v 24 urah v primerjavi s 50 mg enkrat na dan približno podvojila.
The effect by the Q148-mutations (H/R/K) was also verified in passage experiments with site directed mutants.
Vpliv mutacij Q148 (H/R/K) je bil potrjen tudi v poskusih prehajanja s točkovnimi mutanti.
Co-administration with dofetilide (see section 4.5).
Sočasna uporaba z dofetilidom (glejte poglavje 4.5).
This is supported by 96 week data from an open-label, randomized and activecontrolled study FLAMINGO (ING114915) and additional data from the open-label phase of SINGLE to 144 weeks.
To potrjujejo 96-tedenski podatki odprte, randomizirane, z učinkovino kontrolirane študije FLAMINGO (ING114915) in dodatni podatki odprte faze študije SINGLE do 144. tedna.
For children aged between 6 and 12 years your doctor will decide on the correct dose of Tivicay, depending on the weight of your child.
Za otroke, stare od 6 do 12 let, bo ustrezen odmerek zdravila Tivicay določil zdravnik glede na otrokovo telesno maso.
Response was associated with baseline INI mutation pathway, as shown in Table 7.
Odziv je bil povezan z osnovnim potekom mutacije INI, kot je prikazano v preglednici 7.
If you could get pregnant while receiving Tivicay, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Če bi lahko med jemanjem zdravila Tivicay zanosili, morate za preprečitev nosečnosti poleg drugih načinov kontracepcije, vključno s peroralnimi (kontracepcijske tablete) ali drugimi hormonskimi kontracepcijskimi sredstvi (na primer vsadki, injekcije), uporabljati zanesljiv način pregradne kontracepcije (na primer kondom).
Resistance in vivo
Odpornost in vivo
Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir at the time of conception compared with mothers exposed to nondolutegravir containing regimens (0.1%).
Predhodni podatki iz opazovalne študije so pokazali večjo incidenco okvar nevralne cevi (0,9 %) pri materah, ki so bile ob spočetju izpostavljene dolutegravirju, v primerjavi z materami, ki so bile izpostavljene režimom, ki niso vsebovali dolutegravirja (0,1 %).
1 Historical or phenotypic evidence of INI resistance only.
1 Samo retrospektivni ali fenotipski podatki o odpornost na INI
The effect of severe hepatic impairment on the pharmacokinetics of Tivicay has not been studied.
Vpliva hude okvare jeter na farmakokinetiko zdravila Tivicay niso raziskali.
The E92Q mutation has been selected in patients with pre-existing raltegravir resistance who were then treated with dolutegravir (listed as a secondary mutation for dolutegravir).
Mutacija E92Q je bila izbrana pri bolnikih, ki so že bili odporni na raltegravir in so bili nato zdravljeni z dolutegravirjem (navedena kot sekundarna mutacija za dolutegravir).
In contrast, starting with mutants harbouring mutation Q148H (FC 1), a variety of secondary mutations were seen with a consequent increase of FC to values >10.
Nasprotno pa so pri začetku z mutanti, ki so vključevali mutacijo Q148H (FC 1), opazili vrsto sekundarnih mutacij s posledičnim porastom vrednosti FC >10.
Within-subject variability (CVw%) is lower than between-subject variability.
Intraindividualna variabilnost (CVw%) je manjša kot interindividualna variabilnost.
Based on limited available data in children and adolescents (6 to less than 18 years of age and weighing at least 15 kg), there were no additional types of adverse reactions beyond those observed in the adult population.
Na podlagi omejenih razpoložljivih podatkov pri otrocih in mladostnikih (starih od 6 do manj kot 18 let, s telesno maso vsaj 15 kg) ni bilo nobenih dodatnih neželenih učinkov poleg tistih, ki so jih zabeležili pri odraslih.
20 mg once daily (Taken as two 10 mg tablets)
20 mg enkrat na dan (Uporabljen kot dve 10 mg tableti)
Children and adolescents weighing at least 40 kg can take the adult dose of one tablet (50 mg), once a day.
Otroci in mladostniki, ki tehtajo vsaj 40 kg, lahko jemljejo odmerek za odrasle, to je eno tableto (50 mg) enkrat na dan.
If you take more Tivicay than you should
Če ste vzeli večji odmerek zdravila Tivicay, kot bi smeli
Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Pri nekaterih osebah, ki jemljejo kombinacijo zdravil za HIV, se lahko pojavi stanje, imenovano osteonekroza.
Cohort IIA (6 to <12 years) (n=23)
Kohorta IIA (od 6 do < 12 let) (n = 23)
What Tivicay is and what it is used for
Kaj je zdravilo Tivicay in za kaj ga uporabljamo
Primary mutations for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q and T66I) do not affect the in vitro susceptibility of dolutegravir as single mutations.
Primarne mutacije za raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q, T66I) ne vplivajo na dovzetnost dolutegravirja in vitro kot posamezne mutacije.
Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2).
Na podlagi in vivo in/ali in vitro podatkov ni pričakovati, da bi dolutegravir vplival na farmakokinetiko zdravil, ki so substrati glavnih encimov ali prenašalci, kot so CYP3A4, CYP2C9 in P-gp (za več informacij glejte poglavje 5.2).
There is currently limited experience with overdosage in dolutegravir.
Trenutno je le malo izkušenj s prevelikim odmerjanjem pri dolutegravirju.
Dolutegravir is the predominant circulating compound in plasma; renal elimination of unchanged active substance is low (< 1% of the dose).
Dolutegravir je prevladujoča snov, ki kroži v plazmi; izločanje nespremenjene učinkovine preko ledvic je majhno (< 1 % odmerka).
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Pomembni primeri so citomegalovirusni retinitis, generalizirane in/ali fokalne okužbe z mikobakterijami in pljučnica zaradi Pneumocystis jirovecii.
Don't stop unless your doctor advises you to.
Ne prenehajte z jemanjem, razen če vam tega ne priporoča zdravnik.
If possible, show them the Tivicay pack.
Po možnosti jima pokažite ovojnino zdravila Tivicay.
The linearity of dolutegravir pharmacokinetics is dependent on dose and formulation.
Linearnost farmakokinetike dolutegravirja je odvisna od odmerka in oblike.
Tivicay should be prescribed by physicians experienced in the management of HIV infection.
Zdravilo Tivicay smejo predpisovati zdravniki, ki imajo izkušnje z zdravljenjem okužb z virusom HIV.
With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Pri tej bolezni deli kostnega tkiva odmrejo zaradi zmanjšane prekrvitve kosti.
If you forget to take Tivicay
Če ste pozabili vzeti zdravilo Tivicay
Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Dolutegravir zavira integrazo HIV z vezavo na aktivno mesto integraze in preprečuje prenos zapisa pri vgradnji retrovirusne deoksiribonukleinske kisline (DNK), ki je bistvenega pomena za replikacijski ciklus HIV.
4.6 Fertility, pregnancy and lactation Women of childbearing potential
4.6 Plodnost, nosečnost in dojenje
Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART.
Čeprav so vzroki za osteonekrozo različni (vključujoč uporabo kortikosteroidov, difosfonatov, uživanje alkohola, hudo imunosupresijo in višji indeks telesne mase), so o primerih osteonekroze poročali predvsem pri bolnikih z napredovalo okužbo s HIV-boleznijo in/ali dolgotrajno izpostavljenostjo CART.
The overall susceptibility score (OSS) of the optimised background regimen (OBR) was not associated with Week 24 response, nor with the week 48 response.
Skupna ocena dovzetnosti (OSS) optimizirane osnovne sheme (OBR) ni bila povezana z odzivom po 24., niti po 48. tednih.
G118R lowers the susceptibility to dolutegravir in site directed mutants (FC 10), but was not detected in patients receiving dolutegravir in the Phase III program.
G118R zmanjša dovzetnost za dolutegravir pri točkovnih mutantih (FC 10), vendar ga niso opazili pri bolnikih, ki so prejemali dolutegravir v programu III. faze.
The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09-0.61).
Povprečna IC50 za 3 izolate HIV-2 je bila 0,18 nM (razpon: od 0,09 do 0,61).
Primary mutation other than Q148H/K/R2
Druga primarna mutacija razen Q148H/K/R2
Some medicines can affect how Tivicay works, or make it more likely that you will have side effects.
Nekatera zdravila lahko vplivajo na delovanje zdravila Tivicay ali povečajo verjetnost, da se pri vas pojavijo neželeni učinki.
Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Ledvični očistek nespremenjene učinkovine je manj pomembna pot izločanja dolutegravirja.
When using the lab-strain HIV-1 IIIB during passage over 112 days, mutations selected appeared slowly, with substitutions at positions S153Y and F, resulting in a maximal fold change in susceptibility of 4 (range 2-4).
112 dni uporablja laboratorijski sev HIV-1 IIIB, se izbrane mutacije pojavljajo počasi, z substitucijami na mestih S153Y in F, kar ima za posledico maksimalno spremembo zavoja pri občutljivosti 4 (razpon 2-4).
35 mg once daily (Taken as one 25 mg and one 10 mg tablet)
35 mg enkrat na dan (Uporabljen kot ena 25 mg in ena 10 mg tableta)
• If you are taking certain other medicines, the dose is one 50 mg tablet twice a day.
• Če jemljete nekatera druga zdravila, je odmerek ena 50 mg tableta dvakrat na dan.
There is no clinical data on the safety or efficacy of the 100 mg twice daily dose.
O varnosti in učinkovitosti odmerka 100 mg dvakrat na dan ni kliničnih podatkov.
Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and children over 6 years old, who weigh at least 15 kg.
Zdravilo Tivicay se uporablja za zdravljenje okužbe z virusom HIV (virus humane imunske pomanjkljivosti) pri odraslih, mladostnikih in otrocih, starejših od 6 let, ki tehtajo vsaj 15 kg.
When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to these primary mutations in experiments with site directed mutants, dolutegravir susceptibility is still unchanged (FC <2 vs wild type virus), except in the case of Q148-mutations, where a FC of 5-10 or higher is seen with combinations of certain secondary mutations.
Ko se mutacije, navedene kot sekundarne mutacije, povezane z zaviralci integraze (za raltegravir/elvitegravir), v poskusih s točkovnimi mutanti dodajo tem primarnim mutacijam, dovzetnost za dolutegravir ostaja še naprej nespremenjena (FC <2 proti virusu divjega tipa), razen v primeru mutacij Q148, kjer je opaziti FC 5 -10 ali več v kombinacijah z določenimi sekundarnimi mutacijami.
• stomach pain (abdominal pain)
• bolečine v trebuhu (abdominalne bolečine)
These mutations were not selected in patients treated with dolutegravir in the clinical studies.
Te mutacije pri bolnikih, zdravljenih z dolutegravirjem, v kliničnih študijah niso bile izbrane.
Delay in stopping treatment with dolutegravir or other suspect active substances after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Odlašanje z ukinitvijo zdravljenja z dolutegravirjem ali drugimi zadevnimi učinkovinami ob pojavu preobčutljivosti ima lahko za posledico življenjsko nevarno alergijsko reakcijo.