natgillin/translations-raw huggingface dataset:
Allergic reactions have occasionally been seen, so it is recommended that the first dose of Dynepo be given under medical supervision. 
Ker je bil v redkih primerih opažen pojav alergijskih reakcij, je priporočeno, da se prvi odmerek daje pod zdravniškim nadzorom.
The effectiveness of Dynepo to treat anaemia has been studied in a total of 1308 patients with chronic renal failure, including two main clinical studies. 
Učinkovitost zdravila Dynepo pri zdravljenju slabokrvnosti je bila raziskana pri 1.308 bolnikih s kronično odpovedjo ledvic, med drugim v dveh večjih kliničnih študijah.
The most common side effects are hypertension (raised blood pressure), headache, and, for patients on dialysis, problems with the dialysis tubes. 
Najbolj pogosti neželeni učinki so hipertenzija (povišan krvni tlak), glavobol, pri bolnikih, ki so na dializi, pa težave z dializnimi cevkami.
Dynepo should not be used in people who may be hypersensitive (allergic) to epoetin delta or any of the other ingredients, and in patients who have uncontrolled high blood pressure. 
Zdravila Dynepo ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin delta ali na katero koli drugo sestavino, ter bolniki s slabo nadzorovanim visokim krvnim tlakom.
Dynepo is used to treat anaemia (fewer than normal red blood cells in the blood) in adult patients with chronic renal failure (long-term kidney disease). 
Dynepo se uporablja za zdravljenje slabokrvnosti (pri kateri je število rdečih krvnih celic v krvi nižje od normalnega) pri odraslih bolnikih s kronično odpovedjo ledvic (dolgotrajno ledvično obolenje).
The main measure of effectiveness in the clinical studies was whether Dynepo increased haemoglobin levels (the protein found in red blood cells that carries oxygen around the body). 
V kliničnih študijah je bil glavni pokazatelj učinkovitosti zdravila Dynepo dvig ravni hemoglobina (beljakovine v rdečih krvnih celicah, ki prenaša kisik po telesu).
Dynepo is a solution for injection in pre-filled syringe. 
Zdravilo Dynepo je raztopina za injiciranje v napolnjeni injekcijski brizgi.
The effectiveness was the same if it was administered intravenously or subcutaneously. 
Učinkovitost zdravila je bila enaka pri intravenskem in subkutanem dajanju.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DYNEPO EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) DYNEPO
In one of these, Dynepo given intravenously was compared with epoetin alfa (a similar type of drug). 
V eni izmed njih so primerjali učinek zdravila Dynepo, ki so ga dajali intravensko, z učinkom epoetina alfa (podobna vrsta zdravila).
Dynepo works by stimulating production of red blood cells in the same way as erythropoietin. 
Zdravilo Dynepo učinkuje tako, da spodbuja tvorbo rdečih krvnih celic na enak način kot eritropoetin.
Dynepo contains the active ingredient epoetin delta. 
Dynepo vsebuje zdravilno učinkovino epoetin delta.
The Committee for Medicinal products for Human Use (CHMP) decided that Dynepo's benefits are greater than its risks for the treatment of anaemia in patients with chronic renal failure. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Dynepo pri zdravljenju slabokrvnosti pri bolnikih s kronično odpovedjo ledvic večje od z njim povezanih tveganj.
Dynepo was as effective as epoetin alfa at increasing haemoglobin levels in patients. 
Zdravilo Dynepo je bilo pri dviganju ravni hemoglobina pri bolnikih enako učinkovito kot epoetin alfa.
Why has Dynepo been approved? 
Zakaj je bilo zdravilo Dynepo odobreno?
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow. 
Hormon, imenovan eritropoetin, spodbuja sintezo rdečih krvnih celic v kostnem mozgu.
They recommended that Dynepo be given marketing authorisation. 
Zato je priporočil, da se za zdravilo Dynepo odobri dovoljenje za promet z zdravilom.
How has Dynepo been studied? 
Kako je bilo zdravilo Dynepo raziskano?
It may be used in patients on dialysis (a blood clearance technique) or not on dialysis. 
Uporablja se lahko pri bolnikih, ki so na dializi (postopek za čiščenje krvi), in pri tistih, ki niso.
The full EPAR for Dynepo is available here. 
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dynepo je na voljo tukaj.
For the full description of the side effects reported with Dynepo, please see the Package Leaflet. 
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Dynepo, najdete v Navodilu za uporabo.
A doctor who has experience in the care of renal failure patients should start any treatment with Dynepo. 
Zdravljenje z zdravilom Dynepo mora začeti zdravnik, ki ima izkušnje z zdravljenjem bolnikov z odpovedjo ledvic.
• If you forget to take a dose, take it as soon as you remember. 
• Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
The interaction was evaluated with ritonavir only. 
Medsebojno delovanje je bilo ovrednoteno le z ritonavirjem.
A positive value favours doravirine over efavirenz. 
Pozitivna vrednost daje prednost doravirinu nad efavirenzom.
Treatment results are shown in Table 6. 
Rezultati zdravljenja so prikazani v preglednici 6.
• if you are allergic to doravirine or any of the other ingredients of this medicine listed in section 6. 
• če ste alergični na doravirin ali katero koli sestavino tega zdravila, navedeno v poglavju 6.
This medicine should be used within 35 days after first opening of the bottle. 
To zdravilo je treba porabiti v 35 dneh od prvega odprtja plastenke.
Blood tests may also show: • increased levels of liver enzymes (ALT) 
Preiskave krvi lahko pokažejo tudi: • zvišanje jetrnih encimov (ALT)
This can happen when you start taking any HIV medicine, including this medicine. 
Ta se lahko pojavi, ko začnete jemati katero koli zdravilo proti virusu HIV, tudi to zdravilo.
The clinical relevance of a 5-10 fold reduction in susceptibility is unknown. 
Klinični pomen od 5- do 10-kratnega zmanjšanja občutljivosti ni znan.
If you take certain medicines, your doctor may need to change the amount of doravirine you take. 
Če jemljete določena druga zdravila, vam bo zdravnik morda moral spremeniti količino doravirina, ki jo jemljete.
There is no information on potential acute symptoms and signs of overdose with doravirine. 
Podatkov o možnih akutnih simptomih in znakih prevelikega odmerjanja doravirina ni.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
These medicinal products include, but are not limited, to the following: 
Med takšna spadajo naslednja zdravila (toda ne samo ta):
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, talk to your doctor about the risks and benefits of taking Pifeltro. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se z zdravnikom posvetujte o tveganjih in koristih jemanja zdravila Pifeltro.
GM: Geometric mean, % CV: Geometric coefficient of variation 
GS: geometrična sredina, % KV: geometrični koeficient variacije
The recommended dose is one 100 mg tablet taken orally once daily with or without food. 
Priporočeni odmerek je ena 100-mg tableta peroralno enkrat na dan s hrano ali brez nje.
30 months After first opening of the bottle use within 35 days. 
30 mesecev Po prvem odprtju plastenke zdravilo uporabite v 35 dneh.
For storage conditions after first opening of the bottle see section 6.3. 
Za navodila glede shranjevanja po prvem odprtju plastenke glejte poglavje 6.3.
Effect of food on oral absorption 
Vpliv hrane na peroralno absorpcijo
Do not take Pifeltro: 
Ne jemljite zdravila Pifeltro:
Pifeltro may have a minor influence on the ability to drive or use machines. 
Zdravilo Pifeltro lahko ima manjši vpliv na sposobnost za vožnjo in upravljanje strojev.
*The 95 % CI for the treatment difference was calculated using stratum-adjusted Mantel-Haenszel method. 
* 95-odstotni interval zaupanja za razliko med zdravljenji je izračunan po Mantel-Haenszelovi metodi s prilagoditvijo za stratume.
Safety and efficacy of doravirine have not been established in patients younger than 18 years of age. 
Varnost in učinkovitost doravirina pri bolnikih, mlajših od 18 let, nista bili dokazani.
Parameter GM (% CV) 
Parameter GS (% KV)
 = increase, ↓ = decrease, ↔ = no change CI = Confidence Interval; SD = Single Dose; QD = Once Daily; BID = Twice Daily *AUC0- for single dose, AUC0-24 for once daily. 
 = povečanje, ↓ = zmanjšanje, ↔ = brez spremembe IZ = interval zaupanja, 1x/dan = enkrat na dan, 2x/dan = dvakrat na dan *AUC0- za enkratni odmerek, AUC0-24 za uporabo enkrat na dan.
*For Week 96, certain subjects with missing HIV-1 RNA were excluded from the analysis. 
* Pri analizi za 96. teden so bili določeni preiskovanci z manjkajočim HIV-1 RNA izkjučeni iz analize.
No human data on the effect of doravirine on fertility are available. 
Podatkov o vplivu doravirina na plodnost pri človeku ni.
The use of Pifeltro in people aged less than 18 years has not yet been studied. 
Uporaba zdravila Pifeltro pri osebah, mlajših od 18 let, še ni raziskana.
What you need to know before you take Pifeltro 
Kaj morate vedeti, preden boste vzeli zdravilo Pifeltro
You should not take Pifeltro if your doctor has told you that the virus causing your infection is resistant to doravirine. 
Zdravila Pifeltro ne smete jemati, če vam je zdravnik povedal, da je virus, ki povzroča okužbo pri vas, odporen proti doravirinu.
Table 1 shows the established and other potential medicinal product interactions with doravirine but is not all inclusive (increase is indicated as , decrease is indicated as ↓, and no change as ↔). 
Preglednica 1 prikazuje ugotovljena in druga možna medsebojna delovanja zdravil z doravirinom, vendar ta preglednica ni izčrpna (povečanje je označeno kot , zmanjšanje kot ↓ in brez spremembe kot ↔).
• increased levels of liver enzymes (AST) 
• zvišanje jetrnih encimov (AST)
Women with HIV should not breast-feed because HIV can be passed on to their babies through breast milk. 
Ženske, okužene z virusom HIV, ne smejo dojiti, ker lahko virus z mlekom prenesejo na otroka.
Pifeltro is used to treat HIV infection in people 18 years of age and older. 
Zdravilo Pifeltro se uporablja za zdravljenje okužbe s HIV pri osebah, starih 18 let ali več.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000). 
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali redki (≥ 1/10.000 do < 1/1.000).
EU/1/18/1332/001 EU/1/18/1332/002 90 (3 x 30) tablets 
EU/1/18/1332/001 EU/1/18/1332/002 90 (3 x 30) tablet
This is because other medicines may affect how Pifeltro works, and Pifeltro might affect the way some other medicines work. 
Druga zdravila namreč lahko vplivajo na delovanje zdravila Pifeltropa tudi zdravilo Pifeltrolahko vpliva na delovanje nekaterih drugih zdravil.
What Pifeltro is and what it is used for 
Kaj je zdravilo Pifeltro in za kaj ga uporabljamo
Because of the potential for HIV-1 transmission and the potential for serious adverse reactions in breast-feeding infants, mothers should be instructed not to breast-feed if they are receiving Pifeltro. 
Zaradi možnosti prenosa HIV-1 z matere na otroka in zaradi potencialno nevarnih neželenih učinkov pri dojenih otrocih je treba matere podučiti, naj ne dojijo, če prejemajo zdravilo Pifeltro.
Doravirine at a dose of 100 mg once daily is not likely to have a clinically relevant effect on the plasma concentrations of medicinal products that are dependent on transport proteins for absorption and/or elimination or that are metabolized by CYP enzymes. 
Ni verjetno, da bi doravirin v odmerku 100 mg enkrat na dan klinično pomembno vplival na plazemsko koncentracijo zdravil, ki so za absorpcijo in/ali odstranjevanje odvisna od transportnih beljakovin oziroma se presnavljajo z encimi CYP.
Pifeltro is used to treat HIV (‘human immunodeficiency virus') infection. 
Zdravilo Pifeltro se uporablja za zdravljenje okužbe z virusom HIV (virusom humane imunske pomanjkljivosti).
This medicine must be used in combination with other medicines for HIV. 
To zdravilo je treba uporabljati v kombinaciji z drugimi zdravili proti virusu HIV.
Rare musculoskeletal pain 
Redki mišično-skeletna bolečina
It is preferable to avoid the use of this medicine during pregnancy. 
Med nosečnostjo se je uporabi tega zdravila bolje izogniti.
Keep the desiccant inside the bottle and do not throw away until you have finished taking all of the medicine. 
Sušilo naj ostane v plastenki in se ga ne sme zavreči, dokler ne porabite vsega zdravila.
Effects on Medicinal Product Levels Geometric Mean Ratio (90 % CI)* 
Vpliv na koncentracijo zdravila Razmerje geometričnih sredin (90 % IZ)*
Patients should be informed that fatigue, dizziness, and somnolence have been reported during treatment with doravirine (see section 4.8). 
Bolnikom je treba povedati, da so med zdravljenjem z doravirinom poročali o utrujenosti, omotici in zaspanosti (glejte poglavje 4.8).
Table 5: Efficacy response at week 24 (Snapshot approach) 
Preglednica 5: Odziv učinkovitosti po 24 tednih (metoda "Snapshot")
Expected: ↔ rosuvastatin ↔ simvastatin 
Pričakovano: ↔ rosuvastatin ↔ simvastatin
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu . 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu .
You can still pass on HIV when taking Pifeltro, although effective therapylowers the risk. 
Tudi med jemanjem zdravila Pifeltro lahko še vedno prenašate virus HIV, čeprav učinkovito zdravljenje zmanjša to tveganje.
If you take more Pifeltro than you should Do not take more than the recommended dose. 
Če ste vzeli večji odmerek zdravila Pifeltro, kot bi smeli Ne vzemite odmerka, večjega od priporočenega.
The following de novo resistance was seen in the resistance analysis subset (subjects with HIV-1 RNA greater than 400 copies per mL at virologic failure or early study discontinuation and having resistance data). 
Naslednjo de novo odpornost so ugotovili v podskupini za analizo odpornosti (preiskovanci, ki so imeli HIV-1 RNA več kot 400 kopij/ml ob virološkem neuspehu ali zgodnjem prenehanju sodelovanja v študiji ter so zanje imeli podatke o odpornosti).
Table 2: Tabulated summary of adverse reactions associated with doravirine used in combination with other antiretrovirals 
Preglednica 2: Povzetek neželenih učinkov, povezanih z uporabo doravirina v kombinaciji z drugimi protiretrovirusnimi zdravili
Doravirine has been evaluated in a limited number of patients with NNRTI resistance (K103N n=7, G190A n=1); all patients were suppressed to < 40 copies/mL at week 48. 
Doravirin so ovrednotili pri majhnem številu bolnikov z odpornostjo proti NNRTI (K103N n = 7, G190A n = 1); vsi bolniki so bili 48. teden suprimirani na < 40 kopij/ml.
No clinically relevant pharmacokinetic differences have been identified between men and women for doravirine. 
V farmakokinetiki doravirina niso ugotovili klinično pomembnih razlik med moškimi in ženskami.
Your doctor may check your blood levels or monitor for side effects if you take the following medicines with Pifeltro: 
Zdravnik vam bo morda kontroliral koncentracijo v krvi ali vas bo nadzoroval glede neželenih učinkov, če skupaj z zdravilom Pifeltro jemljete katero od naslednjih zdravil:
Effects of doravirine on other medicinal products 
Vpliv doravirina na druga zdravila
There are some medicines you must not take with Pifeltro. 
Nekaterih zdravil ne smete jemati skupaj z zdravilom Pifeltro.
Table 6: Efficacy response (Snapshot approach) in the DRIVE-SHIFT study 
Preglednica 6: Odziv učinkovitosti (metoda "Snapshot") v študiji DRIVE-SHIFT
At baseline, the median age of subjects was 43 years, 16 % were female, and 24 % were non-white. 
Izhodiščno je bila mediana starost preiskovancev 43 let, 16 % je bilo žensk in 24 % preiskovancev ni bilo belcev.
Expected: ↔ doravirine ombitasvir/ paritaprevir/ritonavir and dasabuvir+/-ritonavir 
Pričakovano: ↔ doravirin ombitasvir/ paritaprevir/ritonavir in dasabuvir+/-ritonavir
This is because it has not been studied in pregnancy and it is not known if it will harm your baby while you are pregnant. 
Uporaba tega zdravila med nosečnostjo namreč ni raziskana in tako ni znano, ali med nosečnostjo škoduje otroku.
As a precautionary measure, it is preferable to avoid the use of doravirine during pregnancy. 
Iz previdnosti se je med nosečnostjo uporabi doravirina bolje izogniti.
The European Medicines Agency has deferred the obligation to submit the results of studies with doravirine in one or more subsets of the paediatric population in treatment of human immunodeficiency virus-1 (HIV-1) infection, as per Paediatric Investigation Plan (PIP) decision in the granted indication. 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z doravirinom za eno ali več podskupin pediatrične populacije za zdravljenje okužbe s HIV-1 pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP - Paediatric Investigation Plan).
The administration of a single doravirine tablet with a high-fat meal to healthy subjects resulted in a 16 % and 36 % increase in doravirine AUC and C24, respectively, while Cmax was not significantly affected. 
Uporaba ene tablete doravirina z zelo mastnim obrokom je pri zdravih osebah povzročila povečanje AUC doravirina za 16 % in njegove C24 za 36 %, Cmax pa se ni bistveno spremenila.
Method of administration Pifeltro must be taken orally, once daily with or without food and swallowed whole (see section 5.2). 
Zdravilo Pifeltro je treba jemati peroralno, enkrat na dan, s hrano ali brez nje; tableto je treba pogoltniti celo (glejte poglavje 5.2).
Treatment emergent doravirine resistance associated substitutions may confer cross resistance to efavirenz, rilpivirine, nevirapine, and etravirine. 
Med zdravljenjem nastale substitucije, povezane z odpornostjo proti doravirinu, lahko povzročijo navzkrižno odpornost proti efavirenzu, rilpivirinu, nevirapinu in etravirinu.
DOR/3TC/TDF Once Daily ISG 
DOR/3TC/TDF enkrat na dan ISG
• inflammation of the skin due to allergy, redness on the cheeks, nose, chin or forehead, bumps or pimples on the face 
• vnetje kože zaradi alergije, pordelost lic, nosu, brade ali čela, bulice ali mozolji na obrazu
White, oval-shaped, tablet of dimensions 19.00 mm x 9.50 mm, debossed with the corporate logo and 700 on one side and plain on the other side. 
filmsko obložena tableta bela, ovalna, 19,00 mm x 9,50 mm velika tableta z vtisnjenim logotipom podjetja in oznako 700 na eni strani in brez oznake na drugi strani
What Pifeltro is and what it is used for What you need to know before you take Pifeltro How to take Pifeltro 
Kaj je zdravilo Pifeltro in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Pifeltro Kako jemati zdravilo Pifeltro Možni neželeni učinki
Although a limited number of subjects aged 65 years and over has been included (n=36), no clinically relevant differences in the pharmacokinetics of doravirine have been identified in subjects at least 65 years of age compared to subjects less than 65 years of age in a Phase 1 trial or in a population pharmacokinetic analysis. 
Čeprav je bilo vključenih le malo preiskovancev, starih 65 let ali več (n = 36), v preskušanju 1. faze oz. v populacijski farmakokinetični analizi niso ugotovili klinično pomembnih razlik v farmakokinetiki doravirina med preiskovanci, starimi vsaj 65 let, in preiskovanci, mlajšimi od 65 let.
Pregnancy There are no or limited amount of data from the use of doravirine in pregnant women. 
Podatkov o uporabi doravirina pri nosečnicah je malo ali jih sploh ni.
Each film-coated tablet contains 100 mg of doravirine. 
Ena filmsko obložena tableta vsebuje 100 mg doravirina.
• increased levels of creatine phosphokinase 
• zvišanje kreatin fosfokinaze
• The bottle contains a desiccant protecting the tablets from moisture. 
• Plastenka vsebuje sušilo, ki tablete varuje pred vlago.
Other medicines and Pifeltro 
Druga zdravila in zdravilo Pifeltro
*NRTIs in DOR arm: FTC/TDF (333) or ABC/3TC (50); NRTIs in DRV+r arm: FTC/TDF (335) or ABC/3TC (48) **Subjects received FTC/TDF 
*NRTI-ji v skupini z DOR: FTC/TDF (333) ali ABC/3TC (50); NRTI-ji v skupini z DRV+r: FTC/TDF (335) ali ABC/3TC
Common NNRTI-resistant mutations (K103N, Y181C) were not selected in the in vitro study. 
Pogosti mutaciji odpornosti proti NNRTI (K103N, Y181C) se v študiji in vitro nista selekcionirali.
Animal studies do not indicate harmful effects of doravirine on fertility at exposure levels higher than the exposure in humans at the recommended clinical dose (see section 5.3). 
Rezultati študij na živalih niso pokazali škodljivih vplivov doravirina na plodnost ob izpostavljenostih, ki so bile večje od izpostavljenosti pri človeku med uporabo priporočenega kliničnega odmerka (glejte poglavje 5.3).
Rare blood creatine phosphokinase increased insomnia includes: insomnia, initial insomnia and sleep disorder depression includes: depression, depressed mood, major depression, and persistent depressive disorder anxiety includes: anxiety and generalised anxiety disorder abdominal pain includes: abdominal pain, and abdominal pain upper abdominal discomfort includes: abdominal discomfort, and epigastric discomfort faeces soft includes: faeces soft and abnormal faeces gastrointestinal motility disorder includes: gastrointestinal motility disorder, and frequent bowel movements rash includes: rash, rash macular, rash erythematous, rash generalised, rash maculo-papular, rash papular, and urticarial alanine aminotransferase increased includes: alanine aminotransferase increased and hepatocellular injury 
Redki zvišanje kreatin-fosfokinaze v krvi nespečnost vključuje: nespečnost, nespečnost v zgodnji fazi in motnje spanja depresija vključuje: depresijo, depresivno razpoloženje, hudo depresijo in persistentno depresivno motnjo anksioznost vključuje: anksioznost in generalizirano anksiozno motnjo bolečine v trebuhu vključujejo: bolečine v trebuhu in bolečine v zgornjem delu trebuha nelagodje v trebuhu vključuje: nelagodje v trebuhu in nelagodje v epigastriju mehko blato vključuje: mehko blato in nenormalno blato motnja gastrointestinalne motilitete vključuje: motnjo gastrointestinalne motilitete in pogosto iztrebljanje izpuščaj vključuje: izpuščaj, makulozen izpuščaj, eritematozen izpuščaj, generaliziran izpuščaj, makulopapulozen izpuščaj, papulozen izpuščaj in urtikarijo zvišanje alanin-aminotransferaze vključuje: zvišanje alanin-aminotransferaze in okvaro jetrnih celic
The 95 % CIs were calculated using Miettinen and Nurminen's method with weights proportional to the size of each stratum (screening HBV-1 RNA > 100,000 copies/mL or ≤ 100,000 copies/mL. 
95 % IZ so bili izračunani po metodi Miettinena in Nurminena, pri čemer so bile uteži sorazmerne velikosti posameznega stratuma (HIV-1 RNA ob presejanju > 100.000 kopij/ml ali ≤ 100.000 kopij/ml).
Excipient with known effect Each film-coated tablet contains 222 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 222 mg laktoze (v obliki monohidrata).
Do not take Pifeltro if the above applies to you. 
Ne vzemite zdravila Pifeltro, če kaj od naštetega velja za vas.
P007 was a Phase 2b trial in antiretroviral treatment-naïve HIV-1 infected adult subjects (n = 340). 
P007 je bilo preskušanje faze 2b pri odraslih, okuženih s HIV-1, ki predhodno še niso prejemali protiretrovirusnega zdravljenja (n = 340).
Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class (see sections 4.4 and 5.1). 
Zdravilo Pifeltro je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih, okuženih s HIV-1, ki nimajo in tudi nikoli niso imeli znakov odpornosti proti nenukleozidnim zaviralcem reverzne transkriptaze (NNRTI) (glejte poglavji 4.4 in 5.1).