natgillin/translations-raw huggingface dataset:
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).
Table 1: Interactions of doravirine with other medicinal products
Preglednica 1: Medsebojna delovanja doravirina z drugimi zdravili
What Pifeltro looks like and contents of the pack Pifeltro is available as a white, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 700 on one side and plain on the other side.
Izgled zdravila Pifeltro in vsebina pakiranja Zdravilo Pifeltro je na voljo v obliki belih filmsko obloženih tablet ovalne oblike z vtisnjenim logotipom podjetja in oznako 700 na eni strani in brez oznake na drugi strani.
See also “Other Medicines and Pifeltro” section.
Glejte tudi poglavje "Druga zdravila in zdravilo Pifeltro".
HIV Antiviral Agents Fusion and Entry Inhibitors enfuvirtide
Protivirusna zdravila proti HIV Zaviralci spojitve in vstopa enfuvirtid
A documented absence of genotypic resistance (prior to starting first therapy) to doravirine, lamivudine, and tenofovir was part of the inclusion criteria for patients who switched from a PI- or INI-based regimen.
Potrjena odsotnost genotipske odpornosti (pred začetkom prvega zdravljenja) proti doravirinu, lamivudinu in tenofovirju je bila del meril za vključitev pri bolnikih, ki so prešli iz sheme na osnovi zaviralcev proteaz (PI - protease inhibitors) ali zaviralcev integraz (INI - integrase inhibitors).
• if you are taking the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for seizures) rifampicin, rifapentine (medicines for tuberculosis) St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it mitotane (a medicine to treat cancer) enzalutamide (a medicine to treat prostate cancer) lumacaftor (a medicine to treat cystic fibrosis)
• če jemljete katero koli od naslednjih zdravil: karbamazepin, okskarbazepin, fenobarbital, fenitoin (zdravila za zdravljenje epileptičnih napadov), rifampicin, rifapentin (zdravili za zdravljenje tuberkuloze), šentjanževko (Hypericum perforatum, zdravilo rastlinskega izvora za zdravljenje depresije in tesnobe) ali izdelke, ki jo vsebujejo, mitotan (zdravilo za zdravljenje raka), enzalutamid (zdravilo za zdravljenje raka prostate), lumakaftor (zdravilo za zdravljenje cistične fibroze).
Therefore caution should be used when co-administering doravirine with medicinal products that are sensitive CYP3A substrates that also have a narrow therapeutic window (e.g., tacrolimus and sirolimus).
Zato je med sočasno uporabo doravirina in zdravil, ki so občutljivi substrati CYP3A in imajo tudi ozko terapevtsko okno (npr. takrolimus in sirolimus), potrebna previdnost.
• nightmares, depression, anxiety, irritability, confusion, suicidal thoughts
• nočne more, depresija, tesnoba (anksioznost), razdražljivost, zmedenost, samomorilne misli
Pifeltro must be used in combination with other medicines for HIV.
Zdravilo Pifeltro je treba uporabljati v kombinaciji z drugimi zdravili proti virusu HIV.
In a pooled analysis combining data from two treatment-naïve trials (P007 and DRIVE-AHEAD), a lower proportion of subjects who discontinued due to an adverse event by week 48 was seen for the combined doravirine (100 mg) treatment groups (2.8 %) compared with the combined EFV treatment group (6.1 %) (treatment difference -3.4 %, p-value 0.012).
V združeni analizi, ki je zajela podatke dveh preskušanj pri predhodno še nezdravljenih bolnikih (P007 in DRIVE-AHEAD), je bil delež preiskovancev, ki so z zdravljenjem do 48. tedna prenehali zaradi kakšnega neželenega učinka, manjši v združenih terapevtskih skupinah z doravirinom (100 mg) (2,8 %) kakor v združeni terapevtski skupini z EFV (6,1 %) (razlika med zdravljenjema -3,4 %, vrednost p 0,012).
If the patient misses a dose of Pifeltro within 12 hours of the time it is usually taken, the patient should take as soon as possible and resume the normal dosing schedule.
Če bolnik izpusti odmerek zdravila Pifeltro in je od časa, ko ga vzame po navadi, minilo manj kot 12 ur, mora zdravilo vzeti čim prej in nato nadaljevati jemanje po običajnem urniku.
Doravirine is primarily metabolized and eliminated by the liver.
Doravirin se v prvi vrsti presnovi in odstrani v jetrih.
Uncommon lipase increased, aspartate aminotransferase increased, amylase increased, haemoglobin decreased
Občasni zvišanje lipaze, zvišanje aspartataminotransferaze, zvišanje amilaze, znižanje hemoglobina
Talk to your doctor before taking the following medicines withPifeltro,as your doctor may need to change thedose ofyour medicines:
Preden vzamete katero od naslednjih zdravil skupajz zdravilom Pifeltro, se posvetujte z zdravnikom, kajti morda vam bo moral spremeniti odmerek vaših zdravil:
Expected:  doravirine glecaprevir, pibrentasvir
Pričakovano:  doravirin glekaprevir, pibrentasvir
Effects of other medicinal products on doravirine
Vpliv drugih zdravil na doravirin
Doravirine steady state pharmacokinetics following administration of 100 mg once daily to HIV-1 infected subjects, based on a population pharmacokinetics analysis, are provided below.
Spodaj je prikazana farmakokinetika doravirina v stanju dinamičnega ravnovesja po uporabi 100 mg enkrat na dan pri preiskovancih, okuženih s HIV-1, na podlagi populacijske farmakokinetične analize.
If a patient misses a dose by more than 12 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time.
Če bolnik izpusti odmerek zdravila in je od časa, ko ga vzame po navadi, minilo več kot 12 ur, naj ne vzame izpuščenega odmerka, temveč naj namesto tega vzame naslednji odmerek ob rednem predvidenem času.
Subjects must have been virologically suppressed (HIV-1 RNA < 40 copies/mL) on their baseline regimen for at least 6 months prior to trial entry, with no history of virologic failure, and a documented absence of RT substitutions conferring resistance to doravirine, lamivudine and tenofovir (see section Resistance).
Preiskovanci so morali biti med uporabo svoje izhodiščne sheme virološko suprimirani (HIV-1 RNA < 40 kopij/ml) vsaj 6 mesecev pred vključitvijo v preskušanje, v anamnezi niso smeli imeti virološkega neuspeha, in so morali imeti potrjeno odsotnost substitucij RT, ki povzročajo odpornost proti doravirinu, lamivudinu in tenofovirju (glejte poglavje Odpornost).
Note: Both doravirine and efavirenz were administered with emtricitabine/tenofovir disoproxil (FTC/TDF).
Opomba: Tako doravirin kot efavirenz sta bila uporabljena skupaj z emtricitabinom/dizoproksiltenofoviratom (FTC/TDF).
See list under “Do not take Pifeltro” section.
Glejte seznam v poglavju "Ne jemljite zdravila Pifeltro".
When used with other medicines, Pifeltro works by preventing HIV from making more viruses in your body.
Če se zdravilo Pifeltro uporablja skupaj z drugimi zdravili, preprečuje pomnoževanje virusa HIV v telesu.
Expected:  doravirine sofosbuvir
Pričakovano:  doravirin sofosbuvir
Uncommon disturbance in attention, memory impairment, paraesthesia, hypertonia, poor quality sleep
Občasni motnje pozornosti, motnje spomina, parestezije, hipertonija, slaba kakovost spanja
At baseline, the median age of subjects was 31 years (range 18-70 years), 85 % were male, 52 % were non-white, 3% had hepatitis B or C co-infection, 14 % had a history of AIDS, 21 % had HIV-1 RNA > 100,000 copies per mL, and 12 % had CD4
V izhodišču je bila mediana starost preiskovancev 31 let (razpon: od 18 do 70 let), 85 % je bilo moških, 52 % je bilo nebelcev, 3 % so imeli sočasno okužbo z virusom hepatitisa B in/ali C, 14 % je imelo v anamnezi aids, 21 % je imelo HIV-1 RNA > 100.000 kopij/ml in 12 % jih je imelo število celic T CD4
• trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality sleep
• težave z zbranostjo, težave s spominom, mravljinčenje v dlaneh in stopalih, togost mišic, slaba kakovost spanja
If co-administration cannot be avoided, one tablet of doravirine should be taken twice daily (approximately 12 hours apart).
Če se sočasni uporabi ni mogoče izogniti, je treba jemati po eno tableto doravirina dvakrat na dan (v presledku približno 12 ur).
In Part I, subjects were randomized to receive one of 4 doses of doravirine or EFV, each in combination with FTC/TDF.
V I. delu so preiskovance randomizirali na prejemanje enega od 4 odmerkov doravirina ali EFV, obeh v kombinaciji s FTC/TDF.
• telotristat ethyl (a medicine to treat diarrhoea in people with carcinoid syndrome)
• etiltelotristat (zdravilo za zdravljenje driske pri osebah s karcinoidnim sindromom),
Opioid Analgesics methadone
Opioidni analgetiki metadon
If your doctor decides you should take these medicines with Pifeltro, one tablet of doravirine should be taken twice daily (approximately 12 hours apart).
Če zdravnik presodi, da morate ta zdravila jemati skupaj z zdravilom Pifeltro, morate vzeti po eno tableto doravirina dvakrat na dan (v presledku približno 12 ur).
Other established NNRTI substitutions yielded a fold change of 5-10 (G190S (5.7), K103N/P225H (7.9), V108I/Y181C (6.9), Y181V (5.1)).
Druge ugotovljene z NNRTI povezane substitucije so povzročile od 5- do 10-kratno spremembo (G190S (5,7-kratno), K103N/P225H (7,9-kratno), V108I/Y181C (6,9-kratno), Y181V (5,1-kratno)).
Respiratory, thoracic and mediastinal disorders Rare dyspnoea, tonsillar hypertrophy
Bolezni dihal, prsnega koša in mediastinalnega prostora Redki dispneja, hipertrofija tonzil
In both parts of the trial, doravirine and EFV were administered as blinded-therapy and FTC/TDF was administered open-label.
V obeh delih preskušanja sta bila doravirin in EFV uporabljena kot slepljeno zdravljenje, kombinacija FTC/TDF pa je bila uporabljena odprto.
Pifeltro contains the active substance doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Zdravilo Pifeltro vsebuje učinkovino doravirin - nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
Mean CD4 change from baseline (cells/mm
Povprečna sprememba CD4 od izhodišča (celic/mm
Refill your prescription or talk to your doctor before it is all gone.
Zdravilo prevzemite v lekarni ali se posvetujte z zdravnikom, še preden vam zmanjka zdravila.
Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccant.
Vsaka škatla vsebuje plastenko iz polietilena velike gostote (HDPE) s polipropilensko, za otroke varno zaporko in silicijevim dioksidom kot sušilom.
Rare hypomagnesaemia
Redki hipomagneziemija
Antiviral activity in combination with other HIV antiviral medicinal products The antiviral activity of doravirine was not antagonistic when combined with the NNRTIs delavirdine, efavirenz, etravirine, nevirapine, or rilpivirine; the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir disoproxil, or zidovudine; the PIs darunavir or indinavir; the fusion inhibitor enfuvirtide; the CCR5 co-receptor antagonist maraviroc; or the integrase strand transfer inhibitor raltegravir.
Protivirusna aktivnost doravirina ni bila antagonistična, če je bil uporabljen z NNRTI-ji delavirdinom, efavirenzem, etravirinom, nevirapinom ali rilpivirinom; NRTI-ji abakavirjem, didanozinom, emtricitabinom, lamivudinom, stavudinom, dizoproksiltenofoviratom ali zidovudinom; zaviralcema proteaz darunavirjem ali indinavirjem; zaviralcem vstopanja v celice (spojitve) enfuvirtidom; CCR5 koreceptorskim antagonistom maravirokom ali zaviralcem prenosa zapisa integraze raltegravirjem.
The efficacy of switching from a baseline regimen consisting of two nucleoside reverse transcriptase inhibitors in combination with a ritonavir- or cobicistat-boosted PI, or cobicistat-boosted elvitegravir, or an NNRTI to DOR/3TC/TDF was evaluated in a randomized, open-label trial (DRIVE-SHIFT), in virologically suppressed HIV-1 infected adults.
Učinkovitost prehoda z izhodiščne sheme (ki je obsegala dva nukleozidna zaviralca reverzne transkriptaze v kombinaciji z zaviralcem proteaz, ojačenim z ritonavirjem ali kobicistatom, ali z elvitegravirjem, ojačenim s kobicistatom, ali z nekim NNRTI) na DOR/3TC/TDF so ocenili v randomiziranem, odprtem preskušanju (DRIVE-SHIFT) pri virološko suprimiranih odraslih, okuženih s HIV-1.
In the DRIVE-SHIFT trial, an immediate switch to DOR/3TC/TDF was demonstrated to be noninferior at Week 48 compared to continuation of the baseline regimen at Week 24 as assessed by the proportion of subjects with HIV-1 RNA < 40 copies/mL.
Preskušanje DRIVE-SHIFT je pokazalo, da takojšen prehod na DOR/3TC/TDF po 48 tednih ni bil inferioren nadaljevanju izhodiščne sheme po 24 tednih, kar je bilo ocenjeno z deležem preiskovancev s HIV-1 RNA < 40 kopij/ml.
Subjects were randomized to either switch to DOR/3TC/TDF at baseline [N = 447, Immediate Switch Group (ISG)], or stay on their baseline regimen until Week 24, at which point they switched to DOR/3TC/TDF [N = 223, Delayed Switch Group (DSG)].
Preiskovance so randomizirali bodisi na prehod na DOR/3TC/TDF izhodiščno [N = 447, skupina s takojšnjim prehodom (ISG - Immediate Switch Group)] bodisi na nadaljevanje izhodiščne sheme do 24. tedna, ko so prešli na DOR/3TC/TDF [N = 223, skupina z odloženim prehodom (DSG - Delayed Switch Group)].
Use caution when driving or riding a bicycle, or operating machines if you feel dizzy, tired, or sleepy after taking this medicine.
Vpliv na sposobnost upravljanja vozil in strojev Če ste po jemanju tega zdravila omotični, utrujeni ali zaspani, bodite previdni pri upravljanju vozil, vožnji s kolesom in upravljanju strojev.
Co-administration of doravirine with other moderate CYP3A inducers has not been evaluated, but decreased doravirine concentrations are expected.
Sočasna uporaba doravirina z drugimi zmernimi induktorji CYP3A ni ovrednotena, pričakuje pa se zmanjšanje koncentracije doravirina.
No dose adjustment of doravirine is needed in elderly patients (see section 5.2).
Starejše osebe Pri starejših bolnikih odmerka doravirina ni treba prilagoditi (glejte poglavje 5.2).
• The active substance is doravirine 100 mg.
• Učinkovina je 100 mg doravirina.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Če imate kakršna koli dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Recommendation Concerning Co-administration with doravirine dasabuvir
Priporočilo glede sočasne uporabe z doravirinom dasabuvir
Baseline Regimen = ritonavir or cobicistat-boosted PI (specifically atazanavir, darunavir, or lopinavir), or cobicistat-boosted elvitegravir, or NNRTI (specifically efavirenz, nevirapine, or rilpivirine), each administered with two NRTIs.
Izhodiščna shema = zaviralec proteaz (specifično atazanavir, darunavir ali lopinavir), ojačen z ritonavirjem ali kobicistatom, ali elvitegravir, ojačen s kobicistatom, ali NNRTI (specifično efavirenz, nevirapin ali rilpivirin), vsi uporabljeni z dvema NRTI.
DRV + r + 2 NRTIs (383)
DRV + r + NRTI*(383)
Pifeltro 100 mg film-coated tablets doravirine
Pifeltro 100 mg filmsko obložene tablete doravirin
Expected: ↔ lisinopril
Pričakovano: ↔ lizinopril
In the DRIVE-SHIFT clinical trial, no subjects developed genotypic or phenotypic resistance to DOR, 3TC, or TDF during the initial 48 weeks (immediate switch, N=447) or 24 weeks (delayed switch, N=209) of treatment with DOR/3TC/TDF.
V kliničnem preskušanju DRIVE-SHIFT se med zdravljenjem z DOR/3TC/TDF pri nobenem preiskovancu v prvih 48 tednih (takojšen prehod, N=447) ali 24 tednih (odložen prehod, N=209) ni pojavila ne genotipska ne fenotipska odpornost proti DOR, 3TC ali TDF.
Consistent results were seen for the comparison at study Week 24 in each treatment group.
V 24. tednu so bili rezultati med obema terapevtskima skupinama primerljivi.
Doravirine should not be coadministered with medicinal products that are strong CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of doravirine (see sections 4.3 and 5.2).
Doravirina se ne sme uporabljati sočasno z zdravili, ki so močni induktorji encima CYP3A, ker je mogoče pričakovati pomembno zmanjšanje koncentracije doravirina v plazmi, to pa lahko zmanjša učinkovitost doravirina (glejte poglavji 4.3 in 5.2).
If you forget to take Pifeltro
Če ste prenehali jemati zdravilo Pifeltro
The pharmacokinetics of doravirine were studied in healthy subjects and HIV-1 infected subjects.
Farmakokinetiko doravirina so proučevali pri zdravih osebah in preiskovancih, okuženih s HIV-1.
If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, the doravirine dose should be increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart) (see section 4.2).
Če se sočasni uporabi z drugimi zmernimi induktorji CYP3A (npr. z dabrafenibom, lesinuradom, bosentanom, tioridazinom, nafcilinom, modafinilom, etiltelotristatom) ni mogoče izogniti, je treba odmerek doravirina povečati na 100 mg dvakrat na dan (te odmerke je treba vzeti v presledku približno 12 ur) (glejte poglavje 4.2).
How Pifeltro works
Kako deluje zdravilo Pifeltro
Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Po začetku jemanja zdravil za zdravljenje okužbe s HIV se lahko pojavijo tudi avtoimunske bolezni (stanja, do katerih pride, ko imunski sistem napade zdravo telesno tkivo).
Pharmacotherapeutic group: Antivirals for systemic use, ATC code: J05AG06
Oznaka ATC: J05AG06
If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 12 hours apart).
Če se sočasni uporabi z drugimi zmernimi induktorji CYP3A (npr. z dabrafenibom, lesinuradom, bosentanom, tioridazinom, nafcilinom, modafinilom, etiltelotristatom) ni mogoče izogniti, je treba jemati po eno 100-mg tableto zdravila Pifeltro dvakrat na dan (v presledku približno 12 ur)
3; these characteristics were similar between treatment groups.
+ < 200 celic/mm 3; te značilnosti so bile med terapevtskima skupinama podobne.
Pifeltro 100 mg film-coated tablets.
Pifeltro 100 mg filmsko obložene tablete
Expected: ↔ canagliflozin ↔ liraglutide ↔ sitagliptin
Pričakovano: ↔ kanagliflozin ↔ liraglutid ↔ sitagliptin
HIV-1 RNA < 40 copies/mL 32 (80) Treatment differences (95 % CI)
HIV-1 RNA < 40 kopij/ml Razlika med zdravljenji (95 % IZ)
Co-administration with medicinal products that are strong cytochrome P450 CYP3A enzyme inducers is contraindicated as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of Pifeltro (see sections 4.4 and 4.5).
Kontraindicirana je sočasna uporaba z močnimi induktorji encima citokroma P450 CYP3A, ker je mogoče pričakovati pomembno zmanjšanje koncentracije doravirina v plazmi, to pa lahko zmanjša učinkovitost zdravila Pifeltro (glejte poglavji 4.4 in 4.5).
Biotransformation Based on in vitro data, doravirine is primarily metabolized by CYP3A.
Na podlagi podatkov in vitro se doravirin v prvi vrsti presnovi s CYP3A.
The tablets are film-coated with a coating material containing the following ingredients: carnauba wax E903; hypromellose E464; lactose monohydrate; titanium dioxide E171; and triacetin E1518.
Tablete so filmsko obložene; sestavine materiala obloge so: karnauba vosek E903, hipromeloza E464, laktoza monohidrat, titanov dioksid E171 in triacetin E1518.
• The other ingredients are croscarmellose sodium E468; hypromellose acetate succinate; lactose monohydrate; magnesium stearate E470b; microcrystalline cellulose E460; and silica, colloidal anhydrous E551.
• Druge sestavine zdravila so premreženi natrijev karmelozat E468, hipromeloza acetat sukcinat, laktoza monohidrat, magnezijev stearat E470b, mikrokristalna celuloza E460 in brezvodni koloidni silicijev dioksid E551.
If you stop taking Pifeltro Do not run out of this medicine.
Če ste pozabili vzeti zdravilo Pifeltro • Pomembno je, da odmerkov tega zdravila ne izpustite in ne preskočite.
HIV-1 RNA copies/mL
HIV-1 RNA kopij/ml
• decreased levels of phosphate
• znižanje koncentracije fosfata
See “Other medicines and Pifeltro” section for a list of medicines.
Za seznam teh zdravil glejte poglavje "Druga zdravila in zdravilo Pifeltro".
If you are not sure, talk to your doctor, pharmacist, or nurse before taking Pifeltro.
Če ste negotovi, se pred začetkom jemanja zdravila Pifeltro posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Film-coating Carnauba wax (E903) Hypromellose (E464) Lactose monohydrate Titanium dioxide (E171)
Filmska obloga karnauba vosek (E903) hipromeloza (E464) laktoza monohidrat titanov dioksid (E171) triacetin (E1518)
Croscarmellose sodium (E468) Hypromellose acetate succinate Lactose monohydrate Magnesium stearate (E470b) Microcrystalline cellulose (E460) Silica, colloidal anhydrous (E551)
Jedro tablete premreženi natrijev karmelozat (E468) hipromeloza acetat sukcinat laktoza monohidrat magnezijev stearat (E470b) mikrokristalna celuloza (E460) silicijev dioksid, koloidni brezvodni (E551)
Expected: ↔ doravirine ↔ raltegravir ritonavir †-boosted elvitegravir
Pričakovano: ↔ doravirin ↔ raltegravir z ritonavirjem† ojačeni elvitegravir
How to take Pifeltro
Kako jemati zdravilo Pifeltro
Expected: ↔ doravirine ↔ tenofovir alafenamide
Pričakovano: ↔ doravirin ↔ tenofovir-alafenamid
If doravirine is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily (approximately 12 hours apart).
Če je doravirin uporabljen sočasno z rifabutinom, je treba odmerek doravirina povečati na 100 mg dvakrat na dan (v presledku približno 12 ur).
If you have been told by your doctor that you have an intolerance to lactose, talk to your doctor before taking this medicine.
Tablete zdravila Pifeltro vsebujejo laktozo Če vam je zdravnik povedal, da ne prenašate laktoze, se z njim posvetujte, preden vzamete to zdravilo.
Expected: ↔ doravirine ↔ maraviroc
Pričakovano: ↔ doravirin ↔ maravirok
Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Pifeltro.
Opozorila in previdnostni ukrepi Preden vzamete zdravilo Pifeltro, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Metabolism and nutrition disorders Uncommon hypophosphataemia
Presnovne in prehranske motnje Občasni hipofosfatemija
•bosentan (a medicine to treat lung disease) •dabrafenib (a medicine to treat skin cancer)
• dabrafenib (zdravilo za zdravljenje kožnega raka),
ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirine 100 mg SD)
ledipasvir + sofosbuvir (90 mg ledipasvirja enkratni odmerek + 400 mg sofosbuvirja enkratni odmerek, doravirin 100 mg enkratni odmerek)