natgillin/translations-raw huggingface dataset:
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).
Istodobna primjena s lijekovima koji su snažni induktori enzima citokroma P450 CYP3A kontraindicirana je jer se očekuju značajna sniženja koncentracija doravirina u plazmi, koja mogu smanjiti učinkovitost lijeka Pifeltro (vidjeti dijelove 4.4 i 4.5).
Nervous system disorders Common headache, dizziness, somnolence
Poremećaji živčanog sustava često glavobolja, omaglica, somnolencija
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)).
Uz ostale utvrđene supstitucije povezane s rezistencijom na NNRTI-je zabilježena je promjena za 5 - 10 puta (G190S [5,7 puta], K103N/P225H [7,9 puta], V108I/Y181C [6,9 puta], Y181V [5,1 put]).
Recommendation Concerning Co-administration with doravirine dasabuvir
Preporuka za istodobnu primjenu s doravirinom dasabuvir
Pifeltro 100 mg film-coated tablets.
Pifeltro 100 mg filmom obložene tablete.
• telotristat ethyl (a medicine to treat diarrhoea in people with carcinoid syndrome)
• etiltelotristat (lijek za liječenje proljeva u osoba s karcinoidnim sindromom)
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.
U ispitivanju DRIVE-SHIFT, prelazak na DOR/3TC/TDF bez odgode pokazao se neinferiornim u 48. tjednu u usporedbi s nastavkom početnog režima u 24. tjednu, što je procijenjeno prema omjeru ispitanika s HIV-1 RNK < 40 kopija/ml.
Uncommon disturbance in attention, memory impairment, paraesthesia, hypertonia, poor quality sleep
Nuspojave manje često poremećaj pažnje, poremećaj pamćenja, parestezija, hipertonija, loša kvaliteta sna
• 1 bottle with 30 film-coated tablets.
• 1 boca s 30 filmom obloženih tableta.
How to take Pifeltro
Kako uzimati Pifeltro
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.
Intervali pouzdanosti od 95% (95% CI) izračunati su Miettinenovom i Nurminenovom metodom, uz pondere proporcionalne veličini svakog stratuma (HBV-1 RNK pri probiru > 100 000 kopija/ml ili ≤ 100 000 kopija/ml) Pristup za postupanje s podacima koji nedostaju: Pristup utemeljen na opaženom neuspjehu liječenja (OF).
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).
Ako se istodobna primjena s drugim umjerenim induktorima CYP3A (npr., dabrafenibom, lesinuradom, bosentanom, tioridazinom, nafcilinom, modafinilom, etiltelotristatom) ne može izbjeći, potrebno je povećati dozu doravirina na 100 mg dvaput na dan (doze je potrebno uzeti u razmaku od približno 12 sati (vidjeti dio 4.2).
In Part I, subjects were randomized to receive one of 4 doses of doravirine or EFV, each in combination with FTC/TDF.
U prvom su dijelu ispitivanja (Part I) ispitanici bili randomizirani za primanje jedne od 4 doze doravirina ili EFV-a, oba u kombinaciji s FTC-om/TDF-om.
• The active substance is doravirine 100 mg.
• Djelatna tvar je doravirin u dozi od 100 mg.
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).
Doravirin se ne smije primjenjivati istodobno s lijekovima koji su snažni induktori enzima CYP3A jer se očekuju značajna sniženja koncentracija doravirina u plazmi, koja mogu smanjiti učinkovitost doravirina (vidjeti dijelove 4.3 i 5.2).
If you take more Pifeltro than you should Do not take more than the recommended dose.
Nemojte uzeti više od preporučene doze.
• feeling weak, general feeling of being unwell
• slabost, opće loše osjećanje.
There were no effects on fertility, mating performance or early embryonic development when doravirine was administered to rats up to 7 times the exposure in humans at the RHD.
Nije bilo učinaka na plodnost, sposobnost parenja ni rani razvoj zametka kada se doravirin primjenjivao štakorima u dozama pri kojima su postignute razine izloženosti do 7 puta veće od onih koje se postižu u ljudi kod primjene preporučene doze za ljude.
HIV-1 RNA < 40 copies/mL 32 (80) Treatment differences (95 % CI)
HIV-1 RNK < 40 kopija/ml Razlike između liječenja (95% CI)
A breakpoint for a reduction in susceptibility, yielded by various NNRTI substitutions, that is associated with a reduction in clinical efficacy has not been established.
Nije utvrđena granična vrijednost za smanjenje osjetljivosti, uzrokovano različitim supstitucijama koje dovode do rezistencije na NNRTI-je, a koje bi bilo povezano sa smanjenjem kliničke djelotvornosti.
Table 6: Efficacy response (Snapshot approach) in the DRIVE-SHIFT study
Snapshot approach) u ispitivanju DRIVE-SHIFT.
Expected:  norgestimate/ethinyl oestradiol
Očekivano:  norgestimat/etinilestradiol
Protease Inhibitors ritonavir
↔ pojačani inhibitori proteaze
Expected: ↔ lisinopril
Očekivano: ↔ lizinopril
• constipation, stomach discomfort, swollen or bloated stomach (abdominal distension),
• zatvor, nelagoda u trbuhu, natečen ili nadut trbuh (distenzija abdomena), probavne smetnje,
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 su obložene film ovojnicom koja sadrži sljedeće sastojke: karnauba vosak (E903), hipromelozu (E464), laktozu hidrat, titanijev dioksid (E171) i triacetin (E1518).
If you stop taking Pifeltro Do not run out of this medicine.
Ako ste zaboravili uzeti Pifeltro • Važno je da ne propuštate ili preskačete doze ovog lijeka.
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).
U podskupini u kojoj je provedena analiza rezistencije (ispitanici kojima je razina HIV-1 RNK bila veća od 400 kopija/ml u trenutku izostanka virološkog odgovora ili prijevremenog povlačenja iz ispitivanja i za koje su postojali podaci o rezistenciji) opažena je sljedeća de novo rezistencija.
If you have been told by your doctor that you have an intolerance to lactose, talk to your doctor before taking this medicine.
Pifeltro tablete sadrže laktozu Ako Vam je liječnik rekao da ne podnosite laktozu, obratite se liječniku prije uzimanja ovog lijeka.
Expected: ↔ doravirine ↔ enfuviritide maraviroc
Očekivano: ↔ doravirin ↔ enfuviritid maravirok
Respiratory, thoracic and mediastinal disorders Rare dyspnoea, tonsillar hypertrophy
Poremećaji dišnog sustava, prsišta i sredoprsja rijetko dispneja, hipertrofija krajnika
ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirine 100 mg SD)
ledipasvir + sofosbuvir (ledipasvir 90 mg SD + sofosbuvir 400 mg SD, doravirin 100 mg SD)
The pharmacokinetics of doravirine were studied in healthy subjects and HIV-1 infected subjects.
Farmakokinetika doravirina ispitivala se u zdravih ispitanika i ispitanika s HIV-1 infekcijom.
Biotransformation Based on in vitro data, doravirine is primarily metabolized by CYP3A.
Prema podacima in vitro, doravirin se primarno metabolizira putem enzima CYP3A.
• decreased levels of phosphate
• snižene razine fosfata
Expected: ↔ doravirine ↔ raltegravir ritonavir †-boosted elvitegravir
Očekivano: ↔ doravirin ↔ raltegravir elvitegravir pojačan ritonavirom
• 90 film-coated tablets (3 bottles of 30 film-coated tablets).
• 90 filmom obloženih tableta (3 boce s 30 filmom obloženih tableta).
Expected:  doravirine (CYP3A inhibition) ↔ elvitegravir
Očekivano: ↑ doravirin (inhibicija CYP3A) ↔ elvitegravir
Pifeltro 100 mg film-coated tablets doravirine
Pifeltro 100 mg filmom obložene tablete doravirin
What Pifeltro is used for
Za što se Pifeltro koristi
In in vitro studies, doravirine was able to suppress the following NNRTI-associated substitutions; K103N, Y181C, and G190A under clinically relevant concentrations.
U ispitivanjima in vitro doravirin je u klinički relevantnim koncentracijama uspio suprimirati sljedeće supstitucije povezane s rezistencijom na NNRTI-je: K103N, Y181C i G190A.
Metabolism and nutrition disorders Uncommon hypophosphataemia
Poremećaji metabolizma i prehrane manje često hipofosfatemija rijetko hipomagnezijemija
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.
Odrasli ispitanici u kojih je postignuta virološka supresija Djelotvornost prelaska na DOR/3TC/TDF s početnog režima koji se sastojao od dva nukleozidna inhibitora reverzne transkriptaze u kombinaciji s inhibitorom proteaze pojačanim ritonavirom ili kobicistatom ili elvitegravirom pojačanim kobicistatom, ili od NNRTI-ja, procijenjena je u randomiziranom ispitivanju otvorenog tipa (DRIVE-SHIFT) u odraslih ispitanika zaraženih HIV-om u kojih je postignuta virološka supresija.
If doravirine is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily (approximately 12 hours apart).
Ako se doravirin primjenjuje istodobno s rifabutinom, dozu doravirina treba povećati na 100 mg dvaput na dan (u razmaku od približno 12 sati).
See “Other medicines and Pifeltro” section for a list of medicines.
Za popis lijekova pogledajte odlomak „Drugi lijekovi i Pifeltro“.
• The other ingredients are croscarmellose sodium E468; hypromellose acetate succinate; lactose monohydrate; magnesium stearate E470b; microcrystalline cellulose E460; and silica, colloidal anhydrous E551.
• Drugi sastojci su umrežena karmelozanatrij (E468), hipromeloza acetat sukcinat, laktoza hidrat, magnezijev stearat (E470b), mikrokristalična celuloza (E460) i bezvodni koloidni silicijev dioksid (E551).
Week 48 and 96 outcomes for DRIVE-FORWARD and DRIVE-AHEAD are provided in Table 4.
Ishodi u 48. i 96. tjednu ispitivanja DRIVE-FORWARD i DRIVE-AHEAD prikazani su u Tablici 4. Režimi temeljeni na doravirinu pokazali su dosljednu djelotvornost kod svih demografskih i početnih prognostičkih faktora.
Croscarmellose sodium (E468) Hypromellose acetate succinate Lactose monohydrate Magnesium stearate (E470b) Microcrystalline cellulose (E460) Silica, colloidal anhydrous (E551)
Jezgra tablete karmelozanatrij, umrežena (E468) hipromeloza acetat sukcinat laktoza hidrat magnezijev stearat (E470b) celuloza, mikrokristalična (E460) silicijev dioksid, koloidni, bezvodni (E551)
Acid-Reducing Agents antacid (aluminium and magnesium hydroxide oral suspension) (20 mL SD, doravirine 100 mg SD)
Lijekovi koji smanjuju količinu želučane kiseline antacid (aluminijev i magnezijev hidroksid u obliku oralne suspenzije) (20 ml SD, doravirin 100 mg SD)
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)].
Immediate Switch Group (ISG)] ili su ostali pri svom početnom režimu do 24. tjedna, nakon čega su prešli na DOR/3TC/TDF [N=223, skupina s odgođenim prelaskom, engl.
Film-coating Carnauba wax (E903) Hypromellose (E464) Lactose monohydrate Titanium dioxide (E171)
Film ovojnica karnauba vosak (E903) hipromeloza (E464) laktoza hidrat titanijev dioksid (E171) triacetin (E1518)
Rare aggression, hallucination, adjustment disorder, mood altered, somnambulism
2, anksioznost razdražljivost, konfuzija, suicidalne misli rijetko agresivnost, halucinacija, poremećaj prilagodbe, promjena raspoloženja, somnambulizam
• Periodic safety update reports (PSURs)
Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
If Pifeltro is co-administered with rifabutin, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 12 hours apart) (see section 4.5).
Ako se Pifeltro primjenjuje istodobno s rifabutinom, treba uzimati jednu tabletu lijeka Pifeltro od 100 mg dvaput na dan (u razmaku od približno 12 sati) (vidjeti dio 4.5).
indigestion, soft stools, stomach spasms
meke stolice, grčevi u trbuhu
Observed emergent amino acid substitutions in RT included: V106A, V106M, V106I, V108I, F227L, F227C, F227V, H221Y, M230I, L234I, P236L, and Y318F.
Opažene aminokiselinske supstitucije u reverznoj transkiptazi koje su se pojavile tijekom liječenja uključivale su sljedeće: V106A, V106M, V106I, V108I, F227L, F227C, F227V, H221Y, M230I, L234I, P236L i Y318F.
When doravirine is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart) (see section 4.2).
Kada se doravirin istodobno primjenjuje s rifabutinom, potrebno je povećati dozu doravirina na 100 mg dvaput na dan (doze je potrebno uzeti u razmaku od približno 12 sati) (vidjeti dio 4.2).
Table 5: Efficacy response at week 24 (Snapshot approach)
Tablica 5: Odgovor s obzirom na djelotvornost u 24. tjednu (Pristup utemeljen na algoritmu za globalnu snimku distribuiranog sustava, engl.
Expected: ↔ doravirine ↔ abacavir
Očekivano: ↔ doravirin ↔ abakavir
0.03 mg ethinyl oestradiol/ 0.15 mg levonorgestrel SD, doravirine 100 mg QD
Oralni kontraceptivi etinilestradiol 0,03 mg/levonorgestrel 0,15 mg SD, doravirin 100 mg QD
Doravirine 25 mg
Doravirin 25 mg
20-200 mg QD individualised dose, doravirine 100 mg QD
Opioidni analgetici metadon individualizirana doza od 20 - 200 mg QD, doravirin 100 mg QD
A panel of 96 diverse clinical isolates containing NNRTI-associated mutations was evaluated for susceptibility to doravirine in the presence of 10 % foetal bovine serum.
Kako bi se utvrdila osjetljivost na doravirin u prisutnosti 10%-tnog fetalnog goveđeg seruma, ocijenjen je panel od 96 različitih kliničkih izolata koji su sadržavali mutacije povezane s rezistencijom na NNRTI-je.
Nucleoside Reverse Transcriptase Inhibitors tenofovir disoproxil (245 mg QD, doravirine 100 mg SD)
Nukleozidni inhibitori reverzne transkriptaze tenofovirdizoproksil (245 mg QD, doravirin 100 mg SD)
Integrase Strand Transfer Inhibitors dolutegravir (50 mg QD, doravirine 200 mg QD)
Inhibitori prijenosa lanca integraze dolutegravir (50 mg QD, doravirin 200 mg QD)
 doravirine AUC 1.15 (1.07, 1.24) Cmax 1.11 (0.97, 1.27) C24 1.24 (1.13, 1.36)
AUC 1,15 (1,07; 1,24) Cmax 1,11 (0,97; 1,27) C24 1,24 (1,13; 1,36)
Expected: ↔ doravirine ↔ maraviroc
Očekivano: ↔ doravirin ↔ maravirok
Expected: ↔ canagliflozin ↔ liraglutide ↔ sitagliptin
Očekivano: ↔ kanagliflozin ↔ liraglutid ↔ sitagliptin
Doravirine 200 mg
Doravirin 200 mg
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.
U nastavku se navode podaci temeljeni na populacijskoj farmakokinetičkoj analizi farmakokinetike doravirina u stanju dinamičke ravnoteže nakon primjene doze od 100 mg jedanput na dan u ispitanika s HIV-1 infekcijom.
Mean CD4 change from baseline (cells/mm
Srednja vrijednost promjene broja CD4 stanica od početka ispitivanja (stanice/mm
How to store Pifeltro
Kako čuvati Pifeltro
 doravirine AUC 3.54 (3.04, 4.11) Cmax 1.31 (1.17, 1.46) C24 2.91 (2.33, 3.62) (Inhibition of CYP3A)
AUC 3,54 (3,04; 4,11) Cmax 1,31 (1,17; 1,46) C24 2,91 (2,33; 3,62) (inhibicija CYP3A)
rifabutin (300 mg QD, doravirine 100 mg SD)
rifabutin (300 mg QD, doravirin 100 mg SD)
Doravirine 50 mg
Doravirin 50 mg
 dolutegravir AUC 1.36 (1.15, 1.62) Cmax 1.43 (1.20, 1.71) C24 1.27 (1.06, 1.53) (Inhibition of BCRP)
↑ dolutegravir AUC 1,36 (1,15; 1,62) Cmax 1,43 (1,20; 1,71) C24 1,27 (1,06; 1,53) (inhibicija BCRP-a)
No dose adjustment of doravirine is required in patients with mild, moderate, or severe renal impairment.
Nije potrebno prilagođavati dozu doravirina u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega.
Doravirine has not been studied in patients with end-stage renal disease and has not been studied in dialysis patients (see section 5.2).
Doravirin se nije ispitivao u bolesnika sa završnim stadijem bubrežne bolesti ni u bolesnika na dijalizi (vidjeti dio 5.2).
Expected: ↔ doravirine ↔ emtricitabine tenofovir alafenamide
Očekivano: ↔ doravirin ↔ emtricitabin tenofoviralafenamid
Pharmacokinetic Enhancers ritonavir (100 mg BID, doravirine 50 mg SD)
Farmakokinetički pojačivači ritonavir (100 mg BID, doravirin 50 mg SD)
Recommendation Concerning Co-administration with doravirine
Preporuka za istodobnu primjenu s doravirinom
Doravirine 100 mg
Doravirin 100 mg
+ T cell count greater than 200 cells per mm
T-stanica veći od 200 stanica/mm
Expected:  doravirine (Inhibition of CYP3A4)
Očekivano: ↑ doravirin (inhibicija CYP3A4)
After week 24, all subjects randomized to receive doravirine were switched to (or maintained on) doravirine 100 mg. Additional subjects were randomized in Part II to receive either doravirine 100 mg or EFV, each in combination with FTC/TDF.
U drugom su dijelu ispitivanja (Part II) dodatni ispitanici randomizirani za primanje doravirina u dozi od 100 mg ili EFV-a, oba u kombinaciji s FTC-om/TDF-om.
Expected: ↔ doravirine ↔ tenofovir alafenamide
Očekivano: ↔ doravirin ↔ tenofoviralafenamid
Recommendation Concerning Co-administration with doravirine emtricitabine
Preporuka za istodobnu primjenu s doravirinom emtricitabin
↔ elvitegravir cobicistat-boosted elvitegravir
↔ elvitegravir elvitegravir pojačan kobicistatom
 doravirine AUC 1.00 (0.89, 1.12) Cmax 1.06 (0.88, 1.28) C24 0.98 (0.88, 1.09)
↔ doravirin AUC 1,00 (0,89; 1,12) Cmax 1,06 (0,88; 1,28) C24 0,98 (0,88; 1,09)
 lamivudine AUC 0.94 (0.88, 1.00) Cmax 0.92 (0.81, 1.05)
↔ lamivudin AUC 0,94 (0,88; 1,00) Cmax 0,92 (0,81; 1,05)
No clinically relevant racial differences in the pharmacokinetics of doravirine have been identified based on a population pharmacokinetic analysis of doravirine in healthy and HIV-1 infected subjects.
U populacijskoj farmakokinetičkoj analizi podataka o primjeni doravirina u zdravih ispitanika i ispitanika s HIV-1 infekcijom nisu utvrđene klinički značajne razlike u farmakokinetici doravirina s obzirom na rasu.
Expected: ↔ buprenorphine ↔ naloxone
Očekivano: ↔ buprenorfin ↔ nalokson
 doravirine AUC 0.74 (0.61, 0.90) Cmax 0.76 (0.63, 0.91) C24 0.80 (0.63, 1.03)
AUC 0,74 (0,61; 0,90) Cmax 0,76 (0,63; 0,91) C24 0,80 (0,63; 1,03)
Common NNRTI-resistant mutations (K103N, Y181C) were not selected in the in vitro study.
U ispitivanju in vitro nisu izdvojene uobičajene mutacije koje uzrokuju rezistenciju na NNRTI-je (K103N, Y181C).
↔ boosted PIs
To može ojačati
Baseline CD4 cell count was carried forward for subjects who discontinued assigned therapy due to lack of efficacy.
U ispitanika koji su prekinuli dodijeljenu terapiju zbog nedostatne djelotvornosti prenosio se početni broj CD4 stanica.
buprenorphine naloxone
buprenorfin nalokson
Expected:  doravirine (inhibition of CYP3A)
Očekivano: ↑ doravirin (inhibicija CYP3A)
Renal and urinary disorders Rare acute kidney injury, renal disorder, calculus urinary, nephrolithiasis General disorders and administration site conditions Common fatigue
Poremećaji bubrega i mokraćnog sustava rijetko akutna ozljeda bubrega, poremećaj bubrega, mokraćni kamenac, nefrolitijaza
If you get any side effects, talk to your doctor,pharmacist, or nurse.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
Viral subtype non-B
Uspješno provedena genotipizacija, n
Difference (95 % CI) 4.2 % (-1.4%, 9.7 %)
Razlika (95 % CI)
cobicistat
Nuspojave
Expected:  doravirine daclatasvir
Očekivano: ↔ doravirin daklatazvir
Your doctor may check your blood levels or monitor for side effects if you take the following medicines with Pifeltro:
Ako uz lijek Pifeltro uzimate i sljedeće lijekove, liječnik će Vam možda provjeriti krvnu sliku ili pratiti
Cobicistat-boosted elvitegravir
Tablični prikaz nuspojava
abacavir
abakavir
• muscle pain, joint pain
• bol u mišićima, bol u zglobovima
†- boosted PIs (atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, saquinavir, tipranavir)
Inhibitori proteaze inhibitori proteaze pojačani ritonavirom (atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, sakvinavir, tipranavir)
Minimum, maximum
Minimum, maksimum
Black or African American White
Crna ili afričko-američka Bijela
50 to < 65
50 do < 65
Median (IQR), months
Medijan (IQR), mjeseci
Overall survival (interim analysis)c
Ukupno preživljenje (interim analiza)
The effect of food
Učinak hrane
As a result, the cancer cells can no longer repair themselves and they die.
Kao rezultat, stanice raka se ne mogu više popravljati i umiru.
You can take Talzenna with food or between meals.
Možete uzeti lijek Talzenna s hranom ili između obroka.
Talzenna could harm an unborn baby.
Talzenna može naškoditi nerođenoj bebi.
Tell your doctor straight away if you notice any of the following symptoms which could be a sign of serious blood disorder:
Odmah obavijestite svog liječnika ako imate ijedan od sljedećih simptoma koji mogu biti znak ozbiljnih poremećaja krvi:
Talzenna with food and drink
Talzenna s hranom i pićem
Age, sex, and body weight
Dob, spol i tjelesna težina
Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant.
- Razgovarajte o kontracepciji s Vašim liječnikom ako postoji ikakva mogućnost da Vi ili Vaša partnerica ostanete trudni.
Recommended dose reductions are indicated in Table 1.
Preporučena smanjenja doze navedena su u tablici 1.
d. Conducted in ITT with measurable disease population who had an objective response.
Provedeno na ITT populaciji s mjerljivom bolešću koja je imala objektivan odgovor.
90537 Feucht Germany
90537 Feucht Njemačka
Contact with the capsule content should be avoided.
Treba izbjeći kontakt sa sadržajem kapsule.
g. For talazoparib Grade 1 is 21% and Grade 2 is 2%.
Za talazoparib stupanj 1 iznosi 21 %, a stupanj 2 iznosi 2 %.
Most of the histopathologic findings were generally reversible while the testes findings were partially reversible after 4 weeks of dosing cessation.
Većina histopatoloških rezultata bila je uglavnom reverzibilna dok su rezultati testisa bili djelomično reverzibilni nakon 4 tjedna prekida doziranja.
If you take more Talzenna than you should
Ako uzmete više lijeka Talzenna nego što ste trebali
Co-administration should only be considered after careful evaluation of the potential benefits and risks.
Istodobnu primjenu treba uzeti u obzir samo nakon pažljive procjene mogućih koristi i rizika.
Objective response by investigatord,e
Objektivni odgovor prema ispitivaču d,e
Take the carton and this leaflet so that the doctor knows what you have been taking.
Uzmite sa sobom kutiju i ovu uputu tako da liječnik zna što uzimate.
If you stop taking Talzenna Do not stop taking Talzenna unless your doctor tells you to.
Ako prestanete uzimati lijek Talzenna Nemojte prestati uzimati lijek Talzenna osim ako Vam liječnik to nije rekao.
The OS interim analysis was performed at 51% for the total number of planned events.
Interim analiza ukupnog preživljenja provedena je kod 51 % za ukupan broj planiranih događaja.
Other medicines and Talzenna
Drugi lijekovi i Talzenna
Talzenna is used when the cancer has spread beyond the original tumour or to other parts of the body.
Talzenna se koristi kada se rak proširi izvan originalnog tumora ili na druge dijelove tijela.