natgillin/translations-raw huggingface dataset:
300 mg once daily tenofovir AUC ↑ 23% tenofovir Cmin ↑ 24% tenofovir Cmax ↑ 19% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
300 mg jedanput dnevno tenofovir AUC ↑ 23% tenofovir Cmin ↑ 24% tenofovir Cmax ↑ 19% rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
Throughout co-administration of rilpivirine with rifabutin, the rilpivirine dose should be increased from 25 mg once daily to 50 mg once daily.
Tijekom istodobnog uzimanja rilpivirina i rifabutina, doza rilpivirina mora se povisiti s 25 mg jedanput dnevno na 50 mg jedanput dnevno.
ANALGESICS Paracetamol* 500 mg single dose paracetamol AUC ↔ paracetamol Cmin NA paracetamol Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↑ 26% rilpivirine Cmax ↔
ANALGETICI Paracetamol* jedna doza od 500 mg paracetamol AUC ↔ paracetamol Cmin NP paracetamol Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↑ 26% rilpivirin Cmax ↔
By baseline viral load (copies/ml)
Prema početnom virusnom opterećenju (kopije/ml)
The exposures at the embryo-foetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
Izloženost štakora i kunića najvećoj dozi kod koje nisu uočene embrio-fetalne nuspojave (NOAEL) bila je 15 odnosno 70 puta viša od izloženosti ljudi pri preporučenoj dozi od 25 mg jedanput dnevno.
Treatment-naïve HIV-1 infected adult patients
Odrasli bolesnici zaraženi virusom HIV-1 koji prethodno nisu bili liječeni
Co-administration of rilpivirine and medicinal products that inhibit CYP3A has been observed to increase the plasma concentrations of rilpivirine.
Primijećeno je da istovremena primjena rilpivirina i lijekova koji inhibiraju CYP3A povećava koncentracije rilpivirina u plazmi.
The evidence of efficacy of rilpivirine is based on the analyses of 96 week data from 2 randomised, double-blinded, active-controlled, Phase III trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE).
Odrasli bolesnici zaraženi s HIV-1 koji prethodno nisu bili liječeni Dokaz djelotvornosti rilpivirina temelji se na analizama podataka iz 96. tjedna dvaju randomiziranih, dvostruko slijepih ispitivanja s aktivnom kontrolom faze III TMC278-C209 (ECHO) i TMC278-C215 (THRIVE).
6 cells/l in the efavirenz arm in the pooled analysis of the ECHO and THRIVE trials [estimated treatment difference (95% CI): 11.3 (-6.8; 29.4)].
6 stanica/l u skupini koja je primala efavirenz [procijenjena terapijska razlika (95% CI): 11,3 (-6,8; 29,4)].
If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose of EDURANT until the next regularly scheduled dose.
Ako bolesnik povraća, a prošlo je više od 4 sata od uzimanja lijeka, bolesnik ne treba uzeti drugu dozu EDURANTA do sljedeće doze prema uobičajenom rasporedu uzimanja.
QT prolonging medicinal products
Lijekovi koji produljuju QT interval
In the week 96 efficacy analysis, the virologic response rate [confirmed undetectable viral load (< 50 HIV-1 RNA copies/ml)] was evaluated in patients receiving rilpivirine 25 mg once daily in addition to a BR versus patients receiving efavirenz 600 mg once daily in addition to a BR.
Stopa virološkog odgovora [potvrđeno nemjerljivo virusno opterećenje (< 50 HIV-1 RNK kopija/ml)] procijenjena je u 96. tjednu analize djelotvornosti u bolesnika koji su primali rilpivirin u dozi od 25 mg jedanput dnevno uz prateće liječenje, u usporedbi s bolesnicima koji su primali efavirenz u dozi od 600 mg jedanput dnevno uz prateće liječenje.
Antiretroviral treatment-naïve HIV-1 infected patients were enrolled who had a plasma HIV-1 RNA ≥ 5,000 copies/ml and were screened for susceptibility to N(t)RTIs and for absence of specific NNRTI resistance-associated mutations.
Uključeni su bili bolesnici zaraženi virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, imali su u plazmi HIV-1 RNK ≥ 5 000 kopija/ml i bili su probrani prema osjetljivosti na N(t)RTI-je te odsutnosti mutacija povezanih sa specifičnom rezistencijom na NNRTI.
The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Farmakokinetika rilpivirina nije ispitana u bolesnika s bubrežnom insuficijencijom.
Lopinavir/ritonavir (soft gel capsule)* 400/100 mg twice daily lopinavir AUC ↔ lopinavir Cmin ↓ 11% lopinavir Cmax ↔ rilpivirine AUC ↑ 52% rilpivirine Cmin ↑ 74% rilpivirine Cmax ↑ 29%
Lopinavir/ritonavir (meke želatinozne kapsule)* 400/100 mg dvaput dnevno lopinavir AUC ↔ lopinavir Cmin ↓ 11% lopinavir Cmax ↔ rilpivirin AUC ↑ 52% rilpivirin Cmin ↑ 74% rilpivirin Cmax ↑ 29%
Pharmacokinetic Results of Total Rilpivirine After Administration of Rilpivirine 25 mg Once Daily as Part of an Antiretroviral Regimen, During the 2
Tablica 7: Farmakokinetički rezultati ukupnog rilpivirina nakon primjene 25 mg rilpivirina jedanput na dan kao dijela antiretrovirusnog režima, tijekom 2. tromjesečja trudnoće, 3. tromjesečja trudnoće i postpartalno
Rifampicin* 600 mg once daily rifampicin AUC ↔ rifampicin Cmin NA rifampicin Cmax ↔ 25-desacetyl-rifampicin AUC ↓ 9% 25-desacetyl-rifampicin Cmin NA 25-desacetyl-rifampicin Cmax ↔ rilpivirine AUC ↓ 80% rilpivirine Cmin ↓ 89% rilpivirine Cmax ↓ 69%
Rifampicin* 600 mg jedanput dnevno rifampicin AUC ↔ rifampicin Cmin NP rifampicin Cmax ↔ 25-dezacetil-rifampicin AUC ↓ 9% 25-dezacetil-rifampicin Cmin NP 25-dezacetil-rifampicin Cmax ↔ rilpivirin AUC ↓ 80% rilpivirin Cmin ↓ 89% rilpivirin Cmax ↓ 69%
nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were, respectively, 21%, 29% and 35% lower as compared to postpartum; during the 3
U žena koje su primale 25 mg rilpivirina jedanput na dan tijekom 2. tromjesečja trudnoće, srednje intra-individualne vrijednosti za ukupni rilpivirin Cmax, AUC24h i Cmin bile su 21%, 29% i 35% niže u usporedbi s onima iz postpartalnog razdoblja; tijekom 3. tromjesečja trudnoće, vrijednosti Cmax, AUC24h i Cmin bile su 20%, 31% i 42% niže u usporedbi s onima iz postpartalnog razdoblja.
The BR consisted of 2 investigator-selected N(t)RTIs: zidovudine plus lamivudine or tenofovir disoproxil fumarate plus emtricitabine.
Osnovni režim sastojao se od 2 N(t)RTI-ja prema izboru ispitivača: zidovudin plus lamivudin ili tenofovir dizoproksil fumarat plus emtricitabin.
Tablet coating
Tablični sažetak nuspojava
HIV Integrase Strand Transfer Inhibitors Raltegravir*
Inhibitori prijenosa lanca integraze HIV-a Raltegravir*
Co-administration of rilpivirine and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine, which could reduce the therapeutic effect of rilpivirine.
Primijećeno je da istovremena primjena rilpivirina i lijekova koji induciraju CYP3A smanjuje koncentracije rilpivirina u plazmi, što može oslabiti terapijski učinak rilpivirina.
6 cells/l (range: 25 to 983 × 10
(raspon: 25 do 983 × 10
Skin and subcutaneous tissue disorders common rash
Poremećaji kože i potkožnog tkiva često osip
There were no new safety concerns identified in the Week 240 analysis of the TMC278-C213 trial in adolescents.
Prema analizama provedenima u 240. tjednu ispitivanja TMC278-C213 u adolescenata, nisu zabilježena nova sigurnosna pitanja.
BR=background regimen
BR = prateće liječenje
Medicinal products by therapeutic areas
Lijekovi prema terapijskim skupinama
The pharmacokinetics of rilpivirine in antiretroviral treatment-naïve HIV-1 infected adolescent subjects receiving EDURANT 25 mg once daily were comparable to those in treatment-naïve HIV-1 infected adults receiving EDURANT 25 mg once daily.
Pedijatrijska populacija (mlađi od 18 godina starosti) Farmakokinetika rilpivirina u adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima i koji su primali EDURANT u dozi od 25 mg jedanput dnevno bila je usporediva s onom u odraslih zaraženih virusom HIV-1 koji prethodno nisu bili liječeni te su primali EDURANT u dozi od 25 mg jedanput dnevno.
In THRIVE, the BR consisted of 2 investigator-selected N(t)RTIs: tenofovir disoproxil fumarate plus emtricitabine or zidovudine plus lamivudine or abacavir plus lamivudine.
U ispitivanju THRIVE, prateće liječenje sastojalo se od 2 N(t)RTI-ja po izboru ispitivača: tenofovir dizoproksil fumarat plus emtricitabin ili zidovudin plus lamivudin ili abakavir plus lamivudin.
Excipient with known effect Each film-coated tablet contains 56 mg lactose monohydrate.
Jedna filmom obložena tableta sadrži 56 mg laktoze hidrata.
Famotidine* 40 mg single dose taken 4 hours after rilpivirine rilpivirine AUC ↑ 13% rilpivirine Cmin NA rilpivirine Cmax ↑ 21%
Famotidin* jedna doza od 40 mg uzeta 4 sata nakon rilpivirina rilpivirin AUC ↑ 13% rilpivirin Cmin NP rilpivirin Cmax ↑ 21%
No dose adjustment of rilpivirine is required in patients with mild or moderate renal impairment.
Nije potrebna prilagodba doze rilpivirina u bolesnika s blagim ili umjerenim oštećenjem bubrega.
In ECHO, the BR was fixed to the N(t)RTIs, tenofovir disoproxil fumarate plus emtricitabine.
U ispitivanju ECHO, prateće liječenje bilo je fiksirano na N(t)RTI-je, tenofovir dizoproksil fumarat plus emtricitabin.
Famotidine* 40 mg single dose taken 2 hours before rilpivirine rilpivirine AUC ↓ 76% rilpivirine Cmin NA rilpivirine Cmax ↓ 85%
Famotidin* jedna doza od 40 mg uzeta 2 sata prije rilpivirina rilpivirin AUC ↓ 76% rilpivirin Cmin NP rilpivirin Cmax ↓ 85%
(Hypericum perforatum)
BILJNI PRIPRAVCI gospina trava (Hypericum perforatum)
Laboratory abnormalities
Laboratorijski poremećaji
400 mg once daily didanosine AUC ↑ 12% didanosine Cmin NA didanosine Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
400 mg jedanput dnevno didanozin AUC ↑ 12% didanozin Cmin NP didanozin Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Deksametazon (za sustavnu primjenu, osim za primjenu jedne doze)
From the week 48 to the week 96 analysis, 24 (3.5%) and 14 (2.1%) additional virologic failures occurred in the rilpivirine and efavirenz arm, respectively.
pojavilo se 24 (3,5%) i 14 (2,1%) dodatnih viroloških neuspjeha u skupini ispitanika liječenih rilpivirinom odnosno efavirenzom.
When rifabutin co-administration is stopped, the rilpivirine dose should be decreased to 25 mg once daily.
Nakon prestanka istodobne primjene s rifabutinom, doza rilpivirina mora se smanjiti na 25 mg jedanput dnevno
This observation was the same in the efavirenz arm.
Isto je primijećeno u skupini koja je primala efavirenz.
HIV PIs - without co-administration of low dose ritonavir Unboosted PIs (atazanavir, fosamprenavir, indinavir, nelfinavir)
Nepojačani inhibitori proteaze (atazanavir, fosamprenavir, indinavir, nelfinavir)
Discontinued for non-AE reason
Prekid liječenja zbog nekog drugog razloga a ne nuspojave
edurant 25 mg
16. PODACI NA BRAILLEOVOM PISMU edurant 25 mg
A strict dosing schedule, with intake of H2-receptor antagonists at least 12 hours before or at least 4 hours after rilpivirine should be used.
H2-receptora najmanje 12 sati prije ili najmanje 4 sata nakon rilpivirina.
A risk for increases in dabigatran plasma concentrations cannot be excluded.
Ne može se isključiti rizik za povećanja koncentracije dabigatrana u plazmi. (inhibicija crijevnog P-gp)
Tell your doctor immediately if you are pregnant or if you plan to become pregnant.
Ako ste trudni ili planirate imati dijete, odmah o tome obavijestite liječnika.
Each tablet of EDURANT contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Jedna tableta EDURANTA sadrži 25 mg rilpivirina u obliku rilpivirinklorida.
Antacids should only be administered either at least 2 hours before or at least 4 hours after rilpivirine.
Antacidi se smiju primijeniti najmanje 2 sata prije ili najmanje 4 sata poslije rilpivirina.
There is limited information regarding the use of EDURANT in patients > 65 years of age.
> 65 godina postoje ograničeni podaci.
The combination of rilpivirine and H2-receptor antagonists should be used with particular caution.
H2-receptora treba primjenjivati s posebnim oprezom.
In the pooled analysis for ECHO and THRIVE, demographics and baseline characteristics were balanced between the rilpivirine arm and the efavirenz arm. Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms.
U analizi objedinjenih podataka iz ispitivanja ECHO i THRIVE, demografske i početne značajke bile su ravnomjerno raspoređene između skupine koja je primala rilpivirin i skupine koja je primala efavirenz.
At week 96, the mean change from baseline in CD4+ cell count was +228 × 10
U analizi objedinjenih podataka u 96. tjednu ispitivanja ECHO i THRIVE, srednja promjena broja stanica CD4+ u odnosu na početne vrijednosti iznosila je +228 × 10
25-O-desacetyl-rifabutin AUC ↔ 25-O-desacetyl-rifabutin Cmin ↔ 25-O-desacetyl-rifabutin Cmax ↔
300 mg jedanput dnevno rifabutin AUC ↔ rifabutin Cmin ↔ rifabutin Cmax ↔ 25-O-dezacetil-rifabutin AUC ↔ 25-O-dezacetil-rifabutin Cmin ↔ 25-O-dezacetil-rifabutin Cmax ↔
6 cells/l Percentage of subjects with: hepatitis B/C virus co-infection Percentage of patients with the following background regimens: tenofovir disoproxil fumarate plus emtricitabine zidovudine plus lamivudine abacavir plus lamivudine
Postotak bolesnika na sljedećim osnovnim režimima: tenofovir dizoproksil fumarat plus emtricitabin zidovudin plus lamivudin abakavir plus lamivudin
ANTIMYCOBACTERIALS Rifabutin*
Rifabutin*
When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Kad su u zdravih odraslih ispitanika ispitivane doze rilpivirina više od preporučenih, 75 mg jedanput dnevno odnosno 300 mg jedanput dnevno, maksimalne srednje vremenski usklađene (95% gornja granica pouzdanosti) razlike u QTcF intervalu u odnosu na placebo nakon početne korekcije bile su
Interaction Geometric mean change (%)
Geometrijska sredina promjene
These rilpivirine resistance-associated mutations should only guide the use of EDURANT in the treatment-naïve population.
Ove mutacije povezane s rezistencijom na rilpivirin trebaju služiti samo kao smjernice u primjeni EDURANTA u bolesnika koji prethodno nisu bili liječeni.
ANTI-INFECTIVES Antiretrovirals HIV NRTIs/N[t]RTIs
Nukleozidni i nukleotidni inhibitori reverzne transkriptaze (NRTI / N[t]RTI) HIV-a Didanozin*
Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than the rilpivirine arm.
Zbog nuspojava, u 96. tjednu, bilo je više prekida liječenja u skupini liječenoj efavirenzom nego u skupini liječenoj rilpivirinom.
There are limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine in pregnant women (see sections 4.4, 5.1 and 5.2).
Podaci o primjeni rilpivirina u trudnica (vidjeti dijelove 4.4, 5.1 i 5.2) su ograničeni (manje od 300 trudnoća).
rilpivirine AUC ↑ 16%* rilpivirine Cmin ↔* rilpivirine Cmax ↑ 43%*
rilpivirin AUC ↑ 16%* rilpivirin Cmin ↔* rilpivirin Cmax ↑ 43%* * u usporedbi s 25 mg rilpivirina samog,
Study TMC278-C204 enrolled 368 HIV-1 infected treatment-naïve adult patients who had a plasma HIV-1 RNA ≥ 5,000 copies/ml, previously received ≤ 2 weeks of treatment with an N(t)RTI or protease inhibitor, had no prior use of NNRTIs and were screened for susceptibility to N(t)RTI and for absence of specific NNRTI resistance-associated mutations.
Ispitivanje TMC278-C204 uključilo je 368 odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni i imali su u plazmi HIV-1 RNK ≥ 5 000 kopija/ml, prethodno su primali
Rilpivirine should not be used in combination with systemic dexamethasone (except as a single dose) as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Rilpivirin se ne smije primjenjivati u kombinaciji s deksametazonom za sustavnu primjenu (osim kao jednostruke doze), jer istovremena primjena može rezultirati gubitkom terapijskog učinka rilpivirina (vidjeti dio 4.3).
No dose adjustment of EDURANT is required in patients with mild or moderate hepatic impairment.
Prilagodba doze EDURANTA nije potrebna u bolesnika s blagim ili umjerenim oštećenjem jetre.
Resistance to emtricitabine/lamivudine % (n/N)
Liječeni efavirenzom Rezistencija na emtricitabin/lamivudin % (n/N)
Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 25 mg rilpivirina u obliku rilpivirinklorida.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOČICI
800/100 mg once daily darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79%
Inhibitori proteaze (IP) HIV-a - uz istovremenu primjenu niske doze ritonavira Darunavir/ritonavir* 800/100 mg jedanput dnevno darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirin AUC ↑ 130% rilpivirin Cmin ↑ 178% rilpivirin Cmax ↑ 79%
50 mg single dose sildenafil AUC ↔ sildenafil Cmin NA sildenafil Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5) Sildenafil* jedna doza od 50 mg sildenafil AUC ↔ sildenafil Cmin NP sildenafil Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
Baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in the ECHO and THRIVE trials (pooled analysis)
Tablica 3: Početne značajke bolesti u odraslih ispitanika zaraženih s HIV-1 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, u ispitivanjima ECHO i THRIVE (analiza objedinjenih podataka) Objedinjeni podaci iz ispitivanja ECHO i THRIVE Rilpivirin + BR N = 686
Triacetin
ANTACIDI
At the recommended dose of 25 mg once daily, no dose adjustment is required when rilpivirine is co-administered with ketoconazole.
Prilagodba doze nije potrebna, kad se rilpivirin primjenjuje u preporučenoj dozi od 25 mg jedanput dnevno istovremeno s ketokonazolom.
Rilpivirine must not be used in combination with proton pump inhibitors as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Rilpivirin se ne smije primjenjivati u kombinaciji s inhibitorima protonske pumpe, jer će istovremena primjena vjerojatno rezultirati gubitkom terapijskog učinka rilpivirina (vidjeti dio 4.3).
The bottle comes with a child resistant cap.
Otvaranje sigurnosnog zatvarača za djecu Boca ima sigurnosni zatvarač za djecu.
Rilpivirine must not be used in combination with these anticonvulsants as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Rilpivirin se ne smije primjenjivati u kombinaciji s ovim antikonvulzivima, jer njihova istovremena primjena može dovesti do gubitka terapijskog učinka rilpivirina (vidjeti dio 4.3).
No dose adjustment is needed for patients with mild or moderate renal impairment.
Prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem bubrega nije potrebna.
Dose dependent decreases in rilpivirine plasma concentrations are expected.
Očekuju se smanjenja koncentracije rilpivirina u plazmi ovisna o dozi. (indukcija enzima CYP3A)
Cardiovascular
ANTIDIJABETICI
Increased exposure of rilpivirine is expected.
Očekuje se povećana izloženost rilpivirinu. (inhibicija enzima CYP3A)
Contact your doctor if uncertain about what to do if you miss a dose or vomit.
Ako niste sigurni što učiniti u slučaju da zaboravite uzeti dozu ili povraćate, obratite se svom liječniku.
Lansoprazole Rabeprazole Pantoprazole Esomeprazole
Pantoprazol Esomeprazol
Rilpivirine must not be used in combination with rifampicin as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Rilpivirin se ne smije primjenjivati u kombinaciji s rifampicinom, jer će istovremena primjena vjerojatno rezultirati gubitkom terapijskog učinka rilpivirina (vidjeti dio 4.3).
No dose adjustments are required when initiating co-administration of methadone with rilpivirine.
Kad se započinje primjena metadona istovremeno s rilpivirinom, nije potrebna prilagodba doze.
HIV PIs - with co-administration of low dose ritonavir Darunavir/ritonavir*
Inhibitori proteaze (IP) HIV-a - bez istovremene primjene niske doze ritonavira
Zidovudine/lamivudine
Nuspojave (Rilpivirin + BR)
Rilpivirine must not be used in combination with rifapentine as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Rilpivirin se ne smije primjenjivati u kombinaciji s rifapentinom jer će istovremena primjena vjerojatno rezultirati gubitkom terapijskog učinka rilpivirina (vidjeti dio 4.3).
Silicified microcrystalline cellulose Magnesium stearate
Jezgra tablete laktoza hidrat karmelozanatrij, umrežena povidon K30 polisorbat 20 mikrokristalična celuloza, silicirana magnezijev stearat
Resistance to efavirenz % (n/N) * The number of patients with virologic failure and paired genotypes (baseline and failure) were 71, 11, and 4 for rilpivirine and 30, 10,
Broj bolesnika s virološkim neuspjehom i sparenim genotipom (početni i neuspjeh) iznosio je 71 uz tenofovir/emtricitabin, 11 uz zidovudin/lamivudin i 4 uz abakavir/lamivudin u skupini koja je primala rilpivirin te 30 uz tenofovir/emtricitabin, 10 uz zidovudin/lamivudin i 2 uz abakavir/lamivudin u skupini koja je primala efavirenz.
Idelvion albutrepenonacog alfa
Idelvion albutrepenonakog alfa
It must also not be used in patients allergic to hamster proteins.
Također se ne smije upotrebljavati u bolesnika alergičnih na proteine hrčka.
This is a summary of the European public assessment report (EPAR) for Idelvion.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Idelvion.
Hypersensitivity (allergic) reactions can occur rarely with Idelvion and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Reakcije preosjetljivosti (alergijske reakcije) mogu se rijetko pojaviti tijekom primjene lijeka Idelvion te obuhvaćaju: oticanje, žarenje i peckanje na mjestu injekcije, zimicu, navalu crvenila, osip praćen svrbežom, glavobolju, koprivnjaču, niski krvni tlak, letargiju, mučninu i povraćanje, nemir, brzo kucanje srca, stezanje u prsima i piskanje pri disanju.
In a study in 80 adults and adolescents and another study in 27 children aged less than 12 years, Idelvion was effective at preventing bleeding, with most patients experiencing no bleeding while on preventive treatment.
U ispitivanju provedenom na 80 odraslih i adolescenata te drugom ispitivanju provedenom na 27 djece mlađe od 12 godina, Idelvion je bio učinkovit u sprečavanju krvarenja, pri čemu većina bolesnika nije krvarila tijekom preventivnog liječenja.
Furthermore, Idelvion was effective in treating bleeding episodes when they did occur; around 93% of the bleeding episodes resolved with one Idelvion injection.
Nadalje, Idelvion je bio učinkovit u liječenju epizoda krvarenja kada je do njih došlo; otprilike 93 % epizoda krvarenja zaustavljeno je jednom injekcijom lijeka Idelvion.
What measures are being taken to ensure the safe and effective use of Idelvion?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Idelvion?
Other information about Idelvion
Ostale informacije o lijeku Idelvion
The full EPAR for Idelvion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Idelvion nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Idelvion was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 February 2010.
Budući da je broj bolesnika s hemofilijom B nizak, bolest se smatra „rijetkom” te se Idelvion označava kao lijek za liječenje rijetkih bolesti od 4. veljače 2010.