natgillin/translations-raw huggingface dataset:
Description of clinical studies of darunavir/ritonavir in adults
Opis kliničkih ispitivanja darunavira/ritonavira u odraslih
Monitoring of renal function may be indicated when REZOLSTA is given in combination with tenofovir disoproxil, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Praćenje funkcije bubrega može biti indicirano kada se REZOLSTA daje u kombinaciji s tenofovirdizoproksilom, posebno kod bolesnika s podležećom sistemskom ili bubrežnom bolešću ili kod bolesnika koji uzimaju nefrotoksične lijekove.
It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with REZOLSTA.
Preporučuje se praćenje internacionalnog normaliziranog omjera (INR) kada se varfarin primjenjuje istodobno s lijekom REZOLSTA.
The safety and efficacy of REZOLSTA, darunavir, or cobicistat have not been established in patients with severe underlying liver disorders.
Sigurnost i djelotvornost lijeka REZOLSTA, darunavira ili kobicistata nisu ustanovljene kod bolesnika s teškim podležećim poremećajima jetre.
Pregnant or breast-feeding mothers should not take REZOLSTA.
Trudnice ili dojilje ne smiju uzimati lijek REZOLSTA.
As darunavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see sections 4.2 and 5.2).
S obzirom da darunavir i kobicistat imaju visok afinitet vezanja na proteine plazme, nije vjerojatno da bi se značajno uklonili hemodijalizom ili peritonealnom dijalizom (vidjeti dijelove 4.2 i 5.2).
Severe hepatic impairment could result in an increase of darunavir and/or cobicistat exposure and a worsening of its safety profile.
Teško oštećenje jetre može rezultirati povećanom izloženošću darunaviru i/ili kobicistatu i pogoršati njegov sigurnosni profil.
No adjustment of methadone dosage is expected when initiating co-administration with REZOLSTA.
Ne očekuje se prilagodba doze metadona kada se započinje istodobna primjena s lijekom REZOLSTA.
Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A and P-glycoprotein (see section 4.5).
Po život opasne i smrtonosne interakcije lijekova prijavljene su u bolesnika liječenih kolhicinom i snažnim inhibitorima CYP3A i P-glikoproteina (P-gp) (vidjeti dio 4.5).
Lurasidone Pimozide Sertindole Quetiapine
Lurasidon Pimozid Sertindol Kvetiapin
Following intravenous administration, the volume of distribution of darunavir alone was 88.1 ± 59.0 l (Mean ± SD) and increased to 131 ± 49.9 l (Mean ± SD) in the presence of 100 mg twice-daily ritonavir.
Nakon intravenske primjene, volumen distribucije samog darunavira bio je 88,1 ± 59,0 l (srednja vrijednost ± SD) i povećao se na 131 ± 49,9 l (srednja vrijednost ± SD) u prisutnosti 100 mg ritonavira dva puta na dan.
- Apixaban, edoxaban, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.
- apiksaban, edoksaban, rivaroksaban, varfarin (smanjuju zgrušavanje krvi) jer njihov terapijski učinak ili nuspojave mogu biti izmijenjene; liječnik će Vam možda htjeti provjeriti krvnu sliku.
The table below shows the efficacy data of the 48 week analyses from the GS-US-216-130 trial:
Tablica ispod pokazuje podatke djelotvornosti iz analize nakon 48 tjedana iz GS-US-216-130 ispitivanja:
(OATP1B and CYP3A inhibition)
(OATP1B i CYP3A inhibicija)
In GS-US-216-130 baseline phenotype was not available
Kod GS-US-216-130 fenotip na početku nije bio dostupan
Stevens-Johnson syndrome
Stevens-Johnsonov sindrom #, angioedem,
The film-coating contains polyvinyl alcoholpartially hydrolyzed, titanium dioxide, polyethylene glycol (macrogol), talc, iron oxide red, and iron oxide black.
Film ovojnica sadrži poli(vinilni alkohol) - djelomično hidroliziran, titanijev dioksid, polietilenglikol (makrogol), talk, željezov oksid, crveni i željezov oksid, crni.
Side effects with unknown frequency: a rash may become severe or potentially life-threatening: - rash with blisters and peeling skin over much of the body - red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever.
Nuspojave s nepoznatom učestalošću: osip može postati težak ili potencijalno može ugroziti život: - osip s mjehurićima i ljuštenjem kože na većim površinama tijela - crveni osip prekriven malim uzdignućima ispunjenim gnojem koja se mogu proširiti po tijelu i ponekad mogu biti popraćena vrućicom.
Patients should be instructed to take REZOLSTA within 30 minutes after completion of a meal (see sections 4.4, 4.5 and 5.2).
Bolesnike se mora uputiti da uzimaju lijek REZOLSTA unutar 30 minuta nakon završetka obroka (vidjeti dijelove 4.4, 4.5 i 5.2).
The most frequent adverse reactions reported during the darunavir/ritonavir clinical development program and as spontaneous reports are diarrhoea, nausea, rash, headache, and vomiting.
Najčešće nuspojave prijavljene tijekom kliničkog razvojnog programa darunavira/ritonavira i spontano prijavljene su proljev, mučnina, osip, glavobolja i povraćanje.
Co-administration of REZOLSTA and rilpivirine can be used without dose adjustments, as the expected increase in rilpivirine concentrations is not considered clinically relevant.
REZOLSTA s rilpivirinom se može istodobno primijeniti bez prilagodbe doze, jer se ne očekuje da će očekivani porast koncentracije rilpivirina biti klinički značajan.
The mean eGFRCG change from baseline was -9.6 mL/min at week 2, and -9.6 mL/min at week 48.
Srednja vrijednost promjene eGFRCG u odnosu na početnu bila je -9,6 ml/min u 2. tjednu, i -9,6 ml/min u 48. tjednu.
Changes were observed in liver (hepatocyte hypertrophy, vacuolation, increased liver enzymes) and thyroid (follicular hypertrophy).
Primijećene su promjene na jetri (hipertrofija hepatocita, vakuolizacija, povišeni enzimi jetre) i štitnjači (hipertrofija folikula).
REZOLSTA should not be used in combination with another antiretroviral that requires pharmacoenhancement since dosing recommendations for such combination have not been established.
REZOLSTA se ne smije uzimati u kombinaciji s drugim antiretrovirusnim lijekom kojemu je potrebno farmakokinetičko pojačanje budući da preporuke doziranja za takve kombinacije nisu ustanovljene.
Rash occurred more commonly in treatment-experienced patients receiving regimens containing darunavir/ritonavir + raltegravir compared to patients receiving darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir (see section 4.8).
Osip se javio češće u bolesnika koji su primali liječenje po režimima koji sadrže darunavir/ritonavir + raltegravir u usporedbi s bolesnicima koji su liječeni darunavirom/ritonavirom bez raltegravira ili raltegravirom bez darunavira/ritonavira (vidjeti dio 4.8).
This effect on serum creatinine, leading to a decrease in the estimated creatinine clearance, should be taken into consideration when REZOLSTA is administered to patients, in whom the estimated creatinine clearance is used to guide aspects of their clinical management, including adjusting doses of co-administered medicinal products.
Ovaj učinak na kreatinin u serumu, koji dovodi do smanjenja procijenjenog klirensa kreatinina, mora se uzeti u obzir kada se REZOLSTA primjenjuje bolesnicima u kojih se na temelju procijenjenog klirensa kreatinina donose odluke o kliničkom liječenju, uključujući prilagodbu doza istodobno primijenjenih lijekova.
Otherwise, there were no effects on mating or fertility with darunavir treatment up to 1,000 mg/kg/day and exposure levels below (AUC-0.5 fold) of that in human at the clinically recommended dose.
S druge strane, nije bilo učinka na parenje ili plodnost s liječenjem darunavirom do 1000 mg/kg/dan i razinama izloženosti ispod onih (AUC - 0,5 puta) kod klinički preporučenih doza za ljude.
The dosage of other medicines might need to be changed since either their own or REZOLSTA's therapeutic effect or side effects may be influenced when combined.
Postoji mogućnost da će biti potrebno promijeniti doziranje drugih lijekova, s obzirom na mogućnost promjene terapijskog učinka ili nuspojava tih lijekova ili lijeka REZOLSTA kada se primjenjuju u kombinaciji.
REZOLSTA is, therefore, contraindicated in patients with severe hepatic impairment.
REZOLSTA je stoga kontraindicirana kod bolesnika s teškim oštećenjem jetre.
OESTROGEN-BASED CONTRACEPTIVES Drospirenone (3 mg once daily)
NA BAZI ESTROGENA Drospirenon (3 mg jedanput na dan)
Concentrations of voriconazole may increase or decrease when co-administered with REZOLSTA.
Koncentracije vorikonazola mogu se povećati ili smanjiti kada se primjenjuju istodobno s lijekom REZOLSTA.
In patients taking REZOLSTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.
U bolesnika koji uzimaju lijek REZOLSTA i raltegravir (za HIV infekciju) u kombinaciji, osipi (obično blagi ili umjereni) se mogu javiti češće nego u bolesnika koji uzimaju samo jedan od ovih lijekova.
In the virologic failures of the GS-US-216-130 trial no cross-resistance with other HIV PIs was observed.
Kod viroloških neuspjeha u ispitivanju GS-US-216-130 nije opažena križna rezistencija s drugim IP HIV-a.
Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see section 5.2), which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child.
Liječenje darunavirom/kobicistatom 800/150 mg tijekom trudnoće rezultira niskom izloženošću darunaviru (vidjeti dio 5.2), što može biti povezano s povećanim rizikom neuspjeha liječenja i povećanim rizikom prijenosa HIV-a na dijete.
Limited information is available in this population, and therefore, REZOLSTA should be used with caution in patients above 65 years of age (see sections 4.4 and 5.2).
Za ovu populaciju dostupne su ograničene informacije, stoga se REZOLSTA u bolesnika starijih od 65 godina mora primjenjivati s oprezom (vidjeti dijelove 4.4 i 5.2).
PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Sildenafil Tadalafil Vardenafil
INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5) Za liječenje erektilne disfunkcije Sildenafil
Based on the very limited renal elimination of cobicistat and darunavir, no special precautions or dose adjustments of REZOLSTA are required for patients with renal impairment.
Temeljeno na vrlo ograničenoj bubrežnoj eliminaciji kobicistata i darunavira, za bolesnike s oštećenjima bubrega nisu potrebne posebne mjere opreza ili prilagodba doze lijeka REZOLSTA.
As REZOLSTA contains darunavir and cobicistat, interactions that have been identified with darunavir (in combination with cobicistat or with low dose ritonavir) or with cobicistat determine the interactions that may occur with REZOLSTA.
Budući da REZOLSTA sadrži darunavir i kobicistat, interakcije koje su identificirane s darunavirom (u kombinaciji s kobicistatom ili s niskom dozom ritonavira) ili s kobicistatom predodređuju interakcije koje se mogu pojaviti s lijekom REZOLSTA.
If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using REZOLSTA, interruption or discontinuation of treatment should be considered promptly.
Ako postoje dokazi o novoj ili pogoršanju disfunkcije jetre (uključujući klinički značajno povišenje jetrenih enzima i/ili simptome poput umora, anoreksije, mučnine, žutice, tamne mokraće, osjetljivosti jetre, hepatomegalije) kod bolesnika koji uzimaju lijek REZOLSTA, mora se odmah razmotriti privremeni ili trajni prekid liječenja.
What REZOLSTA contains - The active substances are darunavir and cobicistat.
Što REZOLSTA sadrži - Djelatne tvari su darunavir i kobicistat.
Some clinical trials suggest raltegravir may cause a modest decrease in darunavir plasma concentrations.
Neka klinička ispitivanja pokazuju da raltegravir može uzrokovati umjereno smanjenje koncentracija darunavira u plazmi.
Immune reconstitution inflammatory syndrome (IRIS)
Upalni sindrom imunološke rekonstitucije (IRIS)
At the highest tested doses, the systemic exposures (based on AUC) to darunavir when co-administered with ritonavir were between 0.4- and 0.7-fold (mice) and 0.7- and 1-fold (rats), relative to those observed in humans at the recommended therapeutic doses.
Pri najvišim ispitivanim dozama, sistemske izloženosti darunaviru (temeljene na AUC) kada je primijenjen istodobno s ritonavirom bile su između 0,4 i 0,7 puta (kod miševa) te 0,7 i 1 puta (kod štakora), u odnosu na opaženu izloženost kod ljudi pri preporučenim terapijskim dozama.
Data based on analyses at week 48
Podaci dobiveni analizama u 48. tjednu
If concomitant use of REZOLSTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Ako je istodobna primjena lijeka REZOLSTA indicirana sa sildenafilom, vardenafilom ili tadalafilom, tada su preporučene sljedeće doze: jednokratna doza sildenafila ne prelazi 25 mg u 48 sati, jednokratna doza vardenafila ne prelazi 2,5 mg u 72 sata ili jednokratna doza tadalafila ne prelazi 10 mg u 72 sata.
REZOLSTA is not recommended for use in paediatric patients (3 to 17 years of age).
Ne preporučuje se primjena lijeka REZOLSTA u pedijatrijskih bolesnika (u dobi od 3 do 17 godina).
As REZOLSTA contains darunavir and cobicistat, the adverse reactions associated with each of the individual compounds may be expected.
Budući da REZOLSTA sadrži darunavir i kobicistat, mogu se očekivati nuspojave povezane sa svakom od pojedinih komponenti.
The overall safety profile of REZOLSTA is based on available clinical trial data from darunavir boosted with either cobicistat or ritonavir, from cobicistat and from post-marketing data from darunavir/ritonavir.
Ukupni sigurnosni profil lijeka REZOLSTA temelji se na dostupnim podacima iz kliničkih ispitivanja darunavira pojačanog bilo kobicistatom bilo ritonavirom, iz kliničkih ispitivanja kobicistata i iz podataka nakon stavljanja lijeka u promet za darunavir/ritonavir.
- This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
- Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po doznoj jedinici, tj. zanemarive količine natrija.
Systemic dexamethasone should be used with caution when combined with REZOLSTA.
Sistemski deksametazon se mora primjenjivati s oprezom kada se kombinira s lijekom REZOLSTA.
Concomitant use of PDE-5 inhibitors for the treatment of erectile dysfunction with REZOLSTA should be done with caution.
Mora se s oprezom istodobno primjenjivati inhibitore PDE-5 za liječenje erektilne disfunkcije s lijekom REZOLSTA.
For these neuroleptics, consider reducing the dose of the neuroleptic upon co-administration with REZOLSTA.
Za te neuroleptike razmotrite smanjenje doze kod istodobne primjene s lijekom REZOLSTA.
Since darunavir and cobicistat are highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substances.
S obzirom da darunavir i kobicistat imaju visoki afinitet vezanja na proteine, nije vjerojatno da bi dijaliza bila korisna za značajnije uklanjanje djelatnih tvari.
Change of estimated glomerular filtration rate calculated by Cockcroft-Gault method (eGFRCG) from baseline was observed within 7 days after start of treatment with cobicistat 150 mg among subjects with normal renal function (-9.9 ± 13.1 mL/min) and mild to moderate renal impairment (-11.9 ± 7.0 mL/min).
Promjena procijenjene brzine glomerularne filtracije izračunata prema Cockcroft-Gaultovoj metodi (eGFRCG) u odnosu na početnu bila je uočena u roku od 7 dana nakon početka liječenja s kobicistatom od 150 mg među ispitanicima s normalnom funkcijom bubrega (-9,9 ± 13,1 ml/min), te s blagim do umjerenim oštećenjem bubrega (-11,9 ± 7,0 ml/min).
Low levels of metabolites are observed in urine and feces and do not contribute to the CYP3A inhibitory activity of cobicistat.
Niske razine metabolita opažene su u mokraći i stolici i ne pridonose inhibitornoj aktivnosti kobicistata na CYP3A.
- The other ingredients are hypromellose, silicified microcrystalline cellulose, colloidal silicon dioxide, crospovidone and magnesium stearate.
- Drugi sastojci su hipromeloza, silicirana mikrokristalična celuloza, koloidni silicijev dioksid, krospovidon i magnezijev stearat.
ANTIFUNGALS Clotrimazole Fluconazole Itraconazole Isavuconazole Posaconazole
ANTIFUNGICI Klotrimazol Flukonazol Itrakonazol Izavukonazol Posakonazol
These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Oni mogu uključiti žutu boju kože ili bjeloočnica, tamnu mokraću (boje čaja), blijede stolice, mučninu, povraćanje, gubitak apetita, ili bol, probadanje ili bol i nelagodu na desnoj strani u predjelu ispod rebara.
In all other ART-experienced patients or if HIV-1 genotype testing is not available, the use of REZOLSTA is not appropriate and another antiretroviral regimen should be used.
Primjena lijeka REZOLSTA nije prikladna za sve druge bolesnike prethodno liječene ART-om ili ako pretrage genotipa HIV-1 nisu dostupne, te se mora primijeniti drugi antiretrovirusni režim.
In the rat, the combination of darunavir with ritonavir lead to a small increase in effect on RBC parameters, liver and thyroid and increased incidence of islet fibrosis in the pancreas (in male rats only) compared to treatment with darunavir alone.
Kod štakora, kombinacija darunavira s ritonavirom dovela je do malog povećanja učinka na parametre eritrocita, jetru i štitnjaču, te povećane incidencije fibroze otočića u pankreasu (samo kod mužjaka štakora) u usporedbi s liječenjem sa samim darunavirom.
HIV-1 RNA < 50 copies/mL Virologic failure No virologic data in 48-week window
HIV-1 RNK < 50 kopija/ml Virološki neuspjeh Bez podataka o virološkom odgovoru tijekom 48 tjedana
Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/mL).
Darunavir pokazuje aktivnost protiv laboratorijskih sojeva i kliničkih izolata HIV-1, te laboratorijskih sojeva HIV-2 u akutno inficiranim linijama T-stanica, humanim mononuklearnim stanicama iz periferne krvi i humanim monocitima/makrofagima s medijanom vrijednosti EC50 u rasponu od 1,2 do 8,5 nM (0,7 do 5,0 ng/ml).
Treatment with REZOLSTA during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2).
Liječenje lijekom REZOLSTA tijekom trudnoće rezultira niskom izloženošću darunaviru (vidjeti dijelove 4.4 i 5.2).
ART-naïve patients The recommended dose regimen is one film-coated tablet of REZOLSTA once daily taken with food.
Bolesnici koji nisu prethodno liječeni antiretrovirusnom terapijom (ART-om) Preporučeni režim doziranja je jedna filmom obložena tableta lijeka REZOLSTA jedanput na dan, uzeta s hranom.
Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as darunavir, where bioavailability is limited and half-life is shortened due to CYP3A-dependent metabolism.
Inhibicija metabolizma posredovanog s CYP3A kobicistatom, povećava sistemsku izloženost supstratima CYP3A, poput darunavira, čija je bioraspoloživost ograničena i poluvijek skraćen radi metabolizma ovisnog o CYP3A.
Expected interactions between REZOLSTA and antiretroviral and non-antiretroviral medicinal products are listed in the table below and are based on the identified interactions with darunavir/ritonavir, darunavir/cobicistat and with cobicistat.
Očekivane interakcije između lijeka REZOLSTA i antiretrovirusnih i ne-antiretrovirusnih lijekova su navedene u tablici niže i temelje se na identificiranim interakcijama s darunavirom/ritonavirom, darunavirom/kobicistatom i s kobicistatom.
Limited data is available in patients with HIV-1 clades other than B (see section 5.1).
Za bolesnike s drugim podtipovima HIV-1 osim B dostupni su ograničeni podaci (vidjeti dio 5.1).
The recommended dose of emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with REZOLSTA.
Preporučena doza emtricitabin/ tenofoviralafenamida kada se uzima s lijekom REZOLSTA je 200/10 mg jedanput na dan.
Darunavir is an inhibitor of CYP3A, a weak inhibitor of CYP2D6 and an inhibitor of P-gp.
Darunavir je inhibitor CYP3A, slabi inhibitor CYP2D6 i inhibitor P-gp-a.
Based on theoretical considerations dolutegravir is not expected to affect the pharmacokinetics of REZOLSTA.
Temeljeno na teorijskim postavkama, ne očekuje se da će dolutegravir utjecati na farmakokinetiku lijeka REZOLSTA.
Plasma concentrations of these medicinal products may be increased when co-administered with REZOLSTA, resulting in reduced serum cortisol concentrations.
Mogu biti povećane koncentracije tih lijekova u plazmi kada se primjenjuju istodobno s lijekom REZOLSTA, što dovodi do smanjenih koncentracija kortizola u serumu.
Non completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0
Bolesnik koji nije završio ispitivanje zabilježen je kao neuspjeh: bolesnicima koji su prijevremeno prekinuli ispitivanje pripisana je promjena jednaka 0.
Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir.
Lijekom izazvan hepatitis (npr. akutni hepatitis, citolitički hepatitis) bio je prijavljen kod liječenja darunavirom/ritonavirom.
A common side effect of REZOLSTA is skin rash (more often when used in combination with raltegravir), itching.
Česta nuspojava lijeka REZOLSTA je kožni osip (češće se javlja u kombinaciji s raltegravirom), svrbež.
Pharmacokinetic results of total darunavir after administration of darunavir/cobicistat 800/150 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy, and postpartum Pharmacokinetics of total darunavir (mean ± SD)
Farmakokinetički rezultati ukupnog darunavira nakon primjene darunavira/kobicistata 800/150 mg jedanput na dan kao dijela antiretrovirusnog režima, tijekom drugog tromjesečja trudnoće, trećeg tromjesečja trudnoće i u postpartalnom razdoblju Farmakokinetika ukupnog darunavira (srednja vrijednost ± SD)
Voriconazole should not be combined with REZOLSTA unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Vorikonazol se ne smije kombinirati s lijekom REZOLSTA osim ako se procijeni da omjer koristi i rizika opravdava primjenu vorikonazola.
Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are co administered with REZOLSTA.
Preporučuju se druge ili zamjenske kontracepcijske mjere kada se kontraceptivi na bazi estrogena primjenjuju istodobno s lijekom REZOLSTA.
These can include, but are not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Oni mogu uključivati, ali nisu ograničeni na, teški osip ili osip praćen vrućicom, općom malaksalosti, umorom, tupim bolovima u mišićima i zglobovima, stvaranjem mjehurića, oralnim lezijama, konjunktivitisom, hepatitisom i/ili eozinofilijom.