FrancophonIA/ELRC3.0 huggingface dataset:
English: 42 gastro-resistant tablets 70 gastro-resistant tablets 210 gastro-resistant tablets
Croatian: 42 želučanootporne tablete 70 želučanootporne tableta 210 želučanootporne tableta
English: The coating of the gastro-resistant tablets is designed to prevent gastric irritation.
Croatian: Ovojnica želučanootpornih tableta služi za sprječavanje iritacije želuca.
English: What Skilarence 30 mg contains - the active substance is dimethyl fumarate.
Croatian: Što Skilarence 30 mg sadrži - Djelatna tvar je dimetilfumarat.
English: - Severe gastrointestinal disorders.
Croatian: Teški gastrointestinalni poremećaji
English: What Skilarence 120 mg contains - the active substance is dimethyl fumarate.
Croatian: Što Skilarence 120 mg sadrži - Djelatna tvar je dimetilfumarat.
English: PASI 75 and PGA score clear or almost clear and non-inferior (using a non-inferiority margin of -15%) to the active comparator (p<0.0003) based on PASI 75.
Croatian: Nakon 16 tjedana liječenja, otkriveno je da je lijek Skilarence superioran u odnosu na placebo (p<0,0001) temeljeno na rezultatima PASI 75 i PGA „čisto“ ili „gotovo čisto“ te da nije inferioran (uz korištenje granice neinferiornosti od 15 %) prema aktivnom komparatoru (p<0,0003) temeljeno na rezultatima PASI 75.
English: What Skilarence is used for
Croatian: Za što se koristi Skilarence
English: Skilarence contains lactose
Croatian: Skilarence sadrži laktozu
English: Abdominal distension* Abdominal pain Nausea
Croatian: Poremećaji probavnog sustava Proljev Distenzija abdomena* Bol u trbuhu
English: Other haematological disorders
Croatian: Drugi hematološki poremećaji:
English: White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg
Croatian: Bijela, filmom obložena, okrugla, bikonveksna tableta promjera približno 6,8 mm.
English: How to store Skilarence
Croatian: Kako čuvati Skilarence
English: 9/L, the blood test must be repeated and if the levels are confirmed to be below 0.7x10
Croatian: /L, treba ponoviti pretragu krvi i ako se potvrde razine ispod
English: No dose adjustment is needed in patients with mild to moderate hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre (vidjeti dio 5.2).
English: No dose adjustment is needed in patients with mild to moderate renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Most patients had moderate psoriasis based on Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA) scores at baseline: the mean PASI score at baseline was 16.35 and 60% of patients scored as moderate on the PGA.
Croatian: Physician's Global Assessment, PGA): početna srednja vrijednost rezultata prema PASI-ju bila je 16,35, a 60 % bolesnika imalo je umjereni rezultat prema PGA-u.
English: The risk of vaccination should be weighed against the benefit.
Croatian: Potrebno je odvagnuti koristi i rizike cijepljenja.
English: Skilarence 120 mg gastro-resistant tablets dimethyl fumarate
Croatian: Skilarence 120 mg želučanootporne tablete dimetilfumarat
English: Skilarence 30 mg gastro-resistant tablets dimethyl fumarate
Croatian: Skilarence 30 mg želučanootporne tablete dimetilfumarat
English: Skilarence contains sodium
Croatian: Skilarence sadrži natrij
English: - the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) and simethicone.
Croatian: - Drugi sastojci su: laktoza hidrat, mikrokristalna celuloza, umrežena karmelozanatrij, bezvodni koloidni silicijev dioksid, magnezijev stearat, metakrilatna kiselina/etilakrilat kopolimer 1:1,
English: • The guide for healthcare professionals shall contain the following key elements: o Relevant information on PML (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for PML o Details on how to minimise the risk of PML through appropriate monitoring and management, including laboratory monitoring of lymphocyte and leukocyte prior to and during treatment, and criteria for treatment discontinuation o Key messages to convey in counselling of patients
Croatian: o Pojedinosti o populaciji koja je izložena većem riziku obolijevanja od PML-a o Pojedinosti o načinu minimizacije rizika obolijevanja od PML-a uz odgovarajuće praćenje i vođenje, uključujući laboratorijsko praćenje limfocita i leukocita prije i tijekom liječenja, te kriterije za prekid terapije.
English: Skilarence 30 mg gastro-resistant tablets Skilarence 120 mg gastro-resistant tablets
Croatian: Skilarence 30 mg želučanootporne tablete Skilarence 120 mg želučanootporne tablete
English: Titanium dioxide (E171) Simethicone
Croatian: talk, trietilcitrat, titanijev dioksid (E171) i simetikon.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog Eritem
English: OUTER CARTON - SKILARENCE 30 mg GASTRO RESISTANT TABLETS
Croatian: VANJSKO PAKIRANJE - SKILARENCE 30 mg ŽELUČANOOTPORNE TABLETE
English: OUTER CARTON - SKILARENCE 120 mg GASTRO RESISTANT TABLETS
Croatian: VANJSKO PAKIRANJE - SKILARENCE 120 mg ŽELUČANOOTPORNE TABLETE
English: One tablet contains 120 mg dimethyl fumarate.
Croatian: Jedna tableta sadrži 120 mg dimetilfumarata.
English: Gastro-resistant tablet.
Croatian: Želučanootporna tableta.
English: One tablet contains 30 mg dimethyl fumarate.
Croatian: Jedna tableta sadrži 30 mg dimetilfumarata.
English: Fatigue Feeling hot Asthenia
Croatian: Osjećaj vrućine Astenija
English: However, Skilarence has not been studied in patients with severe renal impairment, and some cases of renal toxicity have been reported during post-marketing surveillance with fumaric acid esters.
Croatian: Iako Skilarence nije ispitivan u bolesnika s teškim oštećenjem bubrega, u praćenju nakon stavljanja lijeka u promet prijavljeni su neki slučajevi bubrežne toksičnosti uz estere fumaratne kiseline . Zato je Skilarence kontraindiciran u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dio 4.3).
English: See package leaflet for further information.
Croatian: Za daljnje informacije pročitajte uputu o lijeku.
English: Dizziness and fatigue may occur following administration of Skilarence (see section 4.8).
Croatian: Nakon primjene lijeka Skilarence mogu se javiti omaglica i umor (vidjeti dio 4.8).
English: Skilarence has not been studied in patients with severe hepatic impairment, and use of Skilarence is contraindicated in these patients (see section 4.3).
Croatian: Skilarence nije ispitivan u bolesnika s teškim oštećenjem jetre te je primjena lijeka Skilarence kontraindicirana u tih bolesnika (vidjeti dio 4.3).
English: - the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide.
Croatian: talk, trietilcitrat, titanijev dioksid (E171), simetikon, Indigo Carmine (E132) i natrijev hidroksid.
English: - Severe hepatic or renal impairment.
Croatian: Teško oštećenje funkcije jetre ili bubrega
English: Lactose monohydrate Cellulose microcrystalline Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Croatian: Skilarence 30 mg i Skilarence 120 mg Jezgra: laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: Therapy should be discontinued and caution is advised if other pathological results occur.
Croatian: U slučaju drugih patoloških vrijednosti liječenje se mora prekinuti te se preporučuje oprez.
English: Methacrylic acid-ethyl acrylate copolymer (1:1) Talc
Croatian: Ovojnica: metakrilatna kiselina/etilakrilat kopolimer 1:1 talk trietilcitrat titanijev dioksid (E171) simetikon
English: Each gastro-resistant tablet contains 120 mg dimethyl fumarate.
Croatian: Jedna želučanootporna tableta sadrži 120 mg dimetilfumarata.
English: Each gastro-resistant tablet contains 30 mg dimethyl fumarate.
Croatian: Jedna želučanootporna tableta sadrži 30 mg dimetilfumarata.
English: Common Common Common Rare
Croatian: Često Često Rijetko
English: - If you get any side effects, talk to your doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika.
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Industrias Farmaceuticas Almirall, S.A.
English: BLISTER FOIL - SKILARENCE 120 mg GASTRO RESISTANT TABLETS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER FOLIJA - SKILARENCE 120 mg ŽELUČANOOTPORNE TABLETE
English: BLISTER FOIL - SKILARENCE 30 mg GASTRO RESISTANT TABLETS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER FOLIJA - SKILARENCE 30 mg ŽELUČANOOTPORNE TABLETE
English: decrease in all white blood cells (leukopenia) - reddening of the face or body (flushing) - diarrhoea - bloating, stomach pain or stomach cramps - feeling sick (nausea)
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - smanjen broj bijelih krvnih stanica koje se nazivaju limfociti (limfopenija) - smanjen broj svih bijelih krvnih stanica (leukopenija) - crvenilo lica i tijela (navale crvenila) - proljev - napuhnutost, bol u želucu ili grčevi u želucu - mučnina
English: What is Infinia?
Croatian: Što je Infinia?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 July 2017
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21. srpnja 2017.
English: The committee considered that the study failed to show beneficial effects in the population studied.
Croatian: Odbor je smatrao da ispitivanje nije uspjelo pokazati korisne učinke u ispitivanoj populaciji.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju ili programu milosrdnog davanja lijekova te vam je potrebno više informacija o liječenju, obratite se liječniku koji vas liječi.
English: A lack of this enzyme can cause damage to the lungs (such as emphysema and airway obstruction) which leads to breathing problems.
Croatian: Nedostatak ovog enzima može prouzročiti oštećenje pluća (kao što su emfizem i opstrukcija dišnih putova) koje dovodi do tegoba s disanjem.
English: How does Infinia work?
Croatian: Kako djeluje Infinia?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it needed more time to collect additional information that the CHMP requested in relation to this application.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da joj je potrebno više vremena kako bi prikupila dodatne podatke koje je CHMP tražio u odnosu na ovo odobrenje.
English: The company presented results of a main study in 168 patients looking at the effects of the medicine on exacerbations (sudden worsening of symptoms) of the disease.
Croatian: Tvrtka je dostavila podatke iz glavnog ispitivanja u kojem su se na 168 bolesnika pratili učinci ovog lijeka na egzacerbaciju (iznenadno pogoršanje simptoma) bolesti.
English: It was to be available as a solution to be inhaled.
Croatian: Trebao je biti dostupan kao otopina za inhalaciju.
English: In addition, there were concerns about the tolerability and safety profile of the medicine, since patients who were taking Infinia had to stop treatment due to side effects more often than patients taking placebo.
Croatian: Osim toga, razlog za zabrinutost bio je profil podnošljivosti i sigurnosti lijeka jer su bolesnici koji su uzimali lijek Infinia morali češće prekinuti liječenje zbog nuspojava nego bolesnici koji su uzimali placebo.
English: There were also concerns that patients taking Infinia may produce antibodies against it which could reduce its effects or make patients more prone to allergic reactions.
Croatian: Razlog za zabrinutost bilo je i to što bolesnici koji uzimaju lijek Infinia mogu proizvoditi protutijela protiv toga lijeka, a to bi moglo smanjiti njegove učinke ili povećati sklonost bolesnika prema alergijskim reakcijama.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Infinia.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja ili programe milosrdnog davanja lijekova u kojima se koristi lijek Infinia.
English: The medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the length of time patients went without having an exacerbation.
Croatian: Lijek je uspoređen s placebom (lažnim lijekom), a glavna mjera učinkovitosti bila je duljina vremena u kojem se u bolesnika nije pojavila egzacerbacija.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Infinia did not outweigh its risks.
Croatian: Stoga je CHMP u vrijeme povlačenja smatrao kako koristi od lijeka Infinia ne nadmašuju s njim povezane rizike.
English: Infinia is a medicine containing the active substance alpha-1-antitrypsin (also known as alpha1proteinase inhibitor).
Croatian: Infinia je lijek koji sadrži djelatnu tvar alfa-1-antitripsin (poznatu i kao inhibitor alfa1-proteinaze).
English: What was Infinia expected to be used for?
Croatian: Za što se lijek Infinia trebao koristiti?
English: Other medicines containing alpha-1-antitrypsin are authorised in the EU for the same disease but are given as an infusion (drip) into a vein.
Croatian: Europskoj uniji su za liječenje iste bolesti odobreni drugi lijekovi koji sadrže alfa-1-antitripsin, ali oni se daju u obliku infuzije (dripa) u venu.
English: It is obtained from human blood and was intended to replace the missing protein in the lungs of patients with alpha-1-antitrypsin deficiency.
Croatian: Dobiva se iz ljudske krvi, a namijenjen je kao zamjena za protein koji nedostaje u plućima bolesnika s manjkom alfa-1-antitripsina.
English: The active substance in Infinia, alpha-1-antitrypsin, is a protein in the blood which protects lung tissue from damage.
Croatian: Djelatna tvar u lijeku Infinia je alfa-1-antitripsin, protein u krvi koji štiti tkivo pluća od oštećenja.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Infinia could not have been approved for the treatment of adults with lung disease due to congenital deficiency of alpha-1-antitrypsin.
Croatian: Na temelju pregleda podataka u trenutku povlačenja, CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Infinia za liječenje odraslih osoba zbog urođenog manjka alfa-1-antitripsina.
English: Withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Infinia (alfa-1-antitripsin)
English: The medicine was expected to be used for treating lung disease in adults with congenital (inborn) deficiency of alpha-1-antitrypsin.
Croatian: Očekivalo se da će se lijek upotrebljavati za liječenje bolesti pluća u odraslih osoba s urođenim (kongenitalnim) manjkom alfa-1-antitripsina.
English: Withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin) EMA/440995/2017
Croatian: 1-antitripsin) EMA/440995/2017
English: Further information on the orphan designation can be found here.
Croatian: Ovdje možete pronaći dodatne informacije o statusu lijekova za rijetke bolesti.
English: On 21 June 2017, Kamada BioPharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Infinia, for the treatment of adults with lung disease due to congenital deficiency of alpha-1antitrypsin.
Croatian: Limited službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Infinia za liječenje odraslih osoba s bolešću pluća uzrokovanom urođenim manjkom alfa-1-antitripsina.
English: Infinia was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 16 November 2004 for the treatment of emphysema due to congenital alpha-1-antitrypsin deficiency.
Croatian: Dana 16. studenoga 2004. lijek Infinia uvršten je na popis lijekova za rijetke bolesti za liječenje emfizema zbog urođenog manjka alfa-1-antitripsina.
English: Zoely is a contraceptive pill.
Croatian: Zoely je kontracepcijska pilula.
English: In addition, the company will perform a study to further investigate the risk of blood clots.
Croatian: Osim toga, tvrtka će provesti ispitivanje kako bi dodatno ispitala rizik od krvnih ugrušaka.
English: The full EPAR for Zoely can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Zoely nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A lower Pearl Index represents a lower chance of getting pregnant.
Croatian: Niži Pearl indeks predstavlja manju vjerojatnost od pojave trudnoće.
English: Zoely nomegestrol acetate / estradiol
Croatian: Zoely nomegestrolacetat/estradiol
English: Zoely was investigated in two main studies involving a total of 4,433 women aged 18 to 50 years old.
Croatian: Lijek Zoely ispitivan je u dvama glavnim ispitivanjima koja su uključivala ukupno 4433 žena u dobi od 18 do 50 godina.
English: Other information about Zoely
Croatian: Ostale informacije o lijeku Zoely
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoely on 27 July 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Zoely na snazi u Europskoj uniji od 27. srpnja 2011.
English: No clinical study data on Zoely are available in adolescents under 18 years old.
Croatian: Nema podataka o kliničkom ispitivanju lijeka Zoely u adolescentica mlađih od 18 godina.
English: One tablet a day is taken for as long as contraception is required, starting with an active tablet on the first day of the cycle.
Croatian: Uzima se jedna tableta na dan onoliko dugo koliko je potrebna kontracepcija, a primjena započinje uzimanjem aktivne tablete prvog dana ciklusa.
English: What measures are being taken to ensure the safe and effective use of Zoely?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zoely?
English: The main measure of effectiveness was the number of women aged 18 to 35 who became pregnant during or shortly after treatment, expressed in terms of a pregnancy rate using the ‘Pearl Index'.
Croatian: Glavno mjerilo djelotvornosti bio je broj žena u dobi od 18 do 35 godina koje su ostale trudne tijekom ili ubrzo nakon tretmana, izražen u vrijednostima stope trudnoće uz pomoć „Pearl indeksa”.
English: What is Zoely?
Croatian: Što je Zoely?
English: It should not be used in women who have pancreatitis (inflammation of the pancreas), severe liver problems, liver tumours or a history of liver tumours, certain types of cancer, or abnormal bleeding from the genital area whose cause has not been diagnosed.
Croatian: Ne smije se primjenjivati u žena koje imaju pankreatitis (upalu gušterače), teške probleme s jetrom, tumore jetre ili povijest tumora jetre i određenih vrsta raka te u žena kod kojih se javlja abnormalno krvarenje iz genitalnog područja čiji uzrok nije dijagnosticiran.
English: The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 women-years (corresponding to 1,300 menstrual cycles).
Croatian: Pearl indeks standardni je način mjerenja djelotvornosti kontracepcijskih sredstava kojim se mjeri koliko se neželjenih trudnoća javlja u 100 žena koje koriste kontracepcijsko sredstvo godinu dana (što odgovara vrijednosti od 1300 menstrualnih ciklusa).
English: This is a summary of the European public assessment report (EPAR) for Zoely.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zoely.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoely.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Zoely.
English: For more information about treatment with Zoely, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Zoely pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Zoely must not be used when a woman has, or has had, blood clots in the veins or arteries or when a woman has some of the risk factors for blood clots.
Croatian: Lijek Zoely ne smije se primjenjivati ako žena ima ili je imala krvne ugruške u venama ili arterijama ili ako u žene postoje neki od čimbenika rizika od stvaranja krvnih ugrušaka.
English: Estradiol is the same as a hormone naturally produced by the ovaries during a menstrual cycle.
Croatian: Estradiol je jednak hormonu koji jajnici prirodno proizvode tijekom menstrualnog ciklusa.
English: Zoely comes in blisters containing 28 tablets (24 white tablets followed by 4 yellow tablets), which are taken in sequence using stickers to identify the days of the week for each tablet.
Croatian: Lijek Zoely pakiran je u blisterima koji sadrže 28 tableta (24 bijele tablete nakon kojih slijede četiri žute tablete) koje se uzastopno uzimaju uz uporabu naljepnica kojima se označavaju dani u tjednu za svaku tabletu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoely, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Zoely nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati.
English: Zoely is a medicine available as 24 white ‘active' tablets that contain the active substances nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow ‘inactive' (placebo) tablets that do not contain any active substance.
Croatian: Zoely je lijek koji je dostupan u pakiranju koje sadrži 24 bijele „aktivne” tablete koje sadrže djelatne tvari nomegestrolacetat (2,5 mg) i estradiol (1,5 mg) i četiri žute „neaktivne” (placebo) tablete koje ne sadrže djelatne tvari.
English: Zoely works by changing the body's hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).
Croatian: Lijek Zoely djeluje tako da mijenja hormonalnu ravnotežu tijela radi sprečavanja ovulacije izmjenom cervikalne sluzi i stanjivanjem endometrija (sluznice maternice).
English: In women aged 18 to 35, the Pearl Index was around 0.4 with Zoely and 0.8 with the comparator medicine in the first study, and around 1.2 with Zoely and 1.9 with the comparator medicine in the second study.
Croatian: Pearl indeks bio otprilike 0,4 za lijek Zoely i 0,8 za usporedni lijek, dok je u drugom ispitivanju bio 1,2 za lijek Zoely i 1,9 za usporedni lijek.
English: What is the risk associated with Zoely?
Croatian: Koji su rizici povezani s lijekom Zoely?