FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal product interaction studies were not performed with IOA, but two studies with rifampicin and ketoconazole, respectively, were performed with a higher dosed nomegestrol acetate-estradiol combination (nomegestrol acetate 3.75 mg + 1.5 mg estradiol) in post-menopausal women.
Croatian: Nisu provedena ispitivanja interakcija lijekova s lijekom IOA, ali su provedena dva ispitivanja s rifampicinom odnosno ketokonazolom i višim dozama kombinacije nomegestrolacetata i estradiola (3,75 mg nomegestrolacetata + 1,5 mg estradiola) u žena u postmenopauzi.
English: Regular intake of IOA is then resumed after the yellow placebo tablets have been taken of the second pack.
Croatian: Redovito uzimanje lijeka IOA nastavlja se nakon što je žena uzela žute tablete placeba iz drugog pakiranja.
English: • swelling of one leg or along a vein in the leg or foot especially when • pain or tenderness in the leg which may be felt only when
Croatian: • oticanje jedne noge ili oticanje duž vene u nozi ili stopalu osobito ako je praćeno: • bolom ili osjetljivošću u nozi, koji se mogu osjećati samo pri stajanju ili hodanju
English: Nomegestrol acetate and its hydroxylated metabolites undergo extensive phase 2 metabolism to form glucuronide- and sulphate conjugates.
Croatian: Nomegestrolacetat i njegovi hidroksilirani metaboliti prolaze opsežan metabolizam 2. faze, u kojem nastaju glukuronidni i sulfatni konjugati.
English: • If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).
Croatian: • Ako krvni ugrušak nastane u veni noge ili stopala, može uzrokovati duboku vensku trombozu (DVT).
English: [Box for placing day label stating:] Place day label here [Day numbering for each individual tablet:] Start,2, ….28 [Arrows indicating the sequence of the tablets:] →
Croatian: [Okvir za oznake za dane s natpisom:] Ovdje nalijepite naljepnicu s oznakama dana [Broj dana za svaku pojedinu tabletu:] Početak, 2, .... 28
English: This will help you to determine when the baby will be
Croatian: To će Vam pomoći odrediti termin poroda.
English: Maximum serum concentrations of estradiol are about 90 pg/ml and are reached 6 h after dosing.
Croatian: Maksimalne koncentracije estradiola u serumu iznose približno 90 pg/ml, a postižu se 6 sati nakon doziranja.
English: The percentage of women using IOA experiencing intracyclic bleeding after this adaptation period ranged from 15-20 %.
Croatian: IOA i nakon ovog razdoblja prilagodbe imale intraciklično krvarenje bio je u rasponu od 15 do 20%.
English: In addition to the above mentioned adverse reactions, hypersensitivity reactions have been reported in
Croatian: Osim gore navedenih nuspojava, u korisnica koje uzimaju IOA prijavljene su i reakcije preosjetljivosti
English: For a description of the symptoms of these serious side effects please go to “How to recognise a blood
Croatian: Za opis simptoma ovih ozbiljnih nuspojava molimo pročitajte
English: It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of IOA compared with other CHCs, the symptoms of VTE and ATE, the known risk factors and what to do in the event of a suspected thrombosis.
Croatian: Važno je ženi obratiti pozornost na informacije o venskoj i arterijskoj trombozi, uključujući i rizik povezan s lijekom IOA u usporedbi s drugim kombiniranim hormonskim kontraceptivima, na simptome VTE i ATE, poznate čimbenike rizika te što učiniti u slučaju sumnje na trombozu.
English: The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible.
Croatian: Novu tabletu po mogućnosti treba uzeti unutar 12 sati od uobičajenog vremena uzimanja tablete.
English: Positive family history (venous thromboembolism ever in a sibling or parent especially at a relatively early age, e.g., before 50)
Croatian: Pozitivna obiteljska anamneza (venska tromboembolija u braće, sestara ili roditelja, osobito u relativno ranoj dobi, npr., prije 50. godine).
English: Starting your first pack of IOA
Croatian: Kada započeti s prvim pakiranjem lijeka IOA
English: • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see
Croatian: • Molimo budite oprezni i posjetite liječnika ako mislite da imate simptome kakve izaziva krvni ugrušak (pogledajte dio 2 "Krvni ugrušci").
English: With hepatic enzyme-inducing substances, a barrier method should be used during the time of concomitant medicinal product administration and for 28 days after their discontinuation.
Croatian: Ako uzima lijekove koji induciraju jetrene enzime, žena treba koristiti mehaničku kontracepciju tijekom istodobne primjene lijekova i tijekom 28 dana nakon prestanka njihova uzimanja.
English: Factors that increase your risk of a blood clot in a vein The risk of a blood clot with IOA is small but some conditions will increase the risk.
Croatian: Čimbenici koji Vam povećavaju rizik od krvnog ugruška u veni Rizik od nastanka krvnog ugruška uz IOA je mali, ali neka će ga stanja povećati.
English: When changing from another combined hormonal contraceptive (combined pill, vaginal ring, or
Croatian: Ako prelazite s drugog kombiniranog hormonskog kontraceptiva (kombinirane pilule, vaginalnog prstena ili transdermalnog flastera)
English: [In front of day labels intended for second blister:] Blister 2 [In front of day labels intended for third blister:] Blister 3
Croatian: [Ispred naljepnica s oznakama za dane namijenjenih za treći blister:] 3. blister
English: • In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms
Croatian: • U žena s nasljednim angioedemom, egzogeni estrogen može izazvati ili pogoršati simptome angioedema.
English: IOA contains lactose.
Croatian: IOA sadrži laktozu.
English: • The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.
Croatian: • Primjena bilo kojeg kombiniranog hormonskog kontraceptiva (KOK-a) povećava rizik od venske tromboembolije (VTE) u odnosu na nekorištenje lijeka.
English: The use of IOA may need to be stopped several weeks before surgery or while you are less mobile.
Croatian: Možda ćete trebati prestati s primjenom lijeka IOA nekoliko tjedana prije operacije ili za vrijeme mirovanja.
English: Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of
Croatian: Drugi znakovi okluzije krvne žile mogu uključivati: iznenadnu bol, oticanje i plavičastu obojanost ekstremiteta.
English: The IOA blister contains 28 tablets: 24 white tablets with the active substances (number 1-24) and 4 yellow tablets without active substances (number 25-28).
Croatian: Blister s lijekom IOA sadrži 28 tableta: 24 bijele tablete s djelatnim tvarima (brojevi 1-24) i 4 žute tablete bez djelatnih tvari (brojevi 25-28).
English: If any of the conditions or risk factors mentioned below is present, the suitability of IOA should be discussed with the woman .
Croatian: Ako je prisutno neko od niže navedenih stanja ili čimbenika rizika, potrebno je razgovarati sa ženom o prikladnosti lijeka IOA.
English: The woman may switch any day from the minipill and IOA should be started on the next day.
Croatian: Žena može prijeći s minipilule bilo koji dan, a s uzimanjem lijeka IOA treba započeti sljedećeg dana.
English: Changing from a progestogen-only-method (minipill, implant, injectable) or from a hormone-medicated Intra Uterine System (IUS)
Croatian: Prelazak s metode koja sadrži samo progestagen (minipilula, implantat, injekcija) ili s intrauterinog sustava (IUS) koji otpušta hormone
English: Average steady state plasma concentrations are 4 ng/ml.
Croatian: Prosječne koncentracije u plazmi u stanju dinamičke ravnoteže iznose 4 ng/ml.
English: - epilepsy (e.g. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine,
Croatian: - epilepsije (na primjer primidon, fenitoin, fenobarbital, karbamazepin, okskarbazepin,
English: COC tablets (including IOA tablets) no longer required should not be disposed via wastewater or the municipal sewage system.
Croatian: Tablete KOK-a (uključujući tablete lijeka IOA) koje više nisu potrebne ne smiju se uklanjati putem otpadnih voda ili javne kanalizacije.
English: Combined pills (including IOA tablets) no longer required should not be disposed via wastewater or the municipal sewage system.
Croatian: Kombinirane pilule (uključujući tablete IOA) koje više ne trebate ne smijete uklanjati putem otpadnih voda ili javne kanalizacije.
English: Nomegestrol acetate has a strong affinity for the human progesterone receptor and has an anti-gonadotropic activity, a progesterone receptor-mediated anti-estrogenic activity, a moderate anti-androgenic activity, and is devoid of any estrogenic, androgenic, glucocorticoid or
Croatian: Nomegestrolacetat ima jak afinitet vezivanja za progesteronske receptore u ljudi te iskazuje antigonadotropnu aktivnost, antiestrogenu aktivnost posredovanu progesteronskim receptorima te umjerenu antiandrogenu aktivnost, dok nema nikakvo estrogeno, androgeno, glukokortikoidno niti mineralokortikoidno djelovanje.
English: To delay a period the woman should continue with another blister pack of IOA without taking the yellow placebo tablets from her current pack.
Croatian: Za odgađanje menstruacije žena treba nastaviti uzimati tablete iz drugog blister pakiranja lijeka IOA bez uzimanja žutih tableta placeba iz trenutnog pakiranja.
English: Due to metabolism and enterohepatic circulation, a large circulating pool of estrogen sulfates and glucuronides is present.
Croatian: Zbog metabolizma i enterohepatičke cirkulacije prisutna je velika količina estrogenskih sulfata i glukuronida u krvotoku.
English: If any of the above conditions change while you are using IOA, for example a close family member experiences a thrombosis for no known reason or you gain a lot of weight, tell your doctor.
Croatian: Ako se neko od gore navedenih stanja promijeni za vrijeme uzimanja lijeka IOA, na primjer, netko od članova uže obitelji razvije trombozu iz nepoznatog razloga; ili se jako udebljate, obavijestite o tome svog liječnika.
English: • It is not yet known how the risk of VTE with CHCs that contain nomegestrol acetate in combination with estradiol compares with the risk with low dose levonorgestrel-containing
Croatian: • Još nije poznato koliki je rizik od VTE uz KOK-e koji sadrže nomegestrolacetat u kombinaciji s estradiolom u usporedbi s rizikom uz KOK-e koji sadrže nisku dozu levonorgestrela.
English: Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g., transient ischaemic attack, stroke).
Croatian: Epidemiološka ispitivanja povezala su primjenu KOK-a s povećanim rizikom od arterijske tromboembolije (infarkt miokarda) ili cerebrovaskularnog incidenta (npr. tranzitorna ishemijska ataka,
English: • Estradiol, the oestrogen in IOA, is identical to the hormone produced by your ovaries during a
Croatian: • Estradiol, estrogen u lijeku IOA , identičan je hormonu kojeg stvaraju jajnici tijekom mjesečnog ciklusa.
English: If you have taken IOA every day according to these directions, it is unlikely that you are pregnant (see also section 3 ‘If you have missed one or more periods').
Croatian: Ako ste uzimali IOA svaki dan u skladu s ovim uputama, vrlo vjerojatno niste trudni (vidjeti u dijelu 3 'Ako
English: If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g., a ‘common cold').
Croatian: Ako niste sigurni, razgovarajte s liječnikom jer se neki od ovih simptoma, kao što su kašljanje ili nedostatak zraka, mogu zamijeniti s blažim stanjem, kao što je infekcija dišnih puteva
English: Possibly related adverse reactions that have been reported in clinical trials or during postmarketing use with IOA are listed in the table below.
Croatian: Tablični prikaz nuspojava Nuspojave prijavljene u kliničkim ispitivanjima ili nakon stavljanja u promet, a koje bi mogle biti povezane s primjenom lijeka IOA navedene su u sljedećoj tablici.
English: in the yellow placebo film-coated tablets: The tablet does not contain active substances.
Croatian: Žute filmom obložene tablete placeba: Tableta ne sadrži djelatne tvari.
English: Therefore, the use of COCs should not be recommended until the nursing mother has completely weaned her child and an alternative contraceptive method should be proposed
Croatian: Stoga se ne preporučuje primjena KOK-a sve do potpunog prestanka dojenja, a majkama koje žele nastaviti dojiti treba preporučiti drugu metodu kontracepcije.
English: • Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the
Croatian: • Potvrđen nalaz ili sumnja na zloćudni tumor osjetljiv na spolne steroide (npr. na spolnim organima ili dojkama).
English: Other medical conditions associated with
Croatian: Druga zdravstvena stanja povezana s VTE
English: IOA is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis (see section 4.3).
Croatian: IOA je kontraindiciran ako žena ima jedan ozbiljan ili više čimbenika rizika za ATE zbog kojih je izložena većem riziku od arterijske tromboze (vidjeti dio 4.3).
English: Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus
Croatian: Šećerna bolest, hiperhomocisteinemija, valvularna bolest srca i atrijska fibrilacija, dislipoproteinemija i sistemski lupus eritematosus.
English: If you take more IOA than you should
Croatian: Ako uzmete više IOA tableta nego što ste trebali
English: However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait
Croatian: Međutim, ako je žena već imala spolni odnos, prije stvarnog početka uzimanja kombiniranih oralnih kontraceptiva treba isključiti trudnoću ili žena treba pričekati prvu menstruaciju.
English: • Presence or history of severe hepatic disease as long as liver function values have not returned
Croatian: • Prisutnost ili anamneza teške bolesti jetre sve dok se vrijednosti parametara funkcije jetre ne vrate na normalu.
English: • Nomegestrol acetate, the progestogen in IOA, is derived from the hormone progesterone.
Croatian: • Nomegestrolacetat, progestagen u lijeku IOA , dobiva se iz hormona progesterona.
English: If you get pregnant while using IOA you should stop using IOA and contact your doctor.
Croatian: Ako zatrudnite dok uzimate IOA, morate prestati uzimati lijek i obratiti se svom liječniku.
English: Should any of the conditions appear for the first time during IOA use, the medicinal product should be stopped
Croatian: Ako se bilo koje od stanja navedenih u nastavku pojavi prvi put tijekom uzimanja lijeka IOA, primjena lijeka se mora odmah obustaviti.
English: As no epidemiological data are yet available with 17β-estradiol containing CHCs, the contraindications for ethinylestradiol containing CHCs are considered applicable to the use of IOA.
Croatian: S obzirom na to da još uvijek nema epidemioloških podataka za KOK-e koji sadrže 17β-estradiol, smatra se da kontraindikacije za KOK-e koji sadrže etinilestradiol vrijede i za uporabu lijeka IOA.
English: • sudden weakness or numbness of the face, arm or leg, especially on
Croatian: • iznenadna slabost ili obamrlost lica, ruke ili noge, osobito na jednoj strani tijela;
English: Using a combined hormonal contraceptive such as IOA increases your risk of developing a blood clot compared with not using one.
Croatian: KRVNI UGRUŠCI Primjena kombiniranog hormonskog kontraceptiva kao što je IOA povećava rizik od razvoja krvnog ugruška u odnosu na to kad se ne uzima.
English: The decision to prescribe IOA should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with IOA compares with other CHCs (see sections 4.3 and 4.4).
Croatian: Kod donošenja odluke o propisivanju lijeka IOA treba uzeti u obzir čimbenike rizika prisutne u pojedine žene, osobito one za vensku tromboemboliju (VTE), te visinu rizika od VTE kod uzimanja lijeka IOA u usporedbi s drugim kombiniranim hormonskim kontraceptivima (vidjeti dijelove 4.3 i 4.4).
English: However, pregnancy must be ruled out before IOA use is continued, if IOA has not been taken as directed or if two consecutive
Croatian: Ipak, treba isključiti trudnoću prije nastavka uporabe lijeka IOA ako se lijek nije uzimao prema uputama ili su izostala dva uzastopna prijelomna krvarenja.
English: In case a vaginal ring or transdermal patch has been used, the woman should start using IOA preferably on the day of removal, but at the latest when the next application would have been due.
Croatian: Ako je koristila vaginalni prsten ili transdermalni flaster, žena treba početi uzimati IOA po mogućnosti na dan skidanja flastera ili uklanjanja prstena, ali najkasnije na dan sljedeće predviđene aplikacije.
English: • The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related
Croatian: • Pojava ili pogoršanje sljedećih bolesti prijavljenih u trudnoći i kod primjene KOK-a, no nije definitivno dokazana njihova povezanost s kombiniranim oralnim kontraceptivima: žutica i/ili pruritus povezan s kolestazom; nastanak žučnih kamenaca; porfirija; sistemski lupus eritematodes; hemolitički uremijski sindrom; Sydenhamova koreja; gestacijski herpes; gubitak sluha povezan s otosklerozom.
English: • golden brown pigment patches, mostly in the face; excessive hair growth • vaginal smell; discomfort in the vagina or vulva
Croatian: • zlatnosmeđe pigmentne mrlje, ponajviše na licu; prekomjerni rast dlaka
English: It is important to remember that the overall risk of a harmful blood clot due to IOA is small.
Croatian: Važno je zapamtiti da je ukupni rizik od krvnog ugruška sa štetnim posljedicama zbog lijeka IOA mali.
English: After discontinuation of IOA, return to ovulation in the first 28 days after last tablet intake was
Croatian: Nakon prekida primjene lijeka IOA povratak ovulacije u prvih 28 dana nakon uzimanja posljednje tablete opažen je u 79% žena.
English: IOA comes in 1 or 3 blisters of 28 film-coated tablets (24 white active film-coated tablets and 4 yellow placebo film-coated tablets) packed in a ply carton.
Croatian: IOA je dostupan u pakiranjima od 1 ili 3 blistera sa 28 filmom obloženih tableta (24 bijele filmom obložene tablete s djelatnim tvarima i 4 žute filmom obložene tablete s placebom) u kartonskoj kutiji.
English: • if you are less than 12 hours late in taking a tablet, the reliability of the pill is maintained.
Croatian: • ako kasnite s uzimanjem tablete manje od 12 sati, pouzdanost pilule je održana.
English: Estradiol is subject to a substantial first-pass effect after oral administration.
Croatian: Apsorpcija Estradiol podliježe značajnom učinku prvog prolaska kroz jetru nakon peroralne primjene.
English: IOA is not usually recommended for use during breast-feeding.
Croatian: Obično se ne preporučuje uzimanje lijeka IOA tijekom dojenja.
English: Maximum plasma concentrations of nomegestrol acetate of about 12 ng/ml are reached 1.5 h after dosing.
Croatian: Maksimalne koncentracije nomegestrolacetata u plazmi od približno 12 ng/ml postižu se 1,5 sati nakon doziranja.
English: Table: Risk factors for ATE
Croatian: Tablica: Čimbenici rizika za ATE Čimbenik rizika
English: Reproductive toxicity studies performed with the combination have shown foetotoxicity which is
Croatian: Ispitivanja reproduktivne toksičnosti provedena s kombinacijom ovih dvaju lijekova pokazala su fetotoksičnost, što je u skladu s izloženošću estradiolu.
English: An increase in frequency or severity of migraine during CHC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation.
Croatian: KOK-a (koja može biti prodromalni znak cerebrovaskularnog događaja) može biti razlogom trenutačnog prekida primjene.
English: • if you are more than 12 hours late in taking any tablet, the reliability of the pill may be reduced.
Croatian: • ako kasnite s uzimanjem tablete više od 12 sati, pouzdanost pilule može biti smanjena.
English: NAME OF THE MEDICINAL PRODUCT IOA 2.5 mg/1.5 mg film-coated tablets
Croatian: NAZIV LIJEKA IOA 2,5 mg/1,5 mg filmom obložene tablete
English: Influence of IOA on other medicinal products
Croatian: Utjecaj lijeka IOA na druge lijekove
English: But if you are having intercourse, make sure you also use a barrier method of contraception for the first 7 days that you are taking IOA.
Croatian: No, ako imate spolne odnose, svakako koristite i mehaničku metodu kontracepcije tijekom prvih 7 dana uzimanja lijeka IOA.
English: Allergic (hypersensitive) reactions have been reported in users of IOA, but the frequency cannot be
Croatian: U korisnica koje uzimaju IOA prijavljene su alergijske reakcije (reakcije preosjetljivosti), ali se njihova učestalost ne može procijeniti iz dostupnih podataka.
English: However, no effects on ability to drive and use machines have been observed in users of COCs.
Croatian: Međutim, u korisnica KOK-a nisu primijećeni učinci na sposobnost upravljanja vozilima i rada sa strojevima.
English: If she is more than 12 hours late in taking any active tablet, contraceptive protection may be reduced.
Croatian: Ako žena kasni s uzimanjem bilo koje tablete s djelatnim tvarima više od 12 sati, kontracepcijska zaštita može biti umanjena.
English: Common (may affect up to 1 in 10 people): • decreased interest in sex; depression/depressed mood; mood changes
Croatian: • smanjeno zanimanje za spolni odnos; depresija/depresivno raspoloženje; promjene raspoloženja
English: Six multi-centre clinical trials of up to one year duration were used to evaluate safety of IOA.
Croatian: Sigurnost lijeka IOA ispitivana je u 6 multicentričnih kliničkih ispitivanja u trajanju do godine dana.
English: Stop taking the white active tablet immediately and go directly to the yellow placebo tablet interval.
Croatian: Odmah prestanite uzimati bijele tablete s djelatnim tvarima i idite izravno na razdoblje žutih tableta placeba.
English: • if you have (or have ever had) a type of migraine called ‘migraine with aura';
Croatian: - stanje koje se zove hiperhomocisteinemija; • ako imate (ili ste imali) vrstu migrene koja se zove "migrena s aurom";
English: With all combined pills, for the first few months, you can have some irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods.
Croatian: Kod svih kombiniranih pilula, u prvim mjesecima, možete imati neredovito krvarenje iz rodnice
English: IOA must not be used by women who are pregnant, or who think they may be pregnant.
Croatian: Žene koje su trudne ili misle da bi mogle biti trudne ne smiju uzimati IOA.
English: When changing from an injectable, IOA should be started on the day when the next injection would have been due.
Croatian: Prilikom prelaska s injekcijskog preparata, s uzimanjem lijeka IOA treba započeti na dan sljedeće predviđene injekcije.
English: You can start taking IOA the day after you have taken the last tablet from your present pill blister (this means no tablet-free break).
Croatian: Možete započeti uzimati IOA dan nakon što ste uzeli zadnju tabletu iz dosadašnjeg blistera s pilulama
English: However, the missed tablets should be discarded to avoid unintentionally prolonging the
Croatian: Međutim, propuštene tablete treba baciti kako bi se izbjeglo nehotično produljivanje faze uzimanja tableta placeba.
English: PVC/aluminium blister containing 28 film-coated tablets (24 white film-coated tablets and 4 yellow Pack sizes: 28 and 84 film-coated tablets.
Croatian: PVC/aluminij blister s 28 filmom obloženih tableta (24 bijele filmom obložene tablete i 4 žute filmom obložene tablete).