FrancophonIA/ELRC3.0 huggingface dataset:
English: It has a similar composition to that of a combined oral contraceptive (COC).
Croatian: Sastav je sličan sastavu kombiniranih oralnih kontraceptiva (KOK).
English: The increased risk of thromboembolism in the puerperium must be considered (for information on ‘Pregnancy and lactation' see section 4.6).
Croatian: Mora se uzeti u obzir povećan rizik od nastanka tromboembolije u puerperiju (za informacije o “Trudnoći i dojenju” vidjeti dio 4.6).
English: • Concomitant use with another hormonal contraceptive (see section 4.1)
Croatian: • Istodobna primjena s drugim hormonskim kontraceptivom (vidjeti dio 4.1)
English: The need to continue treatment should be evaluated periodically by the treating physician.
Croatian: Potreba za nastavakom liječenja mora se periodički procijenjivati od strane liječnika.
English: Adequate contraception should be initiated because of the teratogenicity of anti-coagulant therapy (coumarins).
Croatian: Odgovarajuća druga kontracepcija se mora započeti zbog teratogenosti antikoagulantne terapije (kumarini).
English: Directly after giving birth, women are at an increased risk of blood clots so you should ask your doctor how soon after delivery you can start taking < invented name >.
Croatian: Neposredno nakon poroda, žene su izložene povišenom riziku od krvnih ugrušaka pa morate pitati svog liječnika koliko brzo nakon poroda možete početi uzimati <zaštićeno ime>.
English: - obesity (body mass index over 30 kg/m2).
Croatian: • pretilošću (indeks tjelesne mase viši od 30 kg/m²).
English: Women using <invented name> should be specifically pointed out to contact their physician in case of possible symptoms of thrombosis.
Croatian: <zaštićeno ime> mora se posebno naglasiti da kontaktiraju svoga liječnika u slučaju mogućih simptoma tromboze.
English: The need to continue treatment should be evaluated periodically by the treating physician (see section 4.2).
Croatian: Potreba za nastavakom liječenja mora se periodički procijenjivati od strane liječnika (vidjeti dio 4.2).
English: Stop taking tablets and see your doctor immediately if you notice possible signs of a blood clot, such as:
Croatian: Prestanite s uzimanjem tableta i odmah se javite svom liječniku ako primijetite moguće znakove krvnog ugruška, kao što su:
English: Duration of use Your doctor will tell you how long you need to keep taking <invented name>.
Croatian: • Trajanje uzimanja • Vaš liječnik će Vam reći koliko dugo trebate uzimati <zaštićeno ime>.
English: Circulatory disorders
Croatian: • Poremećaji cirkulacije
English: Since <invented name> is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see section 4.3).
Croatian: • Kako su <zaštićeno ime> također hormonski kontraceptiv, ne smije se koristiti u kombinaciji s drugim hormonskim kontraceptivima (vidjeti dio 4.3).
English: • Presence or history of cerebrovascular accident
Croatian: • Postojeći ili cerebrovaskularni događaj u anamnezi
English: An increase in frequency or severity of migraine during use of <invented name > (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of <invented name>.
Croatian: Povećanje učestalosti ili jačine migrene tijekom primjene <zaštićeno ime> (što mogu biti prodromi cerebrovaskularnog događaja) može biti razlog trenutnom prekidu uzimanju <zaštićeno ime>.
English: If any of the conditions/risk factors mentioned below is present, the benefits of the use of <invented name> should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using <invented name>.
Croatian: Ukoliko je zapaženo bilo koje od dolje navedenih stanja/faktora rizika, korist primjene<zaštićeno ime> mora se procijeniti u odnosu na moguće rizike za svaku ženu pojedinačno te se sa ženom mora raspraviti prije odluke o početku primjene lijeka <zaštićeno ime>.
English: • Epidemiological studies have shown that the incidence of VTE is 1.5 to 2 times higher in users of <invented name> than in users of levonorgestrel-containing combined oral contraceptives (COCs) and may be similar to the risk for desogestrel / gestodene / drospirenone-containing COCs.
Croatian: • Epidemiološka ispitivanja pokazala su da je incidencija VTE 1,5 do 2 puta veća u korisnica <zaštićeno ime> od one pri primjeni kombiniranih oralnih kontraceptiva (KOK) koji sadrže levonorgestrel i može biti slična riziku KOK-ova koji sadrže dezogestrel / gestoden / drospirenon.
English: In case of suspected or confirmed thrombosis, <invented name> use should be discontinued.
Croatian: U slučaju sumnje na trombozu ili potvrđene tromboze, primjena <zaštićeno ime> mora se prekinuti.
English: The use of a combined pill has been connected with an increased risk of clots in the arteries.
Croatian: Primjena kombiniranog oralnog kontraceptiva je povezana sa povećanim rizikom ugrušaka u arterijama.
English: You should only take <invented name> if your skin condition has not improved after use of other antiacne treatments, including topical treatments and antibiotics.
Croatian: • <Zaštićeno ime> možete uzimati samo ako se stanje Vaše kože nije poboljšalo nakon drugih načina liječenja akni, uključujući lokalno liječenje i antibiotike.
English: Your chances of having a blood clot are only increased slightly by taking <invented name> compared with women who do not take <invented name> or any contraceptive pill.
Croatian: Vaše šanse za nastanak krvnog ugruška su samo blago povišene uzimanjem <zaštićeno ime> u usporedbi sa ženama koje ne uzimaju <zaštićeno ime>, ili bilo koji drugi oralni kontraceptiv.
English: The physician should then decide on whether the use of <invented name> should be discontinued.
Croatian: Liječnik tada mora odlučiti da li se uzimanje <zaštićeno ime> mora prekinuti.
English: <Invented name> is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age.
Croatian: • <zaštićeno ime> se koristi u liječenju stanja kože kao što su akne, jako masna koža i prekomjerni rast dlaka u žena generativne dobi.
English: • Symptoms of venous or arterial thrombosis or of a cerebrovascular accident can include: unusual unilateral leg pain and / or swelling; sudden severe pain in the chest, whether or not it radiates to the left arm; sudden breathlessness; sudden onset of coughing; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; vertigo; collapse with or without focal seizure; weakness or very marked numbness suddenly affecting one side or one part of the body; motor disturbances; ‘acute' abdomen
Croatian: • Simptomi venske ili arterijske tromboze ili cerebrovaskularnog događaja mogu uključivati: neuobičajenu unilateralnu bol i/ili oticanje noge; iznenadnu jaku bol u prsnom košu, koja se može ili ne mora širiti u lijevu ruku; iznenadan nedostatak zraka; iznenadan napad kašlja; neuobičajenu, jaku ili dugotrajnu glavobolju; iznenadni djelomičan ili potpun gubitak vida; diplopiju; nejasan govor ili afaziju; vrtoglavicu; kolaps sa ili bez žarišnih epileptičkih napadaja; iznenadnu slabost ili snažno izraženu obamrlost jedne strane tijela ili jednog dijela tijela; poremećaje motoričkih funkcija; akutni abdomen.
English: Stop taking tablets and contact your doctor immediately if you notice possible signs of a blood clot.
Croatian: Odmah prestanite s uzimanjem tableta i javite se liječniku ako primjetite moguće znakove krvnog ugruška.
English: Blood clots (thrombosis)
Croatian: Krvni ugrušci (tromboza)
English: The risk of blood clots in a vein in users of a combined pill increases further:
Croatian: Rizik za nastanak krvnih ugrušaka u venama u korisnica kombiniranog oralnog kontraceptiva se povećava s:
English: • Epidemiological studies have also associated the use of hormonal contraceptive with an increased risk for arterial (myocardial infarction, transient ischaemic attack) thromboembolism.
Croatian: • Epidemiološka ispitivanja također ukazuju na povezanost primjene hormonskih kontraceptiva s povećanim rizikom za nastanak arterijske tromboembolije (infarkt miokarda, tranzitorna ishemijska ataka).
English: • Hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)
Croatian: • Nasljedna ili stečena predispozicija za vensku ili arterijsku trombozu, kao što je rezistencija na aktivirani protein C (APC), nedostatak antitrombina-III, nedostatak proteina C, nedostatak proteina S, hiperhomocisteinemiju i pojavu antifosfolipidnih protutijela (antikardiolipinska protutijela, lupus antikoagulans)
English: A blood clot in a vein (known as a ‘venous thrombosis') can block the vein.
Croatian: Krvni ugrušak u veni (poznat kao “venska tromboza”) može začepiti venu.
English: Symptoms of blood clots
Croatian: Simptomi krvnih ugrušaka
English: Using a combined pill increases a woman's risk of developing such clots compared with a woman not taking any combined pill.
Croatian: Korištenje kombiniranog oralnog kontraceptiva kod žena povećava rizik za nastanak ugruška u usporedbi sa ženama koje ne uzimaju ni jedan kombinirani oralni kontraceptiv.
English: Blood clots in a vein
Croatian: Krvni ugrušci u veni
English: • The use of <invented name> carries an increased risk of venous thromboembolism (VTE) compared with no use.
Croatian: • Primjena <zaštićeno ime> nosi povećan rizik od nastanka venske tromboembolije (VTE), u usporedbi s neprimjenjivanjem.
English: • The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (see section 4.4) such as: o diabetes mellitus with vascular symptoms o severe hypertension o severe dyslipoproteinaemia
Croatian: • Prisutnost jakog faktora ili višestrukih faktora rizika za nastanak venske ili arterijske tromboze (vidjeti dio 4.4) kao što su: o šećerna bolest s oštećenjima krvnih žila o teška hipertenzija o teška dislipoproteinemija
English: The excess risk of VTE is highest during the first year a woman starts <invented name> or when restarting or switching after a pill-free interval of at least a month.
Croatian: Povišeni rizik od VTE je najveći tijekom prve godine početka uzimanja <zaštićeno ime> ili ponovnog počinjanja uzimanja nakon najmanje mjesec dana razdoblja neuzimanja ovog lijeka ili prelaska na drugi kombinirani oralni kontraceptiv.
English: Other medical conditions, which have been associated with adverse circulatory events, include diabetes mellitus, systemic lupus erythematosus, hemolytic uraemic syndrome, chronic inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) and sickle cell disease.
Croatian: • Druga medicinska stanja koja se povezuju sa štetnim cirkulatornim događajima uključuju šećernu bolest, sistemski lupus eritematodes, hemolitičko-uremijski sindrom, kronične upalne bolesti crijeva (npr. Crohnova bolest ili ulcerozni kolitis) i anemiju srpastih stanica.
English: • Venous thromboembolic disorders
Croatian: • Venski tromboembolijski poremećaji • Arterijski tromboembolijski poremećaji
English: [The following to be included in the table of adverse reactions] • Vascular Disorders Rare (≥ 1/10,000 to < 1/1000): Thromboembolism
Croatian: • Krvožilni poremećaji Rijetko (≥ 1/10 000 do < 1/1000): tromboembolija
English: The risk of developing a blood clot in a vein is highest during the first year a woman uses the pill.
Croatian: Rizik za nastanak krvnog ugruška u veni je kod žena najviši tijekom prve godine primjene kombiniranih oralnih kontraceptiva.
English: • Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g. angina pectoris and transient ischaemic attack).
Croatian: • Postojeća arterijska tromboza ili njeno postojanje u anamnezi (npr. infarkt miokarda) ili prodromalna stanja (npr. angina pektoris i tranzitorna ishemijska ataka)
English: • The user group of <invented name> is likely to include patients that may have an inherently increased cardiovascular risk such as that associated with polycystic ovarian syndrome.
Croatian: • U skupini korisnica <zaštićeno ime> vrlo je vjerojatno da su i bolesnice koje mogu imati prirođenipovećani kardiovaskularni rizik, primjerice povezan sa sindromom policističnih jajnika.
English: • There is an increased risk of thromboembolism for all women who use <invented name> (see section 4.4).
Croatian: • Postoji povećan rizik od tromboembolije u svih žena koje koriste <zaštićeno ime> (vidjeti dio
English: • Extremely rarely, thrombosis has been reported to occur in other blood vessels, e.g. hepatic, mesenteric, renal, cerebral or retinal veins and arteries, in hormonal contraceptive users.
Croatian: • Iznimno rijetko je u korisnica hormonskih kontraceptiva prijavljena pojava tromboze u drugim krvnim žilama, npr. u jetrenim, mezenterijskim, bubrežnim, moždanim ili mrežničnim venama i arterijama.
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any hormonal contraceptive use.
Croatian: Ukoliko postoji sumnja na nasljednu predispoziciju, prije odluke o primjeni bilo kojeg hormonskog kontraceptiva žena se mora uputiti specijalisti radi savjeta.
English: Blood clots in an artery
Croatian: Krvni ugrušci u arteriji
English: For the treatment of acne, <invented name> should only be used after topical therapy or systemic antibiotic treatments have failed.
Croatian: • Za liječenje akni <zaštićeno ime> se smiju koristiti tek kad se lokalno liječenje ili sistemska liječenja antibioticima pokažu neuspješnima.
English: Possible side effects [This wording should be added under ‘Rare side effects'] Venous blood clot.
Croatian: • [Ovaj tekst mora se dodati pod ”Rijetke nuspojave”] • Krvni ugrušak u venama.
English: [This section should replace any existing one and should read as follows:]
Croatian: • [Trenutno odobrene indikacije moraju se pobrisati i zamijeniti:]
English: • The risk of venous thromboembolic events increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age.
Croatian: • - pušenjem (s pušenjem većeg broja cigareta i povećanjem dobi rizik se dodatno povećava, posebno u žena starijih od 35 godina.
English: - hypertension; - migraine; - valvular heart disease; - atrial fibrillation; - a positive family history (arterial thrombosis ever in a sibling or parent at a relatively early age).
Croatian: • - fibrilacijom atrija; - pozitivnom obiteljskom anamnezom (arterijska tromboza u brata/sestre bilo kada ili u roditelja u relativno ranoj dobi).
English: or other part of your body
Croatian: • slabost ili utrnulost u bilo kojem dijelu Vašeg tijela;
English: Section 4.2 Posology and method of administration [The wording below should be inserted in this section]
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi • [Donji tekst mora se uvrstiti u ovaj dio]
English: Taking <invented name> may slightly increase your risk of having a blood clot (called a thrombosis).
Croatian: • Uzimanje <zaštićeno ime> može blago povećati rizik za nastanak krvnog ugruška (što se zove tromboza).
English: • Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism)
Croatian: • Postojeća venska tromboza ili njeno postojanje u anamnezi (duboka venska tromboza, plućna embolija)
English: Tell your doctor if any of the following conditions applies to you before starting to use <invented name>.
Croatian: • Ukoliko se bilo koje od sljedećih stanja odnosi na Vas, recite Vašem liječniku prije početka primjene <zaštićeno ime>.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Croatian: Dodatak III Izmjene i dopune relevantnih dijelova Sažet(a)ka opisa svojstava lijeka i Upute(a) o lijeku
English: Section 4.4 Special warnings and precautions for use [The wording below should be inserted in this section] <invented name> is composed of the progestogen cyproterone acetate and the oestrogen ethinylestradiol and is administered for 21 days of a monthly cycle.
Croatian: • <Zaštićeno ime>se sastoje od progesterona ciproteronacetata i estrogena etinilestradiola te se primjenjuju tijekom 21-og dana mjesečnog ciklusa.
English: Your doctor will also tell you when you can start using <invented name> again after you are back on your feet.
Croatian: Nakon potpunog oporavka liječnik će Vam također reći kada možete ponovno početi koristiti <zaštićeno ime>.
English: Section 4.1 Therapeutic indications [The currently approved indications should be deleted and replaced by the following:] Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
Croatian: • Liječenje umjerenih do teških oblika akni povezanih s osjetljivošću na androgene (sa ili bez seboreje) i/ili hirzutizom, u žena reproduktivne dobi.
English: Section 4.3 Contraindications [The following contraindications related to thromboembolism should be included in this section]
Croatian: • [Sljedeće povezane kontraindikacije moraju se uvrstiti u ovaj dio]
English: Women over 35 years of age should be strongly advised not to smoke if they wish to use <invented name>); - dyslipoproteinemia; - obesity (body mass index over 30 kg/m2);
Croatian: Ženama starijim od 35 godina mora se strogo savjetovati da ne puše ako žele uzimati <zaštićeno ime>);
English: How to take < invented name > [the wording below should be inserted in the relevant sections]
Croatian: • [Donji tekst mora se uvrstiti u odgovarajuće dijelove]
English: • if you have (or have ever had) a migraine, with visual disturbances
Croatian: • ako imate problema s Vašim srcem (poremećaj zalistaka, poremećaj ritma).
English: What you need to know before you use < invented name > [The wording below should be inserted in the relevant sections]
Croatian: Što morate znati prije nego počnete uzimati <zaštićeno ime>
English: When using a hormonal contraceptive like < invented name > you are strongly advised to stop smoking, especially if you are older than 35 years; if you are overweight; if you have high blood pressure; if a close relative has had a heart attack or stroke at a young age; if you have a high level of fat in your blood (cholesterol or triglycerides); if you get migraines; if you have a problem with your heart (valve disorder, disturbance of the rhythm).
Croatian: Liječnik će Vam možda tada savjetovati primjenu drugog liječenja: ako koristite drugi hormonski kontraceptiv ako imate (ili ste nekada imali) krvni ugrušak u nozi (tromboza), plućima (plućna embolija) ili nekom drugom dijelu tijela ako imate (ili ste nekada imali) bolest koja može upućivati na srčani udar u budućnosti (npr. angina pektoris - stanje s jakim bolovima u prsima) ili “mini-moždani udar” (tranzitorna ishemijska ataka) ako imate (ili ste nekada imali) srčani ili moždani udar ako imate stanje koje može povećati rizik od nastanka krvnog ugruška u Vašim arterijama.
English: [The following to be included below the table of adverse reactions]
Croatian: • [Sljedeće treba uključiti u tablicu s nuspojavama]
English: o diabetes affecting your blood vessels o very high blood pressure o a very high level of fat in your blood (cholesterol or triglycerides)
Croatian: • ako imate visoku razinu masnoće u krvi (kolesterol ili trigliceridi);
English: Package Leaflet
Croatian: Moguće nuspojave
English: When using a hormonal contraceptive like <invented name> you are strongly advised to stop smoking, especially if you are older than 35 years; if one of your close relatives has had a blood clot in the leg, lung or other organ at a young age; if you are overweight; if you must have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a plaster cast.
Croatian: Ukoliko koristite hormonski kontraceptiv kao što su <zaštićeno ime>, strogo Vam je preporučeno da prestanete pušiti, posebno ako ste stariji od 35 godina;
English: Antithrombotic treatment should be considered if the use of <invented name> has not been discontinued in advance.
Croatian: <zaštićeno ime> nije prekinuto na vrijeme.
English: The risk of arterial thromboembolic complications or of a cerebrovascular accident increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age.
Croatian: Rizik za nastanak arterijskih tromboembolijskih komplikacija ili cerebrovaskularnog događaja raste s:
English: • if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism)
Croatian: • ako je Vaš bliski rođak imao krvni ugrušak u nozi, plućima ili drugom organu u mladosti;
English: Children and adolescents Daliresp should not be used by children and adolescents under 18 years of age.
Croatian: Djeca i adolescenti Daliresp nije namijenjen djeci i adolescentima mlađim od 18 godina.
English: Date of first authorisation: 28 February 2011 Date of latest renewal: 24 April 2015
Croatian: Datum posljednje obnove: 24. travnja 2015
English: Daliresp may need to be taken for several weeks to achieve its effect (see section 5.1).
Croatian: Daliresp je ponekad potrebno uzimati više tjedana da bi se postigao učinak (vidjeti dio 5.1).
English: In case of an allergic reaction, stop taking Daliresp and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital.
Croatian: U slučaju alergijske reakcije, prestanite uzimati Daliresp i odmah se obratite svom liječniku ili se odmah javite na hitni prijem najbliže bolnice.
English: Daliresp will not help you in this situation.
Croatian: Daliresp Vam u takvim situacijama neće pomoći.
English: Other medicines and Daliresp
Croatian: Drugi lijekovi i Daliresp
English: If you take more Daliresp than you should
Croatian: Ako uzmete više Dalirespa nego što ste trebali
English: 1 What Daliresp is and what it is used for
Croatian: Što je Daliresp i za što se koristi
English: Interim Study Reports - with each PSUR
Croatian: Privremena izvješća ispitivanja - sa svakim
English: Before starting treatment with Daliresp, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects.
Croatian: Prije početka primjene Dalirespa obavijestite liječnika ako patite od takvih simptoma, kao i o svim dodatnim lijekovima koje uzimate, jer neki mogu povećati vjerojatnost pojave takvih nuspojava.
English: What Daliresp is and what it is used for What you need to know before you take Daliresp How to take Daliresp
Croatian: Što je Daliresp i za što se koristi Što morate znati prije nego počnete uzimati Daliresp Kako uzimati Daliresp
English: Warnings and precautions Talk to your doctor or pharmacist before taking Daliresp
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Daliresp.
English: You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Daliresp may be harmful for the unborn baby.
Croatian: Tijekom liječenja ovim lijekom ne smijete zatrudnjeti, te morate koristiti učinkovitu metodu kontracepcije za vrijeme liječenja, jer Daliresp može naškoditi nerođenom djetetu.
English: There is no relevant use of Daliresp in the paediatric population (under 18 years) in the indication COPD.
Croatian: Nema relevantne primjene Dalirespa u pedijatrijskoj populaciji (do 18 godina) u indikaciji KOPB-a.
English: It is important to continue taking Daliresp for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
Croatian: Važno je da Daliresp uzimate onoliko dugo koliko je preporučio liječnik, čak i kad nemate simptome, jer se samo tako može održati kontrola plućne funkcije.
English: You may need to take Daliresp for several weeks to achieve its beneficial effect.
Croatian: Ponekad je Daliresp potrebno uzimati nekoliko tjedana da biste osjetili povoljan učinak.