FrancophonIA/ELRC3.0 huggingface dataset:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u
English: • if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
Croatian: • ako imate (ili ste ikad imali) krvni ugrušak u nekoj krvnoj žili nogu (duboka venska tromboza, DVT), pluća (plućna embolija, PE) ili drugih organa;
English: The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more
Croatian: Rizik može također biti povećan ako ponovno počnete uzimati kombinirani hormonski kontraceptiv (isti ili neki drugi) nakon stanke od 4 ili više tjedana.
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 je iskašljavanje krvi ili nedostatak zraka, mogu zamijeniti s blažim stanjem, kao što je infekcija dišnih puteva (npr. ‘obična prehlada').
English: Risk factor
Croatian: Čimbenik rizika
English: These incidences were estimated from the totality of the epidemiological study data, using relative risks for the different products compared with levonorgestrel-containing CHCs.
Croatian: Ove su incidencije bile procijenjene na temelju ukupnih podataka epidemiološkog ispitivanja, uporabom relativnih rizika za različite lijekove u usporedbi s KOK-ima koji sadrže levonorgestrel.
English: [The folllowing text should be included as these products will be in the Additional monitoring list]
Croatian: [Sljedeći tekst treba uključiti jer će se ti lijekovi nalaziti u popisu lijekova za dodatno praćenje]
English: It is important to remember that the overall risk of a harmful blood clot due to [invented name] is small.
Croatian: Važno je zapamtiti da je ukupni rizik od krvnog ugruška sa štetnim posljedicama zbog [zaštićeno ime] mali.
English: It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of [invented name] 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 [zaštićeno ime] u usporedbi s drugim kombiniranim hormonskim kontraceptivima, na simptome VTE i ATE, poznate čimbenike rizika i što učiniti u slučaju sumnje na trombozu.
English: [The following should be deleted (where applicable)] There is no consensus as to whether the occurrence of these events is associated with the use of CHCs.
Croatian: [Sljedeći tekst treba izbrisati (gdje je primjenjivo)] Nema konsenzusa o tome je li nastanak ovih događaja povezan s primjenom KOK-a.
English: In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of [Invented name] should be discontinued.
Croatian: U slučaju pogoršanja ili prve pojave nekog od navedenih stanja ili čimbenika rizika, ženi treba savjetovati da se obrati svom liječniku kako bi utvrdio treba li prekinuti primjenu [zaštićeno ime].
English: Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Croatian: Kombinirani hormonski kontraceptivi (KOK-i) ne smiju se primjenjivati u sljedećim stanjima:
English: • swelling and slight blue discolouration of an extremity; • severe pain in your stomach (acute abdomen)
Croatian: • oticanje i blago plavičasta boja ekstremiteta; • jaka bol u trbuhu (akutni abdomen)
English: About 5-7 out of 10,000 women
Croatian: oko 5-7 na 10 000 žena
English: Women using [Invented name]
Croatian: Žene koje uzimaju [zaštićeno ime]
English: • if you know you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
Croatian: • ako znate da imate poremećaj koji utječe na zgrušavanje krvi - na primjer, nedostatak proteina C, nedostatak proteina S, nedostatak antitrombina III, faktor V Leiden ili antifosfolipidna protutijela;
English: The use of [invented name] may need to be stopped several weeks before surgery or while you are less mobile.
Croatian: primjenom [zaštićeno ime] će možda trebati prestati nekoliko tjedana prije operacije ili za vrijeme mirovanja.
English: • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks
Croatian: • Malo povećavaju rizik od nastanka krvnog ugruška u venama i arterijama, osobito u prvoj godini primjene ili kad se ponovno počinje s primjenom kombiniranog hormonskog kontraceptiva nakon stanke od 4 ili više tjedana
English: Using a combined hormonal contraceptive such as [invented name] increases your risk of developing a blood clot compared with not using one.
Croatian: Primjena kombiniranog hormonskog kontraceptiva kao što je [zaštićeno ime] povećava rizik od razvoja krvnog ugruška u odnosu na to kad se ne uzima.
English: • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)
Croatian: • Molimo budite oprezni i posjetite liječnika ako mislite da imate simptome kakve izaziva krvni ugrušak (pogledajte dio 2 “Krvni ugrušci”)
English: The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot)
Croatian: Vjerojatnost da razvijete krvni ugrušak može biti veća ako imate neka druga zdravstvena stanja koja povećavaju taj rizik (pogledajte dio 2 za dodatne informacije o stanjima koja povećavaju rizik od krvnih ugrušaka i simptome krvnog ugruška)
English: Blood clots can develop in veins (referred to as a ‘venous thrombosis', ‘venous thromboembolism' or VTE)
Croatian: Krvni ugrušci mogu nastati u venama (što se naziva ‘venska tromboza', ‘venska tromboembolija' ili VTE)
English: Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors
Croatian: Napomena: privremena imobilizacija uključujući putovanje avionom >4 sata također može biti čimbenik rizika za VTE, osobito u žena s drugim čimbenicima rizika.
English: If any of the above conditions change while you are using [invented name], for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
Croatian: Ako Vam se neko od gore navedenih stanja promijeni za vrijeme uzimanja [zaštićeno ime], na primjer, počnete pušiti, član uže obitelji razvije trombozu iz nepoznatog razloga; ili se jako udebljate, obavijestite svog liječnika.
English: Section 4.1 - Therapeutic indications [The wording below should be inserted at the end of this section]
Croatian: Dio 4.1 - Terapijske indikacije [Sljedeći test treba umetnuti na kraj ovog dijela]
English: Seek urgent medical attention - if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clot' (thrombosis) section below.
Croatian: Potražite hitnu medicinsku pomoć - ako primijetite moguće znakove krvnog ugruška koji mogu značiti da imate krvni ugrušak u nozi (tj. duboku vensku trombozu), krvni ugrušak u plućima (tj. plućnu emboliju), srčani ili moždani udar (pogledajte dio ‘Krvni ugrušak (tromboza) niže).
English: • if you have systemic lupus erythematosus (SLE -; a disease affecting your natural defence system);
Croatian: • ako imate sistemski lupus eritematodes (SLE - bolest koja zahvaća prirodni obrambeni sustav
English: Products that contain levonorgestrel, norgestimate (including [invented name]) or norethisterone are associated with the lowest risk of VTE.
Croatian: Lijekovi koji sadrže levonorgestrel, norgestimat (uključujući [zaštićeno ime]) ili noretisteron povezani su s najnižim rizikom od VTE.
English: • Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
Croatian: • Vrlo rijetko, krvni ugrušak može se stvoriti u veni nekog drugog organa, kao što je oko (tromboza vene mrežnice oka).
English: [The wording below should be inserted at the top of this section] General notes
Croatian: [Sljedeći tekst treba umetnuti na početak ovog dijela] Opće napomene
English: [Invented name] 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: [Zaštićeno ime] 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: The decision to prescribe [invented name] should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [invented name] compares with other CHCs (see sections 4.3 and 4.4).
Croatian: Kod donošenja odluke o propisivanju [zaštićeno ime] treba uzeti u obzir čimbenike rizika prisutne u pojedine žene, osobito one za vensku tromboemboliju (VTE), te visinu rizika od VTE kod uzimanja [zaštićeno ime] u usporedbi s drugim kombiniranim hormonskim kontraceptivima (vidjeti dijelove 4.3 i 4.4).
English: If any of the above conditions change while you are using [invented name], 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 Vam se neko od gore navedenih stanja promijeni za vrijeme uzimanja [zaštićeno ime], na primjer, netko od članova uže obitelji razvije trombozu iz nepoznatog razloga; ili se jako udebljate, obavijestite svog liječnika.
English: • if you have any of the following diseases that may increase your risk of a clot in the arteries: - severe diabetes with blood vessel damage - very high blood pressure - a very high level of fat in the blood (cholesterol or triglycerides) - a condition known as hyperhomocysteinaemia
Croatian: • ako imate neku od sljedećih bolesti koja može povećati rizik od stvaranja ugruška u arterijama: - teška šećerna bolest s oštećenjem krvnih žila - vrlo visok krvni tlak - vrlo visoke vrijednosti masnoća u krvi (kolesterola ili triglicerida) - stanje koje se zove hiperhomocisteinemija
English: Limited epidemiological data suggest that the risk of VTE with dienogest-containing CHCs may be similar to the risk with levonorgestrel-containing CHCs.
Croatian: Ograničeni epidemiološki podaci pokazuju da rizik od VTE uz KOK-e koji sadrže dienogest može biti sličan riziku uz KOK-e koji sadrže levonorgestrel.
English: o History of migraine with focal neurological symptoms.
Croatian: o Migrena sa žarišnim neurološkim simptomima u povijesti bolesti.
English: Comment Obesity (body mass index over 30 Risk increases substantially as BMI rises.
Croatian: Napomena Pretilost (indeks tjelesne mase veći od Rizik se znatno povećava s povećanjem indeksa
English: Symptoms of a cerebrovascular accident can include: - sudden numbness or weakness of the face, arm or leg, especially on one side of the body; - sudden trouble walking, dizziness, loss of balance or coordination; - sudden confusion, trouble speaking or understanding; - sudden trouble seeing in one or both eyes; - sudden, severe or prolonged headache with no known cause; - loss of consciousness or fainting with or without seizure.
Croatian: Simptomi cerebrovaskularnog incidenta mogu uključivati: - iznenadnu utrnulost ili slabost lica, ruke ili noge, osobito na jednoj strani tijela; - iznenadne poteškoće s hodanjem, omaglica, gubitak ravnoteže ili koordinacije; - iznenadnu smetenost, otežan govor ili razumijevanje; - iznenadne poteškoće s vidom na jedno ili oba oka; - iznenadna, jaka ili dugotrajna glavobolja bez poznatog uzroka; - gubitak svijesti ili nesvjestica sa ili bez napadaja.
English: - It is not yet known how the risk of a blood clot with [invented name] compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.
Croatian: - Još nije poznato koliki je rizik od krvnog ugruška uz [zaštićeno ime] u usporedbi s rizikom uz kombinirani hormonski kontraceptiv koji sadrži levonorgestrel.
English: It is not yet known how the risk with [invented name] compares with these lower risk products.
Croatian: Nije još poznato koliki je rizik uz [zaštićeno ime] u odnosu na lijekove s niskim rizikom.
English: • severe dyslipoproteinaemia
Croatian: • teška dislipoproteinemija
English: It is not yet known how the risk of VTE with CHCs that contain [progestogen] in combination with estradiol compares with the risk with low dose levonorgestrel-containing CHCs.
Croatian: Još nije poznato koliki je rizik od VTE uz KOK-e koji sadrže [progestogen] u kombinaciji s estradiolom u usporedbi s rizikom uz KOK-e koji sadrže nisku dozu levonorgestrela.
English: • if you are very overweight (body mass index or BMI over 30kg/m2);
Croatian: • ako ste jako pretili (indeks tjelesne mase ili ITM veći od 30 kg/m2);
English: Symptoms of deep vein thrombosis (DVT) can include: - unilateral swelling of the leg and/or foot or along a vein in the leg; - pain or tenderness in the leg which may be felt only when standing or walking, - increased warmth in the affected leg; red or discoloured skin on the leg.
Croatian: Simptomi duboke venske tromboze (DVT) mogu uključivati: - unilateralno oticanje noge i/ili stopala ili oticanje duž vene na nozi; - bol ili osjetljivost noge koja se može osjećati samo pri stajanju ili hodanju, - povećana toplina zahvaćene noge; crvenilo ili promjena boje kože na nozi.
English: Obesity (body mass index over 30 kg/m2)
Croatian: Pretilost (indeks tjelesne mase iznad 30 kg/m2)
English: If the condition develops, or gets worse while you are using [invented name], you should also tell your doctor.
Croatian: Ako se neko od stanja pojavi prvi put ili se ono pogorša dok primjenjujete [zaštićeno ime], o tome također morate obavijestiti svog liječnika.
English: About 9-12 out of 10,000 women
Croatian: oko 9-12 na 10 000 žena
English: The relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Croatian: Odgovarajući dijelovi Sažetka opisa svojstava lijeka, i upute o lijeku rezultat su arbitražnog postupka.
English: [This section should be amended to include the following contraindications] Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Croatian: [Ovaj dio treba izmijeniti kako bi se uključile sljedeće kontraindikacije] Kombinirani hormonski kontraceptivi (KOK-i) ne smiju se primjenjivati u sljedećim stanjima.
English: - rapid or irregular heartbeat.
Croatian: - ubrzan ili nepravilni otkucaji srca.
English: Stroke
Croatian: Napomena
English: [The following graph should be inserted here.]
Croatian: [Ovdje treba umetnuti sljedeći grafikon.]
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: • If you have an inflammation in the veins under the skin (superficial thrombophlebitis);
Croatian: • ako imate upalu potkožnih vena (superficialni tromboflebitis);
English: • If you have varicose veins.
Croatian: • ako imate varikozne vene.
English: - Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
Croatian: Od 10 000 žena koje ne uzimaju nikakvu kombinirani hormonski kontraceptiv i nisu trudne, oko 2 će razviti krvni ugrušak u godinu dana.
English: You should ask your doctor how soon after delivery you can start taking [invented name];
Croatian: Upitajte svog liječnika kad najranije nakon porođaja možete početi uzimati [zaštićeno ime].
English: Positive family history (arterial thromboembolism ever in a sibling or parent especially at relatively early age e.g. below 50).
Croatian: Pozitivna obiteljska anamneza (arterijska tromboembolija u braće, sestara ili roditelja osobito u relativno ranoj dobi, npr., prije 50. godine života).
English: • If you have an inflammation in the veins under the skin (superficial thrombophlebitis).
Croatian: • ako imate upalu potkožnih vena (superficialni tromboflebitis).
English: Risk increases substantially as BMI increases.
Croatian: Rizik se znatno povećava s povećanjem indeksa
English: This corresponds to between about 6 and 12 VTEs in a year out of 10,000 women who use [Invented name].
Croatian: To odgovara broju od približno 6 do 12 slučajeva VTE u godinu dana na 10 000 žena koje koriste Nuvaring.
English: If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).
Croatian: Ako se ravnoteža koristi i rizika smatra negativnom, ne smije se propisati kombinirana hormonska kontracepcija (vidjeti dio 4.3).
English: [Invented name] is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis (see section 4.3).
Croatian: [Zaštićeno ime] je kontraindiciran u žena s većim brojem čimbenika rizika zbog kojih imaju visok rizik od venske tromboze (vidjeti dio 4.3).
English: Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease
Croatian: Karcinom, sistemski lupus eritematodes, hemolitičkouremijski sindrom, kronična upalna bolest crijeva (Crohnova bolest ili ulcerozni kolitis) i anemija srpastih stanica
English: • Presence or risk of arterial thromboembolism (ATE) o Arterial thromboembolism - current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris) o Cerebrovascular disease - current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA) o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
Croatian: • Prisutnost rizika od arterijske tromboembolije (ATE) o Arterijska tromboembolija - postojeća arterijska tromboembolija, arterijska tromboembolija u povijesti bolesti (npr. infarkt miokarda) ili prodromalno stanje (npr. angina pektoris) o Cerebrovaskularna bolest - postojeći moždani udar, moždani udar u povijesti bolesti ili prodromalno stanje (npr. tranzitorna ishemijska ataka, TIA) o Poznata nasljedna ili stečena sklonost arterijskoj tromboemboliji, kao što je hiperhomocisteinemija i antifosfolipidna protutijela (antikardiolipinska protutijela, lupus antikoagulant).
English: Factors that increase your risk of a blood clot in an artery It is important to note that the risk of a heart attack or stroke from using [invented name] is very small but can increase:
Croatian: Važno je zapamtiti da je rizik od srčanog ili moždanog udara zbog primjene [zaštićeno ime] vrlo mali, ali može se povećati:
English: Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus.
Croatian: Šećerna bolest, hiperhomocisteinemija, valvularna bolest srca i fibrilacija atrija, dislipoproteinemija i sistemski lupus eritematodes.
English: [The following graph should be inserted here]
Croatian: [Ovdje treba umetnuti sljedeći grafikon]
English: Symptoms of myocardial infarction (MI) can include: - pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; - discomfort radiating to the back, jaw, throat, arm, stomach; - feeling of being full, having indigestion or choking; - sweating, nausea, vomiting or dizziness; - extreme weakness, anxiety, or shortness of breath; - rapid or irregular heartbeats.
Croatian: Simptomi infarkta miokarda (IM) mogu uključivati: - bol, nelagodu, pritisak, težinu, osjećaj stezanja ili punoće u prsištu, ruci ili ispod prsne kosti; - nelagoda koja se širi u leđa, čeljust, grlo, ruku, želudac; - osjećaj punoće, probavne tegobe ili gušenje; - znojenje, mučnina, povraćanje ili omaglica; - izrazita slabost, anksioznost ili nedostatak zraka; - ubrzan ili nepravilni otkucaji srca.
English: Table: Risk factors for VTE
Croatian: Tablica: Čimbenici rizika za VTE
English: [The wording below should be inserted in this section] In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year.
Croatian: [U ovaj dio treba umetnuti sljedeći tekst]Približno 2 žene na njih 10 000 koje ne primjenjuju KOK-e i nisu trudne razvit će VTE u razdoblju od godinu dana.
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use
Croatian: Ako se sumnja na nasljednu sklonost, ženu treba uputiti po savjet specijalista prije nego što se donese odluka o uporabi bilo kojeg KOK-a
English: [This section should be amended to include the below wording]
Croatian: [Ovaj dio treba promijeniti tako da uključuje sljedeći tekst]
English: [The wording below should be inserted at the top of this section] The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.
Croatian: [Sljedeći odlomak teksta treba umetnuti na početak ovog dijela] Primjena bilo kojeg kombiniranog hormonskog kontraceptiva (KOK-a)povećava rizik od venske tromboembolije (VTE) u odnosu na rizik kad se ne primjenjuje.
English: Current evidence suggests that the risk of VTE with use of norgestimate-containing CHCs is similar to the risk with levonorgestrel-containing CHCs.
Croatian: Sadašnji dokazi pokazuju da je rizik od VTE uz primjenu KOK-a koji sadrže norgestimat sličan riziku uz primjenu KOK-a koji sadrže levonorgestrel.
English: Epidemiological studies in women who use low dose combined oral contraceptives (<50 μg ethinylestradiol) have found that out of 10,000 women between about 6 to 12 will develop a VTE in one year.
Croatian: Epidemiološka ispitivanja u žena koje uzimaju nisku dozu kombiniranih oralnih kontraceptiva (<50 μg etinilestradiola) pronašla su da će oko 6 do 12 žena na njih 10 000 razviti VTE u godinu dana.
English: - The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below)
Croatian: - Rizik od krvnog ugruška može biti različit ovisno o Vašoj osobnoj povijesti bolesti (pogledajte “Čimbenici koji povećavaju
English: Symptoms of pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing;
Croatian: Simptomi plućne embolije (PE) mogu uključivati: - iznenadni nastup neobjašnjivog nedostatka zraka ili ubrzanog disanja;
English: Antithrombotic treatment should be considered if [invented name] has not been discontinued in advance.
Croatian: Ako primjena [zaštićeno ime] nije bila prethodno prekinuta, potrebno je razmotriti antithrombotsko liječenje.
English: Section 4.8 - Undesirable effects [This following wording should be reflected in this section]
Croatian: Dio 4.8 - Nuspojave [U ovom dijelu treba se nalaziti sljedeći tekst]
English: When you should not use [Invented name]
Croatian: Kad ne smijete primjenjivati