FrancophonIA/ELRC3.0 huggingface dataset:
English: [The text below should be inserted in this section and the existing text should be deleted]
Croatian: [Tekst u nastavku potrebno je umetnuti u ovaj dio, a postojeći tekst je potrebno izbrisati]
English: sister or grandmother who has had breast cancer) - Increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”) - Fibroids inside your womb - A very high level of fat in your blood (triglycerides) - Fluid retention due to cardiac or kidney problems.
Croatian: - Povećani rizik od razvoja krvnih ugrušaka (vidjeti „Krvni ugrušci u venama (tromboza)”) - Fibroidi unutar Vaše maternice
English: 1 to 10 patients treated out of 10,000
Croatian: 1 do 10 liječenih bolesnika od njih 10 000
English: Musculoskeletal, connective tissue and bone disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva
English: - Otosclerosis
Croatian: - porfirija.
English: - Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer
Croatian: - čimbenici rizika za tromboembolijske poremećaje (vidjeti u nastavku) - čimbenici rizika za tumore ovisne o estrogenu, npr. 1. stupanj nasljeđivanja za rakom dojke - hipertenzija - poremećaji jetre (npr. adenom jetre)
English: - known or suspected benign or malignant oestrogen-dependent tumours e.g. uterine leiomyoma, endometrial cancer) - history of malignant oestrogen-dependent tumours - Unspecified genital bleeding - Untreated endometrial hyperplasia - Skin diseases in the external genital area caused by bacterial, fungal, or viral infections
Croatian: - poznati ili suspektni benigni ili maligni tumori ovisni o estrogenu npr. lejomiom maternice, rak endometrija) - anamneza malignih tumora ovisnih o estrogenu
English: Risk estimates have been drawn from systemic exposure and it is not known how these apply to local treatments.
Croatian: Procjene rizika temelje se na sistemskoj izloženosti te nije poznato u kojoj mjeri se odnose na lokalna liječenja.
English: Women aged 50 to 79 who are not taking HRT, on average, 9 to 14 in 1000 will be diagnosed with breast cancer over a 5-year period.
Croatian: Kod žena u dobi od 50 do 79 godina koje ne uzimaju HNT, u prosjeku će njih 9 do 14 na 1
English: - Gallbladder disease
Croatian: - bolest žučnog mjehura
English: During the first week of treatment, [invented name] should be applied every other day - i.e. at 48-hourly intervals - and twice a week thereafter (maintenance dose).
Croatian: Tijekom prvog tjedna liječenja [zaštićeni naziv] mora se primjenjivati svaki drugi dan, tj. u
English: Do not use [invented name] if - You are allergic (hypersensitive) to estradiol or any of the other ingredients of [invented name] (listed in Section 6 Further information) - You have or have ever had breast cancer, or you are suspected of having it - You have or have ever had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or you are suspected of having it - You have any unexplained vaginal bleeding - You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated - You have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) - You have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) - You have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina - You have or have ever had a liver disease and your liver function tests have not returned to normal - You have a rare blood problem called “porphyria”, which is passed down in families (inherited).
Croatian: - imate ili ste nedavno imali bolest uzrokovanu krvnim ugrušcima u arterijama poput srčanog udara, moždanog udara ili angine. - imate ili ste imali bolest jetre i Vaši rezultati pretraga jetrene funkcije ne vrate u normalu - imate rijetki problem s krvlju zvan „porfirija” koji se prenosi u obitelji (nasljedan je).
English: [The text below should be inserted in this section.]
Croatian: [Tekst u nastavku potrebno je umetnuti u ovaj dio.]
English: A relationship between ovarian cancer risk and local vaginal oestrogen therapy is uncertain.
Croatian: Odnos između rizika od razvoja raka jajnika i lokalne vaginalne estrogenske terapije nije jasno utvrđena.
English: [The text below should be inserted in this section]
Croatian: [Tekst u nastavku potrebno je umetnuti u ovaj dio]
English: Gallbladder disease
Croatian: Bolest žučnog mjehura
English: A relationship between breast cancer risk and local vaginal oestrogen therapy is uncertain.
Croatian: Povezanost između rizika od razvoja raka dojke i lokalne vaginalne estrogenske terapije nije jasno utvrđena.
English: A relationship between venous thromboembolism and local vaginal oestrogen therapy is uncertain.
Croatian: Odnos između venske tromboembolije i lokalne vaginalne estrogenske terapije nije jasno utvrđen.
English: If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Croatian: potrebno je ispitati razlog, što može uključivati biopsiju endometrija kako bi se isključio malignitet endometrija.
English: Blood clots in a vein (thrombosis)
Croatian: - krvni ugrušci u venama nogu i pluća (venska tromboembolija)
English: - Cholelithiasis
Croatian: Prednizolon
English: - Jaundice or deterioration in liver function
Croatian: - Poremećaj jetre, poput benignog tumora jetre
English: [Invented name] should not be used for more than 4 weeks.
Croatian: Koliko dugo morate nastaviti primjenjivati [zaštićeni naziv]? [Zaštićeni naziv] se ne smije primjenjivati dulje od 4 tjedna.
English: Abnormal uterine bleeding (breakthrough bleeding/spotting), breast pain, breast tenderness, breast enlargement, breast discharge, leukorrhoea
Croatian: bol u dojkama, osjetljivost dojki, uvećane dojke, iscjedak iz dojki, leukoreja
English: If you stop using [invented name]
Croatian: Ako prestanete primjenjivati [zaštićeni naziv]
English: The following side effects can occur with oral and/or transdermal oestrogen treatment:
Croatian: Sljedeće nuspojave mogu se javiti s peroralnim/transdermalnim liječenjem estrogenom: - bolest žučnog mjehura - različiti kožni poremećaji:
English: [The text below should be inserted in this section.
Croatian: [Tekst u nastavku potrebno je umetnuti u ovaj dio.
English: [invented name] should not be used in the following cases: - Known, past or suspected breast cancer - Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer) - Undiagnosed genital bleeding - Untreated endometrial hyperplasia - Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) - Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency,
Croatian: - poznati, prijašnji ili suspektni rak dojke - poznati ili suspektni maligni tumori ovisni o estrogenu (npr. rakom endometrija) - nedijagnosticirano genitalno krvarenje
English: Depression
Croatian: Dojenje
English: WHI Studies - Additional risk of VTE over 5 years' use Age range (years) Incidence per 1000 women placebo arm over 5 years
Croatian: WHI ispitivanja - dodatni rizik od VTE-a tijekom petogodišnje uporabe Dobni raspon (godine)
English: - painful swelling and redness of the legs - sudden chest pain - difficulty in breathing
Croatian: Ako zatrudnite Ako primijetite znakove krvnog ugruška poput: - bolnog oticanja i crvenila nogu - iznenadne boli u prsištu
English: [The text below should be inserted]
Croatian: [Tekst u nastavku potrebno je umetnuti]
English: - Epilepsy
Croatian: (kloazma)
English: - history of malignant oestrogen-dependent tumours - tumours of the womb (leiomyoma, uterine myoma).
Croatian: - tumori maternice (lejomiom, miomi maternice).
English: Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period.
Croatian: Za žene u dobi od 50 do 69 godina koje ne uzimaju HNT, u prosjeku dvije žene na njih 1 000
English: - Skin and subcutaneous disorders: erythema multiforme, erythema nodosum, vascular purpura
Croatian: Procjene rizika temelje se na sistemskoj izloženosti te nije poznato u kojoj mjeri se odnose na lokalna liječenja: - kožni i potkožni poremećaji: multiformni eritem, nodozni eritem, vaskularna purpura
English: - Asthma - Epilepsy - Diabetes - Gallstones - High blood pressure - Migraines or severe headaches - A liver disorder, such as a benign liver tumour
Croatian: Terapiju je potrebno prekinuti u slučaju otkrivanja kontraindikacije te u sljedećim situacijama: - žutica ili pogoršavanje funkcije jetre - znatan porast krvnog tlaka - novi napadaj migrenske glavobolje
English: Oestrogen only HRT
Croatian: Samo konjugirani konjski (CEE) estrogen
English: - Gall bladder disease - Various skin disorders: o discoloration of the skin especially of the face or neck known as “pregnancy patches (chloasma) o painful reddish skin nodules (erythema nodosum) o rash with target-shaped reddening or sores (erythema multiforme)
Croatian: - kolelitijaza - migrena ili (teška) glavobolja - sistemski lupus eritematozus - anamneza hiperplazije endometrija (vidjeti u nastavku) - epilepsija - astma - otoskleroza
English: Package Leaflet
Croatian: Blagi iscjedak
English: Before you use [invented name]
Croatian: 2. PRIJE NEGO POČNETE PRIMJENJIVATI[zaštićeni naziv] Nemojte primjenjivati [zaštićeni naziv]
English: - Growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia) - A disease affecting the eardrum and hearing (otosclerosis) - A disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE) - Increased risk of getting an oestrogen-sensitive cancer (such as having a mother,
Croatian: - patite od neobjašnjivih vaginalnih krvarenja - imate prekomjerno zadebljanje sluznice maternice (hiperplazija endometrija) koje se ne liječi - imate ili ste imali krvni ugrušak u veni (tromboza) poput onog u nogama (duboka venska tromboza) ili u plućima (plućna embolija)
English: These may be signs of a liver disease - A large rise in your blood pressure (symptoms may be headache, tiredness, dizziness) - Any of the conditions mentioned in the ‘Do not use [invented name] ' section
Croatian: - veliki porast krvnog tlaka (simptomi mogu biti glavobolja, umor, omaglica)
English: 05 March 2014
Croatian: 05. ožujka 2014.
English: The European Commission issued a decision on 05 March 2014.
Croatian: Europska komisija je usvojila odluku dana 5. ožujka 2014.
English: Outcome of a procedure under Article 29(4) of Directive 2001/83/EC
Croatian: Ishod postupka provedenog u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ
English: What are the conclusions of the CHMP?
Croatian: Koji je zaključak donio CHMP?
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su lijeka bioekvivalenti ako proizvode iste razine aktivne djelatne tvari u tijelu.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Spain) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Germany and the Netherlands).
Croatian: To je postupak u kojem jedna država članica („referenta država članica” u ovom slučaju Španjolska) ocjenjuje lijek sa ciljem izdavanja odobrenja za stavljanje lijeka u promet koji će biti valjan u ovoj državi kao i u drugim državama članicama („država članica sudionica u postupku”, u ovom slučaju Belgija, Njemačka i Nizozemska).
English: This means that storage conditions could potentially have been inadequate leading to the degradation of the active substance, making the samples inadequate for testing.
Croatian: To znači da su uvjeti čuvanja mogli potencijalno biti neprimjereni, što bi rezultiralo degradiranjem djelatne tvari, te učinilo uzorke neprimjerenima za testiranje.
English: However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 31 October 2013.
Croatian: No, države članice nisu uspjele postići sporazum, te je Španjolska regulatorna agencija uputila predmet CHMP-u na arbitražu dana 31. listopada 2013.
English: On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Tibolona Aristo and Tibocina.
Croatian: Dana 19. prosinca 2013., Europska agencija za lijekove završila je arbitražni postupak nakon neslaganja između država članica Europske unije (EU) u vezi s odobrenjem za lijekove Tibolona Aristo i Tibocina.
English: Tibolone is a type of hormone replacement therapy (HRT) and is used to alleviate the symptoms of the menopause (such as hot flushes) in women who have not had a natural period for at least 12 months.
Croatian: Tibolon je tip hormonalne zamjenske terapije (HZT-a) i koristi se za uklanjanje simptoma menopauze (poput naleta vrućine) u žena kojima je prirodna mjesečnica izostala tijekom proteklih 12 mjeseci.
English: The company had supplied additional evidence to indicate that the study samples had been stored and maintained under adequate temperature conditions, further supported by the concentrations recorded in the bioequivalence study.
Croatian: Tvrtka je dostavila dodatni dokaz kako bi sugerirala da su uzorci ispitivanja bili pohranjeni i održavani u primjerenim temperaturnim uvjetima, što je dalje podržano koncentracijama zabilježenima u ispitivanju bioekvivaletnosti.
English: Germany considered that these data were not reliable because of failings in the way the study samples were identified and registered and the cold storage and transport of the samples were recorded.
Croatian: Njemačka je posebice smatra da ovi podaci nisu pouzdani s obzirom na nedostatke u načinu identificiranja i registracije uzoraka ispitivanja te u svezi s prijavom hladnog skladištenja i transporta uzoraka.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicinal product has been shown.
Croatian: Na temelju trenutno dostupnih podatak i znanstvenog zaključka unutar Povjerenstva, CHMP je zaključio da je dokazana bioekvivaletnost s referentnim lijekom.
English: Aristo Pharma GmbH submitted Tibolona Aristo and Tibocina to the Spanish medicines regulatory agency for a decentralised procedure.
Croatian: Aristo Pharma GmbH dostavio je lijekove Tibolona Aristo i Tibocina Španjolskoj regulatornoj agenciji za provedbu decentraliziranog postupka.
English: Tibolona Aristo and Tibocina are medicines that contain the active substance tibolone; they are available as tablets (2.5 mg).
Croatian: Tibolona Aristo i Tibocina su lijekovi koji sadrže djelatnu tvar tibolon; dostupni su u tabletama (2.5 mg).
English: What are Tibolona Aristo and Tibocina?
Croatian: Što su Tibolona Aristo i Tibocina?
English: The grounds for the referral were objections raised by Germany about the data submitted to show that Tibolona Aristo and Tibocina were ‘bioequivalent' to the reference medicine, Liviella.
Croatian: Razlog za upućivanje bile su primjedbe koje je iznijela Njemačka u vezi s dostavljenim podacima kako bi se dokazalo da su Tibolona Aristo i Tibocina „bioekvivalenti” referentno lijeku, Liviella.
English: Tibolona Aristo and Tibocina are generic medicines based on a ‘reference medicine', Liviella, which is authorised in Germany.
Croatian: Tibolona Aristo i Tibocina su generički lijekovi koji se temelje na „referentnom lijeku”, Liviella, koji je odobren u Njemačkoj.
English: Why were Tibolona Aristo and Tibocina reviewed?
Croatian: Zašto su Tibolona Aristo i Tibocina pregledani?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks, and the marketing authorisations can be granted in Spain and in the following Member States of the EU: Belgium, Germany and the Netherlands.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) zaključilo je da koristi lijekova Tibolona Aristo i Tibocina nadmašuju njihove rizike te da se odobrenje za stavljanje lijeka u promet može odobriti u Španjolskoj kao i u sljedećim državama članicama EU-a: Belgiji, Njemačkoj i Nizozemskoj.
English: The CHMP therefore concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks and recommended that the marketing authorisations be granted in the concerned Member States.
Croatian: Stoga je CHMP zaključio da prednosti od lijekova Tibolona Aristo i Tibocina nadmašuju s njima povezane rizike te je preporučilo izdavanje odobrenja za stavljanje ovih lijekova u promet u državama članicama sudionicama u postupku.
English: Patients should be monitored for at least one hour after the first infusion for any reactions.
Croatian: Bolesnike treba nadzirati najmanje sat vremena nakon prve infuzije radi utvrđivanja mogućih reakcija.
English: Further information on Trogarzo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/trogarzo.
Croatian: Više informacija o lijeku Trogarzo dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/trogarzoema.europa.eu/medicines/human/EPAR/tro garzo.
English: If a reaction occurs, the infusion should be stopped and patients should receive appropriate treatment.
Croatian: Ako dođe do reakcije, infuziju treba prekinuti, a bolesnici trebaju primiti odgovarajuće liječenje.
English: Overall, the safety profile of Trogarzo was considered to be acceptable.
Croatian: Ukupno gledajući, sigurnosni profil lijeka Trogarzo smatrao se prihvatljivim.
English: What is Trogarzo and what is it used for?
Croatian: Što je Trogarzo i za što se koristi?
English: Other information about Trogarzo
Croatian: Ostale informacije o lijeku Trogarzo
English: What measures are being taken to ensure the safe and effective use of Trogarzo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Trogarzo?
English: Treatment should be started and monitored by a doctor who is experienced in the treatment of HIV infection.
Croatian: Liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju infekcije HIV-om.
English: Side effects reported with Trogarzo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Trogarzo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: In patients with multi-drug resistant HIV, treatment options are limited and there is therefore an unmet medical need in this group.
Croatian: U bolesnika s multirezistentnim virusom HIV-a opcije liječenja ograničene su i stoga u toj skupini postoji nezadovoljena medicinska potreba.
English: Although the studies submitted were small and did not include a direct comparison with other medicines, the results indicate that adding Trogarzo to other medicines could control the virus in these patients.
Croatian: Premda su dostavljena ispitivanja malih razmjera koja nisu uključivala izravnu usporedbu s drugim lijekovima, rezultati upućuju na to da bi se dodavanjem lijeka Trogarzo drugim lijekovima mogla postići kontrola virusa u tih bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trogarzo have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Trogarzo nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The European Medicines Agency therefore decided that Trogarzo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Trogarzo nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Treatment is started with a single infusion of 2,000 mg followed by 800 mg every 2 weeks; if treatment is interrupted, it should be restarted in the same way.
Croatian: Liječenje započinje jednokratnom infuzijom od 2 000 mg, nakon čega slijedi 800 mg svaka 2 tjedna.
English: The most common side effects with Trogarzo (which may affect up to 1 in 10 patients) are rash, diarrhoea, dizziness, headache, nausea (feeling sick), vomiting and tiredness.
Croatian: Najčešće nuspojave lijeka Trogarzo (koje se mogu javiti u najviše 1 na 10 osoba) jesu osip, proljev, omaglica, glavobolja i mučnina (slabost), povraćanje i umor.
English: Trogarzo does not cure HIV-1 infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Trogarzo ne liječi infekciju HIV-om ni AIDS, ali može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
English: What are the risks associated with Trogarzo?
Croatian: Koji su rizici povezani s lijekom Trogarzo?
English: By attaching to CD4, ibalizumab prevents the virus from entering the T-cells and reproducing, thereby slowing down the spread of infection.
Croatian: Vezivanjem na receptor CD4, ibalizumab sprječava virus da uđe u T-stanice i ondje se razmnožava, čime usporava širenje infekcije.
English: Why is Trogarzo authorised in the EU?
Croatian: Zašto je lijek Trogarzo odobren u EU-u?
English: Similar effects were seen in a second main study with 113 adults, where 44% of patients who had maintenance doses of Trogarzo added to standard treatment had undetectable HIV levels after 25 weeks.
Croatian: Slični su učinci utvrđeni u drugom ispitivanju na 113 odraslih osoba, u kojem je 44 % bolesnika, kojima su uz standardno liječenje dodane doze održavanja lijeka Trogarzo, imalo nemjerljive razine virusa HIV-a nakon 25 tjedana.
English: As for all medicines, data on the use of Trogarzo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Trogarzo kontinuirano se prate.
English: T cells are the main target of the HIV virus, which it uses as a host to reproduce.
Croatian: T-stanice ciljna su mjesta virusa HIV-a, koje on koristi u svojstvu domaćina da bi se razmnožavao.
English: For more information about using Trogarzo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Trogarzo pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: An overview of Trogarzo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Trogarzo i zašto je odobren u EU-u
English: Trogarzo is a medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Trogarzo je lijek za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Trogarzo is given with other HIV medicines when none of the standard combinations work to control the infection because the virus is resistant to them (multi-drug resistant HIV).
Croatian: Trogarzo se daje uz druge lijekove za liječenje infekcije HIV-om kada se nijednom od standardnih kombinacija ne postiže kontrola infekcije jer je virus otporan na njih (multirezistentni virus HIV-a).
English: The company that markets Trogarzo will carry out a study to confirm the benefits of treatment with Trogarzo in patients with multi-drug resistant HIV infection.
Croatian: Tvrtka koja stavlja lijek Trogarzo u promet provest će ispitivanje kako bi se potvrdile koristi od terapije lijekom Trogarzo u bolesnika s infekcijom multirezistentnog virusa HIV-a.