FrancophonIA/ELRC3.0 huggingface dataset:
English: Basic Pharma Manufacturing B.V. Burgemeester Lemmensstraat 352 6163 JT Geleen
Croatian: Burgemeester Lemmensstraat 352 6163 JT Geleen
English: The following risks apply to HRT medicines which circulate in the blood.
Croatian: Sljedeći rizici odnose se na lijekove za hormonsko nadomjesno liječenje koji cirkuliraju u krvi.
English: • The level of risk is dependent on the duration of use (see section 4.4).
Croatian: • Razina rizika ovisi o trajanju terapije (vidjeti dio 4.4).
English: The applicator should then be withdrawn and disassembled, and the two pieces of the applicator should be rinsed for 30 seconds under running water before wiping with paper towel and reassembled.
Croatian: Dva dijela aplikatora treba ispirati 30 sekundi vodom iz slavine, a zatim ih treba obrisati papirnatim ručnikom i ponovno sastaviti.
English: Heart disease (heart attack) / Hypertension
Croatian: Srčana bolest (srčani udar) / hipertenzija
English: Before initiating Intrarosa, a complete personal and family medical history should be taken.
Croatian: Prije početka primjene lijeka Intrarosa treba procijeniti ukupnu osobnu i obiteljsku povijest bolesti.
English: • If you have or have ever had a liver disease and your liver function tests have not returned to normal;
Croatian: • ako imate ili ste imali bolest jetre i vrijednosti funkcije jetre se još nisu vratile na normalu;
English: • any of the conditions mentioned in the ‘DO NOT take Intrarosa' section;
Croatian: • bilo koje stanje navedeno u dijelu „NEMOJTE uzimati lijek Intrarosa“,
English: It is uncertain whether a risk exists with Intrarosa used for long term (more than one year) treatments.
Croatian: Nije sigurno postoji li rizik kod dugotrajne primjene lijeka Intrarosa (više od jedne godine).
English: What Intrarosa is and what it is used for
Croatian: Što je Intrarosa i za što se koristi
English: For signs of a blood clot, see “Stop taking Intrarosa and see a doctor immediately”.
Croatian: Za znakove krvnog ugruška, pogledajte dio „Prekid primjene lijeka Intrarosa i hitan posjet liječniku”.
English: Patients should be told to contact their doctors immediately when they are aware of a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
Croatian: Bolesnice treba savjetovati da se obrate svojim liječnicima čim primijete moguće simptome tromboembolije (npr. bolno oticanje noge, iznenadna bol u prsištu, dispneja).
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Croatian: Tijekom liječenja preporučuju se povremeni pregledi čija se učestalost i vrsta prilagođavaju pojedinoj ženi.
English: It is caused by a drop in the levels of oestrogen in your body.
Croatian: Uzrokuje ih smanjenje razine estrogena u tijelu.
English: Do not take Intrarosa if any of the following applies to you.
Croatian: Nemojte uzimati lijek Intrarosa ako se bilo što od sljedećeg odnosi na Vas.
English: Therefore caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis since intravaginal prasterone has not been studied in women with endometriosis.
Croatian: Stoga se preporučuje oprez pri primjeni ovog lijeka u žena koje su podvrgnute histerektomiji zbog endometrioze, posebno ako imaju rezidualnu endometriozu jer intravaginalni prasteron nije ispitivan u žena s endometriozom.
English: • Insert one prasterone pessary in your vagina once a day at bedtime with an applicator or your finger.
Croatian: • Umetnite jedan vagitorij prasterona u rodnicu jednom dnevno prije spavanja, aplikatorom ili prstom.
English: However, if the next dose is due in less than 8 hours, the patient should skip the missed pessary.
Croatian: Međutim, ako sljedeću dozu treba primijeniti za manje od 8 sati, bolesnica treba preskočiti zaboravljeni vagitorij.
English: Speak to your doctor for advice.
Croatian: Pitajte svojeg liječnika za savjet.
English: 28 pessaries are packed in a carton with 6 applicators.
Croatian: 28 vagitorija pakirano je u kutiju sa 6 aplikatora.
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: • Ako se u bilo kojem trenutku liječenja pojavi krvarenje ili točkasto krvarenje, treba istražiti njegov uzrok, što može uključivati biopsiju endometrija kojom se isključuje zloćudna promjena endometrija.
English: Risk of coronary artery disease
Croatian: Rizik od bolesti koronarnih arterija
English: Do not use two pessaries to make up for a forgotten dose.
Croatian: Nemojte primijeniti dva vagitorija kako biste nadoknadili zaboravljenu dozu.
English: • dimpling of the skin;
Croatian: • Udubljenje na koži,
English: If you forget to use a pessary, insert one as soon as you remember.
Croatian: Ako zaboravite primijeniti vagitorij, umetnite ga čim se sjetite.
English: • Place the flat end of the pessary into the open end of the activated applicator as shown.
Croatian: • Ravni kraj vagitorija stavite u otvoreni kraj aktiviranog aplikatora, kako je prikazano.
English: Read the instructions on how to use Intrarosa at the end of the leaflet carefully before using this medicine.
Croatian: Pažljivo pročitajte upute o tome kako primijeniti lijek Intrarosa na kraju upute o lijeku prije upotrebe lijeka.
English: The number of extra cases of stroke due to use of HRT will increase with age.
Croatian: Broj dodatnih slučajeva moždanog udara zbog primjene HNL-a povećavat će se s godinama.
English: • This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age, see section 4.4.
Croatian: • Taj relativni rizik ne ovisi o dobi ni o trajanju terapije, ali budući da osnovni rizik uvelike ovisi o dobi, ukupni rizik od moždanog udara u žena koje primaju HNL povećavat će se s godinama, vidjeti dio 4.4.
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Croatian: Smanjuje se vezivanje hormona T3 na smolu, što odražava povišeni TBG.
English: Intrarosa contains the active ingredient prasterone, i.e. dehydroepiandrosterone (DHEA), which is biochemically and biologically identical to the endogenous human DHEA, a precursor steroid which is inactive by itself and it is converted into oestrogens and androgens.
Croatian: Intrarosa sadržava djelatnu tvar prasteron, tj. dehidroepiandrosteron (DHEA), koji je biokemijski i biološki jednak endogenom humanom DHEA, prekursorskom steroidu koji je sam neaktivan te se pretvara u estrogene i androgene.
English: If you forget to use Intrarosa
Croatian: Ako ste zaboravili primijeniti lijek Intrarosa
English: If you are not sure about any of the points below, talk to your doctor before taking Intrarosa,
Croatian: Ako niste sigurni u nešto od navedenog, savjetujte se s liječnikom prije primjene lijeka Intrarosa,
English: Hard fat (adeps solidus).
Croatian: kruta mast (adeps solidus)
English: Intrarosa does not stimulate the endometrium as shown by atrophy of the lining of the womb in all women treated with Intrarosa for one year during the clinical trials.
Croatian: Intrarosa ne stimulira endometrij što je dokazano atrofijom sluznice maternice u svih žena koje su uzimale lijek Intrarosa tijekom jedne godine u kliničkim ispitivanjima.
English: The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
Croatian: Hormonsko nadomjesno liječenje (HNL) nosi rizike koje treba uzeti u obzir prilikom odlučivanja o njegovu uvođenju ili nastavku uzimanja.
English: Systemic metabolism has not been studied in this application.
Croatian: Sistemski metabolizam nije ispitivan za ovu primjenu.
English: Follow the above instructions of Step 2, and then insert the pessary into the vagina with your finger as far as it can comfortably go. Do not use force.
Croatian: Slijedite upute navedene u 2. koraku, a zatim umetnite vagitorij u rodnicu prstom što dublje, ali tako da ne osjetite neugodu.
English: Incidence per 1000 women in placebo arm over 5 years
Croatian: Incidencija na 1000 žena u placebo skupini tijekom 5 godina
English: It is less likely that the conditions mentioned below will get worse or come back during treatment with Intrarosa, but you should see your doctor if you are concerned.
Croatian: Malo je vjerojatno da će se stanja navedena u nastavku pogoršati ili vratiti tijekom primjene lijeka Intrarosa, ali u slučaju zabrinutosti obratite se svojem liječniku.
English: • Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis.
Croatian: • Neoponirana stimulacija estrogenom može dovesti do premalignih ili malignih promjena u rezidualnim žarištima endometrioze.
English: On the 389 evaluable end-of-study endometrial biopsies performed after 52 weeks of treatment with Intrarosa, no histological abnormalities were reported on the biopsies.
Croatian: U 389 procjenjivih biopsija endometrija na kraju ispitivanja koje su provedene nakon 52 tjedna liječenja lijekom Intrarosa nisu pronađene histološke abnormalnosti.
English: • In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).
Croatian: • U žena koje nemaju osobnu povijest venske tromboembolije, ali imaju srodnika prvog stupnja koji je bolovao od tromboze u mlađoj dobi, moguće je napraviti probir, ali samo nakon pažljivog savjetovanja o njegovim ograničenjima (samo mali udio trombofilnih poremećaja otkrije se probirom).
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, ceruloplasmin).
Croatian: Moguće je povećanje razine drugih proteina u plazmi (angiotenzinogen/supstrat renina, alfa-I-antitripsin, ceruloplazmin).
English: • fibroids inside your womb;
Croatian: • fibroidi u maternici,
English: At these check-ups, discuss with your doctor the benefits and risks of continuing with Intrarosa.
Croatian: Tijekom tih pregleda razgovarajte s liječnikom o koristima i rizicima nastavka primjene lijeka Intrarosa.
English: • To wash the applicator:
Croatian: • Pranje aplikatora:
English: Elderly No dose adjustment is considered necessary in elderly women.
Croatian: Prilagodba doze nije potrebna u starijih bolesnica.
English: Vaginal douching is recommended.
Croatian: Preporučuje se vaginalno tuširanje.
English: • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina;
Croatian: • ako imate ili ste nedavno imali bolest prouzročenu krvnim ugrušcima u arterijama, na primjer srčani udar, moždani udar ili angina pektoris;
English: • Women with pre-existing hypertriglyceridaemia should be followed closely during oestrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
Croatian: • Žene s već postojećom hipertrigliceridemijom treba pomno nadzirati tijekom nadomjesnog liječenja estrogenom ili hormonskog nadomjesnog liječenja jer je u rijetkim slučajevima prilikom liječenja estrogenom u tom stanju zabilježeno veliko povećanje triglicerida u plazmi koje dovodi do pankreatitisa.
English: • If you have excessive thickening of the womb lining (endometrial hyperplasia ) that is not being treated;
Croatian: • ako imate prekomjerno zadebljanje sluznice maternice (hiperplazija endometrija) koje se ne liječi;
English: • if any of your close relatives has ever had a blood clot in the leg, lung or another organ;
Croatian: • ako je član vaše uže obitelji ikad imao krvni ugrušak u nozi, plućima ili drugom organu,
English: How long to use After initial use, see your doctor at least every 6 months to check if you need to keep using Intrarosa.
Croatian: Nakon prve primjene, posjećujte liječnika barem svakih 6 mjeseci da biste provjerili trebate li nastaviti primjenjivati lijek Intrarosa.
English: Pull back on the plunger until it stops to activate the applicator.
Croatian: Povucite klip do kraja da biste aktivirali aplikator.
English: The beneficial effects on the symptoms and signs of vulvar and vaginal atrophy are exerted through activation of the vaginal oestrogen and androgen receptors.
Croatian: Blagotvorni učinci na simptome i znakove vulvarne i vaginalne atrofije ostvaruju se aktivacijom vaginalnih estrogenskih i androgenih receptora.
English: You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you.
Croatian: Vjerojatnost za nastanak krvnog ugruška u venama raste kako starite i ako se nešto od sljedećeg odnosi na vas.
English: • a liver disorder, such as a benign liver tumour;
Croatian: • poremećaj jetre, kao što je dobroćudni tumor jetre
English: As in all postoperative patients, prophylactic measures need be considered to prevent VTE following surgery.
Croatian: Kao i kod svih postoperativnih bolesnika, nakon kirurškog zahvata treba razmotriti profilaktičke mjere za sprječavanje venske tromboembolije.
English: Prasterone
Croatian: Prasteron
English: • Women already on chronic anticoagulant treatment require careful consideration of the benefitrisk of use of HRT.
Croatian: • Za žene u kojih se već primjenjuje kronična antikoagulantna terapija treba pažljivo procijeniti omjer rizika i koristi primjene HNL-a.
English: If pregnancy occurs during treatment with Intrarosa, the treatment should be withdrawn immediately.
Croatian: Ako dođe do trudnoće tijekom primjene lijeka Intrarosa, liječenje treba odmah prekinuti.
English: Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
Croatian: Ako krvni ugrušak dođe do pluća, može prouzročiti bol u prsnom košu, nedostatak zraka, nesvjesticu, pa čak i smrt.
English: • Estrogen is a metabolite of prasterone.
Croatian: • Estrogen je metabolit prasterona.
English: • Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
Croatian: • Opće prepoznati čimbenici rizika za vensku tromboemboliju uključuju primjenu estrogena, stariju dob, veliki kirurški zahvat, produljenu imobilizaciju, pretilost (BMI > 30 kg/m2), razdoblje trudnoće/nakon porođaja, sistemski eritemski lupus (SLE) i rak.
English: Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Intrarosa.
Croatian: Prije nego što počnete primjenjivati lijek, recite svojem liječniku ako ste ikada imali neki od sljedećih problema, jer se oni mogu ponovno pojaviti ili pogoršati tijekom primjene lijeka Intrarosa.
English: • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestagen therapy for more than 5 years.
Croatian: • Zabilježen je do 2 puta veći rizik od raka dojke u žena koje su primale kombiniranu estrogensku-progestagensku terapiju više od 5 godina.
English: The following diseases are reported more often in women using HRT medicines which circulate in the blood compared to women not using HRT.
Croatian: Sljedeće bolesti prijavljene su češće u žena koje uzimaju lijekove za hormonsko nadomjesno liječenje koji cirkuliraju u krvi u usporedbi sa ženama koje ne primaju hormonsko nadomjesno liječenje.
English: • Remove the applicator.
Croatian: • Izvadite aplikator.
English: For women taking oestrogen-only therapy there is no increased risk of developing a heart disease.
Croatian: U žena koje uzimaju lijekove koji sadrže samo estrogen ne postoji povećani rizik od razvoja srčane bolesti.
English: However, if the next dose is due in less than 8 hours, skip the missed pessary.
Croatian: Međutim, ako sljedeću dozu treba primijeniti za manje od 8 sati, preskočite zaboravljeni vagitorij.
English: The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment.
Croatian: Povećani rizik postaje vidljiv nakon nekoliko godina liječenja, no vraća se na osnovne vrijednosti u roku od nekoliko (najviše pet) godina nakon prekida liječenja.
English: The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in non-users, especially during the first year of taking it.
Croatian: Rizik od krvnih ugrušaka u venama otprilike je 1,3 do 3 puta veći u žena koje primaju hormonsko nadomjesno liječenje nego u žena koje ga ne primaju, posebice u prvoj godini primjene.
English: Intrarosa is only used in adult women.
Croatian: Intrarosa se primjenjuje samo u odraslih žena.
English: The Cmax and AUC0-24 of the metabolites testosterone and estradiol were also slightly higher in women treated with the Intrarosa pessary compared to those receiving placebo but all remained within normal values of postmenopausal women (< 10 pg estradiol/mL; < 0.26 ng testosterone/mL) as measured by validated mass spectrometry-based assays for both the study samples and reference values.
Croatian: Cmax i AUC0-24 metabolita testosterona i estradiola također su bile blago više u žena liječenih Intrarosa vagitorijima u usporedbi sa ženama koje su primale placebo, no sve su ostale u okviru normalnih vrijednosti žena u postmenopauzi (< 10 pg estradiol/mL; < 0,26 ng testosteron/mL) prema mjerenjima validiranih testova temeljenih na masenoj spektrometriji i za uzroke iz ispitivanja i referentne vrijednosti.
English: • Intrarosa may weaken condoms, diaphragms and cervical caps made of latex.
Croatian: • Lijek Intrarosa može oslabiti kondome, dijafragme i cervikalne kapice od lateksa.
English: Two pessaries should not be used to make up for a forgotten dose.
Croatian: Ne smiju se primijeniti dva vagitorija kako bi se nadoknadila zaboravljena doza.
English: • increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer);
Croatian: • povećani rizik od nastanka raka osjetljivog na estrogene (ako je Vaša majka, sestra ili baka imala rak dojke),
English: If you have a premature menopause the risks of using HRT may be different.
Croatian: Ako imate prijevremenu menopauzu, rizici od primjene hormonskog nadomjesnog liječenja mogu se razlikovati.
English: The side effect the most frequently reported in the clinical studies was vaginal discharge.
Croatian: Najčešće zabilježena nuspojava u kliničkim ispitivanjima bila je vaginalni iscjedak.
English: There are no data on the use of Intrarosa in pregnant women.
Croatian: Nema podataka o primjeni lijeka Intrarosa u trudnica.
English: What you need to know before you use Intrarosa
Croatian: Što morate znati prije nego što počnete primjenjivati lijek Intrarosa
English: Age range (years)
Croatian: Dobna skupina (godine)
English: • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
Croatian: • Aktivna ili nedavna arterijska tromboembolijska bolest (npr. angina, infarkt miokarda);
English: Use of Intrarosa with condoms, diaphragms or cervical caps made of latex must be avoided since the rubber may be damaged by the preparation.
Croatian: Mora se izbjegavati primjenu lijeka Intrarosa u kombinaciji s kondomima, dijafragmama ili cervikalnim kapicama od lateksa jer pripravak može oštetiti gumu.
English: Vaginal use.
Croatian: Vaginalna primjena.
English: “Substantial improvement” was restricted to patients who had moderate or severe MBS at baseline and changed from severe to mild or severe or moderate to none.
Croatian: tjednu. „Značajno poboljšanje” ograničeno je na bolesnice koje su imale umjerene ili teške najgore simptome (MBS) na početku ispitivanja i oni su se promijenili iz teških u blage, ili iz teških ili umjerenih simptoma do nikakvih simptoma.
English: • epilepsy;
Croatian: • epilepsija,
English: If a dose is forgotten, it should be taken as soon as the patient remembers.
Croatian: U slučaju da bolesnica zaboravi dozu, treba je primijeniti čim se sjeti.
English: - Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura.
Croatian: - Poremećaji kože i potkožnog tkiva: kloazma, multiformni eritem, nodozni eritem, vaskularna purpura.
English: Fertility Intrarosa is not indicated in fertile women.
Croatian: Plodnost Lijek Intrarosa nije indiciran u plodnih žena.
English: Endometrial hyperplasia and carcinoma
Croatian: Hiperplazija i karcinom endometrija
English: • if you notice signs of a blood clot, such as: - painful swelling and redness of the legs; - sudden chest pain; - difficulty in breathing.
Croatian: • ako primijetite znakove krvnih ugrušaka, na primjer: - bolno oticanje i crvenilo nogu, - iznenadna bol u prsnom košu, - otežano disanje.
English: The risk of ovarian cancer varies with age.
Croatian: Rizik od raka jajnika mijenja se ovisno o dobi.
English: Lying position
Croatian: Ležeći položaj
English: White to off-white, bullet-shaped pessary approximately 28 mm long and 9 mm in diameter at its widest end.
Croatian: Bijeli do gotovo bijeli vagitorij oblika metka približne duljine 28 mm i promjera 9 mm na najširem kraju.
English: • If you have a vaginal infection you will need a course of antibiotics before taking Intrarosa.
Croatian: • Ako imate vaginalnu infekciju, prije primjene lijeka Intrarosa bit će Vam potrebna kura antibiotika.
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Croatian: Razine drugih vezujućih proteina mogu biti povišene u serumu, tj. globulina koji veže kortikosteroide (CBG), globulina koji veže spolne hormone (SHBG) što dovodi do povećanja cirkulirajućih kortikosteroida i spolnih steroida.
English: Due to melting of the hard fat base added to an expected increase in vaginal secretions due to treatment, vaginal discharge can occur although it does not require to stop the medication (see section 4.8).
Croatian: Zbog topljenja tvrdih masti u podlozi vagitorija, uz očekivano povećanje vaginalne sekrecije tijekom terapije, može doći do vaginalnog iscjetka, no to ne zahtijeva prekid liječenja (vidjeti dio 4.8).
English: The flat end of the pessary should be placed into the open end of the activated applicator.
Croatian: Ravni kraj vagitorija treba staviti u otvoreni kraj aktiviranog aplikatora.
English: Other conditions observed with HRT
Croatian: Druga stanja primijećena tijekom HNL-a
English: • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
Croatian: • Akutna bolest jetre ili povijest bolesti jetre dok god pretrage funkcije jetre ne pokazuju normalne vrijednosti;
English: Testosterone
Croatian: Testosteron
English: Other adverse reactions have been reported in association with oestrogen/progestagen treatment: - Gall bladder disease.
Croatian: Zabilježene su i druge nuspojave povezane s liječenjem estrogenima/progestagenima: - Bolest žučnog mjehura.
English: • Hypersensitivity to the active substance or to the excipient listed in section 6.1;
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”);
Croatian: • povećani rizik od nastanka krvnih ugrušaka (vidjeti „Krvni ugrušci u veni (tromboza)“),
English: However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age (see section 4.8).
Croatian: Međutim, budući da je osnovni rizik od moždanog udara uvelike ovisan o dobi, ukupni rizik od moždanog udara u žena koje primaju HNL povećavat će se s godinama (vidjeti dio 4.8).
English: Exogenous prasterone is metabolized in the same manner as endogenous prasterone.
Croatian: Egzogeni prasteron metabolizira se na isti način kao i endogeni prasteron.