FrancophonIA/ELRC3.0 huggingface dataset:
English: It must also not be used in patients with life-threatening allergy to eggs or any of Kanuma's ingredients.
Croatian: Također se ne smije koristiti u bolesnika s po život opasnim alergijama na jaja ili bilo koji sastojak lijeka Kanuma.
English: The Committee noted the lack of any effective treatments for lysosomal acid lipase deficiency and the high mortality in infants with rapidly progressing disease.
Croatian: Odbor je uočio nedostatak bilo kakvih djelotvornih terapija u slučaju nedostatka lizosomske kisele lipaze i visoke stope smrtnosti u djece s bolesti koja brzo napreduje.
English: Sebelipase alfa replaces the missing enzyme, helping to break down fats and stopping them building up in the body's cells.
Croatian: Sebelipaz alfa zamjenjuje enzim koji nedostaje pomažući pri razgradnji masti i sprječava njihovo nakupljanje u tjelesnim stanicama.
English: The company will also provide educational material to all doctors expected to prescribe Kanuma, encouraging them to enroll patients in the registry and informing them of how to monitor patients for antibodies and manage patients who develop severe allergic reactions.
Croatian: Tvrtka će također dostaviti edukacijski materijal liječnicima za koje se očekuje da će propisivati lijek Kanuma, potičući ih da upišu bolesnike u registar i informirajući ih o načinu praćenja bolesnika s obzirom na protutijela i upravljanje bolesnicima koji su razvili ozbiljne alergijske reakcije.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kanuma, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Kanuma nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Treatment with Kanuma should be supervised by a doctor experienced in the treatment of lysosomal acid lipase deficiency, other metabolic diseases or liver diseases.
Croatian: Terapiju lijekom Kanuma treba nadzirati liječnik koji je iskusan u terapiji nedostatka lizosomske kisele lipaze, drugih metaboličkih bolesti ili bolesti jetre.
English: For practical information about using Kanuma, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Kanuma bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: This is an inherited disease caused by the lack of an enzyme called lysosomal acid lipase, which is needed to break down fats within cells.
Croatian: Ovo je nasljedna bolest koja je uzrokovana manjkom enzima naziva lizosomska kisela lipaza, koja je potrebna za razgradnju masti unutar stanica.
English: How does Kanuma work?
Croatian: Kako djeluje Kanuma?
English: What benefits of Kanuma have been shown in studies?
Croatian: Koje su koristi lijeka Kanuma utvrđene u ispitivanjima?
English: The active substance in Kanuma, sebelipase alfa, is a copy of the enzyme that is lacking in patients with lysosomal acid lipase deficiency.
Croatian: Djelatna tvar lijeka Kanuma, sebelipaz alfa, kopija je enzima koji nedostaje u bolesnika s nedostatkom lizosomske kisele lipaze.
English: Kanuma has been studied in 2 main studies in patients with lysosomal acid lipase deficiency.
Croatian: Kanuma je ispitan u dva glavna ispitivanja u bolesnika s nedostatkom lizosomske kisele lipaze.
English: The full EPAR and risk management plan summary for Kanuma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Kanuma kao i sažetak plana upravljanja rizikom za lijek Kanuma nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Kanuma pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Kanuma contains the active substance sebelipase alfa.
Croatian: Lijek sadrži djelatnu tvar sebelipaz alfa.
English: Kanuma is a medicine used to treat patients of all ages with lysosomal acid lipase deficiency.
Croatian: Kanuma je lijek koji se koristi za liječenje bolesnika svih dobnih skupina s nedostatkom lizosomske kisele lipaze.
English: How is Kanuma used?
Croatian: Kako se Kanuma koristi?
English: For the full list of all side effects reported with Kanuma, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Kanuma potražite u uputi o lijeku.
English: --1 Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 ............................................................................................................. ≥ 1 RPU* *Relative Potency Units (ELISA)
Croatian: Biofilm Adhesion Component, BAC) iz Streptococcus uberis, soj 5616 .................................................................................................................. ≥ 1 RPU* *relativne jedinice potencije (engl.
English: EU (MA) number Invente d name
Croatian: EU broj odobrenja Izmišljeno ime
English: Cattle Intramuscular Vial (glass) 1 dose (2 ml)
Croatian: 1 doza (2 ml)
English: 20 vials
Croatian: 20 bočice Nula dana
English: Do not use force.
Croatian: Ne upotrebljavajte silu.
English: The potential risk in humans is unknown.
Croatian: Mogući rizik u ljudi nije poznat.
English: • if you become pregnant;
Croatian: • ako ste trudni,
English: Date of first authorisation: 08 january 2018
Croatian: Datum prvog odobrenja: 08 siječanj 2018
English: Physiological responses (objective measures)
Croatian: Fiziološki odgovori (objektivne mjere)
English: Your doctor may decide to perform a physical examination.
Croatian: Vaš liječnik može napraviti fizikalni pregled.
English: − Rinse the 2 pieces for 30 seconds under running water;
Croatian: − Ispirite 2 komada 30 sekundi pod tekućom vodom;
English: If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy.
Croatian: Ako je prošlo manje od 12 mjeseci od Vaše posljednje menstruacije ili ako imate manje od 50 godina, možda ćete i dalje trebate koristiti dodatnu kontracepciju za sprječavanje trudnoće.
English: The additional risk becomes clear within a few years.
Croatian: Dodatni rizik postaje očit nakon nekoliko godina.
English: − Take it to pieces;
Croatian: Rastavite ga na dijelove;
English: • Regularly check your breasts.
Croatian: • Redovito pregledavajte dojke.
English: However, they should be considered in case of long term or repeated use of this product.
Croatian: Međutim, treba ih uzeti u obzir pri dugotrajnoj ili ponovljenoj primjeni ovog lijeka.
English: • Hold the applicator between your thumb and middle finger.
Croatian: • Aplikator držite između palca i srednjeg prsta.
English: “Improvement” was defined as a reduction in the severity score of 1 or more.
Croatian: „Poboljšanje” je definirano kao smanjenje ocjene težine za 1 ili više.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svojeg liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Place the applicator on a clean surface.
Croatian: Aplikator stavite na čistu površinu.
English: Endoceutics S.A. Rue Belliard 40 1040 Brussels Belgium
Croatian: Endoceutics S.A. Rue Belliard 40 1040 Bruxellesu Belgija
English: See your doctor if you notice any changes such as:
Croatian: Posjetite liječnika ako primijetite promjene kao što su:
English: The applicator should be kept in a clean place until next use.
Croatian: Aplikator treba držati na čistom mjestu do sljedeće upotrebe.
English: Substantial improvement Intrarosa Placebo Intrarosa Placebo Intrarosa Placebo
Croatian: Značajno poboljšanje Intrarosa Placebo Intrarosa Placebo Intrarosa Placebo
English: Remove 1 applicator from the package.
Croatian: Izvadite 1 aplikator iz pakiranja.
English: Free or biological active hormone concentrations are unchanged.
Croatian: Koncentracije slobodnog ili biološki aktivnog hormona su nepromijenjene.
English: Additionally, you are advised to join mammography screening programs when offered to you.
Croatian: Nadalje, savjetuje se napraviti mamografske preglede kada su Vam ponuđeni.
English: #Overall risk ratio.
Croatian: # Omjer ukupnog rizika.
English: • any lumps you can see or feel.
Croatian: • kvržice koje se mogu vidjeti ili napipati.
English: 28 pessaries.
Croatian: 28 vagitorija.
English: Results of the WHI studies are presented:
Croatian: Navedeni su rezultati WHI ispitivanja:
English: Keep it in a clean place.
Croatian: Čuvajte na čistom mjestu.
English: Treatment should not be restarted until the woman is completely mobilised.
Croatian: Liječenje se ne smije ponovno uvoditi sve dok bolesnica ne bude potpuno pokretna.
English: For more information about these side effects, see section 2.
Croatian: Za više informacija o ovim nuspojavama, vidjeti dio 2.
English: (years)
Croatian: (godina)
English: It is not known if this medicine affects fertility.
Croatian: Nije poznato utječe li ovaj lijek na plodnost.
English: Ask your doctor when you can start taking Intrarosa again.
Croatian: Pitajte liječnika kada možete ponovno početi primjenjivati lijek Intrarosa.
English: No studies in animals were performed with regard to the reproductive toxicity (see section 5.3).
Croatian: Nisu provedena ispitivanja na životinjama u pogledu toksičnosti za reprodukciju (vidjeti dio 5.3).
English: If so, you should see your doctor more often for check-ups:
Croatian: U tom slučaju, trebate češće ići liječniku na preglede:
English: If you need to have surgery
Croatian: Ako trebate na operaciju
English: This happens naturally after the menopause.
Croatian: To je prirodna pojava nakon menopauze.
English: • HRT use does not improve cognitive function.
Croatian: • Primjenom HNL-a ne poboljšava se kognitivna funkcija.
English: • you are seriously overweight (BMI >30 kg/m2);
Croatian: • ako ste ozbiljno pretili (BMI >30 kg/m2),
English: Inform your doctor if any of these situations applies to you:
Croatian: Obavijestite svojeg liječnika ako se nešto od navedenog odnosi na Vas:
English: Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer' below).
Croatian: Ženama treba reći koje promjene na dojkama trebaju prijaviti liječniku ili medicinskoj sestri (vidjeti „Rak dojke“ u nastavku).
English: Note: Intrarosa is not a contraceptive.
Croatian: Napomena: Intrarosa nije kontraceptiv.
English: • If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
Croatian: • Ako je bilo koje stanje u nastavku trenutačno prisutno, prethodno se pojavilo i/ili se pogoršalo tijekom trudnoće ili prethodne hormonske terapije, bolesnicu treba pomno nadzirati.
English: B. Using the finger
Croatian: Upotreba prsta
English: Each applicator should be discarded after one week of usage (two extra applicators are provided).
Croatian: Svaki aplikator treba baciti nakon jednog tjedna upotrebe (priložena su dva dodatna aplikatora).
English: Therefore, if repeated, treatment should be reviewed at least annually.
Croatian: Ako se liječenje ponavlja, potrebna je ponovna procjena barem jednom godišnje.
English: Free T4 and free T3 concentrations are unaltered.
Croatian: Koncentracije slobodnih hormona T4 i T3 su nepromijenjene.
English: Wash it or throw it away after using for one week (two extra applicators are provided).
Croatian: Operite ga ili bacite nakon tjedan dana upotrebe (priložena su dva dodatna aplikatora).
English: • Endometrial safety of long-term of local vaginally administered prasterone has not been studied for more than one year.
Croatian: • Endometrijska sigurnost pri dugotrajnoj lokalnoj vaginalnoj primjeni prasterona nije ispitivana dulje od jedne godine.
English: Other medicines and Intrarosa
Croatian: Drugi lijekovi i Intrarosa
English: “Relief” was defined as no or only mild symptoms at week 12.
Croatian: „Olakšanje” je definirano kao nedostatak simptoma ili samo blagi simptomi u 12.
English: - Probable dementia over the age of 65 (see section 4.4).
Croatian: - Vjerojatna demencija u dobi iznad 65 godina (vidjeti dio 4.4).
English: • Porphyria.
Croatian: • Porfirija.
English: However, it returns to normal within a few years (at most 5) after stopping treatment.
Croatian: Međutim, vraća se u normalno stanje unutar nekoliko godina (najviše 5) od prekida terapije.
English: The following adverse effects were also reported:
Croatian: Zabilježene su i sljedeće nuspojave:
English: In addition, the vaginal pH decreased towards the normal range, thus facilitating the growth of the normal bacterial flora.
Croatian: Nadalje, vaginalna pH vrijednost smanjila se do normalnih vrijednosti i na taj način olakšala razvoj normalne bakterijske flore.
English: The applicator must be activated before use.
Croatian: Aplikator treba aktivirati prije upotrebe.
English: • If a pessary falls on an unsanitary surface, replace it with a new one.
Croatian: • Ako vagitorij padne na nehigijensku površinu, zamijenite ga novim.
English: If you get bleeding or spotting, it's usually nothing to worry about, but you should make an appointment to see your doctor.
Croatian: Ako primijetite krvarenje ili točkasto krvarenje, to obično nije razlog za zabrinutost, ali trebali biste posjetiti svojeg liječnika.
English: Before you start (or restart) HRT, your doctor will ask about your own and your family's medical history.
Croatian: Prije nego što započnete (ili ponovno počnete) hormonsko nadomjesno liječenje, liječnik će vas pitati o vašoj i obiteljskoj povijesti bolesti.
English: These may be signs of a liver disease;
Croatian: To mogu biti znakovi bolesti jetre,
English: This may include an examination of your breasts and/or an internal examination, if necessary.
Croatian: Prema potrebi to može uključivati pregled dojki i/ili internistički pregled.
English: Standing position
Croatian: Stojeći položaj
English: • If you are allergic (hypersensitive) to prasterone or any of the other ingredients of Intrarosa (listed in section 6 Further information).
Croatian: • ako ste alergični (preosjetljivi) na prasteron ili bilo koji drugi sastojak lijeka Intrarosa (naveden u dijelu 6. Druge informacije).
English: • Empty your bladder and wash your hands before handling the pessary and applicator.
Croatian: • Ispraznite mjehur i operite ruke prije rukovanja vagitorijem i aplikatorom.
English: Contents of the pack and other information What Intrarosa contains
Croatian: Sadržaj pakiranja i druge informacije Što Intrarosa sadrži
English: 4 *no differentiation was made between ischaemic and haemorrhagic stroke.
Croatian: 4*nije napravljena diferencijacija između ishemijskog i hemoragijskog moždanog udara.
English: Investigations, including Pap smears and blood pressure measurements should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Croatian: Pretrage, uključujući Papa test i mjerenja krvnog tlaka, treba provoditi u skladu s trenutačno prihvaćenom praksom za probir, prilagođenom kliničkim potrebama pojedinca.
English: • Carefully remove the pessary from the plastic wrap.
Croatian: • Pažljivo izvadite vagitorij iz plastičnog omota.
English: What Intrarosa looks like and contents of the pack
Croatian: Kako Intrarosa izgleda i sadržaj pakiranja
English: • Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Croatian: • Navedeni su rezultati najvećeg randomiziranog placebom kontroliranog ispitivanja (WHI ispitivanje) i najvećeg epidemiološkog ispitivanja (MWS).
English: • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery);
Croatian: • ako niste mogli hodati dulje vrijeme zbog velike operacije, ozljede ili bolesti (vidjeti i dio 3.
English: The applicator is made of LDPE and 1% colorant (Titanium dioxide).
Croatian: Aplikator se sastoji od LDPE-a i 1 % bojila (titanijev dioksid).
English: • If you have a rare blood problem called “porphyria” which is passed down in families (inherited);
Croatian: • ako imate rijedak poremećaj krvi pod nazivom „porfirija“ koji se prenosi u obitelji (nasljedan je);
English: If you are going to have surgery, tell the surgeon that you are taking Intrarosa.
Croatian: Ako idete na operaciju, recite kirurgu da uzimate lijek Intrarosa.
English: Carcinogenic and reproductive and development toxicity studies were not performed.
Croatian: Nisu provedena ispitivanja kancerogenosti te reproduktivne i razvojne toksičnosti.
English: • migraine or severe headaches;
Croatian: • migrena ili jake glavobolje,
English: This leaflet was last revised in MM/YYYY.
Croatian: Ova je uputa zadnji puta revidirana MM/GGGG.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera koristi i rizika, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: The relative risk does not change with age or time since menopause.
Croatian: Relativni rizik ne mijenja se ovisno o dobi ili vremenu proteklom od menopauze.
English: • a very high level of fat in your blood (triglycerides);
Croatian: • vrlo visoka razina masnoća u krvi (triglicerida),
English: Apart from the main two 12-week phase III clinical studies, the safety data of Intrarosa has also been obtained from one non comparative open-label safety study of one year.
Croatian: Osim dva glavna klinička ispitivanja faze III u trajanju od 12 tjedana, podaci o sigurnosti primjene lijeka Intrarosa dobiveni su i iz jednog jednogodišnjeg nekomparativnog otvorenog ispitivanja sigurnosti primjene.
English: It is inserted into your vagina, so the hormone is released where it is needed.
Croatian: Umeće se u rodnicu tako da se hormon otpušta gdje je potrebno.
English: You may need to stop taking Intrarosa about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein).
Croatian: Možda ćete trebati prestati uzimati lijek Intrarosa otprilike 4 do 6 tjedana prije operacije da biste smanjili rizik od nastanka krvnog ugruška (vidjeti dio 2. Krvni ugrušci u veni).
English: • If you have or have ever had breast cancer, or if you are suspected of having it;
Croatian: • ako imate ili ste imali rak dojke ili ako postoji sumnja da ga imate;
English: Before you start
Croatian: Prije početka primjene
English: Of note, this case was present before start of treatment and was bearing a BRCA1 mutation.
Croatian: Napomena: u navedenom slučaju, rak je bio prisutan prije početka liječenja te je postojala mutacija gena BRCA1.
English: In the event of overdose, vaginal douching is recommended.
Croatian: U slučaju predoziranja, preporučuje se vaginalno tuširanje.
English: Intrarosa is thus different from the oestrogens preparations since it delivers also androgen metabolites.
Croatian: Intrarosa se stoga razlikuje od pripravaka koji sadrže estrogen jer isporučuje i androgene metabolite.
English: If you use more Intrarosa than you should
Croatian: Ako primijenite više lijeka Intrarosa nego što ste trebali
English: The European Medicines Agency has waived the obligation to submit the results of studies with Intrarosa in all subsets of the paediatric population.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Intrarosa u svim podskupinama pedijatrijske populacije.
English: The distribution of intravaginal (exogenous) prasterone is mainly local but some increase in systemic exposure is observed especially for the metabolites but within normal values.
Croatian: Distribucija Distribucija intravaginalnog (egzogenog) prasterona uglavnom je lokalna, ali zabilježeno je blago povećanje sistemske izloženosti, posebno za metabolite, no u okviru normalnih vrijednosti.
English: - The only other ingredient is the hard fat (adeps solidus).
Croatian: - Jedini drugi sastojak je tvrda mast kruta mast (adeps solidus).
English: Pharmacotherapeutic group: Other sex hormones and modulators of the genital system, ATC code: G03XX01.
Croatian: Farmakoterapijska skupina: Ostali spolni hormoni, ATK oznaka: G03XX01.
English: Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary.
Croatian: Vaš će Vam liječnik propisati najnižu dozu i što kraću terapiju za Vaše simptome.
English: Elimination Systemic elimination has not been studied specifically for this application.
Croatian: Sistemska eliminacija nije ispitivana za ovu primjenu.
English: A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.311.56).
Croatian: Meta-analiza 52 epidemiološka ispitivanja zabilježila je povećani rizik od raka jajnika u žena koje trenutačno primaju HNL u usporedbi sa ženama koje nikada nisu primale HNL (RR 1,43, 95 % CI 1,31 - 1,56).
English: HRT is therefore contraindicated in these patients (see section 4.3).
Croatian: Stoga je HNL kontraindiciran u tih bolesnica (vidjeti dio 4.3).
English: Intrarosa has not been studied in women with uncontrolled hypertension (blood pressure above 140/90 mmHg) and cardiovascular disease.
Croatian: Lijek Intrarosa nije ispitivan u žena s nekontroliranom hipertenzijom (krvni tlak veći od 140/90 mmHg) i kardiovaskularnom bolesti.
English: However, Intrarosa has been shown to have very low absorption into the blood, therefore the addition of a progestagen is not necessary.
Croatian: Međutim, dokazano je da se Intrarosa vrlo malo apsorbira u krv te stoga nije potrebna dodatna primjena progestagena.
English: • If you have any unexplained vaginal bleeding;
Croatian: • ako imate bilo kakvo neobjašnjivo krvarenje iz rodnice;
English: Please talk to your doctor.
Croatian: Obratite se svojem liječniku.
English: • fluid retention due to cardiac or kidney problems.
Croatian: • zadržavanje tekućine zbog srčanih ili bubrežnih problema.
English: The occurrence of such an event is more likely in the first year of HRT than later (see section 4.8).
Croatian: Pojava takvog događaja vjerojatnija je u prvoj godini HNL-a nego kasnije (vidjeti dio 4.8).
English: Prasterone was not mutagenic or clastogenic in a standard battery of in vitro and in vivo studies.
Croatian: Prasteron nije bio mutagen ni klastogen u standardnom skupu in vitro i in vivo ispitivanja.
English: If prolonged immobilisation is to follow elective surgery temporarily stopping HRT 4 to 6 weeks earlier is recommended.
Croatian: Ako nakon elektivnog kirurškog zahvata slijedi produljena imobilizacija, preporučuje se privremeni prekid HNL-a 4 do 6 tjedana prije zahvata.
English: Blister composed of an outer layer of PVC and an inner layer of LDPE.
Croatian: Blister koji se sastoji od vanjskog PVC sloja i unutrašnjeg LDPE sloja.
English: Women with vaginal infection should be treated with appropriate antimicrobial therapy before starting Intrarosa.
Croatian: Žene s vaginalnom infekcijom treba liječiti odgovarajućom antimikrobnom terapijom prije početka primjene lijeka Intrarosa.
English: Warnings and precautions When to take special care with Intrarosa
Croatian: Upozorenja i mjere opreza Kada je potreban poseban oprez pri primjeni lijeka Intrarosa
English: • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE);
Croatian: • bolest imunološkog sustava koja utječe na mnoge organe u tijelu (sistemski eritemski lupus,