FrancophonIA/ELRC3.0 huggingface dataset:
English: Final maturation of follicles can be induced by administering human chorionic gonadotrophin (hCG).
Croatian: Konačno sazrijevanje folikula može se potaknuti primjenom ljudskog korionskog gonadotropina (hCG).
English: Orgalutran inhibits the action of GnRH, resulting in suppression of the release of especially LH.
Croatian: Orgalutran sprječava djelovanje GnRH-a, čime se prije svega sprječava otpuštanje LH-a.
English: Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland.
Croatian: GnRH-a, koji modulira os hipotalamus-hipofiza-gonade kompetitivnim vezanjem na receptore GnRH-a u hipofizi.
English: How to store Orgalutran
Croatian: Kako čuvati Orgalutran
English: The needle cover contains dry natural rubber/latex which comes into contact with the needle.
Croatian: Poklopac igle sadrži suhu prirodnu gumu/lateks, koji dolazi u doticaj s iglom.
English: Multiple births or birth defects
Croatian: Višepolodne trudnoće i urođeni nedostaci
English: PRE-FILLED SYRINGES TEXT Orgalutran 0.25 mg/0.5 mL
Croatian: ŠTRCALJKI Orgalutran 0,25 mg/0,5 ml
English: Therefore, the use of Orgalutran is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).
Croatian: Stoga je primjena lijeka Orgalutran kontraindicirana u bolesnica s umjerenim ili teškim oštećenjem funkcije jetre (vidjeti dio 4.3).
English: Orgalutran should be administered subcutaneously, preferably in the upper leg.
Croatian: Orgalutran treba primijeniti supkutano, po mogućnosti u natkoljenicu.
English: The pH may have been adjusted with sodium hydroxide and acetic acid.
Croatian: Voda za injekcije pH može biti podešen natrijevim hidroksidom i acetatnom kiselinom
English: The table below shows all adverse reactions in women treated with Orgalutran in clinical studies using recFSH for ovarian stimulation.
Croatian: U tablici niže prikazane su sve nuspojave iz kliničkih ispitivanja u žena liječenih lijekom Orgalutran uz primjenu rekombinantnog FSH-a za stimulaciju jajnika.
English: Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes.
Croatian: Ganireliks se primjenjuje u žena koje se podvrgavaju kontroliranoj hiperstimulaciji jajnika u sklopu postupka potpomognute oplodnje.
English: There is a slightly increased risk of pregnancy outside of the uterus (an ectopic pregnancy) in women with damaged fallopian tubes.
Croatian: U žena s oštećenjem jajovoda malo je povećan rizik od izvanmaternične trudnoće (ektopična trudnoća).
English: The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions.
Croatian: Incidencija kongenitalnih malformacija nakon postupka potpomognute oplodnje može biti veća nego nakon spontanog začeća.
English: Very rare
Croatian: manje često malaksalost
English: Allergic reactions, both generalised and local, including hives (urticaria), swelling of the face, lips tongue, and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis) have been reported.
Croatian: Prijavljene su alergijske reakcije, generalizirane i lokalne, uključujući koprivnjaču (urtikariju) te oticanje lica, usana, jezika i/ili grla, koje može uzrokovati otežano disanje i/ili gutanje (angioedem i/ili anafilaksija). (Pogledajte i dio 4.) Ako razvijete alergijsku reakciju, prestanite uzimati lijek Orgalutran i odmah potražite liječničku pomoć.
English: Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques (ART).
Croatian: Orgalutran treba koristiti tijekom kontrolirane stimulacije jajnika u sklopu postupka potpomognute oplodnje.
English: How to use Orgalutran
Croatian: Kako primjenjivati Orgalutran
English: 1 pre-filled syringe contains 0.25 mg ganirelix in 0.5 mL aqueous solution.
Croatian: 1 napunjena štrcaljka sadrži 0,25 mg ganireliksa u 0,5 ml vodene otopine.
English: Use only syringes with clear, particle-free solutions and from undamaged containers.
Croatian: Koristite štrcaljku samo ako je neoštećena te ako je otopina bistra i ne sadrži čestice.
English: Each pre-filled syringe is affixed with a needle closed by a needle cover of dry natural rubber/latex which comes into contact with the needle.
Croatian: Na svaku napunjenu štrcaljku pričvršćena je igla sa zaštitnim poklopcem od suhe prirodne gume/lateksa koji dolazi u doticaj s iglom (vidjeti dio 4.4).
English: The start of Orgalutran may be delayed in absence of follicular growth, although clinical experience is based on starting Orgalutran on day 5 or day 6 of stimulation.
Croatian: Iako se kliničko iskustvo temelji na započinjanju primjene lijeka Orgalutran 5. ili 6. dana stimulacije, primjena lijeka Orgalutran se može odgoditi ako nema rasta folikula.
English: Orgalutran 0.25 mg/0.5 mL solution for injection
Croatian: Orgalutran 0,25 mg/0,5 ml otopina za injekciju
English: Removing the syringe
Croatian: Ubod iglom
English: Orgalutran 0.25 mg/0.5 mL solution for injection Ganirelix
Croatian: Orgalutran 0,25 mg/0,5 ml otopina za injekciju ganireliks
English: The adverse reactions with Orgalutran using corifollitropin alfa for ovarian stimulation are expected to be similar.
Croatian: Očekuje se da će nuspojave biti slične i kod primjene lijeka Orgalutran uz stimulaciju jajnika korifolitropinom alfa.
English: Cases of hypersensitivity reactions (both generalised and local), have been reportedwith Orgalutran, as early as with the first dose, during post-marketing surveillance.
Croatian: Tijekom praćenja nakon stavljanja lijeka u promet, već kod primjene prve doze lijeka Orgalutran, prijavljeni su slučajevi reakcija preosjetljivosti (generalizirane i lokalne reakcije).
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: + 421 2 58282010 dpoc_czechslovak@merck.com
Croatian: Česká republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 dpoc_czechslovak@merck.com
English: Magyarország MSD Pharma Hungary Kft. Tel.: + 36 1 888 5300 hungary_msd@merck.com
Croatian: Tel.: + 36 1 888 5300 hungary_msd@merck.com
English: Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation.
Croatian: Tijekom ili nakon stimulacije jajnika može nastupiti sindrom hiperstimulacije jajnika (engl. ovarian hyperstimulation syndrome, OHSS).
English: • Hives (urticaria)
Croatian: • oticanje lica
English: Inspect the solution before use.
Croatian: Prije primjene provjerite štrcaljku.
English: Gastrointestinal disorders Uncommon Nausea
Croatian: Poremećaji probavnog sustava manje često mučnina
English: Orgalutran is used to prevent premature LH surges in women undergoing COH.
Croatian: Orgalutran se koristi za prevenciju prijevremenog naglog porasta razine LH-a u bolesnica koje se podvrgavaju kontroliranoj hiperstimulaciji jajnika.
English: Read all of this leaflet carefully, because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu jer sadrži Vama važne podatke.
English: Approximately half of the patients in each group were male.
Croatian: Približno polovica bolesnika u svakoj skupini bili su muškarci.
English: The safety and efficacy of Praxbind in children below the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Praxbinda u djece u dobi do 18 godina nisu još ustanovljene.
English: Your doctor or nurse will give you this medicine by injection or infusion into a vein.
Croatian: Vaš će Vam liječnik ili medicinska sestra dati ovaj lijek injekcijom ili infuzijom u venu.
English: A maximum daily dose has not been investigated.
Croatian: Maksimalna dnevna doza nije ispitana.
English: No other infusion should be administered in parallel via the same intravenous access.
Croatian: Niti jedna druga infuzija ne smije se paralelno primjenjivati kroz isti intravenski pristup.
English: • For emergency surgery/urgent procedures
Croatian: • za hitne kirurške zahvate/hitni postupci
English: What you need to know when you receive Praxbind 3.
Croatian: Što morate znati kada primite Praxbind 3.
English: Each pack contains two vials.
Croatian: Svako pakiranje sadrži dvije bočice.
English: Like all medicines, this medicine may cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može izazvati nuspojave iako se one neće javiti kod svakoga.
English: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product shall be used immediately after opening.
Croatian: S mikrobiološkog stajališta, osim ako metoda otvaranja ne isključuje rizik od mikrobne kontaminacije, lijek je potrebno upotrijebiti odmah nakon otvaranja.
English: Older people/Sex/Race
Croatian: Stariji bolesnici/spol/rasa
English: • The enclosed package leaflet contains additional information for healthcare professionals
Croatian: • Priložena uputa o lijeku sadrži dodatne informacije za zdravstvene radnike.
English: In single cases the transient proteinuria persisted for more than 24 hours.
Croatian: U pojedinačnim slučajevima prolazna proteinurija se održala dulje od 24 sata.
English: In this case, the substance sorbitol contained in this medicine may cause serious adverse reactions.
Croatian: U tom slučaju, tvar sorbitol sadržana u ovom lijeku može izazvati ozbiljne nuspojave.
English: In rare cases you may still have too much dabigatran in your blood after a first dose of Praxbind and your doctor may decide to give you a second 5 g dose in specific situations.
Croatian: U rijetkim slučajevima možete i dalje imati previše dabigatrana u krvi nakon prve doze Praxbinda, pa liječnik može odlučiti propisati Vam drugu dozu od 5 g u specifičnim situacijama.
English: • volume expanders.
Croatian: • ekspanderima volumena;
English: Of the total 503 patients, 101 patients died; each of these deaths could be attributed either as a complication of the index event or associated with co-morbidities.
Croatian: Od ukupno 503 bolesnika, 101 bolesnik je preminuo; svaka od tih smrti može se ili pripisati komplikaciji navedenog događaja ili povezati s komorbiditetima.
English: It will not remove other medicines used to prevent the formation of blood clots.
Croatian: On neće ukloniti druge lijekove koji se koriste za sprječavanje stvaranja krvnih ugrušaka.
English: Detailed instructions for your doctor or nurse on how to administer Praxbind can be found at the end of this package leaflet (see 'Handling instructions').
Croatian: Detaljne upute za Vašeg liječnika ili medicinsku sestru o načinu primjene Praxbinda mogu se naći na kraju ovih uputa o lijeku (pogledajte „Upute o rukovanju“).
English: It is unlikely that Praxbind will influence the effect of other medicines or that other medicines will influence Praxbind.
Croatian: Nije vjerojatno da će Praxbind utjecati na učinak drugih lijekova ili da će drugi lijekovi utjecati na učinak Praxbinda.
English: The median age was 78 years and the median creatinine clearance was 52.6 mL/min.
Croatian: Medijan dobi je bio 78 godina, a medijan klirensa kreatinina je bio 52,6 ml/min.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1056/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1056/001
English: Reversal effects were evident immediately after administration.
Croatian: Antagonistički učinci bili su evidentni odmah nakon primjene.
English: The remaining part of the dose is assumed to be eliminated via protein catabolism, mainly in the kidney.
Croatian: Pretpostavlja se da se preostali dio doze eliminirao putem katabolizma proteina, većinom u bubrezima.
English: What you need to know when you receive Praxbind
Croatian: Što morate znati kada primite Praxbind
English: Once opened, Praxbind is intended for immediate use.
Croatian: Nakon otvaranja, Praxbind je namijenjen za neposrednu uporabu.
English: • In life-threatening or uncontrolled bleeding.
Croatian: • u slučaju po život opasnog ili nekontroliranog krvarenja.
English: Handling instructions:
Croatian: Upute za rukovanje:
English: After dabigatran has been removed from your body, you are not protected from the formation of blood clots.
Croatian: Nakon što se dabigatran uklonio iz Vašeg tijela, niste zaštićeni od stvaranja krvnih ugrušaka.
English: Urinary protein testing
Croatian: Određivanje proteina u urinu
English: Thrombotic events were reported in 34 patients (23 out of the 34 patients were not on antithrombotic therapy at the time of the event) and in each of these cases, the thrombotic event could be attributed to the underlying medical condition of the patient.
Croatian: Trombotski događaji prijavljeni su u 34 bolesnika (23 od tih 34 bolesnika nisu bila na antitrombotskoj terapiji u vrijeme događaja), a u svakom se od ovih slučajeva trombotski događaj mogao pripisati podležećem medicinskom stanju bolesnika.
English: All of these pathways involve biodegradation of the antibody to smaller molecules, i.e. small peptides or amino acids, which are then reabsorbed and incorporated in the general protein synthesis.
Croatian: Svi ovi putevi obuhvaćaju biodegradaciju antitijela na manje molekule, tj. male peptide ili aminokiseline, koje se potom reapsorbiraju i inkorporiraju u opću sintezu proteina.
English: The solution should not be exposed to light for more than 6 hours (in unopened vial and/or inuse).
Croatian: Otopina ne smije biti izložena svjetlosti dulje od 6 sati (u neotvorenoj bočici i/ili u primjeni).
English: Based on its mechanism of action and the characteristics of proteins no carcinogenic or genotoxic effects are anticipated.
Croatian: Na temelju njegovog mehanizma djelovanja i karakteristika proteina, ne očekuju se karcinogeni ili genotoksični učinci.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2015
Croatian: Datum prvog odobrenja: 20. studeni 2015.
English: Safety pharmacology studies have demonstrated no effects on the respiratory, central nervous or cardiovascular system.
Croatian: Ispitivanja sigurnosne farmakologije nisu pokazala učinke na dišni, središnji živčani ili kardiovaskularni sustav.
English: • patients require a second emergency surgery/urgent procedure and have prolonged clotting times.
Croatian: • bolesnicima je potreban drugi hitni kirurški zahvat/hitni postupak, a imaju produljena vremena zgrušavanja.
English: Several pathways have been described that may contribute to the metabolism of antibodies.
Croatian: Opisano je nekoliko puteva koji mogu doprinijeti metabolizmu antitijela.
English: Restarting Antithrombotic Therapy
Croatian: Ponovno započinjanje antitrombotske terapije
English: This is equivalent to 2.5 % of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 2,5% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: Based on the pharmacokinetic properties and the high specificity in binding to dabigatran, clinically relevant interactions with other medicinal products are considered unlikely.
Croatian: Na temelju farmakokinetičkih svojstava i visoke specifičnosti vezanja za dabigatran, klinički značajne interakcije s drugim lijekovima ne smatraju se vjerojatnim.
English: Pharmacotherapeutic group: all other therapeutic products, antidotes, ATC code: V03AB37
Croatian: Farmakoterapijska skupina: ostali terapijski pripravci, antidoti, ATK oznaka: V03AB37
English: Therefore, preclinical results do not suggest a risk to fertility or embryo-fetal development.
Croatian: Stoga, neklinički rezultati ne ukazuju na rizik za plodnost ili embriofetalni razvoj.
English: Praxbind may be used during pregnancy, if the expected clinical benefit outweighs the potential risks.
Croatian: Praxbind se smije primjenjivati tijekom trudnoće, ako očekivana klinička korist nadilazi potencijalne rizike.
English: Dabigatran exerts pronounced effects on parameters of the endogenous thrombin potential (ETP).
Croatian: Dabigatran ispoljava izražene učinke na parametre endogenog trombinskog potencijala (ETP).
English: A causal relationship to idarucizumab could not be established.
Croatian: Nije se mogao ustanoviti uzročni odnos s idarucizumabom.
English: Restoration of haemostasis was achieved in 80.3% of evaluable patients who had serious bleeding and normal haemostasis was observed in 93.4% of patients who required an urgent procedure.
Croatian: Obnova hemostaze postigla se u 80,3% bolesnika u kojih je bila moguća evaluacija i koji su imali ozbiljno krvarenje, a normalna hemostaza je opažena u 93,4% bolesnika kojima je bio potreban hitni postupak.
English: A value above the normal range may reflect residual active dabigatran or other clinical conditions e.g., presence of other drugs or transfusion coagulopathy.
Croatian: Vrijednost iznad normalnog raspona može odražavati rezidualnu aktivnost dabigatrana ili druga klinička stanja, npr. prisutnost drugih lijekova ili transfuzijsku koagulopatiju.
English: What Praxbind is and what it is used for 2.
Croatian: Što je Praxbind i za što se koristi 2.
English: Thrombin generation parameters
Croatian: Parametri stvaranja trombina
English: Idarucizumab effectively and rapidly reversed the life-threatening bleeding within 15 min after the injection.
Croatian: Idarucizumab je učinkovito i brzo poništio po život opasno krvarenje unutar 15 minuta nakon injekcije.
English: Praxbind does not affect any functions in the body as such, so your doctor may decide to give you this medicine, if the expected benefits outweigh any potential risks.
Croatian: Sam Praxbind ne utječe na funkcije u tijelu, stoga liječnik može odlučiti da Vam propiše ovaj lijek, ako očekivane koristi nadilaze sve potencijalne rizike.
English: There is no clinical experience with overdoses of Praxbind.
Croatian: Nema kliničkog iskustva s predoziranjem Praxbindom.
English: Praxbind is for single-use only and does not contain preservatives (see section 6.3).
Croatian: Praxbind je namijenjen samo za jednokratnu uporabu i ne sadrži konzervanse (vidjeti dio 6.3).
English: Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate.
Croatian: Liječenje Praxbindom može se primijeniti zajedno sa standardnim suportivnim mjerama, koje se smatraju medicinski odgovarajućima.
English: Reproductive and developmental toxicity studies have not been performed, given the nature and the intended clinical use of the medicinal product.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti nisu izvođena s obzirom na vrstu i namijenjenu kliničku primjenu ovog lijeka.
English: Based on pharmacokinetic data from 12 patients with liver disease, the AUC of idarucizumab was increased by 10% as compared to patients without liver disease.
Croatian: Na temelju farmakokinetičkih podataka u 12 bolesnika s bolešću jetre, AUC idarucizumaba bio je povišen za 10% u usporedbi s onim u bolesnika bez bolesti jetre.
English: The investigated population consisted of healthy subjects and subjects exhibiting specific population characteristics covering age, body weight, race, sex and renal impairment.
Croatian: Ispitivana populacija sastojala se od zdravih dobrovoljaca te ispitanika koji su pokazivali specifične karakteristike populacije s obzirom na dob, tjelesnu težinu, rasu, spol i oštećenje bubrega.
English: What Praxbind looks like and contents of the pack
Croatian: Kako Praxbind izgleda i sadržaj pakiranja
English: The majority of the patients showed sustained reversal of dabigatran plasma concentrations up to 12 hours (≥90%).
Croatian: Većina bolesnika pokazala je održano poništenje plazmatskih koncentracija dabigatrana do 12 sati (≥ 90%).
English: For additional instructions for use and handling see section 6.6.
Croatian: Za dodatne upute o primjeni i rukovanju vidjeti dio 6.6.
English: Prior to use, the unopened vial may be kept at room temperature (up to 30°C) for up to 48 hours, if stored in the original package in order to protect from light.
Croatian: Neotvorena bočica može se prije uporabe čuvati na sobnoj temperaturi (do 30°C) do 48 sati, ako se čuva u originalnom pakiranju kako bi se zaštitila od svjetlosti.
English: RE-VERSE AD included data for 503 patients: 301 patients with serious bleeding (Group A) and 202 patients requiring an urgent procedure/surgery (Group B).
Croatian: Ispitivanje RE-VERSE AD uključivalo je podatke za 503 bolesnika: 301 bolesnika s ozbiljnim krvarenjem (skupina A) i 202 bolesnika kojima je bio potreban hitan postupak/kirurški zahvat (skupina B).
English: Other medicines and Praxbind
Croatian: Drugi lijekovi i Praxbind
English: Please note this medicine is mainly used in emergency situations and the doctor will have decided that you needed it. - Keep this leaflet.
Croatian: Napominjemo da se ovaj lijek uglavnom primjenjuje za hitne situacije, a liječnik će odlučiti treba li Vam lijek.
English: Mild symptoms of potential hypersensitivity (pyrexia, bronchospasm, hyperventilation, rash or pruritus) were reported.
Croatian: Prijavljeni su blagi simptomi potencijalne preosjetljivosti (pireksija, bronhospazam, hiperventilacija, osip ili pruritus).
English: Praxbind is used in adults in emergency situations where your doctor decides that rapid inactivation of the effect of Pradaxa is required - For emergency surgery/urgent procedures - In life-threatening or uncontrolled bleeding.
Croatian: Praxbind se koristi u odraslih u hitnim situacijama kada Vaš liječnik odluči da je potrebno brzo poništenje učinka Pradaxe: - za hitne kirurške zahvate/hitne postupke - u slučaju po život opasnog ili nekontroliranog krvarenja.
English: A pre-existing intravenous line may be used for administration of Praxbind.
Croatian: Već postojeća intravenska linija može se upotrijebiti za primjenu Praxbinda.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se lijek ne upotrijebi odmah, korisnik je odgovoran za vrijeme i uvjete čuvanja prije uporabe.
English: The recommended dose of Praxbind contains 4 g sorbitol as an excipient.
Croatian: Preporučena doza Praxbinda sadrži 4 g sorbitola kao pomoćnu tvar.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Praxbind in one or more subsets of the paediatric population in the prevention and treatment of dabigatran associated haemorrhage (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Praxbind u jednoj ili više podskupina pedijatrijske populacije u prevenciji i liječenju krvarenja povezanog s dabigatranom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: All nine patients were redosed within 6 days after the first idarucizumab dose.
Croatian: Svih devet bolesnika ponovno je primilo dozu unutar 6 dana nakon prve doze idarucizumaba.
English: Studies to evaluate the mutagenic and carcinogenic potential of idarucizumab have not been performed.
Croatian: Ispitivanja u svrhu procjene mutagenog i karcinogenog potencijala idarucizumaba nisu provedena.
English: If Praxbind is administered in these patients, intensified medical care during Praxbind exposure and within 24 hours of exposure is required.
Croatian: Ako se Praxbind primjenjuje u ovih bolesnika, potrebna je intenzivirana medicinska skrb tijekom izloženosti Praxbindu i unutar 24 sata nakon izloženosti.
English: A key secondary endpoint was the restoration of haemostasis.
Croatian: Ključna sekundarna mjera ishoda bila je obnova hemostaze.
English: • other anticoagulants (e.g. thrombin inhibitors other than dabigatran, Factor Xa inhibitors including low-molecular weight heparin, vitamin K-antagonists, heparin).
Croatian: • drugim antikoagulansima (npr. inhibitorima trombina osim dabigatrana, inhibitorima faktora Xa uključujući heparin niske molekulske mase, antagoniste vitamina K, heparin).
English: It will not reverse the effects of other anticoagulants (see section 5.1).
Croatian: On neće poništiti učinke drugih antikoagulansa (vidjeti dio 5.1).