FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients should be observed closely for signs and symptoms of thyroid dysfunction on pazopanib treatment.
Croatian: Tijekom terapije pazopanibom, sve bolesnike treba pomno pratiti zbog razvijanja znakova ili simptoma poremećaja funkcije štitnjače.
English: Stomatitis
Croatian: Dojenje
English: Thrombocytopenia 80 (7%) Neutropenia
Croatian: Pazopanib Placebo HR (95% CI) P vrijednost (dvostrano)
English: Leiomyosarcoma*
Croatian: Podgrupe sinovijalnog sarkoma*
English: 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Croatian: 1 prethodno zarolani matriks od 4,8 x 4,8 cm
English: MA (EU) number
Croatian: Broj (EU) odobrenja Zaštićeno ime
English: (Invented) name Pharmaceutical form Route of administration
Croatian: Farmaceutski oblik Put primjene
English: Continue with the remaining steps.
Croatian: Nastavite s preostalim koracima.
English: ● Wash your hands well with soap and water.
Croatian: Dobro operite ruke sapunom i vodom.
English: >48 hours
Croatian: > 48 sati
English: In children less than one year of age, the blood system is still developing.
Croatian: U djece mlađe od 1 godine krvni se sustav još uvijek razvija.
English: Higher scores indicate better quality of life.
Croatian: Viši rezultati ukazuju na bolju kvalitetu života.
English: Get ready:
Croatian: Pripremite se:
English: Loss of efficacy was reported in 1 out of 398 patients.
Croatian: Gubitak djelotvornosti prijavljen je u 1 od 398 bolesnika.
English: ● Additional risk minimisation measures
Croatian: Dodatne mjere minimizacije rizika
English: Do not use if they appear damaged or if they have been dropped.
Croatian: Nemojte ga upotrijebiti ako izgleda oštećeno ili ako Vam je pao.
English: Check with your healthcare provider if you are not sure.
Croatian: Provjerite sa zdravstvenim radnikom ako niste sigurni.
English: Children below the age of 1 year
Croatian: Djeca mlađa od 1 godine
English: <24 hours 24-48 hours
Croatian: < 24 sata 24 - 48 sati
English: ● This medicine has been prescribed for you only.
Croatian: Ovaj je lijek propisan samo Vama.
English: Further management should be tailored to the individual clinical circumstances.
Croatian: Daljnje liječenje treba prilagoditi individualnim kliničkim okolnostima.
English: No dose adjustment is required for this demographic factor.
Croatian: Nije potrebno prilagođavati dozu prema tom demografskom faktoru.
English: In case of clinical signs of loss of efficacy, a change of treatment should be considered.
Croatian: U slučaju kliničkih znakova gubitka djelotvornosti treba razmotriti promjenu liječenja.
English: In some cases, this can cause damage to the kidneys and other organs.
Croatian: U nekim slučajevima to može dovesti do oštećenja bubrega i drugih organa.
English: If you stop using Hemlibra, you may no longer be protected against bleeding.
Croatian: Ako prestanete primjenjivati lijek Hemlibra, možda više nećete biti zaštićeni od krvarenja.
English: Please see below recommended features:
Croatian: Vidjeti u nastavku za preporučene značajke:
English: ● Risk Management Plan (RMP)
Croatian: LIJEKA ● Plan upravljanja rizikom (RMP)
English: ● Let the skin dry for about 10 seconds.
Croatian: Pričekajte približno 10 sekundi da se koža osuši.
English: Injecting into a muscle could cause discomfort.
Croatian: Injiciranje u mišić moglo bi biti neugodno.
English: Hemlibra is intended for long-term prophylactic treatment.
Croatian: Hemlibra je namijenjena za dugoročno profilaktičko liječenje.
English: No cases required anticoagulation therapy.
Croatian: Nijedan slučaj nije zahtijevao antikoagulacijsku terapiju.
English: Clinically meaningful difference: Total score: 7 points; Physical Health: 10 points.
Croatian: Klinički važna razlika: ukupan rezultat: 7 bodova; tjelesno zdravlje: 10 bodova.
English: ● Do not try to warm the vial by any other way.
Croatian: Nemojte pokušavati zagrijati bočicu na neki drugi način.
English: This belongs to a group of medicines called “monoclonal antibodies”.
Croatian: On pripada skupini lijekova koji se zovu ‘monoklonska protutijela'.
English: Chugai Pharma Manufacturing Co., Ltd. 5-1, Ukima 5-Chome Kita-Ku, Tokyo
Croatian: Chugai Pharma Manufacturing Co., Ltd. 5-1, Ukima 5-Chome Kita-Ku, Tokio
English: Examples:
Croatian: Primjeri:
English: Important information after the injection:
Croatian: Važne informacije nakon injiciranja:
English: Each time you use Hemlibra, record the name and batch number of the medicine.
Croatian: Svaki put kad primijenite lijek Hemlibra, zabilježite ime i broj serije lijeka.
English: ● If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Croatian: ● Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se liječniku ili ljekarniku za savjet prije nego primijenite ovaj lijek.
English: Use aPCC only if no other treatment can be used.
Croatian: Primijenite aPCC samo ako se ne može primijeniti nijedno drugo liječenje.
English: ● if you are allergic to emicizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: ● ako ste alergični na emicizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka u uporabi odgovornost su korisnika.
English: If aPCC is required, talk to your doctor in case you feel you need a total of more than 50 units/kg of aPCC.
Croatian: Međutim, ako je primjena aPCC-a neophodna, razgovarajte sa svojim liječnikom ako mislite da ukupno trebate više od 50 jedinica/kg aPCC-a.
English: ● Syringe with Low Dead Space (LDS) Plunger Important:
Croatian: ● Štrcaljka s malim „mrtvim prostorom“ (engl. low dead space, LDS) Važno:
English: ● Only use the vial once.
Croatian: ● Bočicu smijete upotrijebiti samo jednom.
English: Other medicines and Hemlibra
Croatian: Drugi lijekovi i Hemlibra
English: Human IgG is known to be present in human milk.
Croatian: Zna se da je ljudski IgG prisutan u majčinom mlijeku.
English: * An instance of aPCC treatment is defined as all doses of aPCC received by a patient, for any reason, until there was a 36-hour treatment-free break.
Croatian: * Epizoda liječenja aPCC-om definira se kao sve doze aPCC-a koje je bolesnik primio iz bilo kojeg razloga sve do pauze u liječenju u trajanju od 36 sati.
English: However, self-administration is not recommended for children below 7 years of age.
Croatian: Međutim, samoinjiciranje se ne preporučuje za djecu mlađu od 7 godina.
English: The safety profile of Hemlibra was overall consistent between infants, children, adolescents, and adults.
Croatian: Sigurnosni profil lijeka Hemlibra sveukupno je bio dosljedan u male djece, djece, adolescenata i odraslih.
English: Includes all instances of aPCC treatment excluding those in the first 7 days and those that occurred 30 days after the discontinuation of Hemlibra.
Croatian: Uključuje sve epizode liječenja aPCC-om, osim onih tijekom prvih 7 dana i onih koje su se dogodile 30 dana nakon prekida liječenja lijekom Hemlibra.
English: Hemlibra increases the patient's coagulation potential.
Croatian: Hemlibra povećava koagulacijski potencijal bolesnika.
English: Hemlibra is for subcutaneous use only, and it should be administered using appropriate aseptic technique (see section 6.6).
Croatian: Hemlibra je namijenjena samo za supkutanu primjenu i treba je primijeniti odgovarajućom aseptičnom tehnikom (vidjeti dio 6.6).
English: If your child is less than one year old, your doctor may prescribe Hemlibra only after carefully weighing the expected benefits and risks of using this product.
Croatian: Ako je Vaše dijete mlađe od 1 godine, liječnik mu može propisati lijek Hemlibra samo nakon što je pažljivo odvagnuo očekivane koristi i rizike primjene ovog lijeka.
English: Be cautious if you are at high risk for this condition (have had this condition in the past, or a member of your family have suffered from it), or if you are taking medicines that can increase the risk of developing this condition, such as ciclosporin, quinine or tacrolimus.
Croatian: Budite na oprezu ako imate visok rizik za razvoj ovog stanja (ako ste imali ovo stanje u prošlosti ili je od njega patio član Vaše obitelji) ili ako uzimate lijekove koji mogu povećati rizik od razvoja ovog stanja, kao što su ciklosporin, kinin ili takrolimus.
English: Do not inject two doses on the same day to make up for a forgotten dose.
Croatian: Nemojte injicirati dvije doze u istom danu kako biste nadoknadili zaboravljenu dozu.
English: If bleeding does not stop, please contact your healthcare provider.
Croatian: Ako krvarenje ne prestane, obratite se svom zdravstvenom radniku.
English: Dosage adjustments during treatment
Croatian: Prilagodbe doze tijekom liječenja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2018
Croatian: Datum prvog odobrenja: 23. veljače 2018.
English: ● If you do not hear a click, look to see that the needle is fully covered by the safety shield.
Croatian: Ako ne čujete klik, provjerite je li sigurnosni pokrov potpuno prekrio iglu.
English: IgG antibodies are mainly catabolised by lysosomal proteolysis and then eliminated from or reused by the body.
Croatian: IgG protutijela uglavnom se kataboliziraju lizosomskom proteolizom, nakon čega se eliminiraju ili ih tijelo ponovno koristi.
English: Only the first five emicizumab doses had to be administered under supervision to ensure safety and injection technique proficiency.
Croatian: Samo se prvih pet doza emicizumaba moralo primijeniti pod nadzorom radi osiguravanja sigurnosti i svladavanja pravilne tehnike injiciranja.
English: Clinically meaningful difference: VAS: 7 points, Index Utility Score: 0.07 points
Croatian: Klinički važna razlika: VAS: 7 bodova; indeks korisnosti: 0,07 bodova.
English: Monoclonal antibodies are a type of protein that recognise and bind to a target in the body.
Croatian: Monoklonska protutijela su vrsta proteina koja prepoznaju ciljnu tvar u tijelu i vezuju se za nju.
English: The loading dose regimen is the same, irrespective of the maintenance dose regimen.
Croatian: Režim primjene udarne doze isti je neovisno o režimu primjene doze održavanja.
English: Factor VIII (FVIII) prophylaxis may be continued for the first 7 days of Hemlibra treatment.
Croatian: Profilaksa faktorom VIII (FVIII) može se nastaviti tijekom prvih 7 dana liječenja lijekom Hemlibra.
English: The medicine prevents bleeding or reduces bleeding episodes in people with this condition.
Croatian: Ovaj lijek sprječava krvarenje ili smanjuje broj epizoda krvarenja u osoba s tom bolešću.
English: Table 11 HAVEN 2: Overview of efficacy (interim analysis)
Croatian: Tablica 11 HAVEN 2: Pregled djelotvornosti (interim analiza)
English: What Hemlibra looks like and contents of the pack
Croatian: Kako Hemlibra izgleda i sadržaj pakiranja
English: ● Do not inject yourself or someone else unless you have been shown how to by your healthcare provider.
Croatian: Nemojte injicirati lijek sebi ni nekome drugome ako Vam zdravstveni radnik nije pokazao kako se to radi.
English: Each pack of Hemlibra contains 1 glass vial.
Croatian: Jedno pakiranje lijeka Hemlibra sadrži 1 staklenu bočicu.
English: ● Once you have been trained, you should be able to inject this medicine at home, by yourself or with the help of a caregiver.
Croatian: ● Nakon što prođete obuku, trebali biste moći injicirati lijek kod kuće, bilo sami ili uz pomoć njegovatelja.
English: ● Remove and throw away the plastic blister pack.
Croatian: ● Skinite i bacite plastično blister pakiranje.
English: Pharmacotherapeutic group: antihemorrhagics, other systemic hemostatics; ATC code: B02BX06
Croatian: Farmakoterapijska skupina: antihemoragici, ostali sistemski hemostatici, ATK oznaka: B02BX06 Mehanizam djelovanja
English: This medicine is not likely to affect your ability to drive or use machines.
Croatian: Nije vjerojatno da će ovaj lijek utjecati na Vašu sposobnost upravljanja vozilima ili rukovanja sa strojevima.
English: Median Efficacy Period (weeks)
Croatian: Medijan trajanja razdoblja za ocjenu djelotvornosti (tjedni)
English: Parameters
Croatian: Parameteri
English: No studies have been conducted to assess the impact of emicizumab on milk production or its presence in breast milk.
Croatian: Nisu provedena ispitivanja kojima bi se ocijenio učinak emicizumaba na proizvodnju mlijeka ili njegova prisutnost u majčinom mlijeku.
English: The vials should never be exposed to temperatures above 30 °C.
Croatian: Bočice se nikada ne smiju izlagati temperaturama iznad 30°C.
English: Large air bubbles can reduce the dose you receive.
Croatian: Veliki mjehurići zraka mogu smanjiti dozu koju ćete primiti.
English: Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with
Croatian: Hemlibra je indicirana za rutinsku profilaksu epizoda krvarenja u:
English: Hemlibra increases the ability of your blood to clot.
Croatian: Hemlibra povećava Vašu sposobnost zgrušavanja krvi.
English: Tell your doctor if you are using Hemlibra before you have laboratory tests to measure how well your blood is clotting.
Croatian: Recite svom liječniku da primjenjujete lijek Hemlibra prije obavljanja laboratorijskih pretraga kojima se određuje koliko Vam se dobro zgrušava krv.
English: Your healthcare provider should show you how to prepare, measure, and inject Hemlibra properly before you use it for the first time.
Croatian: Vaš zdravstveni radnik mora Vam pokazati kako pravilno pripremiti, odmjeriti i injicirati lijek Hemlibra prije nego što ga prvi puta primijenite.
English: Pharmacokinetic parameters derived from the population PK model.
Croatian: Farmakokinetički parametri dobiveni su iz populacijskog farmakokinetičkog modela.
English: Prior to launch of Hemlibra in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Hemlibra na tržište, nositelj odobrenja mora u svakoj državi članici s nacionalnim nadležnim tijelom dogovoriti sadržaj i format edukacijskog programa, uključujući načine komunikacije, oblike distribucije i sve druge aspekte programa.
English: If you cannot remove all medicine, turn the vial upright to reach the remaining amount
Croatian: Ako ne možete izvući sav lijek, preokrenite bočicu u uspravan položaj da biste došli do preostale količine.
English: Patients who receive an accidental overdose should immediately contact their physician and be monitored closely.
Croatian: Bolesnici koji slučajno prime preveliku dozu trebaju se odmah obratiti svom liječniku te ih treba pažljivo nadzirati.
English: What you need to know before you use Hemlibra
Croatian: Što morate znati prije nego počnete primjenjivati lijek Hemlibra
English: Instructions for Use Hemlibra Injection
Croatian: Upute za uporabu Hemlibra Injekcija
English: If you use more Hemlibra than you are supposed to, tell your doctor immediately.
Croatian: Ako primijenite više lijeka Hemlibra nego što ste trebali, odmah o tome obavijestite svog liječnika.
English: Do not stop using Hemlibra without talking to your doctor.
Croatian: Nemojte prestati primjenjivati lijek Hemlibra bez prethodnog razgovora s liječnikom.
English: ● severe damage of the skin tissue (skin necrosis)
Croatian: ● teško oštećenje kožnog tkiva (nekroza kože)
English: The patient dose (in mg) and volume (in mL) should be calculated as follows:
Croatian: Doza za bolesnika (u mg) i volumen (u ml) izračunavaju se na sljedeći način:
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ni neizravne toksične učinke na reprodukciju (vidjeti dio 5.3).
English: Injection site reactions (ISRs) were reported very commonly (20 %) from clinical trials.
Croatian: Reakcije na mjestu injiciranja prijavljene su vrlo često (20%) u kliničkim ispitivanjima.
English: Patient treatment preference was also assessed using a preference survey.
Croatian: Ocjenjivale su se i terapijske preferencije bolesnika primjenom ankete o preferencijama.
English: Includes data before up-titration only, for patients whose dose was up-titrated.
Croatian: Uključuje samo podatke prije povećanja doze za bolesnike kojima je doza povećana.
English: ● If you have bruising (small area of bleeding under the skin), an ice pack can also be pressed gently on the site.
Croatian: Ako se pojavi modrica (malo područje krvarenja ispod kože), na mjesto primjene također možete staviti led i lagano pritisnuti.
English: Haem-A-QoL at week 25
Croatian: Rezultati upitnika Haem-A-QoL u 25. tjednu
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, ime i broj serije primijenjenog lijeka treba jasno evidentirati.
English: Hemlibra should be used during pregnancy only if the potential benefit for the mother outweighs the potential risk to the fetus taking into account that, during pregnancy and after parturition, the risk for thrombosis is increased and that several pregnancy complications are linked to an increased risk for disseminated intravascular coagulation (DIC).
Croatian: Hemlibra se tijekom trudnoće smije primjenjivati samo ako moguća korist za majku nadmašuje mogući rizik za plod, uzimajući u obzir činjenicu da je tijekom trudnoće i nakon poroda rizik od tromboze povećan i da se nekoliko komplikacija u trudnoći povezuje s povećanim rizikom od diseminirane intravaskularne koagulacije (DIK).
English: If you use more Hemlibra than you should
Croatian: Ako primijenite više lijeka Hemlibra nego što ste trebali
English: ● Prepare and give the injection in clean and germ-free conditions using aseptic technique.
Croatian: Pripremite i primijenite injekciju u čistim i sterilnim uvjetima primjenom aseptične tehnike.
English: Thus, the effect of emicizumab on male and female fertility is unknown.
Croatian: Stoga je učinak emicizumaba na plodnost muškaraca i žena nepoznat.
English: Effects of emicizumab on coagulation tests
Croatian: Učinci emicizumaba na testove koagulacije
English: ● Remove syringe cap (if required).
Croatian: ● Skinite zatvarač štrcaljke (ako je potrebno).
English: In healthy subjects, the absolute bioavailability following subcutaneous administration of 1 mg/kg was between 80.4% and 93.1% depending on the injection site.
Croatian: U zdravih je ispitanika apsolutna bioraspoloživost nakon supkutane primjene doze od 1 mg/kg iznosila između 80,4% i 93,1%, ovisno o mjestu injiciranja.
English: Clinical experience indicates a drug interaction exists with emicizumab and aPCC (see sections 4.4 and 4.8).
Croatian: Kliničko iskustvo ukazuje na to da dolazi do interakcija između emicizumaba i aPCC-a (vidjeti dijelove 4.4 i 4.8).
English: ● Do not throw away any used sharps disposal container in your household waste unless your local guidelines permit this.
Croatian: Nemojte baciti upotrijebljen spremnik za odlaganje oštrih predmeta u kućni otpad, osim ako to ne dopuštaju lokalne smjernice.
English: Your doctor will consider the benefit of you taking Hemlibra against the risk to your baby.
Croatian: Liječnik će razmotriti koristi liječenja lijekom Hemlibra za Vas u odnosu na rizik za Vaše dijete.
English: This is because Hemlibra in the blood may interfere with some laboratory tests, leading to inaccurate results.
Croatian: Naime, Hemlibra u krvi može utjecati na nalaze nekih laboratorijskih pretraga i tako dovesti do netočnih rezultata.
English: ● Take the vial out of the refrigerator 15 minutes before use and allow it to reach room temperature (below 30°C) before preparing an injection.
Croatian: ● Izvadite bočicu iz hladnjaka 15 minuta prije primjene i pričekajte da se ugrije na sobnu temperaturu (ispod 30°C) prije nego što pripremite injekciju.
English: Do not inject into moles, scars, bruises,
Croatian: Nemojte injicirati u madeže, ožiljke,
English: ● Your doctor or nurse will show you how to inject Hemlibra.
Croatian: Vaš liječnik ili medicinska sestra pokazat će Vam kako injicirati lijek Hemlibra.
English: Accidental overdose may result in hypercoagulability.
Croatian: Nehotično predoziranje može dovesti do hiperkoagulabilnosti.
English: Always use Hemlibra exactly as your doctor has told you, and check with your doctor, pharmacist or nurse if you are not sure.
Croatian: Hemlibra točno onako kako Vam je rekao liječnik te provjerite sa svojim liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni.
English: ● If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for at least 10 seconds, until bleeding has stopped.
Croatian: Ako na mjestu injiciranja vidite nekoliko kapi krvi, možete ga pritisnuti sterilnom pamučnom vatom ili gazom i držati tako najmanje 10 sekundi, dok se krvarenje ne zaustavi.
English: Alternating the site of injection may help prevent or reduce injection site reactions (see section 4.8).
Croatian: Mijenjanjem mjesta injiciranja može se spriječiti ili smanjiti pojava reakcija na mjestu injiciranja (vidjeti dio 4.8).
English: ● Place the supplies on a clean, well-lit flat work surface.
Croatian: Položite pribor na čistu i dobro osvijetljenu ravnu radnu površinu.
English: After you inject your dose, throw away any unused Hemlibra left in the vial.
Croatian: Nakon što injicirate dozu, bacite sav neupotrijebljen lijek Hemlibra koji je ostao u bočici.
English: Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).
Croatian: Važno je da uhvatite nabor kože kako biste bili sigurni da ćete lijek injicirati pod kožu (u masno tkivo), a ne dublje (u mišić).
English: You may need to use more than 1 vial to give yourself the correct dose.
Croatian: Možda ćete morati upotrijebiti više od 1 bočice da biste primijenili točnu dozu.
English: It is not known whether emicizumab can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Croatian: Nije poznato može li emicizumab naškoditi plodu kada se primjenjuje trudnicama niti može li utjecati na reproduktivnu sposobnost.
English: If you are not sure, talk to your doctor, pharmacist or nurse before using Hemlibra.
Croatian: Ako niste sigurni, razgovarajte s liječnikom, ljekarnikom ili medicinskom sestrom prije nego primijenite lijek Hemlibra.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Hemlibra therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Hemlibra uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Hemlibra has no influence on the ability to drive and use machines.
Croatian: Hemlibra ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The MAH shall ensure that in each Member State where Hemlibra is marketed, all healthcare professionals, patients/carers who are expected to prescribe, dispense or use Hemlibra, and laboratory professionals, have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja pobrinut će se da u svakoj državi članici u kojoj će Hemlibra biti na tržištu svi zdravstveni radnici i bolesnici/njegovatelji za koje se očekuje da će propisivati, izdavati ili primjenjivati lijek Hemlibra, kao i laboratorijski zdravstveni radnici, imaju pristup/dobiju sljedeći paket edukacijskih materijala: