FrancophonIA/ELRC3.0 huggingface dataset:
English: - stomach irritation (gastritis), bleeding from the stomach or intestine.
Croatian: Gastritis, gastrointestinalno krvarenje (uključujući analno krvarenje, krvarenje iz želuca, krvarenje iz crijeva, krvarenje iz donjeg dijela gastrointestinalnog sustava, rektalno krvarenje)
English: K-M at year 1/2, % (95% CI)c K-M at year 4/5, % (95% CI)c Median, weeks (95% CI)
Croatian: K-M u 4./5. godini, % (95% CI)
English: s r.o.
Croatian: Trajanje CHR/OHR-a e
English: Titanium dioxide (E171) Macrogol 3350
Croatian: Bosulif 500 mg filmom obložene tablete poli(vinilni alkohol) titanijev dioksid (E171) makrogol 3350 talk (E553b) željezov oksid, crveni (E172)
English: Stevens-Johnson Syndrome**, Toxic epidermal necrolysis** Musculoskeletal and connective tissue disorders Very common Arthralgia, Back pain Common
Croatian: , toksična epidermalna nekroliza Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često
English: Vivian Corporation Ltd. Tel: +356 21344610
Croatian: Tel: +356 21344610
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Ispitivanje s radioaktivno [
English: CARTON
Croatian: Kancerogenost
English: The following active substances may affect the heart rhythm: - amiodarone, disopyramide, procainamide, quinidine and sotalol used to treat heart disorder.
Croatian: Sljedeće djelatne tvari mogu utjecati na srčani ritam: - amiodaron, dizopiramid, prokainamid, kinidin i sotalol koriste se za liječenje srčanih poremećaja; - klorokin, halofantrin koriste se za liječenje malarije; - antibiotici klaritromicin i moksifloksacin koriste se za liječenje bakterijskih infekcija; - haloperidol, koristi se za liječenje psihotičnih bolesti poput shizofrenije; - domperidon, koristi se za liječenje mučnine i povraćanja ili za poticanje stvaranja majčinog mlijeka; - metadon, koristi se za liječenje boli.
English: Duration of CHR/OHRe K-M at year 1/2, % (95% CI)c K-M at year 4/5, % (95% CI)
Croatian: K-M u 1./2. godini, % (95% CI)
English: Overall, % (95% CI) Major, % (95% CI) Complete, % (95% CI)
Croatian: Ukupni, % (95% CI)
English: The following active substances may increase the risk of side effects with Bosulif: - ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole, used to treat fungal infections.
Croatian: Sljedeće djelatne tvari mogu povećati rizik od nuspojava s lijekom Bosulif: - ketokonazol, itrakonazol, vorikonazol, posakonazol i flukonazol, koriste se za liječenje gljivičnih infekcija; - klaritromicin, telitromicin, eritromicin i ciprofloksacin, koriste se za liječenje bakterijskih infekcija; - nefazodon, koristi se za liječenje depresije; - mibefradil, diltiazem i verapamil, koriste se za smanjivanje krvnog tlaka u osoba s visokim krvnim tlakom; - ritonavir, lopinavir/ritonavir, indinavir, nelfinavir, sakvinavir, atazanavir, amprenavir,
English: Vascular disorders
Croatian: Pleuralni izljev
English: QTc syndrome)
Croatian: Stevens-Johnsonov sindrom
English: Iron oxide yellow (E172) Iron oxide red (E172)
Croatian: makrogol 3350 talk (E553b) željezov oksid, žuti (E172)
English: Annex related to the Art. 127a
Croatian: Prilog vezan za članak 127a
English: The Member State shall ensure that the MAH shall implement a pregnancy prevention programme (PPP) within their territory.
Croatian: Država članica osigurat će da nositelj odobrenja provodi Program prevencije trudnoće unutar svojeg područja.
English: Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Croatian: Pojedinosti Programa prevencije trudnoće uključujući donošenje nacionalnih mjera za ocjenu učinkovitosti programa i sukladnost s programom prevencije trudnoće treba dogovoriti s nacionalnim nadležnim tijelima u svakoj državi članici i isti ustrojiti prije stavljanja lijeka u promet.
English: - Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are provided with a physician information pack containing the following: - Educational Health Care Professional's kit - Educational brochures for Patients - Patient cards - Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Croatian: Država članica dogovorit će pojedinosti kontrolirane distribucije lijeka s nositeljem odobrenja te mora provoditi taj program na nacionalnoj razini kako bi osigurala da će: - prije stavljanja lijeka u promet, svi liječnici koji namjeravaju propisivati pomalidomid i svi ljekarnici koji bi mogli izdavati pomalidomid primiti pismo zdravstvenim radnicima kako je opisano u nastavku. - prije propisivanja (gdje je to prikladno, a u dogovoru s nacionalnim nadležnim tijelom i prije izdavanja) svi zdravstveni radnici koji namjeravaju propisivati (i izdavati) pomalidomid dobiti će paket s informacijama za liječnike koji sadrži sljedeće: - edukacijski materijal za zdravstvene radnike - edukacijske knjižice za bolesnike - kartice za bolesnike - sažetak opisa svojstava lijeka (SmPC), uputu o lijeku i označivanje.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member State shall agree the details of a controlled distribution system with the Marketing Authorisation Holder (MAH) and must implement such programme nationally to ensure that: - Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may dispense pomalidomide receive a Direct Healthcare Professional Communication as described below.
Croatian: Države članice moraju osigurati da su svi niže opisani uvjeti ili ograničenja vezani uz sigurnu i učinkovitu primjenu lijeka provedeni:
English: 5 x 1012 vg/ml Concentrate and solvent for solution for injection
Croatian: 5 x 1012 vg/ml Koncentrat i otapalo za otopinu za injekciju
English: Subretinal use
Croatian: Subretinalno
English: 1 concentrate vial + 2 solvent vials
Croatian: 1 bočica koncentrata + 2 bočice otapala
English: Solvent: 1.7 ml
Croatian: Koncentrat: 0,5 ml; Otapalo: 1,7 ml
English: Concentrate: vial (COC);
Croatian: Koncentrat: bočica (COC); Otapalo: bočica (COC)
English: For other procedures, larger volumes may be required.
Croatian: Za druge postupke mogu biti potrebni veći volumeni.
English: The device is now ready to use.
Croatian: Uređaj je sada spreman za upotrebu.
English: The frequency of this type of event is not known.
Croatian: Učestalost ove vrste događaja nije poznata.
English: If it does not seem to be enough, a second layer can be applied.
Croatian: Ako se to ne čini dovoljnim, može se nanijeti drugi sloj.
English: Discard if the package is damaged.
Croatian: Baciti ako je pakiranje oštećeno.
English: Currently available data are described in section 5.1, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.1, međutim nije moguće dati preporuku o doziranju.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being treated with this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije liječenja ovim lijekom.
English: The temperature of the water bath must not exceed 37 ºC.
Croatian: Temperatura vodene kupelji ne smije prelaziti 37 ºC.
English: Tip will retain its shape.
Croatian: Nastavak će zadržati svoj oblik.
English: Allergic reactions are possible.
Croatian: Alergijske reakcije su moguće.
English: VeraSeal is not recommended for use in children and adolescents under 18 years of age.
Croatian: VeraSeal se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
English: The safety and efficacy of VeraSeal in children aged 0 to 18 years has not yet been established.
Croatian: Sigurnost i djelotvornost VeraSeala u djece u dobi od 0 do 18 godina nisu još ustanovljene.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and acute toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i akutne toksičnosti.
English: Such substances should be removed to the greatest possible extent before applying the product.
Croatian: Takve tvari treba ukloniti u najvećoj mogućoj mjeri prije primjene lijeka.
English: None were reported in clinical trials; thus it is not possible to establish frequencies.
Croatian: Nijedna nije zabilježena u kliničkim ispitivanjima; stoga nije moguće ustanoviti učestalost.
English: VeraSeal is available in the following pack sizes:
Croatian: VeraSeal je dostupan u sljedećim veličinama pakiranja:
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka treba primijeniti standardno medicinsko liječenje protiv šoka.
English: Fibrin sealants may, in rare cases (up to 1 in 1,000 people), cause an allergic reaction.
Croatian: Fibrinska tkivna ljepila mogu u rijetkim slučajevima (u do 1 na 1000 osoba), prouzročiti alergijsku reakciju.
English: In clinical trials, the individual dosages have typically ranged from 0.3 to 12 ml.
Croatian: U kliničkim ispitivanjima, individualne doze obično su se kretale u rasponu od 0,3 do 12 ml.
English: Therefore, the product should be administered to pregnant and breast-feeding women only if clearly needed.
Croatian: Stoga se proizvod smije primijeniti trudnicama i dojiljama samo ako je to izrazito potrebno.
English: Read this leaflet before you open the package.
Croatian: Pročitajte ove upute prije nego što otvorite pakiranje.
English: Pharmacotherapeutic group: Antihaemorrhagics, local hemostatics, ATC code: B02BC
Croatian: Farmakoterapijska skupina: antihemoragici, lokalni hemostatici, ATK oznaka: B02BC
English: What VeraSeal is and what it is used for
Croatian: Što je VeraSeal i za što se koristi
English: There is also a theoretical possibility that your immune system will produce proteins to attack VeraSeal and, that these may interfere with your blood clotting.
Croatian: Postoji također i teoretska mogućnost da Vaš imunosni sustav proizvede proteine koji će napasti VeraSeal, a to može ometati zgrušavanje krvi.
English: Remove carton from freezer, open it and take out the two blisters.
Croatian: Izvadite kutiju iz zamrzivača, otvorite je i izvadite dva blister pakiranja.
English: Before administration of VeraSeal, care must be taken that the parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Croatian: Prije primjene VeraSeala mora se paziti da su dijelovi tijela izvan predviđenog područja primjene dovoljno zaštićeni (prekriveni) kako bi se spriječilo lijepljenje tkiva na neželjenim mjestima.
English: There is also a risk of a severe allergic reaction.
Croatian: Postoji i rizik od teške alergijske reakcije.
English: The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area.
Croatian: Početni volumen lijeka za primjenu na odabrano anatomsko mjesto ili ciljnu površinu treba biti dovoljan da potpuno prekrije odabrano područje.
English: - very rare (<1/10,000) - not known (cannot be estimated from the available data).
Croatian: nepoznato (ne može se procijeniti iz dostupnih podataka).
English: No formal interaction studies have been performed.
Croatian: Nisu provedena službena ispitivanja interakcija.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 November 2017
Croatian: Datum prvog odobrenja: 10. studenoga 2017.
English: Eleven paediatric subjects aged 16 years or younger were treated with VeraSeal in the described clinical studies.
Croatian: Jedanaest pedijatrijskih ispitanika u dobi od 16 godina ili mlađih liječeno je VeraSealom u opisanim kliničkim ispitivanjima.
English: *All these reactions are class effect.
Croatian: *Sve ove nuspojave učinak su skupine lijekova.
English: The fibrin adhesion system initiates the last phase of physiological blood coagulation.
Croatian: Fibrinski adhezijski sustav pokreće završnu fazu fiziološkog zgrušavanja krvi.
English: It is applied to the surface of bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are not sufficient.
Croatian: Nanosi se na površinu tkiva koje krvari, kako bi se smanjilo krvarenje za vrijeme i poslije operacije kada standardne kirurške tehnike nisu dovoljne.
English: What VeraSeal looks like and contents of the pack
Croatian: Kako VeraSeal izgleda i sadržaj pakiranja
English: As with any protein product, allergic type hypersensitivity reactions are possible.
Croatian: Kao i sa svakim proteinskim lijekom, moguće su reakcije preosjetljivosti alergijskog tipa.
English: The safety of fibrin sealant/haemostatic products for use in human pregnancy or breast-feeding has not been established in controlled clinical trials.
Croatian: Sigurnost primjene fibrinskih tkivnih ljepila/hemostatika tijekom trudnoće ili dojenja nije ustanovljena u kontroliranim kliničkim ispitivanjima.
English: VeraSeal comes ready to use in sterilized packages and must be handled using sterile technique in aseptic conditions.
Croatian: VeraSeal dolazi spreman za upotrebu u steriliziranim pakiranjima i njime se mora rukovati sterilnom tehnikom u aseptičnim uvjetima.
English: The application can be repeated, if necessary.
Croatian: Ako je potrebno, primjena se može ponoviti.
English: Unknown
Croatian: nepoznato
English: Factor XIIIa, which is activated from factor XIII by thrombin, crosslinks fibrin.
Croatian: Faktor XIIIa, koji nastaje aktivacijom faktora XIII trombinom, ukriženo povezuje fibrin.
English: Your doctor will decide whether you should be treated with VeraSeal.
Croatian: Liječnik će odlučiti smije li Vas se liječiti VeraSealom.
English: Consequently, intravascular pharmacokinetic studies were not performed in man.
Croatian: Posljedično tomu, nisu provedena intravaskularna farmakokinetička ispitivanja na ljudima.
English: What you need to know before you are treated with VeraSeal
Croatian: Što morate znati prije liječenja VeraSealom
English: Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.
Croatian: Prekomjerna debljina ugruška može negativno utjecati na djelotvornost lijeka i proces cijeljenja rane.
English: The cold storage chain must not be interrupted until use.
Croatian: Hladni lanac čuvanja ne smije se prekinuti do upotrebe.
English: Instituto Grifols, S.A. Polígono Levante c/Can Guasc 2
Croatian: Polígono Levante c/Can Guasc 2
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: To se također odnosi na bilo kakve nepoznate viruse ili na viruse koji se tek pojavljuju ili na druge vrste infekcija.
English: Position the Airless Spray Tip at least 2 cm away from the target tissue.
Croatian: Bezračni nastavak za raspršivanje postavite najmanje 2 cm od ciljnog tkiva.
English: Use sterile technique to avoid the possibility of contamination due to improper handling, and follow the steps below accurately.
Croatian: Upotrebom sterilne tehnike izbjegnite mogućnost kontaminacije zbog nepravilnog rukovanja i točno se pridržavajte koraka opisanih u nastavku.
English: To prevent uncontrolled clotting, allow the drops to separate from each other and from the end of the drip tip.
Croatian: Kako bi se spriječilo nekontrolirano zgrušavanje, pustite da se kapi odvajaju jedna od druge i od vrha nastavka za primjenu kapanjem.
English: Discard damaged packages as re-sterilisation is not possible.
Croatian: Bacite oštećena pakiranja jer ponovna sterilizacija nije moguća.
English: 08150 Parets del Vallès SPAIN
Croatian: 08150 Parets del Vallès ŠPANJOLSKA
English: Please see pictograms at the end of this leaflet.
Croatian: Pogledajte slike na kraju ove upute.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with VeraSeal in one or more subsets of the paediatric population for the treatment of haemorrhage resulting from a surgical procedure as per paediatric investigational plan (PIP) decision, for the granted indication (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka VeraSeal u jednoj ili više podskupina pedijatrijske populacije u liječenju krvarenja koje je posljedica kirurškog postupka prema uvjetima zadanim po Planu istraživanja u pedijatrijskoj populaciji (PIP-u) za odobrenu indikaciju (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: In the event of overdose, patients must be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment and supportive measures instituted.
Croatian: U slučaju predoziranja bolesnike treba pažljivo pratiti zbog znakova ili simptoma nuspojava i započeti s odgovarajućim simptomatskim liječenjem i potpornim mjerama.
English: Special safety warning
Croatian: Posebna sigurnosna upozorenja
English: This medicine must not be used after the expiry date which is stated on the label and carton after EXP.
Croatian: Lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake EXP.
English: VeraSeal contains human fibrinogen and human thrombin, two proteins extracted from the blood that form a clot when they are mixed together.
Croatian: VeraSeal sadrži ljudski fibrinogen i ljudski trombin, dva proteina izdvojena iz krvi koja izmiješana stvaraju fibrinski ugrušak.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Croatian: Poduzete mjere smatraju se djelotvornim za viruse s ovojnicom kao što je virus humane imunodeficijencije (HIV), virus hepatitisa B i virus hepatitisa C te za virus bez ovojnice hepatitisa A.
English: The volume of VeraSeal to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient.
Croatian: Volumen VeraSeala za primjenu i učestalost primjene treba uvijek odrediti prema osnovnim kliničkim potrebama bolesnika.
English: When using the provided Dual Applicator, follow the connection instructions described above.
Croatian: Za upotrebu priloženog dvojnog aplikatora slijedite prethodno opisane upute za spajanje.
English: The cold storage chain (- 18 ºC or colder) must not be interrupted until use.
Croatian: Hladni lanac čuvanja (na -18 ºC ili nižoj temperaturi) ne smije se prekinuti do upotrebe.
English: What VeraSeal is and what it is used for What you need to know before you are treated with VeraSeal How VeraSeal is used
Croatian: Što je VeraSeal i za što se koristi Što morate znati prije liječenja VeraSealom
English: Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and post-natal development.
Croatian: Ispitivanja na životinjama su nedostatna da bi se procijenila sigurnost s obzirom na reprodukciju, razvoj embrija ili fetusa, tijek gestacije te perinatalnog i postnatalnog razvoja.
English: If these symptoms occur during surgery, the use of the medicine should be stopped immediately.
Croatian: Ako se ovi simptomi pojave tijekom kirurškog zahvata, primjenu lijeka treba odmah prekinuti.
English: Increase distance accordingly to achieve desired coverage of the target area.
Croatian: Udaljenost povećavajte koliko je potrebno da biste prekrili željenu površinu ciljnog područja.
English: If you experience any of these symptoms after surgery, you should immediately consult your doctor or surgeon.
Croatian: Ako osjetite bilo koji od tih simptoma nakon kirurškog zahvata, morate se odmah posavjetovati s liječnikom ili kirurgom.
English: In isolated cases, these reactions have progressed to severe anaphylaxis.
Croatian: U izoliranim slučajevima te su reakcije napredovale do teške anafilaksije.
English: Prior to applying VeraSeal, the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Croatian: Prije nanošenja VeraSeala, površinu rane treba osušiti standardnim tehnikama (npr. naizmjeničnom primjenom kompresa, vatenih jastučića, uređaja za usisavanje).
English: The surgeon will decide how much is appropriate, and will apply just enough to form a thin, even layer.
Croatian: Kirurg će odlučiti koja je količina odgovarajuća i nanijet će upravo onoliko koliko je dovoljno da stvori tanki, ujednačeni sloj.
English: After thawing, it is not necessary to warm the product for its use.
Croatian: Poslije odmrzavanja lijek nije potrebno zagrijavati za primjenu.
English: VeraSeal must be kept out of the sight and reach of children.
Croatian: VeraSeal se mora čuvati izvan pogleda i dohvata djece.
English: The amount of VeraSeal that will be applied depends on a number of factors, including the type of surgery, the size of the area to be treated during your operation and the way VeraSeal is applied.
Croatian: Količina VeraSeala koja će biti primijenjena ovisi o više čimbenika, uključujući vrstu kirurškog zahvata, veličinu površine koju treba liječiti tijekom operacije i način na koji se VeraSeal primjenjuje.
English: Adequate data are not available to support the use of this product in tissue gluing, neurosurgery, application through a flexible endoscope for treatment of bleeding or in gastrointestinal anastomoses.
Croatian: Nema odgovarajućih podataka koji bi podržali primjenu ovog lijeka za lijepljenje tkiva, u neurokirurgiji, za liječenje krvarenja upotrebom fleksibilnog endoskopa ili kod gastrointestinalnih anastomoza.
English: In isolated cases, these reactions may progress to a severe allergic reaction.
Croatian: U izoliranim slučajevima te reakcije mogu napredovati u tešku alergijsku reakciju.
English: If this product is accidentally placed inside a blood vessel, it can lead to blood clots, including disseminated intravascular coagulation (DIC) (when blood clots form throughout the blood vessels in the body).
Croatian: U slučaju da ovaj lijek slučajno dospije u krvnu žilu, može doći do nastanka krvnih ugrušaka, uključujući i diseminiranu intravaskularnu koagulaciju (kada se krvni ugrušci stvaraju u svim krvnim žilama u tijelu).
English: Frequencies have been evaluated according to the following convention:
Croatian: Učestalosti su procijenjene prema sljedećem dogovoru:
English: During dripping, keep the end of the drip tip as close to the tissue surface as possible without touching the tissue during application.
Croatian: Tijekom kapanja, završetak nastavka za primjenu kapanjem držite što je bliže moguće površini tkiva, ali da ne dodiruje tkivo.
English: The product should only be administered according to the instructions and with the devices recommended for this product (see section 6.6.
Croatian: Lijek se smije primijeniti samo prema uputama te uz pribor i uređaje preporučene za ovaj lijek (vidjeti dio 6.6).
English: Calcium ions are required for both, the conversion of fibrinogen and the crosslinkage of fibrin.
Croatian: Kalcijevi ioni potrebni su za oboje; i za pretvorbu fibrinogena i za križno povezivanje fibrina.
English: VeraSeal is intended for epilesional use only.
Croatian: VeraSeal je namijenjen samo za epilezijsku primjenu.
English: The most frequent surgery types were simple or radical hysterectomies, abdominoplasties, and radical cystectomies.
Croatian: Najčešće vrste kirurških zahvata bile su jednostavne ili radikalne histerektomije, abdominoplastike i radikalne cistektomije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1239/001-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1239/001-004