FrancophonIA/ELRC3.0 huggingface dataset:
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: To se odnosi i na još nepoznate ili novootkrivene viruse ili druge vrste infekcija.
English: No patient experienced HBV re-infection.
Croatian: Nijedan bolesnik nije se ponovno inficirao HBV-om.
English: No re-infection was observed.
Croatian: Nije utvrđena nijedna ponovna infekcija.
English: Open each syringe only when you are ready for an injection.
Croatian: Otvorite svaku štrcaljku tek kad budete spremni za injiciranje.
English: Your doctor will be able to explain this to you.
Croatian: To će Vam podrobnije objasniti Vaš liječnik.
English: The mean anti-HBs serum level before switching was 393 ± 139 IU/l.
Croatian: Srednja vrijednost razine anti-HBs u serumu prije prelaska na supkutanu primjenu bila je 393±139 IU/l.
English: Get rid of any air bubbles that may be in the syringe.
Croatian: Izbacite sve mjehuriće zraka koji se možda nalaze u štrcaljki.
English: However, if your antibody levels are sufficient and you have a fixed dose regimen, you or your caregiver may be trained to carry out the injection at home (see below).
Croatian: Međutim, ako imate dovoljnu razinu antitijela i stalan režim doziranja, Vi ili Vaš njegovatelj možete proći obuku za davanje injekcije kod kuće (pogledajte u nastavku).
English: At the time of transplantation 21 patients (42.9%) were tested positive for HDV, patients with a positive HIV or HCV test were excluded from study participation.
Croatian: U vrijeme transplantacije 21 bolesnik (42,9%) bio je pozitivan na HDV, a bolesnici s pozitivnim HIV ili HCV testom isključeni su iz sudjelovanja u ispitivanju.
English: The maximum IgA content is 6,000 micrograms/ml.
Croatian: Maksimalni sadržaj IgA je 6 000 mikrograma/ml.
English: You may be allergic to immunoglobulins (antibodies) without knowing it, even if you have tolerated previous treatments with human immunoglobulins.
Croatian: Možda ste alergični na imunoglobuline (antitijela) a da to ne znate, čak i ako ste podnosili prethodna liječenja ljudskim imunoglobulinima.
English: Information on the starting material of Zutectra and the possibility of transmission of infectious agents:
Croatian: Informacije o početnom materijalu lijeka Zutectra i mogućnosti prijenosa infekcije:
English: Avoid surgical scars.
Croatian: Izbjegavajte ožiljke od kirurških zahvata.
English: You should inject Zutectra into the fatty layer between the skin and muscle (about 8 to 12 mm under the skin).
Croatian: Zutectra se injicira u masno tkivo između kože i mišića (oko 8 do 12 mm ispod kože).
English: A failure rate of 0 % was also found for the facultative extension phase (week 24) (95 % CI: [0, 20.6 %])
Croatian: Stopa neuspješnosti od 0 % utvrđena je i u neobaveznoj fazi produljenog ispitivanja (24. tjedan) (95 % CI: [0, 20,6 %])
English: Using the Clopper Pearson method, the failure rate after 18 weeks was 0 % for patients of the ITT set (95 % CI: [0, 14.8 %]).
Croatian: Prema Clopper Pearsonovoj metodi stopa neuspješnosti nakon 18 tjedana bila je 0 % za bolesnike u skupini predviđenoj za liječenje (ITT) (95 % CI: [0, 14,8 %]).
English: If you are HBs antigen positive you will not receive Zutectra since there is no benefit in administering this medicine to you.
Croatian: Ako ste pozitivni na HBs antigen, nećete primati lijek Zutectra jer nema koristi od davanja tog lijeka.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj se lijek ne smije miješati s drugim lijekovima.
English: Try standing in front of a mirror to locate the site or you may want to ask your caregiver to give you the injection.
Croatian: Pokušajte stati ispred ogledala kako biste locirali mjesto ili zamolite njegovatelja da Vam da injekciju.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/600/001
Croatian: EU/1/09/600/001
English: Immunoglobulins are normal constituents of the human body, therefore toxicity testing in heterologous species is of no relevance.
Croatian: Imunoglobulini su normalni sastavni dijelovi ljudskog tijela, stoga ispitivanje toksičnosti heterolognih vrsta nije relevantno.
English: If you have an allergic reaction to Zutectra, the injection will be stopped immediately.
Croatian: Ako nastupi alergijska reakcija na lijek Zutectra, injekcija će se odmah prekinuti.
English: Please note that alcohol swabs and needles are not contained in the pack and you need to supply them yourself.
Croatian: Napominjemo da gaze natopljene alkoholom i igle nisu u pakiranju i morate ih nabaviti sami.
English: The starting material or what Zutectra is made from is human blood plasma (this is the liquid part of the blood).
Croatian: Početni materijal od kojeg je proizveden lijek Zutectra jest ljudska krvna plazma (tekući dio krvi).
English: It should be clear and contain no particles.
Croatian: Treba biti bistra i bez čestica.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: Summary of Product Characteristics).
English: Interference with serological testing
Croatian: Interferencija sa serološkim pretragama
English: Inject the liquid by pressing gently on the plunger.
Croatian: Ubrizgajte tekućinu nježnim pritiskom na klip.
English: The following instructions are intended to explain how to inject Zutectra.
Croatian: Sljedeće upute objašnjavaju kako injicirati lijek Zutectra.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER
English: If you do choose to inject your arm yourself, try to pinch up the tissue by placing your upper arm over the back of a chair or brace it against a wall.
Croatian: Ako odlučite ubrizgati lijek u nadlakticu, pokušajte stisnuti tkivo tako da stavite ruku preko naslona stolice ili je stisnite o zid.
English: One pre-filled syringe of 1 ml Zutectra contains 500 IU.
Croatian: Jedna napunjena štrcaljka od 1 ml lijeka Zutectra sadrži 500 IU.
English: Antibody levels >100 IU/l should be maintained.
Croatian: Potrebno je održavati razine antitijela > 100 IU/l.
English: Distribution of IgG subclasses: IgG1:
Croatian: Distribucija IgG podklasa: IgG1:
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to human immunoglobulins.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na ljudske imunoglobuline.
English: Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell antibodies, for example the direct antiglobulin test (DAT, direct Coombs' test).
Croatian: Pasivno prenesena antitijela protiv eritrocitnih antigena, npr. A, B, D, mogu interferirati s nekim serološkim testovima na antitijela na crvene krvne stanice, primjerice s direktnim antiglobulinskim testom (DAT, izravni Coombsov test).
English: Keep out of the sight and reach of children.
Croatian: Čuvajte izvan pogleda i dohvata djece.
English: The physician must therefore weigh the benefit of treatment with Zutectra against the potential risk of hypersensitivity reactions.
Croatian: Liječnik stoga mora procijeniti koristi od liječenja lijekom Zutectra u odnosu na potencijalnu opasnost od reakcija preosjetljivosti.
English: Injection into a vein or a blood vessel may result in allergic shock.
Croatian: Injiciranje u venu ili krvnu žilu može prouzročiti alergijski šok.
English: No treatment failures occurred during the 6month study period.
Croatian: Nije bilo neuspjeha u liječenju tijekom šestomjesečnog trajanja ispitivanja.
English: Your doctor will regularly check your condition and tell you how much and how often you need to use Zutectra.
Croatian: Vaš će liječnik redovito provjeravati vaše zdravstveno stanje i reći Vam koliko te kako često trebate primijeniti lijek Zutectra.
English: In case of any adverse event after the injection speak to your doctor immediately.
Croatian: U slučaju bilo kakve štetne reakcije nakon injekcije odmah se obratite liječniku.
English: It's harder to give yourself an injection here.
Croatian: Na tom mjestu teško ćete dati sami sebi injekciju.
English: Keep the syringes and syringe disposal unit out of the reach of children; lock the supplies if possible.
Croatian: Opće informacije: Držite štrcaljke i otpadni materijal izvan dohvata djece; ako je moguće, zaključajte ih.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Gently pinch the skin together around the disinfected injection site (to raise it up a little) and push the needle into the skin with a rapid, confident movement at an angle of 45 to 90 degrees.
Croatian: Nježno stisnite kožu oko dezinficiranog mjesta (kako biste je malo podigli) i ubodite kožu iglom brzim i sigurnim pokretom pod kutom od 45 do
English: Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Croatian: Klinička iskustva s imunoglobulinima upućuju da ne treba očekivati štetne učinke na tijek trudnoće, fetus ni novorođenče.
English: The following adverse reactions have been reported in the context of 4,810 subcutaneous applications of Zutectra during four completed clinical trials and 1,006 applications during a non-interventional post marketing safety study (PASS).
Croatian: Sljedeće nuspojave zabilježene su kod 4810 supkutanih primjena lijeka Zutectra tijekom četiri završena klinička ispitivanja i kod 1006 primjena tijekom neintervencijskog ispitivanja sigurnosti primjene nakon stavljanja lijeka u promet (PASS).
English: Keep the container in the outer carton in order to protect from light.
Croatian: Spremnik čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
English: You may have to wait at least 3 months after the last injection of Zutectra before you can have live attenuated vaccines.
Croatian: Možda ćete morati pričekati najmanje 3 mjeseca nakon zadnje injekcije lijeka Zutectra prije primanja cjepiva sa živim oslabljenim uzročnicima.
English: Nederland Infarama BVBA Stationsstraat 27
Croatian: Infarama BVBA Stationsstraat 27
English: No serious adverse events were reported to be related to study medication.
Croatian: Nije prijavljen nijedan štetni događaj povezan s ispitivanim lijekom.
English: Particularly if you do not have enough immunoglobulins of the type IgA in your blood, allergic reactions such as a sudden fall in blood pressure or shock may occur.
Croatian: Posebice ako u krvi nemate dovoljno imunoglobulina tipa IgA, mogu nastupiti alergijske reakcije poput iznenadnog pada tlaka ili šoka.
English: If the solution is discoloured, cloudy or contains particles, discard it and start again with a new syringe.
Croatian: mutna je ili sadrži čestice, bacite je i počnite ponovno s novom štrcaljkom.
English: - Hold the syringe with the needle pointing upwards, and tap the syringe gently with your fingers until the air has collected at the tip.
Croatian: - Držite štrcaljku tako da igla bude okrenuta prema gore i nježno je lupkajte prstima dok se zrak ne sakupi na vrhu.
English: One ml solution in a pre-filled syringe (Type I glass) with a stopper (bromobutyl) and a tip cap (bromobutyl rubber).
Croatian: Jedan ml otopine u napunjenoj štrcaljki (staklo tipa I) s čepom (bromobutil) i zatvaračem vrha (bromobutilna guma).
English: Pack size of five syringes in a blistered pack.
Croatian: Veličina pakiranja od pet štrcaljki u blister pakiranju.
English: No serious adverse reaction was reported.
Croatian: Nije prijavljena nijedna ozbiljna nuspojava.
English: Zutectra can reduce the effectiveness of some vaccines (measles, rubella, mumps, chicken pox) for a period of up to 3 months.
Croatian: Zutectra može smanjiti učinkovitost nekih cjepiva (protiv ospica, rubeole, zaušnjaka, vodenih kozica) na razdoblje do 3 mjeseca.
English: Before preparing the injection, decide where you are going to inject.
Croatian: Prije pripreme injekcije odlučite se za mjesto ubrizgavanja.
English: If you have any further questions, ask your doctor or pharmacist.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: However, if you have used more than the prescribed dose of Zutectra, contact your doctor, healthcare professional or pharmacist straight away for advice.
Croatian: Međutim, ako ste uzeli više od propisane doze lijeka Zutectra, obratite se odmah za savjet liječniku, zdravstvenom djelatniku ili ljekarniku.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: The maximum immunoglobulin A (IgA) content is 6,000 micrograms/ml.
Croatian: Maksimalni sadržaj imunoglobulina A (IgA) je 6000 mikrograma/ml.
English: In very rare cases human normal immunoglobulins may cause a serious allergic reaction.
Croatian: U vrlo rijetkim slučajevima ljudski normalni imunoglobulini mogu izazvati ozbiljne alergijske reakcije.
English: Driving and using machines Zutectra has no or negligible effects on your ability to drive or use machines.
Croatian: Upravljanje vozilima i strojevima Zutectra ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Prepare the Zutectra syringe:
Croatian: Pripremite štrcaljku lijeka Zutectra:
English: Zutectra contains 150 mg/ml of human plasma protein of which at least 96 % is immunoglobulin G (IgG).
Croatian: Zutectra sadrži 150 mg/ml proteina ljudske plazme od kojih je najmanje 96% imunoglobulin G (IgG).
English: In a local tolerance trial in rabbits, there was no evidence of irritation attributable to Zutectra.
Croatian: U ispitivanju lokalne tolerancije u kunića nije bilo dokaza o iritaciji koja bi se mogla pripisati lijeku
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA.
Croatian: U osoba s nedostatkom IgA postoji mogućnost razvoja IgA antitijela i može doći do anafilaktičkih reakcija nakon primjene sastojaka krvi koji sadrže IgA.
English: Manufacturers of these medicines also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Croatian: Proizvođači tih lijekova također poduzimaju mjere kojima tijekom obrade krvi ili plazme mogu inaktivirati ili ukloniti viruse.
English: This will help the skin stay supple and help the medicine be absorbed evenly.
Croatian: Time ćete održati mekoću kože i pomoći u ravnomjernoj apsorpciji lijeka.
English: (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Serum antiHBs trough levels of 100 IU/l and higher (primary efficacy endpoint) were maintained for all patients during the 18 to 24 week trial period.
Croatian: Razine anti-HBs u serumu od 100 IU/l i više (primarni ishod djelotvornosti) održavane su za sve bolesnike tijekom razdoblja ispitivanja od 18 do 24 tjedna.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere sprječavanja infekcija zbog upotrebe lijekova proizvedenih od ljudske krvi ili plazme obuhvaćaju odabir donora, provjere pojedinačnih donacija krvi i pulova plazme radi otkrivanja specifičnih markera infekcije te uključivanje učinkovitih postupaka inaktivacije/uklanjanja virusa tijekom proizvodnje.
English: Do not use solutions that are cloudy or have particles.
Croatian: Nemojte koristiti otopine koje su mutne ili u kojima su vidljive čestice.
English: Avoid using the belt line area, as rubbing may irritate the injection site.
Croatian: Izbjegavajte područje oko pojasa jer bi trljanje moglo nadražiti mjesto injiciranja.
English: If you are administering Zutectra yourself, please read instructions in the section “How to inject Zutectra by yourself or by caregiver” carefully.
Croatian: Ako lijek Zutectra primjenjujete samostalno, pažljivo pročitajte upute u dijelu „Kako samostalno injicirati lijek Zutectra ili kako će Vam ga injicirati njegovatelj”.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Živa atenuirana virusna cjepiva
English: Hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs).
Croatian: Imunoglobulin protiv hepatitisa B sadrži uglavnom imunoglobulin G (IgG) sa specifično visokim sadržajem antitijela protiv površinskog antigena virusa hepatitisa B (HBs).
English: Zutectra must not be administered intravascularly.
Croatian: Zutectra se ne smije primjenjivati intravaskularno.
English: Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps, measles and varicella for a period of 3 months.
Croatian: Primjena imunoglobulina može poremetiti razvoj imunološkog odgovora na živa atenuirana virusna cjepiva poput onih protiv rubele, mumpsa, ospica i varičela tijekom 3 mjeseca.
English: If the recipient is a carrier of HBsAg, there is no benefit in administering this medicinal product.
Croatian: Ako je primatelj nositelj HBsAg, nema koristi od primjene ovog lijeka.
English: The > 100 IU/l safety margin is the generally accepted level of effective prevention against HBV re-infection in liver transplant patients at risk.
Croatian: Sigurnosna granica od > 100 IU/l općenito je prihvaćena kao razina učinkovite prevencije protiv ponovne infekcije HBV-om u rizičnih bolesnika s transplantiranom jetrom.
English: Serum anti-HBs antibody levels should be measured at least every 2-4 weeks and at the discretion of the physician in charge for at least half a year.
Croatian: Razine anti-HBs antitijela u serumu potrebno je kontrolirati najmanje svaka 2 do 4 tjedna te prema procjeni nadležnog liječnika tijekom najmanje pola godine.
English: It is strongly recommended that every time Zutectra is used (both at hospital or in a home treatment), the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Croatian: Preporučuje se da se pri svakoj primjeni lijeka Zutectra (u bolnici i kod kuće) zabilježe naziv i serijski broj lijeka kako bi se sačuvao podatak o iskorištenim serijama.
English: The objectives of the open, prospective, single-arm clinical trial were the investigation of feasibility of home self-administration (including patient compliance), efficacy and safety of subcutaneous application of Zutectra in a population of stable patients during long-term treatment for prophylaxis against re-infection of a transplanted liver in 66 patients.
Croatian: Ciljevi otvorenog prospektivnog kliničkog ispitivanja s jednom skupinom bili su ispitivanje izvedivosti samostalne primjene kod kuće (uključujući suradljivost ispitanika) te djelotvornost i sigurnost supkutane primjene lijeka Zutectra u populaciji stabilnih bolesnika tijekom dugoročnog liječenja radi profilakse ponovne infekcije transplantirane jetre na 66 bolesnika.
English: Choose the area where you will make the injection and make a note of it in the diary.
Croatian: Injiciranje 1. Odaberite područje injiciranja i zabilježite taj podatak u dnevniku.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: Any unused medicine or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
English: You are likely to have more fatty tissue the closer you are to the hip and the further you are from the knee.
Croatian: Više masnog tkiva nalazi se bliže kukovima, odnosno dalje od koljena.
English: The ADRs reported in four trials are summarised and categorised according to the MedDRA system organ class and frequency below.
Croatian: Nuspojave zabilježene u četiri ispitivanja sažete su i kategorizirane prema organskom sustavu MedDRA i učestalosti navedenima u nastavku.
English: The best places for injections are where the skin is loose and soft for example in the abdomen, arm, thigh or buttocks, and away from joints, nerves, bones.
Croatian: Najbolja mjesta za injiciranje su tamo gdje je koža opuštena i mekana, kao na primjer na trbuhu, ruci, bedru ili stražnjici te daleko od zglobova, živaca i kostiju.
English: This recommendation applies also for documentation in the treatment diary during self-administration of the medicinal product in a home treatment.
Croatian: Ta se preporuka odnosi i na dokumentiranje u dnevniku liječenja u slučaju da bolesnik sam sebi daje lijek u okviru kućne njege.
English: Uncommon (may affect up to 1 in 100 people): - headache - upper abdominal pain (from your chest to the belly button)
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): - glavobolja - bolovi u gornjem dijelu abdomena (od prsa do pupka)
English: The other ingredients are glycine and water for injections.
Croatian: Pomoćne tvari su glicin i voda za injekcije.
English: Please tell your doctor or healthcare professional prior to treatment if you have been told that you have antibodies against immunoglobulins of the type IgA in your blood.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili zdravstvenom djelatniku prije nego što počnete uzimati lijek ako vam je rečeno da u krvi imate antitijela protiv imunoglobulina tipa IgA .
English: Common (may affect up to 1 in 10 people): - injection site reactions: pain, hives (urticaria) at injection site, haematoma (a collection of blood in tissue under the skin), reddening of the skin (erythema).
Croatian: Često (mogu se javiti u do 1 na 10 osoba): - reakcije na mjestu injiciranja: bol, koprivnjača (urtikarija) na mjestu injiciranja, hematom (nakupljanje krvi u tkivu ispod kože), crvenilo na koži (eritem).
English: What Zutectra is and what it is used for
Croatian: Što je Zutectra i za što se koristi
English: Slovenija MEDIS, d.o.o.
Croatian: MEDIS, d.o.o.
English: Keep this leaflet.
Croatian: Sačuvajte ovu uputu.
English: One non-serious adverse event was reported to be related to Zutectra (injection site haematoma).
Croatian: Prijavljen je jedan štetni događaj povezan s lijekom Zutectra koji nije bio ozbiljan (hematom na mjestu injiciranja).