FrancophonIA/ELRC3.0 huggingface dataset:
English: In replacement therapy the dose may need to be individualised for each patient depending on the pharmacokinetic and clinical response.
Croatian: Kod zamjenske terapije, moguća je potreba individualiziranja doze za svakog bolesnika ovisno o farmakokinetičkom i kliničkom odgovoru.
English: If signs and/or symptoms of haemolysis develop during or after an IVIg infusion, discontinuation of the IVIg treatment should be considered by the treating physician (see also section 4.8).
Croatian: Ako se znakovi i/ili simptomi hemolize razviju za vrijeme ili nakon infuzije i.v.Ig-om, prestanak liječenja i.v.Ig-om bi trebao biti uzet u obzir od strane nadležnog liječnika (vidjeti dio 4.8).
English: Hypersensitivity True hypersensitivity reactions are rare.
Croatian: Preosjetljivost Prave reakcije preosjetljivosti su rijetke.
English: Long-term experience has shown that no harmful effects during the course of the pregnancy or to the newborn are to be expected.
Croatian: Dugoročno iskustvo pokazalo je da se ne očekuju štetni učinci na tijek trudnoće ili na novorođenčad.
English: The posology in children and adolescents (0-18 years) is not different from that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Croatian: Pedijatrijska populacija Doziranje u djece i adolescenata (0-18 godina) ne razlikuje se od onog za odrasle osobe jer je doziranje za svaku indikaciju određeno tjelesnom težinom i prilagođeno je kliničkom ishodu prethodno navedenih stanja.
English: 25 patients (aged 13-69 years) participated in the pharmacokinetic (PK) assessment.
Croatian: 25 bolesnika (u dobi od 13 do 69 godina) sudjelovalo je u ocjeni farmakokinetike (PK).
English: 9 patients responded after receiving the initial induction dose by week 4, 16 patients responded by week 10.
Croatian: Devet bolesnika je nakon primanja početne indukcijske doze odgovorilo do 4. tjedna, a 16 bolesnika odgovorilo je do 10. tjedna.
English: Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.
Croatian: Doza se prilagođava prema potrebi kako bi se postigla optimalna zaštita protiv infekcija; povećanje može biti potrebno u bolesnika s perzistirajućom infekcijom, a smanjenje doze može se razmotriti kada bolesnik nema infekciju.
English: Replacement therapy should be commenced and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Croatian: Nadomjesno liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju imunodeficijencija.
English: Privigen belongs to the class of medicines called human normal immunoglobulins.
Croatian: Privigen pripada skupini lijekova koji se nazivaju ljudskim normalnim imunoglobulinima
English: • Do not use this medicine if you notice that the solution is cloudy or contains particles floating within the solution.
Croatian: • Nemojte upotrebljavati lijek ako uočite da je otopina zamućena ili da sadrži čestice koje plutaju.
English: Palpitations, tachycardia
Croatian: Palpitacije, tahikardija
English: For storage conditions after first opening of the medicinal product and after dilution, see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja lijeka i nakon razrjeđivanja vidjeti u dijelu 6.3.
English: Depending on the clinical response (e.g. infection rate), adjustment of the dose and/or the dose interval may be considered in order to aim for higher trough levels.
Croatian: Ovisno o kliničkom odgovoru (npr. stopa infekcije) može se razmotriti prilagodba doze i/ili intervala doziranja s ciljem postizanja viših najnižih koncentracija IgG.
English: Other medicines and Privigen
Croatian: Drugi lijekovi i Privigen
English: CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 Switzerland or
Croatian: CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 Švicarska ili
English: Privigen is made from human plasma.
Croatian: Privigen se dobiva iz ljudske plazme.
English: • if you are allergic to human immunoglobulins or to proline.
Croatian: • ako ste alergični na ljudske imunoglobuline ili na prolin.
English: However, in studies where the dosing was designed to reflect the clinical indications for Privigen, no effects on brain development were observed.
Croatian: Međutim, u ispitivanjima gdje je doziranje osmišljeno kao odraz kliničke indikacije za Privigen nije uočen utjecaj na razvoj mozga.
English: The efficacy and safety profile in the PRIMA and the PATH study in CIDP patients were overall comparable.
Croatian: Profil djelotvornosti i sigurnosti u PRIMA i PATH ispitivanju u bolesnika s KUDP-om bili su općenito usporedivi.
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Croatian: Trudnoća Sigurnost primjene ovog lijeka u trudnoći nije ustanovljena kontroliranim kliničkim ispitivanjima i prema tome može se primijeniti samo uz oprez trudnicama i dojiljama.
English: By adjusted INCAT score, the responder rate by week 13 was 72.9 % (151 / 207 patients), with 149 patients responding already by week 10.
Croatian: Prema prilagođenom rezultatu INCAT, stopa odgovora u 13. tjednu bila je 72,9% (151/207 bolesnika), a 149 bolesnika reagiralo je već do 10. tjedna.
English: *Produced from the plasma of human donors.
Croatian: *Lijek je proizveden iz plazme ljudskih davatelja.
English: After receiving Privigen, the efficacy of certain vaccinations may be impaired.
Croatian: Nakon primitka Privigena djelotvornost određenih cjepiva može biti umanjena.
English: Will be placed in the upper right corner of the main face of the box to give total content and volume of the container
Croatian: Bit će smješteno u gornjem desnom kutu prednje strane kutije u svrhu označivanja ukupnog sadržaja i volumena spremnika
English: What you need to know before you are given Privigen
Croatian: Što morate znati prije nego primite Privigen
English: Privigen is isotonic, with an approximate osmolality of 320 mOsmol/kg.
Croatian: Privigen je izotoničan, s približnom osmolalnošću od 320 mOsmol/kg.
English: When may slowing or stopping the infusion be required?
Croatian: Kada može biti potrebno usporavanje ili prekid infuzije?
English: Date of first authorisation: 25 April 2008 Date of latest renewal: 28 November 2017
Croatian: Datum prvog odobrenja: 25. travnja 2008.
English: Patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies (PID)).
Croatian: bolesnici koji su rođeni sa poremećenom sposobnošću ili nesposobnošću stvaranja imunoglobulina (primarne imunodeficijencije (PID)).
English: For your personal safety, treatment with Privigen will take place under the supervision of your doctor or healthcare professional.
Croatian: Radi Vaše sigurnosti liječenje Privigenom treba provoditi pod nadzorom liječnika ili zdravstvenog radnika.
English: The safety and efficacy of Privigen was evaluated in 6 prospective, open-label, single-arm, multicenter studies performed in Europe (ITP, PID and CIDP studies) and the USA (PID study).
Croatian: Sigurnost i djelotvornost Privigena procijenjena je u 6 prospektivnih, otvorenih, multicentričnih ispitivanja s jednom skupinom ispitanika, provedenih u Europi (ITP, PID i KUDP ispitivanja) i SAD-u (PID ispitivanja).
English: Very Common (may occur with more than 1 in 10 patients):
Croatian: Vrlo često (može se javiti u više od 1 na 10 bolesnika):
English: Detailed information on this medicine is available on the European Medicines Agency website: 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: Six clinical studies were performed with Privigen, which included patients with PID, ITP and CIDP.
Croatian: Provedeno je šest kliničkih ispitivanja s lijekom Privigen, koja uključuju bolesnike s PID-om, ITPom i KUDP-om.
English: Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections.
Croatian: Imunoglobulini su također poznati kao protutijela, a to su proteini u krvi koji pomažu Vašem organizmu u borbi protiv infekcija.
English: Previously treated patients were withdrawn from IVIG until confirmed deterioration before start of Privigen.
Croatian: Prethodno liječeni bolesnici bili su povučeni iz liječenja i.v.Ig-om sve dok se nije dokazalo pogoršanje prije početka liječenja Privigenom.
English: - If you have any further questions, ask your doctor or healthcare professional.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku ili zdravstvenom radniku.
English: • The other ingredients (excipients) are the amino acid proline and water for injections.
Croatian: • Ostali sastojci (pomoćne tvari) su aminokiselina prolina i voda za injekcije.
English: • You may be allergic (hypersensitive) to immunoglobulins without knowing it.
Croatian: • Možete biti alergični (preosjetljivi) na imunoglobuline iako toga možda niste svjesni.
English: While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products containing various excipients such as sucrose, glucose and maltose, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number.
Croatian: Iako su ovi izvještaji o disfunkciji bubrega i akutnom zatajenju bubrega bili povezani s uporabom mnogih odobrenih i.v.Ig lijekova koji sadržavaju razne pomoćne tvari kao što su saharoza, glukoza i maltoza, oni koji sadržavaju saharozu kao stabilizator odgovorni su za neproporcionalni udio u ukupnom broju slučajeva.
English: L-proline, water for injections.
Croatian: L-prolin, voda za injekcije.
English: Will be placed in the upper right corner of the label to give total content and volume of the container
Croatian: Bit će smješteno u gornjem desnom kutu naljepnice u svrhu označivanja ukupnog sadržaja i volumena spremnika
English: The maximum IgA content is 25 micrograms/ml.
Croatian: Maksimalan sadržaj IgA je 25 mikrograma/ml.
English: In a second prospective, multicenter randomized, placebo-controlled clinical study (Polyneuropathy and Treatment with Hizentra, PATH trial), 207 subjects with CIDP were treated with Privigen in the prerandomization phase of the study.
Croatian: U drugoj prospektivnoj, multicentričnoj, randomiziranoj, placebo kontroliranom kliničkom ispitivanju (Polyneuropathy and Treatment with Hizentra, PATH ispitivanje), 207 bolesnika s KUDP-om liječeno je Privigenom u prerandomizacijskoj fazi ispitivanja.
English: • if you have developed antibodies against immunoglobulins of the type IgA in your blood.
Croatian: • ako ste razvili protutijela na imunoglobuline tipa IgA u Vašoj krvi.
English: Frequencies were evaluated according to the following conventions: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000).
Croatian: <1/10), manje često (≥/1000 i <1/100) rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000).
English: Tell your doctor or healthcare professional if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili zdravstvenog radnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: The dosing and intervals may have to be adapted according to the individual course of the disease.
Croatian: Doziranje i intervale doziranja će možda trebati prilagoditi individualnom tijeku bolesti.
English: It may happen particularly if you have developed antibodies against immunoglobulins of the type IgA.
Croatian: Može se dogoditi posebice ako ste razvili protutijela na imunoglobuline tipa IgA.
English: 771 infusions were administered and the median dose administered was 492.3 mg IgG/kg bw.
Croatian: Primijenjeno je 771 infuzija, a medijan primijenjene doze iznosio je 492,3 mg IgG/kg TT.
English: Medicines containing antibodies have been used in pregnant and breast-feeding women.
Croatian: Lijekovi koji sadrže protutijela korišteni su u trudnica i dojilja.
English: If the treatment is effective, long term treatment should be subject to the physician's discretion based upon the patient response.
Croatian: Ako je liječenje učinkovito, dugoročno liječenje treba provoditi prema odluci liječnika na temelju bolesnikova odgovora.
English: Certain severe adverse reactions may be related to the rate of infusion.
Croatian: Pojedine teške nuspojave mogu biti povezane s brzinom infuzije.
English: The syndrome usually begins within several hours to 2 days following IVIg treatment.
Croatian: Sindrom obično počinje unutar nekoliko sati do dva dana nakon liječenja i.v.Ig-om.
English: In this study, the median half-life of Privigen in PID patients was 36.6 days.
Croatian: U ovom ispitivanju pokazano je da je medijan poluvijeka Privigena u bolesnika s PID-om bio je 36,6 dana.
English: The dosage recommendations are summarised in the following table:
Croatian: Preporuke za doziranje sažete su u sljedećoj tablici:
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Croatian: Ljudski normalni imunoglobulin sadrži uglavnom imunoglobulin G (IgG) sa širokim spektrom protutijela protiv infektivnih agensa.
English: Tell your doctor or healthcare professional immediately if you notice such reactions during the infusion of Privigen.
Croatian: Odmah obavijestite svog liječnika ili zdravstvenog radnika ako primijetite takve reakcije tijekom infuzije lijeka Privigen.
English: This may happen particularly if you are a patient at risk, for example if you are elderly or if you suffer from a heart or kidney disease.
Croatian: Vjerojatnost za to je povećana ako spadate u rizičnu skupinu bolesnika, primjerice ako ste stariji ili ako bolujete od bolesti srca ili bubrega.
English: Tell your doctor or healthcare professional if you are pregnant, plan to become pregnant or are breast-feeding.
Croatian: Obavijestite svog liječnika ili zdravstvenog radnika ako ste trudni, namjeravate zatrudnjeti ili dojite.
English: • increase in blood creatinine level,
Croatian: • porast razine kreatinina u krvi,
English: Following clinical deterioration during IVIg withdrawal, clinical improvement of CIDP was primarily defined by a decrease of ≥ 1 point at the adjusted INCAT score.
Croatian: Nakon kliničkog pogoršanja tijekom ustezanja i.v.Ig-a kliničko poboljšanje KUDP prvenstveno je definirano smanjenjem za ≥ 1 bod u rezultatu na prilagođenoj INCAT ljestvici.
English: In post marketing reports it is observed that the proportion of haemolysis cases to all case reports occurring in children is slightly higher than in adults.
Croatian: U postmarketinškim izvješćima uočeno je da je udio slučajeva hemolize u odnosu na sve slučajeve koji se događaju kod djece blago povišen u odnosu na odrasle osobe.
English: This also applies to any unknown or emerging viruses and other types of infections.
Croatian: To se također odnosi na nepoznate viruse ili novootkrivene i druge tipove infekcije.
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.
Croatian: Farmakoterapijska skupina: imuni serumi i imunoglobulini: imunoglobulini, normalni ljudski, za intravaskularnu primjenu, ATK oznaka: J06BA02.
English: Overall, in 42 subjects (74 %) the platelet count increased at least once to ≥ 50×109 / l within 6 days after the first infusion, which was well within the expected range.
Croatian: Sveukupno, kod 42 ispitanika (74%) broj trombocita porastao je bar jednom na ≥50x109/1 unutar 6 dana nakon prve infuzije, što je bilo unutar predviđenog raspona.
English: - Kawasaki disease.
Croatian: - Kawasakijeve bolesti.
English: For patients suffering from diabetes mellitus and requiring dilution of Privigen to lower concentrations, the presence of glucose in the recommended diluent should be taken into account.
Croatian: Za bolesnike sa šećernom bolešću čije stanje zahtijeva razrjeđivanje Privigena na niže koncentracije, potrebno je uzeti u obzir prisutnost glukoze u preporučenom otapalu.
English: The two ITP studies were performed with 57 patients each.
Croatian: Dva ispitivanja ITP-a provedena su na 57 bolesnika.
English: After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Croatian: Nakon primjene ovog lijeka mora proći vremenski interval od 3 mjeseca prije cijepljenja s cjepivima koja sadrže žive atenuirane viruse.
English: At the beginning of the infusion you will receive Privigen at a slow infusion rate.
Croatian: U početku infuzije primat ćete Privigen malom brzinom.
English: Excipients with known effects: Privigen contains approximately 250 mmol/L (range: 210 to 290) of L-proline.
Croatian: Privigen sadrži približno 250 mmol/l (raspon: 210 do 290) L-prolina.
English: Haemolysis has rarely been reported in patients given replacement therapy for PID.
Croatian: Hemoliza je rijetko uočena u bolesnika koji su primali nadomjesnu terapiju za PID.
English: Cmax, maximum serum concentration; Cmin, trough (minimum level) serum concentration; t½, elimination half-life
Croatian: C max, maksimalna koncentracija u serumu, Cmin, najmanja (minimalna razina) koncentracija u serumu, t½, poluvijek eliminacije
English: Tell your doctor or healthcare professional prior to treatment if any of the circumstances listed below applies to you:
Croatian: Obavijestite svog liječnika ili zdravstvenog radnika prije liječenja ili ako se bilo koja od okolnosti u nastavku odnosi na Vas:
English: After injection of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Croatian: Nakon injiciranja imunoglobulina zabilježen je prolazan porast različitih pasivno prenesenih protutijela u bolesnikovu krv što može uzrokovati lažno pozitivne rezultate seroloških testiranja.
English: • Because the solution contains no preservative, your healthcare professional must infuse it immediately after opening the vial.
Croatian: • S obzirom da otopina ne sadrži konzervanse, Vaš zdravstveni radnik mora je primijeniti infuzijom odmah nakon otvaranja bočice.
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: The safety of Privigen has been assessed in several preclinical studies, with particular reference to the excipient L-proline.
Croatian: Sigurnost Privigena procijenjena je u nekoliko pretkliničkih ispitivanja, s posebnim osvrtom na pomoćnu tvar L-prolin.
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: Pasivan prijenos protutijela protiv eritrocitnih antigena npr. A, B i D mogu interferirati s nekim serološkim testovima za protutijela eritrocita, primjerice s direktnim antiglobulinskim testom (DAT, direktni Coombsov test).
English: The PID pivotal study included a total of 80 patients aged between 3 and 69 years old.
Croatian: U pivotalno ispitivanje PID-a uključeno je ukupno 80 bolesnika u dobi između 3 i 69 godina.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se također odnosi na nepoznate viruse ili novootkrivene viruse i druge patogene.
English: Loss of kidney function with fatal outcome has occurred in isolated haemolysisrelated cases.
Croatian: Gubitak funkcije bubrega sa smrtonosnim ishodom opisan je u izoliranim slučajevima povezanim s hemolizom.
English: • If the 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: Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
Croatian: Postoje ograničena iskustva u primjeni intravenskih imunoglobulina u djece s KUDP.
English: In post marketing reports it is observed that IVIG high-dose indications in children, particularly Kawasaki disease, are associated with an increased reporting rate of haemolytic reactions compared to other IVIG indications in children.
Croatian: U postmarketinškim izvješćima uočeno je da su indikacije koje zahtijevaju visoke doze i.v.Ig-om u djece, posebice kod Kawasakijeve bolesti, povezane s većom stopom prijavljenih hemolitičkih reakcija u usporedbi s drugim indikacijama za i.v.Ig-om u djece.
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 za sprječavanje infekcija koje su posljedica uporabe lijekova proizvedenih iz ljudske krvi ili plazme uključuju odabir davatelja, ispitivanje prisutnosti specifičnih markera infekcije u pojedinačnim donacijama i sveukupnoj prikupljenoj plazmi te uvođenje djelotvornih proizvodnih postupaka kojima se inaktiviraju/odstranjuju virusi.
English: The INCAT responder rate was 60.7% (95% confidence interval [42.41, 76.4]).
Croatian: Stopa odgovora na ljestvici INCAT iznosila je 60,7% (interval pouzdanosti 95% [42,41; 76,4]).
English: In the ITP pivotal study, in total 57 patients aged between 15 and 69 years old were treated with 2 infusions of Privigen for a total of 114 infusions.
Croatian: U pivotalnom ispitivanju ITP-a ukupno je 57 bolesnika u dobi između 15 i 69 godina liječeno s dvije infuzije Privigena i ukupno 114 infuzija.
English: Thromboembolic events, vasculitis (including peripheral vascular disorder)
Croatian: Tromboembolijski događaji, vaskulitis (uključujući periferni krvožilni poremećaj)
English: This will lead to non-heart related accumulation of fluid in the air spaces of the lungs (non-cardiogenic pulmonary oedema).
Croatian: Ona vodi do nakupljanja tekućine, koje nije povezano sa srcem, u zračne prostore pluća (nekardiogeni plućni edem).
English: Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment.
Croatian: Predoziranje može dovesti do preopterećenja tekućinom i hiperviskoznosti, osobito u rizičnih bolesnika, uključujući bolesnike starije životne dobi ili bolesnike sa srčanim oštećenjem ili oštećenjem bubrega.
English: Patients should receive concomitant treatment with acetylsalicylic acid.
Croatian: Bolesnici istodobno trebaju primati i acetilsalicilatnu kiselinu.
English: Pivotal Study (N= 25) ZLB03_002CR Median (Range)
Croatian: Pivotalno ispitivanje (N = 25) ZLB03_002CR Medijan (Raspon)
English: Experimental studies of the excipient L-proline carried out in animals found no direct or indirect toxicity affecting pregnancy, embryonal or foetal development.
Croatian: L-prolina životinjskog porijekla nisu pokazala nikakvu direktnu ili indirektnu toksičnost na trudnoću, embrionalni ili fetalni razvoj.
English: The treatment required depends on the nature and severity of the adverse reaction.
Croatian: Odgovarajuće liječenje ovisi o prirodi i težini nuspojava.
English: The product should be brought to room temperature (25°C) before use.
Croatian: Prije primjene lijek treba postići sobnu temperaturu (25°C).