FrancophonIA/ELRC3.0 huggingface dataset:
English: Cmax (peak, g/l) Cmin (trough, g/l)
Croatian: Cmax (najviše, g/l) Cmin (najniže, g/l)
English: This is a slowly progressive disease of the motor nerves with weakness of arms and legs.
Croatian: To je sporo progresivna bolest motoričkih živaca s slabostima u rukama i nogama.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA
English: Guillain-Barré syndrome 0.4 g/kg bw/day over 5 days.
Croatian: Guillain-Barréov sindrom 0,4 g/kg TT/dan tijekom 5 dana.
English: 19 children (3 to 11 years), 12 adolescents (12 to 16 years) and 49 adults were treated with Privigen over 12 months.
Croatian: Devetnaestero djece (3 do 11 godina), 12 adolescenata (u dobi od 12 do 16 godina) i 49 odraslih bolesnika liječeni su Privigenom tijekom 12 mjeseci.
English: Increase in serum creatinine level and/or acute renal failure have been observed.
Croatian: Opaženo je povećanje razine serumskog kreatinina i/ili akutno zatajenje bubrega.
English: Extension Study (N=13) ZLB05_006CR Median (Range)
Croatian: Produžetak ispitivanja (N = 13) ZLB05_006CR Medijan (Raspon)
English: IgG trough levels should be measured and assessed in conjunction with the incidence of infection.
Croatian: Najniže koncentracije IgG-a treba mjeriti i procijeniti prema incidenciji infekcija.
English: Therefore, your vaccinating doctor should check the effectiveness of the measles vaccination.
Croatian: Zato bi vaš liječnik trebao provjeriti učinkovitost cijepljenja protiv ospica.
English: In an extension of this study, 13 PID patients (aged 3-65 years) participated in a PK substudy.
Croatian: U nastavku ovog ispitivanja 13 PID bolesnika (u dobi od 3 do 65 godina) sudjelovalo je u PK podispitivanju.
English: Package leaflet: Information for the user Privigen 100 mg/ml (10%) solution for infusion
Croatian: Uputa o lijeku: Informacije za korisnika Privigen 100 mg/ml (10%) otopina za infuziju
English: - Guillain-Barré syndrome.
Croatian: - Guillain-Barréovog sindroma.
English: Immunoglobulins are a normal constituent of the human body.
Croatian: Imunoglobulini su normalni sastavni dio ljudskog tijela.
English: The grip strength of the dominant hand improved by 14.1 kPa (17.0 kPa in IVIg-untreated and 10.8 kPa in IVIg pretreated subjects) in the PRIMA study, while in PATH the grip strength of the dominant hand improved by 12.2 kPa.
Croatian: Snaga hvata šake dominantne ruke povećana je za 14,1 kPa (17,0 kPa u prethodno neliječenih i.v.Igom i 10,8 kPa u prethodno liječenih i.v.Ig-om) u PRIMA-i, dok je u PATH-u snaga hvata šake dominantne ruke poboljšana za 12,2 kPa.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti također dio
English: Once the vial has been entered under aseptic conditions, its contents should be used promptly.
Croatian: Nakon što je bočica otvorena u aseptičkim uvjetima, njezin sadržaj treba iskoristiti odmah.
English: Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae.
Croatian: Prekid liječenja i.v.Ig-om uzrokovao je remisiju AMS-a unutar nekoliko dana bez posljedica.
English: The following risk factors are associated with the development of haemolysis: high doses, whether given as a single administration or divided over several days; non-O blood group; and underlying inflammatory state.
Croatian: Slijedeći su čimbenici rizika povezani s razvojem hemolize: visoke doze, bez obzira daju li se kao pojedinačna doza ili podijeljena u nekoliko doza; krvna grupa različita od 0; podležeće upalno stanje.
English: What Privigen is and what it is used for What Privigen is
Croatian: Što je Privigen i za što se koristi Što je Privigen
English: Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Croatian: Ljudski normalni imunoglobulin je odmah i u potpunosti bioraspoloživ u cirkulaciji primatelja nakon intravenske primjene.
English: In these circumstances, immunoglobulins may increase the risk of serious rapid loss of kidney function (acute renal failure) although only very rarely.
Croatian: U tim okolnostima imunoglobulini mogu povećati rizik od ozbiljnog i brzog gubitka funkcije bubrega (akutno zatajenje bubrega) iako samo u vrlo rijetkim slučajevima.
English: Guillain-Barré syndrome
Croatian: Guillain-Barréov sindrom
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Croatian: Kad se lijekovi dobivaju iz ljudske krvi ili plazme treba poduzeti određene mjere kako bi se spriječio prijenos infekcije na bolesnike.
English: Replacement therapy in adults, and children and adolescents (0-18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production (see section
Croatian: Nadomjesno liječenje odraslih, djece i adolescenata (0-18 godina) kod: - Sindroma primarne imunodeficijencije (PID) s poremećenim stvaranjem antitijela (vidjeti dio
English: Possible side effects may be reduced or even avoided by infusing Privigen at a slow infusion rate.
Croatian: Moguće nuspojave mogu se smanjiti ili čak i izbjeći primjenom spore infuzije lijeka Privigen.
English: Pharmacokinetic parameters of Privigen in PID patients Parameter
Croatian: Farmakokinetički parametri Privigena u PID bolesnika
English: The in-use stability of Privigen after dilution with a 5% glucose solution to a final concentration of 50 mg/ml (5%) has been demonstrated for 10 days at 30°C; however, the microbial contamination aspect was not studied.
Croatian: Stabilnost Privigena nakon razrjeđivanja s otopinom 5%-tne glukoze na konačnu koncentraciju od 50 mg/ml (5%) dokazana je tijekom 10 dana na 30° C, međutim aspekt mikrobiološke kontaminacije nije proučavan.
English: 13 children (3 to 11 years), 8 adolescents (12 to 15 years) and 34 adults were treated with Privigen over 29 months.
Croatian: Trinaestoro djece (3 do 11 godina), 8 adolescenata (u dobi od 12 do 15 godina) i 34 odrasla bolesnika liječeni su Privigenom tijekom 29 mjeseci.
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Croatian: Distribucija podrazreda imunoglobulina G proporcionalna je onoj u nativnoj ljudskoj plazmi.
English: Your doctor will calculate the correct dose for you taking into account your weight, the specific circumstances listed under section 2 “Warnings and precautions” and response to treatment.
Croatian: Vaše tjelesne težine te specifičnih okolnosti navedeni u dijelu 2 "Upozorenja i mjere opreza" te Vašeg odgovora na liječenje.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Doziranje i način primjene
English: Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA.
Croatian: Preosjetljivost na ljudske imunoglobuline, osobito kod bolesnika s anti-IgA protutijelima.
English: The following dose regimens are given as a guideline.
Croatian: Sljedeći načini doziranja preporučaju se kao smjernice.
English: Distribution of the IgG subclasses (approx. values): IgG1 69 %
Croatian: Raspodjela podrazreda IgG (približne vrijednosti): IgG1 ………………..
English: • Keep the vial in the outer carton in order to protect from light.
Croatian: • Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: How Privigen works
Croatian: Kako Privigen djeluje
English: In Privigen clinical studies with paediatric patients, the frequency, nature and severity of adverse reactions did not differ between children and adults.
Croatian: U kliničkim ispitivanjima Privigena kod pedijatrijskih bolesnika nije bilo razlike u učestalosti, prirodi i težini nuspojava između djece i odraslih.
English: Flushing of the infusion tubes with physiological saline or 5% glucose solution is permitted.
Croatian: Dozvoljeno je ispiranje cijevi za infuziju fiziološkom otopinom ili 5%-tnom otopinom glukoze.
English: In these circumstances, it has been commonly reported that immunoglobulins increase the risk of breakdown of red blood cells (haemolysis).
Croatian: U tim okolnostima, zabilježeno je kako imunoglobulini povećavaju rizik od razgradnje eritrocita (hemoliza).
English: In these circumstances, immunoglobulins may increase the risk of heart attack (cardiac infarction), stroke, blood clots in the lung (lung embolism), or blockage of a blood vessel in the leg, although only very rarely.
Croatian: U tim slučajevima imunoglobulini mogu povećati rizik od srčanog udara (infarkt srca), moždanog udara, krvnog ugruška u plućima (embolija pluća) ili začepljenje krvne žile u nozi, iako samo vrlo rijetko.
English: They can occur in patients with anti-IgA antibodies.
Croatian: Mogu se pojaviti u bolesnika s anti-IgA protutijelima.
English: • severe hypersensitivity reactions such as a sudden fall in blood pressure or anaphylactic shock
Croatian: • teške reakcije preosjetljivosti poput naglog pada krvnog tlaka ili anafilaktičkog šoka (primjerice,
English: Very rarely: Transfusion related acute lung injury and thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses.
Croatian: Vrlo rijetko: Akutne ozljede pluća povezane s transfuzijom i tromboembolijske reakcije kao što su infarkt miokarda, moždani udar, plućna embolija i duboka venska tromboza.
English: In the case of measles vaccinations the impairment may persist for up to 1 year.
Croatian: U slučaju ospica umanjenja djelotvornost može potrajati i do godinu dana.
English: Replacement therapy Primary immunodeficiency syndromes (PID)
Croatian: Nadomjesna terapija kod sindroma primarne imunodeficijencije (PID)
English: He or she will decide whether to decrease the infusion rate or to stop the infusion completely.
Croatian: Liječnik će tada odlučiti hoće li smanjiti brzinu infuzije ili u potpunosti prekinuti infuziju.
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Croatian: Bolesnici koji razviju nuspojave tijekom liječenja bi trebali pričekati dok se te nuspojave ne povuku prije nego upravljaju vozilima ili rade sa stojevima.
English: Anaemia, haemolysis (including haemolytic anaemia), leukopenia
Croatian: Anemija, hemoliza (uključujući hemolitičku anemiju), leukopenija
English: AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment.
Croatian: AMS se može javiti učestalije kod liječenja višim dozama i.v.Ig-a (2 g/kg).
English: • Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici bočice iza „Rok valjanosti“.
English: • The active substance is human normal immunoglobulin (antibodies of the type IgG).
Croatian: • Djelatna tvar je ljudski normalni imunoglobulin (protutijela tipa IgG).
English: The two CIDP studies were performed with 28 and 207 patients, respectively.
Croatian: Dva KUDP ispitivanja provedena su na 28 odnosno na 207 bolesnika.
English: MRC sum score in PRIMA improved by 6.9 points (7.7 points for IVIg-untreated and 6.1 points for IVIg-pretreated) and by 3.6 points in PATH.
Croatian: Ukupan rezultat MRC-a u PRIMA-i poboljšan je za 6,9 bodova (7,7 bodova za prethodno neliječene i.v.Ig-om i 6,1 bodova za prethodno liječene i.v.Ig-om) i 3,6 bodova u PATH-u.
English: Live attenuated virus vaccines
Croatian: Cjepiva koja sadrže žive atenuirane viruse
English: Most adverse drug reactions (ADRs) observed in the six clinical studies were mild to moderate in nature.
Croatian: Većina nuspojava lijeka uočenih u 6 kliničkih ispitivanja su bile blage do umjerene.
English: Vomiting, diarrhoea, abdominal pain
Croatian: Povraćanje, dijareja, bol u abdomenu
English: The product should be brought to room or body temperature before use.
Croatian: Prije upotrebe lijek treba dosegnuti sobnu ili tjelesnu temperaturu.
English: They may occur even if you have previously received human immunoglobulins and had tolerated them well.
Croatian: Mogu se javiti čak i ako ste prije primali ljudske imunoglobuline i ako ste ih dobro podnosili.
English: Uncommon (may occur with up to 1 in 100 patients):
Croatian: Manje često (može se javiti u do 1 na 100 bolesnika):
English: Privigen contains immunoglobulins that have been prepared from the blood of healthy people.
Croatian: Privigen sadrži imunoglobuline koji su izolirani iz plazme krvi zdravih ljudi.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) and for the non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19.
Croatian: Navedene mjere smatraju se učinkovitima za viruse s ovojnicom kao što su virus humane imunodeficijencije (HIV), virus hepatitisa B (HBV) i virus hepatitisa C (HCV) i za viruse bez ovojnice kao što su virus hepatitisa A (HAV) i parvovirus B19.
English: Although limited data is available, it is expected that the same interactions may occur in the paediatric population.
Croatian: Iako su dostupni ograničeni podaci, očekuju se interakcije jednake onima navedenima za odraslu populaciju.
English: Once the vial has been broached, its contents should be used promptly.
Croatian: Nakon otvaranja bočice njen sadržaj treba odmah upotrijebiti.
English: Each vial of 25 ml solution contains: 2.5 g human normal immunoglobulin Each vial of 50 ml solution contains: 5 g human normal immunoglobulin Each vial of 100 ml solution contains: 10 g human normal immunoglobulin Each vial of 200 ml solution contains: 20 g human normal immunoglobulin Each vial of 400 ml solution contains: 40 g human normal immunoglobulin
Croatian: Svaka bočica od 25 ml otopine sadrži: 2,5 g ljudskog normalnog imunoglobulina Svaka bočica od 50 ml otopine sadrži: 5 g ljudskog normalnog imunoglobulina Svaka bočica od 100 ml otopine sadrži: 10 g ljudskog normalnog imunoglobulina Svaka bočica od 200 ml otopine sadrži: 20 g ljudskog normalnog imunoglobulina Svaka bočica od 400 ml otopine sadrži: 40 g ljudskog normalnog imunoglobulina
English: In PRIMA, the percentage of responders in the overall Medical Research Council (MRC) score (defined as an increase by ≥ 3 points) was 85 % (87 % in the IVIg-untreated and 82 % in IVIgpretreated) and 57 % in PATH.
Croatian: U PRIMA-i, postotak ispitanika s odgovorom prema ukupnom rezultatu MRC-a (definiran kao povećanje za ≥ 3 boda) bio je 85% (87% u ispitanika koji nisu prethodno liječeni i.v.Ig-om i 82% u ispitanika koji su prethodno liječeni i.v.Ig-om) i 57% u PATH-u.
English: The medicine works in exactly the same way as the immunoglobulins naturally present in human blood of healthy people.
Croatian: Lijek djeluje isto kao i imunoglobulini prirodno prisutni u plazmi zdravih ljudi.
English: Excipients: L-proline, water for injections.
Croatian: Pomoćne tvari: L-prolin, voda za injekcije.
English: • You have or had previously problems with your kidneys or take medicinal products that may harm your kidneys (nephrotoxic medicinal products).
Croatian: • Ako imate ili ste imali problema s bubrezima ili uzimate lijekove koji mogu oštetiti bubrege
English: Therefore, patients receiving measles vaccine should have their antibody status checked.
Croatian: Prema tome, bolesnicima koji se cijepe protiv morbila treba provjeriti status protutijela.
English: On the adjusted 10 point INCAT (Inflammatory Neuropathy Cause and Treatment) scale a clinically meaningful improvement of at least 1-point from baseline to treatment week 25 was observed in 17 out of 28 patients.
Croatian: [Uzrok i liječenje upalne neuropatije]) od 10 točaka, klinički značajno poboljšanje od barem 1 točke od početka liječenja do 25. tjedna uočeno je u 17 od 28 bolesnika.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: On day 3 patients could receive a second dose of 1 g/ kg bw, for patients with a platelet count of < 50×109 / l on day 3 this second dose was mandatory.
Croatian: Treći dan bolesnici su mogli primiti drugu dozu od 1 g/kg TT, a za bolesnike s brojem trombocita od <50 x 109/1 treći dan je druga doza bila obavezna.
English: The scheduled dose of 1 g/kg bw per infusion was closely adhered to in all patients (median 2 g IgG/kg bw).
Croatian: Strogo se pridržavalo dogovorene doze od 1 g/kg TT po infuziji za sve bolesnike (medijan 2 g IgG/kg TT).
English: Trough levels should be measured and assessed in conjunction with the patient's clinical response.
Croatian: Najniže razine potrebno je mjeriti i procijeniti ovisno o kliničkom odgovoru bolesnika.
English: Starting dose: 2 g/kg given over 2-5 consecutive days.
Croatian: Početna doza: 2 g/kg tijekom 2-5 uzastopnih dana.
English: Some published studies pertaining to hyperprolinaemia have shown that longterm, high doses of L-proline have effects on brain development in very young rats.
Croatian: visoke doze L-prolina imaju utjecaj na razvoj mozga u vrlo mladih štakora.
English: Privigen 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Croatian: Privigen 100 mg/ml otopina za infuziju Ljudski normalni imunoglobulin (i.v.Ig)
English: Symptoms typically appear within 1 to 6 hours following treatment.
Croatian: Simptomi se obično javljaju unutar 1 do 6 sati nakon liječenja.
English: IVIg is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern.
Croatian: Intravenski globulini nisu indicirani kod bolesnika sa selektivnim nedostatkom IgA, kada je nedostatak IgA jedini poremećaj.
English: IVIg recipients should be monitored for clinical signs and symptoms of haemolysis.
Croatian: Primatelje i.v.Ig terapije nužno je pratiti kako bi se uočili klinički znakovi i simptomi hemolize
English: Information on safety with respect to infections Privigen is made from human blood plasma (this is the liquid part of the blood).
Croatian: Privigen se dobiva iz ljudske plazme (to je tekući dio krvi).
English: Three to six months are required after the initiation of therapy for equilibration to occur.
Croatian: Za uspostavljanje ravnoteže, potrebno je 3 do 6 mjeseci od početka liječenja.
English: • You are overweight, are elderly, have diabetes, have been bedridden for a long time, have high blood pressure, have low blood volume (hypovolaemia), have problems with your blood vessels (vascular diseases), have an increased tendency for blood clotting (thrombophilia or thrombotic episodes) or have a disease or a condition which causes your blood to thicken (hyperviscous blood).
Croatian: • Prekomjerne ste težine, starija ste osoba, imate šećernu bolest, prikovani ste za krevet već dulje vrijeme, imate visoki krvni tlak, nizak volumen krvi (hipovolemija), probleme s krvnim žilama (vaskularna bolest), povećanu sklonost stvaranju ugrušaka (trombofilija ili trombotičke epizode) ili imate bolest ili stanje koje uzrokuje povećanje gustoće krvi (hiperviskozna krv).
English: The following table shows an overview of the ADRs observed in the six clinical studies categorized according the MedDRA System Organ Class (SOC), Preferred Term Level (PT) and frequency.
Croatian: Tablica u nastavku pokazuje pregled nuspojava zabilježenih u 6 kliničkih ispitivanja kategoriziranih prema MedDRA klasifikaciji organskih sustava, razini preporučenog pojma i učestalosti.
English: Isolated cases of haemolysis-related renal dysfunction/renal failure or disseminated intravascular coagulation and death have occurred.
Croatian: Opisani su izolirani slučajevi disfunkcije/zatajenja bubrega povezanog s hemolizom ili diseminirane intravaskularne koagulacije i smrti.
English: If insufficient treatment effect is seen after 6 months, the treatment should be discontinued.
Croatian: Nakon svakog ciklusa potrebno je procijeniti terapijski učinak; ako se terapijski učinak ne opazi nakon 6 mjeseci, liječenje treba prekinuti.
English: There are 5 groups: Patients who do not have enough blood platelets (primary immune thrombocytopenia (ITP) and who are at high risk of bleeding or will have surgery in the near future.
Croatian: Postoji 5 skupina: bolesnici koji nemaju dovoljno trombocita (primarna imunološka trombocitopenija (ITP)) te koji su pod povećanim rizikom od krvarenja ili koji će se uskoro podvrgnuti kirurškom zahvatu. bolesnici s Guillain-Barréovim sindromom.
English: The dosage interval when steady state has been reached varies from 3 to 4 weeks.
Croatian: Nakon postizanja stanja dinamičke ravnoteže interval doziranja varira od 3 do 4 tjedna.
English: In patients at risk, the use of IVIg products that do not contain sucrose should therefore be considered.
Croatian: Stoga, u rizičnih bolesnika treba razmotriti primjenu i.v.Ig lijekova koji ne sadrže saharozu.
English: A second dose in subjects with platelet counts ≥ 50×109 /l after the first dose provided a relevant additional benefit in terms of higher and longer-lasting increases in platelet counts compared to a single dose.
Croatian: Druga doza kod ispitanika s brojem trombocita ≥50x109/1 nakon prve doze pružila je relevantnu dodatnu korist u smislu većeg i dužeg rasta broja trombocita u usporedbi s pojedinačnom dozom.
English: • chest pain, chest discomfort, painful respiration due to transfusion related lung injury (TRALI) Tell your doctor or healthcare professional immediately if you have any of the above symptoms.
Croatian: • bol u prsištu, nelagoda u prsištu, bolno disanje zbog akutne ozljede pluća povezane s transfuzijom Ako imate jedan od gore navedenih simptoma, odmah obavijestite svog liječnika ili zdravstvenog radnika.
English: In subjects with platelet counts < 50×109 / l after the first dose, 30% showed a platelet response of ≥ 50×109 / l after the mandatory second dose.
Croatian: Kod bolesnika s brojem trombocita <50x109/1 nakon prve doze, 30% ih je pokazalo odgovor trombocita od ≥50x109/1 nakon obavezne druge doze.
English: Muscle strength as measured by the MRC (Medical Research Council) Score improved in all patients by 6.9 points (95% confidence interval [4.11, 9.75], in previously treated patients by 6.1 points (95% confidence interval [2.72, 9.44]) and in untreated patients by 7.7 points (95% confidence interval [2.89, 12.44]).
Croatian: Medical Research Council [Vijeće za medicinska istraživanja]) poboljšala se u svih bolesnika za 6,9 bodova (interval pouzdanosti 95% [4,11; 9,75], u prethodno liječenih bolesnika za 6,1 bodova (interval pouzdanosti 95% [2,72; 9,44] te u neliječenih bolesnika za 7,7 bodova (interval pouzdanosti 95% [2,89; 12,44]).
English: Rarely human normal immunoglobulins including Privigen may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Croatian: Rijetko se događa da normalni ljudski imunoglobulini uključujući Privigen izazivaju nagli pad krvnog tlaka i, u izoliranim slučajevima, anafilaktički šok, čak kada u bolesnika nije zabilježena preosjetljivost na taj lijek pri prijašnjim primjenama.