FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Croatian: Bolesnici u kojih se jave nuspojave tijekom liječenja trebali bi čekati da se one povuku prije vožnje ili rada sa strojevima.
English: Due to the study design, the same subject could receive both doses during the study; 72 subjects received doses of 0.4 g/kg and 73 subjects received doses of 0.2 g/kg during the efficacy evaluation period.
Croatian: Zbog dizajna ispitivanja, isti ispitanik je mogao primiti obje doze tijekom ispitivanja; 72 ispitanika primilo je doze od 0,4 g/kg i 73 ispitanika primilo je doze od 0,2 g/kg tijekom perioda procjene djelotvornosti.
English: Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Croatian: Imunoglobulini se izlučuju u majčino mlijeko i mogu pridonijeti prijenosu zaštitnih protutijela na novorođenče.
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Croatian: Njegova distribucija imunoglobulina podvrste G približno je proporcionalna onoj kod prirodne ljudske plazme.
English: Clean the stopper with an alcohol wipe or antiseptic preparation and allow it to dry.
Croatian: Očistite čep s alkoholnom maramicom ili antiseptikom i ostavite da se osuši.
English: One ml contains 200 mg of human normal immunoglobulin, of which at least 98% is immunoglobulin type G (IgG).
Croatian: Jedan ml otopine sadrži 200 mg ljudskog normalnog imunoglobulina, od kojih najmanje 98% imunoglobulina tipa G (IgG).
English: For dosing every two weeks, your doctor will double the weekly Hizentra dose.
Croatian: Za doziranje svaka dva tjedna, Vaš liječnik će udvostručiti tjednu dozu Hizentre.
English: If you think you should receive Hizentra more or less frequently, please speak to your doctor.
Croatian: Ako mislite da biste Hizentru trebali primiti češće ili rjeđe, porazgovarajte sa svojim liječnikom.
English: phase III study (n = 115), and 1 extension study (n = 82) in patients with CIDP (total N = 502 patients; 26,646 infusions).
Croatian: (n=74), iz 1 ispitavanja faze III (n=115) i 1 nastavka ispitivanja (n=82) u bolesnika s KUDP-om (ukupno N=502 bolesnika; 26 646 infuzija).
English: However, medicines that contain immunoglobulins have been used in pregnant or breast-feeding women for years, and no harmful effects on the course of pregnancy or on the baby have been observed.
Croatian: Ipak, lijekovi koji sadrže imunoglobuline korišteni su godinama u liječenju trudnica ili dojilja te se nisu uočili štetni učinci na tijek trudnoće ili na dijete.
English: The medicine must be infusedslowly at first.
Croatian: Lijek se u početku mora primjenjivati sporom infuzijom.
English: If the Hizentra pre-filled syringe size does not match the pump requirements, then the contents of the pre-filled syringe can be transferred to another syringe of a size specific for the pump.
Croatian: Ukoliko Hizentra napunjena štrcaljka veličinom ne odgovara zahtjevima pumpe, onda se sadržaj napunjene štrcaljke može prebaciti u drugu štrcaljku veličine koja odgovara pumpi.
English: Hizentra contains proline
Croatian: Hizentra sadrži prolin
English: Kaplan-Meier Plot Time to CIDP Relapse
Croatian: Slika 1. Kaplan-Meierov dijagram vremena do relapsa KUDP-a
English: 30 ml/hour/site 60 ml/hour/site 120 ml/hour/site
Croatian: 30 ml/sat/mjestu 60 ml/sat/mjestu 120 ml/sat/mjestu
English: If you think you have missed a dose, speak to your doctor as soon as possible.
Croatian: Ako mislite da ste propustiili dozu, razgovarajte sa svojim liječnikom što je prije moguće.
English: If you notice such signs during the infusion of Hizentra, stop the infusion and contact your doctor or go to the nearest hospital immediately.
Croatian: Ako primijetite takve reakcije tijekom infuzije Hizentre, odmah prekinite infuziju i obratite se svom liječniku ili otiđite u najbližu bolnicu.
English: Clinical trials with Hizentra showed a similar overall safety profile in paediatric and adult patients with PID.
Croatian: U kliničkim ispitivanjima Hizentra je pokazala sličan ukupni sigurnosni profil kod pedijatrijskih i starijih bolesnika s PID-om.
English: Subcutaneous infusion for home treatment must be initiated and monitored by a healthcare professional experienced in the guidance of patients for home treatment.
Croatian: Supkutanu infuziju za kućno liječenje mora započeti i nadzirati zdravstveni radnik s iskustvom u vođenju bolesnika na kućnom liječenju.
English: In particular, patients naïve to human normal immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse reactions.
Croatian: Posebice bolesnike koji prije nisu liječeni ljudskim normalnim imunoglobulinom, bolesnike koji su prešli s drugih lijekova ili kada je prošao dugi interval od prethodne infuzije, trebaju biti promatrani tijekom prve infuzije i za vrijeme prvog sata nakon prve infuzije, a u svrhu otkrivanja mogućih nuspojava.
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and
Croatian: • pažljiv odabir krvi i plazme donora kako bi oni s potencijalnom mogućnošću prijenosa infekcije bili isključeni, te
English: No serious bacterial infections were reported during the efficacy period in subjects receiving Hizentra during clinical studies.
Croatian: Nisu uočene ozbiljne bakterijske infekcije u ispitanika liječenih Hizentrom tijekom kliničkih ispitivanja.
English: • the infused volume, flow rate, the number and location of infusion sites.
Croatian: • volumen primjenjen infuzijom, protok, broj i lokaciju mjesta primjene infuzije.
English: 1 Clean surface Thoroughly clean a table or other flat surface using an antiseptic wipe.
Croatian: Temeljito očistite stol ili drugu ravnu površinu upotrebom antiseptičke maramice.
English: Simulations by empirical Population Pharmacokinetic models suggested that comparable IgG exposure levels (AUC0-14days, Cmin 14days) may be obtained if Hizentra is administered subcutaneously every two weeks using double the weekly dose during maintenance therapy.
Croatian: Simulacije prema empirijskim modelima populacijske farmakokinetike su ukazivale na to da se usporedive razine izloženosti IgG (AUC0-14dana, Cmin 14dana) mogu dobiti ako se Hizentra primjenjuje supkutano svaka dva tjedna koristeći dvostruku tjednu dozu tijekom terapije održavanja.
English: Chills (including Hypothermia)
Croatian: Zimica (uključujući hipotermiju)
English: Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Croatian: Ljudski normalni imunoglobulin sadrži IgG protutijela prisutna u općoj populaciji.
English: Your doctor will determine your weekly Hizentra dose.
Croatian: Vaš liječnik će odrediti Vašu tjednu dozu Hizentre.
English: Patients should be informed about first symptoms of thromboembolic events including shortness of breath, pain and swelling of a limb, focal neurological deficits and chest pain and should be advised to contact their physician immediately upon onset of symptoms.
Croatian: Bolesnike se treba upoznati s prvim simptomima tromboembolijskih događaja uključujući nedostatak zraka, bol i oticanje udova, žarišnim neurološkim deficitima i bol u prsištu i treba ih savjetovati da se odmah po pojavi simptoma obrate svom liječniku.
English: The recommended infusionrate given under section 3“How to use Hizentra” must be closely followed.
Croatian: Potrebno je strogo se pridržavati preporučene brzine infuzije navedene u dijelu 3 "Kako primjenjivati Hizentru".
English: Excipients: L-proline, polysorbate 80, water for injections.
Croatian: Pomoćne tvari: L-prolin, polisorbat 80, voda za injekcije.
English: The safety of Hizentra has been assessed in several preclinical studies, with particular reference to the excipient L-proline.
Croatian: Sigurnost Hizentre procijenjena je u nekoliko pretkliničkih ispitivanja, s posebnim osvrtom na pomoćnu tvar L-prolin.
English: The mean dose administered each week was 0.12 g/kg body weight (bw).
Croatian: Srednja doza primijenjena svakog tjedna bila je 0,12 g/kg tjelesne težine (tt).
English: These simulations further suggested that comparable serum IgG trough levels can be achieved when the weekly maintenance dose of Hizentra is administered in proportional amounts more frequently than once a week (e.g. 2 times per week, 3 times per week, 5 times per week or daily).
Croatian: Ove simulacije, nadalje su ukazivale na to kako se usporedive najniže razine IgG u serumu mogu postići kad se tjedna doza održavanja lijeka Hizentra primjenjuje u proporcionalnim količinama češće od jedanput tjedno (npr., 2 puta tjedno, 3 puta tjedno, 5 puta tjedno ili dnevno).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section
Croatian: Preosjetljivost na djelatnu tvar ili na neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti dio 4.4).
English: Musculoskeletal pain, Arthralgia
Croatian: Mišićno-koštana bol, artralgija
English: If you are breast-feeding and receive Hizentra, the immunoglobulins of the medicine can also be found in the breast milk.
Croatian: Ako primate Hizentru u vrijeme dojenja, imunoglobulini iz ovog lijeka također će se naći u majčinom mlijeku.
English: In total, 57 subjects received 1514 infusions in the placebo group, 57 subjects received 2007 infusions in the 0.2 g/kg bw Hizentra group, and 58 subjects received 2218 infusions in the 0.4 g/kg bw Hizentra group (in total 5739 infusions).
Croatian: Ukupno 57 ispitanika dobilo je 1514 infuzija u skupini koja je primala placebo, 57 je primilo 2007 infuzija u Hizentra skupini liječenoj s 0,2 g/kg tt i 58 ispitanika primilo je 2218 infuzija u Hizentra skupini liječenoj s 0,4 g/kg (ukupno 5739 infuzija).
English: No clinically relevant differences in the serum IgG trough concentrations were observed between the baseline at day 1 and the end of the study in all subjects.
Croatian: Nisu primijećene klinički značajne razlike u najnižim koncentracijama IgG-a u serumu između početne vrijednosti prvog dana i na kraju ispitivanja kod svih ispitanika.
English: Solution for subcutaneous injection.
Croatian: Otopina za supkutanu injekciju.
English: Tremor (including Psychomotor hyperactivity)
Croatian: Tremor (uključujući psihomotoričku preosjetljivost)
English: The safety and effectiveness of Hizentra have been established in paediatric subjects 2 to 18 years of age.
Croatian: Sigurnost i učinkovitost Hizentre utvrđene su kod pedijatrijskih ispitanika u dobi od 2 do 18 godina.
English: Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
Croatian: Rijetko, ljudski normalni imunoglobulin može izazvati pad krvnog tlaka s anafilaktičkom reakcijom, čak i u bolesnika koji su podnosili prethodno liječenje ljudskim normalnim imunoglobulinom.
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 treba proći interval od 3 mjeseca prije cijepljenja živim atenuiranim virusnim cjepivom.
English: Infusion devices appropriate for subcutaneous administration of immunoglobulins can be used.
Croatian: Odgovarajući uređaj za infuziju može se upotrebljavati za supkutanu primjenu imunoglobulina.
English: Hizentra maintenance therapy in CIDP has not been studied for periods longer than 18 months.
Croatian: Hizentra terapija održavanja u KUDP-u nije proučavana dulje od 18 mjeseci.
English: Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.
Croatian: - Hizentra je indicirana u liječenju bolesnika s kroničnom upalnom demijelinizirajućom polineuropatijom (KUDP) kao terapija održavanja nakon stabilizacije sa i.v.Ig.
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: To se također odnosi na nepoznate viruse ili viruse u nastajanju te na druge vrste infekcija.
English: For spontaneous post-marketing ADRs, the reporting frequency is categorised as unknown.
Croatian: Za spontane prijave nuspojava nakon stavljanja lijeka u promet, učestalost je klasificirana kao nepoznato.
English: The hazard ratios (95 % CI) for the lower dose and higher dose compared to placebo was 0.48 (0.27, 0.85) and 0.25 (0.12, 0.49), respectively.
Croatian: Omjeri hazarda (95% CI) za nižu dozu i višu dozu u usporedbi s placebom bili su 0,48 (0,27; 0,85) odnosno 0,25 (0,12; 0,49).
English: • The other ingredients (excipients) are L-proline, polysorbate 80 and water for injections.
Croatian: • Drugi sastojci (pomoćne tvari) su L-prolin, polisorbat 80 i voda za injekcije.
English: If you have any further questions, ask your doctor or healthcare professional.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili zdravstvenom radniku.
English: The ADRs reported in these clinical studies are summarised and categorised according to the MedDRA System Organ Class (SOC and Preferred Term level) and frequency below.
Croatian: Prijavljene nuspojave u ovim kliničkim ispitivanjima sažete su i kategorizirane prema MedDRA klasifikaciji organskih sustava (i preporučenim pojmovima) i učestalosti navedenoj u nastavku.
English: Grasp the skin between 2 fingers and insert the needle into the subcutaneous tissue.
Croatian: 8 Umetnite iglu Uhvatite kožu između 2 prsta i umetnite iglu u potkožno tkivo.
English: The amount of product infused into a particular site may vary.
Croatian: Količina lijeka koja se infundira na različita mjesta može se razlikovati.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (liver inflammation), and for the non-enveloped hepatitis A virus and parvovirus B19.
Croatian: Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom kao što su virus humane imunodeficijencije (HIV, virus AIDS-a), virus hepatitisa B i hepatitisa C (upala jetre), te za viruse bez ovojnice kao što su virus hepatitisa A i parvovirus B19.
English: In the efficacy scores (INCAT score, mean grip strength, and Medical Research Council sum score), subjects in both Hizentra dose groups remained stable while subjects in the placebo group deteriorated.
Croatian: Medical Research Council sum score) združeni skor), ispitanici u obje Hizentra dozne skupine ostali su stabilni dok su ispitanici u placebo skupini imali pogoršanje.
English: In the clinical studies with CIDP patients, 61 subjects >65 years of age were treated with Hizentra.
Croatian: U kliničkim ispitivanjima sa KUDP ispitanicima, 61 ispitanik sa > 65 godina liječen je s Hizentrom.
English: Adverse Reactions (ARs) have been collected in Hizentra clinical trials from 7 phase III studies in patients with primary immunodeficiency (n = 231), 2 phase IV studies in patients with PID (n=74), 1
Croatian: Nuspojave na liječenje Hizentrom prikupljene su iz 7 kliničkih ispitivanja faze III u bolesnika s primarnom imunodeficijencijom (n = 231), iz 2 klinička ispitivanja faze IV u bolesnika s PID-om
English: Therefore, after receiving this medicine you may have to wait up to 3 months before receiving your live-attenuated vaccine.
Croatian: Stoga će nakon primitka Hizentre možda biti potrebno pričekati do 3 mjeseca prije primitka živog oslabljenog cjepiva.
English: Example a 1g/kg IVIG dose given every 3 weeks would convert into a 0.33g/kg weekly Hizentra dose.
Croatian: Primjer: doza 1 g/kg i.v.Ig koja se daje svakih 3 tjedna pretvorila bi se u tjednu dozu Hizentre od 0,33 g/kg.
English: A phase III, multicentre, 48-week open-label extension study enrolled 82 CIDP patients from the PATH study.
Croatian: U fazi III, multicentričnog, otvorenog nastavka ispitivanja u trajanju od 48 tjedana upisano je 82 bolesnika s KUDP-om iz PATH ispitivanja.
English: (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000),
Croatian: Učestalost po bolesniku ili po infuziji ocijenjena je prema sljedećim kriterijima: 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
English: Data from prospective clinical trials on the use of human normal immunoglobulin in pregnant women is limited.
Croatian: Podaci iz prospektivnih kliničkih ispitivanja o primjeni ljudskog normalnog imunoglobulina u trudnica su ograničeni.
English: • Tiredness (fatigue), including generally feeling unwell (malaise)
Croatian: • Vrućica • Uumor, uključujući opće loše osjećanje (malaksalost)
English: Down-titrating patients in the extension study who completed the PATH study on either dose from 0.4 g/kg to 0.2 g/kg bw dose was possible in 67.9 % of subjects (19/28 patients) without occurrence of relapse; all of the 9 relapsers recovered within 4 weeks after treatment with 0.4 g/kg bw dose.
Croatian: Bolesnici sa sniženim titrom, u nastavku ispitivanja, koji su završili PATH ispitivanje na bilo kojoj dozi od 0,4 g/kg do 0,2 g/kg tt doze kod 67,9% ispitanika (19/28 bolesnika) je bilo bez pojave relapsa; svih 9 relapsera oporavili su se unutar 4 tjedna nakon liječenja dozom od 0,4 g/kg tt.
English: In the European pivotal prospective open label, single arm and multicentre study, a total of 51 subjects with primary immunodeficiency syndromes aged between 3 and 60 years old were treated with Hizentra for up to 41 weeks.
Croatian: U europskom pivotalnom prospektivnom otvorenom, multicentričnom ispitivanju s jednom skupinom, ukupno 51 ispitanik sa sindromom primarne imunodeficijencije u dobi između 3 i 60 godina bio je liječen Hizentrom do 41 tjedna.
English: Therefore, Hizentra should only be given with caution to pregnant women.
Croatian: Stoga se Hizentra treba trudnicama davati s oprezom.
English: No paediatric-specific dose requirements were necessary to achieve the desired serum IgG levels.
Croatian: Nisu bile potrebne specifične pedijatrijske doze za postizanje željenih razina IgG u serumu.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se također odnosi na nepoznate viruse ili viruse u nastajanju te na druge patogene.
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: Kod dobivanja lijekova od ljudske krvi ili plazme, provode se određene mjere predostrožnosti koje sprječavaju prijenos infekcija na bolesnike.
English: The medicinal product should be brought to room or body temperature before use.
Croatian: Prije uporabe lijek treba doseći sobnu ili tjelesnu temperaturu.
English: In the case of measles vaccinations the impairment may persist for up to 1 year.
Croatian: U slučaju ospica, smanjeni učinak može potrajati i do godinu dana.
English: Treatment of low immunoglobulin levels and recurrent bacterial infections in patients with multiple myeloma (MM), another kind of blood cancer.
Croatian: Liječenje niskih razina imunoglobulina i opetovanih bakterijskih infekcija kod bolesnika s multiplim mijelomom (MM), drugom vrstom raka krvi.
English: If you use more Hizentra than you should If you think you have had too much Hizentra, speak to your doctor as soon as possible.
Croatian: Ako primijenite više Hizentre nego što ste trebali Ako mislite da ste primili previše Hizentre, razgovarajte sa svojim liječnikom što je prije moguće.
English: Blood creatinine increased
Croatian: Povišenje vrijednosti kreatinina u krvi
English: Therefore patients receiving measles vaccine should have their antibody status checked.
Croatian: Stoga je u bolesnika koji primaju cjepivo protiv morbila potrebno provjeriti status protutijela.
English: What Hizentra contains
Croatian: Što Hizentra sadrži
English: Nausea, Vomiting
Croatian: Mučnina, povraćanje
English: If well-tolerated (see also section 4.4), the infusion rate can be increased up to 2.0 ml/min/site (120 ml/hour/site).
Croatian: Ukoliko se dobro podnosi (vidjeti također dio 4.4) brzina infuzije se može povećavati do 2.0 ml/min/mjestu (120 ml/sat/mjestu).
English: In the first patient group receiving Hizentra via the manual push technique (n=16), 2 to 7 infusions per week were administered with the flow rates of 30, 60 and 120 ml/hour/site (see section 4.2).
Croatian: U prvoj skupini bolesnika koji su primali lijek Hizentra tehnikom ručnog potiska (n = 16) primjenjivano je 2 do 7 infuzija tjedno s brzinama protoka od 30, 60 i 120 ml/sat/mjestu (vidjeti dio 4.2).
English: The primary endpoint was the percentage of subjects responding to a higher infusion parameter:
Croatian: Primarna mjera ishoda bio je postotak ispitanika s uspjehom pri višem infuzijskom parametaru.
English: • Abnormal result of a blood test that may indicate impaired liver and kidney function
Croatian: • Odstupanja u rezultatima krvnih nalaza mogu ukazivati na oštećenje jetrene i bubrežne funkcije
English: 172 adults with definite or probable CIDP who were previously treated with and responded to IVIg were randomised to weekly 0.2 g/kg bw Hizentra, weekly 0.4 g/kg bw Hizentra or placebo groups, and followed for a subsequent 24 weeks.
Croatian: U ispitivanju su 172 odrasle osobe s definitivnim ili vjerojatnim KUDP-om, koje su prethodno liječene i reagirale na i.v.Ig, randomizirane u skupine liječene Hizentrom od 0,2 g/kg tt tjedno, 0,4 g/kg tt tjedno ili placebo skupinu, te praćene sljedećih 24 tjedna.
English: Side effects observed in post-marketing are of unknown frequency:
Croatian: Nuspojave primijećene nakon stavljanja lijeka u promet su nepoznate učestalosti:
English: Paediatric population The same warnings and precautions apply to the paediatric population.
Croatian: Pedijatrijska populacija Ista se upozorenja i mjere opreza odnose i na pedijatrijsku populaciju.
English: Side effects such as these may occur even when you have previously received human immunoglobulins and tolerated them well.
Croatian: Do nuspojava poput ovih može doći čak i ako ste već primali ljudski imunoglobulin te ga dobro podnosili.
English: After steady state IgG levels have been attained, maintenance doses are administered at repeated intervals to reach a cumulative monthly dose of the order of 0.4 to 0.8 g/kg (2.0 to 4.0 ml/kg) body weight.
Croatian: Nakon što je postignuto stanje dinamičke ravnoteže razina IgG, doze održavanja se daju u ponavljajućim intervalima dok se ne dostigne kumulativna mjesečna doza od 0,4 - 0,8 g/kg (2,0 - 4,0 ml/kg) tjelesne težine.
English: If you need to administer an additional Hizentra syringe, you must use a new sterile injection needle and change the infusion site.
Croatian: Ako trebate primijeniti dodatnu štrcaljku lijeka Hizentra morate upotrijebiti novu sterilnu iglu za injekciju i promijeniti mjesto infuzije.
English: Rarely human normal immunoglobulins 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: U rijetkim slučajevima, normalni ljudski imunoglobulin može uzrokovati nagli pad krvnog tlaka i, u izoliranim slučajevima, anafilaktički šok, čak i kada bolesnik nije pokazao preosjetljivost kod prethodne primjene lijeka.
English: • combination of low level or absence of immunoglobulins and absence or non-functional immune cells (severe combined immunodeficiency)
Croatian: • kombinacija niske razine ili nedostatka imunoglobulina i nedostatka ili nefunkcionalnih stanica imunološkog sustava (teška kombinirana imunodeficijencija)
English: • low immunoglobulin levels (hypogammaglobulinaemia) or absence of immunoglobulins (agammaglobulinaemia) in the blood
Croatian: • niska razina imunoglobulina (hipogamaglobulinemija) ili nedostatak imunoglobulina (agamaglobulinemija) u krvi