FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Za doseganje optimalne zaščite pred okužbami je treba odmerek prilagoditi, kot je potrebno, in sicer ga je treba pri bolnikih s trdovratnimi okužbami povečati, če pa se pri bolniku okužba ne pojavi, pride v poštev zmanjšanje odmerka.
English: Information on the source material of KIOVIG
Slovenian: Podatki o izvoru zdravila KIOVIG
English: To reduce the rate of bacterial infection, it may be necessary to increase the dose and aim for higher trough levels.
Slovenian: Za zmanjšanje pojavnosti bakterijskih okužb bo morda potreben večji odmerek, da se dosežejo višje vrednosti najnižje koncentracije.
English: There are two groups:
Slovenian: Obstajajo dve skupini teh bolnikov:
English: Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
Slovenian: Imunoglobulini se izločajo v materino mleko in lahko prispevajo k zaščiti novorojenčka pred bolezenskimi povzročitelji, ki vstopajo preko sluznic.
English: Kawasaki Disease
Slovenian: Kawasakijev sindrom
English: Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thromboses.
Slovenian: Zelo redko: tromboembolične reakcije, kot so miokardni infarkt, možganska kap, pljučna embolija in globoka venska tromboza.
English: How to use KIOVIG
Slovenian: Kako uporabljati zdravilo KIOVIG
English: For further precautions for use see section 4.4.
Slovenian: Za dodatne previdnostne ukrepe glejte poglavje 4.4.
English: The dose required to achieve a trough level of 5-6 g/L is of the order of 0.2-0.8 g/kg/month.
Slovenian: Odmerek, s katerim dosežete najnižjo koncentracijo 5-6 g/l, je reda velikosti 0,2-0,8 g/kg/mesec.
English: Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Slovenian: Bolnike morate natančno spremljati in jih ves čas infundiranja skrbno opazovati, da bi ugotovili morebitne simptome.
English: Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and AB.
Slovenian: Pri bolnikih, zlasti tistih s krvnimi skupinami A, B in AB, so opažali reverzibilne hemolitične reakcije.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Slovenian: Odmerek na podlagi telesne mase bo pri bolnikih s premajhno ali preveliko telesno maso morda treba prilagoditi.
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.
Slovenian: V redkih primerih lahko humani polispecifični imunoglobulini povzročijo nenadno zmanjšanje krvnega tlaka in (v posameznih primerih) anafilaktični šok, celo pri bolnikih, ki pri predhodnem zdravljenju niso pokazali znakov preobčutljivosti.
English: Replacement therapy in secondary immunodeficiency
Slovenian: Nadomestno zdravljenje pri sekundarni imunski pomanjkljivosti
English: However, medicines that contain antibodies have been used in pregnant or breast-feeding women, and it has been shown that there are no harmful effects on the course of pregnancy or the baby to be expected.
Slovenian: Zdravila, ki vsebujejo protitelesa, uporabljajo pri nosečnicah in doječih materah in ugotovili so, da ni pričakovati nobenih škodljivih učinkov na potek nosečnosti ali na dojenčka.
English: 0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse).
Slovenian: 0,4 g/kg dnevno skupaj 5 dni (odmerjanje se v primeru relapsa lahko ponovi).
English: KIOVIG is intended for intravenous administration (infusion into a vein).
Slovenian: Zdravilo KIOVIG je namenjeno za intravensko uporabo (infuzijo v veno).
English: Dilution of KIOVIG with a 5% glucose solution may result in increased blood glucose levels.
Slovenian: Redčenje zdravila KIOVIG s 5 % raztopino glukoze lahko povzroči višje koncentracije glukoze v krvi.
English: Human protein, 100 mg/ml, at least 98% is IgG.
Slovenian: humane beljakovine 100 mg/ml, od tega najmanj 98 % IgG
English: • avoidance of concomitant use of loop diuretics (see 4.5).
Slovenian: • izogibanje sočasni uporabi diuretikov Henlejeve zanke (glejte 4.5)
English: Non-clinical data reveal no special risk for humans based on conventional studies of safety pharmacology and toxicity.
Slovenian: Neklinični podatki iz običajnih študij farmakološke varnosti in toksičnosti ne kažejo posebnega tveganja za človeka.
English: Smaller children below the age of 5 years may be particularly susceptible to volume overload.
Slovenian: Majhni otroci, mlajši od petih let, so lahko še posebej dovzetni za volumsko preobremenitev, zato je treba pri tej populaciji odmerek natančno izračunati.
English: • Primary immunodeficiency syndromes (PID) with impaired antibody production (see section 4.4).
Slovenian: • Sindromi primarne imunske pomanjkljivosti (Primary immunodeficiency - PID) z okvarjenim nastajanjem protiteles (glejte poglavje 4.4).
English: Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA containing product can result in anaphylaxis.
Slovenian: Bolniki s selektivno pomanjkljivostjo IgA, pri katerih se pojavijo protitelesa proti IgA, saj dajanje zdravila, ki vsebuje IgG, lahko povzroči anafilakso.
English: VIAL LABEL (5G, 10G, 20G AND 30G)
Slovenian: NALEPKA NA VIALI (5 G, 10 G, 20 G, 30 G)
English: Infusion reaction
Slovenian: Reakcija na infundiranje
English: Tell your doctor if you are diabetic.
Slovenian: Svojemu zdravniku tudi povejte, če imate sladkorno bolezen.
English: Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Slovenian: Humani polispecifični imunoglobulin je pri intravenski uporabi takoj in popolnoma biološko uporaben v krvnem obtoku prejemnika.
English: IVIg products can contain blood group antibodies that may act as haemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction (Coombs' test) and, rarely, haemolysis.
Slovenian: imunoglobulinov lahko vsebujejo protitelesa proti krvnim skupinam, ki lahko delujejo kot hemolizini in sprožijo in vivo pritrjevanje imunoglobulinov na eritrocite, kar povzroči pozitivno direktno antiglobulinsko reakcijo (Coombsov test) in v redkih primerih hemolizo.
English: Incremental recovery (mg/dl)/(mg/kg)
Slovenian: Prirastek uporabnosti (mg/dl)/(mg/kg)
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).
Slovenian: A, B, D) lahko ovira nekatere serološke preiskave za protitelesa proti eritrocitom, na primer direktni antiglobulinski test (DAT, direktni Coombsov test).
English: 5 g / 50 ml 10 g / 100 ml 20 g / 200 ml 30 g / 300 ml
Slovenian: 5 g v 50 ml 10 g v 100 ml 20 g v 200 ml 30 g v 300 ml
English: 4.44 3.30 to 4.90 4.43 3.78 to 5.16 4.50 3.99 to 4.78
Slovenian: 4,44 3,30 do 4,90 4,43 3,78 to 5,16 4,50 3,99 do 4,78
English: • in case of high rate of infusion
Slovenian: • pri veliki hitrosti infundiranja
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: • Če imate kakršnakoli dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; congenital AIDS and recurrent bacterial infections
Slovenian: Hipogamaglobulinemija in ponavljajoče se bakterijske okužbe pri bolnikih s kronično limfocitno levkemijo, ki jih ne preprečijo profilaktični antibiotiki; hipogamaglobulinemija in ponavljajoče se bakterijske okužbe pri bolnikih z multiplim mielomom v fazi platoja, ki jih ne prepreči cepljenje proti pnevmokoku; kongenitalni AIDS in ponavljajoče se bakterijske okužbe.
English: From post-marketing data with KIOVIG no clear correlation of AMS to higher doses was observed.
Slovenian: Podatki iz obdobja trženja zdravila KIOVIG ne kažejo jasne povezave AMS z velikimi odmerki.
English: Marketing Authorisation Holder Takeda Manufacturing Austria AG Industriestrasse 67
Slovenian: Imetnik dovoljenja za promet z zdravilom Takeda Manufacturing Austria AG Industriestrasse 67
English: Clinical data obtained from a limited number of patients also indicate that adult PID patients may tolerate an infusion rate of up to 8 ml/kg BW/hr.
Slovenian: Klinični podatki, pridobljeni pri omejenem številu bolnikov, kažejo tudi, da lahko odrasli bolniki s primarno imunsko pomanjkljivostjo prenašajo hitrost infundiranja do 8 ml/kg TM na uro.
English: When medicines are made from human blood or plasma, a number of measures are put in place to prevent infections being passed on to patients.
Slovenian: Kadar se zdravila pripravljajo iz človeške krvi ali plazme, z več postopki preprečimo prenos okužb na bolnike.
English: • Multifocal Motor Neuropathy (MMN).
Slovenian: • Multifokalna motorična nevropatija (MMN).
English: For obtaining an immunoglobulin solution of 50 mg/ml (5%), KIOVIG 100 mg/ml (10%) should be diluted with an equal volume of the glucose solution.
Slovenian: Za pripravo 50 mg/ml raztopine imunoglobulinov (5 %) je treba zdravilo KIOVIG 100 mg/ml (10 %) razredčiti z enako prostornino raztopine glukoze.
English: Patients with inborn lack of antibody production (primary immunodeficiency syndromes).
Slovenian: Bolniki s prirojenim pomanjkanjem nastajanja protiteles (sindromi primarne imunske pomanjkljivosti).
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Slovenian: Navedeni postopki so učinkoviti proti virusom z ovojnico, kot so HIV, HBV in HCV, ter proti virusoma brez ovojnice HAV in parvovirus B19.
English: What KIOVIG looks like and contents of the pack
Slovenian: Izgled zdravila KIOVIG in vsebina pakiranja
English: OUTER CARTON (1G, 2.5G, 5G, 10G, 20G AND 30G)
Slovenian: ZUNANJA OVOJNINA (1 G, 2,5 G, 5 G, 10 G, 20 G, 30 G)
English: Patients with a disease which results in multiple inflammations of several organs of the body (Kawasaki disease).
Slovenian: Bolniki z boleznijo, ki povzroči vnetje v številnih telesnih organih (Kawasakijev sindrom).
English: TRALI is characterised by severe hypoxia, dyspnoea, tachypnoea, cyanosis, fever and hypotension.
Slovenian: Za TRALI so značilni huda hipoksija, dispneja, tahipneja, cianoza, povišana telesna temperatura in hipotenzija.
English: Below is a list of side effects reported with KIOVIG:
Slovenian: Sledi seznam neželenih učinkov, ki so jih opazili pri zdravilu KIOVIG:
English: • 0.8-1g/kg given on day one; this dose may be repeated once within 3 days
Slovenian: • 0,8-1 g/kg, ki se uporabi 1. dan; ta odmerek lahko ponovite enkrat v naslednjih 3 dneh
English: 0.4 g/kg/d for 5 days
Slovenian: 0,4 g/kg/d za 5 dni
English: • Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
Slovenian: • Primarna imunska trombocitopenija (ITP) pri bolnikih z velikim tveganjem za krvavitve ali pred kirurškim posegom za korekcijo števila trombocitov.
English: For safety with respect to transmissible agents, see section 4.4.
Slovenian: Glede zaščite pred prenosljivimi povzročitelji bolezni glejte poglavje 4.4.
English: It is strongly recommended that every time that KIOVIG is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Slovenian: Vsakič, ko bolniku date zdravilo KIOVIG, morate zapisati ime bolnika in serijo zdravila, s čimer boste zagotovili povezavo med bolnikom in serijo zdravila.
English: VIAL LABEL (2.5G)
Slovenian: OVOJNINAH NALEPKA NA VIALI (2,5 G)
English: If dilution of KIOVIG to lower concentrations is required for patients suffering from diabetes mellitus, the use of 5% glucose solution for dilution may have to be reconsidered.
Slovenian: Če je potrebno redčenje zdravila KIOVIG na manjše koncentracije pri bolnikih s sladkorno boleznijo, boste morda morali ponovno pretehtati uporabo 5 % raztopine glukoze za redčenje zdravila.
English: • Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.
Slovenian: • Sekundarne imunske pomanjkljivosti (Secondary immunodeficiency - SID) pri bolnikih s hudimi ali ponavljajočimi se okužbami, neučinkovitim protimikrobnim zdravljenjem in bodisi dokazano neuspešno tvorbo specifičnih protiteles (proven specific antibody failure - PSAF)* ali ravnjo IgG v serumu < 4 g/l.
English: • The product must be brought to room or body temperature before use.
Slovenian: • Pred uporabo morate zdravilo segreti na sobno ali telesno temperaturo.
English: If dilution to lower concentrations is required, immediate use after dilution is recommended.
Slovenian: Če je potrebno redčenje zdravila na manjše koncentracije, priporočamo, da ga uporabite takoj po redčenju.
English: Transfusion Related Acute Lung Injury (TRALI)
Slovenian: S transfuzijo povezana akutna poškodba pljuč (TRALI)
English: The trough levels should be maintained above 5g/l.
Slovenian: Najnižja koncentracija mora biti najmanj 5 g/l.
English: These include acute renal failure, acute tubular necrosis, proximal tubular nephropathy and osmotic nephrosis.
Slovenian: To vključuje akutno ledvično odpoved, akutno tubularno nekrozo, nefropatijo proksimalnih tubulov in osmotsko nefrozo.
English: The product should be brought to room or body temperature before use.
Slovenian: Pred uporabo morate zdravilo segreti na sobno ali telesno temperaturo.
English: VIAL LABEL (1G)
Slovenian: OVOJNINAH NALEPKA NA VIALI (1 G)
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.
Slovenian: Klinične izkušnje z uporabo imunoglobulinov pa kažejo, da ni pričakovati škodljivih učinkov na potek nosečnosti ali na plod ter novorojenčka.
English: Depending on your doctor's decision the rate of infusion can be slowed or the infusion can be stopped altogether.
Slovenian: Vaš zdravnik se lahko odloči, da bo zmanjšal hitrost infundiranja ali popolnoma ustavil infuzijo zdravila.
English: Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation
Slovenian: Hipogamaglobulinemija pri bolnikih po alogenski presaditvi krvotvornih matičnih celic
English: Replacement therapy in primary immunodeficiency syndromes
Slovenian: Nadomestno zdravljenje pri sindromih primarne imunske pomanjkljivosti
English: Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.
Slovenian: Sekundarne imunske pomanjkljivosti (Secondary immunodeficiency - SID) pri bolnikih s hudimi ali ponavljajočimi se okužbami, neučinkovitim protimikrobnim zdravljenjem in bodisi dokazano neuspešno tvorbo specifičnih protiteles (proven specific antibody failure - PSAF)* ali ravnjo IgG v serumu < 4 g/l.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Slovenian: Kljub tem postopkom pri uporabi zdravil pripravljenih iz človeške krvi ali plazme ni mogoče popolnoma izključiti možnosti za prenos okužbe.
English: • Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: • Morebitno neuporabljeno zdravilo ali odpadke zavrzite v skladu z lokalnimi predpisi.
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Slovenian: Porazdelitev podrazredov IgG je zelo podobna porazdelitvi teh podskupin v nativni človeški plazmi.
English: KIOVIG 100 mg/ml solution for infusion
Slovenian: KIOVIG 100 mg/ml raztopina za infundiranje
English: The dose interval when steady state has been reached varies from 3-4 weeks.
Slovenian: Časovni presledek med odmerki v stanju dinamičnega ravnovesja je od 3 do 4 tedne.
English: After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Slovenian: Po uporabi tega zdravila morajo preteči 3 meseci, preden lahko bolnika cepite z živim oslabljenim virusnim cepivom.
English: • KIOVIG must only be administered intravenously.
Slovenian: • Zdravilo KIOVIG je namenjeno le za intravensko uporabo.
English: The measures taken for the manufacture of KIOVIG are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus and parvovirus B19.
Slovenian: Uporabljeni postopki pri izdelavi zdravila KIOVIG so učinkoviti proti virusom z ovojnico, kot so človeški virus imunske pomanjkljivosti (HIV) in virusa hepatitisa B in C, ter proti virusu hepatitisa A in parvovirusu B19, ki nimata ovojnice.
English: Immunomodulation in adults, and children and adolescents (0-18 years) in:
Slovenian: Imunomodulacija pri odraslih ter otrocih in mladostnikih (starih od 0 do 18 let) pri naslednjih boleznih in motnjah:
English: Avoidance of concomitant use of loop diuretics.
Slovenian: Izogibajte se sočasni uporabi diuretikov Henlejeve zanke.
English: • Do not use this medicine after the expiry date which is printed on the label and carton after
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatlici poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: • The active substance of KIOVIG is human normal immunoglobulin.
Slovenian: • Zdravilna učinkovina v zdravilu KIOVIG je humani polispecifični imunoglobulin.
English: Cmax (mg/dl)/(mg/kg) (peak level)
Slovenian: Cmax (mg/dl)/(mg/dl) (največja vrednost)
English: Replacement therapy in primary immunodeficiency starting dose: 0.4-0.8 g/kg maintenance dose: 0.2-0.8 g/kg every 3-4 weeks to obtain IgG trough level of at least 5-6 g/l
Slovenian: Nadomestno zdravljenje pri primarni imunski pomanjkljivosti začetni odmerek: 0,4-0,8 g/kg vzdrževalni odmerek: 0,2-0,8 g/kg vsake 3 do 4 tedne, da dosežete najnižjo koncentracijo IgG vsaj 5-6 g/l
English: Be sure that you take adequate fluids so you are not dehydrated and notify your physician if you are known to have medical problems.
Slovenian: Pazite, da boste uživali dovolj tekočin, da ne bi postali dehidrirani.
English: 0.2-0.4 g/kg every 3-4 weeks
Slovenian: 0,2-0,4 g/kg vsake 3-4 tedne
English: • It is recommended that every time KIOVIG is administered, the name and batch number of the product is recorded.
Slovenian: • Vsakič, ko bolniku date zdravilo KIOVIG, zapišite ime in številko serije zdravila.
English: Table 1 shows the adverse reactions from clinical trials and Table 2 shows the post-marketing ARs.
Slovenian: V preglednici 1 so neželeni učinki, ugotovljeni v kliničnih preskušanjih, v preglednici 2 pa so neželeni učinki, ugotovljeni po pridobitvi dovoljenja za promet z zdravilom.
English: Nervous system disorders Transient ischemic attack, cerebral vascular accident
Slovenian: Bolezni živčevja prehodna ishemična ataka, cerebrovaskularni insult neznani
English: • 1 ml of KIOVIG contains 100 mg of human protein of which at least 98% is immunoglobulin G (IgG).
Slovenian: • 1 ml zdravila KIOVIG vsebuje 100 mg humanih beljakovin, od tega je najmanj 98 %
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.
Slovenian: imunoglobulinskih pripravkov, ki vsebujejo pomožne snovi, kot so saharoza, glukoza in maltoza, so poročila v zvezi s pripravki, ki vsebujejo saharozo kot stabilizator, predstavljala nesorazmerno velik delež celotnega števila vseh poročil.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded.
Slovenian: Kljub temu pa pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni mogoče popolnoma izključiti možnosti za prenos povzročiteljev nalezljivih bolezni.
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored at the hospital during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Slovenian: imunoglobulinskega pripravka na zdravilo KIOVIG, ali tiste, pri katerih je od zadnje infuzije minilo več časa, v bolnišnici pozorno spremljati med prvo infuzijo in v prvi uri po prvi infuziji, da bi ugotovili znake morebitnih neželenih učinkov.
English: Caution should be exercised in prescribing and infusion of IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypertension, use of estrogens, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, hypercoagulable disorders, patients with prolonged periods of immobilisation, severely hypovolaemic patients, patients with diseases which increase blood viscosity, patients with indwelling vascular catheters and patients with high dose and rapid infusion).
Slovenian: Intravenske imunoglobulinske pripravke morate predpisovati in infundirati previdno pri bolnikih s čezmerno telesno maso, bolnikih s prisotnimi dejavniki tveganja za trombotične dogodke (kot so ateroskleroza v anamnezi, več kardiovaskularnih dejavnikov tveganja, višja starost, slabši minutni volumen srca, hipertenzija, uporaba estrogenov, sladkorna bolezen in bolezni ožilja ali trombotične epizode v anamnezi, bolnikih s pridobljenimi ali dednimi trombofilnimi boleznimi, boleznimi hiperkoagulacije, dolgotrajno imobiliziranih bolnikih, močno hipovolemičnih bolnikih, bolnikih z boleznimi, ki povečajo viskoznost krvi, bolnikih s stalnim vaskularnim katetrom ter bolnikih z visokimi odmerki in hitrim infundiranjem).
English: 0.4 g/kg/d on day 1, possibly repeated once within 3 days for 2-5 days
Slovenian: 0,4 g/kg/d prvi dan, možna ponovitev enkrat v treh dneh za 2-5 dni
English: • in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.
Slovenian: • pri bolnikih, ki prvič prejemajo humani polispecifični imunoglobulin, v redkih primerih, ko bolnik preide z drugega zdravila s humanim polispecifičnim imunoglobulinom na zdravilo
English: • 0.4 g/kg given daily for two to five days.
Slovenian: • 0,4 g/kg na dan skupaj 2 do 5 dni.
English: If well tolerated (see section 4.4), the rate of administration may gradually be increased to a maximum of 6 ml/kg BW/hr.
Slovenian: Če ga bolnik dobro prenaša (glejte poglavje 4.4), lahko hitrost infuzije postopoma povečate na največ 6 ml/kg TM na uro.