FrancophonIA/ELRC3.0 huggingface dataset:
English: Privigen belongs to the class of medicines called human normal immunoglobulins.
Slovenian: Zdravilo Privigen sodi v razred zdravil, imenovanih humani polispecifični imunoglobulini.
English: The two ITP studies were performed with 57 patients each.
Slovenian: Dve študiji z ITP sta bili opravljeni pri 57 bolnikih za vsako študijo.
English: In these circumstances, it has been commonly reported that immunoglobulins increase the risk of breakdown of red blood cells (haemolysis).
Slovenian: V teh okoliščinah so pogosto poročali, da imunoglobulini povečajo tveganje za razkroj eritrocitov (hemoliza).
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Replacement therapy Primary immunodeficiency syndromes (PID)
Slovenian: Nadomestno zdravljenje Sindromi primarne imunske pomanjkljivosti (PID)
English: The information given should be taken into consideration by you and your doctor before you are given Privigen.
Slovenian: Preden boste prejeli zdravilo Privigen, morate vi in vaš zdravnik upoštevati te informacije.
English: In the second ITP study, 57 patients with ITP (baseline platelet counts ≤ 30×109 / l) aged between 18
Slovenian: V drugi študiji ITP je 57 bolnikov z ITP (izhodiščno število trombocitov ≤ 30×109/l), starih od 18 do
English: Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because antibodies against these infections, which are contained in the product, are protective.
Slovenian: Imunoglobulini niso bili povezani z okužbami s hepatitisom A ali parvovirusom B19, verjetno zato, ker so protitelesa proti tem okužbam, ki jih zdravilo vsebuje, zaščitna.
English: The MRC responder rate, an increase of at least 3 points, was 84.8% which was similar in previously treated (81.5% [58.95, 100.00]) and untreated (86.7% [69.46, 100.00]) patients.
Slovenian: Stopnja odzivnosti bolnikov po MRC, zvišana za vsaj 3 točke, je bila 84,8 %, kar je podobno kot pri predhodno zdravljenih (81,5 % [58,95; 100,00]) in nezdravljenih (86,7 % [69,46; 100,00]) bolnikih.
English: Privigen is made from human plasma.
Slovenian: Zdravilo Privigen je proizvedeno iz človeške plazme.
English: Symptoms typically appear within 1 to 6 hours after receiving treatment.
Slovenian: Simptomi se navadno pojavijo v 1 do 6 urah po prejemu zdravljenja.
English: Such side effects may occur even if you have previously received human immunoglobulins and tolerated them well.
Slovenian: Ti neželeni učinki se lahko pojavijo celo, če ste predhodno že prejeli humane imunoglobuline in ste jih dobro prenašali.
English: - If you have any further questions, ask your doctor or healthcare professional.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali zdravstvenim delavcem.
English: At the beginning of the infusion you will receive Privigen at a slow infusion rate.
Slovenian: Na začetku infundiranja boste zdravilo Privigen prejeli z majhno hitrostjo.
English: • temporary non-infectious meningitis (reversible aseptic meningitis), Tell your doctor or healthcare professional immediately if you have a stiff neck together with one or more of the following symptoms: fever, nausea, vomiting, headache, abnormal sensitivity to light, mental disturbances.
Slovenian: • začasnem neinfekcioznem meningitisu (reverzibilni aseptični meningitis), Svojemu zdravniku ali zdravstvenemu delavcu takoj povejte, če imate tog vrat z enim ali več od naslednjih simptomov: zvišana telesna temperatura, slabost, bruhanje, glavobol,
English: Loss of kidney function with fatal outcome has occurred in isolated haemolysisrelated cases.
Slovenian: Odpoved delovanja ledvic s smrtnim izidom se je pojavila v posameznih primerih, povezanih s hemolizo.
English: Once the vial has been broached, its contents should be used promptly.
Slovenian: Ko prebodete zamašek viale, morate njeno vsebino porabiti takoj.
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]).
Slovenian: Rezultat mišične moči, izmerjen po MRC (Medical Research Council), se je pri vseh bolnikih izboljšal za 6,9 točke (95-% interval zaupanja [4,11; 9,75], pri predhodno zdravljenih bolnikih za 6,1 točke (95% interval zaupanja [2,72; 9,44]) in pri nezdravljenih bolnikih za 7,7 točke (95-% interval zaupanja [2,89; 12,44]).
English: Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
Slovenian: Izkušenj z intravensko uporabo imunoglobulinov pri otrocih s CIDP je malo.
English: Marketing Authorisation Holder and Manufacturer CSL Behring GmbH
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec CSL Behring GmbH
English: What Privigen is and what it is used for What Privigen is
Slovenian: Kaj je zdravilo Privigen in za kaj ga uporabljamo Kaj je zdravilo Privigen
English: Three to six months are required after the initiation of therapy for equilibration to occur.
Slovenian: Za pojav ravnovesja po začetku zdravljenja je potrebnih tri do šest mesecev.
English: There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Slovenian: Klinične izkušnje glede odsotnosti prenosa virusa hepatitisa A ali parvovirusa B19 z imunoglobulini so spodbudne, predpostavljajo pa tudi, da vsebnost protiteles pomembno prispeva k varnosti pred virusi.
English: They can occur in patients with anti-IgA antibodies.
Slovenian: Pojavijo se lahko pri bolnikih s protitelesi proti IgA.
English: What you need to know before you are given Privigen
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Privigen
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.
Slovenian: Drugi odmerek pri preiskovancih s številom trombocitov ≥ 50×109/l po prvem odmerku je prinesel ustrezne dodatne koristi v smislu večjega in dolgotrajnejšega povečanja števila trombocitov v primerjavi z enkratnim odmerkom.
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.
Slovenian: Dokazana je bila 10-dnevna stabilnost zdravila Privigen po razredčitvi s 5odstotno raztopino glukoze do končne koncentracije 50 mg/ml (5 %) pri 30 °C; vendar vidika mikrobne kontaminacije niso preučili.
English: • if you have developed antibodies against immunoglobulins of the type IgA in your blood.
Slovenian: • če so se v vaši krvi razvila protitelesa proti imunoglobulinom vrste IgA.
English: The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Slovenian: Mehanizem delovanja pri indikacijah (razen nadomestnega zdravljenja) ni popolnoma raziskan,
English: and 65 years were treated with Privigen at 1 g/kg bw.
Slovenian: 65 let, prejemalo zdravilo Privigen v odmerku 1 g/kg telesne mase.
English: Symptoms typically appear within 1 to 6 hours following treatment.
Slovenian: Simptomi se navadno pojavijo v 1 do 6 urah po zdravljenju.
English: EU/1/08/446/001 5 g/50 ml EU/1/08/446/002 10 g/100 ml EU/1/08/446/003 20 g/200 ml EU/1/08/446/004 2.5 g/25 ml EU/1/08/446/005 10 g/100 ml (3 vial pack size) EU/1/08/446/006 20 g/200 ml (3 vial pack size) EU/1/08/446/007 40 g/400 ml
Slovenian: EU/1/08/446/001 5 g/50 ml EU/1/08/446/002 10 g/100 ml EU/1/08/446/003 20 g/200 ml EU/1/08/446/004 2,5 g/25 ml EU/1/08/446/005 10 g/100 ml (pakiranje s 3 vialami) EU/1/08/446/006 20 g/200 ml (pakiranje s 3 vialami) EU/1/08/446/007 40 g/400 ml
English: Patients with an acquired immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or serum IgG level of <4 g/l.
Slovenian: bolniki s pridobljeno imunsko pomanjkljivostjo (SID - secondary Immunodeficiency), ki imajo hude ali ponavljajoče se okužbe, neučinkovito protimikrobno zdravljenje ter bodisi dokazano okvarjeno nastajanje specifičnih protiteles ali serumske ravni IgG <4 g/l.
English: Patients may experience effects, such as dizziness or nausea, during treatment with Privigen that might affect the ability to drive and use machines.
Slovenian: Bolniki lahko med zdravljenjem z zdravilom Privigen doživijo učinke, kot sta omotica ali slabost, ki lahko vplivajo na sposobnost upravljanja vozil in strojev.
English: The medicine works in exactly the same way as the immunoglobulins naturally present in human blood of healthy people.
Slovenian: Zdravilo deluje na povsem enak način kot imunoglobulini, ki so običajno prisotni v človeški krvi.
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.
Slovenian: V teh okoliščinah lahko imunoglobulini povečajo tveganje za srčno kap (srčni infarkt), možgansko kap, krvne strdke v pljučih (pljučna embolija) ali zaporo žile v nogi, čeprav le zelo redko.
English: Patients with Kawasaki disease.
Slovenian: bolniki s Kawasakijevo boleznijo.
English: After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Slovenian: Po uporabi tega zdravila morajo pred cepljenjem z živimi atenuiranimi virusnimi cepivi preteči vsaj 3 meseci.
English: Aseptic meningitis syndrome (AMS)
Slovenian: Sindrom aseptičnega meningitisa (AMS - Aseptic meningitis syndrome)
English: Very rarely: Transfusion related acute lung injury and thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses.
Slovenian: Zelo redko: s transfuzijo povezana akutna okvara pljuč in trombembolične reakcije, kot so miokardni infarkt, možganska kap, pljučna embolija in globoka venska tromboza.
English: There are no data on pharmacokinetic properties in paediatric patients with CIDP.
Slovenian: Podatkov o farmakokinetičnih lastnostih v pediatrični populaciji s CIDP ni.
English: The overall median time to first MRC sum score response in PRIMA was 6 weeks (6 weeks in the IVIg-untreated and 3 weeks in the IVIg-pretreated) and 9.3 weeks in PATH.
Slovenian: V celoti je bil mediani čas do prvega odziva glede na sumarno oceno MRC v študiji PRIMA 6 tednov (6 tednov pri tistih, ki še niso prejemali IVIg, in 3 tedne pri tistih, ki so že prejemali IVIg) in v študiji PATH 9,3 tedna.
English: Frequency of injections
Slovenian: Pogostnost infundiranja
English: Replacement therapy in primary immunodeficiency (PID) syndromes The dose regimen should achieve a trough IgG level (measured before the next infusion) of at least 5 to 6 g/l.
Slovenian: Nadomestno zdravljenje sindromov primarne imunske pomanjkljivosti (PID) Režim odmerjanja mora doseči najnižjo raven IgG (ki se meri pred naslednjim infundiranjem) vsaj 5
English: Guillain-Barré syndrome
Slovenian: Guillain-Barréjev sindrom
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).
Slovenian: ● Če ste debeli, starejši, imate sladkorno bolezen, ste bili dolgotrajno priklenjeni na posteljo, imate visok krvni tlak, imate premajhen krvni volumen (hipovolemija), imate težave s krvnimi žilami (žilne bolezni), imate povečano nagnjenost k strjevanju krvi (trombofilija ali trombotične epizode) ali imate bolezen ali stanje, ki povzroča zgoščevanje krvi (hiperviskozna kri).
English: In the case of measles vaccinations the impairment may persist for up to 1 year.
Slovenian: Pri ošpicah lahko zmanjšana učinkovitost cepiva traja do 1 leta.
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.
Slovenian: Z razvojem hemolize so bili povezani naslednji dejavniki tveganja: visoki odmerki, dani v enkratnem odmerku ali deljenih odmerkih v več dneh; vse krvne skupine, razen 0; in osnovna vnetna bolezen.
English: This is a chronic disease that is characterised by inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and upper limbs.
Slovenian: To je kronična bolezen, za katero je značilno vnetje perifernih živcev, ki povzroča mišično oslabelost in/ali odrevenelost, povečini v nogah in zgornjih okončinah.
English: Pivotal Study (N= 25) ZLB03_002CR Median (Range)
Slovenian: Osrednja študija (N = 25) ZLB03 002 CR Srednja vrednost (razpon)
English: Extension Study (N=13) ZLB05_006CR Median (Range)
Slovenian: Podaljšana študija (N = 13) ZLB05_006CR Srednja vrednost (razpon)
English: Kawasaki disease
Slovenian: Kawasakijeva bolezen
English: Information on safety with respect to infections Privigen is made from human blood plasma (this is the liquid part of the blood).
Slovenian: Zdravilo Privigen je narejeno iz človeške krvne plazme (tekočega dela krvi).
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 mleko in lahko prispevajo k zaščiti novorojenčka pred povzročitelji bolezni, ki vstopajo skozi sluznico.
English: The dose required to achieve a trough level of 5 to 6 g/l is of the order of 0.2 to 0.8 g/kg bw/month.
Slovenian: Odmerek, potreben za doseganje najnižje ravni 5 do 6 g/l, se doseže z 0,2 do 0,8 g/kg tm/mesec.
English: Cmax, maximum serum concentration; Cmin, trough (minimum level) serum concentration; t½, elimination half-life
Slovenian: t½ (dnevi) Cmax - največja koncentracija v serumu; Cmin - najmanjša koncentracija (najnižja raven) v serumu; t½
English: Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactoid reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
Slovenian: Redko lahko humani polispecifični imunoglobulin inducira padec tlaka z anafilaktoidno reakcijo, tudi pri bolnikih, ki so predhodna zdravljenja s humanim polispecifičnim imunoglobulinom tolerirali.
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.
Slovenian: V redkih primerih lahko humani polispecifični imunoglobulini, vključno z zdravilom Privigen, povzročijo nenadno znižanje krvnega tlaka, v posameznih primerih pa anafilaktični šok, celo kadar bolnik pri predhodni uporabi ni pokazal preobčutljivosti.
English: How to use Privigen
Slovenian: Kako uporabljati zdravilo Privigen
English: 1 vial (2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml or 40 g/400 ml), 3 vials (10 g/100 ml or 20 g/200 ml).
Slovenian: 1 viala (2,5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml ali 40 g/400 ml), 3 viale (10 g/100 ml ali 20 g/200 ml).
English: Patients with Guillain-Barré syndrome.
Slovenian: bolniki z Guillain-Barréjevim sindromom.
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
Slovenian: Vsaka viala s 25 ml raztopine vsebuje: 2,5 g humanega polispecifičnega imunoglobulina Vsaka viala s 50 ml raztopine vsebuje: 5 g humanega polispecifičnega imunoglobulina Vsaka viala s 100 ml raztopine vsebuje: 10 g humanega polispecifičnega imunoglobulina Vsaka viala z 200 ml raztopine vsebuje: 20 g humanega polispecifičnega imunoglobulina Vsaka viala z 400 ml raztopine vsebuje: 40 g humanega polispecifičnega imunoglobulina
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.
Slovenian: Sumarna ocena MRC se je v študiji PRIMA izboljšala za 6,9 točke (7,7 točke pri tistih, ki še niso prejemali IVIg, in 6,1 točke pri tistih, ki so že prejemali IVIg) in v študiji PATH za 3,6 točke.
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Slovenian: O primerih akutne ledvične odpovedi so poročali pri bolnikih, ki so prejemali zdravljenje z i.v.
English: This is an acute disease that is characterised by inflammation of the peripheral nerves that causes severe muscle weakness mainly in the legs and upper limbs.
Slovenian: To je akutna bolezen, za katero je značilno vnetje perifernega živčevja, ki povzroča hudo mišično šibkost, večinoma v nogah in zgornjih udih;
English: This is a slowly progressive disease of the motor nerves with weakness of arms and legs.
Slovenian: To je počasi napredujoča bolezen motoričnih živcev, ki se kaže s šibkostjo rok in nog.
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.
Slovenian: Ig pri otrocih, zlasti s Kawasakijevo boleznijo, povezani z višjo stopnjo poročil o hemolitičnih reakcijah v primerjavi z drugimi i.v.
English: Reversible haemolytic reactions have been observed in patients, especially those with non-O blood groups in immunomodulatory treatment.
Slovenian: Pri bolnikih, zlasti s krvnimi skupinami, ki niso 0, so pri imunomodulacijskem zdravljenju opazili reverzibilne hemolitične reakcije.
English: Human normal immunoglobulin should be infused intravenously at an initial infusion rate of 0.3 ml/kg bw/hr for approximately 30 min.
Slovenian: Humani polispecifični imunoglobulin je treba infundirati intravensko z začetno hitrostjo infundiranja 0,3 ml/kg tm/uro približno 30 minut.
English: Pack sizes
Slovenian: Velikosti pakiranja
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.
Slovenian: Moč stiska dominantne roke se je v študiji PRIMA izboljšala za 14,1 kPa (17,0 kPa pri tistih, ki še niso prejemali IVIg, in 10,8 kPa pri tistih, ki so že prejemali IVIg) in v študiji PATH za 12,2 kPa.
English: Routine laboratory tests may commonly reveal changes to liver functions (hyperbilirubinaemia) as well as changes in blood count (e.g. Coombs' (direct) test positive), increased alanine aminotransferase, increased aspartate aminotransferase, increased blood lactate dehydrogenase).
Slovenian: Rutinski laboratorijski testi lahko pogosto odkrijejo spremembe delovanja jeter (hiperbilirubinemija) kot tudi spremembe v krvni sliki (npr. pozitiven (neposreden) Coombsov test, zvišanje ravni alaninaminotransferaze, zvišanje aspartatne aminotransferaze, zvišanje ravni laktatne dehidrogenaze v krvi).
English: He or she will decide whether to decrease the infusion rate or to stop the infusion completely.
Slovenian: Odločil se bo za zmanjšanje hitrosti ali popolno ustavitev infundiranja.
English: In the pivotal PID study, 80 patients were enrolled and treated with Privigen.
Slovenian: V osrednji študiji PID je bilo vključenih 80 bolnikov, ki so se zdravili z zdravilom Privigen.
English: • transient decrease in red blood cells (reversible haemolytic anaemia/haemolysis), anaemia, leukopenia, anisocytosis (including microcytosis).
Slovenian: ● prehodnem zmanjšanju števila eritrocitov (reverzibilna hemolitična anemija/hemoliza), anemiji, levkopeniji, anizocitozi (vključno z mikrocitozo).
English: In PID patients who have tolerated the infusion rate of 4.8 ml/kg bw/hr well, the rate may be further increased gradually to a maximum of 7.2 ml/kg bw/hr.
Slovenian: Pri bolnikih s PID, ki dobro prenašajo hitrost infundiranja 4,8 ml/kg tm/uro, se lahko hitrost dajanja postopoma še poveča na največ 7,2 ml/kg tm/uro.
English: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps, and varicella.
Slovenian: Živa atenuirana virusna cepiva Uporaba imunoglobulina lahko za vsaj 6 tednov do 3 mesecev poslabša učinkovitost živih atenuiranih virusnih cepiv, kot so ošpice, rdečke, mumps in norice.
English: In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
Slovenian: V primeru neželenih učinkov je treba hitrost dajanja zmanjšati ali infundiranje ustaviti.
English: Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Slovenian: Humani polispecifični imunoglobulin je v bolnikovem obtoku popolnoma biološko uporaben takoj po intravenski uporabi.
English: What Privigen looks like and contents of the pack
Slovenian: Izgled zdravila Privigen in vsebina pakiranja
English: • In very rare cases transfusion-related acute lung injury (TRALI) can occur after receiving immunoglobulins including Privigen.
Slovenian: • V zelo redkih primerih se lahko po prejemu imunoglobulinov, vključno z zdravilom Privigen,
English: IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells (RBC) with immunoglobulin, causing a positive direct antiglobulin reaction (Coombs' test) and, rarely, haemolysis.
Slovenian: imunoglobulini lahko vsebujejo protitelesa proti krvnim skupinam, ki lahko delujejo kot hemolizin in sprožijo in vivo pritrjevanje imunoglobulinov na eritrocite, kar povzroči pozitivno direktno antiglobulinsko reakcijo (Coombov test) in v redkih primerih hemolizo.
English: Excipients: L-proline, water for injections.
Slovenian: Pomožne snovi: L-prolin, voda za injekcije.
English: Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolaemic patients, patients with diseases which increase blood viscosity).
Slovenian: Ig pri debelih bolnikih in bolnikih s predhodnimi dejavniki tveganja za trombotične dogodke (kot so starost, hipertenzija, sladkorna bolezen in anamneza bolezni ožilja ali trombotičnih epizod, bolniki s pridobljenimi ali prirojenimi trombofiličnimi motnjami, bolniki s podaljšanimi obdobji imobilizacije, hudo hipovolemični bolniki, bolniki z boleznimi, ki povečajo viskoznost krvi).
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.
Slovenian: V študiji PRIMA se je glede na sumarno oceno MRC (Medical Research Council) odzvalo (odziv je bil opredeljen kot povečanje za ≥ 3 točke) 85 % bolnikov (87 % tistih, ki še niso prejemali IVIg, in 82
English: Vaccinations Tell your vaccinating doctor prior to a vaccination about your treatment with Privigen.
Slovenian: Cepljenje Pred cepljenjem zdravnika, ki vas bo cepil, obvestite, da se zdravite z zdravilom Privigen.
English: Cmax (peak, g/l) Cmin (trough, g/l)
Slovenian: Cmax (največja, g/l)