natgillin/translations-raw huggingface dataset:
Possible side effects may be reduced or even avoided by infusing Privigen at a slow infusion rate.
Možni neželeni učinki se lahko zmanjšajo ali se jim lahko celo izognete s počasnim infundiranjem zdravila Privigen.
Privigen is intended solely for the infusion into a vein (intravenous infusion).
Zdravilo Privigen je namenjeno samo infundiranju v veno (intravenska infuzija).
It may happen particularly if you have developed antibodies against immunoglobulins of the type IgA.
To se lahko še zlasti zgodi, če so se pri vas razvila protitelesa proti imunoglobulinom vrste IgA.
The recommended infusion rate given under section 4.2 must be closely followed.
Natančno je treba upoštevati priporočeno hitrost infundiranja v poglavju 4.2.
Although limited data is available, it is expected that the same interactions may occur in the paediatric population.
Pediatrična populacija Čeprav je podatkov malo, je pričakovati, da se lahko pri pediatrični populaciji pojavijo enake interakcije.
Privigen is isotonic, with an approximate osmolality of 320 mOsmol/kg.
Zdravilo Privigen je izotonično, s približno osmolalnostjo 320 mOsmol/kg.
Medicines containing antibodies have been used in pregnant and breast-feeding women.
Kljub temu pa so se zdravila, ki vsebujejo protitelesa, uporabljala pri nosečnicah in doječih materah.
Additional measures of CIDP improvement were an increase in R-ODS (Rasch-built Overall Disability Scale) score of ≥ 4 points, a mean grip strength increase of ≥ 8 kPa, or an MRC sum score increase of ≥ 3 points.
Dodatne mere izboljšanja CIDP so bile: povečanje ocene R-ODS (Rasch-built Overall Disability Scale) za ≥ 4 točke, povečanje povprečne moči stiska za ≥ 8 kPa ali povečanje sumarne ocene MRC za ≥ 3 točke.
• 0.8 to 1g/kg bw given on day 1; this dose may be repeated once within 3 days
• 0,8 do 1g/kg tm 1. dan; ta odmerek se lahko ponovi enkrat v 3 dneh
In most cases risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
V večini primerov so ugotovili dejavnike tveganja, kot so obstoječa ledvična insuficienca, sladkorna bolezen, hipovolemija, debelost, sočasno jemanje nefrotoksičnih zdravil ali starost nad 65 let.
Hypersensitivity True hypersensitivity reactions are rare.
Preobčutljivost Prave preobčutljivostne reakcije so redke.
IVIg recipients should be monitored for clinical signs and symptoms of haemolysis.
Ig je treba spremljati glede kliničnih znakov in simptomov hemolize.
Special precautions
Posebni previdnostni ukrepi
It is usually administered by your doctor or healthcare professional.
Navadno ga infundira zdravnik ali zdravstveni delavec.
19 children (3 to 11 years), 12 adolescents (12 to 16 years) and 49 adults were treated with Privigen over 12 months.
19 otrok (3 do 11 let), 12 mladostnikov (12 do 16 let) in 49 odraslih so 12 mesecev zdravili z zdravilom Privigen.
* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
* PSAF = nezmožnost doseči najmanj 2-kratno povečanje v titru protiteles IgG proti pnevmokoknemu cepivu, ki vsebuje polisaharidne in polipeptidne antigene
Guillain-Barré syndrome 0.4 g/kg bw/day over 5 days.
Guillain-Barréjev sindrom 0,4 g/kg tm/dan 5 dni.
Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.
Farmakoterapevtska skupina: imunski serumi in imunoglobulini: imunoglobulini, normalni humani, za intravaskularno uporabo, oznaka ATC: J06BA02.
CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 Switzerland or
CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 Švica ali
The product should be brought to room temperature (25°C) before use.
Zdravilo je treba pred uporabo segreti na sobno temperaturo (25 °C).
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment.
Preveliko odmerjanje lahko povzroči čezmerno nabiranje tekočine in hiperviskoznost, predvsem pri bolnikih s tveganjem, vključno s starejšimi osebami ali bolniki s srčno ali ledvično okvaro.
Immunoglobulins are a normal constituent of the human body.
Imunoglobulin je normalen sestavni del človeškega telesa.
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).
Pasivni prenos protiteles na eritrocitne antigene, na primer A, B, D, lahko vpliva na nekatere serološke preiskave za eritrocitna protitelesa, na primer neposredni antiglobulinski test (DAT, neposredni Coombsov test).
The syndrome usually begins within several hours to 2 days following IVIg treatment.
Sindrom se običajno začne nekaj ur do 2 dni po zdravljenju z i.v.
In these circumstances, immunoglobulins may increase the risk of serious rapid loss of kidney function (acute renal failure) although only very rarely.
V teh okoliščinah lahko imunoglobulini povečajo tveganje za resno hitro odpoved delovanja ledvic (akutna ledvična odpoved), čeprav le zelo redko.
IgG trough levels should be measured and assessed in conjunction with the incidence of infection.
Najnižje ravni IgG je treba meriti in ocenjevati v povezavi s pogostnostjo okužb.
This will lead to non-heart related accumulation of fluid in the air spaces of the lungs (non-cardiogenic pulmonary oedema).
To vodi v nabiranje tekočine v zračnih prostorih pljuč, ki ni povezano s srcem (nekardiogeni pljučni edem).
Privigen contains immunoglobulins that have been prepared from the blood of healthy people.
Zdravilo Privigen vsebuje imunoglobuline, pripravljene iz krvi zdravih oseb.
Replacement therapy should be commenced and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Nadomestno zdravljenje mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju imunskih pomanjkljivosti.
• You have or had previously problems with your kidneys or take medicinal products that may harm your kidneys (nephrotoxic medicinal products).
● Imate ali ste imeli težave z ledvicami ali jemljete zdravila, ki lahko škodujejo vašim ledvicam
Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Klinične izkušnje z imunoglobulini nakazujejo, da škodljivih učinkov na plodnost ni pričakovati.
Somnolence, tremor
pogosti somnolenca, tremor občasni
The maximum IgA content is 25 micrograms/ml.
Največja vsebnost IgA je 25 mikrogramov/ml.
• acute renal failure,
• akutni ledvični odpovedi,
Please refer to section 4.4 for details on risk factors and monitoring recommendations.
Za podrobnosti o dejavnikih tveganja in priporočilih za spremljanje glejte poglavje 4.4.
771 infusions were administered and the median dose administered was 492.3 mg IgG/kg bw.
Dali so 771 infuzij, pri čemer je bil mediani uporabljeni odmerek 492,3 mg IgG/kg telesne mase.
Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA.
Preobčutljivost na humane imunoglobuline, zlasti pri bolnikih s protitelesi proti IgA.
Certain severe adverse reactions may be related to the rate of infusion.
Nekateri resni neželeni učinki so lahko povezani s hitrostjo infundiranja.
The dosage interval when steady state has been reached varies from 3 to 4 weeks.
Presledek med odmerjanji, ko se doseže dinamično ravnovesje, je od 3 do 4 tedne.
The product should be brought to room or body temperature before use.
Zdravilo je treba pred uporabo segreti na sobno ali telesno temperaturo.
The mean improvement at the end of the treatment period compared to reference visit was 1.4 points in the PRIMA (1.8 points in IVIg pretreated subjects) and 1.2 points in PATH study.
Povprečno izboljšanje na koncu zdravljenja je bilo v primerjavi z referenčnim obiskom v študiji PRIMA 1,4 točke (1,8 točke pri preiskovancih, predhodno že zdravljenih z IVIg) in v študiji PATH 1,2 točke.
The safety of Privigen has been assessed in several preclinical studies, with particular reference to the excipient L-proline.
Varnost zdravila Privigen so ocenili v številnih predkliničnih študijah, pri čemer so bili posebno pozorni na pomožno snov L-prolin.
The dosage recommendations are summarised in the following table:
Povzetek priporočil za odmerjanje je v spodnji preglednici:
• Because the solution contains no preservative, your healthcare professional must infuse it immediately after opening the vial.
• Ker raztopina ne vsebuje konzervansa, vam jo mora vaš zdravstveni delavec po odprtju viale infundirati čim prej.
The PID pivotal study included a total of 80 patients aged between 3 and 69 years old.
V osrednjo študijo PID je bilo vključenih skupno 80 bolnikov, starih med 3 in 69 let.
• The other ingredients (excipients) are the amino acid proline and water for injections.
● Druge sestavine (pomožne snovi) so aminokislina prolin in voda za injekcije.
TRALI may be managed using oxygen therapy with adequate ventilatory support.
TRALI lahko zdravimo s terapijo s kisikom z ustreznim mehanskim predihavanjem.
By adjusted INCAT score, the responder rate by week 13 was 72.9 % (151 / 207 patients), with 149 patients responding already by week 10.
Na podlagi prilagojene ocene INCAT je bil delež odzivnih bolnikov do 13. tedna 72,9 % (151/207 bolnikov); 149 bolnikov se je odzvalo že do 10. tedna.
Non-clinical data reveal no special risk for humans based on safety pharmacology and toxicity studies.
Neklinični podatki na podlagi varnostne farmakologije in študij toksičnosti niso pokazali nobenega posebnega tveganja.
If the treatment is effective, long term treatment should be subject to the physician's discretion based upon the patient response.
Če je zdravljenje učinkovito, se zdravnik po svoji presoji odloči za dolgoročno zdravljenje na podlagi bolnikovega odziva.
Excipients with known effects: Privigen contains approximately 250 mmol/L (range: 210 to 290) of L-proline.
Zdravilo Privigen vsebuje približno 250 mmol/l (razpon: 210 do 290) L-prolina.
13 children (3 to 11 years), 8 adolescents (12 to 15 years) and 34 adults were treated with Privigen over 29 months.
13 otrok (3 do 11 let), 8 mladostnikov (12 do 15 let) in 34 odraslih so 29 mesecev zdravili z zdravilom Privigen.
Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially infusing the product slowly (0.3 ml/kg bw/hr); - are carefully monitored for any symptoms throughout the infusion period.
Morebitnim zapletom se pogosto lahko izognete tako, da se prepričate, da: - bolniki niso občutljivi za humani polispecifični imunoglobulin, tako da na začetku zdravilo infundirate počasi (0,3 ml/kg tm/uro), - se bolniki skrbno spremljajo, če se pojavi kateri koli simptom med infundiranjem.
Flushing of the infusion tubes with physiological saline or 5% glucose solution is permitted.
Izpiranje infuzijskih cevk s fiziološko raztopino ali 5-odstotno raztopino glukoze je dovoljeno.
The results of this study show the median half-life of Privigen to be 31.1 days (see table below).
V tej študiji je bila mediana razpolovnega časa zdravila Privigen 31,1 dneva (glejte spodnjo preglednico).
The efficacy and safety profile in the PRIMA and the PATH study in CIDP patients were overall comparable.
Profil učinkovitosti in varnosti je bil pri bolnikih s CIDP v študiji PRIMA in študiji PATH v celoti podoben.
Unknown
“neznana”.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Kadar se zdravila proizvajajo iz človeške krvi ali plazme, je treba uvesti nekatere ukrepe za preprečevanje okužb oziroma njihovega prenosa na bolnike.
They may occur even if you have previously received human immunoglobulins and had tolerated them well.
Pojavijo se lahko, tudi če ste predhodno že prejeli humane imunoglobuline in ste jih dobro prenašali.
• Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP.
• Tega zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na zunanji škatli in viali poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Privigen contains proline
Zdravilo Privigen vsebuje prolin
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.
Spodnja preglednica prikazuje pregled neželenih učinkov zdravila (ADR), o katerih so poročali v šestih študijah, glede na MedDRA klasifikacijo organskih sistemov (System Organ Class - SOC), priporočenih izrazov in pogostnost.
Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Humani polispecifični imunoglobulin vsebuje protitelesa IgG, prisotna v normalni populaciji.
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.
Obstaja 5 skupin: bolniki s premajhnim številom trombocitov (primarna imunska trombocitopenija (ITP) in z velikim tveganjem krvavitve ali ki bodo imeli v bližnji prihodnosti kirurški poseg;
If you receive more Privigen than you should
Če ste prejeli večji odmerek zdravila Privigen, kot bi smeli:
In replacement therapy the dose may need to be individualised for each patient depending on the pharmacokinetic and clinical response.
Pri nadomestnem zdravljenju bo morda treba odmerek glede na farmakokinetični in klinični odziv prilagoditi posameznemu bolniku.
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.
INCAT (Inflammatory Neuropathy Cause and Treatment - vzrok in zdravljenje vnetne nevropatije) so do 25. tedna zdravljenja pri 17 od 28 bolnikov opazili klinično pomembno izboljšanje za vsaj 1 točko od izhodišča.
Tell your doctor or healthcare professional immediately if you notice such reactions during the infusion of Privigen.
Svojemu zdravniku ali zdravstvenemu delavcu takoj povejte, če med infundiranjem zdravila Privigen opazite take reakcije.
Secondary immunodeficiencies (as defined in 4.1) The recommended dose is 0.2 - 0.4 g/kg every three to four weeks.
Sekundarne imunske pomanjkljivosti (kot je opredeljeno v poglavju 4.1) Priporočeni odmerek je 0,2 - 0,4 g/kg vsake tri do štiri tedne.
Human normal immunoglobulin 100 mg IgG purity ................................. ≥ 98% IgA ............................ ≤ 25 micrograms
humani polispecifični imunoglobulin 100 mg čistost IgG ............................... ≥ 98 % IgA ......................... ≤ 25 mikrogramov
The treatment can be repeated if relapse occurs.
Če se pojavi relaps, se lahko zdravljenje ponovi.
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.
Tretji dan so bolniki lahko prejeli drugi odmerek 1 g/kg telesne mase, za bolnike, ki so imeli na 3. dan število trombocitov < 50×109/l, je bil ta drugi odmerek obvezen.
It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Distribucija podrazredov imunoglobulina G je skoraj sorazmerna z distribucijo v avtohtoni človeški plazmi.
The scheduled dose of 1 g/kg bw per infusion was closely adhered to in all patients (median 2 g IgG/kg bw).
Načrtovani odmerek 1 g/kg telesne mase na infuzijo so pri vseh bolnikih strogo upoštevali (mediani odmerek 2.000 mg IgG/kg telesne mase).
In the ITP pivotal study, in total 57 patients aged between 15 and 69 years old were treated with 2 infusions of Privigen for a total of 114 infusions.
V osrednjo študijo ITP je bilo vključenih skupno 57 bolnikov, starih med 15 in 69 let, ki so prejeli 2 infuziji zdravila Privigen, kar je skupaj 114 infuzij.
Transfusion-related acute lung injury (TRALI)
S transfuzijo povezana akutna okvara pljuč (Transfusion-related acute lung injury (TRALI))
You will recognize TRALI by severe difficulty in breathing (respiratory distress), abnormally low level of oxygen in the blood (hypoxemia), normal heart function (left ventricular function) and increased body temperature (fever).
TRALI boste prepoznali po hudih težavah z dihanjem (dihalna stiska), nenormalno nizki koncentraciji kisika v krvi (hipoksemija), normalnem delovanju srca (funkcija levega prekata) in zvišani telesni temperaturi (vročini).
Pharmacokinetic parameters of Privigen in PID patients Parameter
Farmakokinetični parametri zdravila Privigen pri bolnikih s PID
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Humani polispecifični imunoglobulin večinoma vsebuje funkcionalno nepoškodovan imunoglobulin G (IgG) s širokim spektrom protiteles proti infekcioznim povzročiteljem.
Privigen belongs to the class of medicines called human normal immunoglobulins.
Zdravilo Privigen sodi v razred zdravil, imenovanih humani polispecifični imunoglobulini.
The two ITP studies were performed with 57 patients each.
Dve študiji z ITP sta bili opravljeni pri 57 bolnikih za vsako študijo.
In these circumstances, it has been commonly reported that immunoglobulins increase the risk of breakdown of red blood cells (haemolysis).
V teh okoliščinah so pogosto poročali, da imunoglobulini povečajo tveganje za razkroj eritrocitov (hemoliza).
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Replacement therapy Primary immunodeficiency syndromes (PID)
Nadomestno zdravljenje Sindromi primarne imunske pomanjkljivosti (PID)
The information given should be taken into consideration by you and your doctor before you are given Privigen.
Preden boste prejeli zdravilo Privigen, morate vi in vaš zdravnik upoštevati te informacije.
In the second ITP study, 57 patients with ITP (baseline platelet counts ≤ 30×109 / l) aged between 18
V drugi študiji ITP je 57 bolnikov z ITP (izhodiščno število trombocitov ≤ 30×109/l), starih od 18 do
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.
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.
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.
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.
Privigen is made from human plasma.
Zdravilo Privigen je proizvedeno iz človeške plazme.
Symptoms typically appear within 1 to 6 hours after receiving treatment.
Simptomi se navadno pojavijo v 1 do 6 urah po prejemu zdravljenja.
Such side effects may occur even if you have previously received human immunoglobulins and tolerated them well.
Ti neželeni učinki se lahko pojavijo celo, če ste predhodno že prejeli humane imunoglobuline in ste jih dobro prenašali.
- If you have any further questions, ask your doctor or healthcare professional.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali zdravstvenim delavcem.
At the beginning of the infusion you will receive Privigen at a slow infusion rate.
Na začetku infundiranja boste zdravilo Privigen prejeli z majhno hitrostjo.
• 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.
• 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,
Loss of kidney function with fatal outcome has occurred in isolated haemolysisrelated cases.
Odpoved delovanja ledvic s smrtnim izidom se je pojavila v posameznih primerih, povezanih s hemolizo.
Once the vial has been broached, its contents should be used promptly.
Ko prebodete zamašek viale, morate njeno vsebino porabiti takoj.
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]).
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]).
Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
Izkušenj z intravensko uporabo imunoglobulinov pri otrocih s CIDP je malo.
Marketing Authorisation Holder and Manufacturer CSL Behring GmbH
Imetnik dovoljenja za promet z zdravilom in izdelovalec CSL Behring GmbH
What Privigen is and what it is used for What Privigen is
Kaj je zdravilo Privigen in za kaj ga uporabljamo Kaj je zdravilo Privigen
Three to six months are required after the initiation of therapy for equilibration to occur.
Za pojav ravnovesja po začetku zdravljenja je potrebnih tri do šest mesecev.
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.
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.
They can occur in patients with anti-IgA antibodies.
Pojavijo se lahko pri bolnikih s protitelesi proti IgA.
What you need to know before you are given Privigen
Kaj morate vedeti, preden boste prejeli zdravilo Privigen
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.
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.
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.
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.
• if you have developed antibodies against immunoglobulins of the type IgA in your blood.
• če so se v vaši krvi razvila protitelesa proti imunoglobulinom vrste IgA.
The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Mehanizem delovanja pri indikacijah (razen nadomestnega zdravljenja) ni popolnoma raziskan,
and 65 years were treated with Privigen at 1 g/kg bw.
65 let, prejemalo zdravilo Privigen v odmerku 1 g/kg telesne mase.
Symptoms typically appear within 1 to 6 hours following treatment.
Simptomi se navadno pojavijo v 1 do 6 urah po zdravljenju.