natgillin/translations-raw huggingface dataset:
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
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
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.
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.
Patients may experience effects, such as dizziness or nausea, during treatment with Privigen that might affect the ability to drive and use machines.
Bolniki lahko med zdravljenjem z zdravilom Privigen doživijo učinke, kot sta omotica ali slabost, ki lahko vplivajo na sposobnost upravljanja vozil in strojev.
The medicine works in exactly the same way as the immunoglobulins naturally present in human blood of healthy people.
Zdravilo deluje na povsem enak način kot imunoglobulini, ki so običajno prisotni v človeški krvi.
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.
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.
Patients with Kawasaki disease.
bolniki s Kawasakijevo boleznijo.
After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Po uporabi tega zdravila morajo pred cepljenjem z živimi atenuiranimi virusnimi cepivi preteči vsaj 3 meseci.
Aseptic meningitis syndrome (AMS)
Sindrom aseptičnega meningitisa (AMS - Aseptic meningitis syndrome)
Very rarely: Transfusion related acute lung injury and thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses.
Zelo redko: s transfuzijo povezana akutna okvara pljuč in trombembolične reakcije, kot so miokardni infarkt, možganska kap, pljučna embolija in globoka venska tromboza.
There are no data on pharmacokinetic properties in paediatric patients with CIDP.
Podatkov o farmakokinetičnih lastnostih v pediatrični populaciji s CIDP ni.
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.
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.
Frequency of injections
Pogostnost infundiranja
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.
Nadomestno zdravljenje sindromov primarne imunske pomanjkljivosti (PID) Režim odmerjanja mora doseči najnižjo raven IgG (ki se meri pred naslednjim infundiranjem) vsaj 5
Guillain-Barré syndrome
Guillain-Barréjev sindrom
• 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).
● 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).
In the case of measles vaccinations the impairment may persist for up to 1 year.
Pri ošpicah lahko zmanjšana učinkovitost cepiva traja do 1 leta.
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.
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.
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.
To je kronična bolezen, za katero je značilno vnetje perifernih živcev, ki povzroča mišično oslabelost in/ali odrevenelost, povečini v nogah in zgornjih okončinah.
Pivotal Study (N= 25) ZLB03_002CR Median (Range)
Osrednja študija (N = 25) ZLB03 002 CR Srednja vrednost (razpon)
Extension Study (N=13) ZLB05_006CR Median (Range)
Podaljšana študija (N = 13) ZLB05_006CR Srednja vrednost (razpon)
Kawasaki disease
Kawasakijeva bolezen
Information on safety with respect to infections Privigen is made from human blood plasma (this is the liquid part of the blood).
Zdravilo Privigen je narejeno iz človeške krvne plazme (tekočega dela krvi).
Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
Imunoglobulini se izločajo v mleko in lahko prispevajo k zaščiti novorojenčka pred povzročitelji bolezni, ki vstopajo skozi sluznico.
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.
Odmerek, potreben za doseganje najnižje ravni 5 do 6 g/l, se doseže z 0,2 do 0,8 g/kg tm/mesec.
Cmax, maximum serum concentration; Cmin, trough (minimum level) serum concentration; t½, elimination half-life
t½ (dnevi) Cmax - največja koncentracija v serumu; Cmin - najmanjša koncentracija (najnižja raven) v serumu; t½
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.
Redko lahko humani polispecifični imunoglobulin inducira padec tlaka z anafilaktoidno reakcijo, tudi pri bolnikih, ki so predhodna zdravljenja s humanim polispecifičnim imunoglobulinom tolerirali.
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.
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.
How to use Privigen
Kako uporabljati zdravilo Privigen
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).
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).
Patients with Guillain-Barré syndrome.
bolniki z Guillain-Barréjevim sindromom.
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
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
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.
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.
Cases of acute renal failure have been reported in patients receiving IVIg therapy.
O primerih akutne ledvične odpovedi so poročali pri bolnikih, ki so prejemali zdravljenje z i.v.
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.
To je akutna bolezen, za katero je značilno vnetje perifernega živčevja, ki povzroča hudo mišično šibkost, večinoma v nogah in zgornjih udih;
This is a slowly progressive disease of the motor nerves with weakness of arms and legs.
To je počasi napredujoča bolezen motoričnih živcev, ki se kaže s šibkostjo rok in nog.
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.
Ig pri otrocih, zlasti s Kawasakijevo boleznijo, povezani z višjo stopnjo poročil o hemolitičnih reakcijah v primerjavi z drugimi i.v.
Reversible haemolytic reactions have been observed in patients, especially those with non-O blood groups in immunomodulatory treatment.
Pri bolnikih, zlasti s krvnimi skupinami, ki niso 0, so pri imunomodulacijskem zdravljenju opazili reverzibilne hemolitične reakcije.
Human normal immunoglobulin should be infused intravenously at an initial infusion rate of 0.3 ml/kg bw/hr for approximately 30 min.
Humani polispecifični imunoglobulin je treba infundirati intravensko z začetno hitrostjo infundiranja 0,3 ml/kg tm/uro približno 30 minut.
Pack sizes
Velikosti pakiranja
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.
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.
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).
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).
He or she will decide whether to decrease the infusion rate or to stop the infusion completely.
Odločil se bo za zmanjšanje hitrosti ali popolno ustavitev infundiranja.
In the pivotal PID study, 80 patients were enrolled and treated with Privigen.
V osrednji študiji PID je bilo vključenih 80 bolnikov, ki so se zdravili z zdravilom Privigen.
• transient decrease in red blood cells (reversible haemolytic anaemia/haemolysis), anaemia, leukopenia, anisocytosis (including microcytosis).
● prehodnem zmanjšanju števila eritrocitov (reverzibilna hemolitična anemija/hemoliza), anemiji, levkopeniji, anizocitozi (vključno z mikrocitozo).
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.
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.
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.
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.
In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
V primeru neželenih učinkov je treba hitrost dajanja zmanjšati ali infundiranje ustaviti.
Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Humani polispecifični imunoglobulin je v bolnikovem obtoku popolnoma biološko uporaben takoj po intravenski uporabi.
What Privigen looks like and contents of the pack
Izgled zdravila Privigen in vsebina pakiranja
• In very rare cases transfusion-related acute lung injury (TRALI) can occur after receiving immunoglobulins including Privigen.
• V zelo redkih primerih se lahko po prejemu imunoglobulinov, vključno z zdravilom Privigen,
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.
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.
Excipients: L-proline, water for injections.
Pomožne snovi: L-prolin, voda za injekcije.
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).
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).
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.
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
Vaccinations Tell your vaccinating doctor prior to a vaccination about your treatment with Privigen.
Cepljenje Pred cepljenjem zdravnika, ki vas bo cepil, obvestite, da se zdravite z zdravilom Privigen.
Cmax (peak, g/l) Cmin (trough, g/l)
Cmax (največja, g/l)
The measures taken 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.
Ukrepi so učinkoviti proti virusom z ovojnico, kot so virus imunske pomanjkljivosti (HIV), virusa hepatitisa B in C, ter za viruse brez ovojnice - virus hepatitisa A in viruse B19.
- 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.
sekundarni imunski pomanjkljivosti (SID - Secondary Immunodeficiency) pri bolnikih s hudimi ali ponavljajočimi se okužbami, pri neučinkovitem protimikrobnem zdravljenju ter pri bolnikih z bodisi dokazanim okvarjenim nastajanjem specifičnih protiteles (PSAF - Proven Specific Antibody Failure)* ali serumskimi ravnimi IgG <4 g/l.
Blood tests Tell your doctor about your treatment with Privigen prior to having any blood tests.
Krvne preiskave Predno imate katero koli krvno preiskavo zdravnika obvestite, da prejemate zdravilo Privigen.
In the PID extension study, 55 patients were enrolled and treated with Privigen.
V podaljšani PID študiji je bilo vključenih 55 bolnikov, ki so prejemali zdravilo Privigen.
Privigen 100 mg/ml solution for infusion
Privigen 100 mg/ml raztopina za infundiranje
CSL Behring GmbH, D-35041 Marburg, Germany
CSL Behring GmbH, D-35041 Marburg, Nemčija
Therefore, patients receiving measles vaccine should have their antibody status checked.
Zato je treba pri bolnikih, ki se cepijo proti ošpicam, preveriti status protiteles.
- Kawasaki disease.
Kawasakijevi bolezni.
The INCAT responder rate was 60.7% (95% confidence interval [42.41, 76.4]).
Stopnja odziva po INCAT je bila 60,7 % (95-% interval zaupanja [42,41; 76,4]).
If well tolerated (see section 4.4), the rate of administration may gradually be increased to a maximum of 4.8 ml/kg bw/hr.
Če se dobro prenaša (glejte poglavje 4.4), se hitrost dajanja lahko postopoma poveča na največ 4,8 ml/kg tm/uro.
Isolated cases of haemolysis-related renal dysfunction/renal failure or disseminated intravascular coagulation and death have occurred.
Pojavili so se posamični primeri ledvične disfunkcije/ledvične odpovedi ali diseminirane intravaskularne koagulacije in smrti, povezani s hemolizo.
Affected are vaccinations with live attenuated virus vaccines such as vaccinations against measles, mumps, rubella and varicella.
Vpliva na celjenje s cepivi z živimi oslabljenimi virusi, kot je cepljenje proti ošpicam, mumpsu, rdečkam in noricam.
The recommended starting dose is 0.4 to 0.8 g/kg body weight (bw) given once, followed by at least 0.2 g/kg bw every 3 to 4 weeks.
Priporočeni začetni odmerek je enkrat od 0,4 do 0,8 g/kg telesne mase (tm), ki mu sledi vsaj 0,2 g/kg tm vsake 3 do 4 tedne.
Aseptic meningitis syndrome has been reported to occur in association with IVIg treatment.
Poročali so o pojavu sindroma aseptičnega meningitisa v povezavi z zdravljenjem z i.v.
• Do not store above 25 °C.
• Zdravilo shranjujte pri temperaturi do 25 °C.
Distribution of the IgG subclasses (approx. values): IgG1 69 %
Porazdelitev podrazredov IgG (približne vrednosti):
Immunomodulation in adults, and children and adolescents (0-18 years) in: - Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
Imunomodulacija pri odraslih, otrocih in mladostnikih (0 - 18 let) pri: primarni imunski trombocitopeniji (ITP) pri bolnikih z velikim tveganjem za krvavitve ali pred kirurškimi posegi za povečanje števila trombocitov.
Privigen comes as a ready-to-use solution in single-use vials.
Zdravilo Privigen se dobavlja v obliki raztopine, pripravljene za uporabo, v vialah za enkratno uporabo.
In subjects with platelet counts < 50×109 / l after the first dose, 30% showed a platelet response of ≥ 50×109 / l after the mandatory second dose.
Med preiskovanci s številom trombocitov < 50×109/l po prvem odmerku jih je 30 % po obveznem drugem odmerku doseglo odziv trombocitov ≥ 50×109/l.
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.
Ig, ki vsebujejo različne pomožne snovi kot so saharoza, glukoza in maltoza, so zdravila s saharozo kot stabilizatorjem obsegala nesorazmeren delež skupnega števila.
If the product is diluted to lower concentrations (see section 6.6), immediate use after dilution is recommended.
Če se zdravilo redči, se priporoča takojšnja uporaba zdravila, razredčenega na nižje koncentracije (glejte poglavje 6.6).
No differences were seen in the pharmacokinetic parameters between adult and paediatric study patients with PID.
Razlik v farmakokinetičnih parametrih med odraslimi in pediatričnimi bolniki s PID v študiji niso opazili.
Overall, 91 % of subjects (188 patients) showed improvement in at least one of the criteria above by week 13.
tedna zabeležili izboljšanje vsaj enega od omenjenih meril pri 91 % preiskovancev (188 bolnikov).
0.2 - 0.4 g/kg bw every 3 to 4 weeks
0,2 - 0,4 g/kg tm vsake 3 do 4 tedne
Replacement therapy in adults, and children and adolescents (0-18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production (see section
Nadomestno zdravljenje odraslih, otrok in mladostnikov (0 - 18 let) pri: sindromih primarne imunske pomanjkljivosti (PID - Primary immunodeficiency syndromes) z okvarjenim nastajanjem protiteles (glejte poglavje 4.4).
Chronic inflammatory demyelinating polyneuropathy (CIDP)* The recommended starting dose is 2 g/kg bw divided over 2 to 5 consecutive days followed by maintenance doses of 1 g/kg bw over 1 to 2 consecutive days every 3 weeks.
Kronična vnetna demielinizacijska polinevropatija (CIDP)* Priporočeni začetni odmerek je 2 g/kg tm v deljenih odmerkih 2 do 5 zaporednih dni, ki mu sledijo vzdrževalni odmerki 1 g/kg tm 1 do 2 zaporedna dneva vsake 3 tedne.
It is strongly recommended that every time Privigen 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.
Vsakokrat, ko damo bolniku zdravilo Privigen, moramo zabeležiti ime in serijo zdravila, da tako ohranimo sledljivost med bolnikom in serijo zdravila.
Because the solution contains no preservative, Privigen should be infused as soon as possible.
Raztopina ne vsebuje konzervansov, zato je treba zdravilo Privigen infundirati čim prej.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Kljub temu pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni mogoče popolnoma izključiti prenosa povzročiteljev.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) and for the non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19.
(HIV), virus hepatitisa B (HBV) in virus hepatitisa C (HCV), ter za viruse brez ovojnice, kot sta virus hepatitisa A (HAV) in parvovirus B19.
Your doctor will calculate the correct dose for you taking into account your weight, the specific circumstances listed under section 2 “Warnings and precautions” and response to treatment.
Vaš zdravnik bo izračunal pravilni odmerek ob upoštevanju vaše telesne mase, posebnih okoliščin,
Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae.
Ig je imela za posledico remisijo AMS v nekaj dneh brez posledic.
Privigen 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Privigen 100 mg/ml raztopina za infundiranje humani polispecifični imunoglobulin (i.v.
What you need to know before you are given Privigen 3.
"Kaj morate vedeti, preden boste prejeli zdravilo Privigen".
Contents of the pack and other information
Shranjevanje zdravila Privigen Vsebina pakiranja in dodatne informacije
Decreased haemoglobin (including decreased red blood cell count, decreased haematocrit), Coombs` (direct) test positive, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood lactate dehydrogenase
Preiskave znižana koncentracija hemoglobina (vključno z zmanjšanjem števila eritrocitov, zmanjšan hematokrit), pozitivni (neposredni) Coombsov test, povečana alanin-aminotransferaza, povečana aspartat-aminotransferaza, zvišanje ravni laktatdehidrogenaze v krvi pogosti