natgillin/translations-raw huggingface dataset:
These include: careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, the testing of each donation and pools of plasma for signs of virus/infections, the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
• preiskovanje vsake darovane in zbrane plazme za znake virusa/okužb, • vključevanje korakov pri obdelavi krvi ali plazme, ki lahko deaktivirajo ali odstranijo viruse.
If dilution prior to infusion is desired, Privigen may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5%).
Če želite pred infundiranjem zdravilo razredčiti, lahko zdravilo Privigen razredčite s 5-odstotno raztopino glukoze, da dosežete končno koncentracijo 50 mg/ml (5 %).
Because the solution contains no preservative, Privigen should be infused immediately.
Raztopina ne vsebuje konzervansov, zato je treba zdravilo Privigen infundirati takoj.
1.6 - 2 g/kg bw or in divided doses over 2 to 5 days in association with acetylsalicylic acid
1,6 - 2 g/kg tm ali 2 g/kg tm v razdeljenih odmerkih v obdobju 2 do 5 dni, skupaj z acetilsalicilno kislino v enem odmerku, skupaj z acetilsalicilno kislino
The solution should be clear or slightly opalescent and colourless or pale yellow.
Raztopina mora biti bistra ali rahlo opalescentna ter brezbarvna ali rumenkasta.
There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, cerebral vascular accident (including stroke), pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients.
Ig in trombemboličnimi dogodki, kot so miokardni infarkt, cerebrovaskularni dogodek (vključno z možgansko kapjo), pljučna embolija in globoka venska tromboza, za katero se zdi, da je povezana z relativnim povečanjem viskoznosti krvi zaradi velikega dotoka imunoglobulina pri bolnikih s tveganjem.
For obtaining an immunoglobulin solution of 50 mg/ml (5%), Privigen 100 mg/ml (10%) should be diluted with an equal volume of the glucose solution.
Za imunoglobulinsko raztopino 50 mg/ml (5 %) morate zdravilo Privigen 100 mg/ml (10 %) razredčiti z enako količino raztopine glukoze.
No differences were seen in the pharmacodynamic properties between adult and paediatric study patients.
Pediatrična populacija Razlik v farmakodinamičnih lastnostih med odraslimi in pediatričnimi bolniki v študiji niso opazili.
- Guillain-Barré syndrome.
Guillain-Barréjevem sindromu.
If dilution is desired, 5% glucose solution should be used.
Če želite zdravilo razredčiti, uporabite 5-odstotno raztopino glukoze.
For obtaining an immunoglobulin solution of 50 mg/ml (5%), Privigen 100 mg/ml (10%) should be diluted with an equal volume of the 5% glucose solution.
Za imunoglobulinsko raztopino 50 mg/ml (5 %) morate zdravilo Privigen 100 mg/ml (10 %) razredčiti z enako količino 5-odstotne raztopine glukoze.
Chronic inflammatory demyelinating polyneuropathy (CIDP)*
Kronična vnetna demielinizacijska polinevropatija (CIDP)*
Headache (including sinus headache, migraine, head discomfort, tension headache)
Bolezni živčevja glavobol (vključno z sinusnim glavobolom, migreno, neprijetnim občutkom v glavi, tenzijski glavobol)
Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally in connection with intravenous administration of human immunoglobulin including Privigen.
Občasno se lahko pojavijo neželeni učinki, kot so mrzlica, glavobol, omotica, povečana telesna temperatura, bruhanje, alergijske reakcije, navzea, bolečine v sklepih, nizek krvni tlak in zmerna bolečina v križu v povezavi z intravenskim dajanjem humanih imunoglobulinov, vključno z zdravilom
If well tolerated, the rate of administration may gradually be increased to a maximum of 4.8 ml/kg bw/hr.
Če se dobro prenaša, se hitrost dajanja lahko postopoma poveča na največ 4,8 ml/kg tm/uro.
• The active substance is human normal immunoglobulin (antibodies of the type IgG).
● Učinkovina je humani polispecifični imunoglobulin (protitelesa vrste IgG).
starting dose: 0.4 - 0.8 g/kg bw maintenance dose: 0.2 - 0.8 g/kg bw every 3 to 4 weeks to obtain IgG trough levels of at least 5 - 6 g/l
0,4 - 0,8 g/kg tm vzdrževalni odmerek: 0,2 - 0,8 g/kg tm vsake 3 do 4 tedne, da se doseže najnižja raven IgG vsaj 5-6 g/l
Haemolysis has rarely been reported in patients given replacement therapy for PID.
Pri bolnikih, ki so dobivali nadomestno zdravljenje za PID, so redko poročali o hemolizi.
Your doctor will decide whether you can receive Privigen during your pregnancy or while you are breast-feeding.
Zdravnik se bo odločil, ali lahko prejemate zdravilo Privigen med nosečnostjo ali dojenjem.
Myalgia (including muscle spasms, musculoskeletal stiffness, musculoskeletal pain)
Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija (vključno z mišičnimi krči, mišično skeletno otrdelostjo, mišično-skeletno bolečino)
Will be placed in the upper right corner of the label to give total content and volume of the container
Oznaka za skupen volumen in volumen vsebnika bo v zgornjem desnem kotu embalaže.
Will be placed in the upper right corner of the main face of the box to give total content and volume of the container
Oznaka za skupno vsebnost in volumen vsebnika bo v zgornjem desnem kotu prednje strani škatle.
Privigen is essentially sodium free.
Zdravilo Privigen je v bistvu brez natrija.
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.
Pri bolnikih s trdovratnimi okužbami bo morda potrebno odmerek povečati; če se okužbe pri bolniku ne ponavljajo več, pa lahko razmislimo o zmanjšanju odmerka.
Temporary non-infectious meningitis (reversible aseptic meningitis), irregularity of red blood cell shape (microscopic finding), presence of high platelet counts in the blood (thrombocytosis), sleepiness, shiver (tremor), palpitations, tachycardia, thromboembolic events, lack of blood supply to the lower extremities causing e.g. pain when walking (peripheral vascular disorder), presence of an excess of serum proteins in the urine (proteinuria including increased blood creatinine), injection site pain
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): Prehoden neinfekcijski meningitis (reverzibilen aseptični meningitis), nepravilna oblika rdečih krvnih celic (mikroskopski izvid), visoka koncentracija trombocitov v krvi (trombocitoza), zaspanost, drgetanje (tremor), palpitacije, tahikardija, trombembolični dogodki, nezadosten pretok krvi v spodnjih okončinah, ki povzroči npr. bolečino pri hoji (bolezen perifernih žil), prekomerna količina serumskih beljakovin v urinu (proteinurija vključno s povečanim kreatininom v krvi), bolečina na mestu injiciranja.
Do not store above 25 °C.
Zdravilo shranjujte pri temperaturi do 25 °C.
Sodium content Privigen is essentially sodium-free.
Vsebnost natrija Zdravilo Privigen je v bistvu brez natrija.
IVIg products have been shown to cross the placenta, increasingly during the third trimester.
Ig prehajajo skozi posteljico, še najbolj v tretjem trimesečju.
Temporary lowering of red blood cell count (anaemia), breakdown of red blood cells (haemolysis), decreased number of white blood cells (leukopenia), hypersensitivity, dizziness (including vertigo), high blood pressure (hypertension), flushing (including hot flush, hyperaemia), hypotension (including decreased blood pressure), breathlessness (dyspnoea including chest pain, chest discomfort, painful breathing), vomiting, loose stools (diarrhea), stomach pain, skin disorder (including rash, itching (pruritus), hives (urticaria), maculopapular rash, redness of the skin (erythema), peeling of the skin (skin exfoliation)), pain in the muscles (including muscle cramps and rigidity), tiredness (fatigue), physical weakness (asthenia), weakness in the muscles, .
visok krvni tlak (hipertenzija), zardevanje (vključno z valovi vročine, hiperemija), hipotenzija (nizek krvni tlak), težko dihanje (dispneja, vključno z bolečinami v prsnem košu, nelagodjem v prsnem košu, bolečim dihanjem), bruhanje, mehko blato (driska), bolečine v trebuhu, kožne motnje (vključno z izpuščajem), srbenje (pruritus), koprivnica (urtikarija), makulo-papulozen izpuščaj, pordelost kože (eritem), lupljenje kože (eksfoliacija kože), bolečine v mišicah (vključno z mišičnimi krči in togostjo),
Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown) have been observed with human normal immunoglobulin including Privigen.
Pri humanem polispecifičnem imunoglobulinu, vključno z zdravilom Privigen, so opazili primere reverzibilnega aseptičnega meningitisa in redke primere prehodnih kožnih reakcij (vključno s kožnim eritematoznim lupusom - neznana pogostnost).
What Privigen is used for
Za kaj se uporablja zdravilo Privigen
In a second prospective, multicenter randomized, placebo-controlled clinical study (Polyneuropathy and Treatment with Hizentra, PATH trial), 207 subjects with CIDP were treated with Privigen in the prerandomization phase of the study.
(preskušanje PATH - "Polinevropatija in zdravljenje z zdravilom Hizentra") so v predrandomizacijski fazi študije 207 preiskovancev s CIDP zdravili z zdravilom Privigen.
Infections and infestations
Povzročitelji nalezljivih bolezni
The solution is clear or slightly opalescent and colourless to pale yellow.
Raztopina je bistra do rahlo opalescentna, brezbarvna do bledo rumena.
Fatigue, asthenia (including muscular weakness) Common Injection site pain
zelo pogosti utrujenost, astenija (vključno z mišično šibkostjo) pogosti bolečina na mestu injiciranja občasni
In an extension of this study, 13 PID patients (aged 3-65 years) participated in a PK substudy.
V razširitvi te študije je bila pri trinajstih bolnikih s PID (starih od 3-65
(e.g. you may feel light-headed, dizzy, faint on standing, cold in the hands and feet, sense an abnormal heart beat or chest pain, or have blurred vision) even when you have shown no hypersensitivity on previous infusions, Tell your doctor or healthcare professional immediately if you notice such signs during the infusion of Privigen.
(npr. občutek prazne glave, omotičnosti, omedlevice v stoječem položaju, občutek mraza v rokah in nogah, občutek nenavadnega srčnega utripa ali bolečine v prsih ali zamegljen vid), celo kadar preobčutljivosti ni bilo pri predhodnih infundiranjih;
- Chronic inflammatory demyelinating polyneuropathy (CIDP).
Kronični vnetni demielinizacijski polinevropatiji (CIDP - Chronic inflammatory demyelinating polyneuropathy).
Patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
bolniki s kronično vnetno demielinizirajočo polinevropatijo (CIDP - chronic inflammatory demyelinating polyneuropathy).
• 0.4 g/kg bw given daily for 2 to 5 days.
• 0,4 g/kg/tm vsak dan 2 do 5 dni.
Patients with multifocal motor neuropathy (MMN).
bolniki z multifokalno motorično nevropatijo (MMN).
Aseptic technique must be strictly observed during the dilution of Privigen.
Med redčenjem zdravila Privigen je treba dosledno uporabljati aseptično tehniko.
Multifocal Motor Neuropathy (MMN)
Multifokalna motorična nevropatija (MMN)
200 or 400 ml of solution in a single vial (type II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
200 ali 400 ml raztopine v eni viali (steklo vrste II) z zamaškom (elastomernim), zaporko (z aluminijastim navojem), s tesnilom Flip Off (plastičnim), oznako z vgrajeno zanko.
• formation of blood clots which may be carried off in the blood circulation (thromboembolic reactions) and which may result e.g. in myocardial infarction (e.g. when you have sudden chest pain or shortness of breath), stroke (e.g. when you have a sudden onset of muscle weakness, have loss of sensation and/or balance, decreased alertness or difficulty in speaking), blood clots in the arteries of the lungs (e.g. when you have chest pain, difficulty in breathing or are coughing up blood), deep vein thrombosis (e.g. when you have redness, feel warmth, pain, tenderness, or have a swelling of one or both legs),
● tvorbi krvnih strdkov, ki lahko potujejo po krvnem obtoku (trombembolične reakcije) in lahko npr. povzročijo miokardni infarkt (npr. če občutite nenadno bolečino v prsih ali kratko sapo), možgansko kap (npr. če doživite nenadno mišično oslabelost, izgubo občutenja in/ali ravnotežja,
Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment including Privigen (see section 4.4).
imunoglobulina, vključno z zdravilom Privigen, razvije hemolitična anemija, zaradi katere je potrebna transfuzija (glejte poglavje 4.4).
Therefore, your vaccinating doctor should check the effectiveness of the measles vaccination.
preveriti učinkovitost cepiva proti ošpicam.
Primary immune thrombocytopenia (ITP)
Imunomodulacija Primarna imunska trombocitopenija (ITP)
In patients defined as INCAT non-responders, muscle strength improved by 5.5 points (95% confidence interval [0.6, 10.2]) as compared to INCAT responders (7.4 points (95% confidence interval [4.0, 11.7])
interval zaupanja [0,6; 10,2]) v primerjavi z bolniki, odzivnimi po INCAT (7,4 točke (95-% interval zaupanja [4,0; 11,7]).
In case of renal impairment, IVIg discontinuation should be considered.
Pri ledvični okvari je treba pretehtati možnost prekinitve zdravljenja z i.v.
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 during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Ig, ali bolniki, pri katerih je bil presledek od predhodnega infundiranja dolg, se spremljajo med prvim infundiranjem in še prvo uro po prvem infundiranju, da bi ugotovili morebitne neželene znake.
The median doses administered for the 3-week and 4-week treatment schedules were almost identical to each other (428.3 vs. 440.6 mg IgG/ kg bw).The PID extension study included a total of 55 patients aged between 4 and 81 years old.
Mediani odmerki, dani v 3-tedenskem in 4-tedenskem režimu zdravljenja so bili skoraj identični (428,3 oz. 440,6 mg IgG/kg telesne mase).
Dizziness (including vertigo)
zelo pogosti omotica (vključno z vrtoglavico)
For spontaneous post-marketing ADRs, the reporting frequency is categorized as unknown.
Pogostnost spontano poročanih neželenih učinkov zdravila (ADR) iz obdobja trženja je ocenjena kot
Skin disorder (including rash, pruritus, urticaria, maculo-papular rash, erythema, skin exfoliation)
Bolezni kože in podkožja bolezni kože (vključno z izpuščajem, pruritusom, urtikarijo, makulo-papuloznim izpuščajem,
50 or 100 ml of solution in a single vial (type I or II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
50 ali 100 ml raztopine v eni viali (steklo vrste I ali II) z zamaškom (elastomernim), zaporko (z aluminijastim navojem), s tesnilom Flip Off (plastičnim), oznako z vgrajeno zanko.
- If you get any side effects, talk to your doctor or healthcare professional.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali zdravstvenim delavcem.
Anaemia, haemolysis (including haemolytic anaemia), leukopenia
Bolezni krvi in limfatičnega sistema anemija, hemoliza (vključno s hemolitično anemijo), levkopenija pogosti anizocitoza (vključno z mikrocitozo),
1.6 to 2.0 g/kg bw should be administered in divided doses over 2 to 5 days or 2.0 g/kg bw as a single dose.
Kawasakijeva bolezen V 2 do 5 dneh je treba dati od 1,6 do 2,0 g/kg tm v deljenih odmerkih ali 2,0 g/kg tm v enem odmerku.
IgG4 ......................... 2 %
IgG2 ....................... 26 % IgG3 ......................... 3 % IgG4 ......................... 2 %
Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced RBC sequestration.
Hemolitična anemija se lahko razvije po zdravljenju z i.v.
Stability after dilution:
Obstojnost po redčenju:
25 ml of solution in a single vial (type I glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
25 ml raztopine v eni viali (steklo vrste I) z zamaškom (elastomernim), zaporko (z aluminijastim navojem), s tesnilom Flip Off (plastičnim), oznako z vgrajeno zanko.
If you get any side effects, talk to your doctor or healthcare professional.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali zdravstvenim delavcem.
0.4 g/kg bw/d for 5 days
0,4 g/kg tm/dan
• You receive this medicine in high doses either on 1 day or over several days and you have a blood group A, B or AB and/or you have an underlying inflammatory condition.
Pred zdravljenjem zdravniku ali zdravstvenemu delavcu povejte, če katere od naštetih okoliščin veljajo za vas: ● 1 dan ali več dni ste prejemali visoke odmerke tega zdravila, vaša krvna skupina pa je A, B ali
Dyspnoea (including chest pain, chest discomfort, painful respiration)
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja (vključno z bolečino v prsih, tiščanjem v prsih), boleče dihanje)
For safety with respect to transmissible agents and additional details on risk factors, see section 4.4.
Za informacije o varnosti glede povzročiteljev nalezljivih bolezni glejte poglavje 4.4.
Certain adverse reactions may occur more frequently: - in case of high rate of infusion, - in patients with hypogammaglobulinaemia or agammaglobulinaemia, with or without IgA deficiency, - 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.
- pri bolnikih, ki prvič prejmejo humani polispecifični imunoglobulin, ali v redkih primerih, kadar se zdravilo s humanim polispecifičnim imunoglobulinom zamenja ali kadar obstaja dolg presledek od predhodnega infundiranja.
Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks.
Začetni odmerek: 2 g/kg v obdobju 2 do 5 zaporednih dni Vzdrževalni odmerek: 1 g/kg vsake 2 do 4 tedne ali 2 g/kg vsakih 4 do 8 tednov.
Nervous system disorders
Organski sistem po MedDRA
A) to increase abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy):
A) Povečanje nenormalno nizkih ravni imunoglobulinov v vaši krvi na normalno raven (nadomestno zdravljenje): bolniki s prirojeno zmanjšano sposobnostjo ali nesposobnostjo proizvajanja imunoglobulinov (primarna imunska pomanjkljivost (PID - primary immunodeficiencies)).
If signs and/or symptoms of haemolysis develop during or after an IVIg infusion, discontinuation of the IVIg treatment should be considered by the treating physician (see also section 4.8).
Če se znaki in/ali simptomi hemolize pojavijo med infundiranjem i.v.
Hepatobiliary disorders Hyperbilirubinaemia
Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija pogosti
How Privigen works
Kako deluje zdravilo Privigen
TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever.
Za TRALI so značilni huda dihalna stiska, pljučni edem, hipoksemija,
There are two alternative treatment schedules:
Primarna imunska trombocitopenija (ITP) Na voljo sta dva možna režima zdravljenja:
In the first CIDP study, a prospective multicenter open label trial (Privigen impact on mobility and autonomy PRIMA study), 28 patients (13 subjects who have previously received IVIG and 15 subjects not) were treated with a Privigen loading dose of 2g/kg bw given over 2-5 days followed by 6 maintenance doses of 1g/kg bw over 1-2 days every three weeks.
Ig in 15 preiskovancev, ki ga predhodno niso prejemali) zdravili z zdravilom Privigen s polnilnim odmerkom 2 g/kg tm 2-5 dni, ki mu je sledilo 6 vzdrževalnih odmerkov 1g /kg tm 1-2 dni vsake tri tedne.
Palpitations, tachycardia
Srčne bolezni palpitacije, tahikardija občasni
Do NOT take Privigen
NE uporabljate zdravila Privigen
- Multifocal motor neuropathy (MMN)
multifokalni motorični nevropatiji (MMN).
IgG3 3 %
Čistost IgG ≥ 98 %.
Other side effects presented in order of decreasing frequency:
Nekateri neželeni učinki se lahko pojavijo pogosteje:
starting dose: 2 g/kg bw in divided doses over 2 to 5 days maintenance dose: 1 g/kg bw every 3 weeks over 1 to 2 days
2 g/kg tm vzdrževalni odmerek: 1g/kg tm v razdeljenih odmerkih v obdobju 2 do 5 dni vsake 3 tedne v obdobju 1 do 2 dni
Subjects all with IVIg pretreatment of at least 8 weeks and with an IVIg-dependence confirmed by clinically evident deterioration during an IVIg withdrawal phase of up to 12 weeks, received a Privigen loading dose of 2 g/kg bw followed by up to 4 Privigen maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks.
Vsi preiskovanci so predhodno vsaj 8 tednov prejemali intravenske imunoglobuline (IVIg) in so bili od njih odvisni; slednje je bilo potrjeno s klinično opaznim poslabšanjem med fazo do 12 tednov trajajoče odtegnitve IVIg.
In patients at risk, the use of IVIg products that do not contain sucrose should therefore be considered.
Pri bolnikih s tveganjem je treba pretehtati možnost uporabe zdravil i.v.
A vented infusion line should be used for the administration of Privigen.
Privigen je treba uporabiti prezračevano infuzijsko cevko.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI
Hypertension, flushing (including hot flush, hyperaemia), hypotension
Žilne bolezni hipertenzija, navali vročine (vključno z vročinskimi oblivi, hiperemijo), hipotenzija pogosti trombembolični dogodki, vaskulitis (vključno s periferno žilno motnjo)
Tell your doctor or healthcare professional prior to treatment if any of the circumstances listed below applies to you:
Svojemu zdravniku ali zdravstvenemu delavcu takoj povejte, če imate katerega od zgornjih simptomov.
Previously treated patients were withdrawn from IVIG until confirmed deterioration before start of Privigen.
Ig, dokler niso potrdili poslabšanja stanja, nakar so začeli dobivati zdravilo Privigen.
Pain (including back pain, pain in extremity, arthralgia, neck pain, facial pain) pyrexia (including chills), influenza like illness (including nasopharyngitis, pharyngolaryngeal pain, oropharyngeal blistering, throat tightness)
Splošne težave in spremembe na mestu aplikacije bolečine (vključno z bolečinami v hrbtu, bolečinami v okončinah, artralgijo, bolečinami v vratu, obrazno bolečino), pireksija (vključno z mrazenjem), gripi podobno obolenje (vključno z nazofaringitisom, bolečinami v žrelu in grlu,
Monitor patients for pulmonary adverse reactions.
Bolnike je treba nadzirati glede pojava neželenih učinkov na dihalih.
• chest pain, chest discomfort, painful respiration due to transfusion related lung injury (TRALI) Tell your doctor or healthcare professional immediately if you have any of the above symptoms.
• bolečina v prsnem košu, občutek neugodja v prsnem košu, boleče dihanje zaradi s transfuzijo povezane akutne okvare pljuč (TRALI).
Vomiting, diarrhoea, abdominal pain
zelo pogosti bruhanje, driska, bolečina v trebuhu pogosti
Privigen is presented as a solution for infusion.
Zdravilo Privigen je raztopina za infundiranje.
Please also refer to section 2 “What you need to know before you are given Privigen” for additional details on circumstances which increase the risk of side effects.
Za dodatne informacije o okoliščinah, ki povečujejo tveganje neželenih učinkov, glejte tudi poglavje 2
1 ml contains: Human normal immunoglobulin 100 mg. IgG purity ≥ 98%.
humani polispecifični imunoglobulin 100 mg.
In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Pri bolnikih s tveganjem trombemboličnih neželenih učinkov je treba zdravila z i.v.