natgillin/translations-raw huggingface dataset:
It is strongly recommended that every time you receive a dose of Flebogamma DIF, the name and batch number of the medicine (stated on the label and carton after Lot) are recorded in order to maintain a record of the batches used.
Zelo priporočljivo je, da vsakič, ko prejmete odmerek zdravila Flebogamma DIF, zabeležite ime in serijsko številko zdravila (navedena na nalepki in škatli poleg oznake Lot), da tako vodite evidenco o uporabljenih serijah zdravila.
Treatment of adults, children and adolescents (2 - 18 years) with certain autoimmune disorders (immunomodulation).
Zdravljenje odraslih, otrok in mladostnikov (2-18 let) z nekaterimi avtoimunskimi motnjami (imunomodulacija).
• Primary immune thrombocytopenia (ITP), a condition where the number of platelets in the blood stream is greatly reduced.
• Primarna imunska trombocitopenija (ITP), pri kateri je število trombocitov v krvi močno zmanjšano.
Frequency of injections
Pogostnost injiciranja
Secondary immunodeficiencies
Sekundarne imunske pomanjkljivosti
• blood volume decrease
• zmanjšan volumen krvi
INFORMATION IN BRAILLE Justification for not including Braille accepted
PISAVA V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna
Hypersensitivity reactions are rare.
Preobčutljivostne reakcije so redke.
In babies and young children (aged 0 - 2 years) hereditary fructose intolerance (HFI) may not yet be diagnosed and may be fatal, thus, they must not receive this medicinal product.
Pri dojenčkih in majhnih otrocih (starih od 0-2 leti) morda še ni bila postavljena diagnoza dedne intolerance za fruktozo (HFI - hereditary fructose intolerance), ki je lahko smrtna, zato ne smejo prejemati tega zdravila.
Multifocal motor neuropathy (MMN)
Multifokalna motorična nevropatija (MMN)
• Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare and progressive disease causing limb weakness, numbness, pain and fatigue.
• Kronična vnetna demielinizacijska poliradikulonevropatija (CIDP), redka in napredujoča bolezen, ki povzroča oslabelost okončin, otopelost, bolečine in utrujenost.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Kljub tem ukrepom pri uporabi zdravil, ki so pripravljena iz človeške krvi ali plazme, ni mogoče popolnoma izključiti možnosti prenosa okužbe.
• history of vascular disease or thrombosis
• žilna obolenja ali trombozo
• Patients with Secondary Immunodeficiency Syndromes (SID) with severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l (group 2)
• Bolniki s sekundarnimi sindromi imunske pomanjkljivosti (SID) z resnimi ali ponavljajočimi se okužbami, neučinkovitim protimikrobnim zdravljenjem ter potrjenim neuspehom specifičnega protitelesa (PSAF)* ali serumsko ravnjo IgG <4 g/l (skupina 2).
Information on overdose in children has not been established with Flebogamma DIF.
Informacij o prevelikem odmerjanju zdravila Flebogamma DIF pri otrocih ni.
The dose in children is not considered to be different to that of adults as it will be given depending on the illness and body weight of the children.
Odmerjanje pri otrocih se ne razlikuje od odmerjanja pri odraslih, saj bo zdravilo dano v odmerku, ki je odvisen od bolezni in telesne mase otroka.
• 0.8 - 1 g/kg given on day one; this dose may be repeated once within 3 days.
• odmerek 0,8-1 g/kg prvi dan; ta odmerek lahko ponovite enkrat v roku 3 dni,
● bronchitis
● bronhitis,
- If you do not have enough immunoglobulins of the type IgA in your blood or have developed antibodies to IgA.
- Če nimate dovolj imunoglobulinov vrste IgA v krvi ali imate protitelesa proti imunoglobulinom IgA.
Replacement therapy: Primary immunodeficiency syndromes
Nadomestno zdravljenje: Sindromi primarne imunske pomanjkljivosti
To hang pull here
Da obesite, povlecite tukaj.
Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA-containing product can result in anaphylaxis.
Bolniki s selektivno pomanjkljivostjo IgA, ki so razvili protitelesa proti IgA, saj lahko dajanje zdravila, ki vsebuje IgA, povzroči anafilaksijo.
• alanine aminotransferase (hepatic transaminase) increased
• zvišana alanin aminotransferaza (jetrna transaminaza),
Do not store above 30 ºC.
Shranjujte pri temperaturi do 30 ºC.
This medicinal product contains less than 29,41 mg sodium per vial of 400 ml, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
To zdravilo vsebuje manj kot 29,41 mg natrija na vialo s 400 ml, kar je enako 1,5 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
Platelets form an important part of the clotting process and a reduction in their numbers may cause unwanted bleeding and bruising.
Trombociti so pomembni za strjevanje krvi, zmanjšanje števila trombocitov pa lahko povzroči neželeno krvavitev in modrice.
Flebogamma DIF should not be mixed with other medicines or intravenous solutions and it should be administered by a separate intravenous line.
Zdravila Flebogamma DIF ne smete mešati z drugimi zdravili ali intravenskimi raztopinami, uporabiti se mora z ločeno intravensko cevko.
Source of the safety database from clinical trials and post-authorisation safety studies in a total of 160 patients exposed to Flebogamma DIF 100 mg/ml (with a total of 915 infusions)
Vir zbirke podatkov o varnosti iz kliničnih preskušanj in študij varnosti po pridobitvi dovoljenja za promet pri skupno 160 bolnikih, izpostavljenih zdravilu Flebogamma DIF 100 mg/ml (s skupno 915 infuzijami)
One ml contains 50 mg of D-sorbitol.
En ml vsebuje 50 mg D-sorbitola.
In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations.
Pri pripravkih z imunoglobulini so pri redkih in posameznih primerih poročali o naslednjih neželenih učinkih.
TRALI is characterised by severe hypoxia, dyspnoea, tachypnoea, cyanosis, fever and hypotension.
Za TRALI so značilne resna hipoksija, dispneja, tahipneja, cianoza, zvišana telesna temperatura in hipotenzija.
The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Mehanizem delovanja pri indikacijah, ki niso del nadomestnega zdravljenja, ni v celoti pojasnjen,
The product is also used in patients at high risk of bleeding or prior to surgery to correct the platelet count.
To zdravilo se uporablja tudi pri bolnikih z velikim tveganjem krvavitve ali pred kirurškimi posegi za povečanje števila trombocitov.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use
POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko uporabo
● radicular syndrome (neck or back pain and other symptoms such as numbness, tingling and weakness in the arms or legs)
● nespečnost, ● radikularni sindrom (bolečine v vratu in hrbtu in drugi simptomi, kot so otopelost, mravljinčenje ter šibkost rok in nog),
Can Guasc, 2 - Parets del Vallès 08150 Barcelona - Spain
Can Guasc, 2 - Parets del Vallès 08150 Barcelona - Španija
Source of the safety database from clinical trials and post-authorisation safety studies in a total of 128 patients exposed to Flebogamma DIF 50 mg/ml (with a total of 1318 infusions)
Vir zbirke podatkov o varnosti iz kliničnih preskušanj in študij varnosti po pridobitvi dovoljenja za promet pri skupno 128 bolnikih, izpostavljenih zdravilu Flebogamma DIF 50 mg/ml (s skupno 1318 infuzijami)
Dose based on body weight may require adjustment in underweight or overweight patients.
Odmerek na osnovi telesne mase bo morda treba prilagoditi pri bolnikih s premajhno ali preveliko telesno maso.
It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Porazdelitev podrazredov imunoglobulina G je izjemno podobna tisti pri naravni človeški plazmi.
After receiving Flebogamma DIF, the results of certain blood tests (serological tests) may be interfered for a certain time.
Po uporabi zdravila Flebogamma DIF so lahko rezultati nekaterih krvnih preiskav (seroloških testov)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 g / 10 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,5 g / 10 ml
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Instituto Grifols, S.A.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Instituto Grifols, S.A.
Therefore patients receiving measles vaccine should have their antibody status checked.
Zato se mora pri bolnikih, ki bodo prejeli cepivo proti ošpicam, preveriti prisotnost protiteles.
Do not use this medicine if you notice that the solution is cloudy or has deposits.
Tega zdravila ne uporabljajte, če opazite, da je raztopina motna ali da je v njej oborina.
• Thromboembolic reactions such as myocardial infarction (tight band around the chest with feeling like your heart is beating too fast), stroke (muscle weakness in the face, arm, or leg, trouble speaking or understanding others who are speaking), pulmonary embolism (shortness of breath, chest pain and fatigue), deep vein thromboses (pain and swelling in an extremity).
• Trombembolični dogodki, kot so miokardni infarkt (občutek stiskanja okoli prsi in prehitrega utripanja srca), možganska kap (šibkost mišic obraza, rok ali nog, težave z govorjenjem ali razumevanjem govorice drugih), pljučna embolija (kratka sapa, bolečine v prsih in utrujenost)
• (very rarely) thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses
• (zelo redko) trombembolične dogodke, kot so miokardni infarkt, možganska kap, pljučna embolija in globoke venske tromboze,
While 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 z dovoljenjem za promet, ki vsebujejo različne pomožne snovi, kot so saharoza, glukoza in maltoza, so zdravila s saharozo kot stabilizatorjem odgovorna za nesorazmerno velik delež celotnega števila poročil.
You must make up the infusion in exactly the way you have been shown in order to stop germs getting in. You must never self-administer it alone; a responsible adult must be always present.
Nikoli ne opravljajte infuzije sami, zmeraj mora pri infundiranju biti prisotna odgovorna odrasla oseba.
• diseases which increase blood viscosity • age over 65
• bolezni, ki povečujejo viskoznost krvi
• infusion site reactions (erythema, extravasation, inflammation, pain)
• reakcije na mestu infundiranja (eritem, ekstravazacija, vnetje, bolečina),
SPECIAL STORAGE CONDITIONS Do not store above 30 ºC.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
In case of inadvertent administration and suspicion of fructose intolerance the infusion has to be stopped immediately, normal glycaemia has to be re-established and organ function has to be stabilized by means of intensive care.
Če se zdravilo uporabi nenamerno in obstaja sum na intoleranco za fruktozo, je treba infundiranje takoj prekiniti, doseči normalno glikemijo in z intenzivno nego stabilizirati delovanje organov.
What Flebogamma DIF is and what it is used for What you need to know before you use Flebogamma DIF How to use Flebogamma DIF Possible side effects
Kaj je zdravilo Flebogamma DIF in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Flebogamma DIF Kako uporabljati zdravilo Flebogamma DIF
Post-authorisation Safety Study
Študija o varnosti zdravila po pridobitvi dovoljenja za promet
If you have a renal disease and you are receiving Flebogamma DIF for the first time, you may suffer a problem in your kidneys.
Bolniki z ledvičnimi težavami Če imate bolezen ledvic in prejemate zdravilo Flebogamma DIF prvič, lahko pride do ledvičnih težav.
OTHER To hang pull here
DRUGI PODATKI Da obesite, povlecite tukaj.
In patients receiving IVIg, there have been some reports of acute non-cardiogenic pulmonary oedema [Transfusion Related Acute Lung Injury (TRALI)].
Ig, so poročali o nekaj primerih akutnega nekardiogenega pljučnega edema [s transfuzijo povezane akutne poškodbe pljuč (TRALI - Transfusion Related Acute Lung Injury)].
Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Humani polispecifični imunoglobulin je po intravenski uporabi takoj in v celoti biološko uporaben v krvnem obtoku prejemnika.
If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response.
Če je zdravljenje učinkovito, mora zdravnik na osnovi bolnikovega odziva in vzdrževanja odziva presoditi, ali je primerno dolgotrajno zdravljenje.
In babies and young children (aged 0 - 2 years) hereditary fructose intolerance may not yet be diagnosed and may be fatal, thus, they must not receive this medicine (see special warnings about excipients at the end of this section).
Pri dojenčkih in majhnih otrocih (starih od 0-2 leti) morda še ni bila postavljena diagnoza dedne intolerance za fruktozo, ki je lahko smrtna, zato ne smejo prejemati tega zdravila (glejte posebna opozorila o pomožnih snoveh na koncu tega poglavja).
IVIg recipients should be monitored for clinical signs and symptoms of haemolysis.
Ig spremljati klinične znake in simptome hemolize.
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 hepatitis A and parvovirus B19 viruses.
Ti ukrepi so učinkoviti pri virusih z ovojnico, kot so virus humane imunske pomanjkljivosti (HIV), virus hepatitisa B (HBV) in virus hepatitisa C (HCV) ter pri virusih brez ovojnice virusu hepatitisa A (HAV) in parvovirusu B19.
The dose interval when steady state has been reached varies from 3 - 4 weeks.
Presledek med odmerki v stanju dinamičnega ravnovesja je od 3-4 tedne.
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Kronična vnetna demielinizacijska poliradikulonevropatija (CIDP)
Infusion reaction
Reakcija na infuzijo
Precautions for use
Previdnostni ukrepi za uporabo
Cyanosis was reported in one child but not in adults.
Pri enem otroku, ne pa tudi pri odraslih, so poročali o cianozi.
For patients experiencing adverse reactions, it is advisable to reduce the infusion rate in subsequent infusions and limit the maximum rate to 0.04 ml/kg/min, or administer IVIg at a 5% concentration.
Pri bolnikih, pri katerih se pojavijo neželeni učinki, je priporočljivo zmanjšati hitrost infundiranja pri nadaljnjih infuzijah in omejiti največjo hitrost na 0,04 ml/kg/min ali uporabiti i.v.
Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks.
Vzdrževalni odmerek: 1 g/kg vsake 2-4 tedne ali 2 g/kg vsakih 4-8 tednov.
IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction (Coomb's test) and, rarely, haemolysis.
Ig lahko vsebujejo protitelesa krvne skupine, ki lahko delujejo kot hemolizini in sprožijo vezavo imunoglobulinov na eritrocite in vivo, kar povzroči pozitivno neposredno antiglobulinsko reakcijo (Coombov test) in redko hemolizo.
Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.
Farmakoterapevtska skupina: imunski serumi in imunoglobulini: humani polispecifični imunoglobulini za intravaskularno uporabo; oznaka ATC: J06BA02.
Paediatric population It is recommended to monitor vital signs when administering Flebogamma DIF to paediatric patients.
Pediatrična populacija Kadar dajemo zdravilo Flebogamma DIF pediatričnim bolnikom, je priporočljivo spremljati bolnikove vitalne znake.
• cases of Transfusion Related Acute Lung Injury (TRALI)
• primere s transfuzijo povezane akutne poškodbe pljuč (TRALI).
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 and parvovirus B19 viruses.
Ti ukrepi so učinkoviti pri virusih z ovojnico, kot so virus imunske pomanjkljivosti (HIV), virus hepatitisa B in hepatitisa C, in pri virusih brez ovojnice hepatitisa A in parvovirusu B19.
You will be watched carefully until an hour after the infusion to detect potential side effects.
Da bi lahko odkrili morebitne neželene učinke, vas bodo še eno uro po infuziji skrbno opazovali.
Other medicines and Flebogamma DIF
Druga zdravila in zdravilo Flebogamma DIF
In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
V primeru neželenega učinka je treba upočasniti ali prekiniti infundiranje.
As the dosage for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions, the dosage in children is not considered to be different to that of adults.
Odmerjanje se določa za posamezno indikacijo glede na telesno maso in se prilagaja glede na klinični izid, zato se odmerjanje pri otrocih ne razlikuje od odmerjanja pri odraslih.
If you get more Flebogamma DIF than you should, your body may take on too much fluid.
Če ste uporabili večji odmerek zdravila Flebogamma DIF, kot bi smeli Če ste dobili večji odmerek zdravila Flebogamma DIF, kot bi smeli, ste s tem lahko v svoje telo dobili preveč tekočine.
This medicine contains 50 mg of sorbitol per ml.
To zdravilo vsebuje 50 mg sorbitola na ml.
In case of renal impairment, IVIg discontinuation should be considered.
V primeru ledvične okvare je treba razmisliti o prekinitvi zdravljenja z i.v.
How to store Flebogamma DIF Contents of the pack and other information
Shranjevanje zdravila Flebogamma DIF Vsebina pakiranja in dodatne informacije
This medicine contains less than 1 mmol sodium (23 mg) per vial of 10 ml, 50 ml, 100 ml and 200 ml, that is to say essentially “sodium free”.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo z 10 ml, 50 ml, 100 ml in 200 ml, kar v bistvu pomeni ‘brez natrija'.
This leaflet was last revised in MM/YYYY
DATUM ZADNJE REVIZIJE BESEDILA MM/LLLL
The maximum IgA content is 100 micrograms/ml.
Največja vsebnost IgA je 100 mikrogramov/ml.
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 pa pri uporabi zdravil, ki so pripravljena iz človeške krvi ali plazme, ni mogoče popolnoma izključiti možnosti prenosa povzročiteljev okužb.
What you need to know before you use Flebogamma DIF
Kaj morate vedeti, preden boste uporabili zdravilo Flebogamma DIF
Flebogamma DIF is a solution for infusion.
Flebogamma DIF je raztopina za infundiranje.
The solution is clear or slightly opalescent and colourless or pale yellow.
Raztopina je bistra ali rahlo opalescentna in brezbarvna ali bledo rumena.
The solution should be clear or slightly opalescent and colourless or pale yellow.
Raztopina mora biti bistra ali rahlo opalescentna in brezbarvna ali bledo rumena.
METHOD AND ROUTE(S) OF ADMINISTRATION To hang pull here
POSTOPEK IN POT(I) UPORABE ZDRAVILA Da obesite, povlecite tukaj.
The recommended starting dose is 0.4 - 0.8 g/kg given once followed by at least 0.2 g/kg given every three to four weeks.
Priporočljiv začetni odmerek je 0,4-0,8 g/kg (enkraten odmerek), kateremu naj sledi najmanj 0,2 g/kg, ki se daje vsake tri do štiri tedne.
Three clinical trials were performed with Flebogamma DIF, one for replacement therapy in patients with primary immunodeficiency (in both adults and in children above 6 years) and two for immunomodulation, in patients with immune thrombocytopenic purpura (one in adult patients and another in both adults and in children between 3 and 16 years).
Z zdravilom Flebogamma DIF so izvedli tri klinična preskušanja, eno kot nadomestno zdravljenje pri bolnikih s primarno imunsko pomanjkljivostjo (pri odraslih in pri otrocih, starih nad 6 let), in dve kot imunomodulacijo pri bolnikih z imunsko trombocitopenično purpuro (eno pri odraslih bolnikih, drugo pa pri odraslih in pri otrocih, starih od 3 do 16 let).
In a Post-authorisation Safety Study that included 66 patients, Flebogamma DIF 100 mg/ml showed a higher rate (18.46%, n=24/130) of infusions associated with potentially related adverse events than Flebogamma DIF 50 mg/ml (2.22%, n=3/135).
bolnikov, je bilo pri zdravilu Flebogamma DIF 100 mg/ml več (18,46 %, n=24/130) infuzij s potencialno povezanimi neželenimi učinki kot zdravilo Flebogamma DIF 50 mg/ml (2,22 %,
● maculopathy (illness of the macula, in the retina of the eyes)
● makulopatija (bolezen makule oziroma pege v očesni mrežnici), ● zamegljen vid,
Uncommon Rare
izpuščaj redki
Flebogamma DIF 100 mg/ml is contraindicated in children aged 0 to 2 years (see section 4.3).
Zdravilo Flebogamma DIF 100 mg/ml je kontraindicirano pri otrocih, starih od 0 do 2 leti (glejte poglavje 4.3).
Flebogamma DIF 50 mg/ml is contraindicated in children aged 0 to 2 years (see section 4.3).
Zdravilo Flebogamma DIF 50 mg/ml je kontraindicirano pri otrocih, starih od 0 do 2 leti (glejte poglavje 4.3).
It is strongly recommended that every time that Flebogamma DIF 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.
Zelo priporočljivo je, da vsakič, ko bolniku daste zdravilo Flebogamma DIF, zabeležite ime in serijsko številko zdravila, saj tako ohranjate povezavo med bolnikom in serijo zdravila.
If you forget to use Flebogamma DIF
Če ste pozabili uporabiti zdravilo Flebogamma DIF
● ecchymosis (large skin haematoma)
● ekhimoza (veliki kožni hematomi),
The most reported post-marketing ADRs received since the product was authorised for both concentrations were chest pain, flushing, blood pressure increased and decreased, malaise, dyspnoea, nausea, vomiting, pyrexia, back pain, headache and chills.
Neželeni učinki zdravila, o katerih so najpogosteje poročali po odobritvi obeh koncentracij zdravila, so bili bolečina v prsih, napadi rdečice, zvišanje in znižanje krvnega tlaka, splošno slabo počutje, dispneja, navzea, bruhanje, zvišana telesna temperatura, bolečina v hrbtu, glavobol in mrzlica.
The maximum IgA content is 50 micrograms/ml.
Največja vsebnost IgA je 50 mikrogramov/ml.
It contains trace amounts of IgA (lower than 50 micrograms/ml).
Vsebuje sledove IgA (manj kot 50 mikrogramov/ml).
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, and patients with diseases which increase blood viscosity).
Ig predpisujete in infundirate bolnikom s čezmerno telesno maso in bolnikom, pri katerih obstajajo dejavniki tveganja za trombotične dogodke (kot so visoka starost, hipertenzija, sladkorna bolezen in žilna obolenja ali trombotične epizode v anamnezi, bolniki s pridobljenimi ali prirojenimi trombofilnimi motnjami, bolniki z dolgo dobo imobilizacije, bolnikih z resno hipovolemijo in bolniki z boleznimi, ki povečujejo viskoznost krvi).
Adverse reactions may occur more frequently - 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 - in patients with an untreated infection or underlying chronic inflammation
- pri bolnikih, ki humani normalni imunoglobulin prejemajo prvič, ali v redkih primerih, ko bolniki zamenjajo zdravilo s humanim normalnim imunoglobulinom ali ko je od prejšnjega infundiranja preteklo veliko časa, - pri bolnikih z nezdravljeno okužbo ali osnovnim kroničnim vnetjem.
Infections and infestations Influenza, Meningitis aseptic, Urinary tract infection
Infekcijske in parazitske bolezni gripa, aseptični meningitis, okužba sečil občasni občasni