natgillin/translations-raw huggingface dataset:
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
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. 
Pri zdravilih, ki so izdelana iz človeške krvi ali plazme, je prenos okužbe na bolnike preprečen z več ukrepi.
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 povezana s trombemboličnimi dogodki, kot so miokardni infarkt, cerebralni vaskularni insult (vključno z možgansko kapjo), pljučna embolija in globoka venska tromboza, za katere domnevajo, da so povezani z relativnim povečanjem viskoznosti krvi zaradi dovajanja velike količine imunoglobulina pri bolnikih s tveganjem.
Replacement therapy in primary immunodeficiency syndromes The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 6 g/l or within the normal reference range for the population age. 
Nadomestno zdravljenje pri sindromih primarne imunske pomanjkljivosti Z režimom odmerjanja morate doseči najnižjo raven IgG (izmerjeno pred naslednjo infuzijo) najmanj
● heart rate increased 
● povečan srčni utrip,
Do not use Flebogamma DIF if you notice that the solution is cloudy or has deposits. 
Ne uporabljajte zdravila Flebogamma DIF, če opazite, da je raztopina motna ali ima usedlino.
● infusion related reaction and infusion site reaction (including infusion site erythema and infusion site pain) 
● reakcije, povezane z infundiranjem, in reakcije na mestu infundiranja (vključno z eritemom na mestu infundiranja in bolečino na mestu infundiranja),
• A sudden fall in blood pressure and, in isolated cases, anaphylactic shock (which signs are rash, hypotension, palpitation, wheezing, coughing, sneezing and difficulty breathing among others), even if you have shown no hypersensitivity to previous administration. 
• Nenaden padec krvnega tlaka, v posameznih primerih pa anafilaktični šok (znaki so lahko med drugim izpuščaj, hipotenzija, palpitacije, sopenje, kašljanje, kihanje in težave z dihanjem),
This typically occurs within hours or days after IVIg administration and resolves spontaneously within 7 to 14 days. 
Ig in spontano izzveni v 7-14 dneh.
● oedema peripheral 
● periferni edem,
Acne, Alopecia, Ecchymosis, Erythema, Hyperhidrosis, Palmar erythema, Purpura 
Bolezni kože in podkožja pruritus, izpuščaj pogosti občasni akne, alopecija, ekhimoza, eritem, hiperhidroza, palmarni eritem, purpura občasni
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. 
Navodilo je bilo nazadnje revidirano dne MM/LLLL Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
● cyanosis (bluish discoloration of the skin) 
● cianoza (modrikasta obarvanost kože),
The solution should be clear or slightly opalescent. 
Raztopina mora biti bistra ali rahlo opalescentna.
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 Coomb's test). 
A, B in D, lahko izzove motnje pri nekaterih seroloških preiskavah za protitelesa proti eritrocitom, na primer na direktni antiglobulinski test (DAT, direktni Coombov test).
Three clinical trials were performed with Flebogamma DIF, two for replacement therapy in patients with primary immunodeficiency (one in both adults and in children above 10 years and another in children between 2 to 16 years) and another for immunomodulation in adult patients with immune thrombocytopenic purpura. 
Z zdravilom Flebogamma DIF so izvedli tri klinična preskušanja, dve kot nadomestno zdravljenje pri bolnikih s primarno imunsko pomanjkljivostjo (eno pri odraslih kot tudi pri otrocih, starih nad 10 let, in drugo pri otrocih, starih 2 leti do 16 let) in tretje kot imunomodulacijo pri odraslih bolnikih z imunsko trombocitopenično purpuro.
Do not use Flebogamma DIF 
Ne uporabljajte zdravila Flebogamma DIF
Flebogamma DIF is isotonic, with an osmolality from 240 to 370 mOsm/kg. 
Njegova osmolalnost je od 240 do 370 mOsm/kg.
Each ml of this medicinal product contains 50 mg of sorbitol. 
En ml tega zdravila vsebuje 50 mg sorbitola.
Maintenance doses: 1 g/kg over 1 - 2 consecutive days every 3 weeks. 
Vzdrževalni odmerki: 1 g/kg, v obdobju 1-2 zaporednih dni vsake 3 tedne.
● chest discomfort/chest pain 
● neugodje/bolečine v prsnem košu,
Flebogamma DIF 100 mg/ml has a half-life of about 34 - 37 days. 
Razpolovni čas zdravila Flebogamma DIF 100 mg/ml je od 34 do 37 dni.
The product should be brought at room temperature (no more than 30 ºC) before use. 
Navodila za ravnanje in odstranjevanje Zdravilo pred uporabo segrejte na sobno ali telesno temperaturo (ne nad 30 ºC).
● syncope vasovagal (temporary loss of consciousness) 
● vazovagalna sinkopa (začasna izguba zavesti), ● konjunktivitis (vnetje očesne veznice),
It contains trace amounts of IgA (lower than 100 micrograms/ml). 
Vsebuje sledove IgA (manj kot 100 µg/ml).
● hypertension (high blood pressure) 
● hipertenzija (visok krvni tlak),
1 g/kg or 
1 g/kg
Flebogamma DIF 50 mg/ml has a half-life of about 30 - 32 days. 
Razpolovni čas zdravila Flebogamma DIF 50 mg/ml je od 30 do 32 dni.
 You should avoid the concomitant use of medicines that increase the excretion of water from your body (loop diuretics) during treatment with Flebogamma DIF. 
 Med zdravljenjem z zdravilom Flebogamma DIF se morate izogibati sočasni uporabi zdravil, ki zvečajo izločanje vode iz vašega telesa (diuretiki henlejeve zanke).
Immunomodulation in adults, children and adolescents (2 - 18 years) in: - Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count - Guillain Barré syndrome - Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2) - Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - Multifocal motor neuropathy (MMN) 
Imunomodulacija pri odraslih, otrocih in mladostnikih (2-18 let) pri: - Primarni imunski trombocitopeniji (ITP) pri bolnikih z velikim tveganjem za krvavitve ali pred kirurškim posegom za korekcijo števila trombocitov - Guillain-Barréjevem sindromu - Kawasakijevem sindromu (ob sočasnem zdravljenju z acetilsalicilno kislino; glejte poglavje 4.2)
● abdominal pain (including abdominal pain upper) 
● bolečina v trebuhu (vključno z bolečino v zgornjem delu trebuha),
• Cases of transfusion related acute lung injury (TRALI) that causes hypoxia (lack of oxygen), dyspnoea (difficulty in breathing), tachypnoea (rapid breathing), cyanosis (lack of oxygen in the blood), fever and hypotension. 
(pomanjkanje kisika), dispnejo (oteženo dihanje), tahipnejo (pospešeno dihanje), cianozo (pomanjkanje kisika v krvi), zvišano telesno temperaturo in hipotenzijo.
2 g/kg in divided doses over 2 - 5 consecutive days every 2 - 4 weeks every 4 - 8 weeks in divided doses over 2 - 5 days 
2 g/kg razdeljeno na več odmerkov v obdobju 2-5 zaporednih dni vsake 2-4 tedne vsakih 4-8 tednov, razdeljeno na več odmerkov v obdobju 2-5 dni
10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber). 
10 ml, 50 ml, 100 ml, 200 ml ali 400 ml raztopine v vialah (steklo tipa II) z zamaškom (klorobutilna guma).
2.0 g/kg should be administered as a single dose. 
Odmerek 2,0 g/kg dajte kot enojni odmerek.
• oedema peripheral 
• periferni edem,
Replacement therapy in adults, children and adolescents (2 - 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production 
Nadomestno zdravljenje pri odraslih, otrocih in mladostnikih (2-18 let) pri: - Sindromih primarne imunske pomanjkljivosti (PID) z zmanjšano tvorbo protiteles.
• 0.4 g/kg given daily for two to five days. 
• odmerek 0,4 g/kg na dan, dva do pet dni.
*PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. 
*PSAF = neuspeh pri doseganju vsaj 2-kratnega zvišanja titra protiteles IgG po cepljenju s pnevmokoknimi polisaharidnimi in polipeptidnimi antigenskimi cepivi.
● pain 
● bolečina
Human normal immunoglobulin …………..100 mg (purity of at least 97% IgG) 
Humani polispecifični imunoglobulin ...... 100 mg (čistost vsaj 97 % IgG)
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium free”. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni ‘brez natrija'.
Frequencies have been evaluated according to the following convention: 
Pogostnost neželenih učinkov je določena z naslednjimi merili:
50 ml, 100 ml or 200 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber). 
50 ml, 100 ml ali 200 ml raztopine v vialah (steklo tipa II) z zamaškom (klorobutilna guma).
Human normal immunoglobulin ……….. 50 mg (purity of at least 97% of IgG) 
Humani polispecifični imunoglobulin………..50 mg (čistost vsaj 97 % IgG)
* PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines 
*PSAF = neuspeh pri doseganju vsaj 2-kratnega zvišanja titra protiteles IgG po cepljenju s pnevmokoknimi polisaharidnimi in polipeptidnimi antigenskimi cepivi
Three to six months are required after the initiation of therapy for equilibration (steady-state IgG levels) to occur. 
Ravnovesje (ravni IgG v stanju dinamičnega ravnovesja) dosežete po treh do šestih mesecih po začetku zdravljenja.
The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued. 
Če po 6 mesecih ni opaznega učinka zdravljenja,
● hypotension (low blood pressure) 
● hipotenzija (nizek krvni tlak),
The recommended dose is 0.2 - 0.4 g/kg every three to four weeks. 
Priporočljiv odmerek je 0,2-0,4 g/kg na vsake tri do štiri tedne.
• pruritus (itching) 
• pruritus (srbenje),
A transient decrease in neutrophil count and/or episodes of neutropenia, sometimes severe, have been reported after treatment with IVIgs. 
Ig so poročali o prehodnem znižanju števila nevtrofilcev in/ali epizodah nevtropenije, ki je bila včasih resna.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (0.5 g) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (0,5 g)
At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 ml/kg/min). 
Na začetku infundiranja boste prejeli zdravilo Flebogamma DIF počasi (0,01 ml/kg/min).
Asthenia, Chest pain, Infusion site erythema, Infusion site extravasation, Infusion site inflammation, Infusion site pain, Injection site oedema, Injection site pain, Injection site pruritus, Injection site swelling, Oedema peripheral 
eritem na mestu infundiranja, ekstravazacija na mestu infundiranja, vnetje na mestu infundiranja, bolečine na mestu infundiranja, edem na mestu injiciranja, bolečine na mestu injiciranja, pruritus na mestu injiciranja, oteklina na mestu injiciranja, periferni edem občasni redki
Contents of the pack and other information What Flebogamma DIF contains - The active substance is human normal immunoglobulin (IVIg). 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Flebogamma DIF - Učinkovina je humani polispecifični imunoglobulin (i.v.
● haematemesis (vomiting blood) 
● hematemeza (bruhanje krvi),
Flebogamma DIF contains sorbitol 
Zdravilo Flebogamma DIF vsebuje sorbitol
The dose recommendations are summarised in the following table: Indication 
Priporočljivi odmerki so povzeti v naslednji preglednici:
● anorexia (lack of appetite) 
● anoreksija (izguba teka),
At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 - 0.02 ml/kg/min). 
Na začetku infundiranja boste prejeli zdravilo Flebogamma DIF počasi (0,01-0,02 ml/kg/min).
PHARMACEUTICAL FORM AND CONTENTS Solution for infusion 
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za infundiranje 1 viala
• blood pressure fluctuation 
• nihanja krvnega tlaka,
MARKETING AUTHORISATION HOLDER Instituto Grifols, S.A. 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Instituto Grifols, S.A.
Flebogamma DIF is supplied as 0.5 g/10 ml, 2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml and 20 g/400 ml vials. 
Zdravilo Flebogamma DIF je na voljo v vialah po 0,5 g/10 ml, 2,5 g/50 ml, 5 g/100 ml, 10 g/200 ml in 20 g/400 ml.
• nasopharyngitis 
• nazofaringitis,
Flebogamma DIF is given by injection into your veins (intravenous administration). 
Kako uporabljati zdravilo Flebogamma DIF Zdravilo Flebogamma DIF se daje z injiciranjem v vene (intravenska uporaba).