FrancophonIA/ELRC3.0 huggingface dataset:
English: 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)
Croatian: Imunomodulacija odraslih, djece i adolescenata (2 - 18 godina) kod: - primarne imunotrombocitopenije (ITP) u bolesnika s visokim rizikom od pojave krvarenja ili prije kirurškog zahvata u svrhu korekcije broja trombocita - Guillain-Barréovog sindroma - Kawasakijeve bolesti (zajedno s acetilsalicilatnom kiselinom, vidjeti dio 4.2) - kronične upalne demijelinizacijske poliradikuloneuropatije - multifokalne motorne neuropatije.
English: Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA-containing product can result in anaphylaxis.
Croatian: Bolesnici sa selektivnim nedostatkom IgA koji su razvili protutijela na IgA, jer primjena lijeka koji sadrži IgA može rezultirati anafilaksijom.
English:  Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Croatian: Drugi lijekovi i Flebogamma DIF  Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove.
English: • 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.
Croatian: • Akutno oštećenje pluća povezano s transfuzijom koje uzrokuje hipoksiju (nedostatak kisika), dispneju (otežano disanje), tahipneju (ubrzano disanje), cijanozu (nedostatak kisika u krvi), vrućicu i nizak krvni tlak.
English: In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
Croatian: U slučaju nuspojava potrebno je ili smanjiti brzinu primjene infuzije ili zaustaviti infuziju.
English: • 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)
Croatian: • bolesnici sa sindromima sekundarne imunodeficijencije s teškim ili ponavljajućim infekcijama, neučinkovitim antimikrobnim liječenjem te ili s dokazanim izostankom odgovora specifičnog protutijela (engl. proven specific antibody failure, PSAF)* ili s razinom IgG-a u serumu < 4 g/l (skupina 2).
English: ● influenza like illness
Croatian: ● bolest nalik gripi
English: ● conjunctivitis (inflammation of the conjuntiva of the eyes)
Croatian: ● konjunktivitis (upala konjunktive oka)
English: The maximum IgA content is 100 micrograms/ml.
Croatian: Maksimalni sadržaj IgA iznosi 100 mikrograma/ml.
English: • Increase in serum creatinine level (a test which measures your kidney function) and/or acute renal failure (which signs are low back pain, fatigue, decrease in the amount of urine).
Croatian: • povećanje razine serumskog kreatinina (test koji mjeri funkciju bubrega) i/ili akutno zatajenje bubrega (čiji su znakovi bol u donjem dijelu leđa, umor, smanjena količina mokraće)
English: 2.0 g/kg should be administered as a single dose.
Croatian: Dozu od 2,0 g/kg treba primijeniti jednokratno.
English: Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dl. AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment.
Croatian: Pleocitoza do nekoliko tisuća stanica po mm3 pretežno granulocitne loze i povišene razine proteina do nekoliko stotina mg/dl često su prisutni u cerebrospinalnoj tekućini.
English: 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 (see section 4.4).
Croatian: U bolesnika kod kojih se javljaju nuspojave preporuča se smanjiti brzinu infuzije pri sljedećim primjenama i ograničiti maksimalnu brzinu na 0,04 ml/kg/min ili primijeniti i.v. Ig u koncentraciji od 5% (vidjeti dio 4.4).
English: 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.
Croatian: Poduzete mjere se smatraju učinkovitima za viruse s ovojnicom kao što su virus ljudske imunodeficijencije (HIV), hepatitis B virus i hepatitis C virus te za viruse bez ovojnice kao što su hepatitis A virus i parvovirus B19.
English: The maximum IgA content is 50 micrograms/ml.
Croatian: Maksimalni sadržaj IgA iznosi 50 mikrograma/ml.
English: Acne, Alopecia, Ecchymosis, Erythema, Hyperhidrosis, Palmar erythema, Purpura
Croatian: Učestalost po infuziji tkiva akne, alopecija, ekhimoza, eritem, hiperhidroza, palmarni eritem, purpura manje često
English: • hyperhidrosis (excessive sweating)
Croatian: • hiperhidroza (prekomjerno znojenje)
English: Patients with a kidney problem
Croatian: Bolesnici s bubrežnim problemima
English: Can Guasc, 2 - Parets del Vallès 08150 Barcelona - Spain
Croatian: Can Guasc, 2 - Parets del Vallès 08150 Barcelona
English: What Flebogamma DIF looks like and contents of the pack
Croatian: Kako Flebogamma DIF izgleda i sadržaj pakiranja
English: What Flebogamma DIF is and what it is used for
Croatian: Što je Flebogamma DIF i za što se koristi
English: ● tachycardia (acceleration of the heart activity)
Croatian: ● tahikardija (ubrzani rad srca)
English: Flebogamma DIF contains sorbitol
Croatian: Flebogamma DIF sadrži sorbitol
English: • (rarely) a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration
Croatian: hemolitičku anemiju koja zahtijeva transfuziju • (rijetko) iznenadni pad krvnog tlaka i, u izoliranim slučajevima, anafilaktički šok čak i kada bolesnik nije pokazao preosjetljivost kod prethodne primjene
English: 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).
Croatian: Provedena su tri klinička ispitivanja s Flebogamma DIF-om; jedno za nadomjesnu terapiju u bolesnika s primarnom imunodeficijencijom (u odraslih i djece starije od 6 godina) i dva ispitivanja za imunomodulaciju u bolesnika s imunološkom trompocitopeničnom purpurom (jedno u odraslih bolesnika i drugo u odraslih i djece u dobi između 3 i 16 godina).
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP. Do not store above 30 ºC.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i pakiranju iza oznake „Rok valjanosti“ ili EXP.
English: 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).
Croatian: Potrebna je pozornost u propisivanju i primjeni i.v. infuzije Ig u pretilih bolesnika i u bolesnika s postojećim čimbenicima rizika za trombotske događaje (poodmakla životna dob, visoki tlak, šećerna bolest, anamneza krvožilnih bolesti ili trombotskih epizoda, bolesnici sa stečenim ili naslijeđenim trombofilnim poremećajima, bolesnici s duljim razdobljima imobilizacije, bolesnici s teškom hipovolemijom te bolesnici s bolestima koje povećavaju viskoznost krvi).
English: ● haematemesis (vomiting blood)
Croatian: ● hematemeza (povraćanje krvi)
English: 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.
Croatian: Provedena su tri klinička ispitivanja s Flebogamma DIF-om; dva za nadomjesnu terapiju u bolesnika s primarnom imunodeficijencijom (jedno u odraslih i djece starije od 10 godina, a drugo u djece u dobi između 2 i 16 godina) i jedno ispitivanje za imunomodulaciju u odraslih bolesnika s imunološkom trompocitopeničnom purpurom.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion.
Croatian: OBLIK I SADRŽAJ Otopina za infuziju.
English: 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.
Croatian: Ig lijekova koji sadržavaju razne pomoćne tvari kao što su saharoza, glukoza i maltoza, oni koji sadržavaju saharozu kao stabilizator odgovorni su za neproporcionalni udio u ukupnom broju slučajeva.
English: 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
Croatian: Nuspojave se mogu razviti češće - u bolesnika koji prvi put prime normalni ljudski imunoglobulin ili, u rijetkim slučajevima, kada se s lijeka s ljudskim normalnim imunoglobulinom prijeđe na neki drugi lijek ili kada je od prethodne infuzije prošlo dugo razdoblje
English: Therefore, IVIg recipients must be monitored for and IVIg infusion must be immediately stopped in case of pulmonary adverse reactions.
Croatian: Stoga je bolesnike koji primaju i.v. Ig potrebno pratiti, a infuziju odmah zaustaviti u slučaju plućnih nuspojava.
English: These are used to treat conditions where the body's defence system against disease is not working properly.
Croatian: Ovi se lijekovi koriste u terapiji raznih poremećaja rada obrambenog sustava tijela.
English: Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks.
Croatian: Doza održavanja: 1 g/kg svaka 2 do 4 tjedna ili 2 g/kg svakih 4 do 8 tjedana.
English: Certain adverse reactions (e.g. headache, flushing, chills, myalgia, wheezing, tachycardia, lower back pain, nausea, and hypotension) may be related to the rate of infusion.
Croatian: Određene nuspojave (npr. glavobolja, navale crvenila, zimica, mialgija, piskanje, tahikardija, bol u donjem dijelu leđa, mučnina i hipotenzija) mogu biti povezane s brzinom infuzije.
English: 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.
Croatian: Postoje klinički podaci koji potvrđuju povezanost i.v. primjene Ig i tromboembolijskih događaja kao što su to infarkt miokarda, cerebralni krvožilni događaj (uključujući i moždani udar), plućna embolija i duboka venska tromboza za koje se smatra da su posljedica relativnog povećanja viskoznosti krvi zbog visokog dotoka imunoglobulina u rizičnih bolesnika.
English: 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.
Croatian: U bolesnika kod kojih se javljaju nuspojave preporuča se smanjiti brzinu infuzije pri sljedećim primjenama i ograničiti maksimalnu brzinu na 0,04 ml/kg/min ili primijeniti i.v. Ig u koncentraciji od 5%.
English: It was observed that the proportion of headache, pyrexia, tachycardia and hypotension in children was higher than in adults.
Croatian: Primijećeno je da je u djece udio glavobolje, pireksije, tahikardije i hipotenzije bio viši nego u odraslih.
English: 0.8 - 1 g/kg or
Croatian: 0,8 - 1 g/kg ili
English: • history of vascular disease or thrombosis
Croatian: • krvožilne bolesti ili trombozu u povijesti bolesti
English: Do not use this medicine if you notice that the solution is cloudy or has deposits.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je otopina mutna ili sadrži krute čestice.
English: The safety results for 4 paediatric patients (those ≤ 17 years old) included in the PID study and the results for the 13 children (aged 3 to 16 years old) included in the ITP study were evaluated.
Croatian: ≤ 17 godina) uključena u PID ispitivanje i rezultati za 13-ero djece (u dobi od 3 do 16 godina) uključene u ITP
English: - The active substance is human normal immunoglobulin (IVIg).
Croatian: - Djelatna tvar je normalni ljudski imunoglobulin (i.v. Ig).
English: MARKETING AUTHORISATION HOLDER Instituto Grifols, S.A.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Instituto Grifols, S.A.
English: ● injection site reaction
Croatian: • reakcija na mjestu injekcije
English: Platelets form an important part of the clotting process and a reduction in their numbers may cause unwanted bleeding and bruising.
Croatian: Trombociti igraju važnu ulogu u procesu zgrušavanja i smanjen broj trombocita može uzrokovati neželjeno krvarenje i stvaranje podljeva (hematoma).
English: ● feeling jittery (nervousness)
Croatian: ● osjećaj razdražljivosti (nervoza)
English: 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)
Croatian: Izvor podataka bila je baza podataka o sigurnosti primjene iz kliničkih ispitivanja i ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet provedenih u ukupno 160 bolesnika izloženih lijeku Flebogamma DIF 100 mg/ml (ukupno 915 infuzija)
English: Infections and infestations Influenza, Meningitis aseptic, Urinary tract infection
Croatian: Infekcije i infestacije gripa, aseptički meningitis, infekcija mokraćnih puteva manje često manje često
English: Flebogamma DIF 50 mg/ml is contraindicated in children aged 0 to 2 years (see section 4.3).
Croatian: Pedijatrijska populacija Lijek Flebogamma DIF 50 mg/ml kontraindiciran je u djece u dobi od 0 do 2 godine (vidjeti dio 4.3).
English: 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)
Croatian: Izvor podataka bila je baza podataka o sigurnosti primjene iz kliničkih ispitivanja i ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet u ukupno 128 bolesnika izloženih lijeku Flebogamma DIF 50 mg/ml (ukupno 1318 infuzija)
English: Special precautions
Croatian: Posebne mjere opreza
English: IVIg products have been shown to cross the placenta, increasingly during the third trimester.
Croatian: Ig lijekovi prolaze kroz posteljicu, i to povećano tijekom trećeg trimestra.
English: 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).
Croatian: pokazalo se da je stopa infuzija s potencijalno povezanim nuspojavama bila veća uz primjenu lijeka Flebogamma DIF 100 mg/ml (18,46%, n = 24/130) nego uz lijek Flebogamma DIF 50 mg/ml (2,22%, n = 3/135).
English: Flebogamma DIF 100 mg/ml has a half-life of about 34 - 37 days.
Croatian: Poluvijek 100 mg/ml Flebogamma DIF-a je oko 34 - 37 dana.
English: • productive cough
Croatian: • produktivni kašalj
English: Flebogamma DIF 50 mg/ml has a half-life of about 30 - 32 days.
Croatian: Poluvijek 50 mg/ml Flebogamma DIF-a je oko 30 - 32 dana.
English: After receiving Flebogamma DIF, the results of certain blood tests (serological tests) may be interfered for a certain time.
Croatian: Nakon primjene, Flebogamma DIF može neko vrijeme utjecati na rezultate nekih krvnih pretraga
English: *PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
Croatian: * PSAF = neuspjeh postizanja najmanje dvostrukog porasta titra IgG protutijela na polisaharidne i polipeptidne antigene pneumokoknih cjepiva.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion
Croatian: OBLIK I SADRŽAJ Otopina za infuziju
English: • diseases which increase blood viscosity • age over 65
Croatian: • bolesti koje uzrokuju povišen viskozitet krvi
English: Paediatric population It is recommended to monitor vital signs when administering Flebogamma DIF to paediatric patients.
Croatian: Kada se Flebogamma DIF primjenjuje pedijatrijskim bolesnicima preporučuje se nadzirati vitalne znakove bolesnika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (0.5 g)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (0,5 g)
English: 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.
Croatian: Primjena imunoglobulina može umanjiti djelotvornost cjepiva koja sadrže žive atenuirane viruse kao što su to ospice, rubeola, zaušnjaci i vodene kozice u razdoblju od najmanje 6 tjedana do 3 mjeseca.
English: ● ecchymosis (large skin haematoma)
Croatian: ● ekhimoza (veliki hematom na koži)
English: The solution is clear or slightly opalescent and colourless or pale yellow.
Croatian: Otopina je bistra ili blago opalescentna i bezbojna ili blijedožuta.
English: • oedema peripheral
Croatian: • periferni edem
English: Infusion reaction
Croatian: Reakcija na infuziju
English: ● hyperhidrosis (excessive sweating)
Croatian: ● hiperhidroza (prekomjerno znojenje)
English: Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Croatian: A ili parvovirusa B19 vjerojatno zbog zaštitnih protutijela protiv ovih infekcije sadržanih u lijeku.
English: In persons more than 2 years old with problems to tolerate fructose, a spontaneous reaction for fructose-containing foods develops which may have the following symptoms: vomiting, gastro-intestinal disorders, apathy, height and weight retardation.
Croatian: U osoba starijih od 2 godine koje ne podnose fruktozu nastaje spontana reakcija na hranu koja sadrži fruktozu i ta reakcija može imati sljedeće simptome: povraćanje, probavne tegobe,
English: The recommended dose is 0.2 - 0.4 g/kg every three to four weeks.
Croatian: Preporučena doza iznosi 0,2 - 0,4 g/kg svaka tri do četiri tjedna.
English: The solution should be clear or slightly opalescent and colourless or pale yellow.
Croatian: Otopina treba biti bistra ili blago opalescentna i bezbojna ili blijedožuta.
English: Renal parameters should be assessed prior to infusion of IVIg, particularly in patients judged to have a potential increased risk for developing acute renal failure, and again at appropriate intervals.
Croatian: Ig-a i to osobito u bolesnika u kojih je, prema prosudbi, potencijalno povećan rizik od razvoja akutnog zatajenja bubrega, a zatim u odgovarajućim intervalima.
English: METHOD AND ROUTE(S) OF ADMINISTRATION To hang pull here
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Da biste objesili, povucite ovdje Za intravensku primjenu
English: 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.
Croatian: Najčešće prijavljene nuspojave nakon dobivanja odobrenja za stavljanja lijeka u promet za obje koncentracije lijeka, bile su bol u prsnom košu, navale crvenila, povišen i snižen krvni tlak,
English: ● hypotension (low blood pressure)
Croatian: ● hipotenzija (nizak krvni tlak)
English: Frequencies have been evaluated according to the following convention:
Croatian: Učestalosti nuspojava procijenjene su sukladno sljedećem:
English: Flebogamma DIF is supplied as 5 g/50 ml, 10 g/100 ml and 20 g/200 ml.
Croatian: Flebogamma DIF je dostupan u bočicama od 5 g/50 ml, 10 g/100 ml i 20 g/200 ml.
English: 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.
Croatian: Flebogamma DIF je dostupan u bočicama od 0,5 g/10 ml, 2,5 g/50 ml, 5 g/100 ml, 10 g/200 ml i 20 g/400 ml.
English: In patients at risk for acute renal failure, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Croatian: U bolesnika u kojih postoji rizik od akutnog zatajenja bubrega, i.v. Ig lijekove treba primjenjivati pri najmanjoj mogućoj brzini infuzije i dozi.
English: 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.
Croatian: Preporučena početna doza iznosi 0,4 - 0,8 g/kg tjelesne težine primijenjena jedanput, a nakon nje je potrebno svaka 3 do 4 tjedna dati dozu od najmanje 0,2 g/kg.
English: 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 (Coombs' test) and, rarely, haemolysis.
Croatian: I.v. Ig lijekovi mogu sadržavati protutijela na krvne grupe koja mogu reagirati kao hemolizini i in vivo dovesti do oblaganja eritrocita imunoglobulinom uzrokujući tako pozitivnu direktnu antiglobulinsku reakciju (Coombsov test) i rijetko hemolizu.
English: • 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.
Croatian: • nagli pad krvnog tlaka i u izoliranim slučajevima anafilaktični šok (čiji su znakovi, između ostalog, osip, hipotenzija, palpitacije, pištanje u plućima, kašljanje, kihanje i otežano disanje),
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Croatian: Bolesnici koji razviju nuspojave tijekom terapije ne bi smjeli upravljati vozilima ili raditi na strojevima dok se te nuspojave ne povuku.
English: There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to viral safety.
Croatian: Prema postojećem kliničkom iskustvu imunoglobulinima se ne prenosi hepatitis A ili parvovirus B19, a također se smatra da protutijela pridonose obrani od virusa.
English: There are five groups:
Croatian: Pet je skupina takvih poremećaja:
English: • chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain
Croatian: • zimicu, glavobolju, omaglicu, vrućicu, povraćanje, alergijske reakcije, mučninu, artralgiju,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL (0.5 g and 2.5 g)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE (0,5 g i 2,5 g)
English: It contains trace amounts of IgA (lower than 100 micrograms/ml).
Croatian: IgA je sadržan u tragovima (manje od 100 mikrograma/ml).
English: ● oedema peripheral
Croatian: ● periferni edem
English: At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 - 0.02 ml/kg/min).
Croatian: Na početku infuzije primit ćete lijek Flebogamma DIF malom brzinom (0,01 - 0,02 ml/kg/min).