FrancophonIA/ELRC3.0 huggingface dataset:
English: The absence of mortality in the non-clinical studies performed with Flebogamma DIF with doses up to 2500 mg/kg, and the lack of any confirmed relevant adverse sign affecting respiratory, circulatory and central nervous system of the treated animals support the safety of Flebogamma DIF.
Croatian: Odsutnost smrtnosti u nekliničkim ispitivanjima Flebogamma DIF-a u dozama do 2500 mg/kg i odsutnost bilo koje ozbiljnije nuspojave u dišnom, krvožilnom ili središnjem živčanom sustavu pokusnih životinja podržavaju sigurnost primjene Flebogamma DIF-a.
English: Fructose intolerance (see section 4.4).
Croatian: Nepodnošenje fruktoze (vidjeti dio 4.4).
English: • cases of increased serum creatinine level and/or occurrence of acute renal failure
Croatian: • slučajevi povišenih razina kreatinina u serumu i/ili nastanak akutnog zatajenja bubrega
English: After the administration of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Croatian: Nakon primjene imunoglobulina zabilježen je prolazni porast raznih pasivno prenesenih protutijela u krvi bolesnika što može uzrokovati lažno pozitivne rezultate seroloških testiranja.
English: • Kawasaki disease (in this case in conjunction with acetylsalicylic acid therapy), an illness in children where the blood vessels (arteries) in the body become enlarged.
Croatian: • Kawasakijeva bolest (u ovom slučaju zajedno s terapijom acetilsalicilatnom kiselinom), dječja bolest kod koje se proširuju krvne žile (arterije) u tijelu.
English: The product should be brought at room temperature (no more than 30 ºC) before use.
Croatian: Prije uporabe lijek mora dostići sobnu temperaturu (ne više od 30 ºC).
English: ● red blood cells and white blood cells decreased
Croatian: ● smanjenje broja crvenih i bijelih krvnih stanica
English: It is expected that the same interactions than those mentioned for the adults may be presented by the paediatric population.
Croatian: U pedijatrijskoj populaciji očekuju se interakcije jednake onim navedenima za odraslu populaciju.
English: If you have a renal disease and you are receiving Flebogamma DIF for the first time, you may suffer a problem in your kidneys.
Croatian: Imate li bolest bubrega i ovo je prvi put da primate lijek Flebogamma DIF, mogli biste imati probleme s bubrezima.
English: Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also section 4.4):
Croatian: Nuspojave uzrokovane normalnim ljudskim imunoglobulinima (navedene od veće prema manjoj učestalosti) obuhvaćaju (vidjeti također dio 4.4):
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Croatian: Kada se lijek proizvodi iz ljudske krvi ili plazme, poduzimaju se određene mjere u svrhu sprječavanja prijenosa infekcija na bolesnike.
English: The percentage of IgG subclasses is approximately 66.6% IgG1, 27.9% IgG2, 3.0% IgG3 and 2.5% IgG4.
Croatian: Postoci IgG podvrsta su otprilike 66,6% IgG1, 27,9% IgG2, 3,0% IgG3 i 2,5% IgG4.
English: • abnormal behaviour
Croatian: • neuobičajeno ponašanje
English: In the case of measles, this impairment may persist for up to 1 year.
Croatian: U slučaju ospica, to umanjivanje djelotvornosti cjepiva može potrajati do jedne godine.
English: Instituto Grifols, S.A. Polígono Levante Can Guasc, 2
Croatian: Polígono Levante Can Guasc, 2
English: • asthma
Croatian: • astma
English: It may happen particularly if you do not have enough immunoglobulins of the type IgA in your blood or have developed antibodies to IgA.
Croatian: Mogu se javiti osobito ako imate nedostatak imunoglobulina vrste IgA u krvi ili ste razvili protutijela na IgA.
English: ● fever (body temperature increased)
Croatian: • vrućica (povišena tjelesna temperatura)
English: • reversible haemolytic reactions; especially in those patients with blood groups A, B, and AB and (rarely) haemolytic anaemia requiring transfusion
Croatian: • reverzibilne hemolitičke reakcije, osobito u bolesnika krvne grupe A, B i AB te (rijetko)
English: Effects of the product on the immune system of the newborn have not been studied.
Croatian: Učinak lijeka na imunološki sustav novorođenčadi nije ispitivan.
English: If you use more Flebogamma DIF than you should
Croatian: Ako primijenite više lijeka Flebogamma DIF nego što ste trebali
English: • alanine aminotransferase (hepatic transaminase) increased
Croatian: • povišena alanin aminotransferaza (jetrena transaminaza)
English: This medicine contains less than 29,41 mg sodium (main component of cooking/table salt) in each vial of 400 ml.
Croatian: Ovaj lijek sadrži manje od 29,41 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici od 400 ml.
English: Patients may experience reactions (for example dizziness or nausea) during treatment, which might affect the ability to drive and use machines.
Croatian: Bolesnici tijekom liječenja mogu imati reakcije (na primjer omaglicu ili mučninu), koje mogu utjecati na sposobnost upravljanja vozilima i strojevima.
English: TRALI is characterised by severe hypoxia, dyspnoea, tachypnoea, cyanosis, fever and hypotension.
Croatian: TRALI karakteriziraju teška hipoksija, dispneja, tahipneja, cijanoza, vrućica i hipotenzija.
English: Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Croatian: Normalni ljudski imunoglobulin sadrži IgG protutijela koja su prisutna u normalnoj populaciji.
English: 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.
Croatian: Nadomjesna terapija kod sindroma primarnih imunodeficijencija Režimom doziranja treba se postići najniža IgG razina (izmjereno prije svake infuzije) od najmanje 6 g/l ili razina unutar normalnog referentnog raspona za dob populacije.
English: TRALI is a potentially life-threatening condition requiring immediate intensive-care-unit management.
Croatian: TRALI je stanje koje može ugroziti život i zahtijeva neodgodivo liječenje u jedinici intenzivne skrbi.
English: Polígono Levante Can Guasc, 2, E-08150 Parets del Vallès Barcelona, Spain
Croatian: Polígono Levante Can Guasc, 2, E-08150 Parets del Vallès Barcelona, Španjolska
English: • Cases of temporary reduction in the number of the red cells in the blood (reversible haemolytic anaemia/haemolysis).
Croatian: • privremeno smanjenje broja eritrocita u krvi (povratna hemolitička anemija/hemoliza).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene slijedom prema sve manjoj ozbiljnosti.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Cjepiva koja sadrže žive atenuirane viruse
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Croatian: Distribucija podvrsta imunoglobulina G proporcionalna je onoj u nativnoj ljudskoj plazmi.
English: Infusion rates during the initial infusions should be slow.
Croatian: Na početku infuzija mora teći sporo.
English: OTHER To hang pull here
Croatian: Da biste objesili, povucite ovdje
English: Multifocal motor neuropathy (MMN)
Croatian: Multifokalna motorna neuropatija
English: • 0.8 - 1 g/kg given on day one; this dose may be repeated once within 3 days.
Croatian: • 0,8 - 1 g/kg primijenjeno prvi dan; ta se doza može ponoviti još jednom u iduća 3 dana
English: • the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Croatian: • u postupke obrade krvi i plazme uključeni su koraci kojima se mogu deaktivirati ili odstraniti virusi.
English: 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.
Croatian: Doziranje u djece ne razlikuje se od doziranja u odraslih osoba jer se doza također određuje ovisno o bolesti i tjelesnoj težini djeteta.
English: Aseptic meningitis syndrome (AMS)
Croatian: Sindrom aseptičkog meningitisa (AMS)
English: Interferences with determination of blood glucose levels are not expected.
Croatian: Ne očekuje se utjecaj na rezultate mjerenja razine glukoze u krvi.
English: If there are no adverse reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate.
Croatian: Ako nema nuspojava, brzinu infuzije pri sljedećim primjenama moguće je postupno polako povisivati sve do maksimalne brzine.
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.
Croatian: Farmakoterapijska skupina: imunološki serumi i imunoglobulini: imunoglobulini, normalni ljudski, za intravaskularnu primjenu, ATK oznaka: J06BA02.
English: Transmissible agents
Croatian: Prenosivi agensi
English: 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
Croatian: Što je Flebogamma DIF i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Flebogamma DIF Kako primjenjivati lijek Flebogamma DIF
English: Treatment of adults, children and adolescents (2 - 18 years) who do not have sufficient antibodies (Flebogamma DIF is used as replacement therapy).
Croatian: Koristi se u terapiji odraslih, djece i adolescenata (2 - 18 godina) koji nemaju dovoljno protutijela (Flebogamma DIF služi kao nadomjesna terapija).
English: Instructions for handling and disposal
Croatian: Upute za rukovanje i zbrinjavanje
English: Immunoglobulins are excreted into human milk.
Croatian: Imunoglobulini se izlučuju u majčino mlijeko.
English: Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Croatian: Prema kliničkim iskustvima s primjenom imunoglobulina ne treba očekivati štetne učinke na tijek trudnoće ili na fetus i novorođenče.
English: ● maculopathy (illness of the macula, in the retina of the eyes)
Croatian: ● makulopatija (bolest makule, u mrežnici oka)
English: Each ml of this medicinal product contains 50 mg of sorbitol.
Croatian: Svaki ml ovog lijeka sadrži 50 mg sorbitola.
English: • in case of high rate of infusion
Croatian: • u slučaju visoke brzine infuzije
English: In patients receiving IVIg, there have been some reports of acute non-cardiogenic pulmonary oedema [Transfusion Related Acute Lung Injury (TRALI)].
Croatian: U bolesnika koji su primali i.v. Ig bilo je zabilježeno nekoliko slučajeva akutnog nekardiogenog plućnog edema (akutno oštećenje pluća povezano s transfuzijom [engl.
English: In case of rubella, mumps and varicella a period of up to 3 months should elapse after receiving this medicine and before receiving these vaccines.
Croatian: U slučaju cjepiva protiv rubeole, zaušnjaka i vodenih kozica, nakon primanja ovog lijeka treba proteći do 3 mjeseca prije cijepljenja ovim cjepivima.
English: • Cases of temporary non-infective meningitis (which signs are headache, fear or intolerance of light, stiff neck).
Croatian: • privremeni neinfektivni meningitis (čiji su znakovi glavobolja, strah ili nepodnošenje svjetlosti, ukočeni vrat)
English: Depending on how comfortable you feel, your doctor may then gradually increase the infusion rate (up to 0.08 ml/kg/min).
Croatian: Ovisno o tome kako se osjećate, Vaš liječnik može postupno povećati brzinu infuzije (do 0,08 ml/kg/min).
English: • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare and progressive disease causing limb weakness, numbness, pain and fatigue.
Croatian: • kronična upalna demijelinizacijska poliradikuloneuropatija, rijetka i progresivna bolest koja uzrokuje slabost udova, utrnulost, bol i umor
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
Croatian: • pažljiv izbor davatelja krvi i plazme kako bi se isključili potencijalno rizični davatelji
English: The dose that you will be given will depend on your illness and body weight and will be worked out by your doctor (please see section “Instructions for healthcare professionals” given at the end of this leaflet).
Croatian: Doza koju ćete primiti ovisi o Vašoj bolesti i tjelesnoj težini što će izračunati Vaš liječnik (vidjeti dio
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: Therefore patients receiving measles vaccine should have their antibody status checked.
Croatian: Prema tome, bolesnicima koji se cijepe protiv ospica treba provjeriti status protutijela.
English: • if you are having Flebogamma DIF for the first time, or it has been switched from an alternative human normal immunoglobulin (IVIg) product, or it is a long time since your last infusion (e.g. several weeks).
Croatian: • ako primate lijek Flebogamma DIF prvi put ili ste do tada primali drugi lijek koji sadrži ljudski imunoglobulin ili ako je prošlo mnogo vremena od prethodne infuzije (npr. nekoliko tjedana).
English: How to store Flebogamma DIF Contents of the pack and other information
Croatian: Kako čuvati lijek Flebogamma DIF Sadržaj pakiranja i druge informacije
English: Side effects may be reduced by switching to Flebogamma DIF 50 mg/ml.
Croatian: Nuspojave se mogu smanjiti prijelazom na lijek Flebogamma DIF 50 mg/ml.
English: Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Croatian: Normalni ljudski imunoglobulin je nakon intravenske primjene odmah i u potpunosti bioraspoloživ u cirkulaciji primatelja.
English: • (very rarely) thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses
Croatian: • (vrlo rijetko) tromboembolijske reakcije kao što su infarkt miokarda, moždani udar, plućna embolija, duboka venska tromboza
English: The dose interval when steady state has been reached varies from 3 - 4 weeks.
Croatian: Za održavanje postignutog stanja dinamičke ravnoteže, interval između doziranja varira od 3 do 4 tjedna.
English: • blood volume decrease
Croatian: • smanjeni volumen krvi
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
English: 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.
Croatian: Ovaj lijek sadrži manje od 29,41 mg natrija po bočici od 400 ml, što odgovara 1,5% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO-a za odraslu osobu.
English: The dose required to achieve a trough level of IgG of 6 g/l is of the order of 0.2 - 0.8 g/kg/month.
Croatian: Doza potrebna za postizanje najniže razine IgG-a od 6 g/l iznosi 0,2 - 0,8 g/kg na mjesec.
English: Information on overdose in children has not been established with Flebogamma DIF.
Croatian: Ne postoje podaci o predoziranju u djece za lijek Flebogamma DIF.
English: If you get more Flebogamma DIF than you should, your body may take on too much fluid.
Croatian: Ako ste primili više lijeka Flebogamma DIF nego što ste trebali, u organizmu može nastati suvišak tekućine.
English: 0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse).
Croatian: Doza od 0,4 g/kg na dan tijekom 5 dana (u slučaju recidiva doziranje se može ponoviti).
English: One ml contains 50 mg of D-sorbitol.
Croatian: Jedan ml lijeka sadrži 50 mg D-sorbitola.
English: • Patients with Primary Immunodeficiency Syndromes (PID), an inborn lack of antibodies (group 1)
Croatian: • bolesnici sa sindromima primarne imunodeficijencije, urođenim nedostatkom protutijela (skupina 1)
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Croatian: Usprkos ovim mjerama, pri primjeni lijekova proizvedenih iz ljudske krvi ili plazme, ne može se potpuno isključiti mogućnost prijenosa infekcije.
English: Flebogamma DIF is given by injection into your veins (intravenous administration).
Croatian: Flebogamma DIF se daje injekcijom u vene (intravenska primjena).
English: • infusion site reactions (erythema, extravasation, inflammation, pain)
Croatian: • reakcije na mjestu infuzije (eritem, ekstravazacija, upala, bol)
English: For intravenous use.
Croatian: Za intravensku primjenu.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Usprkos tome, pri primjeni lijekova proizvedenih iz ljudske krvi ili plazme, ne može se potpuno isključiti mogućnost prijenosa infektivnih agensa.
English: 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).
Croatian: Pasivno prenesena protutijela protiv eritrocitnih antigena, npr. A, B, D, mogu interferirati s nekim serološkim testovima na protutijela na crvene krvne stanice, primjerice s izravnim antiglobulinskim testom (DAT, izravni Coombsov test).
English: Replacement therapy:
Croatian: Nadomjesna terapija:
English: 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.
Croatian: Budući da doziranje za svaku indikaciju ovisi o tjelesnoj težini i prilagođava se kliničkom ishodu gore navedenih stanja, doziranje u djece i adolescenata (2 - 18 godina) ne razlikuje se od doziranja u odraslih bolesnika.
English: 0.4 g/kg/d on day 1, possibly repeated once within 3 days for 2 - 5 days
Croatian: 0,4 g/kg/d prvog dana, može se ponoviti još jednom unutar 3 dana tijekom 2 - 5 dana
English: Do not use Flebogamma DIF if you notice that the solution is cloudy or has deposits.
Croatian: Ne koristite lijek Flebogamma DIF ako primijetite da je otopina mutna ili sadrži krute čestice.
English: Transfusion related acute lung injury (TRALI)
Croatian: Transfusion Related Acute Lung Injury,
English: For intravenous use
Croatian: Za intravensku primjenu
English: 0.4 g/kg/d for 5 days
Croatian: 0,4 g/kg/d tijekom 5 dana
English: 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.
Croatian: Ne smijete nikad primijeniti lijek kad ste sami; s Vama uvijek mora biti odgovorna odrasla osoba.
English: Treatment of adults, children and adolescents (2 - 18 years) with certain autoimmune disorders (immunomodulation).
Croatian: Koristi se u terapiji odraslih, djece i adolescenata (2 - 18 godina) koji imaju određene autoimune poremećaje (imunomodulacija).
English: • cases of Transfusion Related Acute Lung Injury (TRALI)
Croatian: • slučajevi akutnog oštećenja pluća povezanog s transfuzijom (TRALI).
English: Flebogamma DIF is a solution for infusion.
Croatian: Flebogamma DIF je otopina za infuziju.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Instituto Grifols, S.A.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Instituto Grifols, S.A.
English: In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
Croatian: U većini slučajeva u tih su bolesnika identificirani čimbenici rizika kao što su to postojeća bubrežna insuficijencija, šećerna bolest, hipovolemija, pretilost, istodobna terapija nefrotoksičnim lijekovima ili dob iznad
English: If the patient tolerates the infusion well, additional increments of 0.02 ml/kg/min may be made at 30-minute intervals up to a maximum of 0.08 ml/kg/min.
Croatian: Ako bolesnik dobro podnosi infuziju, brzinu je moguće povećavati za po 0,02 ml/kg/min svakih 30 minuta do maksimalnih 0,08 ml/kg/min.
English: 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.
Croatian: Navedene mjere smatraju se učinkovitima za viruse s ovojnicom kao što su virus humane imunodeficijencije (HIV), virus hepatitisa B (HBV) i virus hepatitisa C (HCV) i za viruse bez ovojnice kao što su virus hepatitisa A i parvovirus B19.
English: Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae.
Croatian: Ig terapije rezultirao je remisijom AMS-a unutar nekoliko dana bez posljedica.
English: Replacement therapy: Primary immunodeficiency syndromes
Croatian: Nadomjesna terapija kod sindroma primarnih imunodeficijencija
English: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Croatian: Prema kliničkim iskustvima s primjenom imunoglobulina ne treba očekivati štetne učinke na plodnost.
English: • 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).
Croatian: • tromboembolijske reakcije kao što su infarkt miokarda (stezanje u prsima s osjećajem prebrzog rada srca), moždani udar (slabost mišića lica, ruke ili noge, otežan govor ili razumijevanje govora), plućna embolija (nedostatak daha, bol u prsnom košu i umor), duboka venska tromboza (bolovi i oticanje udova)
English: Pack size of 1 vial.
Croatian: Veličina pakiranja je 1 bočica.
English: Indication
Croatian: Indikacija
English: The safety results for 29 paediatric patients (those ≤ 17 years old) included in the PID studies were evaluated.
Croatian: Procijenjeni su sigurnosni rezultati za 29 pedijatrijskih bolesnika (onih u dobi
English: Aseptic meningitis syndrome has been reported to occur in association with IVIg treatment.
Croatian: Prijavljena je pojava sindroma aseptičkog meningitisa povezana s i.v. Ig terapijom.
English: • 0.4 g/kg given daily for two to five days.
Croatian: • 0,4 g/kg primijenjeno svakodnevno tijekom dva do pet dana.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 ºC.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30 ºC.
English: 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).
Croatian: Dojenčad i mala djeca (u dobi od 0 - 2 godine), u kojih nasljedno nepodnošenje fruktoze vjerojatno još nije utvrđeno i moglo bi biti smrtonosno, ne smiju primati ovaj lijek (vidjeti posebna upozorenja o pomoćnim tvarima na kraju ovog dijela).
English: • Primary immune thrombocytopenia (ITP), a condition where the number of platelets in the blood stream is greatly reduced.
Croatian: • primarna imunotrombocitopenija (ITP), stanje u kojem je broj trombocita u krvi znatno snižen.
English: ● bronchitis
Croatian: • bronhitis
English: Flebogamma DIF 100 mg/ml is contraindicated in children aged 0 to 2 years (see section 4.3).
Croatian: Lijek Flebogamma DIF 100 mg/ml kontraindiciran je u djece u dobi od 0 do 2 godine (vidjeti dio 4.3).