FrancophonIA/ELRC3.0 huggingface dataset:
English: It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3 - 5 days equilibrium is reached between the intra- and extravascular compartments.
Croatian: Raspodjeljuje se relativno brzo između plazme i ekstravaskularne tekućine, nakon približno 3 - 5 dana postiže se ravnoteža između intra- i ekstravaskularnih odjeljaka.
English: It is worth considering that these 2 subjects contributed to the higher frequency of infusions with reactions in this group.
Croatian: Valja uzeti u obzir da su ta 2 ispitanika pridonijela većoj učestalosti infuzija s reakcijama u toj skupini.
English: Symptoms of TRALI typically develop during or within 6 hours of a transfusion, often within 1 - 2 hours.
Croatian: Simptomi TRALI-ja obično se razviju tijekom ili unutar 6 sati od transfuzije, često unutar 1 - 2 sata.
English: This half-life may vary from patient to patient, in particular in primary immunodeficiency.
Croatian: Taj poluvijek može se razlikovati od bolesnika do bolesnika, a naročito u primarnoj imunodeficijenciji.
English: Assessment of vital signs in clinical trials of the paediatric population did not indicate any pattern of clinically relevant changes.
Croatian: Procjena vitalnih znakova u kliničkim ispitivanjima pedijatrijske populacije nije pokazala nikakav obrazac klinički značajnih promjena.
English: You must not be given a double dose to make up for a forgotten dose.
Croatian: Ne smijete primiti dvostruku dozu kako bi se nadoknadila zaboravljena doza.
English: • Guillain Barré syndrome, where the immune system damages the nerves and hinders them from working properly.
Croatian: • Guillain-Barréov sindrom, pri kojem imunološki sustav oštećuje živce ometajući tako njihov ispravan rad.
English: Maintenance dose:
Croatian: Doza održavanja:
English: ● general physical health deterioration
Croatian: ● pogoršanje općeg tjelesnog zdravlja
English: It is usually prepared from pooled plasma from not fewer than 1000 donors.
Croatian: Normalno je pripremljen iz pûla plazme od najmanje 1000 davatelja.
English: Tell your doctor or pharmacist immediately and follow his/her instructions.
Croatian: Odmah obavijestite svog liječnika ili ljekarnika i pridržavajte se njegovih/njenih uputa.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primite ovaj lijek.
English: Patients with pre-existing risk factors
Croatian: Bolesnici s postojećim čimbenicima rizika
English: Seek medical care with no delay if any of the following side effects happen during or after the infusion:
Croatian: Zatražite medicinsku skrb bez odlaganja ako se tijekom ili nakon infuzije pojavi bilo koja od sljedećih nuspojava:
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka potrebno je uvesti standardno medicinsko liječenje za šok.
English: The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Croatian: Mehanizam djelovanja u indikacijama osim onih za nadomjesnu terapiju još nije u potpunosti razjašnjen, ali uključuje imunomodulatorni učinak.
English: Neutropenia/Leukopenia
Croatian: Neutropenija/leukopenija
English: For safety information with respect to transmissible agents, see section 4.4.
Croatian: Za informacije o sigurnosti u pogledu prenosivih agensa, vidjeti dio 4.4.
English: 2 g/kg in one dose in association with acetylsalicylic acid
Croatian: 2 g/kg u jednoj dozi, zajedno s acetilsalicilatnom kiselinom
English: Single dose toxicity studies were carried out in rats and mice.
Croatian: Ispitivanja toksičnosti jednostruke doze su rađena na štakorima i miševima.
English: In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations.
Croatian: U rijetkim i izoliranim slučajevima, sljedeće nuspojave su zabilježene za pripravke imunoglobulina.
English: You will be watched carefully until an hour after the infusion to detect potential side effects.
Croatian: Pomno će Vas nadzirati jedan sat nakon završetka infuzije kako bi se uočile potencijalne nuspojave.
English: No evidence is available to require a dose adjustment.
Croatian: Nema dokaza da je potrebna prilagodba doze.
English: ● photophobia (excessive sensitivity to light)
Croatian: ● fotofobija (prekomjerna osjetljivost na svjetlo)
English: All other patients should be observed for at least 20 minutes after administration
Croatian: Sve druge bolesnike treba promatrati barem 20 minuta nakon primjene lijeka.
English: Guillain Barré syndrome
Croatian: Guillain-Barréov sindrom
English: 6.6 Special precautions for disposal and other handling The product should be brought to room or body temperature before use.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Lijek mora dostići sobnu temperaturu ili temperaturu tijela prije uporabe.
English: - The other ingredients are sorbitol and water for injections (see section 2 for further information about ingredients).
Croatian: Drugi sastojci su sorbitol i voda za injekcije (za dodatne informacije o sastojcima, vidjeti dio 2).
English: Patients with rare hereditary problems of fructose intolerance must not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim nepodnošenjem fruktoze ne smiju primiti ovaj lijek.
English: Distribution of the IgG subclasses (approx. values): IgG1 66.6%
Croatian: Raspodjela podvrsta IgG (približne vrijednosti): IgG1 66,6%
English: MedDRA System Organ Class (SOC)
Croatian: MedDRA klasifikacija organskih sustava (SOC)
English: Your doctor will consider your risk factors and take measures such as to decrease the rate of infusion or to stop the treatment.
Croatian: Liječnik će razmotriti čimbenike rizika koje imate i poduzeti mjere opreza kao što su smanjenje brzine infuzije ili prekid liječenja.
English: Cyanosis (lack of oxygen in the blood) was reported in one child but not in adults.
Croatian: Cijanoza (nedostatak kisika u krvi) zabilježena je u slučaju jednog djeteta, ali ne i u odraslih.
English: This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your heart or your kidneys.
Croatian: To se naročito može dogoditi ako ste rizični bolesnik, primjerice stariji bolesnik ili bolesnik sa srčanim ili bubrežnim problemima.
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Croatian: Sigurnost primjene ovog lijeka u trudnoći nije utvrđena kontroliranim kliničkim ispitivanjima i prema tome može se samo uz oprez primijeniti u trudnica i dojilja.
English: There were no other subjects with more than 1 infusion with adverse reactions in both groups.
Croatian: Od ostalih ispitanika, ni jedan nije imao više od 1 infuzije s nuspojavama u obje skupine.
English: - very common (>1/10) - common (>1/100 to <1/10) - uncommon (>1/1,000 to <1/100) - rare (>1/10,000 to <1/1,000) - very rare (<1/10,000) - not known (cannot be estimated from the available data)
Croatian: - često (≥1/100 i <1/10) - manje često (≥1/1000 i <1/100) - rijetko (≥1/10 000 i <1/1000) - vrlo rijetko (<1/10 000) - nepoznato (ne može se procijeniti iz dostupnih podataka)
English: • the testing of each donation and pools of plasma for signs of virus/infections,
Croatian: • testiranje svake donacije i pûla plazme na viruse/infekcije
English: Certain side effects may occur more frequently:
Croatian: Neke nuspojave mogu biti češće od drugih:
English: ● reticulocyte count increased
Croatian: ● povećan broj retikulocita
English: IgG trough levels should be measured and assessed in conjunction with the incidence of infection.
Croatian: Najniže razine IgG-a potrebno je mjeriti i procijeniti povezano s incidencijom infekcije.
English: The dosing and intervals may have to be adapted according to the individual course of the disease.
Croatian: Doziranje i intervale može biti potrebno prilagoditi prema individualnom tijeku bolesti.
English: Effects on blood tests
Croatian: Učinci na krvne pretrage
English: Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.
Croatian: Dozu treba prilagoditi prema potrebi kako bi se postigla optimalna zaštita protiv infekcija; dozu može biti potrebno povisiti u bolesnika s perzistirajućom infekcijom, a sniženje doze može se uzeti u obzir kada u bolesnika ne dolazi do pojave infekcija.
English: Patients should receive concomitant treatment with acetylsalicylic acid.
Croatian: Istodobno bi bolesnici trebali primati acetilsalicilatnu kiselinu.
English: - If you have fructose intolerance, a quite rare genetic condition where the enzyme for breaking down fructose is not produced.
Croatian: - ako imate poremećaj nepodnošenja fruktoze, vrlo rijedak genetski poremećaj u kojem se ne stvara enzim za razgrađivanje fruktoze.
English: No dose adjustment unless clinically warranted, see section 4.4.
Croatian: Nije potrebna prilagodba doze, osim kada je to klinički opravdano, vidjeti dio 4.4.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, nor with any other IVIg products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima, ni s bilo kojim drugim i.v. Ig lijekom.
English: This typically occurs within hours or days after IVIg administration and resolves spontaneously within 7 to 14 days.
Croatian: To se obično događa u roku od nekoliko sati ili dana nakon primjene i.v. imunoglobulina, a povuče se spontano unutar 7 do 14 dana.
English: • Effects on vaccines: Flebogamma DIF may reduce the effectiveness of certain types of vaccines (live attenuated virus vaccines).
Croatian: • Učinak na cjepiva: Flebogamma DIF može smanjiti djelotvornost nekih vrsta cjepiva (cjepiva koja sadrže žive oslabljene viruse).
English: • dermatitis contact
Croatian: • kontaktni dermatitis
English: Interference with serological testing
Croatian: Utjecaj na serološka testiranja
English: The dose and dose regimen is dependent on the indication.
Croatian: Doza i režim doziranja ovisi o indikaciji.
English: However, as in adult population, overdose may lead to fluid overload and hyperviscosity as with any other intravenous immunoglobulins.
Croatian: Međutim, kao i u odrasloj populaciji predoziranje može dovesti do preopterećenja tekućinom i hiperviskoznosti kao i nakon intravenske primjene bilo kojeg imunoglobulina.
English: However, depending on the required dose, the patient may receive more than 1 vial.
Croatian: Međutim, ovisno o potrebnoj dozi, bolesnik može primiti više od 1 bočice.
English: Flebogamma DIF does not contain sucrose, maltose or glucose.
Croatian: Flebogamma DIF ne sadrži saharozu, maltozu ili glukozu.
English: To reduce the rate of bacterial infections, it may be necessary to increase the dosage and aim for higher trough levels.
Croatian: Kako bi se smanjila stopa bakterijskih infekcija može biti potrebno povisiti dozu s ciljem postizanja viših željenih najnižih razina.
English: Hypersensitivity reactions are rare.
Croatian: Reakcije preosjetljivosti su rijetke.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 August 2007
Croatian: Datum prvog odobrenja: 23. kolovoza 2007.
English: Secondary immunodeficiencies (as defined in 4.1)
Croatian: Sekundarne imunodeficijencije (kako je definirano u dijelu 4.1)
English: Talk to your doctor, pharmacist or nurse before using Flebogamma DIF.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego što primite lijek Flebogamma DIF.
English: Flebogamma DIF contains human normal immunoglobulin, highly purified protein extracted from human plasma (part of the blood of donors).
Croatian: Flebogamma DIF sadrži prirodni ljudski imunoglobulin, visoko pročišćeni protein koji se izdvaja iz ljudske plazme (sastavni dio krvi darivatelja).
English: The treatment required depends on the nature and severity of the adverse reaction.
Croatian: Liječenje koje je potrebno ovisi o naravi i težini nuspojave.
English: Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4).
Croatian: Predoziranje može dovesti do preopterećenja tekućinom i hiperviskoznosti, osobito u rizičnih bolesnika, uključujući starije bolesnike ili bolesnike s oštećenjem srčane ili bubrežne funkcije (vidjeti dio 4.4).
English: The treatment can be repeated if relapse occurs.
Croatian: Ako nastupi relaps, liječenje se može ponoviti.
English: If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response.
Croatian: Ako je liječenje učinkovito, o dugotrajnom liječenju treba odlučiti liječnik na temelju bolesnikova odgovora i trajanja odgovora.
English: If you have a blood test after receiving Flebogamma DIF, please tell the analyst or your doctor that you have been given this medicine.
Croatian: Ako ćete raditi pretrage krvi nakon dobivanja Flebogamma DIF-a, obavijestite laboranta ili svog liječnika da ste primili ovaj lijek.
English: Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
Croatian: Odgovarajuće doze ovog lijeka mogu povratiti abnormalno niske vrijednosti imunoglobulina G u normalni raspon vrijednosti.
English: However one subject treated with Flebogamma DIF 100 mg/ml presented mild episodes of headache in all infusions and one more patient had 2 episodes of pyrexia in 2 infusions.
Croatian: Međutim, jedan ispitanik liječen lijekom Flebogamma DIF 100 mg/ml imao je epizode blage glavobolje kod svih infuzija, dok je drugi bolesnik imao 2 epizode pireksije kod 2 infuzije.
English: Flebogamma DIF is isotonic, with an osmolality from 240 to 370 mOsm/kg.
Croatian: Flebogamma DIF je izotonična otopina, osmolalnosti od 240 do 370 mOsm/kg.
English: A significant increase in median platelet levels was achieved in a clinical trial in chronic ITP patients (64,000/µl) although it did not reach normal levels.
Croatian: Značajno povećanje u medijanu razine trombocita postignuto je u kliničkom ispitivanju u bolesnika s kroničnom ITP-om (64 000/µl), iako nisu postignute normalne razine.
English: ● tremor (to tremble)
Croatian: ● tremor (drhtanje)
English: Flebogamma DIF should not be mixed with other medicines or intravenous solutions and it should be administered by a separate intravenous line.
Croatian: Flebogamma DIF se ne smije miješati s drugim lijekovima ili intravenskim otopinama i mora se primijeniti u odvojenoj intravenskoj infuziji.
English: It may be self-administered if you have been fully trained by hospital staff.
Croatian: Lijek možete primijeniti sami sebi ako Vas je bolničko osoblje u potpunosti obučilo za to.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se također odnosi na nepoznate viruse ili viruse u nastajanju i druge patogene.
English: Do not store above 30 ºC.
Croatian: Ne čuvati na temperaturi iznad 30 ºC.
English: • (rarely) transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown)
Croatian: • (rijetko) prolazne kožne reakcije (uključujući kožni eritemski lupus - učestalost nije poznata)
English: This medicine belongs to the group of medicines called intravenous immunoglobulins.
Croatian: Ovaj lijek pripada skupini lijekova koji se nazivaju intravenski imunoglobulini.
English: The syndrome usually begins within several hours to 2 days following IVIg treatment.
Croatian: Taj sindrom obično počinje unutar nekoliko sati do 2 dana nakon i.v.
English: This applies to any unknown or emerging viruses or other types of infections.
Croatian: To se odnosi na bilo koji nepoznati virus ili virus u nastajanju ili druge oblike infekcija.
English: LIST OF EXCIPIENTS D-sorbitol, water for injections.
Croatian: D-sorbitol, voda za injekcije.
English: Secondary immunodeficiencies
Croatian: Sekundarne imunodeficijencije
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Tablica prikazana u nastavku je prema MedDRA klasifikaciji organskih sustava (SOC i razina preporučenog pojma).
English: 08150 Barcelona - Spain
Croatian: 08150 Barcelona
English: ● meningitis aseptic (non-infective meningitis)
Croatian: ● aseptički meningitis (neinfektivni meningitis)
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Croatian: Normalni ljudski imunoglobulin sadrži uglavnom imunoglobulin G (IgG) s protutijelima širokog spektra protiv infektivnih agensa.
English: The dose may need to be individualised for each patient dependent on the clinical response.
Croatian: Doziranje treba individualizirati za svakog bolesnika ovisno o kliničkom odgovoru.
English: Please consult your doctor should you have increased side effects.
Croatian: Molimo Vas da se posavjetujete s liječnikom ako se nuspojave povećaju.
English: ● radicular syndrome (neck or back pain and other symptoms such as numbness, tingling and weakness in the arms or legs)
Croatian: ● radikularni sindrom (bolovi u vratu ili leđima i drugi simptomi kao što su utrnulost, trnci i slabost u rukama ili nogama)
English: ● syncope vasovagal (temporary loss of consciousness)
Croatian: ● vazovagalna sinkopa (privremeni gubitak svijesti)
English: Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies.
Croatian: Ispitivanja toksičnosti ponovljene doze i ispitivanja embriofetalne toksičnosti nisu izvediva zbog indukcije protutijela kao i interferencije s protutijelima.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere za sprječavanje infekcija koje su posljedica uporabe lijekova proizvedenih iz ljudske krvi ili plazme uključuju odabir davatelja, ispitivanje prisutnosti specifičnih markera infekcije u pojedinačnim donacijama i pûlu plazme te uvođenje proizvodnih postupaka kojima se inaktiviraju/odstranjuju virusi.
English: The product is also used in patients at high risk of bleeding or prior to surgery to correct the platelet count.
Croatian: Lijek se također koristi u bolesnika s visokim rizikom od pojave krvarenja ili prije kirurškog zahvata u svrhu korekcije broja trombocita.
English: Cyanosis was reported in one child but not in adults.
Croatian: Cijanoza je bila prijavljena za jedno dijete, ali nije zabilježena u odraslih.
English: ● blood pressure increased or decreased
Croatian: ● krvni tlak povišen ili snižen
English: No negative effects on the breastfed newborns/infants are anticipated.
Croatian: Ne očekuju se negativni učinci na dojenu novorođenčad/dojenčad.
English: Special safety warning
Croatian: Posebna upozorenja o sigurnosti
English: Please tell your doctor if you have any other condition and/or illness, as control is required in patients with pre-existing risk factors for thrombotic events (formation of blood clots inside your blood).
Croatian: Obavijestite svog liječnika ako imate bilo koje drugo stanje i/ili bolujete od neke druge bolesti, jer je bolesnike s postojećim čimbenicima rizika za trombotske događaje (stvaranje krvnih ugrušaka u krvi) potrebno kontrolirati.
English: Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Croatian: 4.2 Doziranje i način primjene Nadomjesnu terapiju treba započeti i provoditi pod nadzorom liječnika iskusnog u liječenju imunodeficijencije.
English: No differences of the pharmacokinetic properties are expected in the paediatric population.
Croatian: U pedijatrijskoj populaciji ne očekuju se drukčija farmakokinetička svojstva.
English: Dose based on body weight may require adjustment in underweight or overweight patients.
Croatian: Dozu koja se određuje na temelju tjelesne težine može biti potrebno prilagoditi u pothranjenih ili pretilih bolesnika.
English: Very common (may affect more than 1 in 10 infusions): ● headache
Croatian: Vrlo često (mogu se pojaviti kod više od 1 na 10 infuzija): ● glavobolja
English: Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients (see sections 4.4 and 6.1).
Croatian: Preosjetljivost na djelatnu tvar (ljudski imunoglobulini) ili neku od pomoćnih tvari (vidjeti dijelove 4.4 i 6.1).
English: 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.
Croatian: U slučaju nenamjerne primjene lijeka i sumnje na nepodnošenje fruktoze, infuziju treba odmah prekinuti, a postupcima intenzivnog liječenja ponovno uspostaviti normalnu glikemiju i stabilizirati funkciju organa.
English: Patients exhibiting such signs and symptoms should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
Croatian: U bolesnika u kojih se pojave takvi znakovi i simptomi potrebno je provesti temeljiti neurološki pregled, uključujući i analizu cerebrospinalne tekućine, kako bi se isključili drugi uzroci meningitisa.
English: • cases of reversible aseptic meningitis
Croatian: • slučajevi reverzibilnog aseptičkog meningitisa
English: Additional side effects in children and adolescents
Croatian: Dodatne nuspojave u djece i adolescenata
English: After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Croatian: Nakon primjene ovog lijeka mora proći vremenski interval od 3 mjeseca prije cijepljenja s cjepivima koja sadrže žive atenuirane viruse.
English: • Multifocal motor neuropathy (MMN), a rare disease causing slow progressive asymmetric limb weakness without sensory loss.
Croatian: • multifokalna motorna neuropatija, rijetka bolest koja uzrokuje sporu progresivnu asimetričnu slabost udova, bez gubitka osjeta.
English: Primary immunodeficiency syndromes Starting dose:
Croatian: Sindromi primarne imunodeficijencije Početna doza:
English: The dose recommendations are summarised in the following table:
Croatian: Preporučene doze prikazane su u sljedećoj tablici:
English: ● alopecia
Croatian: ● alopecija
English: E-08150 Parets del Vallès Barcelona, Spain
Croatian: E-08150 Parets del Vallès Barcelona, Španjolska
English: Increase in the frequency of adverse reactions through the clinical trials likely related to the increased infusion rate has been observed (see section 4.2).
Croatian: Primijećeno je povećanje učestalosti nuspojava tijekom kliničkih ispitivanja vjerojatno povezanih s povećanom brzinom infuzije (vidjeti dio 4.2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg) One ml contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Normalni ljudski imunoglobulin (i.v. Ig) Jedan ml lijeka sadrži:
English: The percentage of IgG subclasses is approximately 66.6% IgG1, 28.5% IgG2, 2.7% IgG3 and 2.2% IgG4.
Croatian: Postoci IgG podvrsta iznose otprilike 66,6% IgG1, 28,5% IgG2, 2,7% IgG3 i 2,2% IgG4.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 g / 10 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,5 g / 10 ml
English: ● anorexia (lack of appetite)
Croatian: ● anoreksija (gubitak apetita)