FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to use Flebogamma DIF
Croatian: Ako ste zaboravili primijeniti lijek Flebogamma DIF
English: In babies and young children (aged 0 - 2 years) hereditary fructose intolerance (HFI) may not yet be diagnosed and may be fatal, thus, they must not receive this medicinal product.
Croatian: Dojenčad i mala djeca (u dobi od 0 - 2 godine), koja možda još nemaju dijagnosticirano nasljedno nepodnošenje fruktoze a koje bi moglo biti smrtonosno, ne smiju primati ovaj lijek.
English: IVIg recipients should be monitored for clinical signs and symptoms of haemolysis.
Croatian: Ig terapije nužno je promatrati kako bi se uočili klinički znakovi i simptomi hemolize (vidjeti dio 4.8).
English: It contains trace amounts of IgA (lower than 50 micrograms/ml).
Croatian: IgA je sadržan u tragovima (manje od 50 mikrograma/ml).
English: 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”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici od 10 ml, 50 ml, 100 ml i 200 ml, tj. zanemarive količine natrija.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ovaj lijek sadrži 50 mg sorbitola po ml. Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije nego primite ovaj lijek.
English: ● hypertension (high blood pressure)
Croatian: • hipertenzija (visok krvni tlak)
English: Starting dose: 2 g/kg
Croatian: Doza održavanja: 1 g/kg ili
English: • dyspnoea (difficulty in breathing)
Croatian: • dispneja (otežano disanje)
English: At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 ml/kg/min).
Croatian: Na početku infuzije primit ćete lijek Flebogamma DIF malom brzinom (0,01 ml/kg/min).
English: Blood pressure diastolic decreased, Blood pressure increased, Blood pressure systolic increased, Heart rate increased
Croatian: povišen krvni tlak, povišen sistolički krvni tlak, povećana srčana frekvencija manje često snižen dijastolički krvni tlak,
English: In all patients, IVIg administration requires: - adequate hydration prior to the initiation of the infusion of IVIg - monitoring of urine output - monitoring of serum creatinine levels - avoidance of concomitant use of loop diuretics (see 4.5)
Croatian: - odgovarajuću hidraciju prije početka i.v. infuzije Ig - bilježenje volumena izlučene mokraće - praćenje razine serumskog kreatinina
English: If well tolerated, the rate of administration may gradually be increased to a maximum of 0.1 ml/kg/min.
Croatian: Ako se dobro podnosi, brzinu infuzije moguće je postupno povećavati do najviše 0,1 ml/kg/min.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu.
English: 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
Croatian: 2 g/kg u podijeljenim dozama tijekom 2 - 5 uzastopnih dana svaka 2 - 4 tjedna svakih 4 - 8 tjedana u podijeljenim dozama tijekom 2 - 5 dana
English: It is strongly recommended that every time you receive a dose of Flebogamma DIF, the name and batch number of the medicine (stated on the label and carton after Lot) are recorded in order to maintain a record of the batches used.
Croatian: Strogo se preporučuje bilježenje naziva i broja serije lijeka (navedenog na naljepnici i kutiji iza oznake „Serija”) pri svakoj primjeni lijeka Flebogamma DIF u svrhu evidencije korištenih serija za bolesnika.
English: What Flebogamma DIF contains
Croatian: Što Flebogamma DIF sadrži
English: A Post-Authorisation Safety Study suggested a higher rate of infusions associated with potentially related adverse events for Flebogamma DIF 100 mg/ml compared to Flebogamma DIF 50 mg/ml (see section 5.1).
Croatian: Ispitivanje sigurnosti primjene lijeka nakon stavljanja u promet Ispitivanje sigurnosti primjene lijeka nakon stavljanja u promet pokazalo je višu stopu infuzija s potencijalno povezanim nuspojavama uz primjenu lijeka Flebogamma DIF 100 mg/ml nego uz lijek Flebogamma DIF 50 mg/ml (vidjeti dio 5.1).
English: 1 g/kg or
Croatian: 2 g/kg
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (at an initial rate of 0.01 - 0.02 ml/kg/min) - are carefully monitored for any symptoms throughout the infusion period.
Croatian: - provjeri da bolesnici nisu osjetljivi na normalni ljudski imunoglobulin, što se ispituje polaganom početnom brzinom injiciranja lijeka (od 0,01 - 0,02 ml/kg/min) - bolesnike pažljivo promatra tijekom infuzije kako bi se opazili mogući simptomi.
English:  You should avoid the concomitant use of medicines that increase the excretion of water from your body (loop diuretics) during treatment with Flebogamma DIF.
Croatian: • Tijekom liječenja lijekom Flebogamma DIF morate izbjegavati istodobnu primjenu lijekova koji povećavaju izlučivanje vode iz tijela (diuretici Henleove petlje).
English: Blood pressure systolic decreased, Haemoglobin decreased, Heart rate decreased, Reticulocyte count increased
Croatian: snižen hemoglobin, smanjena srčana frekvencija, povećan broj retikulocita manje često
English: It was observed that the proportion of headache, fever, heart rate increased and low blood pressure in children was higher than in adults.
Croatian: Opaženo je da se glavobolja, vrućica, ubrzani otkucaji srca i nizak krvni tlak javljaju u djece u većem udjelu nego u odraslih.
English: 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.
Croatian: Strogo se preporučuje da se pri svakoj primjeni lijeka Flebogamma DIF zabilježi broj serije lijeka kako bi se evidentirala povezanost bolesnika sa serijom lijeka koji je primio.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (2.5 g, 5 g, 10 g and 20 g)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (2,5 g, 5 g, 10 g i 20 g)
English: - If you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na normalni ljudski imunoglobulin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako imate nedostatak imunoglobulina vrste IgA u krvi ili stvarate protutijela na IgA
English: Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin Each vial of 100 ml contains: 5 g of human normal immunoglobulin Each vial of 200 ml contains: 10 g of human normal immunoglobulin Each vial of 400 ml contains: 20 g of human normal immunoglobulin
Croatian: Jedna bočica od 10 ml sadrži: 0,5 g normalnog ljudskog imunoglobulina Jedna bočica od 50 ml sadrži: 2,5 g normalnog ljudskog imunoglobulina Jedna bočica od 100 ml sadrži: 5 g normalnog ljudskog imunoglobulina Jedna bočica od 200 ml sadrži: 10 g normalnog ljudskog imunoglobulina Jedna bočica od 400 ml sadrži: 20 g normalnog ljudskog imunoglobulina
English: Tachycardia
Croatian: • urtikarija
English: ● infusion related reaction and infusion site reaction (including infusion site erythema and infusion site pain)
Croatian: ● nelagoda u mišićima i kostima ● reakcije povezane s infuzijom i reakcije na mjestu infuzije (uključujući eritem na mjestu infuzije i bol na mjestu infuzije)
English: The following dosage regimens are given as a guideline.
Croatian: Stoga postoje sljedeće okvirne smjernice o režimu doziranja.
English: ● postnasal drip (excessive mucus)
Croatian: ● postnazalni drip (prekomjerno lučenje sluzi)
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored at the hospital during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Croatian: Ig lijek te bolesnike u kojih je mnogo vremena prošlo od prethodne infuzije; njih je potrebno u bolnici promatrati tijekom trajanja prve infuzije te jedan sat nakon završetka prve infuzije kako bi se uočile moguće nuspojave.
English: • injection site reactions (including injection site oedema, pain, pruritus and swelling)
Croatian: • reakcije na mjestu injekcije (uključujući edem, bol, svrbež i oticanje na mjestu injekcije)
English: • migraine
Croatian: • migrena
English: ● influenza (flu)
Croatian: ● gripa
English: Uncommon Rare
Croatian: manje često rijetko
English: • blood pressure increased
Croatian: • povišen krvni tlak
English: ● rigors (cold shivering sensation) or chills
Croatian: ● tresavica (osjećaj hladne drhtavice) ili zimica
English: The solution should be clear or slightly opalescent.
Croatian: Otopina treba biti bistra ili blago opalescentna.
English: Maintenance dose: 1 g/kg or 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
Croatian: Doza održavanja: 1 g/kg ili 2 g/kg u podijeljenim dozama tijekom 2 - 5 uzastopnih dana svaka 2 - 4 tjedna svakih 4 - 8 tjedana u podijeljenim dozama tijekom 2 - 5 dana
English: Contents of the pack and other information What Flebogamma DIF contains - The active substance is human normal immunoglobulin (IVIg).
Croatian: Što Flebogamma DIF sadrži - Djelatna tvar je normalni ljudski imunoglobulin (i.v. Ig).
English: It was observed that the proportion of headache, chills, pyrexia, nausea, vomiting, hypotension, heart rate increase and back pain in children was higher than in adults.
Croatian: Primijećeno je da je u djece udio glavobolje, zimice, pireksije, mučnine, povraćanja, hipotenzije, povećane srčane frekvencije i bolova u leđima bio viši nego u odraslih.
English: In persons more than 2 years old with HFI, a spontaneous aversion for fructose-containing foods develops and may be combined with the onset of symptoms (vomiting, gastro-intestinal disorders, apathy, height and weight retardation).
Croatian: U osoba s nasljednim nepodnošenjem fruktoze starijih od 2 godine razvija se spontana averzija prema hrani koja sadrži fruktozu, a ona može biti povezana s nastupom simptoma (povraćanje,
English: ● dyspnoea (difficulty in breathing)
Croatian: ● dispneja (otežano disanje)
English: Starting dose: 2 g/kg divided over 2 - 5 consecutive days.
Croatian: Početna doza: 2 g/kg u podijeljenim dozama tijekom 2 do 5 uzastopnih dana.
English: ● abdominal pain (including abdominal pain upper)
Croatian: • bol u trbuhu (uključujući bol u gornjem dijelu trbuha)
English: Therefore a detailed history with regard to HFI symptoms has to be taken of each patient prior to receiving Flebogamma DIF.
Croatian: Stoga se u svakog bolesnika prije primanja lijeka Flebogamma DIF mora uzeti detaljna anamneza u pogledu simptoma nasljednog nepodnošenja fruktoze.
English: Uncommon (may affect up to 1 in 100 infusions):
Croatian: Manje često (mogu se pojaviti kod manje od 1 na 100 infuzija):
English: Secondary immunodeficiencies (as defined in
Croatian: Sekundarne imunodeficijencije (kako su definirane u dijelu 4.1)
English: ● acne
Croatian: ● akne
English: 0.2 - 0.4 g/kg every 3 - 4 weeks
Croatian: 0,2 - 0,4 g/kg svaka 3 - 4 tjedna
English: 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
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija vrlo često često zimica, reakcija na mjestu injekcije, bol, rigor često manje često astenija, bol u prsnom košu, eritem na mjestu infuzije, ekstravazacija na mjestu infuzije, upala na mjestu infuzije, bol na mjestu infuzije, edem na mjestu injekcije, bol na mjestu injekcije, svrbež na mjestu injekcije, oticanje na mjestu injekcije, periferni edem,
English: ● cyanosis (bluish discoloration of the skin)
Croatian: ● cijanoza (plavkasta boja kože)
English: Starting dose: 0.4 - 0.8 g/kg
Croatian: Sindromi primarne imunodeficijencije Početna doza: 0,4 - 0,8 g/kg
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: It was observed that the proportion of headache, chills, fever, nausea, vomiting, low blood pressure, heart rate increase and back pain in children was higher than in adults.
Croatian: Opaženo je da se glavobolja, zimica, vrućica, mučnina, povraćanje, nizak krvni tlak, ubrzani otkucaji srca i bol u leđima javljaju u djece u većem udjelu nego u odraslih.
English: Chronic inflammatory demyelinating polyneuropathy (CIDP)
Croatian: Kronična upalna demijelinizacijska polineuropatija
English: Common (may affect up to 1 in 10 infusions):
Croatian: Često (mogu se pojaviti kod manje od 1 na 10 infuzija):
English: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Croatian: Kronična upalna demijelinizacijska poliradikuloneuropatija
English: • Cases of transient cutaneous reactions (side effects on your skin).
Croatian: • prolazne kožne reakcije (nuspojave na koži)
English: 0.2 - 0.8 g/kg every 3 - 4 weeks
Croatian: 0,2 - 0,8 g/kg svaka 3 - 4 tjedna
English: Three to six months are required after the initiation of therapy for equilibration (steady-state IgG levels) to occur.
Croatian: (razine IgG-a u stanju dinamičke ravnoteže) potrebno je tri do šest mjeseci od početka terapije.
English: ● thrombosis
Croatian: ● tromboza
English: ● myalgia (muscle pain)
Croatian: ● mialgija (bol u mišićima)
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 100 mg/ml solution for infusion
Croatian: NAZIV LIJEKA Flebogamma DIF 100 mg/ml otopina za infuziju
English: Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin
Croatian: Jedna bočica od 50 ml sadrži: 5 g normalnog ljudskog imunoglobulina Jedna bočica od 100 ml sadrži: 10 g normalnog ljudskog imunoglobulina Jedna bočica od 200 ml sadrži: 20 g normalnog ljudskog imunoglobulina
English: • device dislocation
Croatian: • pomicanje uređaja
English: Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Croatian: - bolesnike pažljivo promatra tijekom infuzije kako bi se opazili mogući simptomi.
English: Frequency per patient
Croatian: Učestalost po bolesniku
English: ● chest discomfort/chest pain
Croatian: ● nelagoda u prsnom košu / bol u prsnom košu
English: A transient decrease in neutrophil count and/or episodes of neutropenia, sometimes severe, have been reported after treatment with IVIgs.
Croatian: Nakon liječenja i.v. imunoglobulinima zabilježeno je prolazno smanjenje broja neutrofila i/ili epizode neutropenije koje su katkad teške.
English: ● epistaxis (haemorrhage from the nose)
Croatian: ● epistaksa (krvarenje iz nosa)
English: ● hypersensitivity
Croatian: ● preosjetljivost
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 50 mg/ml solution for infusion
Croatian: NAZIV LIJEKA Flebogamma DIF 50 mg/ml otopina za infuziju
English: Anaphylaxis can develop in patients - with undetectable IgA who have anti-IgA antibodies - who had tolerated previous treatment with human normal immunoglobulin
Croatian: Anafilaksija se može razviti u bolesnika - u kojih je IgA nemjerljivo nizak, a imaju anti-IgA protutijela
English: ● erythema (redness of the skin)
Croatian: ● eritem (crvenilo kože)
English: Cardiovascular disorder
Croatian: Oštećenje bubrežne funkcije
English: Immunomodulation: Primary immune thrombocytopenia
Croatian: Imunomodulacija: Primarna imunotrombocitopenija
English: • epistaxis (haemorrhage from the nose)
Croatian: • epistaksa (krvarenje iz nosa)
English: 10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber).
Croatian: Staklena bočica (staklo tip II) s 10 ml, 50 ml, 100 ml, 200 ml ili 400 ml otopine s gumenim čepom (klorobutil guma).
English: Human normal immunoglobulin …………..100 mg (purity of at least 97% IgG)
Croatian: Normalni ljudski imunoglobulin …………..100 mg
English: What Flebogamma DIF is
Croatian: Što je Flebogamma DIF
English: If well tolerated, advance to 0.02 ml/kg/min for the second 30 minutes.
Croatian: Ako se dobro podnosi, brzinu infuzije potrebno je povisiti na 0,02 ml/kg/min tijekom idućih 30 minuta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (5 g, 10 g and 20 g)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (5 g, 10 g i 20 g)
English: Therefore, patients should be examined for the symptoms of Hereditary Fructose Intolerance prior to receiving Flebogamma DIF.
Croatian: Stoga, prije primanja lijeka Flebogamma DIF bolesnike treba pregledati na simptome nasljednog nepodnošenja fruktoze.
English: This medicinal product 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”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici od 10 ml, 50 ml, 100 ml i 200 ml,
English: • blood pressure fluctuation
Croatian: • nestabilan krvni tlak
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Croatian: U bolesnika liječenih i.v. Ig zabilježeni su slučajevi akutnog zatajenja bubrega.
English: • blood pressure decreased
Croatian: • snižen krvni tlak
English: What you need to know before you use Flebogamma DIF
Croatian: Što morate znati prije nego počnete primjenjivati lijek Flebogamma DIF Nemojte primjenjivati lijek Flebogamma DIF
English: Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced red blood cells (RBC) sequestration.
Croatian: Ig terapije zbog pojačane sekvestracije crvenih krvnih stanica.
English: Rare (may affect up to 1 in 1000 infusions):
Croatian: Rijetko (mogu se pojaviti kod manje od 1 na 1000 infuzija): • preosjetljivost
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
English: Grifols UK Ltd. Tel: +44 845 2413090
Croatian: Tel: +44 845 2413090
English: ● heart rate increased
Croatian: ● ubrzani otkucaji srca
English: ● insomnia
Croatian: ● nesanica
English: Flushing, Haematoma, Lymphoedema, Systolic hypertension, Thrombosis
Croatian: limfedem, sistolička hipertenzija,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/006-008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/404/006-008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/001-005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/404/001-005
English: • Official batch release
Croatian: • Službeno puštanje serije lijeka u promet
English: Flebogamma DIF 50 mg/ml should be infused intravenously at an initial rate of 0.01 - 0.02 ml/kg/min for the first thirty minutes.
Croatian: Lijek Flebogamma DIF 50 mg/ml treba primijeniti u intravenskoj infuziji početnom brzinom od 0,01 - 0,02 ml/kg/min tijekom prvih 30 minuta.
English: Frequency per infusion
Croatian: Učestalost po infuziji
English: Urticaria
Croatian: Nuspojava
English: One ml contains 100 mg of human normal immunoglobulin, of which at least 97% is IgG.
Croatian: Jedan ml lijeka sadrži 100 mg normalnog ljudskog imunoglobulina, od čega IgG čini najmanje 97%.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Replacement therapy in adults, children and adolescents (2 - 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l
Croatian: - sindroma primarne imunodeficijencije (PID) s poremećenim stvaranjem protutijela - sekundarnih imunodeficijencija (SID) u bolesnika s teškim ili rekurentnim infekcijama, neučinkovitim antimikrobnim liječenjem te ili dokazanim izostankom odgovora specifičnog protutijela (engl. proven specific antibody failure, PSAF)* ili razinom IgG-a u serumu < 4 g/l.
English: Flebogamma DIF 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Croatian: Flebogamma DIF 100 mg/ml otopina za infuziju normalni ljudski imunoglobulin (i.v. Ig)
English: One ml contains 50 mg of human normal immunoglobulin, of which at least 97% is IgG.
Croatian: Jedan ml lijeka sadrži 50 mg normalnog ljudskog imunoglobulina, od čega IgG čini najmanje 97%.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije reakcija povezana s infuzijom manje često manje često
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: Flebogamma DIF 50 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Croatian: Flebogamma DIF 50 mg/ml otopina za infuziju normalni ljudski imunoglobulin (i.v. Ig)
English: In case of renal impairment, IVIg discontinuation should be considered.
Croatian: U slučaju oštećenja bubrežne funkcije dolazi u obzir prekid i.v.
English: Chest discomfort, Chest pain, Fatigue, Feeling cold, Infusion site reaction, Malaise, Oedema peripheral, Pain
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija, rigor vrlo često često zimica često nelagoda u prsnom košu, bol u prsnom košu, umor, osjećaj hladnoće, reakcija na mjestu infuzije, malaksalost, periferni edem, bol osjećaj nervoze, bolest slična gripi,
English: Immune system disorders Hypersensitivity
Croatian: Poremećaji imunološkog sustava preosjetljivost često manje često
English: Flebogamma DIF 100 mg/ml should be infused intravenously at an initial rate of 0.01 ml/kg/min for the first thirty minutes.
Croatian: Lijek Flebogamma DIF 100 mg/ml treba primijeniti u intravenskoj infuziji početnom brzinom od 0,01 ml/kg/min tijekom prvih 30 minuta.
English: How to store Flebogamma DIF
Croatian: Kako primjenjivati lijek Flebogamma DIF
English: • rash (eruption of the skin)
Croatian: • osip (izbijanje promjena na koži)
English: ● wheezing
Croatian: ● mučnina
English: Migraine
Croatian: • glavobolja
English: • dizziness (motion sickness)
Croatian: • omaglica (bolest kretanja)
English: The ability to drive and operate machines may be impaired by some adverse reactions, such as dizziness, associated with Flebogamma DIF.
Croatian: Neke nuspojave povezane s lijekom Flebogamma DIF, primjerice omaglica, mogu utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: Alanine aminotransferase increased, Blood pressure increased
Croatian: Pretrage povišen sistolički krvni tlak,
English: Depending on how comfortable you feel, your doctor may then gradually increase the infusion rate (up to 0.1 ml/kg/min).
Croatian: Ovisno o tome kako se osjećate, Vaš liječnik može postupno povećati brzinu infuzije (do
English: Grifols Italia S.p.A. Tel: +39 050 8755 113
Croatian: Tel: +39 050 8755 113
English: ● haematoma
Croatian: ● vrtoglavica
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Abdominal pain upper, Abdominal pain, Diarrhoea, Nausea, Vomiting Common
Croatian: bol u abdomenu, proljev, mučnina, povraćanje često manje često
English: ● haemoglobin decreased
Croatian: ● sniženje hemoglobina
English: Maintenance dose: 1 g/kg in divided doses over 2 - 5 days every 3 weeks over 1 - 2 days
Croatian: Doza održavanja: 1 g/kg u podijeljenim dozama tijekom 2 - 5 dana svaka 3 tjedna, kao jedna doza ili u podijeljenim dozama tijekom 2 dana