FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: (pomanjkanje kisika), dispnejo (oteženo dihanje), tahipnejo (pospešeno dihanje), cianozo (pomanjkanje kisika v krvi), zvišano telesno temperaturo in hipotenzijo.
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
Slovenian: 2 g/kg razdeljeno na več odmerkov v obdobju 2-5 zaporednih dni vsake 2-4 tedne vsakih 4-8 tednov, razdeljeno na več odmerkov v obdobju 2-5 dni
English: 10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber).
Slovenian: 10 ml, 50 ml, 100 ml, 200 ml ali 400 ml raztopine v vialah (steklo tipa II) z zamaškom (klorobutilna guma).
English: 2.0 g/kg should be administered as a single dose.
Slovenian: Odmerek 2,0 g/kg dajte kot enojni odmerek.
English: • oedema peripheral
Slovenian: • periferni edem,
English: Replacement therapy in adults, children and adolescents (2 - 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production
Slovenian: Nadomestno zdravljenje pri odraslih, otrocih in mladostnikih (2-18 let) pri: - Sindromih primarne imunske pomanjkljivosti (PID) z zmanjšano tvorbo protiteles.
English: • 0.4 g/kg given daily for two to five days.
Slovenian: • odmerek 0,4 g/kg na dan, dva do pet dni.
English: *PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
Slovenian: *PSAF = neuspeh pri doseganju vsaj 2-kratnega zvišanja titra protiteles IgG po cepljenju s pnevmokoknimi polisaharidnimi in polipeptidnimi antigenskimi cepivi.
English: ● pain
Slovenian: ● bolečina
English: Human normal immunoglobulin …………..100 mg (purity of at least 97% IgG)
Slovenian: Humani polispecifični imunoglobulin ...... 100 mg (čistost vsaj 97 % IgG)
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni ‘brez natrija'.
English: Frequencies have been evaluated according to the following convention:
Slovenian: Pogostnost neželenih učinkov je določena z naslednjimi merili:
English: 50 ml, 100 ml or 200 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber).
Slovenian: 50 ml, 100 ml ali 200 ml raztopine v vialah (steklo tipa II) z zamaškom (klorobutilna guma).
English: Human normal immunoglobulin ……….. 50 mg (purity of at least 97% of IgG)
Slovenian: Humani polispecifični imunoglobulin………..50 mg (čistost vsaj 97 % IgG)
English: * PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Slovenian: *PSAF = neuspeh pri doseganju vsaj 2-kratnega zvišanja titra protiteles IgG po cepljenju s pnevmokoknimi polisaharidnimi in polipeptidnimi antigenskimi cepivi
English: Three to six months are required after the initiation of therapy for equilibration (steady-state IgG levels) to occur.
Slovenian: Ravnovesje (ravni IgG v stanju dinamičnega ravnovesja) dosežete po treh do šestih mesecih po začetku zdravljenja.
English: The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued.
Slovenian: Če po 6 mesecih ni opaznega učinka zdravljenja,
English: ● hypotension (low blood pressure)
Slovenian: ● hipotenzija (nizek krvni tlak),
English: The recommended dose is 0.2 - 0.4 g/kg every three to four weeks.
Slovenian: Priporočljiv odmerek je 0,2-0,4 g/kg na vsake tri do štiri tedne.
English: • pruritus (itching)
Slovenian: • pruritus (srbenje),
English: A transient decrease in neutrophil count and/or episodes of neutropenia, sometimes severe, have been reported after treatment with IVIgs.
Slovenian: Ig so poročali o prehodnem znižanju števila nevtrofilcev in/ali epizodah nevtropenije, ki je bila včasih resna.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (0.5 g)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (0,5 g)
English: At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 ml/kg/min).
Slovenian: Na začetku infundiranja boste prejeli zdravilo Flebogamma DIF počasi (0,01 ml/kg/min).
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
Slovenian: eritem na mestu infundiranja, ekstravazacija na mestu infundiranja, vnetje na mestu infundiranja, bolečine na mestu infundiranja, edem na mestu injiciranja, bolečine na mestu injiciranja, pruritus na mestu injiciranja, oteklina na mestu injiciranja, periferni edem občasni redki
English: Contents of the pack and other information What Flebogamma DIF contains - The active substance is human normal immunoglobulin (IVIg).
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Flebogamma DIF - Učinkovina je humani polispecifični imunoglobulin (i.v.
English: ● haematemesis (vomiting blood)
Slovenian: ● hematemeza (bruhanje krvi),
English: Flebogamma DIF contains sorbitol
Slovenian: Zdravilo Flebogamma DIF vsebuje sorbitol
English: The dose recommendations are summarised in the following table: Indication
Slovenian: Priporočljivi odmerki so povzeti v naslednji preglednici:
English: ● anorexia (lack of appetite)
Slovenian: ● anoreksija (izguba teka),
English: At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 - 0.02 ml/kg/min).
Slovenian: Na začetku infundiranja boste prejeli zdravilo Flebogamma DIF počasi (0,01-0,02 ml/kg/min).
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za infundiranje 1 viala
English: • blood pressure fluctuation
Slovenian: • nihanja krvnega tlaka,
English: MARKETING AUTHORISATION HOLDER Instituto Grifols, S.A.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Instituto Grifols, S.A.
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.
Slovenian: Zdravilo Flebogamma DIF je na voljo v vialah po 0,5 g/10 ml, 2,5 g/50 ml, 5 g/100 ml, 10 g/200 ml in 20 g/400 ml.
English: • nasopharyngitis
Slovenian: • nazofaringitis,
English: Flebogamma DIF is given by injection into your veins (intravenous administration).
Slovenian: Kako uporabljati zdravilo Flebogamma DIF Zdravilo Flebogamma DIF se daje z injiciranjem v vene (intravenska uporaba).
English: • dyspnoea (difficulty in breathing)
Slovenian: • dispneja (oteženo dihanje),
English: (See section 4.8)
Slovenian: (navedeno v poglavju 6).
English: Human normal immunoglobulin (IVIg)
Slovenian: Humani polispecifični imunoglobulin (i.v.
English: ● fatigue
Slovenian: ● utrujenost,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/404/006
English: It was observed that the proportion of headache, pyrexia, tachycardia and hypotension in children was higher than in adults.
Slovenian: Ugotovili so, da je bil delež glavobola, zvišane telesne temperature, tahikardije in hipotenzije pri otrocih večji kot pri odraslih.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL (5 g)
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA VIALI (5 g)
English: ● acne
Slovenian: ● akne,
English: ● epistaxis (haemorrhage from the nose)
Slovenian: ● epistaksa (krvavitev iz nosu),
English: Thromboembolism
Slovenian: Trombembolija
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (2.5 g, 5 g, 10 g and 20 g)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (2,5 g, 5 g, 10 g in 20 g)
English: ● myalgia (muscle pain)
Slovenian: ● mialgija (bolečine v mišicah),
English: • injection site reactions (including injection site oedema, pain, pruritus and swelling)
Slovenian: • reakcije na mestu injiciranja (vključno z edemom, bolečino, pruritusom in oteklino na mestu injiciranja),
English: Depending on how comfortable you feel, your doctor may then gradually increase the infusion rate (up to 0.1 ml/kg/min).
Slovenian: Odvisno od tega kako udobno se boste počutili, lahko zdravnik postopoma poveča hitrost infuzije (do
English: Starting dose: 2 g/kg divided over 2 - 5 consecutive days.
Slovenian: Začetni odmerek: 2 g/kg, razdeljeno na več odmerkov v obdobju 2-5 zaporednih dni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg) One ml contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Humani polispecifični imunoglobulin (i.v.
English: 1 g/kg in divided doses over 2 - 5 days every 3 weeks over 1 - 2 days
Slovenian: 1 g/kg razdeljeno na več odmerkov v obdobju 2-5 dni vsake 3 tedne, v obdobju 1-2 dni
English: 0.2 - 0.8 g/kg every 3 - 4 weeks
Slovenian: 0,2-0,8 g/kg vsake 3-4 tedne
English: Discontinuation of IVIg treatment has resulted in remission of AMS within several days without sequelae.
Slovenian: Ig je po več dneh prišlo do remisije AMS brez posledic.
English: Immunomodulation: Primary immune thrombocytopenia
Slovenian: Imunomodulacija: Primarna imunska trombocitopenija
English: Common (may affect up to 1 in 10 infusions):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 infuzij):
English: • hypertension
Slovenian: • hipertenzija,
English: Special precautions
Slovenian: Posebni varnostni ukrepi
English: Water for injections
Slovenian: D-sorbitol voda za injekcije
English: 0.4 g/kg/d for 5 days
Slovenian: 0,4 g/kg/dan 5 dni
English: ● injection site reaction
Slovenian: ● reakcija na mestu injiciranja,
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.
Slovenian: Ig, ali pa bolnike, pri katerih je od predhodnega infundiranja preteklo veliko časa, med prvim infundiranjem in še eno uro po prvem infundiranju spremljati v bolnišnici, da bi ugotovili znake morebitnih neželenih učinkov.
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.
Slovenian: - da bolniki niso občutljivi za humani polispecifični imunoglobulin, in sicer tako, da zdravilo prvikrat infundirate počasi (z začetno hitrostjo 0,01-0,02 ml/kg/min), - skrbno spremljanje bolnikov ves čas trajanja infuzije, da bi ugotovili morebitne simptome.
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.
Slovenian: Opazili so, da je delež glavobola, mrzlice, zvišane telesne temperature, navzee, bruhanja, znižanega krvnega tlaka, zvečanega srčnega utripa in bolečin v hrbtu pri otrocih večji kot pri odraslih.
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 100 mg/ml solution for infusion
Slovenian: IME ZDRAVILA Flebogamma DIF 100 mg/ml raztopina za infundiranje
English: 0.2 - 0.4 g/kg every 3 - 4 weeks
Slovenian: 0,2-0,4 g/kg vsake 3-4 tedne
English: • blood pressure decreased
Slovenian: • znižan krvni tlak.
English: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Slovenian: Plodnost Klinične izkušnje z imunoglobulini ne kažejo na vpliv na sposobnost razmnoževanja.
English: Uncommon (may affect up to 1 in 100 infusions):
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 infuzij):
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.
Slovenian: Če bolnik infundiranje dobro prenaša, lahko dodatno povečujete hitrost infundiranja v korakih po 0,02 ml/kg/min v 30-minutnih presledkih, do največ
English: IgG trough levels should be measured and assessed in conjunction with the incidence of infection.
Slovenian: Glede na incidenco okužb je treba izmeriti in oceniti najnižje ravni IgG.
English: ● thrombosis
Slovenian: ● tromboza,
English: ● erythema (redness of the skin)
Slovenian: ● eritem (rdečica kože),
English: ● hypotension
Slovenian: • hipotenzija.
English: ● dyspnoea (difficulty in breathing)
Slovenian: ● dispneja (oteženo dihanje),
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 50 mg/ml solution for infusion
Slovenian: IME ZDRAVILA Flebogamma DIF 50 mg/ml raztopina za infundiranje
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.
Slovenian: Prav tako v teh študijah niso potrdili pomembnih neželenih učinkov na respiratorni sistem, krvni obtok in centralni živčni sistem preskušanih živali, kar potrjuje varnost zdravila Flebogamma DIF.
English: Instructions for handling and disposal
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: What Flebogamma DIF is and what it is used for
Slovenian: Kaj je zdravilo Flebogamma DIF in za kaj ga uporabljamo Kaj je zdravilo Flebogamma DIF
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 ml/kg/min) - are carefully monitored for any symptoms throughout the infusion period.
Slovenian: - da bolniki niso občutljivi za humani polispecifični imunoglobulin, in sicer tako, da zdravilo prvikrat infundirate počasi (z začetno hitrostjo 0,01 ml/kg/min) - skrbno spremljanje bolnikov ves čas trajanja infuzije, da bi ugotovili morebitne simptome.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema bicitopenija, levkopenija občasni občasni
English: What Flebogamma DIF looks like and contents of the pack
Slovenian: Izgled zdravila Flebogamma DIF in vsebina pakiranja
English: • diabetes
Slovenian: • sladkorno bolezen
English: • epistaxis (haemorrhage from the nose)
Slovenian: • epistaksa (krvavitev iz nosu),
English: • migraine
Slovenian: • migrena,
English: Primary immune thrombocytopenia
Slovenian: Primarna imunska trombocitopenija
English: 0.8 - 1 g/kg or
Slovenian: 0,8-1 g/kg ali
English: MM/YYYY
Slovenian: (MMN)
English: ● rigors (cold shivering sensation) or chills
Slovenian: ● okorelost (občutek mrzlice) ali mrzlica,
English: ● hyperhidrosis (excessive sweating)
Slovenian: ● hiperhidroza (prekomerno potenje),
English: Immune system disorders Hypersensitivity
Slovenian: Bolezni imunskega sistema preobčutljivost občasni redki
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.
Slovenian: Določeni neželeni učinki, kot so npr. glavobol, rdečica, mrzlica, mialgija, sopenje, tahikardija, bolečine v križu, navzea in nizek krvni tlak, so lahko povezane s hitrostjo infundiranja.
English: It has been reported that the frequency of adverse reactions to IVIg increases with the infusion rate.
Slovenian: Poročali so, da se pogostnost neželenih učinkov i.v.
English: • chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain
Slovenian: • mrzlico, glavobol, omotico, zvišano telesno temperaturo, bruhanje, alergijske reakcije, navzeo,
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
Slovenian: Ena 10-mililitrska viala vsebuje: 0,5 g humanega polispecifičnega imunoglobulina Ena 50-mililitrska viala vsebuje: 2,5 g humanega polispecifičnega imunoglobulina Ena 100-mililitrska viala vsebuje: 5 g humanega polispecifičnega imunoglobulina Ena 200-mililitrska viala vsebuje: 10 g humanega polispecifičnega imunoglobulina Ena 400-mililitrska viala vsebuje: 20 g humanega polispecifičnega imunoglobulina
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL (10 g and 20 g)
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA VIALI (10 g in 20 g)
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).
Slovenian: • če prejemate zdravilo Flebogamma DIF prvič, če ste prešli z drugega zdravila, ki vsebuje humani polispecifični imunoglobulin (i.v.
English: - The active substance is human normal immunoglobulin (IVIg).
Slovenian: - Učinkovina je humani polispecifični imunoglobulin (i.v.
English: Dermatitis contact, Hyperhidrosis, Rash
Slovenian: • kontaktni dermatitis, • hiperhidroza (prekomerno potenje),
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih reakcija, povezana z infuzijo občasni občasni
English: Very common Common
Slovenian: pogosti občasni
English: Flebogamma DIF 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Slovenian: Flebogamma DIF 100 mg/ml raztopina za infundiranje humani polispecifični imunoglobulin (i.v.
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Slovenian: S transfuzijo povezana akutna poškodba pljuč (TRALI) Pri bolnikih, ki so prejeli i.v.
English: Starting dose: 2 g/kg
Slovenian: Vzdrževalni odmerek: 1 g/kg ali
English: Flushing, Haematoma, Lymphoedema, Systolic hypertension, Thrombosis
Slovenian: Žilne bolezni hipotenzija pogosti pogosti diastolična hipertenzija, hipertenzija občasni rdečica, hematom, limfedem, sistolična hipertenzija, tromboza občasni
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
Slovenian: Ena 50-mililitrska viala vsebuje: 5 g humanega polispecifičnega imunoglobulina Ena 100-mililitrska viala vsebuje: 10 g humanega polispecifičnega imunoglobulina Ena 200-mililitrska viala vsebuje: 20 g humanega polispecifičnega imunoglobulina
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 Distribution of the IgG subclasses (approx. values): IgG1 66.6%
Slovenian: Ena viala s 50 ml vsebuje: 5 g humanega polispecifičnega imunoglobulina Ena viala s 100 ml vsebuje: 10 g humanega polispecifičnega imunoglobulina Ena viala s 200 ml vsebuje: 20 g humanega polispecifičnega imunoglobulina Odstotki podrazredov IgG znašajo približno 66,6 % IgG1, 27,9 % IgG2, 3,0 % IgG3 in 2,5 % IgG4.
English: What Flebogamma DIF contains
Slovenian: Zdravilo Flebogamma DIF vsebuje natrij
English: How to store Flebogamma DIF
Slovenian: Shranjevanje zdravila Flebogamma DIF
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.
Slovenian: Zdravilo Flebogamma DIF 100 mg/ml infundirajte intravensko z začetno hitrostjo 0,01 ml/kg/min prvih trideset minut.
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).
Slovenian: 100 mg/ml kot pri zdravilu Flebogamma DIF 50 mg/ml (glejte poglavje 5.1).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Flebogamma DIF 50 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Flebogamma DIF 50 mg/ml raztopina za infundiranje humani polispecifični imunoglobulin (i.v.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL (0.5 g and 2.5 g)
Slovenian: OVOJNINAH NALEPKA VIALE (0,5 g in 2,5 g)
English: One ml contains 50 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Slovenian: En ml vsebuje 50 mg humanega polispecifičnega imunoglobulina (IVIg), ki vsebuje vsaj 97 % IgG.
English: Blood pressure diastolic decreased, Blood pressure increased, Blood pressure systolic increased, Heart rate increased
Slovenian: Preiskave zvišana telesna temperatura pogosti pogosti zvišan diastolični krvni tlak, zvišan krvni tlak, zvišan sistolični krvni tlak, zvišan srčni utrip občasni znižan sistolični krvni tlak, zmanjšana koncentracija hemoglobina, znižan srčni utrip, povečano število retikulocitov občasni
English: Urticaria
Slovenian: bruhanje
English: One ml contains 100 mg of human normal immunoglobulin, of which at least 97% is IgG.
Slovenian: En ml vsebuje 100 mg humanega polispecifičnega imunoglobulina, ki vsebuje vsaj 97 % IgG.
English: • blood pressure increased
Slovenian: • zvišan krvni tlak,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (5 g, 10 g and 20 g)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (5 g, 10 g in 20 g)
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.
Slovenian: Imunoglobulinov ne povezujejo z okužbami s hepatitisom A ali parvovirusom B19.
English: One ml contains 50 mg of human normal immunoglobulin, of which at least 97% is IgG.
Slovenian: En ml vsebuje 50 mg humanega polispecifičnega imunoglobulina, ki vsebuje vsaj 97 % IgG.
English: IVIg products have been shown to cross the placenta, increasingly during the third trimester.
Slovenian: Ig prehajajo skozi posteljico, in sicer do tega pojava izraziteje prihaja v tretjem trimesečju.
English: Frequency per infusion
Slovenian: Pogostnost na infundiranje
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL (5 g, 10 g and 20 g)
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA VIALI (5 g, 10 g in 20 g)
English: It was observed that the proportion of headache, fever, heart rate increased and low blood pressure in children was higher than in adults.
Slovenian: Dodatni neželeni učinki pri otrocih in mladostnikih Opazili so, da je delež glavobola, vročine, zvečanega srčnega utripa in znižanega krvnega tlaka pri otrocih večji kot pri odraslih.
English: Wheezing
Slovenian: Odmerek
English: Solutions that are cloudy or have deposits should not be used.
Slovenian: Ne uporabljajte raztopin, ki so motne ali imajo usedline.
English: Please consult your doctor should you have increased side effects.
Slovenian: V primeru zvečanih neželenih učinkov se posvetujte z zdravnikom.
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.
Slovenian: Še posebej pri bolnikih, za katere je bilo ocenjeno, da lahko imajo povečano tveganje za razvoj akutne ledvične odpovedi, je treba parametre delovanja ledvic oceniti pred infundiranjem i.v.
English: Therefore, IVIg recipients must be monitored for and IVIg infusion must be immediately stopped in case of pulmonary adverse reactions.
Slovenian: Ig spremljati glede neželenih učinkov na pljuča in ob njihovem pojavu infundiranje takoj prekiniti.
English: In patients at risk, the use of IVIg products that do not contain these excipients may be considered.
Slovenian: Pri bolnikih s tveganjem premislite o uporabi zdravil z i.v.
English: ● pruritus
Slovenian: ● bruhanje,
English: ● dizziness (motion sickness)
Slovenian: ● omotica (potovalna bolezen),