natgillin/translations-raw huggingface dataset:
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).
Obvestite svojega zdravnika, če imate katerokoli stanje in/ali bolezen, saj je potreben nadzor pri bolnikih z obstoječimi dejavniki tveganja za trombotične dogodke (nastajanje krvnih strdkov v krvi).
Fructose intolerance (see section 4.4).
Intoleranca za fruktozo (glejte poglavje 4.4).
Distribution of the IgG subclasses (approx. values): IgG1 66.6%
Odstotki podrazredov IgG (približne vrednosti): IgG1 66,6 %
If there are no adverse reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate.
Če neželenih učinkov ni, se lahko hitrost infundiranja pri nadaljnjih infuzijah počasi povečuje do največje hitrosti.
Cyanosis (lack of oxygen in the blood) was reported in one child but not in adults.
O cianozi (pomanjkanju kisika v krvi) so poročali pri enem otroku, pri odraslih pa ne.
Pack size of 1 vial.
Velikost pakiranja: 1 viala.
The safety results for 29 paediatric patients (those ≤ 17 years old) included in the PID studies were evaluated.
Ovrednotili so rezultate varnosti pri 29 pediatričnih bolnikih (starih ≤ 17 let), ki so sodelovali v študijah PID.
 Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
• Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
• the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
• vključitev postopkov pri obdelovanju krvi ali plazme, ki lahko onemogočijo ali odstranijo viruse.
Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies.
Preizkusi toksičnosti pri ponavljajočih odmerkih in študije embrio-fetalne toksičnosti so zaradi indukcije nastanka protiteles in interferenc s protitelesi neizvedljivi.
However, as in adult population, overdose may lead to fluid overload and hyperviscosity as with any other intravenous immunoglobulins.
Vendar pa lahko tako kot pri odraslih preveliko odmerjanje povzroči tekočinsko preobremenitev in hiperviskoznost, kot pri vseh intravensko danih imunoglobulinih.
Symptoms of TRALI typically develop during or within 6 hours of a transfusion, often within 1 - 2 hours.
Simptomi TRALI se ponavadi razvijejo med infundiranjem ali do 6 ur po njem, pogosto v 1-2 urah.
The percentage of IgG subclasses is approximately 66.6% IgG1, 28.5% IgG2, 2.7% IgG3 and 2.2% IgG4.
Odstotki podrazredov IgG znašajo približno 66,6 % IgG1, 28,5 % IgG2, 2,7 % IgG3 in 2,2 % IgG4.
● influenza (flu)
● influenca (gripa),
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
● fever (body temperature increased)
● vročina (zvišana telesna temperatura),
Frequency per patient
Pogostnost na bolnika
• the testing of each donation and pools of plasma for signs of virus/infections,
• preiskovanje vsake darovane enote ter združene plazme za pokazatelje virusov/okužb,
MedDRA System Organ Class (SOC)
Razvrstitev po organskem sistemu (SOC) MedDRA
There were no other subjects with more than 1 infusion with adverse reactions in both groups.
V nobeni od teh dveh skupin ni bilo drugih bolnikov z več kot 1 infuzijo z neželenimi učinki.
Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Bolnike je treba ves čas infundiranja natančno spremljati in skrbno opazovati glede kakršnih koli simptomov.
In the case of measles, this impairment may persist for up to 1 year.
V primeru ošpic lahko zmanjšanje učinkovitosti traja tudi do 1 leta.
- If you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
- Če ste alergični na humani polispecifični imunoglobulin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• abnormal behaviour
• nenormalno vedenje,
Interferences with determination of blood glucose levels are not expected.
Motnje pri določanju ravni glukoze v krvi se ne pričakujejo.
The dose may need to be individualised for each patient dependent on the clinical response.
Odmerek bo morda treba prilagoditi posameznemu bolniku na podlagi kliničnega odziva.
• Multifocal motor neuropathy (MMN), a rare disease causing slow progressive asymmetric limb weakness without sensory loss.
• Multifokalna motorična nevropatija (MMN), redka bolezen, ki povzroča počasi napredujočo asimetrično oslabelost okončin brez izgube zaznave.
Guillain Barré syndrome
Guillain-Barréjev sindrom
Effects of the product on the immune system of the newborn have not been studied.
Študij učinkov zdravila na imunski sistem novorojenčkov niso izvedli.
Special safety warning
Posebno varnostno opozorilo
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.
Po dajanju imunoglobulina lahko začasni porast različnih pasivno prenesenih protiteles v krvi bolnika povzroči lažno pozitivne rezultate seroloških preiskav.
Patients exhibiting such signs and symptoms should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
Pri bolnikih s tovrstnimi znaki in simptomi je treba opraviti temeljit nevrološki pregled, vključno s preiskavami cerebrospinalne tekočine, da se izključijo drugi vzroki meningitisa.
The dose and dose regimen is dependent on the indication.
Odmerek in režim odmerjanja sta odvisna od indikacije.
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.
Znatno zvišanje srednje ravni trombocitov so dosegli v kliničnem preskušanju pri bolnikih s kronično ITP (64,000/µl), čeprav niso dosegli normalnih ravni.
- If you have fructose intolerance, a quite rare genetic condition where the enzyme for breaking down fructose is not produced.
- Če imate intoleranco za fruktozo, redko dedno bolezen, pri kateri ne nastaja encim za razgradnjo fruktoze.
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).
Preveliko odmerjanje lahko vodi do prevelike količine tekočine in hiperviskoznosti, še posebej pri bolnikih s povečanim tveganjem, vključno s starejšimi bolniki in bolniki s srčnimi ali ledvičnimi okvarami (glejte poglavje 4.4).
Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Nadomestno zdravljenje mora začeti in nadzorovati zdravnik, ki ima ustrezne izkušnje pri zdravljenju imunske pomanjkljivosti.
These include:
Med slednjimi so:
• reversible haemolytic reactions; especially in those patients with blood groups A, B, and AB and (rarely) haemolytic anaemia requiring transfusion
• reverzibilne hemolitične reakcije, še posebej pri bolnikih s krvnimi skupinami A, B in AB, ter (redko) hemolitično anemijo, zaradi katere je potrebna transfuzija,
6.6 Special precautions for disposal and other handling The product should be brought to room or body temperature before use.
6.6 Posebni varnostni ukrepi za odstranjevanje Zdravilo pred uporabo segrejte na sobno ali telesno temperaturo.
Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients (see sections 4.4 and 6.1).
Preobčutljivost na učinkovino (humane imunoglobuline) ali katero koli pomožno snov (glejte poglavji 4.4 in 6.1).
Flebogamma DIF does not contain sucrose, maltose or glucose.
Zdravilo Flebogamma DIF ne vsebuje saharoze, maltoze ali glukoze.
The syndrome usually begins within several hours to 2 days following IVIg treatment.
Sindrom ponavadi nastopi v več urah do 2 dneh po zdravljenju z zdravili z i.v.
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.
Odmerek je treba ustrezno prilagoditi za doseganje optimalne zaščite prek okužbami; pri bolnikih s trdovratno okužbo bo morda treba odmerek povečati, pri bolnikih, ki nimajo okužb, pa je mogoče razmisliti o zmanjšanju odmerka.
It may be self-administered if you have been fully trained by hospital staff.
Infundiranje lahko opravite tudi sami, če so vas zdravstveni delavci v celoti podučili o uporabi.
● tachycardia (acceleration of the heart activity)
● tahikardija (pospešeno delovanje srca),
• 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.
• Kawasakijev sindrom (v tem primeru se uporablja v kombinaciji z zdravljenjem z acetilsalicilno kislino), otroška bolezen, pri kateri se v telesu povečajo krvne žile (arterije).
● tremor (to tremble)
● tremor (tresenje),
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Živa oslabljena virusna cepiva
Kawasaki disease
Kawasakijev sindrom
● meningitis aseptic (non-infective meningitis)
● aseptični meningitis (neinfekcijski meningitis),
• Effects on vaccines: Flebogamma DIF may reduce the effectiveness of certain types of vaccines (live attenuated virus vaccines).
• Učinki na cepiva: zdravilo Flebogamma DIF lahko zmanjša učinkovitost določenih vrst cepiv
No negative effects on the breastfed newborns/infants are anticipated.
Učinkov na dojene novorojence/dojenčke se ne pričakuje.
• in case of high rate of infusion.
• v primeru velike hitrosti infundiranja.
Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Bolniki, ki imajo med zdravljenjem neželene učinke, naj počakajo, da minejo, preden spet vozijo ali upravljajo stroje.
• Cases of transient cutaneous reactions (side effects on your skin).
• Primeri prehodnih kožnih reakcij (neželeni učinki na vaši koži).
Immunoglobulins are excreted into human milk.
Imunoglobulini se izločajo v materino mleko.
The following dosage regimens are given as a guideline.
Naslednji režimi odmerjanja so dani kot smernice.
No differences of the pharmacokinetic properties are expected in the paediatric population.
Pri pediatrični populaciji ni pričakovati razlik v farmakokinetičnih lastnostih.
Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also section 4.4):
Neželeni učinki, ki jih povzročijo humani normalni imunoglobulini (navedeni po padajoči pogostnosti), zajemajo (glejte tudi poglavje 4.4):
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Humani polispecifični imunoglobulin vsebuje predvsem imunoglobulin G (IgG) s širokim spektrom protiteles proti povzročiteljem okužb.
Seek medical care with no delay if any of the following side effects happen during or after the infusion:
Brez odlašanja poiščite zdravniško pomoč, če med ali po infundiranju opazite katerega koli izmed spodaj navedenih neželenih učinkov:
• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
• skrben izbor darovalcev krvi in plazme, da je zagotovljena izključitev prenašalcev okužb,
The posology in children and adolescents (2 - 18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Odmerjanje pri otrocih in mladostnikih (2-18 let) se ne razlikuje od odmerjanja pri odraslih, saj se za posamezno indikacijo določa glede na telesno maso in se prilagaja glede na klinični izid zgoraj omenjenih stanj.
• (rarely) transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown)
• (redko) prehodne kožne reakcije (vključno s kožnim eritematoznim lupusom - neznana pogostnost),
● blood pressure increased or decreased
● zvišan ali znižan krvni tlak,
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.
V nadzorovanih kliničnih preskušanjih varnosti uporabe tega zdravila med nosečnostjo niso ugotavljali in ga je zato treba pri nosečnicah in doječih materah uporabljati previdno.
Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
Uporaba imunoglobulina lahko za najmanj 6 tednov pa vse do 3 mesecev zmanjša učinkovitost cepiv z živim oslabljenim virusom, kot so cepiva proti ošpicam, rdečkam, mumpsu in noricam.
Treatment of adults, children and adolescents (2 - 18 years) who do not have sufficient antibodies (Flebogamma DIF is used as replacement therapy).
Zdravljenje odraslih, otrok in mladostnikov (2-18 let), ki nimajo zadostnih protiteles (zdravilo Flebogamma DIF se uporablja kot nadomestno zdravljenje).
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo zdravila posvetujte z zdravnikom.
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).
Količino odmerka bo izračunal vaš zdravnik (glejte poglavje »Navodila za zdravstveno osebje« na koncu teh navodil za uporabo).
For intravenous use
za intravensko uporabo
However, depending on the required dose, the patient may receive more than 1 vial.
Vendar lahko bolnik prejme več kot 1 vialo, kar je odvisno od potrebnega odmerka.
Flebogamma DIF contains human normal immunoglobulin, highly purified protein extracted from human plasma (part of the blood of donors).
Zdravilo Flebogamma DIF vsebuje humani polispecifični imunoglobulin, visoko prečiščeno beljakovino, pridobljeno iz človeške plazme (dela krvi krvodajalcev).
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Spodnja preglednica temelji na podatkovni bazi MedDRA glede na organske sisteme (SOC in raven priporočenih izrazov).
After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Po uporabi tega zdravila morajo preteči 3 meseci, preden bolnika cepite z živim oslabljenim virusnim cepivom.
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.
So se pa pri enem bolniku, zdravljenem z zdravilom Flebogamma DIF 100 mg/ml, pojavile epizode blagega glavobola pri vseh infuzijah, drug bolnik pa je imel 2 epizodi zvišane telesne temperature pri 2 infuzijah.
This medicine contains less than 29,41 mg sodium (main component of cooking/table salt) in each vial of 400 ml.
To zdravilo vsebuje manj kot 29,41 mg natrija (glavne sestavine kuhinjske soli) na vialo s 400 ml.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to viral safety.
Obstajajo pomirjujoče klinične izkušnje, ki kažejo, da se hepatitis A in parvovirus B19 ne prenašata z imunoglobulini, prav tako domnevajo, da vsebnost protiteles v veliki meri prispeva k varnosti pred virusi.
LIST OF EXCIPIENTS D-sorbitol, water for injections.
SEZNAM POMOŽNIH SNOVI D-sorbitol, voda za injekcije.
Very common (may affect more than 1 in 10 infusions): ● headache
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 infuzij): ● glavobol.
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.
Prenosljivi povzročitelji bolezni Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, ki so bila pripravljena iz človeške krvi ali plazme so med drugim izbor darovalcev, presejanje posameznih enot darovane krvi in združene plazme na specifične označevalce okužbe in vključitev učinkovitih postopkov za inaktivacijo/odstranitev virusov.
• (rarely) a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration
• (redko) nenaden padec krvnega tlaka in v osamljenih primerih anafilaktični šok, tudi v primerih, ko bolnik ni kazal preobčutljivosti na predhodno dajanje zdravila,
It may happen particularly if you do not have enough immunoglobulins of the type IgA in your blood or have developed antibodies to IgA.
Lahko se pojavijo zlasti, če nimate dovolj imunoglobulinov vrste IgA v krvi ali imate protitelesa proti imunoglobulinom IgA.
Anaphylaxis can develop in patients - with undetectable IgA who have anti-IgA antibodies - who had tolerated previous treatment with human normal immunoglobulin
Anafilaksija se lahko razvije pri bolnikih: - z nezaznavnim IgA, ki imajo protitelesa proti IgA, - ki so prenašali predhodno zdravljenje s humanim normalnim imunoglobulinom.
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.
V primeru cepiv proti rdečkam, mumpsu in noricam morajo po prejemanju tega zdravila preteči vsaj 3 meseci pred cepljenjem.
• productive cough
• produktiven kašelj,
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. Do not store above 30 ºC.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in ovojnini poleg oznake EXP.
If you have a blood test after receiving Flebogamma DIF, please tell the analyst or your doctor that you have been given this medicine.
Če imate po prejemu zdravila Flebogamma DIF preiskave krvi, obvestite osebo, ki kri analizira ali svojega zdravnika, da ste prejeli omenjeno zdravilo.
Interference with serological testing
Vpliv na serološke preiskave
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, nor with any other IVIg products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, vključno z drugimi i.v.
• cases of reversible aseptic meningitis
• primere reverzibilnega aseptičnega meningitisa,
The dose recommendations are summarised in the following table:
Priporočljivi odmerki so povzeti v naslednji razpredelnici:
E-08150 Parets del Vallès Barcelona, Spain
E-08150 Parets del Vallès Barcelona, Španija
Live attenuated virus vaccines
(živih oslabljenih virusnih cepiv).
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.
Klinične izkušnje z imunoglobulini ne kažejo škodljivih učinkov na potek nosečnosti ali plod ter novorojenca.
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.
Odmerek, s katerim dosežete najnižjo raven IgG 6 g/l, je reda velikosti 0,2-0,8 g/kg/mesec.
● influenza like illness
● bolezen, podobna gripi,
Polígono Levante Can Guasc, 2, E-08150 Parets del Vallès Barcelona, Spain
Polígono Levante Can Guasc, 2, E-08150 Parets del Vallès Barcelona, Španija
Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dl. AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment.
Študije likvorja so pogosto pozitivne s pleocitozo do več tisoč celic na mm3, zlasti iz granulocitne linije, in zvišanimi ravnmi beljakovin do več sto mg/dl. AMS se lahko pojavi pogosteje v povezavi z velikimi odmerki
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.
V večini primerov so ugotovili dejavnike tveganja, kot so obstoječa ledvična insuficienca, sladkorna bolezen, hipovolemija, čezmerna telesna masa, sočasno zdravljenje z nefrotoksičnimi zdravili ali starost nad
• Patients with Primary Immunodeficiency Syndromes (PID), an inborn lack of antibodies (group 1)
• Bolniki s primarnimi sindromi imunske pomanjkljivosti, prirojenim pomanjkanjem protiteles (skupina 1),
• cases of increased serum creatinine level and/or occurrence of acute renal failure
• primere zvišane ravni kreatinina v serumu in/ali akutne odpovedi ledvic,
2 g/kg in one dose in association with acetylsalicylic acid
Kawasakijev sindrom2 g/kg v enem odmerku, ob sočasnem zdravljenju z acetilsalicilno kislino
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).
V kliničnih preskušanjih so opazili povečanje pogostnosti neželenih učinkov, ki je verjetno povezano s povečano hitrostjo infundiranja (glejte poglavje 4.2).
• Increase in serum creatinine level (a test which measures your kidney function) and/or acute renal failure (which signs are low back pain, fatigue, decrease in the amount of urine).
• Zvišanje ravni kreatinina v serumu (test, s katerim se izmeri delovanje ledvic) in/ali akutna odpoved ledvic (znaki so lahko bolečine v križu, utrujenost, zmanjšana količina urina).
The safety results for 4 paediatric patients (those ≤ 17 years old) included in the PID study and the results for the 13 children (aged 3 to 16 years old) included in the ITP study were evaluated.
Ovrednotili so rezultate varnosti pri 4 pediatričnih bolnikih (starih ≤ 17 let), ki so sodelovali v študiji PID, in rezultate pri 13 otrocih (starih od 3 do 16 let), ki so sodelovali v študiji ITP.
Side effects may be reduced by switching to Flebogamma DIF 50 mg/ml.
Neželene učinke je možno zmanjšati s prehodom na zdravilo Flebogamma DIF 50 mg/ml.
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).
Pri osebah s HFI, starejših od 2 let, se razvije spontana averzija za hrano, ki vsebuje fruktozo, lahko tudi v kombinaciji z nastankom simptomov (bruhanje, prebavne motnje, apatija, zaostajanje v višini in telesni masi).
The ability to drive and operate machines may be impaired by some adverse reactions, such as dizziness, associated with Flebogamma DIF.
Na sposobnost vožnje in upravljanja strojev lahko vplivajo neželeni učinki, povezani z zdravilom Flebogamma DIF, kot je omotica.
• Cases of temporary non-infective meningitis (which signs are headache, fear or intolerance of light, stiff neck).
• Primeri prehodnega neinfekcijskega meningitisa (znaki so lahko glavobol, strah pred svetlobo ali neprenašanje svetlobe, otrpel tilnik).
0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse).
0,4 g/kg/dan v obdobju 5 dni (odmerjanje lahko ponovite, če pride do ponovitve bolezni).