FrancophonIA/ELRC3.0 huggingface dataset:
English: Since this is below the predefined threshold of one infection per year, this indicates that the medicine is effective in replacing the patient's antibodies.
Slovenian: Ker je ta vrednost nižja od vnaprej določene mejne vrednosti, enake eni okužbi na leto, to kaže, da je zdravilo učinkovito pri nadomeščanju bolnikovih protiteles.
English: It contains immunoglobulin G (IgG), which is a type of antibody.
Slovenian: Ta vsebuje imunoglobulin G (IgG), ki je vrsta protitelesa.
English: The main measure of effectiveness was the highest blood platelet level that was achieved during the three-month study.
Slovenian: Glavno merilo učinkovitosti je bila najvišja koncentracija trombocitov v krvi, dosežena med trimesečno študijo.
English: The full EPAR for Flebogamma DIF can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Flebogamma DIF je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In the first study, involving 46 patients with PID, the medicine was infused every 21 to 28 days.
Slovenian: V prvi študiji, v katero je bilo vključenih 46 bolnikov s sindromom primarne imunske pomanjkljivosti, je bilo zdravilo infundirano vsakih 21 do 28 dni.
English: They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing haematopoietic stem cell transplantation, without the need for specific studies in these diseases.
Slovenian: Odobrena so lahko tudi za zdravljenje bolnikov z Guillain-Barréjevim sindromom, bolnikov s Kawasakijevim sindromom ter bolnikov, pri katerih je bila izvedena presaditev krvotvornih matičnih celic, ne da bi bilo treba za te bolezni izvajati posebne študije.
English: This is a summary of the European public assessment report (EPAR) for Flebogamma DIF.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Flebogamma DIF.
English: • Guillain-Barré syndrome, which causes multiple inflammations of the nerves in the body;
Slovenian: • Guillain-Barréjevega sindroma, ki povzroča večkratna vnetja živcev v telesu;
English: Therefore, the CHMP concluded that Flebogamma DIF's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zato zaključil, da so koristi zdravila Flebogamma DIF večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Flebogamma DIF is used in patients who need more antibodies in their blood to help fight infections and other diseases.
Slovenian: Zdravilo Flebogamma DIF se uporablja pri bolnikih, ki potrebujejo več protiteles v krvi, da jim pomagajo pri premagovanju okužb in drugih bolezni.
English: The name of the medicine was changed to Flebogamma DIF on 2 September 2010.
Slovenian: Ime zdravila je bilo 2. septembra 2010 spremenjeno v Flebogamma DIF.
English: Flebogamma DIF was not compared with any other treatment in either study.
Slovenian: Zdravila Flebogamma DIF v nobeni študiji niso primerjali s kakim drugim zdravljenjem.
English: • Acquired immune deficiency syndrome (AIDS) in children who contracted HIV from birth and have frequent infections.
Slovenian: • sindroma pridobljene imunske pomanjkljivosti (aidsa) pri otrocih, ki so se z virusom HIV okužili ob rojstvu in imajo pogoste okužbe.
English: As human normal immunoglobulin has been used to treat these diseases for some time, only two small studies were needed to establish the effectiveness and safety of Flebogamma DIF in patients.
Slovenian: Ker se humani normalni imunoglobulin že dlje časa uporablja za zdravljenje teh bolezni, sta za potrditev učinkovitosti in varnosti zdravila Flebogamma DIF pri bolnikih zadostovali le dve manjši študiji.
English: For more information about treatment with Flebogamma DIF, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Flebogamma DIF preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: • Hypogammaglobulinaemia (low levels of antibodies) in patients: with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) and frequent bacterial infections after preventive treatment with antibiotics has failed; with multiple myeloma (another cancer of a type of white blood cell) and frequent bacterial infections and in whom vaccination against ‘pneumococcal' bacteria has failed; who have had haematopoietic (blood) stem cell transplantation (when the patient receives stem cells from a matched donor to help restore the bone marrow).
Slovenian: • hipogamaglobulinemije (nizkih ravni protiteles) pri bolnikih: s kronično limfocitno levkemijo (rakom vrste belih krvnih celic) in pogostimi bakterijskimi okužbami po neuspelem preventivnem zdravljenju z antibiotiki; z multiplim mielomom (drugo obliko raka vrste belih krvnih celic) in pogostimi bakterijskimi okužbami po neuspelem cepljenju proti pnevmokoknim bakterijam; s presaditvijo hematopoetskih (krvotvornih) matičnih celic (kadar bolnik prejme matične celice darovalca, ki se ujemajo z njegovimi in pomagajo obnoviti kostni mozeg);
English: Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in a few cases, anaphylactic shock (a severe allergic reaction) even when the patient had no previous allergic reaction to the medicine.
Slovenian: Humani normalni imunoglobulini lahko v redkih primerih povzročijo nenaden padec krvnega tlaka, v posameznih primerih pa anafilaktični šok (hudo alergijsko reakcijo), četudi bolnik pred tem ni imel alergijske reakcije na zdravilo.
English: Flebogamma DIF is also used to treat certain immune system disorders:
Slovenian: Zdravilo Flebogamma DIF se uporablja tudi za zdravljenje nekaterih motenj imunskega sistema:
English: Flebogamma DIF must not be used in people who are allergic to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulin, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Slovenian: Zdravila Flebogamma DIF ne smejo uporabljati osebe, ki so alergične na humani normalni imunoglobulin ali katero koli drugo sestavino zdravila, ter bolniki, ki so alergični na druge tipe imunoglobulina, zlasti če imajo pomanjkanje (zelo nizko raven) imunoglobulina A (IgA) ter imajo protitelesa proti IgA.
English: The medicine must not be used in patients who are intolerant to fructose (a type of sugar).
Slovenian: Zdravila Flebogamma DIF ne smejo uporabljati bolniki, ki ne prenašajo fruktoze (vrste sladkorja).
English: According to current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be approved for use in the treatment of all types of primary immunodeficiency, as well as low antibody levels due to blood cancers and AIDS in children.
Slovenian: V skladu z veljavnimi smernicami je mogoče zdravila, ki so se izkazala kot učinkovita pri bolnikih s sindromom primarne imunske pomanjkljivosti in bolnikih z idiopatsko trombocitopenično purpuro, odobriti tudi za uporabo pri zdravljenju vseh vrst primarne imunske pomanjkljivosti ter tudi nizkih ravni protiteles zaradi krvnega raka ali aidsa pri otrocih.
English: Flebogamma DIF is given by infusion into a vein by a doctor or nurse, but patients (or their carers) may administer it themselves once they have been trained.
Slovenian: Zdravilo Flebogamma DIF se uporablja kot intravenska infuzija, ki jo daje zdravnik ali medicinska sestra, vendar si ga bolniki lahko dajejo tudi sami (oziroma jim ga dajejo njihovi skrbniki), če so bili ustrezno usposobljeni.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Flebogamma DIF.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Flebogamma DIF, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The second study looked at using Flebogamma DIF in 20 patients with ITP.
Slovenian: V drugi študiji so proučevali uporabo zdravila Flebogamma DIF pri 20 bolnikih z idiopatsko trombocitopenično purpuro.
English: It contains the active substance human normal immunoglobulin.
Slovenian: Vsebuje zdravilno učinkovino humani normalni imunoglobulin.
English: Previously known as Flebogammadif
Slovenian: 1 Prej znano kot Flebogammadif.
English: The active substance in Flebogamma DIF, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Slovenian: Zdravilna učinkovina zdravila Flebogamma DIF, humani normalni imunoglobulin, je visoko prečiščena beljakovina, pridobljena iz človeške plazme (dela krvi).
English: What benefit has Flebogamma DIF shown during the studies?
Slovenian: Kakšne koristi je zdravilo Flebogamma DIF izkazalo med študijami?
English: Flebogamma DIF works by restoring abnormally low IgG levels to their normal range in the blood.
Slovenian: Zdravilo Flebogamma DIF deluje tako, da nenormalno nizko koncentracijo IgG vrne v območje njene normalne vrednosti v krvi.
English: Flebogamma DIF is made like Flebogamma, another medicine containing human normal immunoglobulin, with some additional steps in the purification of the product from human plasma.
Slovenian: Zdravilo Flebogamma DIF se proizvaja enako kot zdravilo Flebogamma, ki prav tako vsebuje humani normalni imunoglobulin, le da je pri izdelavi zdravila nekaj dodatnih korakov v postopku prečiščevanja izdelka iz človeške plazme.
English: human normal immunoglobulin
Slovenian: humani normalni imunoglobulin
English: • Primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies).
Slovenian: • sindromov primarne imunske pomanjkljivosti (PID, kadar imajo bolniki prirojeno nezmožnost tvorjenja zadostnega števila protiteles);
English: Other information about Flebogamma DIF
Slovenian: Druge informacije o zdravilu Flebogamma DIF
English: • Idiopathic thrombocytopenic purpura (ITP), a condition where people do not have enough platelets in the blood;
Slovenian: • idiopatske trombocitopenične purpure (ITP), obolenja, pri katerem ljudje nimajo dovolj trombocitov v krvi;
English: Side effects such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate low back pain may occasionally occur with Flebogamma DIF.
Slovenian: Občasno se lahko pri uporabi zdravila Flebogamma DIF pojavijo neželeni učinki, kot so mrzlica, omotica, povišana telesna temperatura, bruhanje, alergijske reakcije, slabost, artralgija (bolečina v sklepih), nizek krvni tlak ter zmerna bolečina v ledvenem delu hrbta.
English: Flebogamma DIF is a solution for infusion (drip into a vein).
Slovenian: Zdravilo Flebogamma DIF je raztopina za infundiranje (kapalna infuzija v veno).
English: What is the risk associated with Flebogamma DIF?
Slovenian: Kakšna tveganja so povezana z zdravilom Flebogamma DIF?
English: Why has Flebogamma DIF been approved?
Slovenian: Zakaj je bilo zdravilo Flebogamma DIF odobreno?
English: • Kawasaki disease, which causes multiple inflammations of several organs in the body.
Slovenian: • Kawasakijevega sindroma, ki povzroča večkratno vnetje več organov v telesu; Izdaja zdravila je le na recept.
English: What is Flebogamma DIF?
Slovenian: Kaj je zdravilo Flebogamma DIF?
English: What is Flebogamma DIF used for?
Slovenian: Za kaj se zdravilo Flebogamma DIF uporablja?
English: How has Flebogamma DIF been studied?
Slovenian: Kako je bilo zdravilo Flebogamma DIF raziskano?
English: How is Flebogamma DIF used?
Slovenian: Kako se zdravilo Flebogamma DIF uporablja?
English: How does Flebogamma DIF work?
Slovenian: Kako zdravilo Flebogamma DIF deluje?
English: You may need to use both hands.
Slovenian: Morda boste morali uporabiti obe roki.
English: This is unlikely to happen again.
Slovenian: Ni verjetno, da bi se to ponovilo.
English: Call a doctor immediately.
Slovenian: Nemudoma pokličite zdravnika.
English: The results have been negative.
Slovenian: Rezultati so bili negativni.
English: Not known (cannot be estimated from the available data).
Slovenian: Neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: This is rare.
Slovenian: To je redko.
English: This leaflet is changed from time to time.
Slovenian: To navodilo se občasno spreminja.
English: At the present time, it is not known for how long patients should be treated.
Slovenian: V tem trenutku ni znano, kako dolgo naj bi bolnike zdravili.
English: The activity against other standards is not known.
Slovenian: Aktivnost po drugih standardih ni znana.
English: The figures are based on how many people said they'd had them.
Slovenian: Številke temeljijo na izjavah ljudi, ki so trdili, da so jih imeli.
English: Experience with exposure during the second and third trimester is very limited.
Slovenian: Izkušnje z izpostavljenostjo v drugem in tretjem trimesečju so zelo omejene.
English: Sensitivity to light.
Slovenian: Občutljivo na svetlobo.
English: If you inject more than you should
Slovenian: Če ste injicirali več, kot bi smeli
English: These notes are a reminder.
Slovenian: Te opombe so opozorilo.
English: Alternative assay techniques are not sufficiently sensitive.
Slovenian: Alternativne tehnike analize niso dovolj občutljive.
English: This is the safety lock.
Slovenian: To je varnostna zapora.
English: An effect on MRI parameters was also seen.
Slovenian: Viden je bil tudi učinek na MRI parametre.
English: These symptoms are not really flu.
Slovenian: Ti simptomi niso prava gripa.
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Slovenian: Na podlagi študij na živalih (glejte poglavje 5.3) obstaja možnost povečanega tveganja za spontani splav.
English: This latter clinical effect was observed after more than one year of treatment.
Slovenian: Ta klinični učinek se je opazovalo po več kot enem letu zdravljenja.
English: Relax your muscle.
Slovenian: Sprostite mišico.
English: Date of first authorisation: 13 March 1997 Date of latest renewal: 13 March 2007
Slovenian: Datum zadnjega podaljšanja: 13. marec 2007
English: Signs are:
Slovenian: Znaki so:
English: These symptoms are usually present during the first few months of treatment.
Slovenian: Ti simptomi se navadno pojavljajo v prvih nekaj mesecih zdravljenja.
English: 1171 LP Badhoevedorp The Netherlands
Slovenian: 1171 LP Badhoevedorp Nizozemska
English: No harmful effects on the breastfed newborn/infant are anticipated.
Slovenian: Škodljivih učinkov na dojene novorojence/otroke se ne pričakuje.
English: Serious side effects: get medical help Serious allergic reactions
Slovenian: Resni neželeni učinki: poiščite zdravniško pomoč Resne alergijske reakcije
English: Alternate the left and right thighs.
Slovenian: Menjajte levo in desno stegno.
English: Allow the skin to dry.
Slovenian: Počakajte, da se koža posuši.
English: No direct comparison with the dose currently recommended in adults is available.
Slovenian: Neposredna primerjava z odmerki, ki se trenutno priporočajo za odrasle, ni na voljo.
English: You may also wish to make a note of these details in case you are asked for this information in the future.
Slovenian: Tudi vi si lahko zabeležite te podatke, če bi jih v prihodnosti potrebovali.
English: MS also tends to flare up from time to time: this is called a relapse.
Slovenian: MS občasno znova vzplamti: temu se reče ponovitev.
English: The window will now appear yellow when the full dose has been delivered.
Slovenian: Okence postane rumeno, če je bil dostavljen celotni odmerek.
English: The formulation does not contain a preservative.
Slovenian: Formulacija ne vsebuje konzervansa.
English: No formal interaction studies have been performed in humans.
Slovenian: Uradnih študij medsebojnega delovanja pri ljudeh niso izvedli.
English: If this happens to you, or if you get any other side effects that could affect your ability, do not drive or use machines.
Slovenian: Če se to zgodi vam ali če čutite druge neželene učinke, ki bi lahko vplivali na vašo sposobnost, ne vozite in ne upravljajte strojev.
English: Elderly: Clinical studies did not include a sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients.
Slovenian: Starejši bolniki: V klinične študije ni bilo vključeno zadostno število bolnikov, starih 65 let ali več, da bi lahko ugotovili, če se ti odzivajo drugače kot mlajši bolniki.
English: Always follow your local guidelines.
Slovenian: Sledite lokalnim predpisom.
English: It may be possible for your doctor to prescribe you a shorter and thinner needle, depending on your body type.
Slovenian: Morda vam bo lahko vaš zdravnik predpisal krajšo in tanjšo iglo glede na vaš tip telesa.
English: Waste paper and used wipes can be put in an ordinary rubbish bin.
Slovenian: Odpadni papir in uporabljene krpice lahko odvržete v navaden koš za smeti.
English: In any case, treatment should only be considered for patients classified at high risk.
Slovenian: V vsakem primeru pa pride zdravljenje v poštev le za bolnike, razvrščene v razred z visokim tveganjem.
English: On each left hand page you'll find useful tips and explanations on how to get the best from your medicine.
Slovenian: Na vsaki levi strani najdete koristne nasvete in razlage o najboljši uporabi svojega zdravila.
English: It was also shown that there was a one-third reduction in annual relapse rate.
Slovenian: Pokazalo se je tudi zmanjšanje števila relapsov na leto za eno tretjino.
English: It may make you feel faint.
Slovenian: Morda se boste počutili slabotno.
English: You can't pass it on to anyone else.
Slovenian: Ne morete je prenesti na drugega.
English: • Check the safety lock is released.
Slovenian: • Preverite, ali je varnostna zapora sproščena.
English: • Look through the oval display window.
Slovenian: • Poglejte skozi ovalno okence.
English: Wash your hands thoroughly with soap and water and dry them.
Slovenian: Temeljito si umijte roke z milom in vodo ter jih osušite.
English: Although the list of possible side effects can seem worrying, it's possible that you may not have any of them.
Slovenian: Čeprav je seznam vseh možnih neželenih učinkov lahko zaskrbljujoč, morda ne boste imeli niti enega.
English: Point the needle cover away from you and anyone else.
Slovenian: Pokrovček igle držite proč od sebe in drugih ljudi.
English: It only happens when you inject and the effects soon pass.
Slovenian: Zgodi se samo ob injiciranju, učinki pa kmalu prenehajo.
English: Interferons are natural substances made in your body to help protect you from infections and diseases.
Slovenian: Interferoni so naravne snovi, ki se v telesu proizvajajo za zaščito pred okužbami in boleznimi.
English: 2The frequency of occurrence is higher at the beginning of treatment.
Slovenian: 2Pogostnost pojavljanja je večja ob začetku zdravljenja.
English: They can also differ with respect to their cellular sites of synthesis.
Slovenian: Razlikujejo se lahko tudi glede na mesto v celici, kjer poteka njihova sinteza.
English: In order to obtain adequate efficacy, a dose of 30 micrograms once a week should be reached and maintained after the initial titration period.
Slovenian: Za ustrezno učinkovitost morate doseči odmerek 30 mikrogramov enkrat na teden in ga vzdrževati po obdobju začetnega titriranja.
English: Talk to your doctor to see if this is appropriate for you.
Slovenian: Pogovorite se z zdravnikom in ugotovite, kaj je za vas primerno.
English: In MS, your body's defence system reacts against its own myelin - the ‘insulation' that surrounds nerve fibres.
Slovenian: Pri MS se obrambni sistem telesa odzove na lastni mielin - „izolacijo“, ki obdaja živčna vlakna.
English: This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers.
Slovenian: Ta vezava sproži zapleteno kaskado znotrajceličnih procesov, ki vodijo do izražanja številnih interferonsko povzročenih genskih produktov in označevalcev.
English: Johnson & Johnson Romania S.R.L.
Slovenian: România Johnson & Johnson Romania S.R.L.
English: However, the effects of interferon beta that are dependent on glycosylation are not fully defined.
Slovenian: Vendar pa učinki interferona beta, ki so odvisni od glikozilacije, niso v celoti določeni.
English: The potential of additive effects from multiple medicinal products or other hepatotoxic agents (e.g. alcohol) has not been determined.
Slovenian: Možnosti aditivnega delovanja večih zdravil ali drugih hepatotoksičnih snovi (npr. alkohola) niso ugotovili.
English: Do not use this medicine after the expiry date stated on the label.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
English: You will hear a “click” indicating the injection process has begun.
Slovenian: Slišali boste klik, ki nakazuje začetek postopka injiciranja.
English: The interaction of AVONEX with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Slovenian: Medsebojno delovanje zdravila AVONEX s kortikosteroidi ali adrenokortikotropnim hormonom (ACTH) ni bilo sistematično preučeno.
English: Pharmacotherapeutic Group: Interferons, ATC code: L03 AB07.
Slovenian: Farmakoterapevtska skupina: interferoni, oznaka ATC: L03 AB07.
English: More about depression.
Slovenian: Več o depresiji.
English: With appropriate adjustment for the rate of absorption from the injection site, the calculated bioavailability is approximately 40%.
Slovenian: Ob ustreznem upoštevanju hitrosti absorpcije z mesta injiciranja znaša izračunana biološka uporabnost približno 40 %.
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Slovenian: Tveganja za spontani splav pri nosečnicah, ki so izpostavljene interferonu beta, na podlagi trenutno razpoložljivih podatkov ni mogoče ustrezno oceniti, vendar pa podatki do sedaj ne kažejo povečanega tveganja.
English: However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed.
Slovenian: Vendar pa trajanje izpostavljenosti v prvem trimesečju ni natančno določeno, saj so bili podatki zbrani, ko je bila uporaba interferona beta med nosečnostjo kontraindicirana in je bilo zdravljenje verjetno prekinjeno, ko je bila nosečnost ugotovljena in/ali potrjena.
English: If you feel dizzy, do not drive.
Slovenian: Če ste omotični, ne vozite.
English: The intramuscular injection site should be varied each week (see section 5.3).
Slovenian: Mesto intramuskularnega injiciranja naj se spremeni vsak teden (glejte poglavje 5.3).
English: • Dispose of rubbish properly.
Slovenian: • Odpadke ustrezno odstranite.
English: For example, 100 person-years could be observed in 100 patients who were on treatment for one year or in 200 patients who were on treatment for half a year.
Slovenian: Na primer: rezultat 100 oseb x let bi lahko dobili pri 100 bolnikih, ki so bili zdravljeni eno leto, ali pri 200 bolnikih, ki so bili zdravljeni pol leta.
English: Do not make changes unless your doctor tells you.
Slovenian: Ne izvajajte sprememb, razen po naročilu zdravnika.
English: Because Avonex is based on a protein, there is a small chance of an allergic reaction.
Slovenian: Ker je zdravilo Avonex izdelano na osnovi beljakovine, obstaja majhna verjetnost alergijske reakcije.