natgillin/translations-raw huggingface dataset:
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.
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.
human normal immunoglobulin
humani normalni imunoglobulin
• Primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies).
• sindromov primarne imunske pomanjkljivosti (PID, kadar imajo bolniki prirojeno nezmožnost tvorjenja zadostnega števila protiteles);
Other information about Flebogamma DIF
Druge informacije o zdravilu Flebogamma DIF
• Idiopathic thrombocytopenic purpura (ITP), a condition where people do not have enough platelets in the blood;
• idiopatske trombocitopenične purpure (ITP), obolenja, pri katerem ljudje nimajo dovolj trombocitov v krvi;
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.
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.
Flebogamma DIF is a solution for infusion (drip into a vein).
Zdravilo Flebogamma DIF je raztopina za infundiranje (kapalna infuzija v veno).
What is the risk associated with Flebogamma DIF?
Kakšna tveganja so povezana z zdravilom Flebogamma DIF?
Why has Flebogamma DIF been approved?
Zakaj je bilo zdravilo Flebogamma DIF odobreno?
• Kawasaki disease, which causes multiple inflammations of several organs in the body.
• Kawasakijevega sindroma, ki povzroča večkratno vnetje več organov v telesu; Izdaja zdravila je le na recept.
What is Flebogamma DIF?
Kaj je zdravilo Flebogamma DIF?
What is Flebogamma DIF used for?
Za kaj se zdravilo Flebogamma DIF uporablja?
How has Flebogamma DIF been studied?
Kako je bilo zdravilo Flebogamma DIF raziskano?
How is Flebogamma DIF used?
Kako se zdravilo Flebogamma DIF uporablja?
How does Flebogamma DIF work?
Kako zdravilo Flebogamma DIF deluje?
You may need to use both hands.
Morda boste morali uporabiti obe roki.
This is unlikely to happen again.
Ni verjetno, da bi se to ponovilo.
Call a doctor immediately.
Nemudoma pokličite zdravnika.
The results have been negative.
Rezultati so bili negativni.
Not known (cannot be estimated from the available data).
Neznana (ni mogoče oceniti iz razpoložljivih podatkov).
This is rare.
To je redko.
This leaflet is changed from time to time.
To navodilo se občasno spreminja.
At the present time, it is not known for how long patients should be treated.
V tem trenutku ni znano, kako dolgo naj bi bolnike zdravili.
The activity against other standards is not known.
Aktivnost po drugih standardih ni znana.
The figures are based on how many people said they'd had them.
Številke temeljijo na izjavah ljudi, ki so trdili, da so jih imeli.
Experience with exposure during the second and third trimester is very limited.
Izkušnje z izpostavljenostjo v drugem in tretjem trimesečju so zelo omejene.
Sensitivity to light.
Občutljivo na svetlobo.
If you inject more than you should
Če ste injicirali več, kot bi smeli
These notes are a reminder.
Te opombe so opozorilo.
Alternative assay techniques are not sufficiently sensitive.
Alternativne tehnike analize niso dovolj občutljive.
This is the safety lock.
To je varnostna zapora.
An effect on MRI parameters was also seen.
Viden je bil tudi učinek na MRI parametre.
These symptoms are not really flu.
Ti simptomi niso prava gripa.
Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Na podlagi študij na živalih (glejte poglavje 5.3) obstaja možnost povečanega tveganja za spontani splav.
This latter clinical effect was observed after more than one year of treatment.
Ta klinični učinek se je opazovalo po več kot enem letu zdravljenja.
Relax your muscle.
Sprostite mišico.
Date of first authorisation: 13 March 1997 Date of latest renewal: 13 March 2007
Datum zadnjega podaljšanja: 13. marec 2007
Signs are:
Znaki so:
These symptoms are usually present during the first few months of treatment.
Ti simptomi se navadno pojavljajo v prvih nekaj mesecih zdravljenja.
1171 LP Badhoevedorp The Netherlands
1171 LP Badhoevedorp Nizozemska
No harmful effects on the breastfed newborn/infant are anticipated.
Škodljivih učinkov na dojene novorojence/otroke se ne pričakuje.
Serious side effects: get medical help Serious allergic reactions
Resni neželeni učinki: poiščite zdravniško pomoč Resne alergijske reakcije
Alternate the left and right thighs.
Menjajte levo in desno stegno.
Allow the skin to dry.
Počakajte, da se koža posuši.
No direct comparison with the dose currently recommended in adults is available.
Neposredna primerjava z odmerki, ki se trenutno priporočajo za odrasle, ni na voljo.
You may also wish to make a note of these details in case you are asked for this information in the future.
Tudi vi si lahko zabeležite te podatke, če bi jih v prihodnosti potrebovali.
MS also tends to flare up from time to time: this is called a relapse.
MS občasno znova vzplamti: temu se reče ponovitev.
The window will now appear yellow when the full dose has been delivered.
Okence postane rumeno, če je bil dostavljen celotni odmerek.
The formulation does not contain a preservative.
Formulacija ne vsebuje konzervansa.
No formal interaction studies have been performed in humans.
Uradnih študij medsebojnega delovanja pri ljudeh niso izvedli.
If this happens to you, or if you get any other side effects that could affect your ability, do not drive or use machines.
Če se to zgodi vam ali če čutite druge neželene učinke, ki bi lahko vplivali na vašo sposobnost, ne vozite in ne upravljajte strojev.
Elderly: Clinical studies did not include a sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients.
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.
Always follow your local guidelines.
Sledite lokalnim predpisom.
It may be possible for your doctor to prescribe you a shorter and thinner needle, depending on your body type.
Morda vam bo lahko vaš zdravnik predpisal krajšo in tanjšo iglo glede na vaš tip telesa.
Waste paper and used wipes can be put in an ordinary rubbish bin.
Odpadni papir in uporabljene krpice lahko odvržete v navaden koš za smeti.
In any case, treatment should only be considered for patients classified at high risk.
V vsakem primeru pa pride zdravljenje v poštev le za bolnike, razvrščene v razred z visokim tveganjem.
On each left hand page you'll find useful tips and explanations on how to get the best from your medicine.
Na vsaki levi strani najdete koristne nasvete in razlage o najboljši uporabi svojega zdravila.
It was also shown that there was a one-third reduction in annual relapse rate.
Pokazalo se je tudi zmanjšanje števila relapsov na leto za eno tretjino.
It may make you feel faint.
Morda se boste počutili slabotno.
You can't pass it on to anyone else.
Ne morete je prenesti na drugega.
• Check the safety lock is released.
• Preverite, ali je varnostna zapora sproščena.
• Look through the oval display window.
• Poglejte skozi ovalno okence.
Wash your hands thoroughly with soap and water and dry them.
Temeljito si umijte roke z milom in vodo ter jih osušite.
Although the list of possible side effects can seem worrying, it's possible that you may not have any of them.
Čeprav je seznam vseh možnih neželenih učinkov lahko zaskrbljujoč, morda ne boste imeli niti enega.
Point the needle cover away from you and anyone else.
Pokrovček igle držite proč od sebe in drugih ljudi.
It only happens when you inject and the effects soon pass.
Zgodi se samo ob injiciranju, učinki pa kmalu prenehajo.
Interferons are natural substances made in your body to help protect you from infections and diseases.
Interferoni so naravne snovi, ki se v telesu proizvajajo za zaščito pred okužbami in boleznimi.
2The frequency of occurrence is higher at the beginning of treatment.
2Pogostnost pojavljanja je večja ob začetku zdravljenja.
They can also differ with respect to their cellular sites of synthesis.
Razlikujejo se lahko tudi glede na mesto v celici, kjer poteka njihova sinteza.
In order to obtain adequate efficacy, a dose of 30 micrograms once a week should be reached and maintained after the initial titration period.
Za ustrezno učinkovitost morate doseči odmerek 30 mikrogramov enkrat na teden in ga vzdrževati po obdobju začetnega titriranja.
Talk to your doctor to see if this is appropriate for you.
Pogovorite se z zdravnikom in ugotovite, kaj je za vas primerno.
In MS, your body's defence system reacts against its own myelin - the ‘insulation' that surrounds nerve fibres.
Pri MS se obrambni sistem telesa odzove na lastni mielin - „izolacijo“, ki obdaja živčna vlakna.
This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers.
Ta vezava sproži zapleteno kaskado znotrajceličnih procesov, ki vodijo do izražanja številnih interferonsko povzročenih genskih produktov in označevalcev.
However, the effects of interferon beta that are dependent on glycosylation are not fully defined.
Vendar pa učinki interferona beta, ki so odvisni od glikozilacije, niso v celoti določeni.
The potential of additive effects from multiple medicinal products or other hepatotoxic agents (e.g. alcohol) has not been determined.
Možnosti aditivnega delovanja večih zdravil ali drugih hepatotoksičnih snovi (npr. alkohola) niso ugotovili.
Do not use this medicine after the expiry date stated on the label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
You will hear a “click” indicating the injection process has begun.
Slišali boste klik, ki nakazuje začetek postopka injiciranja.
The interaction of AVONEX with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Medsebojno delovanje zdravila AVONEX s kortikosteroidi ali adrenokortikotropnim hormonom (ACTH) ni bilo sistematično preučeno.
Pharmacotherapeutic Group: Interferons, ATC code: L03 AB07.
Farmakoterapevtska skupina: interferoni, oznaka ATC: L03 AB07.
More about depression.
Več o depresiji.
With appropriate adjustment for the rate of absorption from the injection site, the calculated bioavailability is approximately 40%.
Ob ustreznem upoštevanju hitrosti absorpcije z mesta injiciranja znaša izračunana biološka uporabnost približno 40 %.
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.
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.
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.
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.
If you feel dizzy, do not drive.
Če ste omotični, ne vozite.
The intramuscular injection site should be varied each week (see section 5.3).
Mesto intramuskularnega injiciranja naj se spremeni vsak teden (glejte poglavje 5.3).
• Dispose of rubbish properly.
• Odpadke ustrezno odstranite.
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.
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.
Do not make changes unless your doctor tells you.
Ne izvajajte sprememb, razen po naročilu zdravnika.
Because Avonex is based on a protein, there is a small chance of an allergic reaction.
Ker je zdravilo Avonex izdelano na osnovi beljakovine, obstaja majhna verjetnost alergijske reakcije.
Glycosylation of other proteins is known to affect their stability, activity, biodistribution, and half-life in blood.
Znano je, da lahko glikozilacija drugih proteinov vpliva na njuno stabilnost, aktivnost, bioporazdelitev in razpolovno dobo v krvi.
• Patients diagnosed with relapsing multiple sclerosis (MS).
• bolnikov z diagnozo ponavljajoče se multiple skleroze (MS).
Dispose of the rubbish properly
Pravilno odstranite odpadke
Prepare alcohol wipes and sticking plasters (not supplied) if you need them.
Pripravite alkoholne krpice in obliže (niso priloženi), če jih potrebujete.
Leave it at room temperature for half an hour.
Za pol ure ga pustite na sobni temperaturi.
This may allow you to sleep through the effects.
Morda boste tako učinke prespali.
For example, if you are prescribed other medicines, or if you have a blood test, Avonex may affect the other medicines or the test result.
Na primer, če vam predpisujejo druga zdravila ali če izvajajo krvni test, lahko zdravilo Avonex vpliva na druga zdravila ali rezultate testa.
Doctors may prescribe a 25 mm, 25 gauge needle to patients for whom such a needle is appropriate to administer an intramuscular injection.
Zdravnik lahko predpiše uporabo 25 mm igle, dimenzije 25 G (gauge) tistim bolnikom, za katere je takšna igla za intramuskularno injiciranje ustrezna.
Tip: If you twist the needle cover to remove it, you may accidentally remove the needle as well.
Nasvet: Če boste pokrovček igle zasukali, da ga odstranite, boste morda nenamerno odstranili tudi iglo.
Mutagenesis: Limited but relevant mutagenesis tests have been carried out.
Mutageneza: izvedeno je bilo malo število testov mutageneze, vendar so ti pomembni.
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Znano je, da se depresija in samomorilna nagnjenja pogosteje pojavljajo pri populaciji bolnikov z multiplo sklerozo in v povezavi z uporabo interferona.
In some cases, these reactions have occurred in the presence of other medicinal products that have been associated with hepatic injury.
V nekaterih primerih so te reakcije nastopile v prisotnosti drugih zdravil, ki so jih že pred tem povezovali s poškodbami jeter.
AVONEX exerts its biological effects by binding to specific receptors on the surface of human cells.
Zdravilo AVONEX doseže svoj biološki učinek s tem, da se veže na specifične receptorje na površini človeških celic.
After a single intramuscular dose of AVONEX, serum levels of these products remain elevated for at least four days and up to one week.
Po enem samem intramuskularnem odmerku zdravila AVONEX so ostale ravni teh produktov v serumu povišane vsaj štiri dni in do enega tedna.
The use of various assays to detect serum antibodies to interferons limits the ability to compare antigenicity among different products.
Uporaba različnih analiz, da bi odkrili serumska protitelesa za interferone, omejuje zmožnost za primerjavo antigenosti med različnimi zdravili.
- Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
- Pri bolnikih s prisotno hudo depresijo in/ali samomorilnimi nagnjenji (glejte poglavji 4.4 in 4.8).
Tip: Place the pen down on the table before beginning step 2.
Nasvet: Napolnjen injekcijski peresnik položite na mizo, preden začnete s korakom 2.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nosečnost in dojenje Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Even if you have used Avonex before, some of the information may have changed.
Tudi če ste zdravilo Avonex že uporabljali, so se morda nekateri podatki spremenili.
Some of these products have been measured in the serum and cellular fractions of blood collected from patients treated with AVONEX.
Nekatere od teh produktov so merili v frakcijah seruma in celičnih frakcijah krvi bolnikov, ki so se zdravili z zdravilom AVONEX.
When myelin is damaged, the messages between the brain and other parts of the body are disrupted.
Zaradi poškodovanega mielina so sporočila med možgani in drugimi deli telesa motena.
It is estimated that the plateau for the incidence of neutralising antibody formation is reached after 12 months of treatment.
Ocenjuje se, da je prag, pri katerem se začnejo proizvajati nevtralizirajoča protitelesa, dosežen po 12 mesecih zdravljenja.
Do not use two injections to make up for a missed injection.
Ne uporabite dveh injekcij, da bi nadomestili zamujeni odmerek.
No studies on the effects of AVONEX on the ability to drive and use machines have been performed.
Študij o vplivu zdravila AVONEX na sposobnost vožnje in upravljanja strojev niso izvedli.
Otherwise it may leak.
sicer lahko pušča.
It gives you an idea how likely you are to get similar side effects.
Predstavljate si lahko, kakšna je možnost, da bi imeli podobne neželene učinke.
The concentration is 30 micrograms per 0.5 ml.
Koncentracija je 30 mikrogramov na 0,5 ml.
Do not use any more Avonex until you have spoken to a doctor.
Ne uporabljajte več zdravila Avonex, dokler se ne pogovorite z zdravnikom.
Now pull off the plastic needle cover.
Sedaj snemite plastičen pokrovček igle.
More about depression
Več o depresiji
However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Vendar pa na osnovi podatkov o izločanju učinkovine ni teoretičnega razloga za morebitne zahteve po prilagajanju odmerka pri starejših bolnikih.
After you have finished each injection, put the needle and syringe into a special container (such as a sharps bin), not in ordinary rubbish.
Ko končate z injiciranjem, odvrzite iglo in injekcijsko brizgo v poseben zabojnik (zabojnik za ostre predmete) in ne v običajen koš za odpadke.
Local Tolerance: Intramuscular irritation has not been evaluated in animals following repeated administration to the same injection site.
Lokalna toleranca: intramuskularna iritacija pri živalih po večkratni aplikaciji zdravila na isto mesto ni bila določena.
It is important to continue using Avonex regularly.
Pomembno je, da z uporabo zdravila Avonex nadaljujete redno.
The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body.
Protein v zdravilu Avonex je sestavljen iz natančno enakih sestavin, kot interferon beta, ki se nahaja v človeškem telesu.
• Do not remove the needle cover.
• Ne odstranite pokrovčka igle.
AVONEX PEN is available in pack sizes of four or twelve.
AVONEX PEN je na voljo v velikosti pakiranja po štiri ali dvanajst.
Interferon beta is produced by various cell types including fibroblasts and macrophages.
Interferon beta proizvajajo različni tipi celic, med njimi tudi fibroblasti in makrofagi.
In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file.
Da bi izboljšali sledljivost tega zdravila, mora zdravnik ali farmacevt v vašo zdravstveno kartoteko zabeležiti ime in številko serije zdravila, ki ste ga prejeli.
Not for children
Ne uporabljajte pri otrocih
Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Bolnike z depresijo morate med zdravljenjem skrbno spremljati in jih ustrezno zdraviti.
These effects have been seen in people using Avonex, but we do not know how likely they are to happen.
Te učinke so opazili pri ljudeh, ki so uporabljali zdravilo Avonex, vendar nimamo podatkov o pogostnosti pojavljanja.
If clinically needed, the use of Avonex may be considered during pregnancy.
Če je klinično potrebno, se lahko pretehta možnost uporabe zdravila Avonex med nosečnostjo.
At very high doses, anovulatory and abortifacient effects in test animals were observed (see section 5.3).
Pri zelo visokih odmerkih so pri poskusnih živalih opazili anovulacijske in abortivne učinke (glejte poglavje 5.3).
If you have a fever, drink plenty of water to keep you hydrated.
Če imate zvišano telesno temperaturo, pijte veliko vode, da ne dehidrirate.
Recent clinical studies with patients treated up to three years with AVONEX suggest that approximately 5% to 8% develop neutralising antibodies.
Nedavne klinične študije, pri katerih so se bolniki z zdravilom AVONEX zdravili do tri leta, kažejo, da približno 5 % do 8 % bolnikov razvije nevtralizirajoča protitelesa.
Find a clean, hard surface to lay out the items needed for your injection.
Najdite čisto in trdno površino, na katero boste položili predmete, ki jih potrebujete za injiciranje.
If you have severe depression or thoughts about suicide, you must not use Avonex.
Če imate hudo depresijo ali mislite na samomor, ne smete uporabljati zdravila Avonex.
Keep a note of where you have injected each week.
Vsak teden si zabeležite, kam ste zdravilo injicirali.
In some cases these symptoms are associated with flu-like symptoms.
V nekaterih primerih so ti simptomi združeni z gripi podobni simptomi.
• Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1).
• bolnikov, ki so doživeli en demielinizacijski napad z aktivnim vnetnim procesom, če je bil dovolj resen, da upravičuje zdravljenje z intravenoznimi kortikosteroidi, če so bile druge možne diagnoze izključene in če je bolnik uvrščen v visoko stopnjo tveganja, da se bo pri njem/njej razvila klinično jasna multipla skleroza (glejte poglavje 5.1).
Three simple ways to help reduce the impact of flu-like symptoms:
Trije preprosti načini za zmanjšanje učinkov gripi podobnih simptomov:
In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three-years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
V kliničnih študijah so to opisali kot dva ali več akutnih poslabšanj (relapsov) v preteklih treh letih, brez dokazov o postopnem napredovanju med relapsi; zdravilo AVONEX upočasnjuje napredovanje prizadetosti in zmanjšuje pogostnost relapsov.
Tell your doctor if you are using, have recently used or might use any other medicines, especially those used to treat epilepsy or depression.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, še zlasti tista za zdravljenje epilepsije ali depresije.
However, the impact of early treatment with AVONEX is unknown even in this high-risk subgroup as the study was mainly designed to assess the time to the second event rather than the long-term evolution of the disease.
Učinek zgodnjega zdravljenja z zdravilom AVONEX niti v tej podskupini z visokim tveganjem ni znan, saj je bila študija namenjena predvsem ocenjevanju časa do drugega napada, ne pa dolgoročnega razvoja bolezni.
• Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound.
• Ne uporabljajte predela kože, ki ima modrice, je vnet ali okužen ter predela z odprtimi ranami.
Treatment should be discontinued if the patient develops chronic progressive MS.
Zdravljenje je potrebno prekiniti, če se pri bolniku razvije kronična napredujoča MS.