natgillin/translations-raw huggingface dataset:
If some areas are too difficult for you to reach, you may need a family member or friend to help you with these injections.
Če nekatera mesta težko dosežete, prosite za pomoč člana družine ali prijatelja, da vam pomaga pri injiciranju.
An abnormal response by the body's immune system is thought to play an important part in the process which damages the CNS.
Predvidevajo, da ima nenormalen odziv imunskega sistema telesa pomembno vlogo v procesu, ki uničuje OŽ.
Administration of Extavia injections every other day does not lead to serum level increase, and the pharmacokinetics do not seem to change during therapy.
Injiciranje zdravila Extavia vsak drugi dan ne povzroči povečanja koncentracije v serumu in kot kaže, se farmakokinetika med zdravljenjem ne spremeni.
- During treatment with Extavia your body may produce substances called neutralising antibodies, which may react with Extavia.
- Med zdravljenjem z zdravilom Extavia lahko vaše telo proizvede snovi, imenovane nevtralizirajoča protitelesa, ki lahko reagirajo z zdravilom Extavia.
The development of neutralising activity is associated with a reduction in clinical efficacy only with regard to relapse activity.
Pojav nevtralizirajoče aktivnosti je povezan z zmanjšanjem klinične učinkovitosti, le kar zadeva recidivno aktivnost.
Generally, dose titration is recommended at the start of treatment.
Na splošno se na začetku zdravljenja priporoča titracija odmerka.
As rodents do not react to human interferon beta, repeated dose studies were carried out with rhesus monkeys.
Ker se glodalci ne odzovejo na človeški interferon beta, so študije ponavljajočih odmerkov naredili na opicah rhesus.
No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Formalnih kliničnih preskušanj ali farmakokinetičnih študij pri otrocih ali mladostnikih niso opravili.
Extavia should not be used in children under 12 years of age as there is no information available for this age group.
Zdravila Extavia ni dovoljeno uporabljati pri otrocih, starih manj kot 12 let, ker za to starostno skupino ni na voljo nobenih podatkov.
Interferon beta-1b has been given to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week without serious adverse events compromising vital functions.
Interferon beta-1b so dajali odraslim bolnikom z rakom v individualnih odmerkih do 5,500 mikrogramov (176 milijonov i.e.) intravensko trikrat na teden in pri tem ni prišlo do resnih neželenih učinkov, ki bi ogrožali vitalne funkcije.
Extavia is indicated for the treatment of:
Zdravilo Extavia je indicirano za zdravljenje:
• Vial adapters for use when reconstituting your medicine
• adapterje za vialo, ki jih potrebujete za rekonstitucijo zdravila
These will be performed before you start using Extavia, regularly after treatment with Extavia has been initiated and then periodically during treatment, even if you have no particular symptoms.
Preiskave je treba opraviti preden začnete jemati zdravilo Extavia, redno po začetku zdravljenja z zdravilom Extavia in nato v presledkih med zdravljenjem, tudi če nimate posebnih simptomov.
In the absence of clinical evidence for liver damage, and after normalisation of liver enzymes, a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
V odsotnosti kliničnih znakov okvare jeter in po normalizaciji jetrnih encimov je mogoče razmisliti o ponovni uvedbi zdravljenja z ustreznim nadaljnjim spremljanjem jetrnega delovanja.
Reproduction studies with rhesus monkeys revealed maternal toxicity and an increased rate of abortion, resulting in prenatal mortality.
Reprodukcijske študije pri opicah rhesus so razkrile maternalno toksičnost in povečano pogostost splavov, ki sta povzročila prenatalno umrljivost.
In-use stability demonstrated for 3 hours at 2°C - 8°C.
Stabilnost po pripravi je dokazana za 3 ure pri temperaturi od 2 °C do 8 °C.
Extavia is a type of medicine known as interferon used to treat multiple sclerosis.
Extavia je vrsta zdravila, znanega kot interferon, za zdravljenje multiple skleroze.
- disease of the heart muscle (cardiomyopathy), (rare).
- obolenje srčne mišice (kardiomiopatija) (redki).
The relation of multiple sclerosis disease activity as measured by MRI and clinical outcome is currently not fully understood.
Razmerje med bolezensko aktivnostjo multiple skleroze, merjeno z MRS, in kliničnim izidom trenutno ni povsem jasno.
• 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 z enkratnim demielinizacijskim dogodkom, z aktivnim vnetnim procesom, če je dovolj resen, da je potrebno intravensko zdravljenje s kortikosteroidi, če je bila alternativna diagnoza izključena in če je ugotovljeno, da je tveganje za razvoj klinično dokončne multiple skleroze veliko (glejte poglavje 5.1);
6 - Inject the medicine (by pushing the plunger slowly and steadily all the way in until the syringe is empty).
6 - Injicirajte zdravilo (s počasnim in enakomernim potiskanjem bata do konca, dokler ne izpraznite brizge).
The list also includes side effects which occurred commonly (may affect up to 1 in 10 people) but were significantly associated with the treatment:
Seznam obsega tudi neželene učinke, ki so se pojavljali pogosto (lahko prizadenejo največ 1 od 10 bolnikov), a so pomembno povezani z zdravljenjem:
If you come back to an area after one Rotation Cycle choose the most distant injection site within this area.
Če se po enem rotacijskem ciklu vrnete na isti predel, izberite mesto injiciranja znotraj tega predela, ki je najbolj oddaljeno od prejšnjega.
Your doctor may decide together with you to change the time intervals for dose increase depending on side effects you may experience at the start of treatment.
Vaš zdravnik se lahko skupaj z vami odloči za spremembo presledka za povečanje odmerka glede na neželene učinke ob začetku zdravljenja.
No data are available on the use of Extavia in children under 12 years of age and therefore Extavia should not be used in this population.
Podatkov o uporabi zdravila Extavia pri otrocih, mlajših od 12 let, ni na voljo, zato se ga pri tej populaciji ne sme uporabljati.
This medicinal product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Zdravilo vsebuje človeški albumin in zato obstaja potencialno tveganje za prenos virusnih bolezni.
You may need extra monitoring by your doctor.
Morda vas bo moral zdravnik posebej nadzirati.
C) Reconstituting and drawing up the solution for injection, step by step
C) Rekonstitucija in izvlek raztopine za injiciranje po korakih
Please refer to the rotation schedule at the end of this Annex to learn how to choose an injection site.
Oglejte si načrt menjavanja na koncu tega Dodatka, da se naučite izbrati mesto injiciranja.
No acute toxicity studies have been performed.
Študij akutne toksičnosti niso izvedli.
Note: It may be necessary to adjust the plunger position back and forth a few times to ensure the excess air bubbles are gone and there is 1 ml of solution in the syringe.
Pozor: Morda boste morali bat nekajkrat potisniti nazaj in naprej, da boste odstranili odvečne zračne mehurčke in zagotovili, da bo v brizgi 1 ml raztopine.
The following instructions and pictures explain how to prepare Extavia for injection and how to inject Extavia yourself.
Naslednja navodila in slike pojasnjujejo, kako zdravilo Extavia pripravite za injiciranje in kako si ga sami injicirate.
This study consisted of two phases, a placebocontrolled phase followed by a pre-planned follow-up phase.
Ta študija je imela dva dela: s placebom kontroliranemu prvemu delu je sledil vnaprej načrtovan kontrolni del študije.
Patients should be monitored for signs of hepatic injury.
Bolnike je treba nadzirati glede znakov okvare jeter.
The reconstituted product is colourless to light yellow and slightly opalescent to opalescent.
Pripravljeno zdravilo je brezbarvno do rumenkasto in rahlo opalescentno do opalescentno.
Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
Bolniki z dekompenzirano boleznijo jeter (glejte poglavja 4.4, 4.5 in 4.8).
There is evidence that the patients included in this study had overall less active disease than in the other study in secondary progressive multiple sclerosis.
Obstajajo dokazi, da so imeli bolniki v tej raziskavi v celoti manj aktivno bolezen kot v omenjeni prvi raziskavi pri sekundarno progresivni multipli sklerozi.
In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (89) of the patients treated immediately with Extavia.
V študiji pri bolnikih z enim samim kliničnim dogodkom, ki kaže na multiplo sklerozo, so nevtralizacijsko aktivnost, izmerjeno vsakih 6 mesecev, opazili vsaj enkrat pri 32 % (89) bolnikov, ki so takoj prejeli zdravilo Extavia.
For relapsing-remitting multiple sclerosis, efficacy has been demonstrated for therapy for the first two years.
Pri recidivno-remitentni multipli sklerozi je dokazana učinkovitost zdravljenja za prvi dve leti.
To reconstitute and inject your medicine you will need to use an ExtaviPro 30G application kit (supplied separately to your medicine), which contains the following components and instructions on how to use them:
Za rekonstitucijo in injiciranje zdravila boste morali uporabiti komplet ExtaviPro 30G (dobite ga ločeno), ki vsebuje naslednje pripomočke in navodila za njihovo uporabo:
Your doctor will regularly check the way you inject yourself, particularly if you have experienced injection site reactions.
Zdravnik bo redno preverjal vaš način samoinjiciranja, še zlasti, če se pojavijo reakcije na mestu injiciranja.
Experience with Extavia in patients with multiple sclerosis (MS) is limited, consequently those adverse events which occur very rarely may not yet have been observed.
Izkušnje z zdravilom Extavia so pri bolnikih z multiplo sklerozo (MS) pomanjkljive, zato je mogoče, da neželeni učinki, ki se pojavljajo zelo redko, še niso bili opaženi.
• Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
• bolnikov s sekundarno progresivno multiplo sklerozo, pri katerih je bolezen aktivna, kar se kaže z recidivi.
The most serious were reported in patients taking other medicines or who were suffering from diseases that can affect the liver (e.g. alcohol abuse, severe infection).
O najresnejših učinkih so poročali pri bolnikih, ki so dobivali še druga zdravila ali so imeli bolezni, ki vplivajo na jetra (npr. zloraba alkohola, resne okužbe).
► Stop using Extavia and tell your doctor immediately if any of these happens to you.
► Takoj prenehajte uporabljati zdravilo Extavia in obvestite svojega zdravnika, če se vam zgodi karkoli od naštetega.
The recommended dose is every other day (once every two days), 1.0 ml of the prepared Extavia solution (see Annex “Self-injection procedure” in the second part of this leaflet) injected under the skin (subcutaneously).
Priporočeni odmerek je vsak drugi dan (enkrat na dva dni) 1,0 ml pripravljene raztopine zdravila Extavia (glejte prilogo "Postopek samoinjiciranja" v drugem delu tega Navodila za uporabo) injicirane pod kožo (subkutano).
Hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1.
Preobčutljivost na naravni ali rekombinantni interferon beta, humani albumin ali katero koli pomožno snov, navedeno v poglavju 6.1.
Patients with anaemia, thrombocytopenia or leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Pri bolnikih z anemijo, trombocitopenijo ali levkopenijo (samo ali v kateri koli kombinaciji) bo morda potrebno pozornejše spremljanje celotne krvne slike, diferencialne krvne slike in števila trombocitov.
The powder is white to off-white in colour.
Prašek je bele do belkaste barve.
Between 43% and 55% of these patients converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the trial concerned.
Od 43 % do 55 % teh bolnikov je med poznejšim opazovalnim obdobjem posameznega preskušanja prišlo do konverzije v stabilni antigensko negativni status (na osnovi dveh zaporednih negativnih titrov).
What you need to know before you use Extavia
Kaj morate vedeti, preden boste uporabili zdravilo Extavia
Your doctor will closely monitor you during treatment.
Med zdravljenjem vas bo zdravnik pozorno nadziral.
Nephrotic syndrome, glomerulosclerosis (see section 4.4)* , #
Bolezni sečil nefrotski sindrom, glomeruloskleroza (glejte poglavje 4.4)*
Relapsing-remitting multiple sclerosis: People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
Recidivno-remitentna multipla skleroza: bolniki z recidivno-remitentno MS imajo občasne napade ali relapse, med katerimi se simptomi znatno poslabšajo.
In general, treatment should be started at a low dose of 0.25 ml (62.5 microgram).
Na splošno je treba zdravljenje začeti z majhnim, 0,25-mililitrskim odmerkom (62,5 mikrograma).
If you become depressed while you are on Extavia, you may need special treatment and your doctor will closely monitor you and may also consider stopping your treatment.
Če postanete med jemanjem zdravila Extavia depresivni, vas bo morda treba posebej zdraviti, zdravnik pa vas bo pozorno nadziral ali pretehtal možnost prekinitve zdravljenja.
7 - Discard the syringe in the disposal unit.
7- Brizgo zavrzite v posodo za odstranjevanje.
There is no evidence of an effect of Extavia on the duration of relapses or on symptoms in between relapses, and no significant effect was seen on the progression of the disease in relapsing-remitting multiple sclerosis.
Ni dokazov, da bi zdravilo Extavia vplivalo na trajanje recidivov ali na simptome med recidivi, in opazili niso nobenega pomembnega vpliva na napredovanje bolezni pri recidivno-remitentni multipli sklerozi.
A number of these products have been measured in the serum and cellular fractions of blood collected from patients treated with interferon beta-1b.
Številne takšne produkte so izmerili v serumski in celični frakciji krvi bolnikov, zdravljenih z interferonom beta-1b.
A large amount of data (more than 1,000 pregnancy outcomes) from interferon beta registries, national registries and post-marketing experience indicates no increased risk of major congenital anomalies, after pre-conception exposure or exposure during the first trimester of pregnancy.
Veliko število podatkov (več kot 1000 izidov nosečnosti) iz registra izpostavljenosti nosečnic interferonu beta, nacionalnih registrov in izkušenj uporabe po prihodu zdravila na trg ne kaže, da bi izpostavljenost zdravilu pred spočetjem oziroma v prvem trimesečju nosečnosti povečevala tveganje za pomembne prirojene nepravilnosti.
During the post-marketing period very rare reports have been received of temporary worsening of cardiac status at the start of Extavia therapy in patients with pre-existing significant cardiac disease.
V obdobju trženja so prejeli zelo redka poročila o prehodnem poslabšanju bolezni srca na začetku zdravljenja z zdravilom Extavia pri bolnikih z obstoječo boleznijo srca.
Other medicines and Extavia Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
The procedure for self-administration by the patient should be reviewed periodically, especially if injection site reactions have occurred.
Bolnikov postopek samoinjiciranja je treba redno kontrolirati, zlasti če so se pojavile reakcije na mestu aplikacije.
The risk for progression to CDMS within two years in patients with monofocal onset was 47% for placebo and 24% for Extavia, without gadolinium (Gd-) enhancement 41% and 20%, with less than 9 T2 lesions 39% and 18%.
Tveganje za napredovanje do CDMS v dveh letih pri bolnikih z monofokalnim začetkom je bilo pri placebu 47 % in 24 % pri zdravilu Extavia, brez ojačitve z gadolinijem (Gd) 41 % in 20 %, z manj kot 9 lezij T2 39 % in 18 %.
Patients with mild disease and those unable to walk were not studied.
Bolnikov z blago boleznijo in bolnikov, nezmožnih hoje, niso proučevali.
PART III: EXTAVIA Medication record
DEL III: Kartica o uporabi zdravila EXTAVIA
Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia, should be monitored for worsening of their cardiac condition, particularly during initiation of treatment with Extavia.
Pri bolnikih z obstoječimi pomembnimi srčnimi boleznimi, kot so kongestivna srčna odpoved, bolezen koronarnih arterij ali aritmija, je treba spremljati poslabšanje bolezni srca, zlasti pri začetku zdravljenja z zdravilom Extavia.
Depression and suicidal ideation are known to occur with increased frequency in the multiple sclerosis population and in association with interferon use.
Znano je, da sta depresija in samomorilno razmišljanje med bolniki z multiplo sklerozo in v povezavi z uporabo interferona pogostejša.
Changes to liver function values occurred in patients treated with Extavia during clinical studies.
Spremembe vrednosti preiskav delovanja jeter so se pojavile pri bolnikih, ki so jih med kliničnimi študijami zdravili z zdravilom Extavia.
There have been no formal clinical trials undertaken in children or adolescents.
Formalnih kliničnih preskušanj pri otrocih in mladostnikih niso opravili.
Extavia should also be used with caution in patients who suffer from pre-existing cardiac disorders.
Zdravilo Extavia je treba uporabljati previdno pri bolnikih, ki imajo že obstoječe bolezni srca.
Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
Mutipla skleroza (MS) je dolgotrajna bolezen, ki vpliva na osrednje živčevje (OŽ), še zlasti na delovanje možganov in hrbtenjače.
- Be consistent - use this medicine as described in section 3 of the leaflet, “How to use Extavia”.
- Bodite dosledni - to zdravilo uporabljajte, kot je opisano v poglavju 3.
To help you rotate the injection sites appropriately, we recommend that you keep a record of the date and location of your injection.
Da bi ustrezno rotirali mesta injiciranja, priporočamo, da si datum in mesto zapišete.
- severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arterial hypertension), (frequency unknown).
- hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerihkri teče iz srca v pljuča (pljučna arterijska hipertenzija), (pogostnost neznana).
In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Za doseganje ustrezne učinkovitosti je treba doseči odmerek 250 mikrogramov (1,0 ml) vsak drugi dan.
Extavia prolonged the time to CDMS by 363 days, from 255 days in the placebo group to 618 days in the Extavia group (based on the 25th percentiles).
Zdravilo Extavia je podaljšalo čas do CDMS za 363 dni, od 255 pri bolnikih, ki so prejemali placebo, na 618 dni pri bolnikih, ki so prejemali zdravilo Extavia (na temelju 25. percentila).
What Extavia is and what it is used for What you need to know before you use Extavia How to use Extavia
Kaj je zdravilo Extavia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Extavia Kako uporabljati zdravilo Extavia Možni neželeni učinki
In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres.
V različnih nadzorovanih kliničnih preskušanjih se je pri 23 % do 41 % bolnikov pojavila nevtralizacijska aktivnost interferona beta-1b v serumu, ki so jo potrdili z vsaj dvema zaporednima pozitivnima titroma.
Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function, is recommended, especially in patients at higher risk of renal disease.
Priporočeno je redno spremljanje zgodnjih znakov oziroma simptomov, kot so edemi, proteinurija in zmanjšana ledvična funkcija, zlasti pri bolnikih s povečanim tveganjem za ledvične bolezni.
- severe loss of appetite leading to weight loss (anorexia), (rare).
- huda izguba apetita, ki povzroči zmanjšanje telesne mase (anoreksija) (redki).
When you use the solution, warm it up by holding the syringe or vial in your hands before injecting to avoid pain.
Ko želite raztopino uporabiti, jo segrejte tako, da brizgo ali vialo pred injiciranjem nekaj časa držite med dlanmi, da bi preprečili bolečino pri injiciranju.
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 was likely interrupted when the pregnancy was detected and/or confirmed.
Podatki o izpostavljenosti v prvem trimesečju nosečnosti so pri tem nezanesljivi, saj so podatke zbirali v času, ko je bila uporaba interferona beta v času nosečnosti kontraindicirana, tako da so zdravljenje večinoma prekinili, ko so odkrili in/ali potrdili nosečnost.
250 microgram (8.0 million IU) per ml after reconstitution.
250 mikrogramov (8,0 milijonov i.e.) na ml po rekonstituciji
Extavia can be used during breast-feeding.
Zdravilo Extavia se lahko uporablja med dojenjem.
The Extavia powder is provided in a 3-millilitre vial.
Prašek zdravila Extavia je na voljo v 3-mililitrski viali.
In the second trial of Extavia in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
V drugi raziskavi zdravila Extavia pri sekundarno progresivni multipli sklerozi niso opazili odloga do napredovanja invalidnosti.
• Alcohol swabs
• alkoholne blazinice
1 - Choose a site for the injection (refer to the section “Choosing an injection site” and the diagrams at the end of this leaflet) and make a note of it in your medication record.
1 - Izberite mesto injiciranja (glejte poglavje “Izbira mesta injiciranja” in diagrame ob koncu tega navodila) in dogodek zabeležite v kartici uporabe zdravila.
Secondary progressive multiple sclerosis (SP-MS) Two controlled clinical trials were performed with Extavia involving a total of 1,657 patients with secondary progressive multiple sclerosis (baseline EDSS 3 to 6.5, i.e. patients were able to walk).
Sekundarno progresivna multipla skelroza (SPMS) Narejeni sta bili dve kontrolirani klinični raziskavi z zdravilom Extavia, ki sta skupaj zajeli 1.657 bolnikov s sekundarno progresivno multiplo sklerozo (izhodiščni EDSS 3 do 6,5, tj. bolniki so lahko hodili).
Each cycle will be 8 injections (16 days), given in area 1 through to area 8 in turn.
Vsak cikel sestavlja 8 injekcij (16 dni), ki se zaporedoma dajejo v predele 1 do 8.
Table 1 Adverse events and laboratory abnormalities with incidence rates ≥10% and the respective percentages under placebo; significantly associated side effects <10% based on reports from clinical trials
Preglednica 1 Neželeni učinki in nenormalni rezultati laboratorijskih preiskav s pogostnostjo ≥10 % in ustrezni odstotki pri placebu; statistično značilno povezani neželeni učinki <10 % na podlagi poročil iz kliničnih študij
If you forget to use Extavia
Če ste pozabili uporabiti zdravilo Extavia
The two studies showed inconsistent results for the primary endpoint time to confirmed progression, representing delay of disability progression:
Izsledki obeh raziskav niso konsistentni, kar zadeva primarno končno točko do potrjenega napredovanja, ki pomeni odlog napredovanja invalidnosti.