natgillin/translations-raw huggingface dataset:
Extavia serum levels were followed in patients and volunteers by means of a bioassay that was not completely specific.
Koncentracijo zdravila Extavia v serumu so pri bolnikih in prostovoljcih spremljali z ne povsem specifičnim biološkim preizkusom.
It can be extensive and may involve muscle fascia as well as fat and therefore can result in scar formation.
Lahko je razširjena in lahko zajame mišično fascijo in maščobe, kar lahko povzroči nastanek brazgotin.
The dose should be increased at every fourth injection in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml).
Odmerek je treba v štirih korakih povečati ob vsaki četrti injekciji (0,25 ml, 0,5 ml, 0,75 ml, 1,0 ml).
Push the plunger down slowly so that the liquid runs down the inside of the vial.
Bat brizge počasi potisnite navzdol, da steče tekočina navzdol po notranjosti viale.
Your doses will then be increased gradually to the full dose of 1.0 ml (250 microgram).
Odmerek vam bodo nato postopoma večali do končnega odmerka 1,0 ml (250 mikrogramov).
The following adverse event listings are based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from post-marketing surveillance (Table 2, frequencies - where known - based on pooled clinical trials (very common 1/10, common 1/100 to <1/10, uncommon 1/1,000 to <1/100, rare 1/10,000 to <1/1,000, very rare <1/10,000)) of Extavia use.
Spodnja seznama neželenih učinkov temeljita na poročilih iz kliničnih raziskav (preglednica 1, neželeni učinki in nenormalni rezultati laboratorijskih preiskav) in iz nadzora v obdobju trženja zdravila Extavia (preglednica 2, pogostnosti, ki - kjer je to znano - temeljijo na združenih podatkih iz kliničnih študij (zelo pogosti 1/10, pogosti 1/100 do <1/10, občasni 1/1.000 do <1/100, redki 1/10.000 do <1/1.000, zelo redki <1/10.000)).
Suicide attempt (see also section 4.4), Emotional lability
Psihiatrične motnje stanje zmedenosti poskus samomora (glejte tudi poglavje 4.4), emocionalna labilnost
Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
Izključena je morala biti kakršna koli bolezen, ki bi bolje ustrezala bolnikovim znakom in simptomom.
If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with his/her physician before continuing injections with Extavia.
Če bolnik opazi poškodbo kože, ki je lahko povezana z otekanjem ali vlaženje na mestu injiciranja, mu je treba svetovati, da se pred nadaljevanjem injiciranja zdravila Extavia posvetuje z zdravnikom.
Carcinogenicity studies have not been performed.
Študije karcinogenosti ni bilo.
► Stop injecting Extavia and talk to your doctor.
► prenehajte z injiciranjem zdravila Extavia in se posvetujte z zdravnikom;
What Extavia is used for Extavia is for use in patients ► who have experienced for the first time symptoms which indicate a high risk of developing multiple sclerosis.
Zdravilo Extavia je namenjeno za uporabo pri bolnikih ► ki so prvič imeli simptome, ki predstavljajo veliko tveganje za razvoj multiple skleroze.
The best places for injections are where the skin is loose and soft, and away from joints, nerves and bones, for example the abdomen, arm, thigh or buttocks.
Najboljše mesto za injiciranje je predel, kjer je koža mlahava in mehka, proč od sklepov, živcev in kosti, na primer trebuh, roka, stegno ali zadnjica.
The reconstituted product should be inspected visually before use.
Pripravljeno zdravilo je treba pred uporabo pregledati.
Using Extavia with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
Uporaba zdravila Extavia z drugimi zdravili, ki spreminjajo odziv imunskega sistema, ni priporočena; izjema so protivnetna zdravila imenovana kortikosteroidi in adrenokortikotropni hormon (ACTH).
The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Uporaba citokinov pri bolnikih z obstoječo monoklonsko gamopatijo je povezana z razvojem sindroma sistemske kapilarne krvavitve s simptomi, podobnimim šoku in smrtnim izidom.
The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or human in vivo studies.
Delovanje interferona beta-1b je omejeno na vrsto, zato najrelevantnejše informacije o farmakologiji interferona beta-1b izvirajo iz raziskav človeških celic v kulturah in iz in vivo študij pri ljudeh.
In patients receiving Extavia there was a reduction in the frequency (30%) and severity of clinical relapses and in the number of hospitalisations due to disease.
Bolniki, ki so dobivali zdravilo Extavia, so imeli redkejše (30 %) in manj hude klinične recidive in manj hospitalizacij zaradi bolezni.
Extavia should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Zdravilo Extavia morate previdno uporabljati pri bolnikih s predhodnimi ali trenutnimi depresivnimi motnjami, zlasti pri tistih, ki so že imeli samomorilna razmišljanja (glejte poglavje 4.3).
Although no natural rubber latex is detected in the cap, the safe use of Extavia pre-filled syringe in latex-sensitive individuals has not been studied and there is therefore a potential risk for hypersensitivity reactions which cannot be completely ruled out.
V pokrovčku sicer niso našli samega naravnega lateksa, vendar varnosti uporabe napolnjene injekcijske brizge z zdravilom Extavia niso proučevali pri osebah, ki so preobčutljive na lateks, in tako obstaja možnost tveganja za preobčutljivostne reakcije, ki je ni mogoče povsem izključiti.
Patients treated with Extavia should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Bolnikom, ki dobivajo zdravilo Extavia, je treba naročiti, naj o morebitnih simptomih depresije ali samomorilnega razmišljanja nemudoma obvestijo zdravnika, ki je predpisal zdravilo.
By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days).
Če boste upoštevali takšen časovni razpored, se boste na prvi predel (npr. na desno stran trebuha) vrnili po 8 injekcijah (16 dneh).
- Extavia contains human albumin and therefore carries a potential risk for transmission of viral diseases.
- Zdravilo Extavia vsebuje humani albumin, zato obstaja morebitno tveganje za prenos virusnih bolezni.
After mixing Extavia, you should administer the injection immediately (if this medicine is not used immediately, see section 5 of the leaflet, “How to store Extavia”).
Ko zmešate zdravilo Extavia, ga morate nemudoma injicirati (če tega zdravila ne porabite takoj, glejte poglavje 5.
During Extavia treatment you are likely to experience injection site reactions.
Med zdravljenjem z zdravilom Extavia se bodo verjetno pojavile reakcije na mestu injiciranja.
Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
Zdraviti ni priporočljivo bolnikov z recidivno-remitentno multiplo sklerozo, ki so v zadnjih 2 letih doživeli manj kot 2 recidiva, in bolnikov s sekundarno progresivno multiplo sklerozo, ki v zadnjih 2 letih niso imeli aktivne bolezni.
In retrospective meta-analyses including the data of both studies, a statistically significant overall treatment effect was found (p=0.0076; 8.0 million IU Extavia versus all placebo patients).
Z retrospektivno metaanalizo podatkov obeh raziskav so ugotovili statistično značilen celotni učinek zdravljenja (p=0,0076; 8,0 milijonov i.e. zdravila Extavia v primerjavi z vsemi bolniki na placebu).
For skin disinfection use an appropriate disinfectant recommended by your pharmacist.
Za razkuževanje kože uporabite ustrezno razkužilo po nasvetu svojega farmacevta.
However, limited published data suggest that the safety profile in adolescents from 12 to 17 years of age receiving Extavia 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Vendar pomankljivi objavljeni podatki kažejo, da je varnostni profil pri mladostnikih, starih od 12 do 17 let, ki so vsak drugi dan subkutano prejemali 8,0 milijonov i.e. zdravila Extavia, podoben varnostnemu profilu, ki so ga opazili pri odraslih.
Extavia should be administered with caution to patients with a history of seizures, to patients receiving treatment with anti-epileptics, and in particular to patients with epilepsy who are not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
Zdravilo Extavia je treba previdno uporabljati pri bolnikih z anamnezo epileptičnih napadov in bolnikih, ki dobivajo antiepileptična zdravila, zlasti pri tistih, pri katerih epilepsija z antiepileptičnimi zdravili ni ustrezno obvladana (glejte poglavji 4.5 in 4.8).
The treatment with Extavia should be initiated under the supervision of a physician experienced in the treatment of the disease.
Zdravljenje z zdravilom Extavia se mora začeti pod nadzorstvom zdravnika, izkušenega v zdravljenju te bolezni.
To reduce the risk of side effects at the start of treatment, your doctor should start you on a low dose of Extavia and increase it gradually (see section 3, “How to use Extavia”).
Za zmanjšanje tveganja za neželene učinke ob začetku zdravljenja bo vaš zdravnik začel z majhnim odmerkom zdravila Extavia, ki ga bo postopoma večal (glejte poglavje 3.
EXAMPLE OF A MEDICATION RECORD:
PRIMER KARTICE O UPORABI ZDRAVILA:
If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Extavia is recommended.
Če je TMA diagnosticirana, je potrebno takojšnje zdravljenje (razmisliti o izmenjavi plazme), priporoča pa se tudi takojšnje prenehanje zdravljenja z zdravilom Extavia.
Instructions for keeping track of your injection sites and dates
Navodila za zapisovanje mest injiciranja in datumov
16 - Take the needle out of its wrapping and screw it firmly onto the top of the syringe.
16 - Odstranite ovojnino z igle in iglo čvrsto privijte na vrh brizge.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Za opis določene reakcije je uporabljen najustreznejši izraz po MedDRA, njegove sopomenke in povezana stanja.
The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated by means of the currently available data, but the data suggest no increased risk so far.
Na osnovi trenutno razpoložljivih podatkov ni mogoče ustrezno ovrednotiti tveganja za spontani splavi pri nosečnicah, ki so bile izpostavljene interferonu beta, podatki pa zaenkrat ne kažejo na povečano tveganje.
Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with Extavia.
Pljučna arterijska hipertenzija se lahko pojavi ob različnih časovnih točkah zdravljenja, vključno nekaj let po začetku zdravljenja z zdravilom Extavia.
It is best to use your thumb rather than your nail, as your nail could break.
Ne odpirajte je z nohtom, ker se vam noht lahko zlomi.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite zdravnika, farmacevta ali medicinsko sestro.
5 - Remove the swab from the top of the vial.
5 - Odstranite blaznico z vrha viale.
In multifocal patients, the risk for CDMS was independent from MRI findings at baseline, indicating a high risk for CDMS because of the dissemination of the disease based on clinical findings.
Pri multifokalnih bolnikih je bilo tveganje za CDMS neodvisno od izhodiščnih rezultatov preiskav MRS. Ti bolniki imajo veliko tveganje za nastanek CDMS, zaradi diseminacije bolezni, za katere dajejo dokaze klinična preskušanja.
If your depression and/or suicidal thoughts are severe, you will not be prescribed Extavia (see also “Do not use Extavia”).
Če so vaša depresija in/ali samomorilne misli resne, vam ne bodo predpisali zdravila Extavia (glejte tudi Ne uporabljajte zdravila Extavia).
The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.
Vezava interferona beta-1b na te receptorje izzove ekspresijo številnih genskih produktov, ki veljajo za mediatorje biološkega delovanja interferona beta-1b.
- sudden shortness of breath (bronchospasm), (rare).
- nenadna kratka sapa (bronhospazem) (redki).
Patients exhibiting depression should be monitored closely during therapy with Extavia and treated appropriately.
Depresivne bolnike je treba med zdravljenjem z zdravilom Extavia natančno nadzirati in ustrezno zdraviti.
In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three years.
Pri bolnikih z enim samim kliničnim dogodkom, ki nakazuje multiplo sklerozo, je bila učinkovitost dokazana za obdobje treh let.
Secondary progressive multiple sclerosis: In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS. With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
V nekaterih primerih pri bolnikih z recidivno-remitentno MS ugotovijo večjo izraženost njihovih simptomov in napredovanje v drugo obliko MS, imenovano sekundarna progresivna MS. Bolniki s to obliko postajajo vedno bolj prizadeti, ne glede na to, ali imajo relapse ali ne.
Infections and infestations Infection
Infekcijske in parazitske bolezni Infekcije
Contents of the pack and other information Annex - self-injection procedure
Shranjevanje zdravila Extavia Vsebina pakiranja in dodatne informacije Priloga - postopek samoinjiciranja
In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an auto-injector was used in the majority of patients.
V ključni študiji pri bolnikih z enim samim kliničnim dogodkom, ki kaže na multiplo sklerozo, so avtoinjektor uporabili pri večini bolnikov.
PART II: ROTATING INJECTION SITES
DEL II: MENJAVANJE MEST INJICIRANJA
If you stop using Extavia
Če ste prenehali uporabljati zdravilo Extavia
• 1 Extavia vial (with powder for solution for injection)
• 1 vialo zdravila Extavia (s praškom za raztopino za injiciranje)
Due to the lack of clinical experience in multiple sclerosis patients, the use of Extavia together with immunomodulators other than corticosteroids or ACTH is not recommended.
Zaradi pomanjkanja kliničnih izkušenj zdravila Extavia pri bolnikih z multiplo sklerozo ni priporočljivo uporabljati skupaj z drugimi imunomodulatorji (razen kortikosteroidov ali ACTH).
Cases of pancreatitis were observed with Extavia use, often associated with hypertriglyceridaemia.
Pri uporabi zdravila Extavia so opažali primere pankreatitisa, ki je bil pogosto povezan s hipertrigliceridemijo.
If reactions are severe, Extavia should be discontinued and appropriate medical intervention instituted.
Če so reakcije hude, je treba zdravljenje z zdravilom Extavia prekiniti in ustrezno ukrepati.
- If you feel noticeably more sad or hopeless than before the treatment with Extavia, or if you develop thoughts of suicide.
- če se počutite izrazito bolj žalostni ali brezupno, kot ste se pred začetkom zdravljenja z zdravilom Extavia, ali če se pojavijo samomorilne misli.
To increase tolerability of Extavia in the study of patients with a first clinical event, a dose titration was applied and nonsteroidal anti-inflammatory medicinal products were administered at start of therapy.
Da bi povečali toleranco na zdravilo Extavia, so v študiji pri bolnikih s prvim kliničnim dogodkom odmerek titrirali, na začetku zdravljenja pa so uporabili nesteroidna protivnetna zdravila.
Further subgroup analyses indicated a high risk for progression to CDMS within 2 years in monofocal patients with at least 9 T2lesions (55% risk for placebo, 26% for Extavia) or Gd-enhancement (63% versus 33%).
Nadaljnja analiza podskupin kaže na veliko tveganje za napredovanje do CDMS v 2 letih pri monofokalnih bolnikih z vsaj 9 lezijami T2 (55-odstotno tveganje pri placebu, 26 % z zdravilom Extavia) ali ojačanjem z Gd (63 % proti 33 %).
Therefore, the tip cap may contain natural rubber latex, which should not be handled by persons sensitive to this substance.
Pokrovček bi lahko zato vseboval naravni lateks, s katerim osebe, ki so preobčutljive na to snov, ne smejo priti v stik.
- If you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
- če opazite kakršnekoli nenavadne modrice, čezmerne krvavitve po poškodbi ali če se vam zdi, da pogosto zbolevate za okužbami.
Secondary Progressive Multiple Sclerosis (European Study)
sekundarno progresivna multipla skleroza (evropska raziskava)
Your doctor may perform tests to check your kidney function.
Vaš zdravnik vas bo napotil na preiskave za preverjanje delovanja ledvic.
Slowly pull the plunger back to draw all of the solution into the syringe.
Počasi potegnite bat nazaj, da potegnete v brizgo vso raztopino.
After your injection, fill in the used injection site and date in the table in your injection record (see the example: Keeping track of your injection sites and dates).
- Po injekciji v tabelo v kartici vpišite datum in mesto injiciranja, ki ste ga uporabili (glejte primer: Zapisovanje mest injiciranja in datumov).
Treatment with Extavia should be started under the supervision of a doctor who is experienced in the treatment of multiple sclerosis.
Zdravljenje z zdravilom Extavia je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem multiple skleroze.
Human albumin Mannitol (E421)
6.1 Seznam pomožnih snovi Prašek humani albumin manitol (E421)
Aspartate aminotransferase increased (SGOT >5 times baseline)
zvišane vrednosti aspartat aminotransferaze (SGOT >5-kratna izhodiščna vrednost)
From various studies mean clearance rates and half-lives of disposition phases from serum were estimated to be at most 30 ml·min
Na temelju različnih raziskav je bil ocenjeni povprečni očistek največ 30 ml·min
However, it is known that the biological response-modifying properties of interferon beta-1b are mediated through its interactions with specific cell receptors found on the surface of human cells.
Znano pa je, da se tiste lastnosti interferona beta1b, ki spreminjajo biološki odziv, posredujejo prek njegovih interakcij s specifičnimi celičnimi receptorji na površini človeških celic.
In both trials there was a reduction (30%) in frequency of clinical relapses in patients with secondary progressive multiple sclerosis patients receiving Extavia.
V obeh preskušanjih se je pogostnost kliničnih recidivov zmanjšala (30 %) pri bolnikih s sekundarno progresivno multiplo sklerozo, ki so dobivali zdravilo Extavia.
Side effects derived only during post marketing:
Neželeni učinki, ki so jih opažali samo v času trženja zdravila:
There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years.
Za bolnike z recidivnoremitentno multiplo sklerozo obstajajo podatki o spremljanju v kontroliranih kliničnih pogojih za obdobje do 5 let, za bolnike s sekundarno progresivno multiplo sklerozo za obdobje do 3 let.
If excessive foaming is present - which can happen if the vial is shaken or swirled too vigorously - let the vial sit undisturbed until the foam settles.
Če je v viali preveč pene, kar se lahko zgodi, če jo premočno pretresete ali zavrtite, pustite vialo mirovati, da se pena usede.
Extavia should be used with caution with: - medicines which need a certain liver enzyme system (known as cytochrome P450 system) for their removal from the body, for example medicines used to treat epilepsy (such as phenytoin).
Zdravilo Extavia je treba uporabljati previdno z: - zdravili, ki potrebujejo določen jetrni encimski sistem (t.i. sistem citokroma P450) za izločitev iz telesa, na primer zdravili, ki se uporabljajo za zdravljenje epilepsije (kot je fenitoin); - zdravili, ki vplivajo na nastajanje krvnih celic.
• Medicine
• Zdravilo
Annex: SELF-INJECTION PROCEDURE
Priloga: POSTOPEK SAMOINJICIRANJA
EU/1/08/454/008 15 vials with powder and 15 pre-filled syringes with solvent EU/1/08/454/010 5 vials with powder and 5 pre-filled syringes with solvent EU/1/08/454/011 14 vials with powder and 14 pre-filled syringes with solvent EU/1/08/454/013 14 vials with powder and 15 pre-filled syringes with solvent
EU/1/08/454/008 15 vial s praškom in 15 napolnjenih injekcijskih brizg z vehiklom EU/1/08/454/010 5 vial s praškom in 5 napolnjenih injekcijskih brizg z vehiklom EU/1/08/454/011 14 vial s praškom in 14 napolnjenih injekcijskih brizg z vehiklom EU/1/08/454/013 14 vial s praškom in 15 napolnjenih injekcijskih brizg z vehiklom
What Extavia looks like and contents of the pack Extavia is a powder and solvent for solution for injection.
Izgled zdravila Extavia in vsebina pakiranja Zdravilo Extavia je prašek in vehikel za raztopino za injiciranje.
You need to choose a new site for each injection to allow the area time to recover and help prevent infection.
Za vsako injiciranje je treba izbrati drugo mesto, da si predeli opomorejo in da preprečite okužbo.
As you get started, you may find the following tips helpful:
Na začetku vam bodo v pomoč naslednji koraki:
Debridement and, less often, skin grafting are occasionally required and healing may take up to 6 months.
Za zdravljenje je včasih potrebno čiščenje in redkeje presaditev kože, zdravljenje pa lahko traja do 6 mesecev.
To minimise the risk of injection site necrosis patients should be advised to: use an aseptic injection technique, rotate the injection sites with each dose.
Za zmanjšanje tveganja za nekrozo na mestu injiciranja, je treba bolnikom svetovati, da: uporabljajo aseptično tehniko injiciranja, pri vsakem odmerku zamenjajo mesto injiciranja.
This may suggest a disease of the heart muscle (cardiomyopathy) which has been reported in patients using Extavia.
Morda je to znak bolezni srčne mišice (kardiomiopatija), o kateri poročajo pri bolnikih, ki jemljejo zdravilo Extavia.
The following side effects listing is based on reports from clinical trials with Extavia (List 1) and from side effects reported on the marketed product (List 2).
Naslednji pregled neželenih učinkov temelji na poročilih iz kliničnih preskušanj z zdravilom Extavia (seznam 1) in neželenih učinkih, o katerih so poročali po začetku trženja zdravila (seznam 2).
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Extavia should be considered.
V primeru nefrotskega sindroma je potrebno takojšnje zdravljenje, treba pa je razmisliti tudi o prekinitvi zdravljenja z zdravilom Extavia.
Very common side effects which have occurred in clinical trials with Extavia (may affect more than 1 in 10 people) and at a higher percentage than those observed with placebo.
Seznam 1: Zelo pogosti neželeni učinki, ki so se pojavljali v kliničnih preskušanjih zdravila Extavia (pojavijo se lahko pri več kot 1 od 10 bolnikov) in v višjem odstotku kot pri placebu.
14 - Remove any excess air bubbles by gently tapping the syringe.
14 -.Odvečne zračne mehurčke odstranite tako, da nežno potrkate po brizgi.