natgillin/translations-raw huggingface dataset:
Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period.
Znano je, da se humani imunoglobulini G izločajo v materino mleko v prvih nekaj dneh po porodu, kmalu nato pa se njihova koncentracija zniža na nizko raven, vendar iz tega razloga tveganja za dojenega otroka v tem kratkem obdobju ni mogoče izključiti.
Patients had a median age of 43 years, 83% were female and 94% were white.
Mediana starost bolnikov je bila 43 let, 83 % je bilo žensk in 94 % je bilo belcev.
Your doctor or nurse will give you or your caregiver training in the right way to prepare and inject Aimovig.
Vaš zdravnik ali medicinska sestra bosta vas ali vašega negovalca ustrezno usposobila, da boste znali pripraviti in injicirati zdravilo Aimovig.
The mutagenic potential of erenumab has not been evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes.
Mutagenega potenciala erenumaba niso ocenjevali, a monoklonska protitelesa predvidoma ne spreminjajo strukture DNK in kromosomov.
In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: 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).
Pri tem ustrezna kategorija pogostnosti posameznega neželenega učinka temelji na naslednjem dogovoru: 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
If you forget to use Aimovig - If you forget an Aimovig dose, take it as soon as possible after you realise.
Če ste pozabili uporabiti zdravilo Aimovig - Če ste si pozabili dati odmerek zdravila Aimovig, si ga odmerite čimprej po tem, ko to ugotovite.
Talk to your doctor before using Aimovig: - if you have ever had an allergic reaction to rubber latex.
Pred začetkom uporabe zdravila Aimovig se posvetujte z zdravnikom: - če ste že kdaj imeli alergijsko reakcijo na lateks iz kavčuka.
Differences from placebo were observed from Month 1 onwards.
Razliko v primerjavi z uporabo placeba so opažali od 1. meseca dalje.
d p value is calculated based on the odds ratios.
Vrednost p je izračunana na osnovi razmerij obetov (OR-odds ratio).
For the secondary endpoints, all p-values are reported as unadjusted p-values and are statistically significant after adjustment for multiple comparisons.
Za sekundarne cilje študije so vse vrednosti p podane kot neprilagojene vrednosti p in so statistično značilne po prilagajanju na multiple primerjave.
Use Aimovig exactly as prescribed by your doctor.
Zdravilo Aimovig uporabljajte natančno tako, kot vam predpiše zdravnik.
In both studies, the patients enrolled had at least a 12-month history of migraine (with or without aura) according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria.
V obe študiji so bili vključeni bolniki z najmanj 12-mesečno anamnezo migrene (z avro ali brez nje) po diagnostičnih kriterijih mednarodne klasifikacije glavobolov (ICHD-III-International Classification of Headache Disorders).
If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.
Če morate uporabiti isti predel kože, poskrbite, da na tem predelu ne boste izbrali iste točke kot prejšnjikrat.
Common: may affect up to 1 in 10 people - allergic reactions such as rash, swelling or hives - constipation - itching - muscle spasms - injection site reactions, such as pain, redness and swelling where the injection is given.
Pogosti: lahko se pojavijo pri največ 1 od 10 ljudi - alergijske reakcije, kot so izpuščaj, otekanje ali koprivnica - obstipacija (zaprtje) - srbenje - mišični spazmi - reakcije na mestu injiciranja, kot so bolečina, rdečina in oteklina na mestu injiciranja
Treatment difference (95% CI)
razlika zaradi zdravljenja (95-odstotni IZ)
Pregnancy Your doctor will decide whether you should stop using Aimovig during pregnancy.
Nosečnost Vaš zdravnik bo odločil, ali morate v času nosečnosti prekiniti z uporabo zdravila Aimovig.
At low concentrations, the elimination is predominately through saturable binding to target (CGRP-R), while at higher concentrations the elimination of erenumab is largely through a non-specific proteolytic pathway.
Pri nizkih koncentracijah se učinkovina izloča pretežno s saturabilno vezavo na ciljni receptor (CGRP-R), pri višjih koncentracijah pa izločanje erenumaba poteka večinoma z nespecifičnimi proteolitičnimi reakcijami.
On the basis of the scientific conclusions for erenumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing erenumab is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za erenumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) erenumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Patients had a median age of 42 years, 85% were female and 89% were white.
Mediana starost bolnikov je bila 42 let, 85 % je bilo žensk in 89 % je bilo belcev.
Overall, 68% had failed one or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability, and 49% had failed two or more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability.
Skupno je pri 68 % prišlo do neuspeha z eno ali več predhodnih profilaktičnih farmakoterapij zaradi nezadostne učinkovitosti ali slabega prenašanja, pri 49 % pa je prišlo do neuspeha z dvema ali več predhodnih profilaktičnih farmakoterapij zaradi nezadostne učinkovitosti ali slabega prenašanja.
The European Medicines Agency has deferred the obligation to submit the results of studies with Aimovig in prevention of migraine headaches in one or more subsets of the paediatric population (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Aimovig pri preprečevanju migrenskih glavobolov za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
There was no impact of anti-erenumab antibody development on efficacy or safety.
Razvoj protiteles proti erenumabu ni vplival na učinkovitost in varnost erenumaba.
Push down
Pritisnite navzdol
In contrast with other neuropeptides, CGRP levels have been shown to increase significantly during migraine and return to normal with headache relief.
Za razliko od drugih nevropeptidov so za CGRP dokazali, da se njegova koncentracija bistveno zviša med napadom migrene in se vrne v okvir normalnih vrednosti, ko glavobol mine.
Aimovig may cause skin reactions such as rash or itching which are usually mild.
Zdravilo Aimovig lahko povzroča kožne reakcije, kot sta izpuščaj ali srbenje, ki so običajno blage.
The CGRP receptor is located at sites that are relevant to migraine pathophysiology, such as the trigeminal ganglion.
Receptor za CGRP je lociran na mestih, ki so pomembna za patofiziologijo migrene, kot je trigeminalni ganglij.
Patients with renal impairment Patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) have not been studied.
Uporabe pri bolnikih s hudo okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije eGFR <30 ml/min/1,73 m2) niso proučevali.
It is normal to see a drop of liquid at the end of the needle or safety guard.
Normalno je, če pri tem opazite kapljico tekočine na vrhu igle ali varnostnega ščitnika.
Aimovig showed similar exercise duration compared to placebo and did not aggravate myocardial ischaemia in these patients.
Zdravilo Aimovig je omogočilo podobno trajanje obremenitve kot placebo in pri teh bolnikih ni poslabšalo miokardne ishemije.
Throughout the dosing period erenumab is predominantly eliminated via a non-specific proteolytic pathway with the effective half-life of 28 days.
Ves čas odmerjanja zdravila se erenumab pretežno izloča po nespecifični proteolitični poti z efektivnim razpolovnim časom 28 dni.
Patients were allowed to use acute headache treatments during the study.
V času študije so bolnikom dovolili uporabo zdravil za akutne glavobole.
What Aimovig is and what it is used for
Kaj je zdravilo Aimovig in za kaj ga uporabljamo
After you remove the pen from the skin, the needle will automatically be covered by the safety guard.
Opozorilo: ko dvignete injekcijski peresnik s kože, bo varnostni ščitnik samodejno pokril iglo.
The most frequent injection site reactions were localised pain, erythema and pruritus.
Najbolj pogoste reakcije na mestu injiciranja so bile lokalizirana bolečina, rdečina in srbenje.
A total of 366 (96%) patients in the erenumab arms and 265 (93%) patients in the placebo arm completed the study (i.e. completed Week 12 assessment).
Skupno je 366 bolnikov (96 %) v skupinah z erenumabom in 265 bolnikov (93 %) v skupini s placebom zaključilo študijo (kar pomeni, da so zaključili ocenjevanje po 12 tednih).
Erenumab is a fully human IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Erenumab je popolnoma humano monoklonsko protitelo IgG2, pridobljeno s tehnologijo rekombinantne DNK na ovarijskih celicah kitajskega hrčka.
Do not stop using Aimovig without talking to your doctor first.
Če ste prenehali uporabljati zdravilo Aimovig Ne prenehajte z uporabo zdravila Aimovig, ne da bi se prej posvetovali s svojim zdravnikom.
Pruritus includes preferred terms of generalised pruritus, pruritus and pruritic rash.
Izraz pruritus vključuje prednostne izraze generalizirano srbenje, srbenje in srbeč izpuščaj.
Elderly patients (>65 years), patients with opioid overuse in study in chronic migraine, patients with medication overuse in study in episodic migraine, and also patients with pre-existing myocardial infarction, stroke, transient ischaemic attacks, unstable angina, coronary artery bypass surgery or other re-vascularisation procedures within 12 months prior to screening were excluded.
Starejši bolniki (stari več kot 65 let), bolniki, ki so prekomerno uporabljali opioidna zdravila v študiji kronične migrene, bolniki, ki so prekomerno uporabljali zdravila v študiji epizodne migrene, ter bolniki , ki so preboleli miokardni infarkt, možgansko kap, tranzitorno ishemično atako ali so imeli nestabilno angino pektoris oziroma so prestali koronarno premostitveno operacijo ali drug revaskularizacijski poseg v 12 mesecih pred presejalnim postopkom za posamezno študijo, v navedenih študijah niso bili vključeni.
If you need 2 injections, they should be given in different sites to avoid hardening of the skin and should not be given into areas where the skin is tender, bruised, red or hard.
Če potrebujete dve injekciji, ju morate dati na različni mesti injiciranja, da ne bi koža postala trda, poleg tega pa se jih ne sme dajati na predele, kjer je koža občutljiva, podpluta, pordela ali trda.
Note: When you remove the syringe, if it looks like there is still medicine in the syringe barrel this means you have not received a full dose.
Opozorilo: če pri umikanju injekcijske brizge opazite, da je v telesu brizge ostalo zdravilo, to pomeni, da niste prejeli celotnega odmerka.
While pinching, insert the syringe needle into the skin at an angle of 45 to 90 degrees.
Medtem ko držite kožno gubo, potisnite iglo v kožo pod kotom 45 do 90 stopinj.
Aimovig is given as an injection under your skin (known as a subcutaneous injection).
Zdravilo Aimovig je treba bolniku dati z injekcijo pod kožo (kar imenujemo subkutana injekcija).
When done, release your thumb, and gently lift the syringe off of the skin and then release the pinched skin.
Ko ste končali, dvignite palec z bata in nežno potegnite injekcijsko brizgo iz kože, nato pa spustite kožno gubo.
Carcinogenicity studies have not been conducted with erenumab.
Z erenumabom niso izvajali študij kancerogenosti.
The solution should not be injected if it is cloudy, distinctly yellow or contains flakes or particles.
Raztopine se ne sme injicirati, če je motna, izrazito rumena ali če vsebuje kosmiče ali delce.
Comprehensive instructions for administration are given in the instructions for use in the package leaflet.
Podrobna navodila za odmerjanje so navedena v poglavju z navodili za uporabo v priloženem Navodilu za uporabo.
Measurable erenumab serum concentrations were observed in the infant monkeys at birth, confirming that erenumab, like other IgG antibodies, crosses the placental barrier.
Pri opičjih mladičih so ob rojstvu opažali merljive koncentracije erenumaba v serumu, kar potrjuje, da erenumab tako kot druga protitelesa IgG prehaja placentarno bariero.
Following a single 140 mg intravenous dose, the mean (SD) volume of distribution during the terminal phase (Vz) was estimated to be 3.86 (0.77) l.
Po enkratnem intravenskem odmerku 140 mg je bil ocenjeni povprečni volumen porazdelitve v končni fazi (Vz) 3,86 l (SD 0,77 l).
It is normal to see a drop of liquid at the end of the needle.
Normalno je, če pri tem opazite kapljico tekočine na vrhu igle.
Animal studies showed no impact on female and male fertility (see section 5.3).
Študije na živalih ne kažejo vpliva na plodnost pri ženskah in moških (glejte poglavje 5.3).
Following a single subcutaneous dose of 140 mg or 70 mg erenumab administered to healthy adults, median peak serum concentrations were attained in 4 to 6 days, and estimated absolute bioavailability was 82%.
Po enkratnem subkutanem odmerku 140 mg oziroma 70 mg erenumaba, ki so ga dali zdravim odraslim, je učinkovina dosegla mediano najvišje koncentracije v serumu v 4 do 6 dneh, ocenjena absolutna biološka uporabnost zdravila pa je bila 82 %.
Reduction in mean monthly migraine days from placebo was observed in a monthly analysis from Month 1 and in a follow-up weekly analysis an onset of erenumab effect was seen from the first week of administration.
Zmanjšanje povprečnega števila migrenskih dni na mesec v primerjavi s placebom so pri mesečni analizi opažali od 1. meseca, pri kontrolni tedenski analizi pa so opažali začetek delovanja erenumaba od prvega tedna odmerjanja zdravila.
What you need to know before you use Aimovig
Kaj morate vedeti, preden boste uporabili zdravilo Aimovig
Erenumab, as a human monoclonal antibody, is not metabolised by cytochrome P450 enzymes and hepatic clearance is not a major clearance pathway for erenumab (see section 4.2).
Erenumab se kot humano monoklonsko protitelo ne presnavlja z encimi citokroma P450 in izločanje skozi jetra ni poglaviten način izločanja erenumaba (glejte poglavje 4.2).
There were also no adverse effects on surrogate markers of fertility (anatomical pathology or histopathology changes in reproductive organs) in these studies.
Poleg tega v navedenih študijah niso opažali neželenih učinkov na nadomestne označevalce plodnosti (anatomsko patološke ali histopatološke spremembe reproduktivnih organov).
The recommended dose is 70 mg erenumab every 4 weeks.
Priporočeni odmerek je 70 mg erenumaba enkrat na vsake 4 tedne.
For HIT-6: Change and reduction from baseline were evaluated in the last 4 weeks of the 12-week double-blind treatment phase.
Pri vprašalniku HIT-6: spremembe in zmanjšanje vrednosti od izhodišča so ocenjevali v zadnjih 4 tednih 12-tedenskega obdobja dvojno slepega zdravljenja.
Monoclonal antibodies like Aimovig are known to pass into breast milk during the first few days after birth, but after this first period Aimovig can be used.
Znano je, da monoklonska protitelesa, kakršno je tudi zdravilo Aimovig, v prvih nekaj dneh po rojstvu prehajajo v materino mleko, po tem prvem obdobju pa mati lahko uporablja zdravilo Aimovig.
Note: The prescribed dose of Aimovig is either 70 mg or 140 mg.
Opozorilo: predpisani odmerek zdravila Aimovig je bodisi 70 mg bodisi 140 mg.
Aimovig (erenumab) was evaluated for prophylaxis of migraine in two pivotal studies across the migraine spectrum in chronic and episodic migraine.
Zdravilo Aimovig (erenumab) so za profilakso migrene ocenjevali v dveh ključnih študijah v okviru migrenskega spektra pri kronični in epizodni migreni.
Population pharmacokinetic analysis of integrated data from the Aimovig clinical studies did not reveal a difference in the pharmacokinetics of erenumab in patients with mild or moderate renal impairment relative to those with normal renal function (see section 4.2).
Rezultati populacijske farmakokinetične analize združenih podatkov iz kliničnih študij z zdravilom Aimovig ne kažejo razlike v farmakokinetiki erenumaba med bolniki z blago ali zmerno okvaro ledvic in tistimi z normalno ledvično funkcijo (glejte poglavje 4.2).
Do not put Aimovig back in the refrigerator once it has been removed.
Ko zdravilo Aimovig vzamete iz hladilnika, ga ne smete več postaviti nazaj.
Make sure that you inject the entire contents of both pens.
Poskrbite, da boste injicirali celotno vsebino obeh injekcijskih brizg.
A study evaluated the effect of a single intravenous dose of 140 mg Aimovig in subjects with stable angina under controlled exercise conditions.
V študiji so ovrednotili učinek enkratnega intravenskega odmerka 140 mg zdravila Aimovig pri preiskovancih s stabilno angino pektoris med obremenitvenim testiranjem.
For exploratory endpoints, no p-value is presented.
Za eksploratorne cilje študije vrednosti p niso podane.
Intravenous infusion of CGRP induces migraine-like headache in patients.
Pri bolnikih intravenska infuzija CGRP sproži migreni podoben glavobol.
When you remove the pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose.
če se po dvigu injekcijskega peresnika s kože okence ne obarva rumeno ali če se vam zdi, da se zdravilo še injicira, to pomeni, da niste prejeli celotnega odmerka.
Illustration of the syringe Before use
Slikovni prikaz injekcijske brizge Pred uporabo
Injection site pain typically subsided within 1 hour after administration.
Bolečina na mestu injiciranja se je običajno zmanjšala v 1 uri po odmerjanju zdravila.
Gather all materials needed for the injections:
Pripravite vse, kar potrebujete za injiciranje:
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Odbor CHMP priporoča spremembo pogojev dovoljenja za promet z zdravilom.
No cases of overdose have been reported in clinical studies.
V kliničnih študijah niso poročali o nobenem primeru prevelikega odmerjanja.
Erenumab potently and specifically competes with the binding of CGRP and inhibits its function at the CGRP receptor, and has no significant activity against other calcitonin family of receptors.
Erenumab s peptidom CGRP močno in specifično tekmuje za vezavo in tako zavira njegovo delovanje na receptor za CGRP, pri tem pa ne izkazuje pomembne aktivnosti na druge receptorje iz kalcitoninske družine.
For data collection a recall period of 3 months has been used.
Podatke so zbirali v okviru 3-mesečnega obdobja priklica.
The removable cap of the Aimovig pre-filled syringe/pen contains dry natural rubber latex, which may cause allergic reactions in individuals sensitive to latex.
Snemljiv pokrovček napolnjene injekcijske brizge oziroma napolnjenega injekcijskega peresnika z zdravilom Aimovig vsebuje suh naravni lateks iz kavčuka, ki lahko pri posameznikih, ki so preobčutljivi na lateks, povzroča alergijske reakcije.
Aimovig contains sodium Aimovig contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
Zdravilo Aimovig vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni “brez natrija”.
Do not try to inject Aimovig until this training has been given.
Ne poskušajte si sami injicirati zdravila Aimovig, dokler niste za to ustrezno usposobljeni.
Figure 2 Change from baseline in monthly migraine days over time in Study 2 (including primary endpoint over Months 4, 5 and 6)
Slika 2 Časovni potek spreminjanja števila migrenskih dni na mesec od izhodišča v Študiji 2 (vključno s primarnim ciljem študije po 4, 5 in 6 mesecih)
Other medicines and Aimovig 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.
Before administration, the solution should be inspected visually.
Pred odmerjanjem je treba raztopino pregledati.
Talk to your doctor about using Aimovig while breast-feeding in order to help you decide whether you should stop breast-feeding or stop using Aimovig.
O uporabi zdravila Aimovig v času dojenja se pogovorite s svojim zdravnikom, ki vam bo pomagal pri odločitvi, ali bi morali prenehati z dojenjem ali z uporabo zdravila Aimovig.
A total of 294 patients (92%) for 140 mg, 287 (91%) patients for 70 mg and 284 patients (89%) in the placebo arm completed the double-blind phase.
Skupno je 294 bolnikov (92 %) z odmerkom 140 mg, 287 bolnikov (91 %) z odmerkom 70 mg in 284 bolnikov (89 %) v skupini s placebom zaključilo obdobje dvojno slepega zdravljenja.
Stretch skin firmly by moving your thumb and fingers in opposite directions, creating an area about five cm wide.
Kožo močno raztegnite tako, da jo s palcem vlečete v nasprotno smer kot z ostalimi prsti in oblikujete približno pet centimetrov široko polje.
Note: You must push all the way down but do not touch the start button until you are ready to inject.
Opozorilo: injekcijski peresnik potisnite v kožo, dokler gre, pri tem pa se ne dotikajte sprožilnega gumba, dokler niste pripravljeni na injiciranje.
Aimovig has not been studied in elderly patients.
Pri starejših bolnikih zdravila Aimovig niso proučevali.
Needle cap contains latex.
Pokrovček igle vsebuje lateks.
955 patients were randomised in a 1:1:1 ratio to receive 140 mg (n = 319) or 70 mg (n = 317) erenumab or placebo (n = 319).
955 bolnikov so randomizirali v razmerju 1:1:1 na prejemanje 140 mg (n = 319) ali 70 mg erenumaba (n = 317) ali placeba (n = 319).
If there is any blood on the skin, press a cotton ball or gauze pad onto the injection site.
Če na koži opazite nekaj krvi, na mesto injiciranja pritisnite kosem vate ali zloženec iz gaze.
If your doctor prescribes the 70 mg dose you should have one injection once every 4 weeks.
Če vam zdravnik predpiše odmerek 70 mg, morate prejeti eno injekcijo enkrat na 4 tedne.
You may need to use either one or two syringes based on your prescribed dose.
Morda boste morali uporabiti enega ali dva injekcijska peresnika, odvisno od odmerka, ki vam je predpisan.
Before you use the Aimovig pre-filled syringe, read this important information:
Pred uporabo zdravila Aimovig v napolnjeni injekcijski brizgi preberite naslednje pomembne informacije:
Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Zdravilo Aimovig je indicirano za profilakso migrene pri odraslih, ki imajo najmanj 4 migrenske dni na mesec.
If you have received more Aimovig than you should or if the dose has been given earlier than it should have been, tell your doctor.
Če ste uporabili večji odmerek zdravila Aimovig, kot bi smeli Če ste prejeli več zdravila Aimovig, ko bi ga smeli, ali če so vam odmerek dali predčasno, povejte svojemu zdravniku.
Contact your doctor.
O tem obvestite zdravnika.
What Aimovig is and what it is used for What you need to know before you use Aimovig How to use Aimovig
Kaj je zdravilo Aimovig in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Aimovig Kako uporabljati zdravilo Aimovig Možni neželeni učinki
Note: Do not touch the start button yet.
Opozorilo: sprožilnega guba se še ne dotikajte.
Your symptoms may return if you stop the treatment.
Če prenehate z zdravljenjem, se vaši simptomi lahko ponovijo.
In the integrated 12-week placebo-controlled phase of the studies, injection site reactions were mild and mostly transient.
Po podatkih, združenih iz 12-tedenskih, s placebom kontroliranih, obdobij zdravljenja v obeh študijah, so bile reakcije na mestu injiciranja blage in večinoma prehodne.