natgillin/translations-raw huggingface dataset:
Double-Blind Clinical Responses at Week 12
Dvojno slepi klinični odzivi po 12 tednih
LIFMIOR can be taken with or without food or drink.
Zdravilo LIFMIOR se lahko uporablja skupaj s hrano ali pijačo ali brez njiju.
Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Priporočeni so redni pregledi kože pri vseh bolnikih, še posebno pri tistih, ki imajo dejavnike tveganja za kožnega raka.
Etanercept is cleared slowly from the body.
Etanercept se počasi odstranjuje iz telesa.
Significant improvement was also observed for the ASAS partial remission and BASDAI 50.
Pomembno izboljšanje so opazili tudi pri delni remisiji ASAS in BASDAI 50.
LIFMIOR is recommended for use in patients as defined in section 4.1.
Uporaba zdravila LIFMIOR je priporočena pri bolnikih, kot je opredeljeno v poglavju 4.1.
Consequently, the choice of intermittent or continuous therapy should be based upon physician judgment and individual patient needs.
Zato naj izbira zdravljenja v presledkih ali stalnega zdravljenja temelji na presoji zdravnika in potrebah posameznega bolnika.
Note - If you are unable to start the injection as described, press the pen more firmly against your skin, then press the green button again.
Opozorilo - Če ne morete začeti injiciranja, kakor je opisano, peresnik močneje pritisnite ob kožo in nato znova pritisnite zeleni gumb.
Dosing for adult patients (aged 18 years or over)
Odmerjanje pri odraslih bolnikih (starih 18 let ali več)
• The pen should be used once only - it should never be re-used.
• Peresnik je namenjen le za enkratno uporabo - nikoli ga ne smete ponovno uporabiti.
Undesirable effects in adults
Neželeni učinki pri odraslih
The effects of etanercept on pregnancy outcomes have been investigated in two observational cohort studies.
Učinke etanercepta na izide nosečnosti so preučevali v 2 opazovalnih kohortnih študijah.
Do not use this medicine if you notice the solution is not clear or contains particles.
Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra ali vsebuje delce.
(Note: After you have completed these steps, a small amount of liquid may remain in the vial.
(Opozorilo: Tudi če ste postopek izvedli pravilno, lahko v viali ostane malo tekočine.
• Teaching guide to facilitate training of the patients in the safe use of the pre-filled pen
• učni pripomoček za olajšanje poučevanja bolnikov o varni uporabi napolnjenega peresnika
Some white foam may remain in the vial - this is normal.
V viali lahko ostane nekaj bele pene - to je normalno.
Store in a refrigerator (2° - 8°C).
Shranjujte v hladilniku (2 C - 8 C).
The observed rates and incidences in these clinical trials were similar to those expected for the population studied.
Ugotovljene stopnje in pojavnosti v teh kliničnih preskušanjih so bile podobne tistim, ki so jih pričakovali za raziskovano populacijo.
The appropriate dose and frequency of dosing for the child or adolescent will depend on body weight and disease.
Ustrezen odmerek in pogostnost odmerjanja za otroka ali mladostnika sta odvisna od njegove telesne mase in bolezni.
Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Bolniki so bili prej zdravljeni z NSAID (86 %), DMARD (80 %) in kortikosteroidi (24 %).
Read all (both sides) of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred začetkom uporabe zdravila natančno preberite navodilo (obe strani), ker vsebuje za vas pomembne podatke!
The powder must be dissolved before use.
Prašek morate pred uporabo raztopiti.
These reactions were generally transient and did not recur with treatment.
Te reakcije so bile običajno prehodne in se med zdravljenjem niso ponavljale.
The clinical significance of this is unknown.
Klinični pomen tega ni znan.
On hearing the second ‘click' (or, if you do not hear a second ‘click', after 10 seconds have passed), your injection will be complete (see Diagram 6).
Ko zaslišite drugi klik (ali, če ne zaslišite drugega klika, ko bo minilo 10 sekund), bo injiciranje končano (glejte sliko 6).
In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death.
V nekaterih primerih določenih glivičnih in drugih oportunističnih okužb niso prepoznali, zaradi česar je prišlo do zakasnitve ustreznega zdravljenja in včasih bolnikove smrti.
Improvements in health-related quality of life and physical function were also maintained through 2 years of therapy.
Izboljšanja z zdravjem povezane kakovosti življenja in telesne funkcije so se prav tako vzdrževala med celotnim 2-letnim zdravljenjem.
Do not try to use the pen again, and do not try to use another pen without agreement from your nurse or pharmacist.
Ne poskušajte ponovno uporabiti peresnika in ne poskušajte uporabiti drugega peresnika brez dovoljenja medicinske sestre ali farmacevta.
Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1).
Za nekatere odrasle bolnike bo morda primerno stalno zdravljenje, daljše od 24 tednov (glejte poglavje 5.1).
Long-term experience with LIFMIOR was generally comparable to the original 48-week study and did not reveal any new safety findings.
Dolgoročne izkušnje z zdravilom LIFMIOR so v splošnem primerljive s prvotno 48-tedensko študijo in niso pokazale novih dognanj o varnosti.
Injection site reactions usually occurred in the first month.
Reakcije na mestu injiciranja so se običajno pojavljale v prvem mesecu.
With the other hand, hold the syringe like a pencil.
Z drugo roko držite brizgo, kot bi držali svinčnik.
Mean duration was approximately 3 to 5 days.
Povprečno trajanje tovrstnih reakcij je bilo 3 do 5 dni.
• Infections/monitoring: Tell your doctor of any recent travel outside the European region.
Okužbe/spremljanje: Povejte zdravniku za morebitno nedavno potovanje izven Evrope.
The youngest children (4 years of age) had reduced clearance (increased clearance when normalised by weight) compared with older children (12 years of age) and adults.
Pri najmlajših bolnikih (4 leta) so opazili zmanjšan očistek (povečan, če je bil normaliziran s težo) v primerjavi s starejšimi otroki (12 let) in odraslimi.
If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgotten dose.
Če se pozabljenega odmerka spomnite šele na dan, ko je že čas za naslednjo injekcijo, ne uporabite dvojnega odmerka (dveh odmerkov v istem dnevu), da bi nadomestili pozabljeni odmerek.
The clinical significance of this interaction is unknown.
Klinični pomen te interakcije ni znan.
This appearance is normal for LIFMIOR.
Tak izgled je normalen za zdravilo LIFMIOR.
Follow the directions given by the doctor.
Upoštevajte navodila zdravnika.
The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria.
Rezultate tega nadzorovanega preskušanja so prikazali kot odstotek izboljšanja revmatoidnega artritisa po kriterijih odziva ACR (American College of Rheumatology).
LIFMIOR should only be used during pregnancy if clearly needed.
Zdravilo LIFMIOR lahko med nosečnostjo uporabljamo le, če je to nujno potrebno.
The clinical impact of this is unknown, however, infants may be at increased risk of infection.
Klinični učinek tega ni znan, vendar pa lahko pri dojenčkih obstaja povečano tveganje za razvoj okužbe.
The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience.
Spodnji seznam neželenih učinkov temelji na izkušnjah iz kliničnih preskušanj pri odraslih ter na izkušnjah iz obdobja trženja.
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Ta pregled mora zajeti natančno medicinsko anamnezo z osebno anamnezo tuberkuloze ali možnim predhodnim stikom s tuberkulozo in predhodnim in/ali sedanjim imunosupresivnim zdravljenjem.
It blocks the activity of another protein in the body that causes inflammation.
V telesu zavre delovanje neke druge beljakovine, ki povzroča vnetje.
Injection advice:
Nasvet za injiciranje:
At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years.
Na koncu dvojno slepe študije so se bolniki lahko vključili v dolgoročno odprto podaljšano študijo, ki je v celoti trajala do 2 leti.
Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose.
Etanercept se počasi absorbira z mesta subkutane injekcije in doseže največjo koncentracijo po enkratnem odmerku po približno 48 urah.
It is important that you tell the baby's doctors and other healthcare professionals about the use of LIFMIOR during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Pomembno je, da o uporabi zdravila LIFMIOR med nosečnostjo obvestite dojenčkovega zdravnika in ostale zdravstvene delavce, preden dojenček prejme katerokoli cepivo (za več informacij glejte poglavje 2 “Cepljenja”).
Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.
Etanercept vsebuje 934 aminokislin in ima navidezno molekulsko maso približno 150 kilodaltonov.
ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively.
Odziva ASAS 50 in 70 sta bila definirana po istih kriterijih, le da je šlo za 50 % oziroma 70 % izboljšanje.
This study also showed no increased risks of minor birth defects, preterm birth, stillbirth, or infections in the first year of life for infants born to women exposed to etanercept during pregnancy.
Ta študija prav tako ni pokazala povečanih tveganj za manjše prirojene napake, prezgodnji porod, mrtvorojenost ali okužbe v prvem letu življenja pri dojenčkih, katerih matere so bile v času nosečnosti izpostavljene etanerceptu.
In evaluating patients for infections, the patient's risk for relevant opportunistic infections (e.g., exposure to endemic mycoses) should be considered.
Pri pregledovanju bolnikov glede okužb moramo upoštevati bolnikovo tveganje za relevantne oportunistične okužbe (npr. izpostavljenost endemičnim mikozam).
Worsening of hepatitis C
Poslabšanje hepatitisa C
Psoriatic Arthritis Response n = 104
Odziv psoriatičnega artritisa n = 104
Inject slowly, at an angle of 45° to 90° to the skin.
Injicirajte počasi, pod kotom 45 do 90 stopinj proti koži.
A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial.
Vprašalnik za oceno zdravstvenega stanja HAQ (Health Assessment Questionaire), ki je vključeval invalidnost, vitalnost, duševno zdravje, splošno zdravstveno stanje in poddomene zdravstvenega stanja, povezane z artritisom, so med preskušanjem uporabili vsake 3 mesece.
Responses of Patients with Psoriasis in Studies 2, 3 And 4
Odzivi bolnikov s psoriazo v študijah 2, 3 in 4
Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ.
Kakovost življenja bolnikov s psoriatričnim artritisom je bila ocenjena v vsaki časovni točki z uporabo indeksa invalidnosti po HAQ.
The Patient's Alert Card should contain the following key elements for patients treated with LIFMIOR:
Opozorilna kartica za bolnika mora vsebovati naslednje ključne sestavine za bolnike, ki se zdravijo z zdravilom LIFMIOR:
Invasive fungal infections accounted for more than half of the fatalities amongst patients who developed opportunistic infections.
Invazivne glivične okužbe so povzročile več kot pol smrtnih primerov pri bolnikih, pri katerih so se razvile oportunistične okužbe.
Whilst waiting for the solution in the pen to reach room temperature, read Step 2 (below), and choose an injection site.
Medtem ko čakate, da bo raztopina v peresniku dosegla sobno temperaturo, preberite korak 2 (spodaj) in izberite mesto injiciranja.
The syringe and needle should NEVER be re-used.
Brizge in igle ne smete NIKOLI ponovno uporabiti.
The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l.
Osrednji volumen porazdelitve etanercepta je 7,6 l, volumen porazdelitve v stanju dinamičnega ravnovesja pa je 10,4 l.
In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and Joint Space Narrowing (JSN) score.
V tej študiji je bila strukturna poškodba sklepov ocenjena radiografsko in izražena kot sprememba skupne Sharpove ocene (TSS - Total Sharp Score) in njenih komponent, ocene erozije sklepov in ocene zožitve sklepne špranje (JSN - Joint Space Narrowing).
LIFMIOR is a medicine that is made from two human proteins.
Zdravilo LIFMIOR je pridobljeno iz dveh človeških beljakovin.
The effect of LIFMIOR on radiographic progression was maintained in patients who continued on treatment during the second year.
Učinek zdravila LIFMIOR na radiografsko napredovanje bolezni se je ohranjal pri bolnikih, ki so nadaljevali zdravljenje še drugo leto.
Similar results were obtained in the 2 smaller ankylosing spondylitis trials.
Podobni rezultati so bili dobljeni pri 2 manjših preskušanjih ankilozirajočega spondilitisa.
However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections.
Vendar je pri zdravljenju starostnikov potrebna previdnost, posebno pozornost pa je treba posvetiti pojavljanju okužb.
In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2.
V prvem delu študije je 51 od 69 (74 %) bolnikov pokazalo klinični odziv in se vključilo v drugi del študije.
Please consult your doctor before you or the child receive any vaccines.
Posvetujte se z zdravnikom, preden vi ali otrok prejmete katerokoli cepivo.
The types of major birth defects were consistent with those most commonly reported in the general population and no particular pattern of abnormalities was identified.
Vrste resnih prirojenih napak so bile skladne s tistimi, o katerih so najpogosteje poročali pri splošni populaciji, pri tem pa niso odkrili nobenega posebnega vzorca nepravilnosti.
Patients with complete ankylosis of the spine were not included in the study.
Bolniki s popolno ankilozo hrbtenice niso bili vključeni v študijo.
LIFMIOR contains no antibacterial preservative, and therefore solutions prepared with water for injections should be administered as soon as possible and within 6 hours following reconstitution.
Zdravilo LIFMIOR ne vsebuje antibakterijskih konzervansov, zato je treba raztopino, pripravljeno z vodo za injekcije, injicirati čimprej oziroma najkasneje v 6 urah po rekonstituciji.
Name and address of the manufacturers responsible for batch release Wyeth Pharmaceuticals
Ime in naslov izdelovalcev, odgovornih za sproščanje serij Wyeth Pharmaceuticals
Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
Druga možnost je dajanje 50 mg enkrat na teden; dokazali so, da je ta možnost varna in učinkovita (glejte poglavje 5.1).
Placebo N=106 to 109*
Placebo n = 106 do 109*
See section 4.4.
Glejte poglavje 4.4.
To avoid damaging the needle inside the pen, do not bend the white needle cap while you are removing it, and do not re-attach it once it has been removed.
Da ne bi poškodovali igle v peresniku, ne upogibajte belega pokrovčka igle, medtem ko ga odstranjujete, in ga ne natikajte več nazaj, potem ko je bil odstranjen.
• Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with LIFMIOR.
Zdravnik vam bo izročil tudi opozorilno kartico za bolnika, ki vsebuje pomembne podatke o varnosti, s katerimi morate biti seznanjeni pred zdravljenjem z zdravilom LIFMIOR in med zdravljenjem z njim.
a. One MYCLIC pre-filled pen and one alcohol swab (take these from the carton of pens you keep in your refrigerator).
a. En napolnjen peresnik MYCLIC in eno alkoholno blazinico (vzemite ju iz škatle s peresniki, ki jo hranite v hladilniku).
Before starting treatment with LIFMIOR, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Pred začetkom zdravljenja z zdravilom LIFMIOR je treba vse bolnike pregledati tako glede aktivne kot tudi glede neaktivne ('latentne') tuberkuloze.
No formal clinical trials have been conducted in children aged 2 to 3 years.
Uradnih kliničnih preskušanj pri otrocih, starih od 2 do 3 let, niso izvedli.
Administration of live vaccines to infants for 16 weeks after the mother's last dose of LIFMIOR is generally not recommended.
Uporaba živih cepiv v prvih 16 tednih po tem, ko so matere dojenčkov prejele zadnji odmerek zdravila LIFMIOR, pri dojenčkih običajno ni priporočljiva.
Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during LIFMIOR therapy and for three weeks after discontinuation of therapy.
Ženske v rodni dobi morajo razmisliti o uporabi ustrezne kontracepcije za preprečitev nosečnosti med zdravljenjem z zdravilom LIFMIOR in še tri tedne po prenehanju zdravljenja.
LIFMIOR treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Zdravljenje z zdravilom LIFMIOR je povzročilo izboljšanje telesne funkcije v dvojno slepem obdobju, ta koristni učinek pa se je ohranjal med dolgotrajnejšo izpostavljenostjo, ki je trajala do 2 leti.
Step 4: Disposing of the used MYCLIC pen
Korak 4: Odstranjevanje uporabljenega peresnika MYCLIC
Study 3 evaluated 583 patients and had the same inclusion criteria as study 2.
Študija 3 je ocenila 583 bolnikov in je imela enaka vključitvena merila kot študija 2.
Do NOT use any other syringe.
NE uporabljajte drugih brizg.
An analysis of clinical trial data did not reveal any baseline disease characteristics that would assist clinicians in selecting the most appropriate dosing option (intermittent or continuous).
Analiza podatkov iz kliničnih preskušanj ni pokazala nobenih značilnosti osnovne bolezni, ki bi zdravnikom pomagala pri izbiri najustreznejšega odmerjanja (v presledkih ali stalno).
Treatment with LIFMIOR 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
Z zdravljenjem s 25 mg zdravila LIFMIOR so dosegli bistveno izboljšanje pri 12 mesecih - približno 44 % bolnikov je doseglo normalen rezultat HAQ (manj kot 0,5).
Do NOT remove the white collar that remains on the syringe.
NE odstranjujte belega omota, ki ostane na brizgi.
Some children and teenage patients who have received LIFMIOR or other medicines that work the same way as LIFMIOR have developed cancers, including unusual types, which sometimes resulted in death.
Pri nekaterih otrocih in mladostnikih, ki so prejemali zdravilo LIFMIOR ali druga podobna zdravila z enakim načinom delovanja kot zdravilo LIFMIOR, se je razvil rak, vključno z neobičajnimi oblikami, ki se je včasih končal s smrtjo.
For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment.
Razpoložljivi podatki kažejo, da je klinični odziv pri vseh zgoraj navedenih indikacijah ponavadi dosežen v obdobju 12 tednov zdravljenja.
Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3.
Študija 4 je ocenila 142 bolnikov in je imela podobna vključitvena merila kot študiji 2 in 3.
Reports have included fatal and life-threatening infections and sepsis.
Poročali so o smrtnih in življenjsko nevarnih okužbah in sepsi.
A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Tveganja za razvoj malignosti pri otrocih in mladostnikih, zdravljenih z antagonisti TNF, ni mogoče izključiti.
Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age.
Ocenjene vrednosti očistka in volumna pri bolnikih, starih od 65 do 87 let, so bile podobne tistim pri bolnikih, mlajših od 65 let.
• if the child has an infection of any kind.
če ima otrok kakršnokoli okužbo.
In long-term (up to 34 months) open-label studies where LIFMIOR was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.
V dolgoročnih (do 34 mesecev) odprtih študijah, v katerih so dajali zdravilo LIFMIOR brez prekinitev, so bili klinični odzivi trajni, varnost pa je bila primerljiva s tisto v krajših študijah.
In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life.
Poleg tega uporaba Fc območja imunoglobulina kot elementa združitve pri konstrukciji dimernega receptorja podaljša razpolovno dobo zdravila v serumu.
If you received LIFMIOR during pregnancy, your baby may have a higher risk of getting an infection.
Če ste med nosečnostjo prejeli zdravilo LIFMIOR, lahko pri vašem dojenčku obstaja povečano tveganje za razvoj okužbe.
No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
Be careful not to push down on the plunger.
Pazite, da ne pritisnete na bat brizge.
Simulation of dosing suggests that while older children (10-17 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Simulacija odmerjanja kaže, da bodo imeli starejši otroci (10 do 17 let) podobne serumske koncentracije kot odrasli, mlajši otroci pa znatno nižje.
In postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
V obdobju trženja je bilo približno pol vseh primerov okužb, opisanih v poročilih o primerih oportunističnih okužb po vsem svetu, invazivnih glivičnih okužb.
Appropriate screening tests, i.e., tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Pri vseh bolnikih je treba opraviti ustrezne presejalne teste, tj. tuberkulinski kožni test in rentgensko slikanje prsnega koša (morda obstajajo nacionalna priporočila glede teh preiskav).
Information in this leaflet is organised under the following 7 sections:
Informacije v tem navodilu so razvrščene v naslednjih 7 poglavij:
The use of LIFMIOR in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Uporaba zdravila LIFMIOR v kombinaciji z drugimi sistemskimi zdravljenji ali fototerapijo za zdravljenje psoriaze ni raziskana.
In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil morata biti v bolnikovi kartoteki jasno dokumentirana (ali navedena) lastniško ime in številka serije prejetega zdravila.
Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
Med bolniki, ki so dokončali polnih 24 mesecev zdravljenja v študiji, je bil odstotek nenapredovanja 78 %, 70 % in 61 %.