natgillin/translations-raw huggingface dataset:
EndolucinBeta is not to be administered directly to patients.
Radionuklidni predhodnik EndolucinBeta se ne sme dajati neposredno bolnikom.
Contact your nuclear medicine doctor if you have any questions.
Če imate kakršna koli vprašanja, se posvetujte z zdravnikom nuklearne medicine.
If you are pregnant Medicines radiolabelled with EndolucinBeta must not be administered if you are pregnant.
Zdravilo, radioaktivno označeno z radionuklidnim predhodnikom EndolucinBeta, se pri vas ne sme uporabiti:
The toxicological properties of Lutetium (177Lu)-labelled medicinal products prepared by radiolabelling with EndolucinBeta prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
5.3 Predklinični podatki o varnosti Toksikološke lastnosti z lutecijem (177Lu) označenih zdravil, pripravljenih z radioaktivnim označevanjem z radionuklidnim predhodnikom EndolucinBeta pred dajanjem, bodo odvisne od zdravila, ki bo radioaktivno označeno.
Anaemia, thrombocytopenia, leucopenia, lymphopenia, and less commonly neutropenia may occur during radioligand therapy with Lutetium (177Lu).
Pri radioligandni terapiji z lutecijem (177Lu) se lahko pojavi anemija, trombocitopenija, levkopenija,
1 mL of solution contains 40 GBq Lutetium (177Lu) chloride on activity reference time (ART), corresponding to 10 micrograms of Lutetium (177Lu) (as chloride).
activity reference time), kar ustreza 10 mikrogramom lutecija (177Lu) (v obliki klorida).
EndolucinBeta has to be combined with a carrier medicine in a process called radiolabelling before administration.
V postopku, imenovanem radioaktivno označevanje, je treba radionuklidni predhodnik EndolucinBeta pred dajanjem kombinirati z nosilnim zdravilom.
A. Before you start
A. Preden začnete
Date of first authorisation: 14 January 2016
Datum prve odobritve: 14. januar 2016
• Do not recycle.
• Ne reciklirajte.
c Remission is defined as DAS <1.6.
c Remisija je definirana kot DAS < 1,6.
Wash your hands with soap and water.
Umijte si roke z milom in vodo.
Key results of studies 2, 3 and 4 are shown below.
Ključni rezultati študij 2, 3 in 4 so prikazani spodaj
There may be new information.
Morda bodo dodane nove informacije.
Other information (please complete)
Druge informacije (izpolnite)
The healthcare professional's educational material should contain the following key elements:
Izobraževalno gradivo za zdravstvene delavce mora vsebovati naslednje ključne elemente:
The absolute bioavailability is 76%.
Absolutna biološka uporabnost 76 %.
The device will click a second time.
Naprava še drugič klikne.
This is important to make the medicine easier and more comfortable to inject.
To je pomembno, da se zdravilo lažje in udobneje injicira.
Do not warm in any other way.
Raztopine ne segrevajte na noben drug način.
Find a well-lit, clean surface and gather all the equipment you need:
Izberite čisto, dobro osvetljeno, ravno delovno površino in vse pripomočke, ki jih potrebujete:
Ask your doctor to record the dates and the results of your last screening for TB below:
Zdravnika prosite, da spodaj zabeleži datume in rezultate vašega zadnjega presejanja za TB:
• The risk of opportunistic infections and tuberculosis (TB)
• Tveganje za oportunistične okužbe in tuberkulozo (TB)
If you do not understand this information, please ask your doctor to explain it to you.
Če teh informacij ne razumete, prosite zdravnika, da vam jih razloži.
Doctor's phone:
Zdravnikov telefon:
Open
odprite
After the second click, count slowly to 15 to make sure that the injection is complete.
Po drugem kliku počasi štejte do 15, da zagotovite popolno injiciranje.
• if you or the child have an infection of any kind.
• če imate vi ali otrok kakršno koli okužbo.
Responses of patients with psoriasis in studies 2, 3 and 4
Odzivi bolnikov s psoriazo v študijah 2, 3 in 4
Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.
"Čisto" ali "skoraj čisto" definirano kot 0 ali 1 na lestvici od 0
The needle guard will completely cover the needle.
Varnostni ščit igle bo iglo povsem prekrilo.
● You should be evaluated for tuberculosis (TB).
● Pri vas je treba opraviti preizkus za tuberkulozo (TB).
b Values for Disease Activity Score (DAS) are means.
b Vrednosti za oceno aktivnosti bolezni (DAS - Disease Activity Score) so povprečne vrednosti.
Please consult your doctor before you or the child receive any vaccines.
Posvetujte se z zdravnikom, preden vi ali otrok prejmete katero koli cepivo.
● Show this card to any doctor involved in your or your child's treatment.
● To kartico pokažite vsem zdravnikom, ki sodelujejo pri vašem zdravljenju ali zdravljenju vašega otroka.
SE = standard error a p = 0.0001
SE = standard napaka a p = 0,0001
• Infections/monitoring: Tell your doctor of any recent travel outside the European region.
• Okužbe/spremljanje: Povejte zdravniku za morebitno nedavno potovanje izven Evrope.
If you notice any of the following, you or the child may need urgent medical attention.
Če opazite kar koli od naslednjega, boste vi ali vaš otrok morda potrebovali nujno zdravniško pomoč.
79 (75%)a sPGA “clear” or “minimal”, n (%)
79 (75 %)a sPGA “čisto” ali “minimalno”, n (%)
Results: ● Please ask your physician to list your other medicines that may increase your risk of infection.
Rezultati: ● Zdravnika prosite, da navede vsa druga zdravila, ki lahko povečajo tveganje za okužbo.
Etanercept is recommended for use in patients as defined in section 4.1.
Uporaba etanercepta je priporočena pri bolnikih, kot je opredeljeno v poglavju 4.1.
Long-term experience with etanercept was generally comparable to the original 48-week study and did not reveal any new safety findings.
Dolgoročne izkušnje z etanerceptom so v splošnem primerljive s prvotno 48-tedensko študijo in niso pokazale novih dognanj o varnosti.
The observed rates and incidences in these clinical trials were similar to those expected for the population studied.
Ugotovljene stopnje in incidence v teh kliničnih preskušanjih so bile podobne tistim, ki so jih pričakovali za raziskovano populacijo.
The specific activity of etanercept is 1.7 × 106 units/mg.
Specifična aktivnost etanercepta je 1,7 x 106 enot/mg.
Benepali is also prescribed for the treatment of the following diseases in children and adolescents.
Zdravilo Benepali se predpisuje tudi za zdravljenje naslednjih bolezni pri otrocih in mladostnikih:
• if you or the child you are caring for, are allergic to etanercept or any of the other ingredients of Benepali (listed in section 6).
• če ste vi ali otrok, za katerega skrbite, alergični na etanercept ali katero koli sestavino zdravila Benepali (navedeno v poglavju 6).
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 otrocih (starih 4 leta) so opazili zmanjšan očistek (povečan, če je bil normaliziran s težo) v primerjavi s starejšimi otroki (starih 12 let) in odraslimi.
These antibodies have generally been non-neutralising and transient.
Protitelesa na splošno niso bila nevtralizirajoča in so prehodna.
Dose and frequency of dosing for the child or adolescent will depend on body weight and disease.
Odmerek in pogostnost odmerjanja za otroka ali mladostnika sta odvisna od njegove telesne mase in bolezni.
In adults (aged 18 and over), Benepali can be used for:
Pri odraslih (starih 18 let in več) se zdravilo Benepali lahko uporablja za:
The osmolality of the solution is 325 ± 35 mOsm/kg.
Osmolalnost raztopine je 325 ± 35 mOsm/kg.
Pull to open
povlecite, da odprete
Not included in pack: • 1 alcohol swab, gauze pad and plaster
Ni vključeno v pakiranju: • 1 alkoholni zloženec, gaza in obliž
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
If you are injecting into the abdomen, choose a site that is at least 5 cm away from the belly button.
Če injicirate v trebuh, izberite mesto, ki je vsaj 5 cm od popka.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti (navesti) ime in številka serije uporabljenega zdravila v bolnikovo kartoteko.
Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Priporočen so redni pregledi kože pri vseh bolnikih, še posebno pri tistih, ki imajo dejavnike tveganja za kožnega raka.
If you forget to inject Benepali
Če ste si pozabili injicirati zdravilo Benepali
The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
Zdravnik vam bo natančno pojasnil, kako boste pripravili in odmerili primeren odmerek.
When the syringe is empty, remove the needle from the skin at the same angle as inserted.
Ko je brizga prazna, iglo izvlecite iz kože pod istim kotom, kot ste jo vstavili.
This appearance is normal for Benepali.
Takšen izgled je normalen za zdravilo Benepali.
● Keep this card with you for 2 months after the last Benepali dose, since side effects may occur after your last dose of Benepali.
● To kartico nosite pri sebi še 2 meseca po zadnjem odmerku zdravila Benepali, saj se lahko neželeni učinki pojavijo po vašem zadnjem odmerku zdravila Benepali.
a Patients who did not complete 12 months in the study were considered to be non-responders.
a Bolniki, ki v študiji niso sodelovali 12 mesecev, so bili obravnavani kot neodzivni.
Allergic reactions have included angioedema and urticaria; serious reactions have occurred.
Alergijske reakcije so vključevale angioedem in urtikarijo, pojavile so se resne reakcije.
Hepatitis B reactivation, listeria
reaktivacija hepatitisa B, listeria
If an alternate dose is required, other etanercept products offering such an option should be used.
Če je treba dati drugačen odmerek, je treba uporabiti druga zdravila z etanerceptom, ki to možnost omogočajo.
A total of 401 patients were enrolled, from which 203 were treated with etanercept.
Sodeloval je 401 bolnik in od tega so bili 203 zdravljeni z etanerceptom.
Benepali is a medicine that is made from two human proteins.
Zdravilo Benepali je pridobljeno iz dveh človeških beljakovin.
• Do not try to give yourself the injection unless your doctor or nurse has shown you how to give the injection.
• Zdravila si ne poskušajte injicirati sami, če vas zdravnik ali medicinska sestra nista poučila o injiciranju.
● You should not use Benepali if you have an infection.
● Zdravila Benepali ne smete uporabljati, če imate okužbo.
The use of etanercept in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Uporaba etanercepta v kombinaciji z drugimi sistemskimi zdravljenji ali fototerapijo za zdravljenje psoriaze ni raziskana.
Patient's name:
Bolnikovo ime:
If you received Benepali during pregnancy, your baby may have a higher risk of getting an infection.
Če ste med nosečnostjo prejeli zdravilo Benepali, lahko pri vašem dojenčku obstaja povečano tveganje za razvoj okužbe.
Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue Benepali therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Ker se imunoglobulini, tako kot mnoga druga zdravila, lahko izločajo v mleko pri človeku, se je treba odločiti med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom Benepali, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
The safety and efficacy profiles of the two etanercept treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Profil varnosti in učinkovitosti obeh režimov zdravljenja z etanerceptom je bil po 8 tednih primerljiv glede učinka na znake in simptome revmatoidnega artritisa; podatki po 16 tednih niso pokazali primerljivosti (neinferiornosti) med obema režimoma.
Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including sulfasalazine), even those not prescribed by your doctor.
Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo (vključno s sulfasalazinom), tudi če ga ni predpisal vaš zdravnik.
Etanercept 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 etanerceptom 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.
Benepali may increase your risk of getting infections, which could be serious.
Zdravilo Benepali lahko poveča tveganje za okužbe, ki so lahko resne.
To help you remember, it may be helpful to write in a diary which day(s) of the week Benepali should be used.
Da si boste lažje zapomnili, vam bo morda pomagalo, če si v koledarju zabeležite dan (dneve) v tednu, ko morate uporabiti zdravilo Benepali.
In long-term (up to 34 months) open-label studies where etanercept 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 etanercept brez prekinitev, so bili klinični odzivi trajni, varnost pa je bila primerljiva s tisto v krajših študijah.
Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of etanercept.
Natančen odmerek za otroka bo določil zdravnik in predpisal ustrezno jakost etanercepta.
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.
There have been reports of worsening of hepatitis C in patients receiving etanercept.
Poročali so o poslabšanju hepatitisa C pri bolnikih, ki so prejemali etanercept.
The effect of etanercept on radiographic progression was maintained in patients who continued on treatment during the second year.
Učinek etanercepta na radiografsko napredovanje bolezni se je ohranjal pri bolnikih, ki so nadaljevali zdravljenje še drugo leto.
Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State, consisting of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen/prefilled syringes and to inform them that the product is not for use in children and adolescents who weigh less than 62.5 kg, and a Patient Alert Card which is to be given to patients using Benepali.
Pred prihodom na trg v vsaki državi članici se bo imetnik dovoljenja za promet s pristojnim organom v državi članici dogovoril glede končnega izobraževalnega gradivo, ki ga bodo sestavljale informacije za vse zdravstvene delavce, za katere se pričakuje, da bodo zdravilo predpisovali, glede pravilne in varne uporabe napolnjenih injekcijskih peresnikov in napolnjenih injekcijskih brizg, z obvestilom o neprimernosti zdravila za uporabo pri otrocih in mladostnikih s telesno maso manj kot 62,5 kg, in opozorilno kartico za bolnika, ki jo bo pred uporabo zdravila Benepali prejel bolnik.
The Patient Alert Card should contain the following key elements for patients treated with Benepali:
Opozorilna kartica za bolnike naj vsebuje naslednje ključne elemente za bolnike, zdravljene z zdravilom Benepali:
• if you or the child have, or are at risk of developing a serious blood infection called sepsis.
• če imate vi ali otrok resno okužbo krvi, imenovano sepso.
Some children and teenage patients who have received etanercept or other medicines that work the same way as etanercept have developed cancers, including unusual types, which sometimes resulted in death.
Pri nekaterih otrocih in mladostnikih, ki so prejemali etanercept ali druga podobna zdravila z enakim načinom delovanja kot etanercept, se je razvil rak, vključno z neobičajnimi oblikami, ki se je včasih končal s smrtjo.
• Do not pinch the skin.
• Kože ne ščipajte.
Two large clinical trials evaluating the use of etanercept in the treatment of CHF were terminated early due to lack of efficacy.
Dve veliki klinični preskušanji za ovrednotenje uporabe etanercepta pri zdravljenju KSP sta bili predčasno prekinjeni zaradi slabe učinkovitosti zdravila.
It is important that you tell the baby's doctors and other healthcare professionals about the use of Benepali during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Pomembno je, da o uporabi zdravila Benepali med nosečnostjo obvestite dojenčkovega zdravnika in ostale zdravstvene delavce, preden dojenček prejme katero koli cepivo (za več informacij glejte poglavje 2 "Cepljenja").
Before starting treatment with Benepali, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Pred začetkom zdravljenja z zdravilom Benepali je treba vse bolnike pregledati tako glede aktivne kot tudi glede neaktivne ('latentne') tuberkuloze.
Treatment with etanercept 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
25 mg etanercepta so dosegli bistveno izboljšanje pri 12 mesecih - približno 44 % bolnikov je doseglo normalen rezultat HAQ (manj kot 0,5).
Benepali should only be used during pregnancy if clearly needed.
Zdravilo Benepali lahko med nosečnostjo uporabljamo le, če je to nujno potrebno.
Other medicines and Benepali
Druga zdravila in zdravilo Benepali
In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life-threatening, or requiring hospitalisation or intravenous antibiotics) was observed.
V preskušanjih, nadzorovanih s placebom, niso opazili zvečanja incidence resnih okužb (s smrtnim izidom, življenjsko ogrožajočih okužb ali takih, ki so zahtevale hospitalizacijo ali intravenske antibiotike).
- 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 Benepali.
- Zdravnik vam bo izročil tudi opozorilno kartico za bolnika, ki vsebuje pomembne podatke o varnosti, s katerimi morate biti seznanjeni pred zdravljenjem z zdravilom Benepali in med zdravljenjem z njim.
Allow the medicine to reach room temperature:
Počakajte, da se zdravilo ogreje na sobno temperaturo:
• Instructional materials to share with patients.
• Gradivo z navodili za bolnike.
Sharps disposal containers may be purchased at your local pharmacy.
Vsebnik za ostre odpadke lahko kupite v lokalni lekarni.
Children and adults taking Benepali may have an increased risk of developing lymphoma or another cancer.
Pri otrocih in odraslih, ki prejemajo zdravilo Benepali, je morda tveganje za nastanek limfoma ali druge oblike raka večje.
Clinical improvement, including onset of action within 2 weeks with etanercept 25 mg, was similar to that seen in the previous trials and was maintained for up to 24 months.
Klinično izboljšanje, vključno z nastopom delovanja zdravila v 2 tednih pri 25 mg etanercepta, je bilo podobno tistemu, ki so ga ugotavljali v prejšnjih preskušanjih, in se je ohranjalo do 24 mesecev.
Solution for injection (injection).
raztopina za injiciranje (injekcija)
Component of a multipack, cannot be sold separately.
Sestavni del večodmernega pakiranja, ni za posamično prodajo.
In this situation, the benefit/risk balance of Benepali therapy should be very carefully considered.
V takem primeru je treba zelo skrbno pretehtati razmerje med koristmi in tveganji zdravljenja z zdravilom Benepali.
What you need to know before you use Benepali Do not use Benepali
Kaj morate vedeti, preden boste uporabili zdravilo Benepali Ne uporabljajte zdravila Benepali
Etanercept did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2,000 mg/kg or a single intravenous dose of 1,000 mg/kg.
Etanercept ni povzročilo smrtnosti ali pomembne toksičnosti pri miših ali podganah po enkratnem subkutanem odmerku 2.000 mg/kg ali enkratnem intravenskem odmerku 1.000 mg/kg.
This card contains important safety information that you need to be aware of before you are given Benepali and during treatment with Benepali.
Ta kartica vsebuje pomembne informacije o varnosti, ki jih morate poznati, preden boste prejeli zdravilo Benepali in v času zdravljenja z zdravilom Benepali.
Check for the yellow plunger rod in the window to confirm that the full dose has been delivered.
Preverite, ali je v okencu rumen bat, saj to potrjuje, da ste prejeli celotni odmerek.
Administration of live vaccines to infants for 16 weeks after the mother's last dose of Benepali is generally not recommended.
Uporaba živih cepiv v prvih 16 tednih po tem, ko so matere dojenčkov prejele zadnji odmerek zdravila Benepali, pri dojenčkih običajno ni priporočljiva.
Toxic epidermal necrolysis
toksična epidermalna nekroliza
There is no known antidote to etanercept.
Znanega antidota za etanercept ni.
Treatment with Benepali should not be initiated in patients with active infections, including chronic or localised infections.
Zdravljenja z zdravilom Benepali ne smete uvesti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi okužbami.
In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received etanercept or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Poleg tega so v eni študiji ugotovili več prirojenih napak, kadar je mati med nosečnostjo prejemala etanercept, v primerjavi z materami, ki niso prejemale etanercepta ali drugih podobnih zdravil (antagonistov TNF), vendar niso poročali o nobeni določeni vrsti prirojene okvare.
Etanercept has not been studied in children aged less than 2 years.
Etanercepta niso preskušali pri otrocih, mlajših od 2 let.
The primary measure of efficacy (ASAS 40) was a 40% improvement in at least three of the four ASAS domains and absence of deterioration in the remaining domain.
Primarno merilo za učinkovitost (ASAS 40) je bilo 40-% izboljšanje vsaj treh od štirih domen ASAS in odsotnost poslabšanja pri četrti domeni.
Contents of the pack and other information Instructions for use (see overleaf)
Vsebina pakiranja in dodatne informacije Navodila za uporabo (glejte drugo stran navodila)
This may include a thorough medical history, a chest X-ray and a tuberculin test.
To bo storil s temeljito medicinsko anamnezo, z rentgenskim slikanjem prsnega koša in s tuberkulinskim testom.
It should be injected into the thigh, abdomen, or back of the upper arm (see image on the left).
Injicirati ga je treba v stegno, trebuh ali v hrbtno stran nadlakti (glejte levo sliko).
Percent of Patients Placebo n = 104
Odstotek bolnikov Placebo n = 104
Benepali works by reducing the inflammation associated with certain diseases.
Zdravilo Benepali deluje tako, da zmanjšuje vnetje, ki spremlja določene bolezni.
lymphoma, leukaemia
limfom, levkemija karcinom
Etanercept was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy.
Etanercept je bil pomembno boljši kot placebo po vseh kriterijih aktivnosti bolezni (p < 0,001) in odzivi so bili podobni, ne glede na sočasno zdravljenje z metotreksatom.