natgillin/translations-raw huggingface dataset:
Stop using Hemlibra and aPCC, and talk to a doctor immediately if you or your caregiver notices any symptoms of blood clots in blood vessels. 
Če vi ali vaš skrbnik opazite kateri koli simptom krvnih strdkov v žilah, nemudoma prenehajte uporabljati zdravilo Hemlibra in aPCC in se nemudoma posvetujte z zdravnikom.
Connect syringe to vial adapter 
Na adapter za vialo namestite brizgo
Step A. Recap transfer needle 
Korak A. Namestite pokrovček nazaj na iglo za prenos
Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility as applicable) of the following safety concerns associated with the use of Hemlibra: - thromboembolic events associated with the concomitant use of emicizumab and activated prothrombin complex concentrate (aPCC), - thrombotic microangiopathy associated with the concomitant use of emicizumab and aPCC - life-threatening bleeding due to misinterpretation of the standard coagulation tests 
Informacije o resnih, življenje ogrožajočih trombemboličnih dogodkih ali dogodkih trombotične mikroangiopatije, ki so jih opazili pri sočasni uporabi emicizumaba s koncentratom aktiviranega protrombinskega kompleksa (aPCC) pri bolnikih, zdravljenih z emicizumabom;
● Do not use the vial if: the medicine is cloudy, hazy or coloured. 
če je zdravilo motno, megličasto ali obarvano.
Each mL of solution contains 150 mg of emicizumab* Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL. 
* Ena 0,4-ml viala vsebuje 60 mg emicizumaba v koncentraciji 150 mg/ml.
240 ml (10 mg/ml) 1 bottle + 1 syringe + 1 adapter 
1 steklenica + 1 brizga + 1 adapter
Strength Pharmaceutical form Route of administration 
Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
Wait 30 minutes for medication to warm. 
Počakajte 30 minut, da se zdravilo ogreje.
First read all the instructions carefully and then follow them step by step. 
Najprej natančno preberite navodilo v celoti, nato pa ga korak za korakom upoštevajte.
Median Time to Failure (months) 
Mediana časa do neuspeha (meseci)
Not known (frequency cannot be estimated from available data): 
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
• Wash your hands with soap and water, then dry them completely. 
• Roke si umijte z milom in vodo, nato jih popolnoma osušite.
Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
• DO NOT attempt to self-inject until you are sure that you understand how to prepare and give the 
• Injekcije si NE poskušajte dati sami, dokler niste prepričani, da razumete, kako je treba injekcijo pripraviti in dati.
• It is normal to see one or more bubbles in the medication. 
• Prisotnost enega ali več mehurčkov v zdravilu je normalna.
Tell your doctor as soon as possible, if you notice any of the following: 
Čim prej obvestite zdravnika, če opazite kaj od naslednjega:
• If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• Physician educational material • Patient information 
• izobraževalno gradivo za zdravnike • informacije za bolnike
Tuberculosis can develop during therapy even if you have received preventative treatment for tuberculosis. 
Tuberkuloza se lahko razvije med zdravljenjem, tudi če ste bili preventivno zdravljenji za tuberkulozo.
Detailed instructions on how to inject Cyltezo are provided in section 7 ‘Instructions for use'. 
Podrobna navodila o injiciranju zdravila Cyltezo so v poglavju 7 ‘Navodila za uporabo'.
This may cause severe allergic reactions in patients sensitive to latex. 
Ta lahko povzroča hude alergijske reakcije pri bolnikih, občutljivih na lateks.
Injecting medication that is cold can cause discomfort. 
Injiciranje hladnega zdravila lahko povzroči neugodje.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not 
• Glede na študije v nosečnosti ni bilo večjega tveganja za defekte ob rojstvu, če je mati jemala adalimumab med nosečnostjo, v primerjavi z materami z enako boleznijo, ki adalimumaba niso jemale.
• Signs or symptoms of the safety concern and when to seek attention from a HCP 
• Znake ali simptome varnostnih pomislekov in kdaj je treba poiskati pomoč zdravstvenega
There may be a need for dose interruption, for instance before surgery or if a serious infection occurs. 
Morda bo potrebno uporabo prekiniti, npr. pred operacijo ali če se pojavi resna okužba.
The primary endpoint was the birth prevalence of major birth defects. 
Primarni opazovani dogodek je bila prevalenca rojstev z večjmi defekti ob rojstvu.
• A warning message for HCPs treating the patient at any time, including in conditions of emergency, 
• Opozorilo za zdravstvene delavce, ki bolnika kadar koli zdravijo, vključno v nujnih primerih,
• DO NOT remove cap until right before injection (step 6). 
• Pokrovček odstranite tik pred injiciranjem (6. korak).
Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period. 
Ker lahko izločanje adalimumaba traja do štiri mesece, je treba bolnike ves ta čas nadzirati.
• If you have a severe infection, including tuberculosis (see “Warnings and precautions”). 
• če imate hudo okužbo, vključno s tuberkulozo (glejte "Opozorila in previdnostni ukrepi").
• Select an area on the upper thighs or abdomen/belly (at least 5 centimetres away from navel). 
• Izberite območje na zgornjem delu stegen ali na trebuhu (vsaj 5 centimetrov stran od popka).
95 % confidence intervals for the differences in change scores between methotrexate and adalimumab. 
95-% intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies 
* Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 ** Vključno pri podaljšanih študijah brez placeba
Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/pretisnem omotu/škatli poleg oznake "EXP".
• Remove needle from skin at the same angle you inserted it (45 degree angle). 
• Iglo odstranite iz kože pod enakim kotom, kot ste jo vstavili (45 stopinj).
Scarring may also occur in affected areas. 
Na prizadetih področjih se lahko pojavijo tudi
The requirements for submission of periodic safety update reports 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 rednega posodobljenega poročila o varnosti zdravila 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
CI 95 % for HR 
95-% IZ za RT
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. 
Zelo pomembno je, da obvestite zdravnika, če ste kadar koli imeli tuberkulozo ali ste bili v tesnem stiku s kom, ki jo je imel.
• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active HBV infection or if you think you might be at risk of contracting HBV. 
• Obvestite zdravnika, če ste nosilec virusa hepatitisa B (HBV), če imate aktivno okužbo s HBV ali če mislite, da bi se lahko nalezli HBV.
• The Summary of Product Characteristics • Guide for healthcare professionals 
• povzetek glavnih značilnosti zdravila • vodnik za zdravstvene delavce
Call your healthcare 
Pokličite zdravstveno osebje.
If you accidentally inject Cyltezo more frequently than you should, call your doctor or pharmacist and explain that you have taken more. 
Če pomotoma injicirate zdravilo Cyltezo pogosteje kot bi morali, se morate posvetovati z zdravnikom ali farmacevtom in mu razložiti, da ste uporabili večji odmerek.
• Certain vaccines contain weakened but live forms of bacteria or viruses that cause diseases, and should not be given while receiving Cyltezo because they may cause infections. 
• Določena cepiva vsebujejo oslabljene, a žive oblike bakterij ali virusov, ki povzročijo bolezni, zato se jih med zdravljenjem z zdravilom Cyltezo ne sme uporabljati, ker lahko povzročijo okužbo.
• Select a different site each time you inject at least 2.5 centimetres away from a previous site. 
• Vsakič izberite drugo mesto injiciranja vsaj 2,5 centimetra stran od predhodno uporabljenega
Read all of this leaflet carefully before you start using this medicine because it contains important 
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne
There is little experience from re-administration after more than 8 weeks since the previous dose. 
Izkušenj s ponovno uporabo po več kot 8 tednih od prejšnjega odmerka
• On rare occasions, treatment with Cyltezo could result in lupus-like syndrome. 
• V redkih primerih lahko zdravljenje z zdravilom Cyltezo povzroči lupusu podoben sindrom.
The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established. 
Varnost in učinkovitost adalimumaba pri otrocih, starih od 4 do 17 let, še nista bili dokazani.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. 
Ta redka oblika T-celičnega limfoma ima zelo agresiven potek bolezni in je običajno smrtna.
You will inject into this raised area of 
Injicirali boste v ta
An asterisk (*) appears in the SOC column if further information is found elsewhere in sections 4.3, 4.4 and 4.8. 
V stolpcu organski sistem se pojavi znak zvezdica (*), če so v zvezi s tem vključene dodatne informacije v poglavjih 4.3, 4.4 in 4.8.
Side effects may occur up to 4 months or more after the last Cyltezo injection. 
Neželeni učinki se lahko pojavijo vsaj še 4 mesece ali več po zadnji injekciji zdravila Cyltezo.
If you forget to give yourself an injection, you should inject the next dose of Cyltezo as soon as you remember. 
Če si pozabite dati injekcijo, si morate naslednji odmerek zdravila Cyltezo injicirati, čim se spomnite.
You and your doctor should pay special attention to signs of infection while you are being treated with Cyltezo. 
Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom Cyltezo.
Cyltezo can also be given alone. 
Zdravilo Cyltezo se lahko daje tudi samo.
It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”). 
Pomembno je, da obvestite zdravnika, če ste imeli ali imate kakšno resno bolezen srca (glejte "Opozorila in previdnostni ukrepi").
Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of 
Dovoljena je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ali imunomodulacijskih zdravil; 80 % bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil.
• If you are over 65 years you may be more susceptible to infections while taking Cyltezo. 
• Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Cyltezo.
The patient alert card shall contain the following key messages: 
Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
• Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of 
• Obvestite zdravnika, če ste imeli v preteklosti ponavljajoče se okužbe ali druge bolezni, ki povečujejo tveganje za okužbe.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC). 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C-8 °C).
No dose recommendations can be made. 
Priporočila odmerjanja niso možna.
• In some patients the body may fail to produce enough of the blood cells to fight off infections or help you to stop bleeding. 
• Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic za premagovanje okužbe ali zaustavljanje krvavitve.
The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic 
Napovedane izpostavljenosti nakazujejo, da lahko polnilni odmerek v odsotnosti metotreksata povzroči začetno povečanje sistemske izpostavljenosti.
• Gently squeeze skin around cleaned injection site and hold firmly. 
• Nežno uščipnite kožo okoli očiščenega mesta injiciranja in močno držite.
In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life 
V redkih primerih, zlasti če uporabljate druga zdravila, ki zavirajo imunski sistem, je reaktivacija okužbe s HBV lahko smrtno nevarna.
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for 
• Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Prior to launch of Cyltezo in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred začetkom trženja zdravila Cyltezo se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom v vsaki državi članici dogovoriti o vsebini in obliki izobraževalnega programa, vključno s komunikacijskimi mediji, načinom razdeljevanja in drugimi vidiki programa.
Adalimumab should only be used during pregnancy if clearly needed. 
Adalimumab se med nosečnostjo lahko uporablja samo, če je brez dvoma
The European Medicines Agency has deferred the obligation to submit the results of the studies with adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use. 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z adalimumabom za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom, za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
The conduct and results of these tests should be recorded on your patient alert card. 
Izvedbo in rezultate teh preiskav je treba zabeležiti na opozorilni kartici za bolnike.
The corresponding proportions of patients with no radiographic progression were 31.3 %, 23.7 % and 36.7 %, 
Ustrezni deleži bolnikov, ki niso imeli rentgenografskih znakov napredovanja, so bili 31,3 %, 23,7 % oz. 36,7 %.
Adalimumab has not been studied in these patient populations. 
Adalimumaba pri tej populaciji bolnikov niso preučili.
Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders. 
Bolniki, ki izpolnjujejo merila, določena v protokolu za izgubo odziva ali pri njih ni bilo izboljšanja, so bili izključeni iz študij in so se šteli kot bolniki brez odgovora (“nonresponders”).
The patients in HS-I and HS-II had Hurley Stage II or III disease with at least 3 abscesses or inflammatory nodules. 
Bolniki v študijah HS-I in HS-II imajo po Hurleyevi razvrstitvi bolezen v stadiju II ali III z vsaj tremi abscesi ali vnetnimi noduli.
• As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Cyltezo. 
• Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom Cyltezo preiskal glede znakov in simptomov tuberkuloze.
If you received Cyltezo while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy. 
Če prejemate zdravilo Cyltezo med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
Your doctor may recommend temporary discontinuation of 
Vaš zdravnik bo morda priporočil začasno prenehanje uporabe
Clear to slightly opalescent solution. 
Bistra do rahlo opalescentna raztopina.
• After proper training, the injection can be given by yourself or given by another person, for example, a 
• Ko ste bili ustrezno poučeni, si lahko zdravilo injicirate sami ali vam ga injicira druga oseba, na
The Guide for healthcare professionals shall contain the following key elements: 
Vodnik za zdravstvene delavce mora vsebovati naslednje ključne elemente:
The impact of long-term treatment with Cyltezo on the development of autoimmune diseases is unknown. 
Vpliv dolgoročnega zdravljenja z zdravilom Cyltezo na nastanek avtoimunskih bolezni ni znan.
If an alternate dose is required, other adalimumab products offering such an option should be used. 
Če je potreben drugačen odmerek, je potrebno uporabiti druga zdravila z adalimumabom, ki ponujajo to možnost.
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with 
Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in
Patients may first be given other disease-modifying medicines, such as methotrexate. 
Bolniki bodo morda najprej dobili druga imunomodulirajoča zdravila, npr. metotreksat.
• Only use each pre-filled syringe for one injection. 
• Vsako napolnjeno injekcijsko brizgo uporabite le za eno injiciranje.
Disease flare criteria were defined as a worsening of ≥ 30 % from baseline in ≥ 3 of 6 Paediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30 % in no more than 1 of the 6 criteria. 
Merila zagona bolezni so bila opredeljena kot poslabšanje ≥ 3 od 6 osnovnih meril Pediatric ACR za ≥ 30 % v primerjavi z izhodiščem, ≥ 2 aktivna sklepa in izboljšanje ne več kot 1 od 6 meril za > 30 %.
TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer. 
TNF-antagonisti, kot je adalimumab, prizadenejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti
Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption. 
Razpoložljivi podatki kažejo, da je adalimumab po ponovni uvedbi, ki je sledila prekinitvi za 70 dni ali več, dosegel enako velik klinični odziv in je imel podobne varnostne značilnosti kot pred
If you do not have all the supplies listed above, contact your pharmacist before proceeding. 
Če nimate vseh zgoraj naštetih pripomočkov, se pred nadaljevanjem obrnite na farmacevta.
There is a window on each side of the pen through which you can see the Cyltezo solution inside the syringe. 
Na vsaki strani peresnika je okence, skozi katerega vidite raztopino zdravila Cyltezo v brizgi.
You should not take Cyltezo with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. 
Zdravila Cyltezo ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept zaradi povečanega tveganja za resne okužbe.
It is important to tell your doctor if you have had or have a serious heart condition. 
Pomembno je, da obvestite zdravnika, če ste imeli ali imate kakšno resno bolezen srca.
Treatment with Cyltezo can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. 
Zdravljenje z zdravilom Cyltezo se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
You will inject into this raised area of • Before injecting, read steps 8 A-C to learn correct way to administer dose. 
Injicirali boste v ta • Pred injiciranjem preberite točke od A do C v 8. koraku, da boste spoznali pravilen način za
The decision to stop using Cyltezo should be discussed with your doctor. 
O odločitvi, da bi prenehali uporabljati zdravilo Cyltezo, se morate posvetovati z zdravnikom.
A. Prepare to administer dose 
A. Pripravite se na injiciranje odmerka
The potential risk with the combination of azathioprine or 6-mercaptopurine and Cyltezo should be carefully considered. 
Potrebno je upoštevati možno tveganje pri sočasni uporabi azatioprina ali 6-merkaptopurina in zdravila Cyltezo.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above. 
Tarča adalimumaba je beljakovina imenovana tumorje nekrotizirajoči faktor (TNFα), ki je pri zgoraj navedenih vnetnih boleznih prisotna v večji koncentraciji.
Before initiation of therapy with Cyltezo, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection. 
Pred začetkom zdravljenja z zdravilom Cyltezo je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN). 
Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, študiji pri Crohnovi bolezni I (CLASSIC I) in študiji pri Crohnovi bolezni II (GAIN).
• opportunistic infections (which include tuberculosis and other infections that occur when resistance to 
• oportunistične okužbe (vključujejo tuberkulozo in druge okužbe, ki se pojavijo ob slabši telesni
• Do not touch this area again before injecting. 
• Pred injiciranjem se tega mesta ne dotaknite znova.
After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks. 
Po odmerkih 0,5 mg/kg (~40 mg) je bil očistek od 11 do 15 ml/uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze približno dva tedna.
Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy. 
Od 417 bolnikov, ki so bili vključeni v nekontrolirani dolgoročni podaljšek študij UV I in UV II, je bilo 46 bolnikov neprimernih (npr. razvili so se sekundarni zapleti, ob diabetični retinopatiji zaradi kirurškega posega sive mrene ali vitrektomije) in so bili izključeni iz primarne analize učinkovitosti.
For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is 
Pri bolnikih, ki so pozitivni na okužbo s hepatitisom B, se priporoča posvetovanje z zdravnikom specialistom za zdravljenje okužb s hepatitisom B.