natgillin/translations-raw huggingface dataset:
Halimatoz can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease. 
Zdravilo Halimatoz lahko zmanjša število vozličev in ognojkov, ki jih imate.
Halimatoz therapy should not be continued in patients failing to respond within this time period. 
Pri bolnikih, ki se v tem času ne odzovejo, zdravljenja z zdravilom Halimatoz ni priporočljivo nadaljevati.
• You might get infections more easily while you are receiving Halimatoz treatment. 
• Med zdravljenjem z zdravilom Halimatoz se lahko poveča dovzetnost za okužbe.
Patients should be instructed to seek medical advice if signs / symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Halimatoz. 
Halimatoz ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje teže, nekoliko zvišano telesno temperaturo).
Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of Halimatoz is an initial dose of 40 mg, followed by 40 mg one week later. 
Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več Običajni odmerek zdravila Halimatoz je 40 mg vsak drugi teden z metotreksatom.
Room spinning sensation (vertigo) and vision disturbances may occur after taking Halimatoz. 
Po dajanju zdravila Halimatoz se lahko pojavita vrtoglavica (občutek vrtenja prostora) in poslabšanje vida.
Treatment with Halimatoz must be discontinued in patients who develop new or worsening symptoms of congestive heart failure. 
Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje z zdravilom Halimatoz prekiniti.
Children and adolescents from 6 to 17 years of age weighing 40 kg or more 
Otroci in mladostniki z luskavico v plakih Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo 30 kg ali več
The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later. 
Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg (kot dve 40 mg injekciji v enem dnevu) na začetku, čemur sledi 40 mg vsak drugi teden dva tedna kasneje.
Halimatoz 40 mg solution for injection in pre-filled syringe: 
Halimatoz 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
(see also section 5.1.) 
(Glejte tudi poglavje 5.1.)
Long-term safety evaluations are ongoing. 
Dolgoročno vrednotenje varnosti še poteka.
Date of first authorisation: 22 May 2014 Date of latest renewal: 12 December 2018 
Datum prve odobritve: 22. maj 2014 Datum zadnjega podaljšanja: 12. december 2018
The reasons for this are not fully known and are possibly related to the mechanism of action. 
Razlogi za to niso povsem pojasnjeni, lahko pa bi bili povezani z mehanizmom delovanja.
There is insufficient information on what effect this may have on your baby. 
Ni dovolj podatkov o tem, kako to vpliva na vašega otroka.
The Physican's Educational Material should contain the following key messages: 
Izobraževalno gradivo za zdravnike mora vsebovati naslednja ključna sporočila:
• if you are going to receive any vaccination or have recently had a vaccination. 
• če boste prejeli katero koli cepivo ali ste pred kratkim bili cepljeni.
Entyvio is not recommended for use in children or adolescents (under 18 years of age) due to the lack of information regarding the use of this medicine in this age group. 
Uporaba zdravila Entyvio pri otrocih in mladostnikih (mlajših od 18 let) ni priporočljiva zaradi pomanjkanja podatkov o uporabi tega zdravila pri tej starostni skupini.
If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution. 
Če se vsebina po 20 minutah popolnoma ne raztopi, počakajte še nadaljnjih 10 minut.
• if you have cancer, tell your doctor. 
• če imate raka, o tem obvestite svojega zdravnika.
Gently swirl the vial for at least 15 seconds. 
Vialo vsaj 15 sekund nežno vrtite.
Reconstituted and diluted solutions: Use immediately. 
Rekonstituirana in razredčene raztopine: uporabite takoj.
Every 8 weeks 
Vsakih 8 tednov
Exploratory analyses provide additional data on key subpopulations studied. 
Eksplorativne analize so dale dodatne podatke o ključnih preiskanih podpopulacijah.
Some infections may become serious and possibly even life-threatening if left untreated. 
Nekatere okužbe lahko postanejo resne in lahko celo ogrozijo življenje, če se jih ne zdravi.
If you feel dizzy, do not drive or use tools or machines. 
Če ste omotični, ne smete upravljati vozil, orodji ali strojev.
• Your doctor will also give you a Patient Alert Card for you to keep with you at all times. 
• Zdravnik vam bo dal tudi opozorilno kartico, ki jo imejte ves čas pri sebi.
• if you are allergic to vedolizumab or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na vedolizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
What Entyvio is and what it is used for 
Kaj je zdravilo Entyvio in za kaj ga uporabljamo
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke !
Administration of the influenza vaccine should be by injection in line with routine clinical practice. 
Cepiva proti gripi je treba injicirati v skladu z rutinsko klinično prakso.
If you have Crohn's disease you will first be given other medicines. 
Če imate Crohnovo bolezen, se boste najprej zdravili z drugimi zdravili.
Live and oral vaccines 
Živa in peroralna cepiva
The exact elimination route of vedolizumab is not known. 
Natančna pot izločanja vedolizumaba ni znana.
Timing of treatment (infusion) 
Čas zdravljenja (infuzije)
These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). 
Vse to so lahko simptomi resne in potencialno smrtne možganske bolezni, imenovane progresivna multifokalna levkoencefalopatija (PML).
The safety and efficacy of vedolizumab in children aged 0 to 17 years old have not been established. 
Pediatrična populacija Varnost in učinkovitost vedolizumaba pri otrocih, starih od 0 do 17 let, nista bili dokazani.
Most infusion related reactions occurred within the first 2 hours. 
Večina reakcij, povezanih z infundiranjem, se je pojavila v prvih 2 urah.
For more detailed information, see infusion and allergic reactions in section 4. 
Za podrobnejše informacije glejte infuzijske in alergijske reakcije v poglavju 4.
The treatment interruption period in clinical trials extended up to one year. 
V kliničnih preskušanjih so obdobja prekinitve zdravljenja trajala do enega leta.
Tell your doctor or nurse immediately when you first receive this medicine, during treatment, and between doses: 
Nemudoma obvestite zdravnika ali medicinsko sestro; preden boste prvič prejeli to zdravilo, med zdravljenjem ali med posameznimi odmerki:
• night sweats 
• nočno znojenje,
What you need to know before you are given Entyvio 
Kaj morate vedeti, preden boste prejeli zdravilo Entyvio
¶Durable clinical remission: Clinical remission at ≥ 80% of study visits including final visit (week 52) 
¶ Trajna klinična remisija: klinična remisija pri ≥ 80 % študijskih obiskov, vključno s finalnim obiskom
• Consider the patient's full medical history, including any prior or concurrent biological medicine use 
• Skrbno je treba preučiti celotno anamnezo bolnika, vključno s kakršno koli predhodno ali sočasno uporabo bioloških zdravil.
These could occur during or after the infusion. 
Ti znaki se lahko pojavijo med ali po infundiranju zdravila.
If you have ulcerative colitis, you will first be given other medicines. 
Če imate ulcerozni kolitis, se boste najprej zdravili z drugimi zdravili.
Other live vaccines may be administered concurrently with vedolizumab only if the benefits clearly outweigh the risks. 
Druga živa cepiva se sočasno z vedolizumabom lahko uporablja le, če koristi cepljenja jasno prevladajo nad tveganji.
You must not be given Entyvio: 
Zdravila Entyvio ne smete prejeti:
Over time, there was no significant increase in the rate of serious infections. 
Delež resnih okužb se s časom ni pomembneje povečal.
Do not vigorously shake or invert. 
Viale ne smete močno stresati ali obračati.
*p < 0.0001 †p ≤ 0.001 ‡p < 0.05 
† p < 0,001 ‡ p < 0,05
Among these patients, 
Bolniki,
Do not hold1 
Ne shranjujte1
Efficacy Results for GEMINI II at week 52 Placebo n = 153* 
Rezultati učinkovitosti v 52. tednu v študiji GEMINI II Placebo n = 153*
Overall, results from the clinical program to date do not suggest an increased risk for malignancy with vedolizumab treatment; however, the number of malignancies was small and long-term exposure was limited. 
Na splošno rezultati kliničnega programa vrednotenja zdravljenja z vedolizumabom do danes ne kažejo na povečano tveganje za razvoj malignih obolenj, vendar pa je bilo število malignih obolenj majhno, dolgotrajna izpostavljenost pa omejena.
Based on plausible mechanism and available number of spontaneous reports of herpes zoster, the PRAC concluded that the product information should be updated with herpes zoster as a new adverse drug reaction with frequency uncommon. 
Na osnovi verjetnega mehanizma in razpoložljivega števila spontanih poročil o herpesu zostru je odbor PRAC sklenil, da je treba podatke o zdravilu posodobiti s herpesom zostrom kot novo neželeno reakcijo na zdravilo z občasno pogostnostjo.
No individual Preferred Term reported as an IRR occurred at a rate above 1%. 
Noben posamezen prednostni izraz, naveden kot reakcija, povezana z infundiranjem, ni bil pogostejši od 1 %.
2 weeks after Treatment 1 
2 tedna po prvem zdravljenju
• wheezing or difficulty breathing 
• sopenje ali težko dihanje,
Population pharmacokinetic analyses indicate that the distribution volume of vedolizumab is approximately 5 litres. 
Analize populacijske farmakokinetike kažejo, da je volumen porazdelitve vedolizumaba približno 5 litrov.
Most infusion related reactions were not serious and occurred during the infusion or within the first hour after infusion is completed. 
Večina reakcij, povezanih z infundiranjem, ni bila resnih, pojavile pa so se med infundiranjem ali v prvi uri po koncu infundiranja.
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Entyvio are provided with a physician pack containing the following: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo pred prihodom zdravila na trg vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Entyvio, prejeli paket izobraževalnih gradiv, ki vsebuje naslednje:
• moderately to severely active Crohn's disease. 
• zmerno do močno aktivne Crohnove bolezni.
Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for vedolizumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vedolizumab is unchanged subject to the proposed changes to the product information. 
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za vedolizumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) učinkovino vedolizumab nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Serum CRP change from baseline to week 6, median (mcg/mL) Overall‡ 
Sprememba serumskega CRP od izhodišča do 6. tedna, mediana vrednost (μg/ml) Celokupno‡
Solution should be clear or opalescent, colourless to light yellow and free of visible particulates. 
Rekonstituirana raztopina mora biti bistra ali opalescentna, brezbarvna do svetlo rumena in brez vidnih trdnih delcev.
Before starting treatment with vedolizumab, patients must be screened for tuberculosis according to the local practice. 
Pred uvedbo zdravljenja z vedolizumabom je treba bolnike pregledati na tuberkulozo v skladu z lokalno prakso.
The formation of anti-vedolizumab antibodies is associated with increased clearance of vedolizumab and lower rates of clinical remission. 
Nastanek protiteles proti vedolizumabu je povezan s povečanim očistkom vedolizumaba in nižjimi stopnjami klinične remisije.
Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs). 
Vedolizumab spada v skupino bioloških zdravil, imenovanih monoklonska protitelesa (mAb).
6 weeks after Treatment 1 
6 tednov po prvem zdravljenju
• moderately to severely active ulcerative colitis 
• zmerno do močno aktivnega ulceroznega kolitisa.
Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML) (see section 4.4). 
Hude aktivne okužbe, kot so tuberkuloza (TB), sepsa, okužba s citomegalovirusom in listerioza, ter oportunistične okužbe, kot je progresivna multifokalna levkoencefalopatija (PML) (glejte poglavje 4.4).
This leaflet is available in formats suitable for the blind or partially sighted patient and can be requested from respective local representative of the Marketing Authorisation Holder. 
To navodilo za uporabo je na voljo tudi v oblikah, primernih za slepe ali slabovidne, ki jih lahko pridobite pri lokalnem predstavništvu imetnika dovoljenja za promet z zdravilom.
Reconstituted solution in the vial 
rekonstituirana raztopina v viali
Long-term animal studies with vedolizumab to assess its carcinogenic potential have not been conducted because pharmacologically responsive models to monoclonal antibodies do not exist. 
Dolgoročne študije na živalih, ki bi ovrednotile kancerogeni potencial vedolizumaba, niso bile izvedene, saj farmakološko odzivni modeli za monoklonska protitelesa ne obstajajo.
If you have previously taken natalizumab (a medicine used to treat multiple sclerosis) or rituximab (a medicine used to treat certain types of cancer and rheumatoid arthritis), tell your doctor, who will decide if you can be given Entyvio. 
Če ste se predhodno zdravili z natalizumabom (zdravilo za zdravljenje multiple skleroze) ali rituksimabom (zdravilo za zdravljenje nekaterih vrst raka in revmatoidnega artritisa), o tem obvestite svojega zdravnika.
Pharmacotherapeutic group: immunosuppressants, selective immunosuppressants, ATC code: L04AA33 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA33
If you do not respond well enough or are intolerant to these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease. 
Če odziv na zdravljenje s temi zdravili ni bil zadosten ali ga niste prenašali, lahko zdravnik za zmanjšanje znakov in simptomov bolezni uvede zdravljenje z zdravilom Entyvio.
Physicians should be aware of the potential increased risk of opportunistic infections or infections for which the gut is a defensive barrier (see section 4.8). 
Zdravniki se morajo zavedati možnega večjega tveganja za pojav oportunističnih okužb ali okužb za katere črevo predstavlja obrambno pregrado (glejte poglavje 4.8).
Although no systemic immunosuppressive effect was noted in healthy subjects the effects on systemic immune system function in patients with inflammatory bowel disease is not known. 
Pri zdravih osebah sistemskega zaviranja imunske odzivnosti sicer niso opazili, vendar pa sistemski vplivi na delovanje imunskega sistema pri bolnikih z vnetno črevesno boleznijo niso znani.
Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to Entyvio 300 mg every four weeks. 
Nekaterim bolnikom, katerim se odziv na zdravljenje zmanjša, morda lahko koristi povečanje pogostnosti odmerjanja zdravila Entyvio v odmerku 300 mg na vsake štiri tedne.
The use of vedolizumab in lactating women should take into account the benefit of therapy to the mother and potential risks to the infant. 
Pri uporabi vedolizumaba pri doječih materah je treba pretehtati prednosti zdravljenja za mater in možnih tveganj za dojenčka.
• if you have an active severe infection, for example, tuberculosis, blood poisoning, severe gastroenteritis, nervous system infection. 
• če imate hudo aktivno okužbo, na primer tuberkulozo, zastrupitev krvi, hudo vnetje želodca in črevesa (gastroenteritis) ali okužbo živčevja.
If PML is suspected, treatment with vedolizumab must be withheld; if confirmed, treatment must be permanently discontinued. 
V primeru suma na PML je treba zdravljenje z vedolizumabom zadržati, če pa se sum potrdi, je treba zdravljenje trajno ukiniti.
Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus. 
Uporaba nekaterih integrinskih zaviralcev in nekaterih zdravil za sistemsko zaviranje imunske odzivnosti je bila povezana s pojavom progresivne multifokalne levkoencefalopatije (PML), redke in pogosto usodne oportunistične okužbe, ki jo povzroča JC virus (John Cunninghamov virus).
• blurred vision (loss of sharpness of eyesight) 
• zamegljen vid (izguba ostrine vida),
The impact on other oral and nasal vaccines is unknown. 
Vpliv na druga cepiva za peroralno ali nazalno uporabo ni znan.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 300 mg
You should use adequate contraception during treatment and for at least 4.5 months after the last treatment. 
Ženske v rodni dobi morajo med zdravljenjem in še najmanj 4,5 meseca po prejemu zadnjega odmerka zdravila
Entyvio should not be given with other biologic medicines that suppress your immune system as the effect of this is not known. 
Zdravila Entyvio se ne sme uporabljati skupaj z drugimi biološkimi zdravili, ki zavirajo imunski sistem, saj učinek tega ni znan.
Instructions for reconstitution and infusion 
Navodila za rekonstitucijo in infundiranje
If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis treatment in accordance with local recommendations, before beginning vedolizumab. 
Če se ugotovi latentno tuberkulozo, je pred uvedbo zdravljenja z vedolizumabom treba začeti ustrezno protituberkulozno zdravljenje v skladu z lokalnimi priporočili.
In this open-label extension study, the benefits of vedolizumab treatment as assessed by partial Mayo score, clinical remission, and clinical response were shown for up to 196 weeks. 
V tej odprti podaljšani študiji, so se koristi zdravljenja z vedolizumabom, ovrednotene z delno oceno Mayo, s klinično remisijo in kliničnim odzivom ohranile do 196 tednov.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Entyvio therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Entyvio, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
• Patients treated with Entyvio should be monitored for any new onset or worsening of neurological signs and symptoms such as those listed below: o Progressive weakness on one side of the body or clumsiness of limbs o Disturbance of vision o Changes in thinking, memory, and orientation, leading to confusion and personality changes 
• Bolnike, ki se zdravijo z zdravilom Entyvio, je treba spremljati glede pojava kakršnih koli novih ali poslabšanja že prisotnih nevroloških znakov in simptomov, kot so: o progresivna oslabelost ene strani telesa ali okornost udov, o motnje vida, o spremembe v mišljenju, spominu in orientaciji, ki vodijo do zmedenosti in osebnostnih sprememb.
Vedolizumab blocks a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis and Crohn's disease, and so the amount of inflammation is reduced. 
Vedolizumab blokira beljakovino na površini belih krvnih celic, ki povzročajo vnetje pri ulceroznem kolitisu in Crohnovi bolezni, in posledično zmanjša vnetje.
In patients who have responded to treatment with Entyvio, corticosteroids may be reduced and/or discontinued in accordance with standard of care. 
Pri bolnikih, ki se odzovejo na zdravljenje z zdravilom Entyvio, se odmerek kortikosteroida morda lahko zmanjša in/ali zdravljenje s kortikosteroidi ukine v skladu s standardnimi smernicami.
Live vaccines, in particular live oral vaccines, should be used with caution concurrently with Entyvio (see section 4.4). 
Živa cepiva, še posebej živa cepiva za peroralno uporabo, je pri sočasni uporabi z zdravilom Entyvio treba uporabljati previdno (glejte poglavje 4.4).
• The infusion will be given to you, by your doctor or nurse, through a drip in one of the veins in your arm (intravenous infusion) over about 30 minutes. 
• Infuzijo zdravila vam bo dal zdravnik ali medicinska sestra v obliki 30-minutne kapljične infuzije v eno od ven na roki (intravenska infuzija).
Patients should be monitored during and after infusion (see section 4.4). 
Bolnike je treba nadzirati tako med infundiranjem kot po njem (glejte poglavje 4.4).
The patient is to be given a Patient Alert Card (see section 4.2). 
Vsak bolnik mora prejeti opozorilno kartico (glejte poglavje 4.2).
Vedolizumab does not bind to, nor inhibit function of, the α4β1 and αEβ7 integrins. 
Vedolizumab se ne veže na integrina α4β1 in αEβ7 in ne zavira njunih funkcij.
Patients should be monitored closely for infections before, during and after treatment. 
Bolnike je treba pred uvedbo zdravljenja, med zdravljenjem in po zdravljenju skrbno nadzirati glede okužb.
The GEMINI II Study was a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52. 
Študija GEMINI II je bila randomizirana, dvojno slepa, s placebom nadzorovana študija, ki je vrednotila opazovane dogodke učinkovitosti v 6. tednu in 52. tednu.
If therapy is interrupted and there is a need to restart treatment with Entyvio, dosing at every four weeks may be considered (see section 5.1). 
Če je bilo zdravljenje z zdravilom Entyvio prekinjeno in ga je treba znova uvesti, se lahko razmisli o odmerjanju na vsake štiri tedne (glejte poglavje 5.1).
Antibodies to vedolizumab may develop during vedolizumab treatment most of which are neutralising. 
Pri zdravljenju z vedolizumabom se lahko razvijejo protitelesa proti vedolizumabu, ki so večinoma nevtralizacijska.
There was no clinically meaningful difference in clinical remission between treatment groups at these time points. 
V teh časovnih točkah se klinična remisija med zdravljenimi skupinami klinično ni pomembneje razlikovala.
Entyvio passes into breast milk. 
Zdravilo Entyvio prehaja v materino mleko.
Induction of remission in Crohn's disease 
Indukcija remisije Crohnove bolezni
Administer the infusion solution over 30 minutes (see section 4.2). 
Raztopino za infundiranje aplicirajte v obliki 30 minutne intravenske infuzije (glejte poglavje 4.2).
Administration of vedolizumab to pregnant cynomolgus monkeys during most of gestation resulted in no evidence of effects on teratogenicity, prenatal or postnatal development in infants up to 6 months of age. 
Pri dajanju vedolizumaba brejim opicam Cynomolgus med večino obdobja gestacije niso odkrili dokazov o teratogenih učinkih ali vplivov na prenatalni ali postnatalni razvoj mladičev do 6. meseca starosti.
All patients should be observed continuously during each infusion. 
Med vsakim infundiranjem zdravila je treba vse bolnike neprekinjeno nadzirati.
Other medicines and Entyvio Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
24 hours2, 3 
24 ur2,3