FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the user Benepali 50 mg solution for injection in pre-filled pen etanercept This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Benepali 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku etanercept Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Benepali is available in packs containing 4 pre-filled syringes and multipacks comprising 3 cartons, each containing 4 pre-filled syringes.
Slovenian: Zdravilo Benepali je na voljo v pakiranjih, ki vsebujejo 4 napolnjene injekcijske brizge, in v večodmernih pakiranjih, ki vsebuje 3 škatle, od katerih vsaka vsebuje po 4 napolnjene injekcijske brizge.
English: ● If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss,
Slovenian: ● Če se razvijejo simptomi, ki kažejo na okužbo, kot so zvišana telesna temperatura, trdovraten kašelj, izguba telesne mase ali ravnodušnost, takoj poiščite zdravniško pomoč.
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: Each pre-filled syringe contains 50 mg of etanercept.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 50 mg etanercepta.
English: • Uncommon (may affect up to 1 in 100 people):
Slovenian: • Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: Inspect the solution: Look at the medicine in the pre-filled syringe.
Slovenian: Zdravilo v napolnjeni injekcijski brizgi preglejte.
English: The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature.
Slovenian: Med čakanjem, da se napolnjen injekcijski peresnik segreje na sobno temperaturo, pokrovčka igle ne smemo odstraniti.
English: The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.
Slovenian: Priporočeni odmerek je 25 mg dvakrat na teden ali 50 mg etanercepta enkrat na teden.
English: 25 mg/0.5 ml
Slovenian: 50 mg 2x/
English: • Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with
Slovenian: • Hepatitis B: Če ste vi ali vaš otrok kdaj imeli hepatitis B, o tem obvestite svojega zdravnika.
English: 25 mg etanercept administered twice weekly is the recommended dose.
Slovenian: Priporočeni odmerek je 25 mg etanercepta dvakrat na teden.
English: Plaque psoriasis The usual dose is 25 mg twice a week or 50 mg once a week.
Slovenian: Običajni odmerek je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study.
Slovenian: Odrasli bolniki z revmatoidnim artritisom Učinkovitost etanercepta je bila ugotovljena v randomizirani, dvojno slepi klinični študiji, nadzorovani s placebom.
English: Always use this medicine exactly as your doctor has told you.
Slovenian: Kako uporabljati zdravilo Benepali Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
English: Increased etanercept concentrations were not observed in patients with acute hepatic failure.
Slovenian: Okvara jeter Pri bolnikih z akutno odpovedjo jeter niso opazili povečanih koncentracij etanercepta.
English: Etanercept did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUCbased serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Slovenian: Tudi pri opicah cynomolgus, ki so subkutano prejemale odmerek 15 mg/kg 2-krat tedensko 4 ali 26 tednov zapored, etanercept ni povzročil toksičnosti, ki bi omejevala višino odmerka, niti toksičnosti za tarčne organe.
English: Check with your healthcare provider for instructions on how to properly dispose a filled sharps container.
Slovenian: Glede navodil o pravilnem odstranjevanju polnega vsebnika za ostre odpadke se posvetujte z zdravstvenim delavcem.
English: Posology and administration are the same as for adults 18-64 years of age.
Slovenian: Starostniki Prilagajanje odmerka ni potrebno; odmerjanje in način uporabe sta enaka kot pri odraslih, starih od 18
English: • Do not twist or bend the needle cover while removing it,
Slovenian: • Da ne bi poškodovali igle, ne upogibajte pokrovčka med odstranjevanjem.
English: Benepali 25 mg solution for injection in pre-filled syringe etanercept
Slovenian: Benepali 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept
English: Benepali 50 mg solution for injection in pre-filled syringe etanercept
Slovenian: Benepali 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku etanercept
English: How to store Benepali
Slovenian: Shranjevanje zdravila Benepali
English: Live vaccines should not be given concurrently with Benepali.
Slovenian: Med zdravljenjem z zdravilom Benepali bolnik ne sme prejeti živih cepiv.
English: Front
Slovenian: Izhodišče
English: • Common (may affect up to 1 in 10 people):
Slovenian: • Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: Plaque psoriasis The usual dose is 50 mg once a week.
Slovenian: Običajni odmerek je 50 mg enkrat na teden.
English: • Benepali is not for use in children and adolescents who weigh less than 62.5 kg.
Slovenian: Zdravilo Benepali ni namenjeno za uporabo pri otrocih in mladostnikih s telesno maso manj kot 62,5 kg.
English: The solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein.
Slovenian: Raztopina mora biti bistra do rahlo opalescentna, brezbarvna ali bledorumena ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
English: 4 pre-filled pens
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: • Do not use the pre-filled syringe past the expiration date.
Slovenian: • Po izteku roka uporabnosti ne uporabljajte napolnjenega injekcijskega peresnika.
English: Posology
Slovenian: Avtoprotitelesa
English: The solution should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein.
Slovenian: Raztopina mora biti bistra do rahlo opalescentna, brezbarvna ali bledorumena ter lahko vsebuje majhne bele ali skoraj prosojne delce beljakovine.
English: Use in adult patients (aged 18 years or over)
Slovenian: Pediatrična psoriaza v plakih (starost 6 let in več)
English: • Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Benepali.
Slovenian: Preden se boste vi ali vaš otrok začeli zdraviti z zdravilom Benepali, mora zdravnik opraviti test prisotnosti okužbe s hepatitisom B. Pri bolnikih, ki so kdaj že bili okuženi z virusom hepatitisa B, lahko zdravljenje z zdravilom Benepali povzroči ponoven zagon hepatitisa B. V takšnem primeru morate zdravilo Benepali prenehati uporabljati.
English: Biogen Netherlands B.V. Tel: + 31 (0)20 808 02 70
Slovenian: Tel: + 31 (0)20 808 02 70
English: Talk to your doctor before taking Benepali.
Slovenian: Pred začetkom uporabe zdravila Benepali se posvetujte z zdravnikom.
English: Marketing Authorisation Holder
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: n = 166 n =
Slovenian: (n = 106)
English: tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon); opportunistic infections (infections that occur because of a weakened immune system); lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes).
Slovenian: Resne alergijske reakcije (vključno s hudim lokaliziranim otekanjem kože in piskajočim dihanjem); limfom (vrsta krvnega raka); levkemija (rak, ki prizadene kri in kostni mozeg); melanom (vrsta kožnega raka); kombinacija znižanja števila trombocitov in rdečih ter belih krvnih celic; motnje živčevja (s hudo mišično oslabelostjo ter z znaki in s simptomi, podobnimi multipli sklerozi ali vnetje očesnih živcev ali hrbtenjače); tuberkuloza; nastanek kongestivnega srčnega popuščanja; epileptični napadi; lupus ali lupusu podoben sindrom (med simptomi so lahko trdovraten izpuščaj, vročina, bolečine v sklepih in utrujenost); kožni izpuščaj, ki lahko povzroči močno mehurjenje in luščenje kože; vnetje jeter, ki je posledica delovanja imunskega sistema proti tkivu lastnega telesa (avtoimunski hepatitis; pri bolnikih, ki sočasno prejemajo metotreksat, je občasen); imunska bolezen, ki lahko prizadene pljuča, kožo in bezgavke (sarkoidoza); vnetje ali brazgotinjenje pljuč (pri bolnikih, ki sočasno prejemajo metotreksat, je vnetje ali brazgotinjenje pljuč občasno); oportunistične okužbe (okužbe, ki se lahko pojavijo zaradi oslabljenega imunskega sistema); Lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah).
English: Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Slovenian: Primarno merilo učinkovitosti (ASAS 20) je bilo ≥ 20 % izboljšanje pri vsaj 3 od 4 domen lestvice Ocenjevanje pri ankilozirajočem spondilitisu (ASAS - Assessment in Ankylosing Spondylitis) (bolnikova splošna ocena, bolečina v hrbtenici, BASFI in vnetje) ter odsotnost poslabšanja pri četrti domeni.
English: Benepali 50 mg solution for injection in pre-filled syringe.
Slovenian: Benepali 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi:
English: Genesis Pharma (Cyprus) Ltd
Slovenian: Genesis Pharma (Cyprus) Ltd Τηλ: + 357 22 00 04 93
English: 25 mg BIW 50 mg BIW
Slovenian: 25 mg 2x/teden 50 mg 2x/teden
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 12 (3 PACKS OF 4 PRE-FILLED PENS) (WITH BLUE BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI VEČODMERNO PAKIRANJE Z 12 (3 PAKIRANJA S PO 4 NAPOLNJENIMI
English: This summary was last updated in 04-2010.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2010.
English: The marketing authorisation is valid for five years, after which it can be renewed.
Slovenian: Dovoljenje za promet je veljavno pet let, nato pa ga je mogoče podaljšati.
English: Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.
Slovenian: Bolniki, starejši od 65 let, in bolniki, ki imajo težave z jetri ali ledvicami, bodo morda potrebovali nižji začetni odmerek, in sicer 5 mg na dan.
English: It is available as white, round film-coated tablets (2.5, 5, 7.5 and 10 mg) and yellow, round orodispersible tablets (5, 10, 15 and 20 mg).
Slovenian: Na voljo je v obliki belih, okroglih filmsko obloženih tablet (2,5, 5, 7,5 in 10 mg) ter rumenih, okroglih orodisperzibilnih tablet (5, 10, 15 in 20 mg).
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Slovenian: Spada med „atipične“ antipsihotike, ker se razlikuje od starejših antipsihotikov, ki so na voljo že od petdesetih let prejšnjega stoletja.
English: Orodispersible tablets are tablets that dissolve in the mouth.
Slovenian: Orodisperzibilne tablete so tablete, ki se raztopijo v ustih.
English: Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
Slovenian: Natančen mehanizem delovanja zdravila ni znan, vendar pa se zdravilo veže z več različnimi vrstami receptorjev na površini živčnih celic v možganih.
English: The recommended starting dose of Olanzapine Apotex depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Slovenian: Priporočeni začetni odmerek zdravila Olanzapine Apotex je odvisen od bolezni, ki jo zdravimo: odmerek 10 mg na dan se uporablja pri shizofreniji in za preprečevanje maničnih epizod, odmerek 15 mg na dan pa se uporablja pri zdravljenju maničnih epizod, razen ob souporabi drugih zdravil, ko lahko začetni odmerek znaša 10 mg na dan.
English: The dose is adjusted according to how well the patient responds to and tolerates the treatment.
Slovenian: Zdravnik prilagaja odmerek glede na to, kako se bolnik odziva na zdravljenje in kako ga prenaša.
English: Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Slovenian: Zdravila so biološko enakovredna, kadar dosegajo enake ravni zdravilne učinkovine v telesu.
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Slovenian: To je duševna bolezen s številnimi simptomi, ki vključujejo neorganizirano mišljenje in govor, halucinacije (bolnik vidi in sliši stvari, ki jih ni), sumničavost ter blodnje (zmotna prepričanja).
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment.
Slovenian: Zdravilo se lahko uporablja tudi za preprečevanje ponovnega pojava simptomov teh epizod pri odraslih z bipolarno motnjo (duševno boleznijo, pri kateri se izmenjujejo obdobja privzdignjenega razpoloženja in depresije), ki so se odzvali na začetno zdravljenje.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Slovenian: Domneva se, da so koristni učinki olanzapina posledica blokiranja receptorjev za živčna prenašalca 5-hidroksitriptamin (imenovanim tudi serotonin) in dopamin.
English: For more information about treatment with Olanzapine Apotex, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Olanzapine Apotex preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Slovenian: Ker ta dva živčna prenašalca običajno sodelujeta pri shizofreniji in bipolarni motnji, olanzapin pomaga uravnati delovanje možganov in tako zmanjša simptome teh bolezni.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Slovenian: S tem se prekine prenos signalov med možganskimi celicami prek živčnih prenašalcev - kemičnih snovi, ki omogočajo komunikacijo med celicami.
English: Olanzapine Apotex is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Slovenian: Zdravilo Olanzapine Apotex je prav tako učinkovito za vzdrževanje izboljšanja stanja pri bolnikih, ki so se odzvali na začetno zdravljenje.
English: Olanzapine Apotex olanzapine
Slovenian: Olanzapine Apotex olanzapin
English: This means that Olanzapine Apotex is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Slovenian: To pomeni, da je podobno „referenčnima zdraviloma“, ki sta že odobreni v Evropski uniji (EU), in sicer zdraviloma Zyprexa in Zyprexa Velotab.
English: This document is a summary of the European Public Assessment Report (EPAR) for Olanzapine Apotex.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Olanzapine Apotex.
English: The full EPARs for the reference medicines can also be found on the Agency's website.
Slovenian: Celotni evropski javni poročili o oceni zdravila (EPAR) za referenčni zdravili sta na voljo na spletni strani agencije.
English: Olanzapine Apotex is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Slovenian: Zdravilo Olanzapine Apotex se uporablja tudi za zdravljenje zmernih do težkih maničnih epizod (izjemno privzdignjeno razpoloženje) pri odraslih.
English: Because Olanzapine Apotex is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicines.
Slovenian: Ker je zdravilo Olanzapine Apotex generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnima zdraviloma.
English: Because Olanzapine Apotex is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as the reference medicines'.
Slovenian: Ker je zdravilo Olanzapine Apotex generično zdravilo in je biološko enakovredno referenčnima zdraviloma, so koristi in tveganja enaki kot pri referenčnima zdraviloma.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Olanzapine Apotex.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Olanzapine Apotex, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Therefore, the CHMP's view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Slovenian: CHMP je zato mnenja, da so koristi, tako kot pri zdravilih Zyprexa in Zyprexa Velotab, večje od z njim povezanih tveganj.
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Apotex has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Olanzapine Apotex primerljivo raven kakovosti kot zdravili Zxprexa in Zyprexa Velotab ter da jima je biološko enakovredno.
English: Other information about Olanzapine Apotex:
Slovenian: Druge informacije o zdravilu Olanzapine Apotex:
English: The Committee recommended that Olanzapine Apotex be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Olanzapine Apotex odobri dovoljenje za promet.
English: The active substance in Olanzapine Apotex, olanzapine, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina zdravila Olanzapine Apotex, olanzapin, je antipsihotično zdravilo.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Apotex to Apotex Europe B.V. on 10 June 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Olanzapine Apotex, veljavno po vsej Evropski uniji, odobrila družbi Apotex Europe B.V.
English: What are the benefit and risk of Olanzapine Apotex?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Olanzapine Apotex?
English: The orodispersible tablets are taken by being placed on the tongue, where they disintegrate in the saliva, or by mixing them in water before swallowing.
Slovenian: Razpon odmerkov je običajno od 5 do 20 mg na dan. Orodisperzibilne tablete se zaužije tako, da se položijo na jezik, kjer jih slina raztopi, ali tako, da se pred zaužitjem zmešajo z vodo.
English: Olanzapine Apotex is a ‘generic medicine'.
Slovenian: Zdravilo Olanzapine Apotex je „generično zdravilo“.
English: Olanzapine Apotex is a medicine containing the active substance olanzapine.
Slovenian: Olanzapine Apotex je zdravilo, ki vsebuje zdravilno učinkovino olanzapin.
English: Olanzapine Apotex is used to treat adults with schizophrenia.
Slovenian: Zdravilo Olanzapine Apotex se uporablja za zdravljenje shizofrenije.
English: Why has Olanzapine Apotex been approved?
Slovenian: Zakaj je bilo zdravilo Olanzapine Apotex odobreno?
English: The full EPAR for Olanzapine Apotex can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Olanzapine Apotex je na voljo tukaj.
English: What is Olanzapine Apotex?
Slovenian: Kaj je zdravilo Olanzapine Apotex?
English: How has Olanzapine Apotex been studied?
Slovenian: Kako je bilo zdravilo Olanzapine Apotex raziskano?
English: What is Olanzapine Apotex used for?
Slovenian: Za kaj se zdravilo Olanzapine Apotex uporablja?
English: How does Olanzapine Apotex work?
Slovenian: Kako zdravilo Olanzapine Apotex deluje?
English: How is Olanzapine Apotex used?
Slovenian: Kako se zdravilo Olanzapine Apotex uporablja?
English: United Kingdom Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
Slovenian: Velika Britanija Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, Velika Britanija
English: Annex I List of medicinal products and presentations
Slovenian: Priloga I Seznam zdravil in njihovi farmacevtskih oblik ter jakosti
English: These occur in more than 1 in 10 people.
Slovenian: Ti učinki so se pojavili pri več kot 1 osebi od 10.
English: Ocrevus is used in two types of patients:
Slovenian: Zdravilo Ocrevus se uporablja pri dveh vrstah bolnikov:
English: The first two infusions are given two weeks apart and subsequent infusions are given every six months.
Slovenian: Prvi dve infuziji je treba dati v razmiku dveh tednov, nadaljnje infuzije pa vsakih šest mesecev.
English: What measures are being taken to ensure the safe and effective use of Ocrevus?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ocrevus?
English: The full EPAR for Ocrevus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ocrevus je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ocrevus must not be used in patients with active infections or severely weakened immune systems or in patients with cancer.
Slovenian: Zdravilo Ocrevus se ne sme uporabljati pri bolnikih z aktivnimi okužbami ali močno oslabljenim imunskim sistemom ali pri bolnikih z rakom.
English: Ocrevus ocrelizumab
Slovenian: Ocrevus okrelizumab
English: followed by periods with milder or no symptoms;
Slovenian: (recidive), ki jim sledijo obdobja z blažjimi simptomi ali brez simptomov;
English: Before each infusion, the patient is given other medicines (a corticosteroid and an antihistamine) to help to prevent potentially dangerous reactions.
Slovenian: Bolnik pred vsako infuzijo prejme drugi zdravili (kortikosteroid in antihistaminik), ki pomagata preprečevati morebitne nevarne reakcije.
English: If reactions occur during an infusion it may be stopped or given more slowly.
Slovenian: Če pride med infundiranjem do reakcij, se infuzija lahko ustavi ali daje počasneje.
English: This is a summary of the European public assessment report (EPAR) for Ocrevus.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ocrevus.
English: Other information about Ocrevus
Slovenian: Druge informacije o zdravilu Ocrevus