FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from clinical trials showed that clearance of cilazaprilat was correlated with creatinine clearance in patients with chronic heart failure.
Slovenian: Rezultati kliničnih preskušanj so pokazali, da očistek cilazaprila pri bolnikih s kroničnim srčnimi popuščanjem korelira z očistkom kreatinina.
English: The CHMP agreed with the following wording proposed by the MAH:
Slovenian: CHMP se je strinjal z naslednjim besedilom, ki ga je predlagal imetnik dovoljenja za promet z zdravilom:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Taking into account the recommendation of the CHMP, the following wording proposed by the MAH was agreed:
Slovenian: Ob upoštevanju priporočila CHMP je bilo sprejeto naslednje besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom:
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name}
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica] {Ime}
English: Liver cirrhosis: In patients with liver cirrhosis (but without ascites) who require therapy for hypertension, cilazapril should be dosed with great caution not exceeding 0.5 mg/day accompanied by a careful monitoring of the blood pressure, because significant hypotension may occur.
Slovenian: Ciroza jeter: Bolnikom s cirozo jeter (a brez ascitesa), ki potrebujejo zdravljenje hipertenzije, je treba odmerek cilazaprila določiti zelo previdno, odmerek pa ne sme preseči 0,5 mg/dan.
English: In patients with chronic heart failure, the renin-angiotensin-aldosterone and sympathetic nervous systems are generally activated, leading to enhanced systemic vasoconstriction and promotion of sodium and water retention.
Slovenian: Bolniki s kroničnim srčnim popuščanjem imajo praviloma aktivirana sistem renin-angiotenzinaldosteron in simpatični živčni sistem.
English: Whereas
Slovenian: občasni
English: Hypotension, postural hypotension (see section 4.4).
Slovenian: Žilne bolezni pogosti omotica občasni hipotenzija, posturalna hipotenzija (glejte poglavje 4.4).
English: All adverse drug reactions (ADRs) listed in the company reference safety information, the Core Data Sheet (CDS) have been included.
Slovenian: Poglavje 4.8 - Neželeni učinki Vključeni so vsi neželeni učinki zdravil, ki so navedeni v referenčnih informacijah družbe glede varnosti, podatkovnem listu s temeljnimi podatki.
English: Vascace is a specific, long-acting angiotensin-converting enzyme (ACE) inhibitor which suppresses the renin-angiotensin-aldosterone system and thereby the conversion of the inactive angiotensin I to angiotensin II, which is a potent vasoconstrictor.
Slovenian: Zdravilo Vascace je dolgodelujoč zaviralec angiotenzinske konvertaze (ACE), ki zavira sistem reninangiotenzin-aldosteron.
English: If indicated, cilazaprilat, the active form of cilazapril, may be removed from the general circulation by haemodialysis (see section 4.4).
Slovenian: Cilazaprilat, aktivno obliko cilazaprila, je mogoče iz obtoka odstraniti s hemodializo, če je to potrebno (glejte poglavje 4.4).
English: Additional ADRs listed in local SPCs but not in the CDS have been included if appropriate references could be identified.
Slovenian: Če je bilo mogoče opredeliti ustrezne reference, so bili vključeni dodatni neželeni učinki, ki so navedeni v lokalnih povzetkih glavnih značilnosti zdravila, ne pa tudi v podatkovnem listu s temeljnimi podatki.
English: Impotence
Slovenian: Jakost
English: Potassium-sparing diuretics should be used with caution in patients receiving ACE inhibitors, and serum potassium and renal function should be monitored.
Slovenian: Pri bolnikih, ki prejemajo zaviralce ACE, je treba diuretike, ki varčujejo s kalijem, uporabljati previdno.
English: Angioedema (may involve the face, lips, tongue, larynx or gastrointestinal tract) (see section 4.4) Rare
Slovenian: Bolezni krvi in limfatičnega sistema redki nevtropenija, agranulocitoza, trombocitopenija, anemija Bolezni imunskega sistema občasni angioedem (lahko zajame obraz, ustnice, jezik, grlo ali prebavila) (glejte poglavje 4.4) redki anafilaksa (glejte poglavje 4.4)
English: Vascace contains a medicine called cilazapril.
Slovenian: KAJ JE ZDRAVILO VASCACE IN ZA KAJ GA UPORABLJAMO Zdravilo Vascace vsebuje zdravilno učinkovino, imenovano cilazapril.
English: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.
Slovenian: Pri bolnikih, ki so sočasno prejemali zdravljenje z zlatom v parenteralni obliki (natrijev avrotiomalat) ter zaviralci ACE, so redko poročali o nitritoidnih reakcijah (simptomi vključujejo pordevanje obraza, navzeo, bruhanje in hipotenzijo).
English: <10 ml/min
Slovenian: <10 ml/min ni priporočljivo
English: BEFORE YOU TAKE VASCACE
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO VASCACE
English: An additive effect may be observed when cilazapril is administered in combination with other antihypertensive agents.
Slovenian: Če je cilazapril uporabljen v kombinaciji z drugimi antihipertenzivnimi zdravili, se lahko pojavi aditiven učinek.
English: The special dosage recommendation should thus be followed in chronic heart failure patients with impaired renal function.
Slovenian: Zato je treba pri bolnikih s kroničnim srčnim popuščanjem, ki imajo okvarjeno delovanje ledvic, upoštevati posebna priporočila za odmerjanje.
English: Hepatic disorders
Slovenian: Bolezni jeter
English: - if you are on a diet to control how much salt (sodium) you take in. - if you are planning to have treatment to reduce your allergy to bee or wasp stings
Slovenian: - če imate predvideno zdravljenje proti alergiji na pike čebel ali os (desenzibilizacijo).
English: - If you have problems with your kidneys, or if you are elderly, your doctor may give you a lower dose.
Slovenian: Običajen vzdrževalni odmerek je od 1 mg do 2,5 mg na dan. - Če imate težave ledvicami ali če ste starejša oseba, vam zdravnik lahko predpiše manjši odmerek.
English: 2.5 mg once daily
Slovenian: 2,5 mg enkrat na dan
English: 2.5 mg per day.
Slovenian: 2,5 mg enkrat dnevno
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally]
Slovenian: 6.4 Posebna navodila za shranjevanje [Izpolni država članica.]
English: Renal impairment, acute renal failure (see section 4.4), blood creatinine increased, blood urea increased
Slovenian: Bolezni sečil redki okvara ledvic, akutna odpoved ledvic (glejte poglavje 4.4), zvišanje kreatinina v krvi, zvišanje sečnine v krvi hiperkaliemija, hiponatriemija, proteinurija, nefrotski sindrom, nefritis Motnje reprodukcije in dojk občasni impotenca redki ginekomastija
English: - if you are on kidney dialysis.
Slovenian: - če se zdravite z dializo.
English: Because no information is available regarding the safety of cilazapril during breast-feeding, cilazapril is not recommended, and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Zaželena so alternativna antihipertenzivna zdravljenja z bolje uveljavljenim varnostnim profilom, zlasti med dojenjem novorojenčka ali nedonošenčka.
English: Always take Vascace exactly as prescribed.
Slovenian: Pri jemanju zdravila Vascace natančno upoštevajte zdravnikova navodila.
English: Elderly with hypertension: Treatment with Vascace should be initiated with a dose between 0.5 and 1.0 mg once daily.
Slovenian: Starejši bolniki s hipertenzijo: Zdravljenje z zdravilom Vascace je treba začeti z odmerkom od 0,5 mg do 1,0 mg enkrat na dan. Potem je treba vzdrževalni odmerek prilagoditi prenašanju, odzivu in kliničnemu stanju posameznega bolnika.
English: - Sweating more than usual - Flushing - Sleeping problems
Slovenian: - mišični krči ali bolečine v mišicah ali sklepih, - impotenca, - močnejše znojenje kot ponavadi, - zardevanje, - težave s spanjem.
English: This includes medicines obtained without a prescription and herbal medicines.
Slovenian: To velja tudi za zdravila rastlinskega izvora.
English: [To be completed nationally] What Vascace looks like and contents of the pack [To be completed nationally]
Slovenian: Izgled zdravila Vascace in vsebina pakiranja
English: It is available as tablets (2.5, 5, 7.5, 10, 15 and 20 mg) and as ‘orodispersible' tablets (5, 10, 15 and 20 mg).
Slovenian: Na voljo je v obliki tablet (2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg in 20 mg) in orodisperzibilnih tablet (5 mg, 10 mg, 15 mg in 20 mg).
English: The full EPAR for Olanzapine Teva 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 Olanzapine Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Olanzapine Teva on 12 December 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Olanzapine Teva, veljavno po vsej Evropski uniji, odobrila dne 12. decembra 2007.
English: The recommended starting dose of Olanzapine Teva 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 Teva 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: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Slovenian: Domneva se, da so koristni učinki olanzapina posledica blokiranja receptorjev za živčna prenašalca 5-hidroksitriptamin (imenovan tudi serotonin) in dopamin.
English: Since these neurotransmitters are involved in schizophrenia and 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 normalizirati aktivnost možganov in tako zmanjša simptome teh bolezni.
English: Olanzapine Teva is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Slovenian: Zdravilo Olanzapine Teva je prav tako učinkovito pri vzdrževanju izboljšanja stanja pri bolnikih, ki so se odzvali na začetno zdravljenje.
English: For more information about treatment with Olanzapine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Olanzapine Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Two medicines are bioequivalent when produce the same levels of the active substance in the body.
Slovenian: Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni zdravilne učinkovine v telesu.
English: Olanzapine Teva olanzapine
Slovenian: Olanzapine Teva olanzapin
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Teva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Olanzapine Teva.
English: This means that Olanzapine Teva 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 odobrena v Evropski uniji (EU), in sicer zdraviloma Zyprexa in Zyprexa Velotab.
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, tj. kemičnih snovi, ki omogočajo komunikacijo med celicami.
English: What are the benefits and risks of Olanzapine Teva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Olanzapine Teva?
English: Olanzapine Teva is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Slovenian: Zdravilo Olanzapine Teva se uporablja tudi za zdravljenje zmernih do hudih maničnih epizod (izjemno privzdignjenega razpoloženja) pri odraslih.
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 Teva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Olanzapine Teva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Olanzapine Teva 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 Teva generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnima zdraviloma.
English: Because Olanzapine Teva is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.
Slovenian: Ker je zdravilo Olanzapine Teva generično zdravilo in je biološko enakovredno referenčnima zdraviloma, se šteje, da ima enake koristi in tveganja kot referenčni zdravili.
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Teva has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Olanzapine Teva primerljivo raven kakovosti kot zdravili Zyprexa in Zyprexa Velotab ter da jima je biološko enakovredno.
English: Olanzapine Teva is a ‘generic medicine'.
Slovenian: Olanzapine Teva je „generično zdravilo“.
English: Other information about Olanzapine Teva
Slovenian: Druge informacije o zdravilu Olanzapine Teva
English: The active substance in Olanzapine Teva, olanzapine, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina zdravila Olanzapine Teva, olanzapin, je antipsihotično zdravilo.
English: The orodispersible tablets, which can be used as an alternative to the tablets, are taken by being placed on the tongue, where they disintegrate quickly 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, ki se lahko uporabijo kot alternativa tabletam, se zaužijejo tako, da se položijo na jezik, kjer jih slina hitro raztopi, ali tako, da se pred zaužitjem zmešajo z vodo.
English: The Committee recommended that Olanzapine Teva be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Olanzapine Teva odobri dovoljenje za promet.
English: Olanzapine Teva is a medicine containing the active substance olanzapine.
Slovenian: Olanzapine Teva je zdravilo, ki vsebuje zdravilno učinkovino olanzapin.
English: Therefore, the CHMP's view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Slovenian: Zato meni, da so koristi, tako kot pri zdravilih Zyprexa in Zyprexa Velotab, večje od z njim povezanih tveganj.
English: Why has Olanzapine Teva been approved?
Slovenian: Zakaj je bilo zdravilo Olanzapine Teva odobreno?
English: Olanzapine Teva is used to treat adults with schizophrenia.
Slovenian: Zdravilo Olanzapine Teva se uporablja za zdravljenje shizofrenije.
English: How has Olanzapine Teva been studied?
Slovenian: Kako je bilo zdravilo Olanzapine Teva raziskano?
English: What is Olanzapine Teva?
Slovenian: Kaj je zdravilo Olanzapine Teva?
English: What is Olanzapine Teva used for?
Slovenian: Za kaj se zdravilo Olanzapine Teva uporablja?
English: How is Olanzapine Teva used?
Slovenian: Kako se zdravilo Olanzapine Teva uporablja?
English: How does Olanzapine Teva work?
Slovenian: Kako zdravilo Olanzapine Teva deluje?
English: The marketing authorisation holder of SoliCol D3 shall provide evidence that the manufacturing process complies with the requirements of Commission Directive 2003/94/EC laying down the principles and guidelines of Good Manufacturing Practice (GMP) as provided for in Article 8(3) of Directive 2001/83/EC.
Slovenian: Za preklic začasnega umika dovoljenj za promet z zdravilom SoliCol D3 morajo pristojni organi zagotoviti, da je/so imetnik(-i) dovoljenj(a) za promet z zdravilom izpolnil(-i) spodnje pogoje: Imetnik dovoljenja za promet z zdravilom SoliCol D3 mora predložiti dokaz, da je postopek izdelave v skladu z zahtevami Direktive Komisije 2003/94/ES o določitvi načel in smernic dobre proizvodne prakse, kot je določeno v členu 8(3) Direktive 2001/83/ES.
English: Annex III Conditions for lifting the suspension of the marketing authorisation(s)
Slovenian: Priloga III
English: Over 70% of those given Erelzi (186 of 264 patients) and roughly 72% of those given Enbrel (191 of 267) had at least 75% reduction in their symptom score after 12 weeks of treatment, which was the main measure of effectiveness.
Slovenian: Pri več kot 70 % bolnikov, ki so prejemali zdravilo Erelzi (186 od 264 bolnikov) in pri približno 72 % bolnikov, ki so prejemali zdravilo Enbrel (191 od 267), je po 12 tednih zdravljenja prišlo do vsaj 75-odstotnega zmanjšanja simptomov, kar je bilo glavno merilo učinkovitosti.
English: This means that Erelzi is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: What measures are being taken to ensure the safe and effective use of Erelzi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Erelzi?
English: In adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week.
Slovenian: Pri odraslih je priporočeni odmerek 25 mg dvakrat tedensko ali 50 mg enkrat tedensko.
English: The full EPAR for Erelzi 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 Erelzi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In children, the dose will depend on body weight.
Slovenian: Pri otrocih je odmerek odvisen od telesne mase.
English: The educational materials also include a reminder that Erelzi is not for use in children and adolescents who weigh less than 62.5 kg.
Slovenian: Izobraževalno gradivo vključuje tudi opomnik, da zdravilo Erelzi ni namenjeno uporabi pri otrocih in mladostnikih, ki tehtajo manj kot 62,5 kg.
English: This is a summary of the European public assessment report (EPAR) for Erelzi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Erelzi.
English: It is not intended to provide practical advice on how to use Erelzi.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The most common side effects with etanercept (seen in more than 1 patient in 10) are injection-site reactions (including bleeding, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Slovenian: Najpogostejši neželeni učinki zdravila Erelzi (opaženi pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja (vključno s krvavitvami, rdečico, srbečico, bolečino in otekanjem) in okužbe (vključno s prehladi ter vnetji pljuč, mehurja in kože).
English: What benefits of Erelzi have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Erelzi izkazalo v študijah?
English: Erelzi is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough or cannot be used.
Slovenian: Zdravilo Erelzi se uporablja predvsem za huda do srednje huda bolezenska stanja ali kadar druge vrste zdravljenja niso dovolj učinkovite ali se ne smejo uporabljati.
English: Erelzi is an anti-inflammatory medicine for treating the following diseases:
Slovenian: Erelzi je protivnetno zdravilo za zdravljenje naslednjih bolezni:
English: Erelzi must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with active infections.
Slovenian: Zdravila Erelzi ne smejo jemati bolniki, ki imajo sepso ali pri katerih obstaja nevarnost sepse (kadar bakterije in toksini krožijo v krvi in poškodujejo organe), ali bolniki z aktivnimi okužbami.
English: Other information about Erelzi
Slovenian: Druge informacije o zdravilu Erelzi
English: What is Erelzi and what is it used for?
Slovenian: Kaj je zdravilo Erelzi in za kaj se uporablja?
English: The Committee recommended that Erelzi be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Erelzi izda dovoljenje za promet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Erelzi has been shown to have a comparable quality, safety and effectiveness to Enbrel.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Erelzi po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Enbrel.
English: What are the risks associated with Erelzi?
Slovenian: Kakšna tveganja so povezana z zdravilom Erelzi?
English: Erelzi is not for use in children who need doses other than 25 or 50 mg (e.g. those weighing less than 62.5 kg), because it is only available in these doses; an alternative product should be used in such children.
Slovenian: Zdravilo Erelzi ni namenjeno za uporabo pri otrocih, ki potrebujejo odmerke, ki ne zajemajo 25 ali 50 mg (npr. otroci, ki tehtajo manj kot 62,5 kg), ker je na voljo samo v teh odmerkih.
English: The company that markets Erelzi will provide educational material for doctors expected to prescribe the product to teach patients how to use the pre-filled pen correctly and a special alert card for patients so they can recognise serious side effects and know when to seek urgent attention from their doctor.
Slovenian: Družba, ki trži zdravilo Erelzi, bo zagotovila izobraževalno gradivo za zdravnike, ki naj bi ga predpisovali, da bodo bolnike poučili o pravilni uporabi napolnjenega peresnika, in opozorilno kartico za bolnike, da lahko prepoznajo resne neželene učinke in vedo, kdaj poiskati nujno zdravniško pomoč.
English: Patients developing a serious infection should stop Erelzi treatment.
Slovenian: Bolniki, pri katerih se pojavi resna okužba, morajo zdravilo Erelzi prenehati jemati.
English: By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Slovenian: Etanercept z zaviranjem TNF zmanjša vnetje in blaži druge simptome bolezni.
English: The active substance in Erelzi, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor alpha (TNF).
Slovenian: Zdravilna učinkovina v zdravilu Erelzi, etanercept, je beljakovina, katere namen je zavirati delovanje snovi, ki se imenuje dejavnik tumorske nekroze alfa (TNF).