FrancophonIA/ELRC3.0 huggingface dataset:
English: There were 17 (3.6%) deaths due to hepatotoxicity events in the lenvatinib arm and 4 (0.8%) deaths in the sorafenib arm. Hepatotoxicity adverse reactions led to dose interruptions and reductions in 12.2% and 7.4% of lenvatinib-treated patients respectively, and to permanent discontinuation in 5.5%.
Slovenian: S hepatotoksičnostjo povezani neželeni učinki so pri bolnikih, zdravljenih z lenvatinibom, povzročili prekinitev oziroma zmanjšanje odmerjanja pri 12,2 % oziroma 7,4 % bolnikov, trajno ukinitev pa pri 5,5 %.
English: Patients who had received 1 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
Slovenian: razmerje tveganja (95 % IZ)b,c Bolniki, ki so prejeli 1 predhodno zdravljenje, usmerjeno v VEGF/VEGFR (%) število napredovanj ali smrti mediano PFS v mesecih (95 % IZ)
English: Diarrhoea has been reported frequently in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Slovenian: O driski so pri bolnikih, zdravljenih z lenvatinibom, pogosto poročali, navadno se pojavi zgodaj v poteku zdravljenja (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
English: LENVIMA 4 mg hard capsules: - Each hard capsule contains 4 mg of lenvatinib (as mesylate).
Slovenian: LENVIMA 4 mg trde kapsule: - ena trda kapsula vsebuje 4 mg lenvatiniba (v obliki mesilata);
English: Wound Healing Complications
Slovenian: Zapleti pri celjenju ran
English: Dehydration Hypomagnesaemiab Hypercholesterolaemia b
Slovenian: Presnovne in prehranske motnje hipokalciemija‡ hipokaliemija hujšanje zmanjšan apetit dehidracija hipomagneziemijab hiperholesterolemijab
English: • The 10 mg capsule is a yellow body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
Slovenian: • 10-miligramska kapsula ima rumeno telo in rumenkastordeč pokrovček, dolžine približno 14,3 mm, na njej je s črnim črnilom izpisana oznaka »Є« na pokrovčku kapsule in »LENV 10 mg« na telesu kapsule.
English: Dose level
Slovenian: Začetni odmerek
English: • The 4 mg capsule is a yellowish red body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Slovenian: • 4-miligramska kapsula ima rumenkastordeče telo in rumenkastordeč pokrovček, dolžine približno 14,3 mm, na njej je s črnim črnilom izpisana oznaka »Є« na pokrovčku kapsule in »LENV 4 mg« na telesu kapsule.
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 10 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 10 mg lenvatinib (as mesilate).
Slovenian: IME ZDRAVILA LENVIMA 10 mg trde kapsule lenvatinib NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 10 mg lenvatiniba (v obliki lenvatinibijevega mesilata).
English: Back pain Arthralgia Myalgia Pain in extremity Musculoskeletal pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v hrbtu artralgija mialgija bolečina v udu bolečina v mišicah in kosteh
English: • joint or muscle pain
Slovenian: • bolečina v sklepih ali mišicah,
English: Diarrhoea Gastrointestinal and abdominal painsf
Slovenian: Infekcijske in parazitske bolezni okužba sečil perinealni absces
English: In patients with severe renal impairment, the recommended starting dose is 14 mg taken once daily.
Slovenian: Pri bolnikih s hudo okvaro ledvic je priporočeni začetni odmerek 14 mg enkrat na dan. Na podlagi prenašanja posameznega bolnika utegnejo biti potrebne nadaljnje prilagoditve odmerka.
English: Cardiac failure (<1%) and decreased left ventricular ejection fraction have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Slovenian: Pri bolnikih, zdravljenih z lenvatinibom, so poročali o popuščanju srca (< 1 %) in zmanjšani frakciji iztisa levega prekata (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
English: LENVIMA 10 mg hard capsules Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Slovenian: LENVIMA 10 mg trde kapsule Ena trda kapsula vsebuje 10 mg lenvatiniba (v obliki lenvatinibijevega mesilata).
English: Hazard ratio is for lenvatinib vs. sorafenib, based on a Cox model including treatment group as a factor.
Slovenian: Presečni datum zajema podatkov: 13. november 2016. a Razmerje ogroženosti za primerjavo lenvatiniba in sorafeniba s Coxovim modelom, ki je vključeval skupino zdravljenja kot faktor.
English: Gastrointestinal disorders
Slovenian: Ne-gastrointestinalna fistula
English: Renal impairment and renal failure have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Slovenian: Pri bolnikih, zdravljenih z lenvatinibom, so poročali o okvari in odpovedi ledvic (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
English: LENVIMA 10 mg hard capsules: - Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Slovenian: LENVIMA 10 mg trde kapsule: - ena trda kapsula vsebuje 10 mg lenvatiniba (v obliki mesilata).
English: * Identified from post-marketing use of lenvatinib
Slovenian: Ugotovljeno pri uporabi lenvatiniba v obdobju trženja.
English: Hepatotoxicity (see section 4.4)
Slovenian: Hepatotoksičnost (glejte poglavje 4.4)
English: • swelling of the legs
Slovenian: • izpadanje las,
English: Thrombocytopeniaa Leukopeniaa Neutropeniaa
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenijaa levkopenijaa nevtropenijaa limfopenijaa infarkt vranice
English: Second dose reduction 14 mg orally once daily One 10mg capsuleplus one 4 mg capsule Third dose reduction
Slovenian: 14 mg peroralno enkrat na dan ena 10 mg kapsula in ena 4 mg kapsula
English: Black iron oxide (E172) Potassium hydroxide Propylene glycol
Slovenian: Tiskarsko črnilo šelak, črni železov oksid (E172), kalijev hidroksid, propilenglikol.
English: Resolves to Grade 0-1 or baseline.
Slovenian: Izboljša se na stopnjo 0-1 ali v izhodišče stopnja 4
English: Impaired wound healing has been reported in patients receiving lenvatinib.
Slovenian: Pri bolnikih, ki so prejemali lenvatinib, so poročali o slabšem celjenju ran.
English: Hyperkeratosis
Slovenian: Rak jeter
English: In the Phase 3 REFLECT trial (see section 5.1), proteinuria was reported in 26.3% of lenvatinibtreated patients and Grade 3 reactions occurred in 5.9%.
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o proteinuriji pri 26,3 % bolnikov, zdravljenih z lenvatinibom.
English: Hypertension has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Slovenian: Pri bolnikih, zdravljenih z lenvatinibom, so poročali o hipertenziji, ki se navadno pojavi kmalu po začetku zdravljenja (glejte poglavje 4.8 Opis izbranih neželenih učinkov).
English: Proteinuria has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Slovenian: Pri bolnikih, zdravljenih z lenvatinibom, so poročali o proteinuriji, ki se navadno pojavi kmalu po začetku zdravljenja (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
English: Leukopenia includes leukopenia and decreased white blood cell count Lymphopenia includes lymphopenia and lymphocyte count decreased.
Slovenian: Levkopenija vključuje levkopenijo in zmanjšano število belih krvnih celic.
English: Hepatic failure includes: hepatic failure, acute hepatic failure and chronic hepatic failure.
Slovenian: Jetrna odpoved vsebuje: jetrno odpoved, akutno jetrno odpoved in kronično jetrno odpoved.
English: Haemorrhage terms that occurred in 5 or more subjects with HCC were: epistaxis, haematuria, gingival bleeding, haemoptysis, oesophageal varices haemorrhage, haemorrhoidal haemorrhage, mouth haemorrhage, rectal haemorrhage and upper gastrointestinal haemorrhage.
Slovenian: Izrazi za krvavitev, ki so se pojavili pri 5 ali več preiskovancih s HCC, so bili: epistaksa, hematurija, krvavitev iz dlesni, hemoptiza, krvavitev iz ezofagealnih varic, hemoroidna krvavitev, krvavitev iz ust, rektalna krvavitev in krvavitev iz zgornjih prebavil.
English: • heart palpitations
Slovenian: • možganska kap,
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 4 mg hard capsules lenvatinib
Slovenian: LENVIMA 4 mg trde kapsule lenvatinib
English: Temporary interruption of lenvatinib should be considered in patients undergoing major surgical procedures.
Slovenian: Pri bolnikih, pri katerih bo opravljen večji kirurški poseg, je treba razmisliti o začasni prekinitvi zdravljenja z lenvatinibom.
English: The available very limited data are not sufficient to allow for a dosing recommendation for HCC patients with moderate hepatic impairment (Child-Pugh B).
Slovenian: Razpoložljivih podatkov pri bolnikih s HCC z zmerno okvaro jeter (Child-Pugh B) je zelo malo in ne zadostujejo za priporočilo glede odmerjanja.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora disfonija pljučna embolija†,
English: • hair loss
Slovenian: • otekanje spodnjih udov,
English: Diarrhoea (see section 4.4)
Slovenian: Krvavitev (glejte poglavje 4.4)
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 10 mg hard capsules lenvatinib
Slovenian: LENVIMA 10 mg trde kapsule lenvatinib
English: Increased blood bilirubin j, ‡ Hypoalbuminaemiaj
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišan bilirubin v krvi j, ‡
English: • feeling unwell
Slovenian: • slabo počutje,
English: Thrombocytopenia includes thrombocytopenia and decreased platelet count.
Slovenian: Trombocitopenija vključuje trombocitopenijo in zmanjšano število krvnih ploščic.
English: A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
Slovenian: Rumeno telo kapsule in rumenkastordeč pokrovček kapsule, kapsula je dolga približno 14,3 mm in ima s črnim črnilom izpisano oznako »Є« na pokrovčku kapsule in »LENV 10 mg« na telesu kapsule.
English: How to store LENVIMA
Slovenian: Shranjevanje zdravila LENVIMA
English: The standard dose of Clopidogrel Mylan is one 75 mg tablet once a day, taken with or without food.
Slovenian: Običajni odmerek zdravila Clopidogrel Mylan je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
English: This means that Clopidogrel Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je zdravilo Clopidogrel Mylan podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: Clopidogrel Mylan is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Clopidogrel Mylan se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
English: Clopidogrel Mylan can be given to the following groups of patients:
Slovenian: Zdravilo Clopidogrel Mylan se lahko daje naslednjim skupinam bolnikov:
English: Clopidogrel Mylan clopidogrel EPAR summary for the public
Slovenian: Clopidogrel Mylan klopidogrel Povzetek EPAR za javnost
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Mylan has been shown to have comparable quality and to be bioequivalent to Plavix.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Mylan primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Mylan to Mylan S.A.S on 21 September 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Mylan, veljavno po vsej Evropski uniji, odobrila družbi Mylan S.A.S dne 21. septembra .
English: Because Clopidogrel Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Slovenian: Ker je Clopidogrel Mylan generično zdravilo in je biološko enakovreden referenčnemu zdravilu, ima enake koristi in tveganja kot referenčno zdravilo.
English: Other information about Clopidogrel Mylan:
Slovenian: Druge informacije o zdravilu Clopidogrel Mylan:
English: Clopidogrel Mylan can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Clopidogrel Mylan se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
English: The Committee recommended that Clopidogrel Mylan be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Clopidogrel Mylan odobri dovoljenje za promet.
English: Because Clopidogrel Mylan is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Slovenian: Ker je zdravilo Clopidogrel Mylan generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: Clopidogrel Mylan is a ‘generic medicine'.
Slovenian: Clopidogrel Mylan je „generično zdravilo“.
English: What are the benefit and risk of Clopidogrel Mylan?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel Mylan?
English: Clopidogrel Mylan can be started between seven days and six months after the stroke;
Slovenian: Zdravilo Clopidogrel Mylan se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
English: Clopidogrel Mylan is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel Mylan je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: The active substance in Clopidogrel Mylan, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel Mylan, klopidogrel, je zaviralec agregacije trombocitov.
English: The full EPAR for Clopidogrel Mylan can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel Mylan je na voljo tukaj.
English: Why has Clopidogrel Mylan been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel Mylan odobreno?
English: How has Clopidogrel Mylan been studied?
Slovenian: Kako je bilo zdravilo Clopidogrel Mylan raziskano?
English: What is Clopidogrel Mylan used for?
Slovenian: Za kaj se zdravilo Clopidogrel Mylan uporablja?
English: What is Clopidogrel Mylan?
Slovenian: Kaj je zdravilo Clopidogrel Mylan?
English: How is Clopidogrel Mylan used?
Slovenian: Kako se zdravilo Clopidogrel Mylan uporablja?
English: How does Clopidogrel Mylan work?
Slovenian: Kako zdravilo Clopidogrel Mylan deluje?
English: It may help you by:
Slovenian: Pomaga vam lahko tako, da:
English: • improving your ability to perform daily activities.
Slovenian: • izboljša sposobnost za opravljanje vsakodnevnih dejavnosti.
English: Date of first authorisation: 23 June 2017
Slovenian: Datum prve odobritve: 23. junij 2017
English: • The injection can take up to 15 seconds.
Slovenian: • Injiciranje lahko traja do 15 sekund.
English: • You may see an air bubble, this is normal.
Slovenian: • Morda boste videli mehurček zraka, to je normalno.
English: You will also have the tests during your treatment.
Slovenian: Preiskave boste opravljali tudi med zdravljenjem.
English: Date of removal from the refrigerator: .../.../...
Slovenian: Datum odstranitve iz hladilnika: .../.../...
English: Prepare all the equipment you will need on a clean, flat working surface.
Slovenian: Pripravite vse, kar boste potrebovali, na čisti, ravni delovni površini.
English: 50 to 100
Slovenian: Od 50 do 100
English: Less than 50
Slovenian: Manj kot 50
English: Percentage of Patients
Slovenian: Odstotek bolnikov
English: • you have ever had any type of cancer.
Slovenian: • ste kdaj imeli kakršno koli vrsto raka.
English: Component of a multipack, can't be sold separately.
Slovenian: Del skupnega pakiranja, ni mogoče prodati ločeno.
English: • Make sure you can see the window.
Slovenian: • Prepričajte se, da lahko vidite okence.
English: • There will be a “click” when the injection starts.
Slovenian: • Slišali boste “klik”, ko se bo injiciranje začelo.
English: Look at the label.
Slovenian: Poglejte nalepko.
English: The patient alert card shall contain the following key messages:
Slovenian: Opozorilna kartica bolnika mora obsegati naslednja ključna sporočila:
English: • Your doctor may adjust the dose of your medicine based on results of blood tests.
Slovenian: • Zdravnik vam lahko prilagodi odmerek zdravila glede na rezultate preiskav krvi.
English: Simvastatin is a CYP3A4 and OATP1B1 substrate.
Slovenian: Simvastatin je substrat CYP3A4 in OATP1B1.
English: Fatigue was assessed by the FACIT-Fatigue scale.
Slovenian: Utrujenost so ocenjevali z lestvico FACIT-Fatigue.
English: As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
Slovenian: Ker je pojavnost okužb v starejši populaciji na splošno večja, je pri zdravljenju starejših oseb potrebna previdnost.
English: • Slowly push the plunger down as far as it will go until the syringe is empty.
Slovenian: • Počasi potisnite bat, kolikor daleč gre, dokler ni brizga prazna.
English: Interactions with CYP450 substrates
Slovenian: Medsebojna delovanja s substrati CYP450
English: General health status was assessed by the Short Form health survey (SF-36).
Slovenian: Splošno zdravstveno stanje so ocenjevali z vprašalnikom SF-36 (Short Form health survey).
English: Do not press or touch the yellow needle cover with your fingers.
Slovenian: Ne pritiskajte ali dotikajte se rumenega pokrovčka igle s prsti.
English: Step B: Perform the injection - Perform Step B only after completing Step A “Get ready for an injection”
Slovenian: Korak B: Injicirajte - Korak B opravite, šele ko ste dokončali korak A "Pripravite se za injiciranje"
English: Age, gender, ethnicity and body weight
Slovenian: Starost, spol, etnična pripadnost in telesna masa
English: • If you do not hear the second click, you should still check to see if the window has turned fully yellow.
Slovenian: • Če ne slišite še enega klika, morate še vedno preveriti, če se je okence v celoti obarvalo rumeno.
English: Do not inject through your clothes.
Slovenian: Ne injicirajte skozi obleko.
English: Sarilumab was detected in the serum of neonates up to 1 month.
Slovenian: Sarilumab je bil zaznan v serumu novorojenčkov do 1 meseca.
English: • The effects of Kevzara on an unborn baby are not known.
Slovenian: • Učinki zdravila Kevzara na nerojenega otroka niso znani.
English: • if you are allergic to sarilumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na sarilumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The detection of an immune response is highly dependent on the sensitivity and specificity of the assays used and testing conditions.
Slovenian: Odkritje imunskega odziva je močno odvisno od senzitivnosti in specifičnosti uporabljenega preizkusa in od pogojev testiranja.
English: Patients should be managed according to clinical guidelines for the management of hyperlipidaemia.
Slovenian: Bolnike je treba voditi v skladu s kliničnimi smernicami za vodenje hiperlipidemije.
English: In MOBILITY and TARGET, physical function and disability were assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI).
Slovenian: V študijah MOBILITY in TARGET so telesno delovanje in invalidnost ocenjevali z indeksom HAQ-DI (Health Assessment Questionnaire Disability Index).
English: Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Step A: Get ready for an injection 1.
Slovenian: Korak A: Pripravite se za injiciranje
English: The subsequent dose should be administered at the regularly scheduled time.
Slovenian: Naslednji odmerek je treba uporabiti ob redno predvidenem času.
English: There will be a second click.
Slovenian: Slišali boste še en klik.
English: • been exposed to tuberculosis; or
Slovenian: • so bili izpostavljeni tuberkulozi ali
English: Dose modification:
Slovenian: Prilagoditev odmerka:
English: Levels were reduced to normal as early as 4 days after treatment initiation.
Slovenian: Koncentracija se je znižala na normalno že 4 dni po uvedbi zdravljenja.
English: Look at the medicine.
Slovenian: Preglejte zdravilo.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba ime zdravila in številko serije uporabljenega zdravila jasno zabeležiti.
English: Table 6: Efficacy results for MONARCH
Slovenian: Preglednica 6: Rezultati učinkovitosti v študiji MONARCH
English: Name and address of the manufacturer(s) responsible for batch release Sanofi Winthrop Industrie
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serij Sanofi Winthrop Industrie
English: • Check the expiry date (EXP).
Slovenian: • Preverite datum izteka roka uporabnosti (EXP).
English: ALT > 1 to 3 x Upper Limit of Normal (ULN)
Slovenian: ALT > 1- do 3-kratna zgornja normalna meja (ZNM)
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Slovenian: Pogostnost spodaj naštetih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000
English: • Check that you have the correct medicine and the correct dose.
Slovenian: • Preverite, da imate pravo zdravilo in pravi odmerek.
English: EU/1/17/1196/005 EU/1/17/1196/006 EU/1/17/1196/007 EU/1/17/1196/008 EU/1/17/1196/009 EU/1/17/1196/010 EU/1/17/1196/011 EU/1/17/1196/012
Slovenian: EU/1/17/1196/001 EU/1/17/1196/002 EU/1/17/1196/003 EU/1/17/1196/004 EU/1/17/1196/005 EU/1/17/1196/006 EU/1/17/1196/007 EU/1/17/1196/008 EU/1/17/1196/009 EU/1/17/1196/010 EU/1/17/1196/011 EU/1/17/1196/012
English: Tell your doctor straight away if you think you have an infection (which may affect up to 1 in every 10 people).
Slovenian: Zdravnika takoj obvestite, če menite, da imate okužbo (pojavi se lahko pri največ 1 od 10 oseb).
English: In the event of an overdose, the patient should be closely monitored, treated symptomatically, and supportive measures instituted as required.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika skrbno nadzirati, zdraviti simptomatsko in uvesti podporne ukrepe, kot je potrebno.
English: Kevzara should not be used during pregnancy unless the clinical condition of the woman requires treatment with sarilumab.
Slovenian: Zdravila Kevzara se med nosečnostjo ne sme uporabljati, razen če klinično stanje ženske zahteva zdravljenje s sarilumabom.
English: Kevzara can be used alone or together with a medicine called methotrexate.
Slovenian: Zdravilo Kevzara je mogoče uporabljati samo ali skupaj z zdravilom, imenovanim metotreksat.
English: Physician global VAS‡ (0-100 mm) Patient global VAS‡ (0-100 mm) HAQ-DI
Slovenian: VAS† (0-100 mm) Zdravnikova celotna VAS‡ (0-100 mm) Bolnikova celotna VAS‡ (0-100 mm) HAQ-DI
English: For further details on administration of this medicinal product see section 6.6.
Slovenian: Za dodatne podrobnosti o dajanju tega zdravila glejte poglavje 6.6.
English: Patients with severe renal impairment were not studied.
Slovenian: Bolnikov s hudo okvaro ledvic niso raziskali.
English: Before you remove the needle, check that the syringe is empty.
Slovenian: Preden iglo potegnete iz kože, se prepričajte, da je brizga prazna.
English: Hypercholesterolemia Hypertriglyceridemia
Slovenian: Hiperholesterolemija Hipertrigliceridemija