FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja disfonija plućna embolija†
English: Wound Healing Complications
Croatian: Komplikacije cijeljenja rana
English: A single 32-mg dose of lenvatinib did not prolong the QT/QTc interval based on results from a thorough QT study in healthy volunteers; however, QT/QTc interval prolongation has been reported at a higher incidence in patients treated with lenvatinib than in patients treated with placebo (see sections 4.4 and 4.8).
Croatian: Međutim, produljenje QT/QTc intervala bilo je zabilježeno s višom incidencijom u bolesnika liječenih lenvatinibom nego u bolesnika koji su primali placebo (vidjeti dijelove 4.4 i 4.8).
English: • feeling bloated or having excess wind
Croatian: • osjećaj nadutosti ili prekomjerno stvaranje plinova u crijevima
English: 20 mg orally once daily Two 10mg capsules
Croatian: 20 mg peroralno jedanput na dan
English: • Common
Croatian: • često
English: Leukopenia includes leukopenia and decreased white blood cell count Lymphopenia includes lymphopenia and lymphocyte count decreased.
Croatian: Leukopenija uključuju leukopeniju i smanjeni broj bijelih krvnih stanica.
English: <60 kg BW 8 mg (two 4 mg capsules orally once daily)
Croatian: 8 mg (dvije kapsule od 4 mg peroralno jedanput dnevno)
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).
Croatian: U bolesnika liječenih lenvatinibom zabilježena je proteinurija koja obično nastaje rano u tijeku liječenja (vidjeti dio 4.8, Opis odabranih nuspojava).
English: * Identified from post-marketing use of lenvatinib
Croatian: *: Utvrđeno pri primjeni lenvatiniba nakon stavljanja lijeka u promet.
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.
Croatian: Hemoragijski pojmovi koji su je javili u 5 ili više ispitanika sa HCC-om bili su: epistaksa, hematurija, krvarenje iz desni, hemoptiza, krvarenje varikoziteta jednjaka, hemoroidalno krvarenje, krvarenje u ustima, rektalno krvarenje i krvarenje iz gornjeg gastrointestinalnog trakta.
English: Per independent radiology review retrospective analysis.
Croatian: Stopa odgovora (potpun ili djelomičan odgovor) g Prema retrospektivnoj analizi neovisne radiološke procjene.
English: Dysphonia
Croatian: Proljev
English: 24 mg orally once daily Two 10 mg capsules plus one 4 mg capsule
Croatian: Dvije kapsule od 10 mg plus jedna kapsula od 4 mg
English: Renal impairment and renal failure have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Croatian: U bolesnika liječenih lenvatinibom zabilježeno je oštećenje funkcije bubrega i zatajenje bubrega (vidjeti dio 4.8, Opis odabranih nuspojava).
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 4 mg hard capsules lenvatinib
Croatian: LENVIMA 4 mg tvrde kapsule lenvatinib
English: Prompt medical management of diarrhoea should be instituted in order to prevent dehydration.
Croatian: Kako bi se spriječila dehidracija, potrebno je brzo započeti medicinsko zbrinjavanje proljeva.
English: • joint or muscle pain
Croatian: • bol u zglobovima ili mišićima
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 10 mg hard capsules lenvatinib
Croatian: LENVIMA 10 mg tvrde kapsule lenvatinib
English: Haemorrhage (see section 4.4)
Croatian: Proljev (vidjeti dio 4.4)
English: Vomiting Nausea Oral inflammationg Oral painh
Croatian: Infekcije i infestacije infekcija mokraćnog sustava perinealni apsces
English: Hepatic failurek,‡,†
Croatian: slučajevi zatajenja bubregan,†
English: • swelling of the legs
Croatian: • oticanje nogu
English: Increased blood bilirubin j, ‡ Hypoalbuminaemiaj
Croatian: Poremećaji jetre i žuči povišen bilirubin u krvi j, ‡
English: It may help you by:
Croatian: Može Vam pomoći tako što će:
English: • The injection can take up to 15 seconds.
Croatian: • Injekcija može potrajati do 15 sekundi.
English: Date of first authorisation: 23 June 2017
Croatian: Datum prvog odobrenja: 23. lipnja 2017.
English: • you have ever had any type of cancer.
Croatian: • ako ste ikada imali bilo kakvu vrsta raka
English: There were no meaningful differences between doses.
Croatian: Nije bilo značajnih razlika između doza.
English: Less than 50
Croatian: Ispod 50
English: • improving your ability to perform daily activities.
Croatian: • poboljšati Vašu sposobnost izvođenja svakodnevnih aktivnosti
English: • You may see an air bubble, this is normal.
Croatian: • Možda ćete vidjeti mjehurić zraka, što je normalno.
English: Open here
Croatian: Otvoriti ovdje.
English: • been exposed to tuberculosis; or
Croatian: • koji su bili izloženi tuberkulozi; ili
English: Prepare all the equipment you will need on a clean, flat working surface.
Croatian: Sav pribor koji će Vam trebati stavite na čistu i ravnu radnu površinu.
English: Date of removal from the refrigerator: .../.../...
Croatian: Datum vađenja iz hladnjaka: .../.../...
English: • There will be a “click” when the injection starts.
Croatian: • Čut ćete ‘klik' kad injekcija započne.
English: There will be a second click.
Croatian: Čut ćete još jedan ‘klik'.
English: • Make sure you can see the window.
Croatian: • Pobrinite se da vidite prozorčić.
English: Step B: Perform the injection - Perform Step B only after completing Step A “Get ready for an injection”
Croatian: Korak B: Injicirajte lijek - prijeđite na korak B tek nakon što završite korak A ‘Pripremite se za injekciju'
English: Look at the label.
Croatian: Pogledajte naljepnicu.
English: • Slowly push the plunger down as far as it will go until the syringe is empty.
Croatian: • Polako pritišćite klip prema dolje koliko god ide, sve dok štrcaljka ne bude prazna.
English: Look at the window.
Croatian: Pogledajte kroz prozorčić.
English: You will also have the tests during your treatment.
Croatian: Te će se pretrage provoditi i tijekom liječenja.
English: • oral contraceptives
Croatian: • oralne kontraceptive
English: • Keep your hand away from the plunger.
Croatian: • Držite ruku podalje od klipa.
English: Step A: Get ready for an injection 1.
Croatian: Korak A: Pripremite se za injekciju
English: Age, gender, ethnicity and body weight
Croatian: Posebne populacije Dob, spol, etničko podrijetlo i tjelesna težina
English: Do not inject a double dose to make up for a forgotten injection.
Croatian: Nemojte injicirati dvostruku dozu da biste nadoknadili zaboravljenu dozu.
English: The detection of an immune response is highly dependent on the sensitivity and specificity of the assays used and testing conditions.
Croatian: Detekcija imunog odgovora uvelike ovisi o osjetljivosti i specifičnosti korištenih testova i uvjeta u kojima se testiranje provodi.
English: • If you do not hear the second click, you should still check to see if the window has turned fully yellow.
Croatian: • Čak i ako ne čujete drugi ‘klik', ipak provjerite je li prozorčić postao posve žut.
English: • if you have an active severe infection.
Croatian: • ako imate tešku aktivnu infekciju
English: Kevzara is not recommended in children and adolescents under 18 years of age.
Croatian: Kevzara se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: Contents of the pack and other information What Kevzara contains
Croatian: Sadržaj pakiranja i druge informacije Što Kevzara sadrži
English: The median tmax after a single subcutaneous dose was observed in 2 to 4 days.
Croatian: Medijan tmax nakon jednokratne supkutane doze opažen je nakon 2 do 4 dana.
English: • Your doctor may adjust the dose of your medicine based on results of blood tests.
Croatian: • Liječnik može prilagoditi dozu lijeka na temelju nalaza krvnih pretraga.
English: • Check the expiry date (EXP).
Croatian: • Provjerite rok valjanosti (EXP).
English: If the window does not turn fully yellow, do not give yourself a second dose without speaking to your healthcare provider.
Croatian: Ako prozorčić nije postao posve žut, nemojte primijeniti još jednu dozu bez prethodnog razgovora sa svojim liječnikom.
English: • The effects of Kevzara on an unborn baby are not known.
Croatian: • Učinci lijeka Kevzara na nerođeno dijete nisu poznati.
English: As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
Croatian: Budući da je incidencija infekcija općenito viša u populaciji starijih osoba, potreban je oprez pri liječenju starijih bolesnika.
English: Simvastatin is a CYP3A4 and OATP1B1 substrate.
Croatian: Simvastatin je supstrat enzima CYP3A4 i prijenosnika OATP1B1.
English: The safety and efficacy of Kevzara in children up to 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Kevzara u djece u dobi do 18 godina nisu ustanovljene.
English: If somebody else gives you the injection, you can also use the outer area of the upper arm.
Croatian: Ako Vam injekciju daje netko drugi, ona se može primijeniti i u vanjski dio nadlaktice.
English: Sarilumab was detected in the serum of neonates up to 1 month.
Croatian: Sarilumab je bio prisutan u serumu mladunčadi do mjesec dana.
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
Croatian: 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: Table 6: Efficacy results for MONARCH
Croatian: Tablica 6: Rezultati djelotvornosti iz ispitivanja MONARCH
English: These responses persisted through 3 years of therapy in an open-label extension study.
Croatian: Ti su se odgovori održali tijekom 3 godine liječenja u otvorenom produžetku ispitivanja.
English: • statins, used to reduce cholesterol level
Croatian: • statine, koji se koriste za snižavanje razine kolesterola
English: It is a type of protein called a monoclonal antibody.
Croatian: To je jedna vrsta proteina koja se zove monoklonsko protutijelo.
English: • you have had viral hepatitis or other liver disease.
Croatian: • ako ste ikada imali virusni hepatitis ili neku drugu jetrenu bolest.
English: • lived in or travelled to areas of endemic tuberculosis or endemic mycoses.
Croatian: • koji su živjeli u područjima ili putovali u područja gdje su tuberkuloza ili mikoza endemske bolesti
English: Kevzara can be used alone or together with a medicine called methotrexate.
Croatian: Kevzara se može primjenjivati sama ili u kombinaciji s lijekom koji se zove metotreksat.
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).
Croatian: Učestalost nuspojava navedenih u nastavku definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000).
English: Look at the medicine.
Croatian: Pregledajte lijek.
English: ALT > 1 to 3 x Upper Limit of Normal (ULN)
Croatian: ALT > 1 - 3 x iznad gornje granice normale (GGN)
English: Pharmacotherapeutic group: Immunosupressants, Interleukin inhibitors, ATC code: L04AC14
Croatian: Farmakoterapijska skupina: imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC14 Mehanizam djelovanja
English: Dose modification:
Croatian: Prilagodba doze:
English: • Your doctor, pharmacist, or nurse will show you how to inject Kevzara.
Croatian: • Vaš liječnik, ljekarnik ili medicinska sestra pokazat će Vam kako injicirati lijek Kevzara.
English: Non-clinical data reveal no special hazard for humans based on repeated-dose toxicity studies, carcinogenic risk assessment and reproductive and developmental toxicity studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza, kancerogenog potencijala te reproduktivne i razvojne toksičnosti.
English: Women of childbearing potential should use effective contraception during and up to 3 months after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i do 3 mjeseca po njegovu završetku.
English: Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: • if you are allergic to sarilumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na sarilumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • Carefully follow the “Instructions for Use” provided in the carton.
Croatian: • Pažljivo pratite ‘Upute za uporabu' koje se nalaze u kutiji.
English: Levels were reduced to normal as early as 4 days after treatment initiation.
Croatian: Te su se vrijednosti snizile na normalne već 4 dana nakon početka liječenja.
English: The safety of Kevzara in combination with DMARDs was evaluated based on data from seven clinical studies, of which two were placebo-controlled, consisting of 2887 patients (long- term safety population).
Croatian: Sigurnost lijeka Kevzara u kombinaciji s DMARD-ovima ocjenjivala se na temelju podataka iz sedam kliničkih ispitivanja, od kojih su dva bila kontrolirana placebom, a uključivala su 2887 bolesnika (populacija za ocjenu dugoročne sigurnosti).
English: p-value versus adalimumab
Croatian: p-vrijednost naspram adalimumaba
English: At higher concentrations, the elimination is predominantly through the linear, non-saturable proteolytic pathway, while at lower concentrations, non-linear saturable target-mediated elimination predominates.
Croatian: Pri visokim se koncentracijama eliminacija odvija pretežno linearnim, nesaturabilnim, proteolitičkim putem, dok pri nižim koncentracijama prevladava nelinearna, saturabilna eliminacija posredovana ciljnim mjestom.
English: In MOBILITY and TARGET, physical function and disability were assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI).
Croatian: U ispitivanju MOBILITY i TARGET fizička funkcija i onesposobljenost ocjenjivali su se na temelju indeksa onesposobljenosti prema upitniku za ocjenu zdravstvenog stanja (HAQ-DI).
English: • Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action.
Croatian: • Kevzara se vezuje za jedan drugi protein koji se zove receptor interleukina-6 (IL-6) i blokira njegovo djelovanje.
English: Patients should be advised to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction.
Croatian: Bolesnicima treba savjetovati da odmah potraže liječničku pomoć ako se pojavi bilo koji simptom reakcije preosjetljivosti.
English: • other biological medicines used in the treatment of rheumatoid arthritis.
Croatian: • druge biološke lijekove koji se koriste za liječenje reumatoidnog artritisa
English: The symptoms may include fever, sweats, or chills.
Croatian: Simptomi mogu uključivati vrućicu, znojenje ili zimicu.
English: Because IgG1 are excreted in human milk, a decision should be made whether to discontinue breastfeeding or to discontinue sarilumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Budući da se IgG1 izlučuje u majčino mlijeko, treba donijeti odluku o tome hoće li se prekinuti dojenje ili liječenje sarilumabom, uzimajući u obzir korist dojenja za dijete i dobrobit liječenja za ženu.
English: morning stiffness, and fatigue.
Croatian: jutarnja ukočenost i umor.
English: What Kevzara looks like and contents of the pack
Croatian: Kako Kevzara izgleda i sadržaj pakiranja
English: No cases of Hepatitis B reactivation were reported in the clinical studies; however patients who were at risk for reactivation were excluded.
Croatian: U kliničkim ispitivanjima nisu prijavljeni slučajevi ponovne aktivacije virusa hepatitisa B; međutim, bolesnici u kojih je postojao rizik od ponovne aktivacije nisu bili uključeni u ispitivanja.
English: Of these, 2170 patients received Kevzara for at least 24 weeks, 1546 for at least 48 weeks, 1020 for at least 96 weeks, and 624 for at least 144 weeks.
Croatian: Od tih je bolesnika njih 2170 primalo lijek Kevzara tijekom najmanje 24 tjedna, njih 1546 tijekom najmanje 48 tjedana, njih 1020 tijekom najmanje 96 tjedana, a njih 624 tijekom najmanje 144 tjedna.
English: Lipid levels may be reduced in patients with chronic inflammation.
Croatian: Vrijednosti lipida mogu biti snižene u bolesnika s kroničnom upalom.
English: Do not stop using Kevzara without talking to your doctor.
Croatian: Nemojte prestati primjenjivati lijek Kevzara bez prethodnog razgovora sa svojim liječnikom.
English: Interactions with CYP450 substrates
Croatian: Interakcije sa supstratima enzima CYP450
English: Patients should be managed according to clinical guidelines for the management of hyperlipidaemia.
Croatian: Bolesnike treba liječiti u skladu s kliničkim smjernicama za liječenje hiperlipidemije.
English: • then inject your next dose at your regular time.
Croatian: • zatim injicirajte sljedeću dozu u uobičajeno vrijeme
English: Patients with latent or active tuberculosis should be treated with standard antimycobacterial therapy before initiating Kevzara.
Croatian: Bolesnike s latentnom ili aktivnom tuberkulozom treba liječiti standardnom antimikobakterijskom terapijom prije nego što se uvede Kevzara.
English: Check that you have the correct medicine and the correct dose.
Croatian: Provjerite imate li točan lijek i točnu dozu.
English: • IL-6 plays a major role in the symptoms of rheumatoid arthritis such as pain, swollen joints,
Croatian: • IL-6 igra veliku ulogu u simptomima reumatoidnog artritisa kao što su bol, otečeni zglobovi,
English: Clinically appropriate dose modification of concomitant DMARDs should be considered.
Croatian: Treba razmotriti klinički odgovarajuću prilagodbu doze istodobno primijenjenih DMARD-ova.
English: Before you remove the needle, check that the syringe is empty.
Croatian: Prije nego što izvadite iglu, povjerite je li štrcaljka prazna.
English: Physical function response
Croatian: Odgovor fizičke funkcije
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.
Croatian: Kako bi se unaprijedila sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka treba jasno zabilježiti.
English: Do not inject through your clothes.
Croatian: Nemojte injicirati lijek kroz odjeću.
English: • Clean skin with an alcohol wipe.
Croatian: • Očistite kožu tupferom natopljenim alkoholom.
English: When considering anti-tuberculosis therapy, consultation with a physician with expertise in tuberculosis may be appropriate.
Croatian: Kada se razmatra terapija za tuberkulozu, možda bi bilo dobro konzultirati se s liječnikom koji je stručnjak za tu bolest.
English: Put the yellow needle cover on your skin at roughly a 90° angle.
Croatian: Položite žuti pokrov igle na kožu pod kutom od približno 90°.
English: • theophylline, used to treat asthma
Croatian: • teofilin, koji se koristi za liječenje astme
English: • Educate patients on signs or symptoms that could represent serious infections or gastrointestinal perforations to seek for medical attention immediately.
Croatian: • Informacije za edukaciju bolesnika o znakovima ili simptomima koji bi mogli ukazivati na ozbiljne infekcije ili gastrointestinalnu perforaciju, uz upozorenje da u tom slučaju odmah potraže liječničku pomoć.
English: DAS28-ESR (primary endpoint)
Croatian: DAS28-ESR (primarna mjera ishoda)
English: The metabolic pathway of sarilumab has not been characterised.
Croatian: Put metabolizma sarilumaba nije okarakteriziran.
English: ANC 0.5-1
Croatian: ABN 0,5 - 1
English: MTX exposure is not expected to be changed by sarilumab coadministration; however, no clinical data was collected.
Croatian: Ne očekuje se da će istodobna primjena sarilumaba utjecati na izloženost MTX-u; međutim, nisu prikupljeni klinički podaci.
English: For further details on administration of this medicinal product see section 6.6.
Croatian: Za više informacija o primjeni ovog lijeka vidjeti dio 6.6.
English: • Do not take Kevzara if you are pregnant unless your doctor specifically recommends it.
Croatian: • Nemojte primijeniti lijek Kevzara ako ste trudni, osim ako Vam to izričito ne preporuči Vaš liječnik.
English: Table 3: Clinical Response at Weeks 12, 24, and 52 in Placebo-Controlled Studies, MOBILITY and TARGET
Croatian: Tablica 3: Klinički odgovor u 12., 24. i 52. tjednu u placebom kontroliranim ispitivanjima MOBILITY i TARGET
English: The pre-filled syringe/pre-filled pen should be inspected before use.
Croatian: Napunjenu štrcaljku/napunjenu brizgalicu treba pregledati prije uporabe.
English: However, if you are feeling tired or unwell after you use Kevzara, you should not drive or use machines.
Croatian: Međutim, ako se nakon primjene lijek Kevzara osjećate umorno ili loše, ne smijete voziti ni raditi sa strojevima.
English: The most commonly reported infections (5% to 7% of patients) were upper respiratory tract infections, urinary tract infections, and nasopharyngitis.
Croatian: Najčešće prijavljene infekcije (5 - 7% bolesnika) bile su infekcije gornjih dišnih putova, infekcije mokraćnih putova i nazofaringitis.
English: Kevzara can lower your body's ability to fight infection and this means it can make you more likely to get infections or make your infection worse.
Croatian: Kevzara može smanjiti sposobnost tijela da se bori protiv infekcije, što znači da Vas može učiniti podložnijima infekcijama ili pogoršati infekciju koju imate.
English: ANC greater than 1
Croatian: ABN iznad 1
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake ‘EXP'.
English: No long-term animal studies have been performed to establish the carcinogenicity potential of sarilumab.
Croatian: Nisu provedena dugoročna ispitivanja na životinjama kojima bi se utvrdio kancerogeni potencijal sarilumaba.
English: No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving Kevzara.
Croatian: Nema dostupnih podataka o sekundarnom prijenosu infekcije s osobe koja je primila živo cjepivo na bolesnike koji primaju lijek Kevzara.
English: Other medicines and Kevzara
Croatian: Drugi lijekovi i Kevzara
English: Sarilumab is eliminated by parallel linear and non-linear pathways.
Croatian: Sarilumab se usporedo eliminira linearnim i nelineranim putovima.
English: Prepare the injection site.
Croatian: Pripremite mjesto injiciranja.
English: If you use more Kevzara than you should
Croatian: Ako primijenite više lijeka Kevzara nego što ste trebali
English: • Check that you have the correct medicine and the correct dose.
Croatian: • Provjerite imate li točan lijek i točnu dozu.
English: Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: If confirmed by repeat testing, treatment with Kevzara should be discontinued.
Croatian: Ako se potvrdi ponovljenim testiranjem, liječenje lijekom Kevzara treba obustaviti.
English: It is unknown whether sarilumab is excreted in human milk or absorbed systemically after ingestion.
Croatian: Nije poznato izlučuje li se sarilumab u majčino mlijeko niti apsorbira li se sistemski nakon ingestije.
English: Kevzara should not be administered in patients with an active infection, including localised infections.
Croatian: Kevzara se ne smije primijeniti bolesnicima s aktivnom infekcijom, uključujući lokalizirane infekcije.