FrancophonIA/ELRC3.0 huggingface dataset:
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Croatian: Eastbourne, East Sussex BN22 9AG Ujedinjeno Kraljevstvo
English: Washout procedure
Croatian: Ispiranje („washout“ postupak)
English: Pack sizes of 30 and 100 film-coated tablets.
Croatian: Veličine pakiranja od 30 i 100 filmom obloženih tableta.
English: Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=182), methotrexate 7.5 mg/week increasing to 15 mg/week (n=182), or placebo (n=118).
Croatian: U studiji US301, 482 randomizirana bolesnika s aktivnim reumatoidnim artritisom primala su leflunomid 20 mg/dan (n=182), metotreksat 7,5 mg/tjedan, s povećanjem doze na 15 mg/tjedan (n= 182), ili placebo (n=118).
English: Do not take Repso - If you are allergic to leflunomide (especially a serious skin reaction, often with fever, joint pain,
Croatian: - Ako ste alergični na leflunomid (pogotovo ako imate teške kožne reakcije, često udružene s vrućicom, bolovima u zglobovima, crvenim kožnim mrljama ili mjehurićima, npr. Steven
English: Breast-feeding women must, therefore, not receive leflunomide.
Croatian: Žene reproduktivne dobi ne smiju uzimati
English: diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain; colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis
Croatian: proljev, mučnina, povraćanje, poremećaji sluznice usne šupljine (npr. aftozni stomatitis, ulceracije u ustima), bol u trbuhu; kolitis, uključujući mikroskopski kolitis poput limfocitnog kolitisa, kolagenog kolitisa
English: - Unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Croatian: - Kašlja ili problema s disanjem jer to može upućivati na probleme s plućima (intersticijska plućna bolest ili plućna hipertenzija) - Neuobičajenih trnaca, slabosti li bolova u šakama ili stopalima jer mogu upućivati na probleme sa živcima (periferna neuropatija).
English: All elevations resolved, 2 with continuation of both drugs and 3 after discontinuation of leflunomide.
Croatian: Sve su se povišene vrijednosti smanjile u 2 bolesnika koji su nastavili istodobno uzimati oba lijeka i u 3 bolesnika koji su prekinuli uzimati leflunomid.
English: LIST OF EXCIPIENTS Contains lactose (see leaflet for further information).
Croatian: POPIS POMOĆNIH TVARI Sadrži laktozu (vidjeti Uputu o lijeku za dodatne informacije).
English: There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of OAT3 in vivo.
Croatian: Zabilježeno je povećanje prosječne Cmax i AUC (1,43 odnosno 1,54 puta) za cefaklor, nakon ponovljenih doza A771726, što ukazuje da je A771726 inhibitor OAT3 in vivo.
English: Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS (see above and section 2) may also occur with an unknown frequency.
Croatian: Također se mogu javiti druge nuspojave poput zatajenja bubrega, smanjene koncentracije uratne (mokraćne) kiseline u krvi, plućne hipertenzije, muške neplodnosti (koja se povlači nakon prestanka primjene ovoga lijeka), kožnog lupusa (karakteriziran osipom/crvenilom na područjima kože izloženima svjetlu), psorijaze (novonastala psorijaza ili pogoršanje postojeće) i reakcije na lijek s eozinofilijom i sistemskim simptomima (DRESS) (vidjeti gore i dio 2), ali je njihova učestalost nepoznata.
English: Leflunomide is indicated for the treatment of adult patients with
Croatian: KLINIČKI PODACI 4.1 Terapijske indikacije Leflunomid je indiciran u liječenju odraslih bolesnika s
English: - The active substance is leflunomide.
Croatian: - Djelatna tvar je leflunomid.
English: The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Croatian: Aktivni metabolit A771726 ekstenzivno se veže za proteine plazme i uklanja jetrenim metabolizmom te izlučuje putem žuči.
English: The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment with leflunomide.
Croatian: Smanjenje koncentracije A771726 u plazmi na razinu nižu od 0,02 mg/l očekuje se za oko dvije godine nakon prekida liječenja leflunomidom.
English: Some vaccinations should not be given while taking Repso, and for a certain amount of time after stopping treatment.
Croatian: Za vrijeme uzimanja Repsa kao i određeno vrijeme nakon prekida liječenja ne smije se provoditi cijepljenje određenim cjepivima.
English: anaemia, mild thrombocytopenia (platelets < 100 G/l)
Croatian: Manje često: anemija, blaga trombocitopenija (trombociti <100 g/l).
English: What Repso looks like and contents of the pack Repso 20 mg film-coated tablets are dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Croatian: Repso 20 mg filmom obložene tablete su tamno bež, filmom obložene tablete, trokutastog oblika, s utisnutom oznakom „20“ na jednoj strani i „L“ na drugoj.
English: See section 4.
Croatian: DRESS), pogledajte dio 2.
English: Dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Croatian: Tamno bež, trokutaste, filmom obložene tablete, s oznakom „20“ utisnutom na jednoj strani i „L“ na drugoj.
English: In responders, this response was maintained during 48 weeks.
Croatian: U bolesnika u kojih je zabilježen odgovor na liječenje on se održao kroz 48 tjedana (vidjeti dio 4.2.).
English: - Theophylline for asthma - Tizanidine, a muscle relaxant - Oral contraceptives (containing ethinylestradiol and levonorgestrel) - Cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - Indomethacin, ketoprofen for pain or inflammation - Furosemide for heart disease (diuretic, water pill) - Zidovudine for HIV infection - Rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - Sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - Colestyramine (used to lower cholesterol levels and treat itching associated with jaundice) or activated charcoal as these medicines can reduce the amount of Repso absorbed by your body.
Croatian: - Tizanidin, lijek za opuštanje mišića - Oralni lijekovi za sprječavanje trudnoće (koji sadrže etinilestradiol i levonorgestrel) - Cefaklor, benzilpenicilin (penicilin G), ciprofloksacin, za liječenje infekcija - Indometacin, ketoprofen za liječenje boli ili upale - Furosemid za liječenje bolesti srca (diuretik, tableta za vodu) - Zidovudin za liječenje HIV infekcije - Rosuvastatin, simvastatin, atorvastatin, pravastatin za liječenje hiperkolesterolemije
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Croatian: ROK VALJANOSTI Rok valjanosti POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C.
English: What Repso looks like and contents of the pack Repso 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Croatian: Repso 10 mg filmom obložene tablete su bijele, okrugle, filmom obložene tablete, s utisnutom oznakom „10“ na jednoj strani i „L“ na drugoj.
English: Repso 10 mg film-coated tablets leflunomide
Croatian: Repso 10 mg filmom obložene tablete leflunomid
English: Repso 20 mg film-coated tablets leflunomide
Croatian: Repso 20 mg filmom obložene tablete leflunomid
English: Repso 20 mg film-coated tablets
Croatian: Repso 20 mg filmom obložene tablete
English: - If you are male and wish to father a child. As it cannot be excluded that Repso passes into semen, reliable contraception should be used during treatment with Repso.
Croatian: Budući da se ne može isključiti izlučivanje Repsa u sjeme, tijekom terapije Repsom treba primjenjivati učinkovitu kontracepciju.
English: Repso 10 mg film-coated tablets
Croatian: Repso 10 mg filmom obložene tablete
English: Quinoline Yellow Aluminium lake (E104) Indigo Carmine Aluminium Lake (E132)
Croatian: Ovojnica tablete titanijev dioksid (E171) hipromeloza (E464) makrogol 400 željezov oksid, žuti (E172) polisorbat (E433) boja Quinoline Yellow Aluminium lake (E104) boja Indigo Carmine Aluminium Lake (E132)
English: - If you get any side effects , talk to your doctor, pharmacist or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: • Each film-coated tablet contains 20 mg of leflunomide.
Croatian: • Jedna filmom obložena tableta sadrži 20 mg leflunomida.
English: • Each film-coated tablet contains 10 mg of leflunomide.
Croatian: • Jedna filmom obložena tableta sadrži 10 mg leflunomida.
English: Each film-coated tablet contains 20 mg of leflunomide.
Croatian: Jedna filmom obložena tableta sadrži 20 mg leflunomida.
English: EU/1/11/674/008 28 film-coated tablets EU/1/11/674/009 30 film-coated tablets EU/1/11/674/010 100 film-coated tablets
Croatian: EU/1/11/674/008 28 filmom obloženih tableta EU/1/11/674/009 30 filmom obloženih tableta EU/1/11/674/010 100 filmom obloženih tableta
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Repso 10 mg film-coated tablets Each film-coated tablet contains 10 mg of leflunomide.
Croatian: Repso 10 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 10 mg leflunomida.
English: INFORMATION IN BRAILLE Repso 10 mg film-coated tablets
Croatian: NAČIN IZDAVANJA LIJEKA UPUTE ZA UPORABU PODACI NA BRAILLEOVOM PISMU Repso 10 mg filmom obložene tablete
English: The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Croatian: Neki od imunosupresivnih lijekova mogu povećati rizik od pojave tumora, osobito limfoproliferativnih poremećaja.
English: This may affect your ability to concentrate or react properly.
Croatian: Dok uzimate Repso, možete osjećati omaglicu, što može smanjiti Vašu sposobnost koncentriranja i reagiranja.
English: NAME OF THE MEDICINAL PRODUCT Repso 20 mg tablets leflunomide
Croatian: NAZIV LIJEKA Repso 20 mg tablete leflunomid NAVOĐENJE DJELATNE/IH
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: Teva B.V.
English: Rare side effects (may affect up to 1 in 1,000 people) - Severe increase in blood pressure.
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba) - izraziti porast krvnog tlaka; - smanjenje broja svih krvnih stanica (pancitopenija); - značajno smanjenje broja bijelih krvnih stanica, što može povećati sklonost infekcijama
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Repso.
Croatian: Kad se razmatra primjena živih atenuiranih cjepiva nakon prekida liječenja lijekom Leflunomide Winthrop, potrebno je uzeti u obzir dugi poluvijek leflunomida.
English: NAME OF THE MEDICINAL PRODUCT Repso 10 mg film-coated tablets Repso 20 mg film-coated tablets
Croatian: Repso 10 mg filmom obložene tablete Repso 20 mg filmom obložene tablete
English: INFORMATION IN BRAILLE Repso 20 mg film-coated tablets
Croatian: NAČIN IZDAVANJA LIJEKA UPUTE ZA UPORABU PODACI NA BRAILLEOVOM PISMU Repso 20 mg filmom obložene tablete
English: EU/1/11/674/003 28 film-coated tablets EU/1/11/674/004 30film-coated tablets EU/1/11/674/005 100 film-coated tablets
Croatian: EU/1/11/674/003 28 filmom obloženih tableta EU/1/11/674/004 30 filmom obloženih tableta EU/1/11/674/005 100 filmom obloženih tableta
English: NAME OF THE MEDICINAL PRODUCT Repso 20 mg film-coated tablets leflunomide
Croatian: NAZIV LIJEKA Repso 20 mg filmom obložene tablete leflunomid NAVOĐENJE DJELATNE/IH
English: EU/1/11/674/001 30 film-coated tablets EU/1/11/674/002 100 film-coated tablets
Croatian: EU/1/11/674/001 30 filmom obloženih tableta EU/1/11/674/002 100 filmom obloženih tableta
English: EU/1/11/674/006 30 film-coated tablets EU/1/11/674/007 100 film-coated tablets
Croatian: EU/1/11/674/006 30 filmom obloženih tableta EU/1/11/674/007 100 filmom obloženih tableta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/674/001-010
Croatian: EU/1/11/674/001-010
English: Tablet coating
Croatian: zatajenje bubrega
English: Especially if you are taking any of the following: - Other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable - Warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - Teriflunomide for multiple sclerosis - Repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - Daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - Duloxetine for depression, urinary incontinence or in kidney disease in diabetics - Alosetron for the management of severe diarrhoea
Croatian: - Varfarin i druge oralne lijekove koji se koriste za razrjeđivanje krvi, jer je potrebno praćenje kako bi se smanjio rizik od nuspojava tih lijekova - Teriflunomid za liječenje multiple skleroze - Repaglinid, pioglitazon, nateglinid ili roziglitazon za liječenje šećerne bolesti - Daunorubicin, doksorubicin, paklitaksel ili topotekan za liječenje raka
English: NAME OF THE MEDICINAL PRODUCT Repso 10 mg tablets leflunomide
Croatian: NAZIV LIJEKA Repso 10 mg tablete leflunomid NAVOĐENJE DJELATNE/IH
English: NAME OF THE MEDICINAL PRODUCT Repso 10 mg film-coated tablets leflunomide
Croatian: NAZIV LIJEKA Repso 10 mg filmom obložene tablete leflunomid NAVOĐENJE DJELATNE/IH
English: Each film-coated tablet contains 10 mg of leflunomide.
Croatian: TVARI Jedna filmom obložena tableta sadrži 10 mg leflunomida.
English: Very rare side effects (may affect up to 1 in 10,000 people) - An infection characterised by high fever, sore throat, skin lesions and an extreme reduction of white blood cells (agranulocytosis).
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1 000 osoba) - izraziti porast krvnog tlaka; - smanjenje broja svih krvnih stanica (pancitopenija);, - značajno smanjenje broja bijelih krvnih stanica, što može povećati sklonost infekcijama
English: - An increase of lactate dehydrogenase (a blood enzyme).
Croatian: Učinak na suptrate BCRP (protein za rezistenciju na karcinom dojke, engl.
English: Especially if you are taking any of the following: - Other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisible - Warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - Teriflunomide for multiple sclerosis - Repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - Daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - Duloxetine for depression, urinary incontinence or in kidney disease in diabetics
Croatian: Posebno ako uzimate neki od sljedećih lijekova: - Druge lijekove za reumatoidni artritis, kao što su antimalarici (npr. klorokin i hidroksiklorokin), intramuskularno ili peroralno zlato, D-penicilamin, azatioprin i druge imunosupresivne lijekove (npr. metotreksat), jer se te kombinacije ne preporučuju.
English: HDPE tablet containers: 2 years
Croatian: Repso 10 mg filmom obložene tablete HDPE spremnici za tablete: 2 godine.
English: Silica, colloidal anhydrous Lactose anhydrous Magnesium stearate
Croatian: Jezgra tablete laktoza hidrat povidon krospovidon vrste A škrob, prethodno geliran (kukuruzni) talk silicijev dioksid, koloidni, bezvodni laktoza, bezvodna magnezijev stearat
English: Cutaneous use Bottle (PET)
Croatian: Bocu (PET)
English: 1 bottle Not applicable
Croatian: 1 bocu
English: Cutaneous spray, solution
Croatian: Sprej za kožu, otopina.
English: A risk to the child cannot be excluded.
Croatian: Ne može se isključiti rizik za dijete.
English: The plunger may rise up by itself again - this is normal.
Croatian: Klip štrcaljke se može podizati sam od sebe - to je normalno.
English: Unopened vial 4 years.
Croatian: Neotvorena bočica 4 godine.
English: Date removed from refrigerator: ________________________
Croatian: Datum vađenja iz hladnjaka: ________________________
English: Never expose to temperatures above 30 °C.
Croatian: Nikada ne izlažite lijek temperaturi višoj od 30 °C.
English: Differences in the different subpopulations were investigated.
Croatian: Ispitivane su i razlike u različitim podskupinama.
English: Patients were followed for 1 month after discontinuation of treatment.
Croatian: Bolesnici su praćeni 1 mjesec nakon prestanka liječenja.
English: Date of first authorisation: 31 August 2018
Croatian: Datum prvog odobrenja: 31. kolovoz 2018.
English: Children and adolescents Cablivi is not recommended for children under 18 years.
Croatian: Djeca i adolescenti Cablivi se ne preporučuje u djece mlađe od 18 godina.
English: • Wash your hands thoroughly with soap and water.
Croatian: • Temeljito operite ruke sapunom i vodom
English: Total volume of plasma used (liter)
Croatian: Ukupno korišten volume plazme (litra)
English: The recommended treatment is
Croatian: Preporučeno liječenje je
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, osim ako metoda rekonstituiranja isključuje rizik od mikrobiološke kontaminacije, proizvod se mora odmah upotrijebiti.
English: Injury, Poisoning And Procedural Complications
Croatian: Ozljede, trovanja i proceduralne komplikacije
English: Patient age ranged from 18 to 79 years, with a mean of 46 years.
Croatian: Bolesnici su imali između 18 i 79 godina, a srednja dob bila je 46 godina.
English: Although in some cases these events were serious and required medical attention, most were self-limited and all resolved.
Croatian: Iako su u nekim slučajevima ti događaji bili ozbiljni i zahtijevali liječničku pomoć, većina njih bila je ograničena i povukla se sama od sebe.
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
Croatian: Kemijska i fizička stabilnost lijeka u primjeni dokazana je tijekom 4 sata na 25°C.
English: Make sure the needle does not touch anything before the injection.
Croatian: Pazite da igla ništa ne dodiruje prije primjene injekcije.
English: The doctor will say when you can start your treatment again.
Croatian: Liječnik će vam reći kada možete ponovno započeti liječenje.
English: Study ALX0681-C301
Croatian: Ispitivanje ALX0681-C301
English: Contact your doctor immediately if any of the following serious side effects occur.
Croatian: Odmah se javite svom liječniku ako se pojave bilo koje od sljedećih ozbiljnih nuspojava.
English: In case of active clinically significant bleeding, consider actions outlined in sections 4.4 and 4.9.
Croatian: U slučaju aktivnog klinički značajnog krvarenja, razmotrite mjere opisane u dijelu 4.4 i 4.9.
English: In patients with aTTP the central volume of distribution was estimated at 6.33 L.
Croatian: U bolesnika s aTTP-om, središnji volumen distribucije bio je procijenjen na 6,33 L.
English: Body weight was allometrically included in the model.
Croatian: Tjelesna težina je alometrijski uključena u model.
English: Tell your doctor if you are pregnant or plan to get pregnant.
Croatian: Obavijestite svog liječnika ako ste trudni ili planirate trudnoću.
English: • Go to step 8 immediately after these 5 minutes.
Croatian: • Nakon 5 minuta, odmah prijeđite na 8. korak.
English: Tell your doctor if you:
Croatian: Obratite se svom liječniku ako:
English: Do not warm them up in any other way.
Croatian: Nemojte ih ni u kom slučaju zagrijavati.
English: Frequencies are defined as follows: 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), not known (cannot be estimated from the available data).
Croatian: Učestalosti pojave nuspojava definirane su na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Increased risk of bleeding
Croatian: Povećani rizik od krvarenja
English: Step 2 - Before use
Croatian: Korak 2 - Prije upotrebe
English: Very common, may affect more than 1 in 10 people
Croatian: Vrlo često, mogu se javiti u više od 1 na 10 osoba
English: If not used immediately, in-use storage times and conditions are the responsibility of user.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika.
English: The line can be flushed with 0.9% sodium chloride.
Croatian: Linija se može isprati 0,9 %-tno otopinom natrijeva klorida.
English: The most common serious adverse reaction was epistaxis.
Croatian: Najčešća ozbiljna nuspojava bila je epistaksa.
English: Long or excessive bleeding.
Croatian: Dugotrajno ili pretjerano krvarenje
English: Active clinically significant bleeding
Croatian: Aktivno klinički značajno krvarenje
English: In clinical studies, bleeding events occurred in different body systems, independent of treatment duration.
Croatian: U kliničkim ispitivanjima, krvarenja su se događala u različitim organskim sustavima neovisno o trajanju liječenja.
English: Cablivi is available in
Croatian: Cablivi je dostupan u
English: N: number of patients evaluated; SE: Standard Error; ICU: Intensive Care Unit
Croatian: N: broj procijenjenih bolesnika; SE: standardna pogreška;
English: These clots can block blood vessels and damage the brain, heart, kidneys, or other organs.
Croatian: Ti ugrušci mogu blokirati krvne žile i oštetiti mozak, srce, bubrege i ostale organe.
English: This is a rare blood clotting disorder in which clots form in small blood vessels.
Croatian: To je rijedak poremećaj zgrušavanja krvi kod kojeg se ugrušci formiraju u malim krvnim žilama.
English: Length of hospitalization (days)
Croatian: Trajanje hospitalizacije (dani)
English: Your doctor may ask you to stop the treatment.
Croatian: Vaš liječnik vas može zatražiti da prekinete liječenje.
English: Your doctor will decide how you should be treated.
Croatian: Vaš liječnik će odlučiti kako vas treba liječiti.
English: Transfer the entire volume of the reconstituted solution back to the glass syringe and immediately administer the entire volume of the syringe (see section 6.3).
Croatian: Prebacite cijeli volumen rekonstituirane otopine natrag u staklenu štrcaljku i odmah primijenite cijeli volumen štrcaljke (vidjeti dio 6.3).
English: Half of the patients were experiencing their first episode of aTTP.
Croatian: Polovica bolesnika doživjela je prvu epizodu aTTP-a.
English: Never use the kit for another injection.
Croatian: Nikada ne koristite isti set za primjenu druge injekcije.
English: • bleed excessively during treatment.
Croatian: • pretjerano krvarite tijekom liječenja.
English: • Do not use the syringe if this white cap is missing, loose or damaged.
Croatian: • Nemojte upotrijebiti štrcaljku ako bijela kapica nedostaje ili je labava ili oštećena.
English: In studied populations; gender, age, blood group and race did not affect the pharmacokinetics of caplacizumab.
Croatian: U ispitivanim populacijama; spol, dob, krvna grupa i rasa nisu utjecali na farmakokinetiku kaplacizumaba.
English: In patients with coagulopathies
Croatian: Bolesnici s koagulopatijama
English: See section 4.4 for special considerations in patients with severe hepatic impairment.
Croatian: Vidjeti dio 4.4 za posebna razmatranja kod bolesnika s teškim oštećenjem funkcije bubrega.
English: Do not use if the expiry date has passed.
Croatian: Nemojte upotrijebiti ako je prošao rok valjanosti.
English: Avoid foaming.
Croatian: Izbjegavajte pjenu.