FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 270 patients 65 years of age and older, including 46 patients 75 years and older, received subcutaneous abatacept in controlled clinical trials.
Croatian: U kontroliranim kliničkim ispitivanjima abatacept je supkutano primalo ukupno 270 bolesnika u dobi od 65 ili više godina, uključujući i 46 bolesnika u dobi od 75 ili više godina.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 125 mg abatacept in one mL.
Croatian: 2. NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica sadrži 125 mg abatacepta u jednom ml.
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 87.5 mg solution for injection in pre-filled syringe abatacept
Croatian: ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki abatacept
English: Paediatric population Polyarticular juvenile idiopathic arthritis
Croatian: Pedijatrijska populacija Poliartikularni juvenilni idiopatski artritis
English: The percent of abatacept-treated patients achieving ACR 20, 50, and 70 responses in study II (patients with inadequate response to methotrexate), study III (patients with inadequate response to TNFinhibitor), study VI (methotrexate-naive patients), and study SC-I (subcutaneous abatacept) are shown in Table 2.
Croatian: Postotak bolesnika liječenih abataceptom koji su postigli odgovore ACR20, ACR50 te ACR70 u ispitivanju II (bolesnici koji nisu dovoljno dobro odgovorili na metotreksat), ispitivanju III (bolesnici koji nisu dovoljno dobro odgovorili na TNF-inhibitor), ispitivanju VI (bolesnici koji prethodno nisu primali metotreksat) i ispitivanju SC-I (supkutana primjena abatacepta) prikazani su u Tablici 2.
English: The percent of abatacept-treated patients achieving ACR 20, 50, and 70 responses in study II (patients with inadequate response to methotrexate), study III (patients with inadequate response to TNFinhibitor), study VI (methotrexate-naive patients), and study SC-I (subcutaneous abatacept) are shown in Table 3.
Croatian: Postotak bolesnika liječenih abataceptom koji su postigli odgovore ACR20, ACR50 te ACR70 u ispitivanju II (bolesnici koji nisu dovoljno dobro odgovorili na metotreksat), ispitivanju III (bolesnici koji nisu dovoljno dobro odgovorili na TNF-inhibitor), ispitivanju VI (bolesnici koji prethodno nisu primali metotreksat) i ispitivanju SC-I (supkutana primjena abatacepta) prikazani su u Tablici 3.
English: Outer area of upper arms
Croatian: Vanjski dio nadlaktica
English: In the open-label extension of studies I, II, III, and VI durable and sustained ACR 20, 50, and 70 responses have been observed through 7 years, 5 years, 5 years, and 2 years, respectively, of abatacept treatment.
Croatian: Postojani i održani odgovori ACR20, ACR50 odnosno ACR70 zabilježeni su tijekom 7 godina liječenja abataceptom u ispitivanju I, tijekom 5 godina u ispitivanjima II i III, tijekom 2 godine liječenja abataceptom u ispitivanju VI te tijekom 5 godina u ispitivanju SC-I.
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
Croatian: ORENCIA 250 mg prašak za koncentrat za otopinu za infuziju abatacept
English: Read the package leaflet for the shelf-life of the reconstituted product.
Croatian: Pročitajte uputu o lijeku za rok valjanosti pripremljenog lijeka.
English: Abatacept/methotrexate reduced the rate of progression of structural damage compared to placebo/methotrexate after 12 months of treatment as shown in Table 5.
Croatian: Abatacept i metotreksat su nakon 12 mjeseci liječenja smanjili brzinu napredovanja strukturnog oštećenja u usporedbi s primjenom placeba i metotreksata, kako je prikazano u Tablici 5. Brzina napredovanja strukturnog oštećenja je za bolesnike randomizirane na abatacept bila značajno manja u 2. nego u 1. godini (p < 0,0001).
English: NAe
Croatian: NDd
English: Improvement from baseline as measured by HAQ-DI at 24 months and over time was also similar between abatacept SC and adalimumab SC.
Croatian: Poboljšanje u odnosu na početnu vrijednost u 24. mjesecu i tijekom vremena, mjereno indeksom onesposobljenosti iz upitnika za procjenu zdravlja (HAQ-DI), također je bilo slično u skupini koja je primala abatacept za supkutanu primjenu i onoj koja je primala adalimumab za supkutanu primjenu.
English: Don't inject into areas where your skin is tender, bruised, red, scaly, or hard.
Croatian: Nemojte davati injekciju u područja na kojima je koža osjetljiva, gdje su prisutne modrice, crvenilo, ljuskice ili otvrdnuća.
English: ORENCIA solution for injection in pre-filled syringe for subcutaneous administration is available for paediatric patients 2 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA solution for injection in pre-filled syringe).
Croatian: Za liječenje pJIA-a u pedijatrijskih bolesnika u dobi od 2 ili više godina dostupna je ORENCIA otopina za injekciju u napunjenoj štrcaljki za supkutanu primjenu (vidjeti Sažetak opisa svojstava lijeka za ORENCIA otopinu za injekciju u napunjenoj štrcaljki).
English: Bristol-Myers Squibb Kft. Tel: +370 52 369140
Croatian: Bristol-Myers Squibb S.r.l. Tel: + 356 23976333
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+ 49 (0)89 121 42 350)
Croatian: KGaA Tel: 0800 0752002 (+49 (0)89 121 42 350)
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+49 (0)89 121 42 350)
Croatian: KGaA Tel:0800 0752002 (+ 49 (0)89 121 42 350)
English: Subcutaneous use
Croatian: Supkutana formulacija
English: Discard the solution if any particulate matter or discolouration is observed.
Croatian: Otopinu treba baciti ako se uoče čestice ili promjena boje.
English: The percent of abatacept-treated patients achieving ACR 20, 50, and 70 responses in study II (patients with inadequate response to methotrexate), study III (patients with inadequate response to TNFinhibitor), and study VI (methotrexate-naive patients) are shown in Table 3.
Croatian: Postotak bolesnika liječenih abataceptom koji su postigli odgovore ACR20, ACR50 te ACR70 u ispitivanju II (bolesnici koji nisu dovoljno dobro odgovorili na metotreksat), ispitivanju III (bolesnici koji nisu dovoljno dobro odgovorili na TNF-inhibitor) i ispitivanju VI (bolesnici koji prethodno nisu primali metotreksat) prikazani su u Tablici 3.
English: Do not use the vial if a vacuum is not present.
Croatian: Nemojte koristiti bočicu koja nije vakuumirana.
English: DAS28CRP
Croatian: Remisija prema indeksu DAS28-CRPe
English: ORENCIA powder for concentrate for solution for infusion for intravenous administration is available for paediatric patients 6 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA powder for concentrate for solution for infusion).
Croatian: Za liječenje pJIA-a u pedijatrijskih bolesnika u dobi od 6 ili više godina dostupan je ORENCIA prašak za koncentrat za otopinu za infuziju za intravensku primjenu (vidjeti Sažetak opisa svojstava lijeka za ORENCIA prašak za koncentrat za otopinu za infuziju).
English: Comparable trough concentrations across weight tiers and age groups were achieved by the body-weight-tiered subcutaneous dosing regimen.
Croatian: Režimom liječenja supkutanom dozom određenom na temelju tjelesne težine postignute su usporedive najniže koncentracije u svim kategorijama tjelesne težine i dobnim skupinama.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACKS OF 1 AND 4 PRE-FILLED SYRINGES 1.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA PAKIRANJA OD 1 I 4 NAPUNJENE ŠTRCALJKE 1. NAZIV LIJEKA
English: Orange plunger
Croatian: Narančasti klip
English: Pre-filled syringe with UltraSafe Passive Needle guard
Croatian: Proširen rubnik pamučna vata ili gaza napunjena štrcaljka sa štitnikom za iglu UltraSafe Passive spremnik za odlaganje oštrih predmeta
English: NAd
Croatian: NDe
English: Inactive disease*
Croatian: Zloćudne bolesti
English: Needle cover Expiration date
Croatian: Poklopac igle Rok valjanosti
English: See the Package Leaflet for additional disposal information.
Croatian: Za dodatne informacije o odlaganju pročitajte uputu o lijeku.
English: b Each vial provides 250 mg of abatacept for administration.
Croatian: b Iz jedne bočice može se primijeniti 250 mg abatacepta.
English: The transparent tip locks over the needle once the injection is complete and the Pen is removed from the skin.
Croatian: Nakon što injekcija završi i brizgalica se ukloni s kože, prozirni vrh zatvara iglu.
English: A. Dispose of the used syringe in a Sharps container.
Croatian: Odložite upotrijebljenu štrcaljku u posudu za odlaganje oštrih predmeta.
English: Bristol-Myers Squibb spol.
Croatian: Bristol-Myers Squibb Co.
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 50 mg solution for injection in pre-filled syringe abatacept
Croatian: ORENCIA 50 mg otopina za injekciju u napunjenoj štrcaljki abatacept
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 50 mg solution for injection in pre-filled syringe ORENCIA 87.5 mg solution for injection in pre-filled syringe ORENCIA 125 mg solution for injection in pre-filled syringe 2.
Croatian: ORENCIA 50 mg otopina za injekciju u napunjenoj štrcaljki ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki ORENCIA 125 mg otopina za injekciju u napunjenoj štrcaljki 2. KVALITATIVNI I KVANTITATIVNI SASTAV ORENCIA 50 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mg abatacepta u 0,4 ml.
English: Front of thighs
Croatian: Prednji dio bedara
English: Abatacept SC n = 116 Proportion of randomised patients with induction of remission after 12 months of treatment DAS28-Remissiona Odds Ratio (95% CI) vs. MTX P value
Croatian: Udio randomiziranih bolesnika s induciranom remisijom nakon 12 mjeseci liječenja Remisija prema indeksu DAS28a
English: Mean Improvement from Baseline
Croatian: Prosječno poboljšanje od početne vrijednosti
English: Paediatric population in polyarticular juvenile idiopathic arthritis
Croatian: Pedijatrijska populacija s poliartikularnim juvenilnim idiopatskim artritisom
English: MRI Osteitis/Bone Oedema Score
Croatian: MRI rezultat za eroziju MRI rezultat za osteitis/koštani edem
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 250 mg of abatacept.
Croatian: ORENCIA 250 mg prašak za koncentrat za otopinu za infuziju 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 250 mg abatacepta.
English: DO NOT PULL back the plunger at any time.
Croatian: Nemojte nikada povlačiti klip štrcaljke.
English: Liquid
Croatian: Tekućina
English: No significant changes in PASI scores with abatacept treatment were seen over the 24-week doubleblind period.
Croatian: Tijekom 24-tjednog dvostruko slijepog razdoblja nisu primijećene značajne promjene indeksa proširenosti i težine psorijaze (engl.
English: Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discolouration.
Croatian: Prije primjene treba pregledati sadrži li otopina lijeka ORENCIA čestice i je li promijenila boju.
English: Cough
Croatian: Drška
English: Intravenous
Croatian: Cijepljenja
English: Let your ClickJect Pen warm up.
Croatian: 1. PRIPREMITE BRIZGALICU CLICKJECT Pričekajte da se brizgalica ClickJect ugrije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACK OF 4 PRE-FILLED PENS 1.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA PAKIRANJE OD 4 NAPUNJENE BRIZGALICE 1. NAZIV LIJEKA
English: Uncommon Chronic obstructive pulmonary disease exacerbated, bronchospasm, wheezing, dyspnea, throat tightness
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često kašalj manje često egzacerbacija kronične opstruktivne plućne bolesti, bronhospazam, piskanje pri disanju, dispneja, stezanje u grlu
English: Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) in studies II, III, IV, V, and VI and the modified HAQ-DI in study I. In study SC-I, improvement from baseline as measured by HAQ-DI at 6 months and over time was similar between subcutaneous and intravenous administration.
Croatian: U ispitivanju SC-I je poboljšanje u odnosu na početne vrijednosti, mjereno indeksom HAQ-DI nakon 6 mjeseci i tijekom vremena, bilo podjednako kod supkutane i intravenske primjene.
English: In study SC-III, the proportion of subjects with a HAQ response as a measure of clinically meaningful improvement in physical function (reduction from baseline in HAQ-D1 score of ≥ 0.3) was greater for the abatacept+ MTX group vs. the MTX group at month 12 (65.5% vs 44.0%, respectively; treatment difference vs. MTX group of 21.6% [95% CI: 8.3, 34.9]).
Croatian: + MTX nego u skupini koja je primala samo MTX (65,5% naspram 44,0%; razlika između liječenja u odnosu na skupinu koja je primala samo MTX iznosila je 21,6% [95% CI: 8,3; 34,9]).
English: List of side effects:
Croatian: Popis nuspojava:
English: Uncommon Amenorrhea, menorrhagia
Croatian: Poremećaji reproduktivnog sustava i dojki manje često amenoreja, menoragija
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 125 mg solution for injection in pre-filled syringe abatacept
Croatian: ORENCIA 125 mg otopina za injekciju u napunjenoj štrcaljki abatacept
English: NA NA NA
Croatian: ND ND ND
English: 15, 29, and then every 28 days thereafter.
Croatian: (≥ 28 dana nakon posljednje doze).
English: Renal and hepatic impairment
Croatian: ACRP100 Neaktivna bolest*
English: Multipack: 12 pre-filled syringes with needle guard (3 packs of 4) 5.
Croatian: Višestruko pakiranje: 12 napunjenih štrcaljki sa štitnikom za iglu (3 pakiranja po 4) 5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Croatian: 5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Supkutano
English: Doctor's Phone: ____________________
Croatian: Broj telefona liječnika:
English: Reproductive system and breast disorders
Croatian: Oštećenje bubrega i jetre
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 125 mg solution for injection in pre-filled pen abatacept
Croatian: ORENCIA 125 mg otopina za injekciju u napunjenoj brizgalici abatacept
English: Do not wait until your next planned visit.
Croatian: Nemojte čekati do sljedećeg planiranog posjeta.
English: · You will be given one infusion every 3 weeks.
Croatian: • Primit ćete jednu infuziju svaka 3 tjedna.
English: In most cases you will not have any symptoms.
Croatian: U većini slučajeva nećete imati nikakve simptome.
English: Talk to your doctor about this.
Croatian: Razgovarajte s liječnikom o tome.
English: ** The interim analysis for OS was conducted when 331 events were observed.
Croatian: ** Privremena analiza za OS provedena je nakon što je opažen 331 događaj.
English: · Additional risk minimisation measures
Croatian: • Dodatne mjere minimizacije rizika
English: In this patient population:
Croatian: U toj populaciji bolesnika:
English: Repeat LVEF assessment within 3 weeks.
Croatian: Ponovno procijeniti LVEF unutar 3 tjedna.
English: Your doctor will calculate the correct dose for you.
Croatian: Liječnik će izračunati točnu dozu za Vas.
English: (treatment after surgery is called adjuvant therapy).
Croatian: (liječenje nakon kirurškog zahvata naziva se adjuvantnom terapijom).
English: The infusion may be continued after the symptoms improve.
Croatian: Infuzija se može nastaviti nakon što se simptomi poboljšaju.
English: Women who become pregnant must immediately contact their doctor.
Croatian: Žene koje zatrudne moraju se odmah obratiti svome liječniku.
English: Talk to your doctor about the best contraception for you.
Croatian: Razgovarajte s liječnikom o najboljoj kontracepciji za Vas.
English: Date of latest renewal: 17 September 2018
Croatian: Datum posljednje obnove odobrenja: 17. rujna 2018.
English: Patients should have either:
Croatian: Bolesnici su trebali ili:
English: See section 4 for more details about what side effects to look out for.
Croatian: Pogledajte dio 4. za više pojedinosti o tome na koje nuspojave treba pripaziti.
English: A change of 5 points in the TOI-B is considered clinically significant.
Croatian: Promjena od 5 bodova na podljestvici TOI-B smatra se klinički značajnom.
English: These symptoms may indicate nerve damage.
Croatian: Ti simptomi mogu ukazivati na oštećenje živaca.
English: If a planned dose is missed, it should be administered as soon as possible; without waiting until the next planned cycle.
Croatian: Ako bolesnik propusti planiranu dozu, potrebno ju je primijeniti što je prije moguće; ne smije se čekati do sljedećeg planiranog ciklusa.
English: In general, these symptoms were not severe (see section 4.8).
Croatian: Ti simptomi općenito nisu bili teški (vidjeti dio 4.8).
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati ni razrjeđivati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: · Do not throw away any medicines via wastewater or household waste.
Croatian: • Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: These secondary endpoints were not adjusted for multiplicity
Croatian: Te sekundarne mjere ishoda nisu bile prilagođene za multiplicitet.
English: Trastuzumab emtansine n = 495
Croatian: Trastuzumab emtanzin n = 495
English: See Table 6 and Figure 1.
Croatian: Vidjeti Tablicu 6 i Sliku 1.
English: The data are from an open-label study and no firm conclusions can be drawn.
Croatian: Ovo su podaci iz otvorenog ispitivanja te se ne mogu donijeti čvrsti zaključci.
English: Medicinal products to treat such reactions, as well as emergency equipment, should be available for immediate use.
Croatian: Lijekovi za liječenje takvih reakcija te oprema za hitne intervencije moraju biti na raspolaganju za trenutnu uporabu.
English: The reconstituted product contains no preservative and is intended for single use only.
Croatian: Rekonstituirani lijek ne sadrži konzervanse i namijenjen je samo za jednokratnu uporabu.
English: Consideration for re-treatment should be based on clinical assessment of the severity of the reaction.
Croatian: Razmatranje ponovnog liječenja treba temeljiti na kliničkoj ocjeni težine reakcije.
English: Patients may have received more than one HER2-targeted therapy.
Croatian: Bolesnici su mogli primiti više od jedne ciljane HER2 terapije.
English: Since the efficacy boundary was crossed at this analysis, this is considered the definitive analysis.
Croatian: Budući da je u toj analizi prekoračena granična vrijednost za djelotvornost, ona se smatra definitivnom analizom.
English: Women may begin breast-feeding 7 months after concluding treatment.
Croatian: Žene mogu početi dojiti 7 mjeseci nakon završetka liječenja.
English: Most patients will not have symptoms from the heart problems.
Croatian: Većina bolesnika neće imati simptome zbog srčanih problema.
English: These may be signs of inflammation of your lung, which may be serious, and even fatal.
Croatian: To mogu biti znakovi upale pluća, koja može biti ozbiljna ili čak smrtonosna.
English: The results of this descriptive follow-up analysis are consistent with the confirmatory OS analysis.
Croatian: Rezultati ove deskriptivne naknadne analize u skladu su s potvrdnom analizom OS-a.
English: · You should continue to take your contraception for at least 7 months after your last dose of
Croatian: • Morate nastaviti koristiti kontracepciju još najmanje 7 mjeseci nakon posljednje doze lijeka
English: Diagnosis of NRH can be confirmed only by histopathology.
Croatian: Dijagnoza NRH-a može se potvrditi samo histopatološki.
English: Talk to your doctor before stopping your contraception.
Croatian: Razgovarajte s liječnikom prije nego prestanete koristiti kontracepciju.
English: Some of these bleeding events resulted in fatal outcomes.
Croatian: Neki od tih slučajeva krvarenja imali su smrtni ishod.
English: You should tell your doctor immediately if you notice any unexpected bruising or bleeding.
Croatian: Morate odmah obavijestiti svog liječnika ako primijetite neočekivane modrice ili krvarenje.
English: · Heart problems can occur.
Croatian: • mogu se javiti srčani problemi.
English: · Kadcyla is available in packs containing 1 vial.
Croatian: • Kadcyla je dostupna u pakiranjima koja sadrže 1 bočicu.
English: The key efficacy analyses were ORR based on independent radiologic review and duration of objective response.
Croatian: Ključne analize djelotvornosti bile su stopa objektivnog odgovora na temelju neovisne radiološke ocjene i trajanje objektivnog odgovora.
English: Other medicines and Kadcyla Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Kadcyla Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: DM1 did not inhibit major CYP450 enzymes in vitro.
Croatian: DM1 nije inhibirao glavne enzime CYP450 in vitro.
English: · Received prior therapy for locally advanced or metastatic disease, or
Croatian: • prethodno primati terapiju za lokalno uznapredovalu ili metastatsku bolest, ili
English: The next dose should be administered in accordance with the dosing recommendations above.
Croatian: Sljedeću dozu treba primijeniti u skladu s gore navedenim preporukama za doziranje.
English: Emtansine refers to the MCC-DM1 complex.
Croatian: Emtanzin se odnosi na kompleks MCC-DM1.
English: However, based on results from general animal toxicity studies, adverse effects on fertility can be expected.
Croatian: Međutim, na temelju rezultata iz općenitih ispitivanja toksičnosti na životinjama, mogu se očekivati štetni učinci na plodnost.
English: No dose adjustment is required in patients aged ≥ 65 years.
Croatian: Nije potrebna prilagodba doze u bolesnika u dobi od ≥ 65 godina.
English: · Developed disease recurrence during or within six months of completing adjuvant therapy.
Croatian: • imati povrat bolesti tijekom ili unutar šest mjeseci od završetka adjuvantne terapije.
English: The schedule of administration should be adjusted to maintain a 3-week interval between doses.
Croatian: Raspored primjene treba prilagoditi tako da se održi 3-tjedni interval između doza.
English: · The total number of infusions that you will be given depends on how you respond to the treatment and which indication is treated.
Croatian: • Ukupan broj infuzija koje ćete primiti ovisi o Vašem odgovoru na liječenje i o bolesti zbog koje primate lijek.
English: Appropriate aseptic technique should be used.
Croatian: Treba primijeniti odgovarajuću aseptičku tehniku.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Croatian: Uvijek čuvajte ovaj lijek u zatvorenom originalnom pakiranju na temperaturi od 2ºC - 8ºC u hladnjaku.
English: · Keep this leaflet.
Croatian: • Sačuvajte ovu uputu.
English: · Allergic reactions can occur and most patients will have mild symptoms such as itching or tightness in the chest.
Croatian: • mogu nastupiti alergijske reakcije, a većina bolesnika imat će blage simptome poput svrbeži ili stezanja u prsima.
English: Kadcyla will be stored by the health professionals at the hospital or clinic.
Croatian: Lijek Kadcyla čuvaju zdravstveni radnici u bolnici ili klinici.
English: Male patients or their female partners should also use effective contraception.
Croatian: Bolesnici muškog spola ili njihove partnerice također moraju koristiti učinkovitu kontracepciju.
English: There are insufficient data to establish the safety and efficacy in patients ≥ 75 years due to limited data in this subgroup.
Croatian: Nema dovoljno podataka da bi se ustanovile sigurnost i djelotvornost u bolesnika u dobi od ≥ 75 godina jer su podaci u toj podskupini ograničeni.
English: Nodular Regenerative Hyperplasia (NRH)
Croatian: Nodularna regenerativna hiperplazija (NRH)
English: Your doctor will monitor you for signs and symptoms of neurological problems.
Croatian: Liječnik će Vas nadzirati zbog moguće pojave znakova i simptoma neuroloških problema.
English: · you have already received the medicine trastuzumab and a medicine known as a taxane.
Croatian: • ako ste ranije već primali lijek trastuzumab i lijek koji se zove taksan