FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients are eligible for KANJINTI treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Croatian: Liječenje lijekom KANJINTI preporučuje se onim bolesnicima koji imaju izrazitu ekspresiju HER2 opisanu stupnjem 3+ na temelju IHC ili pak pozitivan FISH ili CISH rezultat.
English: • based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of
Croatian: • za udarnu dozu trastuzumaba od 4 mg/kg tjelesne težine ili daljnje tjedne doze održavanja od
English: 4 cycles.
Croatian: Trotjedni ciklusi
English: 1Heart beat irregular
Croatian: 1nepravilni otkucaji srca vrlo često
English: Reactions include chills, fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4).
Croatian: Te reakcije uključuju zimicu, vrućicu, dispneju, hipotenziju, piskanje pri disanju, bronhospazam, tahikardiju, smanjenu zasićenost kisikom, respiratorni distres, osip, mučninu i povraćanje i glavobolju (vidjeti dio 4.4).
English: Primary efficacy analysis DFS Hazard ratios (95% CI) p-value p < 0.0001
Croatian: Primarna analiza djelotvornosti Omjeri hazarda za preživljenje bez bolesti (95% CI) p-vrijednost p < 0,0001
English: Trastuzumab has been used in clinical trials as monotherapy for patients with MBC who have tumours that overexpress HER2 and who have failed one or more chemotherapy regimens for their metastatic disease (trastuzumab alone).
Croatian: Trastuzumab je u kliničkim ispitivanjima primjenjivan kao monoterapija u liječenju bolesnica s metastatskim rakom dojke koji pokazuje povećanu ekspresiju HER2 i progresiju bolesti nakon jedne ili više kemoterapijskih linija liječenja metastatske bolesti (samo trastuzumab).
English: KANJINTI should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
Croatian: KANJINTI treba davati samo onim bolesnicima s metastatskim rakom želuca čije tumorske stanice pokazuju povećanu ekspresiju HER2 određenu imunohistokemijski kao 2+ i potvrđenu SISH-om ili FISH-om, ili određenu imunohistokemijski kao 3+.
English: +1Hypotension
Croatian: +1hipotenzija često vazodilatacija često
English: For patients with EBC, cardiac assessments, as performed at baseline, should be repeated every 3 months during treatment and every 6 months following discontinuation of treatment until 24 months from the last administration of KANJINTI.
Croatian: U bolesnika s ranim rakom dojke, kardiološki pregled istovjetan onom obavljenom u sklopu početne procjene, potrebno je ponavljati svaka 3 mjeseca tijekom liječenja te svakih 6 mjeseci nakon završetka liječenja do 24 mjeseca od posljednje primjene lijeka KANJINTI.
English: • liver damage/failure
Croatian: • oštećenje/zatajenje jetre
English: • The recommended starting dose for the once weekly cycle is 4 mg/kg body weight.
Croatian: • Preporučena početna doza u jednotjednom ciklusu iznosi 4 mg/kg tjelesne težine.
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Croatian: Slaba do umjereno potpuna, bazolateralna ili lateralna membranska reaktivnost u ≥ 10% tumorskih stanica
English: • slow heart rate
Croatian: • usporena brzina srčanih otkucaja
English: Table 8 Final overall survival analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Croatian: Konačna analiza ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831
English: +Anaphylactic shock
Croatian: +anafilaktički šok nepoznato
English: • The other ingredient(s) are histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
Croatian: • Drugi sastojci su histidin, histidinklorid, trehaloza dihidrat, polisorbat 20.
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarised in table 8:
Croatian: Konačni rezultati ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831 sažeto su prikazani u Tablici 8:
English: Rare side effects (may affect up to 1 in 1,000 people):
Croatian: Rijetke nuspojave KANJINTI (mogu se javiti u do 1 na 1000 osoba)
English: Very common side effects (may affect more than 1 in 10 people):
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba)
English: Overall survival No. patients with event
Croatian: Ukupno preživljenje Broj bolesnica s događajem
English: +Anaphylactic reaction
Croatian: +anafilaktička reakcija nepoznato
English: Each 420mg vial of KANJINTI is reconstituted with 20 mL of sterile water for injections (not supplied).
Croatian: Sadržaj jedne bočice lijeka KANJINTI 420 mg rekonstituira se sa 20 ml sterilne vode za injekcije (nije priložena u pakiranju).
English: The recommended starting dose is 8 mg/kg body weight.
Croatian: Preporučena početna doza iznosi 8 mg/kg tjelesne težine.
English: *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including cross-over of 52% of patients from the observation arm to trastuzumab) ***There is a discrepancy in the overall sample size due to a small number of patients who were randomised after the cut-off date for the 12-month median follow-up analysis
Croatian: ***Postoji nesrazmjer u ukupnoj veličini uzorka zbog malog broja bolesnika koji su randomizirani nakon završnog datuma za analizu medijana praćenja od 12 mjeseci
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1281/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1281/001
English: Three-weekly dosing in metastatic breast cancer The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in table 5:
Croatian: Trotjedni ciklusi u liječenju metastatskog raka dojke Rezultati djelotvornosti iz ispitivanja monoterapije i kombinirane terapije trastuzumabom bez kontrolnih skupina prikazani su u Tablici 5:
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive analysis of DFS* are summarised in Table 7.
Croatian: Rezultati djelotvornosti iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831 u trenutku konačne analize preživljenja bez bolesti* prikazani su sažeto u Tablici 7.
English: This will then be reduced to a maintenance dose of 2 mg/kg body weight once weekly, beginning one week after the first dose.
Croatian: Doza će se poslije smanjiti na dozu održavanja od 2 mg/kg tjelesne težine svaki tjedan, a počinje se primjenjivati jedan tjedan nakon prve doze.
English: Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in table 4.
Croatian: Tjedni ciklusi u liječenju metastatskog raka dojke Rezultati djelotvornosti iz ispitivanja monoterapije trastuzumabom ili njegove primjene u kombiniranoj terapiji prikazani su u Tablici 4.
English: Metastatic breast cancer
Croatian: Metastatski rak dojke
English: • hot flush
Croatian: • navale vrućine
English: KANJINTI 150 mg powder for concentrate for solution for infusion 20 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 150 mg of trastuzumab.
Croatian: KANJINTI 150 mg prašak za koncentrat za otopinu za infuziju Staklena bočica od 20 ml (bezbojno staklo tipa I) s butilnim gumenim čepom presvučenim fluororezinskim filmom i aluminijskim prstenom s flip-off zatvaračem sadrži 150 mg trastuzumaba.
English: Dry skin
Croatian: • osipi na koži
English: This will then be reduced to a maintenance dose of 6 mg/kg body weight every three weeks, beginning three weeks after your first dose.
Croatian: Doza će se poslije smanjiti na dozu održavanja od 6 mg/kg tjelesne težine svaka tri tjedna, a počinje se primjenjivati tri tjedna nakon prve doze.
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH
Croatian: AC→D = doksorubicin i ciklofosfamid nakon kojih slijedi docetaksel; AC→DH = doksorubicin i ciklofosfamid nakon kojih slijede docetaksel i trastuzumab; CI = interval pouzdanosti Tablica 10.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1281/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1281/002
English: • 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection, or
Croatian: - Jedna bočica sadrži 150 mg trastuzumaba koji treba otopiti u 7,2 ml vode za injekcije.
English: LIST OF EXCIPIENTS Histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
Croatian: POPIS POMOĆNIH TVARI Histidin, histidinklorid, trehaloza dihidrat, polisorbat 20.
English: Death (OS event) No. patients with event p = 0.0024
Croatian: Smrt (događaj ukupnog preživljenja) broj bolesnica s događajem p = 0,0024
English: Metastatic gastric cancer
Croatian: Metastatski rak želuca
English: DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831.
Croatian: Analiza preživljenja bez bolesti je također provedena prilikom konačne analize ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831.
English: No staining is observed or membrane staining is observed in < 10% of the tumour cells.
Croatian: Nema vidljive obojenosti ili se obojenost membrane primjećuje u < 10% tumorskih stanica.
English: Baseline levels of the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed.
Croatian: Opažene razine odcijepljenog HER2-ECD-a na početku liječenja bolesnika s metastatskim rakom želuca bile su usporedive s onima u bolesnika s metastatskim rakom dojke i ranim rakom dojke, a vidljivi utjecaj na klirens trastuzumaba nije opažen.
English: KANJINTI 420 mg powder for concentrate for solution for infusion 50 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 420 mg of trastuzumab.
Croatian: KANJINTI 420 mg prašak za koncentrat za otopinu za infuziju Staklena bočica od 50 ml (bezbojno staklo tipa I) s butilnim gumenim čepom presvučenim fluororezinskim filmom i aluminijskim prstenom flip-off zatvaračem sadrži 420 mg trastuzumaba.
English: KANJINTI 420 mg powder for concentrate for solution for infusion One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Croatian: Jedna bočica sadrži 420 mg trastuzumaba, humaniziranog IgG1 monoklonskog protutijela proizvedenog u kulturi stanica sisavaca u suspenziji (stanice jajnika kineskog hrčka) i pročišćenog afinitetnom i ionsko-izmjenjivačkom kromatografijom uključujući specifičnu inaktivaciju virusa i postupke uklanjanja.
English: The recommended initial loading dose of KANJINTI is 4 mg/kg body weight.
Croatian: Preporučena početna udarna doza lijeka KANJINTI iznosi 4 mg/kg tjelesne težine.
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba)
English: In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG 006 clinical studies combining DFS events and symptomatic cardiac events and summarised in table 11:
Croatian: Dodatno je provedena post-hoc eksplorativna analiza podataka dobivenih iz skupne analize kliničkih ispitivanja NSABP B-31/NCCTG N9831* i BCIRG 006, koja uključuje preživljenje bez bolesti i simptomatske srčane događaje.
English: These include, but are not limited to, pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency (see section 4.4).
Croatian: Te nuspojave između ostalog uključuju plućne infiltrate, akutni respiratorni distres sindrom, upalu pluća, pneumonitis, pleuralni izljev, respiratorni distres, akutni plućni edem i respiratornu insuficijenciju (vidjeti dio 4.4).
English: Early breast cancer (neoadjuvant-adjuvant setting)
Croatian: Rani rak dojke (neoadjuvantno-adjuvantno liječenje)
English: Chemo only (n = 116)
Croatian: Samo kemoterapija (n = 116)
English: - in combination with neoadjuvant chemotherapy followed by adjuvant KANJINTI therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
Croatian: KANJINTI za lokalno uznapredovalu (uključujući upalnu) bolest ili tumore promjera > 2 cm
English: No reductions in the dose of trastuzumab were made during clinical trials.
Croatian: Tijekom kliničkih ispitivanja doza trastuzumaba nije bila smanjivana.
English: Trastuzumab washout
Croatian: Ispiranje trastuzumaba
English: Tumour cell cluster with a faint/barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Croatian: Nakupina tumorskih stanica s vrlo slabom/jedva primjetnom membranskom reaktivnošću bez obzira na postotak obojenih tumorskih stanica
English: Histidine
Croatian: Histidin
English: The main test method used to determine HER2 positivity in the pivotal trial of docetaxel, with or without trastuzumab, was immunohistochemistry.
Croatian: Glavna metoda određivanja povećane ekspresije HER2 primijenjena u pivotalnom kliničkom ispitivanju docetaksela u monoterapiji ili kombinaciji s trastuzumabom bila je imunohistokemija.
English: or - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over
Croatian: 6 ciklusa (2. dan 1. ciklusa, a potom 1. dan svakog sljedećeg ciklusa) nakon čega je slijedio: - karboplatin - s ciljnom AUC 6 mg/ml/min, primijenjen u intravenskoj infuziji tijekom
English: *defined as absence of any invasive cancer both in the breast and axillary nodes An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3 year event-free survival rate (65% versus 52%).
Croatian: Za skupinu koja je primala trastuzumab procijenjena je apsolutna korist od 13 postotnih bodova za stopu trogodišnjeg preživljenja bez štetnih događaja (65% naspram 52%).
English: The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
Croatian: Volumen središnjeg odjeljka iznosio je 2,62 l u bolesnika s metastatskim rakom dojke i ranim rakom dojke te 3,63 l u bolesnika s uznapredovalim rakom želuca.
English: In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or
Croatian: U skupnoj analizi ispitivanja NSABP B-31 i NCCTG N9831, rani rak dojke je bio ograničen isključivo na žene s operabilnim rakom dojke visokog rizika, definiranim kao HER2 pozitivan s pozitivnim aksilarnim limfnim čvorovima ili HER2 pozitivan s negativnim aksilarnim limfnim čvorovima sa značajkama visokog rizika (veličina tumora > 1 cm i ER negativan ili veličina tumora > 2 cm, bez obzira na hormonski status).
English: In vitro, trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Croatian: In vitro je pokazano da se trastuzumabom posredovana stanična citotoksičnost ovisna o protutijelima odvija s većim afinitetom na tumorskim stanicama koje imaju povećanu ekspresiju HER2 u usporedbi s tumorskim stanicama koje nemaju povećanu ekspresiju HER2.
English: Median TTP (months) (95%CI) Median Survival (months) (95%CI)
Croatian: Medijan trajanja odgovora (mjeseci) (95 %CI) Medijan TTP (mjeseci) (95 %CI) Medijan preživljenja (mjeseci) (95 %CI)
English: LIST OF EXCIPIENTS Excipients: histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: histidin, histidinklorid, trehaloza dihidrat, polisorbat 20.
English: Specific percentages for these are not available.
Croatian: Nema podataka o točnim postotcima za te nuspojave.
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab
Croatian: Smrt (događaj ukupnog preživljenja): broj bolesnica s događajem (%) A: doksorubicin; C: ciklofosfamid; P: paklitaksel; H: trastuzumab
English: 4 adverse reaction in the 2-year treatment arm (20.4%) compared with the 1-year treatment arm
Croatian: Barem jedna nuspojava stupnja 3 ili 4 pojavila se u više bolesnika u skupini liječenoj tijekom 2 godine (20,4%) u usporedbi sa skupinom liječenom tijekom 1 godine (16,3%).
English: +Respiratory failure
Croatian: +respiratorni distres nepoznato
English: Each vial contains either:
Croatian: Bilo koja od navedenih terapija primjenjivana je uz:
English: Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Croatian: Nakupina tumorskih stanica sa slabom do umjerenom potpunom, bazolateralnom ili lateralnom membranskom reaktivnošću bez obzira na postotak obojenih tumorskih stanica
English: Distant recurrence No. patients with event p = 0.0008
Croatian: Pojava udaljenih metastaza broj bolesnica s događajem p = 0,0008
English: Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Croatian: Nakupina tumorskih stanica s jakom potpunom, bazolateralnom ili lateralnom membranskom reaktivnošću bez obzira na postotak obojenih tumorskih stanica
English: QUALITATIVE AND QUANTITATIVE COMPOSITION KANJINTI 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Croatian: Jedna bočica sadrži 150 mg trastuzumaba, humaniziranog IgG1 monoklonskog protutijela proizvedenog u kulturi stanica sisavaca u suspenziji (stanice jajnika kineskog hrčka) i pročišćenog afinitetnom i ionsko-izmjenjivačkom kromatografijom uključujući specifičnu inaktivaciju virusa i postupke uklanjanja.
English: +Acute respiratory distress syndrome
Croatian: +akutni plućni edem nepoznato +akutni respiratorni distres sindrom nepoznato +bronhospazam nepoznato
English: As a three-weekly regimen the recommended initial loading dose of KANJINTI is 8 mg/kg body weight.
Croatian: U trotjednim ciklusima preporučena početna udarna doza lijeka KANJINTI iznosi 8 mg/kg tjelesne težine.
English: 1Palpitation
Croatian: 1palpitacije vrlo često
English: It may take up to 7 months for KANJINTI to be removed from the body.
Croatian: Da bi se KANJINTI uklonio iz tijela, potrebno je i do 7 mjeseci.
English: - in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
Croatian: - u kombinaciji s docetakselom u liječenju bolesnika koji nisu prethodno primali kemoterapiju za metastatsku bolest. - u kombinaciji s inhibitorom aromataze u liječenju postmenopauzalnih bolesnica s metastatskim rakom dojke pozitivnim na hormonske receptore, koje nisu prethodno liječene trastuzumabom.
English: • The recommended starting dose for the three-weekly cycle is 8 mg/kg body weight.
Croatian: • Preporučena početna doza u trotjednom ciklusu iznosi 8 mg/kg tjelesne težine.
English: The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects.
Croatian: Tijekom primjene prve doze, koju ćete primati u infuziji trajanja 90 minuta, zbog mogućnosti razvoja nuspojava bit ćete pod nadzorom stručne medicinske osobe.
English: Aseptic handling must be ensured when preparing the infusion.
Croatian: Kod pripreme infuzije moraju se osigurati aseptički uvjeti rukovanja.
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode.
English: Amgen Europe B.V. Minervum 7061
Croatian: Minervum 7061
English: If left ventricular ejection fraction (LVEF) percentage drops ≥ 10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately
Croatian: Ako postotak LVEF-a padne za ≥ 10 bodova ispod početne vrijednosti
English: Formal cardiological assessment should be considered in patients in whom there are cardiovascular concerns following baseline screening.
Croatian: U bolesnika u kojih nakon početne procjene postoji sumnja na kardiovaskularnu bolest potrebno je razmotriti formalnu kardiološku procjenu.
English: Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule 3.
Croatian: Ispitivanje MO16982: udarna doza 6 mg/kg tjedno kroz 3 tjedna, zatim 6 mg/kg u trotjednim ciklusima 3. Ispitivanje BO15935
English: Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
Croatian: Za informacije o smanjenju ili odgađanju doze paklitaksela, docetaksela ili inhibitora aromataze pogledajte Sažetke opisa svojstava tih lijekova.
English: 1+ A faint/barely perceptible membrane staining is detected in > 10% of the tumour cells.
Croatian: Blijeda, jedva uočljiva obojenost membrane u > 10% tumorskih stanica.
English: This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Croatian: Time se dobiva 21 ml otopine za jednokratnu primjenu, koja sadrži približno 21 mg/ml trastuzumaba.
English: KANJINTI and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Croatian: Kod adjuvantnog liječenja ne smiju se istodobno davati KANJINTI i antraciklini.
English: KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for concentrate for solution for infusion trastuzumab
Croatian: KANJINTI 150 mg prašak za koncentrat za otopinu za infuziju KANJINTI 420 mg prašak za koncentrat za otopinu za infuziju trastuzumab
English: Pre-medication may be used to reduce risk of occurrence of these events.
Croatian: Rizik od pojave reakcija na primjenu lijeka može se smanjiti premedikacijom.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija vrlo često
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in table 2: Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer Score Staining pattern
Croatian: Tablica 2. Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi kod raka dojke
English: KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for concentrate for solution for infusion
Croatian: KANJINTI 150 mg prašak za koncentrat za otopinu za infuziju KANJINTI 420 mg prašak za koncentrat za otopinu za infuziju
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Croatian: Time se dobiva 7,4 ml otopine za jednokratnu primjenu, koja sadrži približno 21 mg/ml trastuzumaba.
English: Disease-free survival No. patients with event p = 0.0003
Croatian: Preživljenje bez bolesti broj bolesnica s događajem p = 0,0003