FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of Diovan in patients with heart failure commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Romanian: Utilizarea Diovan la pacien ii cu insuficien cardiac conduce frecvent la o anumit sc dere a tensiunii arteriale, dar întreruperea tratamentului datorit hipotensiunii arteriale simptomatice persistente nu este, de regul , necesar dac sunt urmate recomand rile privind dozajul (vezi pct. 4.2).
English: • [Storage conditions statements - To be completed nationally]
Romanian: • [Declara iile privind condi iile de p strare - A se completa la nivel na ional]
English: In patients receiving the low dose of valsartan, systolic blood pressure at trough was similar to that of patients who received the placebo treatment.
Romanian: La pacien ii c rora li s-a administrat o doz mic de valsartan, tensiunea arterial sistolic înainte de administrarea dozei urm toare a fost similar cu cea a pacien ilor c rora li s-a administrat tratament placebo.
English: Rixil 80 mg 80 mg
Romanian: Rixil 80 mg
English: The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 µmol/l).
Romanian: La pacien ii hipertensivi cu diabet zaharat de tip 2 i microalbuminurie, s-a constatat c valsartanul reduce excre ia urinar de albumin . Studiul MARVAL (Micro Albuminuria Reduction with Valsartan) a comparat valsartanul (80-160 mg o dat pe zi) cu amlodipina (5-10 mg o dat pe zi) în ceea ce prive te reducerea excre iei urinare de albumin (EUA) la 332 de pacien i cu diabet zaharat de tip 2 (vârsta medie: 58 de ani; 265 de b rba i) cu microalbuminurie (valsartan: 58 µg/min; amlodipin : 55,4 µg/min), cu tensiune arterial normal sau mare i cu func ia renal p strat (creatinina sanguin <120 µmol/l).
English: Tareg 80 mg 80 mg
Romanian: Tareg 80 mg
English: Cordinate 40 mg 40 mg
Romanian: Cordinate 40 mg
English: One film-coated tablet contains 320 mg of valsartan.
Romanian: Un comprimat filmat con ine valsartan 320 mg.
English: Tareg 40 mg 40 mg
Romanian: Tareg 40 mg
English: The recommended starting dose of Diovan is 80 mg once daily.
Romanian: Doza ini ial de Diovan recomandat este de 80 mg, o dat pe zi.
English: Diovane 40 mg 40 mg
Romanian: Diovane 40 mg
English: Cordinate 80 mg 80 mg
Romanian: Cordinate 80 mg
English: Dalzad 80 mg 80 mg
Romanian: Dalzad 80 mg
English: Diovane 80 mg 80 mg
Romanian: Diovane 80 mg
English: Cordinate 320 mg 320 mg
Romanian: Cordinate 320 mg
English: At 24 weeks, UAE was reduced (p<0.001) by 42% (-24.2 µg/min; 95% CI: -40.4 to -19.1) with valsartan and approximately 3% (-1.7 µg/min; 95% CI: -5.6 to 14.9) with amlodipine despite similar rates of blood pressure reduction in both groups.
Romanian: Dup 24 de s pt mâni, EUA a fost redus (p<0,001) cu 42% (-24,2 µg/min; IÎ 95%: între -40,4 i -19,1) cu valsartan i cu aproximativ 3% (-1,7 µg/min; IÎ 95%: între -5,6 i 14,9) cu amlodipin , în ciuda faptului c ratele de reducere a valorilor tensionale au fost similare în cele dou grupuri.
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min.
Romanian: Nu este necesar ajustarea dozei la pacienii copii i adolesceni cu clearance-ul creatininei >30 ml/min.
English: Dalzad 40 mg 40 mg
Romanian: Dalzad 40 mg
English: In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg. Diovan may also be administered with other antihypertensive agents.
Romanian: La unii pacien i a c ror tensiune arterial nu este controlat în adecvat, doza poate fi crescut la 160 mg, pân la maximum 320 mg.
English: Cordinate 160 mg 160 mg
Romanian: Cordinate 160 mg
English: Diovan is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Romanian: Diovan este contraindicat la pacien ii cu insuficien hepatic sever , ciroz biliar i pacien ii cu colestaz (vezi pct. 4.3, 4.4 i 5.2).
English: Diovane 160 mg 160 mg
Romanian: Diovane 160 mg
English: Evaluation of patients with heart failure should always include assessment of renal function.
Romanian: Evaluarea pacien ilor cu insuficien cardiac trebuie s includ întotdeauna i evaluarea func iei renale.
English: Tareg 320 mg 320 mg
Romanian: Tareg 320 mg
English: Tareg 160 mg 160 mg
Romanian: Tareg 160 mg
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients (see sections 4.2 and
Romanian: În prezent, nu exist experien privind utilizarea în condi ii de siguran la pacien ii cu un clearance al creatininei <10 ml/min i la cei dializa i, prin urmare valsartan trebuie utilizat cu precau ie la ace ti pacien i (vezi pct.
English: Diovane 320 mg 320 mg
Romanian: Diovane 320 mg
English: • to treat high blood pressure in children and adolescents 6 to 18 years of age.
Romanian: • pentru tratamentul tensiunii arteriale mari la copii i adolescen i cu vârsta cuprins între 6 i 18 ani.
English: Dalzad 160 mg 160 mg
Romanian: Dalzad 160 mg
English: Evaluation of post-myocardial infarction patients should always include assessment of renal function.
Romanian: Evaluarea pacien ilor post-infarct miocardic trebuie s includ o evaluare a func iei renale.
English: Diovan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used.
Romanian: • pentru tratamentul insuficien ei cardiace simptomatice la pacien i adul i. Diovan este utilizat atunci când medicamentele dintr-un grup numit inhibitori ai enzimei de conversie a angiotensinei (ECA) (medicamente utilizate pentru tratamentul insuficien ei cardiace) nu pot fi utilizate; de asemenea, poate fi utilizat împreun cu inhibitorii ECA atunci când betablocantele (un alt grup de medicamente utilizate pentru tratamentul insuficien ei cardiace) nu pot fi utilizate.
English: One film-coated tablet contains 160 mg of valsartan.
Romanian: Un comprimat filmat con ine valsartan 160 mg.
English: Administration of Diovan to patients with hypertension results in reduction of blood pressure without affecting pulse rate.
Romanian: Administrarea Diovan la pacien ii cu hipertensiune arterial a determinat sc derea tensiunii arteriale f r modificarea frecven ei cardiace.
English: Diovan can be given together with other treatment for heart attack, and your doctor will decide which treatment is suitable for you.
Romanian: Diovan se poate administra împreun cu alte medicamente pentru tratamentul infarctului miocardic, iar medicul dumneavoastr va stabili tratamentul care este potrivit pentru dumneavoastr .
English: Dalzad 320 mg 320 mg
Romanian: Dalzad 320 mg
English: No dose adjustment is required for adult patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2).
Romanian: Nu este necesar o ajustare a dozei la pacien ii adul i cu un clearance al creatininei >10 ml/min (vezi pct. 4.4 i 5.2).
English: Evaluation of post-myocardial infarction patients should always include assessment of renal function (see section 4.2).
Romanian: Evaluarea pacien ilor post-infarct miocardic trebuie întotdeauna s includ evaluarea func iei renale (vezi pct.
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Romanian: Este posibil ca nu toate m rimile de ambalaj s fie comercializate De in torul autoriza iei de punere pe pia i produc torul [Vezi Anexa I - a se completa la nivel na ional]
English: Overall, the three dose levels of valsartan (low, medium and high) significantly reduced systolic blood pressure by 8, 10, 12 mm Hg from the baseline, respectively.
Romanian: În general, cele trei niveluri de dozare a valsartanului (mic, mediu i mare) au sc zut semnificativ tensiunea arterial sistolic cu 8, 10, respectiv 12 mm Hg fa de valoarea ini ial . Pacien ii au fost randomiza i din nou, fie continuând administrarea aceleia i doze de valsartan, fie trecând la placebo.
English: One film-coated tablet contains 80 mg of valsartan.
Romanian: Un comprimat filmat con ine valsartan 80 mg.
English: Hypertension Treatment of hypertension in children and adolescents 6 to 18 years of age.
Romanian: Hipertensiune arterial Tratamentul hipertensiunii arteriale la copii i adolescen i cu vârsta cuprins între 6 i 18 ani.
English: • allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain,
Romanian: • pot ap rea reac ii alergice cu erup ie trec toare pe piele, mânc rime i leziuni; simptome de febr , articula ii umflate i durere la nivelul articula ii, durere muscular , umflarea ganglionilor limfatici i/sau simptome asem n toare gripei (semne ale bolii serului)
English: Diovan 320 mg film-coated tablets can be used
Romanian: Diovan 320 mg, comprimate filmate, poate fi utilizat:
English: All-cause mortality was similar in the valsartan (19.9%), captopril (19.5%), and valsartan + captopril (19.3%) groups.
Romanian: Valsartanul a fost la fel de eficace ca i captoprilul în reducerea mortalit ii dup infarctul miocardic, indiferent de cauz . Mortalitatea indiferent de cauz a fost similar în cazul administr rii valsartanului (19,9%), captoprilului (19,5%) i asocierii de valsartan i captopril (19,3%).
English: High blood pressure increases the risk of heart attacks.
Romanian: Tensiunea arterial mare cre te i riscul unui infarct miocardic.
English: One film-coated tablet contains 40 mg of valsartan.
Romanian: Un comprimat filmat con ine valsartan 40 mg.
English: Fatigue
Romanian: Oboseal
English: Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
Romanian: Nu s-a studiat utilizarea la pacien ii copii i adolescen i cu clearance-ul creatininei <30 ml/min i la pacien ii copii i adolescen i care sunt supu i dializei, prin urmare valsartan nu este recomandat la ace ti pacien i .
English: Ejection fraction in valsartan treated patients was significantly increased and LVIDD significantly reduced from baseline at endpoint compared to placebo.
Romanian: Frac ia de ejec ie a crescut semnificativ i DDIVS s-a redus semnificativ, de la momentul ini ial al studiului pân la închiderea acestuia, la pacien ii trata i cu valsartan fa de cei cu placebo.
English: 160 mg 80 kg to 160 kg 320 mg
Romanian: Doza maxim studiat în cadrul studiilor clinice 18 kg pân la <35 kg 80 mg 35 kg pân la <80 kg 160 mg 80 kg pân la 160 kg 320 mg
English: Evaluation of patients with heart failure should always include assessment of renal function (see section 4.2).
Romanian: Evaluarea pacien ilor cu insuficien cardiac trebuie întotdeauna s includ evaluarea func iei renale (vezi pct.
English: Caution should be observed when initiating therapy in post-myocardial infarction patients.
Romanian: Ini ierea tratamentului la pacien ii post-infarct miocardic trebuie f cut cu pruden .
English: Children and adolescents (6 to 18 years of age) with high blood pressure:
Romanian: Utilizarea la pacien ii copii i adolescen i cu vârsta cuprins între 6 i 18 ani, cu insuficien hepatic
English: Strength Pharmaceutical Form Route of administration
Romanian: Concentraia Form farmaceutic
English: Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 18 years of age.
Romanian: Tratamentul hipertensiunii arteriale esen iale la adul i i tratamentul hipertensiunii arteriale la copii i adolescen i cu vârsta cuprins între 6 i 18 ani.
English: The starting dose is provided by the 40 mg divisible tablet.
Romanian: Doza ini ial este ob inut utilizând comprimatele divizabile de 40 mg.
English: The initial dose is 40 mg once daily for children weighing below 35 kg and 80 mg once daily for those weighing 35 kg or more.
Romanian: Copii i adolescen i cu vârsta cuprins între 6 i 18 ani Doza ini ial este de 40 mg, o dat pe zi, la copii cu mas corporal sub 35 kg i 80 mg, o dat pe zi, pentru copii cu mas corporal de 35 kg i peste.
English: Caution should be observed when initiating therapy in patients with heart failure.
Romanian: Ini ierea tratamentului la pacien ii cu insuficien cardiac trebuie f cut cu pruden .
English: FURTHER INFORMATION What Diovan contains [To be completed nationally]
Romanian: Ce con ine Diovan [A se completa la nivel na ional]
English: The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks.
Romanian: Efectul antihipertensiv este prezent în mod substan ial dup 2 s pt mâni i efectele maxime sunt ob inute dup 4 s pt mâni.
English: Children and adolescents 6 to 18 years of age
Romanian: Copii i adolescen i
English: (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 µmol/l).
Romanian: La pacien ii hipertensivi cu diabet zaharat de tip 2 i microalbuminurie, s-a constatat c valsartanul reduce excre ia urinar de albumin . Studiul MARVAL (Micro Albuminuria Reduction with Valsartan) compar valsartanul (80-160 mg o dat pe zi) cu amlodipina (5-10 mg o dat pe zi) în ceea ce prive te reducerea excre iei urinare de albumin (EUA) la 332 de pacien i cu diabet zaharat de tip 2 (vârsta medie: 58 de ani; 265 de b rba i) cu microalbuminurie (valsartan: 58 µg/min; amlodipin : 55,4 µg/min), cu tensiune arterial normal sau mare i cu func ia renal p strat (creatinina sanguin <120 µmol/l).
English: film coated tablets 40 mg
Romanian: film coated tablets
English: These doses in rats (600 mg/kg/day) are approximately 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Romanian: Aceste doze administrate la obolan (600 mg/kg i zi) sunt de aproximativ 18 ori mai mari decât doza maxim recomandat la om, calculat în mg/m
English: AUC and Cmax values of valsartan are almost proportional with increasing dose over the clinical dosing range (40 to 160 mg twice a day).
Romanian: La pacien ii cu insuficien cardiac , timpul mediu pân la atingerea concentra iilor plasmatice maxime i timpul de înjum t ire plasmatic prin eliminare ale valsartanului sunt similare cu cele observate la voluntarii s n to i. Valorile ASC i Cmax ale valsartanului cresc aproape propor ional cu cre terea dozei în intervalul clinic de dozaj (între 40 i 160 mg de 2 ori pe zi).
English: Rash, Pruritis
Romanian: Cre terea potasemiei
English: EU/1/18/1299/001 YESCARTA
Romanian: EU/1/18/1299/001
English: 0.4 x 1082 x 108 cells
Romanian: YESCARTA 0,4 x 108 -2 x 108 celule
English: Intravenous use bag (ethylene vinyl acetate)
Romanian: Utilizare intravenoasă recipient (etilenacetat de vinil)
English: These Member States were not able to reach an agreement and Sweden referred the reasons for disagreement to the EMEA on 27 September 2007.
Romanian: Statele membre nu au putut ajunge la un acord, iar Suedia a transmis motivele de dezacord către EMEA la 27 septembrie 2007.
English: London, 12 September 2008 EMEA/CHMP/495857/2008
Romanian: Londra, 12 septembrie 2008 EMEA/CHMP/495853/2008
English: The arbitration procedure started on 18 October 2007 with the adoption of a list of questions.
Romanian: Procedura de arbitraj a fost iniţiată la 18 octombrie 2007 prin adoptarea unei liste de întrebări.
English: The Rapporteur was Dr Tomas Salmonson (SE) and Dr Pierre Demolis (FR) was Co-Rapporteur.
Romanian: Raportor a fost Dr. Tomas Salmonson (SE) iar co-raportor a fost Dr. Pierre Demolis (FR).
English: The Decentralised Procedure, SE/H/575/07/DC, started on 1 September 2006.
Romanian: Procedura descentralizată SE/H/575/07/DC a fost iniţiată la 1 septembrie 2006.
English: The Applicant provided written explanations on 7 April 2008.
Romanian: Solicitantul a furnizat explicaţii scrise la 7 aprilie 2008.
English: This refers to the bridging strategy of the Applicant and was considered to be a serious public health concern.
Romanian: Acestea se referă la strategiile de corelare ale solicitantului şi au fost considerate o problemă de sănătate publică de interes major.
English: The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain and United Kingdom.
Romanian: Statul membru de referinţă a fost Suedia, iar statele membre interesate au fost Austria, Belgia, Cipru, Republica Cehă, Danemarca, Estonia, Finlanda, Franţa, Germania, Grecia, Ungaria, Islanda, Irlanda, Italia, Letonia, Lituania, Luxemburg, Norvegia, Polonia, Portugalia, Republica Slovacă, Slovenia, Spania şi Regatul Unit.
English: A positive opinion was adopted by consensus on 26 June 2008
Romanian: Un aviz pozitiv a fost adoptat prin consens la 26 iunie 2008.
English: International Non-Proprietary Name (INN): fentanyl citrate
Romanian: Denumire comună internaţională (DCI): fentanil citrat
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
Romanian: AVIZ CA URMARE A UNEI SESIZĂRI ÎN TEMEIUL ARTICOLULUI 29 ALINEATUL (4)1
English: Rapinyl and associated names
Romanian: Rapinyl şi denumirile asociate
English: Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/risk and the lack of PK data under normal conditions of use of the product.
Romanian: Au fost identificate diferenţe semnificative referitoare la necesarul de studii clinice suplimentare de eficacitate şi siguranţă la administrare pentru evaluarea raportului beneficiu/risc şi lipsa datelor farmacocinetice în condiţii normale de administrare a produsului.
English: During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Rapinyl and associated names, that the objections raised by Germany, France, Norway and United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended.
Romanian: În timpul reuniunii din iunie 2008, CHMP, prin prisma tuturor datelor înaintate şi a discuţiilor ştiinţifice din comisie, a concluzionat că raportul beneficiu/risc este favorabil pentru Rapinyl şi denumirile asociate, că obiecţiile înaintate de Germania, Franţa, Norvegia şi Regatul Unit nu trebuie să împiedice acordarea autorizaţiei de introducere pe piaţă şi că rezumatul caracteristicilor produsului, etichetarea şi prospectul din statul membru de referinţă trebuie modificate.
English: ProStrakan Ltd submitted applications for Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets.
Romanian: ProStrakan Ltd a înaintat solicitările pentru Rapinyl şi denumirile asociate, comprimate sublinguale de 50 µg, 100 µg, 200 µg, 300 µg, 400 µg, 600 µg, 800 µg.
English: Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets is indicated for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Romanian: Rapinyl şi denumirile asociate, comprimate sublinguale de 50 µg, 100 µg, 200 µg, 300 µg, 400 µg, 600 µg, 800 µg, este indicat pentru gestionarea durerii episodice intense la pacienţii adulţi sub tratament opioid cronic pentru durerea cronică din boala canceroasă.
English: 22014 Incheon REPUBLIC OF KOREA
Romanian: 22014 Incheon REPUBLICA COREEA
English: • At the request of the European Medicines Agency.
Romanian: • la cererea Agenției Europene pentru Medicamente;
English: which was followed by
Romanian: care a fost urmat de
English: Herzuma is not recommended for anyone under the age of 18 years.
Romanian: Herzuma nu este recomandat persoanelor cu vârsta sub 18 ani.
English: • The active substance is trastuzumab.
Romanian: • Substanța activă este trastuzumab.
English: The following information is intended for medical or healthcare professionals only
Romanian: Următoarele informații sunt destinate numai medicilor sau profesioniștilor din domeniul sănătății:
English: WestEnd Office Building B torony Hungary
Romanian: WestEnd Office Building B torony Ungaria
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Romanian: TTP = timpul până la progresia bolii ;''ne'' -indică faptul că nu s-a putut estima sau nu a fost atins încă.
English:  you have ever had any other treatment for cancer.
Romanian: • vi s-au administrat vreodată alte tratamente pentru cancer.
English: The primary endpoint was overall survival which was defined as the time from the date of randomisation to the date of death from any cause.
Romanian: Obiectivul primar a fost supraviețuirea generală care a fost definită ca durata de timp de la data randomizării până la data decesului din orice cauză.
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under section 6.6.
Romanian: Acest medicament nu se amestecă sau diluează cu alte medicamente cu excepția celor menționate la pct. 6.6.
English: Herzuma is not genotoxic.
Romanian: Herzuma nu este genotoxic.
English: Any remaining reconstituted solution should be discarded.
Romanian: Orice soluție reconstituită rămasă, trebuie înlăturată.
English: Due to non-linear elimination, total clearance increased with decreasing concentration.
Romanian: Din cauza eliminării non-lineare, clearance-ul total a crescut o dată cu scăderea concentrației.
English: The patient who missed the dose should not wait until the next planned cycle.
Romanian: Pacientul care a omis administrarea unei doze nu trebuie să aștepte până la ciclul următor planificat.
English: It is not known whether trastuzumab can affect reproductive capacity.
Romanian: Nu se cunoaște dacă trastuzumabul poate afecta capacitatea de reproducere.
English: Anaphylactoid reactions have been observed in isolated cases.
Romanian: Reacțiile anafilactice au fost observate în cazuri izolate.
English: The dose of Herzuma depends on your body weight.
Romanian: Doza de Herzuma depinde de greutatea dumneavoastră corporală.
English: Therefore, these patients should not be treated with Herzuma (see section 4.3).
Romanian: Prin urmare, acești pacienți nu trebuie tratați cu Herzuma (vezi pct. 4.3).
English: This medicinal product must not be diluted with glucose solutions since these cause aggregation of the protein.
Romanian: Acest medicament nu trebuie diluat cu soluții de glucoză, deoarece acestea pot produce agregarea proteinelor.
English: Other side effects that have been reported with Herzuma use (frequency cannot be estimated from the available data):
Romanian: Alte reacții adverse care au fost raportate la administrarea de Herzuma (frecvența nu poate fi estimată din datele disponibile):
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Romanian: Unele din aceste simptome pot fi grave și unii pacienți au decedat (vezi pct. 2 subpunctul „Atenționări și precauții”).
English: Therefore, from the mechanism of action there is evidence that trastuzumab can cause tumour lysis syndrome.
Romanian: Prin urmare, din mecanismul de acţiune există dovezi că trastuzumab poate cauza sindromul de liză tumorală.