natgillin/translations-raw huggingface dataset:
Therefore, the combination of valsartan with an ACE inhibitor is not recommended. 
Prin urmare, nu este recomandat asocierea dintre valsartan i un inhibitor ECA.
The combination of captopril and valsartan has shown no additional clinical benefit, instead the risk for adverse events increased compared to treatment with the respective therapies (see sections 4.2 and 5.1). 
Asocierea de captopril i valsartan nu a demonstrat niciun beneficiu clinic suplimentar, în schimb riscul apari iei evenimentelor adverse a crescut comparativ cu tratamentul cu medicamentele respective (vezi pct. 4.2 i 5.1).
In heart failure patients: 
La pacien ii cu insuficien cardiac :
• if you are treated after a heart attack or for heart failure, your doctor may check your kidney function. 
• dac v afla i sub tratament dup un infarct miocardic sau pentru insuficien cardiac , medicul dumneavoastr v-ar putea verifica func ia renal
- Post-myocardial infarction and/or heart failure (studied in adult patients only) 
Post-infarct miocardic i/sau insuficien cardiac (studiate numai la pacien i adul i)
The primary benefit was a 27.5% (95% CI: 17 to 37%) reduction in risk for time to first heart failure hospitalisation (13.9% vs. 18.5%). 
Beneficiul principal a fost reprezentat de o reducere cu 27,5% (IÎ 95%: între 17 i 37%) a riscului privind timpul pân la prima spitalizare datorat insuficien ei cardiace (13,9% fa de 18,5%).
Important information about some of the ingredients of Diovan [To be completed nationally] 
Informa ii importante privind unele componente ale Diovan [A se completa la nivel na ional]
Recent myocardial infarction 
Infarct miocardic recent
The antihypertensive effect persists over 24 hours after dosing. 
Efectul antihipertensiv persist peste 24 ore dup administrare.
• other medicines that lower blood pressure, especially water tablets (diuretics). 
• alte medicamente utilizate pentru sc derea tensiunii arteriale, în special comprimatele pentru eliminarea apei (diuretice).
The primary endpoint was time to all-cause mortality. 
Criteriul final de evaluare principal a fost perioada de timp pân la deces indiferent de cauz .
Baseline therapy included ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta blockers (36%). 
Tratamentul de baz a inclus inhibitori ai ECA (93%), diuretice (86%), digoxin (67%) i beta-blocante (36%).
In a double-blind randomized study in 90 children aged 1 to 6 years, which was followed by a one-year open-label extension, two deaths and isolated cases of marked liver transaminases elevations were observed. 
În cadrul unui studiu dublu-orb, randomizat, la 90 de copii cu vârsta cuprins între 1 i 6 ani, care a fost urmat de o extensie deschis, cu durata de un an, au fost observate dou decese i cazuri isolate de valori serice marcate ale transaminazelor hepatice.
• if you are more than 3 months pregnant (it is also better to avoid Diovan in early pregnancy - see pregnancy section). 
• dac sunte i gravid în mai mult de 3 luni (de asemenea, este mai bine s evita i s lua i
If symptomatic hypotension or renal dysfunction occur, consideration should be given to a dose reduction. 
Dac apare hipotensiunea arterial simptomatic sau disfunc ia renal , trebuie avut în vedere o reducere a dozei.
The study had two primary endpoints: all cause mortality (time to death) and composite mortality and heart failure morbidity (time to first morbid event) defined as death, sudden death with resuscitation, hospitalisation for heart failure, or administration of intravenous inotropic or vasodilator agents for four hours or more without hospitalisation. 
Studiul a avut dou criterii finale de evaluare principale: mortalitatea indiferent de cauz (perioada de timp pân la deces) i criteriul compus reprezentat de mortalitate plus morbiditatea prin insuficien cardiac (perioada pân la primul eveniment morbid) definit ca deces, moarte subit cu resuscitare, spitalizare datorat insuficien ei cardiace sau administrarea intravenoas de medicamente inotrope sau vasodilatatoare timp de patru ore sau mai mult, f r spitalizare.
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data. 
mai pu in frecvente: afecteaz 1 pân la 10 utilizatori din 1 000 rare: afecteaz 1 pân la 10 utilizatori din 10 000 foarte rare: afecteaz mai pu in de 1 utilizator din 10 000 cu frecven necunoscut : frecven a nu poate fi estimat din datele disponibile.
All cause mortality was similar (p=NS) in the valsartan (19.7%) and placebo (19.4%) groups. 
Mortalitatea indiferent de cauz a fost similar (p=NS) în cazul administr rii valsartanului (19,7%) i placebo (19,4%).
Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up. 
Simptomele insuficien ei cardiace includ respira ia dificil i umflarea picioarelor datorit acumul rii de lichid.
Irrespective of treatment, mortality was lower in the group of patients treated with a beta blocker, suggesting that the known beta blocker benefit in this population was maintained in this trial. 
Indiferent de tratamentul medicamentos studiat, mortalitatea a fost mai mic la grupul de pacien i c ruia i s-a administrat beta-blocantul, ceea ce sugereaz c beneficiul terapeutic cunoscut al beta-blocantelor la aceast popula ie s-a men inut în cadrul acestui studiu clinic.
Valsartan may be administered with other heart failure therapies. 
Va1sartan poate fi administrat în asociere cu alte medicamente pentru insuficien a cardiac .
If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. 
Dac nu este tratat , poate afecta vasele de sânge din creier, inim sau rinichi, putând determina accident vascular cerebral, insuficien cardiac sau renal .
The Risk Management Plan should include the following: o In the safety specification: results of juvenile safety studies regarding the risk of nephrotoxicity and its relevance for the use in the different paediatric groups paediatric exposure in clinical trials and in post marketing use by age group, indication (including off label use), dose, duration of use, gender and ethnicity o As safety concerns: 
Planul de gestionare a riscului trebuie s includ urm toarele: o În specifica ia de siguran : rezultatele studiilor de siguran juvenil privind riscul de nefrotoxicitate i relevan a acestuia pentru utilizarea la diferite grupuri de copii i adolescen i expunerea pediatric în studiile clinice i în utilizarea post-punere pe pia în func ie de grupa de vârst , indica ie (inclusiv utilizarea pentru indica ii neaprobate), doz , durata utiliz rii, sex sau etnie o În ceea ce prive te siguran a: Riscuri identificate: hiperkaliemie i hipotensiune.
Diovan belongs to a class of medicines known as angiotensin II receptor antagonist, which help to control high blood pressure. 
Diovan apar ine unei clase de medicamente cunoscute sub denumirea de antagoni ti ai receptorilor angiotensinei II, care ajut la controlarea hipertensiunii arteriale.
Additional information on special populations 
Informa ii suplimentare privind categoriile speciale de pacien i
In a second study in which 75 children aged 1 to 6 years were randomised, no significant liver transaminase elevations or death occurred with valsartan treatment. 
În cadrul unui al doilea studiu în care au fost randomiza i 75 de copii cu vârsta cuprins între 1 i 6 ani , nu au avut loc cre teri semnificative ale valorilor serice ale transaminazelor hepatice sau decese în urma tratamentului cu valsartan.
The study report will be finalized by Q4 2010. 
Raportul studiului va fi finalizat pân în trimestrul IV al anului 2010.
In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). 
În unele cazuri, medicul dumneavoastr v-ar putea prescrie doze mai mari (de exemplu 160 mg sau 320 mg).
High blood pressure increases the workload on the heart and arteries. 
Valorile mari ale tensiunii arteriale cresc sarcina asupra inimii i a arterelor.
The maximum daily dose administered in clinical trials is 320 mg in divided doses. 
Doza zilnic maxim administrat în cadrul studiilor clinice este de 320 mg, administrat frac ionat.
Daily oral dosing of neonatal/juvenile rats (from a postnatal day 7 to postnatal day 70) with valsartan at doses as low as 1 mg/kg/day (about 10-35% of the maximum recommended paediatric dose of 4 mg/kg/day on systemic exposure basis) produced persistent, irreversible kidney damage. 
Dozajul oral zilnic la obolani nou-n scu i/tineri (din ziua 7 pân în ziua 70 postnatal ) cu valsartan la doze de 1 mg/kg i zi (aproximativ 10-35% din doza maxim recomandat pentru copii i adolescen i de 4 mg/kg i zi pe baz de expunere sistemic ) a condus la deteriorarea renal persistent , ireversibil .
Combining valsartan with captopril did not add further benefit over captopril alone. 
Asocierea de valsartan i captopril nu a adus beneficii terapeutice suplimentare fa de administrarea captoprilului în monoterapie.
In patients with heart failure, the triple combination of an ACE inhibitor, a beta blocker and Diovan has not shown any clinical benefit (see section 5.1). 
La pacien ii cu insuficien cardiac , tripla asociere a unui inhibitor ECA, unui beta-blocant i Diovan nu a demonstrat niciun beneficiu clinic (vezi pct. 5.1).
PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal No special requirements. 
6.3 Perioad de valabilitate [A se completa la nivel na ional] 6.4 Precau ii speciale pentru p strare [A se completa la nivel na ional] 6.5 Natura i con inutul ambalajului [A se completa la nivel na ional] 6.6 Precau ii speciale pentru eliminarea reziduurilor Acest medicament nu necesit condi ii speciale de p strare.
• low blood pressure with or without symptoms such as dizziness and fainting when standing up 
• sc derea tensiunii arteriale, cu sau f r simptome cum este senza ia de ame eal i senza ie de le in la ridicarea în picioare
The safety profile of valsartan was consistent with the clinical course of patients treated in the postmyocardial infarction setting. 
Profilul de siguran al valsartanului a fost concordant cu evolu ia clinic a pacien ilor trata i în condi ii de post-infarct miocardic.
Patients were randomised within 12 hours to 10 days after the onset of myocardial infarction symptoms to valsartan, captopril, or the combination of both. 
Pacien ii au fost randomiza i, în intervalul dintre 12 ore pân la 10 zile de la instalarea simptomelor de infarct miocardic, în grupuri c rora li s-a administrat valsartan, captopril sau ambele.
With the exception of isolated gastrointestinal disorders (like abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to 18 years and that previously reported for adult patients. 
Cu excep ia tulbur rilor gastro-intestinale izolate (precum durere abdominal , grea , v rs turi) i a ame elii, nu au fost identificate diferen e relevente în func ie de tipul, frecven a i severitatea reac iilor adverse între profilul de siguran pentru pacien ii copii i adolescen i cu vârsta cuprins între 6 i 18 i cel raportat anterior pentru pacien ii adul i.
In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction. 
La pacien ii stabili din punct de vedere clinic, tratamentul poate fi ini iat, cel mai devreme, la 12 ore dup producerea infarctului miocardic.
Novartis Finland Oy 
Novartis Finlanda OY
Novartis Finland OY 
Novartis Finlanda Oy
The VALsartan In Acute myocardial iNfarcTion trial (VALIANT) was a randomised, controlled, multinational, double-blind study in 14,703 patients with acute myocardial infarction and signs, symptoms or radiological evidence of congestive heart failure and/or evidence of left ventricular systolic dysfunction (manifested as an ejection fraction 40% by radionuclide ventriculography or 35% by echocardiography or ventricular contrast angiography). 
Studiul VALsartan In Acute myocardial iNfarcTion (VALIANT) a fost un studiu randomizat, controlat, multina ional, dublu orb în care au fost înrola i 14703 de pacien i cu infarct miocardic acut i cu semne, simptome sau dovezi radiologice de insuficien cardiac congestiv i/sau dovezi de disfunc ie sistolic a ventriculului stâng (reprezentate de frac ie de ejec ie 40% determinat prin ventriculografie cu radionuclid sau FE 35% determinat prin ecocardiografie sau angiografie de contrast ventricular ).
The mean duration of follow-up was nearly two years. 
Durata medie de urm rire în cadrul studiului a fost de aproape doi ani.
HOW TO TAKE DIOVAN 
CUM S LUA I DIOVAN
Results appearing to favour placebo (composite mortality and morbidity was 21.9% in placebo vs. 25.4% in valsartan group) were observed for those patients receiving the triple combination of an ACE inhibitor, a beta blocker and valsartan. 
Rezultatele par s fie în favoarea placebo (criteriul compus de mortalitate i morbiditate a fost de 21,9% pentru placebo fa de 25,4% pentru valsartan) pentru acei pacien i c rora li s-a administrat tripla asociere dintre un inhibitor al ECA, un beta-blocant i valsartan.
There was no difference between valsartan and captopril in all-cause mortality based on age, gender, race, baseline therapies or underlying disease. 
Nu a existat diferen între valsartan i captopril în ceea ce privete mortalitatea indiferent de cauz, pe criterii de vârst, sex, ras, tratamente de fond sau patologie asociat.
In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised plasma urea, and renal tubular hyperplasia and basophilia in males). 
În studiile non-clinice de siguran , dozele mari de valsartan (între 200 i 600 mg/kg de greutate corporal ) au provocat la obolani o sc dere a parametrilor eritrocitari (num rul de eritrocite, hemoglobina, hematocritul) i dovezi de modificare a hemodinamicii renale (cre tere moderat a ureei plasmatice, hiperplazie tubular renal i bazofilie la masculi).
Regarding renal function, doubling of serum creatinine was observed in 4.2% of valsartan-treated patients, 4.8% of valsartan+captopril-treated patients, and 3.4% of captopril-treated patients. 
În ceea ce prive te func ia renal , a fost observat dublarea valorii creatininei serice la 4,2% dintre pacien ii trata i cu valsartan, la 4,8% dintre cei trata i cu valsartan plus captopril i la 3,4% dintre cei trata i cu captopril.
You obtain the 20 mg dose by dividing the 40 mg tablet. 
Pute i ob ine doza de 20 mg prin divizarea comprimatelor de 40 mg.
Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1). 
Tratamentul pacien ilor adul i, stabili din punct de vedere clinic, cu insuficien cardiac simptomatic sau disfunc ie sistolic ventricular stâng asimptomatic dup un infarct miocardic recent (12 ore-10 zile) (vezi pct. 4.4 i 5.1).
In patients receiving an ACE inhibitor without a beta-blocker, all cause mortality was similar (p=NS) in the valsartan (21.8%) and placebo (22.5%) groups. 
La pacien ii trata i cu un inhibitor al ECA f r beta-blocant, mortalitatea indiferent de cauz a fost similar (p=NS) în cazul administr rii valsartanului (21,8%) i placebo (22,5%).
The combination with ACE inhibitors is not recommended (see sections 4.4 and 5.1). 
Nu este recomandat asocierea cu inhibitorii ECA (vezi pct. 4.4 i 5.1).
When angiotensin II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. 
Atunci când antagoni tii angiotensinei II sunt administra i concomitent cu AINS, poate ap rea atenuarea efectului antihipertensiv.
In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced cough compared to 68.5% of those treated with an ACE inhibitor (p<0.05). 
Într-un studiu clinic efectuat la pacien i cu antecedente de tuse neproductiv în timpul tratamentului cu un inhibitor ECA, 19,5% dintre pacien ii trata i cu valsartan i 19,0% dintre cei trata i un diuretic tiazidic au prezentat tuse, comparativ cu 68,5% dintre pacien ii trata i cu un inhibitor ECA (p <0,05).
Adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common ( 1/10); common ( 1/100 to <1/10); uncommon ( 1/1,000 to <1/100); rare ( 1/10,000 to <1/1,000) very rare (<1/10,000), including isolated reports. 
( 1/1.000, <1/100); rare ( 1/10.000, <1/1.000); foarte rare (<1/10.000), inclusiv raport rile izolate.
Valsartan may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics. 
Valsartanul poate fi utilizat la pacien ii trata i cu alte medicamente utilizate în tratamentul post-infarct miocardic, de exemplu trombolitice, acid acetilsalicilic, beta-blocante, statine i diuretice.
BEFORE YOU TAKE DIOVAN 
ÎNAINTE S LUA I DIOVAN
Patients treated with valsartan had a better quality of life as demonstrated by change in the Minnesota Living with Heart Failure Quality of Life score from baseline at endpoint than placebo. 
Pacien ii trata i cu valsartan au avut o calitate mai bun a vie ii, demonstrat prin modificarea scorului Minnesota Living with Heart Failure Quality of Life, de la momentul ini ial al studiului pân la închiderea acestuia, comparativ cu placebo.
In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak reduction of blood pressure is achieved within 4-6 hours. 
La majoritatea pacien ilor, dup administrarea unei doze orale unice, efectul antihipertensiv începe în decurs de 2 ore, iar reducerea maxim a valorilor tensionale este ob inut dup 4-6 ore.
Children and adolescents (6 to 18 years of age) with high blood pressure In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily. 
Copii i adolescen i (cu vârsta cuprins între 6 i 18 ani) cu tensiune arterial mare La pacien ii cu greutatea corporal sub 35 kg, doza uzual este de 40 mg de valsartan, o dat pe zi.
In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient's tolerability. 
In general, se recomand ca pacien ii s ajung la doza de 80 mg de dou ori pe zi la dou s pt mâni de la începerea tratamentului i doza int maxim de 160 mg de dou ori pe zi, s fie atins dup trei luni, în func ie de tolerabilitatea pacientului.
Composite mortality and morbidity risk was significantly reduced by 18.3% (95% CI: 8% to 28%) with valsartan compared with placebo (31.0% vs. 36.3%). 
Riscul compus reprezentat de mortalitate i morbiditate a fost redus semnificativ, cu 18,3% (IÎ 95%: între 8% i 28%), pentru valsartan comparativ cu placebo (31,0% fa de 36,3%).
Nausea, Diarrhoea 
Grea , diaree
In this subgroup all-cause mortality was significantly reduced with valsartan compared to placebo by 33% (95% CI: -6% to 58%) (17.3% valsartan vs. 27.1% placebo) and the composite mortality and morbidity risk was significantly reduced by 44% (24.9% valsartan vs. 42.5% placebo). 
În acest subgrup, mortalitatea indiferent de cauz a fost semnificativ redus în cazul valsartanului fa de placebo, cu 33% (IÎ 95%: între -6% i 58%) (17,3% pentru valsartan fa de 27,1% pentru placebo) i riscul compus reprezentat de mortalitate i morbiditate a fost redus semnificativ, cu 44% (24,9% pentru valsartan fa de 42,5% pentru placebo).
In patients who continued to receive the medium and high doses of valsartan, systolic blood pressure at trough was -4 and -7 mm Hg lower than patients who received the placebo treatment. 
La pacien ii c rora li s-au administrat în continuare dozele medii i mari de valsartan, tensiunea arterial sistolic înainte de administrarea dozei urm toare a fost cu4 i -7 mm Hg mai mic decât la pacien ii c rora li s-a administrat tratament placebo.
Age does not affect the apparent clearance in heart failure patients. 
La pacien ii cu insuficien cardiac vârsta nu influen eaz clearance-ul aparent.
Discontinuations due to various types of renal dysfunction occurred in 1.1% of valsartan-treated patients, 1.3% in valsartan+captopril patients, and 0.8% of captopril patients. 
Întreruperea tratmentului ca urmare a diferitelor tipuri de disfunc ie renal a intervenit la 1,1% dintre pacien ii trata i cu valsartan, la 1,3% dintre cei trata i cu valsartan plus captopril i la 0,8% dintre cei trata i cu captopril.
• if you have severe heart disease other than heart failure or heart attack. 
• dac ave i o boal cardiac sever , alta decât insuficien a cardiac i infarctul miocardic.
In the overall Val-HeFT population, valsartan treated patients showed significant improvement in NYHA class, and heart failure signs and symptoms, including dyspnoea, fatigue, oedema and rales compared to placebo. 
În popula ia general a studiului Vat-HeFT, pacien ii trata i cu valsartan au prezentat o ameliorare semnificativ a clasei NYHA, precum i a semnelor i simptomelor insuficien ei cardiace, incluzând dispneea, fatigabilitatea, edemele i raluri, comparativ cu placebo.
In some cases your doctor may prescribe higher doses (the dose can be increased to 160 mg and to a maximum of 320 mg). 
În unele cazuri, medicul dumneavoastr v poate prescribe doze mai mari (doza poate fi crescut pân la 160 mg i pân la maximum 320 mg).
This dose is 6 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). 
Aceast doz este de 6 ori doza maxim recomandat la om calculat pe baz de mg/m2 (calculele presupun o doz oral de 320 mg/ zi i o mas corporal a pacientului de 60 kg).
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 
• Dac vreuna dintre reac iile adverse devine grav sau dac observa i orice reac ie advers nemen ionat în acest prospect, v rug m s -i spune i medicului dumneavoastr sau farmacistului.
ADRs that occurred in adult patients with post-myocardial infarction and/or heart failure patients are listed below. 
RA care au ap rut la pacien ii adul i post-infarct miocardic i/sau cu insuficien cardiac sunt prezentate mai jos.
Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I - To be completed nationally] 
Diovan i numele asociate (vezi Anexa I) 40 mg, comprimate filmate Diovan i numele asociate (vezi Anexa I) 80 mg, comprimate filmate Diovan i numele asociate (vezi Anexa I) 160 mg, comprimate filmate Diovan i numele asociate (vezi Anexa I) 320 mg, comprimate filmate [Vezi Anexa I - a se completa la nivel na ional]
In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. 
La pacien ii cu insuficien hepatic u oar pân la moderat , f r colestaz , doza de valsartan nu trebuie s dep easc 80 mg.