natgillin/translations-raw huggingface dataset:
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.
The antihypertensive effect of valsartan have been evaluated in four randomized, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age and 165 paediatric patients 1 to 6 years of age.
Efectul antihipertensiv al valsartanului a fost evaluat în cadrul a patru studii clinice, randomizate, dublu-oarbe, la 561 pacien i copii i adolescen i cu vârsta cuprins între 6 i 18 ani i la 165 pacien i copii cu vârsta cuprins între 1 i 6 ani.
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] Valsartan
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] Valsartan
In patients who weigh 35 kg or more the usual starting dose is 80 mg of valsartan once daily.
La pacien ii cu greutatea corporal de 35 kg sau peste, doza ini ial uzual este de 80 mg de valsartan, o dat pe zi.
• if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.
• dac lua i tratament pentru insuficien cardiac , nu este recomandat asocierea tripl cu inhibitori ai ECA i beta-blocante (medicamente utilizate pentru tratamentul insuficien ei cardiace).
What Diovan looks like and contents of the pack [To be completed nationally]
Cum arat Diovan i con inutul ambalajului [A se completa la nivel na ional]
Like all medicines, Diovan can cause side effects, although not everybody gets them.
REAC II ADVERSE POSIBILE Ca toate medicamentele, Diovan poate provoca reac ii adverse, cu toate c nu apar la toate persoanele.
Excretion:
Excre ia:
Renal function and serum potassium should be closely monitored (see sections 4.4 and 5.2).
Funcia renal i concentraia de potasiu seric trebuie monitorizate cu atenie (vezi pct. 4.4 i 5.2).
Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
Tratamentul simptomatic al insuficien ei cardiace la pacien ii adul i când nu pot fi utiliza i inhibitori ai enzimei de conversie a angiotensinei (ECA) sau ca tratament adjuvant pentru inhibitorii ECA când nu pot fi utilizate beta-blocante (vezi pct. 4.4 i 5.1).
Valsartan was also effective in prolonging the time to and reducing cardiovascular mortality, hospitalisation for heart failure, recurrent myocardial infarction, resuscitated cardiac arrest, and non-fatal stroke (secondary composite endpoint).
De asemenea, valsartanul a fost eficace în ceea ce prive te prelungirea perioadei de timp pân la mortalitatea de cauz cardiovascular i reducerea inciden ei acesteia, reducerea spitaliz rii datorate insuficien ei cardiace, recuren ei infarctului miocardic, resuscit rii în stop cardiac i accidentului vascular cerebral non-letal (criteriu final de evaluare secundar compus).
• if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) is not recommended.
• dac lua i tratament dup un infarct miocardic, nu este recomandat asocierea cu inhibitorii ECA (medicamente utilizate pentru tratamentul infarctului miocardic).
• to treat adult patients after a recent heart attack (myocardial infarction).
• pentru tratamentul pacien ilor adul i care au suferit un infarct miocardic (atac de cord) recent.
Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 24 hours with tablets and 1-2 hours with solution formulation.
Dup administrarea pe cale oral a valsartanului în monoterapie, concentra iile plasmatice maxime de valsartan sunt atinse în 2 - 4 ore la administrarea de comprimate i 1 - 2 ore la administrarea de solu ie.
Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice daily.
Medicul dumneavoastr va cre te treptat aceast doz pe parcursul urm toarelor câteva s pt mâni, pân la doza maxim de 160 mg de dou ori pe zi.
The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients.
Asocierea unui diuretic, cum este hidroclorotiazida va sc dea i mai mult tensiunea arterial la ace ti pacien i.
A somewhat higher systemic exposure to valsartan was observed in some elderly subjects than in young subjects; however, this has not been shown to have any clinical significance.
La unii subiec i vârstnici s-au observat expuneri sistemice la valsartan întrucâtva mai mari decât la subiec ii tineri; totu i, acest lucru nu a p rut s aib o semnifica ie clinic .
Adult patients with heart failure: Treatment starts generally with 40 mg twice daily.
Pacien i adul i cu insuficien cardiac : În general, ini ierea tratamentului se face cu doza de 40 mg de dou ori pe zi.
Val-HeFT was a randomised, controlled, multinational clinical trial of valsartan compared with placebo on morbidity and mortality in 5,010 NYHA class II (62%), III (36%) and IV (2%) heart failure patients receiving usual therapy with LVEF <40% and left ventricular internal diastolic diameter (LVIDD) >2.9 cm/m2.
Val-HeFT a fost un studiu clinic randomizat, controlat, multina ional care a comparat efectul valsartanului cu cel al placebo în ceea ce prive te morbiditatea i mortalitatea la 5010 de pacien i cu insuficien cardiac de clasele II (62%), III (36%) i IV (2%) NYHA, care urmau tratament conven ional, cu o valoare a frac iei de ejec ie a ventriculului stâng (FEVS) <40% i diametru diastolic intern al ventriculului stâng (DDIVS) >2,9 cm/m2.
Use in paediatric patients aged 6 to 18 years with renal impairment 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.
Utilizarea la pacien ii copii i adolescen i cu vârsta cuprins între 6 i 18 ani, cu insuficien renal Nu a fost 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 aceti pacieni.
However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Cu toate acestea, administrarea în asociere a valsartanului cu un inhibitor al ECA i un beta-blocant nu este recomandat (vezi pct. 4.4 i 5.1).
There was no difference in all-cause mortality, cardiovascular mortality or morbidity when beta blockers were administered together with the combination of valsartan + captopril, valsartan alone, or captopril alone.
Nu au existat diferen e în ceea ce prive te mortalitatea indiferent de cauz sau mortalitatea sau morbiditatea cardiovascular când au fost administrate beta-blocante concomitent cu asocierea de valsartan i captopril, cu valsartan în monoterapie sau cu captopril în monoterapie.
Adult patients after a recent heart attack: After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily.
În general, dup un infarct miocardic tratamentul este început dup cel mult 12 ore, de obicei la o doz mic , de 20 mg pe zi.
• purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)
• pete de culoare ro u-purpuriu, febr , mânc rime (semne ale inflama iei vaselor de sânge, numit i vasculit )
Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily.
Medicul dumneavoastr va cre te doza treptat pe parcursul urm toarelor câteva s pt mâni, pân la doza maxim de 160 mg de dou ori pe zi.
The recommended starting dose of Diovan is 40 mg twice daily.
Doza ini ial de Diovan recomandat este de 40 mg, de dou ori pe zi.
Diovan can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.
Diovan se poate administra împreun cu alte medicamente pentru tratamentul insuficien ei cardiace, iar medicul dumneavoastr va stabili tratamentul care este potrivit pentru dumneavoastr .
These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 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).
Aceste doze administrate la obolan (între 200 i 600 mg/kg i zi) sunt de aproximativ 6 pân la 18 ori mai mari decât doza maxim recomandat la om, calculat în mg/m2 (calculul ia în considerare o doz oral de 320 mg/zi i o greutate corporal de 60 kg).
Use of Diovan in post-myocardial infarction patients 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).
Utilizarea Diovan la pacien ii post-infarct miocardic conduce frecvent la o anumit reducere 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).
After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.
Dup administrarea unei doze ini iale de 20 mg de dou ori pe zi, tratamentul cu valsartan trebuie crescut treptat pân la 40 mg, 80 mg i 160 mg de dou ori pe zi, în cursul urm toarelor câteva s pt mâni.