FrancophonIA/ELRC3.0 huggingface dataset:
English: Valsartan does not inhibit ACE (also known as kininase II) which converts Ang I to Ang II and degrades bradykinin.
Romanian: Valsartanul nu inhib ECA (cunoscut i sub numele de kininaz II), care converte te Ang I la Ang II i degradeaz bradikinina.
English: This should be taken into account in patients with diabetes mellitus.
Romanian: Acest lucru trebuie avut în vedere la pacien ii cu diabet zaharat.
English: • muscle pain (myalgia)
Romanian: • durere muscular (mialgie)
English: This may relate to the patients underlying disease.
Romanian: Acest lucru poate avea leg tur cu patologia de baz a pacien ilor.
English: The incidence of ADRs did not appear to be related to dose or treatment duration and also showed no association with gender, age or race.
Romanian: Inciden a RA nu a p rut s fie asociat cu doza sau durata tratamentului i, de asemenea, nu a demonstrat nicio leg tur cu sexul, vârsta sau rasa.
English: For therapeutic doses of valsartan in humans, the hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance.
Romanian: La dozele terapeutice de valsartan la om, hipertrofia celulelor juxtaglomerulare renale nu pare a avea nicio relevan .
English: The purpose of the study was to determine the optimal dose of valsartan for reducing UAE in hypertensive patients with type 2 diabetes.
Romanian: Scopul studiului a fost s determine doza de valsartan optim pentru reducerea EUA la pacien ii hipertensivi cu diabet zaharat de tip 2.
English: 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.
Romanian: Reac iile adverse sunt prezentate în ordinea frecven ei, începând cu cele mai frecvente, dup urm toarea conven ie: foarte frecvente ( 1/10); frecvente ( 1/100, <1/10); mai pu in frecvente ( 1/1.000, <1/100); rare ( 1/10.000, <1/1.000); foarte rare (<1/10.000), inclusiv raport rile izolate.
English: Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance).
Romanian: În urma administr rii intravenoase, clearance-ul plasmatic al valsartanului este de aproximativ 2 l/or iar clearance-ul s u renal este de 0,62 l/or (aproximativ 30% din clearance-ul total).
English: • if you are taking medicines that increase the amount of potassium in your blood.
Romanian: • dac lua i medicamente care cresc cantitatea de potasiu în sânge.
English: Mean absolute bioavailability is 23% and 39% with tablets and solution formulation, respectively.
Romanian: Biodisponibilitatea medie absolut este de 23% i 39% la administrarea de comprimate, respectiv solu ie.
English: Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.
Romanian: De i nu exist date epidemiologice provenite din studii controlate privind riscul indus de utilizarea ARAII, pot exista riscuri similare în cazul acestei clase de medicamente.
English: Your doctor will normally advise you to stop taking Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan.
Romanian: În mod normal, medicul dumneavoastr v va recomanda s înceta i s lua i Diovan înainte de a r mâne gravid sau deîndat ce ti i c sunte i gravid i v va recomanda s lua i un alt medicament în locul Diovan.
English: Side effects in children and adolescents are similar to those seen in adults.
Romanian: Reac iile adverse la copii i adolescen i sunt similare celor observate la adul i.
English: - Post-myocardial infarction and/or heart failure (studied in adult patients only)
Romanian: - Post-infarct miocardic i/sau insuficien cardiac (studiate numai la pacien i adul i)
English: Valsartan is primarily eliminated by biliary excretion in faeces (about 83% of dose) and renally in urine (about 13% of dose), mainly as unchanged drug.
Romanian: Valsartanul este eliminat în principal prin excre ie biliar în fecale (aproximativ 83% din doz ) i pe cale renal , în urin (aproximativ 13% din doz ), în cea mai mare parte sub form nemodificat .
English: These effects above mentioned represent an expected exaggerated pharmacological effect of angiotensin converting enzyme inhibitors and angiotensin II type 1 blockers; such effects are observed if rats are treated during the first 13 days of life.
Romanian: Aceste efecte men ionate mai sus reprezint un efect farmacologic anticipat exagerat al inhibitorilor enzimei de conversie a angiotensinei i blocantelor receptorului angiotensin II de tip 1; aceste efecte sunt observate dac obolanii sunt trata i în primele 13 zile de via .
English: No studies on the effects on the ability to drive have been performed.
Romanian: Nu s-au efectuat studii privind efectele asupra capacit ii de a conduce vehicule sau de a folosi utilaje.
English: PHARMACEUTICAL FORM Clear, colourless to pale yellow solution.
Romanian: FORMA FARMACEUTIC Solu ie limpede, incolor pân la galben pal.
English: Due to the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended.
Romanian: Datorit lipsei de experien privind utilizarea concomitent a valsartanului i litiului, aceast asociere nu este recomandat .
English: • muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
Romanian: • spasme musculare, ritm cardiac anormal (semne de hiperkaliemie)
English: • The oral syringe fits into the bottle adapter and is used to measure out the required amount of medicine from the bottle.
Romanian: • Seringa pentru administrare oral se ata eaz la adaptorul flaconului i se utilizeaz pentru a m sura cantitatea necesar de medicament din flacon.
English: What you will be using
Romanian: Ce ve i utiliza
English: 4.1 Therapeutic indications
Romanian: 4.1 Indica ii terapeutice
English: However, no correlation was observed between plasma valsartan concentration versus degree of hepatic dysfunction.
Romanian: Cu toate acestea, nu a fost observat nicio corela ie între concentra iile plasmatice de valsartan i gradul disfunc iei hepatice.
English: • that can be used if the prescribed dose requires filling the syringe several times.
Romanian: • care poate fi utilizat dac doza prescris necesit umplerea seringii de câteva ori.
English: Change of pharmaceutical form
Romanian: Modificarea formei farmaceutice
English: Check that the plunger is pushed fully into the oral syringe.
Romanian: Verifica i dac pistonul este împins complet în seringa pentru administrare oral .
English: • difficulty in breathing or swallowing
Romanian: • dificult i în respira ie sau la înghi ire
English: A comparative bioavailability study confirming the relative dosing of the tablets and oral solution should be carried out.
Romanian: Trebuie efectuat un studiu comparativ de biodisponibilitate care s confirme dozarea relativ a comprimatelor i solu iei orale.
English: Use in children under 6 years of age.
Romanian: Utilizarea la copii cu vârste mai mici de 6 ani.
English: • Do not use Diovan if you notice that the pack is damaged or shows signs of tampering.
Romanian: • Nu utiliza i Diovan dac observa i c ambalajul a fost deteriorat sau prezint semne de deschidere.
English: Children less than 6 years of age
Romanian: Copii cu vârsta sub 6 ani
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Romanian: DATA REVIZUIRII TEXTULUI [A se completa la nivel na ional]
English: Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day.
Romanian: Valsartan nu are efecte adverse asupra performan ei func iei de reproducere la masculii sau femelele de obolan, la doze orale de pân la 200 mg/kg i zi.
English: • Once you have inserted it, do not remove it.
Romanian: • Odat ata at, nu îl mai scoate i.
English: There is currently no experience on the safe use of Diovan in patients who have recently undergone kidney transplantation.
Romanian: Pân în prezent nu exist experien privind utilizarea în condi ii de siguran a Diovan la pacien ii care au efectuat recent transplant renal.
English: Hydrochloric acid
Romanian: Acid clorhidric
English: National Road No. 1 (12th Km)
Romanian: 1 (12th Km)
English: The rats in the juvenile valsartan study were dosed up to day 70, and effects on renal maturation (postnatal 4-6 weeks) cannot be excluded.
Romanian: obolanilor din studiul cu valsartan administrat la animalele tinere li s-au administrat doze pân în ziua 70 i efectele asupra maturiz rii renale (4-6 s pt mâni postnatale) nu pot fi excluse.
English: 4.3 Contraindications
Romanian: 4.3 Contraindica ii
English: Indirect comparisons suggest that, the oral bioavailability of valsartan with the solution is approximately 2-fold higher than the tablets.
Romanian: Compara iile indirecte sugereaz faptul c biodisponibilitatea oral a valsartanului sub form de solu ie este de aproximativ de 2 ori mai mare decât cea a comprimatelor.
English: Cardiac failure
Romanian: Insuficien cardiac
English: In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan or any of the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Romanian: În cadrul studiilor de interac iune medicamentoas cu valsartan, nu au fost constatate interac iuni cu semnifica ie clinic între valsartan sau oricare dintre urm toarele medicamente: cimetidin , warfarin , furosemid, digoxin , atenolol, indometacin, hidroclorotiazid , amlodipin , glibenclamid .
English: Lowering your blood pressure to normal reduces the risk of developing these disorders.
Romanian: Reducerea tensiunii arteriale la nivelul normal reduce riscul dezvolt rii acestor afec iuni.
English: In marmosets at similar doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy which included raised urea and creatinine.
Romanian: La marmote, la doze similare, modific rile au fost similare dar mai severe, în special la nivel renal, unde modific rile an condus la nefropatie înso it de cre terea ureei i a creatininei.
English: If you have accidentally taken more Diovan solution than you should, contact your doctor, pharmacist, or hospital.
Romanian: Dac a i luat în mod accidental mai mult Diovan solu ie decât trebuie, adresa i-v imediat medicului dumneavoastr , farmacistului sau merge i la spital.
English: The therapeutic measures depend on the time of ingestion and the type and severity of the symptoms; stabilisation of the circulatory condition is of prime importance.
Romanian: M surile terapeutice depind de intervalul de timp scurs de la ingerare i de tipul i severitatea simptomelor, de prim importan fiind stabilizarea parametrilor circulatorii.
English: In the second study, higher doses of valsartan were associated with greater BP reductions, but the dose response trend did not achieve statistical significance and the treatment difference compared to placebo was not significant.
Romanian: În al doilea studiu, dozele mai mari de valsartan au fost asociate cu reduceri mai mari ale tensiunii arteriale, dar tendin a de r spuns în func ie de doz nu a atins un nivel statistic semnificativ i diferen a privind tratamentul fa de placebo nu a fost semnificativ .
English: Concomitant use not recommended
Romanian: Utilizare concomitent nerecomandat
English: In the first study, the efficacy of valsartan was confirmed compared to placebo but a dose-response could not be demonstrated.
Romanian: În primul studiu, a fost confirmat eficacitatea valsartanului fa de placebo, dar nu a putut fi demonstrat un r spuns în func ie de doz .
English: 6.5 Nature and contents of container
Romanian: 6.5 Natura i con inutul ambalajului
English: It is not recommended to switch between Diovan tablets and Diovan oral solution unless clinically required as there is insufficient information to guide an appropriate dose on switching between the two formulations.
Romanian: Nu se recomand trecerea de la Diovan comprimate la Diovan solu ie oral dac acest lucru nu este necesar din punct de vedere clinic, deoarece nu exist informa ii suficiente pentru evaluarea unei doze adecvate la trecerea de la o form la alta.
English: When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
Romanian: În cazul conducerii vehiculelor sau folosirii utilajelor, trebuie avut în vedere c pot ap rea, ocazional, st ri de vertij sau epuizare.
English: Combined with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved.
Romanian: În cazul asocierii cu hidroclorotiazida, se realizeaz o sc dere suplimentar semnificativ a tensiunii arteriale.
English: • Restart the cycle of PSUR submission for Diovan as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Romanian: • Reluarea ciclului de prezentare a Rapoartelor periodice actualizate referitoare la siguran (PSUR) pentru Diovan dup cum urmeaz : o PSUR-uri la ase luni pân la dobândirea unei experien e de doi ani integrali legate de indica ia la copii i adolescen i în cadrul UE o PSUR-uri anuale pentru urm torii doi ani o Ulterior, prezentare la intervale de 3 ani PSUR-urile trebuie s se concentreze asupra utiliz rii la popula ia pediatric .
English: Note: You may not be able to push the bottle adapter down fully but this does not matter as it will be forced into the bottle when you screw the cap back on.
Romanian: Not : Este posibil s nu pute i s ap sa i complet adaptorul, îns acest lucru nu este important pentru c adaptorul va fi ap sat cu for a în flacon când în uruba i capacul pe flacon.
English: 4.6 Fertility, pregnancy and lactation
Romanian: 4.6 Fertilitatea, sarcina i al ptarea
English: For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a "not known" frequency.
Romanian: În cazul tuturor RA raportate în cadrul experien ei ulterioare punerii pe pia i rezultatelor testelor de laborator nu a fost posibil atribuirea unei clase de frecven i, prin urmare, acestea sunt men ionate„cu frecven necunoscut ”.
English: Hypertrophy of the renal juxtaglomerular cells was also seen in both species.
Romanian: De asemenea, la ambele specii a fost observat hipertrofia celulelor renale juxtaglomerulare.
English: Valsartan is not known to bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Romanian: Conform datelor cunoscute, valsartanul nu se leag de i nu blocheaz receptorii altor hormoni sau canalele ionice cunoscute ca având rol important în reglarea cardiovascular .
English: • if you are more than 3 months pregnant (it is also better to avoid Diovan in early pregnancy see pregnancy section).
Romanian: • dac sunte i gravid în mai mult de 3 luni (de asemenea, este mai bine s evita i s lua i
English: Fitting the press in bottle adapter into a new bottle of medicine
Romanian: Montarea unui adaptor pentru flacon pe un nou flacon de medicament
English: • slowly pull the plunger all the way out so that the oral syringe fills with medicine.
Romanian: • trage i lent, complet, pistonul în afar , astfel încât seringa pentru administrare oral s se umple cu medicament.
English: If any of these apply to you, tell your doctor before you take Diovan.
Romanian: Dac v afla i în oricare dintre aceste situa ii spune i medicului dumneavoastr înainte de a lua Diovan
English: Patients were randomized to one of 3 doses of valsartan (160, 320 and 640 mg/od) and treated for 30 weeks.
Romanian: Pacien ii au fost randomiza i pentru una din cele trei doze de valsartan (160, 320 i 640 mg o dat pe zi) i trata i timp de 30 de s pt mâni.
English: • if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).
Romanian: • dac a i pierdut o cantitate mare de lichide (deshidratare) din cauza diareei, v rs turilor sau a dozelor mari de comprimate pentru eliminarea apei (diuretice).
English: Abrupt withdrawal of Diovan has not been associated with rebound hypertension or other adverse clinical events.
Romanian: Întreruperea brusc a tratamentului cu Diovan nu a fost asociat cu fenomene de rebound al hipertensiunii arteriale sau cu alte reac ii clinice adverse.
English: Paediatric heart failure and recent myocardial infarction Diovan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.
Romanian: Insuficien a cardiac i infarctul miocardic recent la copii i adolescen i Diovan nu este recomandat pentru tratamentul insuficien ei cardiace sau al infarctului miocardic recent la copii i adolescen i cu vârsta sub 18 ani, din cauza lipsei datelor privind siguran a i eficacitatea.
English: This reduction in AUC is not, however, accompanied by a clinically significant reduction in the therapeutic effect, and valsartan can therefore be given either with or without food.
Romanian: Totu i, aceast sc dere a ASC nu este înso it de reducerea semnificativ clinic a efectului terapeutic i, prin urmare, administrarea valsartanului poate s se fac înso it sau nu de alimente.
English: Diovan oral solution contains poloxamer (188) which may cause softened stools.
Romanian: Diovan solu ie oral con ine poloxamer (188) care poate provoca scaune moi.
English: • The active substance is valsartan.
Romanian: • Substan a activ este valsartan.
English: • Wipe the outside of the oral syringe with a clean, dry tissue.
Romanian: • terge i exteriorul seringii pentru administrare oral cu un erve el curat i uscat.
English: Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase.
Romanian: Angiotensina II este o substan din organism care determin îngustarea vaselor de sânge, provocând astfel cre terea tensiunii arteriale.
English: High blood pressure increases the workload on the heart and arteries.
Romanian: Tensiunea arterial mare cre te efortul pe care îl fac inima i arterele.
English: 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: Identified risks: hyperkalemia and hypotension.
Romanian: 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.
English: For dosing recommendations in this case, see section 4.2.
Romanian: Pentru recomand ri privind dozajul în acest caz, vezi pct. 4.2.
English: 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.
Romanian: Dac nu este tratat , aceasta poate afecta vasele sanguine de la nivelul creierului, inimii i rinichilor i poate conduce la accident vascular cerebral, insuficien cardiac sau insuficien renal .
English: The increased plasma levels of Ang II following AT1 receptor blockade with valsartan may stimulate the unblocked AT2 receptor, which appears to counterbalance the effect of the AT1 receptor.
Romanian: Concentra iile plasmatice crescute de Ang II, dup blocarea receptorilor AT1 de c tre valsartan, pot stimula receptorii AT2 nebloca i, ceea ce pare s contrabalanseze efectul receptorilor AT1.
English: Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Romanian: Valsartanul se leag în propor ie mare de proteinele plasmatice (94-97%), îndeosebi de albumina plasmatic .
English: Renal and urinary disorders, and obesity were the most common underlying medical conditions potentially contributing to hypertension in the children enrolled in these studies.
Romanian: Tulbur rile renale i urinare i obezitatea au fost cele mai frecvente afec iuni medicale primare care, posibil, au contribuit la hipertensiunea arterial a copiilor înscri i în aceste studii.
English: 6.1 List of excipients
Romanian: 6.1 Lista excipien ilor
English: Read all of this leaflet carefully before you start taking this medicine.
Romanian: Citi i cu aten ie i în întregime acest prospect înainte de a începe s lua i acest medicament.
English: As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
Romanian: Dup cum era de a teptat pentru un medicament în cazul c ruia clearance-ul renal reprezint numai 30% din clearance-ul plasmatic total, nu s-a constatat nicio corela ie între func ia renal i expunerea sistemic la valsartan.
English: The safety profile seen in controlled-clinical studies in adult patients with post-myocardial infarction and/or heart failure varies from the overall safety profile seen in hypertensive patients.
Romanian: Profilul de siguran constatat în cadrul studiilor clinice controlate la pacien ii adul i post-infarct miocardic i/sau cu insuficien cardiac este diferit fa de profilul de siguran general observat la pacien ii hipertensivi.
English: Reductions in systolic blood pressure were comparable in patients receiving valsartan (15 mmHg) and enalapril (14 mm Hg) (non-inferiority p-value <0.0001).
Romanian: Reducerile tensiunii arteriale sistolice au fost comparabile la pacien ii c rora li s-a administrat valsartan (15 mmHg) i enalapril (14 mm Hg) (valoare p non-inferioar <0,0001).
English: Use a new bottle adapter and oral dosing syringe each time you start a new bottle of medicine.
Romanian: Utiliza i un adaptor nou de flacon i o sering dozatoare pentru administrare oral nou de fiecare dat când începe i un flacon nou de medicament.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Romanian: Când este diagnosticat prezen a sarcinii trebuie s fie imediat oprit tratamentul cu ARAII i, dac este cazul, s fie instituit un tratament alternativ (vezi pct. 4.3 i 4.6).
English: Short-term administration of Diovan to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN).
Romanian: Administrarea pe termen scurt de Diovan la doisprezece pacien i cu hipertensiune arterial secundar renovascular datorat stenozei unilaterale de arter renal nu a indus nicio modificare semnificativ în ceea ce prive te hemodinamica renal , creatinina seric sau azotul ureic din sânge (BUN).
English: The frequency of some side effects may vary depending on your condition.
Romanian: Frecven a unora dintre reac iile adverse poate varia în func ie de starea dumneavoastr .
English: In a double-blind randomized study in 90 children aged 1 to 6 years, which was followed by a oneyear open-label extension, two deaths and isolated cases of marked liver transaminases elevations were observed.
Romanian: 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.