FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Romanian: DATA PRIMEI AUTORIZ RI SAU A REÎNNOIRII AUTORIZA IEI [A se completa la nivel na ional]
English: Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.
Romanian: Întrucât nu exist niciun efect asupra ECA i nicio poten are a bradikininei sau substan ei P, este improbabil ca antagoni tii angiotensinei II s fie asocia i cu tusea.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
Romanian: Stenoza valvei aortice i mitrale, cardiomiopatia hipertrofic obstructiv La fel ca în cazul tuturor celorlalte vasodilatatoare, este indicat o atitudine deosebit de precaut la pacien ii care sufer de stenoz aortic sau mitral ori de cardiomiopatie hipertrofic obstructiv (CMHO).
English: Do not store above 30°C.
Romanian: A nu se p stra la temperaturi peste 30°C.
English: • Keep this leaflet.
Romanian: • P stra i acest prospect.
English: • other medicines that lower blood pressure, especially water tablets (diuretics).
Romanian: • alte medicamente utilizate pentru sc derea tensiunii arteriale, în special comprimate pentru eliminarea apei (diuretice).
English: Valsartan shows multiexponential decay kinetics (t½ <1 h and t½ß about 9 h).
Romanian: Valsartanul se caracterizeaz printr-o cinetic multiexponen ial a metaboliz rii (t½ <1 or i t½ß de aproximativ 9 ore).
English: • then, push the plunger all the way back in so that it is empty again.
Romanian: • apoi, ap sa i pistonul complet înapoi, astfel încât s se goleasc .
English: Other conditions with stimulation of the renin-angiotensin system In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
Romanian: Alte probleme date de stimularea sistemului renin -angiotensin La pacien ii a c ror func ie renal poate depinde de activitatea sistemului renin -angiotensin (de exemplu pacien i cu insuficien cardiac congestiv sever ), tratamentul cu inhibitori ai enzimei de conversie a angiotensinei a fost asociat cu oligurie i/sau azotemie progresiv i, în cazuri rare, cu insuficien a renal acut i/sau deces.
English: Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure.
Romanian: Diovan apar ine unei clase de medicamente cunoscute sub denumirea de antagoni ti ai receptorilor angiotensinei II, care ajut la controlarea hipertensiunii arteriale.
English: • Do this after each time that you use the oral syringe.
Romanian: • Proceda i astfel de fiecare dat când utiliza i seringa pentru administrare oral .
English: Take this into account if you have diabetes mellitus.
Romanian: Ave i acest lucru în vedere dac ave i diabet zaharat.
English: Diovan oral solution contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Romanian: Diovan solu ie oral con ine parahidroxibenzoat de metil care poate provoca reac ii alergice (posibil întârziate).
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Romanian: Pentru orice informa ii despre acest medicament, v rug m s contacta i de in torul autoriza iei de punere pe pia .
English: Artificial blueberry flavour (538926 C) Propylene glycol (E1520) Sodium hydroxide
Romanian: Arom artificial de afine (538926 C) Propilenglicol (E 1520) Hidroxid de sodiu
English: • Do not store above 30°C.
Romanian: • A nu se p stra la temperaturi peste 30°C.
English: Remove the cap from the bottle by pushing it down firmly and turning it anti-clockwise (as shown on the top of the cap).
Romanian: Scoate i capacul de pe flacon, ap sând ferm i r sucindu-l în sensul invers al acelor de ceas (cum se arat pe partea superioar a capacului).
English: INFORMATION IN BRAILLE [To be completed nationally]
Romanian: INFORMA II ÎN BRAILLE [A se completa la nivel na ional]
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Romanian: Nu se recomand utilizarea antagoni tilor receptorilor de angiotensin II (ARAII) în primul trimestru de sarcin (vezi pct. 4.4).
English: Hyperkalaemia was more frequently observed in children and adolescents aged 6 to 18 years with underlying chronic kidney disease.
Romanian: Hiperkaliemia a fost observat mai frecvent la copii i adolescen i cu vârsta cuprins între 6 i 18 ani, cu afec iune renal cronic primar .
English: If you take more Diovan than you should
Romanian: Dac lua i mai mult decât trebuie din Diovan
English: 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.
Romanian: Aceste reac ii adverse pot ap rea cu anumite frecven e, care sunt definite dup cum urmeaz : foarte frecvente: afecteaz mai mult de 1 utilizator din 10 frecvente: afecteaz 1 pân la 10 utilizatori din 100 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.
English: Valsartan is highly bound to plasma protein and is unlikely to be removed by dialysis.
Romanian: Valsartanul se leag în propor ie mare de proteinele plasmatice i este pu in probabil s fie eliminat prin dializ .
English: • if you are below 18 years of age and you take Diovan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and the amount of potassium in your blood at regular intervals.
Romanian: • dac ave i vârsta sub 18 ani i lua i Diovan în asociere cu alte medicamente care inhib sistemul renin -angiotensin -aldosteron (medicamente care reduc tensiunea arterial ), medicul dumneavoastr v poate verifica func ia renal i cantitatea de potasiu din sânge, la intervale regulate.
English: 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.
Romanian: 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.
English: The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed below according to system organ class.
Romanian: RA raportate în cadrul studiilor clinice, experien ei ulterioare punerii pe pia i rezultatelor testelor de laborator sunt prezentate mai jos, conform clasific rii pe aparate, sisteme i organe.
English: 2 and 4, rue Lionel Terray
Romanian: Novartis Pharma S.A.S. 2 and 4, rue Lionel Terray
English: Treatment of hypertension in children and adolescents 6 to 18 years of age.
Romanian: Tratamentul hipertensiunii arteriale la copii i adolescen i cu vârsta cuprins între 6 i 18 ani.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
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.
English: [To be completed nationally]
Romanian: [A se completa la nivel na ional]
English: Neurocognitive and developmental assessment of paediatric patients aged 6 to 16 years of age revealed no overall clinically relevant adverse impact after treatment with Diovan for up to one year.
Romanian: Evaluarea neurocognitiv i de dezvoltare a pacien ilor copii i adolescen i cu vârsta cuprins între 6 i 16 ani nu a ar tat niciun impact advers, general, clinic relevant dup tratamentul cu Diovan de pân la un an.
English: AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia); see also section 5.3 “Preclinical safety data”.
Romanian: Se cunoa te c expunerea la tratamentul cu ARAII în timpul celui de-al doilea i al treilea trimestru de sarcin induce toxicitate fetal la om (diminuarea func iei renale, oligohidramnios, întârzierea osific rii craniene) i toxicitate neonatal (insuficien renal , hipotensiune arterial , hiperkalemie); vezi i pct. 5.3, „Date preclinice de siguran ”.
English: • abdominal pain
Romanian: • durere abdominal
English: • elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases)
Romanian: • cre terea valorilor testelor privind func ia hepatic (care pot indica o afectare hepatic ), incluzând o cre tere a cantit ii de bilirubin în sânge (care poate genera colorarea în galben a pielii i ochilor în cazuri severe)
English: Missing information: clinical management and use of pharmacotherapy in paediatric heart failure, paediatric recent myocardial infarction, paediatric hypertension with renal impairment (GFR < 30 mL/min) and paediatric hypertension with mild to moderate hepatic impairment.
Romanian: Informa ii lips : management clinic i utilizarea farmacoterapiei în insuficien a cardiac pediatric , infarctul miocardic pediatric recent, hipertensiunea pediatric cu insuficien renal (RFG < 30 ml/min.) i hipertensiunea pediatric cu insuficien hepatic u oar pân la moderat .
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Romanian: Dac utilizarea acestei asocieri este necesar , se recomand monitorizarea atent a valorilor litiului seric.
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Romanian: DE IN TORUL AUTORIZA IEI DE COMERCIALIZARE [Vezi Anexa I - a se completa la nivel na ional]
English: Because no information is available regarding the use of valsartan during breastfeeding, Diovan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Romanian: Întrucât nu sunt disponibile informa ii privind utilizarea valsartanului în timpul al pt rii, nu se recomand utilizarea Diovan, fiind preferabil un alt tratament, cu un profil de siguran mai bine stabilit în ceea ce prive te al ptarea, în special dac este vorba de al ptarea unui nou-n scut sau a unui sugar n scut prematur.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Romanian: V rug m s spune i medicului dumneavoastr sau farmacistului dac lua i sau a i luat recent orice alte medicamente, inclusiv dintre cele eliberate f r prescrip ie medical .
English: In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan.
Romanian: În studiile clinice controlate la pacien ii adul i cu hipertensiune arterial , inciden a global a reac iilor adverse (RA) a fost comparabil cu cea pentru placebo i este compatibil cu profilul farmacologic al valsartanului.
English: PHARMACEUTICAL PARTICULARS
Romanian: PARTICULARIT I FARMACEUTICE
English: Take Diovan solution once a day
Romanian: Lua i Diovan solu ie o dat pe zi
English: In rats, maternally toxic doses (600 mg/kg/day) during the last days of gestation and lactation led to lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6).
Romanian: La obolan, administrarea unor doze toxice pentru mam (600 mg/kg i zi) în timpul ultimelor zile de gesta ie i a lacta iei au condus la o rat mai mic de supravie uire, o cre tere mai mic în greutate i o întârziere în dezvoltare (deta area pavilionului urechii externe i deschiderea canalului auricular) la pui (vezi pct. 4.6).
English: In hypertension in children and adolescents, where underlying renal abnormalities are common, caution is recommended with the concomitant use of valsartan and other substances that inhibit the renin angiotensin aldosterone system which may increase serum potassium.
Romanian: În cazul hipertensiunii arteriale la copii i adolescen i, unde anomaliile renale primare sunt frecvente, se recomand pruden la utilizarea concomitent de valsartan cu alte substan e care inhib sistemul renin -angiotensin -aldosteron care pot cre te valoarea potasiului seric.
English: You can take Diovan with or without food.
Romanian: Diovan poate fi luat cu sau f r alimente.
English: 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.
Romanian: 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 ani i cel raportat anterior pentru pacien ii adul i.
English: - Severe hepatic impairment, biliary cirrhosis and cholestasis.
Romanian: - Insuficien hepatic sever , ciroz biliar i colestaz .
English: • Keep out of the reach and sight of children.
Romanian: • A nu se l sa la îndemâna i vederea copiilor.
English: Hypotension, Orthostatic hypotension
Romanian: Hipotensiune arterial , hipotensiune arterial ortostatic
English: 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.
Romanian: 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 .
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; IÎ95% : 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: It was concluded that 160-320 mg of valsartan produced clinically relevant reductions in UAE in hypertensive patients with type 2 diabetes.
Romanian: S-a concluzionat c o doz de valsartan de 160320 mg genereaz reduceri semnificative clinic ale EUA la pacien ii hipertensivi cu diabet zaharat de tip 2.
English: Potential risks: renal impairment, elevation of liver function values, hypersensitivity including angioedema and serum sickness, hemoglobin/hematocrit decreased and medication error including overdose.
Romanian: Riscuri poten iale: insuficien renal , cre terea valorilor func iei hepatice, hipersensibilitate, incluzând angioedem i boala serului, sc derea valorii hemoglobinei/hematocritului i eroare de medica ie, inclusiv supradozaj.
English: However, if it is almost time for your next dose, skip the dose you missed.
Romanian: Dac , îns , este aproape timpul s lua i urm toarea doz , omite i doza uitat .
English: Diovan has not been studied in patients with severe hepatic dysfunction (see sections 4.2, 4.3 and 4.4).
Romanian: Diovan nu a fost studiat la pacien ii cu disfunc ie hepatic sever (vezi pct. 4.2, 4.3 i 4.4).
English: In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p<0.05) less in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9% respectively).
Romanian: În studiile clinice în care valsartanul a fost comparat cu un inhibitor ECA, inciden a tusei neproductive a fost semnificativ mai mic (p < 0,05) la pacien ii trata i cu valsartan decât la cei trata i cu un inhibitor ECA (2,6% fa de 7,9%).
English: Each ml solution contains 0.3 g sucrose, 1.62 mg methyl parahydroxybenzoate (E218) and 5 mg poloxamer (188)
Romanian: Fiecare ml de solu ie con ine zah r 0,3 g, parahidroxibenzoat de metil (E218) 1,62 mg i poloxamer (188) 5 mg.
English: The dose should be adjusted based on blood pressure response up to a maximum dose of 80 mg valsartan (corresponding to 27 ml of the solution).
Romanian: Doza trebuie ajustat pe baza r spunsului tensiunii arteriale pân la o doz maxim de 80 mg valsartan (corespondentul a 27 ml de solu ie).
English: 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).
Romanian: 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 tratai un diuretic tiazidic au prezentat tuse, comparativ cu 68,5% dintre pacienii tratai cu un inhibitor ECA (p <0,05).
English: o the usual dose is 40 mg of valsartan (corresponding to 13 ml of the solution).
Romanian: o doza uzual este de 40 mg de valsartan (corespondentul a 13 ml de solu ie).
English: This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well.
Romanian: Din acest motiv, este cu atât mai important s merge i la consulturile medicale programate, chiar dac v sim i i bine.
English: Novartis Finland OY
Romanian: Novartis Finlanda OY
English: Novartis Finland Oy
Romanian: Novartis Finlanda Oy
English: • low blood pressure with or without symptoms such as dizziness and fainting when standing up
Romanian: • 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
English: However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Romanian: Cu toate acestea, deoarece alte medicamente care interfer cu sistemul renin -angiotensin pot cre te ureea sanguin i creatinina plasmatic la pacien i cu stenoz unilateral de arter renal , se recomand monitorizarea func iei renale pe durata tratamentului cu valsartan.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children.
Romanian: ATEN IONARE SPECIAL PRIVIND FAPTUL C MEDICAMENTUL NU TREBUIE P STRAT LA ÎNDEMÂNA I VEDEREA COPIILOR A nu se l sa la îndemâna i vederea copiilor.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Romanian: INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Diovan solution.
Romanian: Dac medicul dumneavoastr v-a aten ionat c ave i intoleran la unele categorii de glucide, v rug m s -l întreba i înainte de a lua Diovan solu ie.
English: Vasculitis
Romanian: Vasculit
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Romanian: În cazul în care expunerea la ARAII a avut loc începând cu cel de-al doilea trimestru de sarcin , se recomand verificarea ecografic a func iei renale i a craniului.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
Romanian: Au fost raportate cre teri reversibile ale concentra iilor plasmatice de litiu i toxicit ii acestuia în timpul administr rii concomitente de inhibitori ECA.
English: Therefore, if switching from Diovan tablets to Diovan oral solution is considered essential on clinical grounds, the valsartan dose should be adjusted as described in the table below and blood pressure should be carefully monitored.
Romanian: Prin urmare, dac trecerea de la Diovan comprimate la Diovan solu ie oral este considerat clinic esen ial , doza de valsartan trebuie ajustat a a cum se prezint în tabelul de mai jos i tensiunea arterial trebuie monitorizat cu aten ie.
English: Nervous system disorders Common
Romanian: Tulbur ri ale sistemului nervos Frecvente
English: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Romanian: La starea de echilibru, volumul de distribu ie al valsartanului dup administrarea intravenoas este de aproximativ 17 litri, indicând faptul c acesta nu se distribuie la nivel tisular într-o propor ie important .
English: Measuring a dose of medicine
Romanian: M surarea unei doze de medicament
English: Diovan oral solution is not bioequivalent to the tablet formulation and patients should not be switched unless clinically essential.
Romanian: Diovan solu ie oral nu este bioechivalent cu comprimatele i pacien ii nu trebuie s treac la aceasta decât dac este clinic esen ial.
English: A press in bottle adapter:
Romanian: Un adaptor pentru flacon:
English: • breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)
Romanian: • lips de aer, dificult i în respira ie în pozi ia culcat, umflarea picioarelor (semne de insuficien cardiac )
English: This may cause allergic reactions possibly occuring some time after you take the solution.
Romanian: Acesta poate provoca reac ii alergice care pot ap rea la scurt timp dup ce a i luat solu ia.
English: Subsequently, frequent blood pressure monitoring should be performed taking into account potential under-dosing and dose should be titrated further based on blood pressure response and tolerability.
Romanian: Ulterior, trebuie monitorizat frecvent tensiunea arterial luându-se în considerare un poten ial supradozaj i ajustarea dozei trebuie efectuat în func ie de r spunsul tensiunii arteriale i tolerabilitate.
English: In some cases your doctor may ask you to take up to 80 mg of valsartan (corresponding to 27 ml of the solution).
Romanian: În unele cazuri, medicul dumneavoastr v poate cere s lua i pân la 80 mg de valsartan (corespondentul a 27 ml de solu ie oral ).
English: 180 ml amber type III glass bottle with a white child resistant polypropylene cap, including a polyethylene sealing disk and a yellow tamper evident ring, in addition the pack includes one dispensing kit containing one 5 ml oral dosing polypropylene syringe, one press in bottle adapter and one 30 ml polypropylene dosing cup.
Romanian: Flacon cu capacitatea de 180 ml din sticl brun , tip III, cu sistem de închidere securizat pentru copii din polipropilen , de culoare alb , incluzând un disc din polietilen i un inel de culoare galben , vizibil; în plus, cutia con ine o trus de administrare care con ine o sering dozatoare pentru administrare oral de 5 ml din polipropilen , un adaptor pentru flacon i o m sur dozatoare de 30 ml din polipropilen .