FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you weigh less than 35 kg o the usual dose is 20 mg of valsartan (corresponding to 7 ml of the solution).
Romanian: • Dac cânt ri i sub 35 kg o doza uzual este de 20 mg de valsartan (corespondentul a 7 ml de solu ie).
English: • The solution is supplied in a pack containing one 180 ml amber glass bottle with a childresistant screw cap and a yellow tamper evident ring.
Romanian: Aceast solu ie este disponibil într-o cutie care con ine un flacon de 180 ml din sticl brun , cu sistem de închidere securizat pentru copii i un inel galben, vizibil.
English: In another clinical study involving 300 hypertensive paediatric patients 6 to 18 years of age, eligible patients were randomized to receive valsartan or enalapril tablets for 12 weeks.
Romanian: În cadrul unui alt studiu clinic la 300 de pacien i copii i adolescen i, cu hipertensiune arterial , cu vârsta cuprins între 6 i 18 ani, pacien ii eligibili au fost randomiza i pentru a li se administra comprimate de valsartan sau enalapril timp de 12 s pt mâni.
English: • increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases)
Romanian: • cre terea cantit ii de potasiu în sânge (care poate genera spasme musculare i ritm cardiac anormal în cazuri severe)
English: Kidney transplantation
Romanian: Transplantul renal
English: • Dry the cup with a clean tissue and place it back over the cap of the bottle.
Romanian: • Usca i m sura cu un erve el curat i pune i-o la loc pe capacul flaconului.
English: • 1 ml oral solution contains 3 mg of valsartan.
Romanian: • 1 ml de solu ie oral con ine valsartan 3 mg.
English: It acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Romanian: El ac ioneaz selectiv asupra subtipului de receptori AT1, care determin efectele cunoscute ale angiotensinei II.
English: If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down.
Romanian: Dac sim i i o stare de o ame eal sever i/sau le in, contacta i medicul imediat i întinde i-v .
English: The systemic exposure and peak plasma concentration of valsartan is higher with the solution compared to the tablets.
Romanian: Expunerea sistemic i concentra iile plasmatice maxime de valsartan sunt mai mari în cazul administr rii solu iei comparativ cu administrarea comprimatelor.
English: At 30 weeks, the percentage change in UAE was significantly reduced by 36% from baseline with valsartan 160 mg (95%CI: 22 to 47%), and by 44% with valsartan 320 mg (95%CI: 31 to 54%).
Romanian: Dup 30 de s pt mâni, sc derea procentual a EUA fa de momentul ini ial a fost semnificativ , de 36% pentru valsartan 160 mg (IÎ 95%: între 22 i 47%) i de 44% pentru valsartan 320 mg (IÎ 95%: între 31 i 54%).
English: LIST OF EXCIPIENTS
Romanian: LISTA EXCIPIEN ILOR
English: Valsartan is unlikely to be removed by haemodialysis.
Romanian: Eliminarea valsartanului prin hemodializ este improbabil .
English: • sudden loss of consciousness (syncope)
Romanian: • pierdere brusc a con tien ei (sincop )
English: • fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia)
Romanian: • febr , durere în gât sau ulcera ii la nivelul gurii determinate de infec ii (simptome ale unui num r sc zut de celule albe sanguine, denumit i neutropenie)
English: In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan.
Romanian: La pacien ii cu deple ie sever sodic i/sau de volum, precum aceia trata i cu doze crescute de diuretice, in cazuri rare poate apare hipotensiune arterial simptomatic dup ini ierea tratamentului cu Diovan.
English: - Second and third trimester of pregnancy (see sections 4.4 and 4.6).
Romanian: - Al doilea i al treilea trimestru de sarcin (vezi pct. 4.4 i 4.6).
English: • if you are suffering from a narrowing of the kidney artery.
Romanian: • dac ave i o îngustare a arterei renale.
English: Diovan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Romanian: Diovan nu este recomandat pentru utilizare în primele luni de sarcin i nu trebuie s îl lua i dac sunte i gravid în mai mult de 3 luni pentru c ar putea afecta grav copilul dumneavoastr dac îl lua i dup cea de-a treia lun de sarcin .
English: 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.
Romanian: 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 cu -4 i -7 mm Hg mai mic decât la pacien ii c rora li s-a administrat placebo.
English: The Diovan Reduction of Proteinuria (DROP) study further examined the efficacy of valsartan in reducing UAE in 391 hypertensive patients (BP=150/88 mmHg) with type 2 diabetes, albuminuria (mean=102 µg/min; 20-700 µg/min) and preserved renal function (mean serum creatinine = 80 µmol/l).
Romanian: Studiul Diovan Reduction of Proteinuria (DROP) a examinat în mod suplimentar eficacitatea valsartanului în reducerea EUA la 391 de pacien i hipertensivi (TA = 150/88 mmHg) cu diabet zaharat de tip 2, albuminurie (valoarea medie = 102 µg/min; 20-700 µg/min) i cu func ia renal p strat (valoarea medie a creatininei serice = 80 µmol/l).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 3 mg of valsartan.
Romanian: DECLARAREA SUBSTAN EI(LOR) ACTIVE Fiecare ml de solu ie con ine 3 mg de valsartan.
English: 5.1 Pharmacodynamic properties
Romanian: 5.1 Propriet i farmacodinamice
English: • Diovan solution contains poloxamer (188).
Romanian: • Diovan solu ie con ine poloxamer (188).
English: Nausea, Diarrhoea
Romanian: Grea, diaree
English: At the end of 2 weeks, valsartan reduced both systolic and diastolic blood pressure in a dose-dependent manner.
Romanian: La sfâr itul celor 2 s pt mâni, valsartanul a redus atât tensiunea arterial sistolic , cât i tensiunea arterial diastolic , în func ie de doz .
English: Instructions for using the oral syringe and the dosing cup
Romanian: Instruc iuni pentru utilizarea seringii pentru administrare oral i a m surii de dozare
English: Contains sucrose, methyl parahydroxybenzoate (E218) and poloxamer (188) (see leaflet for further information).
Romanian: Con ine zah r, parahidroxibenzoat de metil (E 218) i poloxamer (188) (vezi prospectul pentru informa ii suplimentare).
English: To clean the oral syringe:
Romanian: Pentru a cur a seringa pentru administrare oral :
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Romanian: Au fost identificate în plasm concentra ii sc zute ale unui metabolit hidroxilat (mai pu in de 10% din ASC pentru valsartan).
English: POSSIBLE SIDE EFFECTS Like all medicines, Diovan can cause side effects, although not everybody gets them.
Romanian: Ca toate medicamentele, Diovan poate provoca reac ii adverse, cu toate c nu apar la toate persoanele.
English: If you have further questions on the use of this product, ask your doctor or pharmacist.
Romanian: Dac ave i orice întreb ri suplimentare cu privire la acest produs, adresa i-v medicului dumneavoastr sau farmacistului.
English: 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.
Romanian: 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.
English: Renal function and serum potassium should be closely monitored during treatment with valsartan.
Romanian: Func ia renal i concentra ia de potasiu seric trebuie monitorizate cu aten ie în timpul tratamentului cu valsartan.
English: Keeping the bottle upright, insert the oral syringe firmly into the bottle adapter.
Romanian: Men inând flaconul în pozi ie vertical , introduce i seringa pentru administrare oral ferm în adaptorul pentru flacon.
English: ADRs that occurred in adult patients with post-myocardial infarction and/or heart failure are listed below.
Romanian: RA care au ap rut la pacien ii adul i cu post-infarct miocardic i/sau cu insuficien cardiac sunt prezentate mai jos:
English: This applies to both prescription and non-prescription medicines, especially:
Romanian: Acest lucru este valabil atât pentru medicamentele eliberate pe baz de prescrip ie medical cât i pentru cele eliberate f r prescrip ie medical , în special:
English: If hypotension occurs, the patient should be placed in a supine position and blood volume correction should be undertaken.
Romanian: Dac apare hipotensiunea arterial , pacientul trebuie a ezat în pozi ie supin i trebuie efectuat corec ia volemic necesar .
English: 1 bottle containing 160 ml oral solution.
Romanian: 1 flacon con inând 160 ml de solu ie oral .
English: Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Romanian: Adresa i-v medicului dumneavoastr sau farmacistului pentru recomand ri înainte de a lua orice medicament.
English: Children weighing between 18 kg and <35 kg received valsartan 80 mg or enalapril 10 mg; those between 35 kg and <80 kg received valsartan 160 mg or enalapril 20 mg; those 80 kg received valsartan 320 mg or enalapril 40 mg.
Romanian: Copiilor cu greutate corporal între 18 kg i <35 kg li s-au administrat 80 mg de valsartan sau 10 mg de enalapril; celor cu greutate corporal între 35 kg i <80 kg li s-au administrat 160 mg de valsartan sau 20 mg de enalapril; celor cu greutate corporal 80 kg li s-au administrat 320 mg de valsartan sau 40 mg de enalapril.
English: Diovan oral solution contains 0,3 g sucrose per mililiter.
Romanian: Diovan solu ie oral con ine zah r 0,3 g pe mililitru.
English: • If you have any further questions, ask your doctor or pharmacist.
Romanian: • Dac ave i orice întreb ri suplimentare, adresa i-v medicului dumneavoastr sau farmacistului.
English: Absorption:
Romanian: Absorb ie:
English: Overdose with Diovan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock.
Romanian: Supradozajul cu Diovan poate genera o hipotensiune arterial sever , care poate conduce la alterarea st rii de con tien , colaps circulator i/sau oc.
English: These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
Romanian: Acestea includ suplimentele de potasiu, substituentele minerale pentru regim hiposodat care con in potasiu, medicamentele care re in potasiu i heparina.
English: Clinical experience in children less than 6 years of age Two clinical studies were conducted in patients aged 1 to 6 years with 90 and 75 patients, respectively.
Romanian: Au fost efectuate dou studii clinice la pacien i cu vârsta cuprins între 1 i 6 ani, la 90, respectiv 75 pacien i.
English: The dose should be titrated based on blood pressure response and tolerability.
Romanian: Doza trebuie ajustat în func ie de r spunsul tensiunii arteriale i tolerabilitate.
English: • if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Diovan listed at the end of this leaflet.
Romanian: • dac sunte i alergic (hipersensibil) la valsartan sau la oricare dintre celelalte componente ale
English: • allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
Romanian: • pot ap rea reac ii alergice cu erup ie trec toare pe piele, mânc rime i urticarie; simptome de febr , articula ii umflate i durere la nivelul articula iilor, durere muscular , umflarea ganglionilor limfatici i/sau simptome asem n toare gripei (semne ale bolii serului)
English: Preparing a dose of medicine
Romanian: Preg tirea unei doze de medicament
English: Holding the oral syringe in place, carefully turn the bottle and oral syringe upside down.
Romanian: 7. inând seringa pentru administrare oral pe loc, întoarce i atent flaconul i seringa pentru administrare oral cu susul în jos.
English: 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.
Romanian: Efectul antihipertensiv al valsartanului a fost evaluat în cadrul a patru studii clinice, randomizate, dublu-oarbe, la 561 de pacien i copii i adolescen i cu vârsta cuprins între 6 i 18 ani i la 165 de pacien i copii cu vârsta cuprins între 1 i 6 ani.
English: o In the pharmacovigilance plan: Targeted checklists for follow up of adverse events listed above as potential risks in the paediatric population A study primarily aimed at establishing the long-term safety in CKD and non-CKD paediatric patients.
Romanian: o În planul de farmacovigilen : Liste de control specifice pentru urm rirea reac iilor adverse men ionate mai sus drept riscuri poten iale la popula ia pediatric Un studiu care vizeaz în primul rând stabilirea siguran ei pe termen lung la pacien ii copii i adolescen i cu BRC i f r BRC.
English: Remove the oral syringe from the bottle adapter by gently twisting it out.
Romanian: Scoate i seringa pentru administrare oral din adaptorul pentru flacon, r sucindu-o u or în afar .
English: Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
Romanian: Administrarea împreun cu alimentele scade expunerea la valsartan (determinat prin ASC) cu aproximativ 40% i concentra ia plasmatic maxim (Cmax) cu aproximativ 50%, de i dup aproximativ 8 ore de la administrarea dozei concentra iile plasmatice ale valsartanului sunt similare pentru grupul cu administrare în condi ii de repaus alimentar i pentru cel cu administrare împreun cu alimente.
English: Taking Diovan with food and drink You can take Diovan with or without food.
Romanian: Utilizarea Diovan cu alimente i b uturi Diovan poate fi luat cu sau f r alimente.
English: This will help you to use the oral syringe and the dosing cup correctly.
Romanian: Acestea v vor ajuta s utiliza i corect seringa pentru administrare oral i m sura dozatoare.
English: Clinical experience in children at or above 6 years of age In a clinical study involving 261 hypertensive paediatric patients 6 to 16 years of age, patients who weighed <35 kg received 10, 40 or 80 mg of valsartan tablets daily (low, medium and high doses), and patients who weighed 35 kg received 20, 80, and 160 mg of valsartan tablets daily (low, medium and high doses).
Romanian: Experien a clinic la copii cu vârsta de 6 ani i peste În cadrul unui studiu clinic la 261 pacien i copii i adolescen i cu hipertensiune arterial , cu vârsta cuprins între 6 i 16 ani, pacien ilor cu greutate corporal <35 kg li s-au administrat 10, 40 sau 80 mg de valsartan comprimate, zilnic (doze mici, medii i mari), iar pacien ilor cu greutate corporal 35 kg li s-au administrat 20, 80 i 160 mg de valsartan comprimate, zilnic (doze mici, medii i mari).
English: Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2-4 hours with tablets and 1-2 hours with solution formulation.
Romanian: 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.
English: Not known
Romanian: Cu frecven necunoscut
English: In a study of 26 paediatric hypertensive patients (aged 1 to 16 years) given a single dose of a suspension of valsartan (mean: 0.9 to 2 mg/kg, with a maximum dose of 80 mg), the clearance (litres/h/kg) of valsartan was comparable across the age range of 1 to 16 years and similar to that of adults receiving the same formulation.
Romanian: În cadrul unui studiu la 26 de pacien i copii i adolescen i (cu vârsta cuprins între 1 i 16 ani) cu hipertensiune arterial , c rora li s-a administrat o doz unic de suspensie de valsartan (în medie: 0,9 pân la 2 mg/kg, cu o doz maxim de 80 mg), clearance-ul (litri/or /kg) valsartanului a fost comparabil în intervalul de vârst de la 1 pân la 16 ani i similar celui al adul ilor c rora li s-a administrat aceea i form a medicamentului.
English: PHARMACOLOGICAL PROPERTIES
Romanian: PROPRIET I FARMACOLOGICE
English: Hepatic impairment
Romanian: Insuficien hepatic
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains 3 mg of valsartan.
Romanian: COMPOZI IA CALITATIV I CANTITATIV Fiecare ml de solu ie con ine valsartan 3 mg.
English: Excipients:
Romanian: Excre ia:
English: 6.6 Special precautions for disposal
Romanian: 6.6 Precau ii speciale pentru eliminarea reziduurilor
English: 4.2 Posology and method of administration
Romanian: 4.2 Doze i mod de administrare
English: Holding the open bottle upright on a table, push the bottle adapter firmly into the neck of the bottle as far as it will go.
Romanian: 2. inând flaconul deschis, în pozi ie vertical , pe mas , ap sa i adaptorul pentru flacon ferm pe gâtul acestuia cât de mult v permite.
English: If switching from Diovan oral solution to Diovan tablets is considered clinically essential, initially the same dose in milligrams should be given.
Romanian: Dac trecerea de la Diovan solu ie oral la Diovan comprimate este considerat clinic esen ial , ini ial trebuie administrat aceea i doz în miligrame.
English: • Diovan solution contains methyl parahydroxybenzoate (E218).
Romanian: • Diovan solu ie con ine parahidroxibenzoat de metil (E 218).
English: Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Romanian: În plus, folosirea concomitent a antagoni tilor angiotensinei II cu AINS pot duce la cre terea riscului de degradare a func iei renale i la cre terea potasemiei.
English: Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended.
Romanian: Nu se recomand utilizarea concomitent cu suplimentele de potasiu, diureticele care re in potasiu, substituente minerale pentru regim hiposodat care con in potasiu sau alte medicamente care pot cre te potasemia (heparin , etc.).
English: poloxamer (188), citric acid anhydrous, sodium citrate, artificial blueberry flavour, propylene glycol (E1520), sodium hydroxide, hydrochloric acid, purified water.
Romanian: • Celelalte componente sunt zah r, parahidroxibenzoat de metil (E 218), sorbat de potasiu, poloxamer (188), acid citric anhidru, citrat de sodiu, arom artificial de afine, propilenglicol (E 1520), hidroxid de sodiu, acid clorhidric, ap purificat .
English: 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.
Romanian: 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 ace ti pacien i.
English: What Diovan looks like and contents of the pack Diovan 3 mg/ml oral solution is a clear, colourless to pale yellow solution.
Romanian: Diovan 3 mg/ml solu ie oral este o solu ie limpede, incolor pân la galben pal.
English: Hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Diovan oral solution as it contains sucrose.
Romanian: Pacien ii cu afec iuni ereditare rare de intoleran la fructoz , sindrom de malabsorb ie la glucozgalactoz sau insuficien a zaharazei-izomaltazei nu trebuie s utilizeze Diovan solu ie oral pentru c acesta con ine zah r.
English: If the prescribed dose requires filling the syringe several times, you can empty the measured doses of medicine from the syringe into the dosing cup and then check the total volume of solution.
Romanian: Dac doza prescris necesit umplerea seringii de câteva ori, pute i goli dozele m surate din sering în m sura dozatoare.
English: Sodium- and/or volume-depleted patients
Romanian: Pacien ii cu deple ie sodic i/sau de volum
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur.
Romanian: Medicamente anti-inflamatoare nesteroidiene (AINS), incluzând inhibitori selectivi COX-2, acid acetilsalicilic >3 g/zi i AINS neselectivi
English: 5.2 Pharmacokinetic properties
Romanian: 5.2 Propriet i farmacocinetice
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Romanian: NUMELE I ADRESA DE IN TORULUI AUTORIZA IEI DE PUNERE PE PIA [Vezi Anexa I - a se completa la nivel na ional]
English: During repeated dosing, the antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks and persist during long-term therapy.
Romanian: Dup administrarea de doze multiple, efectul antihipertensiv devine prezent în mod substan ial în decurs de 2 s pt mâni, iar efectele maxime se ob in în decurs de 4 s pt mâni i se men in în cazul tratamentului pe termen lung.
English: Dose adjustment is therefore not required in patients with renal impairment (creatinine clearance >10 ml/min).
Romanian: De aceea, nu este necesar o ajustare a dozei la pacien ii cu insuficien renal (clearance-ul creatininei >10 ml/min.
English: The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 µmol/l).
Romanian: La pacien ii cu diabet zaharat de tip 2 i microalbuminurie, s-a constatat c valsartanul reduce excre ia urinar de albumin . Studiul MARVAL (Micro Albuminuria Reduction with Valsartan) a comparat valsartanul (80-160 mg o dat pe zi) cu amlodipina (5-10 mg o dat pe zi) în ceea ce prive te reducerea excre iei urinare de albumin (EUA) la 332 de pacien i cu diabet zaharat de tip 2 (vârsta medie: 58 de ani; 265 de b rba i) cu microalbuminurie (valsartan: 58 µg/min; amlodipin : 55,4 µg/min), cu tensiune arterial normal sau crescut i cu func ia renal p strat (creatinina sanguin <120 µmol/l).
English: Methyl parahydroxybenzoate (E218) Potassium sorbate
Romanian: Parahidroxibenzoat de metil (E 218) Sorbat de potasiu
English: The antihypertensive effect of valsartan has been evaluated in two randomised, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age.
Romanian: Efectul antihipertensiv al valsartanului a fost evaluat în cadrul a dou studii clinice, randomizate, dublu-oarbe, la 561 pacien i copii i adolescen i cu vârsta cuprins între 6 i 18 ani.