FrancophonIA/ELRC3.0 huggingface dataset:
English: The initial dose for the Diovan oral solution is 20 mg (corresponding to 7 ml of the solution) once daily for children below 35 kg of weight and 40 mg (corresponding to 13 ml of the solution) once daily for those weighing 35 kg or more.
Romanian: Doza ini ial de Diovan solu ie oral este de 20 mg (corespondentul a 7 ml solu ie), o dat pe zi, pentru copii cu mas corporal sub 35 kg i 40 mg (corespondentul a 13 ml solu ie), o dat pe zi, pentru copiii care au 35 kg sau peste.
English: Sit upright.
Romanian: Sta i în pozi ie vertical .
English: The final study report should be submitted by the last quarter of 2010.
Romanian: Raportul studiului va fi finalizat pân în trimestrul IV al anului 2010.
English: Immune system disorders Not known
Romanian: Tulbur ri ale sistemului imunitar Cu frecven necunoscut
English: ANNEX III CONDITIONS OF THE MARKETING AUTHORISATION
Romanian: ANEXA III CONDI IILE EMITERII AUTORIZA IEI DE PUNERE PE PIA
English: • decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)
Romanian: • sc derea cantit ii de hemoglobin i sc derea procentului celulelor ro ii în sânge (care poate conduce la anemie în cazuri severe)
English: • unusual bleeding or bruising (signs of thrombocytopenia)
Romanian: • sângerare sau învine ire neobi nuit (semne de trombocitopenie)
English: For children who are unable to swallow tablets, the use of the Diovan oral solution up to 80 mg valsartan (corresponding to 27 ml) is recommended.
Romanian: Copii i adolescen i cu vârsta cuprins între 6 i 18 ani Pentru copiii care nu pot înghi i comprimate, se recomand utilizarea Diovan solu ie oral pân la 80 mg valsartan (corespondentul a 27 ml).
English: Diovan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Romanian: • Spune i medicului dumneavoastr dac al pta i sau urmeaz s începe i s al pta i. Diovan nu este recomandat pentru utilizare la mamele care al pteaz iar medicul dumneavoastr ar putea alege un alt tratament pe care s îl lua i dac dori i s al pta i, în special dac copilul dumneavoastr este nou-n scut sau a fost n scut prematur.
English: INSTRUCTIONS ON USE [To be completed nationally] 16.
Romanian: INSTRUC IUNI DE UTILIZARE [A se completa la nivel na ional]
English: Take special care with Diovan:
Romanian: Ave i grij deosebit când utiliza i Diovan:
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Romanian: În cadrul fiec rei grupe de frecven , reac iile adverse sunt prezentate în ordinea descresc toare a gravit ii.
English: Before you measure your dose you need to get rid of any large bubbles that may be trapped in the oral syringe.
Romanian: Înainte de a m sura doza, trebuie s îndep rta i orice bule mari care se pot afla în seringa pentru administrare oral . Pentru a face acest lucru:
English: Possible side effects
Romanian: Reac ii adverse posibile
English: It comes with a dispensing kit containing one press in bottle adapter, one 5 ml oral polypropylene dosing syringe and one 30 ml polypropylene dosing cup.
Romanian: Este înso it de o trus de administrare con inând un adaptor pentru flacon, o sering dozatoare pentru adminstrare oral de 5 ml din polipropilen i o m sur dozatoare de 30 ml din polipropilen .
English: This may soften your stools.
Romanian: Acesta poate conduce la apari ia de scaune moi.
English: • Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Romanian: • Odat deschis, flaconul poate fi p strat timp de pân la 3 luni la temperaturi sub 30°C.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Diovan in all subsets of the paediatric population in heart failure and heart failure after recent myocardial infarction.
Romanian: Agen ia European a Medicamentului a suspendat obliga ia de depunere a rezultatelor studiilor efectuate cu Diovan la toate subgrupurile de copii i adolescen i în insuficien a cardiac i insuficien a cadiac dup infarctul miocardic recent (vezi pct. 4.2 pentru informa ii privind utilizarea la copii i adolescen i).
English: No dose adjustment is required for adult patients with creatinine clearance >10 ml/min (see sections 4.2 and 5.2).
Romanian: Nu este necesar ajustarea dozei la pacien ii adul i cu clearance-ul creatininei >10 ml/min (vezi pct. 4.2 i 5.2).
English: • Diovan solution contains 0.3 g sucrose per millilitre.
Romanian: • Diovan solu ie con ine zah r 0,3 g pe mililitru.
English: For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in adult patients treated with high blood pressure than in adult patients treated for heart failure or after a recent heart attack.
Romanian: De exemplu, reac iile adverse cum sunt ame elile i sc derea func iei renale au fost observate mai frecvent la pacien ii adul i trata i pentru hipertensiune arterial decât la pacien ii adul i trata i pentru insuficien cardiac sau afla i dup un infarct miocardic recent.
English: 4.8 Undesirable effects
Romanian: 4.8 Reac ii adverse
English: Pack size: 1 bottle containing 160 ml oral solution
Romanian: M rimea ambalajului: 1 flacon con inând 160 ml solu ie oral .
English: Find the marker on the oral syringe that corresponds to the required amount of medicine.
Romanian: G si i grada ia pe seringa pentru administrare oral care corespunde cantit ii necesare de medicament.
English: Abdominal pain
Romanian: Durere abdominal
English: In patients with mild to moderate hepatic impairment without cholestasis, Diovan should be used with caution (see sections 4.2 and 5.2).
Romanian: La pacien ii cu insuficien hepatic u oar pân la moderat , f r colestaz , Diovan trebuie utilizat cu pruden (vezi pct. 4.2 i 5.2).
English: Monitoring of potassium should be undertaken as appropriate.
Romanian: Potasemia terbuie monitorizat dac se consider necesar.
English: If you stop taking Diovan
Romanian: Dac înceta i s lua i Diovan
English: Impaired renal function
Romanian: Insuficien a renal
English: Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Romanian: Odat deschis, flaconul poate fi p strat pân la 3 luni, la temperaturi sub 30°C.
English: Pharma Nagano III.
Romanian: NOVARTIS s.r.o. Pharma Nagano III.
English: NAME OF THE MEDICINAL PRODUCT Diovan and associated names 3 mg/ml oral solution Valsartan
Romanian: DENUMIREA COMERCIAL A MEDICAMENTULUI Diovan i denumirile asociate 3 mg/ml solu ie oral Valsartan
English: Decrease in haemoglobin, Decrease in haematocrit, Neutropenia, Thrombocytopenia
Romanian: Sc derea hemoglobinei, sc derea hematocritului, neutropenie, trombocitopenie
English: Due to the high volume of solution that would be necessary, the use of the solution is not recommended
Romanian: 320 mg Din cauza volumului mare de solu ie care ar fi necesar, nu se recomand utilizarea solu iei orale.
English: Diovan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Romanian: • trebuie s spune i medicului dumneavoastr dac crede i c sunte i (sau a i putea deveni) gravid . 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 în aceast etap (vezi punctul referitor la sarcin ).
English: 1 dispenser kit containing one press in bottle adapter, one 5 ml oral syringe and one 30 ml dosing cup.
Romanian: 1 trus de administrare con inând un adaptor pentru flacon, o sering dozatoare pentru administrare oral de 5 ml i o m sur dozatoare de 30 ml.
English: NAME OF THE MEDICINAL PRODUCT Diovan and associated names 3 mg/ml oral solution
Romanian: DENUMIREA COMERCIAL A MEDICAMENTULUI Diovan i denumirile asociate 3 mg/ml solu ie oral
English: FURTHER INFORMATION
Romanian: INFORMA II SUPLIMENTARE
English: The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Romanian: Utilizarea ARAII în al doilea i al treilea trimestru de sarcin este contraindicat (vezi pct. 4.3 i 4.4).
English: Diovan and associated names 3 mg/ml oral solution Valsartan
Romanian: Diovan i denumirile asociate 3 mg/ml solu ie oral Valsartan
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min (see sections 4.2 and 5.2).
Romanian: Nu este necesar ajustarea dozei la pacien ii copii i adolescen i cu clearance-ul creatininei >30 ml/min (vezi pct. 4.2 i 5.2).
English: In this leaflet:
Romanian: În acest prospect g si i:
English: Renal failure and impairment, Elevation of serum creatinine General disorders and administration site conditions Uncommon
Romanian: Insuficien renal i disfunc ie renal , cre terea creatininemiei Tulbur ri generale i la nivelul locului de administrare Mai pu in frecvente
English: Distribution:
Romanian: Distribu ie:
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Romanian: Cu excep ia cazurilor în care este continuarea tratamentului cu ARAII este considerat esen ial , pacientele care inten ioneaz s r mân gravide trebuie s treac la un tratament anti-hipertensiv alternativ cu medicamente care au un profil de siguran cunoscut pentru utilizarea în sarcin .
English: Renal function and serum potassium should be closely monitored (see sections 4.4 and 5.2).
Romanian: Func ia renal i concentra ia de potasiu seric trebuie monitorizate cu aten ie (vezi pct. 4.4 i 5.2).
English: Renal function and serum potassium should be closely monitored.
Romanian: Func ia renal i concentra ia de potasiu seric trebuie monitorizate cu aten ie.
English: Renal failure and impairment
Romanian: Insuficien a renal i disfunc ie renal
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients.
Romanian: În prezent, nu exist experien privind utilizarea în siguran la pacien ii cu clearance-ul creatininei <10 ml/min i la pacien ii care sunt supu i dializei, ca urmare valsartan trebuie utilizat cu pruden la ace ti pacien i.
English: Impaired hepatic function
Romanian: Insuficien a hepatic
English: Need for dose adaptation when switching between oral solution and tablets.
Romanian: Necesitatea adapt rii dozei la trecerea de la solu ia oral la comprimate i invers.
English: • Always put the dosing cup back onto the cap after use and cleaning.
Romanian: • Pune i întotdeauna m sura dozatoare înapoi pe capac, dup utilizare i cur are.
English: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Romanian: Nu trebuie ini iat tratamentul cu antagoni ti ai receptorilor de angiotensin II (ARAII) în timpul sarcinii.
English: BEFORE YOU TAKE DIOVAN
Romanian: Înainte s lua i Diovan
English: Elevation of liver function values including increase of serum bilirubin
Romanian: Cre terea valorilor testelor func iei hepatice, inclusiv cre terea bilirubinemiei
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
Romanian: Sugarii ai c ror mame au luat ARAII trebuie observa i atent din punct de vedere al apari iei hipotensiunii arteriale (vezi i pct. 4.3 i 4.4).
English: The National Health Authorities shall ensure the following conditions are fulfilled by the Marketing Authorisation Holder:
Romanian: Autorit ile na ionale din domeniul s n t ii se vor asigura de in torul autoriza iei de punere pe pia îndepline te urm toarele condi ii:
English: High blood pressure increases the risk of heart attacks.
Romanian: Tensiunea arterial mare cre te riscul infarctului miocardic.
English: 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
Romanian: 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).
English: A dosing cup:
Romanian: O m sur dozatoare:
English: • if you have severe kidney disease or if you are undergoing dialysis.
Romanian: • dac ave i o boal sever de rinichi sau dac face i dializ .
English: • increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)
Romanian: • cre terea cantit ii de uree din sânge i cre terea valorilor creatininei serice (care pot indica o func ie renal anormal )
English: Respiratory, thoracic and mediastinal disorders Uncommon
Romanian: Tulbur ri respiratorii, toracice i mediastinale Mai pu in frecvente
English: Renal function and serum potassium should be closely monitored (see sections 4.2 and 4.4).
Romanian: Func ia renal i concentra ia de potasiu seric trebuie monitorizate cu aten ie (vezi pct. 4.2 i 4.4).
English: Please read the instructions at the end of this leaflet before you use the oral syringe or the dosing cup.
Romanian: V rug m citi i instruc iunile de la sfâr itul acestui prospect înainte de a utiliza seringa pentru administrare oral sau m sura dozatoare.
English: These doses in rats (600 mg/kg/day) are approximately 18 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of
Romanian: Aceste doze administrate la obolan (600 mg/kg i zi) sunt de aproximativ 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).
English: In patients receiving the low dose of valsartan, systolic blood pressure at trough was similar to that of patients who received the placebo treatment.
Romanian: La pacien ii c rora li s-a administrat o doz mic de valsartan, tensiunea arterial sistolic înainte de administrarea dozei urmtoare a fost similar cu cea a pacienilor crora li s-a administrat placebo.
English: Administration of Diovan to patients with hypertension results in reduction of blood pressure without affecting pulse rate.
Romanian: Administrarea Diovan la pacien ii hipertensivi a determinat sc derea tensiunii arteriale f r modificarea frecven ei cardiace.
English: How to take Diovan
Romanian: Cum s lua i Diovan
English: • dizziness
Romanian: • oboseal
English: No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min.
Romanian: Nu este necesar ajustarea dozei la pacien ii copii i adolescen i cu clearance-ul creatininei >30 ml/min.
English: Syncope, Headache
Romanian: Astenie, oboseal
English: Acute renal failure, Elevation of serum creatinine
Romanian: Insuficien renal acut , cre terea creatininemiei
English: As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3 and 5.2).
Romanian: Similar adul ilor, Diovan este contraindicat la pacien ii copii i adolescen i cu insuficien hepatic sever , ciroz biliar i la pacien ii cu colestaz (vezi pct. 4.3 i 5.2).
English: Use in adults
Romanian: Utilizarea la adul i
English: • decreased kidney function (signs of renal impairment)
Romanian: • sc derea sever a func iei renale (semne de insuficien renal acut )
English: • Rinse the cup with clean water.
Romanian: • Cl ti i m sura cu ap curat .
English: A doubling of exposure (AUC) was observed in patients with mild to moderate hepatic impairment compared to healthy subjects.
Romanian: La pacien ii cu insuficien hepatic u oar pân la moderat s-a constatat o dublare a expunerii (ASC), comparativ cu subiec ii s n to i.
English: 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: Nu s-a 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: 6.3 Shelf life
Romanian: 6.3 Perioad de valabilitate
English: Put the end of the oral syringe into the mouth.
Romanian: Introduce i cap tul seringii pentru administrare oral în gur .
English: Caution required with concomitant use
Romanian: Utilizarea concomitent necesit precau ie
English: PHARMACEUTICAL FORM AND CONTENTS
Romanian: FORMA FARMACEUTIC I CON INUTUL
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients (see sections 4.2 and 4.4).
Romanian: În prezent, nu exist experien privind utilizarea în condi ii de siguran la pacien ii cu un clearance al creatininei <10 ml/min i la cei dializa i, prin urmare valsartan trebuie utilizat cu precau ie la ace ti pacien i (vezi pct.
English: An oral dosing syringe:
Romanian: O sering dozatoare pentru administrare oral :
English: • Always screw the cap back on after use.
Romanian: • Înfileta i întotdeauna sistemul de închidere dup utilizare.
English: Volume to take
Romanian: Volumul de adminstrat
English: Methyl parahydroxybenzoate
Romanian: A M SURII DOZATOARE
English: Overall, the three dose levels of valsartan (low, medium and high) significantly reduced systolic blood pressure by 8, 10, 12 mmHg from the baseline, respectively.
Romanian: În general, cele trei niveluri de dozare a valsartanului (mic, mediu i mare) au sc zut semnificativ tensiunea arterial sistolic cu 8, 10, respectiv 12 mm Hg fa de valoarea ini ial . Pacien ii au fost randomiza i din nou, fie continuând administrarea aceleia i doze de valsartan, fie trecând la placebo.
English: The bottle contains 160 ml of solution.
Romanian: Flaconul con ine 160 ml de solu ie.
English: Use in paediatric patients aged 6 to 18 years with hepatic impairment As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Romanian: Similar adul ilor, Diovan este contraindicat la pacien ii copii i adolescen i cu insuficien hepatic sever , ciroz biliar i la pacien ii cu colestaz (vezi pct. 4.3, 4.4 i 5.2).
English: • purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)
Romanian: • pete de culoare ro u-purpuriu, febr , mânc rime (semne ale inflama iei vaselor de sânge,
English: The amount of sucrose in the Diovan solution may be harmful to your teeth.
Romanian: Cantitatea de zah r din Diovan solu ie poate d una din ilor.
English: If you forget to take Diovan
Romanian: Dac uita i s lua i Diovan
English: 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).
Romanian: 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,
English: Slovak Republic
Romanian: Slovacia
English: Solution
Romanian: Sarcina
English: Fatigue
Romanian: Comprimate
English: • if you have severe liver disease.
Romanian: • dac ave i o boal hepatic .
English: • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
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: INSTRUCTIONS FOR USING THE ORAL SYRINGE AND THE DOSING CUP Please read these instructions carefully before taking the medicine.
Romanian: V rug m citi i aceste instruc iuni cu aten ie înainte de a lua acest medicament.
English: Taking the medicine
Romanian: Administrarea medicamentului
English: In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Diovan has not been established.
Romanian: Nu a fost stabilit siguran a utiliz rii Diovan la pacien ii cu stenoz bilateral de arter renal sau stenoz pe rinichi unic.
English: Carefully turn the bottle and oral syringe back upright.
Romanian: Întoarce i cu aten ie flaconul i seringa pentru administrare oral din nou în pozi ie vertical .
English: Pharmaceutical Form Route of administration
Romanian: Concentraia Form farmaceutic
English: Blood and lymphatic system disorders Not known
Romanian: Tulbur ri hematologice i limfatice Cu frecven necunoscut
English: Renal and urinary disorders Common
Romanian: Tulbur ri renale i ale c ilor urinare Frecvente
English: Metabolism and nutrition disorders Not known
Romanian: Tulbur ri metabolice i de nutri ie Cu frecven necunoscut
English: Children and adolescents 6 to 18 years of age
Romanian: Utilizarea la pacien ii copii i adolescen i cu vârsta cuprins între 6 i 18 ani, cu insuficien hepatic
English: Hypertension (paediatric population)
Romanian: Hipertensiune arterial (copii i adolescen i)
English: 4.4 Special warnings and precautions for use
Romanian: 4.4 Aten ion ri i precau ii speciale pentru utilizare
English: • that has a child- resistant screw cap.
Romanian: • care este prev zut cu un sistem securizat de închidere pentru copii.
English: Increase in Blood Urea Nitrogen General disorders and administration site conditions Uncommon
Romanian: Cre terea concentra iei azotului ureic din sânge Tulbur ri generale i la nivelul locului de administrare Mai pu in frecvente
English: • nausea
Romanian: • grea
English: Slowly push the plunger in and swallow the medicine directly from the oral syringe.
Romanian: Ap sa i u or pistonul i înghi i i medicamentul direct din sering .
English: Marketing Authorisation Holder and Manufacturer
Romanian: De in torul autoriza iei de punere pe pia i produc torul
English: EU/EEA Marketing Authorisation Holder
Romanian: Statul Membru Deintorul autorizaiei de punere pe pia
English: Posology
Romanian: PROSPECT
English: Vascular disorders Common
Romanian: Tulbur ri vasculare Frecvente
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] 15.
Romanian: CLASIFICARE GENERAL PRIVIND MODUL DE ELIBERARE [A se completa la nivel na ional]
English: Lactation
Romanian: Litiul
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Romanian: Acestea includ suplimentele de potasiu, substituentele minerale pentru regim hiposodat care con in potasiu,
English: Vascular disorders Not known
Romanian: Tulbur ri vasculare Cu frecven necunoscut
English: What Diovan contains
Romanian: Ce con ine Diovan
English: • spinning sensation (vertigo)
Romanian: • senza ie de rotire (vertij)
English: Hepato-biliary disorders Not known
Romanian: Tulbur ri hepatobiliare Cu frecven necunoscut
English: Renal and urinary disorders Not known
Romanian: Tulbur ri renale i ale c ilor urinare Cu frecven necunoscut
English: If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised.
Romanian: Diureticele care re in potasiu, suplimentele de potasiu, substituentele minerale pentru regim hiposodat i alte substan e care pot cre te potasiemia Dac se consider necesar asocierea unui medicament care afecteaz potasemia cu valsartan, se recomand monitorizarea concentra iilor plasmatice de potasiu.
English: See section 4.2 for information on paediatric use.
Romanian: 6.4 Precau ii speciale pentru p strare
English: Angioedema, Rash, Pruritus
Romanian: Sincop , cefalee