FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Romanian: Acest medicament se utilizează pentru tratamentul adulţilor infectaţi cu virusul imunodeficienţei umane de tip 1 (HIV-1), virus care produce sindromul imunodeficienţei dobândite (SIDA).
English: It is not intended to provide practical advice on how to use Vitekta.
Romanian: Scopul documentului nu este să ofere recomandări practice referitoare la utilizarea Vitekta.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vitekta, including the appropriate precautions to be followed by healthcare
Romanian: Pe baza acestui plan, în Rezumatul caracteristicilor produsului şi în prospectul pentru Vitekta au fost incluse informaţii referitoare la siguranţă, printre care şi măsurile corespunzătoare de precauţie care trebuie respectate de personalul medical şi de pacienţi.
English: Vitekta can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infections.
Romanian: Vitekta se poate obține numai pe bază de rețetă, iar tratamentul trebuie inițiat numai de către un medic cu experiență în tratarea infecţiei cu HIV.
English: The choice of dose of Vitekta depends on which other medicines it is given with.
Romanian: Alegerea dozei de Vitekta depinde de ce alte medicamente sunt administrate în asociere cu acesta.
English: What benefits of Vitekta have been shown in studies?
Romanian: Ce beneficii a prezentat Vitekta pe parcursul studiilor?
English: The active substance in Vitekta, elvitegravir, is a type of antiviral agent called an ‘integrase inhibitor'.
Romanian: Substanţa activă din Vitekta, elvitegravirul, este un tip de medicament antiviral numit „inhibitor de integrază“.
English: What measures are being taken to ensure the safe and effective use of
Romanian: Ce măsuri se iau pentru utilizarea sigură şi eficace a Vitekta?
English: Vitekta is taken either at the same time as a once-daily protease inhibitor, or with the first dose of a twice-daily protease inhibitor.
Romanian: Vitekta se ia în acelaşi timp cu inhibitorul de protează, administrat o dată pe zi, sau cu prima doză de inhibitor de protează, în cazul în care inhibitorul se administrează de două ori pe zi.
English: Patients who attained a viral load of less than 50 copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Romanian: S-a considerat că au răspuns la tratament pacienții care au atins o încărcătură virală mai mică de 50 copii/ml după 48 de săptămâni de
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Romanian: Comisia Europeană a acordat o autorizaţie de introducere pe piaţă pentru Vitekta, valabilă pe întreg teritoriul Uniunii Europene, la 13.11.2013.
English: Vitekta is available as tablets (85 and 150 mg); the recommended dose is one tablet a day, taken with food.
Romanian: Vitekta este disponibil sub formă de comprimate (85 şi 150 mg);
English: For practical information about using Vitekta, patients should read the package leaflet or contact their
Romanian: Pentru informaţii practice privind utilizarea Vitekta, pacienţii trebuie să citească prospectul sau să se adreseze medicului sau farmacistului.
English: For the full list of all side effects reported with Vitekta, see the package leaflet.
Romanian: Pentru lista completă a efectelor secundare raportate asociate
English: Invented name Strength Pharmaceutical Form
Romanian: Numele inventat Concentraţia Forma farmaceutică Calea de administrareAmbalajul
English: These measures will help to protect the environment.
Romanian: Aceste m suri vor ajuta la protejarea mediului.
English: • This medicine has been prescribed for you.
Romanian: • Acest medicament a fost prescris pentru dumneavoastr .
English: Many may feel quite normal.
Romanian: Mul i dintre ei se pot sim i aproape normal.
English: 18 months
Romanian: 18 luni
English: The expiry date refers to the last day of that month.
Romanian: Data de expirare se refer la ultima zi a lunii respective.
English: How much to take
Romanian: Cât de mult trebuie s lua i
English: • If you weigh 35 kg or more:
Romanian: • Dac cânt ri i 35 kg sau mai mult:
English: You may need to read it again.
Romanian: S-ar putea s fie necesar s -l reciti i.
English: Some symptoms need immediate medical attention:
Romanian: Unele simptome necesit asisten medical imediat :
English: Ask your pharmacist how to dispose of medicines no longer required.
Romanian: Întreba i farmacistul cum s elimina i medicamentele care nu v mai sunt necesare.
English: Do not take a double dose to make up for a forgotten dose.
Romanian: Nu lua i o doz dubl pentru a compensa o doz uitat .
English: • if you suffer from aldosteronism.
Romanian: • dac suferi i de aldosteronism.
English: Available data are described in sections 4.8, 5.1 and 5.2.
Romanian: Datele disponibile sunt descrise la pct. 4.8, 5.1 i 5.2.
English: When a viable and mutually agreed study plan emerges from the dialogue, a new study will be initiated within one year.
Romanian: Dac în urma dialogului rezult un plan de studiu viabil, convenit de comun acord, un nou studiu va fi ini iat în decurs de un an.
English: Do not pass it on to others.
Romanian: Nu trebuie s -l da i altor persoane.
English: • angioedema (see section “Some symptoms need immediate medical attention”)
Romanian: • angioedem (vezi punctul „Unele simptome necesit asisten medical imediat ”)
English: If you forget to take a dose, take it as soon as you remember.
Romanian: Dac a i uitat s lua i o doz , lua i-o cât mai curând dup ce v aduce i aminte.
English: Consequently, a clinical relevance in children <1 year of age cannot be excluded, while preclinical data do not indicate a safety concern for children older than 1 year.
Romanian: Ca urmare, nu poate fi exclus relevan a clinic la copiii cu vârsta <1 an în timp ce date preclinice nu indic o problem legat de siguran la copiii cu vârsta de peste 1 an.
English: People with high blood pressure often do not notice any signs of this problem.
Romanian: Adeseori, persoanele care au hipertensiune arterial nu observ niciun semn al acestei probleme.
English: • lithium, a medicine used to treat some types of psychiatric illness.
Romanian: • litiul, un medicament utilizat pentru tratarea anumitor tipuri de boli psihice.
English: Valsartan does not undergo any noteworthy biotransformation.
Romanian: Valsartanul nu sufer nicio biotransformare notabil .
English: 6.2 Incompatibilities
Romanian: 6.2 Incompatibilit i
English: WHAT DIOVAN IS AND WHAT IT IS USED FOR
Romanian: CE ESTE DIOVAN I PENTRU CE SE UTILIZEAZ
English: For a full list of excipients, see section 6.1.
Romanian: Pentru lista tuturor excipien ilor, vezi pct. 6.1.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Romanian: PRECAU II SPECIALE PRIVIND ELIMINAREA MEDICAMENTELOR NEUTILIZATE SAU A MATERIALELOR REZIDUALE PROVENITE DIN ASTFEL DE MEDICAMENTE, DAC ESTE CAZUL
English: - Hypersensitivity to the active substance or to any of the excipients.
Romanian: - Hipersensibilitate la substan a activ sau la oricare dintre excipien i.
English: Always take Diovan exactly as your doctor has told you in order to get the best results and reduce the risk of side effects.
Romanian: Lua i întotdeauna Diovan exact a a cum v-a spus medicul dumneavoastr , pentru a ob ine cele mai bune rezultate i a reduce riscul de reac ii adverse.
English: You should check with your doctor or pharmacist if you are not sure.
Romanian: Trebuie s discuta i cu medicul dumneavoastr sau cu farmacistul dac nu sunte i sigur.
English: If this applies to you, the use of Diovan is not recommended.
Romanian: Dac este acesta cazul dumneavoastr , nu este recomandat s utiliza i Diovan.
English: The effect of the treatment can be influenced if Diovan is taken together with certain other medicines.
Romanian: Efectele tratamentului pot fi modificate dac Diovan este utilizat împreun cu anumite alte medicamente.
English: For example, if the prescribed dose is 13 ml, it will be necessary to measure out the solution in three separate stages: 5 ml + 5 ml + 3 ml.
Romanian: De exemplu, dac doza prescris este de 13 ml, va fi necesar m surarea solu iei în trei etape distincte: 5 ml + 5 ml + 3 ml.
English: A bottle containing the medicine:
Romanian: Un flacon care con ine medicamentul:
English: • Medicines should not be disposed of via wastewater or household waste.
Romanian: • Medicamentele nu trebuie aruncate pe calea apei menajere sau a reziduurilor menajere.
English: Stopping your treatment with Diovan may cause your disease to get worse.
Romanian: Oprirea tratamentului cu Diovan poate agrava boala dumneavoastr .
English: As a result, blood vessels relax and blood pressure is lowered.
Romanian: Drept rezultat, vasele de sânge se relaxeaz iar tensiunea arterial scade.
English: Slowly pull the plunger out until the top edge of the black ring inside is exactly level with the marker.
Romanian: Trage i încet pistonul în afar pân când marginea superioar a inelului negru din interior este exact la acela i nivel cu marcajul.
English: Take Diovan at about the same time each day.
Romanian: Lua i Diovan aproximativ la aceea i or , în fiecare zi.
English: It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines.
Romanian: Este posibil s fie necesar s schimba i doza, s lua i alte m suri de precau ie sau, în unele cazuri, s înceta i s mai lua i unul dintre medicamente.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Romanian: MODUL I CALEA(C ILE) DE ADMINISTRARE Administrare oral .
English: Overall, the dose-dependent antihypertensive effect of valsartan was consistent across all the demographic subgroups.
Romanian: În general, efectul antihipertensiv în func ie de doz al valsartanului a fost consecvent în cadrul tuturor subgrupelor demografice.
English: • if you have recently undergone kidney transplantation (received a new kidney).
Romanian: • dac a i suferit recent un transplant de rinichi (a i primit un rinichi nou).
English: • swollen face, lips, tongue or throat
Romanian: • umflarea fe ei, buzelor, limbii sau gâtului
English: These cases occurred in a population who had significant comorbidities.
Romanian: Aceste cazuri au ap rut la o categorie cu comorbiditate semnificativ .
English: Approximately 70% of the dose absorbed is eliminated in the bile, essentially in the unchanged form.
Romanian: Aproximativ 70% din doza absorbit este eliminat prin bil , în principal în form nemodificat .
English: No children below the age of 1 year were enrolled in these studies.
Romanian: Nu au fost înscri i în aceste studii copii cu vârsta sub 1 an.
English: Kemistvägen 1B P.O.
Romanian: Kemistvägen 1B P.O. Box 1150
English: OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
Romanian: ALT (E) ATEN IONARE( RI) SPECIAL (E), DAC ESTE(SUNT) NECESAR (E) DATA DE EXPIRARE
English: Method of administration Diovan may be taken independently of a meal.
Romanian: Mod de administrare Diovan poate fi luat independent de mese.
English: Sodium and/or volume depletion should be corrected before starting treatment with Diovan, for example by reducing the diuretic dose.
Romanian: Deple ia sodic i/sau de volum trebuie corectat înaintea începerii tratamentului cu Diovan, de exemplu prin reducerea dozei de diuretic.
English: • Submit a Risk Management Plan (or its update) for Diovan at National level, taking into account the new paediatric data and the CHMP recommendations.
Romanian: • S prezinte un Plan de gestionare a riscului (sau actualizarea acestuia) pentru Diovan la nivel na ional, inând cont de noile date privind popula ia pediatric i de recomand rile CHMP.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Romanian: PROSPECT: INFORMA II PENTRU UTILIZATOR
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Romanian: Acest medicament este autorizat în Statele Membre ale Spa iului Economic European sub urm toarele denumiri comerciale:
English: The study report will be finalized by the first quarter of 2014.
Romanian: Raportul studiului va fi finalizat pân în trimestrul I al anului 2014.
English: Because of these inconsistencies, valsartan is not recommended in this age group (see section 4.8).
Romanian: Din cauza acestor inconsecven e, valsartan nu este recomandat în aceast grup de vârst (vezi pct. 4.8).
English: Diovan works by blocking the effect of angiotensin II.
Romanian: Diovan ac ioneaz prin blocarea efectului angiotensinei II.
English: It may be necessary to check the amount of potassium in your blood at regular intervals.
Romanian: Poate fi necesar determinarea cantit ii de potasiu din sângele dumneavoastr la intervale regulate.
English: Screw the cap back on the bottle.
Romanian: Înurubai capacul înapoi pe flacon.
English: The protocol of the study will be submitted by the applicant in the second quarter of 2010 for agreement with the CHMP with input from the PDCO.
Romanian: Protocolul studiului va fi prezentat de solicitant în trimestrul II al anului 2010 în vederea ajungerii la un acord cu CHMP, cu contribu ii din partea PDCO.
English: 5.3 Preclinical safety data
Romanian: 5.3 Date preclinice de siguran
English: • medicines that increase the amount of potassium in your blood.
Romanian: • medicamente care cresc cantitatea de potasiu în sângele dumneavoastr .
English: 4.7 Effects on ability to drive and use machines
Romanian: 4.7 Efecte asupra capacit ii de a conduce vehicule i de a folosi utilaje
English: It may harm them, even if their symptoms are the same as yours.
Romanian: Le poate face r u, chiar dac au acelea i simptome cu ale dumneavoastr .
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded.
Romanian: Datele epidemiologice privind riscul de teratogenitate în urma expunerii la inhibitorii ECA în primul trimestru de sarcin nu au fost concludente; cu toate acestea, nu poate fi exclus o mic cre tere a gradului de risc.
English: Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Diovan affects you.
Romanian: Înainte de a conduce un vehicul, a folosi o unealt , a folosi un utilaj sau a desf ura alte activit i care solicit concentrare, asigura i-v c ti i cum v afecteaz Diovan.
English: Important information about some of the ingredients of Diovan solution
Romanian: Informa ii importante privind unele dintre componente ale Diovan solu ie
English: 4.5 Interaction with other medicinal products and other forms of interaction
Romanian: 4.5 Interac iuni cu alte produse medicinale sau alte forme de interac iune
English: • certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
Romanian: • un anumit tip de medicamente împotriva durerii numite medicamente anti-inflamatoare nesteroidiene (AINS).
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Romanian: ANEXA I LISTA CU DENUMIRILE COMERCIALE, FORMA FARMACEUTIC , CONCENTRA IILE, CALEA DE ADMINISTRARE A MEDICAMENTULUI, DE IN TORII AUTORIZA IEI DE PUNERE PE PIA ÎN STATELE MEMBRE
English: The half-life of valsartan is 6 hours.
Romanian: Timpul de înjum t ire al valsartanului este de 6 ore.
English: ANNEX II AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Romanian: ANEXA II MODIFIC RI ALE REZUMATULUI CARACTERISTICILOR PRODUSULUI I PROSPECTULUI
English: • you must tell your doctor if you think you are (or might become) pregnant.
Romanian: • Trebuie s spune i medicului dumneavoastr dac crede i c sunte i (sau a i putea deveni) gravid .
English: Biotransformation:
Romanian: Biotransformarea:
English: Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist.
Romanian: Valsartanul este un antagonist activ prin administrare oral , puternic i specific al receptorilor angiotensinei II (Ang II).
English: Drink the entire solution right away.
Romanian: Be i imediat întreaga cantitate de solu ie.
English: However safety and efficacy of Diovan in children aged 1 to 6 years have not been established.
Romanian: Cu toate acestea, nu au fost stabilite siguran a i eficacitatea utiliz rii Diovan la copiii cu vârsta cuprins între 1 i 6 ani.
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA03
Romanian: Grupa farmacoterapeutic : antagoni ti de angiotensin II, codul ATC: C09CA03
English: The Applicant commits to the following:
Romanian: Solicitantul se angajeaz dup cum urmeaz :
English: Patients with primary hyperaldosteronism should not be treated with Diovan as their renin-angiotensin system is not activated.
Romanian: Pacien ii cu hiperaldosteronism primar nu trebuie trata i cu Diovan deoarece sistemul reninangiotensin al acestora nu este activat.
English: Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Romanian: De aceea, la începutul tratamentului se recomand monitorizarea func iei renale precum i hidratarea corespunz toare a pacientului.
English: • if you have severe heart disease, your doctor may check your kidney function.
Romanian: • dac avei o boal cardiac sever, medicul dumneavoastr v poate verifica funcia renal.
English: A long term study in the younger age group (1 to 5 years old).
Romanian: Un studiu pe termen lung la grupa de vârst mai tân r (vârste de 1-5 ani).
English: Depending on the prescribed dose, it may be necessary to repeat steps 10 to 16 several times.
Romanian: În func ie de doza prescris , poate fi necesar repetarea de câteva ori a pa ilor 10 pân la 16.
English: CARTON/BOTTLE LABEL
Romanian: CUTIE/ETICHET DE FLACON
English: • Do not use Diovan after the expiry date which is stated on the pack.
Romanian: • Nu utiliza i Diovan dup data de expirare înscris pe ambalaj.
English: You may experience symptoms of angioedema (a specific allergic reaction), such as
Romanian: Pute i avea simptome de angioedem (o reac ie alergic specific ), cum sunt:
English: • that you insert into the neck of the bottle.
Romanian: • pe care îl ata a i gâtul flaconului.
English: This is a disease in which your adrenal glands make too much of the hormone aldosterone.
Romanian: Acesta este o boal în care glandele dumneavoastr suprarenale produc prea mult hormon numit aldosteron.
English: The antihypertensive effect persists over 24 hours after dosing.
Romanian: Efectul antihipertensiv persist pe o perioad de 24 ore dup administrare.
English: If you get any of these, see a doctor immediately.
Romanian: Dac apare oricare dintre acestea, adresa i-v imediat unui medic.
English: Primary hyperaldosteronism
Romanian: Hiperaldosteronismul primar
English: Note: The total amount of solution that can be measured into the oral syringe is 5 ml.
Romanian: Not : Cantitatea total de solu ie care poate fi m surat în seringa pentru administrare oral este de 5 ml.
English: This applies particularly when valsartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function.
Romanian: Acest lucru se aplic , în special când valsartan este administrat în prezen a altor factori (febr , deshidratare) care pot afecta func ia renal .
English: • that consists of a clear plastic tube with a plunger inside.
Romanian: • care const într-un tub din plastic incolor, cu un piston în interior.
English: Do not take Diovan:
Romanian: Nu lua i Diovan:
English: As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Diovan may be associated with impairment of the renal function.
Romanian: Deoarece valsartanul este un antagonist al angiotensinei II, nu poate fi exclus posibilitatea ca utilizarea Diovan s fie asociat cu deteriorarea func iei renale.
English: Functional renal maturation is an ongoing process within the first year of life in humans.
Romanian: Maturizarea func ional renal este un proces în desf urare în primul an de via la om.
English: Citric acid, anhydrous Sodium citrate
Romanian: Acid citric anhidru Citrat de sodiu
English: This period coincides with 36 weeks of gestation in humans, which could occasionally extend up to 44 weeks after conception in humans.
Romanian: Aceast perioad coincide cu 36 de s pt mâni de gesta ie la om, care ocazional se pot prelungi pân la 44 s pt mâni dup concep ie la om.
English: Hypersensitivity including serum sickness
Romanian: Hipersensibilizare, inclusiv boala serului
English: All changes were considered to be caused by the pharmacological action of valsartan which produces prolonged hypotension, particularly in marmosets.
Romanian: Toate modific rile au fost considerate a fi consecin a ac iunii farmacologice a valsartanului, care produce hipotensiune arterial prelungit , mai ales la marmote.
English: Consistent results were observed for diastolic blood pressure with reductions of 9.1 mmHg and 8.5 mmHg with valsartan and enalapril, respectively.
Romanian: Au fost observate rezultate consecvente pentru tensiunea arterial diastolic cu reduceri cu 9,1 mmHg i 8,5 mmHg la administrarea de valsartan, respectiv enalapril.
English: Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.
Romanian: La fel ca multe alte medicamente utilizate pentru tratamentul tensiunii arteriale, Diovan poate, în rare cazuri, s determine ame eli i s afecteze capacitatea de concentrare.
English: Do not stop taking your medicine unless your doctor tells you to.
Romanian: Nu v opri i din a lua medicamentul decât dac medicul dumneavoastr .v spune acest lucru.
English: A causal relationship to Diovan has not been established.
Romanian: Nu a fost stabilit nicio rela ie cauzal cu Diovan.
English: Diovan 3 mg/ml oral solution can be used to treat high blood pressure in children and adolescents 6 to 18 years of age.
Romanian: Diovan 3 mg/ml solu ie oral poate fi utilizat pentru tratamentul tensiunii arteriale mari la copii i adolescen i cu vârsta cuprins între 6 i 18 ani.
English: The applicant will initiate a scientific dialogue via the CHMP's Scientific Advice with the involvement of the PDCO for protocol assistance with the aim of gaining further insight on a hypertensive clinical trial in younger children with valsartan and to define objectives and design parameters in investigating the efficacy in this population.
Romanian: Solicitantul va ini ia un dialog tiin ific prin Sectorul Consiliere tiin ific al CHMP cu implicarea PDCO pentru asisten a de protocol, cu scopul de a dobândi o mai bun cunoa tere a unui studiu clinic referitor la hipertensiune efectuat la copiii mici cu valsartan i pentru a defini obiectivele i parametrii de concepere în investigarea eficacit ii la aceast popula ie.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Romanian: Datele non-clinice nu au eviden iat nici un risc special pentru om pe baza studiilor conven ionale farmacologice privind evaluarea siguran ei, toxicitatea dup doze repetate, genotoxicitatea, carcinogenitatea.
English: Valsartan is not biotransformed to a high extent as only about 20% of dose is recovered as metabolites.
Romanian: Biotransformarea valsartanului nu se face într-o propor ie mare, întrucât numai aproximativ 20% din doz este recuperat sub form de metaboli i.
English: Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000 fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Romanian: Valsartanul nu prezint nicio activitate de tip agonist par ial asupra receptorilor AT1 i are o afinitate mult mai mare (de aproximativ 20.000 de ori) pentru receptorii AT1 decât pentru receptorii AT2.
English: Driving and using machines
Romanian: Conducerea vehiculelor i folosirea utilajelor