FrancophonIA/ELRC3.0 huggingface dataset:
English: 250 to 500 mg twice daily
Romanian: 250 până la 500 mg de două ori pe zi 500 până la 1000 mg o dată pe zi(2)
English: Levetiracetam Actavis 1,000 mg tablets are oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side.
Romanian: Oval, de culoare albă, 19,0 x 10,0 mm, marcat cu “L” pe una din feţe şi “1000” pe cealaltă faţă.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine (E132)
Romanian: Dioxid de titan (E171) Oxid galben de fier (E172) Indigo carmin (E132)
English: Each film-coated tablet contains 1,000 mg levetiracetam.
Romanian: Fiecare comprimat filmat conţine levetiracetam 1000 mg.
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Romanian: letargie, tremor amnezie, afectarea memoriei, tulburări de coordonare/ataxie,
English: Levetiracetam Actavis 750 mg tablets are oval, orange, 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side.
Romanian: Oval, de culoare portocalie, 19,0 x 9,3 mm, marcat cu “L” pe una din feţe şi “750” pe cealaltă faţă.
English: Each tablet contains 1,000 mg levetiracetam.
Romanian: Fiecare comprimat conţine levetiracetam 1000 mg.
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
Romanian: furie, stare confuzională, atac de panică, labilitate emoţională/modificăr i ale dispoziţiei, agitaţie suicid reuşit, tulburări de personalitate,
English: (2) A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Romanian: (2) În prima zi a tratamentului cu levetiracetam se recomandă o doză de încărcare de 10,5 mg/kg (0,105
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Aluminium/PVC blisters
Romanian: Cutia cu blistere aluminiu/PVC
English: 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) twice daily
Romanian: 3,5 până la 7 mg/kg (0,035 până la 0,07 ml/kg) de două ori pe zi
English: 7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily
Romanian: 7 până la 21 mg/kg (0,07 până la 0,21 ml/kg) de două ori pe zi
English: Levetiracetam Actavis 500 mg tablets are oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side.
Romanian: Oval, de culoare galbenă, 17,1 x 8,1 mm, marcat cu “L” pe una din feţe şi “500” pe cealaltă faţă.
English: Levetiracetam Actavis 1,000 mg film-coated tablets
Romanian: Levetiracetam Actavis 1000 mg comprimate filmate
English: One tablet of Levetiracetam Actavis 250 mg contains 250 mg of levetiracetam.
Romanian: Un comprimat de Levetiracetam Actavis 250 conţine levetiracetam 250 mg.
English: Levetiracetam Actavis 250 mg film-coated tablets Oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side.
Romanian: Oval, de culoare albastru deschis, 13,6 x 6,4 mm, marcat cu “L” pe una din feţe şi “250” pe cealaltă faţă.
English: • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Romanian: Levetiracetam Actavis este utilizat: ca tratament unic la adulţi şi adolescenţi începând cu vârsta de 16 ani, nou diagnosticați cu o anumită formă de epilepsie.
English: Levetiracetam Actavis 750 mg film-coated tablets
Romanian: Levetiracetam Actavis 750 mg comprimate filmate
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) twice daily
Romanian: 10 până la 20 mg/kg (0,10 până la 0,2 ml/kg) de două ori pe zi
English: in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Romanian: • în tratamentul crizelor tonico-clonice primar generalizate, la pacienţi cu Epilepsie Generalizată Idiopatică, adulţi şi adolescenţi începând cu vârsta de 12 ani.
English: 72.2 % of the levetiracetam treated patients and 45.2 % of the patients on placebo had a 50 % or greater decrease in the frequency of PGTC seizures per week.
Romanian: S-a observat o reducere cu cel puţin 50% a frecvenţei crizelor TCPG calculate săptămânal la 72,2% dintre pacienţii trataţi cu levetiracetam şi 45,2% dintre pacienţii cărora li s-a administrat placebo.
English: The NOAEL (No Observed Adverse Effect Level) was 3,600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2
Romanian: Valoarea la care nu se observă reacţii adverse (NOAEL) a fost de 3600 mg/kg şi zi pentru femelele gestante de şobolan (de 12 ori doza zilnică maximă recomandată la om, exprimată în mg/m2 de suprafaţă corporală) şi de 1200 mg/kg şi zi pentru fetus.
English: 5 to 15 mg/kg (0.05 to 0.15 ml/kg) twice daily
Romanian: 5 până la 15 mg/kg (0,05 până la 0,15 ml/kg) de două ori pe zi zi
English: Each film-coated tablet contains 750 mg levetiracetam.
Romanian: Fiecare comprimat filmat conţine levetiracetam 750 mg.
English: Convulsion, balance disorder, dizziness, lethargy, tremor
Romanian: cefalee convulsii, tulburări de echilibru, ameţeli,
English: Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea
Romanian: Tulburări gastrointestinal e dureri abdominale, diaree, dispepsie,
English: 58.3 % of the levetiracetam treated patients and 23.3 % of the patients on placebo had at least a 50 % reduction in myoclonic seizure days per week.
Romanian: S-a observat o reducere cu cel puţin 50% a zilelor cu crize mioclonice calculate săptămânal la 58,3% dintre pacienţii trataţi cu levetiracetam şi 23,3% dintre pacienţii cărora li s-a administrat placebo.
English: • Levetiracetam Actavis is used as a chronic treatment.
Romanian: Levetiracetam Actavis implică un tratament de lungă durată.
English: basis) and 1,200 mg/kg/day for fetuses.
Romanian: 400, 1200 şi 3600 mg/kg şi zi.
English: Each film-coated tablet contains 250 mg levetiracetam.
Romanian: Fiecare comprimat filmat conţine levetiracetam 250 mg.
English: Renal and urinary disorders
Romanian: Tulburări renale şi ale căilor urinare afecţiune renală acută
English: EU/1/11/713/018 30 tablets EU/1/11/713/019 100 tablets EU/1/11/713/020 200 tablets
Romanian: EU/1/11/713/018 30 comprimate EU/1/11/713/019 100 comprimate EU/1/11/713/020 200 comprimate
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
Romanian: 7 până la 14 mg/kg (0,07 până la 0,14 ml/kg) de două ori pe zi
English: 3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
Romanian: 3,5 până la 10,5 mg/kg (0,035 până la 0,105 ml/kg) de două ori pe
English: EU/1/11/713/011 EU/1/11/713/012 EU/1/11/713/013 EU/1/11/713/014 EU/1/11/713/015 EU/1/11/713/016 EU/1/11/713/017 EU/1/11/713/018 EU/1/11/713/019 EU/1/11/713/020 EU/1/11/713/042
Romanian: EU/1/11/713/012 EU/1/11/713/013 EU/1/11/713/014 EU/1/11/713/015 EU/1/11/713/016 EU/1/11/713/017 EU/1/11/713/018 EU/1/11/713/019 EU/1/11/713/020 EU/1/11/713/042
English: Tel.: +34 91 630 86 45
Romanian: Aurovitas Spain, S.A.U. Tel.: +34 91 630 86 45
English: Each tablet contains 750 mg levetiracetam.
Romanian: Fiecare comprimat conţine levetiracetam 750 mg.
English: in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Romanian: • în tratamentul crizelor mioclonice la pacienţi cu Epilepsie Mioclonică Juvenilă, adulţi şi adolescenţi începând cu vârsta de 12 ani.
English: Each film-coated tablet contains 500 mg levetiracetam.
Romanian: Fiecare comprimat filmat conţine levetiracetam 500 mg.
English: Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam
Romanian: Levetiracetam Actavis 750 mg comprimate filmate Levetiracetam
English: Levetiracetam Actavis 1,000 mg film-coated tablets Levetiracetam
Romanian: Levetiracetam Actavis 1000 mg comprimate filmate Levetiracetam
English: Levetiracetam Actavis 500 mg film-coated tablets
Romanian: Levetiracetam Actavis 500 mg comprimate filmate
English: Levetiracetam Actavis 500 mg film-coated tablets Oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side.
Romanian: Levetiracetam Actavis 500 mg comprimate filmate sunt ovale, de culoare galbenă, 17,1 x 8,1 mm,
English: The apparent body clearance was 1.1 ml/min/kg.
Romanian: 1,1 ml/min şi kg.
English: 10 to 30 mg/kg (0.10 to 0.30 ml/kg) twice daily
Romanian: 10 până la 30 mg/kg (0,1 până la 0,3 ml/kg) de două ori pe zi
English: Each tablet contains 250 mg levetiracetam.
Romanian: Fiecare comprimat conţine levetiracetam 250 mg.
English: EU/1/11/713/008 30 tablets EU/1/11/713/009 100 tablets EU/1/11/713/010 200 tablets
Romanian: EU/1/11/713/008 30 comprimate EU/1/11/713/009 100 comprimate EU/1/11/713/010 200 comprimate
English: EU/1/11/713/028 30 tablets EU/1/11/713/029 100 tablets EU/1/11/713/030 200 tablets
Romanian: EU/1/11/713/028 30 comprimate EU/1/11/713/029 100 comprimate EU/1/11/713/030 200 comprimate
English: Levetiracetam Actavis 250 mg tablets Levetiracetam
Romanian: Levetiracetam Actavis 250 mg comprimate Levetiracetam
English: Levetiracetam Actavis 750 mg tablets Levetiracetam
Romanian: Levetiracetam Actavis 750 mg comprimate Levetiracetam
English: Levetiracetam Actavis 250 mg film-coated tablets
Romanian: Levetiracetam Actavis 250 mg comprimate filmate
English: Levetiracetam Actavis 500 mg tablets Levetiracetam
Romanian: Levetiracetam Actavis 500 mg comprimate Levetiracetam
English: Perforated unit dose blisters: EU/1/11/713/042 60 x 1 tablets
Romanian: EU/1/11/713/042 60 x 1 comprimate
English: Levetiracetam Actavis 750 mg film-coated tablets Oval, orange 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side.
Romanian: Levetiracetam Actavis 750 mg comprimate filmate sunt ovale, de culoare portocalie, 19,0 x 9,3 mm,
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
Romanian: (12-17 ani) cu greutate sub 50 kg:
English: EU/1/11/713/038 30 tablets EU/1/11/713/039 100 tablets EU/1/11/713/040 200 tablets
Romanian: EU/1/11/713/038 30 comprimate EU/1/11/713/039 100 comprimate EU/1/11/713/040 200 comprimate
English: Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam
Romanian: Levetiracetam Actavis 250 mg comprimate filmate Levetiracetam
English: Each tablet contains 500 mg levetiracetam.
Romanian: Fiecare comprimat conţine levetiracetam 500 mg.
English: Titanium dioxide (E171) Indigo carmine (E132) Sunset yellow (E110) Iron oxide red (E172)
Romanian: Dioxid de titan (E171) Indigo carmin (E132) Galben amurg (E110)
English: Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam
Romanian: Levetiracetam Actavis 500 mg comprimate filmate Levetiracetam
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 250 mg film-coated tablets
Romanian: Blistere pentru comprimate filmate 250 mg
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily
Romanian: 7 până la 14 mg/kg (0,07 până la 0,14 ml/kg) o dată pe zi(2) (4)
English: 5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
Romanian: 5 până la 10 mg/kg (0,05 până la 0,1 ml/kg) de două ori pe zi
English: Levetiracetam Actavis 1,000 mg film-coated tablets Oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side.
Romanian: Levetiracetam Actavis 1000 mg comprimate filmate sunt ovale, de culoare albă, 19,0 x 10,0 mm,
English: Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Romanian: Doze recomandate la sugari (între 1 şi 23 luni), copii mici (între 2 şi 11 ani) şi adolescenţi
English: EU/1/11/713/001 20 tablets EU/1/11/713/002 30 tablets EU/1/11/713/003 50 tablets EU/1/11/713/004 60 tablets EU/1/11/713/005 100 tablets EU/1/11/713/006 120 tablets EU/1/11/713/007 200 tablets
Romanian: EU/1/11/713/001 20 comprimate EU/1/11/713/002 30 comprimate EU/1/11/713/003 50 comprimate EU/1/11/713/004 60 comprimate EU/1/11/713/005 100 comprimate EU/1/11/713/006 120 comprimate EU/1/11/713/007 200 comprimate
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 750 mg film-coated tablets
Romanian: Blistere pentru comprimate filmate 750 mg
English: EU/1/11/713/031 20 tablets EU/1/11/713/032 30 tablets EU/1/11/713/033 50 tablets EU/1/11/713/034 60 tablets EU/1/11/713/035 100 tablets EU/1/11/713/036 120 tablets EU/1/11/713/037 200 tablets
Romanian: EU/1/11/713/031 20 comprimate EU/1/11/713/032 30 comprimate EU/1/11/713/033 50 comprimate EU/1/11/713/034 60 comprimate EU/1/11/713/035 100 comprimate EU/1/11/713/036 120 comprimate EU/1/11/713/037 200 comprimate
English: Perforated unit dose blisters: EU/1/11/713/043 60 x 1 tablets
Romanian: EU/1/11/713/043 60 x 1 comprimate
English: EU/1/11/713/011 20 tablets EU/1/11/713/012 30 tablets EU/1/11/713/013 50 tablets EU/1/11/713/014 60 tablets EU/1/11/713/015 100 tablets EU/1/11/713/016 120 tablets EU/1/11/713/017 200 tablets
Romanian: EU/1/11/713/011 20 comprimate EU/1/11/713/012 30 comprimate EU/1/11/713/013 50 comprimate EU/1/11/713/014 60 comprimate EU/1/11/713/015 100 comprimate EU/1/11/713/016 120 comprimate EU/1/11/713/017 200 comprimate
English: EU/1/11/713/021 20 tablets EU/1/11/713/022 30 tablets EU/1/11/713/023 50 tablets EU/1/11/713/024 60 tablets EU/1/11/713/025 100 tablets EU/1/11/713/026 120 tablets EU/1/11/713/027 200 tablets
Romanian: EU/1/11/713/021 20 comprimate EU/1/11/713/022 30 comprimate EU/1/11/713/023 50 comprimate EU/1/11/713/024 60 comprimate EU/1/11/713/025 100 comprimate EU/1/11/713/026 120 comprimate EU/1/11/713/027 200 comprimate
English: Povidone
Romanian: Alăptarea
English: Perforated unit dose blisters: EU/1/11/713/041 60 x 1 tablets
Romanian: EU/1/11/713/041 60 x 1 comprimate
English: Levetiracetam Actavis 750 mg film-coated tablets Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Romanian: Blistere : 20, 30, 50, 60, 100, 120 şi 200 comprimate filmate Flacoane: 30, 100 şi 200 comprimate filmate.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 1,000 mg film-coated tablets
Romanian: Blistere pentru comprimate filmate 1000 mg
English: How to store Levetiracetam Actavis
Romanian: Cum se păstrează Levetiracetam Actavis
English: Levetiracetam Actavis 1,000 mg tablets Levetiracetam
Romanian: Levetiracetam Actavis 1000 mg, comprimate Levetiracetam
English: Completed suicide, personality disorder, thinking abnormal, delirium
Romanian: tulburări ale gândirii, delir
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 1,000 mg film-coated tablets in tablet containers
Romanian: Eticheta flaconului cu comprimate filmate 1000 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 500 mg film-coated tablets
Romanian: Blistere pentru comprimate filmate 500 mg
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 500 mg film-coated tablets in tablet containers
Romanian: Eticheta flaconului cu comprimate filmate 500 mg
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 750 mg film-coated tablets in tablet containers
Romanian: Eticheta flaconului cu comprimate filmate 750 mg
English: Levetiracetam Actavis 250 mg film-coated tablets are oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side.
Romanian: 13,6 x 6,4 mm, marcate cu “L” pe una din feţe şi “250” pe cealaltă faţă.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 250 mg film-coated tablets in tablet containers
Romanian: Eticheta flaconului cu comprimate filmate 250 mg
English: Ref. EMEA/554626/2009 EMEA/H/C/1025
Romanian: EMA/554626/2009 EMEA/H/C/1025
English: London, 24 September 2009 Doc.
Romanian: Londra, 24 septembrie 2009 Ref. doc.
English: The main measure of effectiveness was the number of patients who were cured after treatment.
Romanian: Principala măsură a eficacităţii a fost numărul de pacienţi vindecaţi în urma tratamentului.
English: It contains the active substance oritavancin.
Romanian: Conţine substanţa activă oritavancin.
English: The letter from the company notifying the European Medicines Agency of the withdrawal of the application is available here.
Romanian: Scrisoarea prin care societatea înştiinţează Agenţia Europeană pentru Medicamente cu privire la retragerea cererii este disponibilă aici.
English: Questions and answers on the withdrawal of the marketing authorisation application for Ramvocid oritavancin
Romanian: Întrebări şi răspunsuri privind retragerea cererii de autorizaţie de introducere pe piaţă pentru Ramvocid oritavancin
English: What is Ramvocid?
Romanian: Ce este Ramvocid?
English: Patients were given either Ramvocid for seven days or vancomycin with or without cephalexin (other antibiotic medicines) for between 10 and 14 days.
Romanian: Pacienţii au primit fie Ramvocid timp de şapte zile, fie vancomicină cu sau fără cefalexină (alte antibiotice) între 10 şi 14 zile.
English: The effects of Ramvocid were first tested in experimental models before being studied in humans.
Romanian: Efectele Ramvocid au fost testate pe modele experimentale, înainte de a fi studiate pe subiecţi umani.
English: Together, the cell wall and membrane form a barrier between the bacterial cell contents and the external environment.
Romanian: Peretele şi membrana celulară formează împreună o barieră între conţinutul celulei bacteriene şi mediul exterior.
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Romanian: „Complicate” înseamnă că infecţia este dificil de tratat deoarece s-a extins la ţesuturile adânci de sub piele, că poate fi necesar tratament chirurgical sau că pacientul are alte afecţiuni care i-ar putea afecta răspunsul la tratament.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Romanian: Pe baza examinării documentaţiei iniţiale, CHMP întocmeşte o listă de întrebări în ziua 120, care este transmisă societăţii.
English: The Committee was also concerned over the way the company had measured the levels of impurities in the medicine.
Romanian: Comitetul a fost, de asemenea, îngrijorat cu privire la metoda folosită de societate pentru măsurarea impurităţilor din medicament.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to issue a decision on this opinion.
Romanian: După adoptarea avizului CHMP, Comisia Europeană acordă, de regulă, o decizie privind acest aviz în termen de circa două luni.
English: These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Romanian: Acestea cuprind Staphylococcus aureus (inclusiv formele „rezistente la meticilină”, numite “SARM”) şi Streptococcus pyogenes.
English: By disrupting this barrier, oritavancin is expected to kill the bacteria that are causing the infection.
Romanian: Distrugând această barieră, oritavancinul urmează să omoare bacteriile care cauzează infecţia.
English: The company presented results from one main study involving 1,267 patients with complicated skin and soft tissue infections.
Romanian: Societatea a prezentat rezultatele unui studiu care a cuprins 1 267 de pacienţi cu infecţii complicate ale pielii şi ale ţesuturilor moi.
English: It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes.
Romanian: Aceasta ar trebui să acţioneze în două moduri: prin împiedicarea bacteriilor de a-şi construi pereţii celulari şi prin distrugerea membranelor celulare.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Ramvocid?
Romanian: Care sunt consecinţele retragerii cererii pentru pacienţii implicaţi în studii clinice sau în programe de uz compasional care utilizează Ramvocid?
English: The active substance in Ramvocid, oritavancin, is an antibiotic that belongs to the group ‘lipoglycopeptides'.
Romanian: Substanţa activă din Ramvocid, oritavancinul, este un antibiotic din grupa „lipoglicopeptidelor”.
English: On 20 August 2009, Targanta Netherlands B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramvocid, for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria.
Romanian: La 20 august 2009, Targanta Netherlands B.V. a înştiinţat oficial Comitetul pentru produse medicamentoase de uz uman (CHMP) despre intenţia de a-şi retrage cererea de autorizaţie de introducere pe piaţă pentru Ramvocid, pentru tratamentul infecţiilor complicate ale pielii şi ţesuturilor moi cauzate de bacterii grampozitive.
English: Ramvocid is a powder to be made up into a solution for infusion (drip into a vein).
Romanian: Ramvocid este o pulbere din care se prepară o soluţie pentru perfuzie (picurare în venă).
English: The company informed the CHMP that, at the time of the withdrawal, there were no patients in clinical trials or compassionate use programmes for Ramvocid.
Romanian: Societatea a informat CHMP că, în momentul retragerii nu existau pacienţi aflaţi în studii clinice sau programe de uz compasional cu Ramvocid.
English: Ramvocid was to be used when the infection was caused by a group of bacteria known as ‘Grampositive' bacteria.
Romanian: Ramvocid urma să fie utilizat la infecţii cauzate de grupa de bacterii numite „grampozitive”.
English: What was Ramvocid expected to be used for?
Romanian: Pentru ce ar fi trebuit să se utilizeze Ramvocid?
English: The CHMP was concerned that the company had not provided enough evidence to support the use of Ramvocid to treat complicated skin and soft tissue infections at the dose proposed, particularly in patients with MRSA.
Romanian: CHMP a fost îngrijorat că societatea nu a furnizat suficiente dovezi pentru a susţine utilizarea Ramvocid în tratamentul infecţiilor complicate ale pielii şi ţesuturilor moi la dozele propuse, în special în cazul pacienţilor cu SARM.
English: Ramvocid was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Romanian: Ramvocid ar fi trebuit să se utilizeze pentru tratarea adulţilor cu infecţii complicate ale pielii şi „ţesuturilor moi” de sub piele.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ramvocid could not have been approved for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria.
Romanian: Pe baza analizării informaţiilor şi a răspunsurilor societăţii la lista de întrebări a CHMP, în momentul retragerii cererii, CHMP a avut câteva motive de îngrijorare şi a formulat avizul provizoriu conform căruia Ramvocid nu putea fi aprobat pentru tratamentul infecţiilor complicate ale pielii şi ţesuturilor moi cauzate de bacterii grampozitive.
English: How is Ramvocid expected to work?
Romanian: Cum ar trebui să acţioneze Ramvocid?
English: The final opinion was converted into a Decision by the European Commission on 14 June 2010.
Romanian: Avizul final a devenit decizie a Comisiei Europene la 14 iunie 2010.
English: The referral procedure started on 11 February 2009.
Romanian: Procedura de sesizare a fost iniţiată la 11 februarie 2009.
English: Written explanations were provided by the applicants/marketing authorisation holders on 21 April 2009 and 16 September 2009.
Romanian: Au fost puse la dispoziţie explicaţii scrise de către solicitanţi/deţinătorii autorizaţiilor de punere pe piaţă la 21 aprilie 2009 şi 16 septembrie 2009.
English: CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf
Romanian: 2 Orientările revizuite ale CVMP privind RCP-ul produselor antimicrobiene (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf
English: However, due to the known prevalence of resistance to this antimicrobial, changes to the product literature of the relevant products were recommended to reflect the principles for prudent use.
Romanian: Cu toate acestea, din cauza prevalenţei cunoscute a rezistenţei la acest agent antimicrobian, s-a recomandat modificarea literaturii de specialitate referitoare la produs pentru a reflecta principiile utilizării cu prudenţă.