FrancophonIA/ELRC3.0 huggingface dataset:
English: PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Romanian: PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut peginterferon alfa-2b
English: PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 80 micrograms of peginterferon alfa-2b as measured on a protein basis.
Romanian: PegIntron 80 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) preumplut conţine 80 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: Pen label - PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen
Romanian: Cutie PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen
Romanian: PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut PegIntron 80 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut
English: EU/1/00/131/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Romanian: EU/1/00/131/020 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/1/00/131/029 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
English: EU/1/00/131/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Romanian: EU/1/00/131/021 (1 flacon cu pulbere, 1 fiolă cu solvent) EU/1/00/131/022 (1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant)
English: EU/1/00/131/018 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Romanian: EU/1/00/131/018 (4 flacoane cu pulbere, 4 fiole cu solvent) EU/1/00/131/019 (4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante)
English: PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Romanian: PegIntron 80 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) (CLEARCLICK) preumplut se reconstituie cu solventul (apă pentru preparate injectabile) din cartuşul compus din două compartimente, pentru administrarea unei cantităţi de până la 0,5 ml de soluţie.
English: PegIntron 120 micrograms powder for injection peginterferon alfa-2b
Romanian: PegIntron 120 micrograme pulbere pentru soluţie injectabilă peginterferon alfa-2b
English: PegIntron 50 micrograms powder and solvent for solution for injection PegIntron 80 micrograms powder and solvent for solution for injection PegIntron 100 micrograms powder and solvent for solution for injection PegIntron 120 micrograms powder and solvent for solution for injection PegIntron 150 micrograms powder and solvent for solution for injection
Romanian: PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă PegIntron 80 micrograme pulbere şi solvent pentru soluţie injectabilă PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă
English: PegIntron 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Romanian: PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă peginterferon alfa-2b
English: EU/1/00/131/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Romanian: EU/1/00/131/001 (1 flacon cu pulbere, 1 fiolă cu solvent) EU/1/00/131/002 (1 flacon cu pulbere, 1 fiolă cu solvent, 1 seringă, 2 ace pentru injecţie şi 1 tampon dezinfectant)
English: PegIntron 100 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Romanian: PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă peginterferon alfa-2b
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Romanian: PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut peginterferon alfa-2b
English: PegIntron 100 micrograms powder for injection peginterferon alfa-2b
Romanian: PegIntron 100 micrograme pulbere pentru soluţie injectabilă peginterferon alfa-2b
English: PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 150 micrograms of peginterferon alfa-2b as measured on a protein basis.
Romanian: PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) preumplut conţine 150 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: EU/1/00/131/043 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/044 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/046 (12 pens, 12 injection needles and 24 cleansing swabs)
Romanian: EU/1/00/131/043 (1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante) EU/1/00/131/044 (4 stilouri injectoare (pen-uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante) EU/1/00/131/046 (12 stilouri injectoare (pen-uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante)
English: PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Romanian: PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut peginterferon alfa-2b
English: PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Romanian: PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut peginterferon alfa-2b
English: PegIntron 80 micrograms powder and solvent for solution for injection Each vial contains 80 micrograms of peginterferon alfa-2b measured on a protein basis.
Romanian: PegIntron 80 micrograme pulbere şi solvent pentru soluţie injectabilă Fiecare flacon conţine 80 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: Conjunctival haemorrhage, eye pruritus, keratitis, vision blurred, photophobia Ear and labyrinth disorders
Romanian: Hemoragie conjunctivală, prurit ocular, cheratită, vedere înceţoşată, fotofobie
English: PegIntron 150 micrograms powder and solvent for solution for injection Each vial contains 150 micrograms of peginterferon alfa-2b as measured on a protein basis.
Romanian: PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă Fiecare flacon conţine 150 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 50 micrograms of peginterferon alfa-2b as measured on a protein basis.
Romanian: PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) preumplut conţine 50 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Romanian: PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) (CLEARCLICK) preumplut se reconstituie cu solventul (apă pentru preparate injectabile) din cartuşul compus din două compartimente, pentru administrarea unei cantităţi de până la 0,5 ml de soluţie.
English: PegIntron 100 micrograms powder and solvent for solution for injection Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
Romanian: PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă Fiecare flacon conţine 100 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: Pen label - PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen
Romanian: Cutie PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut
English: PegIntron 150 micrograms powder for injection peginterferon alfa-2b
Romanian: PegIntron 150 micrograme pulbere pentru soluţie injectabilă peginterferon alfa-2b
English: PegIntron 120 micrograms powder and solvent for solution for injection Each vial contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.
Romanian: PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă Fiecare flacon conţine 120 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: PegIntron 50 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Romanian: PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă Fiecare flacon va fi reconstituit cu 0,7 ml apă pentru preparate injectabile pentru a se administra o cantitate de până la 0,5 ml soluţie.
English: EU/1/00/131/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/042 (12 pens, 12 injection needles and 24 cleansing swabs)
Romanian: EU/1/00/131/039 (1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante) EU/1/00/131/040 (4 stilouri injectoare (pen-uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante) EU/1/00/131/042 (12 stilouri injectoare (pen-uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante)
English: PegIntron 100 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Romanian: PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă Fiecare flacon va fi reconstituit cu 0,7 ml apă pentru preparate injectabile pentru a se administra o cantitate de până la 0,5 ml soluţie.
English: PegIntron 50 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Romanian: PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă peginterferon alfa-2b
English: - changes in taste, diarrhoea, stomach upset, oral pain, - fainting, palpitations (pounding heart beat), rapid heart rate, flushing, nosebleed, - sores in mouth, scaling lips and clefts in the corners of the mouth, rash, redness of skin, itching,
Romanian: - hipotensiune arterială, paloare, disconfort nazal, secreţii nazale abundente, respiraţie şuierătoare, dificultăţi la respiraţie, disconfort sau durere în piept, - roşeaţă, inflamaţie, durere la nivelul pielii, vezicule (herpes zoster), piele sensibilă la lumina solară, erupţie pe piele cu leziuni punctiforme proeminente, modificări de culoare ale pielii, exfoliere a pielii, fasciculaţii musculare, contracţii musculare, durere la nivelul feţei, vânătăi.
English: EU/1/00/131/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/038 (12 pens, 12 injection needles and 24 cleansing swabs)
Romanian: EU/1/00/131/035 (1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante) EU/1/00/131/036 (4 stilouri injectoare (pen-uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante) EU/1/00/131/038 (12 stilouri injectoare (pen-uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante)
English: PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.
Romanian: PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) preumplut conţine 120 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: Pen label - PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen
Romanian: Cutie PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut
English: PegIntron 120 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Romanian: PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă peginterferon alfa-2b
English: PegIntron 50 micrograms powder for injection peginterferon alfa-2b
Romanian: PegIntron 50 micrograme pulbere pentru soluţie injectabilă peginterferon alfa-2b
English: PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen contains 100 micrograms of peginterferon alfa-2b as measured on a protein basis.
Romanian: PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) preumplut conţine 100 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: PegIntron 50 micrograms powder and solvent for solution for injection Each vial contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
Romanian: PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă Fiecare flacon conţine 50 micrograme de peginterferon alfa-2b măsurat pe proteină ca bază.
English: EU/1/00/131/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Romanian: EU/1/00/131/003 (4 flacoane cu pulbere, 4 fiole cu solvent) EU/1/00/131/004 (4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante)
English: Carton 50 micrograms powder and solvent for solution for injection in pre-filled pen
Romanian: PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut
English: EU/1/00/131/013 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
Romanian: EU/1/00/131/013 (4 flacoane cu pulbere, 4 fiole cu solvent) EU/1/00/131/014 (4 flacoane cu pulbere, 4 fiole cu solvent, 4 seringi, 8 ace pentru injecţie şi 4 tampoane dezinfectante)
English: Carton 100 micrograms powder and solvent for solution for injection in pre-filled pen
Romanian: PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut
English: EU/1/00/131/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Romanian: EU/1/00/131/010 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/1/00/131/027 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
English: EU/1/00/131/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Romanian: EU/1/00/131/005 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/1/00/131/026 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
English: EU/1/00/131/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Romanian: EU/1/00/131/015 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/1/00/131/028 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
English: EU/1/00/131/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/034 (12 pens, 12 injection needles and 24 cleansing swabs)
Romanian: EU/1/00/131/031 (1 stilou injector (pen), 1 ac pentru injecţie şi 2 tampoane dezinfectante) EU/1/00/131/032 (4 stilouri injectoare (pen-uri), 4 ace pentru injecţie şi 8 tampoane dezinfectante) EU/1/00/131/034 (12 stilouri injectoare (pen-uri), 12 ace pentru injecţie şi 24 tampoane dezinfectante)
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Romanian: PegIntron 50 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) (CLEARCLICK) preumplut se reconstituie cu solventul (apă pentru preparate injectabile) din cartuşul compus din două compartimente, pentru administrarea unei cantităţi de până la 0,5 ml de soluţie.
English: EU/1/00/131/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Romanian: EU/1/00/131/025 (6 flacoane cu pulbere, 6 fiole cu solvent) EU/1/00/131/030 (12 flacoane cu pulbere, 12 fiole cu solvent, 12 seringi, 24 ace pentru injecţie şi 12 tampoane dezinfectante)
English: PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Romanian: PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) (CLEARCLICK) preumplut se reconstituie cu solventul (apă pentru preparate injectabile) din cartuşul compus din două compartimente, pentru administrarea unei cantităţi de până la 0,5 ml de soluţie.
English: PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen Each pre-filled pen (CLEARCLICK) is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Romanian: PegIntron 100 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut Fiecare stilou injector (pen) (CLEARCLICK) preumplut se reconstituie cu solventul (apă pentru preparate injectabile) din cartuşul compus din două compartimente, pentru administrarea unei cantităţi de până la 0,5 ml de soluţie.
English: PegIntron 150 micrograms powder and solvent for solution for injection Each vial contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.
Romanian: PegIntron 150 micrograme pulbere şi solvent pentru soluţie injectabilă Fiecare flacon conţine peginterferon alfa-2b 150 micrograme măsurat pe proteină ca bază.
English: Carton 50 micrograms
Romanian: Cutie PegIntron 50 micrograme
English: PegIntron (100 or c µg/week) + ribavirin
Romanian: PegIntron (100 sau cµg/săptămână) + ribavirină (8001,200 mg)
English: Genotype 1* By week 4*** (n=950) HCV-RNA negative 834
Romanian: La săptămâna 4*** (n=950)
English: nd dose reduction of PegIntron is to 20 g/m 2/week.
Romanian: La copii şi adolescenţi, prima reducere a dozei de PegIntron este la 40 µg/m2 şi săptămână, a doua reducere a dozei de PegIntron este la 20 µg/m 2 şi săptămână.
English: Carton 100 micrograms
Romanian: Cutie PegIntron 100 micrograme
English: Carton 120 micrograms powder and solvent for solution for injection in pre-filled pen
Romanian: PegIntron 120 micrograme pulbere şi solvent pentru soluţie injectabilă în stilou injector (pen) preumplut
English: Both active substances have been available in the European Union (EU) as separate preparations for a number of years.
Romanian: Ambele substanțe active sunt disponibile de mai mulți ani în Uniunea Europeană (UE) ca medicamente diferite.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Omidria on 28 July 2015.
Romanian: Comisia Europeană a acordat o autorizație de introducere pe piață pentru Omidria, valabilă pe întreg teritoriul Uniunii Europene, la 28 iulie 2015.
English: With regard to the safety of Omidria, the medicine was generally well tolerated.
Romanian: În ceea ce privește siguranța Omidria, medicamentul a fost, în general, bine tolerat.
English: The full EPAR and risk management plan summary for Omidria can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Romanian: EPAR-ul complet și rezumatul planului de management al riscurilor pentru Omidria sunt disponibile pe site-ul agenției: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Omidria
Romanian: Alte informații despre Omidria
English: This is a summary of the European public assessment report (EPAR) for Omidria.
Romanian: Prezentul document este un rezumat al Raportului public european de evaluare (EPAR) pentru Omidria.
English: Although the effect of Omidria on pain was modest, it was considered clinically important.
Romanian: Deși efectul Omidria asupra durerii a fost modest, a fost considerat important din punct de vedere clinic.
English: A risk management plan has been developed to ensure that Omidria is used as safely as possible.
Romanian: A fost elaborat un plan de management al riscurilor pentru ca Omidria să fie utilizat în cel mai sigur mod posibil.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Omidria are greater than its risks and recommended that it be approved for use in the EU.
Romanian: Comitetul pentru medicamente de uz uman (CHMP) al agenției a hotărât că beneficiile Omidria sunt mai mari decât riscurile asociate și a recomandat aprobarea utilizării sale în UE.
English: What measures are being taken to ensure the safe and effective use of Omidria?
Romanian: Ce măsuri se iau pentru utilizarea sigură și eficace a Omidria?
English: In both studies, the main measures of effectiveness were the change in diameter of the pupil by the end of the surgery, and how much eye pain patients felt soon after surgery, as indicated by the patient using a standard pain scale from 1 to 100.
Romanian: În ambele studii, indicatorii principali ai eficacității au fost schimbarea diametrului pupilei la sfârșitul operației și intensitatea durerii oculare resimțite de pacienți imediat după operație, așa cum a fost indicat de pacient folosind scala standard a durerii de la 1 la 100.
English: It is not intended to provide practical advice on how to use Omidria.
Romanian: Scopul documentului nu este să ofere recomandări practice referitoare la utilizarea Omidria.