FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/16/1124/006 1 pre-filled pen EU/1/16/1124/019 4 pre-filled pens (4 packs of 1) EU/1/16/1124/020 6 pre-filled pens (6 packs of 1) EU/1/16/1124/067 4 pre-filled pens (1 pack of 4) EU/1/16/1124/068 12 pre-filled pens (3 packs of 4)
Romanian: EU/1/16/1124/006 1 stilou injector (pen) preumplut EU/1/16/1124/019 4 stilouri injector (pen) preumplute (4 cutii a 1) EU/1/16/1124/020 6 stilouri injector (pen) preumplute (6 cutii a 1) EU/1/16/1124/067 4 stilouri injector (pen) preumplute (1 cutie a 4) EU/1/16/1124/068 12 stilouri injector (pen) preumplute (3 cutii a 4)
English: Methotrexate can cause birth defects, harm unborn babies or cause miscarriages.
Romanian: Metotrexatul poate produce anomalii congenitale, poate să dăuneze fătului sau să producă avorturi.
English: 4 pre-filled pens (0.5 ml) with pre-assembled needle and 4 alcohol swabs.
Romanian: 4 stilouri injector (pen) preumplute (0,5 ml) cu ac pre-asamblat și 4 tampoane cu alcool.
English: EU/1/16/1124/002 1 pre-filled pen EU/1/16/1124/011 4 pre-filled pens (4 packs of 1) EU/1/16/1124/012 6 pre-filled pens (6 packs of 1) EU/1/16/1124/059 4 pre-filled pens (1 pack of 4) EU/1/16/1124/060 12 pre-filled pens (3 packs of 4)
Romanian: EU/1/16/1124/002 1 stilou injector (pen) preumplut EU/1/16/1124/011 4 stilouri injector (pen) preumplute (4 cutii a 1) EU/1/16/1124/012 6 stilouri injector (pen) preumplute (6 cutii a 1) EU/1/16/1124/059 4 stilorui injector (pen) preumplute (1 cutie a 4) EU/1/16/1124/060 12 stilouri injector (pen) preumplute (3 cutii a 4)
English: 1 pre-filled syringe (0.7 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: 1 stilou injector (pen) preumplut (0,7 ml) cu ac pre-asamblat și 1 tampon cu alcool Ambalaj multiplu: 4 (4 cutii a 1) stilouri injector (pen) preumplute (0,7 ml) cu ac pre-asamblat și tampoane cu alcool.
English: 4 pre-filled pens (0.8 ml) with pre-assembled needle and 4 alcohol swabs.
Romanian: 4 stilouri injector (pen) preumplute (0,8 ml) cu ac pre-asamblat și 4 tampoane cu alcool.
English: Nordimet 17.5 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 17.5 mg methotrexate in 0.7 mL
Romanian: Nordimet 17,5 mg soluţie injectabilă în seringă preumplută Fiecare seringă preumplută cu 0,7 ml soluție conține metotrexat 17,5 mg.
English: Do not breast-feed during treatment because methotrexate passes into breast milk.
Romanian: Metotrexatul trece în laptele matern, de aceea nu trebuie să alăptați pe parcursul tratamentului.
English: 4 pre-filled pens (0.3 ml) with pre-assembled needle and 4 alcohol swabs.
Romanian: 4 stilouri injector (pen) preumplute (0,3 ml) cu ac pre-asamblat și 4 tampoane cu alcool.
English: EU/1/16/1124/044 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/045 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/055 12 pre-filled syringes (12 packs of 1)
Romanian: EU/1/16/1124/044 4 seringi preumplute (4 cutii a 1) EU/1/16/1124/045 6 seringi preumplute (6 cutii a 1) EU/1/16/1124/055 12 seringi preumplute (12 cutii a 1)
English: EU/1/16/1124/019 4 pre-filled pens (4 packs of 1) EU/1/16/1124/020 6 pre-filled pens (6 packs of 1) EU/1/16/1124/068 12 pre-filled pens (3 packs of 4)
Romanian: EU/1/16/1124/019 4 stilouri injector (pen) preumplute (4 cutii a 1) EU/1/16/1124/020 6 stilouri injector (pen) preumplute (6 cutii a 1) EU/1/16/1124/068 12 stilouri injector (pen) preumplute (3 cutii a 4)
English: Nordimet 10 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 10 mg methotrexate in 0.4 mL
Romanian: Nordimet 10 mg soluţie injectabilă în seringă preumplută Fiecare seringă preumplută cu 0,4 ml soluție conține metotrexat 10 mg.
English: EU/1/16/1124/040 1 pre-filled syringe EU/1/16/1124/041 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/042 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/054 12 pre-filled syringes (12 packs of 1)
Romanian: EU/1/16/1124/040 1 seringă preumplută EU/1/16/1124/041 4 seringi preumplute (4 cutii a 1) EU/1/16/1124/042 6 seringi preumplute (6 cutii a 1) EU/1/16/1124/054 12 seringi preumplute (12 cutii a 1)
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 12 (12 cutii a 1) seringi preumplute (0,5 ml) cu ac pre-asamblat și tampoane cu alcool.
English: EU/1/16/1124/041 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/042 6 pre-filled syinges (6 packs of 1) EU/1/16/1124/054 12 pre-filled syringes (12 packs of 1)
Romanian: EU/1/16/1124/041 4 seringi preumplute (4 cutii a 1) EU/1/16/1124/042 6 seringi preumplute (6 cutii a 1) EU/1/16/1124/054 12 seringi preumplute (12 cutii a 1)
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 12 (12 cutii a 1) seringi preumplute (0,7 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Not known: Asthenia, injection site necrosis.
Romanian: Cu frecvență necunoscută: astenie, necroză la locul injectării.
English: EU/1/16/1124/015 4 pre-filled pens (4 packs of 1) EU/1/16/1124/016 6 pre-filled pens (6 packs of 1) EU/1/16/1124/064 12 pre-filled pens (3 packs of 4)
Romanian: EU/1/16/1124/015 4 stilouri injector (pen) preumplute (4 cutii a 1) EU/1/16/1124/016 6 stilouri injector (pen) preumplute (6 cutii a 1) EU/1/16/1124/064 12 stilouri injector (pen) preumplute (3 cutii a 4)
English: 1 pre-filled syringe (0.8 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: 1 stilou injector (pen) preumplut (0,8 ml) cu ac pre-asamblat și 1 tampon cu alcool Ambalaj multiplu : 4 (4 cutii a 1) stilouri injector (pen) preumplute (0,8 ml) cu ac pre-asamblat și tampoane cu alcool.
English: 1 pre-filled syringe (0.8 ml) with pre-assembled needle and needle guard and 2 alcohol swabs.
Romanian: 1 seringă preumplută (0,8 ml) cu ac pre-asamblat și teacă pentru protecția acului și 2 tampoane cu alcool.
English: Nordimet 12.5 mg solution for injection in pre-filled syringe EU/1/16/1124/031 - 1 pack
Romanian: Nordimet 12,5 mg soluţie injectabilă în seringă preumplută EU/1/16/1124/031 - 1 cutie
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 6 (6 cutii a 1) seringi preumplute (0,5 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 12 (12 cutii a 1) seringi preumplute (0,3 ml) cu ac pre-asamblat și tampoane cu alcool.
English: In patients with impaired renal function, concomitant administration of NSAIDs is not recommended.
Romanian: administrarea concomitentă a medicamentelor de tip AINS la pacienții cu afectarea funcției renale.
English: EU/1/16/1124/011 4 pre-filled pens (4 packs of 1) EU/1/16/1124/012 6 pre-filled pens (6 packs of 1) EU/1/16/1124/060 12 pre-filled pens (3 packs of 4)
Romanian: EU/1/16/1124/011 4 stilouri injector (pen) preumplute (4 cutii a 1) EU/1/16/1124/012 6 stilouri injector (pen) preumplute (6 cutii a 1) EU/1/16/1124/060 12 stilouri injector (pen) preumplute (3 cutii a 4)
English: EU/1/16/1124/003 1 pre-filled pen EU/1/16/1124/013 4 pre-filled pens (4 packs of 1) EU/1/16/1124/014 6 pre-filled pens (6 packs of 1) EU/1/16/1124/061 4 pre-filled pens (1 pack of 4) EU/1/16/1124/062 12 pre-filled pens (3 packs of 4)
Romanian: EU/1/16/1124/003 1 stilou injector (pen) preumplut EU/1/16/1124/013 4 stilouri injector (pen) preumplute (4 cutii a 1) EU/1/16/1124/014 6 stilouri injector (pen) preumplute (6 cutii a 1) EU/1/16/1124/061 4 stilouri injector (pen) preumplute (1 cutie a 4) EU/1/16/1124/062 12 stilouri injector (pen) preumplute (3 cutii a 4)
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 6 (6 cutii a 1) seringi preumplute (0,7 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Nordimet 7.5 mg solution for injection in pre-filled syringe Nordimet 10 mg solution for injection in pre-filled syringe Nordimet 12.5 mg solution for injection in pre-filled syringe Nordimet 15 mg solution for injection in pre-filled syringe Nordimet 17.5 mg solution for injection in pre-filled syringe Nordimet 20 mg solution for injection in pre-filled syringe Nordimet 22.5 mg solution for injection in pre-filled syringe Nordimet 25 mg solution for injection in pre-filled syringe methotrexate
Romanian: Nordimet 7,5 mg soluţie injectabilă în seringă preumplută Nordimet 10 mg soluţie injectabilă în seringă preumplută Nordimet 12,5 mg soluţie injectabilă în seringă preumplută Nordimet 15 mg soluţie injectabilă în seringă preumplută Nordimet 17,5 mg soluţie injectabilă în seringă preumplută Nordimet 20 mg soluţie injectabilă în seringă preumplută Nordimet 22,5 mg soluţie injectabilă în seringă preumplută Nordimet 25 mg soluţie injectabilă în seringă preumplută metotrexat
English: EU/1/16/1124/004 1 pre-filled pen EU/1/16/1124/015 4 pre-filled pens (4 packs of 1) EU/1/16/1124/016 6 pre-filled pens (6 packs of 1) EU/1/16/1124/063 4 pre-filled pens (1 pack of 4) EU/1/16/1124/064 12 pre-filled pens (3 packs of 4)
Romanian: EU/1/16/1124/004 1 stilou injector (pen) preumplut EU/1/16/1124/015 4 stilouri injector (pen) preumplute (4 cutii a 1) EU/1/16/1124/016 6 stilouri injector (pen) preumplute (6 cutii a 1) EU/1/16/1124/063 4 stilouri injector (pen) preumplute (1 cutie a 4) EU/1/16/1124/064 12 stilouri injector (pen) preumplute (3 cutii a 4)
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 6 (6 cutii a 1) seringi preumplute (0,3 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Nordimet 17.5 mg solution for injection in pre-filled pen methotrexate
Romanian: Nordimet 17,5 mg soluţie injectabilă în stilou injector (pen) preumplut metotrexat
English: Nordimet 7.5 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 7.5 mg methotrexate in 0.3 mL
Romanian: Nordimet 7,5 mg soluţie injectabilă în seringă preumplută Fiecare seringă preumplută cu 0,3 ml soluție conține metotrexat 7,5 mg.
English: 1 pre-filled syringe (1 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Romanian: 1 seringă preumplută (1 ml) cu ac pre-asamblat și teacă pentru protecția acului și 2 tampoane cu alcool.
English: Response to treatment can generally be expected after 2-6 weeks.
Romanian: De regulă, răspunsul la tratament se produce după 2-6 săptămâni.
English: 1 pre-filled pen (1 ml) with pre-assembled needle and 1 alcohol swab Multipack: 4 (4 packs of 1) pre-filled pens (1.0 ml) with pre-assembled needle and alcohol swabs Multipack: 4 (1 pack of 4) pre-filled pens (1.0 ml) with pre-assembled needle and alcohol swabs Multipack: 6 (6 packs of 1) pre-filled pens (1.0 ml) with pre-assembled needle and alcohol swabs Multipack: 12 (3 packs of 4) pre-filled pens (1.0 ml) with pre-assembled needle and alcohol swabs
Romanian: 1 stilou injector (pen) preumplut (1,0 ml) cu ac pre-asamblat și 1 tampon cu alcool Ambalaj multiplu: 4 (4 cutii a 1) stilouri injector (pen) preumplute (1,0 ml) cu ac pre-asamblat și tampoane cu alcool.
English: 4 pre-filled pens (0.4 ml) with pre-assembled needle and 4 alcohol swabs.
Romanian: 4 stilouri injector (pen) preumplute (0,4 ml) cu ac pre-asamblat și 4 tampoane cu alcool.
English: EU/1/16/1124/013 4 pre-filled pens (4 packs of 1) EU/1/16/1124/014 6 pre-filled pens (6 packs of 1) EU/1/16/1124/062 12 pre-filled pens (3 packs of 4)
Romanian: EU/1/16/1124/013 4 stilouri injector (pen) preumplute (4 cutii a 1) EU/1/16/1124/014 6 stilouri injector (pen) preumplute (6 cutii a 1) EU/1/16/1124/062 12 stilouri injector (pen) preumplute (3 cutii a 4)
English: 1 pre-filled syringe (0.3 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Romanian: 1 seringă preumplută (0,3 ml) cu ac pre-asamblat și teacă pentru protecția acului și 2 tampoane cu alcool.
English: 1 pre-filled syringe (0.6 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: 1 stilou injector (pen) preumplut (0,6 ml) cu ac pre-asamblat și 1 tampon cu alcool Ambalaj multiplu: 4 (4 cutii a 1) stilouri injector (pen) preumplute (0,6 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 12 (12 cutii a 1) seringi preumplute (0,6 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 12 (12 cutii a 1) seringi preumplute (0,4 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Nordimet 12.5 mg solution for injection in pre-filled pen methotrexate
Romanian: Nordimet 12,5 mg soluţie injectabilă în stilou injector (pen) preumplut metotrexat
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 6 (6 cutii a 1) seringi preumplute (0,4 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 6 (6 cutii a 1) seringi preumplute (0,8 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Nordimet 15 mg solution for injection in pre-filled syringe EU/1/16/1124/034 - 1 pack
Romanian: Nordimet 15 mg soluţie injectabilă în seringă preumplută EU/1/16/1124/034 - 1 cutie
English: Nordimet 10 mg solution for injection in pre-filled pen methotrexate
Romanian: Nordimet 10 mg soluţie injectabilă în stilou injector (pen) preumplut metotrexat
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 12 (12 cutii a 1) seringi preumplute (0,8 ml) cu ac pre-asamblat și tampoane cu alcool.
English: 1 pre-filled syringe (0.7 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Romanian: 1 seringă preumplută (0,7 ml) cu ac pre-asamblat și teacă pentru protecția acului și 2 tampoane cu alcool.
English: 1 pre-filled syringe (0.6 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Romanian: 1 seringă preumplută (0,6 ml) cu ac pre-asamblat și teacă pentru protecția acului și 2 tampoane cu alcool.
English: 1 pre-filled syringe (0.9 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Romanian: 1 seringă preumplută (0,9 ml) cu ac pre-asamblat și teacă pentru protecția acului și 2 tampoane cu alcool.
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: Ambalaj multiplu: 6 (6 cutii a 1) seringi preumplute (0,6 ml) cu ac pre-asamblat și tampoane cu alcool.
English: - If you have any further questions, ask your doctor or pharmacist.
Romanian: - Dacă aveţi orice întrebări suplimentare, adresaţi-vă medicului dumneavoastră sau farmacistului.
English: 1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Romanian: 1 stilou injector (pen) preumplut (0,4 ml) cu ac pre-asamblat și 1 tampon cu alcool Ambalaj multiplu: 4 (4 cutii a 1) stilouri injector (pen) preumplute (0,4 ml) cu ac pre-asamblat și tampoane cu alcool.
English: Therefore, theophylline blood levels should be monitored under concomitant methotrexate administration.
Romanian: Metotrexatul poate determina scăderea clearance-ului teofilinei, de aceea concentraţiile teofilinei trebuie monitorizate în cazul utilizării concomitente cu metotrexatul.
English: 1 pre-filled syringe (0.5 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Romanian: 1 seringă preumplută (0,5 ml) cu ac pre-asamblat și teacă pentru protecția acului și 2 tampoane cu alcool.
English: Nordimet 7.5 mg solution for injection in pre-filled pen methotrexate
Romanian: Nordimet 7,5 mg soluţie injectabilă în stilou injector (pen) preumplut metotrexat
English: Nordimet 25 mg solution for injection in pre-filled pen methotrexate
Romanian: Nordimet 25 mg soluţie injectabilă în stilou injector (pen) preumplut metotrexat
English: If you are not sure what to do, talk to your doctor or nurse immediately.
Romanian: Discutați imediat cu medicul sau cu asistenta medicală dacă nu sunteți sigur ce trebuie să faceți.
English: 1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Romanian: 1 seringă preumplută (0,4 ml) cu ac pre-asamblat și teacă pentru protecția acului și 2 tampoane cu alcool.
English: Nordimet 7.5 mg solution for injection in pre-filled pen Nordimet 10 mg solution for injection in pre-filled pen Nordimet 12.5 mg solution for injection in pre-filled pen Nordimet 15 mg solution for injection in pre-filled pen Nordimet 17.5 mg solution for injection in pre-filled pen Nordimet 20 mg solution for injection in pre-filled pen Nordimet 22.5 mg solution for injection in pre-filled pen Nordimet 25 mg solution for injection in pre-filled pen
Romanian: Nordimet 7,5 mg soluţie injectabilă în stilou injector (pen) preumplut Nordimet 10 mg soluţie injectabilă în stilou injector (pen) preumplut Nordimet 12,5 mg soluţie injectabilă în stilou injector (pen) preumplut Nordimet 15 mg soluţie injectabilă în stilou injector (pen) preumplut Nordimet 17,5 mg soluţie injectabilă în stilou injector (pen) preumplut Nordimet 20 mg soluţie injectabilă în stilou injector (pen) preumplut Nordimet 22,5 mg soluţie injectabilă în stilou injector (pen) preumplut Nordimet 25 mg soluţie injectabilă în stilou injector (pen) preumplut
English: Nordimet 15 mg solution for injection in pre-filled pen methotrexate
Romanian: Nordimet 15 mg soluţie injectabilă în stilou injector (pen) preumplut metotrexat
English: For Orlistat 60 mg capsules:
Romanian: Pentru Orlistat 60 mg capsule:
English: The capsule should be swallowed with water.”
Romanian: Capsula trebuie înghiţită cu apă.
English: [Product name] is not recommended for people taking acarbose.”
Romanian: [Denumirea produsului] nu este recomandat persoanelor care iau acarboză.
English: “[Product name] can be taken immediately before, during a meal or up to one hour after a meal.
Romanian: „[Denumirea produsului] poate fi luat imediat înainte de masă, în timpul mesei sau până la cel mult o oră după masă.
English: Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.”
Romanian: Simptomele pot include îngălbenirea pielii şi a globilor oculari, mâncărimi, urină închisă la culoare, dureri de stomac şi sensibilitate la nivelul ficatului (manifestată prin durere în partea dreaptă, în faţă, sub coaste), uneori cu pierderea poftei de mâncare.
English: • “Hepatitis (inflammation of the liver).
Romanian: • „Hepatită (inflamarea ficatului).
English: Section 4.8 “Hepatitis that may be serious”
Romanian: „Hepatită care poate fi gravă”
English: • “oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
Romanian: • Nefropatie oxalică (formarea de oxalat de calciu care poate conduce la formarea de pietre la rinichi).
English: ANNEX III AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS AND PACKAGE LEAFLET
Romanian: MODIFICĂRI CARE TREBUIE INCLUSE ÎN SEC IUNILE RELEVANTE ALE REZUMATULUI CARACTERISTICILOR PRODUSULUI I ALE PROSPECTULUI
English: “Other medicines and [Product name]”
Romanian: “[Denumirea produsului] împreună cu alte medicamente”
English: • “- acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
Romanian: • „Acarboză (medicament antidiabetic folosit pentru tratamentul diabetului zaharat de tip 2).
English: See Chapter 2, take extra care with [Product name]”
Romanian: Vezi capitolul 2 - Aveţi grijă deosebită când utilizaţi [Denumirea produsului].
English: SECTION 4 - POSSIBLE SIDE EFFECTS
Romanian: REACŢII ADVERSE POSIBILE
English: SECTION 2 - BEFORE YOU TAKE [PRODUCT NAME]
Romanian: ÎNAINTE SĂ LUAŢI [DENUMIREA PRODUSULUI]
English: For Orlistat 120 mg capsules: “[Product name] is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).”
Romanian: „[Denumirea produsului] nu este recomadat persoanelor care iau acarboză (un medicament antidiabetic utilizat pentru tratamentul diabetului zaharat de tip 2).
English: The following wording should be included in the package leaflet of the marketing authorisations to be varied, as relevant:
Romanian: Următoarea formulare trebuie inclusă în prospectul asociat autoriza iilor de punere pe pia ă care necesită modificare, dacă este cazul:
English: The following wording should be included in the SmPC of the marketing authorisations to be varied, as relevant:
Romanian: REZUMATUL CARACTERISTICILOR PRODUSULUI (RCP) Următoarea formulare trebuie inclusă în RCP-ul asociat autoriza iilor de punere pe pia ă care necesită modificare, dacă este cazul:
English: SECTION 3 - HOW TO TAKE [PRODUCT NAME]
Romanian: CUM SĂ LUAŢI [DENUMIREA PRODUSULUI]
English: The European Commission issued a decision on 27 February 2017.
Romanian: Comisia Europeană a emis o decizie la 27 februarie 2017.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 February 2017
Romanian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 februarie 2017
English: What is gentamicin?
Romanian: Ce este gentamicina?
English: It is normally used as the sulfate salt.
Romanian: Acesta se utilizează de obicei sub formă de sulfat.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/117)
Romanian: Rezultatul unei proceduri de sesizare inițiate în temeiul articolului 35 din Directiva 2001/82/CE (EMEA/V/A/117)
English: Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections.
Romanian: Gentamicina este un antibiotic aminoglicozid indicat în tratamentul unor infecții bacteriene diverse.
English: Belgium noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pig meat and offal from 28 days to 150 days.
Romanian: Belgia a remarcat faptul că, în cazul bovinelor și al porcinelor, în Uniunea Europeană există diferite perioade de așteptare aprobate pentru medicamentele de uz veterinar care conțin gentamicină prezentate sub formă de soluții injectabile, de exemplu: de la 28 la 210 zile pentru carnea și organele de vită; de la 2 la 7 zile pentru laptele de vacă, în cazul unora dintre medicamente menționându-se „a nu se utiliza la vacile al căror lapte este destinat consumului uman”; și de la 28 la 150 de zile pentru carnea și organele de porc.
English: Questions and answers on veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs EMA/144816/2017
Romanian: Întrebări și răspunsuri privind medicamentele de uz veterinar care conțin gentamicină prezentate sub formă de soluție injectabilă pentru administrarea la bovine și porcine EMA/144816/2017