FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/16/1124/028 1 pre-filled syringe EU/1/16/1124/029 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/030 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/050 12 pre-filled syringes (12 packs of 1)
Spanish: EU/1/16/1124/028 1 jeringa precargada EU/1/16/1124/029 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/030 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/050 12 jeringas pregargadas (12 cajas con 1)
English: 4 pre-filled pens (0.9 ml) with pre-assembled needle and 4 alcohol swabs.
Spanish: 4 plumas precargadas (0,9 ml) con aguja incorporada y 4 torundas impregnadas con alcohol.
English: EU/1/16/1124/037 1 pre-filled syringe EU/1/16/1124/038 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/039 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/053 12 pre-filled syringes (12 packs of 1)
Spanish: EU/1/16/1124/037 1 jeringa precargada EU/1/16/1124/038 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/039 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/053 12 jeringas precargadas (12 cajas con 1)
English: EU/1/16/1124/034 1 pre-filled syringe EU/1/16/1124/035 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/036 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/052 12 pre-filled syringes (12 packs of 1)
Spanish: EU/1/16/1124/034 1 jeringa precargada EU/1/16/1124/035 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/036 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/052 12 jeringas precargadas (12 packs cajas con 1)
English: 1 pre-filled pen (0.6 ml) with pre-assembled needle and 1 alcohol swab.
Spanish: 1 pluma precargada (0,6 ml) con aguja incorporada y 1 torunda impregnada con alcohol.
English: EU/1/16/1124/031 1 pre-filled syringe EU/1/16/1124/032 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/033 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/051 12 pre-filled syringes (12 packs of 1)
Spanish: EU/1/16/1124/031 1 jeringa precargada EU/1/16/1124/032 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/033 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/051 12 jeringas precargadas (12 cajas con 1)
English: 1 pre-filled pen (0.7 ml) with pre-assembled needle and 1 alcohol swab.
Spanish: 1 pluma precargada (0,7 ml) con aguja incorporada y 1 torunda impregnada con alcohol.
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)
Spanish: EU/1/16/1124/006 1 pluma precargada EU/1/16/1124/019 4 plumas precargadas (4 cajas con 1) EU/1/16/1124/020 6 plumas precargadas (6 cajas con 1) EU/1/16/1124/067 4 plumas precargadas (1 caja con 4) EU/1/16/1124/068 12 plumas precargadas (3 cajas con 4)
English: 4 pre-filled pens (0.8 ml) with pre-assembled needle and 4 alcohol swabs.
Spanish: 4 plumas precargadas (0,8 ml) con aguja incorporada y 4 torundas impregnadas con alcohol.
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)
Spanish: EU/1/16/1124/019 4 plumas precargadas (4 cajas con 1) EU/1/16/1124/020 6 plumas precargadas (6 cajas con 1) EU/1/16/1124/068 12 plumas precargadas (3 cajas con 4)
English: Nordimet 15 mg solution for injection in pre-filled pen EU/1/16/1124/004 - 1 pack EU/1/16/1124/015 - 4 pack (4 packs of 1) EU/1/16/1124/016 - 6 pack EU/1/16/1124/063 - 4 pack (1 pack of 4) EU/1/16/1124/064 - 12 pack
Spanish: Nordimet 15 mg solución inyectable en pluma precargada EU/1/16/1124/004 - 1 pluma precargada EU/1/16/1124/015 - 4 plumas precargadas (4 cajas con 1) EU/1/16/1124/016 - 6 plumas precargadas EU/1/16/1124/063 - 4 plumas precargadas (1 caja con 4) EU/1/16/1124/064 - 12 plumas precargadas
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)
Spanish: EU/1/16/1124/002 1 pluma precargada EU/1/16/1124/011 4 plumas precargadas (4 cajas con 1) EU/1/16/1124/012 6 plumas precargadas (6 cajas con 1) EU/1/16/1124/059 4 plumas precargadas (1 caja con 4) EU/1/16/1124/060 12 plumas precargadas (3 cajas con 4)
English: 4 pre-filled pens (0.6 ml) with pre-assembled needle and 4 alcohol swabs.
Spanish: 4 plumas precargadas (0,6 ml) con aguja incorporada y 4 torundas impregnadas con alcohol.
English: 1 pre-filled syringe (0.7 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Spanish: 1 jeringa precargada (0,7 ml) con aguja incorporada con protector de aguja y 2 torundas impregnadas con alcohol.
English: 1 pre-filled pen (0.8 ml) with pre-assembled needle and 1 alcohol swab.
Spanish: 1 pluma precargada (0,8 ml) con aguja incorporada y 1 torunda impregnada con alcohol.
English: EU/1/16/1124/043 1 pre-filled syringe 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)
Spanish: EU/1/16/1124/043 1 jeringa precargada EU/1/16/1124/044 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/045 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/055 12 jeringas precargadas (12 cajas con 1)
English: 4 pre-filled pens (0.7 ml) with pre-assembled needle and 4 alcohol swabs.
Spanish: 4 plumas precargadas (0,7 ml) con aguja incorporada y 4 torundas impregnadas con alcohol.
English: 1 pre-filled pen (0.4 ml) with pre-assembled needle and 1 alcohol swab.
Spanish: 1 pluma precargada (0,4 ml) con aguja incorporada y 1 torunda impregnada con alcohol.
English: 4 pre-filled pens (0.5 ml) with pre-assembled needle and 4 alcohol swabs.
Spanish: 4 plumas precargadas (0,5 ml) con aguja incorporada y torundas impregnadas con alcohol.
English: Not known: Epistaxis, pulmonary alveolar haemorrhage.
Spanish: No conocida: epistaxis, hemorragia alveolar pulmonar.
English: EU/1/16/1124/029 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/030 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/050 12 pre-filled syringes (12 packs of 1)
Spanish: EU/1/16/1124/029 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/030 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/050 12 jeringas precargadas (12 cajas con 1)
English: 1 pre-filled syringe (0.9 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Spanish: 1 jeringa precargada (0,9 ml) con aguja incorporada con protector de aguja y 2 torundas impregnadas con alcohol.
English: 1 pre-filled syringe (0.6 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Spanish: 1 jeringa precargada (0,6 ml) con aguja incorporada con protector de aguja y 2 torundas impregnadas con alcohol.
English: EU/1/16/1124/047 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/048 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/056 12 pre-filled syringes (12 packs of 1)
Spanish: EU/1/16/1124/047 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/048 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/056 12 jeringas precargadas (12 cajas con 1)
English: 1 pre-filled pen (0.3 ml) with pre-assembled needle and 1 alcohol swab.
Spanish: 1 pluma precargada (0,3 ml) con aguja incorporada y 1 torunda impregnada con alcohol.
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)
Spanish: EU/1/16/1124/040 1 jeringa precargada EU/1/16/1124/041 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/042 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/054 12 jeringas precargadas (12 cajas con 1)
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)
Spanish: EU/1/16/1124/013 4 plumas precargadas (4 cajas con 1) EU/1/16/1124/014 6 plumas precargadas (6 cajas con 1) EU/1/16/1124/062 12 plumas precargadas (3 cajas con 4)
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)
Spanish: EU/1/16/1124/011 4 plumas precargadas (4 cajas con 1) EU/1/16/1124/012 6 plumas precargadas (6 cajas con 1) EU/1/16/1124/060 12 plumas percargadas (3 cajas con 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)
Spanish: EU/1/16/1124/003 1 pluma precargada EU/1/16/1124/013 4 plumas precargadas (4 cajas con 1) EU/1/16/1124/014 6 plumas precargadas (6 cajas con 1) EU/1/16/1124/061 4 plumas precargadas (1 caja con 4) EU/1/16/1124/062 12 plumas precargadas (3 cajas con 4)
English: 1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Spanish: 1 jeringa precargada (0,4 ml) con aguja incorporada con protector de aguja y 2 torundas impregnadas con alcohol.
English: EU/1/16/1124/032 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/033 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/051 12 pre-filled syringes (12 packs of 1)
Spanish: EU/1/16/1124/032 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/033 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/051 12 jeringas precargadas (12 cajas con 1)
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)
Spanish: EU/1/16/1124/015 4 plumas precargadas (4 cajas con 1) EU/1/16/1124/016 6 plumas precargadas (6 cajas con 1) EU/1/16/1124/064 12 plumas precargadas (3 cajas con 4)
English: EU/1/16/1124/038 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/039 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/053 12 pre-filled syringes (12 packs of 1)
Spanish: EU/1/16/1124/038 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/039 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/053 12 jeringas precargadas (12 cajas con 1)
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)
Spanish: EU/1/16/1124/004 1 pluma precargada EU/1/16/1124/015 4 plumas precargadas (4 cajas con 1) EU/1/16/1124/016 6 plumas precargadas (6 cajas con 1) EU/1/16/1124/063 4 plumas precargadas (1 caja con 4) EU/1/16/1124/064 12 plumas precargadas (3 cajas con 4)
English: 4 pre-filled pens (0.4 ml) with pre-assembled needle and 4 alcohol swabs.
Spanish: 4 plumas precargadas (0,4 ml) con aguja incorporada y 4 torundas impregnadas con alcohol.
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)
Spanish: EU/1/16/1124/041 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/042 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/054 12 jeringas precargadas (12 cajas con 1)
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)
Spanish: EU/1/16/1124/044 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/045 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/055 12 jeringas precargadas (12 cajas con 1)
English: 1 pre-filled syringe (0.3 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Spanish: 1 jeringa precargada (0,3 ml) con aguja incorporada con protector de aguja y 2 torundas impregnadas con alcohol.
English: EU/1/16/1124/035 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/036 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/052 12 pre-filled syringes (12 packs of 1)
Spanish: EU/1/16/1124/035 4 jeringas precargadas (4 cajas con 1) EU/1/16/1124/036 6 jeringas precargadas (6 cajas con 1) EU/1/16/1124/052 12 jeringas precargadas (12 cajas con 1)
English: 4 pre-filled pens (0.3 ml) with pre-assembled needle and 4 alcohol swabs.
Spanish: 4 plumas precargadas (0,3 ml) con aguja incorporada y torundas impregnadas con alcohol.
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
Spanish: Nordimet 7,5 mg solución inyectable en jeringa precargada Nordimet 10 mg solución inyectable en jeringa precargada Nordimet 12,5 mg solución inyectable en jeringa precargada Nordimet 15 mg solución inyectable en jeringa precargada Nordimet 17,5 mg solución inyectable en jeringa precargada Nordimet 20 mg solución inyectable en jeringa precargada Nordimet 22,5 mg solución inyectable en jeringa precargada Nordimet 25 mg solución inyectable en jeringa precargada metotrexato
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 methotrexate
Spanish: Nordimet 7,5 mg solución inyectable en pluma precargada Nordimet 10 mg solución inyectable en pluma precargada Nordimet 12,5 mg solución inyectable en pluma precargada Nordimet 15 mg solución inyectable en pluma precargada Nordimet 17,5 mg solución inyectable en pluma precargada Nordimet 20 mg solución inyectable en pluma precargada Nordimet 22,5 mg solución inyectable en pluma precargada Nordimet 25 mg solución inyectable en pluma precargada metotrexato
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
Spanish: Nordimet 7,5 mg solución inyectable en jeringa precargada Nordimet 10 mg solución inyectable en jeringa precargada Nordimet 12,5 mg solución inyectable en jeringa precargada Nordimet 15 mg solución inyectable en jeringa precargada Nordimet 17,5 mg solución inyectable en jeringa precargada Nordimet 20 mg solución inyectable en jeringa precargada Nordimet 22,5 mg solución inyectable en jeringa precargada Nordimet 25 mg solución inyectable en jeringa precargada
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
Spanish: Nordimet 7,5 mg solución inyectable en pluma precargada Nordimet 10 mg solución inyectable en pluma precargada Nordimet 12,5 mg solución inyectable en pluma precargada Nordimet 15 mg solución inyectable en pluma precargada Nordimet 17,5 mg solución inyectable en pluma precargada Nordimet 20 mg solución inyectable en pluma precargada Nordimet 22,5 mg solución inyectable en pluma precargada Nordimet 25 mg solución inyectable en pluma precargada
English: 1 pre-filled syringe (0.8 ml) with pre-assembled needle and needle guard and 2 alcohol swabs.
Spanish: 1 jeringa precargada (0,8 ml) con aguja incorporada con protector de aguja y 2 torundas impregnadas con alcohol.
English: Uncommon: Pancytopenia.
Spanish: Poco frecuentes: pancitopenia
English: The capsule should be swallowed with water.”
Spanish: La cápsula debe tragarse con agua.”
English: “[Product name] can be taken immediately before, during a meal or up to one hour after a meal.
Spanish: “Puede tomarse [Nombre del producto] inmediatamente antes, durante la comida o hasta una hora después de la comida.
English: For Orlistat 60 mg capsules:
Spanish: Para Orlistat 120 mg cápsulas:
English: • “Hepatitis (inflammation of the liver).
Spanish: • “Hepatitis (inflamación del hígado).
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.”
Spanish: Los síntomas pueden incluir piel y ojos amarillentos, picores, orina de color oscuro,dolor de estómago e hígado sensible (indicado por dolor debajo de la parte delantera de la caja torácica, en el lado derecho), a veces con falta de apetito
English: Section 4.8 “Hepatitis that may be serious”
Spanish: “Hepatitis que puede ser grave”
English: “Other medicines and [Product name]”
Spanish: “Otros medicamentos y [Nombre del producto]”
English: SECTION 4 - POSSIBLE SIDE EFFECTS
Spanish: POSIBLES EFECTOS ADVERSOS
English: ANNEX III AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS AND PACKAGE LEAFLET
Spanish: MODIFICACIONES QUE DEBERÁN INCLUIRSE EN LAS SECCIONES RELEVANTES DEL RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO Y DEL PROSPECTO
English: • “oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
Spanish: • Nefropatía por oxalato (depósito de oxalato cálcico que puede dar lugar a piedras en el riñón).
English: See Chapter 2, take extra care with [Product name]”
Spanish: Ver la sección 2, tenga especial cuidado con [Nombre del producto].”
English: The following wording should be included in the package leaflet of the marketing authorisations to be varied, as relevant:
Spanish: Se debe incluir el siguiente texto en el prospecto de las autorizaciones de comercialización que se deban modificar, según proceda:
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).”
Spanish: Para Orlistat 60 mg cápsulas: “Acarbosa,(un medicamento andiabético utilizado para tratar la diabetes mellitus tipo 2) el uso de [Nombre del producto] no está recomendado en personas que están tomando acarbosa.”
English: SECTION 3 - HOW TO TAKE [PRODUCT NAME]
Spanish: CÓMO TOMAR [NOMBRE DEL PRODUCTO]
English: The following wording should be included in the SmPC of the marketing authorisations to be varied, as relevant:
Spanish: RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO (RCP) Se debe incluir el siguiente texto en el RCP de las autorizaciones de comercialización que se deban modificar, según proceda:
English: SECTION 2 - BEFORE YOU TAKE [PRODUCT NAME]
Spanish: ANTES DE TOMAR [NOMBRE DEL PRODUCTO]
English: • “- acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
Spanish: No se recomienda [Nombre del producto] para los que esten tomando acarbosa (fármaco antidiabético usado para la diabetes Tipo 2).
English: Strength Pharmaceutical Form Route of Administration Packaging
Spanish: Forma Farmaceutica
English: The European Commission issued a decision on 27 February 2017.
Spanish: La Comisión Europea adoptó una decisión el 27 de febrero de 2017.
English: What is gentamicin?
Spanish: ¿Qué es gentamicina?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 February 2017
Spanish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 de febrero de 2017
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/117)
Spanish: Resultado de un procedimiento de arbitraje conforme al artículo 35 de la Directiva 2001/82/CE (EMEA/V/A/117)
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.
Spanish: Bélgica señaló que en la Unión Europea se han aprobado diferentes períodos de espera para bovino y porcino para los medicamentos para uso veterinario que contienen gentamicina presentados en soluciones inyectables; por ejemplo, carne y despojos de bovino de 28 a 210 días; leche de bovino de 2 a 7 días, indicándose en algunos de los productos «no utilizar en vacas cuando la leche esté destinada a consumo humano»; y carne y despojos de porcino de 28 días a 150 días.
English: On 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs, due to concerns related to the withdrawal periods set for the aforementioned products.
Spanish: El 8 de enero de 2016, Bélgica inició un procedimiento en virtud del artículo 35 de la Directiva 2001/82/CE, relativo a los medicamentos para uso veterinario que contienen gentamicina presentados en soluciones inyectables para administración a bovino y porcino, debido a las dudas relacionadas con los tiempos de espera fijados para los citados productos.
English: The CVMP recommended that the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection should be varied in order to amend the product information accordingly.
Spanish: EL CVMP recomendó quel las autorizaciones de comercialización de los medicamentos veterinarios que contienen gentamicina presentados en soluciones inyectables se modificasen para corregir la información sobre el producto según corresponda.
English: On 10 November 2016, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) for veterinary medicinal products containing gentamicin presented as solutions for injection.
Spanish: El 10 de noviembre de 2016, la Agencia Europea de Medicamentos (la Agencia) llevó a cabo una revisión de la seguridad para los consumidores de los tiempos de espera para el ganado bovino (carne y leche) y porcino (carne y despojos) tratado con medicamentos veterinarios que contienen gentamicina presentados en soluciones inyectables.
English: Why were veterinary medicinal products containing gentamicin presented as solutions for injection reviewed?
Spanish: ¿Por qué se han revisado los medicamentos que contienen gentamicina presentados en soluciones inyectables?
English: Based on the evaluation of the currently available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing gentamicin presented as solutions for injection is positive and agreed that the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) should be amended to provide assurance for consumer safety and also agreed that the subcutaneous route should no longer be recommended for cattle and pigs since the depletion kinetics from the injection site remain unknown.
Spanish: Basándose en la evaluación de los datos disponibles en la actualidad, el CVMP concluyó que la relación beneficio/riesgo para los medicamentos veterinarios que contienen gentamicina presentados en soluciones inyectables es positiva y acordó que los tiempos de espera para el ganado bovino (carne y leche) y porcino (carne y despojos) debía modificarse para garantizar la seguridad de los consumidores, y consideró además que no debía recomendarse la vía subcutánea para el bovino y el porcino, dado que aún no se conoce la cinética de reducción en el lugar de inyección.