FrancophonIA/ELRC3.0 huggingface dataset:
English: Telmisartan Teva Pharma 40 mg tablets Each tablet contains 40 mg telmisartan.
Spanish: Telmisartán Teva Pharma 40 mg comprimidos EFG Cada comprimido contiene 40 mg de telmisartán.
English: Telmisartan Teva Pharma 20 mg
Spanish: Telmisartán Teva Pharma 20 mg
English: Telmisartan Teva Pharma 80 mg
Spanish: Telmisartán Teva Pharma 80 mg
English: Each tablet contains 40 mg telmisartan
Spanish: Cada comprimido contiene 40 mg telmisartán
English: Telmisartan Teva Pharma 80 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Spanish: Telmisartán Teva Pharma 80 mg comprimidos son comprimidos blancos a blanquecinos, con forma ovalada; un lado del comprimido está grabado con el número “93”.
English: Package leaflet: Information for the user Telmisartan Teva Pharma 20 mg Tablets
Spanish: Prospecto: información para el usuario Telmisartán Teva Pharma 20 mg Comprimidos EFG
English: Package leaflet: Information for the user Telmisartan Teva Pharma 40 mg Tablets
Spanish: Prospecto: información para el usuario Telmisartán Teva Pharma 40 mg Comprimidos EFG
English: Telmisartan Teva Pharma 20 mg tablets Each tablet contains 20 mg telmisartan.
Spanish: Telmisartán Teva Pharma 20 mg comprimidos EFG Cada comprimido contiene 20 mg de telmisartán.
English: Metabolism and nutrition disorders Uncommon:
Spanish: Reacción anafiláctica, hipersensibilidad Trastornos del metabolismo y de la nutrición Poco frecuentes:
English: Telmisartan Teva Pharma 40 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Spanish: Telmisartán Teva Pharma 40 mg comprimidos son comprimidos blancos a blanquecinos, con forma ovalada; un lado del comprimido está grabado con el número “93”.
English: Telmisartan Teva Pharma 80 mg tablets Each tablet contains 80 mg telmisartan.
Spanish: Telmisartán Teva Pharma 80 mg comprimidos EFG Cada comprimido contiene 80 mg de telmisartán.
English: Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Spanish: Infecciones del tracto urinario, infecciones del tracto respiratorio superior (p. ej. dolor de garganta, sinusitis, resfriado común), disminución de glóbulos rojos (anemia), niveles elevados de potasio, dificultad para dormirse (insomnio), sentimiento de tristeza (depresión), desmayo (síncope), sensación de girar (vértigo), ritmo del corazón lento (bradicardia), presión arterial baja (hipotensión) en pacientes tratados para la tensión arterial elevada, dificultad para respirar, tos, dolor abdominal, diarrea, molestias en el abdomen, distensión del abdomen, vómitos, picor, aumento de la sudoración, dermatitis medicamentosa, dolor de espalda, calambres musculares, dolor muscular (mialgia), insuficiencia renal incluyendo fallo renal agudo, dolor en el pecho, síntomas de debilidad y niveles elevados de creatinina en sangre.
English: Carefully peel off the top paper layer
Spanish: Separe la capa superior del papel con cuidado 3.
English: Package leaflet: Information for the user Telmisartan Teva Pharma 80 mg Tablets
Spanish: Prospecto: información para el usuario Telmisartán Teva Pharma 80 mg Comprimidos EFG
English: Telmisartan Teva Pharma 20 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Spanish: Telmisartán Teva Pharma 20 mg comprimidos son comprimidos blancos a blanquecinos, con forma ovalada; un lado del comprimido está grabado con el número “93”.
English: Sepsis including fatal outcome1
Spanish: Sepsis incluyendo casos con desenlace mortal1 Trastornos de la sangre y del sistema linfático Poco frecuentes
English: Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan.
Spanish: Cada comprimido de Telmisartán Teva Pharma contiene 80 mg de telmisartán.
English: Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan.
Spanish: Cada comprimido de Telmisartán Teva Pharma contiene 40 mg de telmisartán.
English: Telmisartan Teva Pharma 40 mg tablets telmisartan
Spanish: Telmisartán Teva Pharma 40 mg tablets telmisartán
English: Each tablet contains 80 mg telmisartan
Spanish: Cada comprimido contiene 80 mg de telmisartán
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 30 tablets 28 tablets
Spanish: 14x1 comprimidos 28x1 comprimidos 30x1 comprimidos 40x1 comprimidos 56x1 comprimidos 60x1 comprimidos 84x1 comprimidos 90x1 comprimidos 98x1 comprimidos 100x1 comprimidos 30 comprimidos 28 comprimidos
English: How to store Telmisartan Teva Pharma
Spanish: Conservación de Telmisartán Teva Pharma
English: Telmisartan Teva Pharma 80 mg tablets telmisartan
Spanish: Telmisartán Teva Pharma 80 mg tablets telmisartán
English: Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.
Spanish: Cada comprimido de Telmisartán Teva Pharma contiene 20 mg de telmisartán.
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 28 tablets
Spanish: 14x1 comprimidos 28x1 comprimidos 30x1 comprimidos 40x1 comprimidos 56x1 comprimidos 60x1 comprimidos 84x1 comprimidos 90x1 comprimidos 98x1 comprimidos 100x1 comprimidos 28 comprimidos
English: Telmisartan Teva Pharma 20 mg tablets telmisartan
Spanish: Telmisartán Teva Pharma 20 mg comprimidos telmisartán
English: Each tablet contains 20 mg telmisartan
Spanish: Cada comprimido contiene 20 mg de telmisartán
English: Skin and subcutaneous tissue disorders Uncommon:
Spanish: Función hepática anormal/trastorno hepático3 Trastornos de la piel y del tejido subcutáneo Poco frecuentes:
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Spanish: Sepsis* (frecuentemente llamada “infección de la sangre”, es una infección grave que implica una reacción inflamatoria de todo el organismo y que puede producir la muerte), aumento de ciertas células blancas sanguíneas (eosinofilia), recuento de plaquetas bajo (trombocitopenia), reacción alérgica grave (reacción anafiláctica), reacción alérgica (p. ej. exantema, picor, dificultad para respirar, pitos, hinchazón de la cara o tensión arterial baja) niveles de azúcar en sangre bajos (en pacientes diabéticos), sensación de ansiedad, somnolencia, alteración de la visión, aumento del ritmo cardíaco (taquicardia), sequedad de boca, molestias de estómago, función hepática anormal (es más probable que los pacientes japoneses experimenten estos efectos adveros), hinchazón repentina de la piel y las mucosas que puede causar la muerte (angioedema incluyendo desenlace mortal), ronchas (urticaria), dermatitis medicamentosa severa, dolor en las articulaciones (artralgia), dolor en las extremidades, dolor en los tendones, enfermedad pseudogripal, descenso de la hemoglobina (una proteína de la sangre) aumento de los niveles sanguíneos de ácido úrico, aumento de las enzimas hepáticas o creatina fosfocinasa en sangre.
English: Pharma.
Spanish: Тел.
English: EU/1/11/719/041 14x1 tablets EU/1/11/719/042 28x1 tablets EU/1/11/719/043 30x1 tablets EU/1/11/719/044 40x1 tablets EU/1/11/719/045 56x1 tablets EU/1/11/719/046 60x1 tablets EU/1/11/719/047 84x1 tablets EU/1/11/719/048 90x1 tablets EU/1/11/719/049 98x1 tablets EU/1/11/719/050 100x1 tablets
Spanish: EU/1/11/719/041 14x1 comprimidos EU/1/11/719/042 28x1 comprimidos EU/1/11/719/043 30x1comprimidos EU/1/11/719/044 40x1 comprimidos EU/1/11/719/045 56x1 comprimidos EU/1/11/719/046 60x1 comprimidos EU/1/11/719/047 84x1 comprimidos EU/1/11/719/048 90x1 comprimidos EU/1/11/719/049 98x1 comprimidos EU/1/11/719/050 100x1 comprimidos
English: EU/1/11/719/001 14x1 tablets EU/1/11/719/002 28x1 tablets EU/1/11/719/003 30x1 tablets EU/1/11/719/004 40x1 tablets EU/1/11/719/005 56x1 tablets EU/1/11/719/006 60x1 tablets EU/1/11/719/007 84x1 tablets EU/1/11/719/008 90x1 tablets EU/1/11/719/009 98x1 tablets EU/1/11/719/010 100x1 tablets
Spanish: EU/1/11/719/001 14x1 comprimidos EU/1/11/719/002 28x1 comprimidos EU/1/11/719/003 30x1 comprimidos EU/1/11/719/004 40x1 comprimidos EU/1/11/719/005 56x1comprimidos EU/1/11/719/006 60x1 comprimidos EU/1/11/719/007 84x1 comprimidos EU/1/11/719/008 90x1 comprimidos EU/1/11/719/009 98x1 comprimidos EU/1/11/719/010 100x1 comprimidos
English: EU/1/11/719/031 14x1 tablets EU/1/11/719/032 28x1 tablets EU/1/11/719/033 30x1 tablets EU/1/11/719/034 40x1 tablets EU/1/11/719/035 56x1 tablets EU/1/11/719/036 60x1 tablets EU/1/11/719/037 84x1 tablets EU/1/11/719/038 90x1 tablets EU/1/11/719/039 98x1 tablets EU/1/11/719/040 100x1 tablets EU/1/11/719/061 30 tablets EU/1/11/719/064 28 tablets
Spanish: EU/1/11/719/031 14x1 comprimidos EU/1/11/719/032 28x1comprimidos EU/1/11/719/033 30x1 comprimidos EU/1/11/719/034 40x1 comprimidos EU/1/11/719/035 56x1 comprimidos EU/1/11/719/036 60x1 comprimidos EU/1/11/719/037 84x1 comprimidos EU/1/11/719/038 90x1 comprimidos EU/1/11/719/039 98x1 comprimidos EU/1/11/719/040 100x1 comprimidos EU/1/11/719/061 30 comprimidos EU/1/11/719/064 28 comprimidos
English: EU/1/11/719/021 14x1 tablets EU/1/11/719/022 28x1 tablets EU/1/11/719/023 30x1 tablets EU/1/11/719/024 40x1 tablets EU/1/11/719/025 56x1 tablets EU/1/11/719/026 60x1 tablets EU/1/11/719/027 84x1 tablets EU/1/11/719/028 90x1 tablets EU/1/11/719/029 98x1 tablets EU/1/11/719/030 100x1 tablets
Spanish: EU/1/11/719/021 14x1 comprimidos EU/1/11/719/022 28x1 comprimidos EU/1/11/719/023 30x1 comprimidos EU/1/11/719/024 40x1 comprimidos EU/1/11/719/025 56x1 comprimidos EU/1/11/719/026 60x1 comprimidos EU/1/11/719/027 84x1 comprimidos EU/1/11/719/028 90x1 comprimidos EU/1/11/719/029 98x1 comprimidos EU/1/11/719/030 100x1 comprimidos
English: EU/1/11/719/051 14x1 tablets EU/1/11/719/052 28x1 tablets EU/1/11/719/053 30x1 tablets EU/1/11/719/054 40x1 tablets EU/1/11/719/055 56x1 tablets EU/1/11/719/056 60x1 tablets EU/1/11/719/057 84x1 tablets EU/1/11/719/058 90x1 tablets EU/1/11/719/059 98x1 tablets EU/1/11/719/060 100x1 tablets EU/1/11/719/062 30 tablets EU/1/11/719/065 28 tablets
Spanish: EU/1/11/719/051 14x1 comprimidos EU/1/11/719/052 28x1 comprimidos EU/1/11/719/053 30x1 comprimidos EU/1/11/719/054 40x1 comprimidos EU/1/11/719/055 56x1 comprimidos EU/1/11/719/056 60x1 comprimidos EU/1/11/719/057 84x1 comprimidos EU/1/11/719/058 90x1 comprimidos EU/1/11/719/059 98x1 comprimidos EU/1/11/719/060 100x1 comprimidos EU/1/11/719/062 30 comprimidos EU/1/11/719/065 28 comprimidos
English: Nervous system disorders
Spanish: Trastornos del sistema nervioso Poco frecuentes:
English: Telmisartan Teva Pharma 40 mg tablets
Spanish: Telmisartán Teva Pharma 40 mg comprimidos EFG
English: EU/1/11/719/011 Cartons of 14x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/012 Cartons of 28x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/013 Cartons of 30x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/014 Cartons of 40x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/015 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/016 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/017 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/018 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/019 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/020 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/063 Carton of 28 tablets in aluminium-aluminium blisters
Spanish: EU/1/11/719/029 Cajas de 98x1 comprimidos en blisters de aluminio-aluminio pelables de dosis unitarias perforados EU/1/11/719/030 Cajas de 100x1 comprimidos en blisters de aluminio-aluminio pelables de dosis unitarias perforados EU/1/11/719/031 Cajas de 14x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/032 Cajas de 28x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/033 Cajas de 30x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/034 Cajas de 40x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/035 Cajas de 56x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/036 Cajas de 60x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/037 Cajas de 84x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/038 Cajas de 90x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/039 Cajas de 98x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/040 Cajas de 100x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/061 Caja de 30 comprimidos en blister aluminio-aluminio EU/1/11/719/064 Caja de 28 comprimidos en blister aluminio-aluminio
English: Telmisartan Teva Pharma 20 mg tablets
Spanish: Telmisartán Teva Pharma 20 mg comprimidos EFG
English: Telmisartan Teva Pharma 40 mg tablets EU/1/11/719/021 Cartons of 14x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/022 Cartons of 28x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/023 Cartons of 30x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/024 Cartons of 40x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/025 Cartons of 56x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/026 Cartons of 60x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/027 Cartons of 84x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/028 Cartons of 90x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/029 Cartons of 98x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/030 Cartons of 100x1 tablets in peelable perforated unit-dose aluminiumaluminium blisters EU/1/11/719/031 Cartons of 14x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/032 Cartons of 28x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/033 Cartons of 30x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/034 Cartons of 40x1 tablets in perforated unit-dose aluminium-aluminium blisters
Spanish: EU/1/11/719/004 Cajas de 40x1 comprimidos en blisters de aluminio-aluminio pelables de dosis unitarias perforados EU/1/11/719/005 Cajas de 56x1 comprimidos en blisters de aluminio-aluminio pelables de dosis unitarias perforados EU/1/11/719/006 Cajas de 60x1 comprimidos en blisters de aluminio-aluminio pelables de dosis unitarias perforados EU/1/11/719/007 Cajas de 84x1 comprimidos en blisters de aluminio-aluminio pelables de dosis unitarias perforados EU/1/11/719/008 Cajas de 90x1 comprimidos en blisters de aluminio-aluminio pelables de dosis unitarias perforados EU/1/11/719/009 Cajas de 98x1 comprimidos en blisters de aluminio-aluminio pelables de dosis unitarias perforados EU/1/11/719/010 Cajas de 100x1 comprimidos en blisters de aluminio-aluminio pelables de dosis unitarias perforados EU/1/11/719/011 Cajas de 14x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/012 Cajas de 28x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/013 Cajas de 30x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/014 Cajas de 40x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/015 Cajas de 56x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/016 Cajas de 60x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/017 Cajas de 84x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/018 Cajas de 90x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados EU/1/11/719/019 Cajas de 98x1 comprimidos en blisters de aluminio-aluminio de dosis unitarias perforados
English: EU/1/11/719/011 14x1 tablets EU/1/11/719/012 28x1 tablets EU/1/11/719/013 30x1 tablets EU/1/11/719/014 40x1 tablets EU/1/11/719/015 56x1 tablets EU/1/11/719/016 60x1 tablets EU/1/11/719/017 84x1 tablets EU/1/11/719/018 90x1 tablets EU/1/11/719/019 98x1 tablets EU/1/11/719/020 100x1 tablets EU/1/11/719/063 28 tablets
Spanish: EU/1/11/719/011 14x1 comprimidos EU/1/11/719/012 28x1 comprimidos EU/1/11/719/013 30x1 comprimidos EU/1/11/719/014 40x1 comprimidos EU/1/11/719/015 56x1 comprimidos EU/1/11/719/016 60x1 comprimidos EU/1/11/719/017 84x1 comprimidos EU/1/11/719/018 90x1 comprimidos EU/1/11/719/019 98x1 comprimidos EU/1/11/719/020 100x1 comprimidos EU/1/11/719/063 28 comprimidos
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death
Spanish: Sepsis* (frecuentemente llamada “infección de la sangre”, es una infección grave que implica una reacción inflamatoria de todo el organismo y que puede producir la muerte), aumento de ciertas células blancas sanguíneas (eosinofilia), recuento de plaquetas bajo (trombocitopenia), reacción alérgica grave (reacción anafiláctica), reacción alérgica (p. ej. Exantema, picor, dificultad para respirar, pitos, hinchazón de la cara o tensión arterial baja), niveles de azúcar en sangre bajos (en pacientes diabéticos), sensación de ansiedad, somnolencia, alteración de la visión, aumento del ritmo cardíaco (taquicardia), sequedad de boca, molestias de estómago, función hepática anormal (es más probable que los pacientes japoneses experimenten estos efectos adversos), hinchazón repentina de la piel y las mucosas que puede causar la muerte (angioedema incluyendo desenlace mortal), ronchas (urticaria), dermatitis medicamentosa severa, dolor en las articulaciones (artralgia), dolor en las extremidades, dolor en los tendones, enfermedad pseudogripal, descenso de la hemoglobina (una proteína de la sangre) aumento de los niveles sanguíneos de ácido úrico, aumento de las enzimas hepáticas o creatina fosfocinasa en sangre.
English: Telmisartan Teva Pharma 80 mg tablets
Spanish: Telmisartán Teva Pharma 80 mg comprimidos EFG
English: Strength Pharmaceutical Form Route of Administration Packaging
Spanish: Vía de administración
English: Member State (EU/EEA)
Spanish: Estado miembro (UE/EEE)
English: For the mutual recognition procedure (MRP), Hungary acted as a reference Member State and Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom were concerned Member States.
Spanish: En el procedimiento de reconocimiento mutuo, Hungría actuó como Estado Miembro de referencia y Alemania, Austria, Bélgica, Bulgaria, Chipre, Croacia, Eslovaquia, Eslovenia, Estonia, Finlandia, Grecia, Irlanda, Islandia, Italia, Letonia, Lituania, Países Bajos, Polonia, Portugal, República Checa, Reino Unido, Rumanía y Suecia como Estados miembros concernidos.
English: Add the following text in the relevant sections of the product information:
Spanish: Añadir el texto siguiente en las secciones relevantes de la información del producto:
English: Duration of immunity
Spanish: Duración de la inmunidad
English: Efficacy of the vaccine under practical conditions of use
Spanish: Eficacia de la vacuna en las condiciones prácticas de utilización
English: Furthermore, the formulation of the finished product, either in terms of antigen content or of additional components, was questioned.
Spanish: Además, se cuestionó la formulación del producto acabado, ya fuera en términos de contenido en antígenos o de componentes adicionales.
English: Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%.
Spanish: En concreto, el valor de p es inferior a 0,0001, lo que significa que la probabilidad de una falsa correlación positiva es menor del 0,01 %.
English: The total quantity is 20 x 109 inactivated germs per dose.
Spanish: La cantidad total es 20 x 109 gérmenes inactivados por dosis.
English: Furthermore, it was confirmed that standardisation of variables was applied.
Spanish: Además, se confirmó que se había aplicado el ajuste de variables.
English: Quality and safety were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Spanish: La calidad y la seguridad no se evaluaron en este procedimiento de arbitraje, ya que el Estado miembro de referencia no notificó ningún problema al respecto.
English: Tiendweg 8 c, 2670 AB Naaldwijk The Netherlands
Spanish: Tiendweg 8 c, 2670 AB Naaldwijk Países Bajos
English: The vaccination schedule is 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.
Spanish: La pauta de vacunación es de 2 dosis administradas a los animales a partir de las 7 semanas de edad, con un intervalo de 3 semanas entre las dosis.
English: It is also considered that the indication is acceptable taking account of the intended use of the vaccine and the existing data from the laboratory studies.
Spanish: También se ha considerado que la indicación es aceptable teniendo en cuenta el uso previsto de la vacuna y los datos existentes de los estudios de laboratorio.
English: These batches had been tested according to the requirements when the product was first authorised in Hungary.
Spanish: Los lotes se sometieron a ensayo conforme a los requisitos cuando el producto se autorizó por primera vez en Hungría.
English: 17455 ALIMOS Greece
Spanish: 17455 ALIMOS Grecia