FrancophonIA/ELRC3.0 huggingface dataset:
English: Monthly administration of the product prevents establishment of infection with adult Thelazia callipaeda eyeworm.
Spanish: La administración mensual del producto previene el establecimiento de la infección del gusano ocular adulto Thelazia callipaeda.
English: Dogs living in heartworm endemic areas (where heartworm disease is present), or those which have travelled to endemic areas, may be infested with adult heartworms.
Spanish: Los perros que vivan en áreas endémicas de la dirofilaria (donde la dirofilariosis esté presente), o aquéllos que hayan viajado a áreas endémicas, pueden estar infestados por dirofilarias adultas.
English: 1 chewable tablet 3 chewable tablets 6 chewable tablets 15 chewable tablets
Spanish: 1 comprimido masticable 3 comprimidos masticables 6 comprimidos masticables 15 comprimidos masticables
English: It is therefore recommended that all dogs 8 months of age or more, living in heartworm endemic areas, should be tested for existing adult heartworm infestation before being treated with the product for heartworm prevention.
Spanish: Por lo tanto, se recomienda que en todos los perros de 8 meses de edad o mayores que vivan en áreas endémicas de dirofilaria, se realice un test para comprobar la existencia de infestación por dirofilaria adulta antes de ser tratados con el medicamento para la prevención de la dirofilaria.
English: Afoxolaner: Afoxolaner is an insecticide and acaricide of the isoxazoline family.
Spanish: Afoxolaner: El afoxolaner es un insecticida y acaricida que pertenece a la familia de las isoxazolinas.
English: Milbemycin oxime increases glutamate binding with consequent enhanced chloride ion flow into the cell.
Spanish: La milbemicina oxima incrementa la unión de glutamato, aumentando consecuentemente el flujo de iones cloruro hacia la célula.
English: Manufacturer responsible for batch release: MERIAL,
Spanish: Fabricante responsable de la liberación del lote: MERIAL
English: Fleas and ticks need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of vector-borne diseases cannot be excluded.
Spanish: Las pulgas y garrapatas necesitan comenzar a alimentarse una vez adheridas al hospedador para quedar expuestas al afoxolaner; por lo tanto, no puede descartarse el riesgo de transmisión de enfermedades transmitidas por vectores.
English: NEXGARD SPECTRA can be used as part of the seasonal treatment of fleas and ticks (replacing a product authorised for the treatment of fleas/ticks only) in dogs with diagnosed concurrent gastrointestinal worm infestations.
Spanish: NEXGARD SPECTRA puede usarse como parte del tratamiento estacional de pulgas y garrapatas (reemplazando a un medicamento autorizado para el tratamiento de pulgas y garrapatas solamente) en perros en los que a la vez se han diagnosticado infestaciones por gusanos gastrointestinales.
English: Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks.
Spanish: Tratamiento de infestaciones por pulgas (Ctenocephalides felis y C. canis) en perros durante 5 semanas.
English: Prevention of angiostrongylosis:
Spanish: Prevención de angiostrongilosis:
English: Vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed.
Spanish: Vómitos, diarrea, letargia, anorexia y prurito, se observaron infrecuentemente.
English: Fleas and ticks need to start feeding on the host to become exposed to the substance afoxolaner; therefore the risk of the transmission of diseases by fleas and ticks cannot be excluded.
Spanish: Las pulgas y las garrapatas necesitan empezar a alimentarse una vez adheridas al hospedador para quedar expuestas a la sustancia afoxolaner; por lo tanto, no puede descartarse el riesgo de transmisión de enfermedades por pulgas y garrapatas.
English: Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration.
Spanish: Prevención de angiostrongilosis (por reducción del nivel de infección con etapas de adulto inmaduro (L5) y adulto de Angiostrongylus vasorum) con administración mensual.
English: Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs.
Spanish: Tratamiento de infestaciones por pulgas (Ctenocephalides felis y C. canis) en perros.
English: Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.
Spanish: Prevención del establecimiento de thelaziosis (infección del gusano ocular adulto Thelazia callipaeda) con administración mensual.
English: Macrogol 15 hydroxystearate Glycerol (E422) Triglycerides, medium-chain Citric acid monohydrate (E330) Butylhydroxytoluene (E321)
Spanish: Triglicéridos de cadena media Ácido cítrico monohidrato (E330) Butilhidroxitolueno (E321)
English: Treatment of flea and tick infestations and gastrointestinal worms:
Spanish: Tratamiento de infestaciones de pulga y garrapata y gusanos gastrointestinales:
English: Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks.
Spanish: Tratamiento de infestaciones por garrapatas (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) en perros durante 4 semanas.
English: Dogs 2-3.5 kg Dogs >3.5-7.5 kg Dogs >7.5-15 kg Dogs >15-30 kg Dogs >30-60 kg
Spanish: Perros 2-3,5 kg Perros >3,5-7,5 kg Perros >7,5-15 kg Perros >15-30 kg Perros >30-60 kg
English: Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration.
Spanish: Prevención de la dirofilariosis (larvas de Dirofilaria immitis) con administración mensual.
English: Each chewable tablet contains 9.375 mg afoxolaner and 1.875 mg milbemycin oxime Each chewable tablet contains 18.75 mg afoxolaner and 3.75 mg milbemycin oxime Each chewable tablet contains 37.5 mg afoxolaner and 7.5 mg milbemycin oxime Each chewable tablet contains 75 mg afoxolaner and 15 mg milbemycin oxime Each chewable tablet contains 150 mg afoxolaner and 30 mg milbemycin oxime
Spanish: Cada comprimido masticable contiene 9,375 mg de afoxolaner y 1,875 mg de milbemicina oxima Cada comprimido masticable contiene 18,75 mg de afoxolaner y 3,75 mg de milbemicina oxima Cada comprimido masticable contiene 37,5 mg de afoxolaner y 7,5 mg de milbemicina oxima Cada comprimido masticable contiene 75 mg de afoxolaner y 15 mg de milbemicina oxima Cada comprimido masticable contiene 150 mg de afoxolaner y 30 mg de milbemicina oxima
English: Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs.
Spanish: Tratamiento de infestaciones por garrapatas (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) en perros.
English: Each chewable tablet contains the active substances:
Spanish: Cada comprimido masticable contiene las sustancias activas: NEXGARD SPECTRA
English: It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis.
Spanish: Es activo frente a pulgas adultas, así como también frente a varias especies de garrapatas tales como Rhipicephalus sanguineus, Dermacentor reticulatus y D. variabilis, Ixodes ricinus e I. scapularis, Amblyomma americanum y Haemaphysalis longicornis.
English: It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus, Ixodes hexagonus and I. scapularis, Amblyomma americanum and Haemaphysalis longicornis.
Spanish: Es activo frente a pulgas adultas así como también frente a varias especies de garrapatas tales como Rhipicephalus sanguineus, Dermacentor reticulatus y D.variabilis, Ixodes ricinus, Ixodes hexagonus e I. scapularis, Amblyomma americanum, y Haemaphysalis longicornis.
English: Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis).
Spanish: Tratamiento de las infestaciones por nematodos gastrointestinales adultos de las siguientes especies: ascáridos (Toxocara canis y Toxascaris leonina), anquilostomas (Ancylostoma caninum, Ancylostoma braziliense y Ancylostoma ceylanicum) y tricúridos (Trichuris vulpis).
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-3.5 kg) or rectangular shaped (tablets for dogs >3.5-7.5 kg, tablets for dogs >7.5-15 kg, tablets for dogs >15-30 kg and tablets for dogs >30-60 kg).
Spanish: Comprimidos moteados de color rojo a marrón rojizo, circulares (comprimidos para perros 2-3,5 kg) o rectangulares (comprimidos para perros >3,5-7,5 kg, comprimidos para perros > 7,5-15 kg, comprimidos para perros >15-30 kg y comprimidos para perros >30-60 kg).
English: In regions where heartworm disease is present, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA.
Spanish: En regiones donde esté presente la dirofilariosis, se debería realizar un control en los perros previo a la administración de NEXGARD SPECTRA para comprobar si ha habido infestación por dirofilaria.
English: In heartworm endemic areas, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA.
Spanish: En áreas endémicas de dirofilaria, se debería realizar un control en los perros previo a la administración de NEXGARD SPECTRA para comprobar si ha habido infestación por dirofilaria.
English: Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).
Spanish: Milbemicina oxima es activa frente a varios gusanos gastrointestinales (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), adultos y adultos inmaduros (L5) del verme pulmonar Angiostrongylus vasorum y dirofilaria (larva Dirofilaria immitis).
English: For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal nematode infestations is indicated.
Spanish: Para el tratamiento de las infestaciones por pulgas y garrapatas en perros cuando esté indicado a la vez la prevención de la dirofilariosis (larva Dirofilaria immitis), angiostrongilosis (reducción del nivel de adultos inmaduros (L5) y adultos de Angiostrongylus vasorum), thelaziosis (adultos de Thelazia callipaeda) y/o el tratamiento de infestaciones por nematodos gastrointestinales.
English: For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal worm infestations is indicated.
Spanish: Para el tratamiento de infestaciones por pulgas y garrapatas en perros cuando esté indicado a la vez la prevención de la dirofilariosis (larva Dirofilaria immitis), angiostrongilosis (reducción del nivel de adultos inmaduros (L5) y adultos de Angiostrongylus vasorum), thelaziosis (adultos de Thelazia callipaeda) y/o el tratamiento de infestaciones por gusanos gastrointestinales.
English: It is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and larvae of the heartworm Dirofilaria immitis.
Spanish: Es activo frente a varios gusanos gastrointestinales (tales como: Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), adultos y adultos inmaduros (L5) del verme pulmonar Angiostrongylus vasorum y larva de la dirofilaria Dirofilaria immitis.
English: NEXGARD SPECTRA can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a monovalent flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infestations.
Spanish: Tratamiento de infestaciones de pulga y garrapata y nematodos gastrointestinales: NEXGARD SPECTRA puede usarse como parte del tratamiento estacional de pulgas y garrapatas (reemplazando el tratamiento con un medicamento monovalente contra pulgas y garrapatas) en perros en los que a la vez se han diagnosticado infestaciones por nematodos gastrointestinales.
English: Monthly administration of the product for two consecutive months.
Spanish: Administración mensual del producto hasta que se obtenga dos raspados negativos de la piel con un mes de diferencia.
English: NEXGARD SPECTRA 9 mg/ 2 mg dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg dogs >30-60 kg afoxolaner / milbemycin oxime Tablets
Spanish: NEXGARD SPECTRA 9 mg/ 2 mg perros 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg perros >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg perros >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg perros >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg perros >30-60 kg afoxolaner / milbemycin oxime Comprimidos
English: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg
Spanish: NEXGARD SPECTRA 9 mg/ 2 mg comprimidos masticables para perros 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg comprimidos masticables para perros >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg comprimidos masticables para perros >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg comprimidos masticables para perros >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg comprimidos masticables para perros >30-60 kg
English: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg Afoxolaner, milbemycin oxime
Spanish: NEXGARD SPECTRA 9 mg/ 2 mg comprimidos masticables para perros 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg comprimidos masticables para perros >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg comprimidos masticables para perros >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg comprimidos masticables para perros >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg comprimidos masticables para perros >30-60 kg afoxolaner, milbemicina oxima
English: NEXGARD SPECTRA 9 mg/ 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg chewable tablets for dogs >30-60 kg afoxolaner / milbemycin oxime
Spanish: NEXGARD SPECTRA 9 mg/ 2 mg comprimidos masticables para perros 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg comprimidos masticables para perros >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg comprimidos masticables para perros >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg comprimidos masticables para perros >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg comprimidos masticables para perros >30-60 kg afoxolaner / milbemicina oxima
English: Prevention of heartworm disease:
Spanish: Prevención de dirofilariosis:
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Spanish: ANEXO I RELACIÓN DE LOS NOMBRES DEL MEDICAMENTO, FORMAS FARMACÉUTICAS, DOSIS, VÍA DE ADMINISTRACIÓN Y TITULARES DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN EN LOS ESTADOS MIEMBROS
English: United Kingdom GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
Spanish: GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
English: Intramuscular Use
Spanish: Vía intramuscular
English: CENTRAFARM SERVICES B.V.; Nieuwe Donk 9; 4879 AC ETTENLEUR/NL, Netherlands
Spanish: ; Nieuwe Donk 9; 4879 AC ETTENLEUR/NL, Netherlands
English: MEDA PHARMA B.V. Krijgsman 20, 1186 DM AMSTELVEEN/NL, Netherlands
Spanish: Krijgsman 20, 1186 DM AMSTELVEEN/NL, Netherlands
English: Novartis Farma S.P.A. Largo Umberto Boccioni 1 21040 Origgio Varese, Italy
Spanish: Largo Umberto Boccioni 1 21040 Origgio Varese, Italy
English: Bromocriptine containing medicinal products with Marketing Authorisation in the European Union
Spanish: Medicamentos que contienen bromocriptina con autorización de comercialización en la Unión Europea
English: Meda Pharma S.A. - N.V. Chaussee de la Hulpe 166 - B-1170 Brussels
Spanish: Chaussee de la Hulpe 166 - B-1170 Brussels
English: Gastro-Resistant Tablet
Spanish: Comprimido gastroresistente
English: 0,3 mg/1 m Solution for Injection Intravenous use
Spanish: 0,3 mg/1 m Solución inyectable
English: Dihydroergocryptine containing medicinal products with Marketing Authorisation in the European Union
Spanish: Medicamentos que contienen dihidroergocriptina con autorización de comercialización en la Unión Europea
English: Member State
Spanish: Paises Miembros
English: Powder for Injection
Spanish: Polvo para solución inyectable
English: Prolonged-Release Tablet
Spanish: Comprimido de liberación prolongada
English: Czech Republic MEDA PHARMA s.r.o., Záhřebská, 577, 120 00, Praha 2, Czech Republic
Spanish: República Checa MEDA PHARMA s.r.o., Záhřebská, 577, 120 00, Praha 2, Czech Republic
English: Czech Republic POLICHEM S.A. 50, Val Fleuri, L-1526, Luxembourg
Spanish: República Checa POLICHEM S.A. 50, Val Fleuri, L-1526, Luxembourg
English: Lisuride containing medicinal products with Marketing Authorisation in the European Union
Spanish: Medicamentos que contienen lisurida con autorización de comercialización en la Unión Europea
English: Oral Drops
Spanish: Gotas orales
English: Prolonged-Release Capsule, hard
Spanish: Cápsula dura de liberación prolongada
English: Film-coated Tablet
Spanish: Comprimido recubierto con película
English: Effervescent Tablet
Spanish: Comprimido efervescente
English: Solution for Injection Oral Use
Spanish: Solución inyectable
English: <Content (concentration)>
Spanish: Contenido (concentración)
English: 3 pre-filled syringes + 3 needles
Spanish: 3 ml (10 mg/ml) 3 jeringas precargadas + 3 agujas
English: 1 pre-filled syringe + 1 needle
Spanish: 3 ml (10 mg/ml) 1 jeringa precargada + 1 aguja
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Spanish: Denominación ( de fantasía)
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Spanish: EU/2/99/011/001 Locatim >2.8log10 /ml lactosuero bovino concentrado
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Spanish: Forma farmacéutica Especies a las que va destinado el medicamento
English: Locatim is given to calves less than 12 hours old, preferably within the first four hours after birth, as a supplement to natural colostrum (first milk) that the calves receive from their mother.
Spanish: Terneros recién nacidos de menos de 12 horas de vida
English: The withdrawal period is zero days.
Spanish: 1 Frasco Cero días
English: Locatim is presented in a 60 ml glass bottle.
Spanish: 60 ml
English: European Medicines Agency Veterinary Medicines
Spanish: Vía de administración
English: This document is a summary of the European Public Assessment Report.
Spanish: Número de la EU Marca de fantasía
English: There are no major side effects with Locatim.
Spanish: Envase Contenido Tamaño de envase
English: ©EMEA 2007
Spanish: Vía oral
English: Page 2/2
Spanish: Vidrio tipo III
English: Do not use after the expiry date stated on the label.
Spanish: No usar después de la fecha que figura en la etiqueta.
English: For excipent, see section 6.1.
Spanish: Para excipientes, véase sección 6.1.
English: Using other vaccines
Spanish: Uso de otras vacunas:
English: The active substances are:
Spanish: El principio activo es:
English: If the condition persists or worsens, seek medical attention.
Spanish: Si persisten o empeoran, solicite atención médica.
English: For paediatric use only.
Spanish: Para uso pediátrico solo.
English: The vaccine should be used as supplied; no reconstitution is necessary.
Spanish: La vacuna debe utilizarse como se presenta; no es necesaria una reconstitución.
English: - This vaccine has been prescribed for your child and you should not pass it on to others.
Spanish: - Este medicamento se le ha recetado a su hijo y no debe Vd. pasarlo a otras personas.
English: Of these, 1,110 were monitored for both serious and non-serious adverse experiences.
Spanish: De éstos, 1.110 se monitorizaron en cuanto a efectos adversos graves o no graves.
English: It has been recommended that immunisation should be delayed during the course of an acute febrile illness.
Spanish: Se ha recomendado que la inmunización se retrase durante el transcurso de una enfermedad febril aguda.
English: Potential Adverse Effects
Spanish: Efectos Adversos Potenciales
English: Official batch release: in accordance with Article 114 Directive 2001/83/EEC, the official batch release will be undertaken by a state laboratory or a laboratory disignated for that purpose.
Spanish: Liberación oficial del lote: de acuerdo con el Artículo 114 de la Directiva 114/2001/83/EC, la liberación oficial del lote será realizada por un laboratorio del estado o un laboratorio designado para ese propósito.
English: Thorough agitation is necessary to achieve suspension of the vaccine.
Spanish: Es necesaria una agitación enérgica para conseguir la suspensión de la vacuna.
English: 1 dose (0.5 ml) contains :
Spanish: 1 dosis (0,5 ml) contiene:
English: Like all medicines, PROCOMVAX can have side effects.
Spanish: Al igual que todos los medicamentos PROCOMVAX puede producir efectos secundarios.
English: Take special care with PROCOMVAX:
Spanish: Tenga especial cuidado con PROCOMVAX:
English: Tell your doctor promptly about these or any other unusual symptoms.
Spanish: Informe rápidamente a su médico si su hijo presenta estos u otros síntomas no habituales.
English: Do not use PROCOMVAX: - if your child is allergic to any component of the vaccine.
Spanish: No use PROCOMVAX: - Si su hijo es alérgico a algún componente de la vacuna.
English: PROCOMVAX has been generally well tolerated in clinical trials.
Spanish: PROCOMVAX ha sido generalmente bien tolerada en los ensayos clínicos.
English: After thorough agitation, PROCOMVAX is a slightly opaque, white suspension.
Spanish: Después de la agitación enérgica, PROCOMVAX es una suspensión blanca, ligeramente opaca.
English: If you forget to take PROCOMVAX: Your doctor will decide when to give the missed dose.
Spanish: Si olvidó tomar PROCOMVAX: El médico decidirá cuando se administra la dosis olvidada.
English: Infants with moderate or severe febrile illness should only be vaccinated as soon as they have recovered from the acute phase of the illness.
Spanish: Los niños con enfermedad febril moderada o grave deben ser vacunados en cuanto se recuperen de la fase aguda de la enfermedad.
English: These adverse effects are listed below.
Spanish: Estos efectos adversos se relacionan a continuación.