FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee considered on basis of a target animal safety study that the use of the concerned product in puppies less than 9 weeks of age or dogs less than 2.5 kg is unlikely to give rise to a safety concern and therefore a restriction on use in such animals is unnecessary.
Spanish: El Comité consideró, basándose en un estudio de seguridad en animales diana, que el uso del producto interesado en cachorros menores de 9 semanas de edad o en perros con un peso inferior a 2,5 kg, es poco probable que plantee un problema de seguridad, por lo que no es necesario indicar una restricción sobre el uso en estos animales.
English: The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus (Bayer Animal Health).
Spanish: Los productos afectados son siete duplicados con dosieres idénticos de solicitud híbrida para los que el producto de referencia es Drontal Plus (Bayer Animal Health).
English: The marketing authorisations for Prazitel Plus, Exitel Plus, Cazitel Plus and associated names, authorised by MRP IE/V/0241-0243/001/MR (see Annex I) do not need to be amended.
Spanish: Las autorizaciones de comercialización para Prazitel Plus, Exitel Plus, Cazitel Plus y denominaciones asociadas, autorizadas mediante PRM IE/V/0241-0243/001/MR (ver Anexo I) no tienen que modificarse.
English: In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis.
Spanish: En especial, el espectro de actividad cubre Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum y Trichuris vulpis.
English: Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours.
Spanish: En las administraciones siguientes del medicamento a perros, se alcanzaron las concentraciones máximas en plasma de fenbendazol y oxfendazol aproximadamente a las 7-9 horas.
English: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
Spanish: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus y denominaciones asociadas son comprimidos para perros que contienen praziquantel, embonato de pirantel y febantel, y están indicados para el tratamiento de varias parasitosis.
English: {CARTON FOR PACK SIZES OF 2, 4, 6 AND 8 TABLETS}
Spanish: {CAJA DE CARTÓN PARA BLÍSTER DE 2, 4, 6 y 8 COMPRIMIDOS}
English: • the CVMP considered the primary scope of the referral regarding efficacy against Echinococcus granulosus and Echinococcus multilocularis;
Spanish: • que el CVMP consideró el alcance primario del procedimiento de arbitraje en relación con la eficacia contra Echinococcus granulosus y Echinococcus multilocularis
English: The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus.
Spanish: Los productos afectados son siete duplicados con dosieres idénticos de solicitud híbrida para los que el producto de referencia es Drontal Plus.
English: Risk assessment
Spanish: Evaluación de los riesgos
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Spanish: ADVERTENCIA ESPECIAL QUE INDIQUE “MANTENER FUERA DEL ALCANCE Y LA VISTA DE LOS NIÑOS”
English: A target animal safety study confirmed that the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names) is well tolerated when administered to pups (9 weeks of age) at doses up to five times the recommended treatment dose or when administered at the recommended treatment dose for up to three days.
Spanish: En un estudio de seguridad en el animal diana se confirmó que el producto interesado (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus y denominaciones asociadas) se tolera bien cuando se administra a cachorros (9 semanas de edad) a dosis de hasta cinco veces la dosis terapéutica recomendada o cuando se administra a la dosis terapéutica recomendada durante hasta tres días.
English: In conclusion, based on the totality of data presented, it is accepted that the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) will be effective (up to 100%) in the treatment of immature and mature forms of E. granulosus and E. multilocularis in the dog.
Spanish: En conclusión, basándose en todos los datos presentados, se acepta que el producto interesado (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus y Prazitel Plus y denominaciones asociadas) será eficaz (hasta el 100 %) en el tratamiento de las formas inmaduras y maduras de E. granulosus y E. multilocularis en perros.
English: Within the mammalian system, febantel undergoes ring closure, forming fenbendazole and oxfendazole.
Spanish: En mamíferos, febantel sufre cierre de anillo y forma fenbendazol y oxfendazol.
English: Individual blisters composed of 45 µm, soft temper aluminium foil and 25 µm hard temper aluminium foil, containing 2 or 8 tablets.
Spanish: Blísteres individuales con una lámina de aluminio de temple suave (45 µm) y una de aluminio de temple duro (25 µm) de 2 u 8 comprimidos.
English: 106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 and 1000 tablets.
Spanish: 106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 y 1000 comprimidos.
English: The in vivo data are further supported by the results of the comparative dissolution profiles of the concerned product with the reference product Drontal Plus tablets.
Spanish: Los datos obtenidos in vivo están también avalados por los resultados de los perfiles de disolución comparativos del producto interesado con el producto de referencia: los comprimidos de Drontal Plus.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Discard any unused divided tablets.
Spanish: Período de validez del medicamento veterinario acondicionado para su venta: 3 años.
English: In dogs: Treatment of mixed infections by nematodes and cestodes.
Spanish: En perros: Tratamiento de infestaciones mixtas por nematodos y cestodos.
English: The marketing authorisation holder for the concerned product is Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus, Exitel Plus, Cazitel Plus and associated names were authorised in many Member States (EU/EEA) by mutual recognition procedure (MRP) IE/V/0241-0243/001/MR as duplicate hybrid applications under Article 13(3) of Directive 2001/82/EC as amended.
Spanish: El titular de la autorización de comercialización para el producto afectado es Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus, Exitel Plus, Cazitel Plus y denominaciones asociadas fueron autorizados en muchos Estados Miembros (UE/EEE) mediante un procedimiento de reconocimiento mutuo (PRM) IE/V/02410243/001/MR como solicitudes híbridas duplicadas de conformidad con el artículo 13(3) de la Directiva 2001/82/CE modificado.
English: Chanelle Pharmaceuticals Manufacturing Ltd.has extrapolated the efficacy data available in the public domain for the Bayer Animal Health products (Droncit and Drontal Plus) to the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) by presenting a comparative pharmacokinetic study conducted with the concerned product and Drontal Plus (Bayer Aniamal Health).
Spanish: Chanelle Pharmaceuticals Manufacturing Ltd. ha extrapolado los datos de eficacia de dominio público para los productos de Bayer Animal Health (Droncit y Drontal Plus) al producto interesado (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus y Prazitel Plus y denominaciones asociadas) presentando un estudio farmacocinético comparativo realizado con el producto interesado y Drontal Plus (Bayer Animal Health).
English: Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis.
Spanish: Pirantel actúa como agonista colinérgico a través de la estimulación de los receptores colinérgicos nicotínicos del parásito y la inducción de parálisis espástica en los nematodos, lo que permite eliminarlos del sistema gastrointestinal mediante peristalsis.
English: Overall summary of the scientific evaluation of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names (see annex I)
Spanish: Resumen general de la evaluación científica de Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus y denominaciones asociadas (ver Anexo I)
English: Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).
Spanish: Ascáridos Toxocara canis, Toxascaris leonina (formas adultas e inmaduras tardías).
English: Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).
Spanish: Lombrices: especies de Echinococcus, (E. granulosus, E. multilocularis), especies de Taenia, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (formas adultas e inmaduras).
English: or
Spanish: o
English: The indication for the treatment of immature and mature forms of E. granulosus and E. multilocularis can be accepted for the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Spanish: La indicación para el tratamiento de formas inmaduras y maduras de E. granulosus y E. multilocularis se puede aceptar para el producto interesado (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus y Prazitel Plus y denominaciones asociadas).
English: the CVMP, concluded that the overall benefit/risk balance for these products remains positive subject to the recommended changes in the product information for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, and associated names, authorised by MRP IE/V/0272-0275/001/MR involving Ireland as reference Member State and France as concerned Member State.
Spanish: el CVMP ha concluido que la relación general beneficio/riesgo para estos productos continúa siendo positiva, sujeta a las modificaciones recomendadas en la información sobre el producto para Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, y denominaciones asociadas, autorizados mediante PRM IE/V/0272-0275/001/MR, con Irlanda como Estado miembro de referencia y Francia como Estado miembro interesado.
English: Benefit assessment
Spanish: Evaluación de los beneficios
English: These data are adequate as a bridge between the documented efficacy of the reference product (Drontal Plus) and the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Spanish: Estos datos son adecuados como puente de unión entre la eficacia documentada del producto de referencia (Drontal Plus) y el producto interesado (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus y Prazitel Plus y denominaciones asociadas).
English: Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus were authorised subsequently by MRP IE/V/0272-0275/001/MR as hybrid applications under Article 13(3) of Directive 2001/82/EC, as amended involving Ireland as reference Member State and France as concerned Member State.
Spanish: Milaxyn Plus, Strantel Plus, Prazical Plus y Voxical Plus fueron autorizados después mediante el procedimiento de reconocimiento mutuo IE/V/0272-0275/001/MR como solicitudes híbridas de conformidad con el Artículo 13(3) de la Directiva 2001/82/CE, modificado, en el que participaron Irlanda como Estado miembro de referencia y Francia como Estado miembro interesado.
English: The SPCs for these four products does not include indications against Echinococcus granulosus and Echinococcus multilocularis.
Spanish: Los RCP para estos cuatro productos no incluyen indicaciones contra Echinococcus granulosus ni Echinococcus multilocularis.
English: The SPC for these three products includes indications against Echinococcus granulosus and Echinococcus multilocularis.
Spanish: El RCP para estos tres productos incluye indicaciones contra Echinococcus granulosus y Echinococcus multilocularis.
English: Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized.
Spanish: No utilizar simultáneamente con compuestos de piperazina, puesto que los efectos antihelmínticos de pirantel y piperazina pueden ser antagónicos.
English: Tapeworm infestation is unlikely in pups less than 6 weeks of age.
Spanish: La infestación por tenias es improbable en cachorros de menos de 6 semanas de la edad.
English: Praziquantel, Febantel, Pyrantel.
Spanish: Para completar a nivel nacional Prazicuantel, Febantel, Pirantel
English: 50mg (equivalent to 144 mg pyrantel embonate)
Spanish: 50 mg (el equivalente a 144 mg de embonato de pirantel)
English: 1 tablet per 10 kg bodyweight.
Spanish: 1 comprimido por cada 10 kg de peso corporal.
English: {CARTON FOR PACK SIZES OF 10 TABLETS, AND UPWARDS}
Spanish: {CAJA DE CARTÓN PARA BLÍSTER DE DE 10 o MÁS COMPRIMIDOS }
English: While the majority of references cited by Chanelle Pharmaceuticals Manufacturing Ltd.reported on the efficacy of praziquantel when presented as a monosubstance tablet (Droncit, Bayer Animal Health), a number of the references reported on the efficacy of praziquantel when presented in other pharmaceutical forms (injectable, paste, powder) and/or for administration by other routes (intramuscular, subcutaneous) and/or when combined with other active substances (e.g. Drontal Plus, Bayer Animal Health).
Spanish: Aunque la mayoría de las referencias citadas por Chanelle Pharmaceuticals Manufacturing Ltd. estaban relacionadas con la eficacia de praziquantel en su presentación como comprimido de un solo principio activo (Droncit, Bayer Animal Health), algunas referencias mencionaban la eficacia de praziquantel en su presentación en otras formas farmacéuticas (inyectables, pasta, polvo) y/o para su administración por otras vías (intramuscular, subcutánea) y/o combinado con otros principios activos (p.ej. Drontal Plus, Bayer Animal Health) Con independencia de la vía de administración y de la formulación, se demostró sistemáticamente que una dosis de 5 mg/kg de peso corporal de praziquantel tenía un 100 % de eficacia contra las formas tanto inmaduras como maduras de E. granulosus y E. multilocularis.
English: SPECIAL WARNING(S)
Spanish: ADVERTENCIAS ESPECIALES (SI PROCEDEN)
English: Therefore the CVMP has recommended the variation of the marketing authorisations for which the summaries of product characteristics, labelling and package leaflet are set out in Annex III for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, and associated names, authorised by MRP IE/V/0272-0275/001/MR involving Ireland as reference Member State and France as concerned Member State (see Annex I).
Spanish: Por tanto, el CVMP ha recomendado modificar las autorizaciones de comercialización de los productos cuyos resúmenes de las características del producto, etiquetados y prospectos se exponen en el Anexo III: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, y denominaciones asociadas, autorizados mediante PRM IE/V/0272-0275/001/MR, con Irlanda como Estado miembro de referencia y Francia como Estado miembro interesado (ver Anexo I).
English: In dogs: Treatment of mixed infections by nematodes and cestodes of the following species Nematodes:
Spanish: En perros: Tratamiento de infestaciones mixtas por nematodos y cestodos de las especies siguientes Nematodos:
English: This is equivalent to 1 tablet per 10 kg (22 lbs) bodyweight.
Spanish: Equivalen a 1 comprimido por cada 10 kg (22 lbs) de peso corporal.
English: 4.9 Amounts to be administered and administration route For oral administration only.
Spanish: 4.9 Posología y vía de administración
English: SPECIAL STORAGE CONDITIONS
Spanish: CONDICIONES DE CONSERVACIÓN ESPECIALES
English: The strips or blisters are packed into cartons containing either 2,4, 6, 8, 10, 12, 14, 16, 18, 20,
Spanish: Las tiras o blísteres van en cajas de 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 40, 42,
English: This veterinary medicinal product does not require any special storage conditions Keep out of the reach and sight of children.
Spanish: Este medicamento veterinario no requiere condiciones especiales de conservación.
English: ANNEX I:
Spanish: Anexo I
English: Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs.
Spanish: Con esta combinación fija, pirantel y febantel actúan contra todos los nematodos relevantes (ascáridos, anquilostomas y anquilostomas) en perros.
English: 1 pork flavoured tablet contains 50 mg Praziquantel, 50 mg Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg Febantel.
Spanish: 1 comprimido con sabor carne contiene 50 mg de prazicuantel, 50 mg de pirantel (equivalente a 144 mg de embonato de pirantel) y 150 mg de febantel.
English: The recommended dose rates are: 15 mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel.
Spanish: Las dosis recomendadas son: febantel 15 mg/kg de peso corporal,pirantel 5 mg/kg (el equivalente a 14.4 mg de embonato de pirantel y prazicuantel 5 mg/kg.
English: Strantel Tabletten für Hunde
Spanish: Strantel Tabletter for Hunder
English: Benefit-Risk Assessment
Spanish: Evaluación de la relación beneficio-riesgo
English: Not Applicable
Spanish: No procede
English: Pork flavoured tablets.
Spanish: Comprimidos con sabor carne.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Spanish: MODO Y VÍAS DE ADMINISTRACIÓN
English: 50 mg/tablet Praziquantel, 50 mg/tablet Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg/tablet Febantel.
Spanish: Prazicuantel: 50 mg/comprimido, Pirantel: 50 mg/comprimido (equivalente a 144 mg de embonato de pirantel), Febantel: 150 mg/comprimido.
English: 4.11 Withdrawal period(s)
Spanish: 6.3 Período de validez
English: INN/Strength
Spanish: INN/Concentración Forma farmacéutica
English: Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate)
Spanish: Exitel Plus tabletid koertele Praziquantel 50 mg Pyrantel 50 mg (equivalente a 144 mg pyrantel embonate)
English: For Animal Treatment Only.
Spanish: Uso veterinario.
English: MARKETING AUTHORISATION HOLDER Chanelle Pharmaceuticals Manufacturing Limited, Loughrea,
Spanish: Chanelle Pharmaceuticals Manufacturing Limited Loughrea
English: Exitel Plus tabletės šunims
Spanish: Exitel Plus Tabletes suņiem
English: 150, 180, 200, 204, 206, 250, 280, 300, 500 or 1000 tablets.
Spanish: 280, 300, 500 y 1000 comprimidos.
English: Marketing authorisation holder
Spanish: TITULAR DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN
English: Belgium Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Bélgica Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Romania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Rumania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Hungary Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Hungría Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: France Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Francia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Germany Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Alemania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Finland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Finlandia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Norway Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Noruega Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Eslovaquia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Irlanda Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Países Bajos Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Iceland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Islandia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Denmark Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Dinamarca Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Any part used tablet should be discarded.
Spanish: Precauciones especiales para su uso en animales Los comprimidos utilizados parcialmente deben desecharse.
English: Slovenia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Spanish: Eslovenia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
English: Pyrantel acts as a cholinergic agonist.
Spanish: Embonato de pirantel (pamoato), un derivado de la tetrahidropirimidina.
English: Cazitel Plus tabletten voor honden
Spanish: Cazitel Plus tabletter för hundar
English: Cazitel Tabletten für Hunde
Spanish: Prazitel Tabletten für Hunde
English: Prazitel Plus tabletten voor honden
Spanish: Prazitel Plus tabletter för hundar
English: Exitel Plus tablets for dogs
Spanish: Exitel Plus tabletter för hundar
English: Section 3.
Spanish: Sección 3.
English: Annex III Amendments to relevant sections of the product information
Spanish: Anexo III Modificaciones de las secciones pertinentes de la información sobre el producto
English: Amendments to relevant sections of the product information of methadone tablets containing low molecular weight povidone (K25 or K30)
Spanish: Modificaciones de las secciones pertinentes de la información sobre el producto para los comprimidos de metadona que contienen povidona de bajo peso molecular (K25 o K30)
English: B. Package Leaflet
Spanish: B. Prospecto
English: Section 6.1 List of excipients [Information about the type of povidone, e.g. K25 or K30, should be included in this section.]
Spanish: Sección 6.1 Lista de excipientes [En esta sección debe incluirse información sobre el tipo de povidona; p. ej., K25 o K30]
English: Section 4.2 Posology and method of administration [The following text should be included in this section] This product is for oral use only, and must not be injected.
Spanish: A. Resumen de las características del producto Sección 4.2 Posología y forma de administración [Se debe insertar el texto siguiente en esta sección] Este producto es solo para uso oral y no debe inyectarse.
English: [The following text should be included in this section] This product is for oral use only, and must not be injected.
Spanish: Cómo usar <denominación de fantasía> [Se debe insertar el texto siguiente en esta sección] Este producto es solo para uso oral y no debe inyectarse.
English: The potential risk for pregnant women is unknown.
Spanish: Se desconoce el riesgo potencial para las mujeres embarazadas.
English: Experience of overdose is limited.
Spanish: La experiencia de sobredosis es limitada.
English: Individuals 10 years and older
Spanish: Personas de 10 años de edad y mayores
English: The use of this vaccine should be in accordance with official recommendations.
Spanish: Esta vacuna debe utilizarse de acuerdo con las recomendaciones oficiales.
English: If this occurs, wait until the effects wear off before driving or using machines.
Spanish: Si esto ocurre, espere hasta que los efectos desaparezcan antes de conducir o utilizar máquinas.