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Covers the veterinary product name and presentation, qualitative and quantitative composition, target species and indications, immunity onset and duration, contraindications, special warnings and precautions for safe use, adverse event reporting pathways, and guidance for use during pregnancy, lactation, and laying. Also includes handling and environmental protection precautions and sections for interactions with other medicinal products.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/summary-of-product-characteristics-version-91-112024/175056/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/summary-of-product-characteristics-version-91-112024/175056.png","ImageObject",442,249,{"name":88,"@type":89},"Bintang","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-25","2026-09-02",true,{"@type":98,"interactionType":99,"userInteractionCount":20},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What sections are included in this Summary of Product Characteristics template?","Question",{"text":108,"@type":109},"It includes product name, qualitative and quantitative composition, clinical information (target species, indications, contraindications, warnings, precautions), adverse event reporting, pregnancy/lactation/lay guidance, and interaction information.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How should adverse events be reported?",{"text":113,"@type":109},"Reports should be sent preferably via a veterinarian to the marketing authorisation holder or its local representative, or to the national competent authority through the national reporting system.",{"name":115,"@type":106,"acceptedAnswer":116},"What precautions are specified for safe handling and use?",{"text":117,"@type":109},"The template includes vaccination-only guidance, measures to avoid spread of the vaccine strain to immunosuppressed or unvaccinated animals, personal protective equipment for handlers, and specific instructions for accidental self-injection or contact.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},175056,1788318042,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":20,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":125,"read_time":140},962085564381,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","[Version 9.1,11/2024]\nANNEX I\nSUMMARY OF PRODUCT CHARACTERISTICS\n\u000f1.\tNAME OF THE VETERINARY MEDICINAL PRODUCT\n{(Invented) name of veterinary medicinal product \u003Cstrength> pharmaceutical form \u003Ctarget species>}\n2.\tQUALITATIVE AND QUANTITATIVE COMPOSITION\nActive substances:\n\u003CAdjuvants:>\n\u003CExcipients:>\n3.\tCLINICAL INFORMATION\n3.1\tTarget species\n3.2\tIndications for use for each target species\n\u003COnset of immunity: {x weeks}>\n\u003CDuration of immunity: {x years} {has not been established}>\n3.3\tContraindications\n\u003CNone.>\n\u003CDo not use in….>\n\u003CDo not use in cases of hypersensitivity to the active substance(s) \u003C, to the adjuvant(s)> or to any of the excipient(s).>\n3.4\tSpecial warnings\n\u003CNone.>\n\u003CVaccinate healthy animals only.>\n3.5\tSpecial precautions for use\nSpecial precautions for safe use in the target species:\n\u003CNot applicable.>\n\u003CVaccinated {species} may excrete the vaccine strain up to {x \u003Cdays> \u003Cweeks>} following vaccination. During this time, the contact of immunosuppressed and unvaccinated {species} with vaccinated {species} should be avoided.>\n\u003CThe vaccine strain can spread to {species}. Special precautions should be taken to avoid spreading of the vaccine strain to {species}.>\n\u003CAppropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible species.>\n\u003C{Species} and unvaccinated {species} in contact with vaccinated {species} may react to the vaccine strain, presenting clinical signs such as….>\nSpecial precautions to be taken by the person administering the veterinary medicinal product to animals:\n\u003CNot applicable.>\n\u003CIn case of accidental \u003Cself-administration> \u003Cself-injection> \u003Cingestion> \u003Cspillage onto skin>, seek medical advice immediately and show the package leaflet or the label to the physician.>\n\u003CPeople with known hypersensitivity to {INN} should \u003Cavoid contact with the veterinary medicinal product.> \u003Cadminister the veterinary medicinal product with caution.>>\n\u003CPersonal protective equipment consisting of {specify} should be worn when handling the veterinary medicinal product.>\n\u003CThe veterinary medicinal product should not be administered by pregnant women.>\n\u003CThe \u003Cvaccine> \u003Cimmunological veterinary medicinal product> can be pathogenic for humans. Since this \u003Cvaccine> \u003Cimmunological veterinary medicinal product> has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process.>\n\u003CVaccinated {species} may excrete the vaccine strain up to {x \u003Cdays> \u003Cweeks>} following vaccination.>\n\u003CImmunocompromised persons are advised to avoid contact with the \u003Cvaccine> \u003Cimmunological veterinary medicinal product> and vaccinated animals during {period}.>\n\u003CThe vaccine strain can be found in the environment for up to {x \u003Cdays> \u003Cweeks>}. Personnel involved in attending vaccinated {species} should follow general hygiene principles (changing clothes, wearing gloves, cleaning and disinfection of boots) and take particular care in handling animal waste and bedding materials from recently vaccinated {species}.>\n\u003CTo the user:\nThis veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.\nTo the physician:\nThis veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is re","cbCaid96kKVdDy3A","https://ap.wps.com/l/cbCaid96kKVdDy3A","docx",65678,25,"English","# NAME OF THE VETERINARY MEDICINAL PRODUCT\n## QUALITATIVE AND QUANTITATIVE COMPOSITION\n## CLINICAL INFORMATION\n### Target species\n### Indications for use\n### Contraindications\n### Special warnings\n### Special precautions for use\n### Adverse events\n### Use during pregnancy, lactation or lay\n### Interaction with other medicinal products and other forms of interaction","[{\"question\":\"What sections are included in this Summary of Product Characteristics template?\",\"answer\":\"It includes product name, qualitative and quantitative composition, clinical information (target species, indications, contraindications, warnings, precautions), adverse event reporting, pregnancy/lactation/lay guidance, and interaction information.\"},{\"question\":\"How should adverse events be reported?\",\"answer\":\"Reports should be sent preferably via a veterinarian to the marketing authorisation holder or its local representative, or to the national competent authority through the national reporting system.\"},{\"question\":\"What precautions are specified for safe handling and use?\",\"answer\":\"The template includes vaccination-only guidance, measures to avoid spread of the vaccine strain to immunosuppressed or unvaccinated animals, personal protective equipment for handlers, and specific instructions for accidental self-injection or contact.\"}]","SUMMARY OF PRODUCT CHARACTERISTICS - Version 9.1 - 11/2024 | DOCX",9]