{"id":21,"date":"2024-10-08T10:35:04","date_gmt":"2024-10-08T10:35:04","guid":{"rendered":"https:\/\/ixchiq.ca\/hcp\/?page_id=21"},"modified":"2025-03-27T10:58:49","modified_gmt":"2025-03-27T10:58:49","slug":"safety-information","status":"publish","type":"page","link":"https:\/\/ixchiq.ca\/hcp\/safety-information\/","title":{"rendered":"Safety information"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"21\" class=\"elementor elementor-21\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-08bef8d e-flex e-con-boxed e-con e-parent\" data-id=\"08bef8d\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-e5bc0cd e-con-full e-flex e-con e-child\" data-id=\"e5bc0cd\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-c1b82a0 e-con-full e-flex e-con e-child\" data-id=\"c1b82a0\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-46c3f41 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"46c3f41\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-11eb824 elementor-widget elementor-widget-heading\" data-id=\"11eb824\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">IXCHIQ\u2122 SAFETY INFORMATION<sup>1<\/sup><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8605e22 e-con-full e-flex e-con e-child\" data-id=\"8605e22\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-65020e7 elementor-widget elementor-widget-text-editor\" data-id=\"65020e7\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<strong><u>Clinical use:<\/u><\/strong>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f1a708 elementor-widget elementor-widget-text-editor\" data-id=\"3f1a708\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<strong>Pediatrics (&lt;18 years):<\/strong> The safety and immunogenicity of IXCHIQ\u2122 have not been established; therefore, Health Canada has not authorized an indication for pediatric use. \t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-38aca3c elementor-widget elementor-widget-text-editor\" data-id=\"38aca3c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<strong>Geriatrics (\u226565 years):<\/strong> Clinical studies of IXCHIQ\u2122 include participants 65 years of age and older and their data contribute to the overall assessment of safety and immunogenicity. \t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-494cc6e e-con-full e-flex e-con e-child\" data-id=\"494cc6e\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7751923 elementor-widget elementor-widget-text-editor\" data-id=\"7751923\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<b><u>Contraindications:<\/u><\/b> \t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-68629e8 elementor-widget elementor-widget-text-editor\" data-id=\"68629e8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"para\">\n \t<li>In individuals with a history of immunodeficiency (e.g., from hematologic and solid tumours, receipt of chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised).<\/li>\n \t<li>In patients who are hypersensitive to this vaccine or to any ingredient in the formulation or component of the container.<\/li>\n \t<li>Pregnancy. Women of child-bearing potential should be advised to avoid pregnancy for one month following vaccination.<\/li>\n<\/ul> \t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1bee12b e-con-full e-flex e-con e-child\" data-id=\"1bee12b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-37f7952 elementor-widget elementor-widget-text-editor\" data-id=\"37f7952\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<b><u>Relevant warnings and precautions:<\/u><\/b>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-96f3155 elementor-widget elementor-widget-text-editor\" data-id=\"96f3155\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"para\">\n \t<li>IXCHIQ\u2122 is for intramuscular (IM) injection only.<\/li>\n \t<li>As with other vaccines, vaccination with IXCHIQ\u2122 should be postponed in individuals suffering from an acute severe febrile illness or infection.<\/li>\n \t<li>Syncope (fainting) can occur following, or even before, any vaccination as a vasovagal response to the needle injection in the context of an anxiety-related reaction. It is important that procedures are in place to avoid injury from fainting.<\/li>\n \t<li>Vaccination with IXCHIQ\u2122 may not protect all individuals. It is recommended to continue personal protection measures against mosquito bites after vaccination.<\/li>\n \t<li>Appropriate medical treatment and supervision must be available to manage immediate allergic reactions in the event an acute anaphylactic reaction occurs following administration of IXCHIQ\u2122.<\/li>\n \t<li>No studies on the effects of IXCHIQ\u2122 on the ability to drive and use machines have been performed. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.<\/li>\n \t<li>As with other vaccines administered intramuscularly, IXCHIQ\u2122 should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an IM administration to these individuals.<\/li>\n \t<li>Available data in adults with a history of immune-mediated or clinically relevant arthritis are not sufficient to determine the safety of IXCHIQ\u2122, as this condition was an exclusion criterion for participation in clinical trials.<\/li>\n \t<li>Reproductive and developmental toxicology of IXCHIQ\u2122 was conducted in a single pre- and post-natal developmental toxicity study in pregnant rats which did not identify significant adverse effects in female fertility or in fetal examination. No studies in male fertility were conducted.<\/li>\n \t<li>Available data in pregnant women are not sufficient to determine the safety of IXCHIQ\u2122 regarding pregnancy, embryofetal development, parturition, and postnatal development.<\/li>\n \t<li>Vertical transmission of chikungunya virus (CHIKV) from mothers with viremia at delivery to their infants has been reported and can cause severe, potentially fatal neurological disease in neonates.<\/li>\n \t<li>Vaccine viremia can occur 3\u20137 days after vaccination and is resolved by day 14; the potential for transmission of the vaccine virus from mother to infant is unknown.<\/li>\n \t<li>Women who received IXCHIQ\u2122 during pregnancy are encouraged to report any suspected exposure or adverse reactions to Valneva Canada, or ask their healthcare professional to do so.<\/li>\n \t<li>Potential for transmission of the vaccine virus from mother to infant through breastmilk is unknown. Precaution should be exercised.<\/li>\n \t<li>Any laboratory testing within 2 weeks post-vaccination with IXCHIQ\u2122 may result in transient abnormalities in results, especially among hematology parameters.<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-21e89eb e-con-full e-flex e-con e-child\" data-id=\"21e89eb\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c709948 elementor-widget elementor-widget-text-editor\" data-id=\"c709948\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<strong><u>For more information:<\/u><\/strong> \t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3925e38 elementor-widget elementor-widget-text-editor\" data-id=\"3925e38\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Please consult the Product Monograph at <a href=\"https:\/\/pdf.hres.ca\/dpd_pm\/00076049.PDF\"><span style=\"text-decoration: underline;\">pdf.hres.ca\/dpd_pm\/00076049.PDF<\/span><\/a> for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-855-356-0831.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-185386f elementor-widget elementor-widget-text-editor\" data-id=\"185386f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tThe drug identification number (DIN) for IXCHIQ\u2122 is 02548984.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>IXCHIQ\u2122 SAFETY INFORMATION1 Clinical use:Pediatrics (&lt;18 years): The safety and immunogenicity of IXCHIQ\u2122 have not been established; therefore, Health Canada has not authorized an indication for pediatric use. Geriatrics (\u226565 years): Clinical studies of IXCHIQ\u2122 include participants 65 years of age and older and their data contribute to the overall assessment of safety and immunogenicity. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-21","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Safety information - Ixchiq HCP<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ixchiq.ca\/hcp\/safety-information\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Safety information - Ixchiq HCP\" \/>\n<meta property=\"og:description\" content=\"IXCHIQ\u2122 SAFETY INFORMATION1 Clinical use:Pediatrics (&lt;18 years): The safety and immunogenicity of IXCHIQ\u2122 have not been established; therefore, Health Canada has not authorized an indication for pediatric use. 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Geriatrics (\u226565 years): Clinical studies of IXCHIQ\u2122 include participants 65 years of age and older and their data contribute to the overall assessment of safety and immunogenicity. 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