{"id":8706,"date":"2024-08-18T15:45:59","date_gmt":"2024-08-18T12:15:59","guid":{"rendered":"https:\/\/cedalco.com\/?post_type=dt_portfolio&#038;p=8706"},"modified":"2026-01-09T20:35:14","modified_gmt":"2026-01-09T17:05:14","slug":"aclacedal","status":"publish","type":"dt_portfolio","link":"https:\/\/cedalco.com\/en\/project\/aclacedal\/","title":{"rendered":"AclaCedal"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8706\" class=\"elementor elementor-8706 elementor-8693\" data-elementor-post-type=\"dt_portfolio\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5556016 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5556016\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ad2c9b9\" data-id=\"ad2c9b9\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-a4e246b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a4e246b\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-c33e579\" data-id=\"c33e579\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3792faa elementor-widget elementor-widget-image\" data-id=\"3792faa\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t<figure class=\"wp-caption\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/cedalco.com\/wp-content\/uploads\/2024\/08\/aclacedal5.jpg\" data-elementor-open-lightbox=\"yes\" data-elementor-lightbox-title=\"aclacedal5\" data-e-action-hash=\"#elementor-action%3Aaction%3Dlightbox%26settings%3DeyJpZCI6ODcwNCwidXJsIjoiaHR0cHM6XC9cL2NlZGFsY28uY29tXC93cC1jb250ZW50XC91cGxvYWRzXC8yMDI0XC8wOFwvYWNsYWNlZGFsNS5qcGcifQ%3D%3D\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1181\" height=\"1183\" src=\"https:\/\/cedalco.com\/wp-content\/uploads\/2024\/08\/aclacedal5.jpg\" class=\"elementor-animation-float attachment-full size-full wp-image-8704\" alt=\"\" srcset=\"https:\/\/cedalco.com\/wp-content\/uploads\/2024\/08\/aclacedal5.jpg 1181w, https:\/\/cedalco.com\/wp-content\/uploads\/2024\/08\/aclacedal5-300x300.jpg 300w, https:\/\/cedalco.com\/wp-content\/uploads\/2024\/08\/aclacedal5-1022x1024.jpg 1022w, https:\/\/cedalco.com\/wp-content\/uploads\/2024\/08\/aclacedal5-150x150.jpg 150w, https:\/\/cedalco.com\/wp-content\/uploads\/2024\/08\/aclacedal5-768x769.jpg 768w\" sizes=\"(max-width: 1181px) 100vw, 1181px\" title=\"\">\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t<figcaption class=\"widget-image-caption wp-caption-text\">Click on the photo to enlarge <i class=\"fa fa-search-plus\" aria-hidden=\"true\"><\/i><\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-261dc5a\" data-id=\"261dc5a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9ec9f71 elementor-widget__width-auto elementor-widget-mobile__width-inherit elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"9ec9f71\" data-element_type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">AclaCedal<sup>\u00ae<\/sup><\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eb11d00 elementor-widget elementor-widget-spacer\" data-id=\"eb11d00\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e3caa8f content-align-mobile-left elementor-widget__width-initial elementor-widget-mobile__width-inherit icon-box-vertical-align-top icon-position-left icon-vertical-align-start elementor-widget elementor-widget-the7_icon_box_widget\" data-id=\"e3caa8f\" data-element_type=\"widget\" data-widget_type=\"the7_icon_box_widget.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div class=\"the7-box-wrapper the7-elementor-widget the7_icon_box_widget-e3caa8f\">\t\t\t<div class=\"box-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<a class=\"elementor-icon-div\" >\t\t\t\t\t\t<div class=\"elementor-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-circle-notch\"><\/i>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\t\t\t\t\t\t\t\t<div class=\"box-content\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h4 class=\"box-heading\">\n\t\t\t\t\t\t\t<a >\t\t\t\t\t\t\t\tGeneric Name\t\t\t\t\t\t\t<\/a>\t\t\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"box-description\">Zoledronic acid\n<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-abf9674 content-align-mobile-left elementor-widget__width-initial elementor-widget-mobile__width-inherit icon-box-vertical-align-top icon-position-left icon-vertical-align-start elementor-widget elementor-widget-the7_icon_box_widget\" data-id=\"abf9674\" data-element_type=\"widget\" data-widget_type=\"the7_icon_box_widget.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div class=\"the7-box-wrapper the7-elementor-widget the7_icon_box_widget-abf9674\">\t\t\t<div class=\"box-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<a class=\"elementor-icon-div\" >\t\t\t\t\t\t<div class=\"elementor-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-circle-notch\"><\/i>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\t\t\t\t\t\t\t\t<div class=\"box-content\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h4 class=\"box-heading\">\n\t\t\t\t\t\t\t<a >\t\t\t\t\t\t\t\tBrand Name\t\t\t\t\t\t\t<\/a>\t\t\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"box-description\"><sup>\u00ae<\/sup>AclaCedal<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f946f76 elementor-widget__width-initial elementor-widget-mobile__width-inherit content-align-mobile-left icon-box-vertical-align-top icon-position-left icon-vertical-align-start elementor-widget elementor-widget-the7_icon_box_widget\" data-id=\"f946f76\" data-element_type=\"widget\" data-widget_type=\"the7_icon_box_widget.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div class=\"the7-box-wrapper the7-elementor-widget the7_icon_box_widget-f946f76\">\t\t\t<div class=\"box-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<a class=\"elementor-icon-div\" >\t\t\t\t\t\t<div class=\"elementor-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-circle-notch\"><\/i>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\t\t\t\t\t\t\t\t<div class=\"box-content\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h4 class=\"box-heading\">\n\t\t\t\t\t\t\t<a >\t\t\t\t\t\t\t\tDrug Class\t\t\t\t\t\t\t<\/a>\t\t\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"box-description\">Bisphosphonate, Antiresorptive agent<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a5ce71e elementor-widget__width-initial elementor-widget-mobile__width-inherit content-align-mobile-left icon-box-vertical-align-top icon-position-left icon-vertical-align-start elementor-widget elementor-widget-the7_icon_box_widget\" data-id=\"a5ce71e\" data-element_type=\"widget\" data-widget_type=\"the7_icon_box_widget.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div class=\"the7-box-wrapper the7-elementor-widget the7_icon_box_widget-a5ce71e\">\t\t\t<div class=\"box-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<a class=\"elementor-icon-div\" >\t\t\t\t\t\t<div class=\"elementor-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-circle-notch\"><\/i>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\t\t\t\t\t\t\t\t<div class=\"box-content\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h4 class=\"box-heading\">\n\t\t\t\t\t\t\t<a >\t\t\t\t\t\t\t\tDosage Form\t\t\t\t\t\t\t<\/a>\t\t\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"box-description\">Zoledronic Acid 5 mg\/100ml solution for infusion<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-31f28ad the7-e-tabs-view-vertical icon-align-left elementor-widget elementor-widget-the7-tabs\" data-id=\"31f28ad\" data-element_type=\"widget\" data-settings=\"{&quot;accordion_breakpoint&quot;:&quot;mobile&quot;}\" data-widget_type=\"the7-tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t<div class=\"the7-e-tabs-wrapper\">\n\t\t<div class=\"the7-e-tabs-nav-wrapper\">\n\t\t\t<div class=\"the7-e-tabs-nav-scroll-wrapper\">\n\t\t\t\t<div class=\"the7-e-tabs-nav\" role=\"tablist\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<div id=\"the7-e-tab-title-5231\" class=\"the7-e-tab-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"the7-e-tab-content-5231\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-virus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tIndications\t\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"the7-e-tab-title-5232\" class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"the7-e-tab-content-5232\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-virus-slash\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tContradications\t\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"the7-e-tab-title-5233\" class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"the7-e-tab-content-5233\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-list-ul\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tWarnings and Precautions\t\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"the7-e-tab-title-5234\" class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"the7-e-tab-content-5234\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-hand-holding-medical\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tDosage & Administration\t\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"the7-e-tab-title-5235\" class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"5\" role=\"tab\" tabindex=\"-1\" aria-controls=\"the7-e-tab-content-5235\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"far fa-bell\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tAdverse Reactions\t\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"the7-e-tab-title-5236\" class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"6\" role=\"tab\" tabindex=\"-1\" aria-controls=\"the7-e-tab-content-5236\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fab fa-confluence\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tDrug Interactions\t\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"the7-e-tab-title-5237\" class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"7\" role=\"tab\" tabindex=\"-1\" aria-controls=\"the7-e-tab-content-5237\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-baby\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\t Pregnancy and Lactation\t\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t\t\t\t\t<div id=\"the7-e-tab-title-5238\" class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"8\" role=\"tab\" tabindex=\"-1\" aria-controls=\"the7-e-tab-content-5238\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-box\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tStorage Conditions\t\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"the7-e-tab-nav-button left-button\"><\/div>\n\t\t\t<div class=\"the7-e-tab-nav-button right-button\"><\/div>\n\t\t<\/div>\n\t\t<div class=\"the7-e-tabs-content\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t<div class=\"the7-e-tab-item-wrapper\" data-tab=\"1\">\n\t\t\t\t\t<div class=\"the7-e-tab-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-5231\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-virus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tIndications\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"the7-e-tab-content-5231\" class=\"the7-e-tab-content the7-e-tab-text-content\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"the7-e-tab-title-5231\" tabindex=\"0\" hidden=\"false\"><p>Zoledronic acid is indicated for:<\/p><ul><li>Treatment of osteoporosis<\/li><\/ul><p>\u00a0-in post-menopausal women<\/p><p>\u00a0-in adult men<\/p><p>at increased risk of fracture, including those with a recent low-trauma hip fracture.<\/p><ul><li>Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy<\/li><\/ul><p>&#8211; \u00a0in post-menopausal women<\/p><p>&#8211; \u00a0in adult men<\/p><p>at increased risk of fracture.<\/p><p>Treatment of Paget\u2019s disease of the bone in adults<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t<div class=\"the7-e-tab-item-wrapper\" data-tab=\"2\">\n\t\t\t\t\t<div class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-5232\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-virus-slash\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tContradications\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"the7-e-tab-content-5232\" class=\"the7-e-tab-content the7-e-tab-text-content\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"the7-e-tab-title-5232\" tabindex=\"0\" hidden=\"hidden\"><ul><li>Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipi-ents (mannitol and sodium citrate)<\/li><li>Patients with hypocalcaemia<\/li><li>Severe renal impairment with creatinine clearance &lt; 35 ml\/min<\/li><li>Pregnancy and breast-feeding<\/li><\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t<div class=\"the7-e-tab-item-wrapper\" data-tab=\"3\">\n\t\t\t\t\t<div class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-5233\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-list-ul\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tWarnings and Precautions\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"the7-e-tab-content-5233\" class=\"the7-e-tab-content the7-e-tab-text-content\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"the7-e-tab-title-5233\" tabindex=\"0\" hidden=\"hidden\"><p><em><u>Renal function<\/u><\/em><\/p><p>The use of Zoledronic Acid in patients with severe renal impairment (creatinine clearance &lt; 35 ml\/min) is contraindicated due to an increased risk of renal failure in this population. Renal impairment has been observed following the administration of Zoledronic Acid, espe-cially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration occurring after Zoledronic Acid administration. Renal impairment has been observed in patients after a single administration. Renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.<\/p><p>The following precautions should be taken into account to minimise the risk of renal ad-verse reactions:<\/p><ul><li>Creatinine clearance should be calculated based on actual body weight using the Cock-croft-Grault formula before each Zoledronic Acid dose.<\/li><li>Transient increase in serum creatinine may be greater in patients with underlying im-paired renal function.<\/li><li>Monitoring of serum creatinine should be considered in at-risk patients.<\/li><li>Zoledronic Acid should be used with caution when concomitantly used with other medici-nal products that could impact renal function.<\/li><li>Patients, especially elderly patients and those receiving diuretic therapy, should be appro-priately hydrated prior to administration of Zoledronic Acid.<\/li><li>A single dose of Zoledronic Acid should not exceed 5 mg and the duration of infusion should be at least 15 minutes.<\/li><\/ul><p><em><u>Hypocalcaemia<\/u><\/em><\/p><p>Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D<\/p><p>before initiating therapy with Zoledronic Acid. Other disturbances of mineral metabolism must also be<\/p><p>effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption). Physicians should consider clinical monitoring for these patients.<\/p><p>Elevated bone turnover is a characteristic of Paget\u2019s disease of the bone. Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of Zoledronic Acid.<\/p><p>Adequate calcium and vitamin D intake are recommended in association with Zoledronic Acid administration. In addition, in patients with Paget\u2019s disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic Acid administration.<\/p><p>Patients should be informed about symptoms of hypocalcaemia and receive adequate clin-ical monitoring during the period of risk. Measurement of serum calcium before infusion of Zoledronic Acid is recommended for patients with Paget\u00b4s disease.<\/p><p>Severe and occasionally incapacitating bone, joint and\/or muscle pain have been infre-quently reported in patients taking bisphosphonates, including Zoledronic Acid.<\/p><p><em><u>Osteonecrosis of the jaw (ONJ)<\/u><\/em><\/p><p>ONJ has been reported in the post-marketing setting in patients receiving Zoledronic Acid for osteoporosis.<\/p><p>The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth. A dental examination with preventive den-tistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic Acid in patients with concomitant risk factors.<\/p><p>The following should be considered when evaluating a patient\u2019s risk of developing ONJ:<\/p><p>&#8211; \u00a0Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumula-tive dose of bone resorption therapy.<\/p><p>\u00a0&#8211; Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.<\/p><p>&#8211; \u00a0Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiother-apy to head and neck.<\/p><p>&#8211; Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures, e.g. tooth extractions.<\/p><p>All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, non-healing of sores or discharge during treatment with zoledronic acid. While on treatment, invasive dental procedures should be performed with caution and avoided in close proximity to zoledronic acid treatment.<\/p><p>The management plan for patients who develop ONJ should be set up in close collabo-ration between the treating physician and a dentist or oral surgeon with expertise in ONJ. Temporary<\/p><p>interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.<\/p><p><em><u>Osteonecrosis of the external auditory canal<\/u><\/em><\/p><p>Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and\/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms in-cluding chronic ear infections.<\/p><p><em><u>Atypical fractures of the femur<\/u><\/em><\/p><p>Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bis-phosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often asso-ciated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures are often bilateral; therefore, the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.<\/p><p>During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.<\/p><p><em><u>Acute phase reactions<\/u><\/em><\/p><p>Acute phase reactions (APRs) or post-dose symptoms such as fever , myalgia , flu-like symptoms, arthralgia and headache have been observed, the majority of which occurred within three days following Zoledronic acid administration.<\/p><p>APRs may sometimes be serious or prolonged in duration. The incidence of post-dose symptoms can be reduced with the administration of paracetamol or ibuprofen shortly following Zoledronic acid administration. It is also advisable to postpone treatment if the patient is clinically unstable due to an acute medical condition and an APR could be prob-lematic.<\/p><p><em><u>General<\/u><\/em><\/p><p>Other products containing zoledronic acid as an active substance are available for oncolo-gy indications. Patients being treated with Zoledronic acid should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.<\/p><p>This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml vial of Zole-dronic acid, i.e. essentially \u201csodium free\u201d.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t<div class=\"the7-e-tab-item-wrapper\" data-tab=\"4\">\n\t\t\t\t\t<div class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-5234\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-hand-holding-medical\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tDosage & Administration\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"the7-e-tab-content-5234\" class=\"the7-e-tab-content the7-e-tab-text-content\" data-tab=\"4\" role=\"tabpanel\" aria-labelledby=\"the7-e-tab-title-5234\" tabindex=\"0\" hidden=\"hidden\"><p><strong>Osteoporosis<\/strong><strong>:<\/strong><\/p><p>For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the rec-ommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year.<\/p><p>The optimal duration of bisphosphonate treatment for osteoporosis has not been estab-lished. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risk of Zoledronic Acid on an individual patient basis , particularly after 5 or more years of use.<\/p><p>In patients with a recent low-trauma hip fracture, it is recommended to give the Zoledronic Acid infusion at least two weeks after hip fracture repair. In patients with a recent low-trau-ma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first Zoledronic Acid infusion.<\/p><p><strong>Paget\u2019s disease<\/strong><strong>:<\/strong><\/p><p>For the treatment of Paget\u2019s disease, Zoledronic Acid should be prescribed only by physi-cians with experience in the treatment of Paget\u2019s disease of the bone. The recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid. In patients with Paget\u2019s dis-ease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic Acid administration.<\/p><p><strong>Re-treatment of Paget\u2019s disease<\/strong><strong>:<\/strong><\/p><p>After initial treatment with Zoledronic Acid in Paget\u2019s disease, an extended remission pe-riod is observed in responding patients. Re-treatment consists of an additional intrave-nous infusion of 5 mg Zoledronic Acid after an interval of one year or longer from initial treatment in patients who have relapsed. Limited data on re-treatment of Paget\u2019s disease are available<\/p><p><strong>Special populations<\/strong><\/p><p>Patients with renal impairment<\/p><p>Zoledronic Acid is contraindicated in patients with creatinine clearance &lt; 35 ml\/min<\/p><p>no dose adjustment is necessary in patients with creatinine clearance \u00b3 35 ml\/min.<\/p><p>\u00a0Patients with hepatic impairment<\/p><p>No dose adjustment is required<\/p><p><strong>Elderly (<\/strong><strong>\u2265<\/strong><strong> 65 years )<\/strong><\/p><p>No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.<\/p><p><strong>Paediatric population<\/strong><\/p><p>Zoledronic Acid should not be used in children and adolescents below 18 years of age. There are no data available for children under 5 years of age.<\/p><p><strong>Method of administration<\/strong><\/p><p>Zoledronic Acid (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given slowly at a constant infusion rate. The infusion time must not be less than 15 minutes.<\/p><p><em><u>For single use only<\/u><\/em><em><u>:<\/u><\/em><\/p><p>Only clear solution free from particles and discoloration should be used.<\/p><p>If refrigerated, allow the refrigerated solution to reach room temperature before administra-tion. Aseptic techniques must be followed during the preparation of the infusion.<\/p><p>Any unused medicinal product or waste material should be disposed of in accordance with local requirements.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t<div class=\"the7-e-tab-item-wrapper\" data-tab=\"5\">\n\t\t\t\t\t<div class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"5\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-5235\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"far fa-bell\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tAdverse Reactions\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"the7-e-tab-content-5235\" class=\"the7-e-tab-content the7-e-tab-text-content\" data-tab=\"5\" role=\"tabpanel\" aria-labelledby=\"the7-e-tab-title-5235\" tabindex=\"0\" hidden=\"hidden\"><p>The following adverse reactions, listed below, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:<\/p><p><em><u>Very common (\u2265 1\/10 ) :<\/u><\/em> Pyrexia<\/p><p><em><u>Common (\u2265 1\/100 to &lt; 1\/10 ) :<\/u><\/em> Hypocalcaemia, Headache, dizziness, Ocular hyperaemia, Atrial fibrillation, Nausea, vomiting, diarrhoea, Myalgia, arthralgia, bone pain, back pain, pain in<\/p><p>Extremely , Influenza-like illness, chills, fatigue, asthenia, C-reactive protein increased. AD-verse reactions in Table 1 are listed<\/p><p><em><u>Uncommon (<\/u><\/em><em><u>\u2265<\/u><\/em><em><u>1\/1000 to <\/u><\/em><em><u>&lt;<\/u><\/em><em><u> 1\/100 ) :<\/u><\/em> Influenza, naspharyngitis, Anaemia, decreased appetite, Lethargy, paraesthesia, somnolence, tremor, syncope, dysgeusia, Conjunctivitis, eye pain, Vertigo, Palpitations, hypertension, flushing, Cough, dyspnoea, Dyspepsia, abdominal pain upper, abdominal pain, gastre-oesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis (Observed in patients taking concomitant glu-cocorticosteroids), Rash, hyperhydrosis, pruritus, erythema, Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, , musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness, Blood creatinine increased, pollakiuria, proteinuria, Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain, Blood calcium decreased<\/p><p><em><u>Rare (\u2265 1\/10000 to &lt; 1\/1000 )<\/u><\/em> <em><u>:<\/u><\/em> Hypophosphataemia, Uveitis, episcleritis, iritis, Atypical sub-trochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction and identified in post-marketing experience).<\/p><p><em><u>Very rare (&lt;1\/10,000):<\/u><\/em> Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).<\/p><p>Not known (cannot be estimated from the available data):Hypersensitivity reactions includ-ing rare cases of bronchospasm, urticaria and angioedema, and very rare cases of anaphy-lactic reaction\/shock, Scleritis and parophthalmia, Hypotension (some of the patients had underlying risk factors), Osteonecrosis of the jaw, Renal impairment(Rare cases of renal ailure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period), Dehydration secondary to acute phase reactions (post-dose symptoms such as pyrexia, vomiting and diarrhoea).<\/p><p><strong>Description of selected adverse reactions<\/strong><strong>.<\/strong><\/p><p><em><u>Atrial fibrillation<\/u><\/em><\/p><p>The mechanism behind the increased incidence of atrial is unknown<\/p><p><em><u>Class effects<\/u><\/em><em><u>:<\/u><\/em><\/p><p><em><u>Renal impairment<\/u><\/em><\/p><p>Zoledronic acid has been associated with renal impairment manifested as deterioration in renal function (i.e. increased serum creatinine) and in rare cases acute renal failure. Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, con-comitant diuretic therapy, severe dehydration), with the majority of them receiving a 4 mg dose every 3\u20134 weeks, but it has been observed in patients after a single administration. In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the Zoledronic Acid and placebo treatment groups over three years. There was a transient increase in<\/p><p>serum creatinine observed within 10 days in 1.8% of Zoledronic Acid-treated patients ver-sus 0.8% of placebo-treated patients.<\/p><p><em><u>Hypocalcaemia<\/u><\/em><\/p><p>In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol\/l) following Zoledronic Acid administration. No symptomatic cases of hypocalcaemia were observed.<\/p><p>In the Paget\u2019s disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.<\/p><p>Based on laboratory assessment, transient asymptomatic calcium levels below the nor-mal reference range (less than 2.10 mmol\/l) occurred in 2.3% of Zoledronic Acid-treated patients in a large clinical trial compared to 21% of Zoledronic Acid-treated patients in the Paget\u2019s disease trials. The frequency of hypocalcaemia was much lower following sub-sequent infusions.<\/p><p>All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget\u2019s disease trials. In the trial for the prevention of clinical fractures fol-lowing a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to Zoledronic Acid administration. Local reactions<\/p><p>In a large clinical trial, local reactions at the infusion site, such as redness, swelling and\/or pain, were reported (0.7%) following the administration of zoledronic acid.<\/p><p><strong><em>Osteonecrosis of the jaw<\/em><\/strong><\/p><p>Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid. In a large clinical trial in 7736 patients, osteonecrosis of jaw has been reported in one patient treated with zoledronic acid and one patient treated with placebo. Cases of ONJ have been reported in the post-marketing setting for zoledronic acid.<\/p><p><strong><em>Acute phase reactions<\/em><\/strong><\/p><p>The overall percentage of patients who reported acute phase reactions or post-dose symp-toms (including serious cases) after Zoledronic acid administration is as follows (frequen-cies derived from the study in treatment of post-menopausal osteoporosis): fever (18.1%), myalgia (9.4%) , flu-like symptoms (7.8%) , arthralgia (6.8%) and headache (6.5%), the majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms decreased with subsequent annual doses of Zoledronic acid. The percentage of patients who experienced adverse reactions was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used.<\/p><p>Reporting of suspected adverse reactions<\/p><p>Reporting suspected adverse reactions after authorisation of the medicinal product is im- portant. It allows continued monitoring of the benefit\/risk balance of the medicinal product. Please report<\/p><p>any adverse drug reactions via contacting Cedal Nano.(1)<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t<div class=\"the7-e-tab-item-wrapper\" data-tab=\"6\">\n\t\t\t\t\t<div class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"6\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-5236\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fab fa-confluence\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tDrug Interactions\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"the7-e-tab-content-5236\" class=\"the7-e-tab-content the7-e-tab-text-content\" data-tab=\"6\" role=\"tabpanel\" aria-labelledby=\"the7-e-tab-title-5236\" tabindex=\"0\" hidden=\"hidden\"><p>No interaction studies with other medicinal products have been performed. Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro. Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound medicinal products are therefore unlikely.<\/p><p>Zoledronic acid is eliminated by renal excretion. Caution is indicated when zoledronic acid is administered in conjunction with medicinal products that can significantly impact renal function (e.g. <em><u>aminoglycosides<\/u><\/em> or <em><u>diuretics<\/u><\/em> that may cause dehydration)<\/p><p>In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t<div class=\"the7-e-tab-item-wrapper\" data-tab=\"7\">\n\t\t\t\t\t<div class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"7\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-5237\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-baby\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\t Pregnancy and Lactation\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"the7-e-tab-content-5237\" class=\"the7-e-tab-content the7-e-tab-text-content\" data-tab=\"7\" role=\"tabpanel\" aria-labelledby=\"the7-e-tab-title-5237\" tabindex=\"0\" hidden=\"hidden\"><p><em><u>Women of childbearing potential<\/u><\/em><\/p><p>Zoledronic Acid is not recommended in women of childbearing potential.<\/p><p><strong>Pregnancy<\/strong><\/p><p>Zoledronic Acid is contraindicated during pregnancy. There are no adequate data on the use of zoledronic acid in pregnant women. Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations. The potential risk for humans is unknown.<\/p><p><strong>Breast-feeding<\/strong><\/p><p>Zoledronic Acid is contraindicated during breast-feeding. It is unknown whether zoledronic acid is excreted into human milk.<\/p><p><strong>Fertility<\/strong><\/p><p>Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation. This resulted in exaggerated pharmacological effects considered relat-ed to the compound\u2019s inhibition of skeletal calcium mobilisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study. Thus, these results precluded determining a definitive effect of Zoledronic Acid on fertility in humans.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t\t\t<div class=\"the7-e-tab-item-wrapper\" data-tab=\"8\">\n\t\t\t\t\t<div class=\"the7-e-tab-title\" aria-selected=\"false\" data-tab=\"8\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-5238\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t<span class=\"the7-e-tab-icon elementor-icon\" aria-hidden=\"true\"><i class=\"fas fa-box\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t<h5 class=\"the7-e-tab-title-text\">\n\t\t\t\t\t\t\tStorage Conditions\t\t\t\t\t\t<\/h5>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"the7-e-tab-content-5238\" class=\"the7-e-tab-content the7-e-tab-text-content\" data-tab=\"8\" role=\"tabpanel\" aria-labelledby=\"the7-e-tab-title-5238\" tabindex=\"0\" hidden=\"hidden\"><p><strong>Storage <\/strong><\/p><p><strong>&#8211;<\/strong>Store below 30\u00b0C.Protect from freezing.<\/p><p>&#8211; Store in original package in order to protect from light.<\/p><p>&#8211; The shelf life of Unopened bottle is 2 years.<\/p><p>&#8211; The shelf life after opening: From a microbiological point of view, the solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2\u00b0C-8\u00b0C. The refrigerated solution should then be equilibrated to room temperature prior to administration.<\/p><p>&#8211; Keep the product out of the sight and reach of children.<\/p><p><strong>Disposal and handling<\/strong><\/p><p><u>For single use only<\/u><u>.<\/u><\/p><p>Only clear solution free from particles and discoloration should be used.<\/p><p>If refrigerated, allow the refrigerated solution to reach room temperature before administra-tion. Aseptic techniques must be followed during the preparation of the infusion.<\/p><p>Any unused medicinal product or waste material should be disposed of in accordance with local requirements.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<span class=\"item-divider\" aria-hidden=\"true\"><\/span>\n\t\t\t\t\t<\/div>\n\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-24fbc36 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"24fbc36\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-5ae9a69\" data-id=\"5ae9a69\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ab4801a icon-box-vertical-align-center elementor-widget__width-auto elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile content-align-left icon-position-left icon-vertical-align-start elementor-widget elementor-widget-the7_icon_box_widget\" data-id=\"ab4801a\" data-element_type=\"widget\" data-widget_type=\"the7_icon_box_widget.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div class=\"the7-box-wrapper the7-elementor-widget the7_icon_box_widget-ab4801a\">\t\t\t<div class=\"box-content-wrapper\">\n\t\t\t\t\t\t\t\t<div class=\"box-content\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h4 class=\"box-heading\">\n\t\t\t\t\t\t\t<a href=\"\/wp-content\/uploads\/2023\/02\/5FUEnglish.docx\">\t\t\t\t\t\t\t\tProduct Description File\t\t\t\t\t\t\t<\/a>\t\t\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9499d2c elementor-share-buttons--view-icon elementor-share-buttons--skin-minimal elementor-share-buttons--shape-circle elementor-grid-mobile-6 elementor-share-buttons--align-left elementor-share-buttons--color-custom elementor-widget__width-auto elementor-grid-0 elementor-widget elementor-widget-share-buttons\" data-id=\"9499d2c\" data-element_type=\"widget\" data-widget_type=\"share-buttons.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-grid\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-grid-item\">\n\t\t\t\t\t\t<div\n\t\t\t\t\t\t\tclass=\"elementor-share-btn elementor-share-btn_twitter\"\n\t\t\t\t\t\t\trole=\"button\"\n\t\t\t\t\t\t\ttabindex=\"0\"\n\t\t\t\t\t\t\taria-label=\"Share on twitter\"\n\t\t\t\t\t\t>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-share-btn__icon\">\n\t\t\t\t\t\t\t\t<i class=\"fab fa-twitter\" aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-grid-item\">\n\t\t\t\t\t\t<div\n\t\t\t\t\t\t\tclass=\"elementor-share-btn elementor-share-btn_linkedin\"\n\t\t\t\t\t\t\trole=\"button\"\n\t\t\t\t\t\t\ttabindex=\"0\"\n\t\t\t\t\t\t\taria-label=\"Share on linkedin\"\n\t\t\t\t\t\t>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-share-btn__icon\">\n\t\t\t\t\t\t\t\t<i class=\"fab fa-linkedin\" aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-grid-item\">\n\t\t\t\t\t\t<div\n\t\t\t\t\t\t\tclass=\"elementor-share-btn elementor-share-btn_whatsapp\"\n\t\t\t\t\t\t\trole=\"button\"\n\t\t\t\t\t\t\ttabindex=\"0\"\n\t\t\t\t\t\t\taria-label=\"Share on whatsapp\"\n\t\t\t\t\t\t>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-share-btn__icon\">\n\t\t\t\t\t\t\t\t<i class=\"fab fa-whatsapp\" aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-grid-item\">\n\t\t\t\t\t\t<div\n\t\t\t\t\t\t\tclass=\"elementor-share-btn elementor-share-btn_telegram\"\n\t\t\t\t\t\t\trole=\"button\"\n\t\t\t\t\t\t\ttabindex=\"0\"\n\t\t\t\t\t\t\taria-label=\"Share on telegram\"\n\t\t\t\t\t\t>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-share-btn__icon\">\n\t\t\t\t\t\t\t\t<i class=\"fab fa-telegram\" aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-grid-item\">\n\t\t\t\t\t\t<div\n\t\t\t\t\t\t\tclass=\"elementor-share-btn elementor-share-btn_print\"\n\t\t\t\t\t\t\trole=\"button\"\n\t\t\t\t\t\t\ttabindex=\"0\"\n\t\t\t\t\t\t\taria-label=\"Share on print\"\n\t\t\t\t\t\t>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-share-btn__icon\">\n\t\t\t\t\t\t\t\t<i class=\"fas fa-print\" aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Generic Name Zoledronic acid Brand Name \u00aeAclaCedal Drug Class Bisphosphonate, Antiresorptive agent Dosage Form Zoledronic Acid 5 mg\/100ml solution for infusion Indications Contradications Warnings and Precautions Dosage &#038; Administration Adverse Reactions Drug Interactions Pregnancy and Lactation Storage Conditions Indications Zoledronic acid is indicated for: Treatment of osteoporosis \u00a0-in post-menopausal women \u00a0-in adult men at 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