{"id":1565,"date":"2019-02-26T00:00:00","date_gmt":"2019-02-25T22:00:00","guid":{"rendered":"http:\/\/interchem.epicstation.com\/news\/informacionnoe-obraschenie-otnositelno-preparata-amispiron-%d0%86s\/"},"modified":"2019-02-26T00:00:00","modified_gmt":"2019-02-25T22:00:00","slug":"informacionnoe-obraschenie-otnositelno-preparata-amispiron-Is","status":"publish","type":"news","link":"https:\/\/interchem.ua\/en\/news\/informacionnoe-obraschenie-otnositelno-preparata-amispiron-Is\/","title":{"rendered":"Information appeal regarding to the drug Amispiron IC"},"content":{"rendered":"<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\">The Pharmacovigilance Risk Assessment Committee EMA (PRAC) <a href=\"https:\/\/www.ema.europa.eu\/documents\/referral\/fenspiride-containing-medicinal-products-article-107i-referral-suspension-fenspiride-medicines-due_en.pdf\">recommended&nbsp;temporarily<\/a> <span lang=\"en-US\"><span>to stop <\/span><\/span>us<span lang=\"en-US\"><span>ing<\/span><\/span><span lang=\"en-US\"><span>drugs containing fenspiride<\/span><\/span>.<\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>Suspension is a precautionary measure to protect patients during PRAC review of evidence of the risk of prolonged QT interval and torsades de pointes (disturbances in the electrical activity of the heart, which may lead to disturbances in the heart rhythm).<\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\">On the basis of PRAC data and in accordance <span lang=\"en-US\"><span>to<\/span><\/span> the legislation of Ukraine, the <span lang=\"en-US\"><span>State Drugs and Medication Central Service<\/span><\/span> of Ukraine <a href=\"http:\/\/portal.dls.gov.ua\/PublicSite\/QLA\/Download.ashx?sid=2&amp;fid=40068226796\">temporarily <span lang=\"en-US\"><span>stop<\/span><\/span> the sale and use<\/a> of all series of <span lang=\"en-US\"><span>drugs which<\/span><\/span> contain the active substance fenspiride,<\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><em><span>including,<\/span><\/em><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><em><span>AMISPIRON \u0406\u0421, long-acting tablets of 0.08 g \u211610 and \u211620, production of &#8220;INTERCHEM&#8221; <\/span><span lang=\"en-US\"><span>SLC<\/span><\/span><span>, Ukraine,<\/span><\/em><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>until the end of the PRAC audit and the decision of the European Medicines Agency (EMA) on the conditions for the continuation or withdrawal of a marketing <span lang=\"en-US\">authorisation<\/span> for the circulation of medicines containing fenspiride.<\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>According to the <span lang=\"en-US\">State Drugs and Medication Central Service<\/span> of Ukraine in identifying samples of this medicinal product, the company must take measures to:<\/span><\/span><\/span><\/span><\/p>\n<ul>\n<li>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>withdrawal from circulation by placing in quarantine;<\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>informing the territorial body of the State Service on the location regarding the implementation of this order;<\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span><span style=\"color: #000000;\"><span><span lang=\"uk-UA\"><span><span><span>prevent the purchase, sale and use of the medicinal product listed in this order.<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p lang=\"zxx\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span lang=\"en-US\"><strong>Links<\/strong><\/span><\/span><\/span><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\">: <\/p>\n<p><\/span><\/span><span><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span><span lang=\"ru-RU\"><span><span><span>1)&nbsp;<a href=\"https:\/\/www.ema.europa.eu\/documents\/referral\/fenspiride-containing-medicinal-products-article-107i-referral-suspension-fenspiride-medicines-due_en.pdf\">https:\/\/www.ema.europa.eu\/documents\/referral\/fenspiride-containing-medicinal-products-article-107i-referral-suspension-fenspiride-medicines-due_en.pdf<\/a><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p lang=\"ru-RU\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\">2)&nbsp;<a href=\"http:\/\/portal.dls.gov.ua\/PublicSite\/QLA\/Download.ashx?sid=2&amp;fid=40068226796\">http:\/\/portal.dls.gov.ua\/PublicSite\/QLA\/Download.ashx?sid=2&amp;fid=40068226796<\/a><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\">&nbsp;<\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><strong><span>Information for patients<\/span><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>While authorities review all the evidence, patients are advised to stop taking th<\/span><span lang=\"en-US\"><span>is<\/span><\/span><span> medicines.<\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>If you are taking a cough medicine containing fenspiride, contact your doctor or pharmacist for<\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>advice on alternative treatments, if needed.<\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>If you have any concerns about your medicine, discuss them with your doctor or pharmacist. <\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><strong><span>Information for healthcare professionals<\/span><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>As a precaution and while the review is ongoing, healthcare professionals should advise their<\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>patients to stop taking fenspiride medicines.<\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>Healthcare professionals will be informed in writing about the suspension, and further information<\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>will be provided as needed and once the review has concluded.<\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p align=\"center\">&nbsp;<\/p>\n<p lang=\"uk-UA\" align=\"center\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span lang=\"en-US\"><span>T<\/span><\/span><span>he authorized person on pharmacovigilance of the company<\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"center\"><span style=\"color: #000000;\"><span> <span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\">Margarita Filonenk<span lang=\"en-US\">o<\/span><\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"center\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>050-356-36-56 (round the clock), 097-690-98-50<\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"center\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>0482-34-08-04 (Marketing Department)<\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"center\"><span style=\"color: #000000;\"><span style=\"font-family: 'Times New Roman', serif;\"><span style=\"font-size: small;\"><span>filonenko@interchem.com.ua<\/span><\/span><\/span><\/span><\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-1565","news","type-news","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - 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