{"id":28079,"date":"2022-10-25T10:45:44","date_gmt":"2022-10-25T10:45:44","guid":{"rendered":"https:\/\/zeepedia.com\/?p=28079"},"modified":"2022-10-28T11:23:35","modified_gmt":"2022-10-28T11:23:35","slug":"veraseal","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/veraseal\/","title":{"rendered":"VeraSeal &#8211; Human fibrinogen\/Human thrombin uses, dose and side effects"},"content":{"rendered":"\n<p>solutions for tissue adhesives<br>human fibrinogen\/human thrombin<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What VeraSeal is and what it is used for<\/h2>\n\n\n\n<p>VeraSeal contains human fibrinogen and human thrombin, two\u00a0proteins\u00a0taken from the blood that form a\u00a0clot\u00a0(the blood clots) when mixed.<\/p>\n\n\n\n<p>VeraSeal is used as a tissue adhesive during surgical procedures on adults.&nbsp;It is applied to the surface of the bleeding&nbsp;tissue&nbsp;to reduce bleeding during and after surgery when standard surgical techniques are not enough.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before being treated with Veraseal<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Your surgeon must not treat you with VeraSeal:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to human fibrinogen or human thrombin or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<p>VeraSeal must not be applied inside blood vessels.<\/p>\n\n\n\n<p>VeraSeal must not be used to treat severe or profuse bleeding from an\u00a0artery.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Allergic reactions may occur.\u00a0Signs of such reactions may include hives, skin rash, chest tightness, wheezing, low\u00a0blood pressure\u00a0(which can cause dizziness, fainting, and blurred vision), and\u00a0anaphylaxis\u00a0(a serious reaction that comes on suddenly).\u00a0If such symptoms occur during an operation, the drug should be stopped immediately.<\/p>\n\n\n\n<p>The spray application of VeraSeal should only be used if it is possible to correctly judge the spray distance.\u00a0The spray unit must not be used closer to\u00a0tissue\u00a0than the recommended distance.<\/p>\n\n\n\n<p><strong>Special safety warning<\/strong><\/p>\n\n\n\n<p>In the case of medicines such as VeraSeal that are made from blood or blood plasma that has been donated from humans, certain measures are taken to prevent the transmission of\u00a0infection\u00a0to the patients.\u00a0This means, for example, that blood and plasma donors are carefully selected to ensure that no donors carry any\u00a0infection\u00a0and that both each donation and all collected\u00a0plasma\u00a0are tested to see that there are no signs of viruses\/infections.\u00a0Manufacturers also take various measures when\u00a0preparing\u00a0blood and\u00a0plasma\u00a0that can inactivate or remove\u00a0viruses.\u00a0Despite these measures, the risk of transmission of infectious agents cannot be completely ruled out when using medicines that have been made from human blood or\u00a0human\u00a0plasma.\u00a0This also applies to unknown or new\u00a0viruses\u00a0or other types of\u00a0infection.<\/p>\n\n\n\n<p>The measures taken are considered effective against enveloped\u00a0viruses, such as human immunodeficiency virus (\u00a0HIV\u00a0),\u00a0hepatitis\u00a0B\u00a0virus,\u00a0hepatitis\u00a0C\u00a0virus,\u00a0and the non-enveloped\u00a0hepatitis\u00a0A\u00a0virus\u00a0et.\u00a0The measures taken may be of limited value against non-enveloped\u00a0viruses, such as parvovirus B19.\u00a0Infection\u00a0with parvovirus B19 can be serious for pregnant women (fetal infection) and for people who have a weakened immune system or who have certain types of\u00a0anemia\u00a0(\u00a0blood deficiency\u00a0) (eg sickle cell disease or\u00a0hemolytic anemia).<\/p>\n\n\n\n<p>Each time you are treated with VeraSeal, we strongly recommend that you record the drug name and batch number to create a record of which batches have been used.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>VeraSeal is not recommended for children and adolescents under 18 years of age.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and VeraSeal<\/h2>\n\n\n\n<p>The medicine can be affected by contact with solutions containing alcohol, iodine, or heavy metals (eg antiseptic solutions).<\/p>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being treated with this medicine.\u00a0The doctor will decide if you can be treated with VeraSeal.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How VeraSeals are used<\/h2>\n\n\n\n<p>VeraSeal should only be used by specialist doctors who have received training in how to use VeraSeal.<\/p>\n\n\n\n<p>During the operation, the\u00a0surgeon\u00a0applies a VeraSeal to the surface of various blood vessels or the tissue surface of internal organs using an\u00a0applicator.\u00a0The applicator allows you to add an equal amount of the two components of VeraSeal at the same time and ensures that they are evenly mixed, which is important for the tissue adhesive to work as well as possible.<\/p>\n\n\n\n<p>The amount of VeraSeal that is applied depends on several different factors, e.g.\u00a0the type of operation, how large an area is treated during the operation, and how VeraSeal is applied.\u00a0A surgeon\u00a0decides how much is appropriate, and applies just enough to form a thin, even layer.\u00a0If it doesn&#8217;t seem to be enough, the\u00a0surgeon\u00a0can apply another layer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p>VeraSeal contains the components needed for fibrin glue.\u00a0Fibrin glue can rarely (in up to 1 in 1,000 users) cause an\u00a0allergic reaction.\u00a0If you have an\u00a0allergic reaction, you may have one or more of the following symptoms: swelling under the skin (\u00a0angioedema\u00a0), rash, hives or\u00a0urticaria\u00a0(\u00a0hives\u00a0), chest tightness, chills,\u00a0flushing, headache, low\u00a0blood pressure,\u00a0lethargy\u00a0(extreme tiredness\/ drowsiness), nausea, restlessness, increased\u00a0heart rate, tingling, vomiting or wheezing.\u00a0In rare cases, these reactions have developed into severe\u00a0allergic reactions.\u00a0Such reactions can occur in particular if the medicine is applied repeatedly or is used in patients who are known to be allergic to the ingredients in the product.\u00a0If you get any of these symptoms after the operation, you should immediately contact your doctor or\u00a0surgeon.<\/p>\n\n\n\n<p>There is also a theoretical risk that your immune system develops\u00a0antibodies\u00a0against the\u00a0proteins\u00a0in VeraSeal, which can interfere with the blood&#8217;s ability to\u00a0coagulate.\u00a0It is not known how often this occurs.<\/p>\n\n\n\n<p>If the medicine is accidentally applied to a blood vessel, it can lead to blood clots and disseminated intravascular\u00a0coagulation\u00a0(\u00a0DIC\u00a0) (when blood clots form in all the blood vessels of the body).\u00a0There is also a risk of a serious\u00a0allergic reaction.<\/p>\n\n\n\n<p>Side effects&nbsp;reported during&nbsp;clinical trials&nbsp;with VeraSeal were:<\/p>\n\n\n\n<p><strong>The most serious&nbsp;side&nbsp;effects<\/strong><\/p>\n\n\n\n<p>Uncommon (may affect up to 1 in 100 users):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>an abdominal abscess (swollen area in the abdomen caused by infection)<\/li><li>Abdominal wound rupture (the wound ruptures due to incomplete healing)<\/li><li>leakage of bile (a fluid produced in the liver) after surgery<\/li><li>cellulitis\u00a0(\u00a0infection\u00a0of the skin)<\/li><li>deep\u00a0vein thrombosis\u00a0(clots in the blood vessels)<\/li><li>a liver abscess (swollen area of \u200b\u200bthe liver caused by infection)<\/li><li>peritonitis\u00a0(\u00a0inflammation\u00a0of the peritoneum)<\/li><li>positive test for parvovirus B19 (laboratory tests show\u00a0infection\u00a0with the virus)<\/li><li>wound infection after surgery<\/li><li>pulmonary embolism\u00a0(blood clots in the vessels of the lungs)<\/li><li>wound infection.<\/li><\/ul>\n\n\n\n<p><strong>Other\u00a0side effects\u00a0are<\/strong><\/p>\n\n\n\n<p>Common (may affect up to 1 in 10 users):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>nausea<\/li><li>pain due to surgery<\/li><li>itching.<\/li><\/ul>\n\n\n\n<p>Uncommon (may affect up to 1 in 100 users):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>anemia\u00a0( lack of\u00a0blood, i.e. lack of red blood cells)<\/li><li>anxiety concern<\/li><li>atrial fibrillation\u00a0(irregular heartbeat)<\/li><li>back pain<\/li><li>bladder spasm<\/li><li>overindulge<\/li><li>conjunctival irritation (eye irritation)<\/li><li>constipation<\/li><li>bruise after injury<\/li><li>decreased urine production<\/li><li>dyspnea (difficulty breathing)<\/li><li>pain when urinating or difficulty urinating<\/li><li>bruise on the skin<\/li><li>erythema (redness of the skin)<\/li><li>intestinal gases<\/li><li>headache<\/li><li>fever<\/li><li>high or low blood pressure<\/li><li>high or low levels of\u00a0white blood cells\u00a0in the blood<\/li><li>high potassium levels in the blood<\/li><li>ileus\u00a0(intestine blockage)<\/li><li>impaired blood coagulation<\/li><li>skin redness at the site of the procedure<\/li><li>infection\u00a0at the site of the procedure<\/li><li>increased bilirubin content in the blood<\/li><li>the increased amount of liver enzymes<\/li><li>increased or decreased amount of\u00a0glucose\u00a0in the blood (blood sugar)<\/li><li>sleeping problems<\/li><li>low\u00a0blood pressure\u00a0due to the procedure<\/li><li>low calcium in the blood<\/li><li>low level of magnesium in the blood<\/li><li>low oxygen content in the blood<\/li><li>low level of potassium in the blood<\/li><li>low protein content in the blood<\/li><li>low\u00a0red blood cell count\u00a0due to blood loss<\/li><li>low blood sodium<\/li><li>fluid accumulation in the legs and feet<\/li><li>pain, unspecified<\/li><li>pain at the site of the procedure<\/li><li>pain in arms and legs<\/li><li>plasma cell myeloma (cancer of blood cells)<\/li><li>abnormal amount of fluid around the lungs<\/li><li>pleurisy<\/li><li>bleeding after surgery<\/li><li>infection\u00a0after surgery<\/li><li>pulmonary edema\u00a0(abnormal amount of fluid in the lungs)<\/li><li>accumulation of blood in the abdomen<\/li><li>Ronchi (abnormal breath sounds)<\/li><li>somnolence<\/li><li>urinary retention\u00a0(difficulty emptying the bladder)<\/li><li>the complication in the vascular graft (complication in bypass vessel)<\/li><li>thrombosis\u00a0in the vascular graft (blood clots in bypass vessels)<\/li><li>rapid heartbeat<\/li><li>bruise on the puncture site<\/li><li>vomiting<\/li><li>wheezing<\/li><li>oozing wounds.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store VeraSeal<\/h2>\n\n\n\n<p>VeraSeal must be stored out of the sight and reach of children.<\/p>\n\n\n\n<p>This medicine must be used before the expiry date which is stated on the label and the carton after EXP.<\/p>\n\n\n\n<p>The medicine must be stored in a deep-frozen state at -18 \u00b0C or colder.&nbsp;The frying chain must not be broken before use.&nbsp;Store the sterilized blister in the outer carton.&nbsp;Light sensitive.&nbsp;Allow the solution to thaw completely before use.&nbsp;Do not refreeze after thawing.&nbsp;After thawing, the medicine can be stored for a maximum of 48 hours at 2-8 \u00b0C or 24 hours at room temperature (20-25 \u00b0C) before use.<\/p>\n\n\n\n<p>Once the blister has been opened, VeraSeal should be used immediately.<\/p>\n\n\n\n<p>The medicine must not be used if the solutions are cloudy or contain particles.<\/p>\n\n\n\n<p>Discard the product if the packaging is damaged.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Contents declaration<\/h2>\n\n\n\n<p>The active substances are:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Component 1: human fibrinogen<\/li><li>Component 2: human thrombin<\/li><\/ul>\n\n\n\n<p>Other ingredients are:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Component 1: sodium citrate dihydrate, sodium chloride,\u00a0arginine, isoleucine, glutamic acid, monosodium, and water for injections.<\/li><li>Component 2: calcium chloride, human albumin, sodium chloride,\u00a0glycine, and water for injections.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>The preparation form for VeraSeal is solution for tissue glue.\u00a0It is supplied as a single-use kit with two pre-filled syringes mounted in a syringe holder.\u00a0The solutions are frozen.\u00a0After thawing, the solutions are clear or slightly opalescent and colorless or pale yellow.<\/p>\n\n\n\n<p>A double\u00a0applicator\u00a0with two additional airless spray tips is included with the product, which can be applied as a spray or drops.\u00a0The airless spray tips are radiopaque.\u00a0See the illustration below.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20161130000033#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/imaging\/resources\/33ee4815-3274-4927-9b6c-7afc60bea1c3\" alt=\"Prefilled syringe\" title=\"Prefilled syringe\"\/><\/a><\/figure>\n\n\n\n<p>VeraSeal is available in the following pack sizes:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>VeraSeal 2 ml (1 ml human fibrinogen and 1 ml human thrombin)<\/li><li>VeraSeal 4 ml (2 ml human fibrinogen and 2 ml human thrombin)<\/li><li>VeraSeal 6 ml (3 ml human fibrinogen and 3 ml human thrombin)<\/li><li>VeraSeal 10 ml (5 ml human fibrinogen and 5 ml human thrombin)<\/li><\/ul>\n\n\n\n<p>Not all pack sizes may be marketed.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing authorization holder and manufacturer<\/h2>\n\n\n\n<p>Instituto Grifols, SA<\/p>\n\n\n\n<p>Can Guasc, 2 &#8211; Parets del Vall\u00e8s E-08150 Barcelona<\/p>\n\n\n\n<p>Spain<\/p>\n\n\n\n<p>Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>AT\/BE\/BG\/CY\/EE\/EL\/ES\/HR\/HU\/IE\/LV\/ LT\/LU\/MT\/NL\/RO\/SI\/SK<\/strong>Instituto Grifols, SA Tel: +34 93 571 01 00<\/td><td><strong>CZ<\/strong>Grifols SROPhone: +4202 2223 1415<\/td><\/tr><tr><td><strong>THE<\/strong>Grifols Deutschland GmbH Tel: +49 69 660 593 100<\/td><td><strong>DK\/FI\/IS\/NO\/SE<\/strong>Grifols Nordic AB Tel: +46 8 441 89 50<\/td><\/tr><tr><td><strong>FR<\/strong>Johnson &amp; Johnson Medical SAS Tel: +33 (0)1 55 00 22 33<\/td><td><strong>IT<\/strong>Grifols Italia SpA Tel: +39 050 8755 113<\/td><\/tr><tr><td><strong>PL<\/strong>Grifols Polska Sp.&nbsp;z o. o. Phone: +48 22 378 85 60<\/td><td><strong>PT<\/strong>Grifols Portugal, Lda.&nbsp;Phone: +351 219 255 200<\/td><\/tr><tr><td><strong>UK<\/strong>Grifols UK Ltd.Phone: +44 845 2413090<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>VeraSeal contains human fibrinogen and human thrombin, two\u00a0proteins\u00a0taken from blood that form a\u00a0clot\u00a0(the blood clots) when mixed.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,22502],"tags":[2932,2936,25961,27294,27287,27289,27291,27293,27290,27292,27286,27288],"class_list":["post-28079","post","type-post","status-publish","format-standard","hentry","category-medicines","category-v","tag-human-fibrinogen","tag-human-fibrinogen-side-effects","tag-human-thrombin","tag-human-thrombin-side-effects","tag-veraseal","tag-veraseal-side-effects","tag-what-human-fibrinogen-is-used-for","tag-what-human-thrombin-is-used-for","tag-what-is-human-fibrinogen","tag-what-is-human-thrombin","tag-what-is-veraseal","tag-what-veraseal-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/28079","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=28079"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/28079\/revisions"}],"predecessor-version":[{"id":28472,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/28079\/revisions\/28472"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=28079"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=28079"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=28079"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}