\n\nsolutions for tissue adhesives
human fibrinogen, human thrombin<\/p>\n\n\n\n
EVICEL is a human fibrin glue, which is supplied in packs containing two separate bottles, each containing 1 ml, 2 ml, or 5 ml solution (human fibrinogen and human thrombin, respectively).
<\/p>\n\n\n\n
An applicator and suitable accessory tips are supplied separately.
<\/p>\n\n\n\n
Fibrinogen is a concentrate of coagulable protein and thrombin is an enzyme that causes the coagulable protein to coagulate. Therefore, when the two components are mixed, they coagulate instantly.
<\/p>\n\n\n\n
EVICEL is used in adults during surgery to reduce bleeding and leakage during and after surgery.
<\/p>\n\n\n\n
EVICEL can be used for vascular surgery and surgery on the posterior abdominal wall. EVICEL can also be used to support a watertight closure of the meninges (dura mater) in neurosurgery when other surgical techniques are insufficient.
<\/p>\n\n\n\n
It is dripped or sprayed on cut tissue, where it forms a thin layer that seals tissue and\/or stops bleeding.
<\/p>\n\n\n\n
Life-threatening air or gas embolism has occurred when using spray devices that use a pressure regulator to apply EVICEL. The occurrence seems to be related to the fact that the spray device was used with a pressure above the recommended and\/or very close to the tissue surface. Spray application of EVICEL should only be used if it is possible to make a correct assessment of the spray distance, especially during laparoscopy. Spray distance from tissue and pressure must be within the intervals recommended by the manufacturer (see the table in the section Instructions for use). When spraying EVICEL, monitor any changes in blood pressure, heart rate, oxygenation, and end-time CO 2<\/sub>as there is a risk that air or gas embolism may occur. Spray devices and accessory tips provide operating instructions with recommendations for pressure range and proximity to the tissue surface, which must be followed carefully. The measures taken in the manufacture of fibrinogen and thrombin are considered to be effective for viruses with a lipid envelope, such as human immunodeficiency virus ( HIV ), hepatitis B virus and hepatitis C virus, and hepatitis A virus without an envelope. The measures taken may have limited value against parvovirus B19. Parvovirus B19 infection can be serious in pregnant women (fetal infection) and in people whose immune systems are impaired or who have certain types of anemia (eg sickle cell anemia or hemolytic anemia ). Healthcare professionals will register the name of the medicine and the batch number to be able to trace a possible source of infection.<\/p>\n\n\n\n There are insufficient data to confirm the safety and efficacy of EVICEL in children and adolescents.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n There is not enough information available to know if there are any specific risks associated with the use of EVICEL during pregnancy or breast-feeding. However, as EVICEL is used during a surgical procedure, you should discuss the general risks of the operation with your doctor if you are pregnant or breast-feeding. Your doctor will administer EVICEL while you are having surgery. During the operation, the doctor will drip or spray EVICEL on the operating tissue with the help of an applicator. The applicator makes it possible to administer an equal amount of EVICEL’s two components at the same time, and ensures that they are evenly mixed, which is important for the adhesive to have an optimal effect. The amount of EVICEL that will be applied depends on the area of \u200b\u200bthe tissue surface to be treated during the operation. It will be dropped on tissue one in very small amounts or sprayed in short bursts (0.1-0.2 ml) to give a thin, even layer. If the application of a single layer of EVICEL does not stop the bleeding completely, a second layer can be applied.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. The following adverse reactions that occurred during clinical trials were considered to be related to the use of EVICEL: The most serious adverse reaction was<\/em><\/p>\n\n\n\n If you get any of the above symptoms or any other symptoms associated with your surgery, contact your doctor or surgeon immediately. If you do not feel well, tell your doctor immediately, even if the symptoms are different from those just described. Other side effects are<\/em><\/p>\n\n\n\n Other side effects that have been reported are common in clinical trials with EVICEL, ie. may occur in up to 1 in 10 users) including meningitis, and accumulation of CSV fluid in the brain cavity ( hydrocephalus ). The frequency of all these effects was common.<\/strong> Adverse reactions that were uncommon during clinical trials with EVICEL (ie may occur in up to 1 in 100 users) included infection, blood clotting (hematoma), swelling, decreased hemoglobin, and postoperative wound complications (including bleeding or infection ). EVICEL is a fibrin glue. Fibrin glue in general can, in rare cases (up to 1 patient in 1,000 users) cause allergic reactions. If you suffer from an allergic reaction, you may have one or more of the following symptoms: skin rash, hives or hives, pressure over the chest, chills, redness, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting or wheezing breath. No allergic reactions have been reported so far in patients treated with EVICEL. There is also a theoretical possibility that you may develop antibodies to the proteins in EVICEL, which may interfere with blood coagulation. The frequency of this type of event is not known (cannot be determined with available data). Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The bottles must be stored upright. Store in a freezer at -18 \u00b0 C or colder. Store the bottles in the outer carton. Sensitive to light. Do not freeze again. After thawing, unopened bottles can be stored at 2 \u00b0 C \u2011 8 \u00b0 C and protected from light for up to 30 days, without being re-frozen during this time. The new expiration date at 2 \u00b0 C \u2011 8 \u00b0 C should be noted on the carton, but should not exceed the expiration date printed by the manufacturer on the carton and label. At the end of this period, the medicine must be used or discarded. The fibrinogen and thrombin components are stable at room temperature for up to 24 hours. EVICEL must not be placed in the refrigerator after it has reached room temperature. Once drawn up in the applicator, they must be used immediately. Discard unused product after 24 hours at room temperature.<\/p>\n\n\n\n The active substances are as follows: Component 1: Human coagulable protein-containing mainly fibrinogen and fibronectin (50-90 mg\/ml)<\/p>\n\n\n\n Component 2: Human thrombin (800\u20131,200 IU \/ ml) Other ingredients are: Component 1: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, and water for injections.<\/p>\n\n\n\n Component 2: calcium chloride, human albumin, mannitol, sodium acetate, and water for injections.<\/p>\n\n\n\n Pack sizes<\/em> EVICEL is a human fibrin glue, which is delivered in a package containing two separate glass bottles, each containing 1 ml, 2 ml, or 5 ml of human fibrinogen and human thrombin, respectively. EVICEL is available in the following pack sizes: 2 x 1 ml, 2 x 2 ml and 2 x 5 ml. Not all pack sizes may be marketed in all countries. An applicator and suitable accessory tips are supplied separately.<\/p>\n\n\n\n Omrix Biopharmaceuticals NV<\/p>\n\n\n\n Leonardo Da Vinci Avenue 15<\/p>\n\n\n\n B-1831 Diegem<\/p>\n\n\n\n Belgium<\/p>\n\n\n\n Tel: + 32 2 746 30 00<\/p>\n\n\n\n Fax: + 32 2 746 30 01 Manufacturer<\/strong> Omrix Biopharmaceuticals Ltd<\/p>\n\n\n\n Plasma Fractionation Institute<\/p>\n\n\n\n Sheba Hospital, Tel Hashomer<\/p>\n\n\n\n Ramat Gan 5262000, Israel<\/p>\n\n\n\n Tel: + 972-3-5316512<\/p>\n\n\n\n Fax: + 972-3-5316590<\/p>\n\n\n\n <\/p>\n","protected":false},"excerpt":{"rendered":" solutions for tissue adhesives
<\/p>\n\n\n\n
<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and EVICEL<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use EVICEL<\/h2>\n\n\n\n
<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n5. How to store EVICEL<\/h2>\n\n\n\n
<\/p>\n\n\n\n
The expiration date is the last day of the specified month.
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nWhat EVICEL looks like and the contents of the pack<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nMarketing Authorisation Holder<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
\nhuman fibrinogen, human thrombin<\/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":[2205,2200],"tags":[3415,3417,3418,3416,3419,3422,3423,3420,2507,2212],"class_list":["post-8516","post","type-post","status-publish","format-standard","hentry","category-e","category-medicines","tag-evicel","tag-evicel-dose","tag-evicel-side-effects","tag-evicel-uses","tag-fibrin-sealant","tag-fibrin-sealant-dose","tag-fibrin-sealant-side-effects","tag-fibrin-sealant-uses","tag-liquid","tag-medicine"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8516","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=8516"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8516\/revisions"}],"predecessor-version":[{"id":10063,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8516\/revisions\/10063"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=8516"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=8516"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=8516"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}