{"id":14217,"date":"2021-09-27T07:13:41","date_gmt":"2021-09-27T07:13:41","guid":{"rendered":"https:\/\/zeepedia.com\/?p=14217"},"modified":"2022-12-30T10:01:55","modified_gmt":"2022-12-30T10:01:55","slug":"immunate","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/immunate\/","title":{"rendered":"Immunate &#8211; Coagulation Factor VIII Uses, Dose And Side Effects"},"content":{"rendered":"\n<p><strong>Immunate 500 IU, 250 IU, 1000 IU\u00a0powder and solvent for solution for injection or infusion<br>Coagulation factor\u00a0VIII<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Immunate Is And What It Is Used For<\/h2>\n\n\n\n<p>Immunate contains\u00a0coagulation factor\u00a0VIII, absent in people with\u00a0haemophilia\u00a0type A (congenital\u00a0factor VIII\u00a0deficiency), also called\u00a0haemophilia\u00a0.\u00a0Factor VIII\u00a0is important for the blood to coagulate.\u00a0Hemophilia\u00a0type A is an inherited blood disease characterized by bleeding that occurs spontaneously or due to a minor injury.<\/p>\n\n\n\n<p><span style=\"text-decoration: underline;\"><em>Immunate injection <\/em><\/span>is used in the treatment of and to prevent bleeding in people with\u00a0haemophilia\u00a0type A.<\/p>\n\n\n\n<p>Immunate can also be used to treat acquired (non-congenital)\u00a0factor VIII\u00a0deficiency.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What You Need To Know Before Using Immunate<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do Not Use Immunate<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are <a href=\"https:\/\/zeepedia.com\/medical\/diseases\/peanut-allergy-and-nut-allergy\/\">hypersensitive<\/a> (allergic) to the active substance or any of the other ingredients of Immunate.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings And Cautions<\/h2>\n\n\n\n<p>If you get allergic reactions or other\u00a0hypersensitivity reactions, e.g.\u00a0<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Skin rash (\u00a0hives\u00a0)<\/li><li>Pressure over the chest<\/li><li>Difficulty breathing<\/li><li>Dizziness or fainting should be discontinued immediately.\u00a0Contact your doctor immediately.\u00a0See also the section on &#8220;Side effects&#8221;.<\/li><\/ul>\n\n\n\n<p>The development of inhibitors (&nbsp;antibodies&nbsp;) is a known complication that may occur during treatment with any&nbsp;factor VIII&nbsp;drug.&nbsp;The inhibitors, especially at high levels, prevent the treatment from working properly.&nbsp;You or your child will be closely monitored for the development of such inhibitors.&nbsp;If you or your child suffers from bleeding that cannot be controlled with Immunate, tell your doctor immediately.<\/p>\n\n\n\n<p><em>Virus alert<\/em><\/p>\n\n\n\n<p>When medicines are made from human blood or\u00a0plasma,\u00a0special measures are taken to prevent the\u00a0transmission of\u00a0infection\u00a0to patients.\u00a0This includes carefully selecting blood and plasma donors to ensure that those at risk of carrying an\u00a0infection\u00a0are excluded and that each donation and plasma pool is tested for signs of virus\/infection.\u00a0The manufacturers of these products also include steps in managing blood and\u00a0plasma\u00a0that can inactivate or secrete\u00a0viruses.\u00a0Nevertheless, the risk of transmission of\u00a0infection\u00a0can not be completely ruled out when drugs made from human blood or\u00a0plasma\u00a0are given.\u00a0This also applies to new, hitherto unknown viruses\u00a0and other types of\u00a0infection.<\/p>\n\n\n\n<p>The measures taken are considered effective against enveloped\u00a0viruses\u00a0such as\u00a0HIV,\u00a0hepatitis\u00a0B, and\u00a0hepatitis\u00a0C, and for the non-enveloped\u00a0hepatitis\u00a0A\u00a0virus.\u00a0The measures may be of limited value against non-enveloped\u00a0viruses\u00a0such as parvovirus B19.<\/p>\n\n\n\n<p>Your doctor may suggest vaccination against&nbsp;hepatitis&nbsp;A and B if you are regularly \/ repeatedly treated with Immunate.<\/p>\n\n\n\n<p>Immunate contains blood group isoagglutinin (aggregates against blood groups A and B found naturally in people with blood group A, B, or AB).\u00a0In patients with blood groups A, B, or AB, the red\u00a0blood cells\u00a0may rupture (\u00a0hemolysis\u00a0) when the drug is given several times at short intervals or in very high\u00a0doses.<\/p>\n\n\n\n<p>You should note the name and batch number of Immunate at each treatment session.\u00a0This is important so that you can easily check which product kit you used.\u00a0The batch number label is on the vial and can be removed and pasted into the medical record document or equivalent treatment document.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other Drugs And Immunate<\/h2>\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, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n<p>As\u00a0haemophilia\u00a0type A is very rare in women, there is no experience with using Immunate during pregnancy and lactation.\u00a0It is, therefore, not known whether Immunate can cause birth defects.\u00a0Follow the instructions given to you by your doctor during pregnancy and breastfeeding.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving And Using Machines<\/h2>\n\n\n\n<p>There is no evidence that <strong>Immunate vial <\/strong>affects the ability to drive or use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Immunate Contains Sodium<\/h2>\n\n\n\n<p>250 IU and 500 IU: This medicine contains 9.8 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per\u00a0vial.\u00a0This corresponds to 0.5% of adults recommended daily sodium intake.<\/p>\n\n\n\n<p>1000 IU: This medicine contains 19.6 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per\u00a0vial.\u00a0This corresponds to 1% of adults recommended daily sodium intake.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How To Use Immunate<\/h2>\n\n\n\n<p>Immunate uses<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dosage\u00a0and treatment time is individual.\u00a0Follow the dosing instructions given to you by your doctor.<\/li><li>If you have the impression that the effect of Immunate is insufficient, consult your doctor.<\/li><li>Immunate should be given\u00a0intravenously\u00a0after reconstitution with the\u00a0diluent\u00a0provided\u00a0(water for injections).\u00a0Immunate should be injected slowly, and you should not exceed a rate of 2 ml\/min.<\/li><\/ul>\n\n\n\n<p><strong>Preparation\u00a0Of Solution:<\/strong><\/p>\n\n\n\n<p>Use aseptic technique<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>Heat the unopened bottle containing\u00a0diluent\u00a0(aqua ad iniect.) To room or body temperature (max. 37 \u00b0 C).<\/li><li>Remove the protective caps from the powder and water bottles (Fig. A) and\u00a0disinfect\u00a0both rubber stoppers.<\/li><li>Take the transfer needle and press its wavy edge on the water bottle (fig. B).<\/li><li>Remove the protective cover from the other end of the transfer needle without touching the free needle.<\/li><li>Turn the water bottle, transfer the needle upside down over the powder bottle, and insert the free needle through the centre of the rubber stopper, as far as possible, onto the powder bottle (Fig. C).\u00a0The water is sucked into the bottle with powder by vacuum.<\/li><li>After about one minute, separate the two bottles by removing the transfer needle connected to the water bottle from the powder bottle (Fig. D).\u00a0As the preparation dissolves easily, roll the bottle carefully a few turns so that the powder dissolves completely.\u00a0NOTE!\u00a0Do not shake the bottle.<\/li><li>The solution should be clear or slightly opalescent.\u00a0Do not use solutions that are cloudy, discoloured or\u00a0precipitate.<\/li><\/ol>\n\n\n\n<p><strong>Administration:<\/strong><\/p>\n\n\n\n<p>Use an aseptic technique.<\/p>\n\n\n\n<p><em>Injection:<\/em><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>To prevent particles from the rubber stopper from being transferred with the medicine, use the supplied filter needle.&nbsp;Attach the filter needle to the supplied disposable syringe and insert it through the rubber stopper (Fig. E).<\/li><li>Any&nbsp;foam&nbsp;disappears if the syringe is removed from the filter needle for a moment.<\/li><li>Withdraw the solution into the syringe via the filter needle (fig. F).<\/li><li>Remove the filter needle from the syringe and slowly inject the solution&nbsp;intravenously&nbsp;(maximum injection rate: 2 ml per minute) with the supplied &#8220;butterfly&#8221; needle (or with the disposable needle).<\/li><\/ol>\n\n\n\n<p><em>Infusion:<\/em><\/p>\n\n\n\n<p>A single-use infusion set with a suitable filter should be used if the solution is given as an infusion.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=19930630000072#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/Baxter20Medical20AB\/Media\/immunate5fimmunate.jpg\" alt=\"immunate\" title=\"immunate\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>Fig. A<\/td><td>Fig. B<\/td><td>Fig. C<\/td><td>Fig. D<\/td><td>Fig. E<\/td><td>Fig. F<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">If You Take More Immunate Than You Should<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>No symptoms of overdose are known.<\/li><li>Thromboembolic events may occur.<\/li><li>Hemolysis\u00a0(abnormally rapid degradation of\u00a0red blood cells\u00a0) may occur in patients with blood types A, B, or AB.<\/li><li>If you have ingested too much medicine or if, e.g.\u00a0If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">If You Forget To Take IMMUNATE<\/h2>\n\n\n\n<p>Do not take a double\u00a0dose\u00a0to make up for a\u00a0forgotten\u00a0dose.\u00a0Take the next\u00a0dose\u00a0as soon as possible and follow the regular dosing schedule.\u00a0Contact your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible Side Effects<\/h2>\n\n\n\n<p>Like all medicines, Immunate can cause&nbsp;side effects,&nbsp;although not everybody gets them.<\/p>\n\n\n\n<p>Allergic reactions or other\u00a0hypersensitivity reactions\u00a0may occur during treatment with Immunate (uncommon, may affect up to 1 in 100 people).\u00a0In some cases, severe allergic reactions (so-called\u00a0anaphylaxis\u00a0) and shock conditions have occurred.\u00a0Signs of such reactions may include <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Swelling of, e.g.\u00a0face, eyelids, tongue or throat<\/li><li>Hives<\/li><li>Itching<\/li><li>Difficulty breathing<\/li><li>Shortness of breath (due to narrowing of the trachea)<\/li><li>Difficulty swallowing<\/li><li>Burning and stinging sensation at the injection site<\/li><li>Chills<\/li><li>Skin redness<\/li><li>Headache<\/li><li>Rash<\/li><li>Low\u00a0blood pressure\u00a0(with symptoms such as <ul><li>Dizziness<\/li><li>Numbness<\/li><li>Fainting<\/li><\/ul><\/li><li><a href=\"https:\/\/zeepedia.com\/medical\/diseases\/fatigue-syndrome\/\">Fatigue<\/a><\/li><li>Nausea<\/li><li>Restlessness<\/li><li>Palpitations<\/li><li>Chest tightness<\/li><li>Chest <a href=\"https:\/\/zeepedia.com\/medical\/diseases\/brain-and-nerves\/pain\/\">pain<\/a><\/li><li>Tingling<\/li><li>Vomiting<\/li><\/ul>\n\n\n\n<p>If such symptoms occur, stop treatment immediately and contact your doctor immediately.<\/p>\n\n\n\n<p>In children who have not been\u00a0previously\u00a0treated with\u00a0factor VIII\u00a0drugs, inhibitory antibodies are very common to\u00a0develop (see section 2) (occurs in more than 1 in 10 patients).\u00a0However, for patients who have previously been treated with\u00a0factor VIII\u00a0(treatment for more than 150 days), the risk is less, and the complication is less common (it occurs in less than 1 in 100 users).\u00a0If you or your child develop\u00a0antibodies, the medicines may stop working properly, and you or your child may experience persistent bleeding.\u00a0If this happens, consult a doctor immediately.<\/p>\n\n\n\n<p><em><strong>Other&nbsp;side effects&nbsp;reported&nbsp;<\/strong><\/em><strong><em>after using Immunate (affects an unknown number of users)<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Restlessness<\/li><li>Irritating or stinging sensation in the skin (&nbsp;paresthesia&nbsp;)<\/li><li>Dizziness<\/li><li>Headache<\/li><li>Swelling of the eyelid<\/li><li>Fast heartbeat, palpitations<\/li><li>Low&nbsp;blood pressure<\/li><li>Hot flashing<\/li><li>Pallor<\/li><li>Shortness of breath (&nbsp;dyspnoea&nbsp;), <a href=\"https:\/\/zeepedia.com\/medical\/diseases\/cough-in-children\/\">cough<\/a><\/li><li>Vomiting, nausea<\/li><li>Hives&nbsp;(&nbsp;urticaria&nbsp;), rash,&nbsp;itching<\/li><li>Redness of the skin (&nbsp;erythema&nbsp;)<\/li><li>Excessive sweating (&nbsp;hyperhidrosis&nbsp;)<\/li><li>Muscle pain (&nbsp;myalgia&nbsp;)<\/li><li>Chest pain, chest discomfort<\/li><li>Edema&nbsp;(fluid retention)<\/li><li><a href=\"https:\/\/zeepedia.com\/medical\/diseases\/cold\/\">Fever<\/a>, chills<\/li><li>Burning and stinging sensation at the injection site<\/li><\/ul>\n\n\n\n<p>When the drug is given several times at short intervals or in very high&nbsp;doses, the red&nbsp;blood cells&nbsp;may rupture (&nbsp;hemolysis&nbsp;) in patients with blood types A, B, or AB.<\/p>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse if you get any side effects.\u00a0This also applies to any side effects not mentioned in this information.\u00a0You can also report side effects directly to the Medical Products Agency.\u00a0By reporting side effects, you can help increase drug safety information.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How To Store Immunate<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Keep out of sight and reach of children.<\/li><li>Store in a refrigerator (2 \u00b0 C-8 \u00b0 C).\u00a0Do not freeze.\u00a0(The bottle of water may burst.)<\/li><li>Do not use this medicine after the expiry date stated on the vial after EXP.\u00a0The expiration date is the last day of the specified month.<\/li><\/ul>\n\n\n\n<p><strong>Ready-made solution:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Immunate should be given within 3 hours after dissolution at 15 \u00b0 C &#8211; 25 \u00b0 C.<\/li><li>Any remaining solution should be discarded.<\/li><li>Do not use Immunate if you find that the solution is cloudy or has\u00a0precipitated.\u00a0The mixed solution should be inspected visually for particulate matter and discolouration before\u00a0administration.\u00a0The solution should be clear or slightly opalescent.<\/li><\/ul>\n\n\n\n<p>The medicine should not be disposed of via wastewater or household waste.\u00a0Ask your pharmacist how to dispose of medicines that are no longer required.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">6. Contents Of The Packaging And Other Information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content Declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is\u00a0coagulation factor\u00a0VIII<\/li><li>The other ingredients are albumin,\u00a0glycine, lysine hydrochloride, sodium chloride, trisodium citrate dihydrate, calcium chloride dihydrate and water for injections (\u00a0diluent\u00a0)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What The Medicine Looks Like And The Contents Of The Pack<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Immunate is a sterile, lyophilized concentrate of\u00a0coagulation factor\u00a0VIII.<\/li><li>Each pack contains a\u00a0vial\u00a0of powder (concentrate) in strengths of 250, 500, or 1000 IU and a\u00a0vial\u00a0of 5 ml, 5 ml, and 10 ml of\u00a0diluent,\u00a0respectively.\u00a0Also included is a kit for\u00a0preparation\u00a0and\u00a0injection\u00a0containing: a transfer\/filter needle, a disposable syringe, a disposable needle, and a butterfly needle.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder And Manufacturer<\/h2>\n\n\n\n<p>Baxalta Innovations GmbH<\/p>\n\n\n\n<p>Industriestrasse 67<\/p>\n\n\n\n<p>1221 Vienna, Austria<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Takeda Manufacturing Austria AG<\/p>\n\n\n\n<p>Industriestrasse 67<\/p>\n\n\n\n<p>1221 Vienna<\/p>\n\n\n\n<p>Austria<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Immunate is used to treat and prevent bleeding in congenital (haemophilia A) or acquired factor VIII deficiency.<\/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":[2200,12116],"tags":[13038,13044,13035,13040,13043,13039,13037,13042,13036,13041],"class_list":["post-14217","post","type-post","status-publish","format-standard","hentry","category-medicines","category-i","tag-benefits-of-coagulation-factor-viii","tag-benefits-of-immunate","tag-coagulation-factor-viii","tag-immunate","tag-immunate-side-effects","tag-side-effects-of-coagulation-factor-viii","tag-what-coagulation-factor-viii-is-used-for","tag-what-immunate-is-used-for","tag-what-is-coagulation-factor-viii","tag-what-is-immunate"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14217","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=14217"}],"version-history":[{"count":44,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14217\/revisions"}],"predecessor-version":[{"id":42075,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14217\/revisions\/42075"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=14217"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=14217"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=14217"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}