{"id":18846,"date":"2022-02-24T16:29:32","date_gmt":"2022-02-24T16:29:32","guid":{"rendered":"https:\/\/zeepedia.com\/?p=18846"},"modified":"2022-02-25T12:08:43","modified_gmt":"2022-02-25T12:08:43","slug":"neohepatect","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/neohepatect\/","title":{"rendered":"Neohepatect &#8211; Human hepatitis B immunoglobulin uses, dose and side effects"},"content":{"rendered":"\n<p>50 IU \/ ml&nbsp;solution for&nbsp;infusion<br>human&nbsp;hepatitis&nbsp;B immunoglobulin for&nbsp;intravenous&nbsp;administration<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Neohepatect is and what it is used for<\/h2>\n\n\n\n<p>Neohepatect contains the active substance human\u00a0hepatitis\u00a0B immunoglobulin, which may protect you from\u00a0hepatitis\u00a0B. Hepatitis B is an\u00a0inflammation\u00a0of the liver caused by the\u00a0hepatitis\u00a0B\u00a0virus.\u00a0Neohepatect is a solution for\u00a0infusion\u00a0(in a vein) and is supplied in vials containing 2 ml (100 International Units [IU]), 10 ml (500 IU), 40 ml (2,000 IU), and 100 ml (5,000 IU).<\/p>\n\n\n\n<p>Neohepatect is used to provide immediate and long-lasting immunity (protection):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>to prevent&nbsp;hepatitis&nbsp;B&nbsp;infection&nbsp;in patients who have not been vaccinated or who do not have adequate vaccination protection against&nbsp;hepatitis&nbsp;B, and who are at risk of developing a&nbsp;hepatitis B&nbsp;infection .<\/li><li>to prevent&nbsp;infection&nbsp;in a transplanted liver in patients who show positive tests for hepatitis B.<\/li><li>in newborns whose mothers are infected with the&nbsp;hepatitis&nbsp;B&nbsp;virus&nbsp;.<\/li><li>to protect patients who have not received adequate protection from hepatitis B vaccination<\/li><\/ul>\n\n\n\n<p>Human\u00a0hepatitis\u00a0B immunoglobulin contained in Neohepatect may also be approved for the treatment of other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you use Neohepatect<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Neohepatect<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6).&nbsp;<\/li><li>if you have immunoglobulin A (&nbsp;IgA&nbsp;) deficiency, especially if you have&nbsp;antibodies&nbsp;to&nbsp;IgA&nbsp;, as it may lead to&nbsp;anaphylaxis&nbsp;(severe&nbsp;allergic reaction&nbsp;).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p><strong>Talk to your doctor, pharmacist, or nurse before using\u00a0Neohepatect if you<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>have not received this medicine before or it has been a long time (eg several weeks) since you last received it (you must be closely monitored during the&nbsp;infusion&nbsp;one and for one hour after the end of the&nbsp;infusion&nbsp;)<\/li><li>recently received Neohepatect (you must be monitored during&nbsp;infusion&nbsp;one and at least 20 minutes after&nbsp;infusion&nbsp;one)<\/li><li>have an untreated&nbsp;infection&nbsp;or an underlying&nbsp;chronic&nbsp;inflammationhave had a reaction to other&nbsp;antibodies&nbsp;(in rare cases you may be at risk of allergic reactions)<\/li><li>have or have had a kidney disease<\/li><li>have been given medicines that can damage your kidneys (if your kidney function deteriorates, treatment with Neohepatect may need to be stopped).<\/li><\/ul>\n\n\n\n<p>Your doctor should take extra care if you are overweight, elderly, diabetic, or have high\u00a0blood pressure, if you have low blood volume (\u00a0hypovolemia\u00a0), or if your blood is thicker than normal (high blood viscosity) if you have been bedridden or immobile (immobile). for a long time or if you have problems with the blood vessels (vascular diseases) or if you have another risk factor for thrombotic events (blood clots).<\/p>\n\n\n\n<p><strong>Note &#8211; reactions<\/strong><\/p>\n\n\n\n<p>You will be closely monitored during the time you receive&nbsp;an infusion&nbsp;of Neohepatect to ensure that you do not get any reaction (eg&nbsp;anaphylaxis&nbsp;).&nbsp;Your doctor will check that Neohepatect is given as&nbsp;an infusion&nbsp;at a rate that suits you.<\/p>\n\n\n\n<p>If you notice any of the following signs of a reaction, ie.\u00a0headache,\u00a0flushing, chills, muscle aches, tingling, rapid heartbeat, low back pain, nausea, low\u00a0blood pressure\u00a0during\u00a0infusion\u00a0one with Neohepatect, you should tell your doctor immediately.\u00a0The infusion rate can be reduced or the\u00a0infusion\u00a0can be stopped completely.<\/p>\n\n\n\n<p><strong>Information on the transmission of infectious substances<\/strong><\/p>\n\n\n\n<p>Neohepatect is made from&nbsp;human&nbsp;plasma&nbsp;(the liquid part of the blood).<\/p>\n\n\n\n<p>When medicines are made from human blood or\u00a0plasma, certain measures are taken to prevent the transmission of\u00a0infection\u00a0to patients.\u00a0These include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>careful selection of blood and plasma donors to ensure that people at risk of being infected are excluded<\/li><li>testing of individual donations and plasma pools for signs of viruses \/ infections<\/li><li>introduction of steps in&nbsp;the preparation of&nbsp;one of the blood or plasma that can inactivate or secrete&nbsp;viruses&nbsp;.<\/li><\/ul>\n\n\n\n<p>Despite these measures, the risk of transmitting\u00a0infection\u00a0can not be completely ruled out when\u00a0administering\u00a0medicinal products derived from human blood or\u00a0plasma.\u00a0This also applies to new, hitherto unknown\u00a0viruses\u00a0and other types of\u00a0infection.<\/p>\n\n\n\n<p>The measures taken are considered effective for enveloped\u00a0viruses\u00a0such as human immunodeficiency virus (\u00a0HIV\u00a0),\u00a0hepatitis\u00a0B\u00a0virus,\u00a0and\u00a0hepatitis\u00a0C\u00a0virus.<\/p>\n\n\n\n<p>The measures taken may have limited value against&nbsp;uncovered viruses&nbsp;such as&nbsp;hepatitis&nbsp;A&nbsp;virus&nbsp;and parvovirus B19.<\/p>\n\n\n\n<p>Immunoglobulins have not been associated with\u00a0hepatitis\u00a0A or parvovirus B19\u2011\u00a0infections, possibly because\u00a0antibodies\u00a0to these\u00a0infections, which are present in the product, have a protective effect.<\/p>\n\n\n\n<p>When you are given Neohepatect, it is recommended that the product name and batch number be registered to enable the tracking of the product used.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Neohepatect<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.<\/p>\n\n\n\n<p>Neohepatect may reduce the effectiveness of certain vaccines, eg:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>measles<\/li><li>rubella<\/li><li>mumps<\/li><li>chicken-pox<\/li><\/ul>\n\n\n\n<p>You may have to wait up to three months before you can get certain vaccines and up to a year before you can get the measles vaccine.<\/p>\n\n\n\n<p>Do not use loop&nbsp;diuretics&nbsp;with Neohepatect.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding and fertility<\/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>Your doctor will decide if Neohepatect can be used during pregnancy and breastfeeding.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Neohepatect has little effect on the ability to drive and use machines.&nbsp;If you have experienced&nbsp;side effects&nbsp;during treatment, wait until they have subsided before driving or using machines.<\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Neohepatect<\/h2>\n\n\n\n<p>Neohepatect is for&nbsp;intravenous&nbsp;administration&nbsp;(&nbsp;infusion&nbsp;into a vein).&nbsp;You get it from a doctor or a nurse.&nbsp;The recommended&nbsp;dose&nbsp;depends on your condition and your body weight.&nbsp;The doctor knows how much to take.<\/p>\n\n\n\n<p>At the beginning of\u00a0infusion, Neohepatect is administered slowly.\u00a0The doctor can then gradually increase the infusion rate.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or nurse.<\/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><strong>The following&nbsp;side effects&nbsp;have been reported during&nbsp;clinical trials&nbsp;with Neohepatect:<\/strong><\/p>\n\n\n\n<p><strong>No known frequency (can not be calculated from the available data)<\/strong>&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>severe&nbsp;allergic reaction&nbsp;(anaphylactic&nbsp;shock&nbsp;)<\/li><li>hypersensitivity reaction&nbsp;er<\/li><li>headache<\/li><li>dizziness<\/li><li>fast heartbeat (&nbsp;tachycardia&nbsp;)<\/li><li>low&nbsp;blood pressure&nbsp;(&nbsp;hypotension&nbsp;)<\/li><li>nausea<\/li><li>Skin reactions such as rash,&nbsp;itching<\/li><li>fever<\/li><li>feeling sick<\/li><\/ul>\n\n\n\n<p><strong>Preparations containing human normal immunoglobulin generally cause the following&nbsp;side effects&nbsp;(&nbsp;<\/strong><strong>in decreasing frequency):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain, low&nbsp;blood pressure&nbsp;, moderate low back pain<\/li><li>decreased number of&nbsp;red blood cells&nbsp;due to their degradation in the blood vessels ([reversible] haemolytic reactions) and (rare)&nbsp;haemolytic anemia&nbsp;requiring&nbsp;blood transfusion<\/li><li>(rare) a sudden drop in blood pressure and, in rare cases, anaphylactic&nbsp;shock<\/li><li>(rare) transient skin reactions (including&nbsp;cutaneous&nbsp;lupus erythematosus &#8211; no known frequency)<\/li><li>(very rare) thromboembolic reactions such as myocardial infarction (&nbsp;myocardial infarction&nbsp;),&nbsp;stroke&nbsp;, blood clots in the blood vessels of the lungs (&nbsp;pulmonary embolism&nbsp;),blood clots in a vein (deep&nbsp;vein thrombosis&nbsp;)<\/li><li>case of transient&nbsp;acute&nbsp;inflammation&nbsp;of the protective&nbsp;membrane&nbsp;surrounding the brain and spinal cord (&nbsp;meningitis&nbsp;)<\/li><li>blood test results indicating renal impairment and \/ or sudden&nbsp;renal failure<\/li><li>cases of transfusion-related&nbsp;acute&nbsp;lung injury (TRALI).&nbsp;This leads to an accumulation of fluid in the air spaces of the lungs that is not due to heart problems (non-cardiogenic&nbsp;pulmonary edema&nbsp;).&nbsp;You have severe shortness of breath (difficulty breathing), rapid breathing (tachypnea), abnormally low oxygen levels in the blood (&nbsp;hypoxia&nbsp;) and elevated body temperature (fever).<\/li><\/ul>\n\n\n\n<p>If a\u00a0side effect\u00a0occurs, the infusion rate is reduced or the\u00a0infusion\u00a0is stopped.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Neohepatect<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton and vial label.<\/p>\n\n\n\n<p>Keep the vial in the outer carton.&nbsp;Sensitive to light.&nbsp;Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).&nbsp;Do not freeze.<\/p>\n\n\n\n<p>The solution should be clear or slightly opalescent and colorless to light yellow.\u00a0Do not use solutions that are cloudy or contain\u00a0a precipitate.<\/p>\n\n\n\n<p>The solution should be administered immediately after opening the container.&nbsp;The medicine must have reached room or body temperature before use.<\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the package 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 in Neohepatect is human&nbsp;hepatitis&nbsp;B immunoglobulin for&nbsp;intravenous&nbsp;administration&nbsp;.<br>Neohepatect contains 50 mg \/ ml human&nbsp;plasma protein&nbsp;, of which at least 96% is immunoglobulin G (IgG).&nbsp;The content of&nbsp;hepatitis&nbsp;B&nbsp;antibody&nbsp;is 50 IU \/ ml.&nbsp;The maximum immunoglobulin A (&nbsp;IgA&nbsp;) content is 2000 micrograms \/ ml.&nbsp;The distribution of subgroups of IgG is approx.<br>59% IgG1, 35% IgG2, 3% IgG3, 3% IgG4.<\/li><li>The other ingredients are&nbsp;glycine&nbsp;and water for injections.&nbsp;<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Neohepatect is a solution for\u00a0infusion.\u00a0The solution is clear to slightly opal shimmering (milk-colored like an opal) and colorless to light yellow.<\/p>\n\n\n\n<p>Pack size: 1\u00a0vial\u00a0with 2 ml, 10 ml, 40 ml, or 100 ml solution.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Biotest Pharma GmbH<\/p>\n\n\n\n<p>Landsteinerstrasse 5<\/p>\n\n\n\n<p>63303 Three<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p>Tel .: + 49 6103 801-0<\/p>\n\n\n\n<p>Fax: + 49 6103 801-150<\/p>\n\n\n\n<p>Email: mail@biotest.com<\/p>\n\n\n\n<p>Local representative:<\/p>\n\n\n\n<p>Unimedic Pharma AB<br>Box 6216<br>SE-102 34 Stockholm<br>Tel: +46 8 130 99 50<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Neohepatect contains the active substance human hepatitis B immunoglobulin, which may protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus . Neohepatect is a solution for infusion (in a vein) and is supplied in vials containing 2 ml (100 International Units [IU]), 10 ml (500 IU), 40 ml (2,000 IU) and 100 ml (5,000 IU) .<\/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":[2200,15581],"tags":[18764,18769,18760,18763,18765,18768,18762,18761,18766,18767],"class_list":["post-18846","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-human-hepatitis-b-immunoglobulin","tag-benefits-of-neohepatect","tag-human-hepatitis-b-immunoglobulin","tag-human-hepatitis-b-immunoglobulin-side-effects","tag-neohepatect","tag-neohepatect-side-effects","tag-what-human-hepatitis-b-immunoglobulin-is-used-for","tag-what-is-human-hepatitis-b-immunoglobulin","tag-what-is-neohepatect","tag-what-neohepatect-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18846","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=18846"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18846\/revisions"}],"predecessor-version":[{"id":18908,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18846\/revisions\/18908"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=18846"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=18846"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=18846"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}